11–14–00 Tuesday Vol. 65 No. 220 Nov. 14, 2000 Book 1 of 2 Books Pages 68065–68260

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1 II Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000

The FEDERAL REGISTER is published daily, Monday through SUBSCRIPTIONS AND COPIES Friday, except official holidays, by the Office of the Federal Register, National Archives and Records Administration, PUBLIC Washington, DC 20408, under the Federal Register Act (44 U.S.C. Subscriptions: Ch. 15) and the regulations of the Administrative Committee of Paper or fiche 202–512–1800 the Federal Register (1 CFR Ch. I). The Superintendent of Assistance with public subscriptions 512–1806 Documents, U.S. Government Printing Office, Washington, DC 20402 is the exclusive distributor of the official edition. General online information 202–512–1530; 1–888–293–6498 Single copies/back copies: The Federal Register provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 512–1800 Federal agencies. These include Presidential proclamations and Assistance with public single copies 512–1803 Executive Orders, Federal agency documents having general FEDERAL AGENCIES applicability and legal effect, documents required to be published Subscriptions: by act of Congress, and other Federal agency documents of public interest. Paper or fiche 523–5243 Assistance with Federal agency subscriptions 523–5243 Documents are on file for public inspection in the Office of the Federal Register the day before they are published, unless the issuing agency requests earlier filing. For a list of documents currently on file for public inspection, see http://www.nara.gov/ fedreg. The seal of the National Archives and Records Administration authenticates the Federal Register as the official serial publication established under the Federal Register Act. Under 44 U.S.C. 1507, the contents of the Federal Register shall be judicially noticed. The Federal Register is published in paper and on 24x microfiche. It is also available online at no charge as one of the databases on GPO Access, a service of the U.S. Government Printing Office. The online edition of the Federal Register is issued under the authority of the Administrative Committee of the Federal Register as the official legal equivalent of the paper and microfiche editions (44 U.S.C. 4101 and 1 CFR 5.10). It is updated by 6 a.m. each day the Federal Register is published and it includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. GPO Access users can choose to retrieve online Federal Register documents as TEXT (ASCII text, graphics omitted), PDF (Adobe Portable Document Format, including full text and all graphics), or SUMMARY (abbreviated text) files. Users should carefully check retrieved material to ensure that documents were properly downloaded. On the World Wide Web, connect to the Federal Register at http:/ /www.access.gpo.gov/nara. Those without World Wide Web access can also connect with a local WAIS client, by Telnet to swais.access.gpo.gov, or by dialing (202) 512-1661 with a computer and modem. When using Telnet or modem, type swais, then log in as guest with no password. For more information about GPO Access, contact the GPO Access User Support Team by E-mail at [email protected]; by fax at (202) 512–1262; or call (202) 512–1530 or 1–888–293–6498 (toll free) between 7 a.m. and 5 p.m. Eastern time, Monday–Friday, except Federal holidays. The annual subscription price for the Federal Register paper edition is $638, or $697 for a combined Federal Register, Federal Register Index and List of CFR Sections Affected (LSA) subscription; the microfiche edition of the Federal Register including the Federal Register Index and LSA is $253. Six month subscriptions are available for one-half the annual rate. The charge for individual copies in paper form is $9.00 for each issue, or $9.00 for each group of pages as actually bound; or $2.00 for each issue in microfiche form. All prices include regular domestic postage and handling. International customers please add 25% for foreign handling. Remit check or money order, made payable to the Superintendent of Documents, or charge to your GPO Deposit Account, VISA, MasterCard or Discover. Mail to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250–7954. There are no restrictions on the republication of material appearing in the Federal Register. How To Cite This Publication: Use the volume number and the page number. Example: 65 FR 12345.

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2 III

Contents Federal Register Vol. 65, No. 220

Tuesday, November 14, 2000

Agricultural Marketing Service Drug Enforcement Administration NOTICES NOTICES Dry whey; standards, 68120 Applications, hearings, determinations, etc.: Stepan Co., 68158 Agricultural Research Service NOTICES Education Department Meetings: NOTICES Agricultural Biotechnology Advisory Committee, 68120– Grants and cooperative agreements; availability, etc.: 68121 Postsecondary Education Improvement Fund, 68130– 68131 Agriculture Department See Agricultural Marketing Service Employment and Training Administration See Agricultural Research Service NOTICES See Animal and Plant Health Inspection Service Agency information collection activities: See Farm Service Agency Proposed collection; comment request, 68159–68160 Meetings: Alcohol, Tobacco and Firearms Bureau Native American Employment and Training Council, NOTICES 68160–68161 Senior Executive Service: Performance Review Board; membership, 68170 Energy Department Animal and Plant Health Inspection Service See Federal Energy Regulatory Commission NOTICES RULES Natural gas exportation and importation: Interstate transportation of animals and animal products Fina Natural Gas Co. et al., 68131–68132 (quarantine): Brucellosis in cattle and bison— State and area classifications, 68065 Engineers Corps NOTICES Army Department Environmental statements; availability, etc.: See Engineers Corps Williamson and Johnson Counties, IL; new municipal NOTICES water supply reservoir, 68129 Patent licenses; non-exclusive, exclusive, or partially exclusive: Environmental Protection Agency Laminated textile substrate for body heating or cooling RULES garment, manufacturing method, etc., 68128–68129 Air quality implementation plans; approval and Load securing and releasing system, 68129 promulgation; various States: New Hampshire, 68078–68082 Arts and Humanities, National Foundation PROPOSED RULES See National Foundation on the Arts and the Humanities Air quality implementation plans; approval and promulgation; various States: Centers for Disease Control and Prevention California, 68111–68119 NOTICES New Hampshire, 68111 Organization, functions, and authority delegations: NOTICES Program Services Office et al., 68144–68150 Meetings: Clean Air Act Advisory Committee, 68133 Commerce Department Reports and guidance documents; availability, etc.: See International Trade Administration State/local/Tribal rules submission in place of Section 112 hazardous air pollutant requirements, 68133 Water quality criteria: Commission of Fine Arts Ambient water quality criteria— NOTICES Methylmercury; reference dose document, 68133– Grants and cooperative agreements; availability, etc.: 68134 National Capital Arts and Cultural Affairs Program, 68128

Defense Department Executive Office of the President See Army Department See Trade Representative, Office of United States See Engineers Corps Farm Service Agency Defense Nuclear Facilities Safety Board NOTICES NOTICES Agency information collection activities: Meetings; Sunshine Act, 68129–68130 Proposed collection; comment request, 68121

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Federal Aviation Administration Health Care Financing Administration RULES See Inspector General Office, Health and Human Services Airworthiness directives: Department Aerospatiale, 68076–68077 Bombardier, 68072–68074 Inspector General Office, Health and Human Services British Aerospace, 68074–68076 Department CFE Co., 68077–68078 NOTICES Eurocopter France, 68071–68072 Program exclusions; list, 68153–68156 McDonnell Douglas, 68067–68069 Raytheon, 68069–68071 Interior Department SOCATA-Groupe AEROSPATIALE, 68065–68067 See Fish and Wildlife Service See Land Management Bureau Federal Bureau of Investigation See Minerals Management Service NOTICES NOTICES Meetings: Central Utah Water Conservancy District: DNA Advisory Board, 68158–68159 Sanpete County Water Conservancy District et al.; agreement negotiations, 68156 Federal Communications Commission RULES International Trade Administration Television broadcasting: NOTICES Satellite Home Viewer Improvement Act; Antidumping: implementation— Pure magnesium from— Network nonduplication, syndicated exclusivity, and Various countries, 68121–68125 sports blackout rules; application to satellite Countervailing duties: retransmissions, 68082–68107 Industrial phosphoric acid from— Federal Energy Regulatory Commission Israel, 68126 NOTICES Pure magnesium from— Applications, hearings, determinations, etc.: Israel, 68126–68128 Alcoa Power Generating, Inc., 68132 Distrigas of Massachusetts LLC, 68132 International Trade Commission San Diego Gas & Electric Co., 68132–68133 NOTICES Import investigations: Federal Reserve System India; possible modifications to General System of NOTICES Preferences with respect to certain products; advice, Banks and bank holding companies: 68157–68158 Formations, acquisitions, and mergers, 68134–68135 Meetings; Sunshine Act, 68135 Justice Department See Drug Enforcement Administration Federal Trade Commission See Federal Bureau of Investigation NOTICES Premerger notification waiting periods; early terminations, Labor Department 68135–68144 See Employment and Training Administration See Occupational Safety and Health Administration Fine Arts Commission See Commission of Fine Arts Land Management Bureau Fish and Wildlife Service NOTICES Opening of public lands: NOTICES Meetings: Nevada, 68156–68157 Aquatic Nuisance Species Task Force, 68156 Minerals Management Service Food and Drug Administration NOTICES NOTICES Territorial Submerged Lands Act; boundary determinations Reports and guidance documents; availability, etc.: and submerged lands jurisdictions: HACCP records pertaining to safe and sanitary processing U.S. Virgin Islands, including St. Thomas, St. John, and of fish and fishery products; inspection or access St. Croix, 68157 refusal, 68150–68151 Medical devices— National Aeronautics and Space Administration Drugs of abuse; over the counter screening tests; NOTICES premarket notifications, 68151–68152 Patent licenses; non-exclusive, exclusive, or partially Prescription use drugs of abuse assays premarket exclusive: notifications, 68152–68153 Concepts ETI Inc., 68161–68162 Cullimore & Ring Technologies, Inc., 68162 Health and Human Services Department See Centers for Disease Control and Prevention National Foundation on the Arts and the Humanities See Food and Drug Administration NOTICES See Inspector General Office, Health and Human Services Meetings: Department Combined Arts Advisory Panel, 68162

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National Highway Traffic Safety Administration State Department RULES NOTICES Civil monetary penalties; inflation adjustment, 68108– Art objects; importation for exhibition: 68110 Egypt in the Walters Art Gallery, 68166 Motor vehicle safety standards: Unseen Treasures: Imperial Russia and the New World, Occupant crash protection— 68166 Future air bags designed to create less risk of serious Grants and cooperative agreements; availability, etc.: injuries for small women and young children, etc.; Central and East Europe and New Independent States technical workshop, 68107–68108 Research and Training Program, 68166–68169 Nuclear Regulatory Commission Tennessee Valley Authority NOTICES Meetings: NOTICES Nuclear Waste Advisory Committee, 68163–68164 Meetings; Sunshine Act, 68169–68170 Applications, hearings, determinations, etc.: Consumers Energy Co., 68162–68163 Thrift Supervision Office First Energy Operating Co., 68163 NOTICES Agency information collection activities: Occupational Safety and Health Administration Proposed collection; comment request, 68170–68171 RULES Occupational safety and health standards: Trade Representative, Office of United States Ergonomics Program, 68261–68870 NOTICES NOTICES Meetings: Meetings: Trade and Environment Policy Advisory Committee, Occupational Safety and Health National Advisory 68170 Committee, 68161 Office of United States Trade Representative Transportation Department See Trade Representative, Office of United States See Federal Aviation Administration See National Highway Traffic Safety Administration Public Health Service See Centers for Disease Control and Prevention Treasury Department See Food and Drug Administration See Alcohol, Tobacco and Firearms Bureau See Thrift Supervision Office Securities and Exchange Commission NOTICES Intermarket Trading System; plan amendments, 68165– 68166 Separate Parts In This Issue Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC; correction, 68172 Part II National Association of Securities Dealers, Inc.; Labor Department, Occupational Safety and Health correction, 68172 Administration, 68261–68870 Applications, hearings, determinations, etc.: Public utility holding company filings, 68164–68165 Social Security Administration Reader Aids NOTICES Consult the Reader Aids section at the end of this issue for Agency information collection activities: phone numbers, online resources, finding aids, reminders, Submission for OMB review; comment request, 68166 and notice of recently enacted public laws.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

9 CFR 78...... 68065 14 CFR 39 (8 documents) ...... 68065, 68067, 68069, 68071, 68072, 68074, 68076, 68077 29 CFR 1910...... 68262 40 CFR 52...... 68078 Proposed Rules: 52 (3 documents) ...... 68111, 68114 47 CFR 73...... 68082 76...... 68082 49 CFR 571...... 68107 578...... 68108 592...... 68108

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Rules and Regulations Federal Register Vol. 65, No. 220

Tuesday, November 14, 2000

This section of the FEDERAL REGISTER Comments on the interim rule were SUMMARY: This amendment adopts a contains regulatory documents having general required to be received on or before new airworthiness directive (AD) that applicability and legal effect, most of which October 2, 2000. We did not receive any applies to all SOCATA—Groupe are keyed to and codified in the Code of comments. Therefore, for the reasons AEROSPATIALE (Socata) Models MS Federal Regulations, which is published under given in the interim rule, we are 50 titles pursuant to 44 U.S.C. 1510. 880B, MS 885, MS 892A–150, MS 892E– adopting the interim rule as a final rule. 150, MS 893A, MS 893E, MS 894A, MS The Code of Federal Regulations is sold by This action also affirms the 894E, Rallye 100S, Rallye 150T, Rallye the Superintendent of Documents. Prices of information contained in the interim 150ST, Rallye 235C, and Rallye 235E new books are listed in the first FEDERAL rule concerning Executive Order 12866 airplanes. This AD requires you to REGISTER issue of each week. and the Regulatory Flexibility Act, repetitively inspect, and, if necessary, Executive Orders 12372 and 12988, and replace elevator clevis and rudder the Paperwork Reduction Act. DEPARTMENT OF AGRICULTURE Further, for this action, the Office of governor control clevis that are too thin. Management and Budget has waived the This AD is the result of mandatory Animal and Plant Health Inspection review process required by Executive continuing airworthiness information Service Order 12866. (MCAI) issued by the airworthiness authority for France. The actions 9 CFR Part 78 List of Subjects in 9 CFR Part 78 specified in this AD are intended to Animal diseases, Bison, Cattle, Hogs, correct rudder and elevator control [Docket No. 99±052±2] Quarantine, Reporting and clevis that are too thin because of Brucellosis in Cattle; State and Area recordkeeping requirements, abnormal wear, with consequent failure Classifications; Louisiana Transportation. of the rudder and elevator clevis. Such failure could lead to loss of directional AGENCY: Animal and Plant Health PART 78ÐBRUCELLOSIS or pitch control. Inspection Service, USDA. Accordingly, we are adopting as a DATES: This AD becomes effective on ACTION: Affirmation of interim rule as final rule, without change, the interim December 29, 2000. final rule. rule that amended 9 CFR part 78 and The Director of the Federal Register that was published at 65 FR 47653– SUMMARY: We are adopting as a final 47654 on August 3, 2000. approved the incorporation by reference rule, without change, an interim rule of certain publications listed in the that amended the regulations Authority: 21 U.S.C. 111–114a–1, 114g, regulations as of December 29, 2000. concerning the interstate movement of 115, 117, 120, 121, 123–126, 134b, and 134f; cattle by changing the classification of 7 CFR 2.22, 2.80, and 371.4. ADDRESSES: You may get the service Louisiana from Class A to Class Free. Done in Washington, DC, this 6th day of information referenced in this AD from We have determined that Louisiana November 2000 . SOCATA Groupe AEROSPATIALE, meets the standards for Class Free Bobby R. Acord, Customer Support, Aerodrome Tarbes- status. The interim rule relieved certain Acting Administrator, Animal and Plant Ossun-Lourdes, BP 930—F65009 Tarbes restrictions on the interstate movement Health Inspection Service. Cedex, France; telephone: (33) of cattle from Louisiana. [FR Doc. 00–29025 Filed 11–13–00; 8:45 am] (0)5.62.41.73.00; facsimile: (33) EFFECTIVE DATE: The interim rule BILLING CODE 3410±34±P (0)5.62.41.76.54; or the Product Support became effective on July 27, 2000. Manager, SOCATA—Groupe AEROSPATIALE, North Perry Airport, FOR FURTHER INFORMATION CONTACT: Dr. Valerie Ragan, Senior Staff Veterinarian, DEPARTMENT OF TRANSPORTATION 7501 Pembroke Road, Pembroke Pines, Florida 33023; telephone: (954) 894- National Animal Health Programs, VS, Federal Aviation Administration APHIS, 4700 River Road Unit 43, 1160; facsimile: (954) 964–4191. You may examine this information at the Riverdale, MD 20737–1231; (301) 734– 14 CFR Part 39 7708. Federal Aviation Administration (FAA), Central Region, Office of the Regional SUPPLEMENTARY INFORMATION: [Docket No. 2000±CE±34±AD; Amendment 39±11964; AD 2000±22±17] Counsel, Attention: Rules Docket No. Background RIN 2120±AA64 2000–CE–34–AD, 901 Locust, Room In an interim rule effective July 27, 506, Kansas City, Missouri 64106; or at 2000, and published in the Federal Airworthiness Directives; SOCATAÐ the Office of the Federal Register, 800 Register on August 3, 2000 (65 FR Groupe AEROSPATIALE Models MS North Capitol Street, NW, suite 700, 47653–47654, Docket No. 99–052–1), we 880B, MS 885, MS 892A±150, MS 892E± Washington, DC. 150, MS 893A, MS 893E, MS 894A, MS amended the brucellosis regulations in FOR FURTHER INFORMATION CONTACT: Karl 894E, Rallye 100S, Rallye 150T, Rallye 9 CFR part 78 by removing Louisiana Schletzbaum, Aerospace Engineer, FAA, from the list of Class A States in 150ST, Rallye 235C, and Rallye 235E Airplanes Small Airplane Directorate, 901 Locust, § 78.41(b) and adding it to the list of Room 301, Kansas City, Missouri 64106; Class Free States in § 78.41(a). That AGENCY: Federal Aviation telephone: (816) 329–4146; facsimile: action relieved certain restrictions on Administration, DOT. (816) 329–4090. the interstate movement of cattle from ACTION: Final rule. Louisiana. SUPPLEMENTARY INFORMATION:

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Discussion would apply to all Socata Models MS presented above, we have determined 880B, MS 885, MS 892A–150, MS 892E– What Events Have Caused This AD? that air safety and the public interest ´ ´ 150, MS 893A, MS 893E, MS 894A, MS require the adoption of the rule as The Direction Generale de l’Aviation 894E, Rallye 100S, Rallye 150T, Rallye proposed except for minor editorial Civile (DGAC), which is the 150ST, Rallye 235C, and Rallye 235E corrections. We determined that these airworthiness authority for France, airplanes. This proposal was published minor corrections: recently notified the FAA that an unsafe in the Federal Register as a notice of condition may exist on all Socata proposed rulemaking (NPRM) on —Will not change the meaning of the Models MS 880B, MS 885, MS 892A– September 11, 2000 (65 FR 54820). The AD; and 150, MS 892E–150, MS 893A, MS 893E, NPRM proposed to require you to —Will not add any additional burden MS 894A, MS 894E, Rallye 100S, Rallye repetitively inspect the elevator and upon the public than was already 150T, Rallye 150ST, Rallye 235C, and rudder governor control clevis, and, if proposed. Rallye 235E airplanes. The DGAC necessary, replace any clevis that is too reports one failure of the rudder clevis thin. Cost Impact in a Rallye airplane in flight. Abnormal wear of the part resulted in the failure. Was the Public Invited To Comment? How Many Airplanes Does This AD Impact? What Happens if You Do Not Correct Interested persons were afforded an the Condition? opportunity to participate in the making We estimate that this AD affects 81 of this amendment. No comments were airplanes in the U.S. registry. This condition, if not corrected, could received on the proposed rule or the result in failure of the rudder and FAA’s determination of the cost to the What Is the Cost Impact of This AD on elevator clevis and consequent loss of public. Owners/Operators of the Affected directional or pitch control. Airplanes? The FAA’s Determination Has FAA Taken Any Action to This Point? What Is FAA’s Final Determination on We estimate the following costs to This Issue? accomplish each inspection and We issued a proposal to amend part possible replacement and lubrication: 39 of the Federal Aviation Regulations After careful review of all available (14 CFR part 39) to include an AD that information related to the subject

Total cost on U.S. Labor cost Parts cost Total cost per airplane airplane operators

4 workhours $60 per hour = $240 .. $24 per airplane if clevis replace- $264 per airplane ...... $264 × 81 = $21,384. ment is necessary.

These actions are repetitive. We have Flexibility Act. A copy of the final (a) What airplanes are affected by this AD? no way of determining how many of evaluation prepared for this action is This AD affects the following airplane these repetitive actions each owner/ contained in the Rules Docket. A copy models, all serial numbers, certificated in any operator may incur over the life of each of it may be obtained by contacting the category: airplane. Rules Docket at the location provided MS 880B under the caption ADDRESSES. MS 892E–150 Regulatory Impact MS 894A List of Subjects in 14 CFR Part 39 Does This AD Impact Various Entities? Rallye 150T Rallye 235E The regulations adopted herein will Air transportation, Aircraft, Aviation MS 885 not have a substantial direct effect on safety, Incorporation by Reference, MS 893A the States, on the relationship between Safety. MS 894E the national government and the States, Adoption of the Amendment Rallye 150ST or on the distribution of power and MS 892A–150 responsibilities among the various Accordingly, under the authority delegated to me by the Administrator, MS 893E levels of government. Therefore, it is Rallye 100S the Federal Aviation Administration determined that this final rule does not Rallye 235C have federalism implications under amends part 39 of the Federal Aviation Executive Order 13132. Regulations (14 CFR part 39) as follows: (b) Who must comply with this AD? Anyone who wishes to operate any of the Does This AD Involve a Significant Rule PART 39ÐAIRWORTHINESS above airplanes must comply with this AD. or Regulatory Action? DIRECTIVES (c) What problem does this AD address? For the reasons discussed above, I The actions specified by this AD are intended 1. The authority citation for part 39 to correct rudder clevis and elevator control certify that this action (1) is not a continues to read as follows: clevis that are too thin because of abnormal ‘‘significant regulatory action’’ under wear, and the consequent failure of the Executive Order 12866; (2) is not a Authority: 49 U.S.C. 106(g), 40113, 44701. rudder and elevator clevis. Such failure ‘‘significant rule’’ under DOT § 39.13 [Amended] could lead to loss of directional or pitch Regulatory Policies and Procedures (44 control. 2. FAA amends § 39.13 by adding a FR 11034, February 26, 1979); and (3) (d) What actions must I accomplish to new AD to read as follows: will not have a significant economic address this problem? To address this impact, positive or negative, on a 2000–22–17 Socata—Groupe Aerospatiale: problem, you must accomplish the following substantial number of small entities Amendment 39–11964; Docket No. actions: under the criteria of the Regulatory 2000–CE–34–AD.

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Actions Compliance times Procedures

(1) Inspect the elevator and rudder control clev- Within the next 100 hours time-in-service Do this inspection in accordance with the AC- is for abnormal wear. Measure clevis thick- (TIS) after December 29, 2000 (the effec- COMPLISHMENT INSTRUCTIONS of ness. The thickness at the bent section tive date of this AD), and thereafter at inter- Socata Mandatory Service Bulletin SB 155± should be at least 0.043 inch (in)/1.1 milli- vals not to exceed 600 hours TIS. 27, dated April 2000. meter (mm). (2) If, during inspection, the elevator or rudder Before further flight after the inspection where Do this section in accordance with the AC- control clevis measures a thickness less than abnormal wear was found. COMPLISHMENT INSTRUCTIONS of 0.043 in/1.1 mm, replace the clevis. Socata Mandatory Service Bulletin SB 155± 27, dated April 2000. (3) Lubricate the clevis ...... Within the next 100 hours TIS after December Do this action in accordance with the AC- 29, 2000 (the effective date with the of this COMPLISHMENT INSTRUCTIONS of AD), and thereafter at intervals not to ex- Socata Mandatory Service Bulletin SB 155± ceed 100 hours TIS. 27, dated April 2000.

(e) Can I comply with this AD in any other Federal Register, 800 North Capitol Street, outboard flap idler hinge fitting due to way? You may use an alternative method of NW, suite 700, Washington, DC. fatigue cracking, which could result in compliance or adjust the compliance time if: (i) When does this amendment become a deflected flap that may cause an (1) Your alternative method of compliance effective? This amendment becomes effective asymmetric lift and consequent reduced provides an equivalent level of safety; and on December 29, 2000. controllability and structural integrity of (2) The Manager, Small Airplane Note 2: The subject of this AD is addressed Directorate, approves your alternative. in French AD number 2000–174(A), dated the airplane. This action is intended to Submit your request through an FAA May 3, 2000. address the identified unsafe condition. Principal Maintenance Inspector, who may DATES: Effective November 29, 2000. add comments and then send it to the Issued in Kansas City, Missouri, on The incorporation by reference of October 30, 2000. Manager, Small Airplane Directorate. certain publications listed in the Note 1: This AD applies to each airplane Marvin R. Nuss, regulations is approved by the Director identified in paragraph (a) of this AD, Acting Manager, Small Airplane Directorate, of the Federal Register as of November regardless of whether it has been modified, Aircraft Certification Service. 29, 2000. altered, or repaired in the area subject to the [FR Doc. 00–28439 Filed 11–13–00; 8:45 am] requirements of this AD. For airplanes that Comments for inclusion in the Rules BILLING CODE 4910±13±P have been modified, altered, or repaired so Docket must be received on or before that the performance of the requirements of January 16, 2001. this AD is affected, the owner/operator must DEPARTMENT OF TRANSPORTATION ADDRESSES: Submit comments in request approval for an alternative method of triplicate to the Federal Aviation compliance in accordance with paragraph (e) Federal Aviation Administration Administration (FAA), Transport of this AD. The request should include an Airplane Directorate, ANM–114, assessment of the effect of the modification, alteration, or repair on the unsafe condition 14 CFR Part 39 Attention: Rules Docket No. 2000–NM– addressed by this AD; and, if you have not 344–AD, 1601 Lind Avenue, SW., [Docket No. 2000±NM±344±AD; Amendment Renton, Washington 98055–4056. eliminated the unsafe condition, specific 39±11968; AD 2000±22±20] actions you propose to address it. Comments may be inspected at this (f) Where can I get information about any RIN 2120±AA64 location between 9 a.m. and 3 p.m., already-approved alternative methods of Monday through Friday, except Federal compliance? You can contact Karl Airworthiness Directives; McDonnell holidays. Comments may be submitted Schletzbaum, Aerospace Engineer, FAA, Douglas Model DC±9±10, ±9±20, ±9±30, via fax to (425) 227–1232. Comments Small Airplane Directorate, 901 Locust, ±9±40, and ±9±50 Series Airplanes and may also be sent via the Internet using Room 301, Kansas City, Missouri 64016; C±9 (Military) Airplanes the following address: 9-anm- telephone: (816) 329–4146; facsimile: (816) 329–4090. AGENCY: Federal Aviation [email protected]. Comments sent (g) What if I need to fly the airplane to Administration, DOT. via fax or the Internet must contain another location to comply with this AD? The ACTION: Final rule; request for ‘‘Docket No. 2000–NM–344–AD’’ in the FAA can issue a special flight permit under comments. subject line and need not be submitted sections 21.197 and 21.199 of the Federal in triplicate. Comments sent via the Aviation Regulations (14 CFR 21.197 and SUMMARY: This amendment adopts a Internet as attached electronic files must 21.199) to operate your airplane to a location new airworthiness directive (AD) that is be formatted in Microsoft Word 97 for where you can accomplish the requirements applicable to certain McDonnell Windows or ASCII text. of this AD. (h) Are any service bulletins incorporated Douglas Model DC–9–10, –9–20, –9–30, The service information referenced in into this AD by reference? Actions required –9–40, and –9–50 series airplanes and this AD may be obtained from Boeing by this AD must be done in accordance with C–9 (military) airplanes. This action Commercial Aircraft Group, Long Socata Mandatory Service Bulletin SB 155– requires, among other actions, Beach Division, 3855 Lakewood 27, dated April, 2000. The Director of the measuring the diameter of the hole Boulevard, Long Beach, California Federal Register approved this incorporation counterbore of the outboard idler hinge 90846, Attention: Technical by reference under 5 U.S.C. 552(a) and 1 CFR fitting of the left and right wing flap; Publications Business Administration, part 51. You can get copies from SOCATA performing repetitive high frequency Dept. C1–L51 (2–60). This information Groupe AEROSPATIALE, Customer Support, eddy current inspections (HFEC) to may be examined at the FAA, Transport Aerodrome Tarbes-Ossun-Lourdes, BP 930— F65009 Tarbes Cedex, France; telephone: (33) detect cracks at the flap idler hinge Airplane Directorate, 1601 Lind (0)5.62.41.73.00. You can look at copies at fitting, if necessary; and replacing the Avenue, SW., Renton, Washington; or at the FAA, Central Region, Office of the flap idler hinge fitting with a new like the FAA, Los Angeles Aircraft Regional Counsel, 901 Locust, Room 506, part, if any crack is detected. This action Certification Office, 3960 Paramount Kansas City, Missouri, or at the Office of the is necessary to prevent failure of the Boulevard, Lakewood, California; or at

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68068 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations the Office of the Federal Register, 800 the airplane. This AD requires The postcard will be date stamped and North Capitol Street, NW., suite 700, accomplishment of the actions specified returned to the commenter. Washington, DC. in the service bulletin described Regulatory Impact FOR FURTHER INFORMATION CONTACT: previously. The regulations adopted herein will Wahib Mina, Aerospace Engineer, Determination of Rule’s Effective Date Airframe Branch, ANM–120L, FAA, Los not have a substantial direct effect on Angeles Aircraft Certification Office, Since a situation exists that requires the States, on the relationship between 3960 Paramount Boulevard, Lakewood, the immediate adoption of this the national Government and the States, or on the distribution of power and California 90712; telephone (562) 627– regulation, it is found that notice and responsibilities among the various 5324; fax (562) 627–5210. opportunity for prior public comment hereon are impracticable, and that good levels of government. Therefore, it is SUPPLEMENTARY INFORMATION: The FAA cause exists for making this amendment determined that this final rule does not has received reports of a failed or effective in less than 30 days. have federalism implications under cracked flap idler hinge fitting at the Executive Order 13132. lower outboard stud location on certain Comments Invited The FAA has determined that this McDonnell Douglas Model DC–9 series Although this action is in the form of regulation is an emergency regulation airplanes. Investigation revealed that a final rule that involves requirements that must be issued immediately to these discrepancies were caused by affecting flight safety and, thus, was not correct an unsafe condition in aircraft, fatigue cracking initiating at the lower preceded by notice and an opportunity and that it is not a ‘‘significant outboard mounting hole with a 11⁄8-inch for public comment, comments are regulatory action’’ under Executive diameter counterbore. Such fatigue invited on this rule. Interested persons Order 12866. It has been determined cracking, if not corrected, could result are invited to comment on this rule by further that this action involves an in failure of the outboard flap idler submitting such written data, views, or emergency regulation under DOT hinge fitting. A failed outboard flap arguments as they may desire. Regulatory Policies and Procedures (44 idler hinge fitting could result in a Communications shall identify the FR 11034, February 26, 1979). If it is deflected flap, which may cause an Rules Docket number and be submitted determined that this emergency asymmetric lift and consequent reduced in triplicate to the address specified regulation otherwise would be controllability and structural integrity of under the caption ADDRESSES. All significant under DOT Regulatory the airplane. communications received on or before Policies and Procedures, a final Explanation of Relevant Service the closing date for comments will be regulatory evaluation will be prepared Information considered, and this rule may be and placed in the Rules Docket. A copy amended in light of the comments of it, if filed, may be obtained from the The FAA has reviewed and approved received. Factual information that Rules Docket at the location provided Boeing Alert Service Bulletin DC9– supports the commenter’s ideas and under the caption ADDRESSES. 57A218, including Appendix, dated suggestions is extremely helpful in List of Subjects in 14 CFR Part 39 September 20, 2000, which describes evaluating the effectiveness of the AD the following procedures: action and determining whether Air transportation, Aircraft, Aviation 1. Measuring the diameter of the hole additional rulemaking action would be safety, Incorporation by reference, counterbore of the outboard idler hinge needed. Safety. fitting of the left and right wing flap; Submit comments using the following Adoption of the Amendment 2. Installing a new nut, plain washer, format: and PLI washer; • Organize comments issue-by-issue. Accordingly, pursuant to the 3. For certain cases, performing For example, discuss a request to authority delegated to me by the repetitive high frequency eddy current change the compliance time and a Administrator, the Federal Aviation inspections (HFEC) to detect cracks at request to change the service bulletin Administration amends part 39 of the the flap idler hinge fitting; and reference as two separate issues. Federal Aviation Regulations (14 CFR 4. Replacing the flap idler hinge • For each issue, state what specific part 39) as follows: fitting with a new like part, if any crack change to the AD is being requested. is detected. • Include justification (e.g., reasons or PART 39ÐAIRWORTHINESS Accomplishment of the actions data) for each request. DIRECTIVES specified in the service bulletin is Comments are specifically invited on 1. The authority citation for part 39 intended to adequately address the the overall regulatory, economic, continues to read as follows: identified unsafe condition. environmental, and energy aspects of the rule that might suggest a need to Authority: 49 U.S.C. 106(g), 40113, 44701. Explanation of the Requirements of the modify the rule. All comments Rule § 39.13 [Amended] submitted will be available, both before 2. Section 39.13 is amended by Since an unsafe condition has been and after the closing date for comments, adding the following new airworthiness identified that is likely to exist or in the Rules Docket for examination by directive: develop on other McDonnell Douglas interested persons. A report that Model DC–9–10, –9–20, –9–30, –9–40, summarizes each FAA-public contact 2000–22–20 McDonnell Douglas: and –9–50 series airplanes and C–9 concerned with the substance of this AD Amendment 39–11968. Docket 2000– NM–344–AD. (military) airplanes series airplanes of will be filed in the Rules Docket. the same type design, this AD is being Commenters wishing the FAA to Applicability: Model DC–9–10, –9–20, –9– 30, –9–40, and –9–50 series airplanes and C– issued to prevent failure of the outboard acknowledge receipt of their comments 9 (military) airplanes, as listed in Boeing flap idler hinge fitting due to fatigue submitted in response to this rule must Alert Service Bulletin DC9–57A218, dated cracking, which could result in a submit a self-addressed, stamped September 20, 2000; certificated in any deflected flap that may cause an postcard on which the following category. asymmetric lift and consequent reduced statement is made: ‘‘Comments to Note 1: This AD applies to each airplane controllability and structural integrity of Docket Number 2000–NM–344–AD.’’ identified in the preceding applicability

VerDate 112000 16:49 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68069 provision, regardless of whether it has been Note 2: Information concerning the feed valve operating lever, and the modified, altered, or repaired in the area existence of approved alternative methods of presence of chafing; this amendment subject to the requirements of this AD. For compliance with this AD, if any, may be also requires corrective action, if airplanes that have been modified, altered, or obtained from the Los Angeles ACO. necessary. The actions specified by this repaired so that the performance of the requirements of this AD is affected, the Special Flight Permits AD are intended to detect and correct owner/operator must request approval for an (c) Special flight permits may be issued in chafing of the wire bundle exiting panel alternative method of compliance in accordance with sections 21.197 and 21.199 ‘‘JA’’ due to insufficient clearance from accordance with paragraph (b) of this AD. of the Federal Aviation Regulations (14 CFR the fuel cross-feed valve operating lever. The request should include an assessment of 21.197 and 21.199) to operate the airplane to Such chafing of the wire bundle could the effect of the modification, alteration, or a location where the requirements of this AD result in a fire in the area of the fuel repair on the unsafe condition addressed by can be accomplished. system in a confined space. This action this AD; and, if the unsafe condition has not Incorporation by Reference is intended to address the identified been eliminated, the request should include unsafe condition. specific proposed actions to address it. (d) The actions shall be done in accordance Compliance: Required as indicated, unless with Boeing Alert Service Bulletin DC9– DATES: Effective December 19, 2000. accomplished previously. 57A218, including Appendix, dated The incorporation by reference of To prevent failure of the outboard flap September 20, 2000. This incorporation by reference was approved by the Director of the certain publications listed in the idler hinge fitting due to fatigue cracking, regulations is approved by the Director which could result in a deflected flap that Federal Register in accordance with 5 U.S.C. may cause an asymmetric lift and consequent 552(a) and 1 CFR part 51. Copies may be of the Federal Register as of December reduced controllability and structural obtained from Boeing Commercial Aircraft 19, 2000. Group, Long Beach Division, 3855 Lakewood integrity of the airplane, accomplish the ADDRESSES: The service information following: Boulevard, Long Beach, California 90846, Attention: Technical Publications Business referenced in this AD may be obtained Measurement Administration, Dept. C1–L51 (2–60). Copies from Raytheon Aircraft Company, 9709 (a) Before the accumulation of 24,000 total may be inspected at the FAA, Transport East Central, Wichita, Kansas 67206. landings, or within 90 days after the effective Airplane Directorate, 1601 Lind Avenue, This information may be examined at date of this AD, whichever occurs later, SW., Renton, Washington; or at the FAA, Los the Federal Aviation Administration measure the diameter of the hole counterbore Angeles Aircraft Certification Office, 3960 (FAA), Transport Airplane Directorate, of the outboard idler hinge fitting of the left Paramount Boulevard, Lakewood, California; Rules Docket, 1601 Lind Avenue, SW., and right wing flap, per Boeing Alert Service or at the Office of the Federal Register, 800 Renton, Washington; or at the FAA, Bulletin DC9–57A218, including Appendix, North Capitol Street, NW., suite 700, Wichita Aircraft Certification Office, Washington, DC. dated September 20, 2000. 1801 Airport Road, Room 100, Mid- Acceptable Measurement of 0.875 (7⁄8) Inch: Effective Date Continent Airport, Wichita, Kansas; or Installation of Certain Parts (e) This amendment becomes effective on at the Office of the Federal Register, 800 (1) If the diameter of any hole counterbore November 29, 2000. North Capitol Street, NW., suite 700, 7 is 0.875 ( ⁄8) inch, before further flight, install Issued in Renton, Washington, on Washington, DC. a new nut, plain washer, and PLI washer, per November 1, 2000. the service bulletin. FOR FURTHER INFORMATION CONTACT: Donald L. Riggin, Philip Petty, Aerospace Engineer, Unacceptable Measurement of 1.125 (11⁄8) Acting Manager, Transport Airplane Systems and Propulsion Branch, ACE– Inches: Repetitive Inspections and Directorate, Aircraft Certification Service. 116W, FAA, Wichita Aircraft Corrective Actions, If Necessary [FR Doc. 00–28480 Filed 11–13–00; 8:45 am] Certification Office, 1801 Airport Road, (2) If the diameter of any hole counterbore BILLING CODE 4910±13±U Room 100, Mid-Continent Airport, 1 is 1.125 (1 ⁄8) inches, before further flight, do Wichita, Kansas 67209; telephone (316) a high frequency eddy current inspection 946–4139; fax (316) 946–4407. (HFEC) to detect cracks at the flap idler hinge DEPARTMENT OF TRANSPORTATION fitting, per the service bulletin. SUPPLEMENTARY INFORMATION: A (i) Condition 1. If no crack is detected, Federal Aviation Administration proposal to amend part 39 of the Federal before further flight, install a new nut, plain Aviation Regulations (14 CFR part 39) to washer, and PLI washer, per the service include an airworthiness directive (AD) bulletin. Repeat the HFEC inspection every 14 CFR Part 39 1,000 landings until the replacement that is applicable to certain Model [Docket No. 2000±NM±46±AD; Amendment Hawker 800XP and Hawker 800 (U– specified in paragraph (a)(2)(ii) has been 39±11970; AD 2000±22±22] done. 125A) series airplanes was published in (ii) Condition 2. If any crack is detected, RIN 2120±AA64 the Federal Register on August 8, 2000 before further flight, replace the flap idler (65 FR 48404). That action proposed to hinge fitting with a new like part, per the Airworthiness Directives; Raytheon require inspection of the wire bundle to service bulletin. Within 24,000 landings after Model Hawker 800XP and Hawker 800 relay ‘‘KT’’ on panel ‘‘JA’’ for correct accomplishment of the replacement, do the (U±125A) Series Airplanes routing, adequate clearance from the HFEC inspection required by paragraph (a)(2) fuel cross-feed valve operating lever, of this AD. AGENCY: Federal Aviation Administration, DOT. and the presence of chafing. That action Alternative Methods of Compliance also proposed to require corrective ACTION: Final rule. (b) An alternative method of compliance or action, if necessary. adjustment of the compliance time that SUMMARY: This amendment adopts a Comments provides an acceptable level of safety may be new airworthiness directive (AD), used if approved by the Manager, Los applicable to certain Raytheon Model Interested persons have been afforded Angeles Aircraft Certification Office (ACO), FAA. Operators shall submit their requests Hawker 800XP and Hawker 800 (U– an opportunity to participate in the through an appropriate FAA Principal 125A) series airplanes, that requires making of this amendment. No Maintenance Inspector, who may add inspection of the wire bundle to relay comments were submitted in response comments and then send it to the Manager, ‘‘KT’’ on panel ‘‘JA’’ for correct routing, to the proposal or the FAA’s Los Angeles ACO. adequate clearance from the fuel cross- determination of the cost to the public.

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Conclusion contained in the Rules Docket. A copy Aircraft Service Bulletin SB 24–3212, dated of it may be obtained from the Rules August 1999 (for Model 800XP series The FAA has determined that air airplanes); or SB 24–3213, Revision 1, dated safety and the public interest require the Docket at the location provided under the caption ADDRESSES. February 2000 (for Model 800 (U–125A) adoption of the rule as proposed. series airplanes; as applicable. Cost Impact List of Subjects in 14 CFR Part 39 (1) Ensure that the wire bundle is routed correctly, in accordance with Figure 1 of the Air transportation, Aircraft, Aviation There are approximately 148 applicable service bulletin. airplanes of the affected design in the safety, Incorporation by reference, (2) Ensure that a minimum clearance of worldwide fleet. The FAA estimates that Safety. 0.25-inch exists between the wire bundle 60 airplanes of U.S. registry will be Adoption of the Amendment from relay ‘‘KT’’ and the fuel cross-feed valve affected by this required AD, that it will operating lever throughout its range of travel. take approximately 1 work hour per Accordingly, pursuant to the Note 2: For the purposes of this AD, a airplane to accomplish the required authority delegated to me by the detailed visual inspection is defined as: ‘‘An intensive visual examination of a specific inspection, and that the average labor Administrator, the Federal Aviation Administration amends part 39 of the structural area, system, installation, or rate is $60 per work hour. Based on assembly to detect damage, failure, or these figures, the cost impact of the Federal Aviation Regulations (14 CFR part 39) as follows: irregularity. Available lighting is normally inspection required by this AD on U.S. supplemented with a direct source of good operators is estimated to be $3,600, or PART 39ÐAIRWORTHINESS lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, $60 per airplane. DIRECTIVES No estimate is provided for the cost magnifying lenses, etc., may be used. Surface impact of repairing the wire bundle or 1. The authority citation for part 39 cleaning and elaborate access procedures modifying the routing of the wire continues to read as follows: may be required.’’ (b) If the wire bundle is routed correctly bundle or ensuring adequate clearance Authority: 49 U.S.C. 106(g), 40113, 44701. between the wire bundle and the fuel and sufficient clearance exists, no further § 39.13 [Amended] action is required by this AD. cross-feed valve operating lever because (c) If the wire bundle is not routed these costs will depend on the extent of 2. Section 39.13 is amended by correctly or if sufficient clearance does not the repairs or modifications required. adding the following new airworthiness exist, prior to further flight, perform a The cost impact figure discussed directive: detailed visual inspection of the wire bundle above is based on assumptions that no to relay ‘‘KT’’ for chafing, in accordance with operator has yet accomplished any of 2000–22–22 Raytheon Aircraft Company: the Accomplishment Instructions of Amendment 39–11970. Docket 2000– Raytheon Aircraft Service Bulletin SB 24– the requirements of this AD action, and NM–46–AD. that no operator would accomplish 3212, dated August 1999 (for Model 800XP Applicability: Model Hawker 800XP series those actions in the future if this AD series airplanes); or SB 24–3213, Revision 1, airplanes, as listed in Raytheon Service dated February 2000 (for Model 800 (U– were not adopted. The cost impact Bulletin SB 24–3212, dated August 1999; and 125A) series airplanes); as applicable. figures discussed in AD rulemaking Hawker 800 (U–125A) series airplanes, as (1) If no chafing is detected, prior to further actions represent only the time listed in Raytheon Service Bulletin SB 24– flight, ensure that the wire bundle is routed necessary to perform the specific actions 3213, dated February 2000; certificated in correctly and ensure that a minimum actually required by the AD. These any category. clearance of 0.25-inch exists between the figures typically do not include Note 1: This AD applies to each airplane wire bundle and the fuel cross-feed valve incidental costs, such as the time identified in the preceding applicability operating valve throughout its range of travel, required to gain access and close up, provision, regardless of whether it has been in accordance with the applicable service planning time, or time necessitated by modified, altered, or repaired in the area bulletin. (2) If any chafing is detected, prior to other administrative actions. subject to the requirements of this AD. For airplanes that have been modified, altered, or further flight, repair the chafed wire, ensure Regulatory Impact repaired so that the performance of the that the wire bundle is routed correctly and requirements of this AD is affected, the ensure that a minimum clearance of 0.25- The regulations adopted herein will owner/operator must request approval for an inch exists between the wire bundle and the not have a substantial direct effect on alternative method of compliance in fuel cross-feed valve operating valve the States, on the relationship between accordance with paragraph (d) of this AD. throughout its range of travel, in accordance the national Government and the States, The request should include an assessment of with the applicable service bulletin. the effect of the modification, alteration, or or on the distribution of power and Alternative Methods of Compliance responsibilities among the various repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not (d) An alternative method of compliance or levels of government. Therefore, it is adjustment of the compliance time that determined that this final rule does not been eliminated, the request should include specific proposed actions to address it. provides an acceptable level of safety may be have federalism implications under used if approved by the Manager, Wichita Executive Order 13132. Compliance: Required as indicated, unless accomplished previously. Aircraft Certification Office (ACO), FAA. For the reasons discussed above, I To detect and correct chafing of the wire Operators shall submit their requests through certify that this action (1) is not a bundle exiting panel ‘‘JA’’ due to insufficient an appropriate FAA Principal Maintenance ‘‘significant regulatory action’’ under clearance from the fuel cross-feed valve Inspector, who may add comments and then Executive Order 12866; (2) is not a operating lever, which could result in a fire send it to the Manager, Wichita ACO. ‘‘significant rule’’ under DOT in the area of the fuel system in a confined Note 3: Information concerning the Regulatory Policies and Procedures (44 space, accomplish the following: existence of approved alternative methods of FR 11034, February 26, 1979); and (3) compliance with this AD, if any, may be Inspection and Corrective Actions obtained from the Wichita ACO. will not have a significant economic (a) Within 50 flight hours or 6 months after impact, positive or negative, on a the effective date of this AD, whichever Special Flight Permits substantial number of small entities comes first, conduct a one-time detailed (e) Special flight permits may be issued in under the criteria of the Regulatory visual inspection of the panel ‘‘JA’’ wire accordance with sections 21.197 and 21.199 Flexibility Act. A final evaluation has bundle in accordance with the of the Federal Aviation Regulations (14 CFR been prepared for this action and it is Accomplishment Instructions of Raytheon 21.197 and 21.199) to operate the airplane to

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The incorporation by reference of Executive Order 12866; (2) is not a Incorporation by Reference certain publications listed in the ‘‘significant rule’’ under DOT (f) The actions shall be done in accordance regulations is approved by the Director Regulatory Policies and Procedures (44 with Raytheon Aircraft Service Bulletin SB of the Federal Register as of December FR 11034, February 26, 1979); and (3) 24–3212, dated August 1999; or Raytheon 19, 2000. will not have a significant economic Aircraft Service Bulletin SB 24–3213, ADDRESSES: The service information impact, positive or negative, on a Revision 1, dated February 2000; as referenced in this AD may be obtained substantial number of small entities applicable. This incorporation by reference from American Eurocopter Corporation, under the criteria of the Regulatory was approved by the Director of the Federal 2701 Forum Drive, Grand Prairie, Texas Flexibility Act. A final evaluation has Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained 75053–4005, telephone (972) 641–3460, been prepared for this action and it is from Raytheon Aircraft Company, 9709 East fax (972) 641–3527. This information contained in the Rules Docket. A copy Central, Wichita, Kansas 67206. Copies may may be examined at the FAA, Office of of it may be obtained from the Rules be inspected at the FAA, Transport Airplane the Regional Counsel, Southwest Docket at the location provided under Directorate, 1601 Lind Avenue, SW., Renton, Region, 2601 Meacham Blvd., Room the caption ADDRESSES. Washington; or at the FAA, Wichita Aircraft 663, Fort Worth, Texas; or at the Office List of Subjects in 14 CFR Part 39 Certification Office, 1801 Airport Road, of the Federal Register, 800 North Room 100, Mid-Continent Airport, Wichita, Kansas; or at the Office of the Federal Capitol Street, NW., suite 700, Air transportation, Aircraft, Aviation Register, 800 North Capitol Street, NW., suite Washington, DC. safety, Incorporation by reference, 700, Washington, DC. FOR FURTHER INFORMATION CONTACT: Jim Safety. Effective Date Grigg, Aviation Safety Engineer, FAA, Adoption of the Amendment Rotorcraft Directorate, Regulations (g) This amendment becomes effective on Group, Fort Worth, Texas 76193–0111, December 19, 2000. Accordingly, pursuant to the telephone (817) 222–5490, fax (817) authority delegated to me by the Issued in Renton, Washington, on 222–5961. Administrator, the Federal Aviation November 1, 2000. Administration amends part 39 of the Donald L. Riggin, SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal Federal Aviation Regulations (14 CFR Acting Manager, Transport Airplane part 39) as follows: Directorate, Aircraft Certification Service. Aviation Regulations (14 CFR part 39) by superseding AD 80–12–04, [FR Doc. 00–28479 Filed 11–13–00; 8:45 am] PART 39ÐAIRWORTHINESS Amendment 39–3790 (45 FR 37180, BILLING CODE 4910±13±P DIRECTIVES June 2, 1980), which applies to Eurocopter France Model SA330F, G, 1. The authority citation for part 39 DEPARTMENT OF TRANSPORTATION and J helicopters, was published in the continues to read as follows: Federal Register on August 10, 2000 (65 Authority: 49 U.S.C. 106(g), 40113, 44701. Federal Aviation Administration FR 48936). That action proposed to require skin bonding and eddy current § 39.13 [Amended] 14 CFR Part 39 inspections of the blade skin for cracks and referenced a more recent SB. 2. Section 39.13 is amended by [Docket No. 2000±SW±14±AD; Amendment Interested persons have been afforded removing Amendment 39–3790 (45 FR 39±11967; AD 2000±22±19] an opportunity to participate in the 37180, June 2, 1980), and by adding a RIN 2120±AA64 making of this amendment. No new airworthiness directive (AD), comments were received on the Amendment 39–11967, to read as Airworthiness Directives; Eurocopter proposal or the FAA’s determination of follows: France Model SA330F, G, and J the cost to the public. The FAA has 2000–22–19 Eurocopter France: Helicopters determined that air safety and the Amendment 39–11967. Docket No. 2000- SW–14–AD. Supersedes AD 80–12–04, AGENCY: Federal Aviation public interest require the adoption of Amendment 39–3790, Docket No. 20384. Administration, DOT. the rule as proposed. Applicability: Model SA330F, G, and J ACTION: Final rule. The FAA estimates that 4 helicopters of U.S. registry will be affected by this helicopters with a tail rotor blade (blade), SUMMARY: This amendment supersedes AD, that it will take approximately 1.5 part number (P/N) 330A12–0000-(all dash an existing airworthiness directive (AD) work hours per helicopter to accomplish numbers), 330A12–0000-(all dash numbers), 330A12–0006-(all dash numbers), installed, that applies to Eurocopter France Model the required actions, and that the certificated in any category. SA330F, G, and J helicopters and average labor rate is $60 per work hour. Note 1: This AD applies to each helicopter requires inspecting the tail rotor blade Based on these figures, the total cost identified in the preceding applicability (blade) skin for cracks and replacing, as impact of the AD on U.S. operators is provision, regardless of whether it has been necessary, the blade. This amendment estimated to be $360. otherwise modified, altered, or repaired in requires skin bonding and eddy current The regulations adopted herein will the area subject to the requirements of this inspections of the blade skin for cracks not have a substantial direct effect on AD. For helicopters that have been modified, and would reference a more recent the States, on the relationship between altered, or repaired so that the performance service bulletin (SB). This amendment the national Government and the States, of the requirements of this AD is affected, the is prompted by improved inspection or on the distribution of power and owner/operator must request approval for an methods and by the manufacturer responsibilities among the various alternative method of compliance in revising the SB referenced in the current levels of government. Therefore, it is accordance with paragraph (b) of this AD. The request should include an assessment of AD. The actions specified by this AD are determined that this final rule does not the effect of the modification, alteration, or intended to prevent fatigue cracking of have federalism implications under repair on the unsafe condition addressed by a blade, failure of a blade, and Executive Order 13132. this AD; and if the unsafe condition has not subsequent loss of control of the For the reasons discussed above, I been eliminated, the request should include helicopter. certify that this action (1) is not a specific proposed actions to address it.

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Compliance: Required as indicated, unless DEPARTMENT OF TRANSPORTATION must be formatted in Microsoft Word 97 accomplished previously. for Windows or ASCII text. To prevent fatigue cracking of a blade, Federal Aviation Administration The service information referenced in failure of a blade, and subsequent loss of this AD may be obtained from control of the helicopter, accomplish the 14 CFR Part 39 Bombardier, Inc., Canadair, Aerospace following: [Docket No. 2000±NM±315±AD; Amendment Group, P.O. Box 6087, Station A, (a) Within 30 hours time-in-service (TIS), 39±11972; AD 2000±23±02] Montreal, Quebec H3C 3G9, Canada. and thereafter at intervals not to exceed 15 This information may be examined at hours TIS for blades equipped with deicing RIN 2120±AA64 the FAA, Transport Airplane systems or 30 hours TIS for blades without Directorate, 1601 Lind Avenue, SW., Airworthiness Directives; Bombardier deicing systems, conduct skin bonding and Renton, Washington; or at the FAA, Model CL±600±2B16 (CL±604) Series eddy current inspections on each affected New York Aircraft Certification Office, Airplanes blade for skin bonding and a crack. Inspect 10 Fifth Street, Third Floor, Valley in accordance with paragraph 1.C of AGENCY: Federal Aviation Stream, New York; or at the Office of the Aerospatiale Service Bulletin 05.71R4, dated Administration, DOT. Federal Register, 800 North Capitol December 18, 1990. Replace any blade failing Street, NW., suite 700, Washington, DC. the skin bonding inspection or eddy current ACTION: Final rule; request for FOR FURTHER INFORMATION CONTACT: inspection before further flight. comments. Serge Napoleon, Aerospace Engineer, (b) An alternative method of compliance or SUMMARY: This amendment adopts a adjustment of the compliance time that Airframe and Propulsion Branch, ANE– new airworthiness directive (AD) that is 171, FAA, New York Aircraft provides an acceptable level of safety may be applicable to certain Bombardier Model used if approved by the Manager, Regulations Certification Office, 10 Fifth Street, CL–600–2B16 (CL–604) series airplanes. Third Floor, Valley Stream, New York; Group, Rotorcraft Directorate, FAA. This action requires, among other Operators shall submit their requests through telephone (516) 256–7512; fax (516) actions, a general visual inspection to an FAA Principal Maintenance Inspector, 568–2716. detect gaps between the vane bracket(s) who may concur or comment and then send SUPPLEMENTARY INFORMATION: Transport and the adjacent skin; corrective it to the Manager, Regulations Group. Canada Civil Aviation (TCCA), which is actions, if necessary; and replacement of Note 2: Information concerning the the airworthiness authority for Canada, the six flap vane actuator beams with recently notified the FAA that an unsafe existence of approved alternative methods of new beams. This action is necessary to compliance with this AD, if any, may be condition may exist on certain detect and correct corrosion of the Bombardier Model CL–600–2B16 (CL– obtained from the Regulations Group. inboard flap actuator beam assembly (c) Special flight permits may be issued in 604) series airplanes. TCCA advises that and gaps between the vane brackets and it has received a report that, during a accordance with sections 21.197 and 21.199 adjacent skin, which could compromise of the Federal Aviation Regulations (14 CFR visual inspection of the flap systems, the structural integrity of the flap corrosion was found in the inboard flap 21.197 and 21.199) to operate the helicopter systems and reduce the controllability to a location where the requirements of this actuator beam assembly, part number of the airplane in the event that a flap (P/N) 600–14250–25, as well as gaps AD can be accomplished. vane actuator or a flap vane bracket fails (d) The inspection shall be done in between the vane brackets, P/N’s 600– during flight. This action is intended to 14306–1 and –2, and adjacent skin. Both accordance with paragraph 1.C of address the identified unsafe condition. Aerospatiale Service Bulletin 05.71R4, dated of these discrepancies have been DATES: December 18, 1990. This incorporation by Effective November 29, 2000. attributed to deficiencies in the reference was approved by the Director of the The incorporation by reference of manufacturing process. These Federal Register in accordance with 5 U.S.C. certain publications listed in the conditions, if not corrected, could 552(a) and 1 CFR part 51. Copies may be regulations is approved by the Director compromise the structural integrity of obtained from American Eurocopter of the Federal Register as of November the flap systems and could reduce the Corporation, 2701 Forum Drive, Grand 29, 2000. controllability of the airplane in the Prairie, Texas 75053–4005, telephone (972) Comments for inclusion in the Rules event that a flap vane actuator or a flap 641–3460, fax (972) 641–3527. Copies may be Docket must be received on or before vane bracket fails during flight. inspected at the FAA, Office of the Regional December 14, 2000. Explanation of Relevant Service Counsel, Southwest Region, 2601 Meacham ADDRESSES: Submit comments in Information Blvd., Room 663, Fort Worth, Texas; or at the triplicate to the Federal Aviation Office of the Federal Register, 800 North Administration (FAA), Transport Bombardier has issued Alert Service Capitol Street, NW., suite 700, Washington, Airplane Directorate, ANM–114, Bulletin A604–27–006, dated April 18, DC. Attention: Rules Docket No. 2000–NM– 2000. The service bulletin describes (e) This amendment becomes effective on 315–AD, 1601 Lind Avenue, SW., procedures for a general visual December 19, 2000. Renton, Washington 98055–4056. inspection to detect gaps between the Issued in Fort Worth, Texas, on October 30, Comments may be inspected at this vane bracket(s) and the adjacent skin; 2000. location between 9:00 a.m. and 3:00 corrective actions, if necessary; p.m., Monday through Friday, except replacement of the six flap vane actuator Mark R. Schilling, Federal holidays. Comments may be beams with new beams; and returning Manager, Rotorcraft Directorate, Aircraft submitted via fax to (425) 227–1232. certain parts to the airplane Certification Service. Comments may also be sent via the manufacturer. The corrective actions [FR Doc. 00–28722 Filed 11–13–00; 8:45 am] Internet using the following address: 9- involve performing a non-destructive BILLING CODE 4910±13±P [email protected]. Comments inspection to detect cracks of the vane sent via the Internet must contain brackets; replacing any cracked vane ‘‘Docket No. 2000–NM–315–AD’’ in the bracket with a new vane bracket; subject line and need not be submitted eliminating the gap by filling the gap in triplicate. Comments sent via fax or with liquid shim or installing a solid the Internet as attached electronic files shim, as applicable; and repairing the

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The TCCA compliance with this proposed AD. submit a self-addressed, stamped classified this service bulletin as postcard on which the following Interim Action mandatory and issued Canadian statement is made: ‘‘Comments to airworthiness directive CF–2000–18, This is considered to be interim Docket Number 2000–NM–315–AD.’’ dated July 11, 2000, in order to assure action until final action is identified, at The postcard will be date stamped and the continued airworthiness of these which time the FAA may consider returned to the commenter. airplanes in Canada. further rulemaking. Regulatory Impact FAA’s Conclusions Determination of Rule’s Effective Date The regulations adopted herein will This airplane model is manufactured Since a situation exists that requires not have a substantial direct effect on in Canada and is type certificated for the immediate adoption of this the States, on the relationship between operation in the United States under the regulation, it is found that notice and the national Government and the States, provisions of section 21.29 of the opportunity for prior public comment or on the distribution of power and Federal Aviation Regulations (14 CFR hereon are impracticable, and that good responsibilities among the various 21.29) and the applicable bilateral cause exists for making this amendment levels of government. Therefore, it is airworthiness agreement. Pursuant to effective in less than 30 days. determined that this final rule does not this bilateral airworthiness agreement, have federalism implications under the TCCA has kept the FAA informed of Comments Invited Executive Order 13132. the situation described above. The FAA Although this action is in the form of The FAA has determined that this has examined the findings of the TCCA, a final rule that involves requirements regulation is an emergency regulation reviewed all available information, and affecting flight safety and, thus, was not that must be issued immediately to determined that AD action is necessary preceded by notice and an opportunity correct an unsafe condition in aircraft, for products of this type design that are for public comment, comments are and that it is not a ‘‘significant certificated for operation in the United invited on this rule. Interested persons regulatory action’’ under Executive States. are invited to comment on this rule by Order 12866. It has been determined Explanation of Requirements of Rule submitting such written data, views, or further that this action involves an arguments as they may desire. emergency regulation under DOT Since an unsafe condition has been Communications shall identify the Regulatory Policies and Procedures (44 identified that is likely to exist or Rules Docket number and be submitted FR 11034, February 26, 1979). If it is develop on other airplanes of the same in triplicate to the address specified determined that this emergency type design registered in the United under the caption ADDRESSES. All regulation otherwise would be States, this AD is being issued to detect communications received on or before significant under DOT Regulatory and correct corrosion of the inboard flap the closing date for comments will be Policies and Procedures, a final actuator beam assembly and gaps considered, and this rule may be regulatory evaluation will be prepared between the vane brackets and adjacent amended in light of the comments and placed in the Rules Docket. A copy skin, which could compromise the received. Factual information that of it, if filed, may be obtained from the structural integrity of the flap systems supports the commenter’s ideas and Rules Docket at the location provided and could reduce the controllability of suggestions is extremely helpful in under the caption ADDRESSES. the airplane in the event that a flap vane evaluating the effectiveness of the AD actuator or a flap vane bracket fails List of Subjects in 14 CFR Part 39 action and determining whether during flight. This AD requires additional rulemaking action would be Air transportation, Aircraft, Aviation accomplishment of the action specified needed. safety, Incorporation by reference, in the service bulletin described Safety. Submit comments using the following previously, except as discussed below. This AD also requires operators to format: Adoption of the Amendment • Organize comments issue-by-issue. return certain parts and submit a data Accordingly, pursuant to the For example, discuss a request to report of those parts to the airplane authority delegated to me by the change the compliance time and a manufacturer. The FAA finds that these Administrator, the Federal Aviation request to change the service bulletin actions are necessary to determine if Administration amends part 39 of the reference as two separate issues. further rulemaking is needed. Federal Aviation Regulations (14 CFR • For each issue, state what specific part 39) as follows: Differences Between Proposed Rule and change to the AD is being requested. Service Bulletin • Include justification (e.g., reasons or PART 39ÐAIRWORTHINESS Operators should note that, although data) for each request. DIRECTIVES the service bulletin specifies that the Comments are specifically invited on manufacturer may be contacted for the overall regulatory, economic, 1. The authority citation for part 39 disposition of certain repair conditions, environmental, and energy aspects of continues to read as follows: this proposal would require the repair of the rule that might suggest a need to Authority: 49 U.S.C. 106(g), 40113, 44701. those conditions to be accomplished in modify the rule. All comments accordance with a method approved by submitted will be available, both before § 39.13 [Amended] either the FAA, or the TCCA (or its and after the closing date for comments, 2. Section 39.13 is amended by delegated agent). In light of the type of in the Rules Docket for examination by adding the following new airworthiness repair that would be required to address interested persons. A report that directive: the identified unsafe condition, and in summarizes each FAA-public contact 2000–23–02 Bombardier Inc. (Formerly consonance with existing bilateral concerned with the substance of this AD Canadair): Amendment 39–11972. airworthiness agreements, the FAA has will be filed in the Rules Docket. Docket 2000–NM–315–AD.

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Applicability: Model CL–600–2B16 (CL– (1) If any crack is detected, before further Special Flight Permits 604) series airplanes, serial numbers 5301 flight, replace the cracked vane bracket with (f) Special flight permits may be issued in through 5374 inclusive, certificated in any a new vane bracket per the service bulletin. accordance with sections 21.197 and 21.199 category. (2) If no crack is detected and if the gap of the Federal Aviation Regulations (14 CFR Note 1: This AD applies to each airplane is up to 0.100 inch (2.54 mm), eliminate the 21.197 and 21.199) to operate the airplane to identified in the preceding applicability gap by filling the gap with liquid shim or a location where the requirements of this AD provision, regardless of whether it has been installing a solid shim, as applicable, per the can be accomplished. modified, altered, or repaired in the area service bulletin. Incorporation by Reference subject to the requirements of this AD. For (3) If no crack is detected and if the gap airplanes that have been modified, altered, or is more than 0.100 inch (2.54 mm), before (g) Except as provided in paragraph (b)(3) repaired so that the performance of the further flight, repair in accordance with a of this AD, the actions shall be done in requirements of this AD is affected, the method approved by the Manager, New York accordance with Bombardier Alert Service owner/operator must request approval for an Aircraft Certification Office (ACO), FAA; or Bulletin A604–27–006, dated April 18, 2000. alternative method of compliance in the Transport Canada Civil Aviation, (or its This incorporation by reference was accordance with paragraph (e) of this AD. delegated agent). For a repair method to be approved by the Director of the Federal The request should include an assessment of approved by the Manager, New York ACO, as Register in accordance with 5 U.S.C. 552(a) the effect of the modification, alteration, or required by this paragraph, the Manager’s and 1 CFR part 51. Copies may be obtained repair on the unsafe condition addressed by approval letter must specifically reference from Bombardier, Inc., Canadair, Aerospace this AD; and, if the unsafe condition has not this AD. Group, P.O. Box 6087, Station A, Montreal, been eliminated, the request should include Quebec H3C 3G9, Canada. Copies may be Replacement of Six Flap Vane Actuator specific proposed actions to address it. inspected at the FAA, Transport Airplane Beams Directorate, 1601 Lind Avenue, SW., Renton, Compliance: Required as indicated, unless Washington; or at the FAA, New York accomplished previously. (c) Replace the six flap vane actuator beams with new beams, per paragraph ‘‘2. Aircraft Certification Office, 10 Fifth Street, To detect and correct corrosion of the Third Floor, Valley Stream, New York; or at inboard flap actuator beam assembly and Accomplishment Instructions,’’ of Bombardier Alert Service Bulletin A604–27– the Office of the Federal Register, 800 North gaps between the vane brackets and adjacent Capitol Street, NW., suite 700, Washington, 006, dated April 18, 2000; at the time skin, which could compromise the structural DC. specified in paragraph (a)(1), (a)(2), or (a)(3) integrity of the flap systems and reduce the Note 4: The subject of this AD is addressed controllability of the airplane in the event of this AD, as applicable. (1) For airplanes having serial numbers in Canadian airworthiness directive CF– that a flap vane actuator or a flap vane 2000–18, dated July 11, 2000. bracket fails during flight, accomplish the 5301 through 5334 inclusive: Within 30 days following: after the effective date of this AD. Effective Date (2) For airplanes having serial numbers General Visual Inspection 5335 through 5354 inclusive: Within 90 days (h) This amendment becomes effective on November 29, 2000. (a) Do a general visual inspection to detect after the effective date of this AD. gaps between the vane bracket(s), part (3) For airplanes having serial numbers Issued in Renton, Washington, on number (P/N) 600–14306–1 and –2, and the 5355 through 5374 inclusive: Within 180 November 3, 2000. adjacent skin, per paragraph ‘‘2. days after the effective date of this AD. Donald L. Riggin, Accomplishment Instructions,’’ of Return of Parts Acting Manager, Transport Airplane Bombardier Alert Service Bulletin A604–27– Directorate, Aircraft Certification Service. 006, dated April 18, 2000; at the time (d) Within 30 days after doing the specified in paragraph (a)(1), (a)(2), or (a)(3) replacement required by paragraph (c) of this [FR Doc. 00–28830 Filed 11–13–00; 8:45 am] of this AD, as applicable. AD, forward any cracked vane bracket and BILLING CODE 4910±13±U (1) For airplanes having serial numbers any two of the six removed flap vane actuator 5301 through 5334 inclusive: Within 30 days assemblies to Bombardier, per paragraph ‘‘2. after the effective date of this AD. Accomplishment Instructions,’’ of DEPARTMENT OF TRANSPORTATION (2) For airplanes having serial numbers Bombardier Alert Service Bulletin A604–27– 5335 through 5354 inclusive: Within 90 days 006, dated April 18, 2000. Data, such as the Federal Aviation Administration after the effective date of this AD. station location of the flap actuator beam (3) For airplanes having serial numbers assembly, the number of flight hours and 14 CFR Part 39 5355 through 5374 inclusive: Within 180 landings of the airplane at removal, must be days after the effective date of this AD. submitted along with the flap vane actuator [Docket No. 2000±NM±113±AD; Amendment 39±11975; AD 2000±23±05] Note 2: For the purposes of this AD, a beam assemblies. Information collection general visual inspection is defined as ‘‘A requirements contained in this regulation RIN 2120±AA64 visual examination of an interior or exterior have been approved by the Office of area, installation, or assembly to detect Management and Budget (OMB) under the Airworthiness Directives; British obvious damage, failure, or irregularity. This provisions of the Paperwork Reduction Act of Aerospace Model BAC 1±11 401/AK level of inspection is made under normally 1980 (44 U.S.C. 3501 et seq.) and have been and 410/AQ Airplanes available lighting conditions such as assigned OMB Control Number 2120–0056. AGENCY: Federal Aviation daylight, hangar lighting, flashlight, or drop- Alternative Methods of Compliance light, and may require removal or opening of Administration, DOT. (e) An alternative method of compliance or access panels or doors. Stands, ladders, or ACTION: Final rule. platforms may be required to gain proximity adjustment of the compliance time that provides an acceptable level of safety may be to the area being checked.’’ SUMMARY: This amendment adopts a used if approved by the Manager, New York new airworthiness directive (AD), Corrective Actions if Any Gap Is Found ACO. Operators shall submit their requests applicable to all British Aerospace (b) If any gap is found during the general through an appropriate FAA Principal Maintenance Inspector, who may add Model BAC 1–11 401/AK and 410/AQ visual inspection required by paragraph (a) of airplanes, that requires replacement of this AD, before further flight, perform a non- comments and then send it to the Manager, destructive inspection to detect cracks of the New York ACO. certain landing gear brake accumulators vane bracket, per paragraph ‘‘2. Note 3: Information concerning the with improved accumulators. The Accomplishment Instructions,’’ of existence of approved alternative methods of actions specified by this AD are Bombardier Alert Service Bulletin A604–27– compliance with this AD, if any, may be intended to prevent loss of hydraulic 006, dated April 18, 2000. obtained from the New York ACO. pressure and possible structural damage

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68075 to the airplane due to failure of the operator has yet accomplished any of 2000–23–05 British Aerospace Airbus accumulator. This action is intended to the requirements of this AD action, and Limited: (Formerly British Aerospace address the identified unsafe condition. that no operator would accomplish Commercial Aircraft Limited, British those actions in the future if this AD Aerospace Aircraft Group): Amendment DATES: Effective December 19, 2000. 39–11975. Docket 2000–NM–113–AD. The incorporation by reference of were not adopted. The cost impact figures discussed in AD rulemaking Applicability: All Model BAC 1–11 401/AK certain publications listed in the and 410/AQ airplanes, certificated in any regulations is approved by the Director actions represent only the time category. of the Federal Register as of December necessary to perform the specific actions Note 1: This AD applies to each airplane 19, 2000. actually required by the AD. These identified in the preceding applicability ADDRESSES: The service information figures typically do not include provision, regardless of whether it has been referenced in this AD may be obtained incidental costs, such as the time modified, altered, or repaired in the area from British Aerospace, Service required to gain access and close up, subject to the requirements of this AD. For Support, Airbus Limited, P.O. Box 77, planning time, or time necessitated by airplanes that have been modified, altered, or other administrative actions. repaired so that the performance of the Bristol BS99 7AR, England. This requirements of this AD is affected, the information may be examined at the Regulatory Impact owner/operator must request approval for an Federal Aviation Administration (FAA), alternative method of compliance in Transport Airplane Directorate, Rules The regulations adopted herein will accordance with paragraph (c) of this AD. Docket, 1601 Lind Avenue, SW., not have a substantial direct effect on The request should include an assessment of Renton, Washington; or at the Office of the States, on the relationship between the effect of the modification, alteration, or the Federal Register, 800 North Capitol the national Government and the States, repair on the unsafe condition addressed by Street, NW., suite 700, Washington, DC. or on the distribution of power and this AD; and, if the unsafe condition has not responsibilities among the various been eliminated, the request should include FOR FURTHER INFORMATION CONTACT: levels of government. Therefore, it is specific proposed actions to address it. Norman B. Martenson, Manager, determined that this final rule does not International Branch, ANM–116, FAA, Compliance: Required as indicated, unless have federalism implications under Transport Airplane Directorate, 1601 accomplished previously. Executive Order 13132. To prevent loss of hydraulic pressure and Lind Avenue, SW., Renton, Washington possible structural damage to the airplane 98055–4056; telephone (425) 227–2110; For the reasons discussed above, I certify that this action (1) is not a due to failure of the landing gear brake fax (425) 227–1149. accumulator, accomplish the following: ‘‘significant regulatory action’’ under SUPPLEMENTARY INFORMATION: A Executive Order 12866; (2) is not a Replacement proposal to amend part 39 of the Federal ‘‘significant rule’’ under DOT Aviation Regulations (14 CFR part 39) to (a) Within 10 months after the effective Regulatory Policies and Procedures (44 date of this AD, replace any Parker landing include an airworthiness directive (AD) FR 11034, February 26, 1979); and (3) gear brake accumulator having part number that is applicable to all British will not have a significant economic (P/N) 1356–653562 with an accumulator Aerospace Model BAC 1–11 401/AK impact, positive or negative, on a having P/N 1356–653562M2, in accordance and 410/AQ airplanes was published in with British Aerospace Service Bulletin 32- substantial number of small entities the Federal Register on September 19, PM6054, dated February 2000. under the criteria of the Regulatory 2000 (65 FR 56506). That action Note 2: The British Aerospace service Flexibility Act. A final evaluation has proposed to require replacement of bulletin references Parker Service Bulletin been prepared for this action and it is certain landing gear brake accumulators 1356–653562–32–100, dated September 23, contained in the Rules Docket. A copy with improved accumulators. 1999, as an additional source of service of it may be obtained from the Rules information for accomplishment of the Comments Docket at the location provided under replacement. the caption ADDRESSES. Interested persons have been afforded Spares an opportunity to participate in the List of Subjects in 14 CFR Part 39 (b) As of the effective date of this AD, no making of this amendment. No Air transportation, Aircraft, Aviation Parker landing gear brake accumulator comments were submitted in response having P/N 1356–653562 shall be installed to the proposal or the FAA’s safety, Incorporation by reference, on any airplane. Safety. determination of the cost to the public. Alternative Methods of Compliance Adoption of the Amendment Conclusion (c) An alternative method of compliance or The FAA has determined that air Accordingly, pursuant to the adjustment of the compliance time that authority delegated to me by the provides an acceptable level of safety may be safety and the public interest require the used if approved by the Manager, adoption of the rule as proposed. Administrator, the Federal Aviation International Branch, ANM–116, FAA, Administration amends part 39 of the Cost Impact Transport Airplane Directorate. Operators Federal Aviation Regulations (14 CFR shall submit their requests through an The FAA estimates that 13 airplanes part 39) as follows: appropriate FAA Principal Maintenance of U.S. registry will be affected by this Inspector, who may add comments and then AD, that it will take approximately 1 PART 39ÐAIRWORTHINESS send it to the Manager, International Branch, work hour per airplane to accomplish DIRECTIVES ANM–116. the required actions, and that the Note 3: Information concerning the average labor rate is $60 per work hour. 1. The authority citation for part 39 existence of approved alternative methods of Required parts will cost approximately continues to read as follows: compliance with this AD, if any, may be Authority: 49 U.S.C. 106(g), 40113, 44701. obtained from the International Branch, $9,940 per airplane. Based on these ANM–116. figures, the cost impact of the AD on § 39.13 [Amended] U.S. operators is estimated to be Special Flight Permits $130,000, or $10,000 per airplane. 2. Section 39.13 is amended by (d) Special flight permits may be issued in The cost impact figure discussed adding the following new airworthiness accordance with sections 21.197 and 21.199 above is based on assumptions that no directive: of the Federal Aviation Regulations (14 CFR

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21.197 and 21.199) to operate the airplane to adversely affect the structural integrity were not adopted. The cost impact a location where the requirements of this AD of these airplanes. figures discussed in AD rulemaking can be accomplished. DATES: Effective December 19, 2000. actions represent only the time Incorporation by Reference ADDRESSES: The service information necessary to perform the specific actions (e) The replacement shall be done in referenced in this AD may be obtained actually required by the AD. These accordance with British Aerospace Service from Aerospatiale, 316 Route de figures typically do not include Bulletin 32–PM6054, dated February 2000. Bayonne, 31060 Toulouse, Cedex 03, incidental costs, such as the time This incorporation by reference was France. This information may be required to gain access and close up, approved by the Director of the Federal examined at the Federal Aviation planning time, or time necessitated by Register in accordance with 5 U.S.C. 552(a) other administrative actions. and 1 CFR part 51. Copies may be obtained Administration (FAA), Transport from British Aerospace, Service Support, Airplane Directorate, Rules Docket, Regulatory Impact 1601 Lind Avenue, SW., Renton, Airbus Limited, P.O. Box 77, Bristol BS99 The regulations adopted herein will Washington; or at the Office of the 7AR, England. Copies may be inspected at not have a substantial direct effect on the FAA, Transport Airplane Directorate, Federal Register, 800 North Capitol the States, on the relationship between 1601 Lind Avenue, SW., Renton, Street, NW., suite 700, Washington, DC. the national Government and the States, Washington; or at the Office of the Federal FOR FURTHER INFORMATION CONTACT: Register, 800 North Capitol Street, NW., suite or on the distribution of power and 700, Washington, DC. Norman B. Martenson, Manager, responsibilities among the various International Branch, ANM–116, FAA, levels of government. Therefore, it is Effective Date Transport Airplane Directorate, 1601 determined that this final rule does not (f) This amendment becomes effective on Lind Avenue, SW., Renton, Washington have federalism implications under December 19, 2000. 98055–4056; telephone (425) 227–2110; Executive Order 13132. Issued in Renton, Washington, on fax (425) 227–1149. For the reasons discussed above, I November 3, 2000. SUPPLEMENTARY INFORMATION: A certify that this action (1) is not a Donald L. Riggin, proposal to amend part 39 of the Federal ‘‘significant regulatory action’’ under Acting Manager, Transport Airplane Aviation Regulations (14 CFR part 39) to Executive Order 12866; (2) is not a Directorate, Aircraft Certification Service. include an airworthiness directive (AD) ‘‘significant rule’’ under DOT [FR Doc. 00–28829 Filed 11–13–00; 8:45 am] that is applicable to all Aerospatiale Regulatory Policies and Procedures (44 BILLING CODE 4910±13±P Model ATR42–500 series airplanes was FR 11034, February 26, 1979); and (3) published in the Federal Register on will not have a significant economic August 29, 2000 (65 FR 52369). That impact, positive or negative, on a DEPARTMENT OF TRANSPORTATION action proposed to require revising the substantial number of small entities Airworthiness Limitations Section of under the criteria of the Regulatory Federal Aviation Administration the Instructions for Continued Flexibility Act. A final evaluation has Airworthiness to incorporate life limits been prepared for this action and it is 14 CFR Part 39 for certain items and inspections to contained in the Rules Docket. A copy detect fatigue cracking in certain of it may be obtained from the Rules [Docket No. 2000±NM±26±AD; Amendment structures. 39±11974; AD 2000±23±04] Docket at the location provided under ADDRESSES. Comments the caption RIN 2120±AA64 Interested persons have been afforded List of Subjects in 14 CFR Part 39 Airworthiness Directives; Aerospatiale an opportunity to participate in the Air transportation, Aircraft, Aviation Model ATR42±500 Series Airplanes making of this amendment. No safety, Safety. comments were submitted in response Adoption of the Amendment AGENCY: Federal Aviation to the proposal or the FAA’s Administration, DOT. determination of the cost to the public. Accordingly, pursuant to the ACTION: Final rule. Conclusion authority delegated to me by the Administrator, the Federal Aviation SUMMARY: This amendment adopts a The FAA has determined that air Administration amends part 39 of the new airworthiness directive (AD), safety and the public interest require the Federal Aviation Regulations (14 CFR applicable to all Aerospatiale Model adoption of the rule as proposed. part 39) as follows: ATR42–500 series airplanes, that requires revising the Airworthiness Cost Impact PART 39ÐAIRWORTHINESS Limitations Section of the Instructions The FAA estimates that 8 airplanes of DIRECTIVES for Continued Airworthiness to U.S. registry will be affected by this AD, incorporate life limits for certain items that it will take approximately 1 work 1. The authority citation for part 39 and inspections to detect fatigue hour per airplane to accomplish the continues to read as follows: cracking in certain structures. This required actions, and that the average Authority: 49 U.S.C. 106(g), 40113, 44701. amendment is prompted by issuance of labor rate is $60 per work hour. Based § 39.13 [Amended] a new revision of the ‘‘Time Limits’’ on these figures, the cost impact of the section of the ATR42–400/500 required AD on U.S. operators is 2. Section 39.13 is amended by Maintenance Planning Document, estimated to be $480, or $60 per adding the following new airworthiness which specifies new inspections and airplane. directive: compliance times for inspection and The cost impact figure discussed 2000–23–04 Aerospatiale: Amendment 39– replacement actions. The actions above is based on assumptions that no 11974. Docket 2000–NM–26–AD. specified by this AD are intended to operator has yet accomplished any of Applicability: All Model ATR42–500 series ensure that fatigue cracking of certain the requirements of this AD action, and airplanes, certificated in any category. structural elements is detected and that no operator would accomplish Note 1: This AD applies to each airplane corrected; such fatigue cracking could those actions in the future if this AD identified in the preceding applicability

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At the time alternative method of compliance in 39±11982; AD 2000±23±12] the SNPRM was published, the manufacturer anticipated that the accordance with paragraph (c) of this AD. RIN 2120±AA64 The request should include an assessment of proposed reduced limits may be the effect of the modification, alteration, or Airworthiness Directives; CFE increased based upon further testing repair on the unsafe condition addressed by Company Model CFE738±1±1B and analysis for the stage 4 and 5 blisk this AD; and, if the unsafe condition has not Turbofan Engines and impeller aft shaft. been eliminated, the request should include Comments Received specific proposed actions to address it. AGENCY: Federal Aviation Compliance: Required as indicated, unless Administration, DOT. One comment was received. The accomplished previously. ACTION: Final rule. manufacturer, using the data obtained To ensure continued structural integrity of from additional testing and analysis, these airplanes, accomplish the following: SUMMARY: This amendment adopts a and life analysis prediction techniques Airworthiness Limitations Revision new airworthiness directive (AD), approved by the FAA, has requested applicable to CFE Company model that the cyclic life limits for the stage 4 (a) Within 30 days after the effective date CFE738–1–1B turbofan engines, that of this AD, revise the Airworthiness and 5 blisk proposed in the published Limitations Section of the Instructions for requires new life limits for certain HPC SNPRM be increased. This analysis Continued Airworthiness by incorporating rotor components in all engines. This showed that the life predictions of two the ‘‘Time Limits’’ section of the ATR42–400/ amendment is prompted by a reduction of the three stage 4 and 5 blisk 500 Maintenance Planning Document, in the calculated service life of certain configurations met initial published part Revision 3, dated February 1999, into the compressor rotor rotating parts to values cyclic life requirements. The analysis Airworthiness Limitations Section. below currently approved service lives. showed that the life of the remaining (b) Except as provided in paragraph (c) of The actions specified by this AD are stage 4 and 5 blisk configuration should this AD: After the actions specified in intended to prevent failure of certain be reduced from the previously paragraph (a) of this AD have been HPC rotor components, which could accomplished, no alternative inspections or approved cyclic life limit. result in an uncontained engine failure The FAA agrees with the revised inspection intervals may be approved for the and damage to the airplane. structural elements specified in the limits for the stage 4 and 5 blisk. This documents listed in paragraph (a) of this AD. DATES: Effective January 16, 2001. final rule has been revised accordingly ADDRESSES: The rulemaking docket may by removing two of the stage 4 and 5 Alternative Methods of Compliance be examined at the FAA, New England blisk configurations listed in the (c) An alternative method of compliance or Region, Office of the Regional Counsel, SNPRM and listing the recalculated adjustment of the compliance time that 12 New England Executive Park, cyclic life for the third stage 4 and 5 provides an acceptable level of safety may be Burlington, MA; or at the Office of the blisk configuration. used if approved by the Manager, Federal Register, 800 North Capitol In addition, reference to inspection International Branch, ANM–116, FAA, Street, NW, suite 700, Washington, DC. Transport Airplane Directorate. Operators work hours was removed from the shall submit their requests through an FOR FURTHER INFORMATION CONTACT: economic analysis section. Inspection appropriate FAA Principal Maintenance Keith Mead, Aerospace Engineer, requirements for these parts were Inspector, who may add comments and then Engine Certification Office, FAA, Engine removed in the SNPRM, and are not send it to the Manager, International Branch, and Propeller Directorate, 12 New applicable to this AD. ANM–116. England Executive Park, Burlington, MA Note 2: Information concerning the 01803–5299; telephone: (781) 238–7744, Economic Analysis existence of approved alternative methods of fax: (781) 238–7199. There are approximately 245 engines compliance with this AD, if any, may be SUPPLEMENTARY INFORMATION: A of the affected design in the worldwide obtained from the International Branch, proposal to amend part 39 of the Federal fleet. The FAA estimates that 156 ANM–116. Aviation Regulations (14 CFR part 39) to engines would be affected by this Special Flight Permits include an airworthiness directive (AD) proposed AD. Required parts, on a pro- (d) Special flight permits may be issued in that is applicable to CFE Company rated basis, would cost approximately accordance with sections 21.197 and 21.199 Model CFE 738–1–1B turbofan engines $13,613 per engine. Based on these of the Federal Aviation Regulations (14 CFR was published in the Federal Register figures, the total cost impact of the 21.197 and 21.199) to operate the airplane to on December 14, 1998 (63 FR 68707). proposed AD on US operators is a location where the requirements of this AD Based on additional material stress estimated to be $2,123628. can be accomplished. testing, the FAA published a Regulatory Impact Effective Date supplemental notice of proposed rule making (SNPRM) on September 23, This rule does not have federalism (e) This amendment becomes effective on 1999 (64 FR 51484). That SNPRM implications, as defined in Executive December 19, 2000. removed the proposal that would have Order 13132, because it would not have Issued in Renton, Washington, on required a dimensional inspection of the a substantial direct effect on the States, November 3, 2000. curvic couplings for parts that contain a on the relationship between the national Donald L. Riggin, machining mismatch and would have government and the States, or on the Acting Manager, Transport Airplane required those parts to be removed from distribution of power and Directorate, Aircraft Certification Service. service. That SNPRM, however, also responsibilities among the various [FR Doc. 00–28828 Filed 11–13–00; 8:45 am] introduced a requirement to remove levels of government. Accordingly, the BILLING CODE 4910±13±U parts prior to a new reduced cyclic life FAA has not consulted with state

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68078 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations authorities prior to publication of this Administrator, the Federal Aviation requirements of this AD. For engines that rule. Administration proposes to amend part have been modified, altered, or repaired so For the reasons discussed above, I 39 of the Federal Aviation Regulations that the performance of the requirements of certify that this action (1) is not a (14 CFR part 39) as follows: this AD is affected, the owner/operator must ‘‘significant regulatory action’’ under request approval for an alternative method of Executive Order 12866; (2) is not a PART 39ÐAIRWORTHINESS compliance in accordance with paragraph (c) ‘‘significant rule’’ under the DOT DIRECTIVES of this AD. The request should include an Regulatory Policies and Procedures (44 assessment of the effect of the modification, FR 11034, February 26, 1979); and (3) 1. The authority citation for part 39 alteration, or repair on the unsafe condition will not have a significant economic continues to read as follows: addressed by this AD; and, if the unsafe impact, positive or negative, on a Authority: 49 U.S.C. 106(g), 40113, 44701. condition has not been eliminated, the substantial number of small entities request should include specific proposed under the criteria of the Regulatory § 39.13 [Amended] actions to address it. Flexibility Act. A final evaluation has 2. Section 39.13 is amended by Compliance: Required as indicated, unless been prepared for this action and is adding the following new airworthiness accomplished previously. contained in the Rules Docket. A copy directive: To prevent failure of certain high pressure compressor of it may be obtained by contacting the 2000–23–12 CFE Company: Amendment Rules Docket at the location provided 39–11982. Docket No. 98–ANE–69–AD. (HPC) rotor components, which could ADDRESSES result in an uncontained engine failure and under the caption . Applicability: CFE Company Model damage to the airplane, accomplish the List of Subjects in 14 CFR Part 39 CFE738–1–1B turbofan engines, installed on but not limited to the Dassault Aviation following: Air transportation, Aircraft, Aviation Falcon 2000 series airplanes. (a) Remove from service certain stage 4 and safety, Safety. Note 1: This airworthiness directive (AD) 5 blisks and impeller aft shafts prior to Adoption of the Amendment applies to each engine identified in the exceeding the new cyclic life limits as preceding applicability provision, regardless follows, and replace with serviceable parts: Accordingly, pursuant to the of whether it has been modified, altered, or authority delegated to me by the repaired in the area subject to the

Part No. Nomenclature (P/N) Cyclic life limit

Stage 4 and 5 Blisk ...... 6079T74P08 6,700 cycles since new (CSN). Impeller Aft Shaft ...... 6079T80P04 5,100 CSN. 6079T80P05 2,160 CSN. 6079T80P06 7,100 CSN. 6079T80P07 7,100 CSN.

(b) Except for the provisions of paragraph Issued in Burlington, Massachusetts, on protocols for Public Service of New (c) of this AD, no parts, identified by P/N in November 6, 2000. Hampshire (PSNH). The regulations and paragraph (a) of this AD, that exceed the new Donald Plouffe, order are part of a regional nitrogen life limits may be installed. Acting Manager, Engine and Propeller oxide ( NOX) reduction program Directorate, Aircraft Certification Service. Alternative Methods of Compliance designed to reduce stationary source [FR Doc. 00–28961 Filed 11–13–00; 8:45 am] NOX emissions during the ozone season (c) An alternative method of compliance or BILLING CODE 4910±13±P in the Ozone Transport Region (OTR) of adjustment of the compliance time that the northeastern United States. Section provides an acceptable level of safety may be 184(a) of the Clean Air Act defines the used if approved by the Manager, Engine ENVIRONMENTAL PROTECTION OTR as the States of Connecticut, Certification Office (ECO). Operators shall AGENCY Delaware, Maine, Maryland, submit their requests through an appropriate Massachusetts, New Hampshire, New FAA Principal Maintenance Inspector, who 40 CFR Part 52 Jersey, New York, Pennsylvania, Rhode may add comments and then send it to the [NH±042±7169a; A±1±FRL±6871±2] Island, Vermont, and the Consolidated Manager, ECO. metropolitan Statistical Area that Note 2: Information concerning the Approval and Promulgation of Air includes the District of Columbia. These existence of approved alternative methods of Quality Implementation Plans; New SIP revisions were submitted pursuant compliance with this airworthiness directive, Hampshire; New HampshireÐNitrogen to section 110 of the Clean Air Act if any, may be obtained from the ECO. Oxides Budget and Allowance Trading (CAA). Special Flight Permits Program DATES: This direct final rule is effective (d) Special flight permits may be issued in AGENCY: Environmental Protection on January 16, 2001 without further accordance with sections 21.197 and 21.199 Agency (EPA). notice, unless EPA receives adverse comment by December 14, 2000. If of the Federal Aviation Regulations (14 CFR ACTION: Direct final rule. 21.197 and 21.199) to operate the airplane to adverse comment is received, EPA will a location where the requirements of this AD SUMMARY: EPA is approving State publish a timely withdrawal of the can be accomplished. Implementation Plan (SIP) revisions direct final rule in the Federal Register submitted by the State of New and inform the public that the rule will Effective Date of This AD Hampshire. This action consists of not take effect. (e) This amendment becomes effective on approving regulations in New ADDRESSES: Comments may be mailed to January 16, 2001. Hampshire, as well as a case-specific David Conroy, Manager, Air Quality order and two emission quantification Planning Unit, Office of Ecosystem

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Protection (mail code CAQ), U.S. May 1, 1996. The basis for the model conduct an audit of the program to Environmental Protection Agency, rule was a memorandum of ensure that the expected reductions are Region I, One Congress Street, Suite understanding entitled, ‘‘Memorandum occurring. 1100, Boston, MA 02114–2023. Copies of Understanding Among the States of III. RACT Order 98–001 & Emission of the documents relevant to this action the Ozone Transport Commission on Quantification Protocols for Public are available for public inspection Development of a Regional Strategy Service of New Hampshire during normal business hours, by Concerning the Control of Stationary appointment at the Office Ecosystem Source Nitrogen Oxide Emissions,’’ In addition to Chapter Env-A 3200, on Protection, U.S. Environmental dated September 27, 1994, otherwise July 27, 1998, New Hampshire also Protection Agency, Region I, One known as the ‘‘OTC MOU.’’ submitted Final RACT Order 98–001 Congress Street, 11th floor, Boston, MA, The OTC MOU committed the MOU which was issued to PSNH under Part and at the New Hampshire Air signatory States to require certain major Env-A 1211. First, the order requires Resources Division, Department of stationary sources to reduce their NOX PSNH’s unit #2 at its Merrimack Station Environmental Services, 6 Hazen Drive, emissions through several regulatory (MK2) to meet an emission limitation of P.O. Box 95, Concord, NH 03301. stages. The NOX RACT regulations 15.4 tons of NOX per 24 hour calendar FOR FURTHER INFORMATION CONTACT: Dan required by section 182 of the Clean Air day by May 31, 1999. This limit can be Brown, (617) 918–1532 or at Act have reduced emissions at major met directly at MK2 or through the use [email protected]. stationary sources of NOX since 1995. of approved emission credits generated Those reductions are considered ‘‘phase in the ozone season at other facilities. SUPPLEMENTARY INFORMATION: I’’ of the OTC program. Under ‘‘phase Second, the order requires PSNH to I. Background II’’ of the program, the MOU committed meet an emissions cap of 4,662 tons the signatory states to imposing a cap on during the period between May 1 and A. Clean Air Act Requirements regional NOX emissions during the five October 1 for the combined NOX Sections 182(b)(1)(A) and 182(c)(2)(A) month periods between May 1 through emissions from the following units: of the CAA require States with areas September 30 of 1999, 2000, 2001, and units #1 and #2 at Merrimack Station, classified as ‘‘moderate,’’ ‘‘serious,’’ and 2002. The third stage of the OTC unit #1 at Newington Station, and units ‘‘severe’’ ozone nonattainment to submit program, i.e., ‘‘phase III,’’ will tighten #4, #5, and #6 at Schiller Station, during revisions to their applicable SIPs to the regional cap and is set to begin on the years 1999, 2000, 2001, and 2002. provide for specific annual reductions May 1, 2003 and continue in each ozone Beginning on May 1, 2003, the order in emissions of volatile organic season thereafter. requires those units, to comply with an compounds (VOCs) and oxides of ozone season cap of 3,627 tons, minus nitrogen as necessary to attain the II. Chapter Env-A 3200 ‘‘ NOX BUDGET any tons allocated to new sources national primary ambient air quality TRADING PROGRAM’’ subject to the program. Additionally, the standard for ozone. Additionally, New Hampshire’s Chapter Env-A order requires the PSNH units to meet section 110 of the Act requires that such 3200 contains both phase II and phase a NOX cap of 8,208 tons between plans be subject to public notice, III NOX budget program reduction October 1 and April 30 of each year, comment, and hearing procedures and requirements. New Hampshire’s NOX beginning in 1999. that the States adopt and submit the budget regulations set a statewide, five Order ARD 98–001 also contains plans to EPA. month (May through October) NOX provisions that allow PSNH to generate As part of New Hampshire’s efforts to ‘‘budget,’’ or mass emission limit in discrete emission reductions (DERs) meet the CAA requirements, on July 27, tons, to reduce the aggregate emissions according to the requirements of 1998, the New Hampshire Department from large fossil fuel fired combustion Chapter Env-A 3100, New Hampshire’s of Environmental Services (NH DES) equipment by as much as 75% from a discrete emission reduction trading submitted a request to revise its SIP by 1990 baseline. In order to achieve the regulation, by reducing emissions below adding CHAPTER Env-A 3200 ‘‘ NOX aggregate NOX reductions, the the NOX limitations contained in Env-A BUDGET TRADING PROGRAM’’ and regulations proportion NOX 1211, Order ARD 97–001, and all other Final RACT Order ARD–98–001. The ‘‘allowances’’ (in tons) to the facilities applicable emission limits. However, regulations and order impose statewide with emission units subject to the because Env-A 3100 has not yet been and source-specific caps on NOX program. The regulations require each approved into the New Hampshire SIP, emissions from certain industrial owner or operator of each unit to hold, New Hampshire submitted the emission equipment (e.g., electric utility boilers, by December 31 of each year, at least as reduction protocols as case-specific SIP industrial boilers, combustion turbines, many NOX allowances in their revisions. The SIP submittal included etc.). New Hampshire’s CHAPTER Env- compliance account as total tons of NOX two credit generation protocols, as well A 3200 is based closely on a model rule emitted during the previous five month as the credits created by the protocols which was developed using the EPA’s ozone season. that were generated by PSNH from May economic incentive program (EIP) Under the NOX Budget regulations, 1, 1995 through September 30, 1997. guidance (67 FR 16690, April 7, 1994) NOX allowances may be bought or sold IV. EPA Evaluation as the regulatory framework. and unused allowances may be banked from one year to another in a central Based on the EIP, EPA finds the NOX B. The OTC MOU Program registry administered by EPA. The cap and trade regulations, case-specific The model rule used by New program requires NOX emissions to be NOX RACT order, and quantification Hampshire was developed by the monitored by either a continuous protocols fully approvable. See Northeast States for Coordinated Air emission monitoring system (CEMS) or ‘‘Technical Support Document for the Use Management (NESCAUM) and the equivalent, although the use of Approval of New Hampshire’s Mid-Atlantic Regional Air Management alternatives is allowed where approved CHAPTER Env-A 3200 NOX BUDGET Association (MARAMA) entitled, by the State and EPA. The program TRADING PROGRAM and Final RACT ‘‘NESCAUM/MARAMA NOX Budget began on May 1, 1999. Starting in 2002 Order 98–001,’’ dated January 7, 1999, Model Rule.’’ The NESCAUM/ and occurring every three years after, for EPA’s detailed evaluation. The MARAMA model rule was issued on New Hampshire and the OTC will technical support document is available,

VerDate 112000 16:49 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68080 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations upon request, from the EPA Regional (November 7, 1997) examined the Final Action: EPA is approving New Office listed in the ADDRESSES section of effects of transport from the 36 States Hampshire’s CHAPTER Env-A 3200 ‘‘ this document. and the District of Columbia which NOX BUDGET TRADING PROGRAM,’’ made up the ozone transport assessment Order ARD 98–001, and two emission V. Issues group (OTAG) region, EPA has not yet quantification protocols. One issue related to New Hampshire’s finalized the NOX SIP call for all 37 The EPA is publishing this action NOX Budget Trading Program involves entities specified in the October 1998 without prior proposal because the the overlap of New Hampshire’s NOX final rulemaking notice. EPA is Agency views this as a noncontroversial Budget Trading Program and the EPA’s continuing to evaluate air quality amendment and anticipates no adverse NOX SIP Call summarized below. modeling for 15 States which were part comments. However, in the proposed of the OTAG region, including New rules section of this Federal Register A. NOX SIP Call Hampshire, in order to make a final publication, EPA is publishing a From 2003 onward, the geographic determination of whether they separate document that will serve as the size of the market for allowances issued significantly contribute to the transport proposal to approve the SIP revision by New Hampshire will be directly of ozone. Whether New Hampshire should relevant adverse comments be affected by the promulgation of EPA’s ultimately will be part of the NOX SIP filed. This rule will be effective January rule entitled, ‘‘Finding of Significant call is uncertain at this time. 16, 2001 without further notice unless Contribution and Rulemaking for the Agency receives relevant adverse Certain States in the Ozone Transport B. Overlap of OTC and NOX SIP call comments by December 14, 2000. Assessment Group Region for Purposes Allowance Trading Programs If the EPA receives such comments, of Reducing Regional Transport of Based on the SIP submittals by then EPA will publish a notice Ozone,’’ otherwise known as the ‘‘ NOX Connecticut, Massachusetts, New Jersey, withdrawing the final rule and SIP call.’’ See 63 FR 57356, October 27, and Rhode Island, EPA anticipates that informing the public that the rule will 1998, aff’d in part, State of Michigan v. the OTR States which are part of the not take effect. All public comments U.S. EPA, No. 98–1497 (D.C. Cir., March OTC NOX budget and allowance trading received will then be addressed in a 3, 2000). program and, which are subject to the subsequent final rule based on the The NOX SIP call requires specified NOX SIP call, will participate in a proposed rule. The EPA will not States to submit SIP revisions to regional cap and trade program to meet institute a second comment period on prohibit specified amounts of NOX the NOX SIP call requirements. the proposed rule. Only parties emissions, in order to reduce emissions Therefore, the issue associated with the interested in commenting on this action in each of those States to a level within approval of the New Hampshire should do so at this time. the statewide NOX emissions budget program relates to the fact that although VI. Administrative Requirements established in the NOX SIP call final New Hampshire is an OTC state, it is rule. The NOX SIP call gives States the not a NOX SIP call state. Under Executive Order 12866 (58 FR flexibility to choose any mix of EPA is currently administering the 51735, October 4, 1993), this action is pollution-reduction measures that will emissions tracking and allowance not a ‘‘significant regulatory action’’ and achieve the required reductions. The tracking systems for the OTC NOX therefore is not subject to review by the NOX SIP call, however, suggests that budget program. EPA will also be Office of Management and Budget. This imposing statewide NOX emissions caps administering the NOX SIP call action merely approves state law as on large fossil-fuel fired industrial emissions and allowance tracking meeting federal requirements and boilers and electricity generators would systems. This means that for States imposes no additional requirements provide a cost effective means for States subject to both the OTC and NOX SIP beyond those imposed by state law. to meet their NOX budgets. In fact, the call programs, 1999 through 2002 NOX Accordingly, the Administrator certifies NOX SIP call State budgets were set at allowances will be tracked in the OTC that this rule will not have a significant levels which reflect the NOX reduction allowance tracking system, and then economic impact on a substantial possible assuming a 0.15 lbs/mmBtu- eligible 2003 and beyond allowances number of small entities under the based cap being applied to the large will be tracked in the NOX SIP call Regulatory Flexibility Act (5 U.S.C. 601 industrial boilers and electricity allowance tracking system. et seq.). Because this rule approves pre- generators. The New Hampshire regulations are existing requirements under state law One option to comply with the NOX not considered a NOX SIP call and does not impose any additional SIP call is the adoption of a State rule submission nor is today’s SIP action an enforceable duty beyond that required based on the EPA’s model NOX Budget approval of trading these allowances for by state law, it does not contain any Trading Program (40 CFR part 96), NOX SIP call purposes. Therefore, unfunded mandate or significantly or which was finalized in the October 1998 because the OTC phase III NOX cap in uniquely affect small governments, as NOX SIP call rule. Part 96 sets forth a New Hampshire is not as stringent as a described in the Unfunded Mandates cap-and-trade program for NOX NOX SIP call cap would be, New Reform Act of 1995 (Public Law 104–4). emissions that employs a cap on total Hampshire OTC phase III allowances For the same reason, this rule also does NOX emissions for the ozone season. will not be transferable to accounts in not significantly or uniquely affect the This mechanism ensures that emissions the NOX SIP call tracking system. As of communities of tribal governments, as reductions are achieved and May 1, 2003, New Hampshire’s NOX specified by Executive Order 13084 (63 maintained, while providing the cost- allowances will not be available for FR 27655, May 10, 1998). This rule will effectiveness of a market-based system. compliance purposes in NOX SIP call not have substantial direct effects on the The NOX SIP call requires the covered affected States. However, because the States, on the relationship between the states to adopt regulations which NOX SIP call program requirements national government and the States, or implement control strategies starting in would be more stringent than the OTC on the distribution of power and 2003 in order to achieve the specific program requirements, NOX SIP call responsibilities among the various statewide budgets by 2007. program allowances will be available for levels of government, as specified in Although EPA’s notice of proposed sources to meet the New Hampshire Executive Order 13132 (64 FR 43255, rulemaking (NPR) for the NOX SIP call OTC phase III emission limits. August 10, 1999), because it merely

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68081 approves a state rule implementing a States prior to publication of the rule in New Hampshire Air Resources Division federal standard, and does not alter the the Federal Register. A major rule on July 27, 1998. relationship or the distribution of power cannot take effect until 60 days after it (i) Incorporation by reference. and responsibilities established in the is published in the Federal Register. (A) Regulation Chapter Env-A 3200 Clean Air Act. This rule also is not This action is not a ‘‘major rule’’ as NOX Budget Trading Program adopted subject to Executive Order 13045 (62 FR defined by 5 U.S.C. 804(2). and effective on July 17, 1998. 19885, April 23, 1997), because it is not Under section 307(b)(1) of the Clean (ii) Additional materials. economically significant. Air Act, petitions for judicial review of In reviewing SIP submissions, EPA’s this action must be filed in the United (A) Letter from the New Hampshire role is to approve state choices, States Court of Appeals for the Air Resources Division dated July 27, provided that they meet the criteria of appropriate circuit by January 16, 2001. 1998 submitting Chapter Env-A 3200 the Clean Air Act. In this context, in the Interested parties should comment in NOX Budget Trading Program as a absence of a prior existing requirement response to the proposed rule rather revision to the New Hampshire State for the State to use voluntary consensus than petition for judicial review, unless Implementation Plan. standards (VCS), EPA has no authority the objection arises after the comment * * * * * to disapprove a SIP submission for period allowed for in the proposal. (64) Revisions to the State failure to use VCS. It would thus be Filing a petition for reconsideration by Implementation Plan submitted by the inconsistent with applicable law for the Administrator of this final rule does New Hampshire Air Resources Division EPA, when it reviews a SIP submission, not affect the finality of this rule for the on July 27, 1998. to use VCS in place of a SIP submission purposes of judicial review nor does it (i) Incorporation by reference. that otherwise satisfies the provisions of extend the time within which a petition (A) Order ARD 98–001 issued by the the Clean Air Act. Thus, the for judicial review may be filed, and New Hampshire Department of requirements of section 12(d) of the shall not postpone the effectiveness of Environmental Services to Public National Technology Transfer and such rule or action. This action may not Service Company of New Hampshire on Advancement Act of 1995 (15 U.S.C. be challenged later in proceedings to July 17, 1998, with attachments: 272 note) do not apply. As required by enforce its requirements. (See section Discrete emission reduction protocol for section 3 of Executive Order 12988 (61 307(b)(2).) Public Service of New Hampshire’s FR 4729, February 7, 1996), in issuing List of Subjects in 40 CFR Part 52 Schiller Station, Units 4, 5 and 6, this rule, EPA has taken the necessary submitted to the New Hampshire steps to eliminate drafting errors and Environmental protection, Air Department of Environmental Services ambiguity, minimize potential litigation, pollution control, Incorporation by on April 10, 1998; and Discrete and provide a clear legal standard for reference, Intergovernmental relations, emission reduction protocol for Public affected conduct. EPA has complied Nitrogen dioxide, Ozone, Particulate Service of New Hampshire’s Newington with Executive Order 12630 (53 FR matter, Reporting and recordkeeping Station, Unit 1, submitted to the New 8859, March 15, 1988) by examining the requirements. Hampshire Department of takings implications of the rule in Dated: September 6, 2000. Environmental Services on April 10, accordance with the ‘‘Attorney Mindy S. Lubber, 1998. General’s Supplemental Guidelines for the Evaluation of Risk and Avoidance of Regional Administrator, EPA-New England. (ii) Additional materials. Unanticipated Takings’ issued under the Part 52 of chapter I, title 40 of the (A) Letter from the New Hampshire executive order. This rule does not Code of Federal Regulations is amended Air Resources Division dated July 17, impose an information collection as follows: 1998 submitting Final RACT Order 98– burden under the provisions of the 001 as a revision to the New Hampshire PART 52Ð[AMENDED] Paperwork Reduction Act of 1995 (44 State Implementation Plan. U.S.C. 3501 et seq.). 1. The authority citation for part 52 * * * * * The Congressional Review Act, 5 continues to read as follows: 3. In § 52.1525, Table 52.1525 is U.S.C. 801 et seq., as added by the Small Authority: 42 U.S.C. 7401 et seq. amended by revising the column Business Regulatory Enforcement heading ‘‘Comments’’ to read Fairness Act of 1996, generally provides Subpart EEÐNew Hampshire ‘‘Explanation’’; adding a new state that before a rule may take effect, the citation for ‘‘Part Env-A 3200’’ in agency promulgating the rule must 2. Section 52.1520 is amended by numerical order to the entries for ‘‘Part submit a rule report, which includes a adding paragraphs (c)(57) and (c)(64) to Env-A’’; and by adding Source specific copy of the rule, to each House of the read as follows: ‘‘Order ARD 98–001’’ in numerical Congress and to the Comptroller General order to the entries for ‘‘Order ARD’’ as § 52.1520 Identification of plan. of the United States. EPA will submit a follows: report containing this rule and other * * * * * required information to the U.S. Senate, (c) * * * § 52.1525 EPA-approved New Hampshire the U.S. House of Representatives, and (57) Revision to the State state regulations. the Comptroller General of the United Implementation Plan submitted by the * * * * *

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TABLE 52.1525.ÐEPAÐAPPROVED RULES AND REGULATIONS 1ÐNEW HAMPSHIRE

State citation Date sub- Date approved Federal Register Title/subject 2 mitted by 52.1520 Explanation chapter State by EPA citation

******* NOX Budget Trading Part Env-A 3200 ...... 7/27/98 11/14/00 65 FR 68082 ...... (c)(57) Approval of OTC Program. NOX budget and al- lowance trading program.

******* Source specific order Order ARD 98±001 ... 7/17/98 11/14/00 65 FR 68082 ...... (c)(64) Source-specific NOX RACT order and discrete emission reduction protocols for Public Service of New Hampshire.

******* NOX Budget Trading Part Env-A 3200 ...... 7/27/98 11/14/00 65 FR 68082 ...... (c)(57) Approval of OTC Program. NOX budget and al- lowance trading program.

******* 1 These regulations are applicable statewide unless otherwise noted in the Explanation section. 2 When the New Hampshire Department of Environmental Services was established in 1987, the citation chapter title for the air regulations changed from CH Air to Env-A.

[FR Doc. 00–28707 Filed 11–13–00; 8:45 am] ADDRESSES: Federal Communications Synopsis of the Order BILLING CODE 6560±50±P Commission, 445 12th Street, SW, Introduction Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: 1. In this Report and Order (‘‘Order’’), FEDERAL COMMUNICATIONS Eloise Gore at (202) 418–7200 or via we adopt network non-duplication, COMMISSION internet at [email protected]. syndicated exclusivity, and sports SUPPLEMENTARY INFORMATION: This is a blackout rules for satellite carriers. 47 CFR Parts 73 and 76 summary of the Commission’s Report These rules implement provisions of the and Order (‘‘Order’’), FCC 00–388, Satellite Home Viewer Improvement Act [CS Docket No. 00±2; FCC 00±388] adopted October 27, 2000; released of 1999 (‘‘SHVIA,’’ Public Law 106–113, 113 Stat. 1501, 1501A–526 to 1501A– Implementation of the Satellite Home November 2, 2000. The full text of the 545 (Nov. 29, 1999)), which provides Viewer Improvement Act of 1999: Commission’s Order is available for statutory copyright licenses for satellite Application of Network inspection and copying during normal carriers to provide additional local and Nonduplication, Syndicated business hours in the FCC Reference national broadcast programming to Exclusivity, and Sports Blackout Rules Center (Room CY–A257) at its subscribers. In enacting the SHVIA, to Satellite Retransmissions of headquarters, 445 12th Street, SW, Congress sought to create parity Broadcast Signals Washington, DC 20554, or may be purchased from the Commission’s copy between satellite carriers and cable AGENCY: Federal Communications contractor, International Transcription operators with regard to the Commission. Service, Inc., (202) 857–3800, 1231 20th retransmission of broadcast ACTION: Final rule. Street, NW, Washington, DC 20036, or programming and to expand the may be reviewed via internet at http:// availability of such programming to SUMMARY: This document adopts www.fcc.gov/csb/ For copies in consumers. Prior to enactment of the regulations to implement certain aspects alternative formats, such as braille, SHVIA, the copyright laws made it of the Satellite Home Viewer audio cassette or large print, please virtually impossible for satellite Improvement Act of 1999, which was contact Sheila Ray at ITS. subscribers to receive television enacted on November 29, 1999. Among broadcast programming by satellite. In other things, the act authorizes satellite Paperwork Reduction Act adopting these rules, the Commission carriers to add more local and national This Report and Order contains new implements the statutory requirements broadcast programming to their or modified information collection(s) and seeks to facilitate competition in the offerings and seeks to place satellite subject to the Paperwork Reduction Act multichannel video programming carriers on an equal footing with cable of 1995 (PRA), Public Law 104–13. The distribution marketplace. operators with respect to availability of Commission is requesting Office of 2. Section 1008 of the SHVIA creates broadcast programming. This document Management and Budget (‘‘OMB’’) a new section 339 of the adopts regulations that apply current approval, under the emergency Communications Act of 1934, as cable rules for network non-duplication, processing provisions of the 1995 Act (5 amended (‘‘Communications Act’’) syndicated program exclusivity and CFR 1320.13), of the information entitled ‘‘Carriage of Distant Television sports blackout to satellite carriers. collection requirements contained in Stations by Satellite Carriers.’’ Section DATES: Effective November 29, 2000. this Report and Order. 339(b) directs the Commission to apply

VerDate 112000 16:49 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68083 the network non-duplication, will be ‘‘as similar as possible’’ to the retransmits a nationally distributed syndicated exclusivity, and sports rules applicable to cable operators. superstation or a distant network station blackout rules, previously applicable carrying that sporting event to a Summary of Decision only to cable television systems, to household within the zone of protection satellite carriers’ retransmission of 5. In implementing these sections of of the holder of exclusive distribution nationally distributed superstations to the SHVIA, the Commission attempts to rights to the event. In all of these cases, satellite subscribers. Congress also be faithful to the clear Congressional the television broadcast station or other requires the Commission to apply the intent to place satellite carriers on an rights holder may require the satellite cable sports blackout rule to satellite equal footing with cable operators, carrier to blackout these particular carriers’ retransmission of network while taking into consideration that the programs for the satellite subscriber stations, but only ‘‘to the extent operational structures of these two households within the protected zone. technically feasible and not Multichannel Video Programming 7. In the NPRM we sought comments economically prohibitive.’’ The Distributors (‘‘MVPD’’s) are very on how we could follow the Commission released a Notice of different. In the context of the SHVIA, Congressional mandate to apply the which is fundamentally part of the Proposed Rulemaking (‘‘NPRM’’) on cable exclusivity rules as closely as copyright laws, we are cognizant also of January 7, 2000, seeking comment on possible to satellite carriers while taking the important protection that the how best to apply these rules to satellite account of the differences between the exclusivity rules provide to broadcasters carriers (65 FR 4927, February 2, 2000). two industries. In general, the and copyright holders. The SHVIA The Commission received 22 comments comments did not provide specific data facilitates satellite carriage of additional and 14 reply comments to the NPRM. on cost or technical difficulties in broadcast stations through the use of a applying the exclusivity rules to Background statutory copyright license. By applying satellite carriers and leave us with the 3. The network non-duplication, the cable exclusivity rules to satellite conclusion that, in most cases, these syndicated exclusivity, and sports carriers, Congress sought to keep the blackout rules (collectively referred to competitive marketplace in balance by rules can be applied directly to satellite herein as ‘‘the exclusivity rules’’), as protecting the broadcasters’ private carriers. There is a general consensus, applied in the cable context, generally contractual arrangements and ensuring however, that the ‘‘community units’’ protect exclusive contractual rights that that satellite carriers have regulatory used for identification of cable systems have been negotiated between program obligations that are as similar as are inapplicable in the satellite context. providers and broadcasters or other possible to cable operators. The We decide here to use zip codes in lieu rights holders. These exclusive statutory language unambiguously of community units to define the contractual rights are potentially directs us to apply all three of the cable various zones of protection afforded threatened by cable systems that are exclusivity rules to satellite carriers under the satellite exclusivity rules capable of importing duplicative with respect to retransmission of adopted today. In large part, the programming from distant sources nationally distributed superstations. notification provisions of the cable beyond the control of the contracting The SHVIA further requires that only exclusivity rules can be applied in the parties. The cable exclusivity rules the sports blackout rule be applied to satellite context, except with respect to provide that specific programs must be satellite carriers’ retransmission of the sports blackout requirements, for deleted from distant television network stations and limits application which we have the statutory flexibility broadcast signals delivered to cable of the cable rule in this context ‘‘to the and record to support slightly different subscribers if the programs are subject extent technically feasible and not requirements. In a further effort to to exclusive rights pursuant to contracts economically prohibitive.’’ provide comparable treatment for the with local stations. Additionally, Congressional intent, as expressed in cable and satellite rules, we adapt the pursuant to the sports blackout rule, the Joint Explanatory Statement, places exceptions to the cable exclusivity rules sporting events carried on distant a heavy burden on showing that rules for small systems to the satellite context. stations must be deleted when carriage similar to the cable rules would be We also require that the contractual would violate sporting teams’ or ‘‘economically prohibitive’’ for satellite language granting exclusive rights in a leagues’ arrangements to protect gate carriers. market clearly apply to satellite carriage, receipts in the local market. 6. In general, under the new statutory and we provide a period of time for 4. Section 339(b)(1)(A) of the provisions, the network non-duplication satellite carriers to phase-in Communications Act, as amended by and syndicated exclusivity rules apply implementation of the new rules. the SHVIA, requires the Commission ‘‘to when a satellite carrier retransmits a Finally, we decline to take the steps apply network non-duplication nationally distributed superstation to a advocated by the National Football protection (47 CFR 76.92), syndicated household within a local broadcaster’s League to go beyond the statutory exclusivity protection (47 CFR 76.151), zone of protection, and the nationally requirements to delete non-duplicating and sports blackout protection (47 CFR distributed superstation carries a sports programming that is part of a 76.67) to the retransmission of the program to which the local station has sports program ‘‘unitary’’ package signals of nationally distributed exclusive rights. The program may fall because it would unnecessarily and superstations by satellite carriers to under either the definition of network unjustifiably further limit the ability of subscribers.’’ Section 339(b)(1)(B) program (delivered simultaneously to consumers to view the programming of requires the Commission to ‘‘apply more than one broadcast station, (47 their choice. sports blackout protection (47 CFR CFR 76.5(m)) or the definition of Statutory Interpretation and 76.67) to the retransmission of the syndicated program (sold, licensed, Definitional Issues signals of network stations by satellite distributed or sold to licensees in more carriers to subscribers’’ ‘‘to the extent than one market (47 CFR 76.5(ii)). In 8. Section 339(b)(1), as created by the technically feasible and not addition, the sports blackout rules will SHVIA, applies to ‘‘satellite carriers.’’ economically prohibitive.’’ The SHVIA apply when a subject sporting event will Section 339(d)(4) defines ‘‘satellite requires that the Commission not be aired live by any local television carrier’’ by reference to the Copyright implement these new rules so that they station, and a satellite carrier Act definition as

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68084 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations an entity that uses the facilities of a satellite Television network means ‘‘a distributed superstations to subscribers or satellite service licensed by the Federal television network in the United States who do not reside in ‘‘unserved Communications Commission and operates which offers an interconnected program households’’ shall not violate the in the Fixed-Satellite Service under part 25 service on a regular basis for 15 or more compulsory copyright license. (An of title 47 of the Code of Federal Regulations or the Direct Broadcast Satellite Service hours per week to at least 25 affiliated unserved household is defined in part under part 100 of title 47 of the Code of broadcast stations in 10 or more States’’ as one that cannot receive over-the-air a Federal Regulations, to establish and operate (47 U.S.C. 339(d)(5)). A ‘‘network signal of Grade B intensity for a primary a channel of communications for point-to- station’’ is ‘‘(A) a television broadcast television network station (17 U.S.C. multipoint distribution of television station station, including any translator station 119(d)(10)).) Thus, we conclude that as signals, and that owns or leases a capacity or or terrestrial satellite station that a result of section 1005(b), there is no service on a satellite in order to provide such rebroadcasts all or substantially all of geographic restriction on the point-to-multipoint distribution, except to the programming broadcast by a retransmission of ‘‘nationally the extent that such entity provides such network station, that is owned or distributed superstations’’ pursuant to distribution pursuant to tariff under the operated by, or affiliated with, one or the compulsory copyright license. Communications Act of 1934, other than for private home viewing. (17 U.S.C. 119(d)(6)) more of the television networks in the 12. In addition, the SHVIA amended United States which offer an the retransmission consent section of Contrary to the arguments of several interconnected program service on a the Communications Act, which commenters, there is nothing in the regular basis for 15 or more hours per generally prohibits MVPDs from SHVIA or the legislative history that week to at least 25 of its affiliated retransmitting the signals of a suggests that satellite carriers operating television licensees in 10 or more broadcaster absent the broadcaster’s in the C-Band were intended to be States’’ or ‘‘(B) a noncommercial written authorization. The SHVIA exempted from the requirements of educational broadcast station (as allows a satellite carrier to retransmit section 339(b)(1). C-Band satellite defined in section 397 of the the signal of a superstation outside the carriers are licensed under part 25 of the Communications Act of 1934)’’ except station’s local market without the Commission’s rules. We do not agree that the term does not include ‘‘the station’s consent if: (i) The station was that an isolated and ambiguous colloquy signal of the Alaska Rural a superstation on May 1, 1991, and (ii) between two Senators overrides Communications Service, or any the station was retransmitted by the unambiguous statutory language. We successor entity to that service.’’ (17 satellite carrier as of July 1, 1998, recognize, however, that C-Band carriers U.S.C. 119(d)(2).) provided the satellite carrier complies operate differently from DBS carriers 10. In the NPRM, we stated that the with the Commission’s non-duplication, and that the number of C-Band television broadcast stations that meet syndicated exclusivity, and sports black subscribers is steadily decreasing, and the foregoing criteria are limited to out rules. This provision differs slightly to the extent C-Band satellite carriers KTLA–TV (Los Angeles), WPIX–TV from the definition of a nationally can be subject to exceptions from any of (New York), KWGN–TV (Denver), distributed superstation in that it does the exclusivity rules we adopt today, WSBK–TV (Boston), WWOR–TV (New not specify that the superstation must they are specifically described below. In York) and WGN–TV (Chicago). KTLA, not be affiliated with a network that the absence of specific language WPIX and KWGN are all now affiliates existed as such as of January 1, 1995. At distinguishing C-Band satellite carriers, of the Warner Brothers Network (‘‘WB’’). this time, this distinction is without references to ‘‘satellite carriers’’ in this In addition, WSBK and WWOR practical significance because the six Order refer to all satellite carriers that currently are affiliated with the UPN television stations cited above meet the meet the definition in the SHVIA. Network. WGN is affiliated with WB but relevant criteria of either definition, and 9. Section 339(b)(1)(A) of the provides a different ‘‘syndex/nondupe there are no additional stations that are Communications Act requires the proof’’ signal for uplink and carriage as included or excluded by operation of Commission to apply network non- a superstation. We note that WB and this third criterion. As discussed in the duplication protection, syndicated UPN did not qualify as ‘‘television NPRM, we conclude that, pursuant to exclusivity protection, and sports networks’’ as of January 1, 1995, the these new statutory mandates in the blackout protection to the operative date referenced in section SHVIA, satellite carriers are permitted retransmission of the signals of 339(d)(2)(A) because they did not satisfy to retransmit the signals of the nationally distributed superstations by each of the statutory criteria as of that nationally distributed superstations satellite carriers to subscribers. For date. We also stated that since no other covered by section 339(b)(1)(A) outside these purposes, a ‘‘nationally station could meet these criteria in the the station’s local market to both served distributed superstation’’ is a term that future due to the date-specific and unserved households without the is defined as a television broadcast conditions set forth in the definition, station’s consent and without station, licensed by the Commission, the foregoing constitutes a finite list of geographic restriction. In a similar but that meets the following three criteria: the nationally distributed superstations not identical provision, the SHVIA (A) is not owned or operated by or covered by the statute. Commenters permits a cable operator or other MVPD affiliated with a television network that, directly addressing this issue generally (other than a satellite carrier) to as of January 1, 1995, offered agree with our conclusion that this list retransmit a television broadcast station interconnected program service on a of nationally distributed superstations is outside of its local market without its regular basis for 15 or more hours per complete and finite. consent, provided the MVPD obtains the week to at least 25 affiliated television 11. By creating this special category signal from a satellite, and the station licensees in 10 or more States; known as nationally distributed was a superstation on May 1, 1991 and (B) on May 1, 1991, was retransmitted superstations, Congress permits satellite was retransmitted by a satellite carrier by a satellite carrier and was not a carriers to retransmit these superstations under the Section 119 statutory license network station at that time; and to subscribers regardless of whether as of July 1, 1998. (C) was, as of July 1, 1998, they are ‘‘served’’ or ‘‘unserved’’ 13. In addition to applying the retransmitted by a satellite carrier under pursuant to the Copyright Act. The existing cable exclusivity rules to the statutory license of section 119 of amended copyright provision provides nationally distributed superstations, title 17, United States Code. that the retransmission of nationally Section 339(b)(1)(B) requires the

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Commission to apply sports blackout affiliated with U.S. networks, citing the station be blacked out. ‘‘Network protection to the retransmission of the inclusion of such stations in the program’’ is something of a misnomer in signals of network stations by satellite compulsory license of Section 1002 of terms of common usage as it appears to carriers to subscribers ‘‘to the extent the SHVIA. We agree with MPAA and suggest a program provided by a technically feasible and not NHL that foreign stations are beyond recognized network. In fact, it is defined economically prohibitive.’’ By its terms, our jurisdiction and therefore unable to as ‘‘any program delivered Section 339(b)(1)(B) applies only to invoke the protection of the exclusivity simultaneously to more than one ‘‘network stations,’’ which are television and sports blackout rules. With respect broadcast station regional or national, broadcast stations owned or operated to retransmission of a foreign station’s commercial or noncommercial’’ (47 CFR by, or affiliated with, the television programming into U.S. markets by a 76.5(m)). It is not necessary that the networks. Affiliates of these networks U.S. licensed satellite carrier, we program be delivered by a ‘‘television are the only entities that meet the conclude that the satellite rules will network.’’ (In addition to full power definition of a television network apply as they do with respect to the television stations, 100 watt translator station contained in the Copyright Act exclusivity rules governing cable stations are allowed to demand network and are the only stations covered by systems. The definition of ‘‘television non-duplication protection under Section 339(b)(1)(B). In the cable broadcast station’’ in 47 CFR 76.5(b) certain circumstances. Translator context, the Commission’s sports includes stations licensed by a foreign stations are not entitled to syndicated blackout rule applies to any television government but provides that such exclusivity protection (47 CFR 76.92(d)). broadcast station and is not limited to foreign station not entitled to assert Due to differential carriage rights, we network stations. Consistent with the program exclusivity. Also, in the DISCO provisions of the statute, we confine the II Order the Commission explained that are not replicating this provision in the application of the satellite sports it will license the earth stations that use satellite non-duplication rules.) A blackout rule to retransmission of a non-U.S. licensed satellite to provide station may assert its exclusivity rights network stations. The SHVIA statutory service to subscribers in the United regardless of whether its signal is license for satellite carriers applies only States, rather than re-license foreign carried by the cable system in question. to retransmission of distant network satellite operators. The earth station Under the cable network non- stations. Thus it is consistent for the operators providing service in the duplication rule, a television station is sports blackout provisions to be United States through these non-U.S. entitled to assert its exclusivity rights similarly limited pursuant to Section licensed satellites are ‘‘satellite carriers’’ against a cable system serving any 339(b)(1)(B). as defined in the SHVIA because they ‘‘cable community unit’’ within the 14. In the NPRM we observed that the are licensed under either part 25 or part station’s ‘‘specified zone’’ that is title of new Section 339, ‘‘Carriage of 100 of the Commission’s rules. carrying duplicative programming for Distant Television Stations by Satellite which the local station has obtained Section 339(B)(1)(A): Application of Carriers,’’ indicates that this section is exclusive distribution rights. (Cable Network Non-Duplication, Syndicated intended to apply to satellite systems are comprised of one or more Exclusivity, and Sports Blackout to retransmission of distant network ‘‘community units’’ that correspond to stations, notwithstanding that the text of Retransmission of Nationally Distributed Superstations separate and discrete communities or Section 339(b)(1) does not specifically municipal entities. The rule applies on so state. The cable exclusivity rules 16. Section 339(b)(1)(A) requires the a community unit basis by requiring the were originally created and apply today Commission to apply network non- cable system for a particular community to address cable importation of distant duplication protection, syndicated unit to black out a specific program stations. We conclude, and most exclusivity protection, and sports based on the priorities established in the commenters agree, that it was Congress’ blackout protection to the rule. The ‘‘specified zone’’ of a intent to apply the sports blackout rules retransmission of signals of nationally television broadcast station is the 35 distributed superstations by satellite to retransmission of distant network mile area surrounding its community of carriers. In this section, we address the stations and not to local network license. The 35 mile specified zone, as application of the network non- stations. We note, too, that the statutory well as all other mileage zones used in copyright license for satellite carriage of duplication and syndicated exclusivity applying the exclusivity rules, is distant network stations relies upon the rules to nationally distributed measured from the relevant station’s definition of ‘‘network station’’ in the superstations together because these two ‘‘reference point’’ in its community of copyright provisions. rules are similar in significant respects. 15. We also sought comment in the 17. The Commission’s cable television license. The rules provide a list of the NPRM on whether stations based in network non-duplication rule allows a reference points to identify television foreign countries are affected by the television broadcast station that has market boundaries used for this SHVIA provisions requiring application purchased exclusive rights to network purpose. See 47 CFR 76.5(e), (dd); 76.53; of the cable exclusivity and sports programming within a specified area to and 76.92(a).) A television station’s blackout rules to satellite protect its exclusivity against carriage of rights within these areas are limited by retransmissions. Certain commenters duplicating programming on local cable the terms of the contractual agreement addressing this issue argue that while systems. The ‘‘specified’’ or ‘‘protected’’ between the station and the holder of the blackout protection afforded by the zone is the smaller of either the area the rights to the program (‘‘rights rules should apply to a foreign station’s protected by the terms of the contract or holder’’). In addition, for local programming carried by a U.S. satellite the 35 or 55 mile area designated by the programming to be protected, the local carrier, a foreign station cannot invoke rules. In the satellite rules, this area is programming must be the same as the these protections against satellite generally termed the ‘‘zone of distant programming that is being importation of programming into its protection’’ or protected zone. (47 CFR imported into a local station’s market. home market. Grupo Televisa, on the 76.92). The rule allows a local television Even the use of different camera crews other hand, argues that the rules should broadcast station to demand that a local and announcers during the production apply in favor of non-U.S. licensed cable system’s duplicate carriage of the of an imported program may result in border stations serving U.S. markets and same program from an otherwise distant the distant program not being

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68086 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations considered the same, per Major League contractual rights and apply even if the merely apply the cable exclusivity rules Baseball, 6 FCC Rcd. 5573 (1991). programming is not shown at all or if to satellite without change. EchoStar 18. The Commission’s syndicated the subscribers subject to the deletion asserts that unless appropriately program exclusivity rule allows local do not have another source to receive mitigated, the rules could lead to the stations to protect their exclusive the programming. cessation of satellite carriage of distribution rights for syndicated Separate Satellite Rules superstations, which would contravene programming on local cable systems in the legislative goal of parity between a local market. (A syndicated program is 20. Initially, we sought comment on cable and satellite operators. EchoStar defined as ‘‘any program sold, licensed, whether we should incorporate the rules also argues that if Congress intended for distributed or offered to television we adopt to implement § 339(b)(1)(A) the Commission to automatically station licensees in more than one into the existing Commission rules, or employ the cable rules in the satellite market within the United States other whether we should adopt separate rules context it would not have directed the than as network programming. * * *’’) for satellite carriers. Commenters Commission to conduct a rulemaking. This rule is similar in operation to the generally recommend that the Alternatively, in support of a separate network non-duplication rule, but it Commission adopt separate rules for rule section, DirecTV asserts that, given satellite carriers patterned after the applies to exclusive contracts for the technological differences between cable exclusivity rules. We concur that, syndicated programming, rather than for cable and satellites, in certain situations even though Congress specifically cited network programming. In this rule, too, it does not make sense, or is simply not the existing rule sections in the statute, a local television station is entitled to technologically feasible, to merely ‘‘lift’’ it will be less confusing and simpler to assert its exclusivity rights within a the cable rules. specified zone of 35 miles surrounding implement a separate set of rules in the the television station’s city of license. satellite context. We agree with DirecTV 22. We reject the arguments that the Unlike the network non-duplication that new rules will be easier to satellite exclusivity rules should be rule, however, the maximum zone of understand and comply with if they are substantially different from the cable protection allowed under the rules is 35 contained in a parallel, but distinct, rules due to technical considerations miles surrounding a television station’s section, which will allow the and the burdens of compliance. city of license in a non-hyphenated differences between the rules applicable Congress directed the Commission to television market and 35 miles to the satellite and cable industries to be make the rules ‘‘as similar as possible’’ surrounding each named city in any size highlighted. This will enable the to the cable rules and to protect the hyphenated market; the zone of Commission to maintain consistency in contractual exclusivity rights purchased protection is not greater in smaller its rules, while adopting the minor by broadcasters and sold by program markets. adjustments that are necessary to rights holders. The statute specifically 19. As with network non-duplication, properly apply the rules to satellite cites the existing network non- the syndicated exclusivity rule applies carriers (e.g., application only to duplication and syndicated exclusivity on a community unit basis by requiring nationally distributed superstations). In rules as guidance. In particular, the the cable system for a particular this regard, we do not agree with WB statute does not provide for any community unit to black out a specific that the direct references to the exemption from these rules based on program based on the priorities corresponding cable rules indicate that technical feasibility or economic established in the rule. In addition, the Congress intended the rules to be hardship as it does for the application geographic limits for exclusivity under identical. The statutory language directs of the sports blackout rules to network the Commission’s rules are limited by us to develop rules that apply the stations. We believe, however, that in the terms of the contractual agreement exclusivity protections in the satellite considering the application of these between the station and the holder of context, not merely to add the words rules to satellite carriers we must the rights to the program. As with ‘‘satellite carriers’’ in the existing cable consider several modifications that network non-duplication, the protected rules. While we are establishing a reflect the practical differences between zone is the smaller of either the area of separate rule section for the exclusivity the two industries and the different exclusivity provided in the contract or rules that apply to satellite carriers, delivery systems they employ, as the 35 mile area surrounding the these rules will not be substantially detailed herein. relevant reference point(s). Thus, if the different from the equivalent cable rights holder grants the television rules. 23. Some broadcasters argue that for station a zone of protection of ten miles, 21. Some satellite industry there to be parity between cable and then that station would be precluded commenters argue that we must take satellite providers, the Commission from exercising its exclusivity rights into account the distinctive should extend the protections of against any cable system located more characteristics of satellite services and network non-duplication to all distant than ten miles from that station’s city of the associated issues of technical network carriage to protect emerging license. In addition, as with the network feasibility and the cost of compliance. networks and notes that the existing non-duplication rules, for syndicated EchoStar contends that the rules for cable rules are not statutorily mandated. programming to be protected, the satellite carriers should be significantly Because Congress provided for the programming covered by the contract different from the cable rules due to the application of the sports blackout rule to must be the same as the distant characteristics of satellite services and network stations, but not for the programming. We note that under both the onerous burdens of compliance. network non-duplication or syndicated of these cable rules, it is not necessary Echostar raises a variety of technical exclusivity rules, we believe that that the broadcast station or rights and administrative issues, such as the extending the rules in this manner is holder asserting protection actually be need to develop a database to determine beyond what Congress intended. We carried on the cable system in question, affected subscribers and the addition of reject this proposal on the same basis nor is it required that the rights holder ‘‘untold layers of complexity to its that we reject the satellite industry’s asserting its rights actually display the authorization/unscrambling request to adopt significantly different programming for which it asserts procedures’’ to delete different programs rules for satellite carriers due to protection. These cable rules protect in different areas of the country if we technical considerations.

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Zone of Protection techniques used to determine served programming that is sold in the vast 24. Under the network non- and unserved households) can be used majority of markets, making EchoStar’s duplication rules, a commercial or to determine whether a household is fear of a crazy quilt pattern of deletions noncommercial television station located in a specified zone. largely unfounded. Moreover, the licensed to a major television market Accordingly, local broadcast television statute unambiguously requires that we may assert exclusivity rights within its stations will be entitled to assert apply the exclusivity rules in these specified zone. That zone is generally exclusivity protection throughout the situations. Adopting EchoStar’s the 35-mile area surrounding a same zones of protection as those proposal to limit application of the rules broadcast television station’s specified in the cable rules. to the non-existent circumstance in community of license. The zone of 26. We reject EchoStar’s proposal that which the broadcaster’s geographic zone protection for stations licensed to a satellite carrier should not be required would cover most of the nation smaller television markets extends an to comply with requests for exclusivity effectively eliminates the application of additional 20 miles (‘‘secondary zone’’), (either network or syndicated) unless the exclusivity rules. The statutory for a total of 55 miles surrounding its the program deletion is requested by language does not give us this choice. community of license. Pursuant to the qualified broadcast stations whose We also reject EchoStar’s proposal to syndicated exclusivity rules, a local geographic zones (not counting establish a procedure to exempt satellite commercial television station is entitled overlaps) cover a substantial majority of carriers on a case-by-case basis upon a showing of extraordinary hardship. We to assert its exclusivity rights only the nation. The ‘‘geographic zone’’ is believe that such a policy is contrary to within a 35-mile geographic zone. There limited to the 35/55 mile area around the intent of the statute to protect the is no extended zone of protection for the reference point in the community of rights of local broadcast licensees. We smaller market stations. For both rules, license. EchoStar argues that this also note that, in adopting exclusivity a station licensed to a hyphenated requirement is needed in order to deal rules in 1988, we eliminated a similar television market, as defined in the with the mosaic of diverse deletion waiver process. rules, is entitled to assert exclusivity requests for the same feed. EchoStar’s within 35 miles surrounding each proposal ignores the exclusivity rights Use of Zip Codes To Determine the named city. However, the zone of of individual broadcasters and Location of Affected Households protection may not exceed the area undermines regulatory objectives, 27. The cable rules apply the agreed upon between the program contrary to congressional intent and, in exclusivity rules on a community unit supplier or network and the television our view, defeats the purpose of the basis within a station’s zone of station nor the area within which the statutory mandate to protect the protection. Community units are station has acquired broadcast territorial exclusivity rights of local broadcast political jurisdictions (i.e., a city, town, exclusivity rights. For purposes of all of stations. Moreover, while EchoStar or county) or portions of political the rules discussed in this Order, we claims that it would have to develop a jurisdictions for which a local refer generally to a ‘‘zone of protection’’ huge database to determine whether a government body has granted a or ‘‘protected zone’’ to apply to the subscriber is within the specified zone, franchise to operate a cable system. entire area protected by the rules’ we observe that satellite carriers already These separate areas may or may not provisions. maintain such databases of subscribers encompass an entire city or county. 25. A majority of commenters support for determining eligibility for local-into- Several commenters support the the adoption of the same zones of local and network signals, for application of these rules on a protection for broadcast stations in this information on the particular services to community unit basis in order that they context because they provide a which a household subscribes, and for be as similar as possible to the cable definitive area within which exclusivity billing purposes. In addition, even rules and to eliminate the possible rights may be asserted. We agree. We though satellite carriers use a confusion to customers in the same also concur that, as with the cable rules, nationwide or multi-state footprint to neighborhood that would be caused by the zone of protection should be limited deliver programming, they provide a program being blacked out if a by the terms of the contractual signals on a household-by-household household subscribed to cable, but not agreement between the station and the basis that enables them to deliver if it subscribed to a satellite service. In program rights holder, with the different programming to different order to promote parity between cable applicable geographic zone set forth in households based upon which operators and satellite carriers, they the rules providing an outside limit on programming package the subscriber argue that it is important that the the permitted zone of protection. selects. Satellite carriers currently delete blackout areas for satellite carriers be as Several commenters mention, but reject, programming when it is required by congruent as possible with the blackout the use of other zones of protection, contracts negotiated in the marketplace. areas for competing cable systems. They such as a station’s grade B contour or a Furthermore, as a practical matter, the further state that requiring satellite zone of protection coextensive with the programming deletions affect only five carriers to black out programming on boundaries of ‘‘local market’’ for of the six nationally distributed the same community unit basis as is retransmission consent purposes. As superstations because WGN is ‘‘largely, applied to cable is the most easily Tribune observes, since Congress did if not completely syndex and nondupe- applied, understood, and enforced not mention a zone different from that proof.’’ With respect to network approach for providers and residents. of the cable rules, it appears appropriate program deletions, we expect significant Other commenters claim that it is to use the existing specified zone. We uniformity across markets where impossible or inappropriate to import also believe that this conclusion is affiliates of WB or UPN assert their the community unit concept from cable consistent with the congressional rights since each superstation is to satellite as cable systems have directive to make these rules as similar affiliated with one of these networks. specific, municipally-granted franchises as possible to the cable rules. We further With respect to syndicated to serve discrete communities, the believe that implementation in the programming, the superstations are boundaries of which are difficult to satellite context is feasible because large market stations, which typically determine and unnecessarily complex to existing methods (e.g., the geocoding acquire the most popular syndicated apply. They propose that subscribers

VerDate 112000 16:49 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68088 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations subject to the blackout rules be vary in their coverage areas and it is the programming are rejected as they are ascertained by means of their zip code, broadcast station or rights holder that beyond the scope of this proceeding. a method currently used by satellite has negotiated such contracts, we 31. On the basis of the record, there carriers for other purposes. These conclude that the party seeking is general agreement that rural route commenters argue that since satellite exclusivity protection will be numbers reasonably approximate the providers do not have identifiers responsible for identifying the affected actual location of the subscriber and are assigned to the communities they serve, zip code areas along with the other acceptable because they are generally as is the case for cable, a comparable information that must be provided to located close to the residential address method for determining the areas to the satellite carrier. This approach is where the subscriber receives the which the zone of protection applies consistent with our existing cable rules satellite programming. Accordingly, we involves reliance on zip codes. This that place the notification burdens on will allow satellite carriers to use the method, like the use of cable the party seeking to assert its exclusivity zip codes associated with rural route community units, is not a perfect means rights. We do not believe that this numbers to determine the location of to achieve congruence between the zip requirement places an undue burden on such subscribers. However, where a code boundary and that of the specified a broadcaster seeking exclusivity. In subscriber chooses to provide a post zone, but it is a workable compromise many cases, the contracts will provide office box for a billing address, we will using a fairly stable identifier. for exclusivity up to the limits of the require that satellite carriers obtain a Moreover, in their reply comments, specified zone and the broadcaster will residential street address—or simply a several proponents of the use of only have to determine the appropriate zip code—where the service is actually community units state that they would zip codes once to cover such contracts. being received. Upon request, satellite be willing to support a zip code Accordingly, we will require broadcast carriers may verify the data provided by approach as a reasonable alternative as stations or rights holders to provide broadcasters and vice versa. We decline long the rules would apply throughout satellite carriers with the list of affected to adopt the reporting and auditing the entire zip code. zip codes, although we will not mandate procedures proposed in the comments, 28. We conclude that it is appropriate that it be in any specific format (e.g., we as they would place an undue burden to use zip codes rather than community will not require an electronic file). We on broadcasters, satellite carriers and units in the satellite context. There are encourage satellite carriers and the Commission. approximately 38,000 five-digit zip broadcasters to work together to 32. In addition, MPAA proposes that codes in the United States, compared effectuate the provisions of the statute, in instances in which the satellite with nearly 33,000 community units. even though we place the onus of carriers serve individual households There is no readily applicable measure determining the affected zip codes on that are within a zip code but outside the specified zone, such subscribers that will precisely match specified the party seeking exclusivity protection. should be permitted to petition for a zones in either the cable or satellite We see no reason to make special or waiver so that their programming is not context. However, zip codes are already separate provisions for satellite carriers blacked out. It contends that, since the used by satellite providers to determine to verify that the list of zip codes is satellite rules apply on a household the location of subscribers for other accurate. If it comes to light that the list basis, this waiver process would serve purposes and it would be more difficult is inaccurate, the satellite carrier may the purposes of the statute (i.e., parity to determine which satellite subscribers object to the broadcaster or rights with cable and protection of rights are located within a cable community holder. unit, which is tied to the cable franchise holders) without unduly depriving process. As with the cable community 30. We believe that for purposes of satellite subscribers beyond the unit concept, reliance on zip codes can complying with these and other specified zone of programming. We often be overinclusive of the zone provisions of the SHVIA, satellite acknowledge the cable rules require covered by the exclusivity rights to be operators must generally be aware of the cable operators to provide exclusivity protected. To closely align the rules for actual physical location of a subscriber. protection throughout community units, satellite carriers with the cable rules, we Several commenters express concerns even if some of their subscribers in that have been urged to require a satellite regarding the accurate location of a unit are located outside the specified provider to provide protection in all subscriber whose address is a post office zone. This requirement is based on our relevant zip codes that fall, in whole or box (e.g., a U.S. Post Office Box or a understanding that it is not technically in part, within the zone of protection. private post office box) or rural route feasible for cable operators to black out We conclude, as described below, that number, stating that a non-street address programming to individual households. if technology permits satellite carriers to makes it impossible to apply any rule On the grounds of maintaining more closely align their deletions to the that relies on a geographic location. regulatory parity, NCTA advocates precise areas of the protected zone, they Since accurate addresses are the requiring satellite carriers to delete may do so. linchpin of a system that relies on programming throughout zip code areas 29. Satellite interests generally geographic location, they propose that that in whole or part overlap the propose that the broadcaster or rights satellite carriers be required to certify broadcaster’s zone of protection. holder asserting its exclusivity rights that they have no basis for believing that Notwithstanding our general interest in provide the satellite carrier with an subscribers have provided inaccurate regulatory parity, we are reluctant to electronic file of the affected zip codes addresses for purposes of evading the require satellite carriers to delete that corresponds to the specified zone. rules. In opposition, DirecTV argues that programming beyond the boundaries of Alternatively, broadcasters contend that there is no parallel provision in the the broadcaster’s or rights holder’s zone the satellite carriers already have zip cable rules to serve as a basis for of protection if they have the technical code information that they use for other imposing this additional obligation on capacity to accommodate such fine- purposes and they should be satellite carriers. In addition, proposals tuning. Due to the unavoidable responsible for determining which to impose a number of restrictions on difference in coverage between the zip subscribers are located in the areas satellite carriers to ‘‘reduce if not code areas and the community units, where the programming must be obviate both the domestic and external there are likely to be some differences blacked out. Since exclusivity contracts grey marketing’’ of satellite between cable and satellite subscribers

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68089 in terms of programming required to be satellite carriers. They contend that this against duplication of programming deleted. Therefore, there is no reason to language invokes the two essential imported under the satellite statutory require deletions outside the protected elements for protection—retransmission copyright license. The special words in zone on the grounds of parity. The pursuant to the compulsory license and the satellite context are similar to those satellite rules provide that satellite reference to the Commission’s rules. required to assert enforceable cable carriers must delete protected They state that any station with syndicated exclusivity. Parties may use programming from subscribers within exclusivity rights vis-a-vis cable should this statement to reference either or both the zone of protection, but need not be considered to hold the same rights the cable and satellite network non- delete programming from subscribers with respect to satellite carriers and that duplication and syndicated exclusivity who live in the part of a zip code area parties should not be required to rules, depending upon whether their that extends beyond the zone of renegotiate existing exclusivity negotiated exclusivity covers protection protection. contracts. We disagree. We cannot against cable, satellite or both. Existing affiliate agreements and other contracts Terms of Contractual Agreements assume that the parties to these existing contracts negotiated for protection that apply to network program non- 33. Pursuant to § 76.93, television against satellite carriage when duplication only in the cable context stations are entitled to exercise network duplicating carriage by satellite was not need not be revised to be effective to non-duplication protection in covered by the Commission’s provide non-duplication protection accordance with their network exclusivity rules. We agree with other pursuant to § 76.92. These special words agreements. The syndicated exclusivity commenters who counter that the rules shall apply to both the network non- rules allow television stations to should only give effect to contracts that duplication and syndicated exclusivity exercise exclusivity rights in accordance unambiguously grant exclusive rights rules to ensure that, in either instance, ` with their syndicated program license vis-aa-vis satellite carriers. They assert the contracting parties contemplated agreement, consistent with the that existing contracts should not be protection from satellite carriage. Where requirements to invoke protection enforceable against satellite carriers existing contracts expressly provide for specified in § 76.159. Under § 76.159, to unless it is clear that the licensee or exclusivity against satellite carriage, be eligible for syndicated exclusivity rights holder has negotiated for and albeit without using these special protection, a station must have a received such rights. Until the SHVIA words, there is no need for contract or other written indicia that it was enacted on November 29, 1999, renegotiation, nor for a six month period holds syndication rights for the there was no certainty of satellite for parties to renegotiate. In these programming. Section 76.159 requires exclusivity requirements. Arguably, situations of remarkable prescience in that contracts contain special language parties could not have a reasonable the contract terms, the normal for the licensee to invoke such expectation of exclusivity protection notification requirements will apply. protection. 38. We will not require, as Echostar 34. We find that the current situation until the rules adopted by this Order take effect. Accordingly, we conclude proposes, that the contracts be non- is analogous to that of 1988 when the discriminatory or be exercised in a non- Commission reinstated syndicated that only those exclusive contracts that specifically cover satellite-delivered discriminatory fashion. We believe that exclusivity rights, and the rule we adopt such requirements are inconsistent with treats these new rights in the same programming or are broad enough to encompass the delivery of duplicating the rights of parties to negotiate the manner as we did syndicated extent of exclusivity that they determine programming by any delivery means exclusivity contracts at that time. That to be in their best interests and were not (e.g., cable, satellite, wireless cable) is, we will give effect to new or existing contemplated by the statute. Such entitle a station to assert exclusivity contracts that unambiguously grant such requirements would also be inconsistent rights under these rules. Without such rights against satellite carriage and with the cable exclusivity rules. permit existing contracts to be clarified specificity, it is not clear whether the or amended if they are ambiguous or did party granting the exhibition rights for Notification Requirements not anticipate a change in the law. the programming intended to convey 39. In order to exercise network non- 35. The cable rules do not prescribe network non-duplication or syndicated duplication rights, a television station specific language needed to invoke exclusivity rights to the broadcaster in must notify each cable system operator network non-duplication protection. the satellite context. of the protection sought. The syndicated Such exclusivity is provided in the 37. In reinstituting the syndicated exclusivity rules contain similar contractual provisions of network- exclusivity rules in 1988, the notification procedures with respect to affiliate agreements that give individual Commission allowed an opportunity for broadcasters or distributors notifying stations the right to be the exclusive parties to amend their contracts to cable systems of the exclusivity sought. distributor of a network’s programming reflect the newly granted rights. Because In both cases, the notices must identify in an area, generally within 35 miles of government protection of both network the party seeking non-duplication its city of license. Where a network- non-duplication and syndicated protection and the affected affiliation agreement does not provide exclusivity rights vis a vis satellite programming. Notices must be provided for network non-duplication protection retransmission did not exist before within 60 calendar days of the signing against satellite carriage of superstations November 29, 1999, consistent with this of the contract. Exclusivity protection because this right was unanticipated or precedent we will provide a transition begins on the date specified in the the contract is ambiguous regarding period of six months to allow parties to notice or the first day of the calendar such rights, parties will be given an amend or clarify their network week that begins 60 days after the cable opportunity to amend their agreements affiliation or syndicated exclusivity operator receives notice from the to include clear, specific language, as agreements to cover the exclusivity broadcaster. In addition, cable operators described below. rights provided in § 339(b)(1)(A) and the may rely on published information 36. Some commenters contend that if rules we adopt today. We will require sources (e.g., newspapers) to determine the special language required by the also that contracts entered into after which programs must be deleted or cable syndicated exclusivity rules release of this Order must include obtain the information from the station appears in a contract, it is applicable to special words to invoke protection seeking protection or the station whose

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68090 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations programming is to be deleted. exclusive territories for the sale and with private consensus agreements Furthermore, the rules require that the service of satellite systems, including among rights holders, broadcasters and party exercising its exclusivity rights those distributors that are authorized by cable operators in 1971. If the must provide a copy of the relevant the satellite carrier to authorize or de- programming in question were shown in portions of its contract to the cable authorize programming for subscribers), the market before the syndicator had an system, upon request. if necessary, since they are in the best opportunity to negotiate for exclusivity, 40. A number of commenters observe position to know which distributors it would diminish the value of the that the current notification procedures serve which areas. Several commenters program. In the NPRM, we requested have proven workable for the parties in suggest that satellite carriers be required comment on whether to apply this the cable context and generally support to designate (e.g., on their Web sites) the provision in the satellite context, and the same notification requirements and name, title, and address to whom the whether the rights holder should notify time periods for satellite carriers. For notices should be sent, with this the satellite carrier directly. MPAA example, DirecTV states that stations information updated as necessary to contends that allowing rights holders to should be required to notify satellite avoid delay and miscommunications. notify carriers directly, as holders of carriers of any exclusivity rights in the While we recognize that such syndication rights can do with cable same manner required under the cable information might be useful, it should systems, gives holders a means to rules. We agree and will model the not be necessary to ensure the protect the value of their programs as satellite notification rules on the cable compliance with exclusivity requests. well as providing parity in the operation requirements. We apply the same 60- We have not required cable systems or of the rules in the cable and satellite day notice requirement following the operators to provide this information contexts. DirecTV, however, argues that signing of a contract providing and see no reason to do so in the it is unnecessary to import this rule to exclusivity and impose the same satellite context. Satellite carriers must the satellite context since the rules will contract disclosure requirements for promptly direct their mail to the apply to a discrete universe of satellite carriers. As in the cable context, appropriate staff. Notice received by the superstations. We believe that it is the satellite carrier will have sufficient corporation is considered receipt of the appropriate to allow distributors to lead time to act on the exclusivity notice for purposes of triggering the notify satellite carriers directly. We request. Accordingly, exclusivity deletion requirements, so it will be in agree they are often the rights holders protection will beginning on the later of: the best interests of satellite carriers to with the greatest need and incentive to (a) the date specified in the notice; or (b) assure that broadcasters and rights protect their rights. In the satellite the first day of the calendar week holders have the necessary current context, syndicated exclusivity (Sunday-Saturday) that begins 60 days information to reach the right person. protection is limited to the six following the satellite carrier’s receipt of We urge stations and rights holders to nationally distributed superstations. the notice from the broadcaster or other follow DirecTV’s suggestion that Allowing the distributor that has the rights holder. Using the same exclusivity notices be addressed to the exclusive syndication rights a one year notification periods reduces the ‘‘Director of Programming Operations’’ period to negotiate exclusive administrative burden on rights holders or marked ‘‘Attention: Program arrangements for each market has and stations and allows them to send a Exclusivity Request’’ to assist satellite worked well in the cable context and single set of notices to cable systems carriers in ensuring that the information should be applied here in the absence and satellite carriers, rather than forcing is directed to the proper department. of a specific reason to treat satellite them to send one notice to cable 42. The cable rules provide that to carriers differently in this regard. systems at one time and a virtually determine the scheduling of programs identical notice to satellite carriers at that must be deleted, cable operators 44. We also acknowledge that, as with another time. In this manner, we also may rely on newspapers and other the cable rules, a broadcast station, minimize the possibility that protection published sources, the broadcaster syndicator, or other rights holder is would be lost inadvertently because of seeking exclusivity protection, or the entitled to assert exclusivity protection differing requirements. It is also broadcast station subject to the based upon contractual rights, as consistent with the general goal of requested deletion. Similarly, the discussed above. It is not necessary that making the cable and satellite rules provision we adopt allows satellite either the entity requesting protection or parallel as much as possible. carriers to rely on such published the program to be protected actually be 41. We will require that the notice sources, the broadcaster seeking carried by the satellite carrier. Thus we asserting exclusivity rights contain the protection, or the nationally distributed recognize that in some cases subscribers same identifying information about the superstation. We received no comments will not be able to receive the deleted programming to be deleted and the on this provision and believe the cable programming from any television extent of the exclusivity (e.g., the dates model will work as well for satellite broadcast station carried by the satellite on which exclusivity is to begin and carriers. carrier. The Commission’s network non- end). As indicated above, the notice 43. Under the cable syndicated duplication and syndicated exclusivity must identify the zip codes included in exclusivity rules, ‘‘distributors’’ of rules protect contractual rights. The the zone of protection (i.e., the specified syndicated programming, who own the rights may apply even in situations in zone or other permitted area covered by rights to the programming for purposes which the rights holder chooses not to the exclusivity contract). Satellite of syndication, are entitled to exercise display the protected programming or in carriers may request a copy of the exclusive rights for a period of one year which the cable system is not carrying relevant contractual provisions, as cable from the initial broadcast syndication the broadcast station asserting operators may do, but it is not required licensing of such programming, protection. We specifically recognize in the notice. We adopt the suggestion although not in areas in which the that in markets in which the satellite that the notice should be served on programming has already been licensed. carrier chooses not to provide local-into- satellite carriers with the carrier having This cable provision is intended to give local carriage, a local station may assert the obligation to disseminate the holders of syndication rights a one year network non-duplication or syndicated information to their distributors period in which to negotiate their exclusivity protection for programming (distributors include parties with agreements in each market. It originated that subscribers in that market cannot

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68091 receive via satellite because the station the satellite carrier has the authority to exclusivity protection, or sports demanding protection is not carried on offer the programming, we believe that blackout. We note that the copyright satellite. Viewers may be able to receive satellite carriers should be permitted to laws do not provide a statutory this programming, however, through use use substitute programming. In copyright license for substitute of over-the-air antennas or on cable. addition, commenters ask that we not programming for satellite carriers as they do for cable operators. Therefore, Substitute Programming limit substitute programming to broadcast programming. We see no unless the statutory provisions are 45. The cable syndicated exclusivity reason to place such a limit on what is changed, satellite carriers may only rules expressly allow a cable operator to permissible and will allow non- substitute programming for which they substitute programming from another broadcast programming to be used as a have copyright and retransmission television station when programming is substitute, as long as its carriage is consent, or otherwise have legal rights required to be deleted, provided carriage consistent with the applicable statutory to carry. is consistent with all the exclusivity and regulatory provisions, and it is clear Transition Period rules, such as sports blackout. No to viewers that the substitute comparable provision is included in the programming is not provided by the 48. When the Commission reinstated network non-duplication rules, but same broadcast station as the the syndicated exclusivity rules, it cable operators are free to substitute any programming for which it is substituted. recognized that cable systems would programming—broadcast or cable—to need several months to implement the 47. We further note that the cable which they have the legal rights. new regulatory requirements. Satellite Commenters addressing this issue rules do not expressly provide for the industry commenters in this proceeding generally support a provision to allow substitution of programming when a requested a similar transition period to satellite carriers to offer substitute program is deleted pursuant to network implement these new rules. Echostar programming for the programming non-duplication protection. The absence suggests that broadcasters and other covered by exclusivity agreements. We of an express provision does not rights holders should submit their agree that it is reasonable to permit necessarily prevent the cable operator deletion requests during the transition substitute programming so that viewers from substituting programming to which period, but satellite carriers’ compliance need not be faced with a blank screen it has the rights. However, we recognize would be tolled for one year. We agree or a slide stating that contractual that if a cable operator were required to that satellite carriers today, like cable limitations require programming to be delete network programming from a operators in 1988, need time to phase- deleted. station, and the network programming in compliance with these new 46. Carriage of programming by subject to deletion constitutes a high exclusivity rules. We reject, however, satellite carriers is governed by a percentage of the station’s programming, proposals for a transition period one number of laws and regulations, the cable operator would likely drop the year in duration. The transition period including the Copyright Act, the entire station from carriage. When the for cable operators was necessary, in Communications Act, and Commission Commission originally adopted the part, to allow time to develop and rules, which differ from those network non-duplication rules, there implement new equipment needed to applicable to cable programming. In were only three commercial broadcast perform the deletions required by the reinstating the syndicated exclusivity networks, and network programming rule. In this proceeding, apart from the rules in 1988, the Commission constituted the majority of the concerns raised by the C-Band carriers encouraged the substitution of programming distributed to viewers by and discussed below, the satellite programming in response to consumer each network affiliate. The superstations carriers have not asserted that they need demands that a distant program be affected by these new rules are affiliated time to develop new equipment. In available in place of the original with emerging networks (i.e., WB, UPN). addition, we do not believe that programming that is deleted. At that These networks distribute significantly EchoStar’s one-year proposal would time, we also noted that such fewer hours of programming to their serve its stated purpose of enabling substitution of programming was affiliates each day and week than the satellite carriers to review deletion consistent with the compulsory license older commercial networks. Thus, we notices and plan a year in advance provisions of the Copyright Act and the believe that when, for satellite carriers, before the implementing the deletions. syndicated exclusivity rules repealed in the non-duplication rules are applied We believe rights holders would not 1981. Unlike the cable compulsory only to nationally distributed bother to submit deletion requests license, however, the satellite statutory superstations, it is likely that a smaller knowing that they will not be acted license does not include provisions for percentage of the programming will be upon for a year. the substitution of programming. In subject to deletion. It is hoped that 49. We will allow satellite carriers a considering permissible substitute satellite carriers will continue to reasonable period of time after the new programming under these rules, we provide the nationally distributed satellite network non-duplication and observe that there are statutory superstations to their subscribers, and, syndicated exclusivity rules take effect provisions that impose a number of thus, the question of substitution to adjust to the new requirements, to limits on the retransmission of signals programming is relevant. To prevent the review the contract language, to ensure by satellite carriers. Under these possibility of a blank screen and that they have adequate equipment and provisions, distant network station undesirable disruptions for consumers, personnel to implement the deletions, signals are limited to two per network we will specifically provide for and to arrange for programming that can per day and restricted to unserved substitution for non-duplication be used to substitute for deleted households, local signals may be deletions with any programming that programming. Normally, as set forth provided only in their own markets, and the satellite carrier is authorized to above, exclusivity protection begins, at the satellite carrier must have carry. Accordingly, we will adopt rules the earliest, within 60 days of retransmission consent for carriage of permitting the use of authorized notification. However, as described any local broadcast signal. To the extent substitute programming for any above, broadcasters will have up to six that carriage of a program is permissible programs deleted to comply with months from the effective date of this under these laws and regulations, and network non-duplication or syndicated Order to renegotiate contracts, and they

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68092 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations must notify satellite carriers of deletion negotiations among the parties for system exception was designed. Each of requests within 60 days of signing the exclusivity rights and the decision the satellite carriers serves millions of renegotiated contract. When no whether or not to assert them in a given subscribers nationally, is well- renegotiation is necessary because the market. Protecting parties’ rights to capitalized and capable of purchasing existing contract clearly pertains to engage in contract negotiations with the necessary equipment, is managed satellite as well as cable carriage, knowledge that exclusive agreements through centralized control centers, and broadcasters must notify satellite would not be abrogated by importation already blacks out programming carriers of their exclusivity protection of distant signals was fundamental to consistent with existing contracts and and deletion requests within 60 days of the Commission’s purpose in creating the programming packages selected by the effective date of this Order. In these the exclusivity rules in the cable individual subscribers. We conclude instances, satellite carriers will have 120 context, and is relevant today to that, with no specific evidence to the days in which to implement deletion application of these rules to satellite contrary, the costs of compliance with requests (e.g., this Order is effective on carriers. these rules, on a per subscriber basis November 29, 2000, therefore a Small System Exception and C-Band and relative to total revenues, will be broadcaster could provide deletion Carriers small given the large subscriber base of notice on January 8, 2001, and the each DBS satellite carrier. 51. Sections 76.95(a) and 76.156(b) deletion would take effect on or after 53. In contrast to DBS carriers, (amended rule § 76.106(b)) provide that May 10, 2001). To provide time for however, we note that C-Band satellite small cable systems serving fewer than satellite carriers to adjust to the new carriers, while still serving 1.3 million requirements, for notices provided 1,000 subscribers are exempt from the network non-duplication and subscribers nationwide, are before June 1, 2001, satellite carriers experiencing a steady decline in will have 120 days before they are syndicated exclusivity requirements, respectively. The Commission originally subscribers from a high in 1995 of required to implement the necessary nearly 2.4 million. C-Band commenters deletions. For notices provided to adopted these exceptions in the mid- 1970s to balance the costs of compliance contend that Congress intended to satellite carriers after June 1, 2001, the exempt them from application of the normal time requirements will apply. for small cable systems against the impact on broadcast stations. The exclusivity rules. However, they offer 50. Echostar also proposes, as an Commission was concerned that the only an isolated and ambiguous alternative or complement to the costs of equipment and manpower colloquy between two Senators in transition period, a ‘‘grandfathering’’ needed to comply with the cable support of this assertion. C-Band provision that would exempt from exclusivity rules would have a commenters describe their subscribers application of the network non- substantial impact on such systems as primarily rural and note that many duplication and syndicated exclusivity when viewed in relation to their gross live in areas that are not served by cable rules all of EchoStar’s 700,000 current revenues. In addition, the Commission systems or are beyond the reach of over- superstation subscribers. We reject this concluded that the cumulative number the-air broadcasters. They contend that proposal because there is nothing in the of homes served by small systems their centralized system of program statute to support it, and it is contrary nationwide constituted a very small delivery and authorization would make to the letter and the intent of the SHVIA percentage of the total number of deletion and substitution of provision requiring the Commission to television households and there would programming economically prohibitive. apply the exclusivity rules to satellite be no significant adverse economic As these commenters note, in 1991 the carriers. This proposal is also impact on broadcasters. When the Commission considered applying the inconsistent with the goal of placing Commission reinstituted the syndicated syndicated exclusivity rules to C-Band comparable requirements on cable exclusivity rules and modified the retransmission of television broadcast operators and satellite carriers. Cable network non-duplication rules in 1988, programming. At that time, Congress subscribers’ viewing options are it again exempted cable systems with had directed the Commission to apply currently subject to the cable exclusivity fewer than 1,000 subscribers out of the the cable syndicated exclusivity rules to rules, which allow for the same same concern. C-Band carriers if the Commission deletions that affect satellite subscribers. 52. Some commenters representing found it would be feasible for the C- In fact, cable subscribers are generally the satellite industry seek similar Band carriers to comply. The subject to a greater impact from exceptions that take into account the Commission sought comment and deletions because the cable rules apply technical feasibility and cost of concluded that the equipment needed to deletions of programming carried on compliance for satellite carriers. While for satellite carriers to implement network stations and other broadcast offering no specific proposal, EchoStar exclusivity protection was not available stations, not only that programming argues that the only way to ensure and could not be developed and carried on the specially defined six equivalent protections for satellite implemented before the expiration in superstations. Adopting EchoStar’s operators is to go back to the rationale 1994 of the interim compulsory proposal would perpetuate the disparity for the exception. However, since the copyright license under which C-Band between cable and satellite that original rationale for the small system carriers retransmitted broadcast Congress clearly sought to eliminate. exception was based on the relative cost programming. C-Band commenters Moreover, when the Commission of compliance compared to such contend that nothing has changed in implemented the network non- systems’ gross revenues, and none of the their capability of deleting duplicating duplication rules and reinstituted the commenters has provided cost data to programming. They argue that network syndicated exclusivity rules with justify such an exception, we are unable non-duplication requirements may respect to cable operators, it did not to conclude that a comparable situation apply to at least 93 markets, 30 weekly provide for grandfathering of existing exists in the satellite context. Satellite programs, with different times for each cable customers. As the Commission carriers are among the largest providers program. They ask that we either explained in those proceedings, the of television programming and are not exempt them from application of the potential impact of the rules is comparable to the ‘‘Mom and Pop’’ cable exclusivity rules or defer ultimately determined by the cable operators for which the small application until after 2004.

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54. The circumstances today differ also believe that this proceeding has because superstations could have dual significantly from 1991 in that the given all sides on this issue ample identities. In the NPRM, we sought provision in the SHVIA does not allow opportunity to present evidence and see comment on the treatment of for consideration of feasibility. Congress no need for a further rulemaking. We do superstations within their own markets. could have provided an exemption for note, however, that we can apply to C- We noted that for must carry purposes, C-Band carriers from application of the Band carriers an exception comparable superstations are treated as local signals exclusivity rules, but did not. Congress to the cable exceptions for small in their local markets (DMAs) and did provide a more generous copyright systems. C-Band has persuasively distant signals elsewhere. In its own license to C-Band carriers, than to DBS argued that the demands of network market, a nationally-distributed carriers, to retransmit distant network non-duplication, syndicated exclusivity, superstation acts as any other local stations to virtually all C-Band and sports blackout, cumulatively, may station and is treated as a local station subscribers. As noted, the network non- exceed the capacity of their existing within its local market. In the context of duplication and syndicated exclusivity system. In this case, the C-Band carriers satellite retransmission of nationally rules do not apply to satellite would have to develop a new system or distributed superstations, however, retransmission of network stations. substantially modify their existing there is an important difference between Currently, C-Band carriers provide only system. We believe that this can be a a station carried as a superstation or four of the six nationally distributed costly burden, and that it is appropriate carried as a local station. As described superstations (C-Band carries KTLA, to provide an exception that recognizes above, satellite carriers are not required WPIX, KWGN, and WGN. WOR–TV the relatively small size of the C-Band to obtain retransmission consent to (New York) and WSBK–TV (Boston) are carriers, as compared with the DBS carry the superstations, but are required no longer available.) One of these, WGN, carriers. Therefore, insofar as any C- to obtain retransmission consent to provides a satellite feed from which all Band carrier has fewer than 1,000 carry a local station within its local duplicating programming has been subscribers within the zone of market. The SHVIA, as it amended the deleted. Thus, the burden on C-Band protection, as expressed by zip code retransmission consent provisions in the carriers under the new network non- areas within the zone, it is not required Communications Act, permits satellite duplication and syndicated exclusivity to delete programming subject to carriers to retransmit the six stations rules is to delete programming from network non-duplication or syndicated that meet the definition of nationally only three nationally distributed exclusivity protection. (See §§ 76.122(l), distributed superstation without their superstations. The information provided 76.123(m), and 76.127(e).) The language consent provided they are transmitted by the satellite commenters in this of these exceptions is not limited to C- outside their local markets. We believe record describes serious technical and Band carriers and may apply, as well, to that the presence or absence of a economic difficulties in accomplishing any satellite carrier with a similarly requirement for retransmission consent deletions and substituting replacement small subscriber base, such as a new for nationally distributed superstations programming. C-Band carriers contend carrier in the future. We will consider, is key to Congress’ determination to that Geolocs cannot accomplish the if presented to us, additional apply the cable exclusivity and sports numerous simultaneous deletions that information on how best to tailor a blackout rules in this satellite context. the network non-duplication and small system exemption that would be Therefore, within their local markets, syndicated exclusivity rules may meaningful for C-Band carriers without the nationally distributed superstations require. However, it appears that these being significantly broader than the are not subject to deletions because they comments contemplate more exemption for small cable systems. are carried as local stations. However, widespread deletions and substitutions Finally, if Congress amends the SHVIA when a satellite carrier is retransmitting than the statute calls for and more than to expressly exempt C-Band carriers the station as a nationally distributed we impose here on either C-Band or from application of any or all of the superstation, without its retransmission DBS carriers. exclusivity rules (including sports consent, it must be treated as a blackout, discussed below), we can 55. Notwithstanding that we may not superstation, and the exclusivity and conduct a rulemaking proceeding to sports blackout rules will apply. Even in provide a blanket exemption for C-Band exempt C-Band from our rules those instances in which the carriers, we have considered their accordingly. proposal that we defer application of the superstation’s terrestrial over-the-air rules until after 2004 or pending a Exceptions Preventing One Local signal is significantly viewed, or the further rulemaking proceeding. We Station From Blacking Out Another protected zone is within its Grade B determine to do neither. We note that 56. The cable rules contain a number contour, if the satellite retransmission is the Commission deferred application of of exceptions that prevent one local outside the station’s local market, we the syndicated exclusivity rules in 1991 station from asserting exclusivity will look to the manner of carriage to due to the expectation of full copyright protection against another station that determine whether the station is treated liability in 1994. Now we are urged has been deemed ‘‘local.’’ Often these as a superstation subject to deletions again, for the same reasons, to defer situations arise because the rules and blackouts, or as a local station that because the statutory copyright license contain several definitions of ‘‘local’’ cannot be blacked out by another, is set to expire in 2004. We are not station. These exceptions—for overlapping local station. To the extent willing to defer application until 2004, significantly viewed stations, stations the exceptions for overlapping areas in and then find that the copyright license whose Grade B includes the community the cable exclusivity rules are relevant is again extended and we are faced unit to be blacked out, and overlapping in the satellite context, we will adopt again with the same issues and specified zones—were adopted to them, as described below. arguments. We believe that C-Band ensure that cable subscribers receive the 57. With respect to the ‘‘significantly carriers will be able to implement these same programming that would be viewed signal exception,’’ a broadcast new regulations, in the limited available to over-the-air viewers in their television station can be declared circumstances in which they will apply communities. Consideration of these ‘‘significantly viewed’’ outside what is to C-Band subscribers, using existing exceptions in the context of satellite usually considered its local market on technology modified as necessary. We carriage is made more complicated the basis of its over-the-air viewing in a

VerDate 112000 14:35 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\14NOR1.SGM pfrm03 PsN: 14NOR1 68094 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations community. Significantly viewed status NCE Must-Carry Exception distant markets due to their fear of confers local treatment on a station 59. Under Section 76.92(g) of the losing gate receipts if the local cable under a number of rules and is intended rules, a cable community unit is not system imported the local sporting to ensure that cable subscribers have the required to delete the duplicating event carried on a distant station. The same local broadcast service that is network programming of any qualified cable sports blackout rule is triggered available to noncable subscribers in noncommercial educational (‘‘NCE’’) when a subject sporting event will not their communities. Section 76.92(f) broadcast television station that is be aired live by any local television provides that a community unit is not carried pursuant to the must carry rules. station carried on a community unit required to delete the duplicating Congress mandated that this provision cable system. Under the cable sports network programming of a significantly be added to the cable network non- blackout rule, the holder of the rights to viewed signal. Similarly, under Section duplication rules as part of the must the event (e.g., a sports team or league, 76.156 (amended rule § 76.106), carry requirements. Congress recognized rather than a broadcaster) has the power syndicated programming covered by an that in some situations an NCE station to demand that the local cable system exclusivity agreement need not be could be considered ‘‘local’’ under the blackout the distant importation of the deleted from a significantly viewed must-carry rules, which are based on a subject sporting event. The zone of signal. A few comments note that a 50-mile zone around the station’s protection afforded by the sports superstation could be significantly community of license, and ‘‘distant’’ for blackout rule is generally 35 miles viewed in areas surrounding its city of purposes of the network non- surrounding the reference point of the license based on over-the-air viewing. duplication rules, which are based on a broadcast station’s community of DirecTV argues that this exception 35-mile specified zone. No commenters license in which the live sporting event could only apply in a few cases in addressed this issue and we believe that is taking place. The 35 mile zone of which the superstation is functioning as this exception is not relevant in this protection is measured from a television a local station and since local stations context. The SHVIA provision applies station’s reference point based upon the are not covered by this section of only to a local station asserting list of reference points in 47 CFR 76.53. SHVIA, the significantly viewed exclusivity rights against one of six The same reference point applies to all exception should not be present in the nationally distributed superstations, stations licensed to the same satellite context. We believe that none of which is an NCE licensee. community regardless of where their pursuant to the SHVIA, the local-into- transmitter or studios are located. When local copyright license can only apply Section 339(B)(1)(A) and (B): sports facilities are located in suburban within the station’s DMA. Thus, once Application of Sports Blackout to areas, the downtown reference points carried outside the DMA, the station Retransmission of Nationally may be inappropriate for purposes of cannot be considered a ‘‘local’’ station. Distributed Superstations and Network calculating the protected zone (e.g., the Therefore, we believe the significantly Stations New England Patriots play mid way viewed and Grade B contour exceptions 60. In addition to requiring between Boston and Providence). will rarely, if ever, be applicable in the application of the network non- Therefore, the Commission has satellite context. duplication and syndicated exclusivity expressed its willingness to consider Overlapping Specified Zones rules, section 339(b)(1)(A) also requires waivers ‘‘to substitute a zone of that we apply the sports blackout rule protection extending out 35 miles from 58. In a related matter, under the to retransmission of nationally the site of a sports event for the network non-duplication rules, if a distributed superstations, and section television station specified zone cable community is located in one or 339(b)(1)(B) requires that we apply the designated by the rule.’’ As with the more overlapping specified zones, sports blackout rule to satellite Commission’s exclusivity rules, the neither station can blackout the other retransmission of network stations. sports blackout rule specifies station’s duplicating programming Unlike the other cable rules we are notification procedures regarding the because both stations have equal required to apply to satellite carriers, sports programming to be deleted. priorities. The NPRM stated that we did only the sports blackout rule applies to However, the time frame allowed for not believe that a similar situation could retransmission of both nationally notification is significantly shorter in occur in the satellite context and sought distributed superstations and network the case of the sports blackout rule than comment on this issue. The one stations. In the case of retransmission of for network non-duplication and commenter addressing this issue network stations, we are instructed to syndicated exclusivity. Notification for contends this exception will not be apply the cable sports blackout rule sports blackout can be given as little as triggered in the satellite context since only ‘‘to the extent technically feasible 24 hours in advance. Notifications for superstations do not have specified and not economically prohibitive. regularly scheduled events subject to zones outside their local markets and 61. The Commission’s sports the sports blackout rule must be SHVIA only applies network non- broadcasts rule (‘‘sports blackout rule’’) received no later than the Monday duplication to nationally distributed is designed to allow the holder of the preceding the calendar week during superstations. As mentioned above, a exclusive distribution rights to local which the deletion is to be made. nationally distributed superstation is a programming, in this case sporting Notifications for events not regularly ‘‘local station’’ when carried by a events, to control, through contractual scheduled, or when the schedule is satellite carrier within its local market. agreements, the display of that event on revised, must be received within 24 When carried as a local station, the local cable systems. The purpose of the hours after the time of the deleted network non-duplication and sports blackout rule is to ensure the telecast is known, but in no event less syndicated exclusivity rules do not continued general availability of sports than 24 hours before the event will take apply to delete its programming. To the programming to the public. The place. The sports blackout rule does not extent the overlapping zones situation Commission adopted this rule based on apply to any community unit with fewer could occur, it will be covered by the a concern that sports teams would than 1,000 subscribers. This exemption exception for significantly viewed or refuse to sell the rights to their local is based on the cost of the equipment Grade B contour discussed above. games to television stations serving needed to delete programming.

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Technical and Economic Effects of We agree with those commenters that and arranging substitute programming is Sports Blackout on Satellite Carriers observe that the statutory language and greater for satellite carriers than for 62. With respect to retransmission of expressions of legislative intent place a cable operators. DirecTV correctly notes nationally distributed superstations, the high burden to justify not imposing the that the time frame allowed for SHVIA requires us to apply the sports sports blackout requirements for notification for sports blackouts is blackout rule from the cable context to satellite retransmission of network significantly shorter than it is for either satellite carriers. With respect to stations. Such burden cannot be network non-duplication or syndicated retransmission of network stations, satisfied by the vague assertions and exclusivity, and recognizes that rights however, the SHVIA provides that the undocumented conclusions offered in holders may not always have the ability sports blackout rules should be applied this record. In contrast, the record to provide more than 24 hours notice. only to the extent technically feasible provides unrefuted information that the The cable sports blackout rules require and not economically prohibitive. The technology to implement the network notice for regularly scheduled events to station sports blackout exists. Indeed, be received on the Monday preceding language limits the application of the the satellite carriers currently black out the calendar week during which the sports blackout rules in this narrow sports programming pursuant to deletion is to be made, and, for events circumstance but only if the technical geographic restrictions in their contracts not regularly scheduled or revisions to and economic difficulties are serious with regional sports networks and previously submitted notices, within 24 and harmful to the satellite carriers. In sports leagues. Consequently, we find hours after the time of the telecast is the NPRM we asked for specific that the heavy burden is not met to known and no later than 24 hours before information on the technical and justify not applying the sports blackout the telecast is to occur. This timing was economic problems that would be obligations to satellite carriers with instituted in 1975 to address sports encountered by satellite carriers. We respect to network stations. interests’ concerns that playoffs and requested per subscriber cost data and weather cancellations often afford little Notification asked whether the existing conditional advance notice of scheduling changes. access mechanisms would work for this 65. In one aspect of the sports DirecTV explains that while it may be purpose. We did not receive specific blackout rules, however, the timing of capable of deleting a sporting event on data or descriptions of how the notification, we find that the record short notice, it cannot accomplish the requirement to black out sporting events supports some modification from the reprogramming necessary in such a on network stations would be unfeasible notification periods in the cable sports short period of time. DirecTV proposes or economically prohibitive to the blackout rules. DirecTV and Echostar a notification period of 60 days prior to degree of posing a serious economic urge that we lengthen the notification the start of a season for sports with a threat to the health of satellite carriers. periods with respect to sports blackouts. specific season, 60 days prior to the 63. DirecTV argues that the In this respect, DirecTV describes a event for nonseasonal but regularly Commission should invoke the blackout system that is notably more scheduled events, 30 days for events not technical/economic hardship exception complex than that of a cable operator. regularly scheduled, and 10 working of section 339(b)(1)(B) and not apply The cable operator controls the days for revisions to previously any sports blackout requirements on programming at a headend, which submitted notices. satellite retransmission of network facilitates blacking out a particular area 67. Commenters respond to DirecTV’s stations but does not explain why the of limited geographic size. The satellite proposal that, while they sometimes can methods it uses to perform the blackouts carrier, in contrast, is controlling provide notice as soon as a season’s required by its contracts with sports programming on a national basis: games are scheduled, the televising leagues cannot be used to black out schedule may not be set until a later network stations. DirecTV does explain First the programmer must notify DirecTV and provide information about the program date. We agree that a 60 day advance that the actual blackouts are ‘‘manually to be blacked out, as well as the areas (by zip notice may allow time for the games to triggered’’ by a person who can watch code) affected. The information provided by be scheduled but not for the telecasts to and monitor only four events at a time. the programmer must then be reformatted for be arranged. Often the televising DirecTV states that additional personnel DirecTV compatibility. Traffic department schedule is not finally decided until a would be needed to monitor and trigger employees must then build the blackout by week before the beginning of the season. the additional events that will be entering the data into the system and notify We find that the satellite carriers, covered by the sports blackout rule. It the scheduling department. The blackout is then scheduled and the data regarding the although not providing sufficient data to asserts there will be ‘‘vast numbers of blackout is processed. The blackout is warrant an exemption from the sports subscribers’’ and ‘‘thousands of blackout checked again for accuracy before it hits the blackout requirements, have offered requests’’ creating a ‘‘monumental, air. Finally the actual blackout itself must be reasonable arguments in support of expensive, and time-consuming task.’’ manually triggered, both in and out, by an revising the notification periods in the There are no specific costs provided. employee who determines when the actual satellite sports blackout rules to the The Echostar comments offer even less event begins and ends by watching an actual extent possible without depriving the specific information. Echostar provides signal of the event. teams and leagues of their contractual no information about particular burdens DirecTV also notes the difficulty of re- rights by establishing time frames that that would be imposed by the programming the time period that has afford no practical protection. requirement to black out sport events been blacked out, especially with very 68. In light of the differences in the from network stations. short advance notice. structure and operation of the satellite 64. As the Network Affiliates point 66. While the process generally and cable industries, we are persuaded out, no commenting party explains why described by DirecTV does not appear to that some adjustment in the application it would be infeasible to develop the present such a serious technical or of the sports blackout rules is justified technology to black out sports economic burden as to excuse and consistent with Congressional programming, if such technology is not compliance with the sports blackout recognition of these differences. We already in use, nor does any commenter rules altogether, it does suggest that the find, however, that the lack of specific offer cost figures to demonstrate that the challenge of implementing multiple, information in the record limits our technology would be cost prohibitive. simultaneous blackouts and identifying ability to finely tailor the requirements

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The notification must include a The Commission has found in previous is appropriate to adjust the notification list of the appropriate zip codes. considerations of the cable sports requirements for satellite carriers to blackout rule that the effect of excepting Exception for Small Community Units, ensure that the holders of rights to up to 1,000 subscribers from a blackout as Applied to Satellite Carriers sporting events will provide the requirement will have a de minimis required notice as promptly as possible. 70. DirecTV advocates excepting effect on the gate receipts. Insofar as we The sports blackout rules for satellite satellite carriers from the sports are using zip codes in lieu of carriers will, therefore, retain the same blackout requirement if the blackout community units, we believe an advance notice requirements for would affect fewer than 5% of the exception based upon the number of regularly scheduled events, including television households in the relevant satellite subscribers, per carrier, in the those events that have a specific season DMA, on a provider-by-provider basis. zip codes affected by a sports blackout (notice must be received the Monday DirecTV asserts that this would have a request is analogous to the exception in before the calendar week in which the de minimis impact on rights holders. the cable sports blackout rule for deletion is to be made) but will also The holders of rights to sporting events community units with fewer than 1,000 require that rights holders notify strongly disagree. The Commissioner of subscribers. In this satellite context we satellite carriers within forty-eight hours Baseball states that satellite subscribers find again that an exception for fewer of the time the telecast is scheduled. We generally constitute less than 5% of than 1,000 subscribers per carrier, per will not make the same requirement for households in most DMAs and contends zip code area comprising a protected events not regularly scheduled due to such an exception would eliminate zone, will not be so detrimental to the the last minute nature of such events. sports blackouts in most cases. We agree sports interests as to warrant the For these unscheduled events, as well as that there should be exceptions to the expense to satellite carriers and the loss for last minute revisions to previously blackout requirements imposed on of sports programming for viewers. We scheduled events, we must take into satellite carriers that are analogous to will reexamine this issue if, in the account the realities for the sports the exceptions for cable systems. We do future, we receive information that the interests of last minute revisions, not agree that 5% of television loss of 1,000 satellite subscribers is particularly due to weather. Therefore, households in a DMA (which would more costly to the sports interests than we retain the 24 hour advance notice include cable subscribers as well as the comparable loss of 1,000 cable minimum to revise previously satellite subscribers) is analogous to the subscribers where the small system scheduled deletions. We hope that small community unit exception for exception applies in the cable sports where satellite carriers have had cable systems. blackout rule. adequate time to line up substitute 71. The cable sports blackout rule Other Provisions of Sports Blackout programming, they will be able to shift does not apply ‘‘to any community unit Rule for Satellite Carriers the substitute programming into the having fewer than 1,000 subscribers.’’ revised time slot even with only 24 Much has been made by some 73. Apart from the changes in the use hours notice. Because this adjustment to commenters of the difference between of zip codes and in the notification the notification requirements reflects the language of this small system requirements described above, we do legitimate differences between satellite exception and the small system not change the other provisions of the carriers and cable operators, we see no exceptions for non-duplication and cable sports blackout rules in their reason to limit this distinction to syndicated exclusivity, which application to satellite carriers. Based retransmission of network stations. For specifically exempt cable systems with upon the general consensus in the purposes of uniformity and clarity, the fewer than 1,000 subscribers. However, comments, the same 35 mile zone of same notification requirements will there appears to be no basis in past protection that applies to cable systems apply to all sports blackout Commission Orders for emphasizing will apply to satellite carriers, and the requirements imposed on satellite this difference in the rule language. The same willingness to consider waivers for carriers, whether with respect to Commission’s rationale for exempting suburban stadiums applies to the network stations or nationally either small systems or small satellite sports blackout rules as well as distributed superstations. community units is the cost of the to the cable sports blackout rules. The equipment for the cable system, and the rights holder will have the obligation of Use of Zip Codes To Determine the relatively de minimis effect on the providing a list of the relevant zip codes Location of Households Subject to protected rights holder of exempting to the satellite carrier with its deletion Sports Blackout such a small system. Because there is no notice. If satellite carriers want to 69. As with the network non- specific cost information in the record evaluate each subscriber’s address and duplication and syndicated exclusivity in this proceeding, it is difficult for us black out only those households within rules, most commenters agree that the to draw a direct connection from the the 35 mile zone, the rules will not sports blackout rule can best be applied Commission’s concerns for small cable prevent them from doing so. For the to satellite carriers by reference to zip systems due to the cost of their blackout same reasons cited in the network non- codes rather than community units. For equipment to the satellite carriers who, duplication and syndicated exclusivity the same reasons discussed in by all reports, already possess the rules, we will not require an electronic connection with network non- necessary equipment to perform the list of zip codes, nor will we require that duplication and syndicated exclusivity, sports blackouts required by statute. satellite carriers designate a particular we agree that the zip codes that 72. We believe that the same type of name or address for receipt of the comprise the specified zones are exception we apply to the satellite notification. We do not have such a appropriate for this purpose. As in the network non-duplication and requirement for cable systems, which

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Satellite carriers Packages may only use substitute programming and digital carriage issues for satellite for which they have copyrights, and, carriers in this context. 79. The NPRM sought comment on an when required, retransmission consent. 76. The responses we received additional issue concerning the They may substitute a different distant concerning this matter are aligned by distribution of sports programming that network station provided they do not industry. Echostar argues that there is is related to, but not directly covered by, retransmit more than two network no legislative authority for the extension the SHVIA. The National Football stations affiliated with the same of the exclusivity rules to digital signals. League sells packages of programming network in a single day. Of course the NAB argues that the SHVIA requires to networks on a national basis, but substitute programming must also exclusivity and sports blackout different games are broadcast locally on comply with the network non- protection to apply to both analog and a regional basis, often in two-game duplication and syndicated exclusivity digital signals. Other broadcast groups, packages. To the extent that broadcasts rules. such as Tribune, argue that Congress did of games are carried into local markets 74. In addition, to afford satellite not indicate an intent that digital signals on distant broadcast signals via satellite, carriers an opportunity to adjust their should be excluded from the new the network non-duplication and other schedules to these new regulatory exclusivity rules and therefore that there rules involved in this proceeding appear requirements, we will require that should be no distinction between analog to offer neither the stations nor the sports rights holders provide 60 days and digital signals under the new rules. leagues involved any protection beyond advance notice for any sports blackout MPAA asserts that syndicated the rights to the particular games that to occur on or before March 31, 2001. exclusivity should apply to both digital local stations are authorized to As of April 1, 2001, the regular notice and analog signals, pointing out that broadcast. We sought comment on the requirements, including 24 hour notice Congress made exceptions for digital question of how the patterns of sports for changes in previously scheduled signals in certain instances but did not carriage involved are addressed by the blackouts, will apply. Because satellite do so for syndicated exclusivity. new law, and whether they can and carriers are currently complying with 77. Because digital exclusivity issues should be addressed in the regulations contractually required sports blackouts, are closely related to digital carriage the Commission is required to adopt we do not believe it is necessary to issues, we believe that it would be pursuant to it. 80. The NFL asks the Commission to provide the same length of time to premature to resolve the matters related ‘‘complete the work that Congress phase-in the implementation of the to this issue at this time. Exclusivity began’’ by applying the network non- sports blackout rules as we find requirements cannot be fully fashioned duplication and syndicated exclusivity warranted for the network non- until both cable operators and satellite rules to network stations as well as to duplication and syndicated exclusivity. carriers know what their carriage nationally distributed superstations. We believe that this 60 day period will responsibilities will be for digital broadcast television. The digital The NFL admits that damage to stations’ be adequate for satellite carriers to exclusivity issues should be decided contractual rights is limited because adjust to the additional sports blackout either when the Commission issues a only unserved and grandfathered requests. Report and Order in the Digital Must households can receive such stations Other Issues Carry proceeding or in another but argues that the numbers of viewers proceeding that discusses a satellite involved are significant nonetheless. Digital Signals carrier’s digital broadcast signal carriage The NFL further contends that the 75. In the NPRM, we stated that responsibilities. Commission should also recognize the section 339(b)(1) and the relevant part of 78. We do address one aspect of this unitary nature of the NFL or any other the Joint Explanatory Statement are issue here. We are disinclined, in the regional television plan and allow local silent regarding application of the early stage of the DTV transition, to affiliates to exercise network non- exclusivity and sports blackout rules to allow a broadcaster to use an exclusive duplication protections to black out the retransmission of digital broadcast contract that applies only to digital other games played at the same time but signals. We noted that in the pending programming to prevent a cable system broadcast in other regions of the country proceeding considering cable mandatory or satellite carrier from providing that (e.g., Redskins versus Cowboys could carriage of digital signals, we requested programming in analog form to its blackout Giants versus Packers). comment on how these cable rules subscribers. However, to the extent Similarly, the National Hockey League would function for cable carriage of contractual rights protect a broadcaster’s expresses concern that a satellite carrier digital signals. In the Notice, we exclusivity for both the analog and that offers local-into-local service could repeated our question of whether digital versions of the same program, we have access to the four games that the Congress intended to apply these rules see no reason to limit the effectiveness NHL plans to regionalize on ABC this to satellite retransmission of digital of the contract to protect only analog year and could thereby create a multi- broadcast signals. We noted that the exclusivity. Therefore, contractual game hockey package to compete SHVIA may be read to apply to both language that expressly applies to unfairly with the ‘‘Center Ice’’ package analog and digital broadcast signals. An analog and digital format of the same on ABC. We note that in the case of alternative interpretation we posited program content will be effective to local-into-local carriage, retransmission was that Congress was only concerned require deletion of both. That is, the rule consent is required, and, presumably, about the carriage of analog signals will provide that neither satellite the stations in question could given that elsewhere in the statute carriers nor cable operators will be contractually prevent this from Congress expressly mentioned digital permitted to carry the digital version of occurring.

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81. The advocates of this expanded would be eligible to receive both maintains that any replacement for application of network non-duplication network stations based on the satellite § 76.5(gg) should incorporate the 1972 have not described why such action carrier’s ‘‘local-into-local’’ license must carry rules definition of a ‘‘local’’ would be in the public interest, because the subscriber resides in the television station’s market area. We although we are persuaded it could be DMA of both stations. Thus, in this agree. The use of DMA’s would in the Leagues’ interest. The NFL and circumstance, the sports blackout unnecessarily undermine the other sports interests advocating this requirement of the SHVIA could, application of the sports blackout rule change ask us to revise the existing conceivably, apply to retransmission of because DMAs may encompass cable rules to require deletion of local, rather than distant, network hundreds of miles. In such a DMA, programming that does not duplicate stations where the geographic area for stations carrying the event located protected programming. As noted in the purposes of the sports blackout zone hundreds of miles distant from the discussion of the network non- surrounding one of the affiliates is relevant protected zone would be duplication rules, supra, the smaller than the DMA. If one of the considered ‘‘local.’’ If considered Commission has determined in the affiliates is not carrying the event, the ‘‘local,’’ the holder of the rights to the cable context that the use of different sports blackout rule might be triggered. event could not assert the sports camera crews and announcers for a If the second affiliate is carrying the blackout rule without blacking out such sporting event results in the distant event, then the satellite carrier might be distant over-the-air carriage if the program not being considered the same required to black out the event being station had must carry rights. as the local program. Here, the NFL asks transmitted by the second affiliate to 85. For the limited purpose of the us to reach a contrary result and decide subscribers within the 35 mile zone. We application of the sports blackout rule, that a different event between different received scant response to this scenario. the provisions of the former § 76.5(gg) teams ‘‘duplicates’’ the protected event. We believe these comments confirm that can be substantially shortened and The NFL and others ask us to expand this situation is unlikely ever to occur consolidated. Because the purpose of the scope of the new satellite exclusivity because the contractual arrangements the sports blackout rule is simply to rules beyond what Congress mandated. allow the rights holder to prohibit both ensure that the rights holders to local In light of the SHVIA’s restrictions on affiliates from broadcasting the event in events can exercise their contractual households that are eligible to receive question. Therefore, we see no reason at exclusivity rights, it is unnecessary to distant network signals, it is not clear to this time to provide for this situation in re-instate the complex definition of what extent carriage of distant signals the rules. ‘‘local’’ that was used for the 1972 must providing different games merits carry regime or the 1987 rate Technical Revisions to the Rules: remedial action. The NFL asserts that regulations. It is not our intention to § 76.5(gg) allowing satellite carriers (and, change the operation of the cable sports presumably, cable systems as well) to 83. The NPRM identified several of blackout rule. This revision merely import distant signals carrying different the cable exclusivity rules that contain incorporates within the cable and games would undermine the NFL’s out-dated cross-references to other satellite sports blackout rules the regional television plan. The NFL sections. We sought comment on how relevant concept from the former cautions that it might ‘‘be forced’’ to these editorial corrections should be § 76.5(gg). made. In particular, we noted that the alter its distribution plan in unspecified Other Technical Corrections ways that would be ‘‘less pro- cable sports blackout rule (§ 76.67, consumer.’’ However, we believe it amended rule § 76.111) contains a cross- 86. The NPRM also included, in would not be pro-consumer to take the reference to § 76.5(gg) to determine Appendix C, two other provisions that action the sports interests request. There when the sports blackout rule is require minor, technical corrections. No can be no doubt of the negative impact triggered. Section 76.5(gg) was comments were received regarding these on viewers of losing access to more and eliminated for reasons unrelated to the provisions. In the absence of any more sports programming. The sports operation of the sports blackout rule, objection, we make these modifications, interests have not provided a and no replacement reference is as proposed, including an editorial compelling need for this additional provided. The NPRM asked whether we change to the top 100 market list protection, and other commenters have should simply reinstate a standard contained in the rules (correcting the argued that it would deprive viewers based on the original criteria markets listed at § 76.51(a)(2) and unnecessarily. For the reasons given, we incorporated into former § 76.5(gg) or (a)(28)), and a correction to § 76.5 to decline to expand the exclusivity rules adopt a new standard. reflect that the reference to § 76.5(o) in to apply to regional or so-called unitary 84. Former § 76.5(gg) of the § 76.5(ii) should be § 76.5(m). packages. If the program for which Commission’s rules referred to the 1972 87. In addition, we note that protection is sought is not, in fact, must carry rules to determine whether § 73.658(m) contains a reference to the duplicated by the distant programming a station was considered ‘‘local.’’ The Arbitron list of smaller markets. As imported by the cable system or satellite cable sports blackout rule is intended to discussed in the Commission’s recent carrier, then neither the network non- be triggered only when no ‘‘local’’ Market Modification Order, Arbitron is duplication nor syndicated exclusivity television station carried by a cable no longer tracking television rules apply. system is broadcasting the subject viewership. The Nielsen Research sporting event for which protection is Company produces a similar list of Two Network Affiliates in One DMA sought. In general, the 1972 must carry markets, which is current. We will, 82. In the NPRM we asked for rules considered a television station therefore, revise this section of the rules comment on the possibility and ‘‘local’’ if the subject cable community to accomplish this updated cross- ramifications of a ‘‘two-affiliates-in-one served was located within the station’s reference. market scenario’’ with respect to the specified zone. In contrast, the current 88. We are also taking this sports blackout rule. We described the must carry rules consider a television opportunity to delete several provisions possibility that, in areas in which there station ‘‘local’’ if it is located in the from the cable exclusivity rules are two affiliates of the same network same DMA as a cable community. The (§§ 76.94, 76.105 (formerly § 76.155), within the same DMA, a subscriber National Hockey League (NHL) 76.97 and 76.163) that have no further

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However, we received some are unable at this time to define or rules become effective within one year comments requesting an exception to quantify the criteria that would of enactment. The SHVIA was enacted the rules analogous to the cable small establish whether a specific television on November 29, 1999. We find good system exception. As discussed in station is dominant in its field of cause exists under the Administrative Sections V.H. and VI.D., we create an operation. Accordingly, the estimates Procedure Act (‘‘APA’’) to have the rules exception to the rules that will assist that follow of small businesses to which adopted in this Report and Order take any small entities subject to these rules rules may apply do not exclude any effect with fewer than 30 days advance now or in the future. television station from the definition of publication in the Federal Register 93. Description and Estimate of the a small business on this basis and are pursuant to section 553(d)(3) of the APA Number of Small Entities to Which the therefore over-inclusive to that extent. due to the statutory deadline. The APA Rules Will Apply. The RFA directs the An additional element of the definition generally requires publication in the Commission to provide a description of of ‘‘small business’’ is that the entity Federal Register of substantive rules 30 and, where feasible, an estimate of the must be independently owned and days prior to their effective date but number of small entities that will be operated. As discussed further below, permits substantive rules to become affected by the proposed rules. The RFA we could not fully apply this criterion, effective with less than 30 days advance defines the term ‘‘small entity’’ as and our estimates of small businesses to publication for good cause. The having the same meaning as the terms which rules may apply may be over- Commission has acted expeditiously to ‘‘small business,’’ ‘‘small organization,’’ inclusive to this extent. The SBA’s adopt these complex rules, and they and ‘‘small government jurisdiction.’’ (5 general size standards are developed will be adopted and published in the U.S.C. 601(6)) In addition, the term taking into account these two statutory Federal Register before the statutory ‘‘small business concern’’ has the same criteria. This does not preclude us from deadline. We note that the rules meaning as the term ‘‘small business taking these factors into account in contemplate a phase-in period to allow concern’’ under Section 3 of the Small making our estimates of the numbers of parties to implement the new Business Act. Under the Small Business small entities. requirements, and thus parties will have Act, a small business concern is one 97. There were 1,509 television time to consider the effect of the rules which: (1) Is independently owned and stations operating in the nation in 1992. before they commence implementation. operated; (2) is not dominant in its field That number has remained fairly of operation; and (3) satisfies any constant as indicated by the Final Regulatory Flexibility Analysis additional criteria established by the approximately 1,616 operating 90. As required by the Regulatory Small Business Administration television broadcasting stations in the Flexibility Act (‘‘RFA’’), see 5 U.S.C. (‘‘SBA’’). The rules we adopt affect nation as of September 1999. For 1992, 603, an Initial Regulatory Flexibility television station licensees and satellite the number of television stations that Analysis (‘‘IRFA’’) was incorporated in carriers. produced less than $10.0 million in the NPRM. The Commission sought 94. Television Stations: The rules and revenue was 1,155 establishments. written public comments on the policies will apply to television Thus, the new rules will affect possible significant economic impact of broadcasting licensees, and potential approximately 1,616 television stations; the proposed policies and rules on small licensees of television service. The SBA approximately 77%, or 1,230 of those entities in the Notice, including defines a television broadcasting station stations are considered small comments on the IRFA. No comments that has no more than $10.5 million in businesses. These estimates may were received on the IRFA. Pursuant to annual receipts as a small business. overstate the number of small entities the RFA, see 5 U.S.C. 604, a Final Television broadcasting stations consist since the revenue figures on which they Regulatory Flexibility Analysis is of establishments primarily engaged in are based do not include or aggregate contained in the Report and Order. This broadcasting visual programs by revenues from non-television affiliated Final Regulatory Flexibility Analysis television to the public, except cable companies. (‘‘FRFA’’) conforms to the RFA. and other pay television services. 98. Small Multiple Video Program 91. Need for, and Objectives of, this Included in this industry are Distributors (‘‘MVPDs’’): SBA has Report and Order. Section 339(b) of the commercial, religious, educational, and developed a definition of small entities Communications Act of 1934, as other television stations. Also included for cable and other pay television amended (‘‘Act’’), 47 U.S.C. 339(b)(1), are establishments primarily engaged in services, which includes all such directed the Commission to ‘‘complete television broadcasting and which companies generating $11 million or all actions necessary to prescribe produce taped television program less in annual receipts. This definition regulations required by this section so materials. Separate establishments includes cable system operators, direct that the regulations shall become primarily engaged in producing taped broadcast satellite services, multipoint effective within 1 year after’’ enactment television program materials are distribution systems, satellite master of the Satellite Home Viewer classified under another SIC number. antenna systems and subscription Improvement Act of 1999. The relevant 95. Pursuant to 5 U.S.C. 601(3), the television services. According to the provisions concern the application of statutory definition of a small business Census Bureau data from 1992, there the cable network non-duplication, applies ‘‘unless an agency after were 1,758 total cable and other pay syndicated program exclusivity, and consultation with the Office of television services and 1,423 had less sports blackout rules to satellite carriers’ Advocacy of the SBA and after than $11 million in revenue. We address retransmission of nationally distributed opportunity for public comment, below services individually to provide a superstations, and, with respect only to establishes one or more definitions of more precise estimate of small entities.

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99. Direct Broadcast Satellite (‘‘DBS’’): 102. Description of Projected the Satellite Home Viewer Improvement There are four licensees of DBS services Reporting, Recordkeeping and other Act of 1999. Among other things, as under Part 100 of the Commission’s Compliance Requirements. This Report described in Sections II and IV, the new Rules. Three of those licensees are and Order establishes a series of rules legislation requires the Commission to currently operational. Two of the implementing the Satellite Home apply the cable network non- licensees which are operational have Viewer Improvement Act of 1999. We duplication rules, syndicated program annual revenues which may be in have adopted a regulatory framework for exclusivity rules, and sports blackout excess of the threshold for a small substantive rules and procedures rules to satellite carriers within one year business. The Commission, however, concerning network non-duplication, of the November 29, 1999 enactment does not collect annual revenue data for syndicated program exclusivity, and date. This legislation applies to both DBS and, therefore, is unable to sports blackout that is substantially small and large entities. Because the ascertain the number of small DBS similar to, but separate from, these rules Commission was instructed to pattern licensees that could be impacted by in the cable context. There are certain the satellite rules after the cable rules, these proposed rules. DBS service compliance requirements involving the the best alternative available to assist requires a great investment of capital for satellite broadcast signal delivery small entities was to create an exception operation, and we acknowledge that process. Foremost is satellite carriers for satellite carriers that have 1,000 or there are entrants in this field that may will have to delete certain programming fewer subscribers within the zip codes not yet have generated $11 million in from the retransmission of nationally areas that comprise the geographic zone annual receipts, and therefore may be distributed superstations to satellite protected by these rules. To the extent categorized as a small business, if subscribers within the protected zone of small entities come within this independently owned and operated. the television broadcast station or other exception, they are exempt from these 100. Home Satellite Delivery (‘‘HSD’’): rights holder asserting network non- rules. duplication, syndicated program The market for HSD service is difficult Ordering Clauses to quantify. Indeed, the service itself exclusivity or sports blackout rights. bears little resemblance to other MVPDs. With respect to satellite retransmission 106. Accordingly, It is ordered that, HSD owners have access to more than of network stations, satellite carriers pursuant authority found in sections 4(i) 265 channels of programming placed on will be required to delete certain sports 4(j), 303(r), and 339 of the C-band satellites by programmers for events from retransmission to satellite Communications Act of 1934, as receipt and distribution by MVPDs, of subscribers located within the rights amended, 47 U.S.C. 154(i), 154(j), which 115 channels are scrambled and holder’s zone of protection. There will 303(r), and 339, the terms of this Report approximately 150 are unscrambled. be costs relating to the time and effort and Order and rules as set forth in the HSD owners can watch unscrambled involved in deleting these superstation rule changes are adopted. The channels without paying a subscription signals and replacing the deleted amendments shall become effective fee. To receive scrambled channels, programming. These costs will largely November 29, 2000, provided that this however, an HSD owner must purchase be borne by satellite carriers. We do not Report and Order (or a summary believe any satellite carrier currently an integrated receiver-decoder from an thereof) and the rules have been subject to these rules is classified as a equipment dealer and pay a published in the Federal Register and small entity. OMB emergency approval of the subscription fee to an HSD 103. In terms of recordkeeping, programming package. Thus, HSD users information collections has been entities will likely have to keep a record obtained on or before that date. include: (1) Viewers who subscribe to a of the deletion and blackout requests packaged programming service, which 107. It is further ordered that the and entities may be required to maintain Consumer Information Bureau, affords them access to most of the same such information within their business programming provided to subscribers of Reference Information Center, Shall environment. This information is for send a copy of this Report and Order, other MVPDs; (2) viewers who receive business purposes and not required to only non-subscription programming; including the Final Regulatory be provided to the Commission as a Flexibility Analysis, to the Chief and (3) viewers who receive satellite matter of course. programming services illegally without Counsel for Advocacy of the Small 104. Steps Taken to Minimize Business Administration. subscribing. Because scrambled Significant Impact on Small Entities, packages of programming are most and Significant Alternatives Considered. List of Subjects in 47 CFR Parts 73 and specifically intended for retail The RFA requires an agency to describe 76 consumers, these are the services most any significant alternatives that it has Cable television, Satellite carriers, relevant to this discussion. considered in reaching its proposed Television broadcast stations. 101. According to the most recently approach, which may include the available information, there are following four alternatives: (1) the Federal Communications Commission. approximately 30 program packagers establishment of differing compliance or William F. Caton, nationwide offering packages of reporting requirements or timetables Deputy Secretary. scrambled programming to retail that take into account the resources Rule Changes consumers. These program packagers available to small entities; (2) the provide subscriptions to approximately clarification, consolidation, or For the reasons discussed in the 2,314,900 subscribers nationwide. This simplification of compliance or preamble, the Federal Communications is an average of about 77,163 subscribers reporting requirements under the rule Commission amends Parts 73 and 76 of per program package. This is for small entities; (3) the use of Title 47 of the Code of Federal substantially smaller than the 400,000 performance, rather than design, Regulations as follows: subscribers used in the commission’s standards; and (4) an exemption from PART 73ÐRADIO BROADCAST definition of a small MSO. Furthermore, coverage of the rule, or any part thereof, SERVICES because this is an average, it is possible for small entities. (5 U.S.C. 603(c).) that some program packagers may be 105. As indicated above, the Report The authority citation for Part 73 smaller. and Order implements certain aspects of continues to read as follows:

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Authority: 47 U.S.C. 154, 303, 334 and 4. Section 76.51 is amended by (1) First, all television broadcast 336. revising the entries for paragraphs (a)(2) stations within whose specified zone 1. Section 73.658(m)(1) is revised to and (a)(28) to read as follows: the community of the community unit read as follows: is located, in whole or in part; § 76.51 Major television markets. (2) Second, all smaller market § 73.658 Affiliation agreements and * * * * * network program practices; territorial television broadcast stations within (a) * * * whose secondary zone the community exclusivity in non-network program (2) Los Angeles-San Bernardino- arrangements. of the community unit is located, in Corona-Riverside-Anaheim, Calif. * * * * * whole or in part. * * * * * (m) Territorial exclusivity in non- (c) For purposes of this section, all (28) Tampa-St. Petersburg-Clearwater, network arrangements. (1) No television noncommercial educational television Florida. station shall enter into any contract, broadcast stations licensed to a arrangement, or understanding, * * * * * community located in whole or in part within a major television market as expressed or implied; with a non- § 76.67 [Removed] network program producer, distributor, specified in § 76.51 shall be treated in or supplier, or other person; which 5. Remove § 76.67. the same manner as a major market prevents or hinders another television 6. Revise Part 76, subpart F to read as commercial television broadcast station, station located in a community over follows: and all noncommercial educational 56.3 kilometers (35 miles) away, as television broadcast stations not Subpart FÐNetwork Non-duplication determined by the reference points licensed to a community located in Protection, Syndicated Exclusivity and contained in § 76.53 of this chapter, (if whole or in part within a major Sports Blackout reference points for a community are television market shall be treated in the not listed in § 76.53, the location of the Sec. same manner as a smaller market main post office will be used) from 76.92 Cable network non-duplication; television broadcast station. broadcasting any program purchased by extent of protection. (d) Any community unit operating in the former station from such non- 76.93 Parties entitled to network non- a community to which a 100-watt or network program producer, distributor, duplication protection. higher power translator is located supplier, or other person, except that a 76.94 Notification. within the predicted Grade B signal 76.95 Exceptions. television station may secure exclusivity contour of the television broadcast 76.101 Cable syndicated program station that the translator station against a television station licensed to exclusivity: extent of protection. another designated community in a 76.103 Parties entitled to syndicated retransmits, and which translator is hyphenated market specified in the exclusivity. carried by the community unit shall, market listing as contained in § 76.51 of 76.105 Notification. upon request of such translator station this chapter for those 100 markets listed, 76.106 Exceptions. licensee or permittee, delete the and for markets not listed in § 76.51 of 76.107 Exclusivity contracts. duplicating network programming of this chapter, the listing as contained in 76.108 Indemnification contracts. any television broadcast station whose 76.109 Requirements for invocation of the Nielsen Media Research DMA reference point (See § 76.53) is more protection. than 88.5 km (55 miles) from the Rankings for the most recent year at the 76.110 Substitutions. time that the exclusivity contract, 76.111 Cable sports blackout. community of the community unit. arrangement or understanding is 76.120 Network non-duplication, (e) Any community unit which complete under practices of the syndicated exclusivity and sports operates in a community located in industry. As used in this paragraph, the blackout for satellite carriers: whole or in part within the secondary term ‘‘community’’ is defined as the Definitions. zone of a smaller market television community specified in the instrument 76.122 Satellite network non-duplication. broadcast station is not required to 76.123 Satellite syndicated program delete the duplicating network of authorization as the location of the exclusivity. station. programming of any major market 76.124 Requirements for invocation of television broadcast station whose * * * * * protection. 76.125 Indemnification contracts. reference point (See § 76.53) is also PART 76ÐMULTICHANNEL VIDEO 76.127 Satellite sports blackout. within 88.5 km (55 miles) of the AND CABLE TELEVISION SERVICE 76.128 Application of sports blackout rules. community of the community unit. 76.130 Substitutions. (f) A community unit is not required 2. The authority citation for Part 76 is to delete the duplicating network revised to read as follows: § 76.92 Cable network non-duplication; programming of any television extent of protection. broadcast station which is significantly Authority: 47 U.S.C. 151, 152, 153, 154, (a) Upon receiving notification 301, 302, 303, 303a, 307, 308, 309, 312, 315, viewed in the cable television 325, 339, 503, 521, 522, 531, 532, 534, 535, pursuant to § 76.94, a cable community community pursuant to § 76.54. 536, 537, 543, 544, 544a, 545, 548, 549, 552, unit located in whole or in part within (g) A community unit is not required 554, 556, 558, 560, 561, 571, 572, 573. the geographic zone for a network to delete the duplicating network 3. Section 76.5(ii) is revised to read as program, the network non-duplication programming of any qualified NCE follows: rights to which are held by a television broadcast station that is commercial television station licensed carried in fulfillment of the cable § 76.5 Definitions by the Commission, shall not carry that television system’s mandatory signal * * * * * program as broadcast by any other carriage obligations, pursuant to § 76.56. (ii) A syndicated program is any television signal, except as otherwise program sold, licensed, distributed or Note: With respect to network provided below. programming, the geographic zone within offered to television station licensees in (b) For purposes of this section, the which the television station is entitled to more than one market within the United order of nonduplication priority of enforce network non-duplication protection States other than as network television signals carried by a and priority of shall be that geographic area programming as defined in § 76.5(m). community unit is as follows: agreed upon between the network and the

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In no event shall such etc.) of the non-duplication protection (ii) Sixty days before the program or rights exceed the area within which the which has been agreed upon by the programs mentioned in the request for television station may acquire broadcast network (or networks) and the information will be broadcast; territorial exclusivity rights as defined in broadcaster. whichever comes later. § 73.658(m) of this Chapter, except that small (c) Except as otherwise provided in (3) The broadcaster requesting market television stations shall be entitled to a secondary protection zone of 32.2 paragraph (d) of this section, a exclusivity. additional kilometers (20 additional miles). broadcaster shall be entitled to non- (f) A broadcaster exercising To the extent rights are obtained for any duplication protection beginning on the exclusivity pursuant to § 76.92 shall hyphenated market named in § 76.51, such later of: provide to the cable system, upon rights shall not exceed those permitted under (1) The date specified in its notice (as request, an exact copy of those portions § 73.658(m) of this Chapter for each named described in paragraphs (a) or (b) of this of the contracts, such portions to be community in that market. section, whichever is applicable) to the signed by both the network and the cable television system; or broadcaster, setting forth in full the § 76.93 Parties entitled to network non- (2) The first day of the calendar week provisions pertinent to the duration, duplication protection. (Sunday through Saturday) that begins nature, and extent of the non- Television broadcast station licensees 60 days after the cable television system duplication terms concerning broadcast shall be entitled to exercise non- receives notice from the broadcaster. signal exhibition to which the parties duplication rights pursuant to § 76.92 in (d) A broadcaster shall provide the have agreed. accordance with the contractual following information to the cable provisions of the network-affiliate television system under the following § 76.95 Exceptions. agreement. circumstances: (a) The provisions of §§ 76.92 through (1) In the event the protection 76.94 shall not apply to a cable system § 76.94 Notification. specified in the notices described in serving fewer than 1,000 subscribers. (a) In order to exercise non- paragraphs (a) or (b) of this section has Within 60 days following the provision duplication rights pursuant to § 76.92, been limited or ended prior to the time of service to 1,000 subscribers, the television stations shall notify each specified in the notice, or in the event operator of each such system shall file cable television system operator of the a time period, as identified to the cable a notice to that effect with the non-duplication sought in accordance system in a notice pursuant to Commission, and serve a copy of that with the requirements of this section. paragraph (b) of this section, for which notice on every television station that Except as otherwise provided in a broadcaster has obtained protection is would be entitled to exercise network paragraph (b) of this section, non- shifted to another time of day or another non-duplication protection against it. duplication protection notices shall day (but not expanded), the broadcaster (b) Network non-duplication include the following information: shall, as soon as possible, inform each protection need not be extended to a (1) The name and address of the party cable television system operator that has higher priority station for one hour requesting non-duplication protection previously received the notice of all following the scheduled time of and the television broadcast station changes from the original notice. Notice completion of the broadcast of a live holding the non-duplication right; to be furnished ‘‘as soon as possible’’ sports event by that station or by a lower (2) The name of the program or series under this paragraph shall be furnished priority station against which a cable (including specific episodes where by telephone, telegraph, facsimile, community unit would otherwise be necessary) for which protection is overnight mail or other similar required to provide non-duplication sought; and expedient means. protection following the scheduled time (3) The dates on which protection is (2) In the event the protection of completion. to begin and end. specified in the modified notices (b) Broadcasters entering into described in paragraph (b) of this § 76.101 Cable syndicated program exclusivity: extent of protection. contracts providing for network non- section has been expanded, the duplication protection shall notify broadcaster shall, at least 60 calendar Upon receiving notification pursuant affected cable systems within 60 days prior to broadcast of a protected to § 76.105, a cable community unit calendar days of the signing of such a program entitled to such expanded located in whole or in part within the contract. In the event the broadcaster is protection, notify each cable system geographic zone for a syndicated unable based on the information operator that has previously received program, the syndicated exclusivity contained in the contract, to furnish all notice of all changes from the original rights to which are held by a the information required by paragraph notice. commercial television station licensed (a) of this section at that time, the (e) In determining which programs by the Commission, shall not carry that broadcaster must provide modified must be deleted from a television signal, program as broadcast by any other notices that contain the following a cable television system operator may television signal, except as otherwise information: rely on information from any of the provided below. (1) The name of the network (or following sources published or Note: With respect to each syndicated networks) which has (or have) extended otherwise made available: program, the geographic zone within which non-duplication protection to the (1) Newspapers or magazines of the television station is entitled to enforce broadcaster; general circulation. syndicated exclusivity rights shall be that (2) The time periods by time of day (2) A television station whose geographic area agreed upon between the (local time) and by network (if more programs may be subject to deletion. If non-network program supplier, producer or than one) for each day of the week that a cable television system asks a distributor and the television station. In no the broadcaster will be broadcasting event shall such zone exceed the area within television station for information about which the television station has acquired programs from that network (or its program schedule, the television broadcast territorial exclusivity rights as networks) and for which non- station shall answer the request: defined in § 73.658(m) of this Chapter. To the duplication protection is requested; and (i) Within ten business days following extent rights are obtained for any hyphenated (3) The duration and extent (e.g., the television station’s receipt of the market named in § 76.51, such rights shall simultaneous, same-day, seven-day, request; or not exceed those permitted under

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§ 73.658(m) of this Chapter for each named sources published or otherwise made system, upon request, an exact copy of community in that market. available. those portions of the exclusivity (1) Newspapers or magazines of contracts, such portions to be signed by § 76.103 Parties entitled to syndicated general circulation; both the distributor and the television exclusivity. (2) A television station whose station, setting forth in full the (a) Television broadcast station programs may be subject to deletion. If provisions pertinent to the duration, licensees shall be entitled to exercise a cable television system asks a nature, and extent of the exclusivity exclusivity rights pursuant to § 76.101 television station for information about terms concerning broadcast signal in accordance with the contractual its program schedule, the television exhibition to which the parties have provisions of their syndicated program station shall answer the request: agreed. license agreements, consistent with (i) Within ten business days following § 76.108 Indemnification contracts. § 76.109. the television station’s receipt of the (b) Distributors of syndicated request; or No licensee shall enter into any programming shall be entitled to (ii) Sixty days before the program or contract to indemnify a cable system for exercise exclusive rights pursuant to programs mentioned in the request for liability resulting from failure to delete § 76.101 for a period of one year from information will be broadcast; programming in accordance with the the initial broadcast syndication whichever comes later. provisions of this subpart unless the licensing of such programming (3) The distributor or television licensee has a reasonable basis for anywhere in the United States; station requesting exclusivity. concluding that such program deletion provided, however, that distributors (d) In the event the exclusivity is not required by this subpart. shall not be entitled to exercise such specified in paragraph (a) of this section § 76.109 Requirements for invocation of rights in areas in which the has been limited or has ended prior to protection. the time specified in the notice, the programming has already been licensed. For a station licensee to be eligible to distributor or broadcaster who has invoke the provisions of § 76.101, it § 76.105 Notification. supplied the original notice shall, as must have a contract or other written soon as possible, inform each cable (a) In order to exercise exclusivity indicia that it holds syndicated television system operator that has rights pursuant to § 76.101, distributors exclusivity rights for the exhibition of previously received the notice of all or television stations shall notify each the program in question. Contracts changes from the original notice. In the cable television system operator of the entered on or after August 18, 1988, event the original notice specified exclusivity sought in accordance with must contain the following words: ‘‘the contingent dates on which exclusivity is the requirements of this section. licensee [or substitute name] shall, by to begin and/or end, the distributor or Syndicated program exclusivity notices the terms of this contract, be entitled to broadcaster shall, as soon as possible, shall include the following information: invoke the protection against notify the cable television system (1) The name and address of the party duplication of programming imported operator of the occurrence of the requesting exclusivity and the television under the Compulsory Copyright relevant contingency. Notice to be broadcast station or other party holding License, as provided in § 76.101 of the furnished ‘‘as soon as possible’’ under the exclusive right; FCC rules [or ‘as provided in the FCC’s this paragraph shall be furnished by (2) The name of the program or series syndicated exclusivity rules’].’’ telephone, telegraph, facsimile, (including specific episodes where Contracts entered into prior to August overnight mail or other similar necessary) for which exclusivity is 18, 1988, must contain either the expedient means. sought; foregoing language or a clear and (3) The dates on which exclusivity is § 76.106 Exceptions. specific reference to the licensee’s to begin and end. (a) Notwithstanding the requirements authority to exercise exclusivity rights (b) Broadcasters entering into of §§ 76.101 through 76.105, a broadcast as to the specific programming against contracts on or after August 18, 1988, signal is not required to be deleted from cable television broadcast signal which contain syndicated exclusivity a cable community unit when that cable carriage by the cable system in question protection shall notify affected cable community unit falls, in whole or in upon the contingency that the systems within sixty calendar days of part, within that signal’s grade B government reimposed syndicated the signing of such a contract. contour, or when the signal is exclusivity protection. In the absence of Broadcasters who have entered into significantly viewed pursuant to § 76.54 such a specific reference in contracts contracts prior to August 18, 1988, and in the cable community. entered into prior to August 18, 1988, who comply with the requirements (b) The provisions of §§ 76.101 the provisions of these rules may be specified in § 76.109 shall notify through 76.105 shall not apply to a invoked only if the contract is amended affected cable systems on or before June cable system serving fewer than 1,000 to include the specific language 19, 1989. A broadcaster shall be entitled subscribers. Within 60 days following referenced in this section or a specific to exclusivity protection beginning on the provision of service to 1,000 written acknowledgment is obtained the later of: subscribers, the operator of each such from the party from whom the broadcast (1) The date specified in its notice to system shall file a notice to that effect exhibition rights were obtained that the the cable television system; or with the Commission, and serve a copy existing contract was intended, or (2) The first day of the calendar week of that notice on every television station should now be construed by agreement (Sunday through Saturday) that begins that would be entitled to exercise of the parties, to include such rights. A 60 days after the cable television system syndicated exclusivity protection general acknowledgment by a supplier receives notice from the broadcaster; against it. of exhibition rights that specific contract (c) In determining which programs language was intended to convey rights must be deleted from a television § 76.107 Exclusivity contracts. under these rules will be accepted with broadcast signal, a cable television A distributor or television station respect to all contracts containing that system operator may rely on exercising exclusivity pursuant to specific language. Nothing in this information from any of the following § 76.101 shall provide to the cable section shall be construed as a grant of

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Notifications as to events not regular basis for 15 or more hours per Whenever, pursuant to the regularly scheduled and revisions of week to at least 25 affiliated television requirements of the syndicated notices previously submitted, must be licensees in 10 or more States; exclusivity rules, a community unit is received within twenty-four (24) hours (2) On May 1, 1991, was retransmitted required to delete a television program after the time of the telecast to be by a satellite carrier and was not a on a broadcast signal that is permitted deleted is known, but in any event no network station at that time; and to be carried under the Commission’s later than twenty-four (24) hours from (3) Was, as of July 1, 1998, rules, such community unit may, the time the subject telecast is to take retransmitted by a satellite carrier under consistent with these rules and the place. the statutory license of Section 119 of sports blackout rules at § 76.111, (d) Whenever, pursuant to this title 17, United States Code. substitute a program from any other section, a community unit is required to (c) Television network. The term television broadcast station. Programs delete a television program on a signal ‘‘television network’’ means a television substituted pursuant to this section may network in the United States which be carried to their completion. regularly carried by the community unit, such community unit may, offers an interconnected program service on a regular basis for 15 or more § 76.111 Cable sports blackout. consistent with the rules contained in hours per week to at least 25 affiliated (a) No community unit located in subpart F of this part, substitute a program from any other television broadcast stations in 10 or more States. whole or in part within the specified (d) Network station. The term broadcast station. A program substituted zone of a television broadcast station ‘‘network station’’ means— licensed to a community in which a may be carried to its completion, and (1) A television broadcast station, sports event is taking place, shall, on the community unit need not return to including any translator station or request of the holder of the broadcast its regularly carried signal until it can terrestrial satellite station that rights to that event, or its agent, carry do so without interrupting a program rebroadcasts all or substantially all of the live television broadcast of that already in progress. the programming broadcast by a event if the event is not available live on (e) The provisions of this section shall network station, that is owned or a television broadcast station meeting not be deemed to require the deletion of operated by, or affiliated with, one or the criteria specified in § 76.128. For any portion of a television signal which more of the television networks in the purposes of this section, if there is no a community unit was lawfully carrying United States which offer an television station licensed to the prior to March 31, 1972. interconnected program service on a community in which the sports event is (f) The provisions of this section shall regular basis for 15 or more hours per taking place, the applicable specified not apply to any community unit having week to at least 25 of its affiliated zone shall be that of the television fewer than 1,000 subscribers. television licensees in 10 or more States; station licensed to the community with or which the sports event or team is § 76.120 Network non-duplication protection, syndicated exclusivity and (2) A noncommercial educational identified, or, if the event or local team broadcast station (as defined in Section is not identified with any particular sports blackout rules for satellite carriers: Definitions. 397 of the Communications Act of community, the nearest community to 1934); except that the term does not For purposes of §§ 76.122–76.130, the which a television station is licensed. include the signal of the Alaska Rural (b) Notification of the programming to following definitions apply: Communications Service, or any be deleted pursuant to this section shall (a) Satellite carrier. The term successor entity to that service. include the following information: ‘‘satellite carrier’’ means an entity that (e) Zone of protection. The term ‘‘zone (1) As to programming to be deleted uses the facilities of a satellite or of protection’’ means— from television broadcast signals satellite service licensed by the Federal (1) With respect to network non- regularly carried by the community Communications Commission and duplication, the zone of protection unit: operates in the Fixed-Satellite Service within which the television station is (i) The name and address of the party under part 25 of title 47 of the Code of entitled to enforce network non- requesting the program deletion; Federal Regulations or the Direct (ii) The date, time and expected duplication protection shall be that Broadcast Satellite Service under part geographic area agreed upon between duration of the sports event the 100 of title 47 of the Code of Federal television broadcast of which is to be the network and the television station. Regulations, to establish and operate a In no event shall such rights exceed the deleted; channel of communications for point-to- (iii) The call letters of the television area within which the television station multipoint distribution of television broadcast station(s) from which the may acquire broadcast territorial station signals, and that owns or leases deletion is to be made. exclusivity rights as defined in (2) As to programming to be deleted a capacity or service on a satellite in § 73.658(m) of this Chapter, except that from television broadcast signals not order to provide such point-to- small market television stations shall be regularly carried by the community multipoint distribution, except to the entitled to a secondary protection zone unit: extent that such entity provides such of 32.2 additional kilometers (20 (i) The name and address of the party distribution pursuant to tariff under the additional miles). To the extent rights requesting the program deletion; Communications Act of 1934, other than are obtained for any hyphenated market (ii) The date, time and expected for private home viewing. named in § 76.51, such rights shall not duration of the sports event the (b) Nationally distributed exceed those permitted under television broadcast of which is to be superstation. The term ‘‘nationally § 73.658(m) of this Chapter for each deleted. distributed superstation’’ means a named community in that market. (c) Notifications given pursuant to television broadcast station, licensed by (2) With respect to each syndicated this section must be received, as to the Commission, that— program, the zone of protection within

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In no event shall such broadcaster; this paragraph shall be furnished by zone exceed the area within which the (5) The time periods by time of day telephone, telegraph, facsimile, e-mail, television station has acquired broadcast (local time) and by network (if more overnight mail or other similar territorial exclusivity rights as defined than one) for each day of the week that expedient means. in § 73.658(m) of this Chapter. To the the broadcaster will be broadcasting (2) In the event the protection extent rights are obtained for any programs from that network (or specified in the notices described in hyphenated market named in § 76.51, networks) and for which non- paragraph (c) of this section has been such rights shall not exceed those duplication protection is requested; expanded, the broadcaster shall, at least permitted under § 73.658(m) of this (6) The duration and extent (e.g., 60 calendar days prior to broadcast of a chapter for each named community in simultaneous, same-day, seven-day, protected program entitled to such that market. etc.) of the non-duplication protection expanded protection, notify each (3) With respect to sports blackout, which has been agreed upon by the satellite carrier that has previously the zone of protection is the ‘‘specified network (or networks) and the received notice of all changes from the zone’’ of a television broadcast station, broadcaster; and original notice. as defined in § 76.5(e). If there is no (7) A list of the U.S. postal zip code(s) (g) In determining which programs television station licensed to the that encompass the zone of protection must be deleted from a television signal, community in which the sports event is under these rules. a satellite carrier may rely on taking place, the applicable specified (d) Broadcasters entering into information from newspapers or zone shall be that of the television contracts providing for network non- magazines of general circulation, the station licensed to the community with duplication protection shall notify broadcaster requesting exclusivity which the sports event or team is affected satellite carriers within 60 protection, or the nationally distributed identified, or, if the event or local team calendar days of the signing of such a superstation. is not identified with any particular contract; provided, however, that for (h) If a satellite carrier asks a community, the nearest community to such contracts signed before November nationally distributed superstation for which a television station is licensed. 29, 2000, the broadcaster may provide information about its program schedule, notice on or before January 31, 2001, or the nationally distributed superstation § 76.122 Satellite network non-duplication. with respect to pre-November 29, 2000 shall answer the request: (a) Upon receiving notification contracts that require amendment in (i) Within ten business days following pursuant to paragraph (c) of this section, order to invoke the provisions of these its receipt of the request; or a satellite carrier shall not deliver, to rules, notification may be given within (ii) Sixty days before the program or subscribers within zip code areas sixty calendar days of the signing of programs mentioned in the request for located in whole or in part within the such amendment. information will be broadcast, zone of protection of a commercial (e) Except as otherwise provided in whichever comes later. television station licensed by the this section, a broadcaster shall be (i) A broadcaster exercising Commission, a program carried on a entitled to non-duplication protection exclusivity pursuant to this section shall nationally distributed superstation beginning on the later of: provide to the satellite carrier, upon when the network non-duplication (1) The date specified in its notice to request, an exact copy of those portions rights to such program are held by the the satellite carrier; or of the contracts, such portions to be commercial television station providing (2) The first day of the calendar week signed by both the network and the notice, except as provided in paragraphs (Sunday through Saturday) that begins broadcaster, setting forth in full the (j), (k) or (l) of this section. 60 days after the satellite carrier provisions pertinent to the duration, (b) Television broadcast station receives notice from the broadcaster; nature, and extent of the non- licensees shall be entitled to exercise Provided, however, that with respect to duplication terms concerning broadcast non-duplication rights pursuant to notifications given pursuant to this signal exhibition to which the parties § 76.122 in accordance with the section prior to June 1, 2001, a satellite have agreed. contractual provisions of the network- carrier is not required to provide non- (j) A satellite carrier is not required to affiliate agreement, and as provided in duplication protection until 120 days delete the duplicating programming of § 76.124. after the satellite carrier receives such any nationally distributed superstation (c) In order to exercise non- notification. that is carried by the satellite carrier as duplication rights pursuant to § 76.122, (f) A broadcaster shall provide the a local station with the station’s television stations shall notify each following information to the satellite retransmission consent pursuant to satellite carrier of the non-duplication carrier under the following § 76.64 sought in accordance with the circumstances: (i) Within the station’s local market; requirements of this section. Non- (1) In the event the protection (ii) If the station is ‘‘significantly duplication protection notices shall specified in the notices described in viewed,’’ pursuant to § 76.54, in zip include the following information: paragraph (c) of this section has been code areas included within the zone of (1) The name and address of the party limited or ended prior to the time protection; or requesting non-duplication protection specified in the notice, or in the event (iii) If the zone of protection falls, in and the television broadcast station a time period, as identified to the whole or in part, within that signal’s holding the non-duplication right; satellite carrier in a notice pursuant to grade B contour. (2) The name of the program or series paragraph (c) of this section, for which (k) A satellite carrier is not required (including specific episodes where a broadcaster has obtained protection is to delete the duplicating programming necessary) for which protection is shifted to another time of day or another of any nationally distributed sought; day (but not expanded), the broadcaster superstation from an individual

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In the event the original notice pursuant to paragraph (d) of this distributors entering into contracts on or specified contingent dates on which section, a satellite carrier shall not after November 29, 2000, which contain exclusivity is to begin and/or end, the deliver, to subscribers located within syndicated exclusivity protection with distributor or broadcaster shall, as soon zip code areas in whole or in part respect to satellite retransmission of as possible, notify the satellite carrier of within the zone of protection of a programming, shall notify affected the occurrence of the relevant commercial television station licensed satellite carriers within sixty calendar contingency. Notice to be furnished ‘‘as by the Commission, a program carried days of the signing of such a contract. soon as possible’’ under this Subsection on a nationally distributed superstation Television broadcast stations or shall be furnished by telephone, when the syndicated program distributors who have entered into telegraph, facsimile, e-mail, overnight exclusivity rights to such program are contracts prior to November 29, 2000, mail or other similar expedient means. held by the commercial television and who comply with the requirements (k) A satellite carrier is not required station providing notice, except as specified in § 76.124 shall notify to delete the programming of any provided in paragraphs (k), (l) and (m) affected satellite carriers on or before nationally distributed superstation that of this section. January 31, 2001; provided, however, is carried by the satellite carrier as a (b) Television broadcast station that with respect to pre-November 29, local station with the station’s licensees shall be entitled to exercise 2000 contracts that require amendment retransmission consent pursuant to exclusivity rights pursuant to this in order to invoke the provisions of § 76.64: Section in accordance with the these rules, notification may be given (1) Within the station’s local market; contractual provisions of their within sixty calendar days of the signing (2) If the station is ‘‘significantly syndicated program license agreements, of such amendment. viewed,’’ pursuant to § 76.54, in zip consistent with § 76.124. (g) Except as otherwise provided in code areas included within the zone of (c) Distributors of syndicated this section, a television broadcast protection; or programming shall be entitled to station shall be entitled to exclusivity (3) If the zone of protection falls, in exercise exclusive rights pursuant to protection beginning on the later of: whole or in part, within that signal’s this Section for a period of one year (1) The date specified in its notice to grade B contour. from the initial broadcast syndication the satellite carrier; or (l) A satellite carrier is not required to (2) The first day of the calendar week licensing of such programming delete the duplicating programming of (Sunday through Saturday) that begins anywhere in the United States; any nationally distributed superstation 60 days after the satellite carrier provided, however, that distributors from an individual subscriber who is receives notice from the broadcaster. shall not be entitled to exercise such located outside the zone of protection, Provided, however, that with respect notwithstanding that the subscriber rights in areas in which the to notifications given pursuant to this programming has already been licensed. lives within a zip code provided by the section prior to June 1, 2001, a satellite broadcaster pursuant to paragraph (d) of (d) In order to exercise exclusivity carrier is not required to provide rights pursuant to this Section, this section. syndicated exclusivity protection until (m) A satellite carrier is not required distributors of syndicated programming 120 days after the satellite carrier to delete programming if it has fewer or television broadcast stations shall receives such notification. than 1,000 subscribers within the notify each satellite carrier of the (h) In determining which programs relevant protected zone who subscribe exclusivity sought in accordance with must be deleted from a television to the nationally distributed the requirements of this paragraph. broadcast signal, a satellite carrier may superstation carrying the programming Syndicated program exclusivity notices rely on information from the distributor for which deletion is requested pursuant shall include the following information: or television broadcast station to paragraph (d) of this section. (1) The name and address of the party requesting exclusivity; newspapers or requesting exclusivity and the television magazines of general circulation; or the § 76.124 Requirements for invocation of broadcast station or other party holding nationally distributed superstation protection. the exclusive right; whose programs may be subject to For a television broadcast station (2)The name of the program or series deletion. licensee or distributor of syndicated (including specific episodes where (i) If a satellite carrier asks a programming to be eligible to invoke the necessary) for which exclusivity is nationally distributed superstation for provisions of § 76.122 or § 76.123 of this sought; information about its program schedule, subpart, it must have a contract or other (3)The dates on which exclusivity is the nationally distributed superstation written indicia that it holds network to begin and end; and shall answer the request: program non-duplication or syndicated

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Contracts television station licensed to the rules. entered on or after November 29, 2000, community in which the sports event is The cable and satellite sports blackout must contain the following words: ‘‘the taking place, the applicable specified rules (§§ 76.111 and 76.127) may apply licensee [or substitute name] shall, by zone shall be that of the television when the sports event is not available the terms of this contract, be entitled to station licensed to the community with live on any of the following television invoke the protection against which the sports event or team is broadcast stations carried by a cable duplication of programming imported identified, or, if the event or local team system or other MVPD: under the Statutory Copyright License, is not identified with any particular (a) Television broadcast stations as provided in § 76.122 or § 76.123 of community, the nearest community to within whose specified zone the the FCC rules [or ’as provided in the which a television station is licensed. community of the community unit or FCC’s satellite network non-duplication (b) Notification of the programming to the community within which the or syndicated exclusivity rules’].’’ be deleted pursuant to this Section shall sporting event is taking place is located, Contracts entered into prior to include the following information: in whole or in part; November 29, 2000, must contain the (b) Television broadcast stations foregoing language plus a clear and (1) The name and address of the party within whose Grade B contours the specific reference to the licensee’s requesting the program deletion; community of the community unit or authority to exercise exclusivity rights (2) The date, time and expected the community within which the as to the specific programming against duration of the sports event the sporting event is taking place is located, signal carriage by the satellite carrier in television broadcast of which is to be in whole or in part; question, or by satellite carriage in deleted; (c) Television broadcast stations general in a protected, geographic or (3) The call letters of the nationally licensed to other designated specified zone. In the absence of such a distributed superstation or network communities which are generally specific reference in contracts entered station(s) from which the deletion is to considered to be part of the same into prior to November 29, 2000, the be made; television market (Example: Burlington, provisions of these rules may be (4) The U.S. postal zip codes that Vt.-Plattsburgh, N.Y. or Cincinnati, invoked only if the contract is amended encompass the specified zone. Ohio-Newport, Ky., television markets); to include the specific language (d) Television broadcast stations that referenced in this section or a specific (c) Notifications given pursuant to are significantly viewed, pursuant to written acknowledgment is obtained this section must be received by the § 76.54, in the community unit or from the party from whom the broadcast satellite carrier, as to regularly community within the specified zone. exhibition rights were obtained that the scheduled events, within forty-eight (48) existing contract was intended, or hours after the time of the telecast to be § 76.130 Substitutions. should now be construed by agreement deleted is known, and no later than the Whenever, pursuant to the of the parties, to include such rights. A Monday preceding the calendar week requirements of the network program general acknowledgment by a supplier (Sunday through Saturday) during non-duplication, syndicated program of exhibition rights that specific contract which the program deletion is to be exclusivity, or sports blackout rules, a language was intended to convey rights made. Notifications as to events not satellite carrier is required to delete a under these rules will be accepted with regularly scheduled and revisions of television program from retransmission respect to all contracts containing that notices previously submitted, must be to satellite subscribers within a zip code specific language. Nothing in this received within twenty-four (24) hours area, such satellite carrier may, section shall be construed as a grant of after the time of the telecast to be consistent with this Subpart, substitute exclusive rights to a broadcaster where deleted is known, but in any event no a program from any other television such rights are not agreed to by the later than twenty-four (24) hours from broadcast station for which the satellite parties. the time the subject telecast is to take carrier has obtained the necessary legal place. rights and permissions, including but § 76.125 Indemnification contracts. (d) A satellite carrier is not required not limited to copyright and No television broadcast station to delete a sports event from an retransmission consent. Programs licensee shall enter into any contract to individual subscriber who is located substituted pursuant to this section may indemnify a satellite carrier for liability outside the specified zone, be carried to their completion. resulting from failure to delete notwithstanding that the subscriber [FR Doc. 00–29028 Filed 11–13–00; 8:45 am] programming in accordance with the lives within a zip code provided by the BILLING CODE 6712±01±U provisions of this Subpart unless the holder of the broadcast rights pursuant licensee has a reasonable basis for to paragraph (b) of this section. concluding that such program deletion (e) A satellite carrier is not required is not required by this Subpart. DEPARTMENT OF TRANSPORTATION to delete a sports event if it has fewer § 76.127 Satellite sports blackout. than 1,000 subscribers within the National Highway Traffic Safety (a) Upon the request of the holder of relevant specified zone who subscribe to Administration the broadcast rights to a sports event, or the nationally distributed superstation its agent, no satellite carrier shall or network station carrying the sports 49 CFR Part 571 retransmit to subscribers within the area event for which deletion is requested [Docket No. NHTSA±2000±8258] comprising the specified zone a pursuant to paragraph (b) of this section. ‘‘nationally distributed superstation’’ or (f) Notwithstanding paragraph (c) of RIN No. 2127±AI10 ‘‘network station’’ carrying the live this section, for sports events to be Federal Motor Vehicle Safety television broadcast of a sports event if deleted on or before March 31, 2001, Standards; Occupant Crash Protection the event is not available live on a notification must be received by satellite television broadcast station meeting the carriers at least 60 full days prior to the AGENCY: National Highway Traffic criteria specified in § 76.128. For day the telecast is to be deleted. Safety Administration (NHTSA), DOT.

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ACTION: Notice of technical workshop. address procedures that were the subject represent. Interested persons wishing to of policy-based objections. For example, bring a particular vehicle to demonstrate SUMMARY: This document announces NHTSA did not provide detailed test the dummy positioning difficulties that NHTSA will hold a technical procedures on how to position the child should also identify for Mr. Jettner the workshop to give NHTSA an or child dummy in static suppression vehicle models they would like to bring opportunity to make sure it understands tests. This lack of specificity was to the workshop. Once we compile a list the petitioners’ issues concerning some intentional since we wanted this of interested persons and problematic of the test procedures for the advanced technology to be robust enough to vehicles, we will determine whether the air bag final rule issued earlier this year. protect all children generally situated in number of representatives per DATES: The workshop will be held the positions required by the final rule. participant must be limited due to space December 6, 2000, at the address listed While there may be a difference of and time constraints. If this proves to be below. Lists of persons wishing to opinion about the appropriateness of the necessary, we will equitably allocate the participate in the workshop and the agency’s position, there is no need to available space among the participating names of the vehicle models that review that issue at a technical companies and organizations and participants wish to bring to the workshop. The agency will respond to among the identified problematic workshop to demonstrate test dummy this and other non-technical issues in vehicles. positioning problems should be the notice responding to the petitions To facilitate communication, NHTSA provided to Ed Jettner at the address or for reconsideration. will provide auxiliary aids to telephone number listed below by We believe that the petitioners raised participants as necessary during the November 22, 2000. Due to space and legitimate technical issues about the meeting. To ensure their availability, time limitations, NHTSA may have to following test procedures, and therefore any person desiring assistance of limit the number of representatives per that only those issues should be auxiliary aids (e.g., sign-language organization as well as the number of addressed at the workshop: interpreter) should contact Ed Jettner. problematic vehicles that will be 1. Cinchdown procedure for child examined. restraints in vehicles equipped with Authority: 15 U.S.C. 1392, 1401, 1403, 1407, delegation of authority at 49 CFR 1.50. ADDRESSES: The workshop will be held static suppression technology to comply at the Vehicle Research and Test Center with the advanced air bag requirements. Issued on November 7, 2000. (VRTC), 10820 State Route 347, East 2. Procedures for positioning the 6- Stephen R. Kratzke, Liberty, Ohio 43319. Directions to VRTC year-old and 3-year-old child dummies Associate Administrator for Safety and the final agenda will be sent to in the passenger seating position in Performance Standards. participants. vehicles equipped with low-risk [FR Doc. 00–28985 Filed 11–13–00; 8:45 am] deployment technology to comply with BILLING CODE 4910±59±P FOR FURTHER INFORMATION CONTACT: Ed the advanced air bag requirements. The Jettner, Office of Crashworthiness workshop will address the method used Standards, NPS–11, National Highway to achieve the final position and the DEPARTMENT OF TRANSPORTATION Traffic Safety Administration, 400 effect that the vehicle seat may have on Seventh Street, SW., Washington, DC achieving that position. National Highway Traffic Safety 20590, telephone (202) 366–4917, Fax 3. Procedures for positioning for the Administration (202) 366–4329, e-mail 5th percentile adult female dummy in [email protected]. the driver seating position for 49 CFR Parts 578 and 592 SUPPLEMENTARY INFORMATION: On May demonstrating compliance with the low- 12, 2000, NHTSA published a final rule risk deployment test of the advanced air [Docket No. NHTSA 2000±8253] amending Standard No. 208, Occupant bag requirements. The workshop will RIN 2127±AI18 Crash Protection, to require that future address the method used to achieve the air bags be designed to create less risk final chin-on-rim position, and the Civil Penalties; Registered Importers of of serious air bag-induced injuries than effect that the vehicle seat may have on Vehicles Not Originally Manufactured current air bags, particularly for small achieving the chin-on-rim and chest-on- to Conform to the Federal Motor women and young children; and module positions. Vehicle Safety Standards provide improved frontal crash NHTSA will announce any resolution protection for all occupants, by means of these issues in the notice responding AGENCY: National Highway Traffic that include advanced air bag to the petitions for reconsideration. Safety Administration (NHTSA), DOT. technology. (65 FR 30680; Docket No. Several petitioners noted that they ACTION: Final rule. NHTSA 00–7013; Notice 1) The period had problems with the above-listed test for submitting petitions for procedures in particular vehicles. We SUMMARY: This document amends reconsideration closed June 26, 2000. request that participants who have NHTSA’s regulations on civil penalties NHTSA received nine petitions for experienced problems with specific and registered importers to reflect reconsideration of the final rule, some of vehicles bring the vehicles to the related amendments to 49 U.S.C. which raised questions concerning some workshop so that we may address as 30165(a) and 30120(g)(1) made by of the new test procedures in the final many of the different vehicle sections of the Transportation Recall rule. We also received three requests for configurations as possible. If no Enhancement, Accountability, and clarification of those procedures. To problematic vehicles are presented at Documentation (TREAD) Act, signed by enable interested parties and NHTSA the workshop, we will limit the the president on November 1, 2000. personnel to better understand the workshop to the cinchdown procedure Under these amendments, the civil questions concerning those test for child seats. penalty for a single violation of 49 procedures, we believe that it would be We request that persons wishing to U.S.C. Chapter 301—Motor Vehicle desirable to hold a technical workshop. participate in the workshop notify Ed Safety is increased from $1,100 to The workshop will be limited to those Jettner not later than November 22, $5,000, and the maximum civil penalty procedures that petitioners have raised 2000. Interested persons should indicate for a related series of violations is as legitimate technical issues. It will not the company or organization which they increased from $925,000 to $15,000,000.

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However, if 49 U.S.C. 30166 Heretofore, Section 30165(a) has TREAD Act. The statutory amendment (inspections, investigations, and authorized the same penalties for also has the effect of requiring RIs to records) or a regulation thereunder has violations of Section 30166 relating to ensure that the service insurance been violated, the maximum penalty is investigations, inspections, and records, policies provided with each vehicle $5,000 per violation per day, and the as for violations of other sections of cover a 10-year period. maximum penalty for a related series of Chapter 301. This has also been EFFECTIVE DATE: The amendments daily violations is $15,000,000. reflected in 49 CFR 578.6(a). However, restate statutory terms that in effect In addition, the TREAD Act extends Section 5(a)(2) of the TREAD Act modified certain regulations; the from 8 to 10 years the period for which amends Section 30165(a) to add a new amendments became effective on a manufacturer must remedy without section (a)(2), Section 30166. The new November 1, 2000. Therefore, no prior charge a noncompliance or safety- section provides that any person who notice and opportunity to comment are related defect. This also requires violates Section 30166 or any regulation required. The penalties apply to conforming amendments to the remedial issued thereunder is liable to the United violations of 49 U.S.C. Chapter 301 obligations of Registered Importers. States Government for a civil penalty for occurring on and after the effective date DATES: Effective date: November 1, failing or refusing to allow or perform of the statutory amendment. 2000. an act required under that section or FOR FURTHER INFORMATION CONTACT: regulation. The maximum penalty for Rulemaking Analyses and Notices Taylor Vinson, Office of Chief Counsel, such violation has been set at $5,000 per violation per day. The maximum Executive Order 12866 and DOT NHTSA, telephone (202) 366–5263, Regulatory Policies and Procedures facsimile (202) 366–3820, electronic penalty for a related series of daily mail ‘‘[email protected]’’, 400 violations is $15,000,000. We are We have considered the impact of this Seventh Street, SW, Washington, DC therefore amending Section 578.6(a) to rulemaking action under E.O. 12866 and 20590. add a new section (a)(2) implementing the Department of Transportation’s Section 5(a)(2) of the TREAD Act. These SUPPLEMENTARY INFORMATION: 49 CFR regulatory policies and procedures. This penalties apply as of the date of Part 578 Civil Penalties is NHTSA’s rulemaking document was not reviewed enactment to obligations existing under regulation setting forth the civil under E.O. 12866, ‘‘Regulatory Planning Section 30166 that were unchanged by penalties authorized by each of the and Review.’’ This action is limited to the TREAD Act. They also apply to statutes that the agency enforces. It the restatement of statutory terms that reflects adjustments to penalties in violations of new Sections added by increased civil penalties for violations statutes that NHTSA administers, TREAD. For example, this includes of 49 U.S.C. Chapter 301 and extended pursuant to the Federal Civil Penalty Reporting of Defects in Motor Vehicles the period of remedy without charge. It Monetary Penalty Inflation Adjustment and Products in Foreign Countries has been determined to be not Act of 1990 (Pub. L. 101–410), as under 30166(l). They will also apply to ‘‘significant’’ under the Department of amended by the Debt Collection violations of new rules to be published Transportation’s regulatory policies and Improvement Act of 1996 (Pub. L. 104– under TREAD such as Early Warning procedures. 134). The principal motor vehicle safety Reporting Requirements (30166(m)) Sale Regulatory Flexibility Act statute is 49 U.S.C. Chapter 301—Motor or Lease of Defective or Noncompliant Vehicle Safety. The civil penalties that Tire (30166(n)) upon promulgation of those regulations. We have also considered the impacts are have been adopted for each violation of this notice under the Regulatory of Chapter 301, or a regulation Subsection (1) of section 4, Remedies Flexibility Act. I certify that this rule promulgated under its authority, are a Without Charge, of the TREAD Act will have no significant economic minimum of $1,100 for each violation, amends 49 U.S.C. 30120(g)(1) by impact on a substantial number of small and a maximum of $925,000 for a increasing from 8 to 10 calendar years entities. The following is my statement related series of violations (49 CFR the period for which the manufacturer providing the factual basis for the 578.6(a)). Penalties for violations of of a motor vehicle or an item of motor certification (5 U.S.C. Sec. 605(b)). The Chapter 301 are authorized by 49 U.S.C. vehicle equipment other than a tire restatement of statutory terms primarily 30165(a). must provide a remedy without charge affect manufacturers and Registered On November 1, 2000, the of a noncompliance or safety-related Importers of motor vehicles. Transportation Recall Enhancement, defect. This requires a corresponding Manufacturers of motor vehicles and Accountability, and Documentation change in 49 CFR Part 592, Registered motor vehicle equipment, and (TREAD) Act was signed into law (PL Importers of Vehicles Not Originally Registered Importers, are generally not 106–414). Section 5(a) of the TREAD Manufactured to Conform to the Federal small businesses within the meaning of Act amends Section 30165 to establish Motor Vehicle Safety Standards. Sec. the Regulatory Flexibility Act. a new Section 30165(a)(1), which 592.6(g)(2)(i) relieves a Registered increases the maximum penalty to Importer (RI) of the obligation to furnish Further, small organizations and $5,000 for each violation and the a remedy without charge of a governmental jurisdictions will not be maximum penalty to $15,000,000 for a noncompliance or safety-related defect significantly affected as the price of related series of violations. These in a vehicle if the vehicle’s first sale motor vehicles ought not to change as penalties are effective as of the date of occurred more than 8 calendar years the result of this rule. As explained enactment of the amendment. We are before the date of notification by the RI. above, this action is limited to restating publishing a conforming amendment to Remedy without charge is also not statutory terms in our regulations. 49 CFR 578.6(a) to reflect the statutory required if notification is provided by Finally, this action will not affect our increase in these penalties. This the original manufacturer and the date civil penalty policy under the Small amendment will redesignate Section of first purchase of the vehicle is more Business Regulatory Enforcement 578.6(a) as 578.6(a)(1) in order to than 8 years from the date of Fairness Act (62 FR 37115, July 10, accommodate the separate civil penalty notification. We are amending these 1997). We shall continue to consider the the TREAD Act establishes for provisions to change 8 years to 10 years appropriateness of the penalty to the violations of Section 30166. in accordance with Sec. 4(1) of the size of the business charged.

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Paperwork Reduction Act reconsideration be filed prior to seeking violation. A separate violation occurs In accordance with the Paperwork judicial review. for each motor vehicle or item of motor vehicle equipment and for each failure Reduction Act of 1980 (P.L. 96–511), we Unfunded Mandates Reform Act of 1995 state that there are no requirements for or refusal to allow or perform an act The Unfunded Mandates Reform Act information collection associated with required by any of those sections. The of 1995 (P.L. 104–4) requires agencies to this rulemaking action. maximum civil penalty under this prepare a written assessment of the cost, paragraph for a related series of National Environmental Policy Act benefits and other effects of proposed or violations is $15,000,000. We have also analyzed this final rules that include a Federal mandate likely to result in the (2) Section 30166. A person who rulemaking action under the National violates section 30166 of Title 49 of the Environmental Policy Act and expenditure by State, local, or tribal governments, in the aggregate, or by the United States Code or a regulation determined that it has no significant prescribed under that section is liable to impact on the human environment. private sector, of more than $100 million annually. Because this rule will the United States Government for a civil Executive Order 13132 (Federalism) not have a $100 million effect, no penalty for failing or refusing to allow or perform an act required under that Executive Order 13132 on Unfunded Mandates assessment will be section or regulation. The maximum ‘‘Federalism’’ requires us to develop an prepared. penalty under this paragraph is $5,000 accountable process to ensure List of Subjects in 49 CFR Parts 578 and per violation per day. The maximum ‘‘meaningful and timely input’’ by State 592 penalty under this paragraph for a and local officials in the development of related series of daily violations is ‘‘regulatory policies that have Imports, Motor vehicle safety, Motor $15,000,000. federalism implications.’’ The E.O. vehicles, Rubber and rubber products, defines this phrase to include Tires, Penalties. * * * * * regulations ‘‘that have substantial direct Accordingly, 49 CFR chapter V is amended as follows: PART 592ÐREGISTERED IMPORTERS effects on the States, on the relationship OF VEHICLES NOT ORIGINALLY between the national government and PART 578ÐCIVIL PENALTIES MANUFACTURED TO CONFORM TO the States, or on the distribution of THE FEDERAL MOTOR VEHICLE power and responsibilities among the 1. The authority citation for 49 CFR SAFETY STANDARDS various levels of government.’’ This part 578 is revised to read as follows: final rule, which increases permissible Authority: Pub. L. 106–414, 114 Stat. 1800 civil penalties and the length of the 1. The authority citation for 49 CFR (49 U.S.C. 30165); delegation of authority at part 592 is revised to to read as follows: period for which remedy must be 49 CFR 1.50. provided without charge, will not have 2. Section 578.6 is amended by Authority: Pub. L. 106–414, 114 Stat. 1800 (49 U.S.C. 322(a), 49 U.S.C. 30141–47); substantial direct effect on the States, on revising paragraph (a) to read as follows: the relationship between the national delegation of authority at 49 CFR 1.50. § 578.6 Civil penalties for violations of government and the States, or on the § 592.6 [Amended] distribution of power and specified provisions of Title 49 of the United responsibilities among the various States Code. 2. In 49 CFR 592.6(g)(2)(i), remove the levels of government, as specified in (a)(1) Motor vehicle safety. A person words ‘‘8 calendar years’’ and ‘‘8 years’’ E.O. 13132. who violates any of sections 30112, and add, in their place, the words ‘‘10 30115, 30117 through 30122, 30123(d), calendar years.’’ Civil Justice Reform 30125(c), 30127, or 30141 through This rule does not have a retroactive 30147 of Title 49 of the United States Issued on: November 8, 2000. or preemptive effect. Judicial review of Code or a regulation prescribed under Sue Bailey, the rule may be obtained pursuant to 5 any of those sections is liable to the Administrator. U.S.C. 702. That section does not United States Government for a civil [FR Doc. 00–29033 Filed 11–13–00; 8:45 am] require that a petition for penalty of not more than $5,000 for each BILLING CODE 4910±59±P

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Proposed Rules Federal Register Vol. 65, No. 220

Tuesday, November 14, 2000

This section of the FEDERAL REGISTER DATES: Written comments must be action on a local rule that regulates contains notices to the public of the proposed received on or before December 14, these emission sources under the Clean issuance of rules and regulations. The 2000. Air Act as amended in 1990 (CAA or the purpose of these notices is to give interested ADDRESSES: Comments may be mailed to Act). We are taking comments on this persons an opportunity to participate in the proposal and plan to follow with a final rule making prior to the adoption of the final David Conroy, Unit Manager, Air rules. Quality Planning, Office of Ecosystem action. protection (mail code CAQ), U.S. DATES: Any comments must arrive by Environmental Protection Agency, EPA- December 14, 2000. ENVIRONMENTAL PROTECTION New England, One Congress Street, ADDRESSES: Mail comments to Andy AGENCY Suite 1100, Boston, MA 02114–2023. Steckel, Rulemaking Office Chief (AIR– Copies of the State submittal and EPA’s 4), U.S. Environmental Protection 40 CFR Part 52 technical support document are Agency, Region IX, 75 Hawthorne [NH±042±7169b; A±1±FRL±6871±1] available for public inspection during Street, San Francisco, CA 94105. normal business hours, by appointment You can inspect copies of the Approval and Promulgation of Air at the Office of Ecosystem Protection, submitted rule revisions and EPA’s Quality Implementation Plans; New U.S. Environmental Protection Agency, technical support document (TSD) at Hampshire, New HampshireÐNitrogen Region I, One Congress Street, 11th our Region IX office during normal Oxides Budget and Allowance Trading floor, Boston, MA, and at the New business hours. You may also see copies Program Hampshire Air Resources Division, of the submitted rule revisions at the Department of Environmental Services, following locations: AGENCY: Environmental Protection 6 Hazen Drive, P.O. Box 95, Concord, Agency (EPA) California Air Resources Board, NH 03301. Stationary Source Division, Rule ACTION: Proposed rule. FOR FURTHER INFORMATION CONTACT: Dan Evaluation Section, 2020 ‘‘L’’ Street, SUMMARY: The EPA is proposing to Brown, (617) 918–1532 or at Sacramento, CA 95812. approve State Implementation Plan [email protected]. Antelope Valley Air Pollution Control (SIP) revisions submitted by the State of SUPPLEMENTARY INFORMATION: For District, 43301 Division Street, Suite New Hampshire (NH). The revisions additional information, see the direct 206, (P.O. Box 4038), Lancaster, CA consists of adding CHAPTER Env–A final rule which is located in the Rules 93539. 3200 NOX BUDGET TRADING section of this Federal Register. FOR FURTHER INFORMATION CONTACT: Al PROGRAM, NOX RACT Order 98–001, Dated: September 6, 2000. Petersen, Rulemaking Office (AIR–4), and two emission quantification Mindy S. Lubber, U.S. Environmental Protection Agency, protocols to the NH SIP. The regulations Regional Administrator, EPA-New England. Region IX, (415) 744–1135. and source specific order in NH are part SUPPLEMENTARY INFORMATION: of a regional nitrogen oxides (NO ) [FR Doc. 00–28708 Filed 11–13–00; 8:45 am] X Throughout this document, ‘‘we,’’ ‘‘us’’ emissions budget and allowance trading BILLING CODE 6560±50±P and ‘‘our’’ refer to EPA. program designed to reduce stationary source NO emissions during the ozone Table of Contents X ENVIRONMENTAL PROTECTION season in the Ozone Transport Region of AGENCY I. The State’s Submittal the northeastern United States. These A. What rule did the State submit? SIP revisions were submitted pursuant 40 CFR Part 52 B. Are there other versions of this rule? to section 110 of the Clean Air Act. In C. What are the changes in the submitted the Final Rules section of this Federal [CA 226±0240; FRL±6897±2] rule? Register EPA is approving the State’s II. EPA’s Evaluation and Action Disapproval of Implementations Plans; A. How is EPA evaluating the rule? SIP submittal as a direct final rule Revision to the California State B. Does the rule meet the evaluation without prior proposal because the Implementation Plan, Antelope Valley criteria? Agency views this as a noncontroversial Air Pollution Control District C. What are the rule deficiencies? submittal and anticipates no adverse D. EPA recommendations to further comments. A detailed rationale for the AGENCY: Environmental Protection improve the rule approval is set forth in the direct final Agency (EPA). E. Proposed action and public comment III. Background information rule. If no adverse comments are ACTION: Proposed rule. received in response to this action, no A. Why was this rule submitted? IV. Administrative Requirements further activity is contemplated. If EPA SUMMARY: EPA is proposing to receives adverse comments, the direct disapprove a revision to the Antelope I. The State’s Submittal final rule will be withdrawn and all Valley Air Pollution Control District public comments received will be (AVAPCD) portion of the California A. What Rule Did the State Submit? addressed in a subsequent final rule State Implementation Plan (SIP). This Table 1 lists the rule addressed by this based on this proposed rule. EPA will revision concerns volatile organic proposal with the dates that it was not institute a second comment period. compound (VOC) emissions from the adopted by the local air agency and Any parties interested in commenting transfer of gasoline to storage tanks or to submitted by the California Air on this action should do so at this time. vehicle fuel tanks. We are proposing Resources Board (CARB).

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TABLE 1.ÐSUBMITTED RULE

Local Agency Rule No. Rule Title Adopted Submitted

Antelope Valley APCD ...... 461 Gasoline Transfer and Dispensing ...... 09/15/98 05/13/99

On June 10, 1999, this rule submittal • Model Volatile Organic Compound C. What are the Rule Deficiencies? was found to meet the completeness Rule for Reasonably Available Control These provisions conflict with section criteria in 40 CFR Part 51 Appendix V, Technology (RACT),’’ Office of Air 110 and part D of the CAA and prevent which must be met before formal EPA Quality Planning and Standards (June full approval of the SIP revision: review. 1992). • The enforceablility is limited, • B. Are There Other Versions of This Issues Relating to VOC Regulation because paragraph (c)(3)(B) references Rule? Cutpoints, Deficiencies, and Deviations, AVAPCD Rule 430. The reference must Clarification to Appendix D (The Blue be removed, because AVAPCD Rule 430 We approved a version of AVAPCD Book), 52 FR 45105 (November 24, Rule 461 into the SIP on October 6, 1996 is not in the SIP and is not appropriate 1987). as a SIP rule. (61 FR 52297). There are no other For the purpose of assisting state and • submittals on which we have not acted. The change of removing the local agencies in developing RACT rules required daily and annual inspections of C. What Are the Changes in the for nonattainment areas, EPA prepared the SCP without replacement provisions Submitted Rule? a series of Control Technique Guideline is a SIP relaxation. This change is The changes are as follows: (CTG) documents which specify the claimed by AVAPCD to be justified • Section (c)(5) of the SIP rule, along minimum requirements that a rule must because the program is ineffective and with the related attachments (C) and (D), contain in order to be approved into the is overly burdensome to the industry, is deleted. This section and the SIP. The CTGs are based on the citing studies conducted by the South attachments concern the Self- underlying requirements of the Act and Coast Air Quality Management District Compliance Program (SCP), which specify the presumptive norms for what (SCAQMD), which developed the SCP. requires daily inspection to ensure is RACT for specific source categories. In 1996 and 1997 SCAQMD conducted proper operating conditions of all Under the CAA, Congress ratified EPA’s reverification of original compliance components of the vapor recovery use of these documents, as well as other tests that revealed a high rate of non- systems and annual inspections to Agency policy, for requiring States to compliance in vapor recovery verify compliance with applicable rules ‘‘fix-up’’ their RACT rules. See section equipment. AVAPCDs conclusion from and regulations. 182(a)(2)(A). There is no applicable CTG these tests was that the SCP is • Section (c)(6) of the SIP rule is for transfer of gasoline into vehicle fuel ineffective in reducing excess emissions deleted. This section concerns the tanks. However, EPA issued the of VOC. Although EPA concurs that training by a District-approved program following for gasoline vapor recovery there are high non-compliance rates for of a person to perform the inspections guidance: vapor recovery equipment, we believe and maintenance required in section • Draft Model Rule, Gasoline that this fact justifies an increased (c)(5). Dispensing facility—Stage II Vapor emphasis in an inspection program, and • Section (e)(3) of the submitted rule Recovery, (August 17, 1992). that removal of the SCP requirement extends the exemption from the rule for In evaluating RACT, EPA also will increase VOC emissions. Therefore, mobile fuellers until 12 months after considered information published since removal of the SCP without a CARB certifies vapor recovery the 1992 Draft Model Rule, including replacement program is a SIP relaxation equipment for mobile fuellers. documents associated with and does not meet the requirements of The TSD has more information about development of CARB’s Enhanced section 110(l) of the CAA or of RACT. this rule. Vapor Recovery Guidelines (March 23, EPA requires a reasonably available II. EPA’s Evaluation and Action 2000) and South Coast Air Quality replacement to the inspections of the Management District’s Draft Rule 461, SCP. EPA recommends that the A. How is EPA Evaluating the Rule? Gasoline Transfer and Dispensing inspection program contain the Generally, SIP rules must be (December 15, 1999). EPA, Region IX, following features: enforceable (see section 110(a) of the has summarized RACT requirements in • Require that reverification of the Act), must require Reasonably Available the Draft Gasoline Vapor Recovery performance tests originally required by Control Technology (RACT) for major Guidelines (April 24, 2000). In general, the CARB Executive Order be performed sources in nonattainment areas (see these guidance documents have been set once every six months or, for gasoline section 182(a)(2)(A)), and must not relax forth to ensure that VOC rules are fully dispensing facilities with In-Station existing requirements (see sections enforceable, meet the requirements of Diagnostics, once every two years. 110(l) and 193). The AVAPCD regulates RACT, and maintain or strengthen the • Require that a written inspection be a severe ozone nonattainment area (see SIP. performed once every week for vapor recovery equipment defects listed in 40 CFR 81), so AVAPCD Rule 461 must B. Does the Rule Meet the Evaluation AVAPCD Rule 461, attachment A, or in meet the requirements of RACT. Criteria? Guidance and policy documents that California Code of Regulations (CCR), we used to define specific enforceability This rule is not consistent with the title 17, section 94006. and RACT requirements include the relevant policy and guidance regarding The removal of the District-approved following: enforceability, RACT, and SIP training program for inspection and • Portions of the proposed post-1987 relaxations. Rule provisions which do maintenance of vapor recovery ozone and carbon monoxide policy that not meet the evaluation criteria are equipment program is not inherently a concern RACT, 52 FR 45044 (November summarized below and discussed SIP relaxation that leads to an increase 24, 1987). further in the TSD. in emissions. Gasoline dispensing

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TABLE 1.ÐOZONE NONATTAINMENT MILESTONES

Date Event

March 3, 1978 ...... EPA promulgated a list of ozone nonattainment areas under the Clean Air Act as amended in 1977. 43 FR 8964; 40 CFR 81.305. May 26, 1988 ...... EPA notified Governors that parts of their SIPs were inadequate to attain and maintain the ozone standard and requested that they correct the deficiencies (EPA's SIP±Call). See section 110(a)(2)(H) of the pre- amended Act. November 15, 1990 ...... Clean Air Act Amendments of 1990 were enacted. Pub. L. 101±549, 104 Stat. 2399, codified at 42 U.S.C. 7401±7671q. May 15, 1991 ...... Section 182(a)(2)(A) requires that ozone nonattainment areas correct deficient RACT rules by this date.

IV. Administrative Requirements not issue a regulation that is not D. Executive Order 13132 required by statute, that significantly or A. Executive Order 12866 Executive Order 13132, entitled uniquely affects the communities of Federalism (64 FR 43255, August 10, The Office of Management and Budget Indian tribal governments, and that 1999) revokes and replaces Executive (OMB) has exempted this regulatory imposes substantial direct compliance Orders 12612, Federalism and 12875, action from Executive Order (E.O.) costs on those communities, unless the Enhancing the Intergovernmental 12866, Regulatory Planning and Review. Federal government provides the funds Partnership. E.O. 13132 requires EPA to B. Executive Order 13045 necessary to pay the direct compliance develop an accountable process to Executive Order 13045, entitled costs incurred by the tribal ensure ‘‘meaningful and timely input by Protection of Children from governments, or EPA consults with State and local officials in the Environmental Health Risks and Safety those governments. If EPA complies by development of regulatory policies that Risks (62 FR 19885, April 23, 1997), consulting, E.O. 13084 requires EPA to have federalism implications.’’ ‘‘Policies applies to any rule that: (1) is provide to the OMB in a separately that have federalism implications’’ is determined to be ‘‘economically identified section of the preamble to the defined in the Executive Order to significant’’ as defined under E.O. rule, a description of the extent of EPA’s include regulations that have 12866, and (2) concerns an prior consultation with representatives ‘‘substantial direct effects on the States, environmental health or safety risk that of affected tribal governments, a on the relationship between the national EPA has reason to believe may have a summary of the nature of their concerns, government and the States, or on the disproportionate effect on children. If and a statement supporting the need to distribution of power and the regulatory action meets both criteria, issue the regulation. In addition, E.O. responsibilities among the various the Agency must evaluate the 13084 requires EPA to develop an levels of government.’’ Under E.O. environmental health or safety effects of effective process permitting elected 13132, EPA may not issue a regulation that has federalism implications, that the planned rule on children, and officials and other representatives of imposes substantial direct compliance explain why the planned regulation is Indian tribal governments ‘‘to provide costs, and that is not required by statute, preferable to other potentially effective meaningful and timely input in the unless the Federal government provides and reasonably feasible alternatives development of regulatory policies on the funds necessary to pay the direct considered by the Agency. matters that significantly or uniquely compliance costs incurred by State and This rule is not subject to E.O. 13045 affect their communities.’’ because it does not involve decisions local governments, or EPA consults with intended to mitigate environmental Today’s proposed rule does not State and local officials early in the health or safety risks. significantly or uniquely affect the process of developing the proposed communities of Indian tribal regulation. EPA also may not issue a C. Executive Order 13084 governments. Accordingly, the regulation that has federalism Under Executive Order 13084, requirements of section 3(b) of E.O. implications and that preempts State Consultation and Coordination with 13084 do not apply to this proposed law unless the Agency consults with Indian Tribal Governments, EPA may rule. State and local officials early in the

VerDate 112000 14:37 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM pfrm03 PsN: 14NOP1 68114 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Proposed Rules process of developing the proposed achieves the objectives of the rule and ENVIRONMENTAL PROTECTION regulation. is consistent with statutory AGENCY This proposed rule will not have requirements. Section 203 requires EPA substantial direct effects on the States, to establish a plan for informing and 40 CFR Part 52 on the relationship between the national advising any small governments that [CA 210±0173; FRL±6897±1] government and the States, or on the may be significantly or uniquely distribution of power and impacted by the rule. Approval and Promulgation of responsibilities among the various Implementation Plans; California State EPA has determined that the levels of government, as specified in Implementation Plan Revision, Lake E.O. 13132, because it merely acts on a proposed action does not include a County Air Quality Management state rule implementing a federal Federal mandate that may result in District, Monterey Bay Unified Air standard, and does not alter the estimated annual costs of $100 million Pollution Control District, Bay Area Air relationship or the distribution of power or more to either State, local, or tribal Quality Management District, and responsibilities established in the governments in the aggregate, or to the Sacramento Metropolitan Air Quality Clean Air Act. Thus, the requirements of private sector. This proposed Federal Management District, San Joaquin section 6 of the Executive Order do not action acts on pre-existing requirements Valley Unified Air Pollution Control apply to this proposed rule. under State or local law, and imposes District no new requirements. Accordingly, no E. Regulatory Flexibility Act AGENCY: Environmental Protection additional costs to State, local, or tribal Agency (EPA). The Regulatory Flexibility Act (RFA) governments, or to the private sector, generally requires an agency to conduct ACTION: result from this action. Proposed rule. a regulatory flexibility analysis of any rule subject to notice and comment G. National Technology Transfer and SUMMARY: EPA is proposing a limited rulemaking requirements unless the Advancement Act approval and limited disapproval of agency certifies that the rule will not revisions to the California State have a significant economic impact on Section 12 of the National Technology Implementation Plan (SIP) which a substantial number of small entities. Transfer and Advancement Act concern the control of volatile organic Small entities include small businesses, (NTTAA) of 1995 requires Federal compound (VOC) emissions from the small not-for-profit enterprises, and agencies to evaluate existing technical transfer of gasoline to storage tanks or to small governmental jurisdictions. standards when developing a new vehicle tanks. EPA is proposing a This proposed rule will not have a regulation. To comply with NTTAA, limited approval and limited disapproval without potential sanctions significant impact on a substantial EPA must consider and use ‘‘voluntary of Lake County Air Quality Management number of small entities because SIP consensus standards’’ (VCS) if available actions under section 110 and District (LCAQMD) Section (Rule) 439.5 and applicable when developing and Monterey Bay Unified Air Pollution subchapter I, part D of the Clean Air Act programs and policies unless doing so do not create any new requirements but Control District (MBUAPCD) Rule 1002. would be inconsistent with applicable EPA is also proposing a limited simply act on requirements that the law or otherwise impractical. State is already imposing. Therefore, approval and limited disapproval with because the Federal SIP action does not EPA believes that VCS are potential sanctions of Bay Area Air create any new requirements, I certify inapplicable to today’s proposed action Quality Management District that this action will not have a because it does not require the public to (BAAQMD) Rule 8–7, Sacramento significant economic impact on a perform activities conducive to the use Metropolitan Air Quality Management substantial number of small entities. of VCS. District (SMAQMD) Rule 449, and San Moreover, due to the nature of the Joaquin Valley Unified Air Pollution List of Subjects in 40 CFR Part 52 Federal-State relationship under the Control District (SJVUAPCD) Rule 4622. Clean Air Act, preparation of flexibility The intended effect of the limited Environmental protection, Air approvals and limited disapprovals is to analysis would constitute Federal pollution control, Incorporation by inquiry into the economic regulate emissions of VOCs in reference, Intergovernmental relations, accordance with the requirements of the reasonableness of state action. The Ozone, Reporting and recordkeeping Clean Air Act forbids EPA to base its Clean Air Act, as amended in 1990 requirements, Volatile organic (CAA or the Act). EPA’s final action on actions concerning SIPs on such compounds. grounds. Union Electric Co. v. U.S. EPA, this proposed rule will incorporate 427 U.S. 246, 255–66 (1976); 42 U.S.C. Authority: 42 U.S.C. 7401 et seq. these rules into the federally approved SIP. 7410(a)(2). Dated: October 20, 2000. DATES: Comments must be received in F. Unfunded Mandates Felicia Marcus, writing on or before December 14, 2000. Under Section 202 of the Unfunded Regional Administrator, Region IX. ADDRESSES: Mail comments to Andrew Mandates Reform Act of 1995 [FR Doc. 00–29064 Filed 11–13–00; 8:45 am] Steckel, Rulemaking Office Chief (AIR– (‘‘Unfunded Mandates Act’’), signed BILLING CODE 6560±50±P 4), Air Division, U.S. Environmental into law on March 22, 1995, EPA must Protection Agency, Region IX, 75 prepare a budgetary impact statement to Hawthorne Street, San Francisco, CA accompany any proposed or final rule 94105. that includes a Federal mandate that You can inspect copies of the may result in estimated annual costs to submitted rule revisions and EPA’s State, local, or tribal governments in the technical support documents (TSDs) at aggregate; or to private sector, of $100 our Region IX office during normal million or more. Under Section 205, business hours. You may also see copies EPA must select the most cost-effective of the submitted rule revisions at the and least burdensome alternative that following locations:

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California Air Resources Board, requirement that nonattainment areas nonattainment areas classified as Stationary Source Division, Rule fix their deficient Reasonably Available moderate or higher must meet the Evaluation Section, 2020 ‘‘L’’ Street, Control Technology (RACT) rules for requirements of RACT according to Sacramento, CA 95812. ozone and established a deadline of May section 182(a)(2)(A) and the gasoline Bay Area Air Quality Management 15, 1991 for states to submit corrections vapor recovery guidance according to District, 939 Ellis Street, San Francisco, of those deficiencies. Section section 182(b)(3) of the CAA. The CA 94105. 182(a)(2)(A) applies to areas designated Monterey Bay Area 4 has since been Lake County Air Quality Management as nonattainment prior to enactment of redesignated as a maintenance District, 883 Lakeport Boulevard, the amendments and classified as attainment area. This area must Lakeport, CA 95453. marginal or above as of the date of implement all measures in the SIP Monterey Bay Unified Air Pollution enactment. It requires such areas to before redesignation as attainment, Control District, 24580 Silver Cloud adopt and correct RACT rules pursuant according to section 175A(d) of the Court, Monterey, CA 93940. to pre-amended section 172(b) as CAA. Control of emissions from Sacramento Metropolitan Air Quality interpreted in pre-amendment gasoline dispensing facilities is not a Management District, 8411 Jackson guidance.1 measure that is relied on to achieve or Road, Sacramento, CA 95826. In section 182(b)(3) of the CAA, maintain attainment; therefore, the San Joaquin Valley Unified Air Congress required the states to submit a Monterey Bay Area is not subject to the Pollution Control District, 1990 East SIP revision to require all owners or requirements of RACT, including Gettysburg Street, Fresno, CA 93726. operators of gasoline dispensing systems gasoline vapor recovery guidance. Lake FOR FURTHER INFORMATION CONTACT: Al in moderate or higher ozone County Air Basin was designated Petersen, Rulemaking Office (AIR–4), nonattainment areas to install a gasoline attainment and is not subject to the Air Division, U.S. Environmental vapor recovery system. The EPA requirements of RACT, including Protection Agency, Region IX, 75 Administrator would issue gasoline gasoline vapor recovery guidance. Hawthorne Street, San Francisco, CA vapor recovery guidance as appropriate This document addresses EPA’s 94105, (415) 744–1135. as to the effectiveness of such a system. proposed action for LCAQMD Section SUPPLEMENTARY INFORMATION: The Monterey Bay Area, San (Rule) 439.5, Retail Gasoline Service Francisco Bay Area, Sacramento Metro Stations, adopted on July 15, 1997; I. Applicability Area, and San Joaquin Valley Area were MBUAPCD 1002, Transfer of Gasoline The rules being proposed for limited designated nonattainment; therefore, into Vehicle Fuel Tanks, adopted on approval and limited disapproval into these areas were subject to the RACT April 21, 1999; BAAQMD Rule 8–7, the California SIP are LCAQMD Section fix-up requirement and the May 15, Gasoline Dispensing Facilities, adopted (Rule) 439.5, Retail Gasoline Service 1991 deadline. The San Francisco Bay on November 17, 1999; SMAQMD Rule Stations, MBUAPCD Rule 1002, Area 2 was later designated attainment 449, Transfer of Gasoline into Vehicle Transfer of Gasoline into Vehicle Fuel and then redesignated nonattainment Fuel Tanks, adopted on April 3, 1997; Tanks, BAAQMD Rule 8–7, Gasoline under subpart 1, part D, of the CAA. and SJVUAPCD Rule 4622, Gasoline Dispensing Facilities; SMAQMD Rule Subpart 1 nonattainment areas must Transfer into Vehicle Fuel Tanks, 449, Transfer of Gasoline into Vehicle meet the requirements of RACT adopted on June 18, 1998. These rules Fuel Tanks; and SJVUAPCD Rule 4622, according to section 172(c)(1) of the were submitted on May 18, 1998, June Gasoline Transfer into Vehicle Fuel CAA and must meet the requirements of 3, 1999, March 28, 2000, May 18, 1998, Tanks. These rules were submitted by the gasoline vapor recovery guidance and August 21, 1998, respectively. the California Air Resources Board according to section 182(b)(3) of the These rules were found to be complete (CARB) to EPA on May 18, 1998, June CAA. The Sacramento Metro Area and on July 17, 1998, June 24, 1999, May 19, 3, 1999, March 23, 2000, May 18, 1998, the San Joaquin Valley Area 3 subpart 2 2000, July 17, 1998, and October 2, and August 21, 1998, respectively. 1998, respectively, pursuant to EPA’s 1 Among other things, the pre-amendment completeness criteria that are set forth II. Background guidance consists of those portions of the proposed in 40 CFR Part 51, Appendix V. 5 On March 3, 1978, EPA promulgated post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044 (November 24, 1987); LCAQMD Section (Rule) 439.5 and a list of ozone nonattainment areas Issues Relating to VOC Regulation Cutpoints, MBUAPCD Rule 1002, are being under the provisions of the 1977 Clean Deficiencies, and Deviations, Clarification to proposed for limited approval and Air Act (1977 CAA or pre-amended Appendix D of November 24, 1987 Federal Register Notice (Blue Book) (notice of availability was limited disapproval without sanctions. Act), that included the San Francisco published in the Federal Register on May 25, 1988); BAAQMD Rule 8–7, SMAQMD Rule Bay Area, Monterey Bay Area, and the existing control technique guidelines 449, and SJVUAPCD Rule 4622 are Sacramento Metro Area, and the San (CTGs). being proposed for limited approval and Joaquin Valley Area. 43 FR 8964; 40 2 On July 10, 1998(63 FR 37258), EPA published limited disapproval with sanctions. the final rule redesignating the San Francisco Bay CFR 81.305. On May 26, 1988, EPA Area to nonattainment with the federal 1-hour The BAAQMD and LCAQMD rules notified the Governor of California, ozone NAAQS. The redesignation was authorized control the emission of volatile organic pursuant to section 110(a)(2)(H) of the under the general nonattainment provisions of compounds (VOCs) from the transfer of pre-amended Act, that the above subpart 1, part D, title I, of the CAA. The Bay Area, gasoline into fuel storage tanks and into therefore, does not have a subpart 2 classification. district’s portions of the SIP were When comparing air quality in the Bay Area to the vehicle fuel tanks. The MBUAPCD, inadequate to attain and maintain the traditional subpart 2 classification system, the Bay SMAQMD, and SJVUAPCD rules control ozone standard and requested that Area’s design value is equivalent to that of a the emission of VOCs from the transfer deficiencies in the existing SIP be moderate nonattainment area. of gasoline into vehicle fuel tanks. VOCs 3 The Sacramento Metro Area and the San Joaquin corrected (EPA’s SIP-Call). On Valley Area retained their designation and were November 15, 1990, amendments to the classified by operation of law pursuant to sections 4 On January 17, 1997 (62 FR 2597), EPA 1977 CAA were enacted. Pub. L. 101– 107(d) and 181(a) upon the date of enactment of the published a direct final rule redesignating Monterey 549, 104 Stat. 2399, codified at 42 CAA. See 56 FR 56694 (November 6, 1991). The San Bay Area as maintenance attainment for ozone. Joaquin Valley Area is classified as serious. On 5 EPA adopted completeness criteria on February U.S.C. 7401–7671q. April 25, 1995, EPA published a final rule granting 16, 1990 (55 FR 5830) and, pursuant to section In amended section 182(a)(2)(A) of the the State’s request to reclassify the Sacramento 110(k)(1)(A) of the CAA, revised the criteria on CAA, Congress statutorily adopted the Metro Area to severe from serious (60 FR 20237). August 26, 1991 (56 FR 42216).

VerDate 112000 16:12 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM pfrm01 PsN: 14NOP1 68116 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Proposed Rules contribute to the production of ground for transfer of gasoline into vehicle fuel CARB pursuant to California Health and level ozone and smog. These rules were tanks. However, EPA issued the Safety Code section 41960.2(c). originally adopted as part of these following for gasoline vapor recovery • Part 4 separates the permitting Districts’ effort to achieve the National guidance: requirements for new, modified, and Ambient Air Quality Standard (NAAQS) • Draft Model Rule, Gasoline existing gasoline dispensing systems. for ozone and in response to EPA’s SIP- Dispensing facility—Stage II Vapor On March 22, 1995, 60 FR 15062, EPA Call and the section 182(a)(2)(A) and Recovery, (August 17, 1992). approved into the SIP a version of 182(b)(3) CAA requirements. • Draft Gasoline Vapor Recovery BAAQMD Rule 8–7. There are no The following is EPA’s evaluation and Guidelines, (April 24, 2000). versions on which EPA has not acted. proposed action for these rules. In evaluating RACT, EPA also The submitted rule includes the III. EPA Evaluation and Proposed considered information published since following significant changes from the Action the 1992 Draft Model Rule, including current SIP: documents associated with • Numerous new standards were In determining the approvability of a development of CARB’s Enhanced added for Phase I and II vapor recovery VOC rule, EPA must evaluate the rule Vapor Recovery Guidelines (March 23, equipment. • for consistency with the requirements of 2000) and South coast air Quality Numerous definitions were added the CAA and EPA regulations, as found Management District’s Draft Rule 461, for clarity. in section 110 and Part D of the CAA • Gasoline Transfer and Dispensing Performance tests of newly installed and 40 CFR Part 51 (Requirements for (December 15, 1999). EPA, Region IX, or modified equipment are required Preparation, Adoption, and Submittal of has summarized RACT requirements in according to the required Authority to Implementation Plans). The EPA the Draft Gasoline Vapor Recovery Construct. interpretation of these requirements, • Guidelines (April 24, 2000). In general, New performance test methods which forms the basis for today’s action, these guidance documents have been set were added. appears in various EPA policy guidance • forth to ensure that VOC rules are fully Recordkeeping requirements were documents including those listed below: enforceable, meet the requirements of added. • Model Volatile Organic Compound On January 23, 1996, 61 FR 1716, EPA RACT, and maintain or strengthen the Rule for Reasonably Available Control approved into the SIP a version of SIP. Technology (RACT),’’ Office of Air SMAQMD Rule 449. There are no There is currently no version of Quality Planning and Standards (June versions on which EPA has not acted. LCAQMD Section (Rule) 439.5 in the 1992). SMAQMD submitted Rule 449 includes • SIP. There are no versions on which Issues Relating to VOC Regulation the following significant changes from EPA has not acted. The submitted rule Cutpoints, Deficiencies, and Deviations, the current SIP: Clarification to Appendix D of includes the following provisions: • • Section 113 deletes the obsolete November 24, 1987 Federal Register (52 The transfer of gasoline to a storage exemption for fueling fork lifts. FR 45044) (The Blue Book). tank (Phase I) and the transfer of • Section 305 adds a modification to Among the requirements for a VOC gasoline to a vehicle fuel tank shall have prohibit hold open latches, if prohibited rule for the nonattainment areas of a submerged fill pipe and CARB- by the local Fire Marshal. BAAQMD, SMAQMD, and SJVUAPCD certified vapor recovery equipment. • • Section 306 requires that the is that it must be enforceable and meet The transfer of gasoline to a vehicle Dynamic Back Pressure Test for gasoline the requirements of RACT. A VOC rule fuel tank (Phase II) shall have CARB- dispensing nozzles must be passed. for LCAQMD attainment area must be certified vapor recovery equipment. Testing could be more frequent than five • enforceable but need not meet the The dispensing equipment shall years, if required by the CARB. requirements of RACT. A rule for a have appropriate warning signs and a On May 2, 1996, 61 FR 19555, EPA maintenance attainment area must be hold open latch. approved into the SIP a version of • enforceable and must implement all The rule contains various SJVUAPCD Rule 4622 that had been measures in the SIP before redesignation exemptions for gasoline stations less adopted by SJVUAPCD on February 17, as attainment, according to section than certain minimum sizes. 1994. There are no versions on which 175A(d). Control of emissions from On February 9, 1996, 61 FR 4892, EPA EPA has not acted. The submitted gasoline dispensing facilities is not a approved into the SIP a version of includes the following significant measure that is relied on to achieve MBUAPCD Rule 1002. There are no changes from the current SIP: attainment in MBUAPCD; therefore, the versions on which EPA has not acted. • Section 5.11, which requires that all MBUAPCD is not subject to the The submitted rule includes the liquid removal devices be maintained to requirements of RACT. following significant changes from the remove at least five milliliters per For the purpose of assisting state and current SIP: gallon, is added. local agencies in developing RACT rules • Section 3.1 continues to require that • Section 6.2.2, which required that for nonattainment areas, EPA prepared vapor recovery equipment be CARB- certified vapor recovery systems be a series of Control Technique Guideline certified, but removes the requirement tested with 60 days of installation or (CTG) documents which specify the that the vapor recovery equipment major modification, is deleted. minimum requirements that a rule must prevents 95% of the gasoline vapors • Section 6.3.1 has added the contain in order to be approved into the from entering the atmosphere. requirement that the APCO, CARB, and SIP. The CTGs are based on the • Subsection 3.2.2 adds the EPA all approve test methods on vapor underlying requirements of the Act and requirement that equipment be tested in recovery systems on which referenced specify the presumptive norms for what accordance with California Code of test methods are precluded. is RACT for specific source categories. Regulations (CCR), Title 17, sections • Sections 6.3.1, 6.3.2, and 6.3.3 have Under the CAA, Congress ratified EPA’s 94000 et seq. three test methods added. use of these documents, as well as other • Section 3.4 is added to describe the EPA has evaluated LCAQMD Agency policy, for requiring States to 7-day period allowed to correct submitted Rule 439.5 for an ozone ‘‘fix-up’’ their RACT rules. See section equipment not in good working order attainment area for consistency with the 182(a)(2)(A). There is no applicable CTG because of defects not specified by CAA, EPA regulations, and EPA policy

VerDate 112000 14:37 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM pfrm03 PsN: 14NOP1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Proposed Rules 68117 and has found that the revisions claimed) should be maintained for at recommends once every six months or, strengthen the SIP by adding a rule to least two years. if In-Station Diagnostics are used, once reduce gasoline vapor emissions during EPA has evaluated BAAQMD Rule 8– every two years. the transfer of gasoline in Phases I and 7 for section 1 ozone nonattainment area • Section 502 contains no II by the use of CARB-certified vapor for consistency with the CAA, EPA recordkeeping period. We recommend recovery equipment. Although regulations, and EPA policy and has that maintenance records, performance LCAQMD Section (Rule) 439.5 will found that the revisions strengthen the test records, reverification of strengthen the SIP, this rule still SIP by adding new standards, adding performance test records, and gasoline contains the following enforceability- test methods, adding recordkeeping throughput records (if an exemption is related deficiencies that must be requirements, and adding performance claimed) be kept for at least two years. corrected pursuant to the section tests on new or modified equipment. EPA has evaluated SJVUAPCD Rule 182(a)(2)(A) and 182(a)(3) requirements Although the rule will strengthen the 4622 for an ozone nonattainment area of the CAA before the rule will qualify SIP, this rule still contains the following for consistency with the CAA, EPA for full approval: enforceability-related deficiencies that regulations, and EPA policy and has • The rule should reference the must be corrected pursuant to the found that the revisions strengthen the specific EPA-approved test methods to section 182(a)(2)(A) and 182(a)(3) SIP by adding three test procedures to be used for performance tests or requirements of the CAA before the rule the rule and by requiring a five milliliter reverification of performance tests for, at will qualify for full approval: per gallon limit for liquid removal a minimum, a static leak test, a dynamic • Paragraphs 302.3 and 306 require devices. Although the rule will back pressure test, an air-to-liquid maintaining equipment free of defects as strengthen the SIP, this rule still volume ratio test, and a liquid removal defined in California Health and Safety contains the following enforceability- rate test. Code 41960.2(c). California Code of related deficiencies that must be • Performance test records, Regulations (CCR), title 17, section corrected pursuant to the section reverification of performance test 94006 should be referenced instead, 182(a)(2)(A) and 182(a)(3) requirements records, maintenance records and because it contains a list of the specific of the CAA before the rule will qualify throughput records (if an exemption is defects. for full approval: claimed) should be maintained for at • Reverification of the performance • Section 5.4.11 contains a reference least two years. tests of the vapor recovery system to CCR, title 17, section 94001 for the EPA has evaluated MBUAPCD Rule originally required by the CARB certification procedure that CARB uses 1002 for a maintenance attainment area Executive Order should be performed for vapor recovery equipment. The for consistency with the CAA, EPA more frequently, because studies have correct reference is CCR, title 17, section regulations, and EPA policy and has shown poor compliance with 94011. found that the revisions strengthen the performance standards. EPA • Section 6.1 contains no SIP with clarifications, by requiring the recommends once every six months or, recordkeeping period. We recommend testing of vapor recovery equipment, if In-Station Diagnostics are used, once that maintenance records and and by requiring that defects be repaired every two years. reverification of performance test in seven days. Although the rule will EPA has evaluated SMAQMD Rule records be kept for at least two years. strengthen the SIP, this rule still 449 for a severe ozone nonattainment • Section 6.2.2 in the SIP rule, which contains the following enforceability- area for consistency with the CAA, EPA required that certified vapor recovery related deficiencies that must be regulations, and EPA policy and has systems be tested within 60 days of corrected pursuant to the section found that the revisions strengthen the installation or major modification, was 182(a)(2)(A) and 182(a)(3) requirements SIP by removing an obsolete exemption deleted from the submitted rule. This is of the CAA before the rule will qualify for fueling forklifts, by requiring the less stringent than the SIP-approved for full approval: passing of the Dynamic Back Pressure rule. Performance testing of vapor • Paragraph 3.2.2 contains obsolete Test, and by improving clarity. recovery equipment should start within references, repealed on July 11, 1996, Although the rule will strengthen the a defined period of completion of for the vapor recovery equipment to be SIP, this rule still contains the following construction of vapor recovery operated, tested, and maintained. enforceability-related deficiencies that equipment. • The rule should reference specific must be corrected pursuant to the • Section 6.3.1 should reference the EPA-approved test methods for section 182(a)(2)(A) and 182(a)(3) specific EPA-approved test method to be performance tests and reverification of requirements of the CAA before the rule used for performance tests and performance tests to be used for, at a will qualify for full approval: reverification of performance tests for an minimum, a static leak test, a dynamic • Section 306 should reference the air-to-liquid volume ratio test. back pressure test, an air-to-liquid specific EPA-approved test method to be • Reverification of the performance volume ratio test, and a liquid removal used for performance tests and tests of the vapor recovery system rate test. reverification of performance tests for an originally required by the CARB • Paragraph 3.3 references ‘‘pursuant air-to-liquid volume ratio test and a Executive Order should be performed to California Health and Safety Code, liquid removal rate test. more frequently, because studies have section 41960.2(c),’’ but this reference • Performance testing of vapor shown poor compliance with does not list any vapor recovery recovery equipment should start within performance standards. EPA equipment defects. The listing of vapor 30 days of completion of construction of recommends once every six months or, recovery equipment defects in CCR, title vapor recovery equipment. if In-Station Diagnostics are used, once 17, section 94006, could be referenced • Reverification of the performance every two years. or the defects could be listed tests of the vapor recovery system A detailed discussion of rule specifically in the rule. originally required by the CARB deficiencies can be found in the • Performance test records, Executive Order should be performed Technical Support Documents for reverification of performance test more frequently, because studies have LCAQMD Section (Rule) 439.5, records, maintenance records and shown poor compliance with MBUAPCD Rule 1002, BAAQMD Rule throughput records (if an exemption is performance standards. EPA 8–7, SMAQMD Rule 449, and

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SJVUAPCD Rule 4622, which are We will accept comments from the matters that significantly or uniquely available from the U.S. EPA, Region IX public on the proposed limited affect their communities.’’ office. approvals and limited disapprovals for Today’s proposed rule does not Because of the enforceability-related the next 30 days. significantly or uniquely affect the deficiencies in LCAQMD Section (Rule) communities of Indian tribal 439.5 and MBUAPCD Rule 1002, EPA IV. Administrative Requirements governments. Accordingly, the cannot grant full approval of these rules A. Executive Order 12866 requirements of section 3(b) of E.O. under section 110(k)(3) of the CAA. 13084 do not apply to this proposed However, sanctions pursuant to section The Office of Management and Budget rule. 179(b) will not be applied, because (OMB) has exempted this regulatory D. Executive Order 13132 these areas are an attainment area and action from Executive Order (E.O.) a maintenance attainment area, 12866, Regulatory Planning and Review. Executive Order 13132, entitled Federalism (64 FR 43255, August 10, respectively. B. Executive Order 13045 Because of the deficiencies in 1999) revokes and replaces Executive BAAQMD Rule 8–7, SMAQMD Rule Executive Order 13045, entitled Orders 12612, Federalism and 12875, 449, and SJVUAPCD Rule 4622, EPA Protection of Children from Enhancing the Intergovernmental cannot grant full approval of these rules Environmental Health Risks and Safety Partnership. E.O. 13132 requires EPA to under section 110(k)(3) and part D. Risks (62 FR 19885, April 23, 1997), develop an accountable process to Also, because the submitted rules are applies to any rule that: (1) Is ensure ‘‘meaningful and timely input by not composed of separable parts which determined to be ‘‘economically State and local officials in the meet all the applicable requirements of significant’’ as defined under E.O. development of regulatory policies that the CAA, EPA cannot grant partial 12866, and (2) concerns an have federalism implications.’’ ‘‘Policies approval of the rules under section environmental health or safety risk that that have federalism implications’’ is 110(k)(3). However, EPA may grant a EPA has reason to believe may have a defined in the Executive Order to limited approval of the submitted rules disproportionate effect on children. If include regulations that have under section 110(k)(3) in light of EPA’s the regulatory action meets both criteria, ‘‘substantial direct effects on the States, authority pursuant to section 301(a) to the Agency must evaluate the on the relationship between the national adopt regulations necessary to further environmental health or safety effects of government and the States, or on the air quality by strengthening the SIP. The the planned rule on children, and distribution of power and approval is limited because EPA’s explain why the planned regulation is responsibilities among the various action also contains a simultaneous preferable to other potentially effective levels of government.’’ Under E.O. limited disapproval. In order to and reasonably feasible alternatives 13132, EPA may not issue a regulation strengthen the SIP, EPA is proposing a considered by the Agency. that has federalism implications, that limited approval of BAAQMD Rule 8–7, imposes substantial direct compliance This rule is not subject to E.O. 13045 SMAQMD Rule 449, and SJVUAPCD costs, and that is not required by statute, because it does not involve decisions Rule 4622, under sections 110(k)(3) and unless the Federal government provides intended to mitigate environmental 301(a) of the CAA. the funds necessary to pay the direct At the same time, EPA is also health or safety risks. compliance costs incurred by State and proposing a limited disapproval of C. Executive Order 13084 local governments, or EPA consults with BAAQMD Rule 8–7, SMAQMD Rule State and local officials early in the 449, and SJVUAPCD Rule 4622, because Under Executive Order 13084, process of developing the proposed they contain deficiencies that have not Consultation and Coordination with regulation. EPA also may not issue a been corrected as required by section Indian Tribal Governments, EPA may regulation that has federalism 182(a)(2)(A) and 182(a)(3)(A) of the not issue a regulation that is not implications and that preempts State CAA, and, as such, the rules do not fully required by statute, that significantly or law unless the Agency consults with meet the requirements of part D of the uniquely affects the communities of State and local officials early in the CAA. Under section 179(a)(2), if the Indian tribal governments, and that process of developing the proposed Administrator disapproves a submission imposes substantial direct compliance regulation. under section 110(k) for an area costs on those communities, unless the This proposed rule will not have designated nonattainment, based on the Federal government provides the funds substantial direct effects on the States, submission’s failure to meet one or more necessary to pay the direct compliance on the relationship between the national of the elements required by the Act, the costs incurred by the tribal government and the States, or on the Administrator must apply one of the governments, or EPA consults with distribution of power and sanctions set forth in section 179(b) those governments. If EPA complies by responsibilities among the various unless the deficiency has been corrected consulting, E.O. 13084 requires EPA to levels of government, as specified in within 18 months of such disapproval. provide to the OMB in a separately E.O. 13132, because it merely acts on a These sanctions would be imposed identified section of the preamble to the state rule implementing a federal according to 40 CFR 52.31. Moreover, rule, a description of the extent of EPA’s standard, and does not alter the the final disapproval triggers the Federal prior consultation with representatives relationship or the distribution of power Implementation Plan (FIP) requirement of affected tribal governments, a and responsibilities established in the under section 110(c). It should be noted summary of the nature of their concerns, Clean Air Act. Thus, the requirements of that the rules covered by this NPR have and a statement supporting the need to section 6 of the Executive Order do not been adopted by the LCAQMD, issue the regulation. In addition, E.O. apply to this proposed rule. MBUAPCD, BAAQMD, SMAQMD, and 13084 requires EPA to develop an SJVUAPCD and are currently in effect in effective process permitting elected E. Regulatory Flexibility Act the Districts. EPA’s final limited officials and other representatives of The Regulatory Flexibility Act (RFA) disapproval action will not prevent Indian tribal governments ‘‘to provide generally requires an agency to conduct these Districts from enforcing these meaningful and timely input in the a regulatory flexibility analysis of any rules. development of regulatory policies on rule subject to notice and comment

VerDate 112000 14:37 Nov 10, 2000 Jkt 194001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM pfrm03 PsN: 14NOP1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Proposed Rules 68119 rulemaking requirements unless the analysis would constitute Federal no new requirements. Accordingly, no agency certifies that the rule will not inquiry into the economic additional costs to State, local, or tribal have a significant economic impact on reasonableness of state action. The governments, or to the private sector, a substantial number of small entities. Clean Air Act forbids EPA to base its result from this action. Small entities include small businesses, actions concerning SIPs on such G. National Technology Transfer and small not-for-profit enterprises, and grounds. Union Electric Co. v. U.S. EPA, Advancement Act small governmental jurisdictions. 427 U.S. 246, 255–66 (1976); 42 U.S.C. This proposed rule will not have a 7410(a)(2). Section 12 of the National Technology significant impact on a substantial Transfer and Advancement Act F. Unfunded Mandates number of small entities because SIP (NTTAA) of 1995 requires Federal approvals under section 110 and Under section 202 of the Unfunded agencies to evaluate existing technical subchapter I, part D of the Clean Air Act Mandates Reform Act of 1995 standards when developing a new do not create any new requirements but (‘‘Unfunded Mandates Act’’), signed regulation. To comply with NTTAA, simply act on requirements that the into law on March 22, 1995, EPA must EPA must consider and use ‘‘voluntary State is already imposing. Therefore, prepare a budgetary impact statement to consensus standards’’ (VCS) if available because the Federal SIP approval does accompany any proposed or final rule and applicable when developing not create any new requirements, I that includes a Federal mandate that programs and policies unless doing so certify that this action will not have a may result in estimated costs to State, would be inconsistent with applicable significant economic impact on a local, or tribal governments in the law or otherwise impractical. substantial number of small entities. aggregate; or to private sector, of $100 EPA believes that VCS are EPA’s proposed disapproval of the million or more. Under section 205, inapplicable to today’s proposed action state request under section 110 and EPA must select the most cost-effective because it does not require the public to subchapter I, part D of the Clean Air Act and least burdensome alternative that perform activities conducive to the use does not affect any existing achieves the objectives of the rule and of VCS. requirements applicable to small is consistent with statutory List of Subjects in 40 CFR Part 52 entities. Any pre-existing federal requirements. Section 203 requires EPA requirements remain in place after this to establish a plan for informing and Environmental protection, Air disapproval. Federal disapproval of the advising any small governments that pollution control, Incorporation by state submittal does not affect state may be significantly or uniquely reference, Intergovernmental relations, enforceability. Moreover, EPA’s impacted by the rule. Ozone, Reporting and recordkeeping disapproval of the submittal does not EPA has determined that the requirements, Volatile organic impose any new Federal requirements. proposed action does not include a compounds. Therefore, I certify that this action will Federal mandate that may result in Authority: 42 U.S.C. 7401 et seq. not have a significant economic impact estimated costs of $100 million or more on a substantial number of small to either State, local, or tribal Dated: October 20, 2000. entities. governments in the aggregate, or to the Felicia Marcus, Moreover, due to the nature of the private sector. This proposed Federal Regional Administrator, Region IX. Federal-State relationship under the action acts on pre-existing requirements [FR Doc. 00–29065 Filed 11–13–00; 8:45 am] Clean Air Act, preparation of flexibility under State or local law, and imposes BILLING CODE 6560±50±P

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Notices Federal Register Vol. 65, No. 220

Tuesday, November 14, 2000

This section of the FEDERAL REGISTER packaging and recommend and Register at 65 FR 44024–44025 on July contains documents other than rules or demonstrate such standards in order to 17, 2000, and the correction to the ZIP proposed rules that are applicable to the encourage uniformity and consistency code as made above are incorporated in public. Notices of hearings and investigations, in commercial practices * * *.’’ AMS is the revised United States Standards for committee meetings, agency decisions and committed to carrying out this authority Dry Whey. rulings, delegations of authority, filing of petitions and applications and agency in a manner that facilitates the The revised United States Standards statements of organization and functions are marketing of agricultural commodities for Dry Whey are available either examples of documents appearing in this and will make copies of official through the above address or by section. standards available upon request. The accessing AMS Home Page on the United States Standards for Dry Whey Internet at www.ams.usda.gov/dairy/ no longer appear in the Code of Federal stand.htm. DEPARTMENT OF AGRICULTURE Regulations (CFR); however, they are Authority: 7 U.S.C. 1621–1627. maintained by USDA. Agricultural Marketing Service AMS is revising the United States Dated: November 7, 2000. Kenneth C. Clayton, [Docket No. DA±98±03] Standards for Dry Whey using the procedures it published in the August Associate Administrator, Agricultural United States Standards for Dry Whey 13, 1997, Federal Register and that Marketing Service. appear in Parts 36 of Title 7 of the CFR. [FR Doc. 00–29024 Filed 11–13–00; 8:45 am] AGENCY: Agricultural Marketing Service, The notice, which included a request BILLING CODE 3410±02±P USDA. for comments on the proposed changes, ACTION: Notice. was published in the Federal Register DEPARTMENT OF AGRICULTURE SUMMARY: This document gives notice of on June 20, 2000 (65 FR 38235–38239), the availability of revisions to the and a correction to the notice was Office of the Under Secretary, United States Standards for Dry Whey. published in the Federal Register on Research, Education, and Economics; The changes will: lower the bacterial July 17, 2000 (65 FR 44024–44025). Notice of the Advisory Committee on estimate of not more than 50,000 per The current United States Standards Agricultural Biotechnology Meeting gram to not more than 30,000 per gram; for Dry Whey have been in effect since incorporate maximum scorched particle October 1, 1990. AMS initiated a review AGENCY: Agricultural Research Service, content as a requirement for U.S. grade; of this standard and discussed possible Agriculture. expand the ‘‘Test Methods’’ section to changes with the dairy industry. The ACTION: Notice of Meeting. allow product evaluation using the American Dairy Products Institute, a SUMMARY: latest methods included in the Standard trade association representing the dry In accordance with the Methods for Examination of Dairy whey industry, provided specific Federal Advisory Committee Act, 5 Products, in the Official Methods of suggestions, including a suggestion to U.S.C. App., the United States Analysis of the Association of Official lower the maximum bacterial content Department of Agriculture announces a Analytical Chemists, and in standards requirement. AMS proposed other meeting of the Advisory Committee on developed by the International Dairy changes to reflect improvements in the Agricultural Biotechnology (ACAB). Federation; reference the Food and Drug quality of dry whey that have occurred SUPPLEMENTARY INFORMATION: The third Administration’s requirements for dry since the standards were last revised meeting of the ACAB has been whey; and make editorial changes that and to promote greater uniformity and scheduled for November 29–30, 2000. would provide consistency with other consistency in the application of this The topics to be discussed will include: U.S. grade standards for dairy products. standard. (1) The USDA’s public seed breeding AMS published the notice in the EFFECTIVE DATE: This notice is effective program and plant germplasm December 14, 2000. Federal Register with an outline of the repositories; (2) impacts of gene flow specific proposed changes and provided from transgenic crops to other plants ADDRESSES: The revised Standards are a comment period of 60 days, which and current and potential USDA roles in available from Duane R. Spomer, Chief, ended on August 21, 2000. addressing them; and (3) biotechnology Dairy Standardization Branch, Dairy The American Dairy Products budget priorities for FY 2002. There will Programs, Agricultural Marketing Institute filed a comment supporting the in addition be several updates on Service, U.S. Department of Agriculture, proposed changes. No other comments current biotechnology developments, Room 2746, South Building, Stop 0230, were received. including the Starlink corn situation, P.O. Box 96456, Washington, DC 20090– AMS discovered a typographical error and on ongoing USDA biotechnology- 6456 or at www.ams.usda.gov/dairy/ in the ZIP code for the Association of related activities. stand.htm. Official Analytical Chemists. The ZIP Background information regarding the FOR FURTHER INFORMATION CONTACT: code that appears in the ‘‘Test Methods’’ work of the ACAB is available on the Duane R. Spomer, (202) 720–7473. section of the revised standard should USDA web site at http://www.usda.gov/ SUPPLEMENTARY INFORMATION: Section read 20877–2417. Accordingly, the agencies/biotech/acab.html. Members of 203(c) of the Agricultural Marketing Act notice revising the United States the public who wish to make oral of 1946, as amended, directs and Standards for Dry Whey published in statements should also inform Dr. authorizes the Secretary of Agriculture the Federal Register at 65 FR 38235– Schechtman in writing or via E-mail at ‘‘to develop and improve standards of 38239 on June 20, 2000, the notice of the indicated addresses at least three quality, condition, quantity, grade, and correction published in the Federal business days before the meeting. On

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November 29, 2000, if time permits, DATES: Comments on this notice must be agency, including whether the reasonable provision will be made for received on or before January 16, 2001 information will have practical utility; oral presentations of no more than five to be assured consideration. (b) the accuracy of the agency’s estimate minutes each in duration. Written FOR FURTHER INFORMATION CONTACT: of burden including the validity of the statements may be submitted to the Phillip Elder, Senior Loan Officer, methodology and assumptions used; (c) Committee before or after the meeting at USDA, Farm Service Agency, Loan ways to enhance the quality, utility and the address indicated below. Servicing Division, 1400 Independence clarity of the information to be collected; (d) ways to minimize the DATES: The meeting will be held in the Avenue, SW., STOP 0523, Washington, burden of the collection of information Empire Room in the Omni Shoreham DC 20013–0523; Telephone (202) 690– on those who are to respond, including Hotel, 2500 Calvert Street, NW, 4012; Electronic mail: _ through the use of appropriate Washington, DC 20008, on November phillip [email protected]. automated, electronic, mechanical, or 29–30, 2000. The meeting is scheduled SUPPLEMENTARY INFORMATION: other technological collection to run from 8:30 am until 6:30 pm on Title: 7 CFR, Part 1951–S—Farmer techniques or other forms of information November 29 and 8:30 am until 5:30 pm Program Account Servicing Policies. technology. These comments should be on November 30. The meeting will be OMB Control Number: 0560–0161. sent to Desk Officer for Agriculture, open to the public, but space is limited. Expiration Date of Approval: January Office of Information and Regulatory If you would like to attend the meetings, 31, 2001. Affairs, Office of Management and you must register by contacting Ms. Type of Request: Extension of Budget, Washington, DC 20503 and to Dianne Harmon at (202) 720–4074, by Currently Approved Information Phillip Elder, Senior Loan Officer, fax at (202) 720–3191 or by E-mail at Collection. USDA, FSA, Farm Loan Programs, Loan [email protected] at least 7 days Abstract: The regulations describe the Servicing Division, 1400 Independence prior to the meeting. Please provide policies and procedures the Agency will Avenue, SW, STOP 0523, Washington, your name, title, business affiliation, use in servicing delinquent FLP loans. Servicing of accounts is administered in DC 20250–0523. address, telephone, and fax number Comments regarding paperwork accordance with the provisions of the when you register. If you require a sign burden will be summarized and Consolidated Farm and Rural language interpreter or other special included in the request for OMB Development Act (CONACT), as accommodation due to disability, please approval of the information collection. amended by the Food Security Act of indicate those needs at the time of All comments will also become a matter 1985, the Agriculture Credit Act of registration. of public record. 1987, the Food, Agriculture, FOR FURTHER INFORMATION CONTACT: Conservation and Trade Act of 1990, the Signed in Washington, DC, on November 3, Michael Schechtman, Designated Agricultural Credit Improvement Act of 2000. Federal Official, Office of the Deputy 1992, and the Federal Agriculture L.W. Mitchell, Secretary, USDA, 202B Jamie L. Whitten Improvement and Reform Act of 1996. Administrator, Farm Service Agency. Federal Building, 12th and The CONACT establishes notification by [FR Doc. 00–29053 Filed 11–13–00; 8:45 am] Independence Avenue, SW, the Agency and response by the BILLING CODE 3410±05±P Washington, DC 20250; Telephone (202) borrower and actions on the borrower’s 720–3817; Fax (202) 690–4265; E-mail request. Specifically, it requires a [email protected]. borrower to document that they can DEPARTMENT OF COMMERCE Dated: November 8, 2000. meet family living and farm operating Richard M. Parry, Jr., expenses and service all debts, International Trade Administration including the loans they are proposing Acting Administrator. [A±508±809, A±821±813, A±570±864] be restructured by the Agency. This [FR Doc. 00–29116 Filed 11–13–00; 8:45 am] information collection is submitted by Initiation of Antidumping Duty BILLING CODE 3410±03±P Agency borrowers to FSA and used by Investigations: Pure Magnesium From Agency officials to consider a Israel, the Russian Federation, and the financially distressed or delinquent DEPARTMENT OF AGRICULTURE People's Republic of China borrower’s request for debt restructuring AGENCY: Import Administration, Farm Service Agency including rescheduling, reamortization, consolidation, deferral, and write down. International Trade Administration, Request for Extension of Currently Estimate of Burden: Public reporting Department of Commerce. Approved Information Collection burden for this collection of information ACTION: Initiation of antidumping duty is estimated to average 47 minutes per investigations. AGENCY: Farm Service Agency, USDA. response. Respondents: Individuals or EFFECTIVE DATE: November 14, 2000. ACTION: Notice and Request for households, businesses or other for FOR FURTHER INFORMATION CONTACT: Comments. profits and farms. Craig Matney or James Nunno at (202) Estimated Number of Respondents: 482–1778 and (202) 482–0783, SUMMARY: In accordance with the 12,000. respectively; Import Administration, Paperwork Reduction Act of 1995, this Estimated Number of Responses per International Trade Administration, notice announces the intent of the Farm Respondent: 1.73. U.S. Department of Commerce, 14th Service Agency (FSA) to request an Estimated Total Annual Burden on Street and Constitution Avenue, NW, extension of a currently approved Respondents: 16,000 hours. Washington, DC 20230. information collection for a regulation The Agency is soliciting comments on INITIATION OF INVESTIGATIONS: used in support of the FSA Farm Loan the burden of all of the above subparts Program (FLP). This renewal does not regarding: (a) Whether the collection of The Applicable Statute and Regulations involve any revisions to the program information is necessary for the proper Unless otherwise indicated, all rules. performance of the functions of the citations to the statute are references to

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 68122 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices the provisions effective January 1, 1995, petition account for: (1) At least 25 turnings, chips, powder, and briquettes. the effective date of the amendments percent of the total production of the Moreover, because the Department made to the Tariff Act of 1930 (the Act) domestic like product; and (2) more specifically excluded granular by the Uruguay Round Agreements Act than 50 percent of the production of the magnesium from earlier proceedings (URAA). In addition, unless otherwise domestic like product produced by that covering pure magnesium (see, e.g., indicated, all citations to the portion of the industry expressing Preliminary Determination of Sales at Department of Commerce’s (the support for, or opposition to, the Less Than Fair Value: Pure and Alloy Department’s) regulations are references petition. Moreover, section 732(c)(4)(D) Magnesium From Canada, 57 FR 6094, to the provisions codified at 19 CFR Part provides that, if the petition does not 6095 (February 20, 1992) aff’d in Pure 351 (April 2000). establish support of domestic producers and Alloy Magnesium From Canada: or workers accounting for more than 50 Final Affirmative Determination; The Petitions percent of the total production of the Rescission of Investigation and Partial On October 17, 2000, the Department domestic like product, the Department Dismissal of Petition, 57 FR 30939 (July received petitions filed in proper form shall either poll the industry or rely on 13, 1992)), we have examined whether by the Magnesium Corporation of other information in order to determine conditions in the magnesium industry America (Magcorp) and the United Steel if there is support for the petition. have changed to an extent that it is now Workers of America, Local 8319. On Section 771(4)(A) of the Act defines appropriate to include both forms in the October 26, 2000, the petitioners the ‘‘industry’’ as the producers of a proceedings covering Israel and Russia. amended the petitions to include the domestic like product. Thus, to Based on our review of the information United Steelworkers of America, Local determine whether the petition has the provided in the petitions, we have 482, as co-petitioners. Collectively, requisite industry support, the statute concluded that conditions have changed these entities are hereinafter referred to directs the Department to look to and that we should include both as ‘‘the petitioners.’’ The Department producers and workers who produce the granular magnesium and magnesium in received information supplementing the domestic like product. The International ingot form in the same proceeding. See petitions throughout the initiation Trade Commission (ITC), which is the Memorandum from the team to period. responsible for determining whether Richard W. Moreland, Deputy Assistant In accordance with section 732(b) of ‘‘the domestic industry’’ has been Secretary, Office of AD/CVD the Act, the petitioners allege that injured, must also determine what Enforcement, Group I entitled ‘‘Like imports of pure magnesium from Israel, constitutes a domestic like product in Product and Industry Support the People’s Republic of China (PRC), order to define the industry. While both Determinations in the Antidumping and the Russian Federation (Russia) are the Department and the ITC must apply Duty Investigations of Pure Magnesium being, or are likely to be, sold in the the same statutory definition regarding from Israel, the People’s Republic of United States at less than fair value the domestic like product (section China, and the Russian Federation and within the meaning of section 731 of the 771(10) of the Act), they do so for the Countervailing Duty Investigation of Act, and that such imports are different purposes and pursuant to Pure Magnesium from Israel,’’ dated materially injuring an industry in the separate and distinct authority. In November 6, 2000 (‘‘Like Product/ United States. addition, the Department’s Industry Support Memo’’). On November 3 and 6, 2000, we determination is subject to limitations of Concerning industry support, for all received a submission from producers of time and information. Although this three countries covered by the petitions, granular pure magnesium. On may result in different definitions of the the petitioners established industry November 6, 2000, the petitioners filed like product, such differences do not support by demonstrating that they a response. The Department has taken render the decision of either agency account for over 25 percent of total these submissions into consideration in contrary to the law.1 production of the domestic like product making the initiation determination. Section 771(10) of the Act defines the (see Antidumping Investigations The Department finds that the domestic like product as ‘‘a product Initiation Checklist, dated November 6, petitioners filed these petitions on which is like, or in the absence of like, 2000 (Initiation Checklist and the Like behalf of the domestic industry because most similar in characteristics and uses Product/Industry Support Memo)), they are interested parties as defined in with, the article subject to an thereby meeting the first requirement sections 771(9)(C) and (D) of the Act and investigation under this subtitle.’’ Thus, under section 732(c)(4)(A) of the Act. they have demonstrated sufficient the reference point from which the On October 30, 2000, the Department industry support with respect to each of domestic like product analysis begins is obtained information from another the antidumping investigations that they ‘‘the article subject to an investigation,’’ significant producer of pure magnesium are requesting the Department to initiate i.e., the class or kind of merchandise to indicating that this company is neutral (see the following section, below). be investigated, which normally will be with respect to the petitions (see the scope as defined in the petition. November 2, 2000, memorandum to the Determination of Industry Support for The domestic like product described file regarding submission of additional the Petitions in the petitions is pure magnesium in all domestic production data). Since those Section 732(b)(1) of the Act requires forms. Based upon our review of parties expressing an opinion support that a petition be filed on behalf of the petitioners’ claims we concur that there the petitions, the second requirement domestic industry. Section 732(c)(4)(A) is a single domestic like product: pure under section 732(c)(4)(A) of the Act is of the Act provides that the magnesium, regardless of chemistry, also met. Department’s industry support form, or size, including, without Because the petitioners represent less determination, which is to be made limitation, ingots, raspings, granules, than 50 percent of the domestic industry before the initiation of the investigation, we have additionally examined industry be based on whether a minimum 1 See Algoma Steel Corp. Ltd., v. United States, support as required by section percentage of the relevant industry 688 F. Supp. 639, 642–44 (CIT 1988); High 732(c)(4)(D) of the Act. We find that, Information Content Flat Panel Displays and supports the petition. A petition meets Display Glass from Japan: Final Determination; based on other information, there is this requirement if the domestic Rescission of Investigation and Partial Dismissal of sufficient support for the petition. producers or workers who support the Petition, 56 FR 32376, 32380–81 (July 16, 1991). Specifically, because the vast majority

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Because this data discussed the scope with the petitioners determine that these petitions are filed represents a FOB foreign-port price, it to ensure that it accurately reflects the on behalf of the domestic industry was not necessary to adjust for U.S. and product for which the domestic industry within the meaning of section international movement expenses. is seeking relief. Moreover, as discussed 732(c)(4)(A) of the Act. Furthermore, the petitioners were not in the preamble to the Department’s able to quantify foreign market Scope of Investigations regulations (see Antidumping Duties; brokerage, handling and inland freight There is an existing antidumping duty Countervailing Duties; Final Rule, 62 FR expenses; therefore, they conservatively order on pure magnesium from the PRC. 27295, 27323 (May 19, 1997)), we are made no adjustment for such expenses. See Notice of Antidumping Duty Orders: setting aside a period for parties to raise No other adjustments to the starting Pure Magnesium From the People’s issues regarding product coverage. The price were made to arrive at net U.S. Republic of China, the Russian Department encourages all parties to price. Federation and Ukraine; Notice of submit such comments within 20 Amended Final Determination of Sales calendar days of publication of this Normal Value at Less Than Fair Value: Antidumping notice. Comments should be addressed The petitioners claimed that there Duty Investigation of Pure Magnesium to Import Administration’s Central were no home market sales of pure From the Russian Federation, 60 FR Records Unit at Room 1870, U.S. magnesium in Israel. Based on the data 25691 (May 12, 1995).2 Department of Commerce, 14th Street in the petition, however, there is The scope of these investigations for and Constitution Avenue, NW, insufficient evidence to conclude that Israel and the Russian Federation Washington, DC 20230. The period of the home market for pure magnesium in includes imports of pure magnesium scope consultations is intended to Israel is not viable. Because the products, regardless of chemistry, form, provide the Department with ample petitioners were unable to provide home or size, including, without limitation, opportunity to consider all comments market price information, we have ingots, raspings, granules, turnings, and consult with parties prior to the relied on CV for purposes of calculating chips, powder, and briquettes. The issuance of the preliminary NV for this initiation. For further scope of the PRC investigation includes determinations. discussion, see the Initiation Checklist all of the foregoing pure magnesium at page 8. Export Price and Normal Value products except pure magnesium that is According to the petitioners, there is already covered by the existing order, The following are descriptions of the only one producer of pure magnesium and classifiable under 8104.11.00 and allegations of sales at less than fair value in Israel, Dead Sea Magnesium Ltd. 8104.19.00 of the Harmonized Tariff upon which the Department based its (DSM). Pursuant to sections 773(a)(4), Schedule of the United States (HTSUS). 773(b) and 773(e) of the Act, the Pure magnesium includes: (1) decision to initiate these investigations. The sources of data for the deductions petitioners calculated CV using the Products that contain at least 99.95 manufacturing costs for pure percent primary magnesium, by weight and adjustments relating to U.S. price, constructed value (CV), and factors of magnesium shown for DSM in the 1999 (generally referred to as ‘‘ultra-pure’’ financial statements of its parent magnesium); (2) products that contain production are also discussed in the Initiation Checklist. Should the need company, Dead Sea Works Ltd. (DSW). less than 99.95 percent but not less than Pursuant to section 773(b)(3) of the Act, 99.8 percent primary magnesium, by arise to use any of this information as facts available under section 776 of the the petitioners calculated CV as the sum weight (generally referred to as ‘‘pure’’ of the cost of materials and fabrication, magnesium); and (3) products that Act in our preliminary or final determinations, we may re-examine the plus amounts for home market general contain 50 percent or greater, but less expenses (i.e., selling, general and than 99.8 percent primary magnesium, information and revise the margin calculations, if appropriate. administrative expenses (SG&A) and by weight, and that do not conform to interest), and packing. We relied on the an ‘‘ASTM Specification for Magnesium Regarding the information involving 3 reported CV amounts except for interest, Alloy’’ (generally referred to as ‘‘off- non-market economies (NME), the which we recalculated using cost of specification pure’’ magnesium). Department presumes, based on the sales as the denominator in the interest The merchandise subject to the Israel extent of central government control in expense ratio consistent with our and the Russian Federation an NME, that a single dumping margin, normal practice. Consistent with section investigations is classifiable under should there be one, is appropriate for 773(e)(2) of the Act, the petitioners also 8104.11.00, 8104.19.00, and 8104.30.00 all NME exporters in the given country. added to CV an amount for profit. Profit of the HTSUS. The merchandise subject In the course of these investigations, all was based upon the 1999 financial to the PRC investigation is classifiable parties will have the opportunity to statements of DSW. We also made the provide relevant information related to 2 following circumstance-of-sale The antidumping duty order with respect to the the issues of a country’s NME status and Russian Federation was revoked. See Notice of final adjustments to the data above: (1) results of five-year (‘‘Sunset’’) review: Revocation of the granting of separate rates to Deducted HM imputed credit expenses antidumping duty order on pure magnesium from individual exporters. See, e.g., Final and HM royalty expenses; and (2) added Russia, 65 FR 41944 (July 7, 2000). Determination of Sales at Less Than U.S. imputed credit expenses and U.S. 3 The meaning of this term is the same as that Fair Value: Silicon Carbide from the used by the American Society for Testing and royalty expenses. The Department Materials in its Annual Book of ASTM Standards: People’s Republic of China, 59 FR 22585 adjusted the petitioners’ calculation of Volume 01.02 Aluminum and Magnesium Alloys. (May 2, 1994). the U.S. imputed credit expense based

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Sales Below Cost Allegation effect, the petitioners determined the Based upon comparisons of EP to NV, Based upon the petitioners’ claim that dumping margin using an NME the revised calculated estimated no viable Israeli market existed for pure analysis. dumping margins range from 161.36 to magnesium, the petitioners looked to The petitioners assert that India is the 305.56 percent. the largest export market other than the most appropriate surrogate country for United States for pure magnesium sales. the PRC, claiming that India is: (1) A Russia The petitioners determined this market market economy; (2) a significant Export Price to be Belgium and stated that Belgium producer of comparable merchandise; The petitioners calculated EP using would be the appropriate third-country and (3) at a level of economic two methodologies. First, the petitioners market for NV. The petitioners alleged, development comparable to the PRC in based EP on their information regarding however, that there were reasonable terms of per-capita gross national sales of Russian magnesium. The grounds to believe or suspect that sales product. Based on the information petitioners calculated a net U.S. price by of pure magnesium to Belgium were provided by the petitioners, we believe deducting from this value the cost of made at prices below the cost of that the petitioners’ use of India as a transporting the subject merchandise production (COP), within the meaning surrogate country is appropriate for from the plant to St. Petersburg, of section 773(b) of the Act, and purposes of initiation of this international freight, U.S. import duties, requested that the Department conduct investigation. and an estimated importer markup of a country-wide sales-below-cost In accordance with 773(c)(4) of the five percent. Because we could not investigation. Because we find that the Act, the petitioners valued the factors of ascertain the validity of the above- petitioners did not adequately support production, where possible, on referenced price of Russian magnesium, their claim that the home market in reasonably available, public surrogate we based one export price on alternate Israel is not viable, however, we have country data. Values for calcinate, No. 2 information contained in the petition not used this third-country price flux, flourite powder, sulfur powder, regarding prices of Russian magnesium. information for purposes of determining and barium chloride were based on We made deductions for foreign inland whether there are reasonable grounds to 1998 Indian import statistics as freight, an importer markup, believe or suspect that sales of the published by the United Nations. The international freight and handling foreign like product were made below value for ferrosilicon was based on the charges, and U.S. import duties as the COP, within the meaning of section average unit value of ferrosilicon reported in the 1999 financial described above. 773(b)(2)(A)(i) of the Act. Since we have The petitioners also based EP on the rejected the use of Belgian prices and statements of an Indian producer of magnesium metal. Values for dolomite unit values for the period April through the petitioners have stated that there are July 2000, as reported in the Bureau of no Israeli prices for pure magnesium, and sulfuric acid were based on the values obtained from the 1995–96 the Census IM–145 data. The petitioners we have no price data upon which to calculated a net U.S. price by deducting perform a sales-below-cost analysis. financial statements of a producer of ferro-alloys and The Financial Express, from this value the cost of transporting Accordingly, we have not initiated a respectively. Labor was valued using the the subject merchandise from the plant country-wide cost investigation. For Department’s regression-based wage rate to St. Petersburg. further discussion, see the Initiation for the PRC, in accordance with 19 CFR Checklist at pages 8–9. Normal Value 351.408(c)(3). Electricity was valued The PRC using the 1998 rates for India published The petitioners assert that Russia is an by the International Energy Agency NME country, and that in all previous Export Price (IEA) in 1999. Coal was valued using investigations, the Department has The petitioners based EP on the 1998 Indian import statistics as determined that Russia is an NME. See, average unit value for the period April published by the United Nations. All e.g., Notice of Final Determination of through July 2000, as reported in the surrogate values that fell outside the Sales at Less Than Fair Value: Solid Bureau of the Census IM–145 data. The anticipated period of investigation Fertilizer Grade Ammonium Nitrate petitioners made no adjustments to the (POI), which in the PRC case is April 1, from the Russian Federation, 65 FR average unit value. 2000, through September 30, 2000, were 42669, 42670–71 (July 11, 2000). Russia adjusted for inflation. will be treated as an NME unless and Normal Value To determine factory overhead, until its NME status is revoked. The petitioners allege that the PRC is depreciation, selling, general, and Pursuant to section 771(18)(C)(i) of the an NME country, and that in all administrative (SG&A) expenses, and Act, because Russia’s status as an NME previous investigations the Department interest expenses, the petitioners relied remains in effect, the petitioners has determined that the PRC is an NME. on rates derived from the financial determined the dumping margin using See, e.g., Notice of Preliminary Results statements of the magnesium metal an NME analysis. of Antidumping Duty Administrative producer noted above. Because these NV was calculated using the same Review: Natural Bristle Paintbrushes financial statements showed a loss, the methodology described above for the and Brush Heads From the People’s petitioners relied on the 1998 financial PRC, except as noted below. Further, Republic of China, 65 FR 13944, 13946 statements of two Indian producers of South Africa was used as the surrogate (Mar. 15, 2000). In accordance with aluminum to derive the profit ratio used country. We believe that South Africa is section 771(18)(c) of the Act, any in their calculations. We, however, have an appropriate surrogate for purposes of determination that a foreign country has excluded profit from the calculation of initiating this case with respect to

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Russia because South Africa is: (1) A statements did not separately identify allegations with respect to the PRC and market economy; (2) a significant SG&A expenses, the petitioners relied Russia. producer of comparable merchandise; on a zinc producer whose electrolytic and (3) at a level of economic process is similar to the magnesium Initiation of Antidumping Investigations development comparable to Russia in production process. In addition, the Based upon our examination of the terms of per-capita gross national petitioners adjusted the factory petitions on pure magnesium, we have product. overhead rate to account for higher found that they meet the requirements Regarding NV, the petitioners valued electrolytic cell rebuilding costs of section 732 of the Act. Therefore, we petroleum coke, magnesium chloride, associated with the production of fluorspar, sulfuric acid, barium magnesium. Based on the information are initiating antidumping duty chloride, barium fluoride, potassium provided by the petitioners, we believe investigations to determine whether chloride, and packing materials using that the surrogate values represent imports of pure magnesium from Israel, South African import statistics as information reasonably available to the the PRC, and Russia are being, or are published by the United Nations. The petitioners and are acceptable for likely to be, sold in the United States at petitioners valued chlorine using a purposes of initiation of this less than fair value. Unless this deadline contemporaneous South African price investigation. is extended, we will make our quote. The petitioners deducted from Because we found certain preliminary determinations no later the surrogate values of the two by- discrepancies with the petitioners’ than 140 days after the date of this products (i.e., chlorine and potassium calculations of surrogate values and initiation. chloride) an amount for profit based on constructed value, we recalculated their own production experience in margins for both Russian producers Distribution of Copies of the Petitions order to account for additional costs using both revised United States price In accordance with section incurred to render these by-products information from the petition and the 732(b)(3)(A) of the Act, a copy of the marketable for sale. The petitioners also United States price based on Census added to the surrogate value for chlorine Bureau data. See Initiation Checklist at public version of each petition has been an amount for re-vaporization based on pages 14 and 15. Based on comparisons provided to the representatives of the the petitioners’ production experience. of EP to NV, the calculated estimated governments of Israel, the PRC, and The petitioners valued carnallite using a dumping margins range from 23.45 to Russia. We will attempt to provide a price quote for dolomite because the 39.14 percent. copy of the public version of each petitioners were unable to find a petition to each exporter named in the Fair Value Comparisons carnallite price quote. Because they petition, as appropriate. Based on the data provided by the were unable to find a surrogate value for International Trade Commission dehydrated carnallite, the petitioners petitioners, there is reason to believe Notification estimated the value of dehydrated that imports of pure magnesium from carnallite as twenty times the value of Israel, the PRC, and Russia are being, or We have notified the ITC of our are likely to be, sold at less than fair carnallite. Labor was valued using the initiations, as required by section 732(d) value. methodology described above for the of the Act. PRC. Electricity was valued using the Allegations and Evidence of Material 2000 electricity rate schedule for large- Injury and Causation Preliminary Determinations by the ITC volume users as published by one of South Africa’s largest utility companies. The petitions allege that the U.S. The ITC will determine, no later than The petitioners valued heavy oil using industry producing the domestic like December 1, 2000, whether there is a a 1999 price published by the product is being materially injured, or is reasonable indication that imports of International Energy Agency. All threatened with material injury, by pure magnesium from Israel, the PRC, surrogate values that fell outside the reason of the individual and cumulated and Russia are causing material injury, anticipated POI were adjusted for imports of the subject merchandise. The or threatening to cause material injury, inflation. The petitioners made purity petitioners contend that the industry’s to a U.S. industry. A negative ITC adjustments for certain factors of injured condition is evident in the determination for any country will production based on information from declining trends in net operating result in the investigations being the investigation of pure and alloy income, net sales volume and value, terminated with respect to that country; magnesium from Russia. profit to sales ratios, and capacity otherwise, these investigations will To determine fixed factory overhead, utilization. The allegations of injury and proceed according to statutory and causation are supported by relevant depreciation, SG&A, interest expenses, regulatory time limits. and profit, the petitioners relied on rates evidence including U.S. Customs import derived for the aluminum operations of data, lost sales, and pricing information. This notice is issued and published two aluminum producers, as reflected We have assessed the allegations and pursuant to section 777(i) of the Act. on their parent company’s financial supporting evidence regarding material Dated: November 6, 2000. statement, and a South African zinc injury and causation, and have Joseph A. Spetrini, producer. Although there are no determined that these allegations are Acting Assistant Secretary for Import producers of magnesium in South properly supported by accurate and Administration. Africa, the petitioners identified two adequate evidence, and meet the primary aluminum producers in South statutory requirements for initiation (see [FR Doc. 00–29083 Filed 11–13–00; 8:45 am] Africa. The petitioners used the Initiation Checklist). In accordance with BILLING CODE 3510±DS±P consolidated financial statement of the section 771(7)(G)(ii)(IV), which provides South African aluminum producers’ an exception to the mandatory parent company because no separate cumulation provision for imports from financial statements for the two Israel, we have considered the aluminum producers were available. petitioners’ allegation of injury with Because the parent company’s financial respect to Israel independent of their

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DEPARTMENT OF COMMERCE DEPARTMENT OF COMMERCE The petitioners state that they have standing to file the petition because they International Trade Administration International Trade Administration are interested parties, as defined under sections 771(9)(C) and (D) of the Act. [C±508±605] [C±508±810] See Determination of Industry Support for the Petition section below. Notice of Initiation of Countervailing Notice of Extension of Time Limit for Scope of the Investigation Countervailing Duty Administrative Duty Investigation: Pure Magnesium Review of Industrial Phosphoric Acid From Israel The scope of this investigation From Israel includes imports of pure magnesium AGENCY: Import Administration, products, regardless of chemistry, form, International Trade Administration, or size, including, without limitation, AGENCY: Import Administration, Department of Commerce. ingots, raspings, granules, turnings, International Trade Administration, EFFECTIVE DATE: November 14, 2000. chips, powder, and briquettes. Department of Commerce. FOR FURTHER INFORMATION CONTACT: Pure magnesium includes: (1) SUMMARY: The Department of Commerce Marian Wells, Blanche Ziv, or Ryan Products that contain at least 99.95 (the Department) is extending the time Langan, Office of CVD/AD Enforcement percent primary magnesium, by weight limit for the final results of the I, Import Administration, International (generally referred to as ‘‘ultra-pure’’ administrative review of the Trade Administration, U.S. Department magnesium); (2) products that contain countervailing duty order on industrial of Commerce, Room 1870, 14th Street less than 99.95 percent but not less than phosphoric acid from Israel, covering and Constitution Avenue, N.W., 99.8 percent primary magnesium, by the period January 1, 1998 through Washington, D.C. 20230, telephone weight (generally referred to as ‘‘pure’’ magnesium); and (3) products that December 31, 1998. (202) 482–6309, (202) 482–4207, or (202) 482–1279, respectively. contain 50 percent or greater, but less EFFECTIVE DATE: November 14, 2000. than 99.8 percent primary magnesium, Initiation of Investigation by weight, and that do not conform to FOR FURTHER INFORMATION CONTACT: The Applicable Statute and Regulations an ‘‘ASTM Specification for Magnesium Sean Carey, AD/CVD Enforcement Alloy’’ 1 (generally referred to as ‘‘off- Office 7, Import Administration, Unless otherwise indicated, all specification pure’’ magnesium). International Trade Administration, citations to the statute are references to The merchandise subject to this U.S. Department of Commerce, 14th the provisions effective January 1, 1995, investigation is classifiable under Street and Constitution Avenue, NW., the effective date of the amendments 8104.11.00, 8104.19.00, and 8104.30.00 Washington, DC 20230, telephone: (202) made to the Tariff Act of 1930 (‘‘the of the Harmonized Tariff Schedule of 482–3964. Act’’) by the Uruguay Round the United States (‘‘HTSUS’’). Although Agreements Act (‘‘URAA’’). In addition, the HTSUS subheading is provided for SUPPLEMENTARY INFORMATION: Under unless otherwise indicated, all citations convenience and customs purposes, the section 751(a)(3)(A) of the Tariff Act of to the Department’s regulations are to written description of the merchandise 1930, as amended (the ‘‘Act’’), the the regulations codified at 19 CFR Part under investigation is dispositive. Department may extend the deadline for 351 (2000). During our review of the petition, we completion of an administrative review discussed the scope with the petitioners if it determines that it is not practicable The Petition to ensure that the scope in the petition to complete the review within the On October 17, 2000, the Department accurately reflects the product for which statutory time limit of 120 days after the of Commerce (‘‘the Department’’) the domestic industry is seeking relief. date on which the notice of preliminary received a petition filed in proper form Moreover, as discussed in the preamble results was published in the Federal by the Magnesium Corporation of to the Department’s regulations Register. In the instant case, the America (‘‘Magcorp’’) and the United (Antidumping Duties; Countervailing Department has determined that it is not Steel Workers of America, Local 8319. Duties; Final Rule, 62 FR 27296, 27323 practicable to complete the review On October 26, 2000, the petitioners (May 19, 1997)), we are setting aside a within the statutory time limit. See amended the petition to include the period for parties to raise issues Memorandum from Barbara E. Tillman United Steelworkers of America, Local regarding product coverage. The to Joseph A. Spetrini (November 1, 482, as co-petitioners. (Collectively, Department encourages all parties to 2000). Therefore, pursuant to section these entities are hereinafter referred to submit such comments within 20 751(a)(3)(A) of the Act, the Department as ‘‘the petitioners.’’) The Department calendar days of publication of this notice. Comments should be addressed is extending the time limit for the final received information supplementing the to Import Administration’s Central results to no later than March 5, 2001, petition throughout the initiation period. Records Unit at Room 1870, U.S. which is 180 days after the publication On November 3 and November 6, Department of Commerce, 14th Street date in the Federal Register of the 2000, we received a submission from and Constitution Avenue, NW, notice of preliminary results for this producers of granular pure magnesium. Washington, D.C. 20230. The period of review. The preliminary results were On November 6, 2000, petitioners filed scope consultations is intended to published in the Federal Register on a response. The Department has taken provide the Department with ample September 6, 2000 (65 FR 53984). these submissions into consideration in opportunity to consider all comments Dated: November 1, 2000. making the initiation determination. and consult with parties prior to the issuance of the preliminary Joseph A. Spetrini, In accordance with section 702(b)(1) determination. Deputy Assistant Secretary for AD/CVD of the Act, the petitioners allege that Enforcement Group III. manufacturers, producers, or exporters of the subject merchandise from Israel 1 The meaning of this term is the same as that [FR Doc. 00–29081 Filed 11–13–00; 8:45 am] used by the American Society for Testing and receive countervailable subsidies within Materials in its Annual Book of ASTM Standards: BILLING CODE 3510±DS±P the meaning of section 701 of the Act. Volume 01.02 Aluminum and Magnesium Alloys.

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Consultations render the decision of either agency thereby meeting the first requirement contrary to the law.2 under section 702(c)(4)(A) of the Act. Pursuant to section 702(b)(4)(A)(ii) of Section 771(10) of the Act defines the On October 30, 2000, the Department the Act, the Department invited domestic like product as ‘‘a product obtained information from another representatives of the Government of which is like, or in the absence of like, significant producer of pure magnesium Israel (‘‘GOI’’) for consultations with most similar in characteristics and uses indicating that this company is neutral respect to the petition filed. The with, the article subject to an with respect to the petition (see Department held consultations with the investigation under this subtitle.’’ Thus, November 2, 2000, memorandum to the GOI on October 31, 2000. (See the the reference point from which the file regarding submission of additional October 31, 2000 memorandum to the domestic like product analysis begins is domestic production data). Since those File regarding these consultations.) ‘‘the article subject to an investigation,’’ parties expressing an opinion support i.e., the class or kind of merchandise to the petition, the second requirement Determination of Industry Support for be investigated, which normally will be under section 702(c)(4)(A) of the Act is the Petition the scope as defined in the petition. also met. Section 702(b)(1) of the Act requires The domestic like product described Because the petitioners represent less in the petitions is pure magnesium in all that a petition be filed on behalf of the than 50 percent of the domestic industry forms. Based upon our review of domestic industry. Section 702(c)(4)(A) we have additionally examined industry petitioners’ claims we concur that there of the Act provides that the support as required by section is a single domestic like product: pure 702(c)(4)(D) of the Act. We find that Department’s industry support magnesium, regardless of chemistry, based on other information, there is determination, which is to be made form, or size, including, without sufficient support for the petition. before the initiation of the investigation, limitation, ingots, raspings, granules, Specifically, the vast majority of the be based on whether a minimum turnings, chips, powder, and briquettes. industry has officially stated its position percentage of the relevant industry Moreover, because the Department for the record, as either supportive or supports the petition. A petition meets specifically excluded granular neutral, meaning that any potential this requirement if the domestic magnesium from earlier proceedings opposition could not represent over 50 producers or workers who support the covering pure magnesium (see percent of the industry that has support petition account for: (1) At least 25 Preliminary Determination of Sales at or opposition to the petition. percent of the total production of the Less than Fair Value; Pure and Alloy Accordingly, we determine that the domestic like product; and (2) more Magnesium from Canada, 57 FR 6094, petition is filed on behalf of the than 50 percent of the production of the 6095 (February 20, 1992), which was domestic industry within the meaning domestic like product produced by that upheld in the final determination), we of section 702(c)(4)(A) of the Act. (See portion of the industry expressing have examined whether conditions in Like Product/Industry Support Memo.) support for, or opposition to, the the magnesium industry have changed petition. Moreover, section 702(c)(4)(D) to an extent that it is now appropriate Injury Test provides that, if the petition does not to include both forms in this Because Israel is a ‘‘Subsidies establish support of domestic producers proceeding. Based on our review of the Agreement Country’’ within the or workers accounting for more than 50 information provided in the petition, we meaning of section 701(b) of the Act, percent of the total production of the have concluded that conditions have section 701(a)(2) applies to this domestic like product, the Department changed and that we should include investigation. Accordingly, the ITC must shall either poll the industry or rely on both granular magnesium and determine whether imports of the other information in order to determine magnesium in ingot form in the same subject merchandise from Israel if there is support for the petition. proceeding. See the Memorandum from materially injure, or threaten material Section 771(4)(A) of the Act defines the team to Richard W. Moreland, injury to, a U.S. industry. Deputy Assistant Secretary, Office of the ‘‘industry’’ as the producers of a Allegations and Evidence of Material AD/CVD Enforcement, Group I entitled domestic like product. Thus, to Injury and Causation ‘‘Like Product and Industry Support determine whether the petition has the The petition alleges that the U.S. requisite industry support, the statute Determinations in the Antidumping Duty Investigations of Pure Magnesium industry producing the domestic like directs the Department to look to product is being materially injured, or is producers and workers who produce the from Israel, the People’s Republic of China, and the Russian Federation and threatened with material injury, by domestic like product. The International the Countervailing Duty Investigation of reason of the imports of the subject Trade Commission (‘‘ITC’’), which is Pure Magnesium from Israel,’’ dated merchandise. The petitioner contends responsible for determining whether or November 6, 2000 (‘‘Like Product/ that the industry’s injured condition is not ‘‘the domestic industry’’ has been Industry Support Memo’’). evident in the declining trends in net injured, must also determine what Concerning industry support, the operating profits, net sales volumes, constitutes a domestic like product in petitioners established industry support profit to sales ratios, and capacity order to define the industry. While both by demonstrating that they account for utilization. The allegations of injury and the Department and the ITC must apply over 25 percent of total production of causation are supported by relevant the same statutory definition regarding the domestic like product (see Initiation evidence including U.S. Customs import the domestic like product (section Checklist, dated November 6, 2000 data, lost sales, and pricing information. 771(10) of the Act), they do so for (Initiation Checklist) and the Like We have assessed the allegations and different purposes and pursuant to Product/Industry Support Memo), supporting evidence regarding material separate and distinct authority. In injury and causation, and have addition, the Department’s 2 See Algoma Steel Corp. Ltd., v. United States, determined that these allegations are determination is subject to limitations of 688 F. Supp. 639, 642–44 (CIT 1988); High properly supported by accurate and time and information. Although this Information Content Flat Panel Displays and adequate evidence, and meet the may result in different definitions of the Display Glass from Japan: Final Determination; Rescission of Investigation and Partial Dismissal of statutory requirements for initiation (see like product, such differences do not Petition, 56 FR 32376, 32380–81 (July 16, 1991). Initiation Checklist).

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Allegations of Subsidies 5. The Infrastructure Grant Program. Dated: November 6, 2000. Section 702(b) of the Act requires the We are not including in our Joseph A. Spetrini, Department to initiate a countervailing investigation the following programs Acting Assistant Secretary for Import duty proceeding whenever an interested alleged to be benefitting producers and Administration. party files a petition, on behalf of an exporters of the subject merchandise in [FR Doc. 00–29080 Filed 11–13–00; 8:45 am] industry, that (1) alleges the elements Israel: Subsidies under the Magnesium BILLING CODE 3510±DS±P necessary for an imposition of a duty Research Institute and the Consortium under section 701(a), and (2) is Research Programs. The petitioners allege that the accompanied by information reasonably THE COMMISSION OF FINE ARTS Magnesium Research Institute (‘‘MRI’’) available to the petitioners supporting and the Consortium Research programs the allegations. 2001 National Capital Arts and Cultural should be investigated by the Affairs Program Initiation of Countervailing Duty Department to determine whether the Investigation Israeli government is conferring Notice is hereby given that Public countervailable subsidies as a result of Law 99–190, as amended, authorizing The Department has examined the the National Capital Arts and Cultural countervailing duty petition on pure the involvement of public universities in these programs. The petitioners Affairs Program, has been funded for magnesium from Israel and found that it 2001 in the amount of $7,000,000.00. complies with the requirements of support their allegation with documentation from DSM’s web page All requests for information and section 702(b) of the Act. Therefore, in applications for grants should be accordance with section 702(b) of the concerning research. The petitioners explain that one of the Israeli Ministry received by December 31, 2000 and Act, we are initiating a countervailing addressed to: Charles H. Atherton, duty investigation to determine whether of Industry and Trade’s major goals is to transition from capital investment Secretary, Commission of Fine Arts, manufacturers, producers, or exporters National Building Museum, Suite 312, of pure magnesium from Israel receive grants to alternative forms of aid, including research and development 441 F Street, NW., Washington, DC countervailable subsidies. See Initiation 20001. Phone: 202–504–2200. Checklist. grants. Petitioners request that the Department initiate an investigation to Deadline for receipt of grant Privatization determine whether the Israeli applications is March 1, 2001. This program provides grants for According to the information in the government is conferring general operating support of petition and presented at consultations, countervailable subsidies by mean of organizations whose primary purpose is one of the parent companies of the the academic involvement in these performing exhibiting, and/or Israeli manufacturer of magnesium, programs. presenting the arts. To be eligible for a Dead Sea Magnesium (‘‘DSM’’), was The petitioners have not provided grant, organizations must be located in almost entirely privatized as of 1998. sufficient evidence regarding the nature the District of Columbia, must be non- Since some of the alleged subsidies of the financial contribution or the profit, non-academic institutions of were provided prior to that date, the benefits conferred on DSW/DSM. demonstrated national repute, and must Department intends to examine whether Accordingly, we are not including this have annual incomes, exclusive of those subsidies continue to benefit the program in our investigation. federal funds, in excess of one million privatized company, in light of the Distribution of Copies of the Petition dollars for each of the past three years. Court of Appeals for the Federal Circuit’s ruling in Delverde, SRL v. In accordance with section Charles H. Atherton, United States, 202 F.3d 1360 (Fed. Cir. 702(b)(4)(A)(i) of the Act, copies of the Secretary. public version of the petition have been 2000). [FR Doc. 00–29076 Filed 11–13–00; 8:45 am] provided to the GOI. We will attempt to Creditworthiness provide copies of the public version of BILLING CODE 6330±01±M The petitioners allege DSM was the petition to all the exporters named uncreditworthy from its inception in the petition, as provided for under DEPARTMENT OF DEFENSE through the end of the POI. This section 351.203(c)(2) of the allegation was supported by financial Department’s regulations. Department of the Army ratios for DSM and its parent company. ITC Notification We will investigate DSM’s Availability of Patents for Exclusive, creditworthiness in years in which we Pursuant to section 702(d) of the Act, Partially Exclusive or Nonexclusive find that government equity infusions, we will notify the ITC of this initiation. Licenses loans or loan guarantees were provided. Preliminary Determination by the ITC AGENCY: U.S. Army Soldier and Programs The ITC will determine by December Biological Chemical Command, U.S. We are including in our investigation 1, 2000, whether there is a reasonable Army, DoD. the following programs alleged in the indication that an industry in the ACTION: Notice. petition to have provided United States is materially injured, or is SUMMARY: countervailable subsidies to producers threatened with material injury, by The Department of the Army and exporters of the subject reason of imports of pure magnesium announces the general availability of merchandise in Israel: from Israel. A negative ITC exclusive, partially exclusive, or 1. Encouragement of Capital determination will result in the nonexclusive licenses under the Investments Law (‘‘ECIL’’) Grants. investigation being terminated; following patents that are listed in the 2. Reduced Tax Rates under ECIL. otherwise, the investigation will SUPPLEMENTARY INFORMATION paragraph. 3. ECIL Preferential Accelerated proceed according to statutory and Any licenses granted shall comply with Depreciation. regulatory time limits. 35 U.S.C. 209 and 37 CFR part 404. 4. Encouragement of Research and This notice is published pursuant to FOR FURTHER INFORMATION CONTACT: Mr. Development Law (‘‘EIRD’’) Grants. section 777(i) of the Act. Robert Rosenkrans at U.S. Army Soldier

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68129 and Biological Chemical Command, DEPARTMENT OF DEFENSE the Draft and Final EIS and the Draft Kansas Street, Natick, MA 01760, and Final Supplement I by reference. Phone; (508) 233–4928 or E-mail: Department of the Army; Corps of Gary J. Gumm, [email protected] . Engineers LTC, Corps of Engineers, Deputy Commander. SUPPLEMENTARY INFORMATION: The Notice of Availability of the Draft [FR Doc. 00–29084 Filed 11–13–00; 8:45 am] following Patent Numbers, title and Supplement II to the Final EIS for the BILLING CODE 3710±JB±M issue dates are provided: Proposed New Water Supply Reservoir Patent Number: 5,538,583. Located in Williamson and Johnson Counties, for the City of Marion, IL Title: Method of Manufacturing a DEFENSE NUCLEAR FACILITIES SAFETY BOARD Laminated Textile Substrate for a Body AGENCY: U.S. Army Corps of Engineers, Heating or Cooling Garment. Louisville District, DoD. Sunshine Act Meeting Issue Date: July 23, 1996. ACTION: Notice of availability. Pursuant to the provision of the Patent Number: 5,320,164. SUMMARY: The City of Marion Illinois, ‘‘Government in the Sunshine Act’’ (5 Title: Body Heating or Cooling has previously applied to the U.S. Army U.S.C. § 552b), notice is hereby given of Garment. Corps of Engineers (Corps), Louisville the Defense Nuclear Facilities Safety Issue Date: June 14, 1994. District for a Department of the Army Board’s (Board) meeting described permit pursuant to Section 404 of the below. Gregory D. Showalter, Clean Water Act for placement of TIME AND DATE OF MEETING: 6:30 p.m., Army Federal Register Liaison Officer. material in Sugar Creek, Williamson November 30, 2000. [FR Doc. 00–29085 Filed 11–13–00; 8:45 am] County, as part of the construction of a PLACE: The Conference Center, 215 The BILLING CODE 3710±08±P new municipal water supply reservoir. Alley, Aiken, South Carolina 29801. DATES: Written comments received by STATUS: Open. While the Sunshine Act January 14, 2001, will be considered by does not require that the scheduled DEPARTMENT OF DEFENSE the Corps in decision making for the discussion be conducted in a meeting, Final Supplement II to the Final EIS. the Board has determined that an open Department of the Army FOR FURTHER INFORMATION CONTACT: meeting in this specific case furthers the Availability of Patents for Exclusive, Questions regarding the Draft public interest underlying both the Partially Exclusive or Nonexclusive Supplement II to the Final EIS may be Sunshine Act and the Board’s enabling legislation. Licenses directed to Mr. Ronny J. Sadri, Project Manager, Regulatory Branch, U.S. Army MATTERS TO BE CONSIDERED: The Board AGENCY: U.S. Army Soldier and Corps of Engineers, Louisville District, is visiting the Savannah River Site (SRS) Biological Chemical Command, U.S. P.O. Box 59, Louisville, KY 40201–0059, as part of its oversight of the Department Army, DoD. ATTN: CELRL–OP–FN, (502) 315–6681. of Energy’s (DOE) management and SUPPLEMENTARY INFORMATION: The operation of defense nuclear facilities. ACTION: Notice. proposed action by the City of Marion The site visit will include discussions of is a new 1,172-acre water supply tritium activities at Defense Programs SUMMARY: The Department of the Army reservoir located in Williamson and facilities as well as nuclear material announces the general availability of Johnson Counties, Illinois, near the stabilization activities at Environmental exclusive, partially exclusive, or community of Creal Springs. The Lake Management facilities. nonexclusive licenses under the of Egypt Water District has an agreement The Board wishes also to avail itself following Australia patent that is listed in principle with the City of Marion to of the opportunity of this visit to meet in the SUPPLEMENTARY INFORMATION purchase water if a new lake on Sugar with members of the public and other paragraph. Any licenses granted shall Creek is built. Two pipelines would be interested persons. This public meeting comply with 35 U.S.C. 209 and 37 CFR constructed for transport of water for is intended to be informal and to part 404. treatment. provide an opportunity for members of As part of the Corps review process, the public, DOE employees, and DOE’s FOR FURTHER INFORMATION CONTACT: Mr. this Draft Supplement II to the Final contractor employees to provide Robert Rosenkrans at U.S. Army Soldier Environmental Impact Statement (EIS) comments and information directly to and Biological Chemical Command, has been prepared. The Louisville the Board regarding any matter affecting Kansas Street, Natick, MA 01760, District prepared a Draft EIS and health and safety at SRS. Specific Phone; (508) 233–4928 or E-mail: released it to the public for comment in matters of particular interest to the [email protected] . October 1994. A public hearing was Board during this visit include: SUPPLEMENTARY INFORMATION: The held in December 1994. A Final EIS was 1. Utilization of F- and H-Canyon following Australia Patent Number, title prepared and released to the public for Facilities. and issue date is provided: comment in July 1995. A Draft 2. Stabilization, Packaging and Storage of Plutonium-bearing Materials. Australia Patent Number: 720323. Supplement I was prepared and released to the public for comment in 3. Stabilization of Highly Enriched Title: Load Securing and Releasing May 1996. Uranium Solutions. System. This Draft Supplement II to the Final 4. High Level Waste Management; Issue Date: May 25, 2000. EIS examines single source options as Including Selection of an Alternative well as combinations of separate Salt Processing Technology. Gregory D. Showalter, alternatives to satisfy current and future CONTACT PERSON FOR MORE INFORMATION: Army Federal Register Liaison Officer. water needs of Marion and the Lake of Richard A. Azzaro, General Counsel, [FR Doc. 00–29086 Filed 11–13–00; 8:45 am] Egypt Water District as separate entities. Defense Nuclear Facilities Safety Board, BILLING CODE 3710±08±P This Draft Supplement II incorporates 625 Indiana Avenue, NW, Suite 700,

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Washington, DC 20004, (800) 788–4016. formation of educational consortia of (b) The extent to which the design of This is a toll-free number. American and Brazilian institutions to the proposed project is appropriate to, Dated: November 9, 2000. encourage cooperation in the and will successfully address, the needs coordination of curricula, the exchange John T. Conway, of the target population or other of students and the opening of identified needs. Chairman. educational opportunities between the (3) The adequacy of resources, as [FR Doc. 00–29228 Filed 11–9–00; 12:47 pm] United States and Brazil. The determined by— BILLING CODE 3670±01±U invitational priority is issued in (a) The extent to which the costs are cooperation with Brazil. Brazilian reasonable in relation to the objectives, institutions participating in any design, and potential significance of the DEPARTMENT OF EDUCATION consortium proposal responding to the proposed project; [CFDA No. 84.116M] invitational priority may apply, (b) The potential for continued respectively, to the Coordination of support of the project after FIPSE/ Fund for the Improvement of Improvement of Personnel of Superior CAPES funding ends, including, as Postsecondary EducationÐSpecial Level (CAPES), Brazilian Ministry of appropriate, the demonstrated Focus Competition (Invitational Education for additional funding under commitment of appropriate entities to Priority: Institutional Cooperation and a separate but parallel Brazilian such support; and Student Mobility in Postsecondary competition. (c) The relevance and demonstrated Education Between the United States Priority commitment of each partner in the and Brazil); Notice Inviting Application proposed project to the implementation for New Awards for Fiscal Year (FY) Invitational Priority and success of the project. 2001. We are particularly interested in (4) The quality of the project Purpose of Program: To provide applications that meet the following personnel, as determined by— (a) The qualifications, including grants or enter into cooperative invitational priority. However, an training and experience, of key project agreements to improve postsecondary application that meets this invitational personnel; and education opportunities by focusing on priority does not receive a competitive (b) The extent to which the applicant problem areas or improvement or absolute preference over other encourages applications for employment approaches in postsecondary education. applications (34 CFR 75.105(c)(1)). from persons who are members of Eligible Applicants: Institutions of Invitational Priority: Projects that groups that have traditionally been higher education or combinations of support consortia of institutions of underrepresented based on race, color, institutions and other public and private higher education that promote national origin, gender, age, or nonprofit institutions and agencies. institutional cooperation and student Deadline for Transmittal of mobility between the United States and disability. Applications: March 30, 2001. Brazil. For Applications Contact: U.S. Department of Education Publications Deadline for Intergovernmental Methods for Applying Selection Criteria Review: May 29, 2001. Center (ED Pubs), P.O. Box 1398, Jessup, The Secretary gives equal weight to Applications Available: November 17, MD 20794–1398. Telephone (toll free): the listed criteria. Within each of the 2000. 1–877–433–7827, fax 301–470–1244, e- Available Funds: $300,000 for FY criteria, the Secretary gives equal weight mail: [email protected] 2001. The estimated amount of funds to each of the factors. You may also contact EDPubs at its Selection Criteria: In evaluating available for awards is based on the website: http://www.ed.gov/pubs/ applications for grants under this Administration’s request for this edpubs.html. program competition, the Secretary uses program for FY 2001. The actual level If you request an application from the following selection criteria chosen of funding, if any, is contingent upon EDPubs, be sure to identify the US- from those listed in 34 CFR 75.210. final congressional action. Brazil Competition as CFDA number (1) The significance of the proposed 84.116M. Estimated Range of Awards: $25,000– project, as determined by— $30,000 for FY 2001; $190,000– (a) The extent to which the proposed FOR FURTHER INFORMATION CONTACT: $210,000 for four-year duration of grant. project involves the development or Copies of the application materials may Estimated Average Size of Awards: demonstration of promising new also be obtained from the Fund for the $30,000 for FY 2001; $200,000 for four- strategies that build on, or are Improvement of Postsecondary year duration of grant. alternatives to, existing strategies; Education (FIPSE), U.S. Department of Estimated Number of Awards: 10. (b) The likely utility of the products Education, 1990 K Street, NW., 8th Note: The Department is not bound by (such as information, materials, Floor, Washington, D.C. 20006–8544, any estimates in this notice. processes, or techniques) that will result telephone 202–502–7500. For additional Project Period: Up to 48 months. from the proposed project, including the program information call Cindy Fisher Applicable Regulations: The potential for their being used in a at the FIPSE office (202–502–7500) Education Department General variety of other settings; and between the hours of 8 a.m. and 5 p.m., Administrative Regulations (EDGAR) in (c) The importance or magnitude of Eastern Time, Monday through Friday. 34 CFR parts 74, 75, 77, 79, 80, 82, 85, the results or outcomes likely to be You may also request application 86, 97, 98, and 99. attained by the proposed project, guidelines by submitting the name of SUPPLEMENTARY INFORMATION: This especially improvements in teaching the competition (US-Brazil) and your program is a Special Focus Competition and student achievement. name and postal address to to support projects addressing a (2) The quality of the design of the [email protected] (e-mail). Applications are particular problem area or improvement proposed project, as determined by— also available on the FIPSE website at approach in postsecondary education. (a) The extent to which the goals, the following site: http://www.ed.gov/ The competition also includes an objectives, and outcomes to be achieved offices/OPE/FIPSE/Brazil/ invitational priority to encourage by the proposed project are clearly Individuals who use a proposals designed to support the specified and measurable; and telecommunications device for the deaf

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(TDD) may call the Federal Information toll free at 1–888–293–6498; or in the ACTION: Notice of orders. Relay Service (FIRS) at 1–800–877– Washington, DC area at (202) 512–1530. 8339. Note: The official version of this document SUMMARY: The Office of Fossil Energy Individuals with disabilities may is the document published in the Federal (FE) of the Department of Energy gives obtain this document in an alternate Register. Free Internet access to the official notice that during October 2000, it format (e.g., Braille, large print, edition of the Federal Register and the Code of Federal Regulations is available on GPO issued Orders granting and amending audiotape, or computer diskette) on Access at: http://www.access.gpo.gov/nara/ authority to import and export natural request to the contact person listed index.html. gas. These Orders are summarized in the under FOR FURTHER INFORMATION attached appendix and may be found on Program Authority: 20 U.S.C. 1138–1138d. CONTACT. the FE website at http:// Individuals with disabilities may Dated: November 7, 2000. www.fe.doe.gov, or on the electronic obtain a copy of the application package A. Lee Fritschler, bulletin board at (202) 586–7853. They in an alternative format, also, by Assistant Secretary, Office of Postsecondary are also available for inspection and contacting that person. However, the Education. copying in the Office of Natural Gas & Department is not able to reproduce in [FR Doc. 00–29087 Filed 11–13–00; 8:45 am] Petroleum Import & Export Activities, an alternate format the standard forms BILLING CODE 4001±01±P Docket Room 3E–033, Forrestal included in the application package. Building, 1000 Independence Avenue, Electronic Access to This Document S.W., Washington, D.C. 20585, (202) DEPARTMENT OF ENERGY You may view this document, as well 586–9478. The docket room is open as all other Department of Education Office of Fossil Energy between the hours of 8:00 a.m. and 4:30 documents published in the Federal p.m., Monday through Friday, except [FE Docket Nos. 91±51±NG, 00±65±NG, 00± Federal holidays. Register, in text or Adobe Portable 68±NG, 00±64±NG, 00±73±NG, 00±63±NG, Document Format (PDF) on the Internet 00±66±NG, 99±89±NG, 99±96±LNG, 00±69± Issued in Washington, D.C., on November at either of the following sites: LNG, 99±22±NG, 99±12±NG, 00±72±NG, 00± 7, 2000. http://ocfo.ed.gov/fedreg.htm 78±NG, 00±75±NG, 00±71±NG, 00±81±NG] John W. Glynn, http://www.ed.gov/news.html Fina Natural Gas Company, et al.; Manager, Natural Gas Regulation, Office of To use the PDF you must have Adobe Orders Granting and Amending Natural Gas & Petroleum, Import & Export Acrobat Reader, which is available free Authority To Import and Export Natural Activities, Office of Fossil Energy. at either of the previous sites. If you Gas have questions about using PDF, call the U.S. Government Printing Office (GPO) AGENCY: Office of Fossil Energy, DOE.

Appendix—Orders Granting and Transferring Import/Export Authorizations

Order Date Importer/Exporter Import Export No. issued FE Docket No. volume volume Comments

563±A .... 10/02/00 Fina Natural Gas Company, 91±51±NG ...... Amendment to blanket import and export authority to include the import of LNG from any international source. 1627 ...... 10/02/00 Pioneer Natural Resources Canada Inc., 76.8 Bcf ...... Import from Canada, beginning on October 00±65±NG. 30, 2000, and extending through October 29, 2002. 1628 ...... 10/05/00 Coastal Oil & Gas Corporation, 00±68±NG 300 Bcf Import and export combined total, including LNG, from and to Canada, beginning on November 1, 2000, and extending through October 31, 2002. 1629 ...... 10/05/00 Montana-Dakota Utilities Co., a Division of 10 Bcf ...... Import from Canada, beginning on Decem- MDU Resources Group, Inc., 00±64±NG. ber 1, 2000, and extending through No- vember 30, 2002. 1630 ...... 10/16/00 Numac Energy (U.S.) Inc., 00±73±NG ...... 50 Bcf ...... Import from Canada, beginning on October 15, 2000, and extending through October 14, 2002. 1631 ...... 10/18/00 WPS Energy Services, Inc., 00±63±NG ...... 25 Bcf 5 Bcf Import and export from and to Canada be- ginning on November 1, 2000, and ex- tending through October 31, 2002. 1632 ...... 10/18/00 Rochester Gas and Electric Corporation, 30 Bcf ...... Import from Canada beginning on Decem- 00±66±NG. ber 1, 2000, and extending through No- vember 30, 2002. 1540±A .. 10/19/00 BP Energy Company (Formerly Amoco En- ...... Name change. ergy Trading Corp.), 99±89±NG. 1542±A .. 10/19/00 BP Energy Company (Formerly Amoco En- ...... Name change. ergy Trading Corp.), 99±96±LNG. 1633 ...... 10/19/00 Duke Energy Trading and Marketing, L.L.C., 200 Bcf Import and export an aggregate from and to 00±69±LNG. Canada and Mexico, including LNG, and import LNG from other countries begin- ning on October 31, 2000, and extending through October 30, 2002. 1474±B .. 10/24/00 Cascade Natural Gas Corporation, 99±22± ...... Amendment extending long-term authority NG. for one year.

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Order Date Importer/Exporter Import Export No. issued FE Docket No. volume volume Comments

1464±A .. 10/24/00 Powerex Corp., 99±12±NG ...... Name change. 1634 ...... 10/24/00 The Montana Power Company, 00±72±NG ...... 4 Bcf Export to Canada beginning on November 1, 2000, and extending through October 31, 2002. 1635 ...... 10/25/00 Prairielands Energy Marketing, Inc., 00±78± 25 Bcf 25 Bcf Import and export from and to Canada be- NG. ginning on June 1, 2000, and extending through May 31, 2002. 1636 ...... 10/26/00 Equitable Energy, L.L.C., 00±75±NG ...... 100 Bcf 100 Bcf Import combined total from Canada and Mexico, and export combined total to Canada and Mexico, beginning on De- cember 1, 2000, and extending through November 30, 2002. 1637 ...... 10/27/00 The Consumers' Gas Company Ltd., 00± 100 Bcf ...... Import from Canada beginning on the date 71±NG. of first delivery after October 27, 2000. 1638 ...... 10/30/00 TransCanada Gas Services Inc., 00±81±NG 700 Bcf 300 Bcf Import from Canada, and export combined total to Canada and Mexico, beginning on November 1, 2000, and extending through October 31, 2002.

[FR Doc. 00–29069 Filed 11–13–00; 8:45 am] file comments, recommendations for Massachusetts. Representatives of BILLING CODE 6450±01±P terms and conditions, protests, and DOMAC will accompany the OEP staff. motions to intervene is extended to and All interested parties may attend the including November 27, 2000. site visit. Those planning to attend must DEPARTMENT OF ENERGY Anyone may file comments, provide their own transportation. For recommendations for terms and further information on attending the site Federal Energy Regulatory conditions, protests, and motions to visit, please contact the Commission’s Commission intervene on the application. The Office of External Affairs at (202) 208– public, federal and state resource [Project No. 2197±042, North Carolina] 0004. agencies are encouraged to provide comments. Send an original and eight David P. Boergers, Alcoa Power Generating, Inc.; Notice Secretary. Extending Public Comment Period for copies of all comments marked with the [FR Doc. 00–29017 Filed 11–13–00; 8:45 am] Non-Project Use of Project Lands project number P–2197–042 to: The Application Secretary, Federal Energy Regulatory BILLING CODE 6717±01±M Commission, 888 First Street, NE, November 7, 2000. Washington, DC 20426. If you have any DEPARTMENT OF ENERGY On August 1, 2000, Alcoa Power questions regarding this notice, please call Steve Hocking at (202) 219–2656. Generating, Inc. (Alcoa) filed a non- Federal Energy Regulatory Comments and protests may be filed project use of project lands application Commission for Commission approval. In its electronically via the internet in lieu of application, Alcoa proposes to grant a paper. See 18 CFR 385.2001(a)(1)(iii) [Docket Nos. EL00±95±000, EL00±98±000, permit to KEJ Marketing Co., Inc., for and the instructions on the EL00±107±000, ER00±3461±000, ER00± the construction of four boat docks with Commission’s web site at http:// 3673±000. www.ferc.fed.us/efi/doorbell.htm. a total of 48 boat slips and one boat San Diego Gas & Electric Company, launch ramp on Narrows Reservoir, part David P. Boergers, Complaint, v. Sellers of Energy and of the Yadkin Hydroelectric Project. Secretary. Ancillary Services Into Markets Alcoa proposes to grant a second permit [FR Doc. 00–29019 Filed 11–13–00; 8:45 am] Operated by the California to Heron Bay Homeowners Association BILLING CODE 6717±01±M Independent System Operator and the for the use and operation of the above California Power Exchange, facilities. The above facilities would not Respondents; Investigation of be open to the public; they would be for DEPARTMENT OF ENERGY Practices of the California Independent Heron Bay residents only. The Yadkin System Operator and the California Project contains the following Federal Energy Regulatory Power Exchange; Public Meeting in reservoirs: High Rock, Tuckertown, Commission San Diego, California; California Power Narrows (Badin) and Falls. [Docket No. CP00±447±000] Exchange Corporation; California On October 2, 2000, Commission staff Independent System Operator issued a public notice for the above Distrigas of Massachusetts LLC; Corporation; Notice of Public application soliciting comments, Notice of Site Visit conference recommendations for terms and conditions, protests, and motions to November 7, 2000. November 7, 2000. intervene by November 13, 2000. On On November 14, 2000, staff from the Notice is hereby given that, on November 3, 2000, the North Carolina Office of Energy Projects (OEP) will November 14, 2000, the Federal Energy Wildlife Resources Commission conduct a pre-certification site visit of Regulatory Commission will convene a (NCWRC) filed a request for an the proposed High Pressure Expansion public conference before the Chairman additional weeks to provide comments. Project at Distrigas of Massachusetts and Commission staff in San Diego. This Upon consideration, the comment LLC’s (DOMAC) existing liquefied conference supplements the closing date for all interested entities to natural gas storage facility in Everett, Commission’s November 9, 2000

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68133 conference, and it is being held ENVIRONMENTAL PROTECTION 112(l) of the Clean Air Act, the EPA is primarily to accord an opportunity to AGENCY authorized to approve alternative S/L/T citizens of San Diego, and others who HAP standards or programs when such are unable to attend the November 9, [FRL±6901±7] requirements are demonstrated to be no 2000, meeting, to address the impacts Clean Air Act Advisory Committee; less stringent than EPA’s rules or on ratepayers of the Commission’s Notice of Charter Renewal requirements. proposed remedies for California On August 30, 2000, the EPA revised wholesale electric markets, as set forth AGENCY: Environmental Protection the 40 CFR part 63, subpart E ‘‘Approval in the Commission’s order dated Agency (EPA). of State Programs and Delegation of November 1, 2000. The conference will ACTION: Notice of charter renewal. Federal Authorities’’ to address commence at 8 a.m. and close at 12 concerns of S/L/T regarding flexibility noon. All interested persons may attend The charter for the Environmental and burdensome requirements. The the conference. Protection Agency’s Clean Air Act changes will help S/L/T preserve the Persons wishing to speak at the Advisory Committee (CAAAC) will be integrity of their existing HAP programs conference must submit a request to renewed for an additional two-year by offering a range of options for make a statement in the above- period, as a necessary committee which demonstrating equivalence with captioned dockets. The request should is in the public interest, in accordance corresponding Federal requirements and be submitted by e-mail to David with the provisions of the Federal expediting the approval process. Boergers at [email protected] Advisory Committee Act (FACA), 5 DATES: The comment period on the draft (include Docket No. EL00–95–000 in the U.S.C. App § 9(c). The purpose of guidance will close on December 14, subject heading of the e-mail), and CAAAC is to provide advice and 2000. recommendations to the Administrator should be followed up, at the same time, ADDRESSES: Comments should be sent to of EPA on issues associated with policy with a letter to the Secretary of the Pamela J. Smith, Information Transfer and technical issues associated with Commission. The request should clearly and Program Integration Division (MD– implementation of the Clean Air Act. specify the name of the person desiring 12), Office of Air Quality Planning and It is determined that CAAAC is in the to speak, his or her title and affiliation, Standards, U.S. EPA, Research Triangle public interest in connection with the and the party or parties the speaker Park, North Carolina 27711, telephone performance of duties imposed on the represents. In addition, the request 919–541–0641, telefax 919–541–5509 or Agency by law. should include a telephone number for E-mail [email protected]. notifying the speaker. The request Inquiries may be directed to Paul Rasmussen, CAAAC Designated Federal FOR FURTHER INFORMATION CONTACT: For should also include a brief summary of more information, please contact the issue or issues the speaker wishes to Officer, U.S. EPA, Ariel Rios Building, 1200 Pennsylvania Ave., NW, Thomas A. Driscoll, Information address, not to exceed one page. All e- Transfer and Program Integration mail requests must be submitted on or Washington, D.C. 20460 (Mail code 6102A). Division (MD–12), Office of Air Quality before November 9, 2000. Planning and Standards, U.S. EPA, The number of persons desiring to Dated: October 31, 2000. Research Triangle Park, North Carolina speak at the conference may exceed the Robert Perciasepe, 27711, telephone 919–541–5135, telefax time available. Thus, interested persons Assistant Administrator for Air and 919–541–5509 or E-mail are encouraged to join with other Radiation. [email protected]. [FR Doc. 00–29062 Filed 11–13–00; 8:45 am] persons with similar interests. Based on SUPPLEMENTARY INFORMATION: A draft of the requests to participate, panels of BILLING CODE 6560±50±U EPA’s guidance is available at http:// speakers will be specified. The www.epa.gov/ttn/uatw/112(l)/112– Secretary will issue a notice listing the lpg.html for public review and speakers and panels for the conference. ENVIRONMENTAL PROTECTION AGENCY comment. The EPA does not intend to In addition, all interested persons are respond to individual comments, but invited to submit written comments on [FRL±6901±9] rather to consider comments and matters addressed at the conference. information from the public in the These comments should be submitted Notice of Availability for Draft preparation of a final guidance on or before November 22, 2000, in the Guidance Document on ``Guidance for document. above-captioned proceedings. All the Submission of State/Local/Tribal Rules in Place of Section 112 Dated: October 19, 2000. comments will be placed in the Henry C. Thomas, Commission’s public files and will be Requirements'' Acting Director, Office of Air Quality Planning available for inspection or copying in AGENCY: Environmental Protection and Standards. the Commission’s Public Reference Agency (EPA). [FR Doc. 00–29063 Filed 11–13–00; 8:45 am] Room during normal business hours. ACTION: Notice of availability. BILLING CODE 6560±50±P Comments are also accessible via the Commission’s Records Information SUMMARY: The EPA is making available Management System (RIMS). for public review and comment a ENVIRONMENTAL PROTECTION The conference will be transcribed. preliminary draft of its pending AGENCY Information about obtaining transcripts guidance on delegation of Federal [FRL±6900±4] will be provided on the Commission’s section 112 hazardous air pollutant website, www.ferc.fed.us. (HAP) requirements to State, Local, and Notice of Availability of Draft Tribal Air Pollution Control Agencies David P. Boergers, Reference Dose Document for (S/L/T). The guidance also includes Methylmercury Secretary. information on the substitution of [FR Doc. 00–29018 Filed 11–13–00; 8:45 am] Federal section 112 requirements with AGENCY: Environmental Protection BILLING CODE 6717±01±M S/L/T requirements. Under section Agency (EPA).

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ACTION: Notice of availability of draft Copies of the draft reference dose water quality criteria for methylmercury reference dose document for document entitled, Reference Dose for based on new data and new analyses. methylmercury. Methylmercury, may be obtained from The draft reference dose document to EPA’s Water Resource Center by phone support the ambient water quality SUMMARY: Section 304(a)(1) of the Clean at (202) 260–7786, or by e-mail to criterion is ready for external scientific Water Act requires the Environmental [email protected] or by peer review. Protection Agency to develop and conventional mail to EPA Water As indicated in the December 10, publish, and from time to time revise, Resource Center, RC–4100, 401 M Street 1998 Federal Register document, the criteria for water to accurately reflect SW., Washington, DC 20460. Agency believes it is important to the latest scientific knowledge. EPA is Alternatively, consult www.epa.gov/ost/ provide the public with an opportunity revising its reference dose in support of criteria/methylmercury/ for download to submit scientific information on draft a revised ambient water quality criterion availability. criteria. EPA is soliciting views from the for methylmercury. Today, EPA is FOR FURTHER INFORMATION CONTACT: Ms. public on issues of science pertaining to notifying the public of the availability of Mary Manibusan, Health and Ecological the information used in deriving the the draft reference dose document and Criteria Division (4304), US EPA, Ariel draft reference dose. EPA will review is also announcing that the draft Rios Building, 1200 Pennsylvania and consider significant scientific document is ready for external scientific Avenue NW., Washington, DC 20460; information submitted by the public peer review. (202) 260–3688; that might not have otherwise been EPA is notifying the public about the [email protected] identified during development of this availability of this draft document and criterion. SUPPLEMENTARY INFORMATION: its peer review in accordance with the Geoffrey H. Grubbs, Agency’s new process for developing or What Is a Reference Dose? Director, Office of Science and Technology. revising criteria (63 FR 68354, December The reference dose is defined as an 10, 1998). As indicated in the December [FR Doc. 00–29061 Filed 11–13–00; 8:45 am] estimate, with uncertainty spanning BILLING CODE 6560±50±U 10, 1998 Federal Register document, the perhaps one order of magnitude, of a Agency believes it is important to daily exposure to the human population provide the public with an opportunity (including sensitive subgroups) that is to submit scientific information on draft likely to be without an appreciable level FEDERAL RESERVE SYSTEM criteria. EPA is soliciting views from the of risk of deleterious effects during a public on issues of science pertaining to lifetime. The RfD is useful as a reference Formations of, Acquisitions by, and the information used in deriving the point from which to gauge the potential Mergers of Bank Holding Companies draft reference dose. effects of the chemical at other doses. The companies listed in this notice DATES: All significant scientific Usually, doses less than the RfD are not information must be submitted to the likely to be associated with adverse have applied to the Board for approval, Agency under docket number W–00–29. health risks and are, therefore, less pursuant to the Bank Holding Company All submissions of significant scientific likely to be of regulatory concern. As the Act of 1956 (12 U.S.C. 1841 et seq.) information are requested to be frequency and/or magnitude of the (BHC Act), Regulation Y (12 CFR Part submitted on or before December 14, exposures exceeding the RfD increase, 225), and all other applicable statutes 2000. Information submitted after this the probability of adverse effects in a and regulations to become a bank date may not receive the degree of human population increases. However, holding company and/or to acquire the consideration of information submitted it should not be categorically concluded assets or the ownership of, control of, or earlier. The Administrative Record that all doses below the RfD are the power to vote shares of a bank or supporting this draft reference dose ‘‘acceptable’’ or risk-free and that all bank holding company and all of the document is available at the Water doses in excess of the RfD are banks and nonbanking companies Docket, Room EB–57, Environmental ‘‘unacceptable’’ or will result in adverse owned by the bank holding company, Protection Agency, 401 M Street SW., effects. including the companies listed below. The applications listed below, as well Washington, DC 20460 on Monday Why Is EPA Notifying the Public About through Friday, excluding Federal as other related filings required by the the Draft Reference Dose Document and Board, are available for immediate holidays, between 9 a.m. and 4 p.m. For Peer Review? access to docket materials call (202) inspection at the Federal Reserve Bank 260–3027 for an appointment. A Today, in order to expand the public’s indicated. The application also will be reasonable fee will be charged for involvement in the criteria development available for inspection at the offices of photocopies. process, EPA is notifying the public the Board of Governors. Interested about the availability of the draft persons may express their views in ADDRESSES: Send an original and three reference dose document for writing on the standards enumerated in copies of any written significant methylmercury and its peer review. the BHC Act (12 U.S.C. 1842(c)). If the scientific information to W–00–15 In following the Agency’s new proposal also involves the acquisition of Comment Clerk, Water Docket, Ariel process, EPA notified the public of its a nonbanking company, the review also Rios 1200 Pennsylvania Ave., NW., intentions to revise the ambient water includes whether the acquisition of the Washington, DC 20460. Comments may quality criteria in the Federal Register nonbanking company complies with the be hand-delivered to the Water Docket, on October 12, 2000 (65 FR 60664). At standards in section 4 of the BHC Act Room EB57, 401 M Street, SW., that time EPA made available to the (12 U.S.C. 1843). Unless otherwise Washington, DC 20460. Issues may also public a list of all references identified noted, nonbanking activities will be be submitted electronically to OW- by a recent literature review and conducted throughout the United States. [email protected]. Information should be solicited any additional pertinent data Additional information on all bank submitted as a WP5.1, 6.1 and/or 8.0 or or scientific views that would be useful holding companies may be obtained an ASCII file with no form of in revising the ambient water quality from the National Information Center encryption. criteria. EPA is revising the ambient website at www.ffiec.gov/nic/.

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Unless otherwise noted, comments FEDERAL RESERVE SYSTEM FEDERAL TRADE COMMISSION regarding each of these applications must be received at the Reserve Bank Sunshine Act Meeting Notice Granting of Request for Early indicated or the offices of the Board of Termination of the Waiting Period Governors not later than December 7, TIME AND DATE: 10:00 a.m., Friday, Under the Premerger Notification 2000. November 17, 2000. Rules A. Federal Reserve Bank of PLACE: Marriner S. Eccles Federal Minneapolis (JoAnne F. Lewellen, Reserve Board Building, 20th and C Section 7A of the Clayton Act, 15 Assistant Vice President) 90 Hennepin Streets, N.W., Washington, D.C. 20551. U.S.C. 18a, as added by Title II of the Avenue, Minneapolis, Minnesota STATUS: Closed. Hart-Scott-Rodino Antitrust 55480–0291: MATTERS TO BE CONSIDERED: Improvements Act of 1976, requires 1. Firstar Corporation, Milwaukee, 1. Personnel actions (appointments, persons contemplating certain mergers Wisconsin; to merge with U.S. Bancorp, promotions, assignments, or acquisitions to give the Federal Trade Minneapolis, Minnesota; and thereby reassignments, and salary actions) Commission and the Assistant Attorney indirectly acquire U.S. Bank National involving individual Federal Reserve General advance notice and to wait Association, Minneapolis, Minnesota; System employees. U.S. Bank National Association ND, designated periods before 2. Any matters carried forward from a consummation of such plans. Section Fargo, North Dakota; U.S. Bank National previously announced meeting. Association MT, Billings, Montana; and 7A(b)(2) of the Act permits the agencies, CONTACT PERSON FOR MORE INFORMATION: in individual cases, to terminate this U.S. Bank National Association OR, Lynn S. Fox, Assistant to the Board; Canby, Oregon. waiting period prior to its expiration 202–452–3204. In connection with this transaction, and requires that notice of this action be Applicant and U.S. Bancorp also have SUPPLEMENTARY INFORMATION: You may published in the Federal Register. call 202–452–3206 beginning at granted cross–options to purchase up to The following transactions were 19.9 percent of the outstanding shares of approximately 5 p.m. two business days before the meeting for a recorded granted early termination of the waiting each other’s common stock. These period provided by law and the options would expire on consummation announcement of bank and bank premerger notification rules. The grants of the merger. Firstar Corporation’s holding company applications subsidiary banks are Firstar Bank, scheduled for the meeting; or you may were made by the Federal Trade National Association, Cincinnati, Ohio; contact the Board’s Web site at http:// Commission and the Assistant Attorney Firstar Bank, National Association, www.federalreserve.gov for an General for the Antitrust Division of the Overland Park, Overland Park, Kansas; electronic announcement that not only Department of Justice. Neither agency and Firstar Bank U.S.A., National lists applications, but also indicates intends to take any action with respect Association, Waukegan, Illinois. procedural and other information about to these proposed acquisitions during the meeting. the applicable waiting period. Board of Governors of the Federal Reserve System, November 7, 2000. Dated: November 9, 2000. Robert deV. Frierson Robert deV. Frierson, Associate Secretary of the Board. Associate Secretary of the Board. [FR Doc. 00–29014 Filed 11–13–00; 8:45 am] [FR Doc. 00–29229 Filed 11–9–00; 12:47 pm] BILLING CODE 6210±01±S BILLING CODE 6210±01±P

Trans # Acquiring Acquired Entities

Transactions Granted Early TerminationÐ09/18/2000

20004705 ...... August Capital III, L.P...... Seagate Technology, Inc ...... Seagate Technology, Inc. 20004778 ...... Genlyte Group Inc. (The) ...... Chloride Group PLC ...... Chloride Power Electronics, Inc. 20004843 ...... Pegusus Partners II, L.P ...... Paperloop.com, Inc ...... Paperloop.com, Inc 20004844 ...... United News & Media plc ...... Paperloop.com, Inc ...... Paperloop.com, Inc. 20004871 ...... TNT Post Group N.V ...... CSX Corporation ...... CTI Logistix, Inc. 20004896 ...... Steven M. Scott, M.C ...... HIP Foundation, Inc ...... HIP Health Plan of Florida, Inc., HIP Insurance Company of Florida, Inc. 20004900 ...... The Cirrus Trust ...... Robert L. Brown ...... Employee Management Services II, Inc., Employee Management Serv- ices III, Inc., Robert Lee Brown, Inc. 20004905 ...... Gerald W. Schwartz ...... LBI Holdings, Inc ...... LBI Holdings, Inc.

Transactions Granted Early TerminationÐ09/19/2000

20004847 ...... Whitehall Street Real Estate Fund ixPedite Communications, Inc ...... ixPedite Communications, Inc. XIII, L.P. 20004851 ...... Apollo Investment Fund IV, L.P ...... Horizon Telecom, Inc ...... Horizon PCS, Inc. 20004858 ...... Adobe Systems Incorporated ...... Hewlett-Packard Company ...... Glassbook, Inc. 20004862 ...... Caraustar Industries, Inc ...... Crane Carton Company LLC ...... Crane Carton Company LLC 20004865 ...... Paxton Media Group, Inc ...... John W. Troutt, Jr ...... Troutt Brothers, Inc. 20004866 ...... Ford Motor Company ...... Alfa, S.V. de C.V ...... Tenedora Nemak S.A. de C.V. 20004872 ...... Dover Corporation ...... Sangyup Steve Lee ...... National Cooler Corporation. 20004878 ...... Sara Lee Corporation ...... Host Apparel, Inc ...... Host Apparel, Inc 20004887 ...... Copart, Inc ...... Charles H. Powers ...... Charles H. Powers

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Trans # Acquiring Acquired Entities

20004888 ...... DLJ Merchant Banking Partners III, Hellman & Friedman Capital Part- Advanstar, Inc. L.P. ners III, L.P. 20004895 ...... Foreset Laboratories, Inc ...... Luca & Lucio Rovati ...... Rotta Research Laboratorium. 20004898 ...... Ohio Farmers Insurance Company ... Old Guard Group, Inc ...... Old Guard Group, Inc. 20004899 ...... Clear Channel Communications, Inc Cumulus Media, Inc ...... Cumulus Media, Inc. 20004901 ...... Donald B. Marron ...... UBS AG ...... UBS AG. 20004904 ...... Joseph J. Grano, Jr ...... UBS AG ...... UBS AG. 20004958 ...... Bain Capital Fund VII, L.P ...... Westpoint Stevens, Inc ...... Westpoint Stevens, Inc.

Transactions Granted Early TerminationÐ09/20/2000

20004706 ...... Halliburton Company ...... Petroleum Place, Inc ...... Petroleum Place, Inc. 20004736 ...... CFW Communications Company ...... R&B Communications Inc ...... R&B Communications Inc. 20004758 ...... Centennial Fund IV, L.P ...... Grande Communications, Inc ...... Grande Communications, Inc. 20004798 ...... Adelphia Communications Corpora- Andre' Chagnon...... OpTel Inc. (debtor-in-possession), tion. Richey Pacific Cable Partners V, L.P. (debtor-in-possession), Richey Pacific Cablevision, Inc. (debtor-in- possession), Transmission Hold- ings, Inc. (debtor-in-possession), TVMAX Telecommunications, Inc. (debtor-in-possession). 20004810 ...... Horry Telephone Cooperative, Inc .... BellSouth Corporation ...... BellSouth Carolinas PCS, L.L.C. BellSouth Carolinas PCS, L.P. 20004873 ...... Dover Corporation ...... Chun Suk Lee ...... National Cooler Corporation. 20004906 ...... Cascades, Inc ...... James A. Wyant ...... Wyant Corporation. 20004908 ...... SCF±VI, L.P ...... Q Services, Inc ...... Q Services, Inc. 20004909 ...... American Power Conversion Cor- Marduk Holding Corporation ...... Marduk Holding Corporation. poration. 20004915 ...... Tysssen Krupp AG ...... Siemans AG ...... Advanced Turbine Components, Inc. 20004919 ...... Kjell Inge Rokke ...... Kjell Inge Rokke ...... Aker Gulf Marine. 20004924 ...... Palladium Equity Partners II, L.P ...... Whitehall Associates, L.P ...... WFI, Inc 20004925 ...... Premier Construction Products Statu- Republic Group Incorporated ...... Republic Group Incorporated. tory Trust. 20004926 ...... Lehman Brothers Holdings, Inc ...... Abraham D. Gosman ...... CCC of New Jersey, Inc.

Transactions Granted Early TerminationÐ09/21/2000

20004683 ...... Courier Corporation...... Blanche Cirker and the Estate of Dover Book Store, Inc., Dover Publi- Hayward Cirker. cations, Inc., Transfolio Express, Inc. 20004775 ...... Flextronics Internatoinal Ltd ...... Siemens AG ...... Siemens Information and Commu- nication Mobile, LLC. 20004801 ...... F.S. Equity Partners IV, L.P ...... Sur La Table, Inc ...... Sur La Table, Inc. 20004897 ...... The Liberty Corporation ...... The Henry/Melton Voting Trust ...... Civic Communications Corporation II. 20004918 ...... Thyssen Krupp AG ...... Mr. Alex Sobel ...... Serge Elevator Co., Inc. 20004928 ...... Bain Capital Fund VI, L.P ...... Michael D. McCreary ...... St. Louis T's, Inc. 20004930 ...... E.D. & F. Man Group Plc ...... Frank C. Meyer ...... Glenwood Capital Investments, LLC, Glenwood Global Management LLC, Glenwood Holdings, LLC. 20004931 ...... Gerald W. Schwartz ...... Bostrom plc ...... Bostrom plc. 20004933 ...... Michael L. Foster ...... JDS Uniphase Corporation ...... JDS Uniphase Corporation. 20004955 ...... Franz Haniel & Cie, GmbH ...... Bridgeway Construction Company .... Bridgeway Construction Company.

Transactions Granted Early TerminationÐ09/22/2000

20004699 ...... Newell Rubbermaid Inc...... The Gillette Company ...... Fountain Holdings Limited, Parker Pen Products, The Gillette Com- pany, Waterman SA. 20004934 ...... Donald R. Scifres ...... JDS Uniphase Corporation ...... JDS Uniphase Corporation. 20004935 ...... David F. Welch ...... JDS Uniphase Corporation ...... JDS Uniphase Corporation. 20004936 ...... MediaNews Group, Inc...... Gannett Co., Inc ...... California Newspapers, Inc., Media West-CNI, Inc. 20004937 ...... iXL Enterprises, Inc ...... CyberStarts, Inc ...... CyberStarts, Inc. 20004945 ...... Quantum Industrial Holdings, Ltd ...... Silicon Access Networks, Inc ...... Silicon Access Networks, Inc.

Transactions Granted Early TerminationÐ09/25/2000

20004946 ...... Boise Cascade Corporation ...... IdentityNow, Inc ...... IdentityNow, Inc. 20004947 ...... Jupiter Partners LP ...... IndentityNow, Inc ...... IndentityNow, Inc. 20004970 ...... Softbank Corp ...... Odimo Incorporated ...... Odimo Incorporated. 20004980 ...... The Chase Manhattan...... First Tennessee National Corpora- First Tennessee Bank National Asso- tion. ciation. 20005038 ...... MBNA Corporation ...... First Financial Credit Union ...... First Financial Credit Union.

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Trans # Acquiring Acquired Entities

Transactions Granted Early TerminationÐ09/26/2000

20003184 ...... BASF Aktiengesellschaft ...... Basell N.V ...... Basell N.V. 20003185 ...... N.V. Koninklijke Nederlandshe Petro- Basell N.V ...... Basell N.V. leum Maatschappij. 20004398 ...... Cap Gemini S.A ...... Corio, Inc ...... Corio, Inc. 20004485 ...... J.R. Simplot Company ...... Nestle' S.A...... Nestle' USA, Inc. 20004777 ...... ING Groep N.V ...... Aetna Inc ...... Aetna Inc. (Financial Services and International Businesses). 20004783 ...... Medicis Pharmaceutical Corporation Corixa Corporation ...... Corixa Corporation. 20004813 ...... Pacific Partners, LLC ...... Del Webb Corporation ...... Del Webb Corporation. 20004850 ...... GS Capital Partners 2000, L.P ...... ixPedite Communications, Inc ...... ixPedite Communications, Inc. 20004863 ...... Nextel Partners, Inc ...... Nextel Communications, Inc ...... Nextel Communications, Inc. 20004864 ...... Nextel Communications, Inc ...... Nextel Partners, Inc ...... Nextel Partners, Inc. 20004868 ...... Clear Channel Communications, Inc. Randall T. Odeneal ...... Mississippi Valley Broadcasting, Inc. 20004869 ...... Clear Channel Communications, Inc. Scott R. McQueen ...... Mississippi Valley Broadcasting, Inc. 20004891 ...... Efficient Networks, Inc ...... Barry McConachie ...... MultiMedia Development Corpora- tion. 20004892 ...... Barry McConachie ...... Efficient Networks, Inc ...... Efficient Networks, Inc. 20004893 ...... Duane Schrodt ...... Efficient Networks, Inc ...... Efficient Networks, Inc. 20004894 ...... Efficient Networks, Inc ...... Duane Schroft ...... MultiMedia Development Corpora- tion. 20004907 ...... Electronic Data Systems Corporation Engineering Animation, Inc ...... Engineering Animation, Inc. 20004914 ...... TCV III (Q), L.P ...... YOUcentric, Inc ...... YOUcentric, Inc. 20004923 ...... Fiserv, Inc ...... Agio Capital Partners I, L.P ...... National Flood Services, Inc. 20004940 ...... Magnequench, Inc ...... Le Carbone Lorraine, S.A ...... Carbone Lorraine North America, Corporation, Deutsche Carbone AG, Ugimag Limited, Ugimag, Inc. 20004943 ...... ConAgra, Inc ...... John Marburger ...... Marburger Group, L.L.C. Marburger Packing, Inc 20004944 ...... ConAgra, Inc ...... JSM Corporation ...... Marburger Group, L.L.C. Marburger Packing, Inc. 20004948 ...... CDC Finance ...... Nvest Companies, L.P ...... Nvest Companies, L.P. 20004949 ...... CDC Finance ...... Nvest, L.P ...... Nvest, L.P 20004954 ...... Dennis Mehiel ...... Howard P. Hoeper ...... Packaging Resources Group, Inc. 20004959 ...... Puget Sound Energy, Inc...... Ronald A. Cindrich, Sr ...... General Industries, Inc. 20004964 ...... Paul G. Allen ...... eStyle, Inc ...... eStyle, Inc. 20004967 ...... Aktiebolaget Volvo ...... Ingersoll-Rand Company ...... Dresser-Rand Company. 20004972 ...... Entravision Communications Cor- Martin W. Hoffman, Trustee in Bank- Astroline Communications Company, poration. ruptcy for Astroline. Limited Partnership. 20004976 ...... Cumberland Swan Holdings, Inc ...... Benjamin Ansehl Company ...... Benjamin Ansehl Company. 20004977 ...... Zoran Corporation ...... Nogatech, Inc ...... Nogatech, Inc. 20004979 ...... The Bryce Company, L.L.C ...... Simpro Holding Corporation, Ltd ...... Simpro Films Corporation, JP Pack Holdings, Inc. 20004984 ...... Mr. William E. Sagan ...... HealthPlan Services Corporation ...... HealthPlan Services Corporation. 20004985 ...... CH Energy Group, Inc ...... National Grid Group PLC ...... AllEnergy Marketing Company, L.L.C. 20004986 ...... The Goldman Sachs Group, Inc ...... SLKLLC ...... SLKLLC. 20004989 ...... Patterson Energy, Inc ...... Ambar, Inc ...... Fluid Services Division.

Transactions Granted Early TerminationÐ09/27/2000

20001806 ...... The Boeing Company ...... General Motors Corporation ...... Hughes Space and Communications Company, Spectrolab, Inc. 20004755 ...... CGW Southeast Partners IV, L.P ..... Mail-Well, Inc ...... Jen-Coat, Inc. 20004969 ...... Citizens Communications Company Qwest Communications International Qwest Communications International Inc. Inc. 20004995 ...... Siemens Aktiengesellschaft ...... PSI Group, Inc ...... PSI Group, Inc. 20004996 ...... DSM N.V ...... Catalytica, Inc ...... Catalytica, Inc. 20004999 ...... Fenway Partners Capital Fund II, L.P HW Holdings, Inc ...... HW Holdings, Inc. 20005003 ...... Shahid R. Khan ...... Jay Alix ...... Peregrine Metalforming, Inc. 20005004 ...... Sunburst Dallas, L.P ...... Salem Communications Corp ...... Salem Communications Corp. 20005005 ...... Salem Communications Corp ...... Sunburst Dallas, L.P ...... Sunburst Dallas, L.P. 20005006 ...... AXA ...... IP Communications, Inc ...... IP Communications, Inc. 20005007 ...... Private Equity Investors IV, L.P ...... IP Communications, Inc ...... IP Communications, Inc. 20005009 ...... NUI Corporation ...... Virginia Gas Company ...... Virginia Gas Company. 20005010 ...... Gerald T. Vento...... Poka Lambro Telephone Coopera- Poka Lambro Telephone Coopera- tive, Inc. tive, Inc.

Transactions Granted Early TerminationÐ09/28/2000

20004458 ...... Republic Services, Inc ...... Allied Waste Industries, Inc ...... Allied Waste Industries, Inc. 20004785 ...... ADC Telecommunications, Inc ...... Broadband Access Systems, Inc ...... Broadband Access Systems, Inc. 20004805 ...... Broadcom Corporation ...... Newport Communications, Inc ...... Newport Communications, Inc.

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Trans # Acquiring Acquired Entities

20004879 ...... Paxton Media Group, Inc ...... Hollinger Inc ...... American Publishing Company of In- diana, American Publishing Com- pany of Michigan, APAC±95 Texas Holdings Inc., Hollinger Inter- national Inc. 20004883 ...... Advocate Healthcare Network ...... Illinois Masonic Medical Center ...... Illinois Masonic Medical Center. 20004950 ...... Dominion Resources, Inc ...... National Grid Group plc ...... New England Power Company. 20004951 ...... Dominion Resources, Inc ...... UIL Holdings Corporation ...... UIL Holdings Corporation. 20004952 ...... Dominion Resources, Inc ...... Northeast Utilities ...... New England Power Company. 20004982 ...... SSCI Investors LP ...... NS Group, Inc ...... Imperial Adhesives, Inc. 20004990 ...... Citigroup Inc ...... MSX International, Inc...... MSX International, Inc. 20004992 ...... Dominion Resources, Inc ...... Energy East Corporation ...... New England Power Company. 20005011 ...... Thomas H. Sullivan ...... Poka Lambro Telephone Coopera- Poka Lambro Telephone Coopera- tive, Inc. tive, Inc. 20005013 ...... Applied Micro Circuits Corp ...... MMC Networks, Inc ...... MMC Networks, Inc. 20005014 ...... Edward P. Roski, Jr ...... Park Place Entertainment Corpora- LVH Corporation. tion. 20005015 ...... McWane, Inc ...... Brunner Engineering & Mfg., Inc ...... Brunner Engineering & Mfg., Inc. 20005016 ...... Celltech Group Plc ...... Cistron Biotechnology, Inc ...... Cistron Biotechnology, Inc. 20005019 ...... Clear Channel Communications, Inc Clifford N. Burnstein ...... Atmosphere Broadcasting Limited Partnership. 20005020 ...... Clear Channel Communications, Inc Peter D. Mensch ...... Atmosphere Broadcasting Limited Partnership. 20005021 ...... Carlyle Partners III, L.P ...... Gentiva Health Services Inc ...... Olsten Flying Nurses Corp., Olsten Health Services (Staffing) Inc. 20005022 ...... SCF±III, L.P ...... SCF±IV, L.P ...... Sooner, Inc. 20005023 ...... SCF±IV, L.P ...... SCF±III, L.P ...... Oil States International, Inc. 20005055 ...... Dan L. Duncan ...... Dixie Pipeline Company ...... Dixie Pipeline Company.

Transactions Granted Early TerminationÐ09/29/2000

20001668 ...... Agrium Inc ...... Unocal Corporation ...... Alaska Nitrogen Products LLC, Prodica LLP. 20003720 ...... Novartis AG ...... Wesley Jessen VisionCare, Inc ...... Wesley Jessen VisionCare, Inc. 20004803 ...... Charles T. Angell ...... A.M. Todd Group, Inc ...... Flavorite Laboratories, Inc. 20004832 ...... Titan Cement Company S.A ...... Anglo American PLC ...... Tarmac America, Inc. 20004835 ...... Vulcan Materials Company ...... Titan Cement Company S.A ...... Tarmac America, Inc., Tarmac, Inc. 20004885 ...... Penton Media, Inc ...... First Communications, Inc ...... Professional Trade Shows, Inc., PTS Delaware, Inc. 20005012 ...... The Hearst Trust ...... WMUR±TV, Inc ...... WMUR±TV, Inc. 20005024 ...... FCCI Mutual Insurance Holding Monroe Guaranty Companies, Inc .... Monroe Guaranty Companies, Inc. Company. 20005027 ...... Ciba Specialty Chemicals Holdings Cytec Industries, Inc ...... Cytec Industries, Inc. Inc. 20005028 ...... Dr. Yogi Bhardwaj ...... USX Corporation ...... Speedway SuperAmerica LLC. 20005031 ...... 2000 Riverside Capital Appreciation Aurora Equity Partners L.P ...... ATC Distribution Group, Inc. Fund L.P. 20005032 ...... Carlyle Partners III, L.P ...... IntelStaf Holdings, Inc ...... IntelStaf Holdings, Inc. 20005034 ...... The MONY Group, Inc ...... The Advest Group, Inc ...... The Advest Group, Inc. 20005040 ...... Peguot Private Equity Fund II, L.P ... US Search.Com Inc ...... US Search.Com Inc. 20005041 ...... American International Group, Inc .... HSB Group, Inc ...... HSB Group, Inc. 20005048 ...... Kerry Group plc ...... ConAgra, Inc ...... ConAgra, Inc. 20005051 ...... Softbank Technology Ventures VI, TeraBeam Networks, Inc ...... TeraBeam Networks, Inc. L.P. 20005052 ...... SOFTBANK Corp ...... TeraBeam Networks, Inc ...... TeraBeam Networks, Inc. 20005053 ...... Teligent, Inc ...... Executive Conference, Inc ...... Executive Conference, Inc. 20005057 ...... Enron Corp ...... HSB Group, Inc ...... Integrated Process Technologies, L.L.C. 20005065 ...... Quokka Sports, Inc ...... Total Sports Inc ...... Total Sports Inc. 20005066 ...... Coachmen Industries, Inc ...... Miller Building Systems, Inc ...... Miller Building Systems, Inc. 20005067 ...... WPS Resources Corporation ...... Wisconsin River Power Company ..... Wisconsin River Power Company. 20005068 ...... Salzgitter AG ...... Vodafone Group Plc ...... Mannesmannrohren-Werke. 20005083 ...... Arrow Electronics, Inc ...... Stonington Capital Appreciation 1994 Merisel Open Computing Alliance, Fund, L.P. Inc. 20005085 ...... H Group Holding, Inc ...... Eli Lilly and Company ...... Eli Lilly and Company. 20005102 ...... CGW Southeast Partners IV, L.P ..... CapeSuccess LLC ...... CapeSuccess LLC. 20005125 ...... Harbin Clinic, LLC ...... PhyCor, Inc ...... PhyCor, Inc.

FOR FURTHER INFORMATION CONTACT: Federal Trade Commission, Premerger Competition, Room 303, Washington, Sandra M. Peay or Parcellena P. Notification Office, Bureau of DC 20580, (202) 326–3100. Fielding, Contact Representatives,

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By Direction of the Commission. Hart-Scott-Rodino Antitrust period provided by law and the Donald S. Clark, Improvements Act of 1976, requires premerger notification rules. The grants Secretary. persons contemplating certain mergers were made by the Federal Trade [FR Doc. 00–29054 Filed 11–13–00; 8:45 am] or acquisitions to give the Federal Trade Commission and the Assistant Attorney BILLING CODE 6750±01±M Commission and the Assistant Attorney General for the Antitrust Division of the General advance notice and to wait Department of Justice. Neither agency designated periods before intends to take any action with respect FEDERAL TRADE COMMISSION consummation of such plans. Section to these proposed acquisitions during 7A(b)(2) of the Act permits the agencies, the applicable waiting period. Granting of Request for Early in individual cases, to terminate this Termination of the Waiting Period waiting period prior to its expiration Under the Premerger Notification and requires that notice of this action be Rules published in the Federal Register. Section 7A of the Clayton Act, 15 The following transactions were U.S.C. 18a, as added by Title II of the granted early termination of the waiting

Trans # Acquiring Acquired Entities

Transactions Granted Early TerminationÐ10/02/2000

20001575 ...... Cox Enterprises, Inc ...... Tyco International Ltd ...... ADT Automotive Holdings, Inc.

20004903 ...... Sanpaolo IMI S.p.A ...... Assicurazioni Generali S.p.A ...... Gruppo Bancario Banco di Napoli. 20004956 ...... ConAgra, Inc ...... Basic American Inc ...... Basic Vegetable Products, L.P. 20004957 ...... North Castle Partners II, L.P ...... MaryGrace and Robert Sexton ...... Orchid Island Juice Company. 20004988 ...... Caisse de depot et placement du Mosaic Entertainment Group, Inc ..... Mosaic Entertainment Group, Inc. Quebec. 20005030 ...... Spencer F. Eccles ...... Wells Fargo & Company ...... Wells Fargo & Company. 20005050 ...... Wolseley plc ...... T.N. Morris, Jr ...... Calcasieu Lumber Company. 20005054 ...... Illinois Tool Works Inc ...... Tony Tako ...... A.J. Gerrard & Company. 20005056 ...... Brian L. Roberts ...... Global Sports, Inc ...... Global Sports, Inc. 20005071 ...... Trans World Entertainment Corpora- Terry Woodward ...... Waxworks, Inc tion. 20005086 ...... KMR Power Corporation ...... FPL Group, Inc ...... FPL International Holdings, Inc., FPL Termovalle, Inc. 20005089 ...... Exelixis, Inc ...... Agritope, Inc ...... Agritope, Inc. 20005092 ...... Coloniale S.r.l...... Specialty Foods Acquisition Corp. Specialty Foods Acquisition Corp. (debtor-in-possession). (debtor-in-possession). 20005106 ...... The SKM Equity Fund III, L.P ...... Radiologix, Inc ...... Radiologix, Inc. 20005110 ...... Anthony Gartland ...... David J. Cherry ...... UVTEC Holdings, Inc. 20005114 ...... SR. Teleperformance ...... Dominion Resources, Inc ...... Dominion Resources, Inc. 20005115 ...... Conoco Inc...... LG&E Energy Corporaiton ...... LG&E Facilities Inc. 20005135 ...... Nordson Corporation ...... John Carter ...... Electron Fusion Devices, Inc. 20005141 ...... Charterhouse Equity Partners III, L.P Edgewater Technology, Inc ...... CFRC, Inc., ClinForce, Inc.

Transactions Granted Early TerminationÐ10/03/2000

20004243 ...... FleetBoston Financial Corporation .... Switch & Data Facilities Company, Switch & Data Facilities Company, Inc. Inc.

20004902 ...... Intel Corporation ...... Ziatech Corporation ...... Ziatech Corporation. 20004911 ...... Safeguard Scientifics, Inc ...... Techspace, Inc ...... Techspace, Inc. 20004929 ...... Morgan Stanley Dean Witter Venture Novalux, Inc ...... Novalux, Inc. Partners. 20005018 ...... ITT Industries, Inc ...... TRW, Inc ...... TRW, Inc. 20005073 ...... RTM, Inc ...... Myron J. Nadler ...... Franchise Associates, Inc. 20005123 ...... Irrevocable Trust of Lynn D. Moore MiTAC International Corporation ...... eManage.com. U/T/A March 18, 1997. 20005124 ...... MiTAC International Corproation ...... Irrevocable Trust of Lynn D. Moore TelePlace, Inc. U/T/A March 18, 1997.

Transactions Granted Early TerminationÐ10/04/2000

20005091 ...... Elan Corporation plc ...... Dura Pharmaceuticals, Inc ...... Dura Pharmaceuticals, Inc.

Transactions Granted Early TerminationÐ10/05/2000

20004916 ...... Citigroup Inc ...... Associates First Capital Corporation Associates First Capital Corporation.

20005166 ...... Pegasus Partners II, L.P ...... Time Products, plc ...... Time Products, Inc.

Transactions Granted Early TerminationÐ10/06/2000 20004993 ...... United Auto Group, Inc ...... Geza Bodnar ...... Bodner Trust Dated May 19, 1992, Continental Motors, Inc.

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Trans # Acquiring Acquired Entities

20005039 ...... Warburg, Pincus Equity Partners, Gryphon Exploration Company ...... Gryphon Exploration Company. L.P. 20005088 ...... Wachovia Corporation ...... Davis Baldwin, Inc ...... Davis Baldwin, Inc. 20005113 ...... Biovail Corporation ...... William Blair Capital Partners Vl, L.P DJ Pharma, Inc. 20005136 ...... GS Capital Partners lll, L.P ...... New Edge Holding Company ...... New Edge Holding Company. 20005172 ...... United Technologies Corporation ...... Linda Sue Shollmier Trust ...... Shollmier Distributing, Inc. 20005173 ...... United Technologies Corporation ...... J. Kenneth Shollmier Trust ...... Shollmier Distributing, Inc. 20005184 ...... Omnicom Group, Inc ...... Novus Marketing, Inc ...... Novus Marketing, Inc.

Transactions Granted Early TerminationÐ10/10/2000

20004922 ...... Harshad Dharod ...... CKE Restaurants, Inc ...... Carl Karcher Enterprises, Inc.

20004974 ...... University Hospitals Health System .. Heather Hill, Inc ...... Heather Hill Rehabilitation Hospital. 20004981 ...... Zale Lipshy University Medical Cen- Texas Health Resources ...... St. Paul Medical Center. ter, Inc. 20005008 ...... RailWorks Corporation ...... United Industrial Corporation ...... AAl Corporation. 20005042 ...... Prison Realty Trust, Inc ...... Prison Management Services, Inc .... Prison Management Services, Inc. 20005044 ...... Prison Realty Trust, Inc...... Juvenile and Jail Facility Manage- Juvenile and Jail Facility Manage- ment Services, Inc. ment Services, Inc. 20005079 ...... Jeffrey H. Smulyan ...... Salem Communications Corporation Salem Communications Corporation. 20005082 ...... Frontenance Vll Limited Partnership International Data Group, Inc ...... FCW Government Technology Group, Inc. 20005093 ...... Oak Investments Partners Vlll, L.P ... GenOA Corporation ...... GenOA Corporation. 20005107 ...... Brian L. Roberts ...... Global Interactive Communications Global Interactive Communications Group, Inc. Group, Inc. 20005120 ...... Manugistics Group, Inc ...... Talus Solutions ...... Talus Solutions. 20005121 ...... GAP Coinvestment Partners, L.P ..... Manugistics Group, Inc ...... Manugistics Group, Inc. 20005122 ...... GAP Coinvestment Partners, L.P ..... Manugistics Group, Inc ...... Manugistics Group, Inc. 20005133 ...... First Data Corporation ...... FleetBoston Financial Corporation .... BankBoston Merchant Services, L.L.C. 20005137 ...... Atos S.A ...... Koninklijke Philips Electronics N.V .... Origin B. V. 20005157 ...... Hewlett-Packard Company ...... Oscar and Zlata Foundation ...... Indigo N.V. 20005186 ...... VINCI S.A ...... Suez Lyonnaise des Eaux ...... GROUPE GTM.

Transactions Granted Early TerminationÐ10/11/2000

20004978 ...... Finisar Corporation ...... Gregory H. Olsen ...... Sensors Unlimited, Inc. 2000±4987 ...... Gregory H. Olsen ...... Finisar Corporation ...... Finisar Corporation. 20005138 ...... Thomas F. Pyle, Jr., and Judith D. Commonwealth Investors II, L.P ...... National Picture & Frame Company, Pyle. debtor-in-possession. 20005143 ...... Tyco International Ltd ...... Urban Media Communications Urban Media Communications Corportion. Corportion. 20005144 ...... Koninklijke Philips Electronics N.V .... Digimarc Corporation ...... Digimarc Corporation. 20005146 ...... AT&T Corp...... Pogo.com Inc (fka TE Networks, Pogo.com Inc (fka TE Networks, Inc.). Inc.) 20005147 ...... Pohlad Companies ...... Whitman Corporation ...... Whitman Corporation. 20005148 ...... Whitman Corporation ...... Pohlad Companies ...... PepsiAmericas, Inc. 20005151 ...... Chevron Corporation ...... Petrocosm Corporation ...... Petrocosm Corporation. 20005152 ...... Motorola, Inc ...... Printrak International Inc ...... Printrak International Inc. 20005159 ...... Reliant Energy, Incorporated ...... Grande Communications, Inc ...... Grande Communications, Inc. 20005160 ...... WESCO International, Inc ...... Harry Felber ...... Champion Industries. 20005161 ...... Timothy J. Mott ...... All Bases Covered, Inc ...... All Bases Covered, Inc. 20005162 ...... TCV IV, L.P ...... All Bases Covered, Inc ...... All Bases Covered, Inc. 20005167 ...... Franz Haniel & Cie GmbH ...... Hubert Family Trust ...... Fusion, LLC, Hurbert Distributing Co., Hubert Enterprises Incor- porated. 20005174 ...... Inktomi Corporation ...... FastFoward Networks, Inc ...... FastFoward Networks, Inc. 20005175 ...... UIL Holdings Corporation ...... Michael McPhee ...... McPhee Electric, Ltd., LLC, McPhee Utility Power and Signal, Ltd. 20005176 ...... Olympus Growth Fund III, L.P ...... Symmetry Medical, Inc ...... Symmetry Medical, Inc. 20005177 ...... Ace Cash Express, Inc ...... Morris Silverman ...... U.S. Money Order Company, Inc. 20005178 ...... Cadbury Schweppes plc ...... Triarc Companies, Inc ...... Snapple Beverage Group, Inc., Royal Crown Company, Inc. 20005180 ...... Societe Generale ...... Unocal Corporation ...... Poco Graphite, Inc., Unocal Corpora- tion. 20005182 ...... Hellman & Friedman Capital Part- UPromise, Inc ...... UPromise, Inc. ners IV. L.P. 20005183 ...... Interpublic Group of Companies, Inc. Michael W. Kempner ...... The MWW Group, Inc. (The). 20005190 ...... Macrovision Corporation ...... Digimarc Corporation ...... Digimarc Corporation. 20005194 ...... Houghton Mifflin Company ...... Classwell Learning Group, Inc ...... Classwell Learning Group, Inc. 20005198 ...... Wilsons The Leather Experts Inc ...... Donald E. Borsack ...... El Portal Group, Inc. 20005208 ...... Alec E. Gores ...... Mattel, Inc ...... Mattel, Inc.

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Trans # Acquiring Acquired Entities

20005220 ...... Reed International PLC ...... PartMiner, Inc ...... PartMiner, Inc. 20010004 ...... Estate of Pierre Peladeau ...... Andre Chagnon ...... La Groupe Videotron Ltee.

Transactions Granted Early TerminationÐ10/12/2000

20005221 ...... Elsevier NV ...... PartMiner, Inc ...... PartMiner, Inc. Transactions Granted Early TerminationÐ10/13/2000

20004544 ...... William and Jerry Ungar (husband American Pad & Paper Company ..... American Pad & Paper Company. and wife). American Pad & Paper Company of Delaware, Inc., American Pad & Paper Sales Company, Inc., AP&P Manufacturing, Inc., WR Aquisition, Inc. 20004971 ...... Exelon Corporation ...... Vivendi S.A ...... Sithe Energies, Inc. 20005215 ...... Warburg, Pincus Equity Partners, ChartOne, Inc ...... ChartOne, Inc. L.P.

FOR FURTHER INFORMATION CONTACT: FEDERAL TRADE COMMISSION 7A(b) (2) of the Act permits the Sandra M. Peay or Parcellena P. agencies, in individual cases, to Fielding, Contact Representatives, Granting of Request for Early terminate this waiting period prior to its Federal Trade Commission, Premerger Termination of the Waiting Period expiration and requires that notice of Notification Office, Bureau of Under the Premerger Notification this action be published in the Federal Competition, Room 303, Washington, Rules Register. DC 20580, (202) 326–3100. The following transactions were Section 7A of the Clayton Act, 15 granted early termination of the waiting By Direction of the Commission. U.S.C. 18a, as added by Title II of Hart- period provided by law and the Donald S. Clark, Scott-Rodino Antitrust Improvements premerger notification rules. The grants Secretary. Act of 1976, requires persons were made by the Federal Trade [FR Doc. 00–29055 Filed 11–13–00; 8:45 am] contemplating certain mergers or Commission and the Assistant Attorney BILLING CODE 6750±01±M acquisitions to give the Federal Trade General for the Antitrust Division of the Commission and the Assistant Attorney Department of Justice. Neither agency General advance notice and to wait intends to take any action with respect designated periods before to these proposed acquisitions during consummation of such plans. Section the applicable waiting period.

Trans # Acquiring Acquired Entities

20010027 ...... United Technologies Corporation ...... Donald Derych ...... A.T. Distributors, Inc.

Transactions Granted Early TerminationÐ10/17/2000

20005058 ...... America Online, Inc...... Synapse Group, Inc...... Synapse Group, Inc. 20005076 ...... American Tower Corporation ...... William F. Somers ...... Flash Technology Corporation of America, Modern Technical Serv- ice, Inc. 20005127 ...... Credit Suisse Group ...... Manufacturers Services Limited ...... Manufacturers Services Limited. 20005139 ...... Credit Suisse Group ...... Duane Reade Inc...... Duane Reade Inc. 20005181 ...... Waste Connections, Inc ...... Waste Corporation of America, Inc ... Northern Plains Disposal, Inc., Okla- homa Landfill Holdings, Inc., Osage Landfill, Inc., Southern Plains Disposal, Inc. 20005189 ...... Credit Suisse Group ...... DLJ Merchant Banking Partners II, Charles River Laboratories, Inc. L.P. 20005191 ...... Credit Suisse Group ...... Nextel Partners, Inc ...... Nextel Partners, Inc. 20005193 ...... Aether Systems, Inc ...... Motient Corporation ...... Motient Corporation. 20005195 ...... Century Aluminum Company ...... Southwire Company ...... Southwire Company, Metalsco Ltd. 20005199 ...... Dover Corporation ...... OK Holdings, Inc ...... OK Holdings, Inc. 20010005 ...... Alberta Energy Company Ltd ...... TransCanada Pipelines Limited ...... TransCanada Pipelines Limited. 20010007 ...... Eastman Chemical Company ...... Hercules Incorporated ...... Hercules Incorporated. 20010020 ...... Mr. Irvine Laidlaw ...... Tribune Company ...... AchieveGlobal, Inc. 20010025 ...... Omnicom Group Inc ...... Icon Holding Corp ...... Icon Holding Corp. 20010035 ...... Brunswick Corporation ...... K2 Inc ...... K2 Inc. 20010036 ...... K2 Inc...... Brunswick Corporation ...... Brunswick Corporation. 20010077 ...... Morgan Stanley Dean Witter Capital Yuasa Corporation ...... Yuasa, Inc. Partners IV, L.P. 20010110 ...... Morgan Stanley Dean Witter Capital HoldCo ...... HoldCo. Partners IV, L.P.

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Trans # Acquiring Acquired Entities

Transactions Granted Early TerminationÐ10/18/2000

20005080 ...... Intersil Holding Corporation ...... John Walton ...... SiCom, Inc. 20005132 ...... Goodyear Tire & Rubber Company Arkansas Best Corporation ...... Treadco, Inc. (The). 20005222 ...... The 1818 Fund III, L.P ...... MedSource Technologies, Inc ...... MedSource Technologies, Inc. 20010033 ...... Harvest Partners III, L.P ...... John McSweeney ...... CFI Holdings, Inc. 20010034 ...... Harvest Partners III, L.P ...... Truman Bassett ...... CFI Holdings, Inc.

Transactions Granted Early TerminationÐ10/19/2000

20005078 ...... Tom T. Gores ...... Billing Concepts Corp ...... Billing Concepts Corp. 20005119 ...... The AES Corporation ...... KMR Power Corporation ...... KMR Power Corporation. 20005165 ...... Mallinckrodt Inc ...... Bank One Corporation ...... First Lafayette Holdings, Inc., Inovision Radiation Measurements, LLC, Victoreen, LLC. 20005187 ...... Time Warner, Inc ...... SignCast, Inc ...... SignCast, Inc. 20005200 ...... Enron Corp ...... Baycorp Holdings, Ltd ...... Baycorp Holdings, Ltd 20005203 ...... Tyco International Ltd ...... CIGI Investment Group, Inc ...... CIGI Investment Group, Inc. 20005204 ...... Sylvan Learning Systems, Inc ...... Classwell Learning Group, Inc ...... Classwell Learning Group, Inc. 20005212 ...... RGS Energy Group, Inc ...... Avrimac Corporation ...... Avrimac Corporation. 20005213 ...... RWE Aktiengesellschaft ...... Thames Water Plc ...... Thames Water Plc. 20005218 ...... Dawn Chemical Company ...... James M. Moran ...... Petro Chemical Products, Inc. 20005223 ...... barnesandnoble.com, Inc ...... Fatbrain.com, Inc ...... Fatbrain.com, Inc. 20005224 ...... Vigilant Holdings LLC ...... Earl Payton ...... Cowden International, Inc., Cowden Metal Finishing, Inc., Hitek Product Finishing, Inc. 20005225 ...... Earl Payton ...... Vigilant Holdings LLC ...... Vigilant Holdings LLC. 20010002 ...... Community Newspaper Holdings Inc Hollinger Inc ...... Hollinger International Inc. 20010003 ...... Eltek, ASA ...... CC Industries, Inc ...... Power Conversion Products, LLC. 20010006 ...... Vulcan Materials Company ...... Titan Cement Company S.A...... Tarmac Mid-Atlantic. 20010015 ...... Wisconsin Label Corporation ...... Superior Label Systems, Inc ...... Superior Label Systems, Inc.

Transactions Granted Early TerminationÐ10/20/2000

20010026 ...... Thomas Weisel Capital Partners, L.P Ion Systems, Inc ...... Ion Systems, Inc. 20010030 ...... Brian L. Roberts ...... Maryland Baseball, LLLP ...... Maryland Baseball, LLLP. 20010043 ...... Anthony Gartland ...... Daniel M. Provenzano ...... Tella Tool and Manufacturing Com- pany. 20010060 ...... SCI Systems, Inc ...... CMS Hartzell Incorporated ...... CMS Hartzell Incorporated. 20010069 ...... Willis Stein & Partners II, LP ...... ECCLETTS, LTD ...... GFS Holdings Co. 20010149 ...... J.H. Whitney IV, L.P ...... Gabriel Communications, Inc ...... Gabriel Communications, Inc.

Transactions Granted Early TerminationÐ10/23/2000

20005118 ...... Joe Fojasek ...... Gary R. Chapman ...... WWLP Holdings, Inc. 20005140 ...... VoiceStream Wireless Corporation ... STPCS Joint Venture, LLC ...... STPCS Joint Venture, LLC. 20005145 ...... SM Cable Holdings, LLC ...... Cox Enterprises, Inc ...... Peak Cablevision, L.L.C. 20005164 ...... Kohler Family Partnership Ltd ...... Internacional de Ceramica, S.A. de Internacional de Ceramica, S.A. de C.V. C.V. 20005188 ...... Professor Kurt Jenny ...... TriPath Imaging, Inc ...... TriPath Imaging, Inc. 20010016 ...... Superior Label Systems, Inc ...... Wisconsin Label Corporation ...... Wisconsin Label Corporation. 20010021 ...... AT&T Corp ...... Dana H. Dalton ...... GCI, Incorporated. 20010024 ...... VS&A Communications Partners III, Thomas L. Phillips ...... Infotech Consulting, Inc., Knowledge L.P. Sciences, Inc., MIN Publishing Co., Inc., Optic Music, Inc., Phillips Business Holdings Limited, Phillips Business Information Limited, Phil- lips Business Information, Inc., Phillips International Inc., Phillips Management Group, LLC. 20010028 ...... VS&A Communications Partners II, Thomas L. Phillips ...... Thomas L. Phillips. L.P. 20010031 ...... Credit Suisee First Boston Equity MascoTech, Inc ...... MascoTech, Inc. Partners, L.P. 20010037 ...... Scott K. Ginsburg ...... Digital Generation Systems, Inc ...... Digital Generation Systems, Inc. 20010038 ...... Digital Generation Systems, Inc ...... Scott K. Ginsburg ...... StarGuide Digital Networks, Inc. 20010040 ...... barnesandnoble.cominc...... MightyWords, Inc ...... MightyWords, Inc. 20010042 ...... Primedia, Inc...... Media/Communications Partners II Adam/Laux Company, Inc. Limited Partnership. 20010044 ...... Paradigm Investment Group, LLC .... CKE Restaurants, Inc ...... Hardee's Food Systems, Inc. 20010058 ...... DHL International Limited ...... DHL Worldwide Express, Inc ...... DHL Worldwide Express, Inc. 20010059 ...... KKR 1996 Fund LP ...... Laporte plc ...... Laporte America Inc. 20010067 ...... The Edward W. Scripps Trust ...... A.H. Belo Corporation ...... Henderson Gleaner, Inc.

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Trans # Acquiring Acquired Entities

20010075 ...... The Savage Companies ...... Waste Management, Inc ...... Waste Management, Inc. 20010078 ...... St. Joseph's Healthcare System, Inc Saint Barnabas Corporation ...... Wayne General Hospital. 20010082 ...... First Data Corporation ...... Kirk E. Sanford ...... CCI Acquisition LLC. 20010083 ...... Coming Incorporated ...... Pirelli S.p.A ...... Optical Technologies USA Comp. 20010085 ...... Golder, Thoma, Gressey, Raunder Equifax Inc ...... RMA Holdings, LLC. Fund V.L.P.

Transactions Granted Early TerminationÐ10/24/2000

20010023 ...... Sisters of St. Joseph of Orange ...... Province Healthcare Company ...... Brim Hospitals, Inc. 20010063 ...... Motorola, Inc ...... Naspers Limited ...... OpenTV Corp. 20010086 ...... J.H. Whitney Fund IV, L.P ...... Affina Corporation ...... Affina Corporation. 20010096 ...... John P. Rochon ...... Nu-kote Holding, Inc ...... Nu-kote Holding, Inc. 20010098 ...... Citizens Communications Company Global Crossing Ltd ...... Frontier Communications of AuSable Valley, Inc., Frontier Communica- tions of New York, Inc., Frontier Communications of Rochester, Inc., Frontier Communications of Seneca-Gorham, Inc., Frontier Communications of Sylvan Lake, Inc., Frontier Subsidiary Telco Inc., Frontier Telephone of Rochester, Inc. 20010102 ...... Stewart A. Resnick and Lynda Rae The Chase Manhattan Corporation ... AFS Holdings Corp. Resnick. 20010103 ...... NBA Media Ventures, LLC ...... Exca Holdings, Inc...... Exca Holdings, Inc. 20010106 ...... Minnesota Corn Processors, LLC ..... Corn Products International, Inc ...... Corn Products International, Inc. 20010108 ...... Kenneth D. Tuchman ...... Boston Communications Group, Inc Celluar Express, Inc. Wireless Tele- services Corp. 20010115 ...... GN Great Nordic Ltd ...... Hello Direct, Inc ...... Hello Direct, Inc. 20010118 ...... DLJ Merchant Banking Partners Ill, Telseon, Inc ...... Telseon, Inc. L.P. 20010127 ...... Conning Capital Partners V, L.P ...... Comcap Holdings Corp ...... Comcap Holdings Corp. 20010129 ...... CNET Networks, Inc ...... Peter Steinlauf ...... Edmunds Holding Company. 20010130 ...... Cedar Creek Partners LLC ...... Mr. Donald J. Long, Sr ...... Imperial, Inc. 20010135 ...... McLeodUSA Incorporated ...... CapRock Communications Corp ...... CapRock Communications Corp. 20010140 ...... Alpha Technologies Group, Inc ...... Mestek, Inc ...... National Northeast Corporation. 20010141 ...... Teijin Limited ...... Manville Personal Injury Settlement Manville Personal Injury Settlement Trust. Trust. 20010147 ...... Promotora de Empresas Zano S.A. Tower Automotive, Inc...... Tower Automotive Products Com- de C.V. pany, Inc. 20010177 ...... Francisco Partners, L.P...... Citron Haligman Bedecarre Incor- Citron Haligman Bedecarre Incor- porated. porated.

Transactions Granted Early TerminationÐ10/25/2000

20010032 ...... Minnesota Mining and Manufacturing ESPE Dental AG ...... ESPE Dental AG. Company. 20010053 ...... Deutsche Lufthansa AG ...... Hawker Pacific Aerospace ...... Hawker Pacific Aerospace. 20010160 ...... Straub Clinic & Hospital, Inc ...... PhyCor, Inc ...... PhyCor of Hawaii, Inc.

Transactions Granted Early TerminationÐ10/26/2000

20005179 ...... Swifty Serve, LLC ...... Elizabeth Wilson Camp ...... Camp Oil Company, CHH, Inc., SATFC, Inc. 20005201 ...... Michael Woods ...... Aztec Technology Partners, Inc ...... Aztec Technology Partners, Inc. 20005202 ...... O. Bruton Smith...... Garry W. McKinney Genesis Auto Bay Meadows Catering, Bay Mead- Group, Inc. ows Operating Company LLC. 20010054 ...... Hitachi Ltd ...... Grant Thomton LLP ...... Grant Thomton LLP. 20010065 ...... Stronach Trust ...... Paine Webber Group, Inc ...... Bay Meadows Catering, Bay Mead- ows Operating Company, LLC 20010084 ...... Group 1 Automotive, Inc ...... Thomas W. Kelley ...... Kelley Automotive Group, Inc. 20010120 ...... Vivendi S.A...... Barry Diller ...... USA Networks, Inc. 20010156 ...... Hanson PLC ...... Lloyd Babler ...... Pacific International Pipe Enterprises of Washington, Inc., Pacific Inter- national Pipe Enterprises, Inc. 20010157 ...... Watson Pharmaceuticals, Inc ...... Rhoda Makoff ...... Makoff R&D Laboratories, Inc. 20010159 ...... debis AirFinance B.V...... AerFi Group plc ...... AerFi Group plc. 20010163 ...... GS Capital Partners 2000, L.P ...... Hexel Corporation ...... Hexel Corporation. 20010176 ...... Carlyle Partners III, L.P ...... Steve and Alice Blair (husband and Forged Metals, Inc. wife). 20010186 ...... Checkpoint Systems, Inc ...... Richard Kam Man Nip ...... Auhaus/Wang Hing, Inc. 20010194 ...... MCSi, Inc ...... Intellisys Group, Inc ...... Intellisys Group, Inc.

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Trans # Acquiring Acquired Entities

Transactions Granted Early TerminationÐ10/27/2000

20003546 ...... Schlumberger Limited ...... Baker Hughes Incorporated ...... Baker Hughes Incorporated. 20005169 ...... The Dow Chemical Company ...... Cargill, Incorporated ...... Cargill, Incorporated. 20010109 ...... Dimension Data Holdings plc ...... TimeBridge Technologies, Inc ...... TimeBridge Technologies, Inc.

FOR FURTHER INFORMATION CONTACT: result, the following organizational of Health and Human Services on Sandra M. Peay or Parcellena P. changes will occur: management matters; and (6) Fielding, Contact Representatives, I. Establish the Office of Management participates in the development of Federal Trade Commission, Premerger and Operations (CAD). CDC’s goals and objectives. Notification Office, Bureau of II. Delete the following components Delete the functional statement for the Competition, Room 303, Washington, and functions from the Office of Office of the Director (CA5A) and insert D.C. 20580, (202) 326–3100. Program Support (CA5) and transfer the following: them, in their entirety, to the Office of (1) Manages, directs, and coordinates By Direction of the Commission. Management and Operations (CAD): the activities of the Office of Program Donald S. Clark, Physical Security Activity (CA5A2), Real Services (OPS); (2) provides the CDC Secretary. Property and Space Management Deputy Director for Program [FR Doc. 00–29056 Filed 11–13–00; 8:45 am] Activity (CA5A3), Facilities Engineering Management and other key officials BILLING CODE 6750±01±M Office (CA52), Design and Construction leadership, guidance, and evaluation of Management Office (CA55), Facilities program service and information Planning and Project Management technology management services performed for or by Centers/Institute/ DEPARTMENT OF HEALTH AND Office (CA56), and Human Resources Offices; (3) maintains liaison with HUMAN SERVICES Management Office (CA57). III. Delete the Financial Management officials of HHS on program service and Centers for Disease Control and Office (CA53) as a component of the information management matters; and Prevention Office of Program Support (CA5) and (4) participates in the development of establish it as a Staff Office with a direct CDC’s goals and objectives. Statement of Organizations, Functions, reporting relationship to the Office of After the functional statement for the and Delegations of Authority the Director, CDC (CA). Office of the Director (CAB1), Office of IV. Retitle the Office of Program Global Health (CAB), insert the Part C (Centers for Disease Control Support (CA5) as the Office of Program following: and Prevention) of the Statement of Services (CA5). Financial Management Office (CAC). Organization, Functions, and Section C–B, Organization and (1) Provides leadership and Delegations of Authority of the Functions, is hereby amended as coordination in the development and Department of Health and Human follows: administration of CDC’s financial Services (45 FR 67772–76, dated Delete the title and functional management policies; (2) develops October 14, 1980, and corrected at 45 FR statement for the Office of Program budget submissions for CDC; (3) 69296, October 20, 1980, as amended Support (CA5) and insert the following: collaborates with CDC’s Office of most recently at 65 FR 58775, dated Office of Program Services (CA5). (1) Program Planning and Evaluation in the October 2, 2000) is amended to (1) Assists and advises in the development, development and implementation of restructure the functions and activities coordination, direction, and assessment long-range program and financing plans; of the Office of Program Support; (2) of program services and related (4) participates in budget reviews and retitle the Office of Program Support as management activities throughout the hearings; (5) manages CDC’s system of the Office of Program Services; (3) Centers for Disease Control and internal budgetary planning and control establish the Financial Management Prevention, and assures consideration of of funds; (6) develops and implements Office with a direct organizational the implications of such in program CDC-wide budgetary, accounting, and reporting relationship to the Office of decisions; (2) conducts CDC’s activities fiscal systems and procedures; (7) the Director, CDC; (4) establish the in the area of management analysis, conducts CDC-wide manpower Office of Management and Operations; studies, and services; information management (including productivity and (5) revise the Order of Succession technologies and systems; grants measurement) activities; provides for the Centers for Disease Control and management, procurement and materiel accounting and auditing services; (8) Prevention. management; publications management; prepares financial reports; (10) serves as The Office of Program Support, library and legislative reference the focal point for domestic and retitled as the Office of Program services; and other delegated authorities international travel policy, procedures Services, is being restructured to focus as may be assigned; (3) manages the and interpretation; (11) provides its mission on the program service planning, evaluation, and adoption of legislation reference services; (12) plans, components and functions of the innovations and technologies in these directs, and conducts internal quality Information Resources Management areas; (4) directly and/or through the assurance reviews; (13) analyzes data Office, the Management Analysis and individual staff offices of the Centers for and makes recommendations to assure Services Office, and the Procurement Disease Control and Prevention, effective safeguards are in place to and Grants Office. The Office of provides leadership, guidance, and prevent fraud, waste and abuse; (14) Management and Operations is being evaluation of administrative assists in identifying or conducting established to provide centralized management services performed for or special financial management training services for human resource by Centers, Offices, and other programs; and (15) maintains liaison management, facilities-related components of the CDC; (5) maintains with the Office of the Secretary, functions, and special initiatives. As a liaison with officials of the Department Department of Health and Human

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Services, and other Government financial information for management to ensure the validity, legality and organizations on financial management purposes, effective control and proper accounting treatment of the matters. accountability of all funds, and suitable charges; (4) reviews authorization Office of the Director (CAC1). (1) integration of CDC accounting with the documents and processes payments and Provides leadership and guidance in all accounting operations of the U.S. credits related to the documents, areas of financial management; (2) Treasury; (3) coordinates activities of including authorization documents such serves as a CDC witness in budget the Accounting Branch with the FMO as negotiated and fixed price contracts, hearings before Committees of Congress, Director, the FMO Budget Branch and purchase orders, delivery orders, Office of Management and Budget, and the FMO Financial Systems Branch; (4) blanket purchase orders, and various Department of Health and Human coordinates accounting policy issues types of personnel agreements; (5) acts Services; (3) participates with top with the HHS Office of Financial Policy; as CDC liaison on all payment issues management in program planning and (5) reviews and develops accounting related to the implementation of the policy determinations, evaluations systems to comply with requirements of Government Impact Card Program; (6) conferences, and decisions concerning HHS and the General Accounting Office determines and computes tax liabilities financial resources; (4) provides a and maintains an integrated system of for individuals serving under the centralized source for current accounts to meet the budgetary and visiting scientists’ program to ensure information on financial management accounting requirements of CDC; (6) proper tax reporting to the Internal legal and regulatory requirements reviews and implements the legal, Revenue Service; and (7) provides governing the prevention and control of accounting and reporting requirements certification for the Department of the diseases; (5) advises the CDC Deputy of the Chief Financial Officers’ Act, the Treasury to reissue returned or canceled Director for Program Management Federal Managers’ Financial Integrity payments. concerning reprogramming of funds; Act, the Principles of Appropriation Payment Services Unit (CAC222). (1) and (6) provides consultation and Law and other regulatory requirements; Performs quality control reviews of assistance in financial management to (7) compiles all accounting information various payment processes and systems State and local health departments for the 5-Year Financial Management in the Accounts Payable Section, when requested by CDC officials. Plan which provides CDC’s financial including reviews to ensure compliance Financial Policy and Internal Quality management vision and objectives for with the Prompt Payment Act and to Assurance Activity (CAC12). (1) the ensuring 5 year period; and (8) validate the legality, propriety and Provides leadership, consultation, develops strategies for employee accounting treatment of the payments, guidance and advice on financial policy training and professional development. reviews of payments authorized using and internal quality assurance matters Accounts Payable Section (CAC22). the U.S. Government Impact Card, for CDC; (2) develops, analyzes, and (1) Develops and implements policies reviews to validate the receipt or evaluates financial management and procedures for all accounts payable acceptance of the goods or services at policies, guidelines, and services which activities at CDC; (2) develops new CDC, and reviews of the Federal Express have CDC-wide impact; (3) works with financial systems to automate accounts payment process; (2) identifies recurring personnel from all disciplines within payable operations and maintains and or widespread problems in the payment CDC to identify the areas in which serves as the CDC focal point on all processes and recommends corrective financial policy needs to be existing automated payment systems; (3) actions or identifies required training to strengthened; (4) reviews, assesses, and reviews obligation documents and correct the deficiencies; (3) monitors the recommends financial policy that is payment requests from a variety of use of and makes suggestions to consistent with internal controls and the private sector and government sources improve existing automated payment hierarchy of Federal and Department of to determine the validity and legality of and payment information systems; (4) Health and Human Services policies the request; (4) compiles and submits a defines user requirements for Electronic and procedures; (5) ensures that variety of cash management and travel Commerce (EC) in the Accounts Payable resources are safeguarded against fraud, reports required by the Department of Section, and recruits additional EC waste, and abuse; managed the Treasury and various other outside trading partners in private industry; (5) economically and efficiently; and agencies; (5) acts as liaison with CIO’s identifies automation opportunities in desired results are achieved; (6) reviews and outside customers to resolve the Section and, when necessary, and independently assesses the problems and provide training and coordinates with Financial Systems soundness, adequacy, and application of advice on payment issues; (6) provides Branch personnel to identify system budgetary and accounting controls; (7) electronic authorization to the requirements and test proposed reviews the reliability and integrity of Department of the Treasury to issue automated systems.; (6) writes and financial and budget information and checks or electronic funds transfers; and maintains automated system and the means used to identify, measure, (7) analyzes various internal reports to process documentation and provides classify, and report such information; provide management information on training to other employees on new or (8) reviews the adequacy and topics such as interest expenses, existing automated systems; (7) serves effectiveness of systems and procedures workload, and various other as the focal point at CDC for vendor and having an impact on expenditures of performance indicators. employee payment questions and funds and use of resources; (9) assesses Payments Unit (CAC223). (1) resolution of payment problems; (8) the reliability and accuracy of Approves and processes payments on validates and prepares daily payment accounting and budgetary data and all payment requests for equipment, schedules for transmission to the reports developed within CDC; and (10) supplies and services procured by CDC; Department of the Treasury; (9) identifies problems and weaknesses in (2) approves charges and credits from monitors and validates open obligations internal controls and provides reliable other Federal sources and ensures related to payments; and (10) maintains information for management to base posting of the expenses to the correct the automated file containing vendor corrective action. general ledger accounts; (3) approves payment address and banking Accounting Branch (CAC2). (1) and posts to CDC’s accounting records information. Develops accounting policies and all payments made to government, Travel Unit (CAC224). (1) Serves as procedures for CDC; (2) provides quasi-government, and private vendors the focal point at CDC for all travel and

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(1) Serves as the primary CDC at CDC, including the use of the of CDC and the U.S. Treasury; (3) focal point for planning, organizing, and automated travel system; (3) interprets coordinates the NIOSH accounting point administering a range of activities for policies, laws, rules and regulations to accounts payable and receivable legislative issues related to analyze the validity, legality, and activities including auditing of vouchers Congressional appropriation legislation correct accounting treatment of and the certification of payments; (4) matters; (2) summarizes Congressional disbursements for local, domestic and reviews the NIOSH accounting point and legislative positions on national international travel, and for change of system for compliance with CDC, HHS public health program issues in order to station vouchers, for civil service and General Accounting Office establish impact on CDC budgetary employees, foreign service employees, requirements; and (5) reconciles NIOSH requirements; (3) reviews and analyzes and commissioned officers; (4) accounting point general ledger new or amended appropriation examines and approves a variety of accounts including cash, property and legislation or report language transportation claims and credits, receivables. concerning public health programs, including Government Transportation General Ledger Section (CAC25). (1) health related research activities, and Requests, Government Bills of Lading, Compiles and submits the Report of scientific research pertinent to CDC’s unused tickets, and MARTA tickets; and Budget Execution which reports the mission and responsibilities and (5) determines Federal Income Tax obligations incurred against the current prepares related issues papers; (4) in liabilities and allowances for relocation year appropriations; (2) compiles and coordination with CIOs, develops claims and ensures the proper submits the annual financial statements appropriation report language related to accounting treatment of the tax required by the Chief Financial Officers’ budget formulation submissions; (5) liabilities. Act; (3) Compiles and submits the develops strategy and background Debt and Property Management monthly Statement of Transactions documentation regarding appropriation Section (CAC24). (1) Compiles and report to the U.S. Treasury which legislative issues and prepares related submits the quarterly HHS Debt reports the CDC cash disbursements by materials; (6) develops appropriation Management report which reports the appropriation; (4) reconciles general legislative background materials for status of all unpaid debts due to CDC ledger cash accounts with the U.S. presentation to HHS, Office of from the public; (2) compiles and Treasury monthly disbursements and Management and Budget (OMB) and submits the annual Treasury report of receipts; (5) performs daily maintenance Congressional Appropriations debts due to CDC; (3) performs all debt on the general ledger accounts including Committees; (7) assists the Director, collection activities in accordance with the asset, liability, capital and budgetary FMO, as the CDC representative at the Debt Collection Act of 1982 and in accounts; (6) makes recommendations appropriations hearings; (9) responds to accordance with requirements provided for improvements to the accounting inquiries regarding appropriation by HHS; (4) prepares customer billings; system and monitors internal controls; budget-related policy issues; and (10) (5) collects and records all amounts (7) analyzes the general ledger accounts, develops training strategies on billed to customers; (6) controls billings prepares system-wide reconciliations legislative issues for the professional and collections processed on the On- and interprets the effect of transactions development of staff. line Payment and Collection System on the CDC’s financial resources; (8) Financial Systems Branch (CAC5). (1) (OPAC); (7) reconciles accounts develops new reports to support budget Responsible for the analysis, design, receivable subsidiary records to the CDC requirements and to support the needs programming, implementation, general ledger receivable accounts; (8) of CDC management; (9) controls input enhancement and documentation of maintains travel advance records and of all funding transactions; (10) automated accounting systems and reconciles subsidiary records to general performs daily maintenance of subsystems for FMO; (2) provides ledger advance accounts; (9) coordinates accounting system tables; (11) controls consultative services to systems CDC’s debt collection activities with grant awards processed through the implementers within CDC, the FMO’s Accounts Payable Section and Payment Management System (PMS) Department and other Federal agencies with CDC program administrative including submission of grant on a broad range of issues including offices; (10) Coordinates all debt obligations to PMS, recording of policy, data integrity, systems collection activities with the U.S. Justice disbursements received from PMS and integration and interfacing issues as Department and with private collection reconciliation of the general ledger they relate to financial management agencies; (11) Prepares and controls accounts. systems; (3) provides technical support daily deposits which are delivered to Budget Branch (CAC3). (1) Provides and assistance to various committees, the Federal Reserve Bank; (12) performs leadership, consultation, guidance, and teams and users in the integration with property accounting activities including advice on budgetary matters to CDC; (2) FMO financial systems and the access maintenance of general ledger property prepares consolidated appropriation and interpretation of financial system accounts and reconciliation with the budget estimates including narrative data; and (4) responsible for hardware CDC Personal Property System; (13) justifications; (3) conducts studies in and software support for Reconciles Tax Withholding Account budget planning to determine proper microcomputers and local network(s) and prepares all monthly, quarterly and relationship between program planning within FMO. annual tax reports which must be and acquisition of funds; (4) develops Office of Management and Operations submitted to IRS. criteria to be used in estimating program (CAD). (1) Provides leadership and Cincinnati Accounting Section needs; (5) conducts CDC-wide direction on the development, (CAC23). (1) Maintains a system of manpower management (including operation, and appraisal on all aspects accounts to meet the budgetary and productivity measurement) activities; of human resource programs and accounting requirements of the NIOSH (6) develops expenditure information policies; (2) designs human resource accounting point; (2) provides financial for preparation of quarterly and annual programs that support and enhance the information for management purposes, budgets; and (7) designs and prepares CDC mission; (3) provides assistance to

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(1) Develops resolution activities; (5) carries out CDC’s program support equipment; (2) architectural designs and engineering facilities and real property and space carries out facilities planning functions specifications for construction of new management functions for CDC, for CDC, including new or expanded facilities and major modifications and including new or expanded facilities, facilities, and a major repair and renovations to CDC-owned facilities; (2) and a major repair and improvement improvement program; (3) develops provides architectural and engineering program; and (6) plans, directs, and services for new, improved, and technical services and consultation on coordinates a physical security program modified equipment to meet program facility project designs; (3) provides in- for CDC facilities and personnel. needs; and (4) conducts CDC’s real house construction administration Office of the Director (CAD1). (1) property and space management services for CDC-owned facilities in Manages, directs, and coordinates the activities, including the acquisition of Atlanta; (4) manages interior design and activities of the Office of Management leased space, the purchase and disposal furniture standards; and (5) coordinates and Operations (OMO); (2) provides of real property, and provides technical development and determination of best leadership, guidance, and evaluation of assistance in space planning to meet methods and means for the planning management operations, human programmatic needs. and conduct of assigned projects, resources management, and facilities Office of the Director (CAD21). (1) including selection of resources. operations performed by or on behalf of Plans, directs and coordinates the Facilities Engineering Office (CAD23). (1) Operates, maintains, repairs, and the Centers/Institute/Offices; (3) advises functions and activities of the Facilities modifies CDC’s Atlanta area plant and assists the Director, CDC, and other Planning and Management Officer facilities and other designated CDC key officials on all phases of these (FPMO); (2) provides management and facilities throughout the United States functions; (4) maintains liaison with administrative direction for budget and Puerto Rico and conducts a officials of the HHS on management planning and execution, property maintenance and repair program for matters; and (5) participates in the management, and personnel CDC’s program support equipment; (2) development of CDC’s goals and management within FPMO; (3) provides leadership and strategic support to develops services for new, improved, objectives. senior managers in the determination of and modified equipment to meet Physical Security Activity (CAD12). CDC’s long term facilities needs; (4) program needs; (3) provides technical (1) Plans, directs, and coordinates a directs the operations of FPMO staff assistance, reviews maintenance and physical security program for CDC involved in the planning, evaluation, operation programs, and recommends facilities and personnel; (2) maintains design, construction, and management appropriate action for all Atlanta area and manages a guard service at CDC- of facilities and acquisition of property; facilities and other designated CDC owned facilities in metropolitan (5) processes data for management and facilities throughout the United States Atlanta; (3) operates and maintains a control systems and develops reports and Puerto Rico; (4) provides computerized control center for and analyses; and (6) assists and advises recommendations, priorities, and surveillance of thermal, smoke, senior CDC officials in the development, services for new, improved, or modified intrusion, and fire alarms for Atlanta coordination, direction, and assessment equipment to meet program needs; (5) area CDC-owned facilities; (4) maintains of facilities and real property activities provides maintenance and operation of and monitors a program of controlled throughout CDC’s facilities and the central energy plant including access to CDC facilities and grounds in operations, and assures consideration of structures, utilities production and the Atlanta area; (5) develops lock/key facilities management implications in utilities distribution systems and plans for CDC facilities in the Atlanta program decisions. equipment; (6) conducts a program of area and issues card keys and door keys Real Property and Space Management custodial services, waste disposal, in concert with that plan; (6) develops, Activity (CAD212). (1) Conducts the incinerations, and disposal of biological implements, and maintains a system for Real Property and Space Management waste and other building services at all preparing and issuing photo Program throughout CDC, including the CDC Atlanta area facilities and other identification cards/badges for acquisition of leased space, the designated CDC facilities throughout the employees and an identification badging purchase sand disposal of real property United States and Puerto Rico; (7) system for visitors; (7) provides of CDC (with emphasis on current and provides landscape development, information and visitor registration at long-range planning for the utilization repair, and maintenance at all CDC Atlanta CDC-owned facilities during of existing and future real property Atlanta area facilities and other regular working hours and emergency resources); (2) provides technical designated CDC facilities throughout the telephone and notification service at all assistance in space planning to meet United states and Puerto Rico; (8) times; (8) provides guidance, when programmatic needs; (3) administers provides hauling and moving services requested, in developing security day-to-day management of leased for CDC in the Atlanta area; (9) provides programs or solving security problems facilities and ensures contact insect and rodent control services for at other locations; (9) issues compliance by lessors; (4) provides CDC in Atlanta area facilities; (10) Government driver’s licenses and technical assistance and prepares develops required contractual services parking and carpool decals; (10) contract specifications for all repair and and provides supervision for work coordinates requests for assistance for improvement projects in leased space; performed in these areas; (11) police, fire, and other emergency (5) maintains liaison with the General establishes and maintains a responses, as required; (11) coordinates Services Administration Regional computerized system for maintenance CDC activities related to tort claims; and Offices; (6) performs all functions services and for stocking and ordering (12) maintains liaison and coordinates relating to leasing and/or acquisition of supplies and replacement parts; (12) physical security activities of CDC with real property under CDC delegation of provides for pick-up and delivery of HHS. authority for leasing special purpose supplies and replacement parts to work

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(1) employee orientation. Management Office and the facilities Provides leadership and technical Career Management Section Planning and Project Management guidance to CDC in planning, (CAD332). (1) Develops and administers Office with facility-related issues. coordinating, and conducting an agency intern and professional Facilities Planning and Project effective personnel program for civil development programs; (2) provides Management Office (CAD24). (1) service (including the Senior consultation, guidance, and technical Provides professional architectural/ Biomedical Research Service [SBRS] assistance to managers and employees engineering capabilities and technical and the Senior Executive Service [SES]), regarding career management and and administrative project support to Title 38, Commissioned Corps, and employee development; (3) implements CDC and the CIOs for renovations and fellowship program peresonnel; (2) and provides advice on distance- improvements to CDC-owned faciliteis plans, directs, and evaluates the learning programs nationwide; (4) and construction of new facilities; (2) activities of the Human Resources acquires, develops, and supports priorotizes design and construction Management Office (HRMO); (3) advises technology-based training; (5) manages needs for requested CIO projects; (3) the Director, CDC, and other CDC the Learning Resource Center including manages and administers the CDC management staff on all matters relating establishing policy, scheduling room renovations and improvement (R&I) to human resources management; (4) usage, providing technical and audio budget; (4) develops project administers the National Performance visual support, and maintaining a management requirements (including Review and Human Resources Learning Library with individualized determination of methods and means of initiatives; (5) develops, coordinates, learning options; (6) creates marketing project completion and selection of and disseminates personnel policies, tools for the Organizational resources), funding sources, and programs, and procedures in position Development Branch; (7) implements budgets; and (5) serves as the point of management, classification, and monitors the CDC Training contact with CIOs for administration compensation, and staffing; (6) Management System for compliance and coordination of all facilities-related establishes objectives, standards, and with the Government Employees needs, i.e., project planning, evaluation, internal controls; evaluates, analyzes, Training Act; (8) maintains employee estimation, and tracking. and makes recommendations to improve training records; (9) collaborates with Human Resources Management Office personnel authorities, policies, systems, the CDC Corporate University Section to (CAD3). (1) Provides service, support, operations, and procedures; (7) develops develop, implement, and administer the advice, and assistance to CDC and monitors proposals and plans human resources leadership organizations, management, and related to the implementation of CDC development and career management employees in all areas of human diversity personnel programs and program for all occupational series resources management; (2) conducts and projects; assists with monitoring throughout CDC; (10) manages formal coordinates personnel management for progress and the success of existing career development and mentoring CDC’s civil service and Commissioned diversity recruitment and placement programs; (11) procures and/or instructs Corps personnel; (3) conducts CDC’s programs; and (8) provides all training courses as part of existing fellowship programs; (4) develops and administrative/management support as functional area curriculum; (12) issues policies and procedures; required in HRMO. establishes partnerships with conducts recruitment, special emphasis, Organizational Development Branch professional organizations and academic staffing, position classification, position (CAD33). (1) Develops, designs, and institutions for the formalization and management, pay administration, implements an accredited recognition of CDC programs and the performance management systems, comprehensive strategic human offering of academic programs onsite employee training and development, resource leadership development and and through distance learning; and (13) and labor relations programs; (5) career management program for all manages the use of technology to offer maintains personnel records and occupational series throughout CDC; (2) desktop instruction through web-based reports, and processes personnel actions develops and implements training training, e.g., interactive CD–ROM. and documents; (6) administers the strategies and activities that contribute CDC Corporate University Section Federal life and health insurance to the agency’s mission, (CAD333). (1) Develops, designs, and programs; (7) administers the employee accomplishments and organizational implements a comprehensive strategic recognition, suggestion, and incentive performance; (3) integrates a variety of human resources leadership awards programs; (8) furnishes advice learning methods to provide training; (4) development and career management

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(1) Plans, develops, Operations Branch (CAD35). (1) surveys, and survey/focus group and provides consultation, guidance, Serves as the primary contact for CDC assessments; (6) develops internal and technical advice on available management and employees in instructor capacity; (7) provides analysis employee services and assistance; obtaining the full range of personnel and data to correlate individual training performance, award, and conduct assistance and management services for with corporate strategic plans; (8) issues; leave administration; on-the-job civil service and Commissioned Corps personnel; (2) provides leadership, maximizes economies of scale through injuries and exposures to infectious technical assistance, guidance, and systematic planning and evaluation of diseases; debt complaints; and other job- consultation in human resource agency-wide training initiatives; (9) related issues; (2) develops and utilization, position management, develops new methodology to administers labor-management and position classification, staffing, determine return on investment on employee relations program including employee relations, reorganization, human capital and intellectual disciplinary actions, grievances and program evaluation, performance investments; (10) designs executive appeals, labor negotiations, collective management, and personnel records and leadership programs in collaboration bargaining, management representation files management; (3) works as a team with CDC C/I/Os; (11) develops agency- before third parties, and partnership wide intern programs for succession with other personnel specialists and activities; (3) serves as liaison with the CDC organizations to develop staffing planning of staffing requirements; and Office of Health and Safety and other (12) develops and maintains continuing plans, identify recruitment needs, and CDC staff for personnel matters relating conduct position management studies, education unit accreditation for school to substance abuse and other employee curricula. desk audits, and job analyses; (4) plans, assistance programs; (4) coordinates the develops, implements, and evaluates Field Operations Branch (CAD34). (1) Fare Share and Dependent Care systems to ensure consistently high Plans, develops, directs, coordinates, programs; (5) coordinates all Family quality personnel services; (5) processes implements, and evaluates human Friendly programs; (6) administers the personnel actions by determining resources management programs, incentive and suggestion awards position classifications, issuing vacancy policies, procedures, and systems; (2) programs; (7) coordinates and processes announcements, assisting in participates in the development of CDC garnishment, child support, and other development of selection criteria, HRMO policy, strategic, long- and short- collection actions for CDC employees; conducting examining under delegated range plans, programs, and resource (8) serves as the primary agency contact examining authority, conducting allocations; (3) serves as the primary on all matters associated with labor- candidate rating and ranking under CDC contact for HRMO remote/field management relations; (9) plans, directs, Merit Promotion Plan, making operations providing a full range of coordinates, and conducts contract qualification determinations, personnel management, advisory negotiations on behalf of agency determining pay, conducting consulting, and information services; (4) management with labor organizations reductions-in-force, and effecting provides leadership, technical direction, holding exclusive recognition; (10) appointments and other actions; (6) and guidance in human resource represents management in third party coordinates with other Federal agencies utilization, program development and proceedings involving labor and for the assignment of CDC personnel in evaluation; organizational development, employee relations issues; (11) serves as other countries; (7) establishes and position management, classification and the authority to ensure validity, maintains personnel and payroll pay administration; employment, consistency, and legality of employee records, files, and controls; and (8) recruitment, and staffing; employee/ relations matters concerning grievances provides assistance in the labor/partnership relations; benefits and (both negotiated and agency implementation of HHS Plan for Drug services; performance management, procedures), disciplinary actions, Free Workplace. awards, training and employee adverse actions, and resultant third Commissioned Corps Section development; transactions, personnel party hearings; (12) plans and (CAD352). (1) Provides technical records, and file management; (5) coordinates all programmatic activities assistance and information on rights, coordinates HRMO remote/field to include preparation of disciplinary benefits, and obligations of the operations with Headquarter’s staff and and adverse action letters and all final Commissioned Corps service to other CDC, HHS, Federal, State, local, agency decisions in grievances and Commissioned Corps personnel and and private organizations; (6) develops appeals; (13) provides technical advice, CDC management; (2) provides annual staffing and recruitment plans, consultation, and training on matters of assistance and information on special recruitment campaigns, employee conduct and performance and Commissioned Corps policies and crediting plans, announcements, provides personnel services on debt systems such as pay, performance advertisements, and special information complaints; (14) serves as the authority management, assignments, health materials; (7) conducts position and primary agency on all matters benefits, training, travel, relocation, management studies, desk audits, associated with labor-management promotions, and retirement; (3) provides qualifications analyses, peer review partnership activities; (15) provides staffing assistance for CDC’s

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Commissioned Corps promotion and support to HRMO organizations and provides leadership in assessing awards programs; and (4) maintains users in achieving automation of progress in achieving overall staffing, liaison and coordinates personnel functions and use of information EEO, and Affirmative Action goals. services for Commissioned Corps technology and systems; (4) develops, Delegations of Authority Statement personnel with the Division of manages, and supports centralized Commissioned Personnel. information technology and systems in All delegations and redelegations of Central Staffing Section (CAD536). (1) support of personnel activities, authority remain in effect until Implements a centralized staffing and including the HHS personnel system; (5) otherwise modified, superseded, or placement program; (2) administers the researches and develops new sources of cancelled. delegated examining authority, the personnel information and access Section C–C, Order of Succession direct hiring authority, and the methods including computer-based temporary limited appointment CDC-wide surveys; (6) coordinates Delete in its entirety Section C–C, authority granted by USOPM; (3) HRMO information resource Order of Succession, and insert the oversees the overall staffing process and management activities with IRMO and following: insures quality control; (4) reviews, CDC information resource management During the absence or disability of the evaluates, and makes recommendations committees; (7) conducts demographic Director, CDC, or in the event of a on the application and implementation analysis of the CDC work force and vacancy in that office, the first official of the USOPM delegated authorities and publishes results in management listed below who is available shall act merit promotion program rules and reports; and (8) develops methodologies as Director, except that during a regulations; (5) provides guidance and to assess the impact of revised planned period of absence, the Director consultation in job analyses and in personnel policies and practices on the may specify a different order of development of knowledge/skills/ work force. succession: abilities (KSAs) crediting plans; and (6) 1. Deputy Director for Science and Outreach and Marketing Branch manages various staffing programs such Public Health; (CAD37). (1) Develops and implements as the CDC summer program, the 2. Deputy Director for Policy and human resource management marketing Voluntary Employee Referral Program, Legislation; campaigns; (2) provides leadership in the Interagency Career Transition 3. Deputy Director for Program identifying the Centers/Institute/Offices’ Assistance Program, and the Career Management. (CIOs) recruiting needs, and assesses, Transition Assistance Program. Dated: October 30, 2000. analyzes, and develops CDC’s short- and Technical Services Section (CAD357). Jeffrey P. Koplan, (1) Provides central personnel services long-range recruitment plans to meet these needs; (3) provides consultation, Director. and assistance in the areas of employee [FR Doc. 00–29023 Filed 11–13–00; 8:45 am] benefits, personnel action processing, guidance, and technical advice on BILLING CODE 4160±18±M data quality control/assessment, and recruitment and special emphasis files/records management; (2) services policies, practices, and procedures, as liaison between CDC and the HHS including search committees; (4) strategizes on the best approach to DEPARTMENT OF HEALTH AND payroll office resolving discrepancies HUMAN SERVICES with pay and leave; (3) administers the recruitment at specific events, and leave donor program and processes time designs and develops recruitment Food and Drug Administration and attendance amendments; (4) materials for events; (5) maintains and provides policy guidance and technical manages the Automated Applicant [Docket No. 00D±1555] Listing System (AALS/Resumix) for advice and assistance on retirement, the Draft Guidance for Industry on Refusal Thrift Savings Plan, health/life storage and retrieval of applications of those individuals with education and of Inspection or Access to HACCP insurance, and savings bonds; (5) codes Records Pertaining to the Safe and and finalizes all personnel actions in the experience appropriate for commonly needed and hard-to-fill positions; Sanitary Processing of Fish and automated personnel data system; (6) Fishery Products; Availability assists with new employee orientation; coordinates, with CIOs, the referral of (7) establishes and maintains the official appropriate candidates from the AGENCY: Food and Drug Administration, personnel files system and administers applicant pool for position vacancies; HHS. personnel records storage and disposal (6) provides leadership on recruitment ACTION: Notice. program; (8) responds to employment activities through the development of verification inquiries; (9) administers policies and practices for effective SUMMARY: The Food and Drug the personnel security program; (10) communication of HRMO programs, Administration (FDA) is announcing the initiates suitability background checks coordinates the development and availability of a draft guidance for and fingerprints for all CDC personnel; dissemination of information among industry entitled ‘‘Refusal of Inspection and (11) provides assistance in the HRMO and the CIOs, provides training or Access to HACCP Records Pertaining implementation of the HHS Plan for a and technical assistance to CIO staff; (7) to the Safe and Sanitary Processing of Drug Free Workplace. manages and operates the CDC Job Fish and Fishery Products.’’ This draft Information Technology and Analysis Information Center, including the guidance sets forth the agency’s Branch (CAD36). (1) Develops strategic automated telephone job line; (8) interpretation of its Hazard Analysis plans for information technology and markets and manages special emphasis Critical Control Point (HACCP) information systems to support CDC’s programs including the Program for regulations for fish and fishery products and HRMO’s personnel information Persons with Disabilities and the as they pertain to the inspection of requirements; (2) acquires and Disabled Veterans Affirmative Action facilities and records. The agency is implements appropriate technology and Program, the Veterans Readjustment clarifying that a processor’s refusal to develops information systems to meet Appointment Program, the Federal allow FDA to inspect its processing CDC-wide information needs on Equal Opportunity Recruitment facilities, or to provide HACCP records personnel, staffing, and work force Program, and college relations and or plans to an inspector during an characteristics and trends; (3) provides student employment programs; and (9) inspection, violates the regulations and

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68151 thus may trigger a regulatory response records and plans available ‘‘for official individuals may submit one copy. by the agency. FDA is issuing this review and copying at reasonable times’’ Comments are to be identified with the clarification because some domestic (§ 123.9(c)). The agency expects that it docket number found in brackets in the firms have questioned whether records will regard the failure to provide records heading of this document. The draft can be made available after an and plans by a domestic or foreign guidance and received comments are inspection (rather than during) and processor as a significant program available for public examination in the some foreign firms have canceled violation, even if a firm volunteers the Dockets Management Branch between 9 scheduled inspections by FDA, but documents after the inspection. a.m. and 4 p.m., Monday through offered to make records available for FDA believes that the best way for a Friday. regulatory authority to determine review. This guidance applies to foreign Dated: October 30, 2000. processors that export fish and fishery whether a processor is effectively Margaret M. Dotzel, products to the United States as well as operating a HACCP system is by to domestic processors. inspecting the processor to assess Associate Commissioner for Policy. [FR Doc. 00–29011 Filed 11–13–00; 8:45 am] DATES: Submit written comments on the whether the system is operating draft guidance by December 14, 2000. properly and is appropriate for the BILLING CODE 4160±01±F General comments on agency guidance circumstances. Review of monitoring documents are welcome at any time. and other records generated by the HACCP system is a critical component DEPARTMENT OF HEALTH AND ADDRESSES: Copies of this draft HUMAN SERVICES guidance for industry are available on of an inspection because it allows the inspector to match records against the Internet at http://vm.cfsan.fda.gov/ Food and Drug Administration dms/guidance.html. Submit written practices and conditions being observed requests for single copies of the draft in the plant and it discourages fraud. [Docket No. 99D±1020] guidance to the Industry Activities Staff, Thus, FDA always has intended that its Medical Devices Draft Guidance on Office of Constituent Operations (HFS– review of processors’ HACCP plans and Over the Counter (OTC) Screening 565), Center for Food Safety and records would occur as part of an Tests for Drugs of Abuse: Guidance Applied Nutrition, Food and Drug inspection of a processor’s entire for Premarket Notifications; Administration, 200 C St. SW., HACCP system. Availability Washington, DC 20204. Send one self- For domestic processors, failure to allow an inspection would not only addressed adhesive label to assist that AGENCY: Food and Drug Administration, office in processing your reuqests. violate the HACCP regulations; it is also a prohibited act under section 301(f) of HHS. Submit written comments on the draft ACTION: Notice. guidance to the Dockets Management the act (21 U.S.C. 331(f)). Moreover, if Branch (HFA–305), Food and Drug a domestic processor refuses an FDA SUMMARY: The Food and Drug Administration, 5630 Fishers Lane, rm. inspection, FDA can obtain an Administration (FDA) is announcing the 1061, Rockville, MD 20852. inspectional warrant from the U.S. availability of the draft guidance district court in which the processor is FOR FURTHER INFORMATION CONTACT: entitled ‘‘Over the Counter (OTC) located. Screening Tests for Drugs of Abuse: Mary I. Snyder, Center for Food Safety Failure to allow an FDA inspection by Guidance for Premarket Notifications.’’ and Applied Nutrition (HFS–415), Food a foreign processor can also result in a FDA is issuing this draft guidance to and Drug Administration, 200 C St. SW., regulatory response. The definition of provide information about studies and Washington, DC 20204, 202–418–3133. ‘‘processor’’ at § 123.3(l) specifically labeling considerations applicable to SUPPLEMENTARY INFORMATION: FDA is includes persons in foreign countries. announcing the availability of a draft Thus, like domestic processors, foreign OTC screening tests that use urine as the guidance for industry entitled ‘‘Refusal processors who ship to the United clinical specimen for any combination of Inspection or Access to HACCP States must operate under conditions of one or more of these drugs: Records Pertaining to the Safe and that satisfy FDA’s HACCP regulations, Amphetamine (and, or Sanitary Processing of Fish and Fishery including the requirement that records methamphetamine), cocaine, Products.’’ This guidance is intended to be made available during the course of cannabinoids, opiates, and clarify that on-site inspection of a an FDA inspection. phencyclidine. This draft guidance processing facility and concurrent This draft guidance is being issued defines OTC use for the purposes of this review of HACCP records are essential consistent with FDA’s good guidance document as use in home, workplace, elements of FDA’s Seafood HACCP practices (65 FR 56468, September 19, insurance, and sports settings, and program as set forth at part 123 (21 CFR 2000). The draft guidance represents the includes requests for comments on part 123). These regulations require agency’s current thinking on refusal of confirmatory testing and OTC alcohol processors of fish and fishery products inspection or access to HACCP records testing. This draft guidance is neither to operate preventive control systems that pertain to the safe and sanitary final nor in effect at this time. for human food safety that incorporate processing of fish and fishery products. DATES: Submit written comments on the the principles of HACCP. The It does not create or confer any rights for draft guidance by February 12, 2001. regulations further provide that fish and or on any person and does not operate ADDRESSES: Submit written requests for fishery products are adulterated under to bind FDA or the public. An single copies on a 3.5 ″ diskette of the section 402(a)(4) of the Federal Food, alternative approach may be used if draft guidance entitled ‘‘Over the Drug, and Cosmetic Act (the act) (21 such approach satisfies the Counter (OTC) Screening Tests for U.S.C. 342(a)(4)) if their processor fails requirements of the applicable statutes Drugs of Abuse: Guidance for Premarket to have and implement a HACCP plan and regulations. Notifications,’’ to the Division of Small when one is necessary, or otherwise Interested persons may submit to the Manufacturers Assistance (HFZ–220), fails to meet any of the requirements of Dockets Management Branch (address Center for Devices and Radiological the regulations, including allowing the above) written comments on the draft Health, Food and Drug Administration, official review of records (§ 123.6(g)). guidance. Two copies of any comments 1350 Piccard Dr., Rockville, MD 20850. Processors must make their HACCP are to be submitted, except that Send two self-addressed adhesive labels

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 68152 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices to assist that office in processing your • Suggest the use of spiked urine IV. Comments request, or fax your request to 301–443– samples instead of urine obtained from Interested persons may submit to 8818. Submit written comments on the individuals using drugs; and • Dockets Management Branch (address draft guidance to the Dockets Suggest combining drugs in these above) written comments regarding this Management Branch (HFA–305), Food spiked urine samples in order to reduce draft guidance by February 12, 2001. and Drug Administration, 5630 Fishers the number of samples tested. Two copies of any comments are to be Lane, rm. 1061, Rockville, MD 20852. II. Significance of Guidance submitted, except that individuals may Comments should be identified with the submit one copy. Comments are to be docket number found in brackets in the This draft guidance represents the agency’s current thinking on identified with the docket number heading of this document. See the found in brackets in the heading of this SUPPLEMENTARY INFORMATION section for submissions for OTC screening tests for drugs of abuse. It does not create or document. The draft guidance and information on electronic access to the received comments may be seen in the guidance. confer any rights for or on any person and does not operate to bind FDA or the Dockets Management Branch between 9 FOR FURTHER INFORMATION CONTACT: Jean public. An alternative approach may be a.m. and 4 p.m., Monday through M. Cooper, Center for Devices and used if such approach satisfies the Friday. Radiological Health (HFZ–440), Food applicable statute, regulations, or both. Dated: November 2, 2000. and Drug Administration, 9200 The agency has adopted good Linda S. Kahan, Corporate Blvd., Rockville, MD 20850, guidance practices (GGP’s), and Deputy Director for Regulations Policy, Center 301–594–1243. published the final rule, which set forth for Devices and Radiological Health. SUPPLEMENTARY INFORMATION: the agency’s policies and procedures for [FR Doc. 00–29109 Filed 11–8–00; 4:21 pm] the development, issuance, and use of BILLING CODE 4160±01±F I. Background guidance documents (65 FR 56468, In the Federal Register of December September 19, 2000). This guidance 30, 1998 (63 FR 71932), FDA announced document is issued as a Level 1 DEPARTMENT OF HEALTH AND the availability for comment of a draft guidance consistent with the GGP’s. HUMAN SERVICES guidance entitled ‘‘Guidance for III. Electronic Access Premarket Submissions for Tests for Food and Drug Administration In order to receive the draft guidance Screening Drugs of Abuse to Be Used By [Docket No. 00D±1587] The Consumer.’’ FDA invited interested entitled ‘‘Over the Counter (OTC) persons to comment on the draft Screening Tests for Drugs of Abuse: Medical Devices Draft Guidance on guidance by March 30, 1999. FDA is Guidance for Premarket Notifications’’ Guidance for Prescription Use Drugs replacing that draft guidance document via your fax machine, call the CDRH of Abuse Assays Premarket with a new draft guidance entitled Facts-On-Demand system at 800–899– Notifications; Availability ‘‘Over the Counter (OTC) Screening 0381 or 301–827–0111 from a touch- Tests for Drugs of Abuse: Guidance for tone telephone. Press 1 to enter the AGENCY: Food and Drug Administration, Premarket Notifications.’’ This second system. At the second voice prompt HHS. draft guidance provides more detailed press 1 to order a document. Enter the ACTION: Notice. recommendations on what to include in document number (2209) followed by the pound sign (#). Follow the SUMMARY: The Food and Drug a premarket notification for this device, Administration (FDA) is announcing the and includes new information remaining voice prompts to complete your request. availability of the draft guidance addressing the relevant least entitled ‘‘Guidance for Prescription Use burdensome provisions of the Food and Persons interested in obtaining a copy of the guidance may also do so using the Drugs of Abuse Assays Premarket Drug Administration Modernization Act Notifications.’’ FDA is issuing this of 1997. Internet. The Center for Devices and Radiological Health (CDRH) maintains guidance to express the general The draft guidance recommends principles FDA applies in evaluating including in the premarket notification: an entry on the Internet for easy access to information including text, graphics, premarket notifications (510(k)s) for • OTC studies showing correct results and files that may be downloaded to a prescription use drugs of abuse assays. at concentrations 50 percent above and personal computer with access to the The principles described in this draft 50 percent below the cutoff; guidance document apply only to in • Internet. Updated on a regular basis, the Description of the patient reporting CDRH home page includes the civil vitro diagnostic (IVD) submissions for format; 510(k) clearance for these devices. This • money penalty guidance documents Studies on the stability of the package, device safety alerts, Federal draft guidance is neither final nor in device; and Register reprints, information on effect at this time. • The confirmatory laboratory’s premarket submissions (including lists DATES: Submit written comments on the credentials. of approved applications and draft guidance by February 12, 2001. The draft guidance also seeks public manufacturers’ addresses), small ADDRESSES: Submit written requests for comment on premarket review of OTC manufacturers’ assistance, information single copies on a 3.5″ diskette of the alcohol tests. on video conferencing and electronic draft guidance entitled ‘‘Guidance for The draft guidance also addresses submissions, mammography matters, Prescription Use Drugs of Abuse Assays labeling for these devices. and other device-oriented information. Premarket Notifications’’ to the Division As part of its efforts to ensure that The CDRH home page may be accessed of Small Manufacturers Assistance FDA considers the least burdensome at http://www.fda.gov/cdrh. ‘‘Over the (HFZ–220), Center for Devices and path to market, the agency has drafted Counter (OTC) Screening Tests for Radiological Health, Food and Drug the guidance to: Drugs of Abuse: Guidance for Premarket Administration, 1350 Piccard Dr., • Clarify that OTC screening tests for Notifications’’ is available at http:// Rockville, MD 20850. Send two self- drugs of abuse ordinarily will be www.fda.gov/cdrh/ode/guidance/ addressed adhesive labels to assist that reviewed as a premarket notification; 2209.pdf. office in processing your request, or fax

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68153 your request to 301–443–8818. Submit touch-tone telephone. Press 1 to enter imposed exclusions in the cases set written comments on the draft guidance the system. At the second voice prompt forth below. When an exclusion is to the Dockets Management Branch press 1 to order a document. Enter the imposed, no program payment is made (HFA–305), Food and Drug document number (152) followed by the to anyone for any items or services Administration, 5630 Fishers Lane, rm. pound sign (#). Follow the remaining (other than an emergency item or 1061, Rockville, MD 20852. Comments voice prompts to complete your request. service not provided in a hospital should be identified with the docket Persons interested in obtaining a copy emergency room) furnished, ordered or number found in brackets in the of the guidance may also do so using the prescribed by an excluded party under heading of this document. See the Internet. The Center for Devices and the Medicare, Medicaid, and all Federal SUPPLEMENTARY INFORMATION section for Radiological Health (CDRH) maintains Health Care programs. information on electronic access to the an entry on the Internet for easy access In addition, no program payment is draft guidance. to information including text, graphics, made to any business or facility, e.g., a FOR FURTHER INFORMATION CONTACT: Jean and files that may be downloaded to a hospital, that submits bills for payment M. Cooper, Center for Devices and personal computer with access to the for items or services provided by an Radiological Health (HFZ–440), Food Internet. Updated on a regular basis, the excluded party. Program beneficiaries and Drug Administration, 9200 CDRH home page includes the civil remain free to decide for themselves Corporate Blvd., Rockville, MD 20850, money penalty guidance documents whether they will continue to use the 301–594–1243. package, device safety alerts, Federal services of an excluded party even SUPPLEMENTARY INFORMATION: Register reprints, information on though no program payments will be premarket submissions (including lists I. Background made for items and services provided by of approved applications and that excluded party. The exclusions This draft guidance recommends data manufacturers’ addresses), small have national effect and also apply to all and labeling that manufacturers should manufacturers’ assistance, information Executive Branch procurement and non- submit in support of substantial on video conferencing and electronic procurement programs and activities. equivalence for prescription use drugs submissions, mammography matters, of abuse assays. The recommendations and other device-oriented information. Subject, city, state Effective and general principles in this draft The CDRH home page may be accessed date guidance are provided to assist at http://www.fda.gov/cdrh. ‘‘Guidance manufacturers in the preparation of for Prescription Use Drugs of Abuse PROGRAM-RELATED CONVICTIONS premarket notifications (510(k)s) for Assays Premarket Notifications’’ will be ASKARI, SOHEILA ...... 11/20/2000 these devices. This document will available at http://www.fda.gov/cdrh/ MONTGOMERY, AL supersede the document, ‘‘Review ode/guidance/152.pdf. BEN, ERIC S ...... 11/20/2000 Criteria for Assessment of In Vitro IV. Comments PORT ST LUCIE, FL Diagnostic Devices for Drugs of Abuse CARNEVALI, STEVEN ER- Assays Using Various Methodologies,’’ Interested persons may submit to NEST JR ...... 11/20/2000 August 31, 1995. This draft guidance Dockets Management Branch (address PITTSBURGH, PA explains the types of studies to conduct above) written comments regarding this CASPER, FRANCES C ...... 11/20/2000 and how to present the study data in draft guidance by February 12, 2001. VIRGINIA BCH, VA greater detail than the document it is Two copies of any comments are to be CHACON, RAUL ENRIQUE ..... 11/20/2000 replacing. VALRICO, FL submitted, except individuals may CHAMBERS, CHARLES ...... 11/20/2000 II. Significance of Guidance submit one copy. Comments are to be ROOSEVELT, NY identified with the docket number CUCHEZ, MARIA ...... 11/20/2000 This draft guidance represents the found in brackets in the heading of this BELL GARDENS, CA agency’s current thinking regarding data document. The draft guidance and CULLINAN, MICHAEL JO- and labeling for prescription use drugs received comments may be seen in the SEPH ...... 11/20/2000 of abuse device submissions for 510(k) Dockets Management Branch between 9 MORGANTOWN, WV clearance. It does not create or confer a.m. and 4 p.m., Monday through DE LOS SANTOS, RAMIRO .... 11/20/2000 any rights for or on any person and does Friday. EAGLE PASS, TX not operate to bind FDA or the public. DE LOS SANTOS GARCIA, An alternative approach may be used if Dated: November 2, 2000. MARILU ...... 11/20/2000 such approach satisfies the applicable Linda S. Kahan, EAGLE PASS, TX statute, regulations, or both. Deputy Director for Regulations Policy, Center DEL TORO PHARMACY ...... 11/20/2000 for Devices and Radiological Health. MIAMI, FL The agency has adopted good DENIS, ALFONSO ...... 11/20/2000 [FR Doc. 00–29110 Filed 11–8–00; 4:21 pm] guidance practices (GGP’s) and EL MONTE, CA published the final rule, which set forth BILLING CODE 4160±01±F DIAZ, RACHEL M ...... 11/20/2000 the agency’s regulations for the HIALEAH, FL development, issuance, and use of DONALDSON, JAMES FRED .. 11/20/2000 guidance documents (65 FR 56468, DEPARTMENT OF HEALTH AND BERRIEN SPRINGS, MI September 19, 2000). This guidance HUMAN SERVICES FERREIRO, CARLOS M ...... 11/20/2000 document is issued as a Level 1 draft MIAMI, FL guidance consistent with the GGP’s. Office of Inspector General FISHER, STEPHEN NEAL ...... 11/20/2000 PITTSBURGH, PA III. Electronic Access Program Exclusions: October 2000 FLORES, JOSE MARTIN ...... 11/20/2000 DOWNEY, CA In order to receive the draft guidance AGENCY: Office of Inspector General, GALE, STACEY R ...... 11/20/2000 entitled ‘‘Guidance for Prescription Use HHS. DONALSONVILLE, GA Drugs of Abuse Assays Premarket ACTION: Notice of program exclusions. GALIANO, CARMEN Notifications’’ via your fax machine, call SOCORRO ...... 11/20/2000 the CDRH Facts-On-Demand system at During the month of October 2000, MIAMI, FL 800–899–0381 or 301–827–0111 from a the HHS Office of Inspector General GARCIA, EDUARDO G ...... 11/20/2000

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MIAMI, FL MONTGOMERY, PA RIDGELEY, WV HERNANDEZ, ALDO ...... 11/20/2000 GRIFFITH, JOHN E JR ...... 11/20/2000 MIAMI, FL FELONY CONTROL SUBSTANCES BELLHAVEN, NC HERNANDEZ, FRANCISCO .... 11/20/2000 CONVICTION MACWAN, NELSON M ...... 11/20/2000 HIALEAH, FL BROOKLYN, NY HUBBARD, EMILY A ...... 11/20/2000 BRANNON, ROBERT WILLIAM 11/20/2000 MYRTLE BEACH, SC HILLIARD, OH LICENSE REVOCATION/SUSPENSION/ ISAAC, LAJUANA ...... 11/20/2000 FARRIS, DEBRA ANN SEARS 11/20/2000 SURRENDERED BLOOMFIELD HILLS, MI CORBIN, KY JOHNSON, VICTOR LEE ...... 11/20/2000 HOPKINS, MARSHA ANN ...... 11/20/2000 ADAMS, SHARON TOTH ...... 11/20/2000 EVANS, GA WAYNESBURG, PA VIRGINIA BCH, VA LIFESTART CLINIC, INC ...... 11/20/2000 LOGSDON, LISA D ...... 11/20/2000 ANDERSON, MICHAEL O ...... 11/20/2000 SCHENECTADY, NY LOUISVILLE, KY RANCHO PALOS VERDES, LITTLEJOHN, JUANITA JO ..... 11/20/2000 MARTENS, ALROY VERN ...... 11/20/2000 CA LINDEN, TX HUTCHINSON, KS BALLARD, JAMES VERNON ... 11/20/2000 MARTIN, CASSANDRA ...... 11/20/2000 MERCER, MICHAEL J ...... 11/20/2000 LILLIAN, AL JAMAICA, NY STUTTGART, AR BARKER, ROBERTA L ...... 11/20/2000 MERRIMAN, MARTIN JAMES 11/20/2000 RITCHIE, HENRY S ...... 11/20/2000 SHENANDOAH, IA WARREN, MI SPARTANBURG, SC BELLIS, BARBARA ...... 11/20/2000 MORENO, JORGE F ...... 11/20/2000 TYSELL, BARBARA PHILADELPHIA, PA MIAMI, FL ELISABETH ...... 11/20/2000 BENDA, CHERYL DENISE ...... 11/20/2000 MYERS, MARY LU ...... 11/20/2000 ROYAL OAK, MI OKARCHE, OK UPPER SANDUSKY, OH BENITEZ, OLGA ...... 11/20/2000 NELLIS, SCOTT LOUIS ...... 11/20/2000 PATIENT ABUSE/NEGLECT CONVICTIONS JACKSON HEIGHTS, NY LAS VEGAS, NV BRIGHT, KRYSTIQUE ANNE .. 11/20/2000 NICKERSON, ANNIE ...... 11/20/2000 BAZZLE, TINA MARIE ...... 11/20/2000 VALLEJO, CA LONG BEACH, CA YUMA, AZ BROWN, KAREN R ...... 11/20/2000 OLADIPO, DOHERTY ...... 11/20/2000 EVANS, CHARLES E ...... 11/20/2000 MIDDLE ISLAND, NY MARIETTA, GA LINDEN, TN BUCHANAN, WALTER ...... 11/20/2000 OVAKIMIAN, SAMVEL ...... 11/20/2000 GLOVER, TYRONE B ...... 11/20/2000 ST LOUIS, MO GLENDALE, CA RIDGELAND, SC CADLE, NANCY J ...... 11/20/2000 PEDRO, CAPOTE N ...... 11/20/2000 GOODYEAR, SARAH ...... 11/20/2000 ONEIDA, TN MIAMI, FL LOS LUNAS, NM CALCIANO, ANGELA W ...... 11/20/2000 PEREZ, ALINA ...... 11/20/2000 HACKLER, LEVESTER ...... 11/20/2000 MEDIA, PA HIALEAH, FL WARRENVILLE, OH CAMPANELLA, CARL JO- PINSKY, ABE ...... 11/20/2000 HALL, ODESSA LEE ...... 11/20/2000 SEPH ...... 11/20/2000 NEW YORK, NY SHREVEPORT, LA DUQUOIN, IL PURVIS, JOHN AUSTIN ...... 11/20/2000 HOSKINS, VIRGINIA ...... 11/20/2000 CAMPBELL, DARLENE ...... 11/20/2000 WARREN, MI GREENVILLE, MS BALTIMORE, MD RODRIGUEZ, CARLOS ...... 11/20/2000 IDLEWOOD ASSOCIATES, CASTELLON, JANET ...... 11/20/2000 MIAMI, FL LTD ...... 11/20/2000 HORN LAKE, MS SANCHUK, DANIEL PAUL ...... 11/20/2000 KNOXVILLE, TN CHERAMIE, SUSAN ...... 11/20/2000 BEL ALTON, MD LEE, JOHN JOON ...... 11/20/2000 CARRIERE, MS SCHNEIDER, BRIAN A ...... 11/20/2000 TUCSON, AZ CHRISTIAN, CYNTHIA ALLISE 11/20/2000 PORT ST LUCIE, FL LICHT, DAVID WAYNE ...... 11/20/2000 HOUSTON, TX SCOTT, CHRISTINE ...... 11/20/2000 PAWNEE, OK CLEMENT, KEITH ALAN ...... 11/20/2000 RIDGELAND, SC MILLS, ANNIE ...... 11/20/2000 SAN FRANCISCO, CA SOKOLOW, LLOYD B ...... 11/20/2000 ROCHESTER, NY COLLINS, SUE ...... 11/20/2000 SCHENECTADY, NY MOZEE, PATRINA ...... 11/20/2000 CHATSWORTH, CA SOKUNBI, BAYO ...... 11/20/2000 JACKSON, MS COLOMBO, JOSEPH STE- MARIETTA, GA SIMMONS, CHRISTIAN ...... 11/20/2000 PHEN ...... 11/20/2000 TAN, EGBERT AUNG KYANG 11/20/2000 LAUREL, MS PITTSBURGH, PA TUCKAHOE, NY SMITH, CALLIE MAE ...... 11/20/2000 DAVIS, CYNTHIA STEPHENS 11/20/2000 TAYLOR, ROSALYN ...... 11/20/2000 BROOKHAVEN, MS ROUGEMONT, NC ZANESVILLE, OH STOKES, PERRY ...... 11/20/2000 DAVIS, DAVID W ...... 11/20/2000 VAINIO, DAVID G ...... 11/20/2000 NASHVILLE, TN HOUSTON, TX BUTTE, MT TENNESSEE, MINNIE ...... 11/20/2000 DEAN, JOHNNIE L ...... 11/20/2000 VUONG, TAN VAN ...... 11/20/2000 JACKSON, MS LONGBEACH, MS SAN DIEGO, CA THOMAS, LAWRENCE ...... 11/20/2000 DEVITT, DANIEL M ...... 11/20/2000 WADE, SHANISHA ...... 11/20/2000 JACKSON, MS CARROLTON, OH COMPTON, CA THOMAS, KATRINA ...... 11/20/2000 DOLENZ, BERNARD JOSEPH 11/20/2000 WATTS, JOHN SHELBY, JR ... 11/20/2000 SARDIS, MS FORREST CITY, AR LOS ANGELES, CA WHATLEY, LORETTA ...... 11/20/2000 DOUGHTY, MARY E ...... 11/20/2000 YOUNGSTOWN, OH JUPITER, FL FELONY CONVICTION FOR HEALTH CARE WILLIAMS, TONY ...... 11/20/2000 DRAKE, JEANETTE MARY ..... 11/20/2000 FRAUD BRANDON, MS SANFORD, FL WOODS, KENDRICK L ...... 11/20/2000 DUGAN, PATRICIA ...... 11/20/2000 JONES, SHAWN R ...... 11/20/2000 MEMPHIS, TN GLENSIDE, PA EAST RIDGE, TN ELDRIDGE, MELISSA R ...... 11/20/2000 KING, NOREEN N ...... 11/20/2000 CONTROLLED SUBSTANCE CONVICTIONS DANVILLE, IL ST STEPHENS, SC ELSENBACH, THERESA MAPLE, DEBORAH D ...... 11/20/2000 ARMENTROUT, ROBERT MARIE ...... 11/20/2000 CAMDEN, SC MARK ...... 11/20/2000 CHICAGO, IL PICARIELLO, JOSEPH ...... 11/20/2000 EVANS, DENA LEA SWETT .... 11/20/2000

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Effective Effective Effective Subject, city, state date Subject, city, state date Subject, city, state date

LOUISVILLE, KY OAK GROVE, MN ST PETERSBURG, FL FALSION, JACK W ...... 11/20/2000 MOORE, VICKIE LEE ...... 11/20/2000 YANULAVICH, MARY JANE .... 11/20/2000 BROCKPORT, NY RALEIGH, NC ESSEX JUNCTION, VT FINKEN, CHRISTINE LYNN .... 11/20/2000 MUCH, WENDY SMITH ...... 11/20/2000 FREEPORT, MN ASTON, PA FEDERAL/STATE EXCLUSION/ FIZER, LAURA A ...... 11/20/2000 NICOLAI, TERRY R ...... 11/20/2000 SUSPENSION RED LION, PA HARCOURT, IA GENTRY, RHONDA S ...... 11/20/2000 NOONAN, CHARLES AN- H & H MEDICAL SUPPLY ...... 11/20/2000 ROCKVALE, TN DREW ...... 11/20/2000 LOS ANGELES, CA GIBSON, ROBERT W ...... 11/20/2000 CONCORD, CA PONCA CITY, OK NOOR-KHAN, NAVEED ...... 11/20/2000 FRAUD/KICKBACKS GILBERT, ANN NIETHHAMER 11/20/2000 BEMUS POINT, NY MONROEVILLE, PA O'DONOHUE, MATTHEW JO- DURAMED, INC ...... 05/19/2000 GILLIS, ROBERT P ...... 11/20/2000 SEPH ...... 11/20/2000 THONOTASASSA, FL NEW YORK, NY BAKERSFIELD, CA GLENNON, MAUREEN ALICE 11/20/2000 OLSON, MARSHA S ...... 11/20/2000 WILLIAMSON, LAURA FLINN 05/19/2000 SUMMITVILLE, NY MT PLEASANT, IA THONOTSASSA, FL GOLDFARB, ARTHUR N ...... 11/20/2000 PANTUSCO, CATHERINE WEST LANCASTER, CA JEANNETTE ...... 11/20/2000 OWNED/CONTROLLED BY CONVICTED GREEN, LYNAYA ...... 11/20/2000 POUGHKEEPSIE, NY EXCLUDED SILVER SPRING, MD PERKINS, KENNY L ...... 11/20/2000 GREEN, TANGELIA C ...... 11/20/2000 DES MOINES, IA BOLTON CHIROPRACTIC MEMPHIS, TN PROCACINA, THERESA LYNN 11/20/2000 SVCS, P C ...... 11/20/2000 GRESKO, JEAN M ...... 11/20/2000 CARNEGIE, PA DENVER, CO POTTSTOWN, PA RAM, GOPAL PRASAD ...... 11/20/2000 BUENA VISTA PHARMACY, GROVE, CYNTHIA K ...... 11/20/2000 WHITESTONE, NY INC ...... 11/20/2000 ODEBOLT, IA REESE, NONA ...... 11/20/2000 NEW YORK, NY GURLEY, MELANIE A ...... 11/20/2000 GREENWOOD SPRINGS, DR TOM ALDEN & ANATOMY COLUMBIA, TN MS CHOICE ...... 11/20/2000 GURULE, MARIE LOUISE ...... 11/20/2000 RICHARD, MICHAEL DAVID ... 11/20/2000 CAMBRIDGE, MA MONTCLAIR, CA KING OF PRUSSIA, PA GALE PHARMACY SERVICE, HAM, KEVIN ROBERT ...... 11/20/2000 RIDLEY, CHARLES INC ...... 11/20/2000 POPLAR BLUFF, MO LYNWOOD ...... 11/20/2000 DONALSONVILLE, GA HAMILTON, BETTY LOUISE SANTA ROSA, CA GROSS COSMETIC & FAM DAVIS ...... 11/20/2000 ROBERTS, ALVIN LEE ...... 11/20/2000 DENT, P C ...... 11/20/2000 PADUCAH, KY ARLINGTON, TX HOMEWOOD, IL HANCE, CLAUDIA B ...... 11/20/2000 RYAN, LINDA GREEN ...... 11/20/2000 MARK F BRADSHAW, D D S, NEWPORT, TN GLASGOW, KY P A ...... 11/20/2000 HARRIS, CLAVE L ...... 11/20/2000 RYE, PHYLLIS ...... 11/20/2000 WACONIA, MN FOREST PARK, IL SPRINGFIELD, TN HARRIS, KAREN JOHNSON ... 11/20/2000 SANDERS, BARBARA JEAN ... 11/20/2000 DEFAULT ON HEAL LOAN UNIVERSAL CITY, TX AMARILLO, TX HARTMAN, TED E ...... 11/20/2000 SANFORD, CINDY L ...... 11/20/2000 ADDISON, MICHAEL A ...... 11/20/2000 AUSTIN, TX OSCEOLA, IA HARTSVILLE, SC HATCHER, MICHELLE L ...... 11/20/2000 SPIRES, MELVIN CURTIS ...... 11/20/2000 BALENT, LAURA ...... 11/20/2000 MILWAUKEE, WI CLARKSVILLE, TN BELLEVUE, WA HAY, BOYD LARUE ...... 11/20/2000 STANLEY, MARYETTA ...... 11/20/2000 BENNETT, JOHN S ...... 11/20/2000 HASTINGS, MN HAMILTON, IA SAN MARCOS, TX HEBRON, DELANO N JR ...... 11/20/2000 STEVENS, EDGAR VINCENT 11/20/2000 BURT, JOSEPH M ...... 10/16/2000 CHICAGO, IL BALDWINSVILLE, NY MYRTLE BEACH, SC HEITMEIER, GENEVIEVE A .... 11/20/2000 STORTO, KATHY BECK ...... 11/20/2000 CANNON, DENNIS J ...... 11/20/2000 MEDIAPOLIS, IA MARSHALLTOWN, IA LEWISVILLE, TX HESTER, PAMELA S ...... 11/20/2000 TAYLOR, SUSAN YANCEY ..... 11/20/2000 DOOLIN, GEORGE G ...... 11/20/2000 W BURLINGTON, IA TIPLERVILLE, MS DUBUQUE, IA HOLLINSHED-TAYLOR, BAR- TIPPINS, TRICIA RANDALL .... 11/20/2000 DRISCOLL, MICHAEL T ...... 11/20/2000 BARA ...... 11/20/2000 ELYSBURG, PA TAMPA, FL JACKSON, MS TISBY, MARY ...... 11/20/2000 EHLENFELD, JEFFREY W ...... 11/20/2000 INGRAM, WILLIAM BRADLEY 11/20/2000 TONAWANDA, NY GREENUP, IL WEST, MS TRABI, GEORGE B ...... 11/20/2000 FARROKHZAD, SARAH ...... 11/20/2000 JOHNSON, ROSEMARY HARRISBURG, PA SAN DIEGO, CA CHRISTINE ...... 11/20/2000 UPTON, TONY ...... 11/20/2000 FORD, THOMAS M ...... 11/20/2000 SHEVLIN, MN BOYLE, MS YORBA LINDA, CA KORANDA, CHARLES L ...... 11/20/2000 VELEZ, AUGUSTINE ...... 11/20/2000 HARRIS, LAWRENCE J ...... 11/20/2000 HIRAM, GA ORCHARD PARK, NY CLEVELAND, OH LEVITT, JEFFREY M ...... 11/20/2000 VENNARD, LEIGH ...... 11/20/2000 HILTON, JAMES R JR ...... 11/20/2000 SCOTTSDALE, AZ DES MOINES, IA BEACON FALLS, CT LIBBY, EUGENE KARL, SR .... 11/20/2000 WALL, CYNTHIA C ...... 11/20/2000 HUFF, GREGORY E ...... 11/20/2000 CYPRESS, CA BETHEL, VT GAINESVILLE, FL LIGHTFOOTE, WILLIAM E II ... 11/20/2000 WHITE, LARA C ...... 11/20/2000 JACKSON, DONALD V ...... 11/20/2000 MCLEAN, VA BRUCE, MS AUSTIN, TX MAGERA, JOHN ALLEN ...... 11/20/2000 WHITE, PATRICIA ...... 11/20/2000 LOWE, DANE E ...... 11/20/2000 BRADFORDWOODS, PA BRANDON, MS IONE, CA MONSSEN, SHEILA ANN ...... 11/20/2000 WILLIAMSON, SANDRA T ...... 11/20/2000 MACDONALD, FRANK R ...... 11/20/2000

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SUMMARY: Public Law 102–575, Section DEPARTMENT OF THE INTERIOR Subject, city, state Effective date 206(a)(1) provides: Fish and Wildlife Service ALLENTOWN, PA After two years from the date of enactment MAEDKE, RICHARD C ...... 11/20/2000 of this Act, the District shall, at the option Aquatic Nuisance Species Task Force MILWAUKEE, WI of an eligible county as provided in Meeting MANIER, LINDA A ...... 11/20/2000 paragraph (2), rebate to such county all of the WASHINGTON, DC ad valorem tax contributions paid by such AGENCY: Fish and Wildlife Service, MATHIESEN, DOUGLAS A ..... 10/16/2000 county to the District, with interest but less Interior. SHAWNEE, KS the value of any benefits received by such ACTION: Notice of meeting. MCCARTY, DANIEL J ...... 11/20/2000 county and less the administrative expenses BUTLER, PA incurred by the District to that date. SUMMARY: This notice announces a NIEMAN, EDWARD H ...... 11/20/2000 meeting of the Aquatic Nuisance BEVERLY HILLS, CA Sanpete County desires to pursue local Species (ANS) Task Force. The meeting OSKIN, TERRI A ...... 11/20/2000 water development projects and is topics are identified in the SPOKANE, WA SUPPLEMENTARY INFORMATION. PARKER, BENJAMIN L ...... 11/20/2000 requesting a rebate of a portion of the ad PADUCAH, KY valorem taxes it has paid to CUWCD, DATES: The Aquatic Nuisance Species RAMIREZ, YOLANDA C ...... 11/20/2000 plus interest, to provide the required 35 Task Force will meet from 8:30 a.m. to ATLANTA, GA percent local funding for such projects. 5:00 p.m., Tuesday, November 28, 2000 SADEGHI, MAHYAR ...... 11/20/2000 In a letter dated October 7, 1996, and 8:30 a.m. to 12:30 p.m., Wednesday, PINOLE, CA November 29, 2000. SCHREIBMAN, MARK R ...... 11/20/2000 Sanpete County requested federal GREELEY, CO funding, equal to 65 percent of the costs ADDRESSES: The ANS Task Force SHAPIRO, FELIX ...... 11/20/2000 as set forth in section 206(b)(1), to meeting will be held at the Arlington HUNTINGDON VALLEY, PA implement the projects. Section Hilton and Towers, 950 Stafford Street, SOLLOM, SHERI L ...... 11/20/2000 206(b)(1) states: Arlington, Virginia. PINE BLUFF, AR FOR FURTHER INFORMATION CONTACT: TESSMER, JOHN F ...... 09/28/2000 Upon the request of any eligible county Sharon Gross, Executive Secretary, BROWNWOOD, TX that elects not to participate in the project as Aquatic Nuisance Species Task Force at TICER, LARRY S ...... 11/20/2000 provided in subsection (a), the Secretary 703–358–2308 or by e-mail at: ELIZABETHTOWN, KY shall provide as a grant to such county an [email protected]. TORRES-ORTIZ, HECTOR R .. 11/20/2000 amount that, when matched with the rebate CAROLINA, PR received by such county, shall constitute 65 SUPPLEMENTARY INFORMATION: Pursuant TYLER, NORMAN E ...... 11/20/2000 percent of the cost of implementation of to section 10(a)(2) of the Federal INDIANAPOLIS, IN measures identified in paragraph (2). Advisory Committee Act (5 U.S.C. App. VAN HORN, WILLIAM A ...... 11/20/2000 I), this notice announces a meeting of RUTHERFORDTON, NC Sanpete County, located within the WIMER, RUSS A ...... 11/20/2000 the Aquatic Nuisance Species Task LESLIE, AR Sevier River Basin in Central Utah, is Force. The Task Force was established WOLTER, CHAD C ...... 11/20/2000 requesting federal funding for the by the Nonindigenous Aquatic Nuisance ONALASKA, WI Mayfield New Well Project and the Prevention and Control Act of 1990. Axtell Culinary Water System Topics to be covered during the ANS Task Force meeting on Tuesday and Dated: November 3, 2000. Improvement Project. Both projects are Wednesday include: updates of Calvin Anderson, Jr., municipal improvement projects intended to increase the reliability and activities from the Task Force’s regional Director, Health Care Administrative stability of their existing culinary water panels; a discussion on improving the Sanctions, Office of Inspector General. coordination with the regional panels; a [FR Doc. 00–29046 Filed 11–13–00; 8:45 am] systems. Two agreements will be negotiated—one to provide funding for discussion of the ballast water BILLING CODE 4150±04±P the Mayfield Project and the other for management program; an overview of the Axtell Project. the activities of the Invasive Species Council and Invasive species Advisory DEPARTMENT OF THE INTERIOR DATES: Dates for public negotiation Committee; updates from several Task sessions will be announced in local Force sub-committees including the Notice of Intent To Negotiate newspapers. Communications, Education and Agreements Among the Central Utah Outreach Committee and the Risk Water Conservancy District, Sanpete FOR FURTHER INFORMATION CONTACT: Assessment committee; and other Water Conservancy District, Sanpete Additional information on matters topics. Minutes of the meeting will be County, and Department of the Interior related to this Federal Register notice maintained by the Executive Secretary, for Implementation of Projects in can be obtained at the address and Aquatic Nuisance Species Task Force, Sanpete County, UT telephone number set forth below: Reed Suite 851, 4401 North Fairfax Drive, Murray, CUP Completion Act Office, Arlington, Virginia 22203–1622, and AGENCY: Office of the Assistant Department of the Interior, 302 East will be available for public inspection Secretary—Water and Science, 1860 South, Provo, UT 84606–6154, during regular business hours, Monday Department of the Interior. (801) 379–1237, [email protected]. through Friday. ACTION: Notice of intent to negotiate Dated: November 8, 2000. agreements among the Central Utah Dated: October 13, 2000. Cathleen I. Short, Water Conservancy District (CUWCD), Ronald Johnston, Sanpete Water Conservancy District, CUP Program Director, Department of the Aquatic Nuisance Species Task Force, Interior. Assistant Director—Fisheries and Habitat Sanpete County, and the Department of Conservation. the Interior for implementation of [FR Doc. 00–29045 Filed 11–13–00; 8:45 am] [FR Doc. 00–29074 Filed 11–13–00; 8:45 am] Projects in Sanpete County, Utah. BILLING CODE 4310±RK±U BILLING CODE 4310±55±M

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DEPARTMENT OF THE INTERIOR Dated: November 1, 2000. Lands jurisdictions in the United States Richard Conrad, Virgin Islands. Bureau of Land Management Assistant Manager, Non-renewable Resources. Description Date [NV±930±1430±HN; Nev±067245] [FR Doc. 00–29044 Filed 11–13–00; 8:45 am] NE20±04, St. Thomas ...... June 4, 2000. BILLING CODE 4310±HC±M Notice of Opening Order of Public (With supporting Supplemental Official OCS Lands; Washoe County, NV Block Diagrams) DEPARTMENT OF THE INTERIOR NE20±07, St. Croix ...... June 4, 2000. SUMMARY: This notice opens the (With supporting Supplemental Official OCS following described 153.48 acres of Minerals Management Service Block Diagrams) public land in Spanish Springs Valley to the operation of the public land laws: Availability of United States Virgin Copies of this information may be Islands Territorial Submerged Lands Mount Diablo Meridian obtained by logging on to the Minerals Act Boundary Determination and Management Service’s website at ftp:// T. 20 N., R. 20 E., Submerged Lands Jurisdictions mmspub.mms.gov/pub/mapping/vi/ Sec. 14, lots 1–3, SW1⁄4NE1⁄4. AGENCY: Minerals Management Service, FOR FURTHER INFORMATION CONTACT: Mr. EFFECTIVE DATE: The effective date of Interior. Leland F. Thormahlen, Chief, Mapping this Notice is November 29, 2000. and Boundary Branch, P.O. Box 25165 ACTION: Availability of United States MS 4011, Denver Federal Center, FOR FURTHER INFORMATION CONTACT: Jo Virgin Islands Territorial Submerged Ann Hufnagle, Realty Specialist, Bureau Lakewood, Colorado 80225, Telephone Lands Act Boundary Determinations (303) 275–7120 or E-Mail of Land Management, Carson City Field and Submerged Lands Jurisdictions. Office, 5665 Morgan Mill Road, Carson [email protected]. City, NV 89701; telephone (775) 885– SUMMARY: Notice is hereby given that Dated: November 8, 2000. 6000. the Minerals Management Service’s Carolita U. Kallaur, Associate Director for Offshore Minerals SUPPLEMENTARY INFORMATION: On Mapping and Boundary Branch has Management. September 5, 1967, Patent No. 27–68– prepared for review and comment by 0044 was issued to Washoe County interested parties on the Territorial [FR Doc. 00–29082 Filed 11–13–00; 8:45 am] pursuant to the Recreation and Public Submerged Lands Act Boundary BILLING CODE 4310±MR±M Purposes Act of June 14, 1926 (44 Stat. Determinations and Submerged Lands 741; 43 U.S.C. 869) as amended, for the Jurisdictions for the United States above-described land. The land was Virgin Islands, including St. Thomas, St. INTERNATIONAL TRADE never developed for recreational use John, and St. Croix. The Mapping and COMMISSION and Washoe County has reconveyed that Boundary Branch has conducted land to the United States. pursuant to 48 U.S.C. 1705(b), coastline ownership record searches, field [Investigation No. 332±420] At 10 a.m. on November 29, 2000, the investigations, baseline point land will become open to the operation development, and review and Advice Concerning Possible of the public land laws generally, mathematical computations to derive Modifications to the U.S. Generalized subject to valid existing rights, the and define these boundaries and System of Preferences With Respect to provisions of existing withdrawals, jurisdictions. The Terrirotial Submerged Certain Products Imported From India other segregations of record and the Lands Act Boundary and Submerged requirements of applicable law. All Lands Jurisdictions referenced in this AGENCY: United States International valid applications received at or prior to notice were derived in part by using Trade Commission. 10 a.m. on November 29, 2000, shall be copies of the most current National considered as simultaneously filed at ACTION: Institution of investigation and Ocean Service nautical charts. The scheduling of hearing. that time. Those received thereafter Territorial Submerged Lands Act shall be considered in the order of Boundary was developed as an filing. SUMMARY: On October 31, 2000, the ambulatory boundary. This means that Commission received a request from the At 10 a.m. on December 14, 2000, the the boundary will continue to move United States Trade Representative land will also be open to location under with the erosions and accretions of the (USTR) for an investigation under the United States mining laws. coastline. Outer Continental Shelf section 332(g) of the Tariff Act of 1930 Appropriation of the land under the Official Protraction Diagrams and for the purpose of providing advice general mining laws prior to the date Supplemental Official Outer concerning possible modifications to the and time of restoration is unauthorized. Continental Shelf Block Diagrams Generalized System of Preferences Any such attempted appropriation, approved on the date indicated below (GSP) with respect to certain products including attempted adverse possession are on file and available to the public for imported from India. under 30 U.S.C. 38, shall vest no rights review, comment, and information in against the United States. Acts required the Minerals Management Service, Following receipt of the request and to establish a location and to initiate a Mapping and Boundary Branch, in accordance therewith, the right of possession are governed by State Lakewood, Colorado. In accordance Commission instituted investigation No. law where not in conflict with Federal with Title 43, U.S.C. Sections 1457 and 332–420 in order to provide advice as to law. The Bureau of Land Management 1458 and Title 48, U.S.C. Section 1705, whether any industry in the United will not intervene in disputes between these diagrams listed below are the States is likely to be adversely affected rival locators over possessory rights basic record for the legal description of by a waiver of the competitive need since Congress has provided for such the Territorial Submerged Lands and limits specified in section 503(c)(2)(A) determination in local courts. Federal and Territorial Submerged of the Trade Act of 1974, with respect

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 68158 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices to the HTS subheadings 1 listed below at the hearing are received by the close Therefore, in accordance with section imported from India: of business on November 27, 2000, the 1301.34 of Title 21, Code of Federal 7113.19.25 7418.19.10 hearing will be canceled. Any person Regulations (CFR), notice is hereby 7113.19.29 9405.50.30 interested in attending the hearing as an given that on February 3, 2000, Stepan 7113.19.50 observer or non-participant may call the Company, Natural Products Department, With respect to the competitive need Secretary to the Commission (202–205– 100 W. Hunter Avenue, Maywood, New limit in section 503(c)(2)(A)(i)(I) of the 1816) after November 28, 2000 to Jersey 07607, made application by 1974 Act, the Commission, as requested, determine whether the hearing will be renewal to the Drug Enforcement will use the dollar value limit of held. Administration to be registered as an $95,000,000. Written Submissions importer of coca leaves (9040), a basic As requested by USTR, the class of controlled substance listed in In lieu of or in addition to appearing Schedule II. Commission will seek to provide its at the public hearing, interested persons advice not later than February 6, 2001. The firm plans to import the coca are invited to submit written statements leaves to manufacture bulk controlled EFFECTIVE DATE: November 6, 2000. concerning the investigation. Written substance. FOR FURTHER INFORMATION CONTACT: (1) statements should be received by the Any manufacturer holding, or Project Manager, Eric Land (202–205– close of business on December 21, 2000. applying for, registration as a bulk 3349), (2) Deputy Project Manager, Commercial or financial information manufacturer of this basic class of Cynthia B. Foreso (202–205–3348). The which a submitter desires the controlled substance may file written above persons are in the Commission’s Commission to treat as confidential comments on or objections to the Office of Industries. For information on must be submitted on separate sheets of application described above and may, at legal aspects of the investigation contact paper, each clearly marked the same time, file a written request for William Gearhart of the Commission’s ‘‘Confidential Business Information’’ at a hearing on such application in Office of the General Counsel at 202– the top. All submissions requesting accordance with 21 CFR 1301.43 is such 205–3091. confidential treatment must conform form as prescribed by 21 CFR 1316.47. with the requirements of section 201.6 Background Any such comments, objections or of the Commission’s Rules of Practice requests for a hearing may be addressed, The subject articles the product of and Procedure (19 CFR 201.6). All in quintuplicate, to the Deputy Assistant India are currently ineligible for duty- written submissions, except for Administrator, Office of Diversion free treatment under the GSP program confidential business information, will Control, Drug Enforcement because imports from India exceed the be made available for inspection by Administration, United States competitive need limits. The USTR interested persons. All submissions Department of Justice, Washington, DC letter noted that as a result of a White should be addressed to the Secretary at 20537, Attention: DEA Federal Register House Initiative with India, the Trade the Commission’s office in Washington, Representative (CCR), and must be filed Policy Staff Committee (TPSC) recently D.C. The Commission’s rules do not no later than (30 days from publication). announced in the Federal Register the authorize filing of submissions with the This procedure is to be conducted initiation of a review to consider Secretary by facsimile or electronic simultaneously with and independent modification of the GSP with respect to means. Hearing-impaired individuals of the procedures described in 21 CFR such products imported from India. are advised that information on this 1301.34(b), (c), (d), (e), and (f). As noted Modifications to the GSP which may matter can be obtained by contacting in a previous notice at 40 FR 43745–46 result from this review will be our TDD terminal on (202) 205–1810. (September 23, 1975), all applicants for announced in the spring of 2001. Issued: November 7, 2000. registration to import a basic class of Public Hearing By order of the Commission. any controlled substance in Schedule I Donna R. Koehnke, or II are and will continue to be required A public hearing in connection with Secretary. to demonstrate to the Deputy Assistant this investigation is scheduled to begin Administrator, Office of Diversion at 9:30 a.m. on December 13, 2000, at [FR Doc. 00–29072 Filed 11–13–00; 8:45 am] BILLING CODE 7020±02±P Control, Drug Enforcement the U.S. International Trade Administration that the requirements Commission Building, 500 E Street SW., for such registration pursuant to 21 Washington, DC. All persons have the DEPARTMENT OF JUSTICE U.S.C. 958(a), 21 U.S.C. 823(a), and 21 right to appear by counsel or in person, CFR 1301.34(a), (b), (c), (d), (e), and (f) to present information, and to be heard. Drug Enforcement Administration are satisfied. Persons wishing to appear at the public hearing should file a letter with the Dated: October 31, 2000. Importation of Controlled Substances; John H. King, Secretary, United States International Notice of Application Trade Commission, 500 E St., SW., Deputy Assistant Administrator, Office of Washington, DC 20436, not later than Pursuant to section 1008 of the Diversion Control, Drug Enforcement the close of business (5:15 p.m.) on Controlled Substances Import and Administration. November 27, 2000. In addition, persons Export Act (21 U.S.C. 958(I)), the [FR Doc. 00–29036 Filed 11–13–00; 8:45 am] appearing should file prehearing briefs Attorney General shall, prior to issuing BILLING CODE 4410±09±M (original and 14 copies) with the a registration under this Section to a Secretary by the close of business on bulk manufacturer of a controlled November 29, 2000. Posthearing briefs substance in Schedule I or II and prior DEPARTMENT OF JUSTICE to issuing a regulation under Section should be filed with the Secretary by Federal Bureau of Investigation close of business on December 21, 2000. 1002(a) authorizing the importation of In the event that no requests to appear such a substance, provide DNA Advisory Board Meeting manufacturers holding registrations for 1 See USTR Federal Register notice of November the bulk manufacture of the substance Pursuant to the provisions of the 1, 2000 (65 FR 65370) for article description. an opportunity for a hearing. Federal Advisory Committee Act, notice

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68159 is hereby given that the DNA Advisory x 11″ xerographic weight paper, one Clearance Memorandum, Form ETA– Board (DAB) will meet on Thursday, side only, and bound only by a paper 795; Migrant Worker Itinerary, Form December 7, 2000 from 10:00 a.m. until clip (not stapled). All pages must be ETA–785; and Job Service Manifest 12:00 p.m. at the DoubleTree Hotel, 300 numbered. Statements should include Record, Form ETA–785A. Army Navy Drive, Arlington, Virginia the Name, Organizational Affiliation, A copy of the proposed information 22202. All attendees will be admitted Address, and Telephone number of the collection request can be obtained by only after displaying personal author(s). Written statements for the contacting the employee or office listed identification which bears a photograph record will be included in minutes of below in the ADDRESSES section of this of the attendee. the meeting immediately following the notice. The DAB’s scope of authority is: To receipt of the written statement, unless DATES: Written comments must be develop, and if appropriate, periodically the statement is received within three submitted to the office listed in the revise, recommended standards for weeks of the meeting. Under this addressee’s section below on or before quality assurance to the Director of the circumstance, the written statement will January 16, 2001. FBI, including standards for testing the be included with the minutes of the ADDRESSES: Roberto Carmona, National proficiency of forensic laboratories, and following meeting. Written statements Monitor Advocate, Office of Career forensic analysts, in conducting analysis for the record should be submitted to Transition Assistance, U.S. Employment of DNA; To recommend standards to the the DFE. Service/ALMIS, Employment and Director of the FBI which specify Inquiries may be addressed to the Training Administration, 200 criteria for quality assurance and DFE, Dr. Dwight E. Adams, Deputy Constitution Avenue, NW., Rm. S–4231, proficiency tests to be applied to the Assistant Director, Laboratory Washington, DC 20210; (202) 219–5257 various types of DNA analysis used by Division—Room 3821, Federal Bureau (not a toll-free number); Internet forensic laboratories, including of Investigation, 935 Pennsylvania address: [email protected]; and/or statistical and population genetics Avenue, NW, Washington, DC 20535– Fax: (202) 208–5844. issues affecting the evaluation of the 0001, (202) 324–6071, FAX (202) 324– frequency of occurrence of DNA profiles 1462. SUPPLEMENTARY INFORMATION: calculated from pertinent population Dated: November 6, 2000. I. Background database(s); To recommend standards Dwight E. Adams, for acceptance of DNA profiles in the The Migrant and Seasonal Farm FBI’s Combined DNA Index System Deputy Assistant Director, Forensic Analysis Worker regulations at 20 CFR 653.500 Branch, Federal Bureau of Investigation. (CODIS) which take account of relevant established procedures for agricultural privacy, law enforcement and technical [FR Doc. 00–29043 Filed 11–13–00; 8:45 am] clearance to all local offices to use the issues; and, To make recommendations BILLING CODE 4410±02±P interstate clearance forms as prescribed for a system for grading proficiency by ETA. Local and State employment testing performance to determine offices use the Agricultural and Food whether a laboratory is performing DEPARTMENT OF LABOR Processing Clearance Order to extend acceptably. job orders beyond their jurisdictions. The topics to be discussed at this Employment and Training Applicants holding local offices use the meeting include: a review of the Administration Agricultural Clearance Memorandum to give notice of action on a clearance minutes from the Wednesday, July 12 Proposed Collection; Comment order, request additional information, and Thursday, July 13, 2000 meeting in Request San Antonio, Texas and review and report results, and to accept or reject the discussion of the Privacy Act Notice. ACTION: Notice. extended job order. State agencies use This is the final meeting of the DAB the Migrant Worker Itinerary to transmit before its term expires on December 31, SUMMARY: The Department of Labor, as employment and supportive service 2000. part of its continuing effort to reduce information to labor-demand areas, and The meeting is open to the public on paperwork and respondent burden to assist migrant workers in obtaining a first-come, first seated basis. Anyone conducts a preclearance consultation employment. The Job Service Manifest wishing to address the DAB must notify program to provide the general public Record shows names, addresses, and the Designated Federal Employee (DFE) and Federal agencies with an characteristics of all people named on in writing at least twenty-four hours opportunity to comment on proposed the Migrant Worker Itinerary. before the DAB meeting. The and/or continuing collections of notification must include the requestor’s information in accordance with the II. Review Focus name, organizational affiliation, a short Paperwork Reduction Act of 1995 The Department of Labor is statement describing the topic to be (PRA95) (44 U.S.C. 3506(c)(2)(A)). This particularly interested in comments addressed, and the amount of time program helps to ensure that requested which: requested. Oral statements to the DAB data can be provided in the desired • Evaluate whether the proposed will be limited to five minutes and format, reporting burden (time and collection of information is necessary limited to subject matter directly related financial resources) is minimized, for the proper performance of the to the DAB’s agenda, unless otherwise collection instruments are clearly functions of the agency, including permitted by the Chairman. understood, and the impact of collection whether the information will have Any member of the public may file a requirements on respondents can be practical utility; written statement for the record properly accessed. • Evaluate the accuracy of the concerning the DAB and its work before Currently, the Employment and agency’s estimate of the burden of the or after the meeting. Written statements Training Administration (ETA) is proposed collection of information, for the record will be furnished to each soliciting comments concerning the including the validity of the DAB member for their consideration proposed extension collection of the methodology and assumptions used; and will be included in the official Agricultural and Food Processing • Enhance the quality, utility, and minutes of a DAB meeting. Written Clearance Order, Form ETA–790; clarity of the information to be statements must be type-written on 81⁄2″ Agricultural and Food Processing collected; and

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• Minimize the burden of the conducts a preclearance consultation (ii) Job order: one year.’’ collection of information on those who program to provide the general public II. Review Focus are to respond, including through the and Federal agencies with an use of appropriate automated, opportunity to comment on proposed The Department of Labor is electronic, mechanical, or other and/or continuing collections of particularly interested in comments technological collection techniques or information in accordance with the which: other forms of information technology, Paperwork Reduction Act of 1995 • Evaluate whether the proposed e.g., permitting electronic submissions (PRA95) (44 U.S.C. 3506(c)(A)). This collection of information is necessary of responses. program helps to ensure that requested for the proper performance of the data can be provided in the desired III. Current Actions functions of the agency, including format, reporting burden (time and whether the information will have This is a request for OMB approval financial resources) is minimized, practical utility; under the Paperwork Reduction Act of collection instruments are clearly • Evaluate the accuracy of the 1995 (44 U.S.C. 3506(C)(2)(a) of an understood, and the impact of collection agency’s estimate of the burden of the extension to an existing collection of requirements on respondents can be proposed collection of information, information previously approved and properly assessed. Currently, the including the validity of the assigned OMB Control No. 1205–0134. Employment and Training methodology and assumptions used; There is no change in burden. Administration is soliciting comments • Enhance the quality, utility, and Type of Review: Extension. concerning the proposed extension clarity of the information to be Agency: Employment and Training collection of data contained on the Job collected; and Administration. Order and Work Application. • Titles: Agricultural and Food A copy of the proposed information Minimize the burden of the Processing Clearance Order, collection request can be obtained by collection of information on those who Agricultural Clearance Memorandum, contacting the office listed in the are to respond, including through the Migrant worker Itinerary, and Job addressees section of this notice. use of appropriate automated, electronic, mechanical, or other Service Manifest Record. DATES: Written comments must be OMB Number: 1205–0134. submitted to the office listed in the technological collection techniques or Frequency: On occasion. addressees section below on or before other forms of information technology, Affected Public: Individuals and January 16, 2000. e.g., permitting electronic submissions households, employers, and State of responses. governments. ADDRESSES: Number of Respondents: 52. Grace A. Kilbane, Administrator, Office III. Current Actions of Workforce Security, Employment Estimated Time Per Respondent: This is a request for OMB approval and Training Administration, 200 under the Paperwork Reduction Act of Constitution Avenue, NW., Rm. S– Volume Hours per Hours 1995 (44 U.S.C. 3506(c)(2)(A) of an Form per year response per year 4231, Washington, DC 20210; (202) extension to previously approved record 219–7831 (not a toll-free number); keeping requirement assigned OMB ETA±790 ... 2,000 1.0 2,000 Internet address: Control No. 1205–0001. There is no ETA±795 ... 3,000 .5 1,500 [email protected]; and/or Fax: ETA±785 ... 3,500 .5 1,750 change in burden. ETA±785A 2,500 .5 1,250 (202) 219–8506); or Eric R. Johnson, Director, Office of Type of Review: Extension, without Career Transition Assistance, change. Estimated Burden Hours: 6,500. Agency: Employment and Training Total Estimated Cost: None. Employment and Training Administration. Comments submitted in response to Administration, 200 Constitution this request will be summarized and/or Avenue, NW., Rm. S–231, Title: Work Application/Job Order included in the request for Office of Washington, DC 20210; (202) 219– Record keeping. Management and Budget approval of the 7831 (not a toll-free number); Internet OMB Number: 1205–0001. information collection request; they will address: [email protected]; and/or Frequency: Record keeping. Fax: (202) 219–0323). also become a matter of public record. Affected Public: State governments. SUPPLEMENTARY INFORMATION: Dated: October 17, 2000. Number of Respondents: 52. Grace A. Kilbane, I. Background Estimated Cost Per Respondent: No Administrator, Office of Workforce Security. States collect basic labor exchange cost to respondent. [FR Doc. 00–29037 Filed 11–13–00; 8:45 am] information, using a system of their Estimated Burden Hours: 208. BILLING CODE 4510±30±M choice. The exact information to be collected is determined by the State. It Hours Total Items States* per year (hours) is information that is essential to the DEPARTMENT OF LABOR operation of the labor exchange job Worker Ap- placement service and normally Employment and Training plication ... 52 4 208 collected as part of Job Matching. At a Job Order .... 52 4 208 Administration minimum, information to be collected is *52 States include Puerto Rico and the Dis- Proposed Collection; Comment that which enables the State to comply trict of Columbia. Request with regulations at 20 CFR part 652, and the Wagner-Peyser Act, as amended. Comments submitted in response to ACTION: Notice. The requirement to retain information this notice will be summarized and/or under 20 CFR 652.8(d)(5) is: ‘‘Each State included in the request for Office of SUMMARY: The Department of Labor, as shall retain basic documents for the Management and Budget approval of the part of its continuing effort to reduce minimum period specified below:’’ information collection request; they will paperwork and respondent burden (i) work application: one year also become a matter of public record.

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Dated: October 17, 2000. Administration, U.S. Department of Veterans Health Administration (VHA) Grace A. Kilbane, Labor, Room N–4641, 200 Constitution related to its safety and health Administrator, Office of Workforce Security. Avenue, NW., Washington, DC 20210. partnership; and a presentation by Dr. [FR Doc. 00–29038 Filed 11–13–00; 8:45 am] Telephone: (202) 219–8502 ext 119 Rita C. Richey of Wayne State (VOICE) or (202) 326–2577 (TDD) (these BILLING CODE 4510±30±M University related to the evaluation of are not toll-free numbers). training programs. Signed at Washington, DC, this 7th day of Written data, views or comments for DEPARTMENT OF LABOR November, 2000. consideration by the committee may be James C. DeLuca, submitted, preferably with 20 copies, to Employment and Training Acting Director, Office of National Programs. Joanne Goodell at the address provided Administration [FR Doc. 00–29040 Filed 11–13–00; 8:45 am] below. Any such submissions received BILLING CODE 4510±30±P prior to the meeting will be provided to Workforce Investment Act: Native the members of the Committee and will American Employment and Training be included in the record of the Council DEPARTMENT OF LABOR meeting. AGENCY: Employment and Training Because of the need to cover a wide Administration, Labor. Occupational Safety and Health variety of subjects in a short period of Administration time, there is usually insufficient time ACTION: Notice of meeting. on the agenda for members of the public National Advisory Committee on SUMMARY: Pursuant to section 10(a)(2) of to address the committee orally. Occupational Safety and Health; Notice the Federal Advisory Committee Act However, any such requests will be of Meeting (FACA) (Pub. L. 92–463), as amended, considered by the chair, who will and section 166(h)(4) of the Workforce Notice is hereby given of the date and determine whether or not time permits. Investment Act (WIA) [29 U.S.C. location of the next meeting of the Any request to make an oral 2911(h)(4)], notice is hereby given of the National Advisory Committee on presentation should state the amount of initial meeting of the Native American Occupational Safety and Health time desired, the capacity in which the Employment and Training Council as (NACOSH), established under section person would appear, and a brief constituted under WIA. 7(a) of the Occupational Safety and outline of the content of the presentation. Individuals with TIME AND DATE: The meeting will begin Health Act of 1970 U.S.C. (29 656) to at 9 a.m. EST on Monday, December 4, advise the Secretary of Labor and the disabilities who need special 2000, and continue until 5 p.m. EST Secretary of Health and Human Services accommodations should contact Veneta that day. The meeting will reconvene at on matters relating to the administration Chatmon (phone: 202–693–1912; FAX: 9 a.m. EST on Tuesday, December 5, of the Act. NACOSH will hold a meeting 202–693–1634) one week before the 2000, and adjourn at 2:55 p.m. EST on on December 5–6, 2000, in Room N3437 meeting. that day. The period from 3 p.m. to 5 A–C of the Department of Labor An official record of the meeting will p.m. EST on December 4 will be Building located at 200 Constitution be available for public inspection in the reserved for participation and Avenue NW., Washington, DC. The OSHA Technical Data Center (TDC) presentation by members of the public. meeting is open to the public and will located in Room N2625 of the Department of Labor Building (202) PLACE: The Monday session will be held begin at 9 a.m. lasting until approximately 4 p.m. each day. 693–2350). For additional information in Room N–5437 A, B, and C, Frances contact: Joanne Goodell, Occupational Perkins Building, the U.S. Department Since the last meeting on September 13–14, three new members have been Safety and Health Administration of Labor, 200 Constitution Avenue, (OSHA) N–3641, 200 Constitution NW., Washington, DC 20210. The added to replace three former members. These include: Public Representative Avenue, NW., Washington, DC 20210 Tuesday session will be held in the (phone 202–693–1925; FAX: 202–693– Arlington Room of the Hyatt Regency Myrtle I. Turner, a Research Scientist at Georgia Tech Research Institute who 1641; e-mail joanne. [email protected]); Crystal City Hotel, 2799 Jefferson Davis or check the National Advisory Highway, Arlington, Virginia 22202. will replace Nancy Lessin; Management Representative Judith S. Freyman, Committee on Occupational Safety and STATUS: The meeting will be open to the Director of Regulatory Affairs at Health information pages located at public. ConAgra Foods who will replace Dennis www.osha.gov. MATTERS TO BE CONSIDERED: The agenda Scullion; and Safety Representative Dated: Signed at Washington, DC this 6th will focus on the following topics: (1) Rixio Enrique Medina, Manager of day of November 2000. Comments from the Department on Health and Safety Services for CITGO, Charles N. Jeffress. overall employment and training issues; who will replace Dave Heller. The first Assistant Secretary of Labor for Occupational (2) FACA orientation for Council day of the meeting will begin with an Safety and Health. Members; (3) status of WIA overview of current activities of the [FR Doc. 00–29039 Filed 11–13–00; 8:45 am] implementation efforts; (4) discussion of Occupational Safety and Health BILLING CODE 4510±26±M WIA management issues; (5) the Council Administration (OSHA) and the report to the Department and Congress; National Institute for Occupational (6) status of technical assistance and Safety and Health (NIOSH). Other training provision for PYs 2000 and agenda items include: a presentation on NATIONAL AERONAUTICS AND 2001; and (7) status of the PY 2000 the new Worker Health Chartbook, SPACE ADMINISTRATION Partnership Plan. 2000, which has just been released by [Notice 00±137] FOR FURTHER INFORMATION CONTACT: NIOSH; a panel presentation by the James C. DeLuca, Chief, Division of National Institute of Environmental Notice of Prospective Patent License Indian and Native American Programs, Health Sciences (NIEHS) related to its Office of National Programs, Worker Education and Training Program AGENCY: National Aeronautics and Employment and Training Partnership; a presentation by the Space Administration.

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ACTION: Notice of Prospective Patent Dated: November 6, 2000. 2:15 p.m. and 3:30 p.m. to 6 p.m. on License. Edward A. Frankle, December 14th, will be closed. General Counsel. SUMMARY: NASA hereby gives notice Museums (Access, Education, and [FR Doc. 00–29015 Filed 11–13–00; 8:45 am] that Concepts ETI Inc., of White River Heritage/Preservation categories) Junction, has applied for a co-exclusive BILLING CODE 7510±01±U December 12–15, 2000, Room 716 license to practice the invention described and claimed in NASA Case A portion of this meeting, from 11 Number MFS 31303–1, entitled NATIONAL FOUNDATION ON THE a.m. to 12:30 p.m. on December 15th, ‘‘Generalized Fluid System Simulation ARTS AND THE HUMANITIES will be open to the public for policy Program (GFSSP),’’ which is assigned to discussion. The remaining portions of the United States of America as National Endowment for the Arts; this meeting, from 9 a.m. to 6:30 p.m. represented by the Administrator of the Combined Arts Advisory Panel on December 12th–14th and from 9 a.m. National Aeronautics and Space to 11 a.m. and 12:30 p.m. to 4 p.m. on Administration. Written objections to Pursuant to section 10(a)(2) of the December 15th, will be closed. the prospective grant of a license should Federal Advisory Committee Act (Public be sent to: Mr. James McGroary, Patent Law 92–463), as amended, notice is The closed portions of these meetings Counsel/LS01, Marshall Space Flight hereby given that five meetings of the are for the purpose of Panel review, Center, Huntsville, AL 35812. Combined Arts Advisory Panel to the discussion, evaluation, and DATES: Responses to this notice must be National Council on the Arts will be recommendation on applications for received by January 16, 2001. held at the Nancy Hanks Center, 1100 financial assistance under the National Pennsylvania Avenue, NW, Washington, FOR FURTHER INFORMATION CONTACT: Mr. Foundation on the Arts and the D.C. 20506 as follows: Sammy Nabors, Marshall Space Flight Humanities Act of 1965, as amended, Center, Technology Transfer Multidisciplinary (Education category) including information given in Department/CD30, Huntsville, AL confidence to the agency by grant November 20–21, 2000, Room 716 35812; Tel. (256) 544–5226. applicants. In accordance with the A portion of this meeting, from 3:45 determination of the Chairman of May Dated: November 6, 2000. p.m. to 4:45 p.m. on November 21st, 12, 2000, these sessions will be closed Edward A. Frankle, will be open to the public for policy to the public pursuant to (c)(4)(6) and General Counsel. discussion. The remaining portions of (9)(B) of section 552b of Title 5, United [FR Doc. 00–29016 Filed 11–13–00; 8:45 am] this meeting, from 9 a.m. to 5:30 p.m. States Code. BILLING CODE 7510±01±U on November 20th, and from 9 a.m. to Any person may observe meetings, or 3:45 p.m. and 4:45 p.m. to 6 p.m. on portions thereof, of advisory panels that November 21st, will be closed. NATIONAL AERONAUTICS AND are open to the public, and, if time SPACE ADMINISTRATION Literature (Access, Education, and allows, may be permitted to participate Heritage/Preservation categories) in the panel’s discussions at the [Notice 00±136] December 4–5, 2000, Room 714 discretion of the panel chairman and with the approval of the full-time Notice of Prospective Patent License A portion of this meeting, from 11 Federal employee in attendance. a.m. to 1 p.m. on December 5th, will be AGENCY: National Aeronautics and open to the public for policy discussion. If you need special accommodations Space Administration. The remaining portions of this meeting, due to a disability, please contact the ACTION: Notice of prospective patent from 9 a.m. to 7 p.m. on December 4th, Office of AccessAbility, National license. and from 9 a.m. to 11 a.m. and 1 p.m. Endowment for the Arts, 1100 Pennsylvania Avenue, N.W., SUMMARY: to 5 p.m. on December 5th, will be NASA hereby gives notice Washington, D.C. 20506; 202/682–5532, that Cullimore & Ring Technologies, closed. TDY–TDD 202/682–5496, at least seven Inc., of Littleton, CO, has applied for a Presenting (Access, Education, and (7) days prior to the meeting. co-exclusive license to practice the Heritage/Preservation categories) invention described and claimed in Further information with reference to NASA Case Number MFS 31303–1, December 11, 2000, Room 730 this meeting can be obtained from Kathy entitled ‘‘Generalized Fluid System A portion of this meeting, from 4:45 Plowitz-Worden, Office of Guidelines & Simulation Program (GFSSP),’’ which is p.m. to 6 p.m., will be open to the Panel Operations, National Endowment assigned to the United States of America public for policy discussion. The for the Arts, Washington, D.C. 20506, or as represented by the Administrator of remaining portions of this meeting, from call 202/682–5691. the National Aeronautics and Space 9 a.m. to 4:45 p.m. and 6 p.m. to 7 p.m., Dated: November 7, 2000. Administration. Written objections to will be closed. the prospective grant of a license should Kathy Plowitz-Worden, Multidisciplinary (Access and Heritage/ be sent to: Mr. James McGroary, Patent Panel Coordinator, Panel Operations, Preservation categories) Counsel/LS01, Marshall Space Flight National Endowment for the Arts. Center, Huntsville, AL 35812. December 12–14, 2000, Room 730 [FR Doc. 00–29079 Filed 11–13–00; 8:45 am] DATES: Responses to this notice must be A portion of this meeting, from 2:15 BILLING CODE 7537±01±U received by January 16, 2001. p.m. to 3:30 p.m. on December 14th, FOR FURTHER INFORMATION CONTACT: Mr. will be open to the public for policy Sammy Nabors, Marshall Space Flight discussion. The remaining portions of Center, Technology Transfer this meeting, from 9 a.m. to 6:30 p.m. Department/CD30, Huntsville, AL on December 12th, from 9 a.m. to 6 p.m. 35812; Tel. (256) 544–5226. on December 13th, and from 9 a.m. to

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NUCLEAR REGULATORY NUCLEAR REGULATORY Maryland 20852–2738. Documents COMMISSION COMMISSION issued subsequent to November 1, 1999 are available electronically through the [Docket No. 50±440±CivP; ASLBP No. 01± [Docket No. 50±255] 784±01±CivP; EA 99±012] Agencywide Documents Access and Management System (ADAMS), with Consumers Energy Company; Notice Atomic Safety and Licensing Board; access to the public through NRC’s of Withdrawal of Application for Notice of Hearing Internet Web site (Public Electronic Amendment to Facility Operating Reading Room Link, ). The PDR and many public The U.S. Nuclear Regulatory Bechhoefer, Chairman, Dr. Richard F. Cole, libraries have terminals for public Commission (the Commission) has Ann Marshall Young. access to the Internet. granted the request of Consumers In the Matter of First Energy Operating At the joint request of FENOC and the Energy Company (the licensee) to Company (FENOC) (Perry Nuclear Power NRC Staff, further proceedings in this Plant, Unit 1; Operating License No. NPF– withdraw its August 28, 2000, 58). case have been suspended until application for proposed amendment to This proceeding involves a proposed December 18, 2000, to afford the parties Facility Operating License No. DPR–20 civil penalty of $110,000. sought to be an opportunity to pursue settlement for the Palisades Plant, located in imposed by the NRC Staff on First negotiations. Except to the extent an Covert, Michigan. Energy Operating Company (FENOC or early settlement or other circumstance The proposed amendment would Licensee) for an alleged violation of renders them unnecessary, the have revised the date for implementing NRC’s employee protection regulations, Licensing Board may, during the course the Palisades Plant Improved Technical based upon the asserted discrimination of this proceeding, conduct one or more Specifications as established by by a FENOC management official prehearing conferences and evidentiary Amendment No. 189, dated November against an employee for engaging in hearing sessions. The time and place of 30, 1999. The implementation date protected activities (i.e., testifying in a these sessions will be announced in would have been changed from ‘‘on or whistleblowing case before the Licensing Board Orders. Except as before October 31, 2000,’’ to ‘‘on or Department of Labor). In response to an limited by the parameters of telephone before December 31, 2000.’’ In its letter Order Imposing Civil Monetary Penalty, conferences (which are in any event to dated October 24, 2000, the licensee published at 65 FR 49,610 (August 14, be transcribed), members of the public stated that Amendment No. 189 was 2000), FENOC on October 18, 2000 filed are invited to attend any such sessions. implemented on October 24, 2000, and a timely request for an enforcement For the Atomic Safety and Licensing that the requested delay of hearing. On October 27, 2000, an Board. implementing Amendment No. 189 was Atomic Safety and Licensing Board, Dated: November 7, 2000; Rockville, no longer needed. Therefore, the consisting of Dr. Richard F. Cole, Ann Maryland. licensee requested that the amendment Marshall Young, and Charles Charles Bechhoefer, application be withdrawn. Bechhoefer, who serves as Chairman, Chairman, Administrative Judge. The Commission had previously was established to preside over this [FR Doc. 00–29031 Filed 11–13–00; 8:45 am] issued a Notice of Consideration of proceeding. 65 FR 65,336 (November 1, BILLING CODE 7590±01±P Issuance of Amendment published in 2000). the Federal Register on September 20, Notice is hereby given that, by 2000 (65 FR 56949). However, by letter Memorandum and Order dated NUCLEAR REGULATORY dated October 24, 2000, the licensee November 7, 2000, the Atomic Safety COMMISSION withdrew the proposed change. and Licensing Board has granted the request for a hearing submitted by Advisory Committee on Nuclear For further details with respect to this FENOC. This proceeding will be Waste; Notice of Meeting action, see the application for conducted under the Commission’s amendment dated August 28, 2000, and The Advisory Committee on Nuclear hearing procedures set forth in 10 CFR Waste (ACNW) will hold its 123rd the licensee’s letter dated October 24, Part 2, Subparts B and G. Parties to this 2000, which withdrew the application meeting on November 27–29, 2000, at proceeding are FENOC and the NRC the Center for Nuclear Waste Regulatory for license amendment. Documents may Staff. The issues to be considered, as set be examined, and/or copied for a fee, at Analyses (CNWRA), 6220 Culebra Road, forth in the Order Imposing Civil Building 189, San Antonio, Texas. the NRC’s Public Document Room, Monetary Penalty, are (a) whether the located at One White Flint North, 11555 The entire meeting will be open to Licensee was in violation of the public attendance. Rockville Pike (first floor), Rockville, Commission’s requirements as set forth Maryland, and accessible electronically The schedule for this meeting is as in the Notice of Violation and Proposed follows: through the ADAMS Public Electronic Imposition of Civil Penalty, dated May Reading Room link at the NRC Web site 20, 1999; and (b) whether, on the basis Monday, November 27, 2000 (http://www.nrc.gov). of such violation, the Order Imposing A. 9:00–11:00 A.M.: Opening Dated at Rockville, Maryland, this 6th day Civil Monetary Penalty should be Statement/Planning and Procedures of November 2000. sustained. (Open)—The Chairman will open the For the Nuclear Regulatory Commission. Documents related to this proceeding, meeting with brief opening remarks. Darl S. Hood, issued prior to December 1, 1999, are The Committee will then review items Senior Project Manager, Section 1, Project available in microfiche form (with print under consideration at this meeting and Directorate III, Division of Licensing Project form available on one-day recall) for consider topics proposed for future Management, Office of Nuclear Reactor public inspection at the Commission’s consideration by the full Committee. Regulation. Public Document Room (PDR), Room— B. 11:15–12:00 Noon: Preparation of [FR Doc. 00–29030 Filed 11–13–00; 8:45 am] O–1 F21, NRC One White Flint North, ACNW Reports (Open)—The Committee BILLING CODE 7590±01±P 11555 Rockville Pike, Rockville, will discuss planned reports on the

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 68164 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices following topics: 10 CFR Part 40, Draft Plan for Research Supporting the ACNW meeting notices, meeting entombment, transportation and Alloy Nuclear Waste Safety Arena. transcripts, and letter reports are now C–22. M. 6:00–7:00 P.M.: Discussion of available for downloading or reviewing C. 1:00–1:15 P.M.: Objectives of Proposed ACNW Reports (Open)—The on the internet at http://www.nrc.gov/ ACNW’s CNWRA Review (Open)—The Committee will continue its discussion ACRSACNW. Committee will discuss the objectives of of proposed ACNW reports. Videoteleconferencing service is this review of the CNWRA’s research available for observing open sessions of Wednesday, November 29, 2000 and technical assistance program. ACNW meetings. Those wishing to use D. 1:15–2:15 P.M.: Program Overview: N. 8:30–10:30 A.M.: Tour of this service for observing ACNW Developing Review Capability and Risk Experimental Facilities—The meetings should contact Mr. Theron Information for Pre-and Post-Closure Committee will tour selected CNWRA Brown, ACNW Audiovisual Technician (Open)—The Committee will discuss experimental facilities. (301/415–8066), between 7:30 a.m. and and hear presentations from O. 10:30–12:00 Noon: Investigation 3:45 p.m. EDT at least 10 days before the representatives of the NRC staff, the and Importance of Coupled Processes meeting to ensure the availability of this CNWRA and consultants regarding a Related to Repository Design (Open)— service. Individuals or organizations proposed regulatory framework, The Committee will discuss ongoing requesting this service will be regulatory guidance for site 2 CNWRA coupled processes responsible for telephone line charges recommendation and license investigations. and for providing the equipment and application reviews, analytical tools, P. 12:00–12: 30 P.M.: Miscellaneous facilities that they use to establish the and field and laboratory experimental (Open)—The Committee will discuss videoteleconferencing link. The facilities. matters related to the conduct of availability of videoteleconferencing E. 2:30–4:00 P.M.: Progress Toward Committee activities and matters and services is not guaranteed. Key Technical Issue Resolution specific issues that were not completed The ACNW meeting dates for (Open)—The Committee will discuss during previous meetings, as time and Calendar Year 2001 are provided below: and hear a presentation from the NRC availability of information permit. ACNW Meeting No. and Meeting Date staff regarding the issue resolution Procedures for the conduct of and process and its current status. participation in ACNW meetings were 124th (Rockville, MD): January 16–18, F. 4:00–6:00 P.M.: ACNW’s published in the Federal Register on 2001 Sufficiency Review Task Action Plan October 11, 2000 (65 FR 60475). In February 2001—No meeting (Open)—The Committee will discuss its accordance with these procedures, oral 125th (Rockville, MD): March 6–8, 2001 Sufficiency Review Task Action Plan. or written statements may be presented April 2001—No meeting 126th (Rockville, MD): G. 6:00–7:00 P.M.: Discussion of by members of the public, electronic May 15–17, 2001 Proposed ACNW Reports (Open)—The recordings will be permitted only 127th (Rockville, MD): June 19–21, 2001 Committee will discuss proposed during those portions of the meeting 128th (Rockville, MD): July 17–19, 2001 ACNW Reports on Part 40, entombment, that are open to the public, and 129th (Rockville, MD): August 28–30, transportation, Alloy C–22 and other questions may be asked only by 2001 matters considered during this meeting. members of the Committee, its September 2001—No meeting consultants, and staff. Persons desiring Tuesday, November 28, 2000 130th (Las Vegas, NV): October 16–18, to make oral statements should notify 2001 H. 8:30–10:00 A.M.: Yucca Mountain Howard J. Larson, ACNW, as far in 131st (Rockville, MD): November 27–29, TPA Code and External Review advance as practicable so that 2001 (Open)—The Committee will discuss appropriate arrangements can be made December 2001—No meeting the TPA external review and current to schedule the necessary time during and planned code capability. the meeting for such statements. Use of Dated: November 7, 2000. I. 10:15–12:30 P.M.: Capability of NRC still, motion picture, and television Andrew L. Bates, Staff to Evaluate Risk-Significance of cameras during this meeting will be Advisory Committee Management Officer. Information Submitted by DOE for Post- limited to selected portions of the [FR Doc. 00–29032 Filed 11–13–00; 8:45 am] Closure (Open)—The Committee will meeting as determined by the ACNW BILLING CODE 7590±01±P hear presentations on the analytical Chairman. Information regarding the tools and methods for evaluating the time to be set aside for taking pictures relative importance of issues and may be obtained by contacting the SECURITIES AND EXCHANGE subissues, parameter-level sensitivity ACNW office, prior to the meeting. In COMMISSION methods, post-processor techniques, view of the possibility that the schedule philosophy for addressing uncertainty, for ACNW meetings may be adjusted by [Release No. 35±27268] and the use of the TPA code to support the Chairman as necessary to facilitate Filings Under the Public Utility Holding decision making for SR and LA. the conduct of the meeting, persons Company Act of 1935, as Amended J. 1:30–2:45 P.M.: Pre-Closure Safety planning to attend should notify Mr. (``Act'') Analysis (PCSA) Tool (Open)—The Larson as to their particular needs. Committee will discuss the status of the Further information regarding topics November 6, 2000. PCSA and an example application. to be discussed, whether the meeting Notice is hereby given that the K. 3:00–5:00 P.M.: Alloy C–22 Studies has been canceled or rescheduled, the following filing(s) has/have been made (Open)—The Committee will review the Chairman’s ruling on requests for the with the Commission pursuant to DOE waste package material selection opportunity to present oral statements provisions of the Act and rules and degradation studies and applicable and the time allotted therefore can be promulgated under the Act. All CNWRA confirmatory studies. obtained by contacting Mr. Howard J. interested persons are referred to the L. 5:00–6:00 P.M.: Draft NRC/RES Larson, ACNW (Telephone 301/415– application(s) and/or declaration(s) for Plan for Waste Research (Open)—The 6805), between 8:00 A.M. and 5:00 P.M. complete statements of the proposed Committee will discuss and review the EDT. transaction(s) summarized below. The

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68165 application(s) and/or declaration(s) and SECURITIES AND EXCHANGE stand-alone system that supports testing any amendment(s) is/are available for COMMISSION of the Consolidated Tape System, Consolidated Quotation System, ITS, public inspection through the [Release No. 34±43520; File No. 4±208] Commission’s Branch of Public and the Participants interfaced with Reference. Intermarket Trading System; Order these systems. The NMTS can be used during normal business hours and ITS Interested persons wishing to Approving Fifteenth Amendment to the ITS Plan Relating to Remote will be responsible for one-third of the comment or request a hearing on the costs of the NMTS. The ITS Plan application(s) and/or declaration(s) Specialists, the National Market System Test System, Trade provisions for the NMTS equally divide should submit their views in writing by the ITS costs among all Participants. November 30, 2000, to the Secretary, Adjustment Procedures, and Technical Revisions The proposal adds Section 6(b)(iv) to Securities and Exchange Commission, the ITS Plan, which codifies the trade Washington, DC 20549–0609, and serve November 3, 2000. adjustment process whereby, and a copy on the relevant applicant(s) and/ On June 6, 2000, the Intermarket circumstances under which, supervisors or declarant(s) at the address(es) Trading System (‘‘ITS’’) submitted to the monitoring Participants’ markets may specified below. Proof of service (by Securities and Exchange Commission request the ITS Control Center to enter affidavit or, in the case of an attorney at (‘‘Commission’’) an amendment to the agreed-upon adjustments to system law, by certificate) should be filed with restated ITS Plan pursuant to Section trades (price, size, buy or sell side, the request. Any request for hearing 11A of theSecurities Exchange Act of cancel or insert trade ‘‘as of’’ a prior should identify specifically the issues of 1934 (‘‘Act’’),1 and Rule 11A3a3–2 day). facts or law that are disputed. A person thereunder.2 The Participants filed the The proposal makes several technical who so requests will be notified of any proposal to recognize the amendments dealing with the ITS/CAES Linkage as adopted by the Commission, hearing, if ordered, and will receive a implementation of remote specialists eliminating the definition of the term copy of any notice or order issued in the and the National Market Test System. In addition, the Participants proposed to ‘‘ITS/CAES security (stock)’’ and matter. After November 30, 2000, the codify procedures for trade adjustment making other conforming changes. In application(s) and/or declaration(s), as and to make technical revisions. Notice addition, the revision reinserts text in filed or as amended, may be granted of the proposal appeared in the Federal the ITS Plan under Section 5(b)(ii) that and/or permitted to become effective. Register on September 8, 2000.3 The the Commission inadvertently omitted.5 The Southern Company (70–8277) Commission received no comments on According to the Participants, the the proposal. For the reasons discussed revisions are otherwise neutral as to The Southern Company (‘‘Southern’’), below, the Commission is approving the their effect on the Commission’s 270 Peachtree Street, NW., Atlanta, proposal. adopted amendment. Lastly, the Georgia 30303, a registered holding The proposal amends Sections revisions redesignate current Sections company, has filed a post-effective 6(a)(ii)(B) and (E), 7(c) and 8(a) of the 12, 13, and 14 as Sections 13, 14, and amendment under sections 6(a) and 7 of ITS Plan to reflect the changed manner 15 respectively, and current Section 15 the Act and rules 53 and 54 under the in which the BSE and the PCX will as Section 12 (with other conforming Act to an application-declaration interact with ITS, in particular that BSE changes), and amending Section 3(a) to previously filed under the Act. and PCX specialists carry out their reflect the change in the Amex’s specialist operations off the floors of the corporate name from ‘‘American Stock By orders dated August 3, 1995 and BSE and the PCX.4 Exchange, Inc.’’ to ‘‘American Stock December 22, 1999 (HCAR Nos. 26349 The proposal recognizes the National Exchange LLC.’’ and 27119), Southern was authorized, Market Test System (‘‘NMTS’’) as a The Commission finds that the among other things, to issue and sell in proposed amendment is consistent with one or more transactions, through 1 15 U.S.C. 78k–1. the Act in general, and in particular, September 30, 2004 (‘‘Authorization 2 17 CFR 240.11Aa3–2. The ITS is a National with Sections 11A(a)(1)(C)(ii) and (D),6 Market System (‘‘NMS’’) plan, which was designed which provide for fair competition Period’’), up to 25 million shares of its to facilitate intermarket trading in exchange-listed authorized but unissued common stock, equity securities based on current quotation among the Participants and their $5 par value (‘‘Authorized Shares’’). The information emanating from the linked markets. See members, and the linking of markets for number of Authorized Shares may be Securities Exchange Act Release No. 19456 (January qualified securities through 27, 1983), 48 FR 4938 (February 3, 1983). communications and data processing adjusted to reflect any share split or The ITS participants include the American Stock distribution authorized by the Exchange LLC (‘‘Amex’’), the Boston Stock facilities that foster efficiency, enhance Commission. Southern now requests Exchange, Inc. (‘‘BSE’’), the Chicago Board Options competition, increase the information Exchange, Inc. (‘‘CBOE’’), the Chicago Stock available to brokers, dealers, and that the number of Authorized Shares Exchange, Inc. (‘‘CHX’’), the Cincinnati Stock investors, facilitate the offsetting of that may be issued during the Exchange, Inc. (‘‘CSE’’), the National Association of investors’ orders, and contribute to the Authorization Period be increased from Securities Dealers, Inc. (‘‘NASD’’), the New York Stock Exchange, Inc. (‘‘NYSE’’), the Pacific best execution of such orders. The 25 million to 35 million. Exchange, Inc. (‘‘PCX’’), and the Philadelphia Stock Commission also finds that the Exchange, Inc. (‘‘PHLX’’) (‘‘Participants’’). For the Commission, by the Division of 3 amendment is consistent with Rule Securities Exchange Act Release No. 43240 7 Investment Management, under delegated (September 1, 2000), 65 FR 54571 (September 8, 11Aa3–2(c)(2), which requires the authority. 2000). Commission to determine that the Margaret H. McFarland, 4 The BSE and PCX filed proposed rule changes amendment is necessary and with the Commission to implement these changes. appropriate in the public interest, for Deputy Secretary. The Commission approved the BSE’s proposal on [FR Doc. 00–29022 Filed 11–13–00; 8:45 am] August 8, 2000. See Securities Exchange Act Release No. 43127 (August 8, 2000), 65 FR 49617 5 See Securities Exchange Act Release No. 42212 BILLING CODE 8010±01±M (August 14, 2000), (SR–BSE–99–01). The (December 9, 1999), 64 FR 70297 (December 16, Commission approved the PCX’s proposal on May 1999) (adopting amendments to expand the ITS/ 5, 2000. See Securities Exchange Act Release No. CAES linkage to all listed securities). 42759 (May 5, 2000), 65 FR 30654 (May 12, 2000), 6 15 U.S.C. 78k–1(a)(1)(C)(ii) and (D). (SR–PCX–99–39). 7 17 CFR 240.11Aa3–2(c)(2).

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 68166 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices the protection of investors and the automated collection techniques or SUMMARY: Notice is hereby given of the maintenance of fair and orderly markets, other forms of information technology. following determinations: Pursuant to to remove impediments to, and perfect The information collection listed the authority vested in me by the Act of the mechanisms of, a national market below has been submitted to OMB for October 19, 1965 (79 Stat. 985, 22 U.S.C. system or otherwise in furtherance of clearance. Written comments and 2459), the Foreign Affairs Reform and the purposes of the Act. recommendations on the information Restructuring Act of 1998 (112 Stat. The proposal provides for the collection would be most useful if 2681, et seq.), Delegation of Authority recognition of the BSE’s and the PCX’s received within 30 days from the date No. 234 of October 1, 1999, and use of remote specialists to carry out of this publication. Comments should be Delegation of Authority No. 236 of their specialist operations off the floors directed to the SSA Reports Clearance October 19, 1999, as amended, I hereby of the BSE and the PCX. The proposal Officer and the OMB Desk Officer at the determine that the objects to be also provides for the implementation of addresses listed after this publication. included in the exhibition ‘‘Egypt in the the National Market Test System, which You can obtain a copy of the OMB Walters Art Gallery’’ imported from supports testing of the Consolidated clearance package by calling the SSA abroad for the temporary exhibition Tape System, Consolidated Quotation Reports Clearance Officer on (410) 965– without profit within the United States, System, and ITS. In addition, the 4145, or by writing to him. are of cultural significance. These proposal provides for the codification of Waiver of Right to Appear, Disability objects are imported pursuant to a loan procedures for trade adjustment. The Hearing—0960–0534. The Social agreement with a foreign lender. I also Commission believes that the foregoing Security Administration uses Form determine that the exhibition or display measures should improve the efficiency SSA–773–U4 to provide claimants with of the exhibit objects at The Walters Art and reliability of ITS. Lastly, the an effective means of requesting waiver Gallery, Baltimore, Maryland, from proposal provides additional technical of their right to appear at a disability January 15, 2001, through January 15, amendments to the ITS Plan consistent hearing. The information collected will 2004, is in the national interest. Public with ITS’s purpose: to facilitate be used as documentation that Notice of these Determinations is intermarket trading in exchange-listed claimants understand their right to ordered to be published in the Federal equity securities. appear and the effects of the decision to Register. For the foregoing reasons, the waive this right. The respondents are FOR FURTHER INFORMATION CONTACT: For Commission finds that the proposed claimants under Title II (Old-Age, further information, including a list of amendment is consistent with Act and Survivors and Disability Insurance) and exhibit objects, contact Jacqueline the rules and regulations thereunder Title XVI (Supplemental Security Caldwell, Attorney-Adviser, Office of applicable to the ITS and, in particular, Income) of the Social Security Act, who the Legal Adviser, U.S. Department of Sections 11A(a)(1)(C)(ii) and (D) of the wish to waive their right to appear at a State (telephone: 202/619–6982). The Act 8 and Rule 11Aa3–2(c)(2).9 disability hearing. address is U.S. Department of State, SA– It is therefore ordered, pursuant to Number of Respondents: 194. 44, 301 4th Street, S.W., Room 700, Section 11A(a)(3)(B) of the Act,10 that Frequency of Response: 1. Washington, D.C. 20547–0001. the proposed amendment be, and Average Burden Per Response: 25 Dated: October 31, 2000. hereby is, approved. minutes. William B. Bader, For the Commission, by the Division of Estimated Average Burden: 81 hours. (SSA Address) Social Security Assistant Secretary for Educational and Market Regulation, pursuant to delegated Cultural Affairs, Department of State. authority.11 Administration, DCFAM, Attn: [FR Doc. 00–29071 Filed 11–13–00; 8:45 am] Margaret H. McFarland, Frederick W. Brickenkamp, 6401 BILLING CODE 4710±08±P Deputy Secretary. Security Blvd., 1–A–21 Operations [FR Doc. 00–29021 Filed 11–13–00; 8:45 am] Bldg., Baltimore, MD 21235 BILLING CODE 8010±01±M (OMB Address) Office of Management DEPARTMENT OF STATE and Budget, OIRA, Attn: Desk Officer for SSA, New Executive Office [Public Notice 3471] Building, Room 10230, 725 17th St., SOCIAL SECURITY ADMINISTRATION NW., Washington, DC 20503 Culturally Significant Objects Imported for Exhibition Determinations: Agency Information Collection Dated: November 7, 2000. Activities: Comment Request Liz Davidson, AGENCY: ‘‘Unseen Treasures: Imperial Acting Reports Clearance Officer, Social Russia and the New World’’ United In compliance with Public Law 104– Security Administration. States Department of State. 13, the Paperwork Reduction Act of [FR Doc. 00–29012 Filed 11–13–00; 8:45 am] ACTION: Amendment. 1995, SSA is providing notice of its BILLING CODE 4190±29±P information collection that requires SUMMARY: On July 30, 1999, Notice was submission to the Office of Management published on page 41488 of the Federal and Budget (OMB). SSA is soliciting Register (Volume 64, Number 146) by comments on the accuracy of the DEPARTMENT OF STATE the Department of State pursuant to agency’s burden estimate; the need for Pub. L. 89–259 relating to the exhibition [Public Notice 3472] the information; its practical utility; ‘‘Unseen Treasures: Imperial Russia and ways to enhance its quality, utility and Culturally Significant Objects Imported the New World.’’ That referenced Notice clarity; and on ways to minimize burden for Exhibition Determinations: ``Egypt is hereby amended as follows: after the on respondents, including the use of in the Walters Art Gallery'' words ‘‘on or about December 31, 2000,’’ insert the following additional 8 15 U.S.C. 78k–1(a)(1)(C)(ii) and (D). AGENCY: United States Department of language: ‘‘and at the Presidio Trust 9 17 CFR 240.11Aa3–2(c)(2). State. Exhibition Hall, San Francisco, 10 California, from on or about March 16, 15 U.S.C. 78k–1(a)(3)(B). ACTION: Notice. 11 17 CFR 200.30–3(a)(29). 2001, to on or about June 15, 2001,’’.

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FOR FURTHER INFORMATION CONTACT: For Part I Congress declared that independently further information, including a list of verified factual knowledge about the Closing Date for Transmittal of countries of that area is ‘‘of utmost exhibit objects, contact Paul W. Applications Manning, Attorney-Adviser, Office of importance for the national security of the Legal Adviser, 202/619–5997, and An application for an award must be the United States, for the furtherance of the address is United States Department mailed or hand-delivered by February 2, our national interests in the conduct of of State, SA–44, Room 700, 301 4th 2001. foreign relations, and for the prudent Street, S.W., Washington, DC 20547– Applications Delivered by Mail management of our domestic affairs.’’ 0001. Congress also declared that the An application sent by mail must be development and maintenance of such Dated: November 6, 2000. addressed to W. Kendall Myers, knowledge and expertise ‘‘depends William B. Bader, Executive Director, Advisory Committee upon the national capability for Assistant Secretary for Educational and for Studies of Eastern Europe and the advanced research by highly trained and Cultural Affairs, Department of State. Independent States of the Former Soviet experienced specialists, available for Union, INR/RES, Room 2251, U.S. [FR Doc. 00–29070 Filed 11–13–00; 8:45 am] service in and out of Government.’’ The Department of State, 2201 C Street, program provides financial support for BILLING CODE 4710±08±U N.W., Washington, D.C. 20520–6510. advanced research, training and other An applicant must show proof of related functions on the countries of the mailing consisting of one of the DEPARTMENT OF STATE region. By strengthening and sustaining following: in the United States a cadre of experts (1) A legibly dated U.S. Postal Service on Central and East Europe and the NIS, [Public Notice # 3473] postmark. the program contributes to the overall (2) A legible mail receipt with the objectives of the FREEDOM Support and Discretionary Grant Programs date of mailing stamped by the U.S. SEED Acts. Application Notice Establishing Postal Service. The full purpose of the Act and the Closing Date for Transmittal of Certain (3) A dated shipping label, invoice, or eligibility requirements are set forth in Fiscal Year 2001 Applications receipt from a commercial center. Pub. L. 98164, 97 Stat. 1047–50, as (4) Any other proof of mailing amended. The countries include AGENCY: The Department of State invites acceptable to the Department of State. Albania, Armenia, Azerbaijan, Belarus, applications from national organizations If any application is sent through the Bosnia and Herzegovina, Bulgaria, with interest and expertise in U.S. Postal Service, the Department of Croatia, Czech Republic, Estonia, conducting research and training to State does not accept either of the Former Yugoslav Republic of serve as intermediaries administering following as proof of mailing: (1) A Macedonia, Georgia, Hungary, national competitive programs private metered postmark; or (2) a mail Kazakhstan, Kyrgyzstan, Latvia, concerning the countries of Central and receipt that is not dated by the U.S. Lithuania, Moldova, Poland, Romania, East Europe and the New Independent Postal Service. Russia, Serbia (including Kosovo and An applicant should note that the States (NIS) of the former Soviet Union. Montenegro), Slovakia, Slovenia, U.S. Postal Service does not uniformly The grants will be awarded through an Tajikistan, Turkmenistan, Ukraine, and provide a dated postmark. Before Uzbekistan. open, national competition among relying on this method, an applicant applicant organizations. The Act establishes an Advisory should check with the local post office. Committee to recommend grant policies Authority for this Program for An applicant is encouraged to use and recipients. The Secretary of State, Research and Training on Eastern registered or at least first class mail. Late after consultation with the Advisory Europe and the Independent States of applications will not be considered and Committee, approves policies and the Former Soviet Union is contained in will be returned to the applicant. makes the final determination on the Soviet-Eastern European Research Applications Delivered by Hand awards. and Training Act of 1983 (22 U.S.C. Applications for funding under the 4501–4508, as amended). An application that is hand delivered Act are invited from U.S. organizations must be taken to W. Kendall Myers, prepared to conduct competitive SUMMARY: The purpose of this Executive Director, Advisory Committee programs on Central and East Europe application notice is to inform potential for Studies of Eastern Europe and the and the NIS and related fields. Applying applicant organizations of fiscal and Independent States of the Former Soviet organizations or institutions should programmatic information and closing Union, INR/RES, Room 2251, 2201 C have the capability to conduct dates for transmittal of applications for Street, NW., Washington, DC. Please competitive award programs that are awards in Fiscal Year 2001 under a phone first at (202) 736–4572 to gain national in scope. Programs of this program administered by the access to the building. nature are those that make awards based Department of State. The program seeks The Advisory Committee staff will upon an open, nationwide competition, to build and sustain expertise among accept hand-delivered applications incorporating peer group review Americans willing to make a career between 9:00 a.m. and 4:00 p.m. EST mechanisms. Individual end-users of commitment to the study of Central and daily, except Saturdays, Sundays, and these funds—those to whom the East Europe and the NIS. Federal holidays. applicant organizations or institutions An application that is hand delivered Organization of Notice: This notice propose to make awards—must be at the will not be accepted after 4:00 p.m. on graduate or post-doctoral level, and contains three parts. Part I lists the the closing date. closing date covered by this notice. Part must have demonstrated a likely career commitment to the study of Central and II consists of a statement of purpose and Part II East Europe and/or the NIS. priorities of the program. Part III Program Information Applications sought in this provides the fiscal data for the program. In the Soviet-Eastern European competition among organizations or Research and Training Act of 1983, the institutions are those that would

VerDate 112000 18:23 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM pfrm08 PsN: 14NON1 68168 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices contribute to the development of a This includes, but is not limited to, acquisition, or preservation. Modest, stable, long-term, national program of such topics as resolution of ethnic and cost-effective proposals to facilitate unclassified, advanced research and other conflict, transition economics, research, by eliminating serious training on the countries of Central and media studies, women’s issues, human cataloging backlogs or otherwise East Europe and/or the NIS by rights, and citizen participation in improving access to research materials, proposing: politics and civil society. For on-site will be considered. (1) National programs which award research, applicants are encouraged to • contracts or grants to American think creatively about how individuals’ Language Support institutions of higher education or not- work may complement democratization The Advisory Committee encourages for-profit corporations in support of and marketization assistance activities attention to the non-Russian languages post-doctoral or equivalent level in the region. Examples might include of Eurasia and the less commonly taught research projects, such contracts or lecturing at a university or participating languages of the Central and East grants to contain shared-cost provisions; in workshops with host government and Europe. Support provided for Russian (2) National programs which offer parliamentary officials, language instruction/study normally graduate, post-doctoral and teaching nongovernmental organizations, and will be only for advanced level. fellowships for advanced training on the other assistance target audiences on Applicants proposing to offer language countries of Central and East Europe issues related to market and democratic instruction are encouraged to apply to a and the NIS, and in related studies, transitions. national program as described above including training in the languages of The Advisory Committee gives that has appropriate peer group review the region, with such training to be priority to programs on Ukraine, Central mechanisms. conducted on a shared-cost basis, at Asia, the Caucasus, and the Balkans, • American institutions of higher especially the former Yugoslavia, where Support for Non-Americans education; gaps in knowledge exist. Proposals for The purpose of the program is to (3) National programs which provide research on Russia should focus on the build and sustain U.S. expertise on the fellowships and other support for regions and areas outside capital cities. countries of Central and East Europe American specialists enabling them to Historical or cultural research that and the NIS. Therefore, the Advisory conduct advanced research on the promotes understanding of current Committee has determined that highest countries of Central and East Europe events in the region also is encouraged priority for support always should go to and the NIS, and in related studies; and if an explicit connection can be made to American specialists (i.e., U.S. citizens those which facilitate research contemporary political and/or economic or permanent residents). Support for collaboration between Government and transitions. such activities as long-term research private specialists in these areas; (4) National programs which provide • Publications fellowships, i.e., nine months or longer, advanced training and research on a should be restricted solely to American Funds awarded in this competition scholars. reciprocal basis in the countries of should not be used to subsidize Support for short-term activities also Central and East Europe and the NIS by journals, newsletters and other should be restricted to Americans, facilitating access for American periodical publications except in special except in special instances where the specialists to research facilities and circumstances, in which cases the funds participation of a non-American scholar resources in those countries; should be supplied through peer-review has clear and demonstrable benefits to (5) National programs which facilitate organizations with national competitive the American scholarly community. In the public dissemination of research programs. methods, data and findings; and those such special instances, the applicant which propose to strengthen the • Conferences must justify the expenditure. Despite national capability for advanced Proposals for conferences, like those this restriction on support for non- research or training on the countries of for research projects and training Americans, collaborative projects are Central and East Europe and the NIS in programs, should be assessed according encouraged—where the non-American ways not specified above. to their relative contribution to the component is funded from other Note: The Advisory Committee will not advancement of knowledge and to the sources—and priority is given to consider applications from individuals to professional development of cadres in institutions whose programs contain further their own training or research, or the fields. Therefore, requests for such an international component. from institutions or organizations whose conference funding should be directed In making its recommendations, the proposals are not for competitive award Committee will seek to encourage a programs that are national in scope as to one or more of the national peer- defined above. Support for specific activities review organizations receiving program coherent, long-term, and stable effort will be guided by the following policies and funds, with proposed conferences being directed toward developing and priorities: evaluated competitively against maintaining a national capability on the countries of Central and East Europe • research, fellowship or other proposals Support for Transitions for achieving the purposes of the grant. and the NIS. Program proposals can be for the conduct of any of the functions The Advisory Committee strongly • encourages support for research Library Activities enumerated, but in making its activities which, while building Funds may be used for certain library recommendations, the Committee will expertise among U.S. specialists on the activities that clearly strengthen be concerned to develop a balanced region, also: (1) Promote fundamental research and training on the countries of national effort that will ensure attention goals of U.S. assistance programs such Central and East Europe and the NIS to all the countries of the area. as helping establish market economies and benefit the fields as a whole. Such Legislation requires and this and promoting democratic governance programs must make awards based upon announcement indicates under Program and civil societies; and (2) provide open, nationwide competition, Information of this section that in knowledge to both U.S. and foreign incorporating peer group review certain cases grantee organizations must audiences related to current U.S. policy mechanisms. Funds may not be used for include shared-cost provisions in their interests in the region, broadly defined. activities such as modernization, arrangements with end-users. Cost-

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Organizations’’; and OMB Circular A– detailed information on the end-user The precise level of funding will not be 133, ‘‘Audits of Institutions of Higher awards made, including, where known until legislative action is Learning and Other Non-Profit applicable, names/affiliations of complete. In Fiscal Year 2000, the Institutions’’; and indicate or provide recipients, and amounts and types of Congress appropriated to the program the following information: awards. Applicants should specify both $4.5 million from the FREEDOM (1) Whether the organization falls past and anticipated applicant to award Support and Support for East European under OMB Circular No. A–21, ‘‘Cost ratios. A summary of an organization’s Democracies (SEED) Acts, which funded Principles for Educational Institutions,’’ past grants under this State Department grants to 9 national organizations, with or OMB Circular No. A–122, ‘‘Cost program also should be included. $3.0 million for activities on the NIS Principles for Nonprofit Organizations;’’ Proposals from national organizations and $1.5 million for those on Central (2) A detailed program budget involving language instruction programs and East Europe, including the Baltic indicating direct expenses with clearly should provide, for those programs states. The number of awards varies identified administrative costs by supported in the past year, information each year, depending on the level of program element and by region (NIS or on the criteria for evaluation, including funding and the quality of the Central and East Europe), indirect costs, levels of instruction, degrees of applications submitted. and the total amount requested. The intensiveness, facilities, methods for The Department legally cannot budget should indicate clearly the total measuring language proficiency commit funds that may be appropriated amount requested as a sum of the (including pre-and post-testing), in subsequent fiscal years. Thus multi- amount requested for NIS activities plus instructors’ qualifications, and budget year projects cannot receive assured the amount requested for Central and information showing estimated costs per funding unless such funding is supplied East Europe activities. The budget also student. out of a single year’s appropriation. should reflect administrative costs as a Certifications Grant agreements may permit the percentage of the total requested expenditure from a particular year’s funding . NB: Indirect costs are limited Applicants must include a description grant to be made up to three years after to 10 percent of total direct program of affirmative action policies and the grant’s effective date. costs. Applicants requesting funds to practices and certifications of Applications supplement a program having other compliance with the provisions of: (1) sources of support should submit a The Drug-Free Workplace Act (Pub. Applications must be prepared and current budget for the total program and L.100–690), in accordance with submitted in 20 copies in 12 pitch in the an estimated future budget for it Appendix C of 22 CFR 137, Subpart F; following format: one-page, single- showing how specific lines in the and (2) Section 319 of the Department spaced Executive Summary; Budget budget would be affected by the of the Interior and Related Agencies presentation; narrative description of allocation of requested grant funds. Appropriations Act (Pub. L. 101–121), proposed programs not to exceed 20 Other funding sources and amounts, in accordance with Appendix A of 22 double-spaced pages; one-page, single- when known, should be identified. CFR 138, New Restrictions on Lobbying spaced vitae of key professional staff; (3) The applicant’s cost-sharing Activities. and required certifications. Applicants proposal, if applicable, containing Technical Review may append other information they appropriate details and cross references consider essential, although bulky to the requested budget; The Advisory Committee for Studies submissions are discouraged and run (4) The organization’s most recent of Eastern Europe and the Independent the risk of not being reviewed fully. audit report (the most recent U.S. States of the Former Soviet Union will evaluate applications on the basis of the Budget Government audit report, if available) and the name, address, and point of following criteria: Because funds will be appropriated contact of the audit agency. N.B.: The (1) Responsiveness to the substantive separately for Central and East Europe threshold for grants that trigger an audit provisions set forth above in Program (including the Baltic states) and New requirement has been raised from Part II, Information (45 points); Independent States programs, proposals $25,000 to $300,000. (2) The professional qualifications of must indicate how the requested funds (5) An indication of the applicant’s the applicant’s key personnel and will be distributed by region, country (to priorities if funding is being requested selection committees, and their the extent possible), and activity. for more than one program or activity. experience conducting national Subsequently, grant recipients must All payments will be made to grant competitive award programs of the type report expenditures by region, country, recipients through the Department of the applicant proposes on the countries and activity. State. of Central and East Europe and/or the Applicants should familiarize NIS (35 points); and themselves with Department of State Narrative Statement (3) Budget presentation and cost grant regulations contained in 22 CFR The Applicant must describe fully the effectiveness (20 points). 145, ‘‘Grants and Cooperative proposed programs, including detailed FOR FURTHER INFORMATION CONTACT: For Agreements with Institutions of Higher information about plans for advertising further information, contact W. Kendall Education, Hospitals, and Other Non- programs, peer review and selection Myers, Executive Director, Advisory Profit Organizations’’; 22 CFR 137, procedures and identification of Committee for Studies of Eastern Europe ‘‘Department of State Government-wide anticipated selection committee and the Independent States of the

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Former Soviet Union, INR/RES, Room Conservation and Natural Resources, for the operation of any trade agreement 2251, U.S. Department of State, 2201 C the operation of a wildlife management and other matters arising in connection Street, NW., Washington, DC 20520– and public recreation area affecting with the development, implementation 6510. Telephone: (202) 736–4572 or approximately 1,500 acres of Wheeler and administration of the trade policy of 736–4386, fax: (202) 736-4851 or (202) Reservoir land in Lawrence and Morgan the United States. The meeting will be 736–4807. Counties, Alabama, Tract No. XTWR– open to the public and press from 11:30 Dated: November 6, 2000. 114WL. a.m. to 12 noon, at which time the W. Kendall Myers, E3. Modification of a release and grant implementation of the Executive Order Executive Director, Advisory Committee for of easement to James B. and Teresa L. on Environmental Reviews of Trade Studies of Eastern Europe and the Grant affecting approximately 0.3 acre Agreements, an other issues will be Independent States of the Former Soviet of former TVA land on Norris Reservoir discussed. Attendance during this part Union. in Anderson County, Tennessee, a of the meeting is for observation only. [FR Doc. 00–29088 Filed 11–13–00; 8:45 am] portion of Tract No. XNR–15:33. Individuals who are not members of the BILLING CODE 4710±32±P E4. Abandonment of a portion of committee will not be invited to transmission line easement right-of-way comment. affecting approximately 1.5 acres of the DATES: The meeting is scheduled for TENNESSEE VALLEY AUTHORITY Weaver-Young Cane transmission line November 30, 2000, unless otherwise in Union County, Georgia, Tract No. notified. Sunshine Act Meeting WYC–52A. For more information: Please call ADDRESSES: The meeting will be held at AGENCY HOLDING THE MEETING: Tennessee TVA Public Relations at (865) 632–6000, the USTR Annex Building in Valley Authority (Meeting No. 1525). Knoxville, Tennessee. Information is Conference Rooms 1 and 2, located at TIME AND DATE: 9 a.m. (CST), November also available at TVA’s Washington 1724 F Street, NW., Washington, DC, 15, 2000. Office (202) 898–2999. People who plan unless otherwise notified. PLACE: Eupora Community House, 101 to attend the meeting and have special FOR FURTHER INFORMATION CONTACT: East Clark Street, Eupora, Mississippi. needs should call (865) 632–6000. Christina Servilla, Office of the United STATUS: Open. Dated: November 8, 2000. States Trade Representative, (202) 395– 6120. Agenda Edward S. Christenbury, Approval of minutes of meeting held General Counsel and Secretary. Charlene Barshefsky, on October 25, 2000. [FR Doc. 00–29261 Filed 11–9–00; 2:28 pm] Untied States Trade Representative. BILLING CODE 8120±08±M [FR Doc. 00–29075 Filed 11–13–00; 8:45 am] New Business BILLING CODE 3190±01±M A—Budget and Financing A1. Approval of tax-equivalent OFFICE OF THE UNITED STATES payments for Fiscal Year 2000 and the TRADE REPRESENTATIVE DEPARTMENT OF THE TREASURY estimated payments in Fiscal Year 2001 Notice of Meeting of the Trade and Bureau of Alcohol, Tobacco and in accordance with Section 13 of the Environment Policy Advisory TVA Act. Firearms Committee (TEPAC) A2. Adoption of Tennessee Valley [Notice No. 907] Authority Financial Statements for AGENCY: Office of the United States Fiscal Year 2000. Trade Representative. Appointment of Individuals To Serve A3. Retention of Net Power Proceeds ACTION: Notice that the November 30, as Members of the Performance and Nonpower Proceeds and Payments 2000, meeting of the Trade and Review Board (PRB); Senior Executive to the U.S. Treasury in March 2001, Environment Policy Advisory Service pursuant to Section 26 of the TVA Act. Committee will be held from 8:30 a.m. SUMMARY: Pursuant to 5 U.S.C. B—Purchase Awards to 12 noon. The meeting will be closed 4314(c)(4), this notice announces the to the public from 8:30 a.m. to 11:30 and B1. Contracts with Verizon Wireless appointment of members of the open to the public from 11:30 a.m. to 12 and Suncom for cellular services. Performance Review Board for the noon. C—Energy Bureau of Alcohol, Tobacco and Firearms (ATF) for the rating period C1. Contract with Innogy Technology SUMMARY: The Trade and Environment beginning October 1, 1999, and ending Ventures Limited for the design of a Policy Advisory Committee will hold a September 30, 2000. This notice effects Regenesys energy storage plant and the meeting on November 30, 2000 from changes in the membership of the ATF manufacture and supply of fuel cell 8:30 a.m. to 12 noon. The meeting will PRB previously appointed November modules. be closed to the public from 8:30 a.m. to 11:30 a.m. The meeting will include 12, 1999 (64 FR 61688). E—Real Property Transactions a review and discussion of current The names and titles of the ATF PRB E1. Sale of noncommercial, issues which influence U.S. trade members are as follows: nonexclusive permanent easement to policy. Pursuant to Section 2155(f)(2) of John J. Manfreda, Chief Counsel, Bureau Carl D. Klimek for construction and Title 19 of the United States Code, I of Alcohol, Tobacco and Firearms, maintenance of recreational water-use have determined that this meeting will Department of the Treasury facilities affecting approximately 0.048 be concerned with matters the John Dooher, Director, Washington acre of Tellico Reservoir shoreline in disclosure of which would seriously Office, Federal Law Enforcement Loudon County, Tennessee, Tract No. compromise the development by the Training Center, Department of the XTELR–218RE. United States Government of trade Treasury E2. Grant of a 30-year term easement policy, priorities, negotiating objectives H. Douglas Cunningham, Deputy to the State of Alabama, Department of or bargaining positions with respect to Assistant Director, Office of

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Administration, U.S. Secret Service, Street, NW., Washington, DC 20552, written request from the public. Department of the Treasury Attention 1550–0075. Indebtedness to correspondent banks FOR FURTHER INFORMATION CONTACT: Delivery: Hand deliver comments to must also be disclosed to the board of Dennis Snyder, Personnel Division, the Guard’s Desk, East Lobby Entrance, directors and made available for OTS Bureau of Alcohol, Tobacco and 1700 G Street, NW., from 9 a.m. to 4 review during examinations. Firearms, 650 Massachusetts Avenue, p.m. on business days, Attention 1550– Current Actions: OTS proposes to NW., Washington, DC 20226; telephone 0075. renew this information collection (202) 927–8610. Facsimiles: Send facsimile without revision. transmissions to FAX Number (202) Type of Review: Renewal. Signed: November 6, 2000. 906–7755, Attention 1550–0075; or Bradley A. Buckles, Affected Public: Business or For (202) 906–6956 (if comments are over 25 Profit. Director. pages). Estimated Number of Respondents: [FR Doc. 00–29048 Filed 11–13–00; 8:45 am] E-Mail: Send e-mails to 1,084. BILLING CODE 4810±31±P ‘‘[email protected]’’, Attention Estimated Time Per Respondent: 11 1550–0075, and include your name and hours per response. telephone number. DEPARTMENT OF THE TREASURY Public Inspection: Interested persons Estimated Total Annual Burden may inspect comments at the Public Hours: 11,924 hours. Office of Thrift Supervision Reference Room, 1700 G St. NW., from Request for Comments: The OTS will 10 a.m. until 4 p.m. on Tuesdays and summarize comments submitted in Proposed Agency Information Thursdays or obtain comments and/or response to this notice or will include Collection Activities; Comment an index of comments by facsimile by these comments in its request for OMB Request telephoning the Public Reference Room approval. All comments will become a at (202) 906–5900 from 9 a.m. until 5 matter of public record. The OTS invites ACTION: Notice and request for comment on: (a) Whether the collection comments. p.m. on business days. Comments and the related index will also be posted on of information is necessary for the SUMMARY: The Department of the the OTS Internet Site at proper performance of the functions of Treasury, as part of its continuing effort ‘‘www.OTS.treas.gov’’. the agency, including whether the to reduce paperwork and respondent information shall have practical utility; FOR FURTHER INFORMATION CONTACT: (b) the accuracy of the agency’s estimate burden, invites the general public and Donna M. Deale, Supervision, Office of other Federal agencies to comment on of the burden of the collection of Thrift Supervision, 1700 G Street, NW., information; (c) ways to enhance the proposed and continuing information Washington, DC 20552, (202) 906–7488. collections, as required by the quality; (d) ways to minimize the SUPPLEMENTARY INFORMATION: Paperwork Reduction Act of 1995, burden of the collection of information Title: Loans to Executive Officers, on respondents, including the use of Public Law 104–13. Today, the Office of Directors, and Principal Shareholders of Thrift Supervision within the automated collection techniques or Savings Associations. other forms of information technology; Department of the Treasury solicits OMB Number: 1550–0075. comments on Loans to Executive and (e) estimates of capital or starting Form Number: Not applicable. costs and costs of operation, Officers, Directors, and Principal Abstract: The regulation requires Shareholders of Savings Associations. maintenance, and purchase of services savings associations to maintain to provide information. DATES: Submit written comments on or detailed records of their extensions of before January 16, 2001. credit to executive officers, directors, Dated: November 7, 2000. ADDRESSES: and principal shareholders. The John E. Werner, Mail: Send comments to Manager, regulation also requires that savings Director, Information & Management Services Dissemination Branch, Information associations report to the OTS all loans Division. Management and Services Division, to executives and disclose the amount of [FR Doc. 00–29042 Filed 11–13–00; 8:45 am] Office of Thrift Supervision, 1700 G its extensions of credit following a BILLING CODE 6720±01±P

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Corrections Federal Register Vol. 65, No. 220

Tuesday, November 14, 2000

This section of the FEDERAL REGISTER SECURITIES AND EXCHANGE contains editorial corrections of previously COMMISSION published Presidential, Rule, Proposed Rule, and Notice documents. These corrections are prepared by the Office of the Federal [Release No. 34±43435; File No. SR±NASD± Register. Agency prepared corrections are 99±69] issued as signed documents and appear in the appropriate document categories Self-Regulatory Organizations; Order elsewhere in the issue. Approving Proposed Rule Change and Notice of Filing and Order Granting Accelerated Approval of Amendment SECURITIES AND EXCHANGE No. 3 Thereto by the National COMMISSION Association of Securities Dealers, Inc. Amending Certain Listing Standards of [Release No. 34±43338; File No. SR±Amex± the Nasdaq Stock Market, Inc. 00±53] Correction Self-Regulatory Organizations; Notice In notice document 00–26803 of Filing and Order Granting appearing on page 62779 in the issue of Accelerated Approval of a Proposed Thursday, October 19, 2000, the docket Rule Change by the American Stock number is corrected to read as set forth Exchange LLC Relating to the above. streetTrackssm Dow Jones Global Titans Index Fund [FR Doc. C0–26803 Filed 11–13–00; 8:45 am] BILLING CODE 1505±01±D Correction In notice document 00–25438 appearing on page 59235 in the issue of Wednesday, October 4, 2000 the docket number is corrected to read as set forth above. [FR Doc. C0–25438 Filed 11–13–00; 8:45 am] BILLING CODE 1505±01±D

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Part II

Department of Labor Occupational Safety and Health Administration

29 CFR Part 1910 Ergonomics Program; Final Rule

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DEPARTMENT OF LABOR analysis and control, training, MSD V. Health Effects management, and program evaluation. VI. Risk Assessment Occupational Safety and Health The standard provides the employer VII. Significance of Risk Administration VIII. Summary of the Final Economic with several options for evaluating and Analysis and Final Regulatory Flexibility controlling risk factors for jobs covered Analysis 29 CFR Part 1910 by the ergonomics program, and IX. Unfunded Mandates Analysis [Docket No. S±777] provides objective criteria for X. Environmental Impact Statement identifying MSD hazards in those jobs XI. Additional Statutory Issues RIN 1218±AB36 and determining when the controls XII. Procedural Issues implemented have achieved the XIII. Federalism Ergonomics Program required level of control. XIV. State Plan States XV. OMB Review under the Paperwork AGENCY: Occupational Safety and Health The final standard would affect Reduction Act of 1995 Administration (OSHA), Department of approximately 6.1 million employers XVI. List of Subjects in 29 CFR Part 1910 Labor. and 102 million employees in general XVII. The Final Ergonomics Program industry workplaces, and employers in Standard ACTION: Final rule. these workplaces would be required References to documents, studies, and SUMMARY: The Occupational Safety and over the ten years following the materials in the rulemaking record are Health Administration is issuing a final promulgation of the standard to control found throughout the text of the Ergonomics Program standard (29 CFR approximately 18 million jobs with the preamble. Materials in the docket are 1910.900) to address the significant risk potential to cause or contribute to identified by their Exhibit numbers, as of employee exposure to ergonomic risk covered MSDs. OSHA estimates that the follows: ‘‘Ex. 26–1’’ means Exhibit 26– factors in jobs in general industry final standard would prevent about 4.6 1 in Docket S–777. A list of the Exhibits workplaces. Exposure to ergonomic risk million work-related MSDs over the and copies of the Exhibits are available factors on the job leads to next 10 years, have annual benefits of in the OSHA Docket Office. musculoskeletal disorders (MSDs) of the approximately $9.1 billion, and impose I. Introduction upper extremities, back, and lower annual compliance costs of $4.5 billion extremities. Every year, nearly 600,000 on employers. On a per-establishment A. Overview basis, this equals approximately $700; MSDs that are serious enough to cause This preamble discusses the data and annual costs per problem job fixed are time off work are reported to the Bureau events that led OSHA to issue the final estimated at $250. of Labor Statistics by general industry Ergonomics Program standard (Section employers, and evidence suggests that DATES: This final rule becomes effective II), and the Agency’s legal authority for an even larger number of non-lost on January 16, 2001. promulgating the rule (Section III). This worktime MSDs occur in these Compliance. Start-up dates for discussion is followed by a detailed workplaces every year. specific provisions are set in paragraph paragraph-by-paragraph summary and The standard contains an ‘‘action (w) of § 1910.900. However, affected explanation of the final rule, including trigger,’’ which identifies jobs with risk parties do not have to comply with the the Agency’s reasons for including each factors of sufficient magnitude, information collection requirements in provision and OSHA’s responses to the duration, or intensity to warrant further the final rule until the Department of many substantive issues that were examination by the employer. This Labor publishes in the Federal Register raised in the proposal and during the action trigger acts as a screen. When an the control numbers assigned by the rulemaking (Section IV). employee reports an MSD, the employer Office of Management and Budget The summary and explanation of the must first determine whether the MSD (OMB). Publication of the control standard is followed by a lengthy is an MSD incident, defined by the numbers notifies the public that OMB discussion of the evidence on the health standard as an MSD that results in days has approved these information effects that are associated with worker away from work, restricted work, collection requirements under the exposure to MSD hazards (Section V). medical treatment beyond first aid, or Paperwork Reduction Act of 1995. The next section discusses the nature MSD symptoms or signs that persist for ADDRESSES: In compliance with 28 and degree of ergonomic-related risks 7 or more days. Once this determination U.S.C. 2112(a), the Agency designates confronting workers in general industry is made, the employer must determine the Associate Solicitor for Occupational jobs (Section VI), and assesses the whether the employee’s job has risk Safety and Health, Office of the significance of those risks (Section VII). factors that meet the standard’s action Solicitor, Room S–4004, U.S. The preamble also contains a summary trigger. The risk factors addressed by Department of Labor, 200 Constitution of the Final Economic and Final this standard include repetition, Avenue, NW., Washington, DC 20210, Regulatory Flexibility Analysis (Section awkward posture, force, vibration, and as the recipient of petitions for review VIII). Finally, the preamble describes contact stress. If the risk factors in the of the standard. the information collections associated employee’s job do not exceed the action FOR FURTHER INFORMATION CONTACT: with the final standard (Section XV). trigger, the employer does not need to OSHA’s Ergonomics Team at (202) 693– implement an ergonomics program for B. The Need for an Ergonomics Program 2116, or visit the OSHA Homepage at Standard that job. www.osha.gov. If an employee reports an MSD Work-related musculoskeletal incident and the risk factors of that SUPPLEMENTARY INFORMATION: disorders (MSDs) currently account for employee’s job meet the action trigger, Table of Contents one-third of all occupational injuries the employer must establish an The preamble and standard are organized and illnesses reported to the Bureau of ergonomics program for that job. The as follows: Labor Statistics (BLS) by employers program must contain the following I. Introduction every year. Although the number of elements: hazard information and II. Events Leading to the Standard MSDs reported to the BLS, like all reporting, management leadership and III. Pertinent Legal Authority occupational injuries and illnesses, has employee participation, job hazard IV. Summary and Explanation declined by more than 20% since 1992,

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Although more and these disorders accounted for $1 of can reduce the reported rate of research is always desirable, OSHA every $3 spent for workers’ musculoskeletal disorders for workers finds that more than enough evidence compensation in that year. This means who perform high-risk tasks’’ (Work- already exists to demonstrate the need that employers are annually paying Related Musculoskeletal Disorders: The for a final standard. In the words of the more than $15 billion in workers’ Research Base, ISBN 0–309–06327–2 American College of Occupational and compensation costs for these disorders, (1998)). A scientific review of hundreds Environmental Medicine, the world’s and other expenses associated with of peer-reviewed studies involving largest occupational medical society, work-related MSDs, such as the costs of workers with MSDs by the National ‘‘there is an adequate scientific training new workers, may increase this Institute for Occupational Safety and foundation for OSHA to proceed * * * total to $45 billion a year. Workers with Health (NIOSH 1997) also supports this and, therefore, no reason for OSHA to severe MSDs often face permanent conclusion. delay the rulemaking process * * *.’’ disability that prevents them from The evidence, which is comprised of D. Information OSHA Is Providing To returning to their jobs or handling peer-reviewed epidemiological, Help Employers Address Ergonomic simple, everyday tasks like combing biomechanical and pathophysiological Hazards their hair, picking up a baby, or pushing studies as well as other published a shopping cart. For example, workers evidence, includes: Much literature and technical who must undergo surgery for work- II. More than 2,000 articles on work- expertise on ergonomics already exists related carpal tunnel syndrome often related MSDs and workplace risk and is available to employers, both lose 6 months or more of work. factors; through OSHA and a variety of other Thousands of companies have taken sources. For example: II. A 1998 study by the National • action to address and prevent these Research Council/National Information is available from problems. OSHA estimates that 46 Academy of Sciences on work- OSHA’s ergonomics Web page, which percent of all employees but only 16 related MSDs; can be accessed from OSHA’s World percent of all workplaces in general • Wide Web site at http://www.osha.gov industry are already protected by an A critical review by NIOSH of more by scrolling down and clicking on ergonomics program, because their than 600 epidemiological studies ‘‘Ergonomics’’; employers have voluntarily elected to addressing the effects of exposure to • Many publications, informational workplace risk factors (1997); implement an ergonomics program. • materials and training courses, which (The difference in these percentages A 1997 General Accounting Office are available from OSHA through shows that many large companies, who report of companies with ergonomics Regional Offices, OSHA-sponsored employ the majority of the workforce, programs; educational centers, OSHA’s state already have these programs, and that I. Other evidence and analyses in the consultation programs for small many smaller employers have not yet Health Effects section of the businesses, and through the Web page; implemented them.) Based on its review preamble to the final rule; • Publications on ergonomics of the evidence in the record as a whole, II. Hundreds of case studies from programs, which are available from OSHA concludes that the final standard companies with successful NIOSH at 1–800–35–NIOSH. NIOSH’s is needed to protect employees in ergonomics programs; and Web page is also ‘‘linked’’ to OSHA’s general industry workplaces who are at I. Testimony and evidence submitted to ergonomics Web page; significant risk of incurring a work- the record by expert witnesses, • OSHA’s state consultation related musculoskeletal disorder but are workers, safety and health programs, which will provide free on- not currently protected by an professionals, and others, which is site consultation services to employers ergonomics program. discussed throughout the preamble requesting help in implementing their to the final rule. ergonomics programs; and C. The Science Supporting the Standard Taken together, this evidence • OSHA-developed compliance A substantial body of scientific indicates that: assistance materials, which are available evidence supports OSHA’s effort to • High levels of exposure to as non-mandatory appendices to the provide workers with ergonomic ergonomic risk factors on the job lead to standard, electronic compliance protection (see the Health Effects, Risk an increased incidence of work-related assistance training materials (e-cats) on Assessment, and Significance of Risk MSDs among exposed workers; specific tasks (e.g., lifting) or work sections (Sections V, VI, and VII, • Reducing exposure to physical risk environments (e.g., nursing homes). respectively) of this preamble, below). factors on the job reduces the incidence OSHA is also making several This evidence strongly supports two and severity of work-related MSDs; publications available on the web, such basic conclusions: (1) There is a positive • Many work-related MSDs are as the Easy Ergonomics Booklet, Fact relationship between work-related preventable; and Sheets, and so on. These materials can musculoskeletal disorders and • Ergonomics programs are be obtained by accessing OSHA’s employee exposure to workplace risk demonstrably effective in reducing risk, Internet home page at www.OSHA.gov. factors, and (2) ergonomics programs decreasing exposure and protecting and specific ergonomic interventions workers against work-related MSDs. II. Events Leading to the Development can substantially reduce the number As with any scientific field, research of the Final Standard and severity of these injuries. in ergonomics is ongoing. The National In this final standard, OSHA has In 1998, the National Research Academy of Sciences is currently relied on its own substantial experience Council/National Academy of Sciences undertaking another review of the with ergonomics programs, the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68264 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations experience of private firms and firmly grounded in the OSH Act and reduce employee turnover and insurance companies, and the results of OSHA policies and experience. The absenteeism (see Section VI of this research studies conducted during the primary lesson to be learned is that preamble, and Chapters IV (Benefits) last 30 years. Those experiences clearly employers with effective, well-managed and V (Costs of Compliance) of OSHA’s show that: (1) Ergonomics programs are ergonomics programs achieve Final Economic Analysis (Ex. 28–1)). an effective way to reduce occupational significant reductions in the severity OSHA’s long experience with MSDs; (2) ergonomics programs have and number of work-related MSDs that ergonomics is apparent from the consistently achieved that objective; (3) their employees experience. These chronology below. As this table shows, OSHA’s standard is consistent with programs also generally improve the Agency has been actively involved these programs; and (4) the standard is productivity and employee morale and in ergonomics for more than 20 years.

OSHA Ergonomics Chronology

March 1979 ...... OSHA hires its first ergonomist. Early 1980s ...... OSHA begins discussing ergonomic interventions with labor, trade associations and professional organizations. OSHA issues citations to Hanes Knitwear and Samsonite for ergonomic hazards. August 1983 ...... The OSHA Training Institute offers its first course in ergonomics. February 1986 ...... OSHA publishes ``Working Safely with Video Display Terminals,'' its first publication concerning ergonomics as it applies to the use of computer technology May 1986 ...... OSHA begins a pilot program to reduce back injuries through review of injury records during inspections and rec- ommendations for job redesign using NIOSH's Work Practices Guide for Manual Lifting. October 1986 ...... The Agency publishes a Request for Information on approaches to reduce back injuries resulting from manual lift- ing. (57 FR 34192) November 1988 ...... OSHA/Iowa Beef Processors reach first corporate-wide settlement to reduce ergonomic hazards at 8 IBP loca- tions nationwide. July 1990 ...... OSHA/UAW/Ford corporate-wide settlement agreement commits Ford to reduce ergonomic hazards in 96 percent of its plants through a model ergonomics program. August 1990 ...... The Agency publishes ``Ergonomics Program Management Guidelines for Meatpacking Plants.'' Fall 1990 ...... OSHA creates the Office of Ergonomics Support and hires more ergonomists. November 1990 ...... OSHA/UAW/GM sign agreement bringing ergonomics programs to 138 GM plants employing more than 300,000 workers. Throughout the early 90s, OSHA signed 13 more corporate-wide settlement agreements to bring ergonomics programs to nearly half a million more workers. July 1991 ...... OSHA publishes ``Ergonomics: The Study of Work,'' as part of a nationwide education and outreach program to raise awareness about ways to reduce musculoskeletal disorders. July 1991 ...... More than 30 labor organizations petition Secretary of Labor to issue an Emergency Temporary Standard on ergonomics. January 1992 ...... OSHA begins a special emphasis inspection program on ergonomic hazards in the meatpacking industry. April 1992 ...... Secretary of Labor denies petition for an Emergency Temporary Standard but commits to moving forward with section 6 (b) rulemaking. August 1992 ...... OSHA publishes an Advance Notice of Proposed Rulemaking on ergonomics. 1993 ...... OSHA conducts a major survey of general industry and construction employers to obtain information on the ex- tent of ergonomics programs in industry and other issues. March 1995 ...... OSHA begins a series of meetings with stakeholders to discuss approaches to a draft ergonomics standard. January 1997 ...... OSHA/NIOSH conference on successful ergonomic programs held in Chicago. April 1997 ...... OSHA introduces the ergonomics web page on the Internet. February 1998 ...... OSHA begins a series of national stakeholder meetings about the draft ergonomics standard under development. March 1998 ...... OSHA releases a video entitled ``Ergonomic Programs That Work.'' February 1, 1999 ...... OSHA begins small business (Small Business Regulatory Enforcement Fairness Act (SBREFA) review of its draft ergonomics rule, and makes draft regulatory text available to the public. March 1999 ...... OSHA/NIOSH/Institute of Industrial Engineers hold Applied Ergonomics Conference in Houston April 30, 1999 ...... OSHA's Assistant Secretary receives the SBREFA report on the draft ergonomics program proposal, and the Agency begins to address the concerns raised in that report. November 23, 1999 ...... OSHA publishes its proposed ergonomics program standard. March 2000 ...... OSHA/NIOSH/Institute of Industrial Engineers hold Applied Ergonomics Conference in Los Angeles March±May 2000 ...... OSHA holds 9 weeks of public hearings and receives 18,337 pages of testimony from 714 witnesses. November 23, 1999 through OSHA receives nearly 11,000 comments and briefs consisting of nearly 50,000 pages collectively, into the docket August 10, 2000. of the ergonomics rulemaking. October 27, 2000 ...... The Occupational Safety and Health Review Commission finds that manual lifting of nursing home patients is a known and recognized risk factor for lower back pain.

A. Regulatory and Voluntary Guidelines health principles of management management guidelines, supplemented Activities commitment and employee by other ergonomics-specific program involvement, worksite hazard analysis, elements (e.g., medical management). In 1989, OSHA issued the Safety and hazard prevention and control, and The ergonomic guidelines were based Health Program Management employee training, also serve as the on the best available scientific evidence, Guidelines (54 FR 3904, Jan. 26, 1989), which are voluntary program foundation for effective ergonomics the best practices of successful management guidelines to assist programs. In August 1990, OSHA issued companies with these programs, advice employers in developing effective safety the Ergonomics Program Management from the National Institute for and health programs. These program Guidelines for Meatpacking Plants (Ex. Occupational Safety and Health management guidelines, which are 2–13), which utilized the four program (NIOSH), the scientific literature, and based on the widely accepted safety and components from the safety and health OSHA’s experience with enforcement

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A 3–95, 3–97, 3–113, 3–121, 3–125), and a Request for Information (RFI) or an summary of the comments has been there has been general agreement among Advance Notice of Proposed placed in the public record (Ex. 26– stakeholders that these program Rulemaking (ANPR) consistent with the 1370). elements should be included in any Administration’s Regulatory Program. During 1998, OSHA met with nearly OSHA ergonomics standard (Exs. 3–27, Subsequently, OSHA formally placed 400 stakeholders to discuss ideas for a 3–46, 3–51, 3–61, 3–89, 3–95, 3–113, 3– ergonomics rulemaking on the proposed standard. The first series of 119, 3–160, 3–184). regulatory agenda (Ex. 2–17) and meetings was held in February in OSHA also has encouraged other decided to issue an ANPR on this topic. Washington, D.C. and focused on efforts to address the prevention of In June 1991, OSHA sent a draft copy general issues, such as the scope of the work-related musculoskeletal disorders. of the proposed ANPR questions for standard and what elements of an For example, OSHA has actively comment to 232 parties, including ergonomics program should be included participated in the work of the ANSI Z– OSHA’s advisory committees, labor in a standard. The second series of 365 Committee, which was entrusted organizations (including the meetings, held in July in Kansas City with the task of developing a consensus petitioners), trade associations, and Atlanta, focused on what elements standard for the control of cumulative occupational groups, and members of and activities should be included in an trauma disorders. The Agency also has the ergonomics community (Ex. 2–18). ergonomics program standard. The third sponsored and participated in more OSHA requested comments on what set of meetings was held in September than 11 Ergonomics Best Practices questions should be presented in the in Washington, D.C. and emphasized conferences. ANPR. OSHA received 47 comments revisions to the elements of the proposal from those parties. In addition, OSHA based on previous stakeholder input. A 1. Petition for Emergency Temporary met with the Chemical Manufacturers summary of those meetings was placed Standard Association, Organization Resources on the OSHA web site and in the public On July 31, 1991, the United Food Counselors, Inc., the AFL–CIO and docket (Ex. 26–1370). OSHA solicited and Commercial Workers Union several of its member organizations. input from its stakeholders again the (UCFW), along with the AFL–CIO and OSHA reviewed the comments and next year, when it posted a working 29 other labor organizations, petitioned submissions received and incorporated draft of its ergonomics standard after its OSHA to take immediate action to relevant suggestions and comments into release for Small Business Regulatory reduce the risk to employees of the ANPR. Enforcement Fairness Act (SBREFA) exposure to ergonomic hazards (Ex. 2– On August 3, 1992, OSHA published Panel review. 16). The petition requested that OSHA the ANPR in the Federal Register (57 FR issue an emergency temporary standard 34192), requesting information for 4. Small Business Regulatory (ETS) on ‘‘Ergonomic Hazards to Protect consideration in the development of an Enforcement Fairness Act (SBREFA) Workers from Work-Related ergonomics standard. OSHA received Panel Musculoskeletal Disorders (Cumulative 290 comments in response to the ANPR. In accordance with SBREFA and to Trauma Disorders)’’ under section 6(c) Those comments have been carefully gain insight from employers with small of the Act. The petitioners also considered by the Agency in developing businesses, OSHA, the Office of requested, consistent with section 6(c), the final ergonomics program standard. Management and Budget (OMB), and that OSHA promulgate, within 6 months the Small Business Administration 3. Outreach to Stakeholders of issuance of the ETS, a permanent (SBA) created a Panel to review and standard to protect workers from In conjunction with the process of comment on a working draft of the cumulative trauma disorders in both developing the proposed ergonomics ergonomics program standard. As general industry and construction. rule, OSHA established various required by SBREFA, the Panel sought Based on the statutory constraints and communication and outreach efforts. the advice and recommendations of legal requirements governing issuance These efforts were initiated in response potentially affected Small Entity of an ETS, OSHA calculated that the to requests by individuals who would Representatives (SERs). A total of 21 basis to support issuance of an ETS was be affected by the rule (stakeholders) SERs from a variety of industries not sufficient. Accordingly, on April 17, that they be provided with the participated in the effort. The working 1992, OSHA decided not to issue an opportunity to present their concerns draft and supporting materials (a brief ETS on ergonomic hazards (Ex. 2–29). about an ergonomics rule and that they summary of a preliminary economic OSHA agreed with the petitioners, be kept apprized of the efforts OSHA analysis, the risk assessment, and other however, that available information, was making in developing a proposed materials) were sent to the SERs for including the Agency’s experience and rule. For example, in March and April their review. On March 24–26, 1999, the information in the ETS petition and 1994, OSHA held meetings with Panel participated in a series of supporting documents, supported the industry, labor, professional and discussions with the SERs to answer initiation of a rulemaking, under section research organizations covering general questions and receive comments. The 6(b)(5) of the Act, to address ergonomic industry, construction, agriculture, SERs also provided written comments, hazards. healthcare, and the office environment. which served as the basis of the Panel’s A list of those attending the meetings final report (Ex. 23). The final SBREFA 2. Advance Notice of Proposed and a record of the meetings has been Panel Report was submitted to the Rulemaking placed in the public record of this Assistant Secretary on April 30, 1999. At the time OSHA issued the rulemaking (Ex. 26–1370). The findings and recommendations Ergonomic Program Management In March, 1995, OSHA provided a made by the Panel are addressed in the Guidelines for Meatpacking Plants (Ex. copy of an early draft proposed proposed rule, preamble, and economic 2–13), the Agency also indicated its ergonomics rule and preamble to these analysis (see the discussion in Section

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VIII, Summary of the Final Economic 6. Solicitation of Public Comment on submissions were received. Collectively, Analysis and Regulatory Flexibility the Proposed Rule a total of nearly 11,000 exhibits Analysis). The notice of proposed rulemaking consisting of nearly 50,000 pages were submitted over the whole period. 5. Issuance of Proposed Rule invited public comment on any aspects of the proposed ergonomics standard B. Other OSHA Efforts In Ergonomics On November 23, 1999, OSHA until the close of the comment period In 1996, OSHA developed a strategy ending on February 1, 2000. published a proposed ergonomics to address ergonomics through a four- After receiving a number of requests program standard to address the pronged program including training, for an extension of the written comment significant risk of work-related education, and outreach activities; study period, OSHA published a Federal musculoskeletal disorders (MSDs) and analysis of the work-related hazards Register notice (65 FR 4795) to extend confronting employees in various jobs that lead to MSDs; enforcement; and the deadline for public, pre-hearing in general industry workplaces (64 FR rulemaking. 65768). The proposed standard would comments to March 2, 2000 and to have required general industry reschedule the informal public hearings 1. Training, Education, and Outreach employers covered by the standard to in Washington, D.C. to begin March 13, a. Training. The OSHA ergonomics 2000 and run through April 7, 2000. establish an ergonomics program web page has been an important part of Subsequently, the Agency published a containing some or all of the elements the Agency’s education and outreach Federal Register notice (65 FR 19702) to typical of successful ergonomics effort. Other OSHA efforts in training, re-schedule and extend the hearings in education and outreach include the programs: management leadership and Portland, OR by 2 days, from April 24, employee participation, job hazard following: 2000 through May 3, 2000. In addition, • analysis and control, hazard information Grants to train workers and a final week of informal public hearings employees about hazards and hazard and reporting, training, MSD (65 FR 13254) was scheduled to take management, and program evaluation, abatement. place in Washington, D.C. from May 8, • Three training courses in depending on the types of jobs in their 2000 through May 12, 2000. workplace and whether a ergonomics through the OSHA Training During the early stages of the public Institute available for OSHA compliance musculoskeletal disorder covered by the comment period, it was brought to officers, one of which is open to the standard had occurred. Employers OSHA’s attention that the proposed public; whose employees perform ergonomics program standard published • One day training for nursing home manufacturing or manual handling jobs on November 23, 1999 (64 FR 65768) operators, at more than 500 nursing were required to implement a basic did not provide an analysis of the homes in each of seven targeted states; ergonomics program in those jobs. economic impacts of the rule on State • Booklets on ergonomics, The basic program would have and local governments, the United ergonomics programs, and computer States Postal Service, or the railroads. included the following elements: workstations, such as ‘‘Ergonomics To provide this additional information management leadership and employee Program Management Guidelines for and analysis, OSHA published a participation, and hazard information Meatpacking Plants’’ and ‘‘Ergonomics: supplement (65 FR 33263) to the the Study of Work,’’ both of which are and reporting. If an employee in a Agency’s Preliminary Economic manufacturing or manual handling job available on OSHA’s Website. Analysis and Initial Regulatory • Videotapes on ergonomics programs experienced an OSHA-recordable MSD Flexibility Analysis (Ex. 28–1) of the determined by the employer to be in general industry and specifically in economic impact of the Ergonomics nursing homes. covered by the standard, the employer Program Rule. OSHA also established would have been required to implement OSHA has awarded almost $3 million pre-hearing and post-hearing comment for 25 grants addressing ergonomics, a full ergonomics program for that job periods ending June 22, 2000 and including lifting hazards in healthcare and all other jobs in that establishment August 10, 2000, respectively, to facilities and hazards in the red meat involving the same physical work address the analysis of economic and poultry industries. These grants activities. The full program would have impacts in those three industries. An have enabled workers and employers to included, in addition to the elements in informal public hearing was held in identify ergonomic hazards and the basic program, a hazard analysis of Atlanta, GA on July 7, 2000, to provide implement workplace changes to abate the job; the implementation of an opportunity for witnesses to question these hazards. engineering, work practice or the OSHA Panel on the supplemental Some grant program highlights follow: administrative controls to eliminate or analysis. • The United Food and Commercial substantially reduce the hazards Collectively, the public hearings concerning the proposed ergonomics Workers International Union (UFCW) identified in that job; training the conducted joint labor-management employees and their supervisors in that program standard generated 18,337 ergonomics training at a meatpacking plant job; and providing MSD management, pages of transcript based on testimony that resulted in a major effort at the plant to including where appropriate, temporary from 714 hearing witnesses, including combat cumulative trauma disorders. The work restrictions and access to a health those representing public entities, program was so successful that management private industry, industry associations, asked the UFCW to conduct the ergonomics care provider or other professional if a labor unions and private individuals. training and work with management at some covered MSD occurred. General More than 5,900 pre-hearing of its other facilities. • industry employees in jobs other than comments were filed in response to the The University of California at Los manufacturing or manual handling who proposed ergonomics program standard. Angeles (UCLA) and the Service Employees experienced a covered MSD determined International Union (SEIU) both had grants A 45-day post-hearing comment period for preventing lifting injuries in nursing by the employer to be covered by the and a 45-day summary and brief period standard also would have been required homes. SEIU developed a training program were established, with final briefs due that was used by UCLA to train nursing home by the proposal to implement an to be postmarked no later than August workers in California. UCLA also worked ergonomics program for those jobs. 10, 2000. A total of 240 post hearing with some national back injury prevention

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The ergonomics programs is in their best goal of reducing lost work days by 15 AMI notes that the Guidelines work and interest and that of their employees. percent. The goal was surpassed, and, six that the industry has made substantial Examples of companies cited under the months after the training, none of those progress in addressing ergonomic issues General Duty Clause for ergonomics trained experienced a lost workday due to since development of the Guidelines (id. hazards and which then realized a back injury. at 1–4). The AMI recommended that the substantial reduction in injuries and • Hunter College in New York City trains ergonomics trainers for the United Guidelines be extended throughout illnesses after implementing ergonomics Paperworkers International Union. The general industry (id. at 4). The utility of programs include: the Ford Motor trainers then return to their locals and OSHA’s Guidelines also was hailed by Company, Empire Kosher Foods, Sysco conduct ergonomics training for union the United Food and Commercial Foods, and the Kennebec Nursing members. As a result of this training, changes Workers’ Union, which noted that upon Home. are being made at some workplaces. publication of the Guidelines, industry Two cases have been decided so far Examples include purchasing new began to respond both from the by the Occupational Safety and Health equipment that eliminates or reduces standpoint of technology as well as workers’ need to bend or twist at the Review Commission. workstation, rotating workers every two ergonomics programs (Ex. 32–210–2, pp. In the first general duty clause case hours with a ten-minute break before each 25–26). The success of the Guidelines litigated by the Occupational Safety and rotation, and modifying workstations to led to their use and acceptance in other Health Review Commission, Pepperidge reduce worker strain. industries. The poultry industry appears Farm, the Review Commission b. Education and Outreach. To to have secured substantial reductions recognized that excessive lifting and provide a forum to discuss ergonomic in chronic MSDs from adherence to the excessive repetitions were recognized programs and to augment information in principles in the document (Ex. 30– ergonomic hazards that had caused and the literature with the experience of 3375, p.1.). were likely to cause serious physical companies of different sizes and from a 2. Ergonomics Best Practices harm to employees whose work tasks variety of industries, OSHA and NIOSH Conferences required such activity. The Commission sponsored the first in a series of specifically noted that carpal tunnel conferences that brought industry, labor, During the period from Sept. 17, 1997 syndrome and other soft tissue injuries researchers, and consultants together to through Sept. 29, 1999, OSHA and its found at the cited plant were caused by discuss what works in reducing MSDs. Regional Education Centers co- work tasks; the Commission relied The 1997 OSHA and NIOSH conference sponsored 11 Ergonomics Best Practices principally on direct medical evidence, was followed by 11 more regional Conferences. These Conferences were expert medical opinion, the incidence of conferences across the country. OSHA designed to provide good examples of injury, and the epidemiological studies and NIOSH held the second national practical and inexpensive ergonomics and testimony in the record in reaching conference on ergonomics in March of interventions implemented by local this finding. The Commission also 1999. More than 200 presentations were companies. The concept was that if agreed that an employer could be given at the conferences on how OSHA and its Regional partners could required to undertake a process-based, companies have successfully reduced initiate the development of a network of incremental approach to abating MSDs. Presentations were made by local employers, contractors, and ergonomic hazards. The citations personnel from large and small educators to provide practical relating to the excessive lifting hazard companies in many different industries. information to solve ergonomics were affirmed by the Commission, while Other examples of successful problems, it would be assisting those relating to the excessive ergonomics programs have come from employers in providing a workplace for repetitions were vacated based on a OSHA’s Voluntary Protection Program employees that would be ‘‘free of finding that the Secretary had failed to (VPP). The VPP program was recognized safety and health hazards.’’ prove feasible means of abatement in established by OSHA to recognize To date, attendance has exceeded 2,400 addition to those found to have been employers whose organizations have participants, including employers, undertaken by the company. exemplary workplace safety health contractors, and employees. Finally, In the second general duty clause case programs. Several sites that have been OSHA has made hundreds of outreach litigated by the Commission, Beverly accepted into VPP have excellent presentations to labor, trade Enterprises, the Commission held that ergonomics programs. associations, large and small businesses, the company’s practices for lifting In addition to OSHA’s enforcement and professional organizations during patients in its nursing homes exposed efforts, the Agency’s Ergonomics the development of the proposed rule. its nursing assistants to a serious Program Management Guidelines for 3. Enforcement recognized hazard. Beverly’s nursing Meatpacking Plants (‘‘Guidelines’’) (Ex. assistants suffered a disproportionate 2–13) are viewed by many as essential In the absence of a federal OSHA number of cases of lower back pain, to the implementation of successful ergonomics standard, OSHA has which was often so severe that the workplace programs addressing addressed ergonomics in the workplace employee would be off work for long ergonomic hazards. For example, in under the authority of section 5(a)(1) of periods of time, in some cases six contrasting OSHA’s proposal to the the OSHAct. This section is referred to months to over a year. The Commission Guidelines, IBP Inc.’s Bob Wing as the General Duty Clause and requires found that manual lifting of nursing acknowledged that the Guidelines had employers to provide work and a work home residents is a known and been successful (Ex. 30–4046, p.1). environment free from recognized recognized risk factor for lower back Similarly, the American Meat Institute hazards that are causing or are likely to pain and that the company recognized (‘‘AMI’’), the main representative for the cause death or serious physical harm. the hazard.

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When serious physical harm cannot in each area office. These coordinators Ergonomic settlement agreements and be documented in the work meet on a monthly basis to discuss corporate-wide settlement agreements environment but hazards have been recent inspections, case developments, (CWSAs) * * * demonstrate industry identified by OSHA, compliance officers and scientific literature on ergonomics; recognition of the existence of MSD both discuss the hazards with the to share knowledge of ergonomic hazards and the elements of a program employer during the closing conference solutions; and to ensure that to prevent worker injuries arising from of an inspection and write a letter to the enforcement resources are provided to exposure to these hazards’’ (Ex. 32–210– employer. These letters are called compliance staff for enforcement. A PhD 2, p. 5). The UFCW confirmed the ‘‘Ergonomic Hazard Alert Letters.’’ From level, professionally certified efficacy of these agreements and fiscal year 1997 through October 3, ergonomist serves as the National resulting programs through a number of 2000, approximately 498 such letters Ergonomics Enforcement Coordinator in examples. One was that of IBP’s Dakota have been sent to public and private OSHA’s Directorate of Compliance City meatpacking plant that sector employers under Section 20 of Programs. implemented a comprehensive program the OSH Act. These letters involve no as a result of citations and subsequent 4. Corporate-Wide Settlement penalty and are strictly consultative in settlement agreement. Cost savings Agreements nature; they reflect OSHA’s attributed to the program ‘‘* * * were responsibility to provide consultation Among the companies that have been realized in the following areas: on ergonomics to employers. Ergonomic cited for MSD hazards, 13 companies [employee] turnover was down Hazard Alert Letters have been sent to covering 198 facilities agreed to enter significantly * * *; [MSD] incidence employers in approximately 50% of into corporate-wide settlement dropped dramatically; surgeries fell; OSHA’s ergonomic inspections. agreements with OSHA. These [and] workers’ compensation costs were Since ergonomic solutions vary from agreements were primarily in the meat reduced significantly’’ (id. at 9). one industry to another, OSHA has processing and auto assembly provided both general and industry- industries, but there also were C. Summary specific training to its compliance agreements with telecommunications, As this review of OSHA’s activities in officers. Currently, the OSHA Training textile, grocery warehousing, and paper the last 20 years shows, the Agency has Institute (OTI) in Des Plaines, IL, offers companies. As part of these settlement considerable experience in addressing three main ergonomic courses to OSHA agreements, the companies agreed to ergonomics issues. OSHA also has used compliance staff: Principles of develop ergonomics programs based on all of the tools authorized by the Act— Ergonomics Applied to Work-Related OSHA’s Meatpacking Guidelines (Ex. 2– enforcement, consultation, training and Musculoskeletal and Nerve Disorders 13) and to submit information on the education, compliance assistance, the (#225); Ergonomics Compliance (#325), progress of their programs. Voluntary Protection Programs, and the an advanced ergonomics course; and OSHA held a workshop in March issuance of voluntary guidelines—to Nursing Home Enforcement Training 1999, in which 10 companies described encourage employers to address (#840). A fourth course, Healthcare their experience under their settlement musculoskeletal disorders, the single (#336), has been in development and agreement and with their ergonomics largest occupational safety and health will be piloted on November 14, 2000 programs. All the companies that problem in the United States today. through November 17, 2000. That reported results to OSHA showed a These efforts, and the voluntary efforts course will be designed to help OSHA substantially lower severity rate for of employers and employees, have led compliance officers, as well as MSDs since implementing their to the recent 5-year decline in the employers, to identify ergonomic and programs (Ex. 26–1420). In addition, number of reported lost workday other hazards within healthcare most companies reported lower ergonomics injuries. However, in 1997, facilities, with a specific emphasis on workers’ compensation costs, as well as there were still more than 626,000 lost hospitals. Over 600 OSHA compliance higher productivity and product quality. workday MSD injuries and illnesses staff members have been trained in A report from the March 1999 workshop reported. these courses within the past three years on corporate-wide settlement Promulgation of an ergonomics alone. The courses typically cover three agreements summarizing the results program standard will add the only tool weeks of material. achieved by the 13 companies involved the Agency has so far not deployed Currently, the Principles of has been placed in the docket (Ex. 26– against this hazard—a mandatory Ergonomics Applied to Work-Related 1420). Only 5 of the 13 companies standard—to these other OSHA and Musculoskeletal and Nerve Disorders consistently reported the number of employer-driven initiatives. Over the course also is open to the public MSD cases or MSD case rates. All five first 10 years of the standard’s through OTI’s 12 Regional Education companies that reported data on MSD- implementation, OSHA predicts that Centers throughout the United States. related lost workday rates showed a more than 3 million lost workday Since that course has been available significant decline in the number of lost musculoskeletal disorders will be nationwide, public interest has been workdays. None of the companies that prevented in general industry. high, and the Education Centers have reported severity statistics showed an Ergonomics programs can lead directly been scheduling courses on a regular increase in lost workdays as a result of to improved product quality by basis to meet the constant demand. the ergonomics program. reducing errors and rejection rates. In an Although the new Healthcare Course is Similarly, the success of OSHA OSHA survey of more than 3,000 available currently only to OSHA enforcement coupled with settlements employers, 17 percent with ergonomics compliance officers, after the pilot requiring comprehensive ergonomics programs reported that their programs period ends it will be open to the public programs was confirmed by the United had improved product quality. In on a limited basis. Food and Commercial Workers addition, a large number of case studies In addition to education and training International Union. The union reported in the literature describe opportunities, OSHA has appointed one recognized that ‘‘* * * [t]he majority of quality improvements. Thus, in addition Regional Ergonomics Coordinator in our successful programs in the to better safety and health for workers, each of OSHA’s 10 regional offices, and meatpacking and poultry industries the standard will save employers one Area Office Ergonomics Coordinator were propelled by OSHA enforcement. money, improve product quality, and

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68269 reduce employee turnover and working lifetime as clearly representing 452 U.S. at 530 n. 55; Lead I, 647 F.2d absenteeism. a significant risk. See Benzene, 448 U.S. at 1272; Lead II, 939 F.2d at 980. at 646; UAW v. Pendergrass, 878 F.2d Section III. Legal Authority A standard is cost effective if the 389, 393 (D.C. Cir. 1989) protective measures it requires are the A. General Criteria for OSH Act (Formaldehyde); Building & Constr. least costly of the available alternatives Standards Trades Dep’t v. Brock, 838 F.2d 1258, that achieve the same level of The purpose of the Occupational 1264 (D.C. Cir. 1988) (Asbestos). But protection. Cotton Dust, 453 U.S. at 514 Safety and Health Act (‘‘OSH Act’’) is nonfatal injuries and illnesses are often n. 32; UAW v. OSHA, 37 F.3d 665, 668 ‘‘to assure so far as possible every disabling and debilitating, and death is (D.C. Cir. 1994) (Lockout/Tagout II). working man and woman in the nation clearly not a precondition to a finding Within the framework of these of significant risk of material safe and healthful working conditions principles, OSHA has considerable impairment. See American Textile Mfrs. and to preserve our human resources.’’ discretion (‘‘virtually unlimited Inst. v. Donovan, 452 U.S. 490, 506 n. 29 U.S.C. 651(b). To further this goal, discretion,’’ in the words of the Lead I 25 (1981) (Cotton Dust) (upholding Congress authorized the Secretary of decision, 647 F.2d at 1230) in choosing OSHA’s finding that cotton dust Labor to promulgate and enforce the measures that are reasonably exposure at levels that caused chronic occupational safety and health necessary or appropriate to reduce and irreversible pulmonary disease standards. Section 6(b) of the OSH Act, significant risk. A standard may address presented a significant risk to workers); 29 U.S.C. 655(b) (authorizing the hazards associated with an industry AFL–CIO v. OSHA, 965 F.2d 962, 975 promulgation of standards pursuant to (e.g., logging, 29 CFR 1910.266), a kind (11th Cir. 1992) (upholding OSHA’s notice and comment); 654(b) (requiring of work (e.g., hazardous waste cleanup, finding that ‘‘there is a level at which 29 CFR 1910.120), a category of employers to comply with OSH Act [sensory] irritation becomes so severe standards). This standard is being equipment (e.g., respirators, 29 CFR that employee health and job 1910.134); an environmental area (e.g., issued pursuant to section 6(b). performance are seriously threatened.’’); The OSH Act defines an confined spaces, 29 CFR 1910.146), a Formaldehyde, 878 F.2d at 396–399 ‘‘occupational safety and health lack of information (e.g., hazard (upholding OSHA’s finding that communication, 29 CFR 1910.1200), a standard’’ as ‘‘a standard which requires exposure limit of 1 ppm would class of harmful agents (e.g., bloodborne conditions, or the adoption or use of one eliminate significant risk of sensory pathogens, 29 CFR 1910.1030), or may or more practices, means, methods, irritation due to formaldehyde require general measures reasonably operations, or processes, reasonably exposure); United Steelworkers v. necessary and appropriate for safety necessary or appropriate to provide safe Marshall, 647 F.2d 1189, 1245–51 (D.C. (e.g., safety and health programs for or healthful employment and places of Cir. 1980), cert. denied, 453 U.S. 913 construction, 29 CFR 1926.20(b)). employment.’’ Section 3(8) of the Act, (1981) (Lead I) (upholding OSHA’s Depending on the nature of the safety 29 U.S.C. 652(8). determination that it was appropriate and health issues, some standards A standard is ‘‘reasonably necessary and necessary to lower lead exposures require highly specific control or appropriate’’ within the meaning of to reduce cases in which workers section 3(8) if it (1) substantially experience subclinical effects of lead measures. E.g., 29 CFR 1926.652 reduces or eliminates a significant risk exposure because such subclinical (excavations). Others require the of material impairment to worker effects are precursors of serious, lead- employer to conduct a hazard health, safety, or functional capacity; (2) related disease); Forging Indus. Ass’n v. assessment and establish measures is technologically and economically Secretary of Labor, 773 F.2d 1436, meant to address the problems found. feasible to implement; (3) is cost 1444–46 (4th Cir. 1985) (en banc) E.g., 29 CFR 1910.119 (process safety effective; (4) is consistent with prior (Noise) (upholding OSHA’s significant management). A typical standard for a agency action or supported by a risk finding that a substantial percentage toxic chemical will contain permissible reasoned justification for departing from of workers exposed to existing exposure limits, a control hierarchy for prior agency action; (5) is supported by workplace noise levels would suffer reaching those limits, and provisions for substantial evidence; and (6) is at least material noise-induced hearing loss). assessing exposure, medical as protective as any applicable national See also American Dental Ass’n v. examinations, medical removal, and consensus standard. 58 FR 16612, 16614 Martin, 984 F.2d 823, 826 (7th Cir.), training. E.g., 29 CFR 1910.1025 (lead). (March 30, 1993). To fulfill the cert. denied, 510 U.S. 859 (1993) Some toxic chemical standards also congressional purpose underlying the (Bloodborne Pathogens) (noting that, in mandate specific work practices that Act, all OSH Act standards must be addition to causing death, AIDS and must be used to control exposures. E.g., highly protective. Id. at 16614–15. Hepatitis B cause protracted pain and 29 CFR 1910.1029 (coke oven OSHA’s determination that a disability). emissions); 29 CFR 1926.1101 particular level of risk is ‘‘significant’’ is A standard is technologically feasible (asbestos). Vaccination against Hepatitis based largely on policy considerations. if the protective measures it requires B is one of the protective measures See Industrial Union Dep’t, AFL–CIO v. already exist, can be brought into required by the bloodborne pathogens Marshall, 448 U.S. 607, 656 n. 62 (1980) existence with available technology, or standard, 29 CFR 1910.1030. Medical (Benzene). The factors that enter into can be created with technology that can removal protection benefits have been such a determination include the reasonably be expected to be developed. mandated when they are needed to seriousness of the injuries or illnesses a See Cotton Dust, 452 U.S. at 513; Lead encourage employees to participate in standard will prevent, the likelihood I, 647 F.2d at 1272; American Iron & medical surveillance. 29 CFR 1910.1025 that a particular employee will contract Steel Inst. v. OSHA, 939 F.2d 975, 980 (lead); 29 CFR 1910.1027 (cadmium); 29 such an injury or illness, and the total (D.C. Cir. 1991) (Lead II). CFR 1910.1048 (formaldehyde); 29 CFR number of employees affected. Where A standard is economically feasible if 1910.1052 (methylene chloride). Job the standard seeks to prevent fatal industry can absorb or pass on the costs hazard analysis and employee training illnesses and injuries, OSHA has of compliance without threatening the are cornerstones of some OSHA generally considered an excess risk of 1 industry’s long-term profitability or standards. E.g., 29 CFR 1910.147 death per 1000 workers over a 45-year competitive structure. See Cotton Dust, (lockout/tagout).

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Section 6(b)(7) of the Act, 29 U.S.C. intended to require OSHA to take into Coalition on Ergonomics); Ex. 32–206– 665(b)(7), requires standards to include account the potential that an employee 1 at p. 32 (American Iron & Steel provisions warning employees of may be exposed to the hazard for his Institute); Ex. 22–337–1 at pp. 3–7 hazards, the means needed to protect entire working lifetime ‘‘so that we can (Integrated Waste Service Association); themselves against those hazards, and, get at something which might not be Ex. 30–1722 at pp. 33–35 (Chamber of where appropriate, medical toxic now, if he works in it a very short Commerce). For a variety of reasons, examinations or tests to determine time, but if he works in it the rest of his OSHA concludes that the standard is whether the health of employees has life it might be very dangerous.’’ not subject to section 6(b)(5). been adversely affected: (Remarks of Senator Dominick in First, the language of the statute itself suggests that this rule is not governed by Any standard promulgated under this colloquy with Senator Williams, Leg. subsection shall prescribe the use of labels or Hist. at 503). section 6(b)(5). That provision applies to other appropriate forms of warning as are Section 6(b)(5) directs OSHA to set ‘‘toxic materials or harmful physical necessary to insure that employees are the standard which will, to the extent agents.’’ The ‘‘toxic materials’’ to which apprised of all hazards to which they are feasible, protect employees from section 6(b)(5) refers include chemicals exposed, relevant symptoms and appropriate material impairment to their health even that are harmful if breathed and/or emergency treatment, and proper conditions if they are exposed regularly to the toxic ingested, such as asbestos, lead, and and precautions of safe use or exposure. chemical or harmful physical agent for mercury. S. Rep. No. 91–1282, 91st Where appropriate, such standard shall also their entire working life. Section 6(b)(5) Cong., 2d Sess. at 2, reprinted in prescribe suitable protective equipment and control or technological procedures to be thus requires that any standard Committee Print, Legislative History of used in connection with such hazards and governed by that section must reduce the Occupational Safety and Health Act shall provide for monitoring or measuring significant risk to the lowest feasible of 1970, (Leg. Hist.) at 142. Ergonomic employee exposure at such locations, and in level. See Cotton Dust, 452 U.S. at 509. risk factors are clearly not a toxic such manner as may be necessary for the Safety standards, which are not material. The ‘‘harmful physical agents’’ protection of employees. In addition, where governed by section 6(b)(5), need not to which Congress referred include laser appropriate, any such standard shall reduce significant risk to the lowest radiation, ultrasonic energy, ionizing prescribe the type and frequency of medical feasible level but must provide a high radiation, noise, and vibration. Id. at examinations or other tests which shall be made available, by the employer or at his degree of employee protection to be 142–43. Of the harmful physical agents cost, to employees exposed to such hazards consistent with the purpose of the Act. mentioned by Congress, only vibration in order to most effectively determine 58 FR at 16614–15. Safety standards is a risk factor addressed by the whether the health of such employees is may therefore ‘‘deviate only modestly ergonomics standard. The remaining adversely affected by such exposure. from the stringency required by § 6(b)(5) risk factors addressed by this standard— for health standards.’’ Lockout/Tagout force, repetition, awkward postures, and B. Section 6(b)(5) II, 37 F.3d at 669. contact stress—-are fundamentally Standards dealing with ‘‘toxic The most important consideration in dissimilar from the harmful physical materials or harmful physical agents’’ construing the scope of section 6(b)(5), agents discussed by Congress in that must, in addition to meeting the as with any statutory provision, is the they relate to the position, movement, ‘‘reasonably necessary or appropriate’’ language of the statute itself. In many and loading on the tissues of a worker’s test of section 3(8), conform to section cases, it is obvious whether a hazard is body rather than an external agent 6(b)(5) of the Act, 29 U.S.C. 655(b)(5). a ‘‘toxic material’’ or ‘‘harmful physical acting on the body. See Pulaski v. That section provides: agent’’ subject to section 6(b)(5). Other California Occupational Safety & Health hazards are less clear cut. OSHA has Standards Board, 90 Cal. Rptr. 2d 54, 66 The Secretary, in promulgating standards looked to several factors in determining dealing with toxic materials or harmful (Cal. Ct. App. 1999) (‘‘a repetitive physical agents under this subsection, shall whether a standard fits within section motion injury is neither a ‘toxic set the standard which most adequately 6(b)(5). These include: Is the hazard material’ nor a ‘harmful physical assures, to the extent feasible, on the basis of likely to cause harm promptly or after agent.’ ’’). Therefore, the language and the best available evidence, that no employee a short period of exposure, or does harm legislative history of the Act indicate will suffer material impairment of health or occur only after a lengthy period of that the majority of the risk factors functional capacity even if such employee exposure? Is the connection between addressed by this rule are not the type has regular exposure to the hazard dealt with exposure and harm apparent, or is it of hazards Congress intended to regulate by such standard for the period of his hidden and subtle? Is the harm under section 6(b)(5). working life. coincident with exposure, or is there a In addition, the hazards addressed by The standards that are governed by latency period with harm frequently the rule differ from those addressed by section 6(b)(5) are sometimes referred to manifesting itself long after exposure section 6(b)(5). A lengthy period of as ‘‘health’’ standards, while non-6(b)(5) has ended? See Benzene, 448 U.S. at 649 exposure—years, decades, or a working standards are often referred to as n. 54; UAW v. OSHA, 938 F.2d 1310, lifetime—is not necessary to create a ‘‘safety’’ standards. In enacting section 1313 (D.C. Cir. 1991) (Lockout/Tagout I); substantial risk of MSDs. As discussed 6(b)(5), Congress recognized ‘‘that there National Grain & Feed Ass’n v. OSHA, below, both acute and chronic were special problems in regulating 866 F.2d 717, 733 (5th Cir. 1989) (Grain exposures to ergonomic risk factors can health risks as opposed to safety risks. Dust). result in MSDs. And, although MSDs In the latter case, the risks are generally Because the hazardous exposures frequently develop gradually as a result immediate or obvious, while in the regulated by this standard cannot be of exposure over time, the period of former, the risks may not be evident neatly categorized by the factors time necessary can be days, weeks, or until a worker has been exposed for long discussed above, whether this standard months, rather than the working lifetime periods of time to particular substances. is governed by section 6(b)(5) poses referred to in the text of section 6(b)(5). It was to ensure that the Secretary took difficult legal issues. Some commenters Moreover, MSDs are unlike illnesses, account of these long-term risks that supported characterizing the rule as a such as cancer, damage to the Congress enacted § 6(b)(5).’’ Benzene, section 6(b)(5) rule (Ex. 32–339–1 at p. reproductive system, and kidney failure, 448 U.S. at 649 n. 54. According to its 15 (AFL–CIO), while others opposed it. that can result from exposure to toxic legislative sponsor, section 6(b)(5) is Ex. 32–368–1 at p. 41–44 (National chemicals and appear long after the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68271 exposure ceased even though the ergonomics standard is more like a musculoskeletal disorders other than exposure caused no overt symptoms typical safety standard than a health those caused by accidents and was while it was occurring. An employee standard because many of the costs of intended to include, e.g., back injuries who is beginning to suffer a work- such injuries in terms of workers’ caused by lifting (for employees for related MSD will frequently recover compensation claims and lost whom manual handling is a core job fully after the exposure to ergonomic productivity are borne by employers as element) without regard to whether the risk factors ceases. For that reason, the MSDs occur. Thus, the ergonomics injury resulted from a particular standard requires that an employee who standard does not implicate section exertion or the cumulative effect of develops a work-related MSD be 6(b)(5)’s concern about hazardous numerous lifting exertions. As OSHA restricted from participating in work exposures that lead to illnesses after elsewhere explained: activities or removed from exposure that lengthy exposure and therefore require The pathogenesis of work-related MSDs will worsen the condition. special attention because employers can can refer to either single, point-in-time The ability of employers and defer or avoid the costs associated with injuries, associated with work tasks that employees to generally recognize a such illnesses. result in activities in which tissue tolerance cause-and-effect relationship between Finally, the type of information on is acutely exceeded, or circumstances in ergonomic risk factors and many MSDs which this standard is based is far more which the performance of specific work tasks also indicates that this final standard is characteristic of a safety standard than or combinations in which the performance of a non-6(b)(5) rule. In recent years, as specific work tasks or combinations of tasks a section 6(b)(5) health standard. The over a prolonged period of time result in both employers and employees have risk assessment for this standard, as for small and repeated tissue damage. become more aware of the connection a typical safety standard, is based on the 64 FR at 65900. between workplace risk factors and number of injuries that have resulted MSDs (see Tr. 5817–19), employers have Moreover, the BLS injury and illness from past exposures to the hazard being data on which OSHA based its proposed reported over 600,000 work-related regulated and the percentage of those MSDs that result in lost workdays each risk assessment (see 64 FR at 65931, injuries that are preventable. By Table VI–3) indicates that many of the year (64 FR at 65931). Employees contrast, for a typical health standard, themselves are often able to recognize injuries considered MSDs resulted from the risk assessment is based on short-term rather than chronic when MSDs result from exposure to risk mathematical projections to determine factors in the workplace. As OSHA exposures. OSHA has reexamined its the significance of the risk at various reasoning in light of these comments noted in the proposal: ‘‘Many employers levels of exposure. See, e.g., have told OSHA that talking with and agrees that the acute-chronic Formaldehyde, 878 F.2d at 392–96 distinction it drew in the proposal is employees is a quick and easy way to (discussing OSHA’s quantitative risk find out what kind of problems are in inappropriate when describing MSDs assessment for formaldehyde exposure). and therefore does not afford a proper the job. They said that talking with In the proposal, OSHA recognized that employees is often the best way to basis for classifying this rule as a section the risk assessment methodology for this 6(b)(5) standard. identify the causes of the problem and standard was similar to that for a safety to identify the most cost-effective As discussed in more detail in the risk standard rather than a typical health assessment section, the injury and solutions to it.’’ 64 FR at 65805 (citing standard: Ex. 26–1370). Testimony at the public illness data reported by BLS categorizes hearing made the same point. Dr. There is no need, in the case of each incident by type of injury or illness Suzanne Rodgers, a physiologist with 32 musculoskeletal disorders, for OSHA to and the nature of the exposure event engage in risk modeling, low-dose years’ experience in industrial leading to the injury or illness (BLS extrapolation, or other techniques of 1992, Ex. 26–1372). Under the BLS data ergonomics, testified that the companies projecting theoretical risk to identify the she had worked with learn about magnitude of the risk confronting workers collection system, employers are ergonomic problems by having exposed to ergonomic risk factors. The instructed to report musculoskeletal employees tell them when a problem evidence of significant risk is apparent in the injuries and illnesses under various exists. (Tr. 2144). Similarly, David annual toll reported by the Bureau of Labor codes, some of which represent Alexander, a certified professional Statistics, the vast amount of medical and musculoskeletal system and connective ergonomist with more than 25 years indemnity payments being made to injured tissue diseases and disorders that result experience, testified that encouraging workers and others every year * * * and the from repetitive activity and some of lost production to the U.S. economy imposed which represent other types of exposure employees to report early signs and by these disorders. symptoms of developing MSDs was a events. The BLS category that accounts 64 FR at 65979. key feature of a successful ergonomics for most of the reported injuries and program. (Tr. 2145–46). In the NPRM, OSHA preliminarily illnesses, 021, includes sprains, strains, Further, Congress provided for special concluded that the proposed and tears of muscles, joints, tendons, treatment of health hazards in section ergonomics standard was a section and ligaments. The category is described 6(b)(5) because it recognized that 6(b)(5) standard. The NPRM stated that as representing traumatic injuries, employers had little incentive to control MSDs are caused by chronic and not by which generally result from a single exposures to toxic chemicals and short-term exposures. 64 FR at 66057. event or exposure. Ex. 26–1372 (BLS harmful physical agents when there is a Some commenters contended that this Occupational Injury and Illness long period between exposure to a statement was inconsistent with Classification Manual). hazard and the manifestation of an OSHA’s proposed definition of MSD In its preliminary risk assessment, the illness. ‘‘In such instances a particular and the inclusion of ‘‘traumatic’’ agency closely examined the BLS data, employer has no economic incentive to injuries in its risk assessment. Ex. 22– excluded from its analysis injuries invest in current precautions, not even 337–1 at p. 7 (Integrated Waste Service caused by accidents (i.e., slips, trips, in the reduction of workmen’s Association); Ex. 32–241–4 at pp. 197– falls, and being struck by objects), and compensation costs, because he seldom 99 (Anheuser-Busch & United Parcel included those codes that will have to pay for the consequences of Service); Ex. 32–300–1 at pp. 15–16 predominantly represented work-related his own neglect.’’ Leg. Hist. at 144. (Edison Electric Institute). The proposed MSDs, including 021, that were reported However, in this respect too, the definition of MSD included under the exposure event categories

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68272 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations most closely representing ergonomic OSHA does not believe that factor alone contribute to a worker’s hearing loss. risk factors. 64 FR at 65928. The largest makes this a section 6(b)(5) standard. Nevertheless, OSHA has the authority to number of these injuries were classified The standard is not a ‘‘vibration’’ regulate harmful noise levels in the under the exposure category for standard but one that addresses the workplace as long as the workplace ‘‘overexertion,’’ which includes multifactorial causes of MSDs. The risk exposures create a significant risk of primarily lifting, lowering, pushing, factors that are not ‘‘harmful physical material impairment of health. Forging pulling, and carrying. 64 FR at 65932. agents’’—force, repetition, awkward Indus. Ass’n v. Secretary of Labor, 773 OSHA has followed this same approach posture, and contact stress—together F.2d 1436, 1442 (4th Cir. 1985) (en in its final rule and in the supporting contribute substantially more to the vast banc) (Noise). risk assessment, i.e., excluding majority of MSDs than does vibration. Noise dealt with a challenge to the musculoskeletal injuries due to Similarly, that a provision in OSHA’s Hearing Conservation Amendment to accidents but including those resulting standard governing access to employee OSHA’s occupational noise standard. from ergonomic risk factors. In OSHA’s exposure and medical records (29 CFR That amendment establishes certain view, when MSDs result from exposure 1910.1020(c)(13)) defines ‘‘toxic requirements that must be met to reduce to ergonomic risk factors, any substance or harmful physical agent’’ as the incidence of and/or prevent hearing distinction between acute and chronic including ‘‘repetitive motion’’ does not impairment due to occupational noise exposures is unimportant. OSHA notes establish that repetitive motion is a exposure. Before issuing the that the classification of these disorders harmful physical agent within the amendment, OSHA found that 10–15% as traumatic is in part a convention of meaning of section 6(b)(5). See Ex. 32– of workers exposed to noise levels the recordkeeping system. OSHA’s 339–1 at p. 15 (AFL–CIO). Whether below the permissible exposure limit general recordkeeping guidelines for repetitive motion is a harmful physical (PEL) would suffer material hearing back disorders instruct that because the agent was not central to that impairment. 773 F.2d at 1443. OSHA specific event causing such a disorder rulemaking, which dealt with the access based this finding on a ‘‘panoply of cannot always be pinpointed, to keep of employees and OSHA personnel to scientific reports and studies,’’ recordkeeping determinations as simple employee records and did not regulate including studies done by the National and equitable as possible, all back particular hazards. In that rulemaking, Institute for Occupational Safety and disorders should be classified as interested parties had no reason to argue Health (NIOSH) and the Environmental (traumatic) injuries rather than whether a standard that regulates Protection Agency (EPA). Id. OSHA also (cumulative exposure) illnesses. BLS, repetitive motion is a section 6(b)(5) found that those employees who had Recordkeeping Guidelines for standard, and OSHA had no occasion to suffered a hearing decrement of 10 Occupational Injuries and Illnesses address that issue. Moreover, the decibels in either ear faced a greater risk (April 1986), at p. 38. Similarly, OSHA’s records access rule was not issued from continued exposure to high levels Ergonomics Program Management for under section 6(b)(5) but under OSHA’s of workplace noise than workers whose Meatpacking Plants states that all back general authority to issue standards hearing was unimpaired. Id. OSHA’s cases are to be classified as injuries even (section 6(b)) and regulations (section Hearing Conservation Amendment though some back conditions may be 8(g)). And it was upheld in court as a provided hearing-endangered workers triggered by an instantaneous event and section 8(g) regulation rather than a with protection in the workplace in others develop as a result of repeated section 6(b) standard. Louisiana Chem. order to decrease the risk of hearing Ass’n v. Bingham, 731 F.2d 280 (5th Cir. impairment. trauma. Ex. 32–210–2–2 at p. 14. 1984), aff’g 550 F. Supp. 1136 (W.D. La. The Forging Industry Association Moreover, a number of experts testified 1982). Therefore, the fact that the (FIA) argued that ‘‘because hearing loss in the hearings that a substantial part of records access rule applies to repetitive may be sustained as a result of activities the MSD injuries classified under the motion cannot be regarded as which take place outside the BLS system as traumatic in fact establishing an OSHA policy that workplace—such as listening to loud represent cumulative exposure. (Tr. repetitive motion is a harmful physical music, age, or engaging in certain 2175–77; 2236–44; 5802–04). In short, agent for purposes of section 6(b)(5). recreational activities—OSHA acted even though an MSD may be classified beyond its statutory authority by as ‘‘traumatic’’ in origin, it will often be C. This Final Rule Does Not Regulate regulating non-occupational conditions the case that, while the onset of the non-Workplace Activities or causes.’’ Noise, 773 F.2d at 1442. The injury was sudden, the cause was Some commenters have pointed out court found ‘‘no merit’’ in FIA’s exposure to ergonomic risk factors over that MSDs can result from personal argument. The court ruled that OSHA some period of time. However, it is activities as well as from workplace properly relied on ‘‘the extensive and neither necessary nor meaningful to exposures. Ex. 32–368–1 at p. 40 thorough research of several scientific limit the standard’s reach to MSDs that (National Coalition on Ergonomics); Ex. institutions in defining the problems only occur because of exposures that 32–241–4 at p. 49 (Anheuser-Busch & related to industrially-caused hearing take place over some period of time. The United Parcel Service). They argue that loss in designing its proposal.’’ Id. at purpose of this standard is to reduce the OSHA is attempting through this rule to 1443. The court also stressed that OSHA number and severity of MSDs by regulate the nonwork activities that may excluded non-occupational hearing loss protecting workers against excessive contribute to MSDs and that the rule is from the rule. Id. at 1444 (‘‘To be sure, exposure to ergonomic risk factors and therefore outside OSHA’s authority. some hearing loss occurs as a part of the MSD hazards, and for that purpose it is However, the rule regulates only aging process and can vary according to irrelevant whether those excessive conditions or activities in workplaces, non-occupational noise to which exposures are ‘‘acute’’ or ‘‘chronic.’’ and OSHA clearly has the authority to employees are exposed. The On reflection, OSHA has determined issue the rule. amendment, however, is concerned that other considerations relied on in Many adverse health conditions can with occupational noise—a hazard of the NPRM are likewise unpersuasive. be caused or aggravated by both work the workplace.’’). The court ruled that Although the standard protects against and nonwork exposures. For example, the fact that non-occupational hazards one risk factor—vibration—that exposures to high noise levels both may contribute to hearing loss does not qualifies as a ‘‘harmful physical agent,’’ inside and outside the workplace can mean that OSHA should refrain from

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68273 regulating workplace conditions that are facto’’ preclude the possibility of ergonomics program standard. OSHA shown to cause such loss: enforcement under section 5(a)(1). Id. did not propose a purpose paragraph, The amendment provides that non- The Commission also analyzed a and thus no comments on this topic occupationally caused hearing loss be significant amount of evidence that were received. OSHA has decided to excluded from its regulation. See 29 CFR showed a causal relationship between include a purpose statement in the final 1910.95(g)(8)(ii), 1910.95(g)(10)(ii) (1984). MSDs and workplace hazards, including rule to clearly indicate the goal of the Assuming, however, that some loss caused by testimony from medical personnel who standard and to differentiate between aging or smaller amounts of noise sustained examined injured workers, those musculoskeletal disorders (MSDs) for shorter periods also aggravates the epidemiological data, and injury that are covered by the standard and hearing loss incurred by an individual employed in a high noise-producing incidence at a Pepperidge Farm plant. those that are not. It clarifies that the industry, that is scant reason to characterize Id. at 2020–26. The Commission standard’s purpose is to reduce the the primary risk factor as non-occupational. ultimately found that there was a causal number and severity of MSDs that are Breathing automobile exhaust and general air connection: caused by occupational exposure to pollution, for example, is damaging to lungs, We therefore conclude that the Secretary ergonomic risk factors (also called whether healthy or not. The presence of has established on this record a causal ‘‘ergonomic stressors’’) on the job. unhealthy lungs in the workplace, however, connection between [MSDs] affecting the As discussed in more detail below, hardly justifies failure to regulate noxious employees at Downington [a Pepperidge the disorders addressed by this rule workplace fumes. Nor would there be logic Farm plant] and their work on the biscuit include those of the muscles, nerves, to characterizing regulation of the fumes as lines. In doing so, we are mindful that many tendons, ligaments, joints, cartilage, non-occupational because the condition of these injuries may have had more than one inflicted is aggravated by outside irritants. blood vessels, and spinal discs causal factor and of the experts who contend occurring in the neck, shoulder, that the specific cause of such injuries is, Noise, 773 F.2d at 1444. forearm, wrist, hand, abdomen (hernias Like the Hearing Conservation essentially, unknowable or presently unknown. As is the case with many only), back, knee, ankle, and foot. They Amendment to the Noise standard, this include conditions classified by the final ergonomics rule regulates occupational ills with multiple possible causes, employees are more or less Bureau of Labor Statistics in its Annual workplace hazards. As discussed in the susceptible to injury on the job because of the Survey as illnesses (e.g., carpal tunnel health effects section of this preamble, individual attributes and backgrounds they syndrome) and as injuries (e.g., low this rule addresses only exposure to bring to the workplace. As with these other back pain), because MSDs include many ergonomic risk factors that occurs in the ills, the Secretary is not thus foreclosed from different disorders, affect many tissues workplace. The MSDs that trigger action attempting to eliminate or significantly reduce the hazard by regulating what is and areas of the body, and may be under the rule must be work-related and described by a wide range of medical they must have occurred in workers shown to be a substantial contributing factor to the worker injuries. diagnoses. whose jobs place them at a heightened 17 O.S.H. Cas. (BNA) at 2029. The terms used to describe this group risk of incurring a MSD because they are of conditions have varied over time and exposed to risk factors at the levels in The Commission’s holding in geographic region. For example, in the Basic Screening Tool. Pepperidge Farm that the susceptibility Australia, MSDs are often called A decision by the Occupational Safety of some employees to a particular ‘‘Occupational Overuse Syndrome’’ and Health Review Commission ailment does not preclude OSHA from injuries. Other frequently used terms supports OSHA’s conclusion that the regulating workplace conditions or include ‘‘repetitive stress injuries,’’ Act can properly address work-related practices that cause or contribute to that ‘‘cumulative trauma disorders,’’ and ergonomic hazards even though type of ailment is supported by other ‘‘soft tissue injuries.’’ In recent years, employees can also be exposed to such cases. In the asbestos rulemaking, OSHA however, the term ‘‘musculoskeletal hazards outside the workplace. In based its significant risk determination, disorders’’ has gained widespread Pepperidge Farm, Inc., 17 O.S.H. Cas. in part, on epidemiologic studies that acceptance by the scientific community, (BNA) 1993 (1997), the Commission included workers who smoked and were and OSHA uses this term, or its held that where work was shown to be therefore significantly more likely to abbreviation, MSD, throughout the a substantial contributing factor to contract cancer than those who did not. regulatory text and supporting analyses. MSDs, the fact that non-work factors Asbestos, 838 F.2d at 1265. The court Paragraph (a) makes explicit that may also play a role did not preclude held that OSHA was justified in doing OSHA’s ergonomics program standard OSHA from requiring the employer to so. Smokers were not, the court said, does not apply to injuries or illnesses abate the workplace hazards. In that ‘‘so far beyond the pale as to require caused by motor vehicle accidents, case, Pepperidge Farm contested a OSHA to ignore them in computing the slips, trips, falls, or similar accidents number of citations for ergonomic risks of asbestos.’’ Id. (emphasis added). that result in traumatic injuries on the violations that OSHA had issued under See also Reich v. Arcadian Corp., 110 job. By ‘‘other similar accidents,’’ OSHA section 5(a)(1) of the Act. In order to F.3d 1192, 1198 (5th Cir. 1997) means, for example, caught in or caught prove a section 5(a)(1) violation, OSHA (Congress intended Act’s general duty between injuries or other accidents had to show that a condition or activity clause to protect all employees, resulting in blunt trauma. (Throughout in the employer’s workplace presents a including those who are especially this notice, OSHA uses the terms ‘‘work- ‘‘hazard to employees.’’ 17 O.S.H. Cas. susceptible). Thus, workers who engage related,’’ ‘‘caused by,’’ ‘‘musculoskeletal (BNA) at 2009 (emphasis added). The in activities outside the workplace that disorders,’’ ‘‘risk factors,’’ and company argued that section 5(a)(1) expose them to ergonomic risk do not ‘‘exposure.’’ For a detailed discussion of should not apply to MSD workplace thereby forfeit on-the-job protection these terms, see the relevant sections of hazards because, among other things, against exposure to excessive ergonomic the Health Effects (Section V of the ‘‘non-workplace factors may cause or risk factors. preamble), Summary and Explanation contribute to the illnesses at issue and IV. Summary and Explanation (Section XI), and Legal Authority that individuals differ in their (Section III) sections of this preamble.) susceptibility to potential causal (a) What Is the Purpose of This Rule? As stated in paragraph (a), the factors.’’ Id. at 2013. The Commission The first paragraph of the final purpose of this standard is to reduce the held that such factors should not ‘‘ipso standard sets out the purpose of this number and severity of MSDs caused by

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68274 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations workplace exposure to ergonomic risk issued today is thus not a ‘‘zero-risk’’ requirement to implement an entire factors, such as force, awkward standard. It recognizes that substantially program when an MSD incident occurs postures, or repetition, either alone or in reducing the number and severity of in a job that meets the Action Trigger is combination. The standard requires these disorders is possible in most, if more practical administratively if employers to implement an ergonomics not all workplaces, although many employers are required to take this program to address risk factors in jobs establishments may not be able to broad approach. that pose an MSD hazard to the eliminate MSDs completely. (For a Moreover, the standard does not employees in those jobs. As discussed discussion of OSHA’s analysis of the apply to jobs or operations that are in detail in Section VI of the preamble, standard’s projected effectiveness, see normally covered exclusively by the Risk Assessment, ergonomics programs the Risk Assessment section of the construction, agriculture and maritime have been shown to reduce the number preamble (Section VI) and Chapter IV, standards, even if those operations are and severity of MSDs in old and new Benefits, of the Final Economic and performed in a general industry facilities, in large and small workplaces, Regulatory Flexibility Analysis.) establishment or for a general industry and in a wide variety of jobs ranging employer. Thus a construction crew from computer use to solid waste Paragraph (b)—Does This Standard Apply To Me? (Scope and Application) whose sole job is to build in-plant handling, from assembly line operations structures in a steel mill is engaged in to patient handling, and from beverage Discussion of the scope and construction and is not covered by this distribution to meat processing. application of the final rule is divided standard, even though the steel mill Reducing the number and severity of into three parts. Part I discusses which itself is a general industry operation. MSDs in the workplace is the goal of employers and operations the standard This is consistent with the operation of successful ergonomics programs covers. Part II explains the exclusions other OSHA standards. everywhere. As the more detailed from coverage of the rule and OSHA’s Although the proposal also applied discussions in this preamble and in the authority to limit the standard’s only in general industry, its scope Agency’s economic analysis will show, coverage to general industry. Part III provision stated that coverage was this goal cannot be achieved overnight, addresses other scope and application further limited to general industry although positive results are generally issues raised during the rulemaking. manufacturing jobs, manual handling observed soon after program jobs, and jobs with MSDs. implementation. One effect of a new Part I—Scope and Application of Manufacturing jobs were defined as ergonomics program, which at first Standard to General Industry ‘‘production jobs’’ in which the glance may not appear to be a positive Employers activities of producing a product made one, is that the number of MSDs and A. Scope of Coverage up a ‘‘significant amount’’ of the MSD signs and symptoms reported in employee’s worktime. Manual handling the first months after the Paragraph (b) states that the standard jobs were those in which the employee implementation of the program may applies to general industry employment, performed ‘‘forceful’’ lifting (i.e., lifting actually increase. This initial increase in which means all employment except for the number of MSD reports reflects the railroads and employment covered by or lowering, pushing or pulling, or heightened awareness of ergonomics, OSHA’s agriculture, construction, and carrying) and the forceful lifting tasks the importance of early reporting, and maritime standards. Unlike other OSHA were a ‘‘core element’’ of the employee’s the value of conservative treatment that general industry standards, however, job. Jobs with MSDs were defined as routinely accompanies program this standard does not cover general jobs in which an OSHA recordable MSD implementation. In most workplaces, industry work performed incidentally to occurred in a job in which the physical this increase is short-lived, generally or in support of construction, maritime, work activities and conditions were lasting less than a year and almost never or agricultural employment or railroad reasonably likely to cause that type of more than two years. The severity of the operations. This means that functions MSD, and the activities were a core MSDs reported, however, generally such as office work, management and element of the job or accounted for a decreases in the first few months after support services are not covered by the significant amount of the employee’s program initiation and declines steadily standard, and that, for example, a worktime (64 FR 65779–82). thereafter, before leveling off as the construction company office or a marine The proposal explained that OSHA program matures. Thus, OSHA intends terminal cafeteria would not be covered. was focusing on general industry in this and expects the final rule to reduce the However, a construction company real first ergonomics rulemaking because the number and severity of MSDs in the estate division engaged in selling the problems in general industry are workplaces covered by the standard finished properties would not be particularly severe and the solutions are over the first few years after the performing functions directly in support well-understood (64 FR 65776). Some standard is fully in effect; OSHA is of the construction operations and commenters agreed with the proposed aware that the standard’s purpose will would be within the scope of the rule’s scope, and its emphasis on not be fully achieved in the short run. standard. manufacturing and manual handling When ergonomic programs mature, they The final rule thus imposes coverage jobs (Exs. 31–3, 31–71, 31–180, 31–252, continue to demonstrate ongoing based on the business category in which 31–284, 32–300). More, however, argued reductions in the number of MSDs the employer belongs, e.g., general either that the rule should not exempt caused by workplace risk factors and in industry as opposed to construction. construction, maritime and agricultural the severity of those MSDs that do This marks a departure from the employment (Exs. 30–400, 30–1294, 31– occur. Agency’s past practice of imposing 14, 31–105, 31-143, 31–156, 31–345, 31– The standard’s purpose paragraph coverage based solely on the job that an 352, 32–198–4, 32–210, 32–359–1, 32– also reflects OSHA’s awareness that employee is performing. The approach 461–1, 30–1294, 500–218), or that the work-related MSDs will continue to adopted in this standard, i.e., basing rule should exempt even more occur in many workplaces even after coverage on the industry classification industries or jobs (Exs. 30–372, 30–494, implementation of an effective of the employer, is appropriate here 1–248, 31–280, 32–77-2, 32–78, 32–234, ergonomics program that complies fully because of the unique nature of 30–2208, 30–3167, 32–77–2, 601–X–1, with this final rule. The standard being ergonomic problems and solutions. The Tr. 3126).

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Many of the commenters who range of problems in diverse jobs and At the rulemaking hearing, many believed that the scope of the proposed industries. Even in those situations employees testified that they had rule was too broad argued that it where significant ergonomic hazards suffered serious work-related MSDs. incorporated a ‘‘one size fits all’’ exist, the commonality of the response Occupations in which these employees approach that was inappropriate for the required by this standard is to were working when they became wide variety of operations found in implement an ergonomics program. The injured include: general industry (Ex. 30–494, see also specific focus of that program will be • Nurse Exs. 30–380, 30–372, 30–531, 30–3167, targeted to the particular hazards and • Home health care aide Tr. 3126, 3332). Some of these conditions at each workplace. The • Nurses’ aide commenters pointed out that there was control strategies for ergonomic hazards • Package delivery great variation in MSD rates, prevalence will be targeted even more specifically • Package sorting of ergonomic risk factors, and levels of to the needs of each workplace. And the • Meatpacking and poultry exposure to those risk factors across extent of each employer’s compliance processing general industry (Exs. 30–541, 30–3167). obligation will be determined by the • Office clerical worker Others pointed out that jobs differed extent of the problem at that employer’s • Internet publishing greatly within and across industries, workplace. Thus the fact that the rule • Machinists and claimed that OSHA did not have applies to a variety of hazards at • Sewing machine operator enough information about effective differing workplaces does not in any • Truck driver controls in all industries (Exs. 30–425, way mean that the employers in all of • Food warehousing and distribution 30–3167, 32–77, 32–211–1, 32–2208). those workplaces need to take the same • Grocery store cashier The focus of both these groups of actions. • Physical therapist comments was that OSHA did not have Work-related MSDs are widespread • Mail carrier enough knowledge or evidence to find throughout general industry. They occur • Letter sorter that the same approach to controlling in every single sector within general • Teacher ergonomic hazards would be industry, according to the Bureau of • Teachers’ aide appropriate in all of these disparate Labor Statistics (BLS). In 1996, • Auto assembly circumstances. according to BLS, there was no industry • Molding and casting machine A number of commenters suggested sector that did not report the occurrence operator ways to limit the standard’s scope. of at least several hundred work-related • Reporter Some urged OSHA to focus the rule MSDs, with a large number of industries • Grocery shelf stocker more narrowly on those jobs or reporting tens of thousands of work- • Sonographer industries with the highest MSD rates or related MSDs. Moreover, high • Television film editor those deemed to have high risk potential concentrations of work-related MSDs • Electrical workers are reported in a wide variety of (Exs. 30–13, 30–425, 30–2208, 30–3167, (Exs. 30–4200, 32–185–3, 32–210–2, 32–198– 31–248, 31-280, 32–78, 32–234, Tr. occupations that are found throughout 3, 32–311, 500–218, Tr. 4009–10, 4235, 4240, 2729–30). For example, Larry Leahy of general industry establishments. BLS 4234, 6004, 6009, 6319, 6321–22, 6333, Ruth Constant & Associates, a home data for 1996 show that general industry 7320–21, 7335–37, 7341–42, 17950). health care service agency, questioned truck drivers, laborers, and janitors, occupations found widely dispersed Doctors and other health care why OSHA was covering all of general professionals (HCPs) also testified that industry when 60 percent of the MSDs throughout general industry sectors, experienced more than 48,000, 38,000 they had treated employees in many occurred in industries representing a different jobs and industries for work- fairly small percentage of the national and 15,000 lost workday (LWD) MSDs, respectively. (See Section VII (Risk related MSDs (Exs. 37–12, 37–28, Tr. workforce (Ex. 30–611). Todd 14973, 15045–46, 16819, 16829). Dr. McCracken, of National Small Business Assessment) of this preamble.) Evidence submitted by rulemaking Robert Harrison testified that, in his United, argued: participants confirms the broad research and practice, he had diagnosed There is a need to focus on particular types distribution of MSDs and MSD hazards and treated over 1,000 patients with of jobs . . . There are specific types of jobs throughout general industry. For work-related MSDs from a wide variety in specific industries where MSDs are much example, the Service Employees of industries and occupations, including more likely to occur (Tr. 2729–30). International Union (SEIU) submitted (Ex. 37–12): Similarly, Organization Resources evidence that union members working • Postal workers Counselors, Inc. (ORC) recommended in a variety of health care settings (e.g., • Materials handlers that the rule only cover high risk hospitals, nursing homes, private • Computer operators occupations or employers whose MSD homes, pharmacies) have suffered MSDs • Grocery checkout clerks incident rates were above the national (Ex. 32–311–1). These health care • Meat processors background level (Ex. 32–78; see also workers include registered nurses, • Assemblers Tr. 10633–35). The Small Business licensed practical nurses, nurses’ aides, • Seamstresses Administration’s Office of Advocacy orderlies, physical therapists, radiology • Telephone operators suggested covering only manual technicians, housekeepers (maids and • Pipefitters handling jobs, which it claimed housemen), laundry workers, laundry • Customer service agents accounted for 78 percent of all MSDs machine operators, maintenance • Machine operators (Ex. 601–X–1). workers, kitchen and food preparation • Automotive manufacturing workers As discussed in detail throughout this workers, central supply workers, and • Aircraft manufacturing workers preamble, OSHA believes that the janitors and cleaners. In addition, SEIU • Optical scanners record supports coverage of all of said that other union members such as • Graphic artists general industry within the overall janitors and cleaners working in a • Restaurant workers scope of the standard. The final variety of other industries, including • Bakers standard does not, however, prescribe a hotels/motels, restaurants, offices have • Plumbers one-size-fits-all solution for a wide also experienced MSDs (Ex. 32–311–1). • Letter sorters

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Dr. Robin Herbert, the medical co- witnesses, including David Alexander • Medical products manufacturing director of the Mt. Sinai Center for (Ex. 37–7), David Caple (Ex. 37–20), All of this evidence supports OSHA’s Occupational and Environmental Dennis Mitchell (Ex. 37–11), Maurice decision to provide the protections of Medicine, testified that she had treated Oxenburgh (Ex. 37–24), Suzanne this standard to all general industry or supervised the treatment of more Rodgers (Ex. 37–25), and John employees. On the other hand, OSHA than 2,000 patients with upper Rosecrance (Ex. 37–26), testified that recognizes that there may be some extremity MSDs in the past 12 years: employers in the following different general industry employers with few or no MSD hazards. Until an MSD is My patients have included journalists, industries had hired them to help computer graphic artists, health care workers, reduce the incidence of work-related reported, the employer’s obligation is technicians for telephone companies, MSDs among employees: limited to distributing the information automobile manufacturing workers, cashiers, • Newspaper in paragraph (d). • garment workers, meat wrappers, dental Luggage manufacturing B. Application of Requirements hygienists, secretaries, and chefs. Industries • Meatpacking from which I have seen patients include • Packaging Unlike the proposal, this final publishing, journalism, entertainment, • Papermaking standard does not differentiate among manufacturing, health care, transportation, • Plumbing supply general industry employers. Under the and telecommunications (Ex. 37–28). • Route sales and delivery proposal, employers of employees Dr. George Piligian, who also works at • Film products manufacturing engaged in manufacturing or manual the Mount Sinai Center, testified about • Hospitals handling would have been required to finding and treating MSDs in dancers, • Heavy appliance manufacturing implement some elements of an musicians, editors, secretaries, • Automobile manufacturing and ergonomics program whether or not telephone operators, sewing machine subassembly their employees had suffered any MSDs. operators and hospital workers (Tr. • Furniture manufacturing Other general industry employers would 7813–20). • Paper and pulp products not have had to take any action until a Similarly, insurance companies, • Forest products ‘‘covered MSD’’ occurred, and a covered employers and trade associations • Food service MSD was defined differently for them representing the following industries • Clerical than for manufacturing and manual testified about the implementation of • Electronics handling employers (64 FR 65782–84, ergonomics interventions and programs • Clothing and textile manufacturing 65791). In this final standard all general because work-related MSDs were • Baking industry employers are required, as occurring among workers in the • Restaurant specified in paragraph (d), to provide following environments: • Home and office furniture basic information on ergonomics and • Chemical manufacturing manufacturing the standard to their employees. The • Pharmaceutical manufacturing • Hospitality—hotel/motel employer has no further obligation until • Automotive manufacturing • Fiber manufacturing the employee reports an MSD or the • Automotive repair • Logistic and supply warehousing signs or symptoms of an MSD (see • Boat manufacturing • Telecommunication paragraph (e)). • Textile manufacturing • Textile and apparel manufacturing OSHA developed its bifurcated • Clothing manufacturing • Metal forging and cast metals proposal because about 60 percent of all • Printing • Electronics manufacturing reported MSDs occurred in • Dental • Health care manufacturing and manual handling • Meatpacking • Petroleum jobs, even though those jobs accounted • Electric utility • Electrical manufacturing for less than 30 percent of general • Hospitals • Airline freight handling industry employment. Although some • Office workers • Steel manufacturing commenters agreed that this might • Hotel/motel • Fishing justify a focus on manufacturing and • Emergency medical services • Aircraft manufacturing manual handling (Ex. 30–4837), very • Furniture manufacturing • Gas and electric utility few expressed satisfaction with the • Oil and gas drilling • Flooring products proposed approach (Exs. 30–400, 31–78, • Moving and storage • 32–198, 32–210, 32–461, 500–218, Tr. • Computer and computer accessory Fabricare manufacturing 3224). Many commenters said that • Nursing homes • manufacturing and manual handling • Plumbing fixtures manufacturing Telephone operation and • Food products manufacturing and jobs should not be singled out because installation MSD hazards were present and MSD • processing Funeral and cemetery • rates were high in other jobs and • Chemical manufacturing Insurance • Printing industries (Exs. 30–626, 30–2208, 31– • Solid waste removal and recycling • • Waste treatment 156, 500–218). For example, Paint manufacturing • • Plastic manufacturing participants said that there were many Poultry processing • • Clothing retail MSD hazards and MSDs in ‘‘any job Food warehousing and distribution • • Power plants involving regular computer use,’’ Beverage delivery • therefore, programming, journalism, • Assembly line Research laboratories • data entry, system administration, • Grocery store Transportation • • Printing accounting, analysis, and insurance jobs Retail clothing • • Foundry Upholstery should have been included by name • Rubber manufacturing (Exs. 30–49, 30–400, 31–3, 31–12, Tr. (see, e.g., Tr. 3337–9, Tr. 5104, Tr. 8458– • Welding 2783, 2932). Likewise, other 8480, Tr. 16553–57). • Mail sorting and delivery commenters argued that custodians and Finally, several of the ergonomists • Transportation supermarket employees including who appeared as OSHA’s expert • Electronics cashiers, bakery personnel, baggers and

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A more thorough reader would Exs. 30–400, 31–78, 32–198, 32–210, note the disclaimer to the effect that ‘‘* * * 31–245, 31–252, 31–259, 32–300), a 32–461, 500–218, Tr. 3224). each job must be considered on the basis of number favored expanding the scope of Another group of commenters its actual physical work condition * * *’’ the rule to cover all industries regulated opposed requiring any employers to and correctly conclude that there is no by OSHA (Exs. 30–400, 30–428, 30– take any type of action before a work- standard against which to compare the actual 1294, 32–210, 500–218, Tr. 2859, 3224, related MSD is reported (Ex. 30–240, physical work conditions’’ (Ex. 31–211). 5592, 9080, 13445, 113745, 14002, 32–300, 30–542, 601–X–1) on the (See also Exs. 30–3032, 30–3853, 32– 17362, 17652). Their arguments fell into grounds that it was a ‘‘waste of 300.) three categories. resources’’ to require a basic program for First, many of these commenters employers with manufacturing and OSHA is accounting for these pointed to the high number and rate of manual handling jobs that have no concerns in this restructuring of the MSDs, especially back injuries, MSDs (Ex. 30–542). For example, one standard’s scope and application occurring in industries excluded from said: provisions. This final rule applies to all the proposed rule (Exs. 30–626, 30– general industry employers, but no If an employer is in one of the targeted 2208, 31–156, 31–183, 31–225, 500– employer is required to evaluate or 218). The Mount Sinai Center for industries but has not had MSDs, why force implement control measures or MSD the bureaucracy of program implementation Occupational and Environmental upon him or her * * * (Ex. 30–240). management until an MSD incident Medicine Construction Hygiene and occurs in a job that involves exposure to And while some participants found Ergonomics Program (CHEP) pointed risk factors at levels meeting those in out that, aside from the transportation the definitions of manufacturing and the Basic Screening Tool in Table 1. The manual handling jobs adequate to industry, construction has the highest only obligation employers have until rate of back injury of any industry: identify whether a particular job was that point is to provide information covered (Exs. 30–3934, 30–4837, 31–38, about ergonomics and the standard to Every year 1 in 100 construction workers 31–36, 31–113, 31–173, 31–205, 31–229, their employees. And, as explained in will miss between 7 and 30 days of work due 31–347), most disagreed (Exs. 30–5, 30– the discussion of paragraph (d) below, to back injuries * * * At one surveyed 46, 30–75, 30-293, 30–1722, 30–3032, worksite all wallcoverers who had worked 15 OSHA is providing that information in years or more in the trade had required 30–3853, 31–4, 31–27, 31–92, 31–106, Appendices A and B and on its website. 31–125, 31–135, 31–211, 31–245, 31– surgery or medical intervention for problems OSHA believes that these changes including carpal tunnel syndrome, pain in 246, 32–78, 32–300, 32–337). Many said respond to most complaints about the the neck, shoulder and back, and knee that the definitions, particularly the scope and application provisions of the problems (Ex. 31–183). definition of manual handling jobs, proposal. By eliminating the additional were too vague (Exs. 30–137, 30–425, Some commenters also favored requirements for manufacturing and expanding coverage because they said 30–1722, 30–3167, 31–77, 31–180, 31– manual handling employment, OSHA is 225, 31–227, 31–248, 31–260, 31–342, that employees in construction, eliminating both the need to define agriculture and maritime are exposed to 32–78, 32–300, 32–337, Tr. 3255–56). those terms and much of the complexity For example, one commenter said: the same risk factors and MSD hazards and vagueness commenters found in the as are employees in general industry The definitions of manufacturing and proposal. By limiting employers’ (Exs. 30–626, 31–22, 31–183, 31–263, manual handling jobs covered by the obligations in establishments that have 31–303, 500–218). They said there was standard are guaranteed to leave employers not experienced MSD incidents, OSHA as much in the dark as they are now. What no reason to distinguish coverage by is also taking account of the facts that industries if the rule was also constitutes ‘‘forceful’’ manual handling? How not all manufacturing and manual much force must be involved to be covered? incorporating an MSD trigger because, Should the strength capabilities of individual handling jobs involve more significant as one put it, ‘‘[a]n injury is an injury, employees be considered? (Ex. 31–211) ergonomic hazards than do other and I have no doubt there are always general industry jobs, and that some of Others were concerned that the ways to handle these jobs just as safely those other jobs are also hazardous. as any others’’ (Ex. 31–19). definitions were too broad and could The minimal burden in paragraph (d) A number of commenters said that at include any job or ‘‘almost every for all general industry employers to least jobs in construction, agriculture employer’’ (Exs. 31–135, 31–180, 31– disseminate information is necessary so and maritime that are essentially the 342). that employees will know how and Many participants told OSHA that same as in general industry, primarily when to report MSDs. Given the they did not know what the terms used manual handling jobs, should be added importance of providing information at in the definitions (‘‘forceful’’ lifting, to the rule (Exs. 31–14, 31–19, 31–65, the earliest possible point and the ‘‘core element,’’ and ‘‘significant 31–98, 31–192, 31–219, 31–307, Tr. minimal burden this requirement will amount’’ of worktime) meant (Exs. 30– 2850–51). For example: impose, OSHA believes that it is 46, 30–293, 30–300, 30–3032, 30–3853, appropriate to apply the initial Many jobs, especially manual handling 30–4837, 31–187, 31–202, 31–223, 31– requirement to all general industry jobs, have similar if not identical hazards to 260, 31–289, 32–337, Tr. 3337). For that of general industry. If an employee is employers. (The issue of the need for example: performing lifting that requires excessive information is discussed in more detail force it does not matter in which industry he How much is significant? 6 hours per 8-hr below in the summary and explanation is performing the lifting. The actions to shift? 4 hours per 8-hr. shift? 2 hours per 8- on paragraph (d)). reduce the risk of injury would be similar for hr. shift? Or 2 2-hr. periods per 8-hr. shift? each industry (Ex. 31–307). (Ex. 30–4837) II. Industries/Employment/Operations Moreover, commenters did not find Excluded From the Final Rule See also (Ex. 31–19; 31–65). the examples of manufacturing and Like the proposal, the final standard Another group of participants said manual handling jobs to be of use: does not cover construction, agriculture, that the record contains sufficient

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68278 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations evidence on the availability and OSHA’s standard-setting history during the construction, agriculture, and maritime effectiveness of ergonomic interventions past 30 years raises serious doubt that in its final rule, OSHA, in the interest to support expanding the rule to the workers excluded from this standard will of fair notice, would have had to amend ever have legal protection from MSD hazards. construction, agriculture and maritime When OSHA has excluded workers from the ergonomics proposal or re-propose industries (Exs. 31–183, Tr. 2849–51, coverage under a promulgated standard, only to include these industries and hold 7478–80, 7482, 7485, 15761–71, 17540– in two cases has the Agency followed up to additional hearings. Expanding the rule 41, 17561). Members of this group extend coverage to those workers—Hazard to cover agriculture, construction and pointed to a number of articles and Communication and Construction. But those maritime would seriously delay studies about effective controls in those actions were as the result of a court decisions addressing the urgent need for industries, especially construction (Tr. and order (hazard communication) * * * or protection for general industry 15761–71). For example, Nancy Clark, legislative mandate by Congress (lead) (Ex. employees, who work in the jobs in 500–218, p. 132–33). co-director of Mt. Sinai CHEP, said: which more than 90 percent of MSDs These participants said that if OSHA are reported. Practical interventions are available for does not cover construction, agriculture many identified risk factors. Many workers In addition, as the proposal pointed devise quick fix, homemade solutions to and maritime in the current rulemaking, out, work conditions and factors present reduce the impact of musculoskeletal stress the Agency should begin further in agricultural, construction and and promote self-preservation. They use team rulemaking immediately and even maritime employment often differ from lifting, mechanized material handlers when establish a deadline for completing that those in general industry. OSHA listed available, floor padding for kneeling and project (Exs. 30–400, 30–576, 30–4837, a number of aspects of construction standing on, stacking supplies to bring the 31–12, 31–263). work to illustrate this statement (64 FR work closer, and alternating work tasks or OSHA is aware that there is 65787): body position (Ex. 31–183) significant evidence in the record • They consist primarily of jobs of Scott Schneider, director of indicating that work-related MSDs exist short duration, occupational safety and health for the in operations and employment beyond • Employees work under a variety of Laborers Health and Safety Fund of general industry (Exs. 31–183, 500–218, adverse environmental and workplace North America, testified: Tr. 7475, 7484–85, 17538–39). Indeed, conditions (e.g., cold, heat, confined the problem appears to exist in virtually spaces, heights), [T]here have been many tool manufacturers every industry. Nonetheless, for several • At non-fixed workstations or non- who have jumped on the ergonomic reasons OSHA believes its decisions to bandwagon and hired ergonomists to develop fixed work sites, regulate MSD hazards through • On multi-employer work sites, better and safer tool designs, from ergonomic • hammers with more comfortable shock- sequential rulemaking proceedings, and They involve the use of ‘‘day absorbing handles to pliers with soil handles to limit the first proceeding to general laborers’’ and other short-term and spring returns to reduce the stress of industry, is appropriate and supported ‘‘temporary workers,’ opening them after each use. The use of by the record. • Involve situations in which portable power tools has increased A primary basis for the Agency’s employees provide their own tools and dramatically in construction as batteries have decision to limit the scope of this equipment, and gotten lighter and more powerful. Cordless rulemaking to general industry is that • Involve employees who may be screw guns have become commonplace in most of the available evidence and data trained by unions or other outside construction over the past few years, relating to ergonomic interventions certifying organizations, rather than by reducing the repetitive use of screwdrivers by addresses general industry. For the employer. hand and the force that had to be used. There are simple pieces of equipment, like drywall example, the vast majority of the studies OSHA did not mean to imply that the carrying handles, which I have here, and a reviewed in both the NIOSH and NAS mere existence of any of these factors, mortar-pan stand to raise the height of the reports pertained to general industry alone or in combination, would be pan, which cost less than $50 and can make (Exs. 26–1, 26–37). Similarly, the enough to justify excluding an entire the work much easier. A D-handle majority of case studies on the industry from the rule. This fact was attachment for a shovel, which I have here, effectiveness of ergonomics programs apparently not clear to some costs less than $20, and has been shown to and control interventions that OSHA commenters, however, who argued that reduce awkward postures during shoveling. had gathered focused on general the presence of some of the listed factors There are simple carts for moving glass or industry (64 FR 65954–75). Although in their industries meant that they too drywall, vibration-dampened jackhammers and equipment for moving them on and off some participants submitted evidence should be excluded from the standard of trucks. (Tr. 15762–63). on ergonomics programs and controls in (Exs. 30–297, 30–626, 31–147, 32–234, the excluded industries, mostly in 32–300). For example, Broccolo Tree These commenters also pointed out that construction (Exs. 32–339–1–25, 32– and Lawn Care Inc., pointed out that many of the controls used in general 3888, 38–65, 38–66, 500–210), most of landscaping jobs involve short-duration industry, such as manual handling aids, the available evidence continues to tasks and no fixed workstations (Ex. 31– were applicable or readily adaptable to pertain to general industry jobs, 147). The National Solid Waste construction, agriculture and maritime operations and workplaces. Management Association (NSWMA) industries (Ex. 31–183). Moreover, tool If it included construction, agriculture said that its employees are also exposed and equipment interventions are and maritime within the scope of this to adverse environmental conditions becoming more widely available ‘‘as rule, OSHA would have had to delay and work at non-fixed work sites (Ex. manufacturers are responding to the issuing the rule for general industry 32–234, p. 6–7). need for better ergonomically designed while it gathered and analyzed the In the proposal, OSHA discussed its tools’’ (Ex. 3–183; see also Tr. 15761–62, necessary evidence. Because it is likely discretion to set appropriate rulemaking 17561). that the rule would have a significant priorities, and to promulgate standards Finally, several participants were impact on small employers in applicable to less than all of American concerned that OSHA’s stated intent to construction, agriculture and maritime, industry. 64 FR 65786–65788. General promulgate an ergonomics standard for OSHA would also have had to convene industry accounts for more than 90 the excluded industries in the future a small business review panel pursuant percent of the more than 620,000 LWD would never come to fruition: to SBREFA. Further, in order to include MSDs reported each year. By

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68279 promulgating a standard addressing B. Railroad Work urged OSHA to exempt the trash general industry first, OSHA is giving Paragraph (b)(3) states that this collection industry from the standard ‘‘due regard to the urgency of the need’’ standard does not cover railroad work. (Ex. 32–234). NSWMA said an for a standard to protect general Although some railroad operations are exemption was warranted because, like industry employees. 29 U.S.C. 655(b)(7). normally covered by OSHA general the construction industry, its working conditions include non-fixed worksites, OSHA has thus ensured that the greatest industry standards, other railroad work number of MSD hazards will be limited supervisory oversight, adverse is regulated by the Federal Railway addressed by this final rule, while the environmental conditions, and high Administration (FRA) and not by Agency determines appropriate employee turnover. In addition, OSHA. 29 U.S.C. 653(b)(4). In addition, regulatory approaches for other according to NSWMA, ‘‘uncontrollable’’ the Preliminary Economic Analysis industries. For example, OSHA has been factors, such as variable load weights, indicated that the standard would not working closely with NIOSH on a study municipal regulations, and its members’ cover any railroad employment, and this of ergonomic hazards and solutions in lack of control over the location of the statement caused some uncertainty the maritime industry. In addition, garbage they collect, also support an among affected parties as to the OSHA recently published an exemption. Finally, NSWMA also Agency’s intent (Ex. 28–1, chapter II, ergonomics best practices guide for the argued that there is little available construction industry on its Web page. p.3). information about health effects and OSHA has also provided training grant In a May 23, 2000 Federal Register effective solutions in the industry. The money targeted to ergonomic hazards in notice (65 FR 33263), OSHA provided West Coast Refuse and Recycling the construction industry. an analysis of the economic impacts of Coalition and the Municipal Waste OSHA intends to develop ergonomics the proposed rule on railroads. On July Management Association (MWMA), rules that can be tailored to the 7, 2000, OSHA also held a supplemental representing municipal solid waste conditions that are unique to the firms hearing on this economic analysis, in agencies in larger cities, requested an in these industries. OSHA agrees with which the Association of American exemption for some of the same reasons commenters who have said that the Railroads (AAR) participated. AAR’s (Ex. OR 323, Tr. 17972–73). Although experience the Agency gains from this comments and testimony, however, OSHA recognizes that employers in this first phase will provide valuable highlighted the complexity of the industry face particular challenges in assistance in developing an effective OSHA/FRA jurisdictional issues (Ex. implementing some types of ergonomic ergonomics rule for the construction, 703–3, Tr. 18272, 18313–16, 18321). controls, it does not believe that the agriculture, and maritime industries OSHA has determined that it needs to arguments presented compel exemption (see, e.g., Ex. 31–252). gather additional information and of the solid waste and recycling As noted earlier, OSHA has decided conduct further analysis on these issues industry from this standard.1 that the final standard should not cover before it can decide whether and how to As noted above, OSHA does not work performed by persons employed address ergonomic hazards in the believe that the fact that some aspects of incidentally to or in support of railroad industry. Therefore, OSHA has an industry’s working conditions are construction, agriculture and maritime decided not to cover any aspect of similar to some of the conditions in operations, regardless of what type of railroad work at this time. exempted industries necessarily activity they perform. To illustrate, the C. Other Exemptions Requested. warrants exempting those industries. In standard does not cover employees of a any event, the working conditions in the residential home building company A number of other rulemaking solid waste industry differ significantly performing office work in support of participants also requested that certain from those in construction. In the solid construction activities, even though jobs, industries or employers be waste industry employees repeat the office work is a general industry excluded from this rule (e.g., same routes every week or more operation under other OSHA standards. ambulances, landscaping, transfer and frequently. The route is a fixed worksite Similarly, the final rule does not cover storage, petroleum and chemical that the employee gets to know. Because janitorial workers employed by a industries, forging industry). Many the route is fixed, the employer is able shipyard or employees performing requesting exemptions did not provide to anticipate and plan for the hazards regular maintenance on power any reasons why they should be that the employees might encounter. industrial trucks in a marine terminal. excluded (see, e.g., Exs. 30–303, 30–491, Likewise, the fixed routes enable Applying the rule to general industry 30–2102, 30–3005, 30–4439, 30–4444, employers to plan for how the changing jobs of a construction employer (the 30–4598, 601–X–1163, 601–X–1438). seasons will affect collection on the office manager of a construction Some merely said they had ‘‘many work route. NSWMA’s testimony that a ‘‘vast company, for example) would present conditions and factors present in the majority * * * if not all’’ of its member the employer with logistical difficulties. industries OSHA has chosen to Requiring construction, agriculture and exempt,’’ but did not discuss either 1 A number of participants who argued that maritime employers to set up an what those factors were or why they compliance with an ergonomics standard would be ergonomics program for the few general supported an exclusion (see, e.g., Exs. infeasible in their industries also submitted industry employees performing 30–2348, 30–3005, 30–3186, 30–3311 examples of industry ‘‘best practice’’ guidelines and similar recommendations to the record. The ancillary functions in their workplaces 30–3462, 30–3482, 30–3582, 33–1181). participants said that even these ‘‘best practices’’ do would not be an efficient allocation of OSHA does not find any basis for not result in enough of a reduction in employee safety and health resources. Several excluding those industries from this exposure to MSD hazards that further MSDs are commenters have told OSHA that it is rule. ‘‘unlikely.’’ OSHA recognizes that some industries will not be able to control exposures completely. most efficient to set up an ergonomics A few requests that included more OSHA also, however, approves of the steps these program on a company-wide basis (see, discussion supporting an exemption are industries are taking to control MSD hazards to the e.g., Exs. 26–1370). Doing so allows discussed individually: extent they can, and commits to working with the employers to implement program industries in the future. This type of arrangement 1. Solid Waste Management will help provide employees in these industries elements such as providing employee with as much protection as possible, while information and training more The National Solid Waste reassuring their employers that OSHA understands efficiently. Management Association (NSWMA) the limits of their capabilities.

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68280 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations companies have safety and health exceed the weight limits (Tr. 12014, work speed and lifting (Tr. 12017, programs that include addressing 13404–06, 18073). In addition, container 13402–06, 17969, 18212). ergonomic hazards on a ‘‘day to day’’ size and location issues are regularly John Legler, of Waste Equipment basis indicates that most industry addressed as part of contract Technology Association, added that employers already are taking these steps negotiations between private collectors garbage trucks are being retrofitted with (Tr. 18074). and municipalities (Tr. 18041). All of mechanical lifts ‘‘quite regularly’’ (Tr. Although NSWMA argued that high this evidence suggests that solid waste 18012–13). Bruce Walker, of Portland’s turnover in the industry supports employers should not have difficulties residential solid waste and recycling exemption in the same way that the use continuing to negotiate contracts that agency, testified that enforcing of ‘‘day laborers’’ in the construction will assist them in complying with this container weight limits had been industry does, NSWMA did not provide final standard. established had led to low MSD rates any evidence on turnover rates in its And contrary to NSWMA’s argument, (Tr. 11968–70). industry, or on how those rates compare the record contains abundant evidence This evidence not only does not to other industries this rule covers. Nor on MSD hazards and ergonomic support exemption, it is clear evidence did NSWMA explain why high turnover solutions in this industry (Ex. 32–234– that effective ergonomic programs and rates pose the same issues as day 2). The industry recognizes that lifting controls are technologically and laborers. Other solid waste associations heavy loads creates a hazard for economically feasible for the industry as and employers did not indicate that employees (Tr. 13406, 13413, 18009). a whole. OSHA recognizes that some of high turnover rates are a problem in the Industry representatives testified that the hazards facing waste industry industry. The solid waste industry has their workers experience work-related employees cannot be eliminated the opportunity to train its workers; in MSDs, particularly MSDs of the lower completely. But the standard only fact NSWMA and MWMA testified that back (Tr. 13379, 13396, 13412, 18009). requires employers to control MSD their members already provide training In fact, NSWMA submitted a manual of hazards ‘‘to the extent feasible.’’ It (Tr. 13404–405, 18079). It explained recommended ergonomic practices expects NSWMA’s member companies that this training is the most effective developed by Environmental Industry to continue to implement the type of way to deal with the fact that its Associations (EIA), NSWMA’s parent safety programs they are already using, workers are often unsupervised: organization, that identified lifting and to continue improving those MR. BEDERMAN: No, the most important bulky loads and twisting and carrying programs as knowledge and technology way to monitor this type of thing is actually loads as risk factors for the industry and advance. not to monitor it, but * * * actually good identified back pain, hernias and 2. Utility Workers training (Tr. 18079). strains, sprains and tears as common MSDs in the industry (Ex. 32–234–2–1). Utility companies asked OSHA to The record also does not support exempt utility line workers and power industry claims that solid waste EIA also recommended that employers establish ergonomics programs for trash plant maintenance workers from the industry employers have little control standard for two reasons. First, they over their employees’ working collection and recycle operations (Ex. 32–234–2–1). pointed out that line workers face some conditions. For example, NSWMA said of the same conditions as construction, that, because of municipal ordinances, The record also includes evidence on a wide range of controls that are agriculture and maritime (e.g., adverse its members have no control over the environmental conditions). They also weight and location of the garbage they successfully in use in the industry. The EIA manual on ergonomic practices said argued that these jobs involve both collect and that municipalities were general industry and construction ‘‘very hesitant’’ to make changes (Ex. the industry ‘‘has many options’’ for addressing ergonomic hazards, activities because utility line workers 32–234–2, Tr. 18041). But 60 percent of not only maintain and repair utility residential collection is privately including weight limits built into residential contracts, the use of lifting lines, a general industry activity, but controlled (Tr. 18046). For the 40 also they install, alter, and improve percent of trash collection that is under devices, and training (Ex. 32–234–2–1). The record indicates that the following lines, activities which are governed by the control of municipalities, as noted OSHA construction standards (Exs. 30– below, the testimony of NSWMA and controls are also in use in the industry: • Mechanical container lifts, 3853, 32–300, Tr. 2893–95). Edison MWMA suggest there is not a significant • Limits on container size and weight Electric Institute (EEI) testified: problem. and requirements for container handles, NSWMA testified that a majority of • As you know, a line worker working on a Carts, dollies and other mechanical pole may at one moment be engaged in what municipalities have already assists for pushing, carrying and lifting implemented container requirements is considered to be construction work under containers, 1910.12(b) and under 1926(b) and at the next (Tr. 18071; see also Tr. 13402). Both • Collection trucks designed for use moment be engaged in what is considered to NSWMA and MWMA testified that the in narrow alleys and streets to eliminate be general industry work under 1910.269. growing trend is toward requiring carrying containers long distances, That is to say that if a person is doing work customers to place garbage containers at • Changes in municipal collection for the improvement of the facility, that is the curbside (to eliminate the need for regulations to reduce lifting hazards construction as defined by OSHA and the employees to carry heavy containers) (e.g., curbside service, container size Review Commission. And if not, then general and limiting container size (to reduce and weight limits, reduction in loads maintenance (Tr. 97–98). injury associated with heavy lifting) (Tr. through increases in collections per EEI also pointed out that it would not 18070–71, 13402–3; see also Tr. 12019). week, separate collections for large be practical for its employees to be Bruce Walker, of Portland’s solid waste bulky items), covered by the standard for only some and recycling agency, said that such • Training in proper lifting of their tasks: weight limits had been positively techniques, • EEI recommends that OSHA clarify that to received in that city (Tr. 12014–15). Work practice controls (e.g., perform a job hazard analysis means to NSWMA, MWMA and Mr. Walker also training not to lift overweight loads), analyze a job, not a task. A job may not said that employers are instructing their • Changes in compensation systems involve only one task, but may involve employees not to lift containers that to eliminate incentives for hazardous multiple tasks depending upon the nature of

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68281 the work on that given day (Ex. 32–300, p. from the standard because home health especially for home settings (Tr. 11743– 29). care employees perform work in private 45). The witnesses said that these OSHA agrees with EEI that homes that are not under the employer’s devices allow mechanical transfer in determining whether a job exposes an control. and out of bed, onto a toilet, and even employee to an MSD hazard requires AAHomecare said its industry should into a tub (Tr. 11745). Other control looking at all of the tasks and activities be exempted because OSHA has measures described in the record that comprise that job. That is what this indicated that it will not impose OSHA include friction reduction sheets, gait job-based standard requires. But as EEI standards on private homes, unless they belts, toilet and shower chairs, slide itself pointed out, some utility are being used as part of the boards, and convertible chairs and companies already have programs in ‘‘manufacturing process’’ (Ex. 30–3862). wheelchairs (Ex. 37–4). To the extent place for analyzing and controlling MSD But the OSHA policy AAHomecare these controls are feasible, and hazards (Ex. 30–2725, Tr. 2384, 2396– refers to only addresses work that employers find them to be effective, 98). Presumably, these companies employees perform in their own homes. employers could provide them to their analyzed the entire jobs of utility line AAHomecare also argues that the home health worker employees. But an workers and power plant maintenance court in the Bloodborne Pathogens employer is not expected to change the personnel rather than just the general decision (American Dental Association. configuration of a patient’s bedroom or industry tasks in those jobs. None of the v. Martin, 994 F.2d 823 (7th Cir. 1993)), bathroom, although it must provide the utility companies indicated that held that the OSH Act ‘‘does not worker with the training and controls construction activities constitute the authorize OSHA to impose work-site necessary to allow him or her work as primary operations of utility companies. related standards on home work sites safely as possible in that location. that are not under the employers Thus, including all rather than part of 5. Small Businesses the tasks of these jobs in the ergonomics control’’ and that the Agency’s directive program this rule requires should not limiting the application of the A number of commenters said OSHA impose a substantial additional burden Bloodborne Pathogens rule at home- should exempt small businesses because for utility companies. OSHA requires based worksites (CPL 2–2.44D) should compliance would be too burdensome utility companies to protect their apply to this standard as well (Ex. 30– (Ex. 30–3167, Tr. 3126–27, 3332). They employees, including those that spend 3862). But the Seventh Circuit did not said that small businesses do not have part of their days performing make as broad a holding as the knowledge or resources to hire construction work. AAHomecare suggests. The court said outside experts to help identify and only that OSHA has an ‘‘obligation to address MSD hazards (Tr. 3127). They 3. Building Materials Distributors consider such questions and the general also said that MSD rates were low for A number of building materials issue that they present before imposing’’ small businesses (Exs. 30–3167, 600–X– distributors argued that they should be a standard. American Dental Assn., 984 1, Tr. 3332). National Small Business exempted because a large portion of F.2d at 830. United (NSBU) said that for the majority their business involves delivering In this case, OSHA is considering of small businesses the occurrence of an supplies to construction sites and to these issues and addressing them here. MSD was rare (Ex. 30–3167). By various places on construction sites In general, employers sending their contrast, another participant (Ex. 26– (Exs. 30–541, 30–4267, 30–4351). employees to work at sites they do not 1370) at OSHA’s stakeholder meetings Because of this, they said, their control are required to do everything for Ergonomics Program Standard employees are exposed to the same within their control to protect those Development specifically supported the ergonomic risk factors and adverse employees, but will not be held liable inclusion of small employers in the rule, working conditions that justified an for the existence of conditions they saying that the rule was particularly exclusion for the construction industry. cannot control. Thus home health care needed in these facilities because they OSHA has never excluded general agencies must provide their employees were less likely already to have either industry employers from standards with the information required by an ergonomics or a safety and health because they provide equipment or paragraph (d), provide those employees program (Exs. 26–1370). materials for exempted industries. Thus, with MSD management where an MSD OSHA considered whether to apply while marine terminals are excluded incident occurs in a job that meets the alternative regulatory provisions to from this standard, manufacturers and levels in the Basic Screening Tool, and small employers as part of the analysis transportation companies that deliver perform job hazard analyses when required by SBREFA and the Regulatory new equipment to marine terminals are necessary. In addition, they must Flexibility Act (64 FR 66040–53). OSHA still covered. comply with the other programmatic does not believe the record supports In addition, almost every comment elements of the standard, in particular such an approach for small business. received from building materials providing the employees with necessary First, employees who work for small distributors indicated that the industry training and equipment to minimize businesses are experiencing work- has already taken substantial steps to ergonomic hazards. related MSDs, and they need the control MSD hazards. For example, But employers’ control obligations protection this standard will provide. Panther Building Materials, Inc., said will be limited by the control they have According to BLS, employees in that it provides hydraulics crane, carts over their employees’ actual working establishments of all sizes have reported and other material handling equipment conditions. Thus an employee who is MSDs that are serious enough to involve in order to safely deliver supplies (Ex. expected to move patients in their own days away from work. 30–4351). It also provide at least two homes should be taught how to do so as In a number of industries comprised employees per truck crew in order to safely as possible. For example, predominantly of small businesses, the minimize carrying. evidence was submitted to the record risk of MSDs is particularly high. This that portable lifting devices and other is especially true in the health care 4. Home Health Care. control measures are available for use in industry. For example, many medical The American Association for home settings (Ex. 37–4, Tr. 11743–45). sonographers are employed by small Homecare (AAHomecare), asked that the According to witnesses, some portable businesses. Joan Baker, of the Society of home health care industry be exempted lifting devices have been designed Diagnostic Medical Sonographers,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68282 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations testified that the MSD prevalence rate Suzanne Rodgers, an ergonomist with do not have that information, the among sonographers exceeds 80 percent 32 years of experience assisting a wide controls they implement may not be and that the frequency and severity of range of companies in addressing MSD successful. Therefore, in order to ensure these MSDs appears to be increasing (Tr. hazards, said that she has provided that an employee is protected from MSD 11881–82). Dr. Linda Morse, chief of training to small businesses at various hazards while performing the general occupational medicine at Kaiser San conferences organized by the Chamber industry tasks, it may be necessary to Francisco, said that the injury rate of Commerce (Ex. 37–25). control risk factors for the job as a among ultrasound technicians in There are also other sources of whole. Northern California was almost 100 information and assistance for small B. Multiple Employer Worksites and percent (Tr. 15045). Many nurses, employers. OSHA and NIOSH provide Contract or Shared Employee Situations nurses’ aides, and orderlies are also free hazard evaluation services for small employed by small businesses, employers. OSHA will be providing A number of participants asked how including small nursing homes and additional information in the the standard would apply at multi- small health care agencies. According to appendices to this final rule and other employer worksites. Similar situations BLS, in 1996 about 15 percent (more materials on the OSHA Webpage arise under many standards, and OSHA than 103,000) of all MSDs resulting in (www.osha.gov). Many other Internet has published a ‘‘Multi-Employer days away from work were reported by sites also provide free ergonomics Citation Policy’’ that discusses the health care workers. In addition, the information. allocation of responsibility among American Nurses Association and the various categories of employers. CPL– Service Employees International Union, III. Other Scope and Application Issues 0.124 (Eff. Dec, 10, 1999). OSHA has not among others, testified that the A. Jobs Involving Both General Industry historically discussed the operation of occurrence of MSDs among home health and Non-General Industry Tasks this policy in rulemaking documents, workers is particularly high (Exs. 32– viewing it as an enforcement issue. In a Several commenters raised questions challenge to OSHA’s Bloodborne 274–1, 502–215). about whether this standard applies OSHA does not believe this standard Pathogens standard, however, the when an employee’s job involves both will be too burdensome for small United States Court of Appeals for the general industry and non-general businesses. The record shows that many Seventh Circuit held that, where parties small businesses have successfully industry activities (Exs. 30–3853, 32– to a rulemaking raise issues about the implemented ergonomics programs (see, 300, Tr. 2893–95). As explained above application of the standard in this e.g., Exs. DC 66, 500–208–3, Tr. 17350– in reference to utility workers, because circumstance, OSHA should discuss the 17355). These programs have paid for this is a job-based standard, OSHA application of this policy. American themselves in terms of reductions in intends employers to include all Dental Ass’n. v. Martin, 984 F.2d 823 medical costs, lost workdays and employees who perform general (7th Cir. 1993). Such a discussion is product reject rates (Tr. 17354). industry work within this standard, particularly useful with respect to some Moreover, if small businesses have low even if those employees also perform of the issues raised by this standard. rates of MSDs, the obligations for those some work that may be classified as Under the multi-employer worksite employers will be commensurately construction, agriculture, or maritime. policy, employers are generally required small (Ex. 30–3167). The only obligation Thus, employers engaged in to take whatever steps are within their that many small employers will have is landscaping or lawn and garden power to protect their own employees, a one-time requirement to provide basic services, a general industry and also to abate hazards within their information to their employees. And classification, are covered by this control when other employees are these employers can satisfy that burden standard even if their employees’ jobs exposed to those hazards. This means by copying, distributing, and posting the include some harvesting of sod or trees, that an employer whose employees are information sheets in Appendices A and an agricultural classification. On the working at a location controlled by B. other hand, nurseries and tree farms, another employer, for example a The record shows that small which are agricultural classifications, temporary services agency, must businesses are easily able to get the need not comply with the standard even provide its employees with the information they need to address MSD if their employees perform some minor information required by paragraph (d). hazards. A number of organizations landscaping or horticultural services. Both employers will need to know if an have developed and are providing Comments by the AFL–CIO best sum up employee reports an MSD, and must model programs, checklists, ‘‘best the need for defining the application of implement measures to share this practices’’ guides and control the standard in this way: information. They should consult to information to small businesses (see, Since this is a job-based standard, it is determine whether the report qualifies e.g., Exs. 32–234–2–1, OR 351). A important that jobs in fact are covered. To as an MSD incident under this standard, number of organizations have developed apply the standard in some aspects of a job but the employer with control over the and are providing model programs, and not others would leave workers without workplace must screen the job to checklists, ‘‘best practices’’ guides and protection and make compliance and determine whether further action is control information (Exs. 32–234–2–1, enforcement confusing and difficult (Ex. required. If so, the employer with OR 351 ). For example, the American 500–218, p. 133). control over the workplace must also Dental Association and state affiliates, In addition, as stated in the implement the program elements such as the Oregon Dental Association, discussion of utility line workers, the required by this standard. And if such have developed and disseminated only way an employer can determine an employer hires a temporary worker information on ergonomics for its whether a job exposes an employee to to work in a job for which an members and held a ‘‘Dental an MSD hazard is to look at all the tasks ergonomics program under this standard Ergonomics Summit Conference’’ this and activities that comprise that job. is already in place, that employer must year (Ex. OR 351). A number of trade Eliminating some tasks from this provide the temporary employee with associations are also providing analysis may prevent identification of any necessary training. The employing ergonomics training for small businesses risk factors that are causing or agency, however, will necessarily be (Ex. 37–25, OR 351). For example, contributing to the hazard. If employers responsible for providing the employee

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68283 with any necessary MSD management, • Boat building and repair through (s) of the final rule. Final including WRP. OSHA believes that this • Airline baggage handlers paragraph (c)(3) denies grandfather • is basically how businesses are Airline reservation and ticket agents status to employers who have policies • Airline maintenance crews currently operating. OSHA expects that • Railroad equipment building and or procedures that discourage they may pay more attention to these rebuilding employees from participating in the issues and address them explicitly in • Maintenance of equipment or structures program or reporting signs or symptoms their contracts after the standard is in • Forestry services of MSDs or the presence of MSD effect. • Forestry nurseries and gathering of forest hazards in the workplace. products In the final rule, OSHA is requiring C. United States Postal Service • Commercial fishing that grandfathered programs be in Questions were also raised as to the • Fish hatcheries and preserves • writing. The final rule’s grandfather effect of this standard on the United Hunting and trapping • Game propagation clause requires the employer to States Postal Service. In 1998, Congress • State and municipal employees (in State demonstrate program effectiveness and, amended Section 3(5) of the OSH Act to Plan States) performing general industry like the proposal, to have a program that include the United States Postal Service operations includes the core elements of effective within the Act’s definition of employer. • U.S. Postal Service programs. The Agency believes that this • 29 U.S.C. 652(5). Postal Service Federal government employees can best be accomplished with a written Enhancement Act, P.L. 105–241. As a performing general industry operations program. Further, both OSHA and the result, this standard applies to all USPS Industries and Jobs This Standard Does Not employer will find compliance with the operations that are not construction, Cover grandfather clause easier to demonstrate agriculture or maritime operations. • Construction employment and if the program is written. By ‘‘written,’’ D. Municipalities operations OSHA also intends that the program can • Agriculture employment and operations be maintained electronically. A number of municipalities asked • Farm labor and management services Final paragraph (c)(1) requires whether the standard applies to local • Livestock and animal specialty services grandfathered programs to include the governments. States and their political • Maritime employment and operations core elements of effective ergonomics subdivisions are not employers under • Ship building and repair • programs: management leadership and the OSH Act, and they are not covered Longshoring • Office workers employed by employee involvement; job hazard by this final rule or any other federal construction, agriculture or maritime analysis and control; training; and OSHA standards. However, the 23 establishments program evaluation. This paragraph also States and 2 Territories with approved • Maintenance workers employed by indicates the subelements within each State Plans are required by Section construction, agriculture or maritime core element that OSHA believes are 18(c)(2) of the OSH Act to issue establishments essential to the proper functioning of standards that are ‘‘at least as effective’’ • Work at the employee’s own home • that core element. These subelements as Federal standards. 29 U.S.C. 667. Railroad work • are stated broadly. For example, a Therefore, State Plan States must adopt Railroad terminal and switching • Airline attendants subelement of management leadership ergonomics program standard within six • Airline pilots (paragraph (c)(1)(i)) that OSHA months of the publication of this considers essential is the establishment standard. Under Section 18(c)(6), State Paragraph (c)—How Does This Standard of an effective reporting system that Plan States must apply such standards Apply if I Already Have an Ergonomics permits employees to report the signs to State employees and to employee’s of Program in Place When the OSHA and symptoms of MSDs and to receive the State’s political subdivisions. (See Ergonomics Program Standard Becomes prompt responses to their reports. The State Plan States section of this Effective? employer’s program must include all of preamble for the list of State plan the subelements of the core elements to States.) Paragraph (c) of the final standard is a grandfather clause, which, under qualify for grandfather status. Industries and Jobs This Standard Covers certain conditions, permits an employer The following discussion explains the subelements comprising each of the core • Agricultural services who has already implemented and • Soil preparation and crop services, evaluated his or her ergonomics elements. Employers are free to include including crop planting, cultivating and program by the date on which the final additional elements or subelements in protecting rule becomes effective to continue that their program, and doing so will not • Crop harvesting program instead of complying with the interfere with the program’s grandfather • Veterinary services OSHA standard. This paragraph permits status, provided that the program • Lawn and garden services employers to do this only if the includes the core elements identified by • Ornamental shrub and tree service • program: is in writing, contains the core paragraphs (c)(1)(i) through (v), and the Tree trimming subelements associated with them. • Landscaping and horticultural services elements of basic ergonomics programs, • Oil and gas drilling/extraction operations and is demonstrably effective. The The proposed rule would have • Health care employees criteria for judging whether an required an existing program to meet a • Truck driving employer’s program adequately ‘‘basic obligation’’ provision for each • Office workers employed by general addresses the core elements are core element. Basic obligations, which industry establishments contained in paragraphs (c)(1)(i) through were intended to capture the essence of • Office workers employed by agricultural (v). Examples of criteria for judging the the more detailed subelements proposed services establishments • effectiveness of the program are for each core element, were proposed Utility line operations including contained in paragraph (c)(1)(v). for each program element. Table 1 maintenance, repair, installation, construction, alteration and improvement Paragraph (c)(2) requires that, within 1 compares the proposed rule’s basic operations year of the standard’s effective date, obligations sections with the • Power plant maintenance operations grandfathered programs have in place corresponding subelements of the final including repair, alteration and an MSD management policy that meets rule’s grandfather clause. The following improvements the requirements of paragraphs (p) discussion also explains OSHA’s

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68284 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations reasons for revising the basic obligations employees have the most direct interest existing ergonomics programs. proposed. in their safety and health on the job, Companies like the Dow Chemical Final paragraph (c)(1)(i) states that they have an in-depth knowledge of the Company (Ex. 32–77; Tr. 5297), Levi grandfathered programs must include tasks they conduct at the worksite, they Strauss (Tr. 14723, 14736, 14746), the management leadership and identifies often have excellent ideas on how to Consolidated Edison Company of New the subelements for that core element. solve ergonomic problems, and their York (Tr. 4644), and IBP, Inc. (Tr. 4973) Employers are required to demonstrate interest in the program is vital to its described a process that includes these management leadership of their success. If employees do not report their job hazard analysis features. ergonomics program through the MSD signs and symptoms or MSD As discussed in the summary and following subelements: an effective hazards, any ergonomics program will explanation for the standard’s job MSD reporting system and prompt fail. OSHA has specifically included in hazard analysis and control responses to employee reports, the paragraph (c)(1)(ii) a provision that requirements (paragraphs (j) through assignment of clear program employees be involved in the (m)) later in this section of the responsibilities, and regular implementation, evaluation, and future preamble, the rulemaking record communication with employees about development of grandfathered programs demonstrates that, currently, employers the ergonomics program. OSHA’s to make it clear that employee with existing programs do not always experience has shown that, to be involvement extends to every element of fix all problem jobs, nor do they effective, management leadership must the program, including program eliminate all MSDs. To address these be active rather than passive. evaluation and future modifications to facts, the final rule’s grandfather clause Leadership that is limited to a ‘‘paper the program to reflect changes over (1) permits employers to bring all program’’ with written policies and time. problem jobs into their programs, and procedures but is not translated into Final paragraph (c)(1)(iii) requires (2) acknowledges that employers will practice by management would not meet grandfathered programs to contain job not eliminate all MSDs. Employers with the intent of this provision. On the other hazard analysis and control, as grandfathered programs must, however, hand, management leadership that is demonstrated by a process for implement controls that (1) control the known throughout the organization identifying, analyzing, prioritizing (if MSD hazards, (2) reduce MSD hazards because of management’s active necessary), and controlling MSD to the levels specified in Appendix D, engagement in the ergonomics process hazards in affected jobs and following or (3) reduce MSD hazards to the extent and appropriate follow-through on up to ensure control effectiveness. This feasible. These are the same compliance commitments would clearly fulfill this is the heart of any ergonomics program. endpoints specified in paragraph (k)(1) intent. The final rule’s management For employees to be protected from of the final rule. These endpoints are leadership subelements are equivalent MSD hazards, it is obvious that those explained in the summary and to those of the proposed basic obligation hazards must be eliminated or explanation for that paragraph. for this core element, except that OSHA controlled. A note following this Thus, the grandfather clause in the has added ‘‘regular communication with paragraph explains that personal final rule will enable employers with employees’’ and ‘‘prompt’’ responses to protective equipment (PPE) may be used existing programs that only address reports to the subelements of the final as a supplement to engineering, work certain jobs to qualify for the rule’s grandfather clause. The Agency practice, and administrative controls. grandfather clause if they include all has added these subelements to make The employer may only use PPE alone problem jobs in their program before the sure that management leadership is where other controls are not feasible. In standard’s effective date. Thus, even responsive to employee reports and that addition, the note explains that, if PPE programs that do not currently address management’s commitment to the is used, the employer must provide it at all problem jobs would not be precluded ergonomics program is communicated no cost to employees. from qualifying for grandfather status, from top management down to the As can readily be seen from Table 1, providing that they revise their employees performing the work and this provision has been changed approach to include all such jobs before implementing the program. Taken as a substantially from the corresponding the standard is in effect. whole, OSHA believes that the requirement in the proposal. The job Final rule paragraph (c)(1)(iv) requires subelements in final paragraph (c)(1)(i) hazard analysis and control subelements grandfathered programs to provide for will ensure that grandfathered programs in the final rule’s grandfather clause are the training of managers, supervisors, have active rather than passive designed to be less prescriptive and and employees in the employer’s management leadership. more flexible than those proposed and ergonomics program and their role in it; Final paragraph (c)(1)(ii) requires that to fit better with the way rulemaking the recognition of MSD signs and grandfathered programs include participants (see, e.g., Ex. 32–77, Tr. symptoms; the importance of early employee involvement, as demonstrated 14723, Tr. 4973) described this process reporting; the identification of MSD by the early reporting of MSDs and in their existing ergonomics programs. hazards, and methods that the employer active employee involvement in the The final rule’s grandfather clause is using to abate them. Training is to be implementation, evaluation, and future requires employers to use a process for provided at no cost to the employees development of the employer’s identifying, analyzing, and controlling trained. Training is necessary to ensure ergonomics program. OSHA has MSD hazards in problem jobs. that employees in problem jobs, their vigorously advocated employee Employers may also prioritize jobs supervisors, and the individuals who set participation in workplace safety and identified as having MSD hazards and up and manage the ergonomics program health issues for many years and is then follow their prioritization scheme are provided with the knowledge and pleased by the growing recognition of when controlling these hazards. skills necessary to recognize MSD signs, the importance of employee Employers with grandfathered programs symptoms, and hazards in their participation on the part of private- must also follow up on their hazard workplace and to effectively participate sector companies, trade associations, control measures to ensure that the in the ergonomics program. These safety and health professionals, and controls implemented are effective. This individuals also need to be trained in employees themselves. OSHA supports is the process that participants in the the need for early reporting. The length employee participation because rulemaking told OSHA they use in their and frequency of training is determined

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This provision, which possible, OSHA is not specifying the is as true for grandfathered programs as is discussed in detail below, ensures frequency with which training must be for those that are not grandfathered. As that only effective programs are provided. discussed at length in connection with Final rule paragraph (c)(1)(v) requires grandfathered. Although paragraph paragraph (r), OSHA has found, both on grandfathered programs to include (c)(1)(v) requires employers to correct this record and in the records of many evaluations of the program, as deficiencies in the program, OSHA other OSHA standards, that wage and demonstrated by regular reviews of the would not consider an employer who benefit protection is essential to early elements of the program, the uncovers major deficiencies in the reporting and employee participation in effectiveness of the program as a whole, program elements or whose evaluation the employer’s program. Without such and the correction of identified does not demonstrate the overall protection, employees fear economic deficiencies. This means that employers effectiveness of the program to be in loss and often simply do not report their must, at a minimum, assess the compliance with this paragraph. signs and symptoms until the injury has functioning of their ergonomics Requiring any program that is progressed to the point where work (and program, compare its provisions to the grandfathered to be demonstrably perhaps full recovery) is no longer elements and subelements specified in effective is basic to employee protection possible. In addition, as fully explained the grandfather clause, identify any and to ensuring that grandfathered in the summary and explanation for deficiencies in the program, and correct programs are at least as effective as the paragraphs (p) through (s) of the final them. Employers are required to make programs required by the standard rule, when an employee reports an sure that the ergonomics program they OSHA is promulgating for all general MSD, early intervention is required to have implemented is eliminating or industry employers and employees. controlling the MSD hazards in jobs in The final rule’s grandfather clause ensure appropriate treatment, work their workplace. A program designed for does not identify specific rates of MSDs restrictions, and follow up. OSHA a large site with many different jobs, for or other similar measures of anticipates that many existing programs example, is likely to be more formal and effectiveness that a grandfathered will be able to meet the requirements of extensive than one designed for a small program must achieve because OSHA is paragraph (s) by use of the dispute site with one or two high-risk jobs. aware that the programs grandfathered resolution mechanisms described in Similarly, an ergonomics program that in will be at many different stages of paragraph (s)(5). fits a manufacturing facility may not be program development and because Final rule paragraph (c)(3) states that appropriate for a work environment in OSHA wishes to recognize as wide a an ergonomics program of an employer the service sector. To make the range of existing effective programs as who has policies or procedures that evaluation requirements for possible. Although the grandfather discourage employee from participating grandfathered programs as flexible as clause does not set a specific reduction in the program or reporting the signs or possible, OSHA is not specifying the goal, employers are required by symptoms of MSDs or the presence of frequency with which evaluations must paragraph (c)(1)(v) to demonstrate the MSD hazards in the workplace does not be conducted. However, employers do effectiveness of their programs. qualify for grandfather status. This need to reevaluate their programs Paragraph (c)(2) of the final rule provision, which is equivalent to periodically to ensure that they are requires employers with grandfathered paragraph (h)(3) of the final rule, performing up to expectations. programs to institute an MSD ensures that employees are as free to Final rule paragraph (c)(1)(v) also management policy (including work participate fully in grandfathered requires the program evaluation to restriction protection) that meets programs as employees in programs that review the effectiveness of the program, paragraphs (p) through (s) of the final are not grandfathered. As discussed at using such measures as: reductions in rule within 12 months of the effective length in connection with paragraph the number or severity of MSDs, date of the standard. Thus, the final (h)(3), OSHA has found that employee increases in the number of jobs in which rule’s grandfather clause is designed to participation is essential to a program’s ergonomic hazards have been recognize existing ergonomics programs effectiveness and that a prohibition on controlled, reductions in the number of that are effective even if they do not policies that inhibit that participation is jobs posing MSD hazards to employees, have an MSD management policy until warranted.

TABLE 1ÐCOMPARISON OF PROPOSED BASIC OBLIGATIONS WITH FINAL GRANDFATHER CLAUSE PROGRAM ELEMENT CORE ELEMENTS AND SUBELEMENTS

Corresponding core elements and subelements of the final grandfather Proposed basic obligation clause

Proposed Management Leadership Obligation Final § 1910.900(c)(1)(i) and (ii) and (c)(3): [Your program must contain the following elements:] You must demonstrate management leadership of your (c)(1)(i) Management leadership, as demonstrated by an effective MSD ergonomics program. Employees (and their designated rep- reporting system and prompt responses to reports, clear program re- resentatives) must have ways to report MSD signs and MSD sponsibilities, and regular communication with employees about the symptoms; get responses to reports; and be involved in devel- program; oping, implementing and evaluating each element of your pro- (c)(3) An employer who has policies or procedures that discourage em- gram. You must not have policies or practices that discourage ployees from participating in the program or reporting the signs or employees from participating in the program or from reporting symptoms of MSDs or the presence of MSD hazards in the work- MSD signs or symptoms. place does not qualify under paragraph (c) of this section.

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TABLE 1ÐCOMPARISON OF PROPOSED BASIC OBLIGATIONS WITH FINAL GRANDFATHER CLAUSE PROGRAM ELEMENT CORE ELEMENTS AND SUBELEMENTSÐContinued

Corresponding core elements and subelements of the final grandfather Proposed basic obligation clause

Proposed Employee Participation Obligation: You must set up a way for employees to report MSD signs and (c)(1)(ii) Employee participation, as demonstrated by the early reporting symptoms and to get prompt responses. You must evaluate em- of MSDs and active involvement by employees and their representa- ployee reports of MSD signs and symptoms to determine wheth- tives in the implementation, evaluation, and future development of er a covered MSD has occurred. You must periodically provide your program; information to employees that explains how to identify and report [See also paragraph (c)(1)(iv).] MSD signs and symptoms. Proposed Job Hazard Analysis and Control Obligation: Final § 1910.900(c)(1)(iii): [Your program must contain the following elements:] You must analyze the problem job to identify the ergonomic risk Job hazard analysis and control, as demonstrated by a process that factors that result in MSD hazards. You must eliminate the MSD identifies, analyzes, and uses feasible engineering and administrative hazards, reduce them to the extent feasible, or materially reduce controls to control MSD hazards or to reduce MSD hazards to the them using the incremental abatement process in this standard. levels specified in Appendix D or to the extent feasible, and evalu- If you show that the MSD hazards only pose a risk to the em- ates controls to assure that they are effective. ployee with the covered MSD, you may limit the job hazard anal- Note to Paragraph (c)(1)(iii): Personal protective equipment (PPE) ysis and control to that individual employee's job. may be used to supplement engineering and administrative controls, but you may only use PPE alone where other controls are not fea- sible. Where PPE is used you must provide it at no cost to employ- ees. Proposed Training Obligation: Final § 1910.900(c)(1)(iv): [Your program must contain the following elements:] You must provide training to employees so they know about MSD Training of managers, supervisors, and employees (at no cost to these hazards and your ergonomics program and measures for elimi- employees) in your ergonomics program and their role in it; the rec- nating or materially reducing the hazards. You must provide ognition of MSD signs and symptoms; the importance of early report- training initially, periodically, and at least every 3 years at no ing; the identification of MSD hazards in jobs in your workplace; and cost to employees. the methods you are taking to control them. Proposed MSD Management Obligation: Final § 1910.900(c)(2): [Your program must contain the following ele- ments:] You must make MSD management available promptly whenever a By January 16, 2002, you must have implemented a policy that pro- covered MSD occurs. You must provide MSD management at vides MSD management as specified in paragraphs (p), (q), (r) and no cost to employees. You must provide employees with the (s) of this section. temporary ``work restrictions'' and ``work restriction protection (WRP)'' this standard requires. Proposed Program Evaluation Obligation: Final § 1910.900(c)(1)(v): [Your program must contain the following ele- ments:] You must evaluate your ergonomics program periodically, and at Program evaluation, as demonstrated by regular reviews of the ele- least every 3 years, to ensure that it is in compliance with this ments of the program; regular reviews of the effectiveness of the standard. program as a whole, using such measures as reductions in the num- ber and severity of MSDs, increases in the number of jobs in which ergonomic hazards have been controlled, or reductions in the num- ber of jobs posing MSD hazards to employees; and the correction of identified deficiencies in the program. At least one review of the ele- ments and effectiveness of the program must have taken place prior to [insert date 60 days after the publication date of this standard].

The following paragraphs discuss the 11290, 11615). Most of these employer’s program had been comments, evidence and testimony commenters argued that the proposed demonstrated to be effective in received on the proposed grandfather standard would only permit existing preventing MSDs. For example, the U.S. clause and present OSHA’s reasons for programs that already met all of the Chamber of Commerce stated this view accepting or rejecting the rulemaking details of the program required by as follows: participants’ suggestions and for OSHA’s standard to be grandfathered OSHA claims that employers who already including the final rule’s grandfather (see, e.g., Exs. 30–1722, 30–3853, 30– have ergonomics programs in place ‘‘may clause requirements. 3934, 30–3956, 32–141; Tr. 11265, Tr. continue that program, even if it differs from 1. Whether the Proposed Standard 11290, Tr. 11615). According to these the one [the proposed] standard requires’’ if Would Recognize Existing Effective commenters, the basic obligation OSHA the program meets certain requirements * * *. The Proposed Rule requires that Programs proposed for each core element would in actuality have required an employer ergonomics programs that were implemented Many rulemaking participants said to meet each of the proposed and evaluated before the effective date of the that the proposed rule’s grandfather subrequirements under that core Proposed Rule must, among other things, (1) satisfy the ‘‘basic obligation’’ of each of the element. Thus, they reasoned that the clause would not, as drafted, recognize standard’s six program elements; and (2) existing effective programs (see, e.g., proposed grandfather clause would only demonstrate that the elements of the Exs. 30–574, 30–973, 30–1722, 30–3765, recognize existing programs that already preexisting program are ‘‘functioning 30–3813, 30–3815, 30–3845, 30–3853, met all of the particulars of the program properly * * *.’’ This provision is 30–3934, 30–3956, 30–4185, 31–297, envisioned by OSHA’s proposed completely inadequate to assist employers 32–141; 500–188; Tr. 3320, 4137, 11265, standard even in cases where the with preexisting programs. The qualifications

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As was attested to by several industry his program satisfies the ‘‘basic obligation’’ of OSHA’s Voluntary Protection Program representatives during the public hearings, each program element. The ‘‘basic (VPP) or through corporate settlement even those programs that OSHA has obligation’’ of each [proposed] element is so agreements (see, e.g., Exs. 30–3392, 30– acknowledged as being among the best in broadly written that it encompasses all 3815, 30–3819, 30–4499). These industry today would not be in compliance requirements enumerated under that rulemaking participants observed that with the proposal. As pointed out in ORC’s particular element. Thus, employers, these ergonomics programs would not oral testimony, it is unlikely that any of the including those Chamber members who have be acceptable under the proposed approximately 150 member companies of [spent] a great deal of effort and money to ORC’s occupational safety and health groups, establish voluntary ergonomics programs, grandfather clause even though they whose safety and health programs are among will be forced to [alter] their preexisting have been recognized as effective by the the most sophisticated and effective in the programs to comply with the Proposed Rule Agency in the past. NAM urged OSHA world, would meet the criteria under section (Ex. 30–1722). in the final rule to grant employers’ 908 of the proposal. This is because of the existing ergonomics programs greater proposed requirement that an employer must Edison Electric Institute’s (EEI’s) acceptance for grandfather status based meet all of the ‘‘basic obligation’’ sections of comments were similar: on the results they achieve. each program element. Virtually all of the EEI supports the concept of a Similarly, Organization Resources proposed ‘‘basic obligations’’ are too ‘‘grandfather’’ clause. However, the proposed Counselors, Inc. (ORC) noted that a prescriptive and should be simplified as version is more illusory than real, for it recent General Accounting Office (GAO) described more fully in ORC’s written comments. In particular, many ORC appears to require that all newly proposed study recommended that OSHA adopt a controls be put in place before the effective employers would not meet the provisions of date of the standard. It is unrealistic and flexible approach in its ergonomics [proposed] sections 911, 917, 923 or 929, unfair to ‘‘grandfather’’ only those programs standard (Ex. 500–214). ORC argued that individually, and almost none would meet that track the proposed standard. It is as if OSHA ignored this GAO all four (Ex. 500–214). OSHA is saying, ‘‘You don’t have to do recommendation in drafting the Summing up the concerns of anything, provided that you have done proposed grandfather clause. As commenters wanting a more flexible everything.’’ A true ‘‘grandfather’’ provision evidence, ORC pointed out that even the grandfather clause, the American Dental would give credit for effective past programs, best ergonomics programs would not regardless of whether those programs Association argued that the proposal qualify for status under the proposal’s would reject alternative programs that conform to the scheme of the proposed grandfather clause, stating: program (Ex. 30–3853). might be equally or even more effective OSHA has predicated its proposed The American Hotel and Motel (Ex. 32–141). The Association Ergonomics Program Standard on its recommended that OSHA establish a Association gave examples of how an observations that many businesses are effective existing program might fail standard based on objective measures or successfully addressing ergonomics issues performance and leave the methods of OSHA’s proposed grandfather test: using similar approaches. In recognition of this conclusion and in order to focus its own achieving those objectives to employers. OSHA does not allow for any variation scarce resources on the areas of greatest need, Several employer representatives from OSHA’s regulation if a [company’s] OSHA has proposed a ‘‘limited grandfather illustrated how various effective ergonomics program does not satisfy ‘‘the clause’’ for employers with existing existing ergonomics programs would basic obligation section of each program ergonomics programs that meet certain element in this standard.’’ An ergonomics fail to meet the proposed grandfather criteria. OSHA’s proposal made numerous program that is proven to be 100 percent clause (see, e.g., Ex. 30–4185; Tr. 8634, references to the 1997 General Accounting effective would fail if it only offered, for 9181, 11265). For example, IBP, Inc., Office (GAO) study of several companies which has a corporate-wide ergonomics example, training every five years. An with ergonomics programs which found that ergonomics program also would likely fail if the companies’ programs reduced work- settlement agreement with OSHA, it provided program evaluation only upon a related MSDs and associated costs, and that identified several aspects of the report of an ergonomic injury yet did not the programs and controls selected by proposed program that their program have a reportable injury in less than three employers to address ergonomic hazards in does not address: responses to every years (Ex. 30–3233). the workplaces were not necessarily costly or MSD symptom, communication with The Center for Office Technology complex. As a result, OSHA said, ‘‘GAO the health care provider, and WRP (Tr. noted that none of the exemplary recommended that OSHA use a flexible 4929, Tr. 5041). In the hearings, an IBP ergonomics programs that have won the regulatory approach in its ergonomics representative stated that its program standard that would enable employers to Center’s ergonomics award have develop their own effective programs.’’ would not meet the grandfather clause requirements for work restriction OSHA claimed that the standard it proposed because of proposed requirements in protection, which would have been reflects this recommendation and ‘‘builds on these three areas (Tr. 5041). Many other required by the proposed standard to be the successful programs that thousands of employer representatives also noted that in place by the standard’s effective date proactive employers have found successful in their programs did not include in order for a program to be dealing with their ergonomic problems’’ (64 provisions providing for work grandfathered (Ex. 30–2208). Thus, the FR 65770). Unfortunately, in crafting the restriction protection and, consequently, Center pointed out that these very good proposed grandfather clause, OSHA ignored would not qualify under the grandfather programs would not meet OSHA’s a major finding of the GAO report: that clause (Tr. 8634, Tr. 9181). although there were common elements in proposed grandfather clause. The Center each of the employer’s programs studied, Constangy, Brooks and Smith stated recommended that OSHA include in the there was significant variety in the way each that their clients could not meet the final rule a grandfather clause that program element was implemented (GAO/ hazard control endpoints in the would allow any program to be HEHS–97163, page 4). There was no proposed standard (Ex. 30–4185). They grandfathered in that was reducing MSD evidence in the GAO study that one method argued that, as drafted, the proposal

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For • The basic obligation for the clients’ programs would not qualify the reasons [summarized by OSHA] below, proposed job hazard analysis and UNITE does not believe that these criteria under the proposed grandfather clause. will provide the appropriate level of workers control section omitted requirements Other commenters also noted that their, protection (Ex. 32–198). that limited the use of personal their members’, or their clients’ protective equipment and mandated programs would not meet the proposed Several unions, including UNITE and that employers provide it at no cost to standard’s grandfather clause for similar the United Food and Commercial employees (Ex. 32–210). reasons (see, e.g., Exs. 30–3344, 30– Workers International Union (UFCW), • The proposal’s requirements for 3347, 30–3368, 30–3845, 30–4137). gave the following reasons why the program evaluation were inadequate One witness at the hearing, Thomas J. proposal’s grandfather clause was and would allow employers to overlook Durbin of PPG Industries, noted that inadequate: • serious program deficiencies (see, e.g., since no one would benefit from the The detailed provisions Exs. 30–4200, 32–198, 32–210). The grandfather clause as it was proposed, implementing each of the proposed unions believed that, because the rule’s OSHA should either put in a true program elements, which would not be evaluation provisions are the primary grandfather clause that recognizes required for grandfathered programs, are means for determining the acceptability programs containing the six core necessary for adequate protection of of an existing program under the elements or eliminate it altogether (Tr. employees. UNITE pointed to OSHA’s grandfather clause, these provisions 3135, Tr. 3147). In questioning, he extensive justification for each of these should be revised in the final rule to stated that he interpreted the proposal proposed provisions in the preamble prevent employers from inappropriately to require the full program as long as and indicated that the justification approving unacceptably weak programs MSDs continued to occur (Tr. 3140). applied just as well to programs in for grandfather status. (Also see the The Boeing Company argued that the existence before the rule becomes summary and explanation for paragraph restrictive nature of the proposal’s effective as to programs implemented (u), later in this section of the grandfather clause ran counter to the afterward (Ex. 32–198). • preamble.) intent of the OSH Act (Ex. 30–1547). In The proposed basic obligation The International Brotherhood of support of their position, they pointed sections for the management leadership Teamsters (IBT) observed that the to section 6(d) of the Act, which and training elements, which would be proposed standard would consider any provides for a variance procedure to the only requirements employers with new ergonomics program coming into recognize alternative approaches to grandfathered programs would have to effect to comply with the standard as compliance with OSHA standards, meet, would allow poorly trained deficient if the new program did not provided that the alternative provides managers to make determinations that meet one or more of the standard’s equivalent employee protections. their program complies with the requirements (Exs. 30–4200, 32–461). Boeing was particularly concerned that standard. The unions noted that training The IBT argued that existing programs the standard, as proposed, would deny for managers was not included as part should be held to the same standard: grandfather status to an employer who of the proposed basic obligation for had a program but who had not yet these elements. They were particularly Any program grandfathered under this completed the implementation of all of concerned that inadequate training of proposal would essentially be judged by a different set of criteria than a program the control measures required by the managers would result in improper developed after the effective date. The proposal. program evaluations (see, e.g., Exs. 30– grandfathered program would be considered On the other hand, many rulemaking 4200, 32–198, 32–210, 32–421). to be in compliance despite having missing participants indicated that the proposed • Job hazard analysis and control and components, provided that the [proposed] standard’s grandfather clause would quick fixes could be performed without basic obligations as currently defined, are allow ineffective programs to be the input of employees because met. An identical program, that was grandfathered (see, e.g., Exs. 30–4200, employee participation is not a part of developed after the effective date and was 32–111, 32–182, 32–198, 32–210, 32– the proposed basic obligation of those not grandfathered would not be considered to 339; Tr. 3477). For example, the United provisions.2 The unions argued that, be fully in compliance and would be cited by compliance officers for each component of Steelworkers of America and others without feedback from employees, a were concerned that employers whose the standard that was lacking, despite provision not addressed in the proposed meeting the very same basic obligations that program evaluations failed to identify basic obligation for the job hazard the grandfathered program met. This deficiencies simply because the analysis section, employers would be weakness can not be used as an argument evaluations were not done properly likely to improperly identify risk factors that compliance is too difficult to determine, could be grandfathered in under the or select improper hazard controls (see, but rather must be viewed as an argument proposed standard (see, e.g., Exs. 32– e.g., Exs. 30–4200, 32–198, 32–210, 32– that the grandfathering provision, as it 111, 32–182). They recommended that 461). currently stands, has serious flaws and must OSHA develop additional regulatory • The proposed MSD management be significantly improved such that every text to strengthen the program worker is provided the same protections basic obligation is missing a under this standard (Ex. 32–461). evaluation provisions. The Union of requirement for health care Needletrades, Industrial and Textile professionals to be provided with At the hearing, OSHA stated that the Employees (UNITE) was also very information about the workplace and Agency’s intent in the proposal was to concerned that the proposed grandfather the employee’s job (Ex. 32–198). include a grandfather provision that clause would inadequately protect According to UNITE, which has had recognized existing effective ergonomics employees (Ex. 32–198), stating: first-hand experience with programs programs: The acceptability of existing programs that do not require such information Other requirements of the proposal that depends largely on the criteria used to OSHA has designed to be flexible include a determine acceptability. Therefore, the 2 UNITE also noted that the proposed quick fix grandfather clause that permits employers correctness of the current criteria— section had no basic obligation section at all. who have already implemented an

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Ergonomics Program to continue to operate examples of some of the specific problems are generally resolved in an that program as long as it meets minimal measures that employers may use to expedient manner before they represent requirements (Tr. 19). demonstrate that their programs are hazards. While all of these are approaches effective. These changes will enable that can support safety in an effective and It is readily apparent from the expedient manner, none of these would rulemaking record that very few, if any, more employers’ programs to qualify for represent sufficient ergonomics programs existing ergonomics programs would be the grandfather clause but will also under the proposal; and that is part of the able to fulfill the requirements of the ensure that only effective existing problem with the proposal: it discounts proposed grandfather clause. Although programs are recognized. The changes systems that work, but that are not as OSHA drafted the language in the also shift the focus from compliance comprehensive or well-documented as the proposed standard generally and in the with the rule to effectiveness in proposal (Ex. 30–3849). grandfather clause specifically to be preventing MSDs. Although OSHA Some rulemaking participants flexible, the Agency recognizes that the believes that having all six elements is recommended that programs be grandfather clause, as proposed, was not vital to qualify a program for grandfathered based solely on one or sufficiently flexible to allow existing grandfather status, OSHA is not more measures of effectiveness (see, e.g., programs that are effective in protecting interested in technical compliance but Exs. 30–1901, 30–3211, 30–3344, 30– employees from MSD hazards to be in real effectiveness. 3348, 30–3361). For example, grandfathered in. On the other hand, 2. Whether Effectiveness of an Armstrong World, Inc., recommended OSHA agrees with many of the union Ergonomics Program Is All That Matters accepting for grandfather status comments, discussed above, that it is programs based on the employer’s Many rulemaking participants important that the grandfather clause injury incidence rates: not recognize programs that are believed that it would be more appropriate for the standard to simply Employers should be exempt from any ineffective in protecting employees from proposed standard based on their MSD hazards. OSHA has structured the accept proven, effective programs than to require that grandfathered programs performance in preventing such injuries. We final rule’s grandfather clause to strike would suggest using 50% of the employers’ an appropriate balance between also include the core elements of industry’s respective SIC Code rates for Total flexibility, on the one hand, and successful programs (see, e.g., Exs. 30– Recordable Cases and Cases With Days Away program effectiveness, on the other. 523, 30–1090, 30–1901, 30–1722, 30– From Work as a meaningful measure of In drafting the proposed and final 2208, 30–3211, 30–3765, 30–3813, 30– accepting existing employer ergonomics rules, OSHA has relied heavily on the 3934, 30–3956; Tr. 3319, 15657). In their processes as they are (Ex. 30–1901). Agency’s experience with effective view, effectiveness is the only part of Other rulemaking participants also ergonomics programs that proactive the program that matters, and therefore recommended using injury rates, either employers have implemented; in fact, any existing program that is effective in absolute terms or in terms of showing the final rule is modeled after such should be grandfathered. Doerle Food a reduction, as a measure of programs. OSHA has concluded that it Services, Inc., exemplified many of effectiveness and qualification for is reasonable for the Agency to include these comments: grandfather status (see, e.g., Exs. 30– in the final rule a grandfather clause OSHA has made its position clear, at 64 3344, 30–3348, 30–3361). For example, that is less prescriptive than the one Fed. Reg. 65791, in which it states that the the Exxon Mobil Production Company proposed and is more closely focused agency believes ‘‘enforcement of the standard suggested that the standard grandfather will be more consistent and more equitable a program if the employer’s records on the effectiveness of existing * * * if the test of an employer’s program programs. The Agency has made several is whether it contains the core elements, demonstrate that the program is changes to the final rule’s grandfather rather than whether it is effective.’’ This is, preventing MSDs and is managing clause to achieve this end. First, OSHA we submit, an incredible statement, and ergonomic concerns (Ex. 30–2433). John has streamlined the subelements (called reflects OSHA’s devotion to its mandated W. Braddock suggested that employers ‘‘basic obligations’’ in the proposed program and ‘‘control’’ strategy, as opposed be permitted to produce evidence that rule) under each core element and has to actual effective programs. It is this outlook the existing program was working and removed some of the more prescriptive which is at the core of the ‘‘grandfather’’ that there is an effective early reporting provision, since it does not accord requirements. For example, the final recognition in any meaningful way to a pre- mechanism in place and to qualify for rule has not carried forward the existing effective program that can be shown grandfather status on this basis (Ex. 30– proposal’s provision that periodic to have minimized the conditions that are at 4301). training and program evaluations in issue. This portion of the standard clearly ORC argued that there are a number grandfathered programs be conducted at needs to be reconsidered and expanded (Ex. of ways to measure program intervals of no more than 3 years. 30–523). effectiveness, which should be the true Second, OSHA is permitting employers The Washington Aviation Group gave gauge of the worthiness of any to add or strengthen elements of their examples of how an employer’s ergonomics program (Ex. 30–3813; Tr. programs, provided that they do so, and ergonomics program might be effective 4112). They suggested several possible evaluate the program at least once, without meeting the proposal’s ways to measure effectiveness: before the effective date of this rule. grandfather criteria: OSHA might place the initial burden of Third, because so many commenters There are a variety of reasons why a demonstrating effectiveness of the program with otherwise effective programs company might experience few or no on the employer and include in a non- reported that their program would not ergonomics problems. The business owner mandatory appendix a number of types of qualify for grandfather status solely may have an intuitive sense of how to performance measures and approaches that because it did not have a WRP promote comfort among the employees that OSHA would consider appropriate. OSHA component, the final rule gives has a beneficial effect on ergonomics issues. mentions some in the preamble, e.g., decreases in the numbers or rates of MSDs employers a year from the effective date The nature of the work might be such that it does not lend itself to repetitive motion and decreases in severity. Other measures of the standard to add such protections disorders or other ergonomics problems. might include reduced workers’ (which are a part of MSD management) Management may have established an compensation claims for MSDs, use by the to their existing programs. Fourth, effective rapport with the employees that is employer of periodic symptoms surveys and OSHA has included, in the final rule, sufficiently responsive so that potential other indicia of effective early reporting, or

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68290 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations demonstration that risk factors have been that grandfathered programs must be in OSHA’s real goal: The reduction in the reduced and/or tools and equipment have place and be judged effective by the number of MSDs experienced by been modified. An employer might time the standard is effective in order to workers. demonstrate effectiveness based on periodic In their post-hearing submission, the program evaluation that measures be grandfathered. The Departments of effectiveness based on an internal ‘‘score Defense and Navy recommended that U.S. Chamber of Commerce criticized card’’ that looks at a number of appropriate the standard provide employers wishing the proposed grandfather clause’s effectiveness measures. to grandfather their programs in with reliance on the proposed core elements’ * * * * * sufficient time to conduct a statistically basic obligations instead of ORC believes strongly that OSHA should significant evaluation of the effectiveness: be focusing its attention on results or effectiveness of the program even if the The Agency claims that existing programs performance, not methodology (Ex. 30–3813). evaluation did not take place until after will be evaluated upon the existence of the However, even though ORC objected to the effective date (Ex. 30–3818; Tr. core elements rather than a program’s the proposed grandfather clause’s 3228). They were concerned that it effectiveness * * * because it will make emphasis on core elements and their would not be possible to perform such such evaluation ‘‘less time-consuming’’ and basic obligations, they did agree with an evaluation before the effective date of ‘‘administratively simpler’’ for both OSHA and the employers. 64 Fed. Reg. at 65791. Of OSHA that there is a need to ensure that the standard, as the proposal required. In addition, they suggested that the course, the real reason that the Agency has any demonstration of effectiveness that chosen to focus on content is that OSHA relies on numbers or rates of MSDs not standard clarify what effectiveness simply cannot judge effectiveness and has no mask any underreporting of MSDs (Exs. measures or evaluation points OSHA idea what it means to be an effective 30–3813, 32–78). would accept for each program element program. Indeed, in order to qualify under Unisea, Inc. suggested the following in grandfathered programs (Ex. 30–3818; the Grandfather Clause, an employer’s language for OSHA to use in the final Tr. 3228). existing program must not only contain the rule to recognize existing ergonomics Other commenters suggested a variety core elements of the Proposed Rule, but must programs based on effectiveness: of indicators of program effectiveness. also be ‘‘functioning properly.’’ And although For example, the American Industrial according to the Preamble ‘‘effectiveness’’ is If a company is able to show by operation Hygiene Association (Ex. 32–133) not a measure of whether or not the program redesign with ergonomics considerations is ‘‘functioning properly,’’ 64 Fed. Reg. at made, or injury records or near-miss reports stressed measures of effectiveness other 65791, Marthe Kent testified to precisely the that a reduction of reported MSD’s has than injury rates: opposite effect: occurred, that company shall be considered OSHA needs to be more specific on what And further [proposed 1910.908], which in compliance of the standard and its intent. constitutes an equivalent program so that says the evaluation indicates that the OR, If a company is able to show a steady mediocre programs do not pass compliance, program elements are functioning properly, overall reduction of injuries, either by total but programs showing improvements will what we mean there is [that the elements] are number or incident rate, that company shall have a reasonable chance to be considered effective. I mean, you cannot have a program be considered in compliance of the standard acceptable. The evaluation of quality of the with the elements functioning properly and and its intent (Ex. 500–158). program should rely on real evidence of it not be effective. Abbott Laboratories argued along hazards identified and risk reduction. Tr. at 1–182. Thus, not only can the similar lines and submitted data in Specifically, have physical risk factors been Agency not determine what ‘‘effectiveness’’ support of its position. According to a reduced and have ergonomics improvements means, it also apparently cannot decide comment in the record, Abbott been made? Indeed, this is the ‘‘bottom line.’’ whether or not ‘‘effectiveness’’ means the Laboratories instituted ergonomics Other things to look at include whether same thing as ‘‘functioning properly.’’ Until the Agency sorts out this conundrum in some programs at three laboratories in the late training has been done, and if there is a reduction in MSDs and associated workers’ understandable way, there can be no real 1980’s (Ex. 500–153). Abbott’s comment compensation costs (Ex. 32–133). Grandfather Clause in the Proposed Rule (Ex. presented the OSHA-recordable illness 500–188). rates at those facilities over the last 9 Herman Miller, Inc., listed several OSHA did not propose a grandfather years. These data are shown in Table 2. measures that employers could use to clause that relied heavily on injury rate Abbott states that the fall in rates over measure effectiveness: ‘‘Reduction in goals to demonstrate effectiveness that period reflected ergonomic MSD hazards, MSD severity rates, lost because, as the Agency noted in the improvements made at each facility and workdays or benchmarked proposal (see 64 FR 65980 et seq.), should qualify these establishments for improvements in employee satisfaction MSDs are currently substantially grandfather status. rates’’ [Ex. 30–518]. They suggested leaving the specific protocol to the underreported, and relying on reported rates would therefore, in many cases, TABLE 2.ÐOSHA RECORDABLE ILL- discretion of the employer and noted overstate effectiveness. Some NESS CASE RATES AT THREE AB- that OSHA compliance officers would need to be given proper training and commenters, however, argued that MSD BOTT LABORATORIES PLANTS tools so that they could make logical rates were appropriate for this purpose (see, e.g., Exs. 30–2989, 30–3845). For Year Plant A Plant B Plant C and qualitative assessments of ergonomics programs and determine example, the Forum for a Responsible 1999 ...... 1.03 1.44 1.46 whether they were effective enough to Ergonomics Standard stated: 1998 ...... 0.47 1.90 2.87 qualify for grandfather status. If OSHA is concerned with how to measure 1997 ...... 1.02 1.81 2.50 Dennis Morikawa, testifying on behalf ‘‘effectiveness,’’ it can prescribe the manner 1996 ...... 0.43 1.00 2.30 of Morgan, Lewis and Bockius, did not in which effectiveness is to be measured, 1995 ...... 0.71 3.27 2.74 specify a particular measure of such as reductions in the number and 1994 ...... 2.69 3.13 3.47 severity of MSDs. OSHA contends, however, 1993 ...... 3.70 4.27 4.51 effectiveness but recommended instead that OSHA make the grandfather clause that most means of measuring ‘‘effectiveness’’ 1992 ...... 3.25 2.52 6.68 have built-in incentives to discourage 1991 ...... 4.41 4.54 7.06 widely available to employers to reporting. See id. This contention ignores the encourage as many of them as possible Source: Ex. 500±153. fact that companies are subject to regulatory to adopt programs before the final rule’s requirements in the proposed rule, backed up Another point raised by commenters effective date (Tr. 15657). He argued by OSHA fines and penalties, to facilitate concerned the proposed requirement that this approach would further employee reporting (Ex. 30–3845).

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A. O. Smith Corporation commented rates can be misleading if efforts are not incidence rate of 19.3 per 1000 that, in its experience, few employers made to ensure that the rates reported employees 3 will experience an MSD discourage reporting of workplace are accurate and that the use of such incidence rate that varies about that injuries: rates is appropriate for the workplace. number from year to year. If employee The provisions in the standard that allude Some of the problems with various exposure to MSD hazards at this to the employer having programs in place objective measures of effectiveness are workplace remains relatively constant, that discourage the reporting of MSD injuries described below. the actual incidence rate in any one year tends to suggest that entire safety and health (a) Incidence rates are dependent on (assuming that the number of employees awareness and accident prevention programs accurate reporting. An employer’s and other factors also remain constant) would be construed as disincentives to recordkeeping system must accurately will probably be reasonably close to that reporting. We do not accept this premise and count work-related MSDs if incidence value. In one year, for example, 17 of find that most employers work hard at rates are to be a meaningful index of the 1000 employees could suffer an making sure their employees are provided a effectiveness. An employer whose safe work environment and a mechanism to MSD, while in the next year, 21 might report injuries should they occur (Ex. 30– employees are reluctant to report, or one be injured. This variability can be seen 2989). who does not record all MSDs, will in the Abbott Laboratories data in Table appear to have a lower incidence rate 2, especially in the last 5 years, after the Other rulemaking participants agreed than a comparable employer with an program had matured. with the approach taken in OSHA’s accurate recordkeeping system, and the Variability is even more pronounced proposal and opposed basing the incidence rate in the first employer’s in a workplace with few employees. If grandfather clause solely on a measure establishment will bear no relationship the employer in the earlier example had of the reduction in the number of MSDs to program effectiveness. There are 10 full-time employees and the same in a workplace (see, e.g., Exs. 30–2387, many reasons why MSDs are overall average MSD incidence rate, the 32–339, 500–207). For example, the underreported (see the discussion of establishment could be expected to have AFL–CIO stated that the elements that this issue in the summary and 0, 1, or 2 MSDs in a given year.4 The OSHA included in the proposal’s explanation for MSD management). If corresponding incidence rates per 1000 grandfather clause are widely there are disincentives to reporting, employees, however, would be 0, 100, recognized as the basic elements of an employees may not report all MSDs. If and 200. If incidence rates alone were effective program (Ex. 32–339). The an employee is not well informed about used as the measure of effectiveness at International Brotherhood of Teamsters MSD signs and symptoms, he or she such a facility, the program would be argued that, to be grandfathered, an probably will not realize that the signs rated very effective in one year and in existing program needed to be and symptoms of an MSD are work- need of major correction in the other comprehensive and to provide workers related and will fail to report them. years. and their representatives with full Employees also fail to report MSDs in In the context of the grandfather information and rights of participation some cases because they do not want to clause, this year-to-year variability in addition to being effective in submit a claim to the workers’ poses problems for OSHA and for reducing the number of MSDs (Ex. 500– compensation system. Thus, incidence employers. If the final rule were to 207). rates must be used with care. identify a specific rate as the sole In response to these comments, OSHA (b) Severity rates are dependent on criterion for grandfathering existing finds that the record evidence consistency in return-to-work policies. programs, then an employer whose demonstrates that the Agency should Severity rates are typically measured in program was acceptable one year might emphasize the effectiveness of terms of days away from work or days be unacceptable the next simply as a grandfathered programs much more in on restricted duty. Changes in how result of this variability. For example, the final rule than it did in the proposal. employers treat injured workers can suppose that the final rule selected 1.45 Record evidence also demonstrates that affect severity rates. For example, if an as the maximum acceptable incidence the core elements are essential to employer who has traditionally rate for a grandfathered program. Abbott effectiveness (see the discussion of the measured severity in terms of lost Laboratories Plant A (from Table 2) core elements below). If a program is not workdays institutes a new policy of would have had an acceptable program demonstrably effective in protecting placing employees with MSDs on in terms of grandfathering since 1995 employees from MSD hazards, OSHA restricted duty rather than removing the (Ex. 500–153). Abbott’s Plant C program believes that such a program should not employee from work, the number of (from Table 2) would never have met qualify for grandfather status and days away from work will decrease. the incidence rate limit in this period should instead have to comply with all Thus, severity rates must also be used and would therefore have had to comply the requirements of the final rule. On carefully to ensure that they are not with the ergonomics standard. Abbott’s the other hand, if an existing reflecting a change in the employer’s Plant B (from Table 2) could have had ergonomics program has the core MSD management process rather than a its program grandfathered in 1996 and elements and is truly effective in true decrease in MSD severity. 1999, but would have had to comply protecting employees, it merits (c) The randomness inherent in injury with the standard in 1997 and 1998. grandfather status. The central question and illness statistics may make From this example, it can be seen that then becomes how to measure incidence rates an unreliable indicator some employers’ programs, after effectiveness; if effectiveness measures of effectiveness. Injuries and illnesses initially qualifying for the grandfather are not carefully chosen, ineffective are events that occur based on programs will be grandfathered in and probability. In other words, hazards do 3 This is the overall MSD incidence rate for SIC the employees in the establishments not automatically lead to injuries or 283. covered by such ineffective programs illnesses; the presence of hazards 4 It would take 100 years for this firm to have will be inadequately protected. simply increases the probability that an 1000 employee-years of experience. If the employer One widely used method of injury or illness will occur. Just as a had an incidence rate of 17 MSDs per 1000 full-time employees, the employer would see 17 incidents measuring effectiveness is the tracking coin flipped 10 times will not over 100 years. Over that period, in most years, no of MSD incidence and severity rates. automatically land heads up 5 times, a MSDs would occur. In other years, one or maybe However, MSD incidence and severity workplace with an average MSD two MSDs would occur.

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OSHA finds that in and sometimes out’’ phenomenon is elements): the core elements are essential to not what OSHA or employers with • OSHA’s VPP, SHARP, and effective ergonomics programs, and the existing ergonomics programs want consultation programs; record provides ample evidence of this from a grandfather clause. • The safety and health programs (see the discussion below on whether Alternatively, the final rule could mandated by 18 states; the core elements are necessary). mandate that, to be grandfathered, the • The safety and health programs Employee participation, for example, is employer’s MSD incidence rates had to recommended by insurance companies a prominent component of the programs decrease over time, as suggested by for their insureds (many of which give of many leading companies (see, e.g., some rulemaking participants (see, for premium discounts for companies that Exs. 32–77, 32–185, 32–210; Tr. 4973, example, the comments of Unisea, Inc., implement these programs or impose Tr. 5339). The core elements also help Ex. 500–158, above). Again, the Abbott surcharges on those that do not); to ensure that employees are reporting • Laboratories data in Table 2 show that The safety and health programs their MSDs, that management is this approach would also be recommended by the National responding to these reports, that jobs are problematic (Ex. 500–153). All three of Federation of Independent Business, the being analyzed and fixed, and that the Abbott Laboratories’ plants experienced Synthetic Organic Chemical program is functioning as it should. The increasing rates in some years in the Manufacturers Association, the core elements thus help to ensure that period reported. Although the overall Chemical Manufacturers Association, programs are not focusing too heavily trend over the full 9-year period is the American Society of Safety on quantitative measures of Engineers, and many others; downward for all of the Abbott plants, • effectiveness, which, as the discussion this is not the case for all time periods. The strong recommendations of above shows, are often misleading. For example, Plant C’s incidence rates OSHA’s Advisory Committees OSHA agrees, however, that went up over the 4-year period from (NACOSH, ACCSH, and MACOSH), effectiveness measures can be useful in 1995 to 1998 (see Table 2). In fact, which consider these program elements determining the degree to which an OSHA’s experience is that, as an essential to effective worker protection ergonomics program is working. employer’s ergonomics program programs. Employers and authors of effectiveness OSHA also is including WRP, or matures, incidence rates begin to level studies routinely rely on them as equivalent protections against wage off, albeit at a much lower rate than evidence that an ergonomics program is loss, as a requirement for all programs before the program was established (see having a positive effect. Of the measures (both those that are grandfathered and Chapter IV of the Economic Analysis). available, incidence and severity rates those complying with the standard) Other ‘‘objective’’ measures of are most commonly used and were most because, without it, OSHA believes that effectiveness recommended by often recommended in the rulemaking many employees will be reluctant to rulemaking participants (see e.g., Ex. record (see, e.g., Exs. 30–1901, 30–2208, report their MSDs because they fear 30–3813; Tr. 4112) pose similar 30–3344, 30–3348, 30–3361). If one of economic loss. There is strong evidence problems. Decreases in the rate of these measures is used, the employer that such underreporting is currently workers’ compensation claims have the must take care to ensure that the taking place, as well as evidence that same problems as incidence rates when calculated incidence or severity rate protecting workers from wage loss they are used as effectiveness measures. accurately reflects conditions at the increases reporting (see the discussion Symptom surveys, although valuable as workplace. First, the effectiveness of underreporting in the summary and an early reporting tool, vary from one measure chosen must be appropriate for explanation for MSD management). workplace to another and therefore the size and nature of the workforce and OSHA’s purpose in including a WRP cannot be used for different sites. the employer’s MSD experience. For provision, both in the grandfather clause Reductions in employee exposure to example, as explained earlier, an and in the standard, is to ensure MSD hazards is a good measure of employer with few employees will not employee participation and free and full whether an ergonomics program is find incidence rates useful to measure reporting of MSDs and MSD hazards. working but, OSHA has no benchmark effectiveness. Instead, such employers Effective ergonomics programs depend that adequately describes the could examine whether employee on such reporting, and the standard also performance of an effective program. exposure to MSD hazards has been depends on employee reporting for its Without a benchmark, reductions in reduced. Second, the employer must effectiveness. Absent such reporting, no employee exposure to MSD hazards check to ensure that some MSDs are not ergonomics program will achieve its cannot be used as the sole criterion for going unreported. If employees are worker protection goals. grandfathering programs at different failing to report MSDs, the employer’s For these reasons, OSHA has sites. calculated incidence and severity rates concluded that quantitative In addition, OSHA has concluded that will not accurately reflect the injury effectiveness measures alone cannot be the core elements (management experience at the workplace. Third, the the sole basis for judging whether an leadership and employee participation, employer should check rates over a employer’s program should be hazard identification and assessment, variety of periods to ensure an overall grandfathered. The Agency’s experience hazard prevention and control, MSD downward trend in the data. Looking at over the last two decades, and that of management, training, and evaluation) data over a single period can be private industry and insurance are essential to a properly functioning misleading. companies, is that safety and health ergonomics program. These elements OSHA finds, based on the evidence in programs, and ergonomics programs, are included in the safety and health the record as a whole, that reliance on containing the core elements are programs recommended or used by both qualitative (the core elements) and effective in lowering injury and illness quantitative (effectiveness measures) 5 Using a rolling average incidence rate would rates. These programs work because components will best assure that any help smooth out, but would not eliminate the year- they involve everyone in the program that is grandfathered deserves to-year variability. organization in finding and fixing this status and will continue to operate

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Employers may use any of a recognized as the basic elements of a explanation for the corresponding broad range of measures, including good ergonomics program (Ex. 32–210). provisions of the standard, below.) reductions in the number or severity of They presented their experience with Further, the Agency finds that it is as MSDs, increases in the number of jobs successful ergonomics programs as important for a grandfathered program in which ergonomic hazards have been follows: to include all of the core elements as it controlled, reductions in the number of The six elements OSHA is proposing in the is for a program brought into existence jobs posing MSD hazards to employees, ergonomics program standard are included in to comply with the final rule to include or any other measure that demonstrates all successful company programs! Further, these elements. Although some program effectiveness to meet the the experience of the myriad of companies commenters, as discussed above, argued grandfather clause’s requirement for a who have successfully tackled the problem that a program could be effective demonstration of program effectiveness. through these elements attests to the feasibility of the methods. The settlement without all of the core elements, OSHA 3. Whether the Core Elements Are agreements OSHA has entered into with IBP, finds their arguments unpersuasive, Necessary Sara Lee, Cargill, ConAgra Poultry, John based both on the record and the Morrell & Co., Empire Kosher, Marshall Agency’s own experience with Some industry representatives Durbin Companies, National Beef, successful programs. objected to the proposed requirement Worthington Packing and Tyson Foods that grandfathered programs contain all contain these six elements—all work, and all The Agency believes that the core the core elements of the proposed are feasible. Many of the companies used elements provide assurance that the standard (see, e.g., Exs. 30–1722, 30– ergonomists, they analyzed the jobs and program will work as intended— 3853, 30–3956; Tr. 5699). They argued developed engineering solutions to address management leadership will ensure that the most egregious jobs. They developed the program has the continued backing that any program that was effective in medical protocols so that workers can get to reducing MSD rates should be accepted of management, which is essential to treatment early rather than waiting until they continued success; employee for grandfather status, even if it did not were crippled and needed surgery. They include all the core elements. protect workers wages and benefits when participation in the program will help For example, the Washington Legal they report MSDs. And in our represented ensure that ergonomic hazards do not go Foundation was particularly concerned companies, all this included the union in a undetected; hazard information and that employee participation was fundamental way. In order to be effective, reporting will ensure that employees are proposed as a required component of ergonomics programs by their very nature informed about MSD symptoms and must be participatory and include workers at how to report them so that work-related grandfathered programs and of the many levels, including those that do the program required by the standard (Tr. problem jobs (Ex. 32–210). MSDs are not ignored; work restriction 11265). They argued against mandatory protection helps to ensure that workers employee participation: Mr. Bawan Saravana-Bawan, a report signs and symptoms as early as representative from the Canadian OSHA’s proposed ergonomic standard possible; job hazard analysis and control province of British Columbia, described are needed to ensure that ergonomic perhaps more so than any other standard how that province handled existing mandates full employee involvement in hazards are found and abated; MSD every aspect of its requirements. programs when its ergonomics standard management is necessary so that MSDs In many ways, the proposed standard came into effect (Tr. 14260). He stated are managed appropriately and injured places employees in the driver’s seat. that existing programs needed to employees get well as soon as possible; Certainly many companies have incorporate any missing elements in and program evaluation is necessary for determined that a [cooperative] relationship order to be accepted. On the basis of his the correction of deficiencies in the with their employees is beneficial on both a experience, he stated that any program. Without the checks and safety and a production level. ergonomics program needed to have all Other companies, however, have reached a balances the core elements provide, the core elements (management OSHA believes that ineffective programs different conclusion. And certainly, the leadership and employee participation, conclusion to be reached may differ may be judged effective on the basis of information dissemination, hazard depending on the type of work involved, the an inappropriate measure, and once- size of the company, the characteristics of the identification, hazard assessment and successful ergonomics programs could work force, and other factors. control, training, and program deteriorate over time and leave evaluation) to be successful. The Washington Legal Foundation does employees unprotected. not believe that it is its place to determine The Department of Defense (DoD) also that some of these [employers] are right and argued that the program elements are Some rulemaking participants agreed others are wrong nor is it the place of the essential. The DoD noted that the that grandfathered programs should federal government to mandate a specific success of their program is due to the include the core elements but argued mode of employer/employee relations (Tr. elements of the program, including, in that compliance with the proposed basic 11265). particular, management leadership, obligation sections for each core On the other hand, some union employee participation, hazard element was not essential to having an representatives argued strongly in favor prevention and control, and monitoring effective program (see, e.g., Exs. 30– of the core elements (see, e.g., Exs. 32– injury records and responding to 1294, 30–3813, 30–3723, 30–3765). 210, 32–461, 500–218). The potential problem areas (Ex. 30–3826). These commenters believe that many International Brotherhood of Teamsters OSHA has concluded that it is employers have effective programs that noted that they had worked with essential for ergonomics programs, would not be recognized by the various employers through the whether grandfathered or not, to address proposed standard because they would collective bargaining process to address all of the core elements: Management not meet the proposed basic obligation ergonomic hazards and that some leadership and employee participation, sections. ORC reflected the thrust of employers’ programs took a piecemeal hazard information and reporting, job these comments as follows:

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Equally important, contrary to OSHA’s can continue to use them. This concept also The Mead Corporation suggested that, contention in the preamble, the ability of an allows companies who may not yet have an if the Agency’s safety and health employer to continue applying an existing existing program to create one tailored to program rule was not promulgated program should not be based on whether the their own needs, rather than use a more ‘‘one before the ergonomics rule, OSHA ‘‘basic obligation section of each program size fits all’’ program as envisioned by this element in this standard’’ is satisfied. OSHA proposal. ‘‘Acceptable (or appropriate) should alter the grandfather clause in has provided no objective evidence that the Equivalence’’ would include those programs the ergonomics rule in one of two ways: requirements of the proposed standard will who have the basic elements of a program, (1) Make the basic obligations less be any more effective than other programs but not all the mandated details or prescriptive and detail acceptable already in place. There is certainly no basis documentation. Such a concept embodies alternatives for prevention-oriented for compelling an employer to rework an ‘‘performance-oriented mandates’’ at their programs, or (2) permit employers with effective program to force it to meet the best as they allow an employer to employ effective programs to maintain them specifics even of the proposed basic those methods of prevention that best meets without making sweeping changes (Ex. obligations (Ex. 30–3813). the needs of its particular workforce and/or 30–2216). Dow, ORC, and others suggested that workplace. OSHA should only be concerned On the other hand, the AFL–CIO OSHA simply require grandfathered with the results (i.e. lower injury rates) rather than the methodology a particular employer argued that the standard should require programs to address the six basic used to obtain that goal (Ex. 30–3765). employers to meet the proposed basic elements of the program instead of obligations for each core element before requiring them to meet the proposal’s At the hearing and in their notice of being grandfathered in (Ex. 32–339; Tr. full basic obligation for each core intention to appear at the public 3477). The AFL–CIO pointed out, element (see, e.g., Exs. 30–2134, 30– hearing, Dow described their however, that the basic obligation 2725, 30–3171, 30–3765, 30–3813, 32– ergonomics program and detailed how sections for several of the proposed core 77). ORC noted that the proposed work they believe their program would fall elements left out important restriction protection requirements were short of the proposal’s requirements (Ex. requirements that were included under particularly troublesome, since 32–77; Tr. 5339). Dow expressed the core elements: ‘‘[v]irtually none of ORC’s member concern that, although their program The AFL–CIO believes that employers with companies, whose ergonomics programs meets the spirit of the proposed existing programs should be permitted to are among the most sophisticated and standard, it would not meet the letter of continue with these programs if they are effective in the country, would meet this the law. comprehensive, provide workers and their requirement * * *’’ (Ex. 30–3813). Dow In response to Dow’s concern, OSHA representatives full information and rights of was concerned that the language in the reviewed the perceived discrepancies participation, and are effectively reducing proposal would not recognize their between the proposed rule and Dow’s MSDs and exposure to hazards. However, as proposed, the ‘‘grandfather’’ provisions are program, which is tailored to fit their description of their program. In every management structure. They stated: deficient in a number of respects and will respect except one, Dow’s program permit employers to continue programs that The so-called Grandfather clause that would have satisfied the proposed do not provide adequate protection. OSHA has proposed is so demanding in its grandfather clause; the discrepancies First, the [proposed] basic obligation requirements that companies that have Dow was concerned about were requirements which all programs must meet, existing and successful ergonomics programs, apparently the result of exclude a number of elements that in our such as Dow, will not be able to take misinterpretation rather than view are essential for an effective program. advantage of this provision to maintain their deficiencies on the part of Dow’s For example: current programs. The Grandfather clause is • The [proposed] basic obligation section so limited that already functioning and program. For example, Dow stated that, for Hazard Information and Reporting * * * successful programs, tailored to the needs of in its program, employees report MSDs does not [include] any requirement to a particular company, business or workplace, using the company’s existing injury and provide employees information about MSD will not be able to satisfy the requirement. illness reporting system rather than a hazards. For example, in Dow’s case, we would not be separate system set up just for MSDs; • The [proposed] basic obligation on able to satisfy the extensive recordkeeping Dow evidently believed that a separate training * * * excludes any requirement for requirements or elements of the WRP section system would have been required by the training supervisors or individuals (since it goes beyond that required by proposal (Ex. 32–77; Tr. 5340). responsible for the ergonomics program, thus Workers’ Compensation laws.) Similarly, permitting programs to be ‘‘grandfathered’’ given Dow’s management structure, we However, the proposed standard would even if persons responsible for the program would not satisfy OSHA’s communication not have required employers to set up do not have the necessary training. The basic and training requirements wherein they a separate system for reporting MSDs as obligation for training also fails to provide for intend a more archaic management structure, long as their existing system included a job specific training on MSD hazards and such as one having ‘‘supervisors’’ and the system for the reporting of MSDs. On control measures. like, than what Dow utilizes. So even though the other hand, Dow was correct in • The [proposed] basic obligation for Dow has had a successful ergonomics stating that their program did not Medical Management * * * does not require program for years and has a lower than include the proposed work restriction that medical evaluations be conducted by a health care provider. average MSD incidence rate, we would have protection provisions and would to scrap our efforts and use a program which • The [proposed] basic obligation for will not fit our needs or management therefore not have been eligible for Program Evaluation * * * does not require structure, just to comply with this standard. grandfather status under the proposed consultation with employees in problem jobs Dow believes this is unacceptable. rule. or their designated representatives to Instead, Dow urges OSHA to delete the In its post-hearing submission, Edison determine their views on the effectiveness of proposed Grandfather clause and replace it Electric Institute argued that the the program (Ex. 32–339). with a provision that allows for an specificity of the proposal’s basic As noted earlier, other rulemaking ‘‘acceptable’’ or ‘‘appropriate equivalent’’ obligations is counter to the goal of participants also urged OSHA to program. Such a concept is not foreign to OSHA or the regulated community as other flexibility, and the Institute strengthen the proposed basic OSHA standards, such as the Process Safety recommended that the final rule reduce obligations sections (see, e.g., Exs. 30– Management (‘‘PSM’’) standard, utilize this the detail in the basic obligation 4200, 32–198, 32–210, 32–461). These concept so that companies that have existing sections to allow employers greater commenters criticized the proposed programs that are functioning successfully latitude (Ex. 500–33). rule’s lack of basic obligation

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UNITE decried the omission Although the AFL–CIO provided OSHA has streamlined and made more from the proposal of a requirement for evidence that some employers do flexible the provisions that rulemaking the health care provider to be furnished provide wage protection for their participants claimed were most with information about the workplace employees, OSHA believes, based on problematic such as the employee and the employee’s job (Ex. 32–198). the record, that very few employers’ participation and WRP provisions. Another commenter objected to the existing ergonomics programs OSHA also has placed the required omission from the proposal of incorporate work restriction protection subelements in the text of the requirements that limited the use of in the form required by the proposed grandfather clause itself rather than in personal protective equipment and standard. Despite the fact that many the basic obligations sections for each of required employers to provide it at no employers have policies (such as sick the core elements, as proposed. OSHA cost to employees (Ex. 32–210). leave, short-term disability, and so on) believes that these changes will make Another group of commenters were that assure employees that they will not the core elements that grandfathered particularly concerned about the fact experience economic loss if they are programs must currently have as that the proposal would not have injured, the record of this rulemaking flexible as possible while still ensuring permitted their otherwise excellent indicates that many workers fear they that the basic components that make programs from being grandfathered will lose wages and benefits if they each core element effective are present. because they did not have work report their injuries (see the detailed In addition to considering the restriction protections now (see, e.g., Ex. discussion of the record in the summary comments of industry representatives 30–3723, 30–3765, 30–3813). SBC and explanation for paragraph (r) objecting to the core elements and their Communications, Inc., represented below). The Agency therefore concludes subelements, OSHA has reviewed the those who opposed the proposed that grandfathered programs must list of subelements that several labor grandfather clause’s requirement for protect against such loss if they are to organizations believed were essential to work restriction protection: achieve the early reporting that is determine whether they should be essential to program success. In order to meet the grandfather clause, a included in the final rule’s grandfather company must have a ‘‘functioning properly’’ Consequently, in paragraph (c)(2) of the clause requirements (Exs. 32–198, 32– Wage Protection Program. Through our final rule, OSHA is allowing existing 339; Tr. 3477). The Agency has included ergonomics programs that otherwise extensive research and benchmarking, no several improvements in the final rule’s meet the criteria of the grandfather company has this element to their grandfather clause as a result of this ergonomics program. Nor did OSHA provide clause up to an additional 12 months to review. First, the grandfather clause’s any evidence of the Wage Protection Program adopt an MSD management policy, training element now contains a being trialed, researched, and/or tested at a including work restriction protection. requirement that employees be trained company. OSHA has made it nearly The MSD management policy must meet impossible for any company to meet the in MSD risk factors (see paragraph paragraphs (p) through (s) of the final requirements of the grandfather clause (Ex. (c)(1)(iv)). This provision ensures that rule. The MSD management 30–3723). employees will be informed of MSD requirements in the final rule contain hazards in their workplace. Second, On the other hand, the AFL–CIO many inter-related provisions that are noted that the hearing testimony key to a successful ergonomics program. OSHA has added a requirement for the demonstrates that some employers do (See the summary and explanation for training of managers and supervisors to currently provide wage protection for paragraphs (p) through (s) of the final this core element. Third, OSHA has employees who suffer MSDs: rule.) The Agency has concluded that, included language specifically requiring The hearing record shows that some because of the many interdependencies employees to be involved in program employers indeed are maintaining the full in final rule paragraphs (p) through (s), evaluation to the core element for wages of workers who are put on medical employers need to follow all of the employee participation (see paragraph restrictions as a result of MSDs (Tr. 16014, detailed requirements of those (c)(1)(ii)). These additions will help Tr. 14357) (Ex. 500–218). paragraphs. However, to ensure that ensure that ineffective programs are not The General Electric Company argued existing programs will still be able to accepted under the grandfather clause. that employers who have employee qualify for grandfather status even if The remaining suggestions from these involvement and an environment free of they do not meet the final rule’s MSD commenters, such as UNITE’s barriers to reporting should not be management requirements, OSHA is recommendation to include a required to follow the rule’s allowing employers up to a year to meet requirement for the health care provider requirements for WRP (Ex. 30–1071). those provisions. to be furnished with information about Novartis Corporation went further, Based on a review of the evidence in the workplace and the employee’s job suggesting that the entire MSD the record, OSHA has concluded that (Ex. 32–198), have been accommodated management element be removed from the proposed standard’s basic obligation by paragraph (c)(2) of the final rule. the standard (Ex. 30–3092). They also requirements failed to provide Existing programs need not currently recommended that compliance with the employers with effective existing have MSD management as a core endpoint provisions not be a condition programs sufficient flexibility with element in order to qualify for for grandfathering existing programs. regard to grandfather status. grandfather status. However, The AFL–CIO recommended that Accordingly, in paragraph (c)(1) of the grandfathered programs will need to OSHA permit existing programs without final rule, OSHA has not carried add an MSD management element work restriction protection to be forward the proposed requirement that meeting paragraphs (p) through (s) grandfathered as long as the employer employers’ programs satisfy the basic within 1 year after the final standard’s incorporates such protections into the obligation of each element and instead effective date. Thus, grandfathered ergonomics program before the effective requires that those programs simply programs will have to meet the same date of the standard (Ex. 500–218). They contain the core elements and certain MSD management requirements as believed that this would help alleviate subelements, which the Agency has programs that are not grandfathered.

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4. Whether the Language of the [W]e strongly urge OSHA to provide protection to employees, including Grandfather Clause Is Vague checklists and evaluation tools to assist those in small firms, or that provides employers with the evaluation of their less protection to employees overall, as Some rulemaking participants argued programs. Employers who want to take effective as the final rule. that the language in the proposed advantage of the ‘‘grandfather’’ provisions grandfather clause was vague (see, e.g., should be required to use a checklist based The second relates to the details of Exs. 30–494, 30–2208, 30–3922, 30– on objective criteria to demonstrate that their grandfathered programs. Paragraph (c) 4467; Tr. 16470). They thought that this program is effectively reducing exposures to of the final rule does not attempt to ergonomic risk factors, reducing the dictate precisely what form a language would make it difficult for an incidence and severity of musculoskeletal employer to determine if he or she grandfathered program must have, disorders, and complies with the standard’s beyond stating that it must have the core qualified under the grandfather clause. basic obligations. These materials are For example, Dennis Morikawa of currently used by many ergonomics programs elements of successful programs, be Morgan, Lewis, and Bockius stated: and could be made available by OSHA demonstrably effective, and be through its website (Ex. 500–207). evaluated and in place by the final These vague requirements do not inform rule’s effective date. OSHA has not OSHA believes that the grandfather employers which ergonomic programs OSHA mandated such program specifics clause in the final standard is clear. For would accept. Specifically, OSHA does not because grandfathered programs will explain what a ‘‘basic obligation’’ is; nor does example, the training element requires the Proposed Rule specify the level of detail the training of managers, supervisors, take many different forms, be at many employers must achieve when they attempt and employees in: (1) The employer’s different stages of development, and be to comply with a basic obligation. Moreover, ergonomics program and their role in it; taking various approaches to achieving the grandfather clause does not make clear (2) the recognition of MSD signs and success. The grandfather clause thus whether an effective, existing program symptoms; (3) the importance of early insists on the fundamentals but leaves without a single-incident trigger would be the specifics to employers. acceptable. For example, if programs that reporting; (4) the identification of MSD risk factors and methods that may be The final standard also requires the satisfy the CAL/OSHA standard discussed employer to demonstrate that an above would be accepted under the used to abate them; and (5) the risk grandfather clause, then most companies factors in problem jobs in the workplace existing program is effective before that would seek to design and install ergonomics and methods of controlling them. To program qualifies under the grandfather programs before the effective date of the new provide employers flexibility, the clause (see paragraph (c)(1)(v)). The Proposed Rule. But if a two-incident trigger standard does not address the details of employer is free to use one of the would not satisfy a ‘‘basic obligation,’’ how that training is provided, but it is measures specified in the standard itself employers would be forced to re-design clear about the topics the training must (that is, reductions in the number or existing programs in order to meet the cover. severity of MSDs, increases in the Proposed Rule, thereby creating a double Other elements provide clear number of jobs in which ergonomic standard of compliance. This, of course, hazards have been controlled, would effectively eviscerate the notion of a direction about how an employer is to grandfather clause. OSHA needs to specify demonstrate compliance. For example, reductions in the number of jobs posing which aspects of the Proposed Rule would be the employer must evaluate the MSD hazards to employees) or any other considered basic obligations, and the amount program, as demonstrated by regular valid measure that the employer of attention to detail that employers must pay reviews of the elements of the program, chooses to evaluate the program and when adhering to these basic obligations. the effectiveness of the program as a demonstrate effectiveness. The Agency Without an assurance from the agency that an whole, and the correction of identified currently provides some compliance adherence to basic obligations would not deficiencies. Again, this language assistance materials that include ways require major overhauls of effective provides clear criteria that employers’ to measure the effectiveness of programs, the grandfather clause is illusory ergonomic interventions. For example, (Ex. 30–4467, p. 13). evaluations must meet in order to be grandfathered in. the ‘‘Ergonomic Program Management Some rulemaking participants stated There are two aspects to Mr. Guidelines for Meatpacking Plants’’ (Ex. that the vagueness of the grandfather Morikawa’s comments (Ex. 30–4467) 2–13) provides a method for monitoring clause would force employers to refer to about the acceptability for grandfather trends in cumulative trauma disorders the more detailed provisions of the clause status of programs meeting the that may be used for this purpose. standard to understand their California standard’s two-incident OSHA’s 1989 Voluntary Safety and compliance obligations (see, e.g., Exs. trigger. The first relates to Federal Health Program Management Guidelines 30–494, 30–4340). They argued that the OSHA’s acceptance of the California (Ex. 2–12) also describe effective effect of this vagueness would be that ergonomics rule under the Act’s program evaluations. These documents employers would be forced to comply provisions for ensuring that state are available on OSHA’s Website (http:/ with the entire standard, which would standards developed by the State Plan /www.osha.gov). OSHA also intends, as render the grandfather clause useless. States are as effective as the Federal resources permit, to provide additional Even some of those who supported standard. OSHA will, after it compliance assistance materials that OSHA’s proposal in general agreed that promulgates this final ergonomics will help employers determine whether the proposed grandfather clause was program standard, evaluate the or not their programs are effectively vague (see, e.g., Exs. 30–4538, 32–210). ergonomic standards developed by State addressing MSDs. These rulemaking participants and Plan States (such as California and In sum, OSHA believes that the final others urged the Agency to provide Washington) to determine whether they grandfather clause provides sufficient compliance assistance material, such as are ‘‘as effective as’’ the Federal information for employers to determine flowcharts, checklists, and other tools, standard. OSHA clearly could not have if their programs qualify for the to help employers determine whether made such a determination at the time grandfather clause. OSHA compliance their programs qualified under the of the proposal, as Mr. Morikawa officers also will be able to assess grandfather clause (see, e.g., Exs. 30– suggests, because the form and content whether the employer’s program 4538, 32–210, 32–339, 500–207). For of the final OSHA rule could not be qualifies for grandfather status. OSHA example, the International Brotherhood known at that time. However, OSHA is will include directions on how this is to of Teamsters stated: unlikely to find any standard that delays be done in a compliance directive to be

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Several rulemaking participants SHE Excellence Center made a similar OSHA agrees, however, that a suggested approaches that would permit recommendation: company that meets the rigorous alternative programs developed after the standards of paragraph (c) and thus standard is in effect to be followed by [One] improvement in the flexibility would be to allow whichever elements that have qualifies for grandfather status should employers in lieu of compliance with been put in place to be grandfathered and be permitted to apply the same excellent the standard (see, e.g., Exs. 30–2216, those which are not in place to be added. The program that was grandfathered to new 30–3765; 30–3813, 32–339, 500–44; Tr. grandfather clause should not be an ‘‘all-or- plants it builds or acquires by merger or 3477). Many of these commenters nothing’’ clause (Ex. 30–2134). acquisition. OSHA believes that argued that their recommendations In addition, ORC, along with other permitting a grandfathered program to would address the previously discussed rulemaking participants, recommended be extended in this way makes sense concerns with the proposed rule’s allowing an employer’s program to be from two perspectives: first, it ensures grandfather clause—concerns such as grandfathered after the effective date of that the new establishments will benefit the perceived illusory nature, the standard, which would permit from the expertise in ergonomics vagueness, and subjectivity of the employers involved in mergers and programs that the parent company proposed grandfather clause. The acquisitions to put their already brings, and, second, it ensures that the alternatives or revisions to the proposed grandfathered programs into place in company will have a single, cohesive grandfather clause suggested by these new establishments (see, e.g., Exs. 30– corporate ergonomics program. For commenters included: 3813, 30–3922, 32–78; Tr. 5538). ORC these reasons, OSHA has decided to • Revising the clause to allow also recommended that OSHA permit extend grandfather status to the programs that are incomplete at the time employers to extend existing programs implemented in newly of the effective date to be grandfathered grandfathered programs to new acquired or built plants of a corporation (see, e.g., Ex. 30–3813; Tr. 4111); that already has a grandfathered • establishments operated by the same Revising the clause to make clear program. that a company whose program had employer (Ex. 500–214). The rulemaking participants who The American Industrial Hygiene been grandfathered could extend that Association (Ex. 32–133) recommended program (and grandfather status) to recommended that the standard permit future alternative ergonomics programs that employers formally request OSHA establishments newly built or owned, or to recognize their programs: acquired through mergers or to be grandfathered did not address how an employer might avoid As the standard puts much of the burden acquisitions (see, e.g., Exs. 30–3813, 30– on employers to adapt the program to their 3922, 32–78; Tr. 5538); noncompliance while developing the program or in the period before the own needs, it would be appropriate for • Revising the clause to allow any OSHA to say that employers can ask to have program developed by an employer at employer had demonstrated the their program ‘‘grandfathered’’. This would any time, including after the standard effectiveness of the new program. OSHA require them to formally document their has become effective, to be implemented does not believe that such an approach program and compare it with the OSHA without fear of citation for would be workable. First, it would be requirements. This should not be a problem noncompliance with the OSHA administratively difficult (if not if the company has a functional program (Ex. 32–133). standard (see, e.g., 30–429, 30–1090; Tr. impossible) to enforce. Second, OSHA is 15657); issuing a final standard addressing Kaiser Permanente made the same • Revising the clause to specify that ergonomic injuries because the varied recommendation in their post-hearing OSHA will certify or approve approaches and often isolated comments (Ex. 500–139). employers’ programs as qualified for interventions that many employers have However, OSHA’s resources do not grandfather status (see, e.g., Ex. 32–133, adopted have not effectively addressed permit it to evaluate employers’ 500–139); the problem, and a uniform and programs for grandfather status; in • Revising the clause to recognize for comprehensive approach to this most addition, a ‘‘paper’’ review of a program grandfather status any program that serious of occupational safety and is not adequate to determine how it is complies with either the Washington health issues is clearly necessary. The working in practice. OSHA continues to State or the California standard (see, approach recommended by the believe that employers are in the best e.g., Exs. 30–429, 30–434, 30–973, 30– commenters would mean that, while position to determine whether their 1090, 30–1547, 30–1671, 30–2835, 30– employers try different programmatic programs qualify for grandfather status. 3813, 30–4134, 31–337, 32–311); approaches, employees would continue The Eastman Kodak Company (Exs. • Delete the grandfather clause and to be exposed to ergonomic hazards 30–429, 30–1090) suggested that the substitute instead provisions giving with no guarantee that the employers Agency adopt a flexible grandfather employers credit for already having would ever qualify for ‘‘grandfather’’ clause that recognizes good faith on the performed some of the required status. Third, OSHA is loathe to require part of employers: elements, such as training, before the the expenditure of resources to make We believe that what OSHA needs is a effective date (see, e.g., Exs. 30–1547, existing, effective programs containing ‘‘good faith’’ grandfather clause that 32–185, 32–311, 32–339, 32–461, 500– all the core elements meet all the recognizes employers for a positive effort and 207; Tr. 6423, 11129, 13092). requirements being imposed by the full ongoing solutions. We believe that it should For example, ORC made several ergonomics standard. Employers be sufficient for an employer to have a suggestions along these lines (Ex. 30– without programs and employers with written active program and show intent, to be compliant. The existing program rule (WAC 3813; Tr. 4111). First, they ineffective programs or programs 296–62–05110) of the Washington State recommended that OSHA rename this missing key elements would need to proposed standard is better suited to this end section ‘‘Alternative Programs expend resources to meet whatever and is recommended for incorporation (Ex. Provision.’’ They also suggested that, as requirements OSHA imposed on 30–429).

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Other rulemaking participants also The final ergonomics standard does Bell recommended the following recommended that OSHA adopt the give credit to employers who have language (Ex. 500–78): proposed Washington State approach already carried out certain procedures How does this standard apply if I towards existing programs (see, e.g., or voluntarily complied with portions of already have an ergonomics program? Exs. 30–434, 30–2835, 30–3813, 30– the standard. For example, employers If you already have an ergonomics 4134, 31–337, 32–311). They argued that who have already performed job hazard program for the jobs this standard Washington’s approach, which accepts analysis in some jobs would not have to covers, you may continue that program alternative programs when the employer re-analyze those jobs (see paragraph provided: can demonstrate that the alternate (j)(1) of the final rule). Likewise, (a) You have a written program that methods taken as a whole are as employers who have already trained contains: effective as the requirements of the their employees in the ergonomic (i) Defined roles and responsibilities; standard, would grandfather far more control measures they instituted would (ii) Training on the prevention of effective programs than OSHA’s not have to duplicate that training (see work-related MSD’s; and (iii) Procedures for completing job proposal. They also noted that this paragraph (t)(5) of the final rule). approach would focus the Agency’s hazard analysis for work-related MSD’s. Some rulemaking participants (b) The controls implemented are efforts on results rather than on details suggested that OSHA recognize for they perceived as minor. intended to reduce or eliminate risk grandfather status any ergonomics factors for work-related MSD’s; The Washington State standard’s program in effect at the time the final grandfather clause reads as follows: (c) You have a program evaluation rule becomes effective (see, e.g., Exs. process; and you have implemented WAC 296–62–05110 When Do 30–494, 30–2989, 30–3781, 500–213; Tr. your program before the effective date of Employers’ Existing Ergonomics 10089). These commenters believe that the final rule (Ex. 500–78). Activities Comply With This Rule? these employers should be rewarded for OSHA has considered Southwestern their proactive stance toward Bell’s suggested language but has Employers may continue to use effective ergonomics. For example, the National rejected it because the programs that alternative methods established before this Council of Agricultural Employers said, would be grandfathered in by such rule’s adoption date. If used, the employer ‘‘a grandfather clause should recognize language would be missing several must be able to demonstrate that the and exempt forward-thinking employers alternative methods, taken as a whole, are as important elements—employee effective as the requirements of this rule in that have already implemented an participation, hazard information and reducing the WMSD hazards of each job and ergonomics program’’ [Ex. 30–3781]. reporting, and MSD management, for providing for employee education, training The National Association of example. As explained earlier, OSHA and participation (Ex. 500–71). Convenience Stores went further to considers these elements essential to Other commenters (see, e.g., Ex. 30– suggest that OSHA also grandfather any successful ergonomics program. In 4467) urged OSHA to accept compliance trade-association-provided programs: addition, Southwestern Bell’s approach with the California ergonomics standard ‘‘OSHA [should] consider does not contain any requirement that as constituting acceptance under the grandfathering existing risk the program be effective, be achieving grandfather clause. management programs or industry- positive results, or be reducing the Again, as discussed above, formal specific programs which trade number of MSDs. recognition of the ‘‘as effective as’’ associations may be able to provide to The American Petroleum Institute status of these two State-plan State their members’ (Tr. 10089). The Air (API) proposed language that would standards must await a formal Conditioning Contractors of America accept an employer’s existing program if determination by Federal OSHA. recommended that OSHA recognize it contained the following seven However, since acceptance under the virtually any existing ergonomics elements: (1) Management leadership final rule’s grandfather clause depends program under the grandfather clause and employee participation, (2) hazard on program effectiveness, confirmation (Ex. 500–53). It said that OSHA could information and reporting, (3) job of that effectiveness through evaluation, require grandfathered programs to be hazard analysis and control, (4) training, and the inclusion in the program of the improved at such time in the future as (5) MSD management, (6) program core elements, many proactive MSD hazards became better understood. evaluation, and (7) recordkeeping (Ex. California and Washington employers’ As explained earlier, OSHA believes 500–80). API’s proposal also would programs are likely to meet the final that it is essential for grandfathered require grandfathered programs to standard’s requirements for grandfather ergonomics programs to include all of contain subelements under each status. The programs of many employers the core elements of successful element. For example, under job hazard in these states may not meet these ergonomics programs and to meet analysis and control, API’s language requirements, however, since neither demonstrable effectiveness criteria. included the following provisions: ‘‘Jobs State standard requires all of the core OSHA agrees that employers who have in the workplace must be assessed to elements. already adopted existing programs are identify the potential for MSD hazards. The AFL–CIO, the International proactive; however, some of these Consistent with the job assessment, an Brotherhood of Teamsters, and others employers are likely to have programs action plan is developed to control suggested that OSHA give employers that are not as protective as the program identified or potential MSD hazards credit for steps, such as training and job OSHA is requiring or programs that do determined to present a significant hazard analysis, they have taken toward not include those elements shown to be risk.’’ Their language also suggested that controlling ergonomic hazards or for essential to program effectiveness. It grandfathered programs demonstrate controlling hazards in problem jobs in would therefore be inappropriate for effectiveness via measures such as the their workplaces (see, e.g., Exs. 30– OSHA to grandfather these programs. following: Decreases in the frequency of 1547, 32–185, 32–311, 32–339, 32–461, Several hearing participants provided reported MSDs, decreases in the severity 500–207; Tr. 6423, Tr. 11129, Tr. OSHA with alternative regulatory of MSDs, reduced workers’ 13092). These commenters believed that language for the grandfather clause in compensation claims related to MSDs, such credit could substitute for a true their post-hearing submissions (Exs. symptoms surveys, and a reduction of grandfather clause. 500–44, 500–78, 500–80). Southwestern MSD risk factors. API did not include

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First, it regarding MSDs and general information and publish it for comment before specifically recognized any program on warning signs associated with MSDs. adopting a final rule (Ex. 500–102). meeting the requirements of an It also includes a provision for They argued that this would give employer’s State OSHA ergonomics providing specific information on industry time to evaluate the new standard. Second, it recognized existing potential ergonomic hazards in an provision and respond to it. OSHA finds programs in both existing workplaces employee’s work area. Third, Dow’s a re-proposal unnecessary, because and newly acquired or built plants of a suggested grandfather clause appears to participants had ample opportunity to corporation that has a grandfathered be designed to tightly match the provide comments on the proposed program (Ex. 500–80). company’s own program rather than to grandfathered clause. The sheer volume API’s approach is similar to the one fit a more widely recognized model of comments received on this topic OSHA is taking in the final standard’s ergonomics program, such as that in provides evidence of this fact. Further grandfather clause. The final standard OSHA’s meatpacking guidelines, a the final rule’s grandfather clause is a includes all of API’s recommended program lauded by many rulemaking logical outgrowth of the proposal. In elements, and also requires the participants who had experience with fact, the final rule responds to the employer to demonstrate that the ergonomics programs (see, e.g., Exs. 30– overwhelming public comment that ergonomics program is effective. API’s 1294, 30–2216, 30–3046, 30–3677, 32– OSHA should focus on effectiveness suggested criteria for determining 185; Tr. 14713). OSHA believes that and recognize existing programs that do effectiveness are also similar to those more employers with effective existing not look exactly like the one required by listed as examples in the final standard. programs will be able to qualify under the rule. Further, the final rule permits OSHA’s final grandfather clause, which Some rulemaking participants employers with grandfathered programs is modeled after the Meatpacking supported the proposal’s approach to extend those programs to new Guidelines program, than those required toward existing programs with only corporate plants. by Dow’s alternative. minor modification (see, e.g., Exs. 30– On the other hand, OSHA is not, as Dow also commented on the discussed above, automatically 973, 30–1547, 30–2387, 30–3748, 32–85, enforcement implications of a 32–111, 32–339, 500–207; Tr. 15893). grandfathering in employers’ programs performance-based grandfather clause: that comply with State-plan State For example, the American Association ergonomics programs. In addition, API’s The verification of compliance to a of Occupational Health Nurses suggested regulatory text would not performance language regulation is most supported the proposed grandfather require employers to provide WRP to effectively achieved when the method used clause, but recommended that OSHA for prescriptive regulation compliance employees who suffer work-related provide guidance for employers to use verification is modified. The method used by in evaluating their programs (Ex. 30– MSDs. As discussed earlier, OSHA has Compliance Officers for a prescriptive concluded that WRP is an essential part 2387). The American Nurses regulation is based on the Officer’s Association supported the proposed of any ergonomics program whether it is knowledge of what is specified by the grandfathered or not. regulation to be the practice, i.e. guard rail requirement that existing program meet The Dow Chemical Company also specification. However, for performance the basic obligation of each of the core provided alternative language for a language regulations, such as the Process elements of an ergonomics program (Ex. grandfather clause (Ex. 500–44). Their Safety Management regulation and the 30–3686). They did, however, alternative provided criteria for seven language suggested by Dow for this proposed recommend allowing employers up to 6 core elements that ergonomics programs regulation. The Compliance Officer only months to modify their programs so that would have to meet to be grandfathered: knows what elements are to be addressed by they meet these basic obligations. an employer’s program: They will not know As noted earlier, program evaluation hazard communication, MSD reporting, what to expect for practices. The means to hazard identification, hazard evaluation address those elements are left to the guidance is already available from the and prioritization, risk mitigation or employer so that they can use whatever Agency. In addition, OSHA will be control, appropriate knowledge and means best match their workplace needs and providing additional compliance skills (that is, training), and program the local culture. The Compliance Officer can assistance materials in the period evaluation. Dow included specific only gain an understanding of that workplace following publication of the final rule. criteria for each of these elements and program from the employer. This, we believe, These materials will help employers an explanation of how the criteria could is where the modification in approach should judge whether their programs are be met for each of the elements. Dow occur (Ex. 500–44). effective and whether they qualify for likened their proposal to OSHA’s OSHA believes that, like a true grandfather status. Process Safety Management Standard performance standard, the final The final grandfather clause (§ 1910.119), which sets the basic grandfather clause is not prescriptive in essentially accommodates the American elements of a process safety nature and leaves the details of Nursing Association’s suggestion. management program and requires the compliance to employers to determine. Employers who, through one of the employer to spell out the details. OSHA compliance personnel will look measures given in paragraph (c)(1)(v), However, OSHA is not adopting first to the employer’s demonstration can demonstrate that their programs are Dow’s alternative grandfather clause that the program includes the core effective are free to add features that approach in the final rule, for several elements and subelements and second will bring them into compliance with reasons. First, Dow’s language does not that the program is effectively the criteria given in paragraph (c)(1) any address several elements of ergonomics addressing MSDs. Compliance officers time before the effective date of the final programs that OSHA considers also may assess whether the employer’s standard. In addition, employers are essential, including management program in practice matches the written given an extra 12 months to incorporate leadership, employee participation, and program that the employer has work restriction protection into their MSD management. Second, Dow’s developed. programs.

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The Eastman Kodak Company argued consistent with the measures used in other employer with an effective existing that the proposal’s grandfather clause agency standards on toxic substances and program would not have employees would have required employers to fix physical agents such as the lead and experiencing MSDs. all problem jobs before their programs formaldehyde standards and those which follow a programmatic approach, such as the Some rulemaking participants were recognized (Exs. 30–429, 30–1090). Process Safety Management and Hazard suggested that OSHA strengthen the The Boeing Company also noted that Communication Standards (Ex. 32–339). grandfather clause in various ways (see, employers may have an acceptable e.g., Exs. 30–2039, 30–4538, 32–182, OSHA believes that the final rule’s program that covers some, but not all, of 32–185). For example, the American grandfather clause is comprehensive the jobs covered by the standard (Exs. Federation of Government Employees enough to ensure that inadequate 30–973, 30–1547). Boeing suggested recommended that employers have a programs do not qualify and is flexible allowing employers up to 2 years after documented program in place for at enough to permit many different kinds the effective date to cover all such jobs. least 2 years before being eligible and of effective programs to qualify. As As noted earlier, the final grandfather that a grandfathered program be explained previously, the Agency clause would permit employers to required to comply with the full believes that requiring programs to meet extend an ergonomics program that was standard if any MSDs occur (Ex. 30– a combination of essential program successful in addressing some problem 4538). They also urged OSHA to require elements and recognized effectiveness jobs to all problem jobs. In addition, that, in evaluating the program, the measures will prevent inadequate because the final rule’s compliance employer determine that it is effective ergonomics programs from achieving endpoints do not contain a set in addition to functioning properly. The grandfather status. On the other hand, compliance deadline, employers may American Federation of State, County, OSHA does not agree that it is necessary prioritize jobs for analysis and control if and Municipal Employees to codify the precise practices used in all jobs could not be controlled by the recommended that OSHA require that 6 the most effective programs, as the final rule’s effective date. Thus, the all elements of an employer’s ergonomic AFL–CIO suggests. Doing so would final standard addresses the concerns of program be effective before the unnecessarily limit an employer’s these two rulemaking participants. employer is eligible under the flexibility in complying with the final Some rulemaking participants grandfather clause (Ex. 32–182). Mr. standard. The Agency believes that the suggested making the grandfather Howard Egerman was concerned that final rule has achieved a balance provisions more comprehensive (see, having the employer evaluate its own between flexibility and e.g., Exs. 32–182, 32–198, 32–210, 32– program was bound to be ineffective comprehensiveness that will recognize 339, 32–461). First, as noted earlier, the because the employer could not be effective ergonomics programs and deny AFL–CIO and others recommended disinterested (Ex. 30–115). grandfather status to inadequate ones. strengthening the basic obligations for Communication Workers of America four of the six core elements (see, e.g., 6. Other Comments on the Proposed Local 2222 recommended that the Exs. 32–198, 32–210, 32–339). Second, Grandfather Clause standard require employees to agree some participants urged OSHA to with the employer’s evaluation before develop and publish checklists and The National Soft Drink Association an existing program would be evaluation tools to assist employers objected to the requirement that the acceptable and that OSHA mediate any with the evaluation of their programs employer’s program be evaluated and disputes (Ex. 30–2039). (see, e.g., Exs. 32–85, 32–210, 32–339). found to be functioning properly before OSHA believes that the grandfather Without these tools, they argued, an the effective date of the standard (Ex. clause in the final rule will be protective employer’s program could be 30–3368). The trade association argued of employees’ safety and health without grandfathered without any solid that a thorough evaluation of any demonstration that it is effective. The program will probably uncover areas the addition of these suggestions. The AFL–CIO argued that the standard that could be improved. Other Agency is therefore not setting a should be as protective as, and rulemaking participants also minimum time period that an consistent with, existing effective recommended that the standard allow employer’s program must have been in ergonomics programs, OSHA general employers to modify their programs so place to be judged effective to qualify duty clause settlement agreements, and that they could be improved (see, e.g., for the grandfather clause. The final OSHA and NIOSH recommended Exs. 30–1547, 30–3765, 30–4130, 30– grandfather clause requires the practice (Ex. 32–339). In keeping with 4537). For example, the Boeing employer to be able to demonstrate that this goal, they developed principles that Company was concerned that an the program is effective and to evaluate employer would not be able to improve its elements and correct any deficiencies they believe should guide OSHA in 7 casting the final standard: an existing program without falling out identified before the effective date. This will ensure that only relatively The standard should codify and reflect the of compliance with the grandfather clause (Ex. 30–1547). In response, mature programs qualify for good industry practices and programs grandfathering. implemented by employers who have OSHA recognizes that all ergonomics effectively addressed ergonomic hazards. It programs will need to be modified over Many rulemaking participants should build on the agency’s enforcement time to correct deficiencies. The testified that MSDs still occur in actions and settlement agreements on standard not only accommodates this, workplaceswith the best ergonomics ergonomic hazards under the general duty but requires it in paragraph (c)(1)(v). programs in place (Exs. 30–3765; 30– clause. The standard also should be Some commenters stated that the 4046; Tr. 14730). OSHA agrees that this proposed grandfather clause would is often the case, and the final rule 6 Even though the final rule’s grandfather clause specifically notes that the occurrence of does not contain a fixed deadline for implementing force existing programs to include the controls for a problem job, an employer with a six core elements if they wished to be MSDs does not constitute a violation of grandfathered program is expected to institute grandfathered even if the employer did permanent controls as soon as possible. An not have an employee with an MSD that 7 However, as explained earlier, the final employer who postponed the control of MSD grandfather clause does permit an employer to hazards beyond a reasonable amount of time would triggered the standard (see, e.g., Exs. 30– incorporate work restriction protection in the have difficulty demonstrating the effectiveness of 715, 30–3678). In response, OSHA ergonomics program within 12 months of the the program. considers it most unlikely that an effective date.

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For example, the Chemical demonstrate that the program is what can reasonably be done in good faith to Manufacturers Association and others effective. This provision, and the minimize problem jobs, they should be stated that an unwarranted paperwork inclusion of the core elements, should protected from second-guessing by burden would be forced on an employer ensure that the evaluation is inspectors. OSHA’s limited resources are because it would have to document that appropriate. In addition, the final better used focusing on worksites where the program met the basic obligations grandfather clause requires qualifying ergonomic hazards have yet to be addressed, and that the program is functioning programs to include employee not on worksites which have already implemented effective ergonomics programs properly (see, e.g., Exs. 30–2835, 30– participation in program evaluation. (Ex. 30–1547). 3356, 30–4628). This will also act as a check on the The final grandfather clause does not accuracy of the evaluation process. For Others believed that it is appropriate require the employer to maintain any these reasons, the Agency believes that for OSHA to require employers to records. In fact, the final standard does the grandfather clause in the final demonstrate the effectiveness of their not require employers whose programs ergonomics standard will provide an programs (see, e.g., Exs. 30–429, 30– are grandfathered to maintain any of the appropriate level of protection for 2835, 30–3813, 30–4134, 31–337, 500– records required by the full standard in employees. 214). These commenters argued that this paragraph (v). Some employers may Some rulemaking participants was the approach taken by Washington choose to maintain certain records to objected to language in the proposal that State in its ergonomics standard, and facilitate their demonstration of required the employer to show that their they believed that it was reasonable. effectiveness. However, some program complies with the basic OSHA finds, based on a review of the effectiveness measures require no evidence in the record as a whole, that obligations and is functioning properly records. For example, the Dow Chemical the final grandfather clause is not likely (see, e.g., Exs. 30–541, 30–562, 30–1355, Company, whose program involves the to lead to uneven enforcement. It is true 30–1547, 30–3117, 30–3783, 30–4607). evaluation of all tasks in high risk jobs that employers will need some method They argued that the burden should be and control of all ergonomic hazards in of assuring themselves that their on OSHA’s compliance staff to address those jobs, would need only show that ergonomics program qualifies for the ergonomic hazards rather than on the adequate controls are in place to grandfather clause, and the method employer to demonstrate that its demonstrate effectiveness. (They also chosen also will be useful to OSHA program qualifies. Some of these would need to show that their program compliance personnel. However, OSHA rulemaking participants argued that includes the elements and subelements will not cite employers who make an given in paragraph (c)(1).) In addition, placing the burden on employers to adequate demonstration 8 that their demonstrate program effectiveness most employers with existing programs programs are effective and include the are already required, under 29 CFR Part would disproportionately affect small elements and subelements in paragraph employers, who do not have the 1904, to maintain injury and illness (c)(1). However, if the Agency finds records. Employers should be able to resources of larger ones (see, e.g., Exs. objective evidence that the employer is 30–3117, 30–3783). Caterpillar, Inc. use those records, with little or no basing the demonstration on inaccurate modification, to demonstrate stated that the subjective nature of the information, OSHA will not consider grandfather clause would lead to effectiveness. Thus, OSHA has that employer’s program as qualifying concluded that comments that the uneven enforcement across employer for grandfather status. groups and across the nation (Ex. 30– grandfather clause would create an OSHA also believes that it is unwarranted paperwork burden are 4607). reasonable and appropriate to place the The American Apparel Manufacturers unfounded. burden of demonstrating that their Some rulemaking participants argued Association also was concerned about programs qualify for grandfather status enforcement and gave the following that companies would be forced to alter on employers because grandfathered their existing safety and health example of how an employer’s programs are the ‘‘exception’’ to the interpretation of what constitutes a programs to meet the OSHA ergonomics standard. Employers who choose to take standard, forcing them to inefficiently problem job could differ from that of an advantage of using a program that is not OSHA compliance officer: allocate resources away from their safety required to meet the full ergonomics and health programs (see, e.g., Exs. 30– An apparel manufacturer may see two standard in all its details can reasonably 2216, 30–3845, 30–4818, 31–310; Tr. sewing jobs as extremely different, involving be expected to produce evidence that 11379, 11403). These commenters different activities and physical their programs qualify for the requirements, but an OSHA inspector with apparently believe that two separate and grandfather clause. OSHA needs incompatible programs would be no experience in the apparel industry may assurance that employees in workplaces well see them as the same. This ambiguity of required or that grandfathering would language may cause penalties against with grandfathered programs will be require major restructuring of their companies who believed they were, in good adequately protected by these programs. current ergonomics program. For faith, running a successful ergonomics For these reasons, the final grandfather example, the Forum for a Responsible program (Ex. 30–4470). clause requires the employer to Ergonomics Standard recommended The Boeing Company was also demonstrate that their programs qualify that OSHA recognize existing programs concerned about being second guessed for grandfather status. that met the goal of reducing or by OSHA enforcement personnel (Exs. eliminating MSD hazards regardless of 8 An adequate demonstration is one that touches 30–973, 30–1547). They recommended on all subelements spelled out in paragraph (c)(1) whether or not they met the technical that the standard unambiguously and that shows effectiveness using an appropriate specifications of the six proposed recognize programs addressing the basic measure of effectiveness. program elements (Ex. 30–3845).

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Otherwise, they argued, the standard In each of these examples, employers will be disruptive or result in an would not only upset the performance are pursuing activities that should be unwarranted reallocation of resources. of existing programs but would result in recognized as meaningful and exceeding Union Carbide recommended that the poor allocation of risk control resources. the level of protection OSHA is standard not require employee They gave examples of what they currently seeking for the control of participation in the development of believed might occur: MSDs. With the proposed standard, existing programs that would otherwise [O]ne Forum member, CCE, has spent however: qualify under the grandfather clause millions of dollars researching and • When persistent symptoms develop at a (Ex. 30–3784). ORC also identified developing methods to reduce injuries job considered to be moderate priority for employee participation in the related to various warehousing and delivery continuous improvement, higher priority development of each element of the activities, such as improving new order changes would be delayed, placing more program as one area that few of its fulfillment systems. In this respect, CCE is employees at higher risk for developing pioneering achievements that likely will MSDs; member companies could comply with eventually be adopted throughout its • Similarly, when partial work aggravation (Tr. 4135). industry. However, particularly with respect associated with a low risk task triggers a OSHA agrees with these rulemaking to employee participation in developing manufacturing job, high priority changes participants that employee participation safety programs, CCE is unlikely to meet the recommended by the ergonomics team based in the development of ergonomics strict requirements for grandfathering. As a upon comprehensive analysis will be result, CCE anticipates that many of its delayed; and programs is not necessary where an current efforts will be derailed as resources, • Documentation of MSD prevention existing program that qualifies for the especially the time of its highly trained staff, activities will be increasingly scrutinized and grandfather clause is at issue. The will have to be diverted to ensuring restricted due to concerns over how OSHA primary purpose of the grandfather compliance with the OSHA standard. Instead would interpret the information (Ex. 30– clause is to recognize ergonomics of developing fixes that will prevent injuries, 2216). programs that employers have already these resources will be directed towards ‘‘fixing’’ the administrative structure of its On the other hand, the American put into place, i.e., that are already well program. Society of Safety Engineers stated that past the developmental stage. According Similarly, many NACS members ergonomics programs fit easily into to ORC, some of these programs have (convenience store operators and petroleum existing safety and health programs: not involved employees in the past marketers) incorporate MSD prevention and development, implementation, or ergonomics issues into their general worker The establishment of basic ergonomic evaluation of the program. As drafted in safety programs that cover a wide range of management programs, increasing employee awareness and involvement on these issues the final rule, employee participation in issues, from dealing with slips and falls to these stages of program implementation robbery deterrents to customer safety issues. is not a burden to employers when compared These programs have been extremely to other safety and health compliance is required as appropriate, from this effective in reducing MSD injuries. If not requirements. time forward. In other words, OSHA is grandfathered, implementing OSHA’s In fact, most efficient and effective not requiring employee participation in proposed standard would require upsetting ergonomic initiatives will usually dovetail the past development of a program as a and dramatically changing these already with other existing safety and health condition of the grandfather clause; it is effective programs (Ex. 30–3845). programs (Tr. 11611). requiring employee participation in the Mead Corporation (Ex. 30–2216) made a The final rule in general, and the implementation, evaluation, and future similar comment: grandfather clause in particular, will development of grandfathered programs, however. Responsible employers would be forced to not, in OSHA’s view, require an alter achieving programs and pursue inefficient reallocation of resources. In Alcoa, Inc., recommended that, for measures that we know are not as effective fact, because MSDs are the leading existing capital-intensive industries and as what we are already doing. The resources cause of on-the-job injuries and equipment, OSHA allow employers that are focused on MSD prevention would illnesses, OSHA believes that the final additional time to come into compliance be shifted toward less meaningful activities. rule will ensure that resources will be with the grandfather clause (Ex. 30– A new infusion of MSDs may result at many devoted to areas where significant 3922). They argued that the workplaces that have effectively controlled improvement in injury and illness rates these types of accidents to date because of implementation of permanent controls the shift in emphasis brought on by can be realized. within 2 years, as proposed, was neither compliance demands. OSHA agrees with the American realistic nor economically feasible for Society of Safety Engineers that some employers. The final rule’s Consider: ergonomics programs fit well as part of grandfather clause allows an employer • Many companies utilize periodic risk comprehensive workplace safety and to have a process for identifying, assessments to update priorities for health programs. The final grandfather analyzing, and controlling MSD hazards ergonomics projects. Risk assessments clause does not require employers to in problem jobs and following up to commonly include a survey of the workplace, divorce ergonomics from their existing discussions with employees about potential ensure control effectiveness. Through a concerns, and analysis of MSDs. Priorities are safety and health programs. Thus, prioritization process, an employer may established and incorporated into a work employers who address ergonomics in choose to temporarily implement plan for the site’s ergonomics/safety team. existing effective safety and health interim controls. Although the employer • When ergonomics teams in Mead programs typically will not need to is expected to institute permanent conduct analyses of jobs, they are encouraged reinvent their ergonomics program just controls as soon as possible, the final to identify as many opportunities for to qualify for the grandfather clause. rule does not provide a date when this continuous improvement (potential risk In addition, as noted earlier, the final must be accomplished. Thus, employers factors) as possible and then to prioritize rule accommodates prioritization of the in all industries with qualifying based upon risk. Action plans are developed for high risk concerns. Lower priorities are implementation of permanent controls, programs will be able to prioritize their not addressed at the time unless they are low as Mead Corporation is doing, where the jobs for control in a rational manner that cost. Teams maintain documentation of these employer cannot fix all problem jobs at permits them to take advantage of the items and may revisit them in the future once once. Therefore, OSHA does not believe capital involvement and replacement higher priority items are resolved that the final rule’s grandfather clause schedules of their industries.

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Paragraph (d)—What Information Must Mark Davidson, Risk Manager for and cost with no potential benefit. The I Provide to my Employees? Safeway Stores testified (Tr. 13674, General Electric Company (Ex. 30–1071) Paragraph (d) of the final rule requires 13658) that he adamantly supported felt that an employer proactively employers to provide their employees pre-injury efforts to train and evaluate identifying ergonomic issues would with basic information about five items: people. He stated the fact that Safeway likely unearth complaints of MSD signs (i) Common musculoskeletal had produced a video to educate and symptoms. The American Iron and disorders (MSDs) and their signs and employees on symptoms of soft tissue Steel Institute (AISI) (Ex. 32–206–1) symptoms; injury and had merely shown it to stated: (ii) The importance of reporting MSDs employees across the United States. The provisions in proposed Sections and their signs and symptoms early and Both Akers Logging (Tr. 12325) and 1910.914 and 1910.916 requiring the the consequences of failing to report Swift Company Timber Management employer * * * to inform workers of the them early; (Tr. 12315–16) believed that this signs and symptoms of MSDs and how to information could be incorporated into report them would create an enormous (iii) How to report MSDs and their potential for abuse of the system. The manner signs and symptoms in the workplace; regular safety meetings, and Mr. Swift testified that the cost would be nominal, in which OSHA is expected to enforce those (iv) The kinds of risk factors, jobs and provisions will only exacerbate the problem work activities associated with MSD if anything. (Ex. 32–206–1, pg. 40). In fact, a number of participants urged hazards; and Other participants also expressed (v) A description of the requirements OSHA to go even further and require employers to survey their employees to concern that providing employees with of OSHA’s ergonomics program additional information about MSDs will standard. identify existing signs and symptoms (see, e.g., Exs. 31–113, 31–150, 30–4538, cause workers to misattribute benign This information must be provided to symptoms to serious injury or disease, new employees within 14 days of 31–243, 31–186, 30–2387, 31–156, 31– 125, 31–105, 31–43, 31–23, and Tr. thereby heightening symptoms and hiring, and must be posted distress, or otherwise to make false conspicuously in the workplace. 4732–33). One commenter (Ex. 31–186) said that, as well as promoting the early reports (Exs. 32–241–3–2, 30–3716, 30– Consistent with applicable law, 3000, 30–4843, Tr.16087, Tr. 10445–6). information may be posted or provided detection of MSDs, thereby saving employers money and lost work time, Omni Services Incorporated (Ex. 30– electronically to employees who have 4496–35) believes it would be easy for electronic access. To assist employers in surveys also send the message that the employer cares about employee health employees to report almost any ache or meeting their obligation under this pain as work-related and get paid time paragraph, OSHA has included and safety. The American Association of Occupational Health Nurses (AAOHN) off until they feel better. nonmandatory Appendices A and B, The Painting and Decorating (Ex. 30–2387) also said that MSD which contain all the information Contractors of America (Ex. 30–3716) symptoms surveys should be strongly needed to comply with this paragraph, voiced concern that the information except for the workplace-specific encouraged, if not required. Other commenters argued that the presented to employees about MSD information on reporting MSDs and benefits of this information provision signs and symptoms and the importance their signs and symptoms. should not be limited to jobs involving of reporting them early would not only The proposed rule also would have require employers to develop expertise manufacturing and materials handling required employers to provide in ergonomics-related injuries, but (Ex. 30–3826). Since implementation of employees with information on how to would encourage employees to classify any ergonomics program outside recognize MSDs (and their signs and almost any job-related ache or pain as manufacturing and manual handling symptoms); on the importance of early an MSD. The Plastics Engineering would have been based on the reporting of MSDs; and on how to report Company (Ex. 30–2435) stated that the occurrence of an OSHA-recordable MSDs at their workplace. It also would requirements would encourage MSD, it made little sense, these have required employees to establish a employees to report both real and commenters felt, not to provide reporting system for MSDs. These phoney or exaggerated MSDs. The employees in other jobs with provisions in the proposed rule, American Road and Transportation information on what and how to report: however, would only have applied to Builders Association (Ex. 30–4676) manufacturing and manual handling Employees cannot be expected to report argued that the number of work-related employers. OSHA expected the early if they are not educated on what signs MSD claims, and the number provisions to serve three purposes: to and symptoms of MSDs are and if the employer is not communicating with them determined to be work-related, would facilitate employees’ active participation the importance of reporting early. Also, if significantly increase. See also Exs. in their employers’ ergonomics employees are not aware of, or do not know 500–127, 31–106, 31–344, 32–82–1, 30– programs; to promote early reporting so the mechanism of reporting, than it is surely 3749, 30–3336, 30–3367. The AAOHN that MSDs could be treated most less likely that they will report * * *. This (Ex. 30–2387), however, pointed out effectively; and to assure prompt will be a great disincentive for reporting (Ex. that often, after ergonomic training, identification of MSD hazards so that 32–210–2, pg. 130). employers experience an increase in the incident trigger of the standard See also, e.g., Exs. 500–126, 32–85–3, MSD complaints and should be would work properly. 30–4538, 32–198–4, 30–2387. prepared for this eventuality. As noted There was a great deal of support, in Some commenters, however, objected elsewhere in the Preamble, these are not general, for requiring employers to that employers should not be required ‘‘new’’ MSDs, but instead the expected provide hazard and reporting to provide hazard and reporting earlier reporting of MSDs that are information to employees (see, e.g., Exs. information before an MSD occurred already occurring. 30–2116, 30–3813, 30–3748, 30–3765, (see, e.g., 30–3723, 30–3867, 30–3086, OSHA does not find evidence that 30–3934, 32–339–1, 32–111–4, 32–185– 30–4465, 30–4607, 30–1012). These encouraging early reporting of MSDs 3, 30–3686, 32–461, 32–210–2, 30–3826, commenters argued that providing the promotes abuse. Evidence discussed in 30–3686, 32–182–1, 30–2116, 30–3748, information would be an unjustified other sections of this Preamble indicates 30–4564, 32–198–2, 500–33, 32–21–1, consumption of resources, infrastructure that programs that encourage early 32–450–1, 30–4247 and 32–450–1). Mr. capacity, and support, adding overhead reporting of MSDs, so that employees

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68304 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations can enter an MSD management program, and symptoms. Particularly for a very reporting them early, and the mechanics actually reduce the time employees are small employer, this could be as basic of how to report them and uses a subject to work restrictions. OSHA also as telling them to report them to a program that emphasizes the has analogous requirements in other supervisor or safety official. Larger information envisioned by this standards, for example, the Bloodborne employers may use their existing provision, it does not support providing Pathogens standard (29 CFR 1910.1030) reporting systems (Ex. 30–3826). a summary of the requirements of the and several of its chemical exposure Although OSHA intended this option standard. The Edison Electric Institute standards (Cadmium, 29 CFR also to be available under the proposed (Ex. 32–300–1) also objected to the 1910.1027; 1,3-Butadiene, 29 CFR rule, several commenters interpreted the requirement that supervisors and 1910.1051; Methylene Chloride, 29 CFR proposal as requiring a reporting system employees be trained in the 1910.1052), and has seen no evidence specific to MSD signs and symptoms requirements of the standard. that the provisions are abused. These (Exs. 31–78, 30–240, 30–3723, 30–3765, Some of these commenters (see, e.g., provisions simply require that the 32–77–2, Tr. 5340, 30–3853, 32–337–1, Exs. 30–1336, 30–2836, 30–2940) voiced employer provide basic information to 30–716, 30–2215, 500–127). In light of concern about not knowing how many employees; have a system in place for the revised language in the final pages of information were sufficient to employees to report possible injuries, standard, these comments are now comply with this requirement, while illnesses, and exposures; and evaluate moot. others (see, e.g., Ex. 30–3782–12) felt and respond to these reports. As is Other commenters, however, urged that how to interpret a ‘‘summary of the discussed more fully in connection with OSHA to adopt a more elaborate MSD standard’’ and how to provide this to paragraphs (e) and (f), a report of an reporting system. The American the employee was left to the employer’s MSD does not impose any obligations Federation of Teachers (Ex. 32–326–1) imagination. These concerns are on employers unless the employer urged OSHA to strengthen the reporting addressed by the inclusion of determines that the MSD is work related requirements by stipulating that nonmandatory Appendix B to the and meets the severity criteria, and the employers document a method for standard. job itself meets the levels of the Basic encouraging employees to report. On the other hand, several Screening Tool in Table 1. Morgan, Lewis, and Bockius (Ex. 30– commenters stated that employees OSHA also agrees with the comments 4467) expressed concern that employers should receive even more information discussed above urging that all general would have no sure way of knowing (Exs. 30–4538, 31–242, 32–461–1, 32– industry employees be provided with whether a reporting system would 210–2, 32–182–1, 32–111–4, 32–339–1, this information. It believes the incident satisfy an OSHA compliance officer’s 500–218, Tr. 3481–82, 500–126, 31–280, trigger in the standard can only be fully interpretation of the standard’s Tr. 4542–43). For example, the AFL– effective if all employees have basic requirements. OSHA does not agree that CIO recommended that the hazard information about MSDs and how and more detail is necessary in this information and training requirements why to report them promptly. This provision. be restructured to move some of the means that some general industry The final standard allows employers training requirements up-front and employers, who under the proposal extensive flexibility to tailor reporting stated: would have had no obligations at all systems to the demands of individual until receiving a report of an MSD, will workplaces. Variations among Specifically, we recommend that the Hazard Information and Reporting section now have to provide this information. employers (e.g., size, management require information and awareness initial OSHA emphasizes, however, the structure, number and type of facilities) training on the following: minimal nature of the burden imposed could lead to some types of reporting 1. Common MSD hazards; by this paragraph. All of the systems being more effective than others 2. The signs and symptoms of MSDs and information, except that on how to for different employers. Some may the importance of recognizing and reporting report MSDs and signs and symptoms to choose written reporting systems, while them early; a particular employer, is contained in others may feel that an oral system is a 3. How to report MSDs, signs and Appendices A and B to this standard, ‘‘better fit’’ for their particular situation. symptoms of MSDs, and MSD hazards and OSHA demands only that, whatever the prohibition against discouraging and will also be posted on OSHA’s employee reports; website. Employers need only copy or approach is used, it must be accessible 4. An explanation of this standard, download the information for and carried out in an orderly way that including ways for employees to participate distribution to their employees. This is recognized and understood by the and how to get a copy of the standard; responds to a number of comments involved parties. 5. An explanation of MSD management, asking OSHA to provide materials to A few commenters questioned the including temporary work restrictions and assist employers in providing requirement to provide employees with work restriction protection; and information to employees (see, e.g., Exs. a summary of the standard (see, e.g., 6. The principles for controlling common 30–429, 30–4492, 30–2987, 30–3232, Exs. 30–3765, 30–1336, 30–3782–12, MSD hazards. (Ex. 32–339–1, pgs. 32–33) 30–3853, 32–337–1, 32–210–2, 32–461– 30–2836, 30–2940, 30–240). The G. Other commenters suggested that 1, 32–461–1, 30–3826, 30–4538, 30– Leblanc Corporation (Ex. 30–4837) additional topics such as employee 3686, 30–2387). stated that, with the exception of this rights to job protection, right to report The requirement that employees be item, the information to be provided to reporting procedures, symptom given information on how to report employees would be very helpful in reporting procedures and training be MSDs and their signs and symptoms is making the reporting/response system included (see, e.g., Exs. 32–461–1, 30– also necessary to ensure the successful. It also felt that inclusion of 4538, 30–3686, 32–198–4, 32–198–4–1, effectiveness of the standard’s exposure the summary resulted in additional cost 32–198–4–13) trigger. This requirement is even more and expertise necessary for providing OSHA has considered these basic than that contained in the the information. The Dow Chemical comments and incorporated some of the proposed rule. It does not require Company (Ex. 30–3765) also suggestions. Other topics are addressed employers to set up any particular commented that, while it supports in the context of ergonomics program reporting system, only that employees telling employees about MSD hazards, training under paragraph (t). The know how to report their MSDs or signs signs and symptoms, the importance of information requirement in this

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68305 paragraph (d), however, is intended to sheet when they are beginning to likely to result in the MSD, and those provide employees with the minimum develop an MSD. activities were either a ‘‘core element’’ amount of information they need to In conclusion, OSHA has considered of the job or accounted for a ‘‘significant perform their function under the all of the comments and testimony amount’’ of the employee’s worktime. In standard: recognizing and reporting received on the proposed provisions manufacturing and manual handling MSDs and their signs and symptoms, requiring employers to provide hazard jobs, an OSHA-recordable MSD was not and doing so as early as possible. information and reporting. It has necessary if an employee reported Employers are free to provide additional decided to retain the requirement that persistent symptoms and the employer information (e.g., explaining their employers covered by the final rule to had knowledge of problems in the job. particular ergonomics program), but provide minimal information to OSHA received a large number of OSHA does not believe that more employees before an MSD incident comments about the proposal’s detailed information is necessary before occurs. OSHA believes the final rule triggering mechanism. These comments any MSD hazards have been found. As provision is adequate without requiring fell into several categories. Many parties previously discussed, the Agency has additional measures such as surveying objected that the single MSD incident attached an information sheet for the employees to identify signs and trigger included in the proposal was employer to use in providing the symptoms of MSDs. either too sensitive or not protective required information. Paragraph (e)—When Must I Take enough. Others objected to the use of an Finally, the issue of the posting of this Further Action? OSHA-recordable MSD, often pointing information was also raised by several out that OSHA has proposed to amend commenters (see, e.g., Exs. 31–70, 31– A. Introduction its recordkeeping regulation, and that 342, 30–240, 30–1726, 30–1104, Tr. The final rule incorporates a two-stage those amendments could also affect this 10586). One commenter (Ex. 31–70) action trigger. It requires further action ergonomic standard. In addition, stated that the final standard should when (1) an employee experiences a commenters complained that the require mandatory posting of work-related MSD involving either one proposed standard’s screening criteria information for employees. Similarly, or more days away from work, one or would be extremely difficult to apply in another commenter (Ex. 31–342) more days of limitations on the work practice, pointing in particular to the commented that there should be a activities of the employee, medical terms ‘‘core element,’’ ‘‘substantial part requirement to either post a notice that treatment beyond first aid, or 7 days of of the workday,’’ and ‘‘reasonably likely employees should report possible MSDs persistent MSD signs or symptoms (2) in to result in the MSD.’’ promptly or inform employees in a job with exposures to risk factors that As explained below, OSHA has made another effective manner. The National meet the Basic Screening Tool in Table a number of changes in response to Association of Orthopaedic Nurses (Ex. 1. Unless both stages of this action these comments. The triggering 30–1104, Tr. 10586) supported a readily trigger are reached, the standard does mechanism in the final rule has more identifiable posting of MSD signs and not require employers to take any action precisely defined elements, and OSHA symptoms, who to report to, and how to beyond providing the information in believes it should be much easier to report. In addition, the University of paragraph (d) to their employees. apply. Wisconsin Extension (Ex. 30–1726) The action trigger in this standard A job meets the action trigger in the urged OSHA to develop ‘‘more serves a purpose analogous to that final standard based on two criteria. The boilerplate’’ on a policy that encourages served by action levels in OSHA first is what has been called the ‘‘single- reporting and to require that this policy standards regulating exposures to air incident trigger.’’ Under this criterion, be posted in the workplace. On the contaminants. Those standards an employee working in the job must other hand, August Mack generally require that airborne levels of have incurred either a work-related Environmental (Ex. 30–240) argued that the contaminant be kept below a MSD severe enough to result in a work posting was redundant, unnecessary permissible exposure level (PEL). At a restriction, medical treatment beyond and posed a problem due to often much lower level, however, employers first aid, or MSD signs or symptoms limited space available for postings. It are required to take actions such as lasting at least 7 consecutive days after felt that the currently required OSHA conducting air monitoring and being reported to the employer. A work poster already contains information on providing training and medical restriction is defined in the standard as how to get additional information about surveillance to exposed employees, one or more days away from work, one OSHA standards. although they do not actually need to or more days of limitations on the work Paragraph (d)(2) of the final standard implement controls to reduce exposures activities of the employee’s current job, requires that the information provided to the regulated substance. Similarly, in or one or more days of temporary to employees must also be posted in a this standard, once a job meets the transfer to alternative duty (see conspicuous place. In addition to an action trigger, the employer must paragraph (z)). Under the final rule, an employee bulletin board, such places implement an ergonomics program that MSD meeting this description is an may be the employee locker room, includes job hazard analysis, training, ‘‘MSD incident.’’ The employer’s first lunch room, or near the time clock. and MSD management (for the injured duty, after receiving a report of an MSD Electronic posting is also permissible employee), although it may not actually or MSD signs or symptoms, is to where all employees have access. While be necessary to control or reduce the determine whether the report the Agency realizes that these options MSD hazard. constitutes an MSD incident. are not available in all facilities, most This concept is similar to the The second step of the action trigger, employers have some area, recognized approach OSHA took in the proposed which must only be addressed after an by employees, where the employer posts rule. In the proposal, an employer was MSD incident occurs, is based on the company announcements and required to take further action if an employee’s exposures to ergonomic risk information. OSHA believes the posting OSHA-recordable MSD occurred in a job factors. If the employee is exposed to requirement is necessary because many meeting certain ‘‘screening criteria,’’ i.e., one or more of the risk factors described employees may not have immediate the job involved physical work activities in the Basic Screening Tool in Table 1 access to their original information and conditions that were reasonably for longer than the time listed for that

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Under the See also (Tr. 9115–16). incident trigger is a reasonable proxy for proposal, employers of workers engaged an increased risk of exposure to MSD OSHA has carefully considered these hazards. For example, some employers in manufacturing and manual handling comments. In response, it has added a would have been required to implement with successful ergonomics or safety proactive element to the definition of an and health programs use reports of MSD some elements of an ergonomics MSD incident. MSD signs and program standard soon after the symptoms or symptom surveys to symptoms that last for 7 consecutive identify jobs posing MSD hazards (Ex. standard took effect, whether or not days since first reported to the employer MSDs had occurred in their jobs. Once 37–2, Tr. 5503, 5358; Tr. 14707, 14723– are considered MSD incidents under 26). Dr. Frederick Gerr, Associate a ‘‘covered MSD’’ meeting the screening this standard. Several health care criteria occurred, those employers Professor of Environmental and professionals testified that, in most Occupational Health at the Rollins would have been required to adopt a cases, MSD signs and symptoms are full ergonomics program. Other School of Public Health at Emory completely reversible when they are University, testified: employers would not be required to take caught at such an early stage (see, e.g., any action before a ‘‘covered MSD’’ Exs. 37–1; 37–2, pp. 14–15; 37–12, p. 5; The use of reported cases of illness, such meeting the screening criteria occurred, 37–16, p. 8; 37–17, p. 4; Tr. 7687–88, as MSDs, to trigger investigation into but once that happened, they also were potentially excessive exposure to known 9884, 13397–98, 13410). Thus, OSHA MSD hazards is a well-established method of required to adopt the full program. In has concluded that its incident-based this final rule, OSHA has clarified that protecting others with similar exposures (Ex. approach can prevent employees from 37–2, p. 15). the only action explicitly triggered by an experiencing permanent damage or Many employers also use MSD reports MSD incident is to apply the Table 1 disability, while at the same time as a way to prioritize their control screen. OSHA finds that the record minimizing burdens for employers who activities (Tr. 10631, 14723, 14746). supports using an MSD incident for this have few or no ergonomics problems Sean Cady, of Levis Strauss & Co., purpose. (Ex. 16969–70). A number of participants objected to Where employers have provided their testified: the proposal’s incident trigger on the employees with appropriate information If we have repetitive motion injuries or basis that it was reactive and appeared to allow the employees to recognize musculoskeletal disorders on various jobs inconsistent with OSHA’s mission ‘‘to MSDs and MSD signs and symptoms, that occur at the same time how do we prevent the first injury’’ (Ex. 500–218, and have also instituted good reporting prioritize which jobs we select for job Tr. 9071, 9156, 12277, 12477). A modification, because we don’t have systems, and employees still are not unlimited resources in the company. So what number of labor organizations favored a reporting MSDs, a full ergonomics proactive approach because, according we do is we review many factors of that job program may not be necessary. OSHA and we qualitatively prioritize jobs. And we to the International Chemical Workers’ agrees with commenters who said that review things like the number of symptoms Union, ‘‘[w]aiting for a covered MSD or a purely hazard-based approach, which reported on a job, possibly the number of persistent MSD symptoms to arise, would require all employers to analyze injuries, or the severity of injuries on a job versus evaluation and prevention, is a all jobs, regardless of whether those jobs (Tr. 14723–24). lose-lose proposition’’ (Ex. 32–198–4, have ever caused an MSD, might result OSHA has made clear throughout this 32–461–1, 500–137; see also Ex. 500– in an inefficient use of resources (Exs. rulemaking that a portion of its intent is 218, Tr. 12365, 17543). The Farm 500–1–329, 500–75, Tr. 3095). to require more employers to implement Workers Justice Fund urged OSHA to This is particularly true because the the kinds of effective programs that are adopt a hazard-based approach because vast majority of employers will not have already in place in many industries (64 in many workplaces employees an MSD incident reported in their FR 65770). Incorporating an approach experience a great deal of pressure not workplace during any given year (Exs. already in wide use is consistent with to report injuries (Tr. 17515). 30–542, 30–3167, 500–1–128, Tr. 2980, this purpose, and will reduce employer Some employers and representatives 3073, 3096). One report prepared for the burden while increasing compliance of employers also supported a hazard- Small Business Administration’s Office with the standard. based rather than an incident-based rule of Advocacy estimated that as many as Other commenters were concerned (Ex. 30–1294, DC67, Tr. 9070–74, 12277, 75 percent of manufacturers employing that OSHA’s use of an incident trigger 13633, 10631, 10636). Mark Davidson, fewer than 11 employees are not likely would doom those preexisting programs of the Oregon Self Insurance to experience any MSD incident for up that involve what these participants Association, preferred a proactive to six years. (Ex. 30–542). (See also Ex. view as a more proactive method of approach because: 500–67; Final Economic Analysis, identifying ergonomic hazards (Ex. 500– If the goal is to cut down on the occurrence chapters II and IV). The testimony of a 1–452, Tr. 9070–74, 10630–32). But of MSD complaints, shouldn’t the regulatory number of hearing participants nothing in this rule prohibits employers effort [focus on] preventing the occurrence representing small businesses confirmed from taking action, analyzing jobs or rather than punish it (Tr. 13633). this (Exs. 30–3167, 500–1–128). They setting up an ergonomics program Anthony Barsotti, of Hoffman told OSHA that they had never had a before MSD incidents are reported. And Construction Company, said that an report of an MSD in their workplace (Tr. the grandfather clause in paragraph (c) incident-based approach was ‘‘heading 2980), did not have MSDs every year, or of this standard specifically allows backwards in terms of prevention’’ had only isolated or few occurrences qualifying employers to continue their versus reaction: (Tr. 3073, 3096). Small employers preexisting programs. Based on the [H]aving the standard be triggered by the comprise 75 percent of all private record, OSHA expects that many injuries seems inconsistent with where we industry establishments (Final employers who have established

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As such, an be permanently disabled (Ex. 38–285). participants complained that the single- employer could be required to institute costly For example, if carpal tunnel syndrome incident trigger in the proposal was too job analysis and corrective actions as a result and other nerve-related MSDs go sensitive (Exs. 30–2208, 31–324, 500–1– of a single injury illness to an overly untreated long enough, damage to the 27, 500–1–28, 500–1–45, 500–1–128, susceptible employee while all other nerves will be irreversible (Ex. 37–17, 500–52, 500–75, Tr. 5506–07). For employees in the same operation or job Tr. 13349 (the nerve dies)). If OSHA location has no discernable adverse reaction. instance, the Association of included a multiple-incident trigger, the Independent Corrugated Converters said Considering this hair trigger and that the Agency has only offered general remediation first employee to be injured could that the ‘‘one-incident threshold makes measures in the proposed rule, small become permanently disabled while full coverage a virtual certainty for business will surely face burdensome waiting for other MSDs to trigger the virtually every sizable employer, and for compliance responsibilities and stressful employer’s obligations to provide MSD the vast majority of small employers’’ decisions including where to best place their management and ergonomic (Ex. 500–1–128, Tr. 16930–31). The limited resources (Tr. 5645). intervention. This would be particularly National Tooling and Machining These commenters urged the Agency likely in small businesses and in Association also said that a single MSD to adopt a MSD trigger having a higher workplaces where relatively few people incident was too low a threshold: threshold. A number of commenters perform the same job (Ex. 32–450–1). In On its own, a single reported MSD might urged OSHA to increase the trigger to addition, not acting on the first MSD not be statistically significant to warrant the two or more MSDs (Ex. 30–3731–1, 500– may discourage other employees from corrective measures required by the proposed 2, 601–X–1). Other commenters said reporting their MSD signs and regulation. NTMA contends that a trigger symptoms (Ex. 32–450–1). mechanism of at least two MSDs should be that incidence rates should be used to trigger action (Exs. 30–3845, 30–3853, The use of a single MSD trigger is also the minimum threshold for the full program, consistent with employer practice. especially for small businesses (Ex. 500–2). 30–4137, 32–77–2, 500–1–128, Tr. 5370, 8842). Several commenters Many employers testified that they Jack Pohlman, of the American recommended that the trigger be a respond to all employee reports of Foundryman’s Society, added that a ‘‘pattern’’ or ‘‘cluster’’ of MSDs or MSD injury or illness, including MSDs (Ex. report of one MSD ‘‘is simply not reports (Ex. 32–330–1, 500–23–1, 500– 37–2, Tr. 5358, 5359–60, 5503, 5539, indicative of systematic problems’’ (Tr. 92). Paul Adams, director of ergonomics 14707, 14739, 17312–13). Even 5636). Marathon Ashland Petroleum at Owens-Corning, suggested that OSHA employers who recommended that agreed, saying that a single incident ‘‘is should adopt a set of alternative triggers OSHA adopt a multiple-incident trigger not reflective of the true nature of risk from which employers could choose (Tr. testified that they themselves conduct that exists in a given facility’’ (Tr. 5540). 10630, 10633). investigations of every report of injury, And the National Paint and Coating OSHA believes many of these including MSD signs and symptoms (Tr. Association complained that a one MSD concerns resulted from a 2920, 5503, 5358). For example, James trigger was biased against large misunderstanding of the screening Lancour, safety and health regulatory employers (Ex. 30–4340). consultant with Southern Company A number of commenters said that a criteria in the proposal. However, the Agency also recognizes the validity of Services, testifying on behalf of Edison one MSD trigger also would unduly Electric Institute, said: burden employers by requiring them to the concerns that those screening respond to ‘‘every ache and pain’’ an criteria were not clear enough to [We] have a reporting mechanism where employee reports (Exs. 30–4340, 500–1– provide adequate assistance to signs and symptoms are reported. Then we have, it’s turned over to the industrial 18 (‘‘a single complaint of pain’’), 500– employers trying to screen out non- work-related MSDs (Exs. 30–1722, 30– hygiene group to go out and do a job 1–385, 500–1–386, Tr. 8772 (‘‘perceived assessment. And, again, depending upon minor problems’’), 12256). The National 3956, 500–18, Tr. 8847, 16969–70). OSHA has addressed these concerns what they find out it may be something that Telecommunications Safety Panel can be unique to that particular person or testified: through the new definition of ‘‘MSD workstation, et cetera, or it may require more incident’’ in paragraph (e)(1) and the in-depth analysis. So basically depending Extremely minor conditions with little or Basic Screening Tool in Table 1. The upon the job they take a look at what they’re no connection to the workplace may trigger result is a single-incident trigger that is trying to determine how simple or complex the standard in many facilities (Tr. 8774). only half of the standard’s action trigger the problem might be, and then go through Several commenters said that the one and does not, by itself, require and develop an assessment protocol based on MSD trigger ignores that ‘‘unique employers to implement a full that operation (Tr. 2920). physical characteristics’’ or ergonomics program or impose other When questioned, no employer testified ‘‘predisposing medical conditions’’ of substantial obligations on them. that it was company policy to wait until the worker may be involved (Exs. 30– A single-MSD trigger is appropriate a second or third employee gets hurt in 328, 30–1651, 30–2208, Tr. 5560–61). for this purpose. Most important, a one a job before investigating the first injury. James Haney, of Wisconsin MSD trigger is necessary to prevent the This suggests that employers Manufacturers & Commerce, said: occurrence of serious and disabling understand the importance of Thus, the most injury- or illness-prone MSDs. There is abundant record responding to each report of injury and, employee becomes the benchmark for evidence that early detection and in practice, do not consider it implementing the proposed standard’s intervention can halt the progression of appropriate to ignore individual reports requirements (Ex. 500–1–27). most MSDs, and reduce their severity of injury. Finally, some commenters argued that (Tr. 7687–88, Ex. 32–450–1). On the Other evidence in the record also imposing a one MSD trigger would be other hand, where medical treatment shows that a one MSD trigger should not

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68308 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations impose an undue burden on employers. where the employer has reason to potential problems that could be caused As discussed above, most small believe that only the injured employee by linking an employer’s obligations manufacturing establishments do not is exposed to awkward postures because under this standard to obligations and experience any injuries or illnesses in he or she is very tall or very short, the interpretations contained in a separate any given year (Exs. 30–542, 30–3167, employer can limit the response to that rule (Exs. 30–3853, 30–4137, 32–77–2, 500–1–128, Tr. 2980, 3073, 3096). In individual employee’s job or Tr. 10632). This problem was fact, many establishments do not workstation. See paragraph (j), below. highlighted by the facts that OSHA has proposed to amend its recordkeeping experience any injuries or illnesses over 3. Definition of ‘‘MSD Incident’’ a considerable period. According to a rule, so that it has not been clear at any report prepared for the Small Business In this standard, the term ‘‘MSD stage of this ergonomics rulemaking Administration Office of Advocacy, 75 incident’’ means either an MSD that is what the definition of an OSHA- work-related and: recordable MSD would be, and that percent of manufacturing • Involves a work restriction, or OSHA incorrectly described the establishments with fewer than 11 • employees, 50 percent with 11–50 Requires medical treatment beyond recordability of one class of MSDs in the first aid, or employees, and 25 percent of those with proposal (Exs. 30–3853, 32–78–1, 32– • Involves MSD signs or symptoms 50–249 employees would experience 300–1). Moreover, according to that are work-related and persist for 7 or almost no MSD incidents in any given commenters, linking the definition of more consecutive days after the MSD incident to the recordkeeping 6-year period. (See also Economic employee reports them to the employer. Analysis, chapters III and IV.) If this regulations would give employers a standard were to adopt a multiple MSD Work restriction is defined to mean strong incentive to underreport MSDs or one or more days away from work, one requirement, particularly one requiring would punish employers who already or more days of limitations on the work at least two MSDs in the same job have effective early intervention activities of the employee’s current job during a single year, injured employees programs (Exs. 30–46, 30–75, 30–137, or temporary transfer to alternative in many establishments might never be 30–1294, 30–1902, 30–4137, Tr. 8848, duty. Reducing an employee’s work provided with needed medical 10630–32). requirements in a new job to reduce intervention or protection from OSHA agrees that these concerns, muscle soreness from the use of muscle additional injuries because it would particularly those related to the ongoing in an unfamiliar way is not considered take so long for the triggering event to recordkeeping rulemaking, outweigh a work restriction under this final rule. occur. any potential benefit employers would Also, the day an employee first reports The changes in the definition of gain from being able to use recordability an MSD is not considered a day away ‘‘MSD incident,’’ and the new Basic criteria to determine whether an MSD from work or a work restriction even if Screening Tool, both discussed below, report triggers further action under this the employee is temporarily removed will also help to address the concerns of standard. Therefore, in this final from work to recover. some commenters that significant standard, OSHA has dropped any Relationship to Recordkeeping Rule. reference to the recordkeeping rule’s employer action will be triggered by the The proposed rule defined a ‘‘covered report of ‘‘any ache or pain,’’ whether or recordability criteria. Although the MSD’’ as an OSHA recordable MSD that definition of an MSD incident in this not it is work related (Exs. 30–1722, 30– occurred in a job in which the physical 2208, 30–3956, 500–52). P.J. Edington, standard uses criteria similar to those work activities and conditions were used in determining recordability, each executive director of the Center for reasonably likely to cause or contribute Office Technology, said: of the criteria used in this rule is to that type of MSD, and those activities supported by evidence in this OSHA assumes any discomfort on the job and conditions were a core element or rulemaking record. This has also is work-related. That leaves all employers in took up a significant amount of the allowed OSHA to tailor the definition of a continuous and costly cycle of trying to employee’s worktime. In this final rule an MSD incident so that it more closely eliminate all ‘‘signs and symptoms’’ of MSDs OSHA has changed the term ‘‘covered (Ex. 30–2208). corresponds with the purposes of this MSD’’ to ‘‘MSD incident’’ to dispel any standard. But employers have the right under implication that any such MSD Definition of ‘‘musculoskeletal this final rule to make reasonable immediately triggers a full ergonomics disorder.’’ For purposes of this rule, an determinations that particular MSDs are program. Although some participants MSD is a disorder of the soft tissues, not work related. And only MSDs severe found the definition of covered MSD to specifically of the muscles, nerves, enough to require medical treatment or be ‘‘relatively clear’’ (Exs. 30–3934, 30– tendons, ligaments, joints, cartilage, a job restriction, or signs and symptoms 4837; 31–173, 31–186, 31–205, 31–229, blood vessels and spinal discs that is persistent enough to last for seven 31–347), many more objected that it not caused by a slip, trip, fall, or motor consecutive days, have any triggering covered too many MSDs, was too vague, vehicle accident. See paragraph (z). This effect. Moreover, the standard’s Basic or was improperly linked to OSHA’s standard covers MSDs affecting the Screening Tool establishes specific recordkeeping rule (Exs. 30–1364, 30– neck, shoulder, elbow, forearm, wrist, thresholds for the duration, magnitude 1722, 30–2088, 30–3167, 30–3845, 30– hand, back, knee, ankle, and foot as well and frequency of exposure to risk factors 3956, 500–73, 500–104, 32–337–1, Tr. as abdominal hernias. It does not, that a job must involve in order for an 4366, 8226, 10000, 12797, 15977). The however, cover eye disorders, even MSD incident in that job to be one that new definitions of MSD and Action when associated with jobs involving triggers the standard’s program Trigger in this standard address these computer monitors. requirements. concerns. Although some commenters The final rule also takes into account OSHA received a great deal of recommended that the standard address the concerns of commenters that a comment on the proposal’s use of an conditions resulting from slips, trips, single incident trigger ignores the fact OSHA-recordable MSD, i.e., an MSD and falls (Ex. DC 58, DC 405), those that an MSD may be related to the required by 29 CFR Part 1904 to be injuries are not caused by exposure to ‘‘unique physical characteristics’’ of the recorded on the employer’s injury/ the risk factors this standard covers. For worker (Exs. 30–328, 30–1651, 30–2208, illness log, as a trigger for further action. the same reason the final rule does not 500–1–27, Tr. 5660–61). For example, Many of these comments pointed out cover computer-related eyestrain, which

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68309 is caused by factors such as glare from OSHA also has responded to concerns when the injured employee either must lights and windows, computer flicker that, once an employee has an MSD, take off the entire work day for and other monitor resolution problems, minor aggravations of the MSD can recuperation or medical treatment, or is and by not blinking or looking away occur very easily (Tr. 3315). In the final able to work for only a portion of the from the screen (Tr. 16159–66). rule, only ‘‘significant’’ aggravation of a workday or to perform only some job ‘‘Work-related.’’ In paragraph (z), pre-existing MSD is considered to be an functions, either regular or alternative ‘‘work-related,’’ is defined to mean that MSD incident. ‘‘Significant aggravation’’ tasks, during the recovery period. The a workplace exposure caused or occurs only when risk factor exposures latter category includes job transfer, contributed to an MSD incident or in the workplace aggravate a pre- light duty jobs, and alternative duty significantly aggravated a pre-existing existing MSD to the extent that it results jobs. Employees who cannot work MSD. This is a change from the in an outcome that it would not regularly scheduled or mandatory proposal, which would have considered otherwise have caused. For example, overtime during the recovery period are an MSD work-related if physical work workplace exposure is considered to also considered to be on work activities and conditions caused or have significantly aggravated an restriction. Neither the initial day on contributed to an MSD or aggravated a employee’s pre-existing MSD if the MSD which the MSD is reported or occurred, pre-existing one. Many commenters would have resolved on its own or with nor any day on which the employee is complained that the proposed definition only first aid, but because of the not scheduled to work, is counted as a of work-related, in essence, established employee’s exposure to identified risk day of work restriction. a presumption of work-relatedness (Exs. factors in the workplace, the MSD has On the other hand, the standard now 30–1722, 30–3934, 30–3956, DC65, 500– progressed to the extent that medical makes clear that work restrictions do 1–28). The Chamber of Commerce said treatment is now necessary. On the not include situations where an that the rule should not cover ‘‘minimal other hand, if an employee experiences employer adjusts the work assignments workplace exposure that merely more pain when at work, simply to deal with the temporary muscle aggravates non-work exposures’’ (Ex. because the employee is using an soreness that an employee may 30–1722, p. 62). Mike Edmunds, injured body part, that extra pain does experience as a result of starting a job corporate safety director for Tyson not constitute significant aggravation. In that requires the use of muscles in an Foods, said: addition, workplace exposure aggravates unfamiliar way (paragraph (z)). The Even if upper extremity musculoskeletal an MSD only where a specific physical record indicates that some employers pain (e.g., wrist pain) arises solely as a result work activity or condition can be have ‘‘conditioning’’ programs, most of non-work-related activities, it is virtually identified as a factor in the progression often lasting about two weeks, to help impossible for an employer or physician to of the pre-existing MSD. employees adjust to this type of new job establish that subsequent work activities did Although the employer is ultimately assignment (64 FR 65955 (Case Study not in some minor way ‘aggravate’ or responsible for determining whether an No. 2), (Exs. 26–1175, 30–4340, Tr. ‘contribute’ in some way to the condition— MSD is work-related, employers may 9225, 9403, 13589). These programs regardless of the job (Ex. 30–4137). consult with others, such as HCPs or recognize that it is not uncommon for To address this concern, a number of safety and health personnel at the employees to experience pain or commenters recommended workplace, in making that stiffness when they begin exercising incorporating language from various determination. Where an employer uses muscle groups in new or more State workers’ compensation regulations an HCP to provide assistance in strenuous ways (Exs. 26–1175, 30– so that an MSD would be considered determining the work-relatedness of an 4340). In these situations, pain or work-related only where work was the MSD, the HCP must use the definition soreness may not indicate the presence predominant cause of the injury or was of work-related in this final rule and not of an MSD hazard. In most cases these more than 50 percent responsible for the criteria for determining work- symptoms resolve as the employee injury (Exs. 30–3934, 32–77–2, Tr. relatedness under workers’ becomes accustomed to the physical 5507). Others recommended that OSHA compensation. activities of the job (Ex. 26–1175). They adopt the definition of work-relatedness Another frequent objection to the do not indicate that a hazard needing to from California’s ergonomics standard, proposed definition was that it did not be controlled may exist. OSHA believes i.e., that work must be 51 percent establish an adequate severity threshold that this clarification will help alleviate responsible for the MSD (Ex. 32–300–1). and, as a result, would have captured all the concerns of some commenters that Several suggested that the MSD incident the ‘‘aches and pains of life’’ that the single-incident trigger would not not include pre-existing MSDs (Tr. employees experience while performing only trigger coverage of passing aches 3097–98). work activities (Ex. 30–3956, see also and pains, but could also trigger WRP OSHA believes that some of these Exs. 30–1722, 30–2208, Tr. 9824). The obligations for employees who concerns resulted from a Chamber of Commerce said that MSD experience symptoms while they are misunderstanding about what was ‘‘so loosely defined as to cover becoming accustomed to a new job (Ex. ‘‘contribute to’’ means. It does not mean unverified complaints of pain rather 30–4340, Tr. 4316–17). that an MSD is considered to be work- than just objectively verifiable medical Medical conditions that result in work related if work contributes in some de conditions’’ (Ex. 30–1722, p. 61). The restrictions are widely recognized as minimis (e.g., ‘‘1% contribution’’ (Ex. severity criteria in the final rule address serious (Exs. 26–1039, 37–1, 37–12, 37– 30–3934)) or vague way. Rather, work this complaint. In deciding to include 28). Repeatedly, physicians and other contributes to an MSD if a specific within its definition only those MSDs HCPs testified that they consider MSDs physical work activity or condition can resulting in a work restriction, in that rise to this level to warrant both be identified as having contributed in medical treatment beyond first aid, and medical evaluation and intervention some discernable way to the onset of the in MSD signs or symptoms lasting at and job interventions (Exs. 37–1, 37–12, MSD or the signs or symptoms of an least 7 days after being reported to the 37–28). Accepted standards of clinical MSD. If nothing specific can be employer, OSHA is adopting practice, reflected in guidelines identified as a factor, then work is not appropriate medical severity thresholds. published by medical associations, also considered to have contributed to the Work restriction. A work restriction in recommend intervention at least at this MSD. this context means at least one full day stage (Exs. 37–12, 500–34, 26–1039). For

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Dr. Bradley Evanoff, treating low back problems) defined low as redness, may be mild and transitory, Assistant Professor of Medicine at back problems as ‘‘activity intolerance not warranting a full program response Washington University School of due to low back symptoms,’’ such as (Exs. 30–3344, 30–3749, 30–4674, 32– Medicine specializing in research and pain (Ex. 26–1039, p. 1). 211). clinical practice addressing The insurance industry also considers ‘‘MSD symptoms,’’ as defined in occupational MSDs, testified: conditions that are severe enough to paragraph (z), are other physical I think whatever the occupation, whatever require work restrictions to constitute indications that an employee may be the type of work, if someone has had medical disability (Exs. 37–1, 37–6, 37– developing an MSD. Symptoms include persistent musculoskeletal symptoms for 12, 37–28). These conditions are often pain, numbness, tingling, burning, some period [of] time, and I think a week is compensable through workers’ cramping, and stiffness. The proposed a reasonable period of time, then they should compensation, and insurance rule would only have addressed be evaluated to see if they have a companies consider them to be serious persistent symptoms in manufacturing musculoskeletal disorder (Tr. 1531). (Ex. 37–6). According to Stover Snook, and manual handling jobs, and then Dr. Robin Herbert, medical director of former director of the Ergonomics only if the employer knew that an MSD the Mount Sinai Center for Laboratories at Liberty Mutual hazard existed in the injured employee’s Occupational and Environmental Insurance Company who conducted job. Medicine, testified that providing early ergonomics research at the company for A number of commenters opposed the intervention for employees whose more than 30 years, the accepted proposal’s inclusion of persistent symptoms persist beyond a few days is definition of ‘‘low back disability’’ in symptoms in its trigger mechanism (Exs. ‘‘consistent with accepted medical the insurance industry is ‘‘lost time or 30–623, 30–898, 30–1722, 30–4777, 30– practice’’ (Tr. 1653). In fact, according to restricted duty that results from low 4821, 32–78, Tr. 10634). Some ACOEM, such intervention is back pain’’ (Ex. 37–6, p. 3). recommended at least limiting the types ‘‘essential’’ (Ex. 30–4468). Dr. Robert Medical treatment beyond first aid. of symptoms included in the definition Harrison, who has treated more than The definition of MSD incident includes of an MSD incident (Ex. 32–78, Tr. 1,000 patients with work-related MSDs MSD signs and symptoms that require 10634). For example, ORC said: over the past 20 years, and has also medical treatment beyond first aid. This conducted research in the area of work- is a familiar concept that is also used in At a minimum, * * * OSHA must limit related MSDs, testified that there is OSHA’s recordkeeping regulation. It coverage to those symptoms that can be ‘‘broad consensus among the medical also makes no difference whether an medically verified and that fall somewhere in the severity range between minor/transient profession that effective treatment and employee obtains medical treatment and severe enough to interfere materially prevention of MSDs relies on early from his or her own HCP or one selected with job performance (Ex. 32–78, p. 17). by the employer; or whether the reporting of symptoms. * * *’’ (Ex. 37– employee obtains medical treatment Other commenters, however, agreed 12). He also summed up why 7 days is before or after reporting the MSD signs with the inclusion of persistent an appropriate threshold: or symptoms to the employer. symptoms in the incident trigger (Ex. [S]even days is early enough to catch the Physicians and other HCPs testified that 500–218, Tr. 12295), and virtually all of symptoms early but is late enough so that MSDs that require medical treatment those urged OSHA to extend this transient symptoms that may last only two or such as physical therapy, prescription criterion to all jobs, not just those in three days don’t come through as a reportable medication or surgery are more serious manufacturing and manual handling symptom to a health care provider. I think it’s a reasonable line (Tr. 1764). than conditions where resting the (Exs. 32–198, 500–218). A number of injured body area is enough to allow the HCPs were among those supporting, The record shows that where signs injury to heal (Exs. 37–1, 37–12, 37–16, including persistent signs and and symptoms persist beyond a few 37–17, 37–28). symptoms in the MSD incident trigger days, they are likely to indicate that an Persistent MSD signs or symptoms. (Exs. 37–1, 37–12, 37–28, Tr. 7660, MSD has occurred. Dr. Gary Franklin The third type of MSD incident is MSD 13349). They said that persistent signs confirmed that MSDs can develop in a signs or symptoms that persist for at and symptoms should be evaluated very short period of time: least 7 days after being reported to the because, left untreated, they often If I was taking the history of the person and employer. ‘‘MSD signs’’ are defined in progress into more serious disorders and getting these kinds of symptoms of numbness paragraph (z) as objective physical permanent damage (Tr. 7660, 7884, see and tingling and burning particularly at findings that an employee may be also Ex. 32–450–1). One study has night, it would not matter to me whether it developing an MSD. MSD signs include shown that employees experiencing was two days or seven days or 14 days, if I deformity, decreased grip strength or MSD symptoms alone are at thought clinically the symptoms were range of motion, and loss of function. approximately 2 to 4 times the risk of correct. I have seen patients that developed Some signs are readily observable, for being off work as employees without [carpal tunnel syndrome] in a day or two (Tr. instance, loss of function when an such symptoms (Ex. 500–71–27). A 13382). employee with carpal tunnel syndrome number of employers now encourage HCPs also testified that employees who cannot hold a powered hand tool employees to report signs and have had MSD signs or symptoms for because of muscle atrophy in the hand. symptoms to prevent such results and only a short period of time can already Other signs, commenters said, may not related costs (Tr. 5539, 5550, 14707, be experiencing physiologic changes or be as observable to non-HCPs (Tr. 7677). 14739). damage (Ex. 37–16). For instance, Dr. For this and other reasons, MSD signs The record establishes clearly that Evanoff testified: are treated in the same way as MSD MSD signs and symptoms that persist I think people who have prolonged symptoms in the final rule. Under the uninterrupted warrant further symptoms, lasting more than a few days proposed rule, any MSD sign would investigation (Ex. 30–4468, 500–71–27, * * * if you want to use the cut off of a week

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Dr. Harrison said: have come earlier (Tr. 7649–50). could create a pathoanatomic injury causing Employees often rapidly and completely disruption, and [tissue] failure (Tr. 2797–98). Dr. Harrison discussed the case of one recover from their MSD with simple worker who did not receive early modification of the work process or change In addition, persistent signs and intervention: symptoms can themselves be severe of job duties to minimize or reduce exposure enough to interfere significantly with to ergonomic risk factors (Ex. 37–12, p. 5). [A] twenty-five year old machine operator recently came into my office for treatment of major life activities (Tr. 13356. 13360, Dr. Franklin added that where employees with carpal tunnel syndrome severe hand pain and swelling. She had 13373). Dr. Connell testified: worked 9 months in a job that required her are provided with early intervention A typical carpal tunnel patient would to use excessive force to press a lever over come in complaining of numbness and they should be able to return right away 20,000 times per day, using her hands in a tingling in the distribution of the median to modified work and that work pinch grip with her wrist in an awkward nerve. Typically it occurs initially at night restrictions should not be needed for a posture. She had developed symptoms after and wakes one out of a sleep for some prolonged period of time (Tr. 13345– three months of work, but had not seen a reason—4 a.m. seems to be the magic number 46). Dr. Bernacki testified that, as a health care provider after her supervisor told (Tr. 2817). result of the early reporting and her that she would ‘‘feel better’’ after she ‘‘got Moreover, the persistence of signs and intervention program at Johns Hopkins, used to the job.’’ By the time she finally came symptoms can be an indication that an there had been only one surgery for to see me, she was unable to drive her car, shake my hand or open a door. My MSD is worsening, and early detection work-related carpal tunnel syndrome examination showed marked swelling and and intervention are ‘‘critical to during the past 5 years, compared with redness of the right wrist, and the pain was prevention of more serious disorders,’’ 26 such surgeries in the previous three so severe she cried [at] my touch or gentle in the words of Dr. Robert McCunney, years (Exs. 32–399–1–4, p. 7–8). movement. My diagnosis was chronic, president of the American College of Early intervention also is likely to be stenosing tenosynovitis. I had little option Occupational and Environmental more effective in helping patients but to remove her from work completely for Medicine (ACOEM) (Tr. 7660). Dr. Marc recover fully (Exs. 37–12, 38–222, 38– four weeks to let the hand rest. Connell, an orthopedic surgeon at 451, 500–71–57). Dr. Harrison said: Unfortunately, she was unable to return to Georgetown University Hospital, added: work in spite of corticosteroid injections, At an early stage of symptom management, splints, analgesic medication and physical ‘‘I think that’s common medical sense treatment with anti-inflammatory therapy. She required surgery to release the that the earlier the treatment is rendered medications, splints, and rest of the affected tendon, and is now in a prolonged the less severe will be the MSD’’ (Tr. body part often results in complete clinical rehabilitation program. 2833). Dr. Edward Bernacki, vice- improvement without any permanent injury (Ex. 37–12, p. 5). This case is not unusual. (Ex. 37–12). president of ACOEM, said: By including persistent signs and Obviously, the earlier you pick up a Dr. Michael Erdil, medical director of symptoms within the standard’s problem, the more reversible it is, so the Connecticut Occupational Health definition of an MSD incident, OSHA obviously, the encouragement of employees Network, said that both scientific assures that early intervention can occur to come in at the first signs of a problem, so evidence and his own clinical and that medical outcomes like that that we could work it up, and then basically experience show that conservative start treating the illness when it is reversible, described by Dr. Harrison will not therapy is much more likely to be occur. in other words, if you have irreversible nerve effective as an early intervention (Ex. damage, that is basically too late. Then, you For these reasons, a number of HCPs need surgical intervention. However, for 37–16, citing Kruger et al. (1991) (Ex. and employers said that they investigate example, in carpal tunnel early on when the 26–910), Gelberman et al. (Ex. 26–916) MSD signs or symptoms as soon as they disease is reversible, mere splinting and (1980), Quebec (1987), Zigenfus et al. are reported (Exs. 30–390, 30–398, 500– restriction of activities are fine, it takes care (2000) (Ex. 38–285). Zigenfus found that 218, Tr. 5539, 5550, 9906, 13382). Dr. of the problem, it disappears (Tr. 7687–88). patients with low back injuries who Franklin stated: (See also Exs. 26–1367, 32–450–1, 37– were provided with medical treatment If I was taking the history from the person 24, Tr. 1530, 1697–98, 2853, 2833, earlier (i.e., less than 8 days after injury) required fewer days away from work and getting these kinds of symptoms of 7649–50, 7687–88, 7883–84, 9831.) numbness and tingling and burning In addition to reducing the severity of and restricted work and had shorter case particularly at night, it would not matter to MSDs, early intervention has been duration (Ex. 38–285). Dr. Evanoff me whether it was two days or seven days shown to reduce MSD rates and explained that the medical literature or 14 days, if I thought clinically the associated medical costs (Exs. 32–12, consistently shows that: symptoms were correct. I have seen patients 32–339–1–87, 32–399–1–4, 32–450–1 [C]onservative management of MSDs is that developed [carpal tunnel] in a day or (citing Hales et al. 1993)). Dr. Bernacki most effective when begun in early stages of two (Tr. 13382). described a study of the effect on 22,000 these disorders, and that patients who are Several employers said that their employees at Johns Hopkins Hospital treated only after a prolonged symptomatic standard response is to investigate any and University of an ergonomics period are less likely to respond favorably report of MSD signs or symptoms (Tr. program that stressed early reporting of than those treated earlier (Ex. 37–1, citing 5539, 5550, 14715–16). Sean Cady, of MSD signs and symptoms (Ex. 32–399– Dellon (1989), Stern (1990), Rystrom & Eversman (1991)). Levi Straus & Co., said: 1–4, Tr. 7691–92). The study reported Similarly, Dr. McCunney of ACOEM Well we believe that symptoms could be an 80 percent reduction in MSDs after precursors to a possible repetitive motion the program and early intervention were testified that: injury. And therefore if we know about a implemented. ACOEM supports the requirement of a symptom early we can evaluate a job for Early intervention also increases the mechanism for employees to report MSD ergonomic risk factors and possibly modify availability and effectiveness of signs and symptoms since early detection is that job to reduce risk factors prior to the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68312 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations possible occurrence of an injury. And also, even the Katz hand paint diagram (Tr. such as nerve conduction tests (Ex. 37– early reporting of symptoms is a trigger for 13380, 13404). According to Dr. 2, Tr. 13363, 13375). our quick response system or quick response Franklin, the best case definition of Other differences between the process (Tr. 14715–16). carpal tunnel syndrome is the presence proposed definition of a ‘‘covered MSD’’ Some employers provide restricted work of symptoms plus a positive nerve and this final standard’s definition of an when an employee reports MSD signs or conduction test. However, Dr. Franklin ‘‘MSD incident’’ further show OSHA’s symptoms to let the symptoms resolve also said that in some circumstances intent not to address the type of minor quickly without medical treatment, and HCPs can reliably determine, based on and transient symptoms that can be to allow the employer to examine the symptoms alone, whether a patient has expected to resolve spontaneously in a job (Ex. 26–1370). Other employers said carpal tunnel syndrome: ‘‘one could matter of days even without their standard practice is to send any make a reasonable determination based intervention. The final rule, unlike the employee who reports MSD signs or on symptoms alone if you thought it proposal, does not include the diagnosis symptoms to an HCP immediately (Tr. was possible that somebody had carpal of an MSD in the definition of MSD 3867). tunnel syndrome.’’ (Tr. 13384–88). Dr. incident. As mentioned, the standard These employers told OSHA that their Margit Bleecker, Director of the Center also now makes clear that an MSD is not early intervention programs, for Occupational and Environmental work-related unless workplace particularly restricted work and light Neurology at Johns Hopkins University, exposures caused or contributed to it, or duty, have proven to reduce the severity testified: were responsible for a significant and costs of MSDs significantly (Ex. 30- aggravation of a preexisting injury. 4137). Even after the rule becomes I think as somebody who has worked many These changes respond to comments effective, OSHA believes that employers years in this area, you certainly can diagnose carpal tunnel syndrome by the history and that the proposal could have required a who have seen the advantage and the physical examination. The only time that full ergonomics program in situations effectiveness of such intervention you absolutely need to have the EMG is if where workplace exposures contributed programs will continue to follow them you’re considering surgery (Tr. 16901). only trivially to the employee’s rather than delaying intervention while condition (Exs. 30–1722, 30–3934, 30– Dr. George Piligian, who is with the they wait to see whether the employee’s 3956, 500–73, Tr. 3097–98). MSD signs or symptoms persist. Mount Sinai Center for Occupational Clearly, MSDs qualifying as MSD However, for those employers who have and Environmental Medicine and for incidents under the definition in the not yet implemented early intervention the past 10 years has been treating final rule are the types of conditions programs, including the persistent signs workers with MSDs, added: that OSHA may act to prevent. See and symptoms criterion in the final rule We use principles in medicine, and as you Occupational Noise Exposure (29 CFR will help to ensure that employees are may or may not know, 80 percent of medical 1910.95, 46 FR 46236), Occupational provided with appropriate MSD diagnoses, all medical diagnoses, not just Exposure to Formaldehyde (29 CFR management and work restrictions work-related ones, are arrived at by history 1910.1048, 52 FR 46168, 46234–37), and while their condition is still reversible. and complaints. Then, we add to them, the Section VII (Significance of Risk) of the This evidence is part of the reason physical diagnosis, and finally, the testing. This has been the way medicine has gone on Preamble. It is even more clearly within that OSHA does not agree with the for ages, and those who have written the OSHA’s authority to require employees commenters who argued that signs and most respectable textbooks say that, and to investigate them further to determine symptoms are too subjective and many doctors who go right to the objective whether they were caused by hazards difficult to verify to be an appropriate number, which they worship, and leave out that this standard addresses. trigger for action under this standard those 80 percent arrive at the wrong (Exs. 30–1722, 30–3345, 30–4340, 500– diagnosis, and thereby give the wrong Paragraph (f)—How Do I Determine 1–23, 500–1–117, Tr. 5507). Other treatment. So, it is still seeing, listening, Whether the Employee’s Job Meets the evidence establishes that MSD signs are recording, putting it all together that arrives Action Trigger? often easily observable (Tr. 2828). For at the medical diagnosis, and they can be Paragraph (f) tells employers how to example, an employee’s decreased range arrived at (Tr. 7851–52). determine whether a job where an MSD of motion can be identified by the OSHA has, however, responded to the incident has occurred meets the employee’s inability to raise his arms comments that certain MSD signs, such standard’s two-part Action Trigger. above his shoulders or to bend over to as redness, may be transient or may be According to paragraph (f)(1)(i), the first lift an object. Objective physical a sign of something other than an MSD part of the Action Trigger is a findings also include positive results on (Tr. 5507). As mentioned, in this final determination that an MSD incident has medical tests such as nerve conduction rule, MSD signs are treated the same occurred. Paragraph (f)(1)(ii) states that velocity tests, CT scans, or x-rays. way as MSD symptoms, so that only the second step is a determination that The presence of MSD symptoms can those signs that persist for 7 days after the injured employee’s job meets the also be confirmed through physical being reported to the employer or that Basic Screening Tool in Table 1 of this examination by an HCP (Ex. 37–12, 37– meet the other severity criteria require standard. Paragraph (f)(2) explains that 28, Tr. 13404). Dr. Robert Harrison further action. The proposal would have if the job does not meet the Action testified that there are several ways to required action whenever an employee Trigger, the employer has no further confirm the presence of both MSD signs reported an MSD sign because all obligations with respect to that job. and symptoms, including palpation or positive signs must be recorded under The second step of the action trigger movement of the affected body part OSHA’s recordkeeping rule. OSHA has requires application of the Basic during the physical examination (Ex. also eliminated the reference in the Screening Tool in Table 1 to the injured 37–12). Dr. Gary Franklin, of the proposal to Finkelstein’s, Phalen’s and employee’s job. A job is screened in, i.e., University of Washington School of Tinel’s tests as examples of the kinds of is determined to meet the levels in the Public Health and Community positive tests that would constitute MSD Basic Screening Tool, if it regularly Medicine, testified that symptoms of signs. The record shows that these tests involves exposure to one or more of the carpal tunnel syndrome, for instance, are not considered reliable by a growing risk factors in the Basic Screening Tool can be verified through absence of number of HCPs and, in any event, have at levels above those specified in the reflexes and nerve conduction tests and been replaced with other medical tests tool. Only where the job is screened in

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68313 does the employer have further applicability of the standard in specific can respond to industry’s requests for more obligations under the standard. situations in the absence of a criteria to guide specific guidance and definitions. We The proposed rule also included an decision-making on whether the work time recommend two possible approaches. The exposure screen. The proposed screen was significant, the applied force was first is to incorporate a list of risk factors and would have ruled out jobs where the forceful, or whether the material handling criteria similar to the ‘‘caution zone job’’ was a core element of the employee’s job. criteria included in the state of Washington’s ‘‘physical work activities and * * * In the absence of an explanation of Ergonomic Standard (WAC 296–62–0515) conditions’’ in the job were not what OSHA intends these subjective terms to which serve a similar purpose as the associated with the ‘‘type of MSD mean, it is unclear how to decide whether a screening criteria in the federal OSHA reported,’’ or were not ‘‘reasonably particular activity fits the definitions and proposal. These ‘‘caution zone job’’ criteria likely’’ to cause or contribute to an therefore whether it is covered by the provide more specific definitions of risk MSD. It also would have ruled out jobs standard. (Ex. 31–289) factors and the amount of time or frequency in which the employee’s exposure to the National Small Business United testified that must be exceeded for these risk factors to be covered by the standard. (Ex. 500–218) risk factors was not a ‘‘core’’ element of that: his or her job, or did not make up a The employers, especially the smaller ORC also expressed qualified support ‘‘significant’’ amount of the employee’s employer, * * * needs more specific for using the state of Washington’s workday. guidance in terms of the types of jobs to be ‘‘caution zone job’’ criteria: Thus, the proposed standard looking at and specifically as the types of Although the Washington State proposal contained performance-oriented activities in those jobs and how much of itself contains significant deficiencies, ORC language (‘‘core element,’’ ‘‘significant what kind of activities is too much for what believes its approach to providing quantified amount’’ of time) to define the terms of type of person. (Tr. 2746) alternative triggers is a rational one that the screening criteria. In the preamble to Con Ed stated: could be considered by OSHA. (Ex. 32–78– the proposal, OSHA also used 1) performance-oriented language in Throughout the standard, OSHA uses terms that are vague and open to See also Tr. 9071–74. discussing the meaning of core element, interpretation such as: reasonably likely, core A preliminary exposure-based describing the term as a ‘‘regular and job element and other similar terms. These assessment as a trigger for further routine exposure.’’ On the whole, most terms require clarification so OSHA and actions is also widely used by commenters supported the concept of employers interpret them consistently. (Tr. at participants in the rulemaking who an exposure screen, but many said that 4628) provided testimony on the specifics of OSHA had not provided enough In addition, ORC added that: their own ergonomics programs (see, guidance for them to understand when The proposed trigger simply does not e.g., Ex. 32–300–1, Tr. at 2920–2927; Tr. a nexus existed between an MSD and a at 5302, Tr. at 10802; Tr. at 14142; Ex. job or what the exposure severity fulfill OSHA’s responsibility to provide adequate guidance with respect to employer’s 32–339–1–4, Tr. at 16839; Tr. at 4643– threshold was for a job. For example, obligations. * * * OSHA must do a better job 4647; Tr. at 5539–5540, 5566–5567, Tr. they complained that the terms were too of defining a point at which an employer’s at 14801; Tr. at 14715). Many of these vague and undefined to answer those obligations are triggered and do a better job commenters use a checklist format questions (see, e.g., Exs. 30–1722, 30– in establishing more objective criteria. (Tr. at which contained specific descriptions of 3032, 30–3853, 30–3956, 30–4340, 30– 4097) risk factors. The Dow Chemical 4837, 31–92, 31–125, 31–223, 31–225, Similar comments were submitted by Company, for example, uses a short 31–260, 31–307, 30–300, 32–337, DC66, EEI (Ex. 32–300–1); Chamber of checklist printed on a pocket size card Tr. 3337, 8849, 8850). Commerce (Ex. 500–188; Tr. at 3044), that contains descriptions of specific The following comments are Color Works (Tr. at 10069), Indiana risk factors along with a duration/timing representative: Chamber of Commerce (Tr. at 3335), component (see, e.g., Tr. 5311–5312, The terms ‘‘core element’’ and ‘‘significant National Roofing Contractors 5359, Ex. 32–77–2–1). NIOSH’s amount’’ are not clear. While extreme Association (Tr. at 4905), Food Elements of an Ergonomics Program (Ex. examples can be easily defined, extreme Distributors International (Tr. at 5634– 26–2), also contains checklists that have examples are few and far between in the real 35), and many others. specific descriptions of risk factors, world. Most of the time, examples fall into Commenters further recommended some with a duration component. ‘‘grey’’ areas. These terms either need that the screening criteria should specific definitions or should be replaced A number of other participants also with other terms (Ex. 30–4837). include specific, exposure-based criteria suggested that OSHA adopt quantitative Does [core element] indicate that the (Ex. 500–218; Ex. 500–214, Tr. at methods of defining the screen (Ex. 30– employee will be required to perform a 17905–6). In particular, ORC stated that: 46, 30–75, 30–137, 30–293, 30–328, 30– manual handling task some time during his/ In place of the proposed screening criteria 3032, 30–3284, 30–4837, 31-23, 31–27, her shift, i.e., one 50-lb. Lift throughout an of section 902, OSHA would set forth 31–95, 31–137, 31–187, 31–31–202, 31– 8-hour work shift, or does it indicate that flexible, but objective, risk-based criteria 301, 31–307, 31–337). Specific some repetition is involved with the manual * * * (Ex. 500–214) suggestions included defining a core handling portion of the task, i.e., lifting 20 10-lb. packages per hour for 8 hours? (Ex. 30– ORC added that such criteria are already element of manual handling jobs in 4837). contained in the record and that ‘‘a terms of frequency rates for lifts (Ex. 31– How much is significant? 6 hours per 8-hr number of models to define at-risk 337), or saying lifting was a core shift? 4 hours per 8-hr. shift? 2 hours per 8- conditions and work routines are element of a job that required one lift hr. shift? Or 22-hr. periods per 8-hr. shift? available in the literature and are cited per hour (Ex. 31–259). Suggestions for a (Ex. 30–4837). by OSHA in its preamble.’’ (Ex. 32–78– definition of the term ‘‘significant The Rohm and Haas Company said: 1) amount of worktime’’ included 50 percent or more of the employee’s [I]t is unclear what OSHA means by the Similarly, the AFL–CIO stated: subjective terms used as shown below. While we believe the content and intent of worktime, Southern California Edison ‘‘* * * significant amount of their worktime OSH’s proposed screening criteria were clear (Ex. 31–23), more than 2 hours a day, * * *’’ * * * [and] ‘‘* * * core element of from the text and Preamble of the proposed UNITE (Ex. 32–198), or routine the employee’s job.’’ It is unclear how OSHA rule, the AFL-CIO has several performance of the same task 4 hours or would be able to determine consistently the recommendations for ways in which OSHA more per shift or 2 hours or more

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In this way, MSD was reasonably likely to have been implement the ergonomics program the screening criteria concept is similar caused by the job. Rodney Smith of described in paragraph (g). to action levels contained in OSHA’s Freeborn & Peters said: The Basic Screening Tool has been health standards (e.g., Benzene, 29 CFR Identifying ergonomic risk factors is designed to minimize employer burdens 190.1028; Ethylene Oxide, 29 CFR difficult due to the vagueness of their in screening jobs. It is similar to a 1910.1047; Formaldehyde, 1910.1048.) definition [in the proposed rule]. But how in number of screening tools that are In those standards, as in the final the world does my employer tell whether already in use (Exs. 26–1008 (Snook ergonomic program standard, the those risk factors constitute a hazard, as that Push/Pull Tables), 32–77–1–2 and Tr. inclusion of an action level is used to term has been defined in the standard. That 5336–37 (Dow Chemical), 502–12 differentiate between more hazardous is, risk factors reasonably likely to cause or (NIOSH Lifting Equation), 502–35 (GM– and less hazardous work operations, contribute to a covered MSD (Tr. 8850). UAW checklist)). It is limited to five risk and to identify those operations where Others also complained that it would be factors and, to streamline the screening the employer needs to focus resources. virtually impossible for them ever to process, the tool applies the same The screening criteria in the final establish that it was not reasonably duration criteria to almost every risk standard consist of the five risk factors likely that exposure to risk factors in a factor/activity. that are covered in the final rule: job could cause MSDs, when at least one The Basic Screening Tool in the final repetition, force, awkward postures, MSD would have already occurred (Ex. standard serves the same function as the contact stress, and vibration. Most of the 30–1722, 30–4137, DC 65). In addition, screen in the proposed rule, but, instead screening tools submitted to the record several commenters found the crucial of performance language, it contains contained similar risk factors. For terms ‘‘extremely subjective,’’ and specific definitions of the risk factors example, the screening tools submitted believed they would be ‘‘open to the and exposure durations that define a job by NIOSH (Ex. 32–30–1–45), UFCW (Ex. individual interpretation of OSHA requiring further analysis. The IL–228), the AFL–CIO (Ex. 500–71–70), inspectors’’ (Ex. 30–3032, 31–22, 31– definitions used in this chart are the Worker’s Compensation Board of 303, 31–307, 32–337). consistent with a number of approaches British Columbia (Ex. 500–142–12), the In response to those and other and screening tools contained in the UAW/General Motors (Ex. Or 348–1), comments, OSHA has further clarified rulemaking record, including the state Dow (Ex. 502–77–2–1), and the and operationalized the proposed of Washington’s Ergonomic Standard’s Washington State Department of Labor exposure screen, or severity threshold. ‘‘caution zone job’’ checklist (Ex. 500– and Industries (Ex. 502–313–6) included Once the employer determines that an 41); the checklists contained in the these same five risk factors as specific MSD incident has occurred in a job, the NIOSH Elements of an Ergonomics risk categories in their screens or employer must screen the job to Program (Ex. 26–2); the checklist included narrative questions directly determine whether it meets criteria developed by tripartite committee of related to or incorporating these same requiring a job hazard analysis to employer, employees and government risk factors. In addition, these are the determine the potential hazard representatives for use in conducting a risk factors addressed in the associated with exposure to risk factors. preliminary job analysis under the epidemiological literature on For ease of use, the criteria are British Columbia Ergonomics Standard ergonomics and discussed in the Health presented in a ‘‘Basic Screening Tool,’’ (Ex. OR–388); and others (Exs. 500–108; Effects section (Section V) of this which is a chart that contains specific 32–77–2–1, 26–2, OR–348–1; 502–67) preamble. descriptions of the risk factors covered By utilizing language from programs The proposal also included static in the final rule along with duration and checklists that have been used postures, whole body vibration, and specifications and illustrations (see successfully by both employers and cold in the list of risk factors. The Table 1 of the regulatory text). In jobs employees for many years, OSHA fully evidence discussed in the Health Effects where an MSD incident has occurred anticipates that employers will have no section of this Preamble has convinced and employee exposure to risk factors difficulty in determining whether a job OSHA that these risk factors should no meets the criteria laid out in the screen, meets the standard’s Action Trigger. longer be addressed independently. the employer must proceed with the Further, as with the proposed rule, Static postures will be covered to some program requirements in paragraph (g) OSHA expects that employers will be extent by the awkward postures element of the standard. able to determine, quickly and of the screen, and employers should be Employers with employees who efficiently, if the job activities of any aware that cold temperatures may report MSDs in jobs that do not meet the employee reporting a MSD meet or aggravate the effects of other risk factors. specific screening criteria are not exceed the criteria of the screen. To give further guidance to required to proceed with any of the Similar to the concept expressed in employers, each risk factor in the chart remaining requirements of the standard. the proposed rule, the basic screening is clearly described (i.e., descriptions of This could include jobs that do not tool in the final standard, when coupled specific job or task activities) and involve the risk factors this standard with the occurrence of an MSD incident includes specific duration, frequency. covers or where the injured employee’s in a specific job, represents an exposure- and magnitude components. In the work activities do not involve the based ‘‘action trigger’’, that requires the chart, repetition includes a separate injured body area. The screen also employer to proceed with some other description for keyboarding/mouse use; allows employers to screen out jobs in provisions of the standard (in particular, force is broken down into lifting, which the employee’s work activities do job hazard analysis and MSD pushing/pulling, and pinching and not involve enough exposure to risk management). However, jobs where the gripping unsupported objects of factors to require further action under employer has determined that an MSD specified weights; awkward postures are this standard. In these cases, the incident occurred and that meet the defined by specific postures, as well as

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Stetson et al.(Ex. 26– levels from equipment such as jigsaws, risk factors such as repetitive precision 1221) found an increased prevalence grinders or sanders. movements, awkward postures (e.g., (65%) of hand/wrist symptoms among In addition, the chart contains a hands above the shoulders, kneeling, workers using a high grip force (> 6 simple grid for employers to use in stooping), gripping, lifting, and carrying. pounds) for more than half of a shift relating the body area affected by an For example, Ekberg et al. (Ex. 26–1238) (defined as ‘‘frequently’’ in the study), MSD incident to a relevant risk factor. reported that the risk of MSDs of the compared to the prevalence in workers Thus, the grid serves to further simplify neck and shoulder increased with the with ‘‘some’’ (40%) or no (41%) this initial determination by assisting hours per day that repetitive precision exposure. A study by Viikari-Juntura et the employer in focusing on only those movements were performed and that al. (Ex. 500–41–50) of trunk twisting risk factors that have a clear nexus with arms were lifted above the head. reported a non-statistically significant the MSD incident that triggered the use Similarly, Kelsey et al. (Ex. 26–709) elevation in risk of neck disorders (OR of the screening tool; this also reflects reported an increased risk of prolapsed = 1.3) among workers having ‘‘little’’ OSHA’s intent in the proposal. For lumbar disc when the frequency of exposure (in hours per day), and example, if an MSD of the back or lower lifting or carrying loads greater than statistically significant increases in risk extremity is reported, the employer, approximately 25 pounds increased among workers with ‘‘moderate’’ when evaluating the risk factor for from 0 to more than 25 times per day. (OR=1.9) and ‘‘much’’ (OR = 2.3) repetition, would focus only on job or Similar dose-response observations exposure. task activities where the employee is were reported by Latza et al. (Ex. 38– However, there were also studies that performing the same motions every few 424), Matsui et al. (Ex. 26–309), showed increased risk of MSDs seconds or repeating a cycle of motions Smedley et al. (Ex. 500–41–40) and Tola associated with exposures of less than 2 involving the affected body part more et al. (Ex. 26–1018). hours daily. For example, Vingard et al. than twice per minute for more than 2 (Ex. 500–41–51) showed an increased OSHA’s review of the studies that consecutive hours in a workday. The risk MSDs of low back area among quantified duration of exposure indicate employer would not need to consider workers in jobs involving forward that, in general, the MSD risk in use of a keyboard and/or mouse in bending for approximately 1 hour per steady manner (the shaded portion of exposed groups of workers increases day (statistically significant for male the chart under the risk factor above that in unexposed groups when workers, but not for female workers). repetition). Similarly, for a reported the duration of exposure to certain risk Holmstrom et al. (Ex. 26–36) found a MSD affecting the back or lower factors or combinations of risk factors significantly increased OR (2.4) for extremity, the employer, when comprises about one-fourth to one-half severe low back pain with impairment evaluating the risk factor for force, of the workday or workweek. For for less than 1 hour per day of kneeling). would only need to focus on job or task example, Holmstrom et al. (Exs. 26– DeKrom et al. (Ex. 26–102) reported a activities involving lifting or pushing/ 1231, 26–36) studied workers using significantly increased OR (1.4) for pulling and not on work tasks involving awkward positions such as stooping, carpal tunnel syndrome among workers pinching or gripping. kneeling, and raising the hands above having 1 to 7 hours per week of wrist Each job or task activity also includes the shoulder and found an increased flexion; 1 to 7 hours per week of wrist a duration/frequency limit. In selecting risk of low back pain (Odds Ratio of 1.4, extension was also associated with an the duration limit for the risk factors, 1.9, and 1.5 for stooping, kneeling and elevated OR for CTS (1.4), but that result OSHA based its decision on balancing hands above the shoulder, respectively) was not statistically significant. Latza et the weight of the scientific evidence with 1 to 4 hours per day of exposure. al. (Ex. 38–24) reported an increase (not against the need for the screening tool Similarly, Nordstrom et al. (Ex. 26–900) statistically significant) in low-back to be clear and easy to use. For many observed that the risk of carpal tunnel pain among workers laying sandstone items in the chart, the agency has syndrome began to increase among for less than 2 hours per day compared chosen to use more than 2 hours total workers whose jobs involved wrist to unexposed workers. English et al. per day as an exposure duration that bending or twisting after exposures of (Ex. 26–848) found positive exposure- triggers jobs for job hazard analysis; this 3.5 hours compared to groups exposed response relationships where ORs for determination is based on an analysis of for less than 3 hours (Odds Ratios of carpal tunnel syndrome or hand/wrist relevant epidemiological data contained 1.34 with 0.25–1.75 hours exposure, disorders increased by 1.8 and 1.6 per in the rulemaking record. 1.23 with 2–3 hours exposure, and 2.33 hour worked per day, respectively, for Many studies in the epidemiological with 3.5–6 hours of exposure). Similar workers performing tasks involving literature clearly demonstrate that the quantitative observations were reported shoulder rotation once per minute. incidence of MSDs increase with by deKrom (Ex. 26–102) for wrist These studies, taken as a whole, increased duration of exposure to flexion, Baron et al. (Ex. 26–697) for demonstrate that for the risk factors certain risk factors or a combination of grocery checking, and Xu et al. (Ex. listed in the basic screening tool, the risk factors. Table IV—SCREEN lists 500–71–53) for frequent twisting and risk of MSDs increased with daily studies that included duration, either bending and for physically hard work duration of exposure. qualitatively or quantitatively, as a (see Table IV—SCREEN). Other studies The studies described above and component of the investigation. These reported results using qualitative contained in Table IV—SCREEN show studies reflect a subset of the many ordinal scales that indicate that risks that, where researchers have studies identified by the Agency that increase, sometimes substantially, with investigated relationships between MSD demonstrate positive exposure-response exposure to risk factors of one-half a day risk and daily duration of exposure, the relationships between the intensity and/ or more. Ekberg et al. (Ex. 26–1238) risk of MSDs has been consistently or duration of exposure to reported ORs of 3.8 and 2.4 for neck/ elevated in groups of workers exposed biomechanical risk factors and the shoulder disorders that were associated for half of the workshift or more (Exs. prevalence or incidence of MSDs. The with a ‘‘medium’’ duration (in hours per 26–1238, 26–697, 26–1221, 38–428, 26–

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1231, 26–36, 26–1018, 500–41–50, 26– hours total per day. This reflects sanders) is set at 2 hours total per day. 102, 26–900, 26–58, 500–71–53). For OSHA’s belief, based on the health Vibration level can be expressed as the exposure durations of one-fourth to one- evidence, that 2 hours of repetitive amount of energy transmitted by the half of the shift, or durations described motion will be less hazardous if spread tool over a certain period of time (e.g., as ‘‘some’’ or ‘‘moderate,’’ several out over the workday because m/s2). OSHA assumes that a moderate studies showed statistically significant musculoskeletal tissue will have an vibration level is approximately 2.5m/ increases in MSD risk (e.g., Exs. 26–697, adequate opportunity to recover. By s2. The duration for moderate vibration 38–428, 26–1231, 26–36, 500–41–50, capturing only those jobs that involve level is more than 2 hours total per day. 26–102) and others reported increased more than 2 consecutive hours of Assuming that a high vibration level is ORs that were not statistically repetitive motion, the standard will not approximately 10m/s2 (4 times the significant (e.g., Exs. 26–1018, 500–41– capture those jobs where employees moderate vibration), the time-energy 50, 26–102, 26–58). For exposures of change tasks during the day, even if the equivalent exposure duration level at less than 2 hours daily duration, results repetitive motion occurs for a total of 2 which risk is increased for activities from these studies are more equivocal; hours over the work shift. involving high vibration levels would be some reported significantly increased The screening tool departs from the 2- 30 minutes (i.e., 1⁄4 of 2 hours). That is, ORs (e.g., Exs. 500–41–51, 26–848, 26– hour duration criterion for a few items. risks for activities at four times the 102, 26–36) while several found non- These include the following: For use of vibration level would occur 1⁄4 the statistically significant increases in ORs keyboard and mouse in a steady amount of time. (e.g., Exs. 500–41–50, 26–102, 500–41– manner, the duration is set at 4 hours For lifting, the chart contains specific 51, 26–36, 26–1231, 38–24). Based on total per workday; for lifting, the screen weight limits, coupled with a specific these studies, OSHA finds it reasonable sets weight and frequency criteria; and limit on the number of times per day the to trigger jobs for job hazard analysis for use of tools or equipment that weight can be lifted. Weight limits are where employees are exposed to the risk typically have high vibration levels specified for weights lifted from below factors indicated on the screen for more (such as chainsaws, jack hammers, the knee, above the shoulder and at than 2 hours during the work shift. percussive tools, riveting or chipping arm’s length. The limits specified are as OSHA believes that a 2-hour duration hammers) the duration is set at 30 follows: lifting more than 75 pounds at criterion for the screen will capture minutes total per day. any one time; more than 55 pounds those exposure situations where the For use of a keyboard or mouse in a more than 10 times per day; or more epidemiological evidence indicates that steady manner, OSHA has set the than 25 pounds below the knees, above MSD risk is most likely to be elevated duration for more than four hours total the shoulder, or at arms’ length more (i.e., jobs involving more than 4 hours per day. In this case, OSHA has chosen than 25 times per day. OSHA has based per day of exposure) as well as those more than four hours based on the these limits on recommendation found jobs involving 2 to 4 hours of exposure epidemiological evidence that in other screening tools as well as during the shift where the evidence demonstrates that, in general, the risk of evidence in the epidemiological suggests that the risk may already be MSDs for workers performing keying literature that shows increased risk of increased, at least in some situations. activities begins to increase after four low back disorders when lifting certain The 2-hour trigger will exclude those hours of exposure (see Table IV— weights at certain frequencies or jobs where the evidence has been less SCREEN). For example, Bernard et al. postures. For example, Arad and Ryan consistent in finding an elevated risk of (Ex. 26–842) studied workers typing at (Ex. 500–41–7) and Smedley et al. (Ex. MSDs (i.e., jobs involving less than 2 video display units and reported an 1249) reported an increase in risk low hours of exposure). This is consistent increased risk of hand/wrist MSDs for back MSDs among healthcare workers with OSHA’s statutory mandate to be exposures of 4 four to six hours. lifting one to four patients per day. protective of workers. However, because Oxenburgh (Ex. 26–1367), observed an Kelsy et al. (Ex. 500–41–73) reported the screen does not necessarily trigger increased prevalence of hand, wrist, increased risks of lumbar disorder an obligation to control a job, OSHA forearm and/or elbow MSDs after 4 among workers in jobs requiring lifting also is not imposing unnecessary costs hours per day at a keyboard. Similarly, more than 25 pounds more than 25 on employers. Polanyi et al. (Ex. 38–3) studied times per day compared to workers who In using this 2-hour cutpoint, OSHA keyboard workers and observed that did not lift these weight. Similar does not intend to imply that all upper extremity MSDs significantly findings were reported by Macfarlane et workers will experience significant increased after exposure durations of al.(Ex. 500–41). adverse effects after 2 hours or more of approximately four hours per day. OSHA finds that the weight of exposure. Rather, OSHA is using this Based on this evidence, OSHA has evidence clearly demonstrates that cutpoint in the screen criteria to give determined that it is appropriate to heavy, frequent or awkward lifting employers guidance about which jobs deviate from the 2 hour duration increases the risks for MSDs. Particular might involve a sufficient duration of criterion set for other job or task studies, such as those described above, exposure such that the job warrants activities, and to set a greater than four provide support for the specific weight closer examination. In addition to being hours total per day for the use of a criteria used in OSHA’s screening tool supported by the scientific literature, keyboard or mouse in a steady manner. for the final standard. Washington State this value is also administratively For using tools or equipment that has used similar data to support its simple for employers to use, thus typically have high vibration levels ‘‘caution zone job criteria’’ for lifting allowing the screening tool to be used (such as chainsaws, jack hammers, (Ex. 500–313–6). OSHA believes that quickly and consistently for a number of percussive tools, riveting or chipping these are reasonable criteria to use for different jobs. hammers) OSHA has set the duration at the screening purposes of this standard For repetitive motion other than use 30 minutes total per day. This level is and that, in general, these criteria reflect of a keyboard or mouse, the screen based on a time-energy equivalent the evidence in the record. triggers jobs into the requirements of the exposure determination. For example, The exposure screen also contains an standard only if the exposure occurs for the time duration for using tools or entry for activities involving pushing more than 2 consecutive hours in a equipment that have moderate vibration and pulling. In a questionnaire survey of workday, as opposed to more than two levels (such as jig saws, grinders, or insurance company policyholders,

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Snook et al.(1978) found 9% of low back as measured by lost or restricted work employers are not screening in jobs for injuries to be associated with pushing days was also found to be associated which they have already implemented and 9% to be associated with pulling with psychophysical stress (Ex. 26–961). controls based on the safe harbor value, (Ex. 26–35). NIOSH (1981) cited Additionally, Park and Punnett found but instead are screening in those jobs evidence that 20% of overexertion psychophysical ratings of ergonomic where risks may begin to occur and for incidents involve pushing and pulling stressors to predict the incidence of in- which a job hazard analysis is objects (Ex. 26–393). Thus, OSHA finds plant medical visits for MSDs among appropriate. that it is appropriate to include pushing 1064 workers in two automobile For performing activities that require and pulling on the screen as a specific manufacturing plants (Ex. 38–160). pinching or gripping unsupported exposure criterion. Based on the reported association objects, the chart specifies weights of For job activities involving pushing or between pushing and pulling and the two pounds or more per hand for pulling, the chart specifies 20 pounds of development of MSDs, and the evidence pinching and 10 pounds or more per initial force as the trigger criterion. To of a relationship between hand for gripping. These values are provide a basis for determining psychophysically derived exposure generally supported by studies such as appropriate workloads for these limits and reported injuries, OSHA those by Chiang et al. (Ex. 500–41–25), activities, Snook and Ciriello (1991) concludes that an exposure criterion Stetson (Ex. 500–41–44), English (Ex. developed tables of maximum based on psychophysically derived 500–41–30) and Roquelaure et al. (Ex. acceptable forces for pushing and limits will serve as a reasonable basis 500–41–112). These investigators pulling (Ex. 26–1008). Maximum for determining when a hazard analysis reported increased risks of carpal tunnel acceptable forces were expressed in is necessary for jobs involving pushing syndrome, thumb disorders, shoulder terms of the percentage of the industrial and pulling activities. disorders, and nerve abnormalities population capable of performing the The 20-pound force criterion for among workers repetitively pinching task. Data were presented separately for pushing and pulling will capture all objects approximately in the range of males or females either pushing or jobs that are designed such that less two pounds or gripping objects pulling, and were given for both initial than 75% of workers (male or female) approximately in the range of 10 forces (the force required to get an object are capable of performing them without pounds. OSHA believes that the weights in motion) and sustained forces (the experiencing overexertion. As explained specified represent reasonable screening force required to keep an object in above, lifting jobs that cannot criteria for identifying conditions likely motion). Variables included frequency, accommodate at least 75-percent of the to cause the type of MSDs reported and distance, and height (vertical distance working population’s physical capacity are similar to values recommended in from floor to hands). have been associated with a three-fold other screening tools. While there may The tables were developed based on higher risk of low back disorders. This be more precise ways of measuring force experiments employing a suggests that jobs should be subject to associated with pinching or gripping, psychophysical methodology (Ex. 37–6). more detailed hazard analysis if an OSHA believes that using the weight of This approach assumes that workers are initial screen indicates that a task objects handled is more able to determine with some accuracy involving pushing or pulling is not administratively simple for employers their highest acceptable workload. designed within 75-percent of the to use and thus will enable employers Subjects were given a task with a set working population’s physical capacity. to more quickly and consistently frequency, distance, and height and While the screening threshold for evaluate jobs. were allowed to control the amount of pushing and pulling forces is based Similarly for contact stress, OSHA has force used. Subjects were instructed to upon an exposure level that is specified a frequency of 10 times per work as hard as they could without protective of 75 percent of the industrial hour when using the hand or knee as a straining themselves or becoming population based on psychophysical hammer. OSHA believes that this value unusually tired, weakened, overheated, measurements relating to overexertion, is also administratively simple and or out of breath. this should not be construed as an reasonable to use for the screening Although acute fatigue was the basis endorsement by the Agency of exposure purposes of this standard. Studies have of the limitations established by this to ergonomic risk factors based on what shown increased risk in MSDs among series of experiments, the results have is considered to be an acceptable level workers using the hand or knee as a been shown to predict the risk of for any given percentage of the hammer (e.g., Little and Ferguson, Ex. developing MSDs. Snook et al.(1978) population. The level chosen in this 26–1144 and Thun, Ex. 26–60). reported that workers performing instance resulted from the fact that the However, little data is available that manual handling tasks that less than evidence in the record indicates that an quantifies the frequency of exposure at 75% of workers are capable of increased risk of developing MSDs which increased risks are observed. performing without overexertion are exists among workers who perform Washington State chose a value of 10 three times more likely to suffer from pushing or pulling activities at levels times per hour for their ‘‘caution zone low back injuries than those workers above those found to be acceptable to 75 job’’ criteria. OSHA believes that this is performing manual handling tasks that percent of the industrial population a reasonable value to use for screening more than 75% of workers are capable based on psychophysical measurements purposes and that it gives the employer of performing (Ex. 26–35). relating to overexertion, not because any guidance in identifying work activities Other research has also supported a particular proportion of the exposed likely to contribute to the type of MSDs relationship between psychophysically population was considered to be reported. derived exposure levels and risk of protected from developing MSDs. In summary, the specific description MSDs. Using an index derived from the The 20-pound force criterion for of risk factors contained in the screen, tables developed by Snook and applying pushing and pulling tasks is consistent coupled with the duration it to 6,912 workers in 55 industrial jobs, with the OSHA ‘‘safe harbor’’ for specifications, all have a sufficient Herrin et al.(1986) found that the pushing/pulling, which is based on the degree of risk to trigger some simple number of overexertion incidents was 90th-percentile values for female additional requirements (job hazard related to the psychophysical stress of workers. Using 20 pounds as screening analysis, MSD management, training the job. The severity of these incidents criteria will help to ensure that and evaluation). It should be kept in

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This screen is illnesses have been approximately one health standards, the duration levels intended to be used in conjunction with third of all incidents. Nearly one-half of were set at levels where the risk begins the event of an MSD incident to identify lost time incidents have been reduced as to rise and additional, simple steps are work conditions where exposure risks well. * * * The guidelines have necessary. may exist such that a job analysis must fostered proactive efforts to eliminate The purpose of this screen is to focus be conducted to determine whether job ergonomic risks and hazards in a wide on those jobs that are likely to have controls are quickly and consistently ranging number of applications [Tr. caused or contributed to the MSDs that necessary. 4940]. are reported. In general, activities A complete discussion of the Paragraph (g)—What Actions Must I causing or contributing to such MSDs widespread support for the proposition Take if the Employee’s Job Meets the are more likely to be ones that make up that ergonomics programs are effective Action Trigger? significant amounts of the employee’s is contained in Chapter III of the Final worktime and represent a core element Paragraph (g) of the final rule defines Economic Analysis for the final rule. In of the employee’s job. As such, these the actions that employers must take if that chapter, OSHA discusses the activities are likely to be a foreseeable an employee with an MSD incident is history of successful ergonomics part of the job that can be reasonably employed in a job that meets or exceeds programs and describes the extensive predicted and thus can be taken into the action trigger. The paragraph use of ergonomic programs throughout account when designing an ergonomics requires that the employer must either broad sectors of industry. In fact, the program. These are the types of jobs that implement the Quick Fix option in number, longevity, and extensive use of OSHA seeks to capture under the final paragraph (o) of the final rule, or ergonomic programs that are similar to standard so that programs can be put in develop and implement an ergonomics those required by OSHA’s final rule place to prevent further MSDs from program that includes the following clearly validate the Agency’s regulatory occurring. elements: approach, as well as demonstrating the In order to better enable employers to (i) Management leadership as inherent feasibility of the standard for capture such jobs, OSHA is setting a specified in paragraph (h) of this covered employers who establish such minimum frequency for job or task section; programs. activities that must occur as a part of the (ii) Employee participation as Many of these programs have most or screening tool. OSHA is setting this specified in paragraph (i) of this section; all of the program elements required by frequency at one day per week or more. (iii) MSD management as specified by paragraph (g) of the final rule. The wide Obviously, there are numerous values paragraphs (p), (q), (r), and (s) of this use of these elements in current that could be chosen. However, OSHA section; programs is evidence that employers believes that this value can reasonably (iv) Job hazard analysis as specified believe them to be essential, workable be used to determine those job or task by paragraph (j) of this section; concepts. The program elements (v) Hazard reduction and control activities that are core element of an contained in the final rule are measures as specified in paragraphs (k), employee’s job, and are foreseeable or summarized and explained in other (l), and (m) of this section, and reasonably predictable. In addition, a sections of this preamble and therefore evaluations as specified in paragraph (u) frequency of once a week or more is will be discussed only briefly here in of this section, if the job hazard analysis likely to capture many work activities the context of the overall program determines that the job presents an MSD that are an element of an employee’s job requirement. that occur on a weekly basis (e.g., hazard; Paragraph (g) of the final rule (vi) Training as specified in paragraph deliveries or maintenance activities). To specifies that if an employee’s job meet the screen, a job must ‘‘routinely’’ (t) of this section. A few commenters suggested that the exceeds the action trigger, the employer involve tasks that meet the designated may implement a quick fix option for criterion at least one day a week. This effectiveness of ergonomics programs in reducing workplace MSD hazards was that job under paragraph (o). An value will also provide guidance in that employer who qualifies for the quick fix it can be used to rule out job or task not demonstrated for the proposed rule. For example, the post hearing brief option does not need to establish an activities that are rare occurrences, that ergonomics program, although he or she are not predictable, or that result from submitted on behalf of the U.S. Chamber of Commerce stated: must follow all of the quick fix unusual work circumstances. procedures. However, if the employer In conclusion, in response to the None of this ‘‘evidence’’ * * * begins to cannot or does not implement a quick comments received on the proposed support the proposition that an Ergonomics fix, then the standard requires an standard, OSHA has developed a Program Standard such as the one contained ergonomics program with the following screening tool that will provide in the Proposed Rule will reduce at all the employers with quantitative guidance incidence of workplace musculoskeletal elements: complaints. [Ex. 500–188] • Management leadership, for determining work activities and • Employee participation, conditions that are likely to cause or In contrast, the use of ergonomics • MSD management, contribute to MSDs and that are a core programs as an effective method for • Job hazard analysis, element of a job or make up a significant addressing workplace MSD hazards was • Hazard reduction and control, amount of the employee’s worktime. endorsed by the vast majority of • Training, and This screening tool includes specific commenters in the rulemaking record • Evaluation. descriptions of tasks and durations that (see, e.g. Exs. 30–3855, 32–185, 500– Management leadership is critical to will enable employers to evaluate jobs, 209, Tr. 4940, Tr. 1491). For example, the successful implementation and quickly and consistently, at their Mr. McCauseland, representing the operation of ergonomics programs.

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Management leadership provides the Evaluation is the process employers supported by a number of responses to focus and direction of the program’s use to ensure that the program they have the ANPR (see, e.g., Exs. 3–27, 3–124, 3– effort as well as the needed resources in established is functioning as intended. 173). terms of both personnel commitment Employers are required to evaluate their The elements of the proposed and and funding. The requirements for programs every three years and at other final management leadership management leadership are described in times if they have reason to beleive that requirements are based on the concept the summary and explanation for the program is not functioning properly. of management leadership expressed in paragraph (h). The requirements for program the literature. OSHA considers the Employee participation is equally evaluation are found in paragraph (a). proposed and final management important. Employees are essential In summary, ergonomic programs leadership provisions to be necessary to sources of information about MSDs, risk similar to OSHA’s in structure have the exercise of leadership of the factors, and MSD hazards in their work been effectively reducing the incidence ergonomics program. areas. They have valuable insights into and/or the severity of MSDs for at least Responses to the proposed effective control measures that can be 10 years throughout the vast majority of management leadership provisions used to reduce risk factors inherent in general industry sectors. Model indicated general support for the their jobs. The requirements for programs that contain OSHA’s program concept of management leadership. employee participation are described in elements have been implemented by a Comment on the provisions pertaining the summary and explanation for wide range of employers, such as large to the assignment and communication paragraph (i). and small manufacturing of responsibilities; provision of MSD management provides for establishments, utilities, and authority, resources, and information; prompt and appropriate management government agencies (see, e.g., Exs. 32– and periodic communication focused on when an employee has experienced an 185, 500–108, 38–50, Tr. 4693, Tr. 5696, the interpretation, rather than the MSD incident. MSD management Tr. 6310, Tr. 5931, Tr. 7031, Tr. 7068, concept, and often criticized the includes access to a health care Tr. 7074, Tr.7918, Tr. 7934, Tr. 7937, Tr. proposal as vague. Comments regarding professional, work restrictions as 7963, Tr.7948, Tr. 7999, Tr. 8826, Tr. policies and practices that discourage needed, work restriction protection, and 14707, Tr. 17350) reporting and participation revealed evaluation and follow-up of the MSD sharply divided opinion on the merits of incident. MSD management is important Paragraph (h)—Management Leadership the proposed provision. largely because it helps ensure that Paragraph (h) contains the final rule’s The importance of management employees promptly report MSDs and requirements for management leadership as a component of an signs and symptoms of MSDs. This, in leadership. It requires that employers effective ergonomics program was turn, ensures that jobs that present MSD assign and communicate responsibilities supported in a number of comments on hazards will be included in the for setting up and managing the the proposed rule (see, e.g., Exs. 30– ergonomics program. The requirements ergonomics program; provide the 2387, 30–3745, 30–3765, 32–78–1, 32– for MSD management are described in authority, resources, and information 85–3, 32–182–1, 32–198–4, 32–339–1, the summary and explanation for necessary to meet those responsibilities; 30–428, 30–3860, 30–4333, Tr. 3479, Tr. paragraphs (p), (q), (r) and (s). ensure that existing policies and 3565, 32–450–1–18–1, Tr. 8004, Tr. Job hazard analysis provides for the practices encourage and do not 1496, Tr. 9070). David LeGrande of the identification of the risk factors for jobs discourage reporting and participation Communications Workers of America, that meet the action trigger. The job in the ergonomics program; and for example, when asked to indicate hazard analysis provides a systematic communicate periodically with what characteristics distinguished approach to identifying and addressing employees about the program and their successful ergonomics programs from the risk factors in the job. The concerns about MSDs. those that fail, explained that the requirements for job hazard analysis are Paragraph (h) of the final rule is commitment of management is the described in the summary and nearly identical in content to the primary factor in determining if a explanation for paragraph (j). proposed management leadership program will succeed (Tr. 9018). Hazard reduction and control is the section (Section 1910.912). OSHA has The inclusion of a distinct heart of the ergonomics program. Under elected to retain the management requirement for management leadership this program element, employers control leadership requirements as proposed in the proposed ergonomics standard, the risk factors in problem jobs due to evidence in the record that however, was considered by some identified during the job hazard supports the need for management parties to be inappropriate (see, e.g., analysis. The requirements for hazard commitment in any effective Exs. 32–78–1, 30–2830, 30–3853, 30– reduction and control are described in ergonomics program. Minor changes 3765, 32–368–1, 500–223, 30–3426). the summary and explanation for have been made to clarify the provision Mandating the assignment of paragraphs (k), (l), and (m). regarding the assignment and responsibilities and provision of Training provides employees with the communication of responsibilities and authority, resources, and information, it information and understanding that to allow for more concise application of was argued, is so vague as to lead to they need to participate effectively in the subelement relating to the uneven enforcement by OSHA the ergonomics program. In addition, encouragement of reporting and personnel, according to these the training required by the final rule participation. commenters (see, e.g., Exs. 30–74, 30– provides the more detailed information OSHA proposed to require 240, 30–1336, 30–3284, 30–3336, 30– that supervisors, team leaders and other management leadership because the 3344, 30–3367, 30–3763, 30–3782, 30– employees involved in setting up and literature on ergonomics programs 3849, 30–3951, 30–4496, 30–4674, 30– managing ergonomics programs need to consistently cites management 4837, 30–4247). The Ameren carry out their program-related commitment as a vital component of an Corporation, for example, stated: responsibilities effectively. The training effective program (see, e.g., Exs. 2–13, Whether an employer has committed requirements are described in the 26–2, 26–5, 26–9, 26–10, 26–13, 26–14, enough ‘‘resources’’, has ‘‘ensured’’ that they summary and explanation for paragraph 26–17, 26–18, 26–22, 26–27). The need have encouraged their employees to report or (t). for management commitment was also participate, or is communicating often

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00059 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68320 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations enough are all highly subjective judgement employees about the program and their authority, resources, and information calls which cannot be consistently made by concerns about MSDs is similarly needed to do so. If a prompt, correct OSHA (Ex. 30–4247). essential to creating an environment response is given to the employee, then Bruno’s Supermarkets and others (see, where both the employer and employees the employer’s assignment of e.g., Exs. 30–2836, 30–2837, 30–2828, are fully aware of issues relating to the responsibility and provision of 30–2839, 30–2840, 30–2841, 30–2842, ergonomics program. If a regular, two- authority, resources, and information 30–2843, 30–2844, 30–2940) concurred way exchange does not take place, it will clearly have been satisfactory. with this assessment, stating: would be impossible for employees to The final rule does not describe how [The proposed standard] requires that keep abreast of changes in the responsibility is to be allocated or how employers communicate ‘‘periodically’’ with ergonomics program, or for the individuals will be held accountable for employees about the ergonomics program. employer to receive feedback regarding their responsibilities. This is to allow Suppose, for example, that an employer the program. Without full knowledge, employers the greatest possible distributes an annual ergonomics bulletin. the benefits of the program will be flexibility in adapting the program to How will the employer know whether an diminished. The endorsement of their particular situation. A concern was OSHA inspector will expect us to management leadership in comments registered that the proposed communicate more frequently, such as once and the incorporation of this element in requirement for assigning responsibility a week or once a month? This section also successful ergonomics programs would conflict with a management requires employers to provide those managing the ergonomics program with supports OSHA’s conviction that structure that did not include ‘‘resources,’’ which are vaguely and broadly management leadership is a critical supervisors (see, e.g., Ex. 30–3765). defined as ‘‘the provisions necessary to component of an ergonomics program. OSHA does not intend to prescribe what develop, implement, and maintain an Those who expressed the sentiment program responsibilities are vested in effective ergonomics program,’’ including that the management leadership any party. An employer may choose to money, etc. We may feel that we have requirements of the proposal were vague designate and empower front line provided adequate resources necessary for or burdensome appeared to believe that employees with any responsibility such an effort, but we will have no way of OSHA compliance personnel would associated with the program, so long as knowing whether the OSHA inspector will arbitrarily decide if the authority, the authority, resources, and agree. The lack of objective, attainable standards will leave employers at the whims resources, and information provided information necessary to meet those of OSHA inspection personnel. (Ex. 30–2836) were satisfactory, or if the frequency of responsibilities are provided. communication was adequate. OSHA The role that contractors, consultants, The term ‘‘periodically’’ was reaffirms its belief, expressed in the and other outside parties may play in an specifically cited by a number of parties proposal, that employers should retain ergonomics program has also been as being unduly subjective and open to broad discretion in deciding who recognized by the Agency. Although not interpretation (see, e.g., Exs. 30–1101, should bear responsibility for the required by the standard, OSHA is 30–1336, 30–3826, 32–337–1, 30–1671, various components of the ergonomics aware that outside expertise may be 30–3336, 30–3367, 30–3782, 30–4674, program, and what authority, resources, beneficial in some instances. 30–3512). Some commenters said that and information are necessary and Accordingly, the final rule allows the determinations about the delegation of appropriate to meet the assigned employer to chose who is designated authority and assignment of resources responsibilities in a given workplace. with regard to the assignment of were outside of OSHA’s expertise and The frequency of communication with responsibility. Ergonomists, safety created excessive administrative employees is also subject to wide professionals, industrial hygienists, and burdens on employers (see, e.g., Exs. latitude in order to account for the others may be involved in the 32–78–1, Tr. 12250). Such mandates needs of different workplaces. The term employer’s program. were believed by some to be beyond the ‘‘periodically’’ is used in the standard to Several commenters suggested that Agency’s authority (see, e.g., Exs. 30– indicate that communication must be OSHA place requirements on employees 2914, 30–4335). performed on a regular basis that is as well as employers in the final rule OSHA has decided to retain a appropriate for the conditions in the (see, e.g., Exs. 30–3765, 30–584, 30– requirement for management leadership workplace. A rigid schedule, however, 3368). These commenters believe that in the final rule. Management is not specified, in order to provide employees must take responsibility for leadership is widely believed to be one flexibility to account for the their actions. OSHA agrees that active of the core elements of any effective circumstances found in different employee involvement in the safety and health (including workplaces and even at different times ergonomics program is essential to ergonomics) program. If no individuals in the same workplace. Additional program effectiveness but does not in a given workplace have been assigned discussion of this topic can be found in believe that this principle should be responsibilities for the ergonomics the section of this preamble devoted to stated in the standard, for a number of program, it is clearly unreasonable to additional statutory issues (see Section reasons. First, the OSH Act itself, at expect that a successful program will XII of the preamble). Section 5(b), states that ‘‘Each employee somehow emerge. Likewise, if The general requirements in shall comply with occupational safety responsibilities are assigned but no paragraph (h) of the final rule for the and health standards and all rules, authority is granted and no resources assignment of responsibilities and regulations, and orders issued pursuant are provided, an ergonomics program is provision of authority, resources and to the OSH Act which are applicable to destined to fail. For example, if an information are designed to complement his own actions and conduct.’’ individual is assigned responsibility for the more specific requirements for However, the courts have repeatedly training workers in a problem job, that action found elsewhere in the standard. held that employers are responsible person needs access to relevant For instance, under paragraph (i) of this under Section 5(a)(2) of the Act for information about the MSD hazards and final rule, employees must receive ensuring worker protection. For controls in the job, sufficient time to prompt responses to reports of MSDs. It example, the court in Brock v. City Oil administer the training, and a suitable is the duty of the employer to assign the Well Service Co., 795 F. 2d 507, 511 (5th location for the training to take place. responsibility for providing those Cir. 1986) held, ‘‘it is the employer’s Communicating periodically with responses and to provide the necessary responsibility to ensure that the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00060 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68321 employees are protected. It may and employee participation elements of • Policies that require every accomplish this objective through others the final rule should be considered the employee reporting an MSD or MSD if it chooses, but the duty to provide the overall conceptual foundation of an signs and symptoms to submit to a drug protection remains the employer’s.’’ If, effective ergonomics program and a vital or alcohol test. for example, an employer has part of the organizational framework of • Direct or reasonably perceived determined that lifting an 80-pound box an effective program. By fully threats of retaliation, including firing or poses an MSD hazard to employees, the understanding the importance of suspension, withholding overtime work employer can establish a policy of management leadership and employee for anyone who reports MSD signs or requiring employees to use a participation, it is expected that symptoms, (even from jobs that do not mechanical lift to raise such a box and program managers will determine how involve exposure to risk factors), train employees how to do this. The best to apply these concepts in a prohibiting the use of sick leave for a employer could then hold the employee particular workplace and how the work-related injury; and sending every accountable for adhering to this policy individual subelements will work most employee who reports MSD signs and in the same manner as other policies or efficiently in their environment. Even symptoms home without pay. rules are enforced. where some overlap could be perceived, Expressed or implied warnings of In addition to providing authority, it is not OSHA’s policy to issue retaliation for reporting MSDs, MSD resources, and information, the duplicate citations for a single violation. signs and symptoms, or MSD hazards proposed management leadership The management leadership element would clearly be considered a practice section included a requirement to also includes requirements unique to that would discourage reporting. If, for provide the training necessary to meet this paragraph, such as the requirement example, a supervisor were to inform assigned responsibilities. Because in paragraph (h)(3). That requirement employees working the day shift that training for those responsible for setting specifies that the employer must ensure reporting MSD signs and symptoms up and managing the program is that their policies and practices would automatically result in transfer to addressed in paragraph (t) of this final encourage and do not discourage the night shift, this action could be rule, training has been deleted from this reporting or participation in the reasonably anticipated to suppress paragraph in order to avoid potential program. OSHA believes that applying reporting. An example of a situation confusion. this provision in an ergonomics program similar to this was described by the Some commenters expressed the is a logical component of management’s UFCW. The union explained that belief that management leadership is effort to direct the ergonomics program employees were reluctant to report implicit in an effective ergonomics in a manner that will be protective of injuries in this situation due to the program, and an independent employee health. consequences they would face: requirement for management leadership OSHA’s proposed requirement for [The company] had established a special is therefore unwarranted (see, e.g., Exs. employers to ensure that their existing ‘‘C’’ shift—the graveyard shift—for 30–3765, 30–1293). Dow Chemical, for policies and practices encourage and do employees suffering from work-related example, while strongly supporting the not discourage reporting and injuries, many of which were cumulative need for management leadership in participation in the ergonomics program trauma disorders. The purported purpose of safety and health activities, expressed elicited a substantial volume of the C shift crew was to assist injured workers the view that it is not appropriate for comment. As explained in the preamble with long term medical restrictions in OSHA to attempt to regulate and enforce of the proposal, this proposed provision returning to regular duty. In fact, however, a leadership. By establishing and was intended to encourage the early number of employees assigned to the crew were taken off regular duty jobs which they evaluating the effectiveness of an reporting of MSDs and meaningful had been performing successfully with their ergonomics program, Dow argued, the employee participation in the restrictions. They were then isolated and employer has in effect demonstrated ergonomics program. OSHA believes segregated on the C shift and assigned leadership (Ex. 30–3765). that employees in all workplaces should degrading, demeaning, make-work tasks such In a similar vein, some parties argued be encouraged by their employers to as picking up cigarette butts in the parking that the requirements for management report injuries, illnesses, and hazards of lot at night with flashlights or scraping rust leadership were largely redundant with all kinds—not just those related to off of pipes in the rendering department (Ex. 32–210–2). other sections of the proposal. They ergonomic issues—because only full pointed out, for example, that and frank reporting allows employers to Some employers have taken this a communicating periodically with identify hazards and do something step further, pursuing policies that employees about the ergonomics about them. discipline workers for reporting injuries, program and their concerns about MSDs Particular attention was paid by without considering the cause of those was part of the proposed management participants regarding the requirement injuries. When rewards or punishment leadership provision, while separate, that employers ensure that their policies are linked to the reporting of MSDs or specific requirements for and practices do not discourage MSD signs and symptoms, employee communication with employees were reporting and participation in the reporting behavior can clearly be proposed as part of the provisions program, and the effect of this provision influenced. Punishment for reporting in pertaining to quick fix, employee on existing employer programs, the form of wage reductions, loss of participation, hazard information and including safety incentive programs and overtime, reprimands, suspensions, or reporting, job hazard analysis and employee drug testing programs. other means can be expected to control, training, MSD management, and Policies and practices given in the discourage reporting. program evaluation. This ‘‘duplication,’’ preamble to the proposal as examples of An example of this approach is a it was argued, could subject employers those that may discourage reporting system of imposing progressively more to being cited twice for a single included: severe penalties when injuries are violation (see, e.g., Exs. 30–3344, 30– • Programs that reward or punish reported, such as a written reprimand 4674). employees on the basis of injury or for the first incident, followed by OSHA believes that there is little, if illness reports by offering incentives or suspension, and finally termination any, overlap with other parts of this awards based on low numbers or rates (see, e.g., Exs. 32–298–2). Another standard. The management leadership of reported MSDs. example is a system that assigns a point

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68322 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations value to an incident based on factors go. And one of the workers got hurt. And the should not discourage employers from such as the cost of the incident to the rest of his coworkers told him, ‘‘Hey, you go utilizing all necessary injury/illness employer or whether lost workdays to medical, there goes the microwave.’’ And prevention tools. There is no basis for the were involved. Progressive levels of this guy realized that his health was more proposed Ergonomics Standard to suggest important than some microwave. But a good punishment are meted out based upon that these effective programs should be many of his coworkers wouldn’t even talk to subject to further scrutiny (Ex. 30–3843). the number of points that an employee him for a couple of weeks as a result of that accumulates (see, e.g., Ex. 500–111–1). (Tr. 15453). Sufficient evidence has already been Kathy Saumier of the United entered in the record, however, for Dr. Richard Bunch of the Industrial Steelworkers described such a program OSHA to reach the conclusion that Safety and Rehabilitation Institute told and its results in the plastics plant MSDs are substantially underreported of an injury sustained but not reported where she worked: (see the discussion of underreporting in early, in order to preserve workers’ the Significance of Risk section of this The company had a policy to give out chances of winning a barbeque pit: points if an employee missed work even due preamble as well as the Benefits chapter to work related injury. After an employee One company was giving a barbeque pit as of the Final Economic Analysis). accumulated seven points, the company a prize if you went so many months without Evidence also supports the belief that reduced the employees’ pay by 50 cents per reporting an injury. And one gentleman had employer policies and practices often a back problem and did not report it because hour. If the employee accumulated 15 points contribute to this underreporting by an employee was then terminated. This the other six members on his team threatened system caused many workers to go to work him with violence. So in that case, he did not discouraging the reporting of MSDs. injured for fear of pay reduction or report it, but ended up going to a full blown A review of the literature on safety termination (Tr. 10992). frank rupture of the disc (Tr. 11638). incentives commissioned by OSHA and The record also included many These accounts of individuals support published in 1998 divided incentive instances where, intentionally or the impression that incentive programs programs into two categories based on inadvertently, employer policies and that tie rewards or punishment to the the behavior they reward. The review practices were said to discourage report of an injury may result in found that the literature strongly employees from reporting MSDs (see, reductions in reported injuries and indicates that programs that measure e.g., Exs. 20–626, 32–111–4, 32–198–4– illnesses, at least in part due to lack of safe work practices, such as wearing 1, 32–198–4–2, 32–210–2, 32–298–2, Tr. reporting rather than an actual safety glasses for eye protection or using 5598, Tr. 6980, Tr. 7715, Tr. 7729, Tr. reduction in the number of injuries that a seat belt when driving, may increase 7387, Tr. 7730, Tr. 8041, Tr. 10153, Tr. occur. Nancy Lessin of the the frequency of such practices. The 10230, Tr. 10763, Tr. 13870, Tr. 14535, Massachusetts AFL–CIO espoused this literature review further disclosed that Tr. 15131, Tr. 15453, Tr. 16766). view: incentive programs that focus on reductions in the number of injuries and Incentive programs that offer rewards Workers can not control the conditions to employees or groups of employees which lead to most work-related injuries and illnesses reported do not improve safety based on a low number of reported illnesses. They can control whether or not practices. No scientific studies were injuries were also mentioned as factors they report an injury or illness. Safety found indicating that such programs inhibiting the reporting of MSDs. Bill incentive programs manipulate the thing had either a positive or a negative Byington of the IBT described how workers can control—the reporting of impact (Ex. 502–281). employees in his workplace were being workplace injuries and illnesses * * * (Ex. Some policies and practices can affect taken to a baseball game for completing 32–298–2). employee participation in the a month of work without a reported The United Steelworkers concurred ergonomics program, as well as injury; he was aware, however, that at with that assessment: employees’ incentive to report. least one of the members of the group We know better than to believe that worker Employees who are punished or had sustained an injury and not behavior is the primary cause of most discouraged from reporting MSDs or reported it (Tr. 15453). Sandy Brooks of workplace accidents. We know that exposure MSD signs and symptoms, may also feel the United Steelworkers related her to workplace hazards causes injuries and discouraged from participating in any experience with a ‘‘safety bingo’’ illness and exposure to ergonomic hazards meetings or discussions about program, where employees receive a causes MSDs. Ergonomic hazards need to be ergonomic problems in the workplace bingo number each day, and the controlled to eliminate MSDs in the same and how to address them. If a worker is manner that we address any workplace employee who wins the bingo game hazard. Incentive programs based on injury threatened with retaliation for pointing receives cash, weekend trips, and rates, and behavior-based safety programs do out hazards or for participating in a job dinners as prizes. The bingo game ends not correct hazards. In fact, these programs hazard analysis, that worker and his or for all employees, however, when an can make a bad situation worse by diverting her co-workers are unlikely to take part OSHA recordable injury is reported. Ms. attention from correctable hazards, and in this activity or future activities. Brooks was also aware of workers who promoting the under reporting of injuries (Ex. Employees are likely to be discouraged did not report injuries because of the 32–111–4). from requesting information to which incentive program (Tr. 7703). Several commenters argued that they may be entitled, such as training An additional factor in group OSHA had not made a determination materials or information about this incentive programs that can serve to that incentive programs result in the standard, if they fear retaliation or if coerce employees to refrain from underreporting of MSDs (see, e.g., Exs. obtaining the information is made reporting MSDs is the peer pressure that 30–4185, 30–1070, 30–3347, 30–4185). inconvenient. Likewise, if employees in can be exerted when group awards are The Synthetic Organic Chemical a problem job are asked for at stake. Joe Enos of the UAW described Manufacturers Association suggested recommendations about eliminating or the result of an incentive program that that OSHA obtain data to support its controlling MSD hazards, but are offered a microwave oven to a team of position, stating: required to attend a meeting at an workers if they reduced reported If OSHA believes that employers are not unreasonable time in an inconvenient injuries 25% from the previous year: properly reporting injuries and illnesses, it place, or that may involve loss of pay in The group had achieved that goal going should address this issue by gathering the order to submit those recommendations, into November and they still had a month to data to substantiate its position. OSHA the likelihood of those employees

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68323 participating in the process would be In contrast to the comments 1364, 601–x–1365, 601–x–1366, 601–x– diminished. describing the pressures on employees 1367, 30–1416, 30–1453, 30–1457, 30– Some commenters were concerned not to report MSDs, a number of parties 1616, 30–1998, 30–1999, 30–2131, 30– that a wide variety of employer policies were concerned that the proposed 2142, 30–2184, 30–2233, 30–2250, 30– and practices could have the potential prohibition on policies or practices 2304, 30–2395, 30–2396, 30–2423, 30– to impact employee participation and could inadvertently eliminate widely 2431, 30–2736, 30–2829, 30–2889, 30– reporting of injuries; even a review of a accepted, sensible, and successful safety 2891, 30–2992, 30–3003, 30–3254, 30– manager’s or supervisor’s performance practices. Many commenters indicated 3334, 30–3393, 30–3551, 30–3597, 30– could be found to constitute a violation concern that the proposed prohibition 3791, 30–3882, 30–3936, 30–3944, 30– of the standard when performance on policies or practices that discourage 3974, 30–3977, 30–3999, 30–4464, 30– criteria in that review include the worker reporting could be interpreted to 4532, 30–4539, 30–4544, 30–4629, 30– number of injuries and illnesses eliminate demonstrably successful 4657, 30–4667, 30–4669, 30–4980, 30– recorded by employees under his or her employee incentive programs (see, e.g., 5034, 30–5076, 30–5095, 30–5101, L30– supervision (Ex. 30–4185). Exs. 30–3765, 32–368–1, 30–656, 30– 4952, L30–4953, L30–5096). OSHA is concerned with the effect of 1048, 30–1070, 30–1349, 30–1551, 30– Caterpillar Inc., for instance, attested a policy on employees’ participation in 1567, 30–1616, 30–1652, 30–1671, 30– to the favorable impact of incentive the ergonomics program and whether 1901, 30–2038, 30–2050, 30–2061, 30– programs in that firm: the program or policy discourages 2499, 30–2514, 30–2799, 30–2811, 30– Incentive programs have always been an reporting. In some cases, making the 2812, 30–2814, 30–2815, 30–2846, 30– excellent vehicle to raise awareness, number of injuries and illnesses 2988, 30–2990, 30–3086, 30–3174, 30– communicate various issues throughout the recorded a part of a manager’s 3177, 30–3336, 30–3349, 30–3353, 30– workplace and show employer concern about performance review can result in a 3354, 30–3678, 30–3721, 30–3736, 30– employee safety. While OSHA considers policy the discourages reporting. Larry these programs to be disincentives [to the 3745, 30–3819, 30–3848, 30–3951, 30– reporting of MSDs and MSD signs and Hall of the United Food and 4122, 30–4185, 30–4334, 30–4496, 30– Commercial Workers described such a symptoms], our experience shows that they 4540, 30–4607, 30–4674, 30–4702, 30– have positive benefits. By increasing situation. 4818, 30–4822, 30–4839, 30–4843, 31– awareness and rewarding safe behaviors One of the things that happens with the 310, 32–21–1, 32–82–1, 32–120–1, Tr. through incentive programs, employers have [manager] bonuses is the worker reports a 10445, Tr. 11502, Tr. 12857, Tr. 16924, seen a reduction in all injury categories (Ex. problem, and the manager immediately tells Tr. 17461, Tr. 17483, 30–4340, 500–1– 30–4607). them how that is going to affect their bonus. 28, 500–1–29, 500–1–42, 500–1–69, If you are working for me and I say, ‘‘Gee, Nothing in this final rule would that is going to really affect my bonus. So, for 500–1–70, 500–1–79, 500–1–86, 500–1– prohibit incentive or award programs. the rest of your life, you get to work nights,’’ 95, 500–1–106, 500–1–112, 500–1–113, The obligation that an employer would these people write their schedules. They 500–1–114, 500–1–136, 500–1–147, have, should they chose to adopt an control their lives. If you are going to 500–1–181, 500–1–117, 500–1–119, incentive program, would be to ensure displease me and take money out of my 500–1–121, 500–1–124, 500–1–125, that the incentive program did not pocket, I can really do a lot to you and stay 500–1–127, 500–1–135, 500–1–137, discourage the reporting of MSDs, MSD within the union contract. (Tr 14538) 500–1–152, 500–1–193, 500–1–442, 32– signs and symptoms, or MSD hazards, OSHA finds that the evidence 258–2, 30–911, 30–1942, 30–3236, 30– or discourage participation in the strongly demonstrates that employer 3339, 500–219, 601–x–1710, 601–x– ergonomics program. As explained policies and practices that reward non- 1711, 30–4527, 30–980, 30–2668, 30– previously, OSHA’s concern is that reporting and punish, threaten, or 4565, 30–3847, 30–2684, L30–4985, 30– discouraging full reporting and otherwise discourage employee 4029, 30–4335, 30–4443, 30–1004, 30– participation in the ergonomics program reporting of MSD incidents have the 1010, 30–1017, 30–1025, 30–1027, 30– will diminish the effectiveness of the effect, in many instances, of suppressing 1035, 30–1038, 30–1042, 30–1044, 30– program. incident reports. This conclusion is 1045, 30–1079, 30–1080, 30–1089, 30– Although incentive programs that are based on the strong record presented by 1099, 30–1163, 30–1164, 30–1401, 30– successful in promoting workplace witnesses and documentary 1403, 30–1423, 30–1424, 30–1436, 30– safety can be expected to result in a submissions as well as on the logic that 1440, 30–1455, 30–1460, 30–1463, 30– reduction in the number of injuries providing incentives to not report 1495, 30–1497, 30–1566, 30–1658, 30– reported, an unsuccessful program that accidents or illnesses is likely to reduce 1659, 30–1674, 30–1675, 30–1682, 30– does not improve workplace safety can the number of such reports, but unless 1684, 30–1685, 30–1686, 30–1687, 30– also result in fewer reported injuries. the cause of those incidents is 1688, 30–1689, 30–1690, 30–1691, 30– When the yardstick for measuring the addressed, it is unreasonable to believe 1916, 30–2124, 30–2126, 30–2234, 30– success of the program is only the that MSD incidents themselves will be 2235, 30–2236, 30–2237, 30–2275, 30– number of injuries reported, the reduced in number. The litany of case 2279, 30–2311, 30–2369, 30–2376, 30– program can distort the true state of reports in the record where employer 2588, 30–2673, 30–2674, 30–2768, 30– affairs and preclude early intervention policies and practices were said to deter 2850, 30–2925, 30–3002, 30–3042, 30– by inducing employees to avoid reporting reinforce this position. The 3044, 30–3080, 30–3083, 30–3087, 30– reporting their injuries. This problem is concealment of MSD incidents would in 3229, 30–3380, 30–344, 30–346, 30– particularly critical with regard to MSD fact have an effect directly opposed to 3822, 30–3985, 30–3988, 30–4037, 30– signs and symptoms, where early the purpose of this standard. Hazards 4059, 30–4507, 30–4770, 30–4841, 30– intervention can be of great importance. that would otherwise be identified and 5044, 30–5106, 30–634, 30–636, 30–638, OSHA encourages employers to focus eliminated or controlled would remain 30–643, 30–649, 30–871, 30–883, 30– any incentives on safe work practices, and continue to threaten employees. 891, 30–903, 30–905, 30–918, 30–978, active participation in safety programs, MSD incidents that, if reported, could 30–994, 30–995, 600–x–10, 600–x–11, and identification of hazards in the be limited in severity through rest or 600–x–12, 600–x–13, 600–x–45, 600–x– workplace. By doing so, the root causes treatment would instead be allowed to 46, 600–x–5, 600–x–6, 600–x–7, 600–x– of injuries and illnesses can be progress. 9, 601–x–1358, 601–x–1363, 601–x– addressed, and a safer workplace can be

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00063 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68324 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations created. The Incentive Federation 500–1–137, 500–1–152, 500–1–193, scheme. In addition, any such inhibiting described the types of activities that a 500–1–411, 500–1–384, 500–1–385, effect is more than outweighed by the safety incentive program can target, 500–1–386, 500–1–413, 500–1–423, workplace accidents and injuries that are rather than using the number or rate of 500–1–442, 500–16, 500–52, 500–23–1, avoided through maintenance of an effective drug-free workplace program (Ex. 30–3819) reported injuries as its objective: 32–258–2, 30–904, 30–911, 30–1942, OSHA is not aware of any basis for ***a good safety incentive program 30–3236, 30–3339, 500–219, 30–4550, often focuses on proactive behavior. For 601–x–1711, 30–1363, 30–4248, 30– concluding that the development of example, it might encourage employees to 4778, 30–2455, 30–4527, 30–2668, 30– MSDs is in any way associated with the make safety suggestions, attend safety 4565, 30–3847, 30–2684, L30–4985, 30– use of drugs or alcohol. The reporting of meetings, promote safety awareness, 3472, 30–3582, 30–4029, 30–4335, 30– MSDs or MSD signs and symptoms participate in safety inspections, report safe 4443, 30–4475, 30–4528, 30–4688, 30– covered under this rule, therefore, behavior, report near misses, and so forth. In 1004, 30–1010, 30–1017, 30–1025, 30– cannot be considered by itself to addition, self-directed safety teams, where 1027, 30–1035, 30–1038, 30–1042, 30– provide any justification for testing. employees observe each other at work and Although subjecting all parties reporting report good and bad safety conduct (without 1044, 30–1045, 30–1079, 30–1080, 30– necessarily using the names of the specific 1089, 30–1099, 30–1163, 30–1164, 30– injuries or all OSHA recordable cases to employees), encourage safe behavior. 1401, 30–1403, 30–1423, 30–1424, 30– testing has sometimes been used by Encouraging this type of employee 1436, 30–1440, 30–1455, 30–1460, 30– employers as a matter of administrative participation is extremely useful, because 1463, 30–1495, 30–1497, 30–1566, 30– convenience in identifying individuals employees are reasonably objective in 1658, 30–1659, 30–1674, 30–1675, 30– for testing, the lack of a relationship observing their peers, and they report good between drug or alcohol use and the and bad behavior. The conduct observed can 1682, 30–1684, 30–1685, 30–1686, 30– 1687, 30–1688, 30–1689, 30–1690, 30– MSDs covered by this rule, along with then be included in periodic reports or the detrimental effect on reporting reviewed in safety meetings to stress safe 1691, 30–1916, 30–2124, 30–2126, 30– behavior. (Ex. 30–1100). 2234, 30–2235, 30–2236, 30–2237, 30– behavior that testing can have, combine to make this an inappropriate practice Drug testing programs, when applied 2275, 30–2279, 30–2311, 30–2369, 30– 2376, 30–2588, 30–2673, 30–2674, 30– where MSDs are concerned. to all workers who report MSDs, were Furthermore, there is no evidence that 2768, 30–2850, 30–2925, 30–3002, 30– also said to hinder full reporting of drug tests discourage workers from 3042, 30–3044, 30–3080, 30–3083, 30– injuries. Chuck Monohan of the reporting injuries only if they fear that 3087, 30–3229, 30–3380, 30–344, 30– International Brotherhood of Electrical drug use will be discovered. Adrienne 346, 30–3822, 30–3985, 30–3988, 30– Workers explained that a fear of false Markowitz of the UFCW described a 4037, 30–4059, 30–4507, 30–4770, 30– positive results was responsible for non- poultry processing plant where workers 4841, 30–5044, 30–5106, 30–634, 30– reporting (Tr. 7378). Other commenters who reported pain in the hands and 636, 30–638, 30–643, 30–649, 30–871, also discussed the chilling effect that wrists were required to be tested for 30–883, 30–891, 30–903, 30–905, 30– drug testing programs can have on illegal drugs: reporting injuries (Tr. 5997, Tr. 13869, 918, 30–978, 30–994, 30–995, 600–x–10, 600–x–11, 600–x–12, 600–x–13, 600–x– This is a church going and religious Tr. 17509) community. Most people were not worried A large number of commenters 45, 600–x–46, 600–x–5, 600–x–6, 600– x–7, 600–x–9, 601–x–1358, 601–x–1363, that drugs would be found because they expressed concern that the proposed didn’t take them. But they weren’t happy prohibition on policies or practices that 601–x–1364, 601–x–1365, 601–x–1366, with having to suffer the indignities of discourage worker reporting could be 601–x–1367, 30–2410, 30–2289, 30– having someone watch them urinate, were interpreted to eliminate widely accepted 3877, 30–2601, 30–3160, 30–3598, 30– afraid that inaccurate testing and laboratory drug testing policies (see, e.g., Exs. 30– 2912, 30–1332, L30–5025, 30–4280, 30– practices [would erroneously indicate illegal 536, 30–2208, 32–368–1, 30–3765, 30– 1416, 30–1453, 30–1457, 30–1616, 30– drug use], were concerned that the medications they took would show up as 419, 30–519, 30–1012, 30–1048, 30– 1998, 30–1999, 30–2131, 30–2142, 30– 2184, 30–2233, 30–2250, 30–2304, 30– illegal drugs, and [were] fearful that the 1070, 30–1261, 30–1332, 30–1348, 30– company supervisors would doctor the 1349, 30–1358, 30–1536, 30–1551, 30– 2395, 30–2396, 30–2423, 30–2431, 30– records. Many, for the reasons I have just 1567, 30–1616, 30–1652, 30–1671, 30– 2736, 30–2829, 30–2889, 30–2891, 30– stated, refused to take the test and were fired. 1901, 30–2050, 30–2061, 30–2499, 30– 2992, 30–3003, 30–3254, 30–3334, 30– And many others just never reported their 2514, 30–2645, 30–2675, 30–2799, 30– 3393, 30–3551, 30–3597, 30–3791, 30– illnesses (Tr. 5998). 2811, 30–2812, 30–2814, 30–2815, 30– 3882, 30–3936, 30–3944, 30–3974, 30– This rule does not in any way prevent 2988, 30–2990, 30–3174, 30–3177, 30– 3977, 30–3999, 30–4464, 30–4532, 30– an employer from conducting testing if 3348, 30–3349, 30–3353, 30–3356, 30– 4539, 30–4544, 30–4629, 30–4657, 30– it is required by law, is based on 3359, 30–3721, 30–3723, 30–3736, 30– 4667, 30–4669, 30–4980, 30–5034, 30– reasonable suspicion, is part of the job 3745, 30–3819, 30–3951, 30–4046, 30– 5076, 30–5095, 30–5101, L30–4952, application process, is part of routine 4122, 30–4567, 30–4607, 30–4628, 30– L30–4953, L30–5096). fitness-for duty examination, is done as 4674, 30–4702, 30–4713, 30–4818, 30– The sentiment that the contribution of follow-up after entering an employee 4822, 30–4839, 30–4844, 31–282, 31– drug-testing programs to workplace assistance or drug rehabilitation 298, 31–310, 32–335, Tr. 4335, Tr. 4909, safety should not be compromised by program, or is administered to assist in Tr. 6112, Tr. 8350, Tr. 9190, Tr. 10444, the requirements of the ergonomics post-accident investigation. A blanket Tr. 12857, Tr. 12958, Tr. 15621, Tr. standard was expressed by Food policy that requires all employees 15644, Tr. 15976, Tr. 17461, Tr. 17483, Distributors International: reporting MSDs or signs and symptoms 30–3725, 30–4340, 30–4146, 500–1–28, In the view of FDI and its members, the of MSDs to submit to drug or alcohol 500–1–42, 500–1–69, 500–1–70, 500–1– possibility that some individuals will feel testing, however, would hinder the 79, 500–1–86, 500–1–95, 500–1–106, constrained to avoid reporting workplace effectiveness of the ergonomics program 500–1–112, 500–1–113, 500–1–114, injuries or accidents because of a drug test requirement that might be triggered is not an if such a policy results in 500–1–136, 500–1–140, 500–1–147, overriding concern. These fears largely will underreporting. 500–1–181, 500–1–185, 500–1–117, relate only to those whose drug use may be Nor is the fear that a back injury or 500–1–119, 500–1–121, 500–1–124, discovered, and their protection should not other MSD may be the result of an 500–1–125, 500–1–127, 500–1–135, be the goal of a major OSHA regulatory accident caused by drug or alcohol use

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00064 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68325 a reason for testing employees for drugs to show negligence on the part of a local Any regulation that has provisions for when reporting an MSD or MSD signs government that allowed ‘‘waivers’’ of its employees ‘‘not feeling discouraged’’ would or symptoms. As stated in paragraph (a), alcohol and drug testing ordinances for be impossible to enforce fairly. For example, this standard does not address injuries employees in order to permit full and free identical employer conduct could be legal in reporting of MSDs (Ex. 30–4810). one plant, or part of a plant, and illegal in caused by slips, trips, falls, vehicle another and the employer might never know accidents, or other similar accidents. OSHA’s concern is that testing not be it (Ex. 500–1–28). The standard addresses injuries that are conducted in a manner that penalizes In order to provide an objective basis the result of exposure to force, individuals reporting MSDs or for enforcement of this provision, OSHA repetition, awkward postures, vibration, participating in ergonomics programs. has concluded that a pattern of and contact stress. Injuries covered by This final rule does not restrict underreporting must be evident in the the standard are commonly associated employers’ drug or alcohol testing workplace before a determination will with prolonged or excessive exposures policies where such policies are be made that any given employer policy authorized by state or federal law. It to these ergonomic risk factors. There is or practice discourages reporting of should be noted, however, that DOT no reason to believe that drugs or MSDs or signs and symptoms of MSDs. regulations, which require post accident alcohol have any relevance to the If underreporting or discouragement of testing and testing of safety sensitive development of these conditions and employee participation in the employees and under certain other certainly no evidence that impairment ergonomics program is found at a circumstances, do not require drug at the time of reporting has any particular establishment as a result of a testing when MSDs or any other type of relevance. Simply reporting MSD signs records review or employee interviews, injury or illness is reported. and symptoms therefore cannot be OSHA will evaluate the situation to viewed as a legitimate reason to suspect Workers compensation and other state determine if employer policies and drug or alcohol abuse. and federal laws that require drug practices have had the effect of Some commenters argued that if an testing following a traffic or other discouraging reporting or participation ergonomics standard did restrict drug accident, are also not generally relevant in the ergonomics program. OSHA’s testing programs, this could conflict to the application of this standard, position is that these policies and with regulatory requirements of the because as explained above, MSDs procedures are not per se illegal, but Department of Transportation or resulting from accidents, slips, trips and they can clearly discourage reporting Nuclear Regulatory Commission, or falls are specifically exempted from this and participation. If an employer has with policies established through rule. policies or procedures with this collective bargaining (see, e.g., Exs. 30– A number of employee potential, the employer must ensure that 3853, 30–3765, 30–1070, 30–1332, 30– representatives expressed the opinion these policies and procedures are not 1671, 30–3284, 30–3359, 32–335, Tr. that policies or practices that can actually discouraging reporting or 15621, 500–1–28, 30–4527, 30–4029, discourage worker participation in the participation. 30–4475, 30–4248). Restrictions on drug ergonomics program, such as incentive OSHA expects that employers will testing were also said to conflict with programs and post-injury drug testing, have ample opportunity to discover requirements for companies with should be explicitly prohibited in the whether employees are being government contracts (see, e.g., Exs. rule (see, e.g., Exs. 32–339–1, 32–111– discouraged through the periodic 601–x–1711, 30–4475). 4, 32–198–4, 32–210–2, 500–50). Absent communication that will take place Language in the proposal that could such a prohibition, it was argued, an under the standard. If policies and affect certain employer drug testing ergonomics standard triggered by practices are determined to discourage policies was said to conflict with state employee reports of injury would be reporting or participation, employers workers’ compensation laws, and thus undermined by employers who would would need to take action to remedy violate Section 4(b)(4) of the pressure employees to avoid reporting this situation. Occupational Safety and Health Act. injuries. These commenters argued that OSHA considers it important that the State workers’ compensation laws, it the case-by-case determination employer not only not discourage, but was said, may require drug testing in approach described in the preamble to actively encourage reporting and certain instances, allow reduced the proposal would be inadequate to participation in the ergonomics insurance premiums for those deter practices that discourage program. The Agency believes that this employers with testing programs, or participation and reporting, and a goal can be accomplished by providing allow impairment to be used as a blanket prohibition in the rule itself is information to employees about the defense in contesting compensation necessary. importance of early reporting in claims (see, e.g., Exs. 500–104, 500– Some parties indicated that they did accordance with paragraph (d), along 104–1). not find the proposal sufficiently clear with effective training on reporting and It was argued that restrictions on drug in indicating what policies or practices the ergonomics program in accordance testing programs could result in liability would be considered by OSHA to with paragraph (t) of this final rule. claims against those employers whose discourage worker participation in the Several parties asked whether the employees acted in an unsafe manner ergonomics program (see, e.g., Exs. 30– proposed prohibition on policies or due to impairment. The New Mexico 3853, 30–4185, 32–337–1, 30–653, 30– practices that discourage reporting Self Insurers Fund stated: 1350, 30–2216, 30–3233, 30–3344, 32– would apply to an employer’s decision OSHA may have had the best intentions 82–1, 30–1101, 500–33). Concern was as to whether or not an employee can when writing the preamble, however if state expressed that compliance would be work overtime (see, e.g., Exs. 32–368–1, and local government municipal employers dependent upon whether or not 30–2208, 30–3765, 30–1671, 30–2050, were to neglect the possibility that alcohol employees feel discouraged, and would 30–2499, 30–3344, 30–3348, 30–3356, and drug use was a factor in an injury, whether or not it is an MSD, municipal thus be determined by the subjective 30–4628, 30–4674, 500–1–140). liability would rise exponentially. The perceptions of employees (see, e.g., Ex. Withholding overtime, it was argued, bottom line is that many local governments 30–3853, 30–4247, 500–33, 32–266–1). may be based on a desire to prevent would not be immune from lawsuits where TXU Business Services, for example, aggravation of the potential MSD, and gross negligence is alleged. It would be easy stated: limiting the employer’s ability to restrict

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00065 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68326 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations overtime would thus conflict with compensation systems or production collective bargaining agent, have ways provisions in the proposed standard that incentives are abandoned (Ex. 30–4362). to report MSDs, MSD signs and allow employers to use administrative OSHA recognizes that these systems symptoms, and MSD hazards; that controls (Ex. 30–1671). The Association sometimes cause employees to expose employees receive prompt responses to of Independent Corrugated Converters themselves to MSD hazards in order to those reports when they are made; that stated: achieve higher rates of compensation. access to the standard and to While some employers do not choose to Because piece rate incentives are not information about MSDs and the impose such restrictions, it seems directly tied to reporting or ergonomics program be provided to unfathomable that involuntary restrictions on participation in the ergonomics employees; and that employees have some overtime work would be deemed an program, however, the Agency does not ways to be involved in the development, inappropriate management step, both before view them as potential sources of implementation, and evaluation of the and after symptoms reported by employees discouragement to reporting and ergonomics program. are analyzed by a health care provider. The participation. With full participation in The requirements of paragraph (i) essence of some MSDs, at least in OSHA’s the ergonomics program, employees closely correspond with the own construct of such conditions, is that overuse in the form of ‘‘excessive’’ repeated compensated under these systems will requirements of the proposed employee exposure is the source of problems in many be provided with the protections of the participation section. This reflects circumstances. It seems oddly inconsistent ergonomics standard, including the OSHA’s determination, based on that on the one hand, the overall thrust of the information and training that will confer evidence in the record, that the ‘‘incremental abatement’’ and job re-design with it the ability to recognize the involvement of employees and their obligation of OSHA’s full ergonomics potential causes of MSDs and representatives in an ergonomics program will focus on avoiding or reducing knowledge of the importance of early program is critical to the effectiveness of exposures, while on the other, an employer’s intervention. the program. It also reflects the support judgement to limit additional exposure is Several commenters (see, e.g., Exs. for the proposed employee participation retaliatory or aimed at discouraging reporting (Ex. 500–1–140). 30–3853, 30–4247) argued that provisions expressed by commenters. subjecting an employer to citation for The proposed employee participation As with incentive programs and drug maintaining policies or practices that requirements were designed to cover and alcohol testing policies, OSHA’s discourage worker participation would those circumstances where the concern about withholding overtime is be contrary to the intent of Congress. involvement of workers was essential to based on the discriminatory application These commenters argued that, by the success of an ergonomics program. of this practice to discourage reporting placing a discrimination provision in The duty to establish a means of or participation in the ergonomics Section 11(c) of the OSH Act, Congress reporting and to provide prompt program. The Agency realizes that work had made clear that anti-discrimination responses to reports was included restrictions, including limitations on the provisions should not be included in because of the vital importance of an number of hours worked, are often standards. These commenters therefore effective reporting system to the proper necessary to prevent an injured believe it inappropriate for OSHA to function of the injury-based trigger of employee’s condition from worsening include a discrimination provision in an the standard. Access to the standard and and to allow damaged tissues to recover. ergonomics standard. information about the ergonomics The provision of work restrictions, Paragraph (h)(3) of the final rule is program was considered by the Agency however, must be viewed separately intended to prevent employers not only to be necessary for employees to from the reporting of MSDs and MSD from discriminating against employees participate effectively in the ergonomics signs and symptoms. for reporting and participating in the program. Employee input into the If overtime is withheld as a matter of ergonomics program, but also to prevent development, implementation, and policy simply because a report of an employers from having policies that evaluation of ergonomic programs was MSD has been made, this could have the discourage employees from reporting considered critical to program success effect of discouraging reporting. An and participating, even where no because of the first-hand knowledge that example of such a situation would be an discrimination has taken place. employees could offer regarding employee who uses a keyboard in a Paragraph (h)(3) thus has a different potential solutions to MSD hazards, the steady manner for eight hours per day, scope than section 11(c). In addition, appropriate content and level of then works an additional two hours as insofar as paragraph (h)(3) addresses training, and the effectiveness of control a receptionist and does not perform any discrimination, it does so as part of a measures. work involving typing or hand activity broader standard that is reasonably The proposed provisions for during that two hours. If this employee necessary and appropriate to address a employee participation generated a were to report the signs and symptoms serious hazard . Nothing in Section considerable volume of comment. of an MSD of the wrist, and as a matter 11(c) indicates that a standard issued in Support for the concept of involving of policy was denied the opportunity to accordance with Section 6(b) may not employees in the ergonomics program work overtime as a receptionist but include such a provision. Provides a was widespread among commenters, continued working eight hours at a different enforcement mechanism than and few disagreed with the proposed keyboard, the effect would be to section 11(c), and nothing in section requirements pertaining to reporting, discourage reporting and would be 11(c) indicates that it is the exclusive providing responses, and furnishing evaluated by OSHA as described above. means of addressing discriminatory access to the standard and to OSHA does not include production policies. information. Comment on these incentives in the category of policies provisions in the context of employee and practices that may discourage Paragraph (i)—Employee Participation participation was primarily limited to reporting or participation in the Paragraph (i) sets forth the final rule’s requests for clarification about how the program. Mosely and Associates provisions regarding employee provisions would apply in practice. registered concern as to how such participation. It requires that employers Substantial differences were expressed, systems would be viewed, and ensure that employees and their however, concerning the level of expressed concern that plants may lose representatives, if the employees are employee involvement appropriately their competitiveness if piece rate represented by a recognized or certified included in a final standard.

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The importance of employee 32–461–1, 32–111–4, 32–210–2, 32– preventive action can still be taken. A participation in the successful 339–1, 500–33). For example, Shipman rigid time frame, however, is not implementation of an ergonomics and Goodwin LLP, on behalf of an specified in the rule, because the program was stressed in a number of unnamed client, stated: Agency recognizes that some flexibility comments (see, e.g., Exs. 30–276, 30– Requesting that employees report signs and is needed to account for the 428, 30–651, 30–3860, 30–4333, 30– symptoms encourages the success of any circumstances found in different 4468, 32–21–1–2, 32–82–1,Tr. 3479, Tr. early intervention program (Ex. 30–2215). workplaces. In general, OSHA believes that reports should be received within a 6930, Tr. 3565, Tr. 5596–5597, Tr. Comments received on this issue are few days in almost all cases, and the 10202, 32–450–1–18–1, Tr. 11182, Tr. presented in greater detail in the Agency expects employers to inform 11380, Tr. 12947, Tr. 14479, Tr. 14902, discussion of paragraph (d), which their employees about the importance of Tr. 16526, Tr. 12366, 500–29, 500–117– includes a requirement that employers early reporting, as required by 2, 500–177–2, 500–220, 500–215, 601-x- provide information to their employees 1587, 20–605). Mark Catlin of the Alice paragraph (d). on how to report MSDs and their signs OSHA proposed that employers Hamilton Occupational Health Center, and symptoms. The ability of employees for example, stated: provide prompt responses to employee to report MSDs and MSD signs and reports of MSD signs and symptoms to Our experience has been * * * that when symptoms depends upon their encourage reporting and provide there is true employee involvement from understanding of the reporting beginning to end, especially in the feedback. OSHA’s reasons for proposing mechanism, and knowledge of what that employer responses to reports be development of solutions, that can be a great constitutes a possible MSD or MSD sign benefit in coming up with a program that made promptly was that timely and works for that specific site that is cost or symptom. good faith responses are essential to effective and will be maintained after it is The final rule, at paragraph (h), adds reinforcing the information exchange initially set up (Tr. 5597). ‘‘MSD hazards’’ to the list of things process. Several commenters asked for employers must ensure that employees The advantages that the knowledge clarification of this proposed provision report. OSHA believes that trained (see, e.g., Exs. 30–3344, 30–3367, 30– and skills of employees have lent to employees will be able to identify MSD successful ergonomics programs were 249, 30–3749). The Society for Human hazards in their workplace before they Resources Management, for example, remarked upon by a number of cause MSDs, and this will result, in commentors (see, e.g., Tr. 4084, Tr. asked OSHA to specify what it would turn, in steps by proactive employers to consider an adequate response. The 4697, Tr. 6188, Tr. 7011, Tr. 7111, Tr. protect workers at risk even before they 7135, Tr. 7142, Tr. 9489, Tr. 10224, Tr. Society questioned whether OSHA suffer an MSD incident. The reporting of would consider acknowledgment of 10547, Tr. 11076, Tr. 12366, Tr. 12297, MSD hazards has therefore been added Tr. 13004, Tr. 14248, Tr. 14320, 20–406, receipt of the report, evaluation of the to paragraph (i)(2) of the final rule. report, or action to prevent the Tr. 17623). For instance, Dr. Robert The specific process employers must McCunney of the American College of condition from worsening as responses establish for reporting MSDs, their signs to the report. Others asked whether the Occupational and Environmental and symptoms, and MSD hazards is not Medicine stated: response must be in writing or whether prescribed in this final rule. OSHA alternative methods of communication In my experience as a physician, I have anticipates that the process will vary (e.g., oral) would be acceptable (see, e.g., been impressed with the knowledge that a lot from workplace to workplace, based on Exs. 30–3344, 30–3367, 30–3826). of workers have about their jobs and the the size and nature of the workplace. A If an employee experiences persistent recommendations that can be made to large facility with an on-site health care MSD symptoms and reports that improve it and reduce factors associated with professional (HCP), for example, may illness * * * [Tr. 17633]. condition to the employer but receives choose to handle reports through the no response, that employee is likely to One aspect of employee participation HCP. Smaller facilities may elect to have consider the ergonomics program included in the proposal was a means reports made directly to supervisors. ineffective. Such a loss of confidence in for the employee to inform the employer The method of submitting a report is the program would clearly discourage when MSDs or MSD signs and likewise not specified. Employers may future reporting and participation. If the symptoms occur. Reporting is essential chose to adopt written, electronic, or employer communicates the results of to allow the employer to become aware other systems for receiving reports. evaluations made based on the report, or of those job situations where further (Note, however, that employers are informs the employee of any actions action is necessary. For example, if an required by paragraph (v) to keep that are being taken as a result, the employee experiences pain and stiffness records of employee reports, primarily reporting employee will better in the shoulders and believes this to be for evaluation purposes.) understand the process and will be the result of workplace factors, the The final rule requires the employer more likely to participate in the future. employer cannot be expected to make to ensure that employees have ways ‘‘to OSHA also recognizes that employers changes to the workplace to mitigate the promptly report’’ their MSDs, signs and will sometimes inform the employee risk factors unless the employer is aware symptoms, and hazards. OSHA received that a given report requires no action, of the existence of a problem. many comments on its use of the word e.g., when an MSD hazard turns out, on Belief in the importance of employee ‘‘prompt’’ in the proposed rule (see, e.g., closer examination, not to warrant reporting of MSDs and their signs and Exs. 30–3826, 30–3853, 30–4467, 30– further action. OSHA continues to symptoms was expressed in a number of 3284, 30–3367, 30–4674). These believe that prompt responses to reports comments on the proposed rule (see, commenters asked OSHA to clarify what are an essential part of the e.g., Exs. 30–240, 30–1104, 30–2116, was meant by ‘‘prompt.’’ OSHA is using communication that must occur 30–2215, 30–2387, 30–2809, 30–3686, the word to indicate that timely between employers and employees in a 30–3765, 32–77–2, 30–3813, 30–3826, reporting is required; the effectiveness functioning ergonomics program, and 30–3849, 30–3859, 30–4185, 30–4468, of the standard and the employer’s final paragraph (i)(2) reflects this 30–4538, 30–4548, 30–4562, 30–4564, program would clearly be compromised conviction. 30–4837, 31–78, 31–174, 31–192, 31– if employees did not report their In order to provide flexibility to 227, 31–303, 31–353, 32–82–1, 32–85–3, problems quickly, at a time when employers to tailor communication

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Employers may chose to employers, nor that providing the OSHA reiterates here, that information adopt written, electronic, or other standard will confuse employees. of a personal nature such as the medical systems for providing responses, Employee access to OSHA standards records of other employees, is not although a record of the response must that affect them is a longstanding OSHA included in the information to which be maintained, as required by paragraph practice (see, for example, OSHA’s employees are required to have access. (v). rule’s governing lead exposure, noise Records of the occurrence of MSDs, for OSHA proposed to require the exposure, and so on). Access to the example, can be presented in a general employer to grant employees access to standard can be provided in several form and do not need to include the standard and to include information forms. A printed copy of the standard personal details. General injury and about the ergonomics program. OSHA may be made available, or an electronic illness information is already available proposed this requirement to ensure version may be provided on CD or via to employees under the provisions of 29 that employees understood what the internet access to OSHA’s web site if CFR 1904.7 with regard to the Log and OSHA standard required and how the employees have access to a computer. Summary of recordable occupational employer’s program worked. The OSHA believes that the standard will injuries and illnesses. program was to include assignment of not be confusing to employees because OSHA also is not convinced by responsibilities in the ergonomics they will be trained to understand the comments suggesting that proprietary program; job hazard analysis results; ergonomics program in their workplace information would be revealed if hazard control plans; records of the and their role in it, in accordance with employees have access to program occurrence of MSDs and reports of MSD paragraph (t) of the final rule. OSHA information. The information required hazards; ergonomic program evaluation does not believe that employees will to be made available, on request, is results; and lists of alternative duty jobs, flood their employees with requests to general information. For example, according to the preamble to the obtain and review the final standard; although an employee’s detailed process proposed rule [64 FR65799]. This instead, the Agency believes that the and production plans might be trade provision recognized that information is standard is likely to be used primarily secrets, the information required by this important to full employee as a reference to compare the provision relates only to the control of understanding of and participation in functioning of their workplace ergonomic hazards. Technical the ergonomics program. ergonomics program with the provisions information regarding machinery or OSHA was requested by commenters of the standard to assure that the production methods is clearly not to define more clearly what was meant program is functioning properly and is by ‘‘access’’ to the standard (Ex. 32– required to be provided. Reports of MSD in compliance. hazards and job hazard analysis results 337–1). The Dow Chemical Company, Because of the importance OSHA are not confidential and are critical for example (Ex. 30–3765) felt that attaches to employee access to the information for employees if they are to employers should not be required to standard, and the relative ease of participate meaningfully in the provide employees access to the providing it, the final rule adds the term ergonomics program. standard. Dow argued that employers ‘‘ready’’ to the original access provision. were required to comply with the This means that whenever an employee Providing employees with basic provisions of the rule but should not be requests access to the standard, the information about the common kinds of additionally burdened by providing employer must assure that ready access MSDs and their signs and symptoms is access to the standard. In Dow’s view, is provided, i.e., that access is provided required by paragraph (d) of the final employees could be confused by within a reasonable time and place. rule. The comments pertaining to this receiving information both on the Because of the importance OSHA paragraph can be found in the summary employer’s ergonomics program and the places on employees being able to easily and explanation for paragraph (d). standard. understand the requirements of the OSHA has decided that information on The National Coalition on Ergonomics standard, the final rule requires MSDs and their signs and symptoms is (Ex. 32–368–1) expressed concern that employers to provide employees with a so basic, and so important to employees, the employee participation provisions of copy of the summary of the standard that it must be provided as part of the proposed standard would require that is required to be made accessible in employee participation as well. The employers to provide employees with paragraph (d). Although the employer is final rule’s employee participation access to the employer’s confidential required in paragraph (d) to make this provisions are only triggered when MSD documents, which might address information available to employees incidents have been reported in a job personnel issues, financial issues, or when they start a job, the employee that meets the action trigger. This means safety audits. If this were the case, the should receive the summary at the time that the employees covered by final Coalition argued, employees with the program is implemented due to the paragraph (i) are those who work in grudges or those involved in labor fact that the exposures in the employees higher-risk jobs; these employees clearly disputes would be able to harass their job have now been shown to exceed the need to be informed about MSDs and employer by disclosing or threatening to levels in the Basic Screening Tool and their signs and symptoms. Thus disclose proprietary information out of considerable time may have passed paragraph (i)(3) requires employers to context or in a fashion that might have since the employee was informed that inform their employees with, at a an adverse impact on the employer. The he or she had access to this information. minimum, the information sheet in non- Coalition argued that this would The summary sheet provided in mandatory Appendix A. OSHA believes discourage employers from performing Appendix B may be used for this that most employers will choose to audits with appropriate depth and purpose. provide more detailed and specific thoroughness. Concern was also The Agency is also not persuaded by information, such as information about expressed that employee access might arguments that confidential company the MSDs and signs and symptoms jeopardize medical confidentiality. (Ex. information or medical records would occurring among employees in jobs in 500–1–116). be distributed if employers provide their establishment.

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The fourth component of the 78–1, 30–4467, 30–541, 30–627, 30– when they are first identified. Safety proposed employee participation 1355, 30–1545, 30–1697, 30–1717, 30– teams that are trained to quickly section was a broad requirement that 2830). Employee involvement, although identify, assess, and fix a hazard would ‘‘ways to be involved in developing, commonly acknowledged as often be supplanted by the more cumbersome implementing and evaluating each beneficial, was not needed in every process required by the standard. element of the ergonomics program’’ be situation, and should therefore not be Whirlpool believes that the standard provided to employees. This mandated, according to these requires the employer to obtain input component, as explained in the commenters. For example, Dr. Kurt from people who may have nothing to preamble to the proposal, was designed Hegmann stated: add to the process, which would to allow employers to take advantage of Hazard remediation efforts are frequently increase the time and expense involved the knowledge, skills, and abilities that enhanced and accelerated with employee without providing any assurance that a workers could contribute to the participation since the ones doing the work better solution would be found (Ex. 30– ergonomics program. 40 hours a week have often thought of the 4779). The United Steelworkers concurred most effective solution. Yet, requiring Some employers interpreted the with OSHA’s initial assessment that employee participation in this and other proposed requirement that employees employee involvement in each element aspects of the rule is inappropriate, as these be involved in developing the program of the ergonomics program was assumptions are not always true [Ex. 30– to mean that, where a current 4779]. appropriate. The union stated: ergonomics program already exists, the Employee involvement in supervisory Workers and their representatives have to employer would be required to develop be involved in all aspects of the introduction training or the evaluation of a new program (Ex. 30–3765). The and implementation of an ergonomics management leadership, for example, Edison Electric Institute stated that it is program in [the] workplace. After all, it is were cited as program elements where impossible to consistently include their bodies and lives that are on the line (Ex. employee involvement was not employee involvement in all elements Tr. 11047). considered necessary (Ex. 32–78–1). In of the ergonomics program, and Vagueness was a concern of some its comments on employee therefore recommended that the final commenters. A number of interested participation, the American College of rule allow greater flexibility to parties indicated that they did not Occupational and Environmental employers and only require that understand what level of employee Medicine stated: employees ‘‘be provided adequate, involvement would be required under * * * employee participation in the regular opportunities to be involved in the proposed standard (see, e.g., Exs. design, modification, and evaluation of all developing, implementing and 30–3344, 30–3848, 30–4607, 30–4674, aspects of an employer’s operation is evaluating appropriate elements of the 30–4713, Tr. 4372). These commenters unnecessary. In most facilities, program’’ (Ex. 500–33). stated that the proposal did not make it manufacturing or industrial engineers The Northwest Food Processors effectively perform many aspects of their jobs clear whether an employer would have Association expressed concern that without employee participation. OSHA’s engaging employees and their unlawfully limited employee requirement for employee participation participation if, for example, employee designated representatives in the should be limited to participation on ergonomics program could be suggestions for ergonomics ergonomics teams and participation in the improvements were rejected (see, e.g., job-specific problem solving process [Ex. 30– inappropriate in some cases because the Exs. 32–78–1, 30–4467, 30–541, 30–627, 4468]. ergonomic interventions they suggested might result in the elimination of jobs 30–652, 30–1355, 30–1697, 30–1717, Another commenter with a similar 30–4843, 601–x–1710). These or otherwise negatively impact view argued that an employer who is employment opportunities. The participants argued that employers able to eliminate MSD hazards without should not be required to follow the association stated that employers should employee participation should not be be given flexibility in the final rule to recommendations of employees or required to consult employees (Ex. 30– obtain their concurrence on a course of determine the appropriate approach to 4467). such situations (see, e.g., Tr. 12198). action, and should retain the authority Several practical problems about how to make all final decisions about Some employers were concerned that the proposed requirements would employees could disrupt the program or compliance with the requirements of the actually work in different situations standard (see, e.g., Exs. 30–3934, 30– decline to participate in it. These were also raised. Union Carbide commenters believe that employee 2208). Corporation indicated that such Some industry representatives stated representatives may attempt to use the involvement would be difficult to standard as a way to force unnecessary that the level of employee involvement implement when the ergonomics proposed by the requirement that or costly changes for reasons unrelated program is developed on a corporate to safety (see, e.g., Exs. 30–2208, 30– employers involve employees in level: developing, implementing and 1294, 30–3348). The Nabisco Company Large employers such as Union Carbide was concerned that requirements for evaluating each element of the program develop their ergonomic programs on a was excessive (see, e.g., Exs. 32–368–1, employee participation could not be met corporate basis using professional staff. Of if employees were unwilling to 32–78–1, 30–4467, 30–240, 30–276, 30– necessity, they rely on employees to assist in 368, 30–429, 30–434, 30–541, 30–562, participate in the program. The implementing the program, and employee company stated: 30–652, 30–1070, 30–1294, 30–1671, evaluation of the program is always welcome. 30–2830, 30–2846, 30–2991, 30–3344, But where programs are developed on a Nabisco strongly supports the concept of 30–3348, 30–3784, 30–3951, 30–4185, corporate basis, it is sometimes difficult to employee involvement and encourages 30–4713, 32–21–1, 32–120–1, Tr. 11679, involve employees in that development [Ex. participation of employees at all levels of our 30–3784]. organization. However, this requirement 500–33, 30–3744). In the view of these assumes that employees and their commenters, OSHA did not demonstrate The Whirlpool Corporation believes representatives will readily volunteer to that this level of employee involvement that adhering to the requirements of the participate in a management program. It has was necessary for an effective standard would hinder the company’s been the experience within some of our ergonomics program (see, e.g., Exs. 32– ability to respond to ergonomic hazards locations that union representatives do not

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A common concern expressed by procedures in place to address safety and 4320, Tr. 4908, Tr. 15537, Tr. 8896– health issues [Tr. 3570]. employers with unionized employees 8897, 30–3345, 500–1–27, 500–1–28, was that the requirements of the A number of labor representatives felt 500–1–29, 500–1–42, 500–1–79, 500–1– proposed standard for employee that the proposed requirement to 86, 500–1–106, 500–1–112, 500–1–113, involvement could serve to disrupt involve employees and their designated 500–1–114, 500–1–116, 500–1–181, established collective bargaining representatives in developing, 500–1–117, 500–1–124, 500–1–125, relationships (see, e.g., Exs. 30–3853, evaluating and implementing each 500–1–193, 500–1–248, 500–1–249, 30–3765, 32–337–1, 30–323, 30–345, element of the ergonomics program 500–1–307, 500–1–329, 500–1–331, 30–538, 30–574, 30–1022, 30–1113, 30– should be modified. Some parties 500–1–411, 500–1–423, 500–1–442, 1349, 30–1567, 30–1616, 30–1652, 30– expressed the opinion that the standard 500–177–2, 30–1942, 30–3236, 30–3339, 2426, 30–2725, 30–2773, 30–3086, 30– should be revised to add employee 30–4535, 30–2600, 30–2592, 30–2577, 3184, 30–3284, 30–3344, 30–3951, 31– representatives to each provision where 30–2583, 30–2256, 30–2259, 30–2201, 332, 500–1–128, 32–266–1, 30–3841). rights are granted to employees. For 30–2243, 30–2260, 30–2272, 30–3428, Many companies and their unions, example, the proposed job hazard 30–3157, 30–3158, 30–3196, 30–3623, according to these commenters, have analysis provision would require the 30–2550, 30–2543, 30–2529, 30–2535, well-established contractual employer to ask employees whether 30–4583, 30–2896, 30–2894, 30–2886, performing the job poses physical mechanisms for addressing employee 30–2868, 30–2863, 30–2862, 30–2854, difficulties; in the view of these safety and health issues. A typical 30–4668, 30–4302, 30–2106, 30–2404, commenters, this should be changed so example is a contract provision 30–2405, 30–2407, 30–2406, 30–2412, that employees and their designated establishing a joint labor-management 30–2292, 30–2293, 30–2300, 30–2287, representatives should be consulted. safety committee. According to the 30–2447, 30–2370, 30–2605, 30–2614, The unions also suggested that the views of these commenters, requiring 30–2772, 30–2791, 30–2793, 30–2828, proposed control obligation section be the employer to engage individual 30–2831, 30–4058, 30–2474, 30–2487, revised to add designated employees in the ergonomics program representatives to the requirement to ask 600–x–34, 600–x–36, 30–4762, 30–2901, would stimulate resentment and conflict employees for control recommendations 30–5036, 30–4566, 30–1971, 30–1972, by forcing the employer to circumvent (see, e.g., Exs. 32–339–1, 32–182–1, 32– 30–1973, 30–2571, 30–4541, 30–4786, the union. PEPCO, for example, 198–4, 32–210–2, Tr. 3566). 30–5027, 601–x–1370, 601–x–1698, expressed this view: Another commonly expressed 601–x–1712, 601–x–1439, 601–x–1440, PEPCO, like most utility companies, has a concern of the employer community 601–x–1441, 601–x–1442, 601–x–1444, long-established relationship with a was that the proposed provision that 601–x–212, 601–x–213, 601–x–1368, collective-bargaining agent that represents employers provide employees ways to 500–1–397, 30–3839, 30–4247, 30–4486, most of our employees (International be involved in developing, 601–x–1711, 601–x–1360, 30–3858, 30– Brotherhood of Electrical Workers, AFL– 3923, 30–4778, 30–2432, 30–3850, 30– CIO). PEPCO has well-established contractual implementing and evaluating each element of the ergonomics program 2593, 30–3728, 30–2270, 30–1995, 30– mechanisms for addressing employee safety 2209, 30–3036, 30–2832, 30–2472, 30– and health issues. We have joint labor- would conflict with provisions of the management safety committees and include National Labor Relations Act (NLRA) or 2439, 30–2438, 30–2397, 30–2389, 30– our union in accident investigations. The with state laws addressing labor 4300, 30–4326, 30–1076, 30–4712, 30– proposal would interfere in established relations (see, e.g., Exs. 30–296, 30–323, 2103, 30–3806, 30–1730, 30–1446, 30– relationships such as these, for in several 30–328, 30–345, 30–368, 30–377, 30– 3220, 30–3235, 30–4335, 30–4337, 30– instances, it would require the employer to 397, 30–523, 30–532, 30–536, 30–380, 4362, 30–4394, 30–4443, 30–4528, 30– deal with or involve not just the employee 30–538, 30–540, 30–541, 30–562, 30– 4709, 30–1651, 30–2410, 30–2289, 30– designated representative, but also the 574, 30–589, 30–594, 30–598, 30–627, 3877, 30–2601, 30–3160, 30–3598, 30– individual unionized employee. This places 30–630, 30–632, 30–648, 30–688, 30– 2912, 30–1332, L30–5025, 30–4280, 30– the employer in the position of having to deal 1416, 30–1453, 30–1457, 30–1616, 30– apart from, or even circumventing, the union 1022, 30–1113, 30–1131, 30–1216, 30– in order to avoid the risk of citation [Ex. 31– 1294, 30–1296, 30–1332, 30–1349, 30– 1998, 30–1999, 30–2131, 30–2142, 30– 332]. 1355, 30–1356, 30–1357, 30–1358, 30– 2184, 30–2233, 30–2250, 30–2304, 30– 1367, 30–1370, 30–1413, 30–1545, 30– 2395, 30–2396, 30–2423, 30–2431, 30– Consolidated Edison Company of 1551, 30–1552, 30–1567, 30–1584, 30– 2736, 30–2829, 30–2889, 30–2891, 30– New York urged OSHA to address this 1616, 30–1652, 30–1683, 30–1697, 30– 2992, 30–3003, 30–3254, 30–3334, 30– issue by indicating that the obligations 1717, 30–1727, 30–1898, 30–1901, 30– 3393, 30–3551, 30–3597, 30–3791, 30– for employee involvement in the final 2049, 30–2050, 30–2054, 30–2061, 30– 3882, 30–3936, 30–3944, 30–3974, 30– rule could be met by affording those 2062, 30–2133, 30–2134, 30–2427, 30– 3977, 30–3999, 30–4464, 30–4532, 30– rights to the union (Ex. 30–2816). Alan 2499, 30–2506, 30–2645, 30–2773, 30– 4539, 30–4544, 30–4629, 30–4657, 30– Ferranto of the National Association of 2799, 30–2811, 30–2812, 30–2813, 30– 4667, 30–4669, 30–4980, 30–5034, 30– Letter Carriers, however, did not believe 2814, 30–2824, 30–2830, 30–2896, 30– 5076, 30–5095, 30–5101, L30–4952, that collective bargaining relationships 2990, 30–3061, 30–3062, 30–3086, 30– L30–4953, L30–5096, 30–3497, 30– would be affected by the proposed rule: 3095, 30–3131, 30–3174, 30–3177, 30– 1938, 30–1989, 30–2217, 30–2384, 30– Inevitably, when a proposal of this nature 3210, 30–3231, 30–3233, 30–3284, 30– 2403, 30–2403, 30–2416, 30–2480, 30– is put forth, there are those who will argue 3336, 30–3344, 30–3716, 30–3745, 30– 2486, 30–2555, 30–2556, 30–2607, 30– that collective bargaining will be affected. As 3765, 30–3845, 30–3853, 32–337–1, 32– 2639, 30–2734, 30–2735, 30–2873, 30– the safety and health officer for a union 368–1, 30–3349, 30–3353, 30–3356, 30– 2878, 30–3578, 30–3742, 30–3776, 30– which represents almost a quarter million postal employees, I’m here to say that this 3364, 30–3367, 30–3473, 30–3513, 30– 4325, 30–4452, 30–4790, L30–4998). A proposal will not affect our collective 3622, 30–3723, 30–3728, 30–3819, 30– discussion of the relationship between bargaining agreement with the postal service. 3849, 30–4122, 30–4143, 30–4153, 30– the requirements of this final rule and In fact, we are satisfied that the employee 4158, 30–4167, 30–4187, 30–4355, 30– the NLRA can be found in the Legal involvement envisioned under OSHA’s 4499, 30–4607, 30–4628, 30–4674, 30– Issues section of this preamble.

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As has already been discussed, the developing, implementing, and the new equipment or to provide potential value of employee evaluating the program; however, appropriate training. It is in these types contributions to the development, reference to ‘‘each element’’ of the of situations, as well as in the initial implementation, and evaluation of an program has been deleted. This change creation of the ergonomics program, ergonomics program is well-established. has been made to grant the employer where the record demonstrates that the The intent of the proposed requirement flexibility to adapt employee involvement of employees can prove that employees have ways to be involvement to the circumstances in a invaluable. involved in developing, implementing, given workplace. OSHA is convinced In response to those employers who and evaluating each program element that the proposed level of employee were concerned that the proposed was to allow employers to take involvement is not practical or justified standard would necessitate advantage of this potential value to in every instance. The Agency never discontinuation of successful programs construct and administer the most intended for employee involvement to that did not incorporate employee effective program possible. pervade every aspect of the program. As involvement in their development, A requirement that employees be explained in the preamble to the OSHA does not intend for the involved in the program in no way proposal, the ‘‘elements’’ referred to requirement in the final rule for abrogates the authority of the employer were the broad ergonomics program employee participation in the to manage the workplace or administer elements (e.g. training, program development of ergonomics programs to the ergonomics program. Regarding evaluation). A requirement for employee apply retroactively to programs that employee suggestions, this general participation in each component of have already been established. The requirement of the final rule for these elements, such as supervisory Agency believes that such a requirement employee involvement requires only training, was not envisioned. OSHA would result in an unnecessary that employers provide a reasonable considers, however, that even greater expenditure of resources to duplicate opportunity for employees to be heard, latitude is appropriate in order to allow the existing program. Rather, OSHA for them to be involved, and for their the employer to most effectively believes that the evaluation of the suggestions to be fairly considered. An construct and administer the effectiveness of the existing program employee recommendation made as part ergonomics program. For example, a will result in the identification and of this process, in and of itself, does not small employer could adopt a training correction of any deficiencies which oblige the employer to take action. For presentation developed by a trade may currently exist, and that employee example, if an employer asks employees association even if employees in that involvement in the ongoing in a problem job for recommendations workplace did not participate in the development of the program will result about eliminating or controlling MSD development of the presentation. The in continuous improvement in the hazards, the employer is not compelled Agency believes, however, that such program over time. Moreover, OSHA to adopt any of the suggestions that the circumstances are the exception rather anticipates that the grandfather clause employees may make. Rather, this is an than the rule, and has retained the in paragraph (c) of this final rule will opportunity for the employer to draw on requirement for employee participation apply to many existing programs. A successful ergonomics program also the knowledge of these workers in in the development, implementation, requires employee involvement in its identifying and examining alternative and evaluation of the ergonomics implementation. Clearly, hazard approaches to addressing hazards. The program due to the evidence of the controls cannot be effective if workers suggestions of employees may be used value of worker involvement in each of to supplement those of professional staff do not use them, and MSD management these stages in the administration of the or consultants. cannot be effective if injured workers do program. Along with the authority for making not report their injuries. A program decisions, the employer retains the OSHA considers that the development cannot fulfill its objectives if it exists responsibility for ensuring the of an ergonomics program is not an only on paper, and is not applied in the effectiveness of the program. If event, but a continuing process. The workplace. Ample opportunity is consultation with employees about the work environment is rarely static; work provided to demonstrate employee effectiveness of the program reveals, for methods and equipment often change involvement in the implementation of example, that training has not been over time, and as a result the physical the program through compliance with understood, then this deficiency must demands upon workers and associated the specific requirements of the be promptly corrected (see paragraph (u) MSD hazards can change as well. standard. For example, if a job has been of the final rule). Likewise, hazard control methods and found to be an MSD hazard due to OSHA realizes that the input of training procedures can evolve over repetition, and the appropriate control employees will not in every instance time. Changes in the workforce can also method has been determined to be prove to be beneficial to the ergonomics impact the effectiveness of an rotating jobs so that no single employee program. Nevertheless, the evidence in ergonomics program. The program may spends more than three hours per day the record shows that contributions to require adjustments to account for these in that job, the employer must ensure the success of ergonomics programs changes. For example, if ergonomics that employees carry out the job rotation have consistently been made by training is conducted in English in a in order for it to be effective as a control participating employees. The workplace where the employees speak measure. involvement of employees need not be and understand English, it may be Employee involvement in the cumbersome or time-consuming. Brief effective. If that employer subsequently evaluation of the ergonomics program is discussions are often sufficient to elicit hires employees who do not understand also needed to assure program employee input. English, an adjustment would be effectiveness. For instance, workers in The proposal would have required necessary to provide the training in a problem jobs are in the best position to that employees have ways to be language the employees understand. determine if control measures are involved in developing, implementing, Similarly, if new equipment is brought successfully controlling MSD hazards, and evaluating each element of the into a workplace, modifications to the or if new hazards have been created. ergonomics program. The final rule ergonomics program may be necessary Employees are also best able to requires that employees be involved in to control MSD hazards related to use of recognize when training is inadequate

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Like the proposal, the final rule does not implementation of the program, The proposal’s job hazard analysis require the employer to perform a job opportunities to demonstrate employee provisions listed the steps required to hazard analysis for every reported MSD, involvement in the evaluation of the analyze a job, and contained a list of 20 but only for those that meet screening program can be found in the specific physical work activities and conditions criteria. Unlike proposed Section requirements for evaluation found in the associated with particular risk factors. 1910.917, however, Paragraph (j)(1) also standard, such as the requirement of The proposal did not provide specific permits an employer to rely on a job paragraph (m)(4) for consultation with guidance on how to determine whether hazard analysis that was conducted employees regarding the effectiveness of the risk factors presented an MSD previously for the job, provided that the controls and the requirement of (u)(1)(i) hazard in any particular case. Several analysis was performed in accordance for consultation with employees on commenters argued that the proposal’s with the procedures of this paragraph (j) effectiveness and problems with the approach was vague and asked for more and is still relevant to the job (i.e., the program. specific measures for identifying MSD job has not been altered in the meantime OSHA does not believe that employee hazards (see, e.g., Exs. 500–197, 30– in a way likely to change or increase participation in the ergonomics program 2435, 30–973, 30–1274, 30–2426, 30– exposure). under this final rule will result in 1350, 30–2428, 30–2986, 30–3000, 30– The purpose of job hazard analysis is adverse repercussions on collective 3086, 30–3853, 30–326, 30–546, 30– threefold: (1) To identify all the bargaining relationships. The final rule 4189). Others (e.g., Ex. 30–3593) thought ergonomic risk factors that are also does not require employers in any that the requirements in the proposed associated with the job being analyzed; way to circumvent any process that may job hazard analysis section were too (2) to measure the duration, frequency currently exist for employer specific, and still others stated that the and magnitude of employee exposure to communication with the employee. The table oversimplified the complex these risk factors; and (3) to evaluate the rule does not specify a precise interactions between various risk factors risk factors identified, individually and mechanism that must be used for in a job and urged OSHA to eliminate in combination. This analysis allows employee participation. Where a system the table of physical work activities employers to determine if the job poses is already in place, such as a union/ from the final rule (see, e.g., Ex. 30– an MSD hazard to employees, i.e., is a management safety and health 3436). The argument made by several ‘‘problem job,’’ as that term is used in committee, nothing in this rule commenters was that the work activities the standard. The results of the job prohibits an employer from using that and risk factors included in the table in analysis, which identify the extent of system to meet its employee the proposal would be hard for the risk factors present in the job, can participation obligations. employers to identify in the workplace later be used as the benchmark against (see, e.g., Exs. 500–197, p. III–12, 30– Paragraph (j)—What Must I Do To which to measure the effectiveness of 3745, 30–2134, 30–2426, 30–2919). Determine Whether a Job That Meets controls. Although some provisions in final The NIOSH publication, Elements of That Action Trigger Poses an MSD paragraph (j) are essentially the same as Hazard to Employees in That Job? Ergonomics Programs (Ex. 26–2), the corresponding sections of the describes a job hazard analysis as an This paragraph addresses the job proposed rule, several have been revised examination of the workplace hazard analyses employers must in response to comments that the conditions and individual elements or perform to identify those MSD hazards proposal did not provide enough tasks of a job to identify and assess the that must be controlled under this final information on how employers could risk factors that are reasonably likely to standard. Paragraph (j)(1) of the final determine whether MSD hazards were be causing or contributing to the standard requires employers with jobs present. In particular, the inclusion of reported MSDs. OSHA received many that meet the standard’s two-part action the tools in this rule provides employers comments supporting its proposed trigger—i.e., who have employees who with much more assistance in approach to job hazard analysis (see, have experienced an MSD incident and compliance than the job hazard analysis e.g., Tr. 5342, Tr. 8978, Exs. 37–1, 37– who work in jobs that have risk factors provisions in the proposal (proposed 25, 500–218, 500–137–1–1). OSHA thus present at levels that meet the screen in sections 1910.917 and 1910.918) would believes that the requirements of Table W–1—to conduct a job hazard have, while preserving a high degree paragraph (j) are consistent with the analysis of the job to determine whether flexibility for employers who do not objectives and steps of job hazard it presents an MSD hazard to choose to use any of the listed tools. In analysis as the process is currently employees. (Employers who qualify for addition, the final rule has been applied by employers with effective and choose to use the Quick Fix option modified to allow employers additional contained in paragraph (o) of the ergonomics programs. flexibility in several aspects of the job The quality of the job hazard analysis standard must follow the procedures of hazard analysis process. The following performed is critical to the success of that paragraph and are not required to discussion describes each provision of the entire ergonomics program, as the conduct the job hazard analysis paragraph (j) of the final rule and United Auto Workers noted: specified in this paragraph (j).) OSHA’s responses to the comments Paragraph (j)(2) tells employers what received on the proposed job hazard The heart of an ergonomics program is the steps they must include in a job hazard analysis provisions. measurement of risk factors on jobs. The analysis, and paragraph (j)(3) lists the presence of risk factors demonstrates that a methods of job hazard analysis that are Paragraph (j)(1) reported MSD is related to a job or workstation, while their absence suggests the acceptable under the rule, including Paragraph (j)(1) of the final rule states MSD arose from other causes. Risk factors referring to a number of tools, included that employers must conduct a job predict MSDs will arise in the future, even in Appendices D–1 and D–2 of the hazard analysis to determine whether a if none are currently reported. And, standard, that employers can use to job that meets the action trigger presents reductions in risk factors indicate that a job conduct their analyses. Paragraph (j)(4) an MSD hazard to employees in that job. has been improved (Ex. 500–220).

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A job hazard analysis can also rule out has resulted in a decrease of almost 40% the same risk factors as hired jobs that do not need to be controlled, in workers’ compensation costs (mostly ergonomists and to successfully identify and can provide employers with the due to reductions in MSD hazards), with solutions. information they need to prioritize their premium costs declining from $103,824 The job hazard analysis required by efforts on the most hazardous jobs or to $61,000, which Mr. Carroll described Paragraph (j) of the final rule serves a tasks that pose the most severe as ‘‘not chicken feed for a small very different function from the Basic problems. Similarly, a job hazard company’’ (Ex. 502–17). Based on this Screening Tool in Table W–1 of the analysis is an efficient way to help record, OSHA agrees with those who standard. The Basic Screening Tool is a employers focus their resources on the commented that an appropriate job simple hazard identification tool that most likely causes of a problem. For hazard analysis actually limits MSD can be used to identify jobs with the example, after analyzing a job, the hazard control costs, either by potential to expose workers in them to employer may find that the amount of determining that no MSD hazard is ergonomic risk factors at levels that may repetition is acceptable if the force and present or by identifying risk factors pose an MSD hazard. It cannot take the awkward posture in the job can be that, in turn, allow the company to place of a job hazard analysis. It can controlled sufficiently. focus on the activities that are only point to possible problems with the Despite these benefits, several associated with the MSD incident. job; it takes a job hazard analysis to commenters (see, e.g., Exs. 30–1393, 30– The UAW also has experience with determine whether controls are actually 1275, 30–3061, 30–3062) were small companies that have implemented necessary. A job hazard analysis concerned that the standard’s ergonomics programs: identifies specific risk factors, or combinations of risk factors, that need requirements for job hazard analysis Employers in the many small facilities would be too costly. Typical of these have voluntarily or through the collective to be controlled. comments was one from the Navy bargaining process, adopted a common Paragraph (j)(1) also allows employers Federal Credit Union: approach to preventing ergonomic injuries to rely on a previously conducted analysis of a job if it was performed in The requirement for employers to perform and abating ergonomic risk factors in the job hazard analyses is extremely onerous and workplace. The program includes all accord with the requirements of this costly. It requires every employer to perform components established in the proposed paragraph, and the analysis is still hazard analyses on the same or similar jobs standard, except appropriate medical relevant. This provision responds to within their industry. OSHA has already management and that can be established concerns expressed by some amassed a substantial amount of data on the without hindering the established processes participants that employers that the likely causes and remedies of MSDs that at the facilities (Ex. 500–220). standard would require significant occur in the workplace. The ergonomics Other commenters argued that the action every time a new MSD occurred, standard should permit employers to rely on proposed approach to job hazard even if a job hazard analysis that OSHA’s identification of hazards and analysis would require the employer to possible remedies for problem occupations complied with the standard had already (Ex. 30–1273). hire a consultant (see, e.g., Exs. 30– shown that no additional controls are 3783, 30–2810, 30–3336, 30–715, 30– necessary (e.g., Ex. 30–3956). To take Other employers, such as August Mack 2834). For example, the Texas advantage of this provision, the Environmental, Inc., disagreed, Association of Business and Chamber of employer must confirm that the job is however: Commerce stated: still being performed in the same way, I do agree that conducting a hazard Because the proposed standard and that the same risk factors are still analysis, if done properly and very inadequately defines the alleged ‘‘risk present. Any changes to the work objectively, requires significant resources. factors’’ or ‘‘conditions or activities’’ or even methods or equipment may have However, if the result were to find that MSD to provide a complete list of the ‘‘conditions introduced new MSD hazards, and a risk factors were not prevalent, and the need or activities’’ during which the ‘‘MSD for full implementation of a comprehensive new job hazard analysis would then be hazards’’ allegedly occur, small employers ergonomics program were eliminated, this required. Additionally, if new will be forced to seek assistance—at [expense] could easily be justified. This is employees are present, the employer due to the estimated amount of resources substantial cost—from those with experience must make sure that no new employee required for the hazard analysis compared to and knowledge in the ergonomics field. In is performing the job in a different way the resources required to implement a addition, the proposed standard does not adequately explain which controls will abate or has physical characteristics that formalized ergonomics program and maintain expose that employee to risk factors not it over time (Ex. 30–240). particular hazards and they will again be forced, and as encouraged by OSHA, to seek present for others. For example, a Other record evidence also makes clear expensive outside help (Ex. 30–2810). particularly tall or short employee might that the cost of MSDs far exceeds the But contrary evidence is also in the need to work in a more awkward costs of controlling MSD hazards (Tr. record: position, or reach further than others in 7122, Tr. 10225, Tr. 4811). order to perform the same tasks. If that Similarly, some commenters also I am not an ergonomist and I do not believe is true, the employer must analyze the expressed concern that performing job you need an ergonomist to do a general check job to identify the risk factors affecting hazard analysis could be too difficult for on the risk factors of most jobs, that most that employee. small companies (see, e.g., Exs. 601–x– workers, especially if you give them a The ‘‘new employee’’ situation framework for thinking about and analyzing 1, 30–3469, 30–2846). However, OSHA’s their own job, can tell you where those risk described above is one of the scenarios experience is that small companies can factors are present, where they’re not present, addressed by the Note to paragraph (j). and do conduct these analyses where they’re present in large quantities That note allows the employer to limit effectively. For example, Wood Pro versus small quantities. You do not need to the job hazard analysis (and response) to Industries in Cabool, Missouri is a VPP be an ergonomist to do that. Many workers the employee who reported the MSD employer with only 100 employees. Its are extremely capable, if you give them a incident when the MSD hazard is safety director (David Carroll, who also framework for analyzing their own jobs limited only to that employee. Evidence wears a number of other hats) began a * * * (Tr. 13764). in the record points to situations in safety and health program that A recent study in the record (Ex. 500– which the physical work activities or identified and controlled ergonomic risk 71–64) reports that trained workers were conditions of a job pose a risk to only factors several years ago. The program able, in 65 to 85% of cases, to identify a single employee (see, e.g., Exs. 30–

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4709, p. 6, 500–145, 30–2208). For • Obtaining information about the job Hazards cannot be addressed efficiently example, a five-foot tall employee in a and problems in it from employees who without an accurate evaluation of the commercial bakery may report a back or perform the job; situation. The line employee is one of the • best sources of this information * * * [those shoulder MSD related to extended Observing employees performing employees are] local process experts (Ex. 3– reaches involved in sorting rolls. the job; 232). However, other, taller, employees who • Identifying specific risk factors in have performed the job for several years the job; and The record contains considerable do not have (and never have had) • Evaluating those factors (i.e., their evidence that many employers talk to employees to get insight into the job difficulty performing the physical work duration, frequency and magnitude) to requirements that only those who work activities of the job. In this case, the determine whether they are causing or at the job can provide (see, e.g., Exs. 30– employer could conclude, based on the contributing to the problem. job hazard analysis, that the problem is 3755, 30–3748, 500–117, 500–137–1–1, The job hazard analysis requirements 500–137–6–1, 500–218, 500–220, Tr. limited to the injured employee. The of the final rule reflect these steps. employer then may limit the further 3890, 13808). These commenters stated Unless the employer qualifies for and that talking with employees is often the action required by the standard (e.g., chooses the Quick Fix Option in best way to identify the causes of the analysis, control, training, paragraph (o), the employer must use problem and to identify the most cost- recordkeeping, evaluation) to that the job hazard analysis process in this effective solutions to it (see, e.g., Ex. 26– employee’s workstation. paragraph to determine whether the 1370). One stated: A similar situation could occur where physical work activities and job Employee participation is vital to this one employee is much taller than others conditions pose an MSD hazard to element. Job Safety Analysis (JSA) [another in the same job. The tall employee workers in that job. Jobs that pose an name for job hazard analysis] has been part reports persistent back pain that rises to MSD hazard to employees are called of the safety vocabulary for many years. the level of an MSD incident, and the ‘‘problem jobs,’’ and must be controlled Many employers are working with the employer observes that having to bend in accordance with paragraphs (k) workers to determine the safest way to do a much further than the other employees through (m) of this final rule. job. Controlling a hazard can be a productive to work at the work surface is likely to When employers perform a tool in many ways. Minimize lost time; reduce training and overtime; and a positive have caused the back problem. Allowing comprehensive job hazard analysis, outlook from the workplace. A worker who employers to limit the analysis and their goal is to identify those ergonomic is set up to succeed is a productive worker. control to a single employee if the risk factors that impose biomechanical A worker who has to jury rig or perform a analysis reveals that the problem is stress on the worker and evaluate task that leaves him or her in discomfort at unique to that employee is consistent magnitude, frequency, and duration as the end of every shift can not be productive with the approach taken by several required by paragraphs (j)(2)(ii) and for a prolonged period of time. (Ex. 500–137) commenters who have successful (j)(3). Once the risk factors and their Discussions with employers who have ergonomics programs (see, e.g., Exs. 30– magnitude, frequency, and duration set up ergonomics programs in response 1071, 30–3755, 30–3745). As one of have been determined, the employer is to corporate settlement agreements with these commenters reported, ‘‘we have required to assess whether the risk OSHA also confirm the need for often modified the job to fit that one factors identified pose an MSD hazard employee input into the job hazard individual—however, modification was to employees. The standard defines an analysis process (Ex. 26–1420). A not needed for co-workers at similar or MSD hazard as the ‘‘presence of risk number of these employers said that identical duty stations’’ (Ex. 30–1071). factors in a job at a level of magnitude, employees need to be involved in the frequency, and/or duration that is analysis and control process because Paragraph (j)(2) reasonably likely to cause MSDs that ‘‘no one knows the job better than the Paragraph (j)(2) of the final rule result in work restrictions or medical person who does it’’ (Ex. 26–1420, See describes the steps the employer must treatment beyond first aid.’’ Ergonomic also Ex. 3–164). Other evidence echoed take in performing the job hazard risk factors are the elements of MSD this concept, confirming that employees analysis. Paragraph (j)(2)(i) states that hazards, and they often work often have the best understanding of the employer must talk to the employees synergistically. That is, jobs that have what it takes to perform each task in a who perform the job, and their multiple risk factors pose a greater risk, job, and thus, what parts of the job are representatives, about tasks that may all things equal, than a single risk factor. the hardest to perform or pose the relate to the MSD incident. Paragraph Paragraph (j)(2)(i) greatest difficulties: ‘‘The people that (j)(2)(ii) requires the employer to are closest to doing the work seem to observe the employees performing the Paragraph (j)(2)(i) of the final rule come up with the best solutions.’’ Tr. job to identify the risk factors and assess requires employers to talk with 4697. the extent of their exposure (its employees and their representatives In addition to helping to ensure that magnitude, frequency, and duration) to about the tasks the employees perform the job hazard analysis is accurate, those risk factors. The employer must that may relate to MSDs. Much has been involving employees can make the job include all of the employees performing written about the value of employee hazard analysis and control process the job, or a sample of those with the participation in the identification of risk more efficient, because employees can greatest exposure to risk factors, in this factors and controls at the hazard help employers pinpoint the causes of analysis. analysis stage (see, e.g., Exs. 3–232, 26– problems more quickly. Employees 4, 26–11, 26–15, 26–18, 26–19, 26–21, often come up with some of the most According to the record (see, e.g., Exs. 26–1370, 26–1420, 32–339–1–42, 38– practical, no-cost or cost-effective, 26–2, 26–5, 26–1370, 37–1, 37–25) 32). Studies have shown substantial solutions (see, e.g., Ex. 26–Tr. 1370, effective job hazard analyses have the improvements in health and safety after 2136, 2582, 12297). following steps or activities in common: participatory ergonomics programs are Some participants opposed this • Obtaining information about the implements (e.g. Ex. 32–38). A comment provision, however (see, e.g., Exs. 30– specific tasks or actions the job from Johnson & Johnson sums up the 3344, 30–74, 30–3557). Several involves; opinion of many participants: expressed concern that asking

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Sooner recommend improvements to the job?’’ those that are short term). or later, for reasons good, bad, or indifferent, tend to elicit useful information and do There are several ways employers somebody will answer ‘‘yes’’ [when asked if not prejudge the answer (Exs. 32–339– may comply with the observation the job presents physical difficulties]. (Ex. 1–82, 500–121–61). In any event, the requirement in paragraph (j)(2)(ii) of the 30–74) employee input is only one aspect of the standard, and participants described Another participant was concerned that job hazard analysis. The employer need how they integrate job observations into employee comments would vary from not place great weight on the views of their job hazard analysis (see, e.g., Tr. employee to employee and thus not be a single employee when those views are 8171, Tr. 11133). First, employers may useful (Tr. 8861). Finally, several inconsistent with the rest of the simply observe employees perform the commenters argued that the employer information obtained during the job tasks; this is often all it takes to and employee should not discuss the analysis. identify the problem. For example, risk factors present in ‘‘normal job The final rule adds the language ‘‘and watching a data processor reaching to activities’’ because doing so might cause employee representatives’’ to this use the mouse because the keyboard employees to feel that there should be provision consistent with the practice in tray is not long enough to accommodate no stress on the job (Exs. 30–3354, 30– the rest of the rule to include the it may be all it takes to identify the 3848). ‘‘employee representative’’ language likely cause of the employee’s shoulder OSHA continues to believe that included in each provision of the pain. Videotaping the job is another employees’ views add significant value standard where OSHA is requiring such common practice for observing jobs (see, to the job hazard analysis process and, participation. The proposal took a more e.g., Ex. 32–198–4). A number of in fact, that not asking employees about general approach to this issue, i.e., it employers, especially in situations their perception of the tasks that may would have required employers to where the work activities are complex cause MSDs would be akin to decide when including employee or the causes of the problem not be performing a quality survey without representatives was important in easily identifiable, report that they involving the customer. Therefore, the ‘‘developing, implementing, and videotape or photograph the job (see, final rule requires the employer to talk evaluating the employer’s program’’ (64 e.g., Ex. 26–1370; Tr. 3059, 4696, 6979, with the employees who perform the FR 66070). 7075, 5805, 5540, 10183). task when conducting this step of the A few commenters also stated that the The value of simply looking at people job hazard analysis process. appropriate focus for a job hazard performing a job was demonstrated OSHA is, moreover, providing enough analysis is the task rather than the job graphically at the hearing. A law firm flexibility in this provision to and objected to OSHA’s use, in the representing a number of participants accommodate employers’ concerns. proposal, of the word ‘‘job’’ in showed several ergonomist witnesses OSHA is not requiring employers to use connection with the component to be pictures of two workers seated at any particular method to talk with analyzed in a job hazard analysis (see, computer workstations (Ex. DC 42), and employees about the tasks they perform. e.g., Exs. 32–300–1, 30–3755). OSHA asked the witnesses to identify the risk Employers may do something as simple agrees, and the language of the final rule factors observable in the photo. as talking with employees informally uses ‘‘tasks’’ instead of ‘‘jobs’’ when Virtually all of the witnesses (Tr. 1754, while observing the job being referring to the units of analysis in this Tr. 1756, Tr. 2249, Tr. 2325–2327, Tr. performed, or they may choose to talk process. 5397, Tr. 9045, Tr. 13228, Tr. 13235, Tr. with employees as part of a regular staff Paragraph (j)(2)(ii) requires employers 13307, Tr. 13762) explained that it or production meeting. Alternatively, to observe the employees performing the would normally be necessary to ask the employers may have affected employees job to identify the risk factors in the job, employees in the jobs reflected in the fill out a survey form or questionnaire. and to evaluate the magnitude, photos pertinent facts about the job Many employers have developed frequency, and duration of exposure to before being able to determine with any effective tools for gathering important these risk factors. Job observation allows certainty whether the exposure job information from employees who do the employer to see how the employee represented in the snapshot posed an the job. For example: does the job and provides information MSD hazard to the worker: about the workstation layout, tools, AMP Inc., a manufacturer of electronic methods, equipment and general Well, again, it would go back to what they components, with 300 employees, uses a one- environmental conditions in the were doing. If they were doing this job for a page ‘‘Ergonomic Evaluation Form’’ that asks long period of time (Tr. 928). employees to answer simple ‘‘yes/no’’ workplace. A number of commenters questions about the employee’s ease and recognized the value of this step (Ex. Nonetheless, when pressed to give the comfort when performing certain job tasks. 30–3755). This paragraph of the final best answer possible based on the After the company’s ergonomic team rule combines paragraphs (c) and (d) of limited amount of available evidence, (comprised of line employees) reviews the proposed section 1910.918. Observing the witnesses reviewing the photos were form, a member of the team interviews the the employees at work is important surprisingly consistent in their employee. (Ex. 26–5). because it allows employers to see identification of ergonomic risk factors In addition, there are ways to ask precisely which tasks may be imposing across witnesses. The table below questions that respond to the concerns biomechanical stress on the worker. summarizes the witnesses’ responses to expressed above. The questions may be Observation is a necessary addition to the snapshot.

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Risk factorsÐshorter Risk factorsÐtaller worker Identified by worker Identified by

Contact Stress ...... Armstrong (TR. 928), Alexander (TR. 2249), Awkward neck posture Armstrong (TR. 929), Alexander (TR. 2250), Fernandez (TR. 5384), LeGrande (TR. Fernandez (TR. 5380), Brossard (TR. 9047), Brossard (TR. 13221), Robbins (TR. 13228), Rich (TR. 9590). 1362). Static Posture ...... Armstrong (TR. 928), Fernandez (TR. 5384), Static posture ...... Fernandez (TR. 5380), Rich (TR. (9592). LeGrande (TR. 4096), Rich (TR. 9592). Awkward neck posture Alexander (TR. 2250), Fernandez (TR. 5385), Awkward wrist posture Rich (TR. 9598). Brossard (TR. 13224). Awkward back posture LeGrande (TR. 4096), Brossard (TR. 13225), Awkward back posture Brossard (TR. 13227). Rich (TR. 9601). Awkward knee posture Fernandez (TR. 5381), Brossard (TR. 13226), Rich (TR. 9596). Contact Stress ...... Brossard (TR. 13230).

Although the participants who the degree of individual control is known need protection since the job has questioned these experts later claimed (Ex. 500–121–61). already been shown to involve exposure that the exchanges demonstrated Other commenters, however, objected levels that are associated with increased ‘‘erratic inconsistency’’ in the to including all same jobs in the risks of injury. As explained in the identification of MSD hazards among analysis (Exs. 30–2208, 30–3765, 500– discussion of paragraph (f), jobs that OSHA’s own experts (Ex. 500–197 at II– 145). For instance, Larry Feeler, a meet the Basic Screening Tool generally 23), OSHA believes they show just the physical therapist and president of pose a risk of MSDs that is three times opposite: that it is often possible to WorkSTEPS, Inc., said that including all higher than jobs that do not. Third, the identify risk factors easily even with same jobs would be too burdensome and requirement is necessary to ensure that only limited knowledge of the costly for employers (Ex. 500–145). And employers have complete information employee’s activities. If the witnesses P.J. Edington, of the Center for Office about the hazards in the job. If the job had had access to the extra information Technology, was concerned that it hazard analysis is limited to the injured they all agreed was necessary, OSHA would be difficult for some employers employee’s job, employers may not get expects that there answers would have to determine whether employees were the information necessary to identify the demonstrated much more uniformity. performing the ‘‘same job’’ and that causes of the problem accurately. Without this information, the control ‘‘Same Jobs’’ OSHA compliance officers might mistakenly classify all office work jobs measures employers implement might Paragraph (j)(2) of the final rule as the ‘‘same job’’ (Ex. 30–2208; see also not be successful in controlling or requires that employers include in the Ex. 500–197). Some commenters urged reducing the hazards to the required levels. job hazard analysis (and control OSHA to limit the job hazard analysis In any event, OSHA believes that the process) not only the injured employee’s requirement only to the injured ‘‘same job’’ requirement will not impose individual job but also all other jobs in employee’s individual job (see, e.g., Exs. undue burdens on employers. As the the establishment that are the ‘‘same’’ as 500–145, 30–2208), or only to other Note to this paragraph explains, like the that job. ‘‘Same jobs’’ are jobs that employees on the same shift (see, e.g., proposal, the requirement does not involve the same physical work 30–3765). apply where employers have reason to activities and tasks as the job that the For several reasons, OSHA believes believe that an MSD hazard only poses injured employee performs, regardless the requirement to analyze other jobs a risk to the employee who experienced of their job title or classification. (See that are the same as that in which an the MSD incident. Commenters the definition of ‘‘job’’ in paragraph (z)). MSD incident occurred is necessary to generally supported this limitation (Exs. All same jobs in the establishment must the final rule. At the same time, OSHA 30–4540, 30–1353, 500–145). Similarly, be included in the job hazard analysis acknowledges the commenters’ where employers have reason to believe and control process, even if they are concerns and has included additional that MSD hazards are present in only a performed at different locations or on explanation and examples of ‘‘same subset of the same jobs, then employers different shifts. The standard, however, jobs’’ in this preamble section, as well would be permitted to limit their does not require employers to apply the as providing flexibility for employers response to that group. For example, job hazard analysis and control process who have a large number of employees where it is clear that the size or width to same jobs in other establishments. in the same job. The requirement is of the grip on a knife poses a hazard The proposed rule contained an important because it helps to make the only for employees with small hands analogous provision, which a number of final rule more proactive and (i.e., need for high hand force in order commenters supported (Exs. 30–4200, preventive. It ensures that employees to hold knife), the employer would be 500–215, Tr. 12894). For example, performing the same physical work free to limit the analysis to employees Suzanne Rodgers, a nationally activities or tasks as someone who with small hands. recognized ergonomist who has been already has been injured are provided In addition, in most establishments, helping companies to develop effective with protection before they too are hurt. relatively few employees perform the ergonomics programs for more than 32 As one commenter put it, the first same job. This is especially true for years, wrote in Occupational Medicine: injured employee may well be a small employers. However, even where ‘‘harbinger’’ of other MSDs among The questions asked on site will give a many employees at an establishment good appreciation of the overall demands of employees in the same job (Ex. 30– perform the same job (e.g., telephone the job * * * It is important, therefore, to 3755). operators, letter sorters, package sorters, look at more than one person doing the job, Second, it is likely that other package delivery, beverage delivery, so individual methods can be assessed and employees performing the same job will trash collectors, janitors, hotel maids),

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Jobs are the same when is especially true when employers have analyze the job of each employee. workers perform the same physical general job classifications, such as office However, analyzing the job for a sample work activities or same job tasks. worker, assembly line workers, of employees allows employers to Employees perform the same job when production staff. ‘‘Office workers’’ may identify the MSD hazards facing all of the discrete elements or physical actions be assigned to tasks as varied as the employees. they perform are the same, even if not answering phones, operating copy OSHA is requiring employers to every aspect of their jobs is identical. machines, filing, or typing. If the MSD sample those employees with the For example, incident affected an office worker typing greatest exposure to the relevant risk • Employees whose jobs involve documents, the employer would only factors to ensure that exposure levels in picking up packages from one conveyor need to include in the job hazard the job are characterized accurately. and putting them onto another are analysis other office workers whose OSHA has used the concept of performing the same job, even if the work task is to type documents. ‘‘representative sampling’’ for hazard packages contain different products, or Likewise, ‘‘lineworkers’’ or ‘‘production identification purposes in several of its are placed on different conveyors. workers’’ in a poultry processing plant standards, such as the asbestos standard • Orderlies whose job tasks involve may perform very different tasks. (29 CFR 1910.1001), the formaldehyde lifting and moving patients have the Sample of Employees standard (29 CFR 1910.1048), and the same job even though some lockout/tagout standard (29 CFR characteristics of the patients, room Paragraph (j)(2) also gives employers 1910.147). The principle behind this layout and the purpose of the lift or the option to include in the job hazard concept is that, if the job hazard move may vary each time. analysis only a sample of the employees • analysis (or the exposure monitoring, in Garbage collectors who pick up in the same job. Where the employer the case of chemical exposures) reveals trash cans and recycle bins, and dump elects to use a sample of employees, the that the exposures to this group of most their contents into the garbage truck, sample must include those employees highly exposed workers are not at levels have the same job even though their with the greatest exposure to the of concern, it is likely that those of other routes are not identical (e.g., variations ‘‘relevant risk factors’’ (i.e., those risk lesser exposed workers will also not be in terrain, traffic, distance from factors that exceed the levels on the of concern. residences). Basic Screening Tool). The proposed A few participants disagreed that the On the other hand, just because the rule also included a similar option and representative sampling option would workstations, tools and equipment many commenters supported it (see e.g., be useful to reduce burdens for employees use is the same does not Exs. 30–3344, 30–3745, 30–3749). employers: mean that these employees have the OSHA believes that this option same job. For example: should help to reduce burdens for OSHA concedes that ‘‘conducting a job • Employees who use VDTs do not employers while at the same time hazard analysis that covers all employees in a problem job may be burdensome’’ * * * It have the same job where one employee’s ensuring that the analysis of risk factors is not possible for an employer to know of job involves steady typing for most of exposure in the job is accurately and account for the multitude of physical the workday while the other employee characterized and not underestimated. factors that affect the way its employees uses the VDT to read and send Some commenters, including Anheuser- work. A sample selected, for instance, could electronic messages for only a few hours Busch and United Parcel Service inadvertently ignore the employee with the a day. reported that they had dozens to widest fingers, the smallest feet or the most • Employees in an automotive hundreds of employees in their sensitive hearing, in violation of the assembly plant who use glue guns or establishments who perform the same proposed rule. OSHA’s ‘‘shortcut’’ for performing a job analysis is to us staple guns do not necessarily have the job (Exs. 32–241). This option also insignificant and illusory—employers will, in same job if they are assembling different should help establishments employing practice, have to observe virtually every aspects of the product (installing seats telephone operators, customer service employee in the problem job—a task that versus windshields), particularly if they representatives, catalog sales even OSHA admits can be burdensome (Ex. use the tools in different ways, with representatives, data processors, trash 500–197). different force, and in different collectors, warehouse selectors, grocery OSHA does not believe that positions. store cashiers, meatpackers, poultry employers will have difficulty For purposes of this standard, job processors and others. Including every identifying the employees in a job who titles or classifications do not determine employee in these ‘‘same jobs’’ in the are most likely to have the greatest whether employees are in the same job. job hazard analysis may be exposure to the risk factors. The specific Where employees are performing the unnecessarily resource intensive, criteria in the Basic Screening Tool will same physical work activities or tasks, especially where the workstation be particularly useful in helping they are in the same job even if they layouts and tools are identical (Ex. 500– employers identify, for example, those have different job titles. Often jobs 145). Employers may be able to identify employees who: involving the same physical work the problem and possible controls after • Repeat the same motion for the activities may have different job titles if analyzing the jobs of only a handful of longest continuous period during the there are working supervisors, some employees. workshift; kinds of seniority systems, or different This option will also help in • Lift the heaviest objects or packages work shifts. For example, a ‘‘Fabricator situations where jobs are of short or the most objects per workshift; II’’ on the third shift may be performing duration or do not have fixed • Have the greatest degree of flexion the same physical work activities as a workstations (e.g., visiting nurses, home or extension of their wrists; ‘‘Junior Fabricator II’’ or ‘‘Apprentice health aides, home repairmen, furniture • Use vibrating hand tools for the Fabricator’’ on the first shift. movers, beverage delivery, package most time during the workshift; and

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• Make the longest reaches during the meaning closer to ‘‘breaking point,’’ as while job tasks are being performed. For workshift. in metal fatigue. In other words, fatigue, example, when a person’s arm is In addition, the body location when used in the context of ergonomics, hanging straight down (i.e., component in the Basic Screening Tool generally means that the muscle is no perpendicular to the ground) with the will help employers identify whether longer able to work and must be allowed elbow close to the body, the shoulder is particular physical capabilities, to recover, or that the point of damage in a neutral position. However, when limitations and characteristics may be or deformation of a tissue has been employees are performing overhead relevant in selecting the sample of reached. Thus, in ergonomics, the term work (e.g., installing or repairing employees for the analysis. For implies more than simply being tired or equipment, grasping objects from a high example, employers do not need to uncomfortable. The force required to shelf) their shoulders are far from the consider the width of employees’ fingers complete a movement increases when neutral position. Other examples when it is kneeling or squatting for more other risk factors are also involved. For include wrists bent while typing, than 2 hours that has triggered the need example, more physical effort may be bending over to grasp or lift an object, for job hazard analysis. And foot size is needed to perform tasks when the speed twisting the back and torso while not relevant when the risk factors being or acceleration of motions increases, moving heavy objects, and squatting. addressed are vibration, intensive when vibration is present, or when the Awkward postures often are significant keyboarding, or high hand force. task also requires awkward postures. contributors to MSDs because they Moreover, once the people Hand tools that require use of pinch increase the exertion and the muscle responsible for conducting job hazard grips require more forceful exertions to force that is required to accomplish the analyses have been trained in the hazard manipulate the tool than do those that task, and compress soft tissues like identification and job hazard analysis permit use of power grips. nerves, tendons, and blood vessels. As process, their knowledge of ergonomic Force can be assessed qualitatively or used in the final rule’s basic screening risk factors and the causes of MSDs will quantitatively. Quantitative measures tool, awkward postures may be either help them determine which employee include strain gauges, spring scales, and static postures held for prolonged physical capabilities and limitations electromyography to measure muscle periods of time, or they may occur may be relevant. They will understand activity. A qualitative assessment of repetitively. that, if the relevant risk factor is force is based on direct observation of Awkward posture is the primary awkward posture associated with the amount of physical exertion ergonomic risk factor to which bending down to monitor a gauge required to complete a task, and is employees are exposed when the height positioned close to the floor, the usually graded on an ordinal scale (i.e., of the working surfaces is not correct. employees with the greatest exposure low, medium, high). Working in awkward postures increases would be those who are taller. And if Repetition. Repetition refers to the the amount of force needed to the risk factor is awkward posture frequency with which a task or series of accomplish an exertion. Awkward caused by reaching above the head, then motions is repeated over and over again postures create conditions where the shorter employees and those with short with little variation in movement. When transfer of power from the muscles to reaches would be the most exposed. motions are repeated frequently (e.g., the skeletal system in inefficient. To every few seconds) for prolonged Risk Factors overcome muscle inefficiency, periods such as several hours or an employees must apply more force both Paragraph (j)(2)(ii) requires employers entire work shift, fatigue and strain of to initiate and complete the motion or to identify the risk factors present in the the muscle and tendons can occur exertion. In general, the more extreme job and to evaluate their magnitude, because there may be inadequate time the postures (i.e., the greater the frequency, and duration. These risk for recovery. Repetition often involves postures deviate from neutral positions), factors include force, repetition, the use of only a few muscles and body the more inefficiently the muscles awkward postures, vibration, and parts, which can become extremely operate and, in turn, the more force is contact stress. Unlike the proposal, the fatigued even though the rest of the needed to complete the task. Thus, final rule does not include cold body is unaffected. awkward postures make forceful temperature and static postures as Repetitive motions occur frequently exertions even more forceful, from the independent risk factors. In addition, in manufacturing operations where standpoint of the muscle, and increase contact stress and vibration are defined production and assembly processes the amount of recovery time that is somewhat more narrowly than they have been broken down into small needed. were in the proposal. 64 FR 65808. sequential steps, each performed by Awkward postures are assessed in the Force. Force refers to the amount of different workers. Repetition is also workplace by observing joint angles physical effort that is required to present in many manual handling during the performance of jobs tasks. accomplish a task or motion. Force also operations, such as warehouse operation Observed postures can be compared refers to the degree of loading to and baggage handling. Repetition is qualitatively to diagrams of awkward muscles and other issues as result of typically assessed by direct observation postures, such as is done in many job applying force to perform work. Tasks or videotaping or as a percent of task analysis tools, or angles can be or motions that require the application cycle time, where a cycle is a pattern of measured quantitatively from videotape of higher force place higher mechanical motions. recordings. loads on muscles, tendons, ligaments, Awkward postures. Awkward Contact stress. Contact stress results and joints (Ex. 26–2). Tasks involving postures are positions of the body (e.g., from activities involving either repeated high forces may cause muscles to fatigue limbs, joints, back) that deviate or continuous contact between sensitive more quickly. Some commenters were significantly from the neutral position 9 body tissue and a hard or sharp object. unclear about the meaning of fatigue in The basic screening tool in the final rule the context of MSDs (see, e.g., Ex. 30– 9 Neutral posture is the position of a body joint includes a particular type of contact 3866). The common use of fatigue, of that requires the least amount of muscle activity to stress, which is using the hand or knee maintain. For example, the wrist is neutral in a course, is as a synonym for ‘‘tired.’’ handshake position, the shoulder is neutral when as a hammer (e.g., operating a punch However, ergonomics has its roots in the elbow is near the waist, and the back is neutral press or using the knee to stretch carpet engineering, where fatigue has a when standing up straight. during installation). Thus, although

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For example, a task may appropriate not to include whole-body Mechanical friction (i.e., pressure of a require the exertion of so much physical vibration in the final rule at this time. hard object on soft tissues and tendons) force that, even though the task does not Cold temperatures can, however, causes contact stress, which is increased involve additional risk factors such as increase the effect of other risk factors. when tasks require forceful exertion. awkward postures or repetition, an MSD By reducing the dexterity and The addition of force adds to the friction is likely to occur. For example, using sensitivity of the hand, cold created by the repeated or continuous the hand or knee as a hammer (e.g., temperatures may cause a worker to contact between the soft tissues and a operating a punch press or using the apply more grip force to hold hand tools hard object. It also adds to the irritation knee to stretch carpet during and objects. Also, prolonged contact of tissues and/or to the pressures on installation) alone may expose the with cold surfaces (e.g., handling cold parts of the body, which can further employee to such a degree of physical meat) can impair dexterity and induce inhibit blood flow and never stress that the employee has a numbness. Cold air blowing from a conduction. significant risk of a serious injury. pneumatic tool, or a draft from the Contact stress commonly affects the Generally, however, ergonomic risk HVAC system, also can result in soft tissue on the fingers, palms, factors act in combination to create an localized cold stress on the hands, arms, forearms, thighs, shins and feet. This MSD hazard. Evidence in the Health neck, or shoulder. Cold also increases contact may create pressure over a small Effects section (Section V) shows that the effects of vibration, such as in tree area of the body (e.g., wrist, forearm) jobs that involve exposure to multiple felling and cutting to length with a that can inhibit blood flow, tendon and risk factors are likely to cause MSDs, chainsaw on a cold day. muscle movement and nerve function. depending on the duration, frequency Performing a job hazard analysis The intensity of exposure to contact and/or magnitude of exposure. Thus it includes determining the magnitude, stress is usually determined is important that ergonomic risk factors frequency, and duration of employee qualitatively through discussion with be considered in light of their combined exposure to the risk factors described the employee and observation of the job. effect in causing or contributing to an above. These terms are discussed below. MSD. This can only be achieved if the Segmental vibration. Vibration refers Duration. Duration refers to the job hazard analysis and control process to the oscillatory motion of a physical cumulative time an employee is includes identification of all the body. Segmental, or localized vibration, exposed to one or more risk factor(s). ergonomic risk factors that may be such as vibration of the hand and arm, The duration of exposure has a present in a job. If all of the risk factors occurs when a specific part of the body substantial effect on the likelihood of are not identified, employers will not comes into contact with vibrating both localized tissue fatigue and general have the information that is needed to objects such as powered hand tools (e.g., cardiovascular fatigue. (Again, the word determine the cause of the MSD chain saw, electric drill, chipping incident or understand what risk factors ‘‘fatigue’’ is used in the ergonomics hammer) or equipment (e.g., wood need to be controlled to eliminate or sense.) In general, the longer the period planer, punch press, packaging reduce the MSD hazard in the job. of continuous work (i.e., the longer the machine). Although using powered Based on its review of the scientific task requires sustained muscle hand tools (e.g., electric, hydraulic, literature available at the time of the contraction), the longer the recovery or pneumatic) may help to reduce MSD proposal, OSHA also identified rest time required (Ex. 26–2). Changing risk factors such as force and repetition, prolonged sitting and standing (a form the sequence of activities or the the tools can expose employees to of static posture) and whole-body recovery time and pattern of exposure vibration. Vibrating hand tools transmit vibration as risk factors for MSDs; in may mitigate the effects of long vibrations to the operator and, addition, OSHA identified cold duration. Breaks or short pauses in the depending on the level of the vibration temperatures as a risk factor because it work routine help to reduce the effects and duration of exposure, may could require workers to increase the of prolonged exposure. contribute to the occurrence of hand- force necessary to perform their jobs Frequency. Frequency refers to the arm vibration syndrome or Raynaud’s (such as having to grip a tool more number of times the exposure is phenomenon (i.e., vibration-induced tightly) (64 FR 65808). The final rule repeated within some unit of time, in white-finger MSDs) (Ex. 26–2). does not explicitly include these risk contrast to duration, which relates to the The level of vibration can be the factors. For prolonged standing and cumulative length of exposure. This result of bad design, poor maintenance, sitting, and for cold temperatures, factor also can be obtained by observing or the age of the powered hand tool. For although there is evidence of an and counting (either by video tape, in example, even new powered hand tools increased risk of MSDs with exposure, person, or mechanically) the number of can expose employees to excessive the available evidence did not permit repetitions or the cycle time associated vibration if it they do not include any the Agency to provide sufficient with each task. The response of muscles devices to dampen the vibration or in guidance to employers and employees and tendons to work is dependent on other ways shield the operator from it. on the levels of exposures that warrant the number of times the tissue is Using vibrating hand tools can also attention. For whole-body vibration, required to respond and the recovery contribute to muscle-tendon contractile there was substantial evidence of a time between these responses. The forces owing to operators having to use causal association with low back frequency of an activity can be increased grip force to steady tools disorders (e.g., see NIOSH 1997); measured at the micro level, such as having high vibration. however, heavy equipment and trucks, grasps per minute or lifts per hour. Vibration from power tools is not easy the most common sources of whole- However, there are some tasks, such as to measure directly without the use of body vibration, are seldom rated for lifting a 150-pound package or pushing sophisticated measuring equipment. vibration frequencies and intensities. In a 400-pound beer barrel, where simply However, vibration frequency rating are addition, measurement of whole-body knowing that the activity occurs, say, on available for many recently designed vibration levels requires special one day every week, is sufficient to hand tools. equipment and training that would be establish that an MSD hazard is present.

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Magnitude is a measure of the identified to determine whether the are present, that are reasonably likely to strength of the risk factor; for example: employee’s exposure to them is the cause or contribute to a covered MSD (Ex. how much force, how deviated the result of an MSD hazard or hazards in 500–218). posture, how great the velocity or the job. To make this determination, Other commenters argued that the acceleration of motion, how much employers must look at the duration, proposed approach to the identification pressure due to compression. Magnitude frequency and magnitude of the of risk factors and MSD hazards was can be measured either in absolute ergonomic risk factors in the job, as vague and that OSHA should instead terms or relative to an individual’s required by paragraph (j)(3). This provide a permissible exposure limit capabilities. There are many qualitative evaluation may allow the employer to (PEL) for each risk factor and each and quantitative ways to determine the rule out some risk factors that do not possible combination of risk factors (see, magnitude of exposure to ergonomic pose a significant risk of injury, as well e.g., Exs. 500–197, 30–2435, 30–973, risk factor(s) (some of these as to identify risk factors that do rise to 30–1274, 30–2426, 30–1350, 30–2428, measurement tools are provided in the level of an MSD hazard. Risk factors 30–3986, 30–3993, 30–3000, 30–3086). Appendix D–1). In relatively simple are sometimes ruled out because the Since some employers have been very cases, one approach is to ask employees exposure does not last long enough, is successful in using simple approaches, to classify the force requirements or not repeated frequently enough, or is such as the one proposed, to identify physical difficulties posed by the job on not intensive enough to pose a risk. On and control MSD hazards, however, a scale of 1 to 5, or on a scale as simple the other hand, a job that requires OSHA finds this argument as ‘‘low,’’ ‘‘medium,’’ and ‘‘high.’’ When significant bending from a neutral unpersuasive. Risk factors and MSD magnitude is assessed qualitatively, the posture for most of the day would be hazards are being identified and employee is making a relative rating, identified as an MSD hazard by the addressed in thousands of workplaces i.e., is rating the perceived magnitude of appropriate hazard identification tool in every day, and employers and the risk factor relative to his or her own Appendix D–1, and the job would employees are using a wide variety of capabilities. Relative ratings can be very therefore be labeled a ‘‘problem job,’’ as approaches to do so. useful in understanding whether the job noted in paragraph (j)(4) of the standard. OSHA recognizes, however, that fits the employees currently doing the The approach to hazard identification although certain of the risk factors job. reflected in paragraph (j)(3) of the final described above are easy to identify and There are a number of ways to rule differs from the proposed approach understand, others are not as apparent measure the magnitude of exposure and responds to comments that objected or observable. Employers who already quantitatively (see, e.g., Exs. 500–218, to the proposed approach (see, e.g., Exs. have ergonomics programs and persons 500–220). For example, the NIOSH 32–300–1, 30–3032). The proposal who manage ergonomics programs Lifting Equation is widely used to included a table that listed 20 physical generally have no difficulty identifying determine recommended weight limits work activities and job conditions such risk factors in the workplace, because for safe lifting and carrying (see, e.g., as ‘‘exerting considerable physical effort they have learned to look for them (see, Exs. 26–521). The Snook Push-Pull to complete a motion’’ and ‘‘using hand e.g., Exs. 30–3755, 500–220, 32–359–1, Tables are also used by many employers and power tools,’’ linked each of these 32–210–2, 32–198–4, 30–3805, Tr. to evaluate and design pushing, pulling activities to a number of risk factors 11427). Because these individuals have and carrying tasks (see, e.g., Ex. 26– likely to be associated with the training and experience, ergonomic risk 1008). For work-related upper extremity performance of such activities, and factors are familiar concepts for them. MSDs the Rapid Upper Limb directed employers to evaluate these Through the process of developing and Assessment (RULA) evaluation tool is risk factors to determine whether an implementing their ergonomics often used to investigate and evaluate MSD hazard was present. programs, these individuals have gained jobs (see, e.g., Ex. 26–1421). These three The National Telecommunications a good working knowledge of the tools are included in Appendix D–1, Safety Panel was one of many ergonomic risk factors that are most and are discussed at greater length in participants who found the proposed likely to be present in their workplaces. connection with that Appendix. hazard identification approach For those employers who are just unhelpful: beginning their programs and have little Paragraph (j)(3) or no training and experience dealing Paragraph (j)(3) of the final rule The members of the Panel strongly believe with ergonomic risk factors, OSHA has that the matrix of ‘‘physical work activities tried in the standard to make the requires the employer to use one of the and conditions’’ and ergonomic risk factors following methods or tools to conduct that may be present * * * provides process of identifying them as the job hazard analysis: insufficient guidance to be included as a straightforward and easy as possible. a. One or more of the hazard mandatory item in a federal rule. (Ex. 30– For this reason, OSHA has provided identification tools listed in Appendix 3745). employers with many different hazard D–1 of this section, if the tools are A similar comment was that the identification tools in mandatory relevant to the risk factors being proposed job analysis approach shifted Appendix D–1 and mandatory D–2. The large number of risk evaluation addressed; or the burden of hazard identification from tools in the record and the many (ii) The occupation-specific hazard OSHA to the employer (Ex. 30–4334). comments OSHA received on the identification tool in Appendix D–2 of Commenting on this point, however, the proposed list of physical activities and this section; or AFL–CIO stated: III. A job hazard analysis conducted conditions have led the Agency to by a professional trained in ergonomics; * * * the obligation placed upon employers include in the final rule several options or in the proposed ergonomics standard, as with for hazard identification that employers (iv) Any other reasonable method that other standards, is to eliminate or reduce an may choose from. Many commenters occupational hazard. In the proposed is appropriate to the job and relevant to ergonomics standard, OSHA has defined discussed hazard identification tools the risk factors being addressed. ‘‘hazard’’ not in numerical terms but in that are currently used by employers The final rule, like the proposal, descriptive terms: ‘‘MSD hazards are physical (see, e.g., Exs. 500–200, 500–218, 30– requires employers to evaluate the work activities and/or physical work 3813, 30–276). Thus, the final rule ergonomic risk factors they have conditions,’’ in which ergonomic risk factors allows a choice of hazard identification

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Paragraph (j)(3)(i) Since the proposed rule is job-based 32–185–3–26, 32–185–3–33), and (particularly targeted to problem jobs), OSHA described several approaches to hazard Paragraph (j)(3)(i) of the final rule should have reviewed the scientific literature identification that employers have used allows the employer to evaluate to identify and publish exposure assessment to identify ergonomic risk factors ergonomic risk factors using one or methods capable of distinguishing problem effectively (Ex. 500–220). These more of the hazard identification tools jobs from non-problem jobs. In its proposed approaches include: listed in Appendix D–1 of this section. rule, OSHA fails to mention existing methods • Appendix D–1 list eight hazard capable of such prediction (e.g. the Strain Development of consistent methods Index) or methods that have the potential for to measure the physical stresses on the identification tools: (1) The Job Strain Index (Ex. 26–883), (2) the NIOSH such predictions (e.g. the Revised NIOSH body. Stress is determined by the force lifting equation) (Ex. 30–3361). lifting equation (Ex. 26–572), (3) the exerted on a body part, the frequency of OSHA selected the tools in Appendix the motion and the posture of the joint. UAW–GM checklist (Ex. 32–185–3–26), (4) the applicable ACGIH threshold D–1 for several reasons. They were The Force-Frequency-Posture paradigm developed by professionals who have is common to both expert and checklist limit values for physical agents (Exs. DC 389, 500–166–1, 502–273), (5) the Rapid extensive training and experience in the approach to ergonomics analysis. identification, analysis and control of • Development of simplified non- Entire Body Assessment (REBA) (Ex. MSD hazards. For instance, the Snook expert approaches to measurement of 500–121–26), (6) the Rapid Upper Limb Push/Pull Hazard Table was developed risk factors (checklists) Assessment (RULA) (Ex. 26–1421), (7) by Dr. Stover Snook , a certified • Formulation of the NIOSH lifting Appendix B to the final Washington professional ergonomist with a PhD. in guide and related biochemical models State ergonomics standard (WAC 296– experimental psychology, who has which take into account the weight of 05174) (Ex. 32–210–2–99), (8) the Snook spent 38 years researching MSDs and 25 an object, distance from the body and Push/Pull Hazard Table (Ex. 26–1008). years teaching ergonomics at the motion of the body in lifting. Tools selected must be relevant to the • Validation of symptom surveys and risk factors being addressed. This Harvard University School of Public discomfort surveys (psychophysical means, for example, that an employer Health (Ex. 37–6). The eight tools in Appendix D–1 are measures) as risk factor identification could not use the NIOSH Lifting also well-documented. They are based tools Equation, which is appropriate for on scientific evidence on the relevant • Validation of the use of risk factor employees exposed to certain types of risk factors, and most been published in checklists and symptom surveys by force, to analyze a job involving peer-reviewed scientific journals (e.g., workforce personnel to identify high repetition and awkward posture. A number of participants submitted Job Strain Index, NIOSH Lifting risk jobs and propose abatement evaluation tools to the record (see, e.g., Equation, RULA, REBA, Snook Push/ methods. Pull Hazard Table). To illustrate, the Dr. Don Chaffin, founder of the Center Exs. 26–2, 26–5, 32–77–2–1, 502–67, steps in the Job Strain Index by Moore for Ergonomics at the University of 26–883, IL–162–Q, 32–185–3–31, 500– and Garg were based on the findings Michigan, testified that the precision of 142–12, OR–348–1, 32–185–3–26, 500– and data of a number of peer-reviewed many tools used to evaluate risk factors 121–61, 38–260, IL–218, IL–228, 32– studies, including the Borg CR–10 scale is very high (Tr. 8255–8286). Ms. Lisa 339–1–82, DC 417–6, 500–121–21, 38– (Ex. 26–883). The summary and Brooks, corporate ergonomist for 93, 500–121–28, 32–111–1, 32–198–4– explanation of Appendix B to the International Paper, commented that 27–1), while others (see, e.g., Exs. 500– Washington State Ergonomics Standard there were many different analysis tools 220, 500–218, Tr. 5567) suggested that includes extensive discussion and tables used throughout the company (Tr. the final rule include tools, such as the documenting the scientific support for 11427). Snook tables and the OSHA The AFL–CIO also commented on the Meatpacking Guidelines (Ex. 30–2387). each element in that tool (Ex. 32–210– widespread availability of risk factor Still other participants merely asked the 2–99). The tools have also been tested, most evaluation tools (Ex. 500–218): Agency to provide more guidance in the final rule for companies to identify of them extensively. For instance, to Testimony and evidence in the record ergonomics risk factors (see, e.g., Exs. develop the Rapid Entire Body demonstrate the job analysis tools such as the 30–276, 30–3818, 30–4290, 500–197, Assessment (REBA) tool, three NIOSH Lifting Equation and Snook—Ciriello ergonomists/physiotherapists Push-Pull Tables are widely utilized by 500–218, 30–3864, Tr. 11601, Tr. 9070, employers, unions, consultants and others to Tr. 17419), and many commenters independently coded 144 posture evaluate exposure to ergonomic risk factors suggested that OSHA provide non- combinations and then incorporated the throughout a wide range of industries and mandatory checklists (see, e.g., Exs. 30– sensitizing concepts of load, coupling businesses. Representatives of International 3765, 30–1671, 30–3284, 30–2387, 32– and activity scores to produce the final Paper (Tr. 11425–26), Owens-Corning (Tr. 300–1, 30–519, 30–4844, 30–3032, 30– REBA score, with accompanying action 10856), Conti Group Corp. (Tr. 10788), Coca 3748, 30–3813). levels (Ex. 500–121–26). Thereafter, two Cola (Tr. 14356) and Levi Strauss (Tr. 14710) Based on this evidence, OSHA has workshops were held involving 14 testified that they routinely used these tools decided to allow employers to occupational safety and health in their ergonomic programs to analyze jobs demonstrate compliance with paragraph processionals (including ergonomists, for ergonomic risk factors. Representatives from the UAW and UNITE! testified how (j)(3) by using one or more of the tools occupational therapists, these and other tools such as UAW–GM in Appendix D–1, assuming it is physiotherapists and nurses) to code Check Lists were used by employers and appropriate to the risk factors being more than 600 additional samples of union representatives to evaluate ergonomic addressed for job hazard analysis postures from several industries (i.e., hazards at Ford (Ex. 32–185–3–42; 46, Tr. purposes. These hazard identification health care, manufacturing and

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The NIOSH Lifting Equation and did to develop the Push/Pull Hazard 30–3864, Tr. 11601, Tr. 9070, Tr. documentation supporting it has been Table: 17419). These tools specifically and published in a peer-reviewed scientific Most of my experiments were clearly operationalize the table of journal. psychophysical investigations of manual physical work activities and conditions Area of the body addressed by NIOSH handling tasks, viz., lifting, lowering, in the proposed rule so they answer Lifting Equation: Lower back. pushing, pulling, and carrying. The purpose commenters’ repeated questions about Risk factors evaluated: Force of these experiments was to collect hard data what proposed terms such as ‘‘over and (distance, coupling), repetition for use in evaluating the risk of manual over,’’ ‘‘considerable physical effort,’’ (frequency), awkward postures (location handling tasks, and to aid in the redesign of ‘‘long reaches’’ and ‘‘heavy’’ objects of the object, travel distance, twist). these tasks. At the time, psychophysics was Examples of jobs that NIOSH Lifting the only method that could yield usable data mean. For example, the Job Strain Index for task evaluation. Psychophysics is a very (Ex. 26–883) defines ‘‘over and over’’ in equation is applicable to or well- old method that is concerned with the terms of efforts per minute (number of designed for: manual handling tasks mathematical relationship between sensation exertions/total observation time). The involving objects weighing more than 10 and their physical stimuli. Psychophysics NIOSH Lifting Equation defines a pounds; forceful lifting tasks in has been applied to practical problems in ‘‘heavy’’ object as weighing 51 pounds production and assembly work; package many areas, including the decibel scale of or more, and then shows users how to sorting, handling, delivery and pickup. loudness, and ratings of perceived exertion reduce the amount of weight that can be ACGIH TLV Hand/Arm (Segmental) (RPEs) * * * lifted within the equation’s limits on the My colleagues and I conducted eleven Vibration TLV major manual handling experiments over a basis of particular conditions in the period of 25 years [citations omitted]. Each workplace. The ACGIH Hand/Arm (Segmental) experiment lasted two to three years. These There are tasks for which each of the Vibration TLV describes how to experiments were unique in hat they used evaluation techniques in Appendix D–1 measure hand tool vibration and realistic manual handling tasks performed by are well suited and tasks where the tool provides threshold limit values for industrial workers (68 males and 51 females) is not appropriate. The following exposure. over long periods of time (at least 80 hours information explains the limits and Areas of the body addressed: Hands, of testing each subject). Physiological appropriate uses for each tool in Arms/Shoulders. measurements of oxygen consumption and Appendix D–1. Risk factors evaluated: Vibration. heart rate were recorded for comparison with Examples of jobs that the Hand/Arm psychophysical measurements. The Job Strain Index experimental design also included 16 to 20 (Segmental) Vibration TLV is applicable hours of physical conditioning and The Job Strain Index is designed to to or well-designed for: Jobs involving psychophysical training. A battery of 41 identify jobs associated with MSDs of use of powered and vibrating hand tools anthropometric measurements were recorded the hand. It does this by measuring or (e.g., grinding, sanding furniture, for each subject to insure that the sample was estimating six task variables: intensity sawing, jigsawing, chain saws). representative of the industrial population. or exertion, duration of exertion per GM–UAW Checklist The results of these experiments were cycle, efforts per minute, wrist posture, combined and integrated into tables of speed of exertion and duration of task The UAW–GM checklist was maximum acceptable weights and forces for per day (Ex. 26–883). The Job Strain developed to evaluate a range of risk various percentages of the working factors in production jobs. The checklist population (Ex. 37–6). Index and documentation supporting it was published in a peer-reviewed uses checks (√) and stars (*) to indicate These tools were also designed for use scientific journal. whether the certain activities and by persons with only minimal training Area of the body covered by the Job conditions are present for less than or in hazard identification. For example, Strain Index: Hand/wrist. more than one-third of the production Washington State said that it designed Risk factors evaluated: Force, cycle or workday. The number of checks Appendix B particularly for small awkward postures, repetition (speed of and stars, in conjunction with the report employers with limited resources who work). of an MSD, is used to determine if the wanted ‘‘maximum clarity and Examples of jobs that Job Strain Index job requires further investigation or certainty.’’ Washington State Appendix is applicable to or well-designed for: control action. B includes illustrations of the relevant Jobs involving high hand repetition, Areas of the body addressed: Hand/ risk factors and a simple 5-step process small parts assembly, keyboarding, wrists, Forearms/elbows, Shoulders, for determining whether particular inspecting (assembly line), sorting, Neck, Back/Trunk, Legs/knees. lifting tasks pose a hazard. The other meatpacking, sewing, packaging. Risk factors evaluated: Force tools in Appendix D–1 use similar (including manual handling), NIOSH Lifting Equation approaches. For instance, the GM–UAW Repetition, Awkward Postures checklist uses a simple stars and checks The NIOSH Lifting Equation, which is (including Static Postures), Vibration, approach to those tasks and activities already widely used, was developed to Contact stress that may warrant further investigation evaluate manual lifting demands. It Examples of jobs that the GM–UAW or controls. provides an empirical method for checklist is applicable to or well- Finally, OSHA has selected these computing a weight limit for manual designed for: cyclical production and eight tools because they all include lifting tasks to prevent or reduce the assembly work jobs. specific and well-defined recommended occurrence of lifting-related low back criteria for when employers need to take pain among workers. Six factors are RULA action and when no further action used to determine the recommended The Rapid Upper Limb Assessment would be necessary. As such, these tools weight for the specific working (RULA) was developed to evaluate

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RULA and significant number of MSDs each year documentation supporting it has been The Snook Push/Pull Table is and occupational computer use is published in a peer-reviewed scientific designed to identify whether pushing, growing. MSDs associated with journal. pulling and carrying activities meet or computer use are reported in a wide Areas of the body addressed: Wrists, exceed established maximum acceptable range of industries (e.g., Forearms/elbows, Shoulders, Neck, loads or force levels for those activities. telecommunication, telephone, banking, Trunk. It does this by examining initial and insurance, catalog and telephone sales, Risk factors evaluated: Awkward sustained forces of loads, horizontal customer service, package delivery posture, force, repetition. distance, vertical distance, frequency service, newspaper) and in businesses of Examples of jobs that RULA is and object weights. These all sizes, including very small applicable to or well-designed for: measurements are compared with the establishments. OSHA believes that its assembly and production work, tabled values corresponding to the task VDT checklist provides these businesses janitorial and maintenance, and considered acceptable for 75% and with an easy and quick way to identify meatpacking, restaurant, grocery 90% of the adult male and female and control hazards in a large number cashier, telephone operator. population. The Snook Push/Pull Table of jobs. and documentation supporting it has OSHA designed this checklist after REBA been published in numerous peer- considering the many examples of The Rapid Entire Body Assessment reviewed scientific journal articles. In computer workstation checklists in the (REBA) is similar to RULA, but it has addition, the table was used in record (see, e.g., Exs. 26–2, 26–1517, been modified to be more useful for the developing the NIOSH Lifting Equation. 26–1337, 32–182–1–6, 502–313–3, IL– working postures found in the health Body areas addressed: Back/Trunk, 258, 500–142–10). The checklist is care and other service industries. REBA Legs, Shoulders. designed to provide employers with a and documentation supporting it has Risk factors evaluated: Force, simple way to identify the five risk been published in a peer-reviewed repetition, awkward posture. factors this standard covers, as they scientific journal. Examples of jobs that Snook Push/ most commonly occur in computer Areas of the body addressed: Wrists, Pull Hazard Table is applicable to or work and workstations. All the Forearms/elbows, Shoulders, Neck, well-designed for: manual handling jobs employer need do is check whether the Legs/knees, Trunk, Back involving pushing or pulling objects or risk factor is or is not present in the Risk factors evaluated: Awkward carrying objects a long distance, and employee’s working conditions and posture, force (load and coupling), hospital laundry and janitorial jobs, workstation equipment, and address repetition. among others. those that are present. Examples of jobs that REBA is The checklist provides clear and Paragraph (j)(3)(ii) applicable to or well-designed for: specific guidance in how the employer Patient lifting and transfer, assembly Paragraph (j)(3)(ii) allows employers can provide or adjust a computer and production work, janitorial and to use the video display terminal (VDT) workstation so it will be comply with maintenance work, meatpacking, hazard identification tool in Appendix the control requirements of this restaurant work, grocery cashier, D–2 of this section for jobs involving standard. Each checklist item is written telephone operator. risk factors related to computer use. to provide the solution to the problem Appendix D–2 is a simple checklist to it identifies. For example, the checklist Washington State Appendix B assess the physical activities and layout items addressing awkward neck The Washington State Appendix B of workstations with a VDT. Like the postures actually show how to position was developed to determine if jobs that tools in Appendix D–1, the VDT the computer monitor to eliminate those were in the Washington State ‘‘caution checklist was added to the final rule to postures (e.g., ‘‘Top line of screen is at zone’’ actually pose an MSD hazard to address comments that the physical or below eye level so employee is able employees in them. The checklist shows activities and conditions listed in the to read it without bending head or neck physical risk factors and lists duration proposal were too vague to be used for down/back,’’ ‘‘Monitor position is (from 2 to 6 hours) by body part. If the job hazard analysis and control (see, directly in front of employee so work activities or conditions apply, the e.g., Exs. 500–197, 30–2435, 30–973, employee does not have to twist head or job poses an MSD hazard. 30–1274, 30–2426, 30–1350, 30–2428, neck,’’ ‘‘No reflected glare (e.g., from Areas of the body: Shoulders, Neck, 30–2986, 30–2993, 30–3000, 30–3086, windows, lights) is present which might Back, Trunk, Knees, Forearms, Wrists, 30–3853, 30–326, 30–546, 30–4189, 30– cause employee to assume an awkward Hands, Elbows. 3845). posture to read screen.’’). Risk factors evaluated: Awkward The function of the checklist is to OSHA expects the VDT checklist to postures, Force (including manual determine if the computer workstation provide significant assistance for lifting and high hand force), Repetition, and layout address the risk factors most employers in industries where MSD Contact Stress, Vibration. commonly found in VDT jobs. The hazards associated with computer use Examples of jobs that Washington analyst using this checklist would talk are the major, or even the only, MSD State Appendix B is applicable to or with and observe the worker(s) while hazards they face. Unlike other well-designed for: very wide range of they are at the computer workstation. If checklists in the record, which include jobs including patient lifting and a condition or activity in the job merits a range of risk factors such as vision and transfer, assembly and production work, the checklist’s ‘‘Yes,’’ the analyst would general environmental conditions, janitorial and maintenance, check the ‘‘Yes’’ box. If there are no OSHA’s checklist addresses only those

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In fact, OSHA use existing hazard identification tools equipment-based checklists, employers believes that in about 85% of cases, or methods that will get the job done. get a passing score only if they have managers, supervisors, and employees If employers choose to avail purchased and installed particular can, with some training in ergonomic themselves of the option in paragraph equipment at each computer principles and job hazard analysis, (j)(3)(iv), they must be sure that the workstation. OSHA’s risk factor-based perform the required analysis of jobs in method of job hazard analysis they checklist, however, gives employers the their workplace that have met the action choose is one that is reasonable and flexibility of deciding how to best trigger. Thus, OSHA believes that, in appropriate for the risk factors present, control the identified hazards. For most cases, employers will be able to i.e., the risk factors identified in the job example, an equipment-based checklist perform job hazard analyses without by the Basic Screening Tool. For asks employers whether they have expert outside help, and that the sheer example, if the job requires the provided adjustable height tables and number of employers who have already employee to sit in a chair and assemble monitor risers. A risk factor-based established effective ergonomics cellular phones for 8 hours a day, then checklist, on the other hand, asks programs on their own (Ex. 502–17) is the method must be appropriate for employers whether the employees’ testimony to the ability of companies to seated work, hand/arm force, and the heads and necks are in a straight rather initiate a program without hiring a motions that are required by the job. A than awkward positions (i.e., bent down consultant. The record has many method that only measures strain to the or back), when they look at the monitor comments (see, e.g., Exs. 502–17, 500– back would clearly not be a reasonable screen. If an employer can achieve this 215, Tr. 11427, Tr. 1008, Tr. 13764) method of job hazard analysis for this result without purchasing new reporting that employers and employees phone assembly job. Paragraph (j)(3)(iv) adjustable equipment, this will satisfy are ‘‘going it alone.’’ encourages employers to continue to use the standard. A number of participants The hazard identification method their own effective analysis techniques, said that they have controlled risk permitted by paragraph (j)(3)(iii), provided they are appropriate, or to factors at VDT workstations without however, is based on the expert develop a tool that fits their needs. purchasing new adjustable equipment judgment of a safety and health Many participants submitted (see e.g., Tr. 2707). professional trained in ergonomics and ergonomic risk factor evaluation tools OSHA stresses that, like the other its application in the workplace. This that they have used in their workplaces tools in Appendix D, its VDT checklist job hazard analysis option, therefore, to the record (see, e.g., Exs. 26–2, 26– is only one of a number of methods assumes that the employer has chosen 5, 32–77–2–1, 502–67, 26–883, IL–162– employers may use to identify and to seek outside help (unless, of course, Q, 32–185–3–31, 500–142–12, OR–348– control MSD hazards related to the workplace has such a safety or 1, 32–185–3–26, 500–121–61, 38–260, computer use. Employers are free to use health professional on staff). Paragraph IL–218, IL–228, 32–339–1–82, DC 417– other checklists in the record or to (j)(3)(iii) is unlike paragraphs (j)(3)(i) 6, 500–121–21, 38–93, 500–121–28, –3, continue using whatever method they and (ii) in this respect. OSHA is aware 32–111–1, 32–198–4–27–1). For currently use to identify and evaluate that some employers (see., e.g., Ex. 502– example, the Dow Chemical Company MSD hazards associated with computer 17) currently rely on outside experts or uses a method that measures posture, use, provided those methods address OSHA’s consultation program for job repetition, force and duration and takes the risk factors this standard covers. hazard analyses. For most employers into consideration frequency and and most jobs, however, OSHA believes environmental factors, such as lighting, Paragraph (j)(3)(iii) that employers will choose to develop for computer workstations (see, e.g., Ex. Paragraph (j)(3)(iii) allows employers the level of in-house expertise needed to 32–77–2–1). The Dow Chemical method to choose to have a job hazard analysis implement the job hazard and control provides for scoring of jobs based on the conducted by a professional trained in requirements of the standard. number of words typed or keystrokes ergonomics. By a ‘‘professional trained per minute (frequency), the time spent in ergonomics,’’ OSHA means an Paragraph (j)(3)(iv) doing the task (duration), and the ergonomist, safety professional, Paragraph (j)(3)(iv) allows the amount of force or amount of deviated industrial hygienist, engineer, or other employer the flexibility to use any other posture (magnitude) used by the worker safety and health professional who has reasonable method of job hazard to perform the task (see, e.g., Ex. 32–77– received training in the principles of analysis that is appropriate to the job 2–1). The final score on the ‘‘Dow card’’ ergonomics and their application in job and relevant to the risk factors being allows the person performing the job hazard analysis and control. Reliance on addressed. This method could consist of analysis (usually the employee in the a trained professional or competent a hazard identification tool of the type job) to determine if there is a problem. person is a concept used in many OSHA in Appendix D, or of a job hazard The United Steelworkers of America rules, such as the Asbestos Standard (29 analysis methodology developed by the developed a survey as a job hazard CFR 1910.1001), the Process Safety company itself. Many employers utilize analysis tool for bus drivers. The survey Management Standard (29 CFR trained workplace ergonomic includes qualitative measurements of 1910.119), and the Telecommunications committees to perform these job reach distances for the steering wheel, Standard (29 CFR 1910.268). analyses. OSHA has included this job floor pedals, clutch, and door handles, A few commenters suggested that the hazard analysis option in the final rule as well as the force required to use work final rule should require specific in recognition of the fact that other site tools. Seating support and visibility qualifications for those individuals hazard identification tools and methods are also evaluated using the tool that has permitted by the rule to perform job are effective in identifying MSD been developed to evaluate exposures hazard analyses (see, e.g., Exs. 30–4674, hazards, and that many employers have for bus drivers see, e.g., Ex. 32–111–1). 32–210–2). OSHA rejected this idea instituted effective ergonomic programs Levi Strauss uses a checklist with because the record contains many that include job hazard analysis measurements by body part for posture,

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These employer may be able to use the Quick Workstation: Overhead conveyor, methods of analysis are applicable to Fix option permitted by paragraph (o). shackles 44 inches above the floor. the tasks and work environments for If the Quick Fix method can be used, the Equipment: Thigh boning knife; wire which they were developed because employer does not need to continue mesh glove for non-knife hand; optional they measure the risk factors that are with the job hazard analysis, although rubber gloves for both hands; hard hat; reasonably expected to be found in he or she must observe all the steps in smock; boots. those tasks and jobs in their respective the Quick Fix process. For more Methods: (1) Grasp and position thigh industries. complex problems and solutions, the with non-knife hand, (2) Cut along thigh In fact, the record contains many employer is required to comply with the bone to separate meat from bone 2–3 examples of employers who are requirements of paragraphs (k), (l), and cuts, (3) Cut remaining tendinous identifying and controlling ergonomics (m) to control the MSD hazard attachments (bone drops into conveyor risk factors on a daily basis. Dow identified. as work release meat and bone. Chemical sites across the country have In other cases, however, the problem Environment: Air-conditioned turkey ° ° been recognized by OSHA and the may require a more detailed analysis plant; turkeys at 38 F, ambient air 45 F. Voluntary Protection Program (VPP) for that could involve breaking the task Risk Factors: their outstanding safety and health down into its various discrete elements 1. Forceful exertions—(knife hand) efforts. Their programs include the or activities and then identifying and holding knife, cutting thighs, (non-knife analysis of ergonomics risk factors: evaluating the extent to which hand) holding thighs for cutting. Force employees are exposed to risk factors in depends on user’s technique, sharpness Dow analyzes tasks utilizing a risk of the blade, worker’s position relative evaluation card. This card looks at the these activities (see, e.g., Ex. 32–210–2). various ergonomic hazards that may be The quantified risk factors are then to the moving turkey. Forces on the present in our workplaces and rates these compared to values that have been cutting hand are greater (up to 38 hazards by a relative risk index or weighting shown to contribute to the MSD hazard pounds) than the hand holding the thigh method. This weighting or indexing (see, e.g., Exs. 26–2, 26–1247, 500–121– (up to 19 pounds). Holding hand is approach is consistent with other risk 26, 32–210–2–99, DC–386, 500–121–21). relaxed between cuts, while the knife indices, which OSHA has supported or hand continues to grasp the knife recommended. Indexing allows employers A job hazard analysis approach that is intermediate between the narrative handle (4 pounds). like Dow to prioritize its limited safety and 2. Repetition—4,320 cuts per hour, health resources in such a way to get the approach and the detailed analysis most ‘‘bang for the buck’’ not only from an discussed above is the use of a checklist. holding thigh 1,080 times per hour. economic perspective concerning appropriate Checklists provide more structure than 3. Awkward/Static posture—Wrist controls, but also from a risk perspective as the narrative approach, but are less time bent and forearm rotated while cutting well. Such an approach has been successful consuming than a detailed job analysis. thighs. The wrist is angled due to the in our workplaces and has been borne out straight knife, type of cut, location and through our experience. Dow’s recordable Several commenters suggested that OSHA include checklists in the orientation of the turkey. rates and incidence of MSDs are much lower Paragraph (j)(4) of the final rule standard (see, e.g., Exs. 30–3748, 30– than the general industry experience (Ex. 30– simply states that jobs that have been 3755, 32–182–1, 30–3826, 30–3818). 3755). determined, through the job hazard OSHA agrees that well-designed Employers are free to select the analysis process, to pose an MSD hazard checklists, when used as intended, can method or tool that best fits their own to employees in that job are called provide an effective hazard jobs, workplace conditions, and culture. ‘‘problem jobs’’ for the purposes of the identification approach for a range of A job hazard analysis is effective as long standard. as it allows the person who is employers, especially small business OSHA finds, based on the comments, performing it to determine whether a job owners. There are many ways in which data, and other evidence on job hazard has risk factor(s) that rise to the level of checklists are useful: identifying analysis in the record, that the job an MSD hazard or does not pose an physical work activities and conditions, hazard analysis approach adopted in MSD hazard. Some employers reported identifying ergonomic risk factors, paragraph (j) of the final rule is widely using simple and fairly informal evaluating jobs, prioritizing jobs for used by employers and employees and procedures to identify hazards in a job further analysis, and providing a is highly effective. Further, the hazard (see, e.g., Tr. 17353, 2979). This was method of evaluating the effectiveness identification tools and methods especially true for employers who have of controls. The American Physical permitted by this paragraph are only limited or isolated ergonomics Therapy Association (APTA) endorsed commonly used in workplaces large and problems. the usefulness of checklists as a job small, for workers with fixed and A job hazard analysis approach used hazard analysis option: mobile worksites, and in the analysis of by many employers is the narrative In APTA’s review, checklists would be an both traditional and ‘‘non-traditional’’ approach. This method of hazard extremely helpful resource to small jobs. identification is similar to job analyses businesses conducting job hazard analyses. used to identify other potential safety (Ex. 30–3748). Paragraph (k)—What Is My Obligation and health hazards (see, for example, The following example of a job hazard To Reduce MSD Hazards? OSHA’s Process Safety Management analysis includes a combination of Paragraph (k) of the final ergonomics Standard, 29 CFR 1910.119, which qualitative and quantitative standard tells employers how far they allows employers to use this approach). observations and measurements (Ex. 38– must go in reducing MSD hazards at the With the narrative approach, the 438): workplace. This paragraph sets the employer and employee discuss the job Title: Turkey processing—thigh control endpoint that employers must requirements and the relationship (if boning. achieve. Final paragraph (k) presents

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00085 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68346 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations three options. Employers are in materials. In other cases, judgment may 32–133, 32–300). OSHA has responded compliance with this paragraph when be required. In any event, the employer to these comments by allowing the controls they have implemented: may refer to the method it used under employers the option of controlling • Control the MSD hazards to the paragraph (j) to determine whether the MSD hazards to the specific levels set extent that they are no longer reasonably job presents a hazard. For example, the out in Appendix D. likely to cause MSDs that result in work employer may use a professional trained Paragraph (k)(1)(iii) restrictions or medical treatment beyond in ergonomics to conduct the analysis first aid, and determine whether job conditions Paragraph (k)(1)(iii) of the final rule • Reduce MSD hazards in accordance present a hazard and to recommend states that employers are in compliance with or to levels below those in the measures to control the hazard. The with the endpoint if they have reduced hazard identification tools in Appendix employer can also make use of its own the hazard to the extent feasible. This D that the employer used to conduct the knowledge and experience gained under paragraph applies when it is not feasible job hazard analysis, or its program. for employers to reach one of the • Reduce MSD hazards to the extent The employer may also use hazard endpoints in paragraphs (k)(1)(i) and feasible. identification tools. As described above (ii). It is included because OSHA has no As described in the Risk Assessment in the explanation of paragraph (j), the authority to require employers to do and Economic Analysis sections of this employer may choose from a variety of what is not feasible or ‘‘capable of being preamble, much evidence in the record such tools. Appendix D lists a number done.’’ American Textile Mfrs. Institute demonstrates that employers with of specific tools that provide safe v. Donovan (Cotton Dust), 452 U.S. 490, existing programs are able to harbors for compliance under paragraph 509, 513 n. 31, 540 (1981). A control successfully control the MSD hazards in (k)(1)(ii); however, the employer may that will reduce a hazard in a job is problem jobs to a level where an MSD also consider other tools that are feasible if it is achievable within the is reasonably unlikely to occur. effective in identifying hazardous levels limits of current technology and Paragraph (k) of the final rule does not of exposure in determining what knowledge and the employer’s financial require employers to eliminate all controls to implement. resources. An employer’s inability to MSDs. OSHA recognizes that, in a These examples are not intended to be afford controls will not establish number of jobs, workplaces, and exhaustive. They are intended to infeasibility if its level of compliance physical work activities it may not be illustrate means employers may use to lags significantly behind the rest of its possible to eliminate MSDs. OSHA is ‘‘control MSD hazards.’’ industry. See Section IV–A.6.a(4)(a) and also aware that employers who have an Several points bear noting. First, the (b) of OSHA’s Field Inspection effective ergonomics program may still obligation is not to reach a level of Reference Manual (CPL 2.103). See also, receive reports of MSDs. The goal of the absolute safety or to assure that no United Steelworkers v. Marshall, 647 final rule is to assure that employers further MSDs will occur: it is to reduce F.2d 1189, 1269 (D.C. Cir. 1980). take effective action to control MSD the hazard so that work activities are not OSHA is also requiring that hazards, and paragraph (k) tells reasonably likely to cause MSDs. employers who meet the compliance employers how far they must go in Second, the hazard reduction is targeted endpoint by being at the limits of implementing controls. to MSDs that result in work restrictions feasibility, but have not fully controlled (including days away from work) or MSD hazards, periodically check to see Paragraph (k)(1)(i) medical treatment beyond first aid. whether new technology has been An employer is in compliance with These are serious conditions by any developed and is available. These paragraph (k)(l)(i) when it reduces MSD measure. Finally, the standard allows checks must be carried out at least once hazards to the extent that they are no the employer to take up to two years to every 3 years. When additional feasible longer reasonably likely to cause MSDs implement permanent controls. This controls are identified, the final rule that result in work restrictions or extended period should be sufficient to requires employers to implement them medical treatment beyond first aid. The allow for situations in which until one of the compliance endpoints hazard analysis conducted under installation of effective controls requires given in paragraph (k)(1)(i) or (k)(1)(ii) paragraph (j) will have identified the a period of adjustment. is reached. Requiring employers to look risk factors of concern. To control the for and implement new control Paragraph (k)(1)(ii) MSD hazard, the employer must reduce methodology ensures that an employer the magnitude, duration, or frequency of The second option is to reduce MSD who has not fully controlled ergonomic the risk factors to the level where they hazards in accordance with or to levels hazards is not relying on obsolete are reasonably unlikely to cause such below those in the hazard identification control measures. MSDs. There are several ways an tools in Appendix D that the employer What Happens When a New MSD Is employer can achieve this goal. used to conduct the job hazard analysis. First, the employer can reduce This appendix is intended to give Reported After Controls Have Been ergonomic risk factors below the levels employers specific guidance to help Implemented? in the Basic Screening Tool. The final them determine whether or not they Paragraph (k)(2) of the final rule tells standard recognizes that risk factors have gone far enough in controlling employers what to do if an employee below the levels in the screening tool MSD hazards. As discussed more fully reports an MSD in a job in which the are not reasonably likely to cause MSDs, below, many rulemaking participants employer has implemented MSD hazard and allows an employer to discontinue felt that the proposed rule was vague controls. If an employee makes such a his or her ergonomics program if it has and shifted the burden of determining report, the employer must check to see reached those levels. how far to control MSD hazards to if the controls are still in place and are Second, the employer can otherwise employers (see, e.g., Exs. 30–1722; 30– functioning and being used properly. control the hazards such that they are 3956, 35–106; Tr. 4110, 15648–15649) The employer must also check to see if reasonably unlikely to cause MSDs. In or suggested that OSHA provide, in the any new hazards exist that were not some cases, the needed controls may be final rule, more guidance on how to present when the job hazard analysis obvious or readily discoverable by make that determination (see, e.g., Exs. was conducted. The employer need not reference to compliance assistance 30–1557, 30–2987, 30–3748, 30–3765, conduct another full job hazard analysis

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00086 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68347 but may undertake a review of the received on the proposed compliance 4334; Tr. 14986). For example, United previous job hazard analysis to endpoint and present OSHA’s reasons States Senator Kit Bond observed that determine if it is adequate. for accepting or rejecting the rulemaking OSHA ignored comments from the Sometimes, after ergonomic control participants’ suggestions and for Small Business Advocacy Review panel measures have been implemented in a including the final rule’s compliance about the vagueness of the word problem job, another employee will endpoint requirements. ‘‘feasible’’ (Ex. 30–4334). The National experience and report an MSD. The 1. Comments That the Proposed Coalition on Ergonomics (NCE) stated injury could be a sign that the controls Compliance Endpoint Was Vague that the lack of a suitable definition are not functioning correctly or that new rendered the option to ‘‘implement hazards have arisen. For example, an Many of the comments and much of controls that reduce the MSD hazards to employer might have, among other the testimony OSHA received on the the extent feasible’’ unclear (Ex. 30– things, installed adjustable keyboard issue of compliance endpoints stated 3956). The Coalition said that OSHA trays at each VDT station and trained that the language used to set compliance had not provided any reliable guidance employees in their use. If one of the goals was vague and confusing (see, e.g., as to what ‘‘feasible’’ meant from either keyboard trays gets out of adjustment, Exs. 30–333, 30–1722, 30–2208, 30– a technological or an economic the operator using that tray might 2387, 30–3765, 30–3813, 30–3853,30– standpoint. The Coalition believed that experience and report tendinitis in his 3956, 30–4185, 30–4334, 30–4467, 32– this left employers with no way of or her wrists. An employer following 300, 32–337, 440, 500–118, 500–188, determining whether a particular hazard paragraph (k)(2) of the final rule would 500–197, 500–221; Tr. 2960, 4109, control was feasible for them. check to ensure that the keyboard tray 14986). In particular, these rulemaking Paul, Hastings, Janofsky, and Walker is still present and is adjusted properly. participants argued that the related LLP also argued that the proposed terms ‘‘material reduction or standard’s attempt at flexibility resulted Note to Paragraph (k) elimination of MSD hazards’’ and in a standard using terminology full of A clarifying note at the end of ‘‘materially reduce the MSD hazards’’ ambiguity (Ex. 30–3231). The law firm paragraph (k) explains that the were so vague that employers would not believed that OSHA’s enforcement staff occurrence of an MSD in a problem job know how far they had to go to control would likewise struggle to understand is not in itself a violation of the MSD hazards. For example, ORC said the rule. standard. This note emphasizes that the that those terms, together with the The National Coalition on Ergonomics focus of the final rule’s compliance phrase ‘‘reasonably anticipated to (Ex. 30–3956) went further to suggest endpoint is on the control of MSD significantly reduce the likelihood’’ in that the proposed language was so vague hazards and not on the elimination of the clarifying note following as to be unconstitutional: MSDs from the workplace. OSHA § 1910.921(a), would prove to be compliance nightmares for employers It is fundamental that ‘‘a statute which recognizes that, for a number of jobs, either forbids or requires the doing of an act workplaces, and physical work and enforcement nightmares for OSHA in terms so vague that men of common activities, it may not be possible to (Ex 30–3813, 32–78). ORC claimed that intelligence must necessarily guess at its eliminate MSDs. OSHA is also aware the language in the note would breed meaning and differ as to its application, that employers who have effective unnecessary confusion. Further, Edison violates the first essential of due process of ergonomics programs may still receive Electric Institute stated that the law.’’ Connally v. General Constr. Co.. 269 reports of MSDs. The goal of the final definition of ‘‘materially reduce MSD U.S. 385, 39 (1926). [Footnote omitted.] Thus, hazards’’ uses three terms, an occupational safety and health standard rule is to have employers put a good must give an employer fair warning of the working system into place so that they ‘‘reasonably,’’ ‘‘significantly,’’ and ‘‘likelihood,’’ that are themselves vague conduct it prohibits or requires, and it must can take effective action to control MSD provide a reasonably clear standard of hazards. (Ex. 32–300). Several rulemaking culpability to circumscribe the discretion of participants believed that this vagueness the enforcing authority and its agents. Dravo The Proposed Rule would lead to unnecessary litigation Corp. v. OSHRC, 613 F.2d 1227, 1232, 7 BNA The proposed rule would have (see, e.g., Exs. 30–3813, 30–3956, 30– OSHC 2089 (3d Cir. 1980). [Footnote required employers to meet one of three 4185, 30–3853, 32–337). James Lancour, omitted.] compliance endpoints: representing EEI, was concerned that * * * * * • Materially reduce MSD hazards in the vagueness would cause employers The language and terminology used by the problem job using the incremental difficulty in program and training OSHA in much of the proposed standard and abatement process; development, stating: Preamble is so vague and ambiguous that it • Reduce MSD hazards in the fails to provide employers with adequate To provide reasonable program notice of what the standard will require and problem job to the extent feasible; or development and training one must clearly • Eliminate MSD hazards in the prohibit and, accordingly, is define the program endpoints and the steps unconstitutionally vague. The proposed problem job. to achieve these endpoints. The endpoints standard fails to provide employers with OSHA explained the first endpoint must also be objectively measurable to adequate notice as to the conditions, achieve the desired results. This proposed with a definition of ‘‘materially reduce circumstances or activities in the workplace standard is so vague and ambiguous that MSD hazards.’’ The definition, which that cause MSDs and what employers must neither the endpoints nor the measurement was repeated in a note following do to eliminate MSDs under the standard. criteria are specifically defined. The following is a partial list of terms proposed § 1910.921(a), read as follows: How does one develop an ergonomic ‘‘’Materially reduce MSD hazards’’ program, give guidance in determining which are either vague and/or undefined and means to reduce the duration, frequency compliance and provide general and specific fail to provide employers with notice of the and/or magnitude of exposure to one or training to facility program facilitators, required performance under the standard— more ergonomic risk factors in a way managers and supervisors and employees ‘‘material reduction or elimination of MSD hazards * * *’’ and ‘‘ergonomic hazard.’’ that is reasonably anticipated to when the terms of compliance are so poorly defined? [Tr. 2897] These terms are so ambiguous as to fail to significantly reduce the likelihood that provide employers * * * notice of what is covered MSDs will occur.’’ Some rulemaking participants argued required with respect to the fundamental The following paragraphs discuss the that OSHA left the word ‘‘feasible’’ provision of feasible control measures. [Ex. comments, evidence, and testimony undefined (see, e.g., Exs. 30–3956, 30– 30–3956]

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The AFL–CIO (Ex. 500–218) believed OSHA has changed the compliance requirement, OSHA then proposes that that the proposed standard was clear endpoints to respond to the vagueness employers will be considered in compliance and that employers would be able to comments and provide greater clarity. ‘‘if they select and implement the controls successfully carry out the obligations OSHA believes that the language of the that a reasonable person would anticipate would achieve a material reduction in the imposed by it. The union countered final rule’s three endpoints gives likelihood of injury.’’ * * * However, the some of the vagueness arguments in its employers clear and understandable ‘‘reasonable person’’ standard is hardly a post-hearing submission: guidance as to what they must do. bright-line means of determining whether an Employers must control exposure to Employers who achieve the objective OSHA inspector will find an employer in ergonomic risk factors to the point that ‘‘safe harbor’’ endpoints in Appendix D compliance. covered MSDs are no longer ‘‘reasonably are assured they are in compliance. This This is only one example of how likely to occur,’’ in other words, to eliminate avoids the problem most frequently compliance with the proposed standard, at the ‘‘MSD hazard,’’ or reduce it to the extent raised by commenters: That the best, is dependent on interpretations of vague feasible. * * * proposal did not give employers standards by OSHA inspection officials— individuals, at least to date, with little or no The record demonstrates that employers objective criteria by which to measure will be able to accomplish this task. Utilizing training in ergonomics, who inevitably will their compliance obligations. The establish differing criteria to be applied to various tools and other available guidance, objective criteria in the Basic Screening employers have been able to measure and employer efforts in this area. [Footnote evaluate exposure to ergonomic risk factors Tool give employers an alternate clear omitted.] This approach invites litigation and identify and implement controls to means of assuring they are in over the meaning of such vague terms. reduce those exposures. There is plentiful compliance. OSHA has also sought to Indeed, the ‘‘reasonable person’’ is a long- testimony in the record demonstrating that clarify the general performance terms standing standard of tort law used by juries employers are able to ascertain conditions like ‘‘MSD hazard’’ and ‘‘control MSD to assess the culpability of an individual; by that present an ergonomics hazard and to hazards’’ used in the standard. OSHA its nature, it is open to interpretation. Forum members fear that the vagaries of identify and implement measures to reduce has clarified that an employer may rely or eliminate the hazard. complying with the proposed standard may on a safe-harbor hazard identification be held against them during the OSHA * * * * * tool, a professional consultation, or any inspection process. By leaving too much to The proposed standard is clear, and with other reasonable method to define interpretation and failing to provide the inclusion of the AFL–CIO’s whether a hazard exists requiring significant guidance, inspectors may be able recommendations, will be even clearer, that control. OSHA has also dropped terms, to cite facilities despite their good faith an employer’s obligation extends only to like ‘‘incremental abatement process’’ efforts to comply. The lack of compliance eliminating hazardous exposures at work. An guidance potentially is a fundamentally fatal employer’s obligation to conduct job analysis and ‘‘material reduction,’’ that commenters asserted were especially flaw with OSHA’s mandatory proposed and institute controls applies only where standard and must be addressed by OSHA there is exposure on the job to an ergonomic unclear. before a reasonable standard can be risk factor or risk factors that occurs at a a. Comments that the language used promulgated. [Ex. 30–3845] sufficient level of duration, intensity, or in the proposed standard is so vague magnitude to present a risk of MSDs. Under and subjective that it would lead to The National Association of OSHA’s proposed screening criteria, an uneven enforcement. Some rulemaking Manufacturers’ post-hearing submission employer is only required to conduct a job participants who claimed the proposed (Ex. 500–1) contained a letter from Scott analysis if there are ‘‘physical work activities endpoints were vague were also Ward of Windings, Inc. Mr. Ward and conditions in the job’’ that are presented an analogy with how an ‘‘reasonably likely to cause or contribute to concerned about the possibility that the alleged vagueness would lead to uneven existing performance standard is the type of MSD’’ being addressed, and enforced. He described an example of ‘‘[t]hese activities and conditions are a core enforcement (see, e.g., Exs. 30–333, 30– element of the job and/or make up a 1274, 30–3765, 30–3839, 30–3845, 30– how the existing standard on personal significant amount of the employee’s 4185, 440, 500–188, 500–197; Tr. 3330, protective equipment has led to worktime.’’ * * * If these screening criteria 5439, 7211, 17891). They believed that disagreements with OSHA’s compliance are not met, the occurrence of an MSD does the proposed definition of ‘‘materially staff and a citation: not trigger any obligations on the employer’s reduce’’ and the corresponding [W]e provided gloves and design changes part. And the proposed standard limits an to a material (woven fiberglass tape) to employer’s control obligations to situations explanation of that term in the preamble to the proposal would call for subjective reduce an irritation—not even a hazard, for where there is substantial exposure to there is no injurious nature to the material— ergonomic risk factors on the job. If the judgments and would lead to disagreements between employers and and re-assigned an employee who suffered employer’s job analysis does not show the the most irritation so as to not aggravate a existence of a hazard, i.e., exposure to OSHA enforcement staff. For example, skin condition. However, a field inspector ergonomic risk factors that are reasonably The Forum for a Responsible cited us for lack of an effective program even likely to cause or contribute to a covered Ergonomics Standard stated: though we had reviewed the material’s MSD, the employer is under no obligation to Enforcement of the proposed ergonomics MSDS, provided the recommended (not institute controls. The standard clearly limits required) personal protection equipment, employers’ obligations to situations where program standard would require a degree of subjectivity in determining compliance accommodated employee’s complaints and there is significant exposure in the the inspector’s own testing indicated that the workplace, and limits employers’ obligations unprecedented in the Agency’s history. This is because of the nature of the area regulated fiberglass dust was well below exposure level to addressing hazardous exposures at work. combined with the vagueness of the limits. We had begun work on ventilation [Ex. 500–218] proposed standard’s requirements. equipment to provide extra equipment and Dr. Frank Mirer of the UAW also For example, proposed Section 1910.921 this engineer, who doesn’t have air fluid believed the proposed rule was clear (a) provides that employers are in dynamics training, said it wouldn’t work. based on General Duty Clause compliance if they implement controls that The citation was reduced but it stood. [Ex. ergonomic settlement language that was ‘‘materially reduce’’ MSD hazards in the job 500–1] * * * OSHA recognizes that ‘‘a number of OSHA received comments and similar to that in the proposal (Tr. MSD hazards are complex and it may not 5932). always be clear what control(s) will achieve testimony that the training of its field OSHA does not agree that the a material reduction in the probability that staff would significantly affect the language of the proposed rule was MSDs will occur.’’ * * * In an attempt to reasonableness of the Agency’s impermissibly vague. Nevertheless, clarify what constitutes compliance with this compliance efforts (see, e.g., Ex. 30–

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1107; Tr. 5439, 7210). William either the employer or the OSHA unattractive alternatives: either to pay Goldsmith, representing the U.S. inspector to know when an employer is expensive penalties for noncompliance with Chamber of Commerce, was particularly in compliance [Ex. 30–2208].’’ a vague and subjective standard or to hire concerned that the lack of training of Some rulemaking participants went expensive lawyers to appeal and litigate the fines. The litigious history of similar OSHA field staff would lead to further, arguing that the vague language language in the ADA removes any doubt that enforcement difficulties: in the proposal forces employers to this scenario as applied to the Ergonomics And it also bears noting that the companies make subjective judgements about standard is not only probable but certain. [Ex. at least the ones that I am familiar with whether they have gone far enough to 500–27] involved in these cases had ergonomics control hazards (see, e.g., Exs. 30–3853, b. Comments that the vagueness of the programs. Dayton Tire did. Hudson Foods 30–3956, 32–337, 500–27; Tr. 6219). rule is compounded by the lack of did. So when one looks at the past history The Integrated Waste Services scientific certainty. Some rulemaking of what has happened with trying to enforce Association and the National Coalition participants argued that the lack of the terms and the concepts that are ripe on Ergonomics (citing AFL–CIO v. throughout this proposed standard, you I guidance was compounded by the OSHA, 965 F.2d 962 (11th Cir. 1992) at scientific uncertainty of whether a given think get a fair picture of what will happen 976) stated that this is in conflict with if the proposed standard becomes a final rule. control measure would abate the That is a compliance officer doing the best the requirements of section 6(b)(5) of the hazards (see, e.g., Exs. 30–294, 30–461, he or she can will come into a facility, will OSH Act for the Agency to set standards 30–494, 30–1722, 30–2986, 30–3853, probably not be not very well trained through using objective criteria. The Coalition 32–337, 500–197; Tr. 3232, 11375). For no fault of his own or indeed the agency’s stated that the Agency cannot expect an example, the U.S. Chamber of own, but because resources are limited, be employer to decide about permissible Commerce stated, ‘‘At first glance, the making guesses as to what ergonomics exposure to MSD hazards when OSHA ‘reasonableness’ element of these stressors appear in what jobs and the is unwilling or unable to make that litigation if that is what it is, if that is where definitions seems to provide an determination. employer a certain amount of leeway in results will begin. [Tr. 7210] Mr. Edward C. Laux of the eliminating or reducing the hazards. International Cemetery and Funeral In their post-hearing submission, the This, however, is not the case. Under Association believed that the term ‘‘to Chamber noted that the American current scientific principles, nobody the extent feasible’’ was subjective and Society of Safety Engineers (at Tr. knows the point at which the likelihood would present compliance difficulties 11616) and the AFL–CIO (at Tr. 3498) of an MSD occurring will be reduced.’’ for employers. Mr. Laux compared agreed that training of OSHA’s The Chamber alleged that OSHA’s compliance under the proposal’s compliance staff would be crucial to the experts admitted as much. The Chamber requirement to control MSD hazards to enforcement of the ergonomics standard quoted small portions of two OSHA the extent feasible with the reasonable (Ex. 500–188). The Chamber doubted, expert witnesses in Secretary of Labor v. accommodation test in Title I of the however, that such training would be Hudson Foods and Secretary of Labor v. Americans with Disabilities Act: successful: Dayton Tire to support this point. The Thus, it is beyond dispute that additional [Section 1910.921] provides that businesses Chamber suggested that the witnesses training is required. Of course, it is difficult must eliminate or materially reduce could not quantify the reduction in the to understand how the Agency will musculoskeletal disorder (MSD) hazards in rate of MSDs resulting from a given the workplace ‘‘to the extent feasible.’’ This successfully provide such training since control measure. The Chamber * * * even the individuals who drafted the highly subjective standard presents Proposed Rule do not know what it means. difficulties of interpretation similar to the concluded: [Ex. 500–188] ‘‘reasonable accommodation’’ test in Title I of These statements were made, it bears the Americans with Disabilities Act (ADA). repeating, by people called by OSHA in Craig Brightup of the National Roofing The ADA ‘‘reasonable accommodation’’ litigated matters to support particular Contractors’ Association, which was test at 42 U.S.C. 102(b)(5) and at 1630.9 of ergonomics allegations individuals whom, concerned about the impact on small the U.S. Equal Employment Commission presumably, OSHA believed qualified businesses, expressed similar concerns: regulations requires employers to make enough to sponsor as experts at trial. Yet alterations in the workplace for disabled OSHA’s lack of enforcement restraint, neither of them could support the efficacy of workers unless the accommodation would their particular recommended abatements in coupled with the vagueness of the ergonomic impose ‘‘undue hardship’’ on the covered standard, would be a disaster for small a particular workplace cited for particular business. Interpretation of the terms violations of the General Duty Clause. business. Chairman Talent stated in his ‘‘reasonable accommodation’’ and ‘‘undue comments, and I quote, ‘‘Instead of Nevertheless, somehow OSHA expects hardship’’ must be made on a case-by-ease employers * * * even small employers like developing a standard that gives small and business-by-business basis. As a result, the overwhelming majority of the Chamber’s businesses guidance and assistance in interpreting these ADA terms has been the members * * * to develop their own implementing physical changes to the subject of administrative appeals and effective control measures. workplace that reduce and eliminate MSDs, expensive litigation of which small Although OSHA has shifted to the OSHA has left it up to employers to figure businesses, in particular, are ill-equipped to employer the burden to identify to what out how to prevent or eliminate MSDs. These afford. degree a ‘‘risk factor’’ must be reduced to vast regulatory crevices into which small The ICFA believes that the ‘‘feasibility’’ prevent an MSD from occurring, that is a businesses will inevitably fall will be filled provision at 1910.921 of the proposed question nobody can answer. Indeed, OSHA by the unfettered discretion of OSHA Ergonomics programs will result in similar concedes that ‘‘[b]ecause of the multifactoral inspectors as they determine compliance. (Tr. conflicts of interpretation that cannot be nature of MSD hazards it is not always clear 3330) resolved in a ‘‘one size fits all’’ application. whether the selected controls will achieve Edison Electric Institute noted the Small businesses, which comprise 87 percent the intended reduction in exposure to MSD possibility that compliance officers of the cemeteries and funeral homes in the hazards.’’ 64 Fed. Reg. at 65827. would second guess employers’ United States, will be confronted by OSHA Furthermore, in some cases, particular inspectors second-guessing their decisions on control measures (Ex. 32– ergonomic controls may cause more harm understanding of this vague provision and than good. 64 Fed. Reg. 65827 ‘‘[m]any 300). The Center for Office Technology imposing fines on these businesses where employers evaluate controls within 30 to 60 was similarly concerned that the they disagree with their judgment. days after implementation. This gives ‘‘subjective terms ‘reasonable’ and At that point, small businesses will be employees enough time to get accustomed to ‘likelihood’ make it impossible for forced to choose between two highly the controls and to see whether the controls

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NCE challenge by his employees and OSHA. Yet 1722] concluded this argument by stating: eliminating all MSDs is beyond any ‘‘OSHA has put the cart before the horse The National Coalition on Ergonomics employer’s technical and financial resources. in promulgating a rule that requires To say nothing of the fact that ergonomic (Ex. 500–197) echoed the Chamber’s employers to produce solutions that ‘‘science’’ is still in its infancy, many MSDs point and argued that the rulemaking reduce ergonomic hazards when no are caused or aggravated by activities— record demonstrated a lack of consensus available or reliable means exist for sports, yard work, a second job—that may be regarding what control measures would predicting or measuring the efficacy of completely outside an employer’s control. be effective in reducing the rate of The proposed rule thus gives OSHA an open- ergonomic interventions.’’ MSDs: ended pretext to inspect, cite, and prosecute LPA, Inc., also objected to the American companies. [Ex. 30–542] Ergonomics experts likewise admit the proposed control endpoints because impossibility of predicting with any degree of ergonomics is not an exact science (Ex. Mayville Engineering Company, accuracy the ergonomic modifications that 30–494). LPA noted that the studies on Inc.(Ex. 30–294) noted that it had will successfully reduce musculoskeletal difficulty applying controls to abate complaints. [Footnote omitted.] In fact an which NIOSH and OSHA relied did not provide sufficient information to ergonomic hazards without having MSD expert testifying for OSHA in a general duty symptoms surface in previously clause enforcement action said he would employers so that they could evaluate need a ‘‘crystal ball’’ to determine whether a jobs, assess exposure to risk factors, and unaffected employees: particular abatement measure would select controls that will eliminate the We had a facility that had 10 identical eliminate ergonomic stressors.10 [Footnote: risk factors. workstations that assembled radiator cores. Transcript, April 6, 2000, at 7191–92. In The Honorable David McIntosh, We had 3 individuals, within a month, report March of 1999, an expert ergonomist hired by Chairman of the House Subcommittee MSDs. The three individuals had worked at OSHA in another matter confessed that there on National Economic Growth, Natural these workstations less [than] 1 year. One of is simply no way to predict in advance the the individuals had only been doing this job outcome of a particular abatement measure. Resources, and Regulatory Affairs, noted 6 months. The other individuals working at He testified that it is impossible for an that even OSHA admits that most the other 7 workstations had been working employer to know ahead of time whether a ergonomic fixes are not 100 percent on these jobs from 3–10 years each and had control measure will materially reduce or effective (Ex. 30–542, 30–3010). He not reported any MSD symptoms. During the even reduce at all the rate of musculoskeletal wrote: hazard evaluation we questioned the 7 as to complaints. Transcript, April 6, 2000, at A second problem is the lack of end points any problems they had with the workstations 7194.] The lack of consensus regarding or clear criteria for determining when an and they felt that the workstations were fine appropriate ergonomic interventions among employer has fulfilled his obligations. OSHA the way they were. the people who ultimately would be relied is an enthusiastic proponent of ergonomic We made modifications to all 10 of the on to implement the proposed rule surfaced ‘‘solutions.’’ But even OSHA admits that workstations based on the MSDs reported. repeatedly in the hearings. The hearings also most ergonomic fixes are not 100 percent The other 7 individuals started to report MSD revealed the highly uneven track record of effective. [Footnote omitted.] For example, in symptoms with in 3 weeks. How would this ergonomic interventions in the workplace shoe manufacturing, installing armrests and be addressed in your Proposed Standard? and the consistent inability of ergonomics footrests, elevation and tilt equipment, better [Ex. 30–294] professionals to measure the effects of designed chairs, and pallet levelers to The National Coalition on Ergonomics ergonomic interventions, or to predict when minimize bending while lifting reduced the noted that the hearing transcript a particular intervention will be effective in ‘‘number of damaging wrist motions in controlling or abating targeted included evidence of other similar assembly jobs by one-third,’’ reduced ‘‘disc instances that the Coalition claimed musculoskeletal complaints. [Ex. 500–197] compression forces in clerical jobs by about The Coalition further contended that 17 percent,’’ and reduced ‘‘disc compression showed that ergonomic interventions no consensus exists as to who is best forces during lifting jobs by more than 50 were either ineffectual or created more situated to identify effective ergonomic percent.’’ [Footnote omitted.] Such problems than they solved (Ex. 500– solutions (Ex. 500–197). The Coalition workstation modifications undoubtedly 197). On this point, NCE cited the noted that some ergonomics reduce the risk of MSDs. But, suppose experience of an office that handles 9– professionals testified that employees another MSD occurs after the employer has 1–1 calls, a municipal solid waste are the best persons to identify controls implemented those changes. What is the department, the Social Security employer’s obligation? Must he experiment Administration, the Communications with more engineering options? Must he slow 10 The full text of the transcript cited in the Workers of America, and Levi Strauss Coalition’s footnote reads as follows: the pace of work, or implement a job rotation system? [Footnote: ‘‘The answer appears to and Company. The Coalition also cited ‘‘With respect to all of your proposed abatements, a passage from Dr. Emil Pascarelli’s proposed possible solutions, as you call them, that be ‘yes.’ Here is the regulatory language: if every single one were implemented with respect ‘[Y]ou must continue this incremental book, Repetitive Strain Injury: A to every single job, there would still be ergonomic abatement process if other feasible controls Computer User’s Guide: ‘‘All the stressors in every single job?’’ are available’ (1910.922(c)).’’] How practical ergonomic equipment in the world Answer, ‘‘I don’t know if there still would be would that be in a small establishment? What won’t prevent RSI unless people who ergonomic stressors in every single job, but there if the only way to eliminate damaging wrist use computer keyboards learn how to might be ergonomic stressors in some jobs, but I motions and disc compression forces is to type safely, pace themselves, and care can’t say that there still would be ergonomic eliminate the jobs that require wrist flexion stressors in every single job. No, sir, I cannot say for their upper bodies.’’ that.’’ and bending while lifting? Ms. Lisa Brooks, testifying on behalf What would it take for you to say one way or An employer can only guess when his efforts to reduce MSDs are adequate in of International Paper Company, stated another whether that would be so?’’ that the current science of ergonomics Answer, ‘‘A crystal ball.’’ OSHA’s eyes, because the rule contains no It is clear from this exchange that the witness was outcome performance measures or did not support interpreting the talking about more than one control measure being benchmarks. Reducing MSDs by 50 percent proposed standard consistently for a applied to more than one job. or even 70 percent below current levels is no particular job or task (Tr. 11375). She

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Dow several subsidiary compliance tasks. that, if an employee’s condition did not Chemical Company suggested that the The Employment Policy Foundation improve after applying the more liberal Agency could put appendix-like provided a table of the tasks that it of the two guides, OSHA would force an material on its Web site (Ex. 30–3765). believed the standard required and employer to use the more conservative Dow also asked for guidance on the type recommended that OSHA include one even though both are nationally and amount of improvement that was like it in the final rule. The recognized. Ms. Brooks argued that the expected under the incremental Foundation’s table included not only language in the proposal left the abatement process and on the amount of compliance endpoint-related tasks, but employer in doubt: time that was allowed to pass between tasks related to all aspects of the Would the determination of the incremental abatement measures. The standard. compliance end point change if the injured American Health Care Association d. OSHA’s response to these employee’s condition did not improve? recommended defining ‘‘feasible’’ and comments. In response to the many The answer to this question depends upon better explaining the term ‘‘materially commenters arguing that the proposed the interpretation of reasonably likely to reduce’’ (Ex. 30–2987). At the hearing, compliance endpoints were too vague occur and significantly reduce the likelihood Frank White described ORC’s position and failed to give adequate notice to for a particular job or task. as follows: employers, would lead to uneven Some could argue that since the injured enforcement, OSHA has added objective employee’s condition did not improve, the How do I know when I’ve achieved compliance endpoints to the final rule. facility only materially reduced the compliance? Now I understand that OSHA musculoskeletal disorder hazards at the struggles with this issue, but the proposed The three acceptable endpoints are: (1) facility and that the facility must continue in sections 921 and 922 we believe are off the Control of MSD hazards, (2) reducing the incremental abatement process and mark. MSD hazards in accordance with or to implement additional feasible controls. In ORC’s opinion, the difficulty of levels below those in the hazard Once in the incremental abatement establishing precise exposure response identification tools in Appendix D that process, the compliance end point becomes relationships between the particular health the employer used to conduct the job tied to the recuperation of an individual. [Tr. effects being regulated and a specific hazard analysis, and (3) controlling 11377] workplace risk factors that allegedly cause hazards to the extent feasible. The Ms. Brooks concluded by urging those condition does not relieve OSHA of the Agency has explained each of these [basic] obligation to provide some OSHA to postpone the promulgation of options above. the ergonomics standard until it could quantitative guidance to employers on a point at which significant risk is The second compliance endpoint, be written so that compliance can be substantially reduced. reducing MSD hazards in accordance consistently and objectively measured Only in this way will an employer be able with or to levels below those in the (Tr. 11381). to determine whether taking action to control hazard identification tools in Appendix c. Comments that OSHA has not particular workplace risk factors is likely to D, provides objective criteria to help provided sufficient guidance for materially reduce the risk of the specific employers attain an endpoint. In employers to comply with the proposed musculoskeletal disorder that has occurred. Appendix D–2, OSHA is providing a standard’s compliance endpoint. Many [Tr. 4109] chart outlining reasonably objective rulemaking participants were concerned The American Industrial Hygiene measures of acceptable levels of that the proposed standard and the Association (AIHA) supported the ergonomic risk factors for VDT preamble discussion of the regulatory proposed standard’s performance-based operations. In Appendix D–1, OSHA is text provided little hazard control compliance endpoint (Ex. 32–133). referencing existing tools that employers guidance for employers (Ex 30–1536, However, AIHA also believed that are currently using to identify and 30–1722, 30–3813, 30–3845, 30–3956, OSHA should provide additional control ergonomic risk factors. OSHA 30–4185, 32–300, 35–106, 500–197). guidance. The Association stated: believes that these tools will provide Some were concerned that employers, AIHA supports the fundamental employers with a bright line method particularly small ones, would not have performance-related elements of the against which they can judge whether the resources to implement the proposed ergonomics standard. their compliance efforts meet the final requirements in the proposed standard The requirement to eliminate or materially standard’s compliance endpoint. or to make the judgments it calls for reduce ergonomic problems to the extent The employer also has the option ‘‘to (see, e.g., Exs. 30–1536, 30–2834, 30– feasible is a valid performance criterion. reduce MSD hazards to the extent that 3077, 30–3348, 30–3751; Tr. 3330, Similarly, the ‘‘incremental abatement they are no longer reasonably likely to 8226). These commenters argued that process’’ is performance-based and cause MSDs that result in work this would force many employers to hire recognizes the complex nature of ergonomic restrictions or medical treatment beyond an expert. problems. first aid.’’ OSHA is providing sufficient Some rulemaking participants Whether a risk-based approach is guidance, in the preamble, appendices considered or not, OSHA should add some believed that OSHA should provide appropriate examples of risk assessments so to the standard, and compliance additional guidance for the terms and that employers can utilize appropriate assistance materials, to help employers concepts used in this part of the guidelines and have an idea of what understand and follow this compliance standard (see, e.g., Exs. 30–1557, 30– compliance officers will be looking for. endpoint. The employer will have to use 2987, 30–3748, 30–3765, 32–133, 32– OSHA should recommend a variety of risk some judgment and will need to be 300). For example, ORC and Edison assessment approaches and describe how knowledgeable about the relationship Electric Institute urged OSHA to include enforcement of the standard will take place. between risk factors and the different a nonmandatory appendix listing risk [Ex. 32–133] types of MSDs when using this factors and examples of acceptable The Employment Policy Foundation endpoint. Many rulemaking participants controls (Ex. 32–300). The American suggested that OSHA include a detailed presented examples of measures they Association of Occupational Health table to serve as a guide to compliance have used to adequately control

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00091 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68352 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations ergonomics hazards (see, e.g., Exs. 32– case, a company representative testified from exposure to perceived ergonomic 274, 500–6, 500–12, 500–50; Tr. 8557, that the company ‘‘put in place a wide hazards. It is the employer that must 8579, 11533, 12564, 14972). They variety of effective controls’’ (Tr. 14706). determine when an employee is at risk from Thus, OSHA has concluded that the hazards that are ‘‘reasonably likely to cause clearly understood what needed to be or contribute to MSD[s].’’ Proposed done to control the hazards and where final rule’s endpoint is scientifically §§ 1910.917, 1910.944, 64 Fed. Reg. at 65832. to find the tools to accomplish that goal. sound and will help reduce the number 65864. And it is up to the employer to The extensive scientific basis for and severity of MSDs in the workplace. determine any combination’’ controls either OSHA’s standard is discussed in the OSHA agrees with commenters, like to eliminate the hazards or to at least reduce Health Effects and Risk Assessment the National Coalition on Ergonomics, them ‘‘to the extent feasible.’’ Proposed sections of this preamble. However, it is the AFL–CIO, and the American Society §§ 1910.917, 1910.920(a), 64 Fed. Reg. at not necessary for an employer to have of Safety Engineers (Tr. 3498, 7210, 65803, 65828. While the Preamble contends 11616), who stated that enforcement of that [t]here are many qualitative and a complete grasp of ergonomics science quantitative ways to determine the in order to comply with the final rule. the final ergonomics standard will magnitude of exposure,’’ * * * the Proposed Many witnesses testified that they had necessitate extensive training of the Rule fails to set objective levels at which an little or no difficulty in addressing jobs Agency’s compliance staff. OSHA employer would be required to act. successfully (See, e.g., Ex. 32–274; Tr. compliance officers will need to be Moreover, the Proposed Rule fails to identify 11532, 12461, 14708, 14836, 15046), educated in the requirements of the specific measures that an employer must and OSHA has given employers standard, signs and symptoms of MSDs, implement to control these supposed extensive flexibility in addressing these ergonomic risk factors, and appropriate hazards. The Act requires the Secretary to make these decisions * * * which the hazards, together with many tools and control measures, among other things, Secretary concedes are impossible to make models to use. In addition, many so that the Agency can enforce the * * * and not simply to foist that obligation problems and solutions are readily standard in a uniform and reasonable on the regulated community under threat of apparent after observing a job and manner. Such training, based on the considerable civil penalties and compliance talking with employee. The availability final standard and on the compliance costs. [Ex. 30–1722] of professionally-developed tools and guidelines contained in this preamble The National Coalition on Ergonomics the compliance assistance tools being and the appendices to the final rule, is made a similar point: provided by the Agency will also help currently being developed and will be provided before the compliance The proposed standard is so vague and employers select appropriate control ambiguous that arguably, through its measures to reduce MSD risk factors deadlines in the standard. adoption, OSHA will have shifted the burden sufficiently. These risk reductions will 2. Comments on Whether the Proposed of identifying the hazard (which is clearly lead to a corresponding reduction in the Compliance Endpoint Would Illegally OSHA’s duty) and the appropriate response to the hazard (which is also clearly OSHA’s incidence and severity of MSDs at the Delegate Rulemaking Responsibility workplace. duty) to employers. At the same time, the With respect to Mayville Engineering a. Comments that the proposed rule proposed standard fails to clearly state or Company’s and the National Coalition would shift the burden of determining place meaningful boundaries on what may be required by enforcement personnel to such on Ergonomics’ comments that efforts to the compliance endpoint to employers. Some rulemaking participants objected [a] degree that, if adopted, the standard control MSD may create other MSD would represent an unconstitutional hazards and lead to more injuries, that the vagueness inherent in the delegation of authority from Congress to OSHA notes that it is possible for proposed language shifted much of the OSHA. [Ex. 30–3956] certain interventions to increase some burden placed by the OSH Act on OSHA to employers (see, e.g., Exs. 30– OSHA believes that the final standard risk factors at the expense of the ones an is sufficiently clear to inform employers employer is trying to control. However, 1722; 30–3956, 35–106; Tr. 4110, 15648–15649). The U.S. Chamber of of their obligations, and therefore does it does not automatically—or not place impossible burdens on normally—follow that decreasing the Commerce argued that the proposal left to employers the determination of the employers. The final rule gives duration, frequency, or magnitude of employers options. Employers may, but one risk factor will increase another. If safe exposure level and the appropriate controls (Ex. 30–1722). Even though it are not required, to use the objective that were the case, ergonomic criteria in Appendix D to determine the intervention studies, such as those recognized that the proposed standard properly allowed the employer hazard control level. The rule also gives depicted in the Risk Assessment section employers the flexibility to use alternate of the preamble, would be very flexibility, the Chamber stated that the proposal went too far: performance-based measures. infrequent, rather than the norm for b. Comments that the proposed rule those employers making a good faith Under the Proposed Rule, it is up to the would shift the burden of determining effort at addressing these hazards. It employer to do the Secretary’s job of setting feasibility and compliance endpoints to should also be noted that in one of the a standard that ‘‘most adequately assures, to OSHA compliance staff. The American the extent feasible, * * * that no employee cases cited by the Coalition, the Iron and Steel Institute (AISI) stated that employer saw an overall decrease in the will suffer material impairment of health or functional capacity,’’ 29 U.S.C. § 655(b)(5), the proposed standard improperly number of MSDs from the control delegated rulemaking authority to measures, and further measures were With respect to the follow-up on the few new OSHA’s compliance staff (Ex. 500–223). taken to lower the risk factors causing MSDs that developed, Mr. August stated: AISI contended that the proposed rule 11 the new MSDs (Tr. 17822 ). In another [T]here were a couple of employees where there was equivalent to requiring each were some shoulder problems that started to surface employer to issue an unlimited number 11 With respect to the initial ergonomic early on when the intervention was made * * *. interventions taken at the 9–1–1 center, Mr. James But the same analysis that was done to identify the of blank checks for ergonomic control August of the American Federation of State, County original problem was used to quickly remedy the measures and allow OSHA to fill in the and Municipal Employees testified: ‘‘This resulting problem from the intervention. amounts. The Institute argued: ‘‘The intervention drastically reduced the injuries. It did So it was not a matter of having to junk the whole mere possibility that the proposed not create more injuries * * *. [F]rom the entire system that was put in and start from scratch. This work force of very high injury rates, virtually all of was a refinement which is what all of us involved standard is written in such a way as to the carpal tunnel and wrist injuries were in the field of ergonomics do on a continuous basis. permit OSHA to adopt * * * an eliminated.’’ (Tr. 17822) [Tr. 17823] unreasonable and impermissible

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[Ex. 500–223]’’ effective to some degree, but that they cannot Agency proffers for this flawed approach is As noted in the discussion of the ensure any rate of success in reducing MSD that OSHA simply cannot determine broad previous issue, OSHA has given injuries or hazard factors. Employers simply standards that would be appropriate for the employers sufficient guidance so that will not be able to guarantee compliance with wide variety of covered industries and jobs. they can determine, before an the standard, no matter what efforts they However, OSHA has fared no better in inspection occurs, whether or not they make to adhere to OSHA’s proposed assessing causation and appropriate are in compliance with the rule. In fact, program. [Ex. 30–3845] abatement when dealing with individual if an employer reduces MSD hazards in The American Iron and Steel Institute workplaces and specific jobs in enforcement accordance with or to levels below those argued that the standard would proceedings. Thus, as noted above, OSHA in the hazard identification tools in necessitate more and more controls as has lost on one or both of those grounds in employees deconditioned by an every ergonomics case it has litigated on the Appendix D (or the more stringent Basic merits * * *. If, as these cases show, OSHA Screening Tool), there is no doubt that increasingly sedentary workplace would cannot determine what causes an employer is complying with the final have less capacity to tolerate demanding musculoskeletal complaints in a particular rule’s compliance endpoint. OSHA physical activity (Ex. 30–3951, 32–206). job-and how to abate them properly, there is compliance staff will therefore have no Under questioning at the hearing, Mr. no reason to think that employers will fare difficulty determining whether an Thomas Durbin of PPG Industries was any better. [Ex. 30–1722] concerned that an employer following employer is complying with Appendix The National Coalition on Ergonomics the incremental abatement process D. The remaining endpoints, controlling detailed this argument in their post- would need to continue to apply control MSD hazards and feasibility, give added hearing submission (Ex. 500–197). The measures even after all workplace flexibility to those employers who Coalition contended that ergonomics believe that they can control MSD ergonomic stress factors were eliminated as long as MSDs continue to professionals are unable to articulate hazards by means other than the effective solutions to ergonomic endpoints in Appendix D or who cannot occur (Tr. 3171). These comments are based on the problems in other than vague feasibly reach those levels. generalities, leaving employers little Consequently, the final rule does not false premise that an employer would not be finished applying ergonomic choice but to engage in trial and error improperly delegate rulemaking experimentation. Because its review of authority to OSHA compliance staff. control measures until all MSDs disappear from the workplace. OSHA the hearing transcript could not identify 3. Comments on Whether the Proposed has drafted the final ergonomics a single witness who was able to Compliance Endpoint Would Force standard to make it clear that this is not identify a particular ergonomic Employers To Go Too Far in Controlling the case. The goal of the final rule is the intervention that is sufficient to satisfy MSD Hazards reduction in workplace MSD hazards, the rule, the Coalition questioned how a. Comments that the proposed that is the reduction in the frequency, well employers would be able to choose standard would force employers into a magnitude, or duration of the risk controls that would bring them into never-ending circle of hazard control factors causing MSDs in problem jobs. compliance. improvements. Some rulemaking When an employer controls these risk In its post-hearing submission, participants were concerned that factors to a level meeting one of the Federal Express (FedEx) gave an employers would face a never-ending compliance endpoints given in example purporting to show how the circle of hazard control improvements paragraphs (k)(1)(i) through (k)(1)(iii), company would be forced into (see, e.g., Exs. 30–1722, 30–3956; Tr. the employer does not have to institute experiments to try to reduce ergonomic 3171). For example, the National further controls even if MSDs continue risk factors further (Ex. 32–208). Federal Coalition on Ergonomics stated that as to occur. Consequently, OSHA has Express noted that the existing long as ergonomic complaints 12 concluded that the final compliance workspace for package handlers is continued, employers would need to go endpoints will not force employers into optimized so that a single employee further and further in the incremental a never-ending circle of hazard control reaches as short a distance as possible abatement process (Ex. 30–3956). In improvements. given the design of the conveyors, addition, the Coalition asserted that, b. Comments that the proposed trucks, and other equipment. FedEx except where the employer can show standard forces employers to indicated that redesigning the space to the problem is unique to an individual experiment with control measures until accommodate a second employee would employee, the employer would be they find one that works. Some actually increase the distance packages obligated to implement corrective action rulemaking participants objected that are handled. The company argued that not only for the complaining employee the incremental abatement process trading one risk factor for another, as but for every employee doing the same would require employers to experiment such a redesign would cause, would job or another job involving the same or with hazard control technologies of have an unpredictable effect on the similar work activities. The Forum for a uncertain efficacy until the employer number of MSDs for that job. Responsible Ergonomics Standard went cannot afford to implement additional On the other hand, Mr. Sittichoke further, arguing that this portion of the controls (see, e.g., Exs. 30–296, 30–402, Huckuntod, testifying on behalf of Levi standard was infeasible: 30–1722, 30–2134, 30–4185; Tr. 4906, Strauss and Company, acknowledged 5645). For example, the Chamber (Ex. that industrial safety design is a system OSHA’s proposal is infeasible, however, 30–1722) argued that OSHA has left to of trial and error by its very nature (Tr. because it requires an undefined ‘‘material employers what the Agency cannot do 14747). The Forum for a Responsible 12 As noted elsewhere in this preamble, the itself, that is, determine what controls Ergonomics Standard noted that Coalition has mischaracterized the proposal’s use of will reduce significant risk to addressing MSD hazards is an iterative the term ‘‘covered MSD’’ as ‘‘complaints.’’ employees: process, often requiring significant trial

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Some employers determine the full scope of the ADA’s ended requirement to use all feasible compliance burden, because the proposed who have little or no expertise in control methods until the risk of an standard would require the ADA to continue ergonomics will indeed need to undergo MSD reaches zero conflicts with well- to implement incremental changes to its some trial and error in their hazard established case law to the contrary (Ex. work environment until it substantially control efforts. As noted by Ms. Sharon 30–3956). The Center for Office reduced or eliminated the incidence of Murray, the former director of Rochester Technology also believed that OSHA is covered MSDs. Because 50% of the ADA’s Office of Emergency Communications (a obligated to set a threshold above zero workforce is engaged in the same or similar 9–1–1 call center), employees might not risk (Ex. 30–2208). Patrick Tyson of work activities, the Association would be use new equipment intended to reduce Constangy, Brooks and Smith asserted required to implement these changes for 200 risk factors in the manner anticipated by employees simultaneously, even though only that the proposed rule, in essence, one employee reported a problem. the employer (Tr. 17819). For example, defined an MSD hazard as the existence The ADA has made—and will continue to when an employer institutes a control of even one MSD in a 3-year period (Ex. make—adjustments to keyboards, monitors measure designed to reduce awkward 30–4185). Mr. Tyson contended that a and other peripheral aspects of its work wrist postures, it might increase long rate of one OSHA recordable MSD every environment, but for reasons of providing a reaches for some employees. In Ms. 3 years does not constitute a significant more comfortable and efficient workplace for Murray’s case, the unanticipated hazard risk. its employees, not because of some highly was a relatively simple problem to Some rulemaking participants were speculative benefit. However, there is no resolve (Tr. 17823). concerned that the standard placed no assurance that these simple measures would The Agency does not believe that this be sufficient to achieve compliance under the limits on the controls that an employer standard’s incremental approach to trial and error is unique to ergonomic would be forced to implement (see, e.g., compliance. [Ex. 32–141] hazards. As Mr. Huckuntod Exs. 30–494, 30–2208, 30–3765, 32–211, acknowledged, industrial safety design 32–234; Tr. 10429, 10950). For example, Federal Express argued that, because is a system of trial and error by its very Dow Chemical Company questioned the of the unique nature of its facilities, the nature (Tr. 14747). A new ventilation extent to which employers would need company would see no appreciable system, for example, might not work as to go to avoid citations (Ex. 30–3765). effect from incremental changes to its it is designed to, and the employer Dow believed that the proposal would workstations (Ex. 32–208). Federal might have to modify it after its initial require employers to adopt the latest Express further argued that only a installation. technology regardless of cost or how complete redesign would accomplish OSHA has removed the proposal’s great the reduction in hazards. Mr. anything more than negligible incremental abatement option and Gregory Watchman of Paul, Hastings, improvements in the number of believes that employers will be able to Janofsky and Walker stated that, if MSD workplace MSDs: meet the final rule’s compliance signs and symptoms continue to occur, While the proposed ergonomics standard endpoints with a minimum of even on a sporadic basis, the employer provides for incremental changes to the work experimentation. As the AFL–CIO (Ex. would be forced to implement environment until ‘‘covered MSD’’ are significantly reduced, [footnote omitted] the 500–218) noted, ‘‘Several experts, additional abatement measures including David Alexander (Tr. 2518, unique nature of the facilities at and the indefinitely (Ex. 32–211). Mr. corporate experience of FedEx is such that 2716), David Caple (Tr. 2716), and Watchman reasoned that the duty to Dennis Mitchell (Tr. 2530), testified that incremental changes would have no implement additional controls would be appreciable effect upon * * * reducing in 80–85 percent of cases, ergonomic triggered very frequently in most ‘‘covered MSD,’’ and only a quantum change problems can be solved with one workplaces because of the frequency involving complete redesign and intervention.’’ With the compliance with which workers experience short- reconstruction of facilities may potentially assistance tools provided by the Agency, term discomfort, aches, and pains. yield measurable results. Even then, it is not even small employers should be able to Mr. George Page, the owner of a small clear that the changes in outcome in which OSHA is interested is the result of these reduce MSD risk factors to acceptable industrial engineering and ergonomics levels with a minimum of changes. The reason for the nebulous impact consulting firm, provided an example of of incremental change is two-fold. First, the experimentation. For these reasons, why he thought the proposal’s OSHA concludes that the final rule will nature of the physical facilities which FedEx compliance endpoints went too far (Tr. operates is such that space limitations do not not lead to undue experimentation by 10429). He testified about a client who allow further design alterations, added employers. had instituted a variety of ergonomic equipment, or additional, extraneous staffing. c. Comments that the proposed initiatives with good results. Mr. Page Second, FedEx’s facilities, operational standard places no limit on how far an was not sure whether the employer process and equipment have all been employer must go in controlling MSD would be in compliance with the designed and employed with the application hazards. Some rulemaking participants of ergonomic principles for the purpose of proposed rule. improving productivity. As a result, objected to any compliance endpoint The American Dental Association that required an employer to eliminate incremental changes to the workplace in the provided a theoretical example of how context of FedEx’s facilities, which are MSD hazards from the workplace far the Association would have to go to because such an endpoint places no already at or near the frontier of automation control MSD hazards at their and technical feasibility will fail to have an limits on how far an employer must go headquarters: appreciable impact upon the reduction rate in controlling MSD hazards (see, e.g., of ‘‘covered MSD.’’ Exs. 30–2208, 30–3765, 30–3956, 30– The ADA headquarters is located in a * * * * * 4185). For example, Dow Chemical building that was built more than 35 years ago. The work areas were designed and To be sure, some incremental changes can Company noted that there is no such furnished before the proliferation of modem be made. FedEx does not assert an ‘‘all or thing as zero risk and that this approach computing activities. It would not be cost- nothing’’ position, wherein absolutely no was inconsistent with OSHA’s effective, or in some cases even possible, to space whatsoever remains for incremental standards on toxic chemicals, which set retrofit them to satisfy the proposed standard. changes to be made in the existing facilities.

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Rather, FedEx asserts that, to effect a material with it. This employer had spent over is offered for sale. Concerned that reduction in work-related ‘‘covered MSD,’’ $19.5 million in capital improvements employers would be forced to conduct the changes required would be quantum in to reduce lifting hazards in six facilities constant reviews of new technology, the nature, so as to necessitate an entirely new and reduced the number of recordable American Health Care Association facility. The space limitation upon the existing facility will admit of some, very MSD cases, including back cases, by less recommended that OSHA provide limited incremental changes, but those than 50 percent over the last 5 years of technology and program upgrade changes would be so limited by space, so the program (through 1999). Mr. Tyson information (Ex. 30–2987). The ephemeral in nature, as to be ineffective in was particularly concerned that the Association believed that the Agency reducing ‘‘covered MSD.’’ standard would require this employer to was in a better position to determine For example, the design for the existing institute further controls. when new and credible research made facilities, while tailored to the number of Here again, these comments are based new control measures available. employees required to complete a task, is not on the false premise that an employer Caterpillar, Inc., stated that once precise to the person with regard to every would not be finished applying ergonomic complaints cease there position in the sort facility or even in the ergonomic control measures until all trucks or customer service stations. Rather, would be no need to review new one additional person can, conceivably, be MSDs disappear from the workplace. technology (Ex. 30–4607). Caterpillar added to the workforce in some capacity in The final rule’s compliance endpoints recommended that the standard not some facilities, in a manner where he or she do not require employers to go that far require the employer to assess will not detract from the efficiency of in controlling MSD hazards. In fact, all additional controls unless a new MSD FedEx’s operations. FedEx maintains, the compliance endpoints in the final occurs. however, that the increase of one additional rule contain discrete stopping points Federal Express argued that, because individual is not an administrative or work that allow an employer to stop even if an employee must handle every package practice control which will render a material MSDs continue to occur. One of the at some point in the delivery process, reduction of any hazard at all. In fact, the endpoints, reducing MSD hazards in effect will not be noticeable, except on complete elimination of human reduced efficiency. Once the workplace is accordance with or to levels below those involvement cannot be achieved in its increased significantly beyond one additional in the hazard identification tools in line of work (Ex. 32–208). In addition, person, however, the facilities’s space Appendix D, provides objective Federal Express believes that it has limitations operate to reduce both measures against which an employer reduced manual handling at its facilities operational efficiency and workplace safety. can determine whether it has fulfilled as much as it can and, thus, is already [Ex. 32–208] its compliance obligations. When the at the limits of technological feasibility. Patrick Tyson of Constangy, Brooks employer reduces the risk factors below Keller and Heckman, L.L.P. believed and Smith objected to the extent to those levels, he or she is finished that the proposed standard would which the proposed endpoint would instituting control measures. The require employers to research and require employers to go to reduce control of MSD hazards endpoint, develop technology to meet the ergonomic hazards (Ex. 30–4185). He although not as specific, also allows an proposal’s compliance endpoint (Ex. stated: employer to stop even if MSDs continue 500–221). The law firm argued that the to occur. That endpoint, paragraph approach taken by the proposal was Having stated our objections, not to the (k)(l)(i), requires reducing the hazard to need to implement engineering controls, but legally indistinguishable from the to the point at which such controls must be the level where MSDs resulting in work research and development requirement implemented, we also submit that contrary to restrictions or medical treatment are that the Third Circuit invalidated in OSHA’s assertion in the Preamble that the reasonably unlikely, not to the level of American Iron & Steel Institute v. proposed Standard establishes ‘‘control absolute safety or no MSDs. The OSHA, 577 F.2d 825, 838 (3rd Cir. endpoints’’ which define when an employer endpoint will not require employers to 1978). In that case, the Court held: is in compliance, there are two inter-related seek to eliminate all aches and pains or problems with § 1910.921. First, for any symptoms of discomfort, as feared by 29 U.S.C. § 665(b)(5) grants authority to the manufacturing jobs in which employees Mr. Watchman. The required hazard Secretary to develop and promulgate perform repetitive motion tasks for a standards dealing with toxic materials or reduction is directed at MSDs that harmful agents ‘‘based upon research, significant part of the work day, as a practical require work restriction or medical matter, an employer’s legal duty will never demonstrations, experiments, and such other be satisfied until employees are no longer treatment. The last endpoint is reducing information as may be appropriate.’’ Under performing the manual tasks. We question MSD hazards to the extent feasible. the same statutory provision the Secretary is whether the Agency should promulgate a When the employer has reached the directed to consider the latest scientific data Standard with this result, even if unintended. limits of feasibility, he or she is in in the field. As we have construed the Secondly, although § 1910.921 is apparently compliance regardless of whether MSDs statute, the Secretary can impose a standard intended to state that employers can be in are continuing to occur, at least until which requires an employer to implement compliance short of automating the job technology ‘‘looming on today’s horizon,’’ additional controls become feasible. and is not limited to issuing a standard solely functions, we believe that there is no d. Comments that requiring employers objective measure of compliance short of based upon technology that is fully to go to the limits of feasibility is developed today. Nevertheless, the statute either automating the job task or function or unreasonable. Some rulemaking eliminating it. [Ex. 30–4185] does not permit the Secretary to place an participants were concerned that the affirmative duty on each employer to He contrasted this with the expectation proposed requirement to control research and develop new technology. of OSHA enforcement staff that hazards to the extent feasible would Moreover, the speculative nature of the employers, under their existing general require employers to continually review research and development provisions renders duty clause obligations, must institute ergonomic research for the latest in any assessment of feasibility practically controls that lead to a reduction in the control technology (see, e.g., Exs. 30– impossible. In holding that the Secretary seriousness of MSDs, not in their 2208, 30–2987, 30–4607, 32–234). For lacks statutory authorization to promulgate the research and development provision, we numbers. He also contrasted the example, the Center for Office note in passing that we need not reach standard’s requirements with the Technology argued that this petitioners’ challenge to the provision as experience of one of his firm’s clients, requirement would be very costly as fatally vague. Accordingly, we hold the who had instituted an ergonomics employers would be forced to replace research and development provision of the program and had 6-years’ experience office furniture every time a new desk standard to be invalid and unenforceable.

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[American Iron & Steel Institute v. OSHA, expresses a preference for physically OSHA has addressed the concerns of 577 F.2d 825, 838 (3rd Cir. 1978) as quoted redesigning the job. the American Health Care Association by Ex. 500–221] When citing ergonomics hazards under the that employers would be forced to Paul, Hastings, Janofsky, and Walker general duty clause, however, OSHA has continually review new technology (Ex. often required substantial physical changes, LLP stated that the preamble to the such as completely redesigning an assembly 30–2987). Paragraph (k)(1)(iii) of the proposal indicated that the standard line and rebuilding the cab of a large crane. final rule requires employers to assess would be technology forcing: In many cases, these engineering controls whether additional feasible controls are The agency’s impossibly burdensome favor automation and result in lost jobs. [Ex. available every 3 years. This provision definition of technological feasibility would 30–494] limits the frequency with which an make compliance * * * virtually impossible. employer would need to review OSHA asserts that a hazard control The AFL–CIO noted that requiring technology, and the assessment could methodology is technologically feasible even employers to eliminate ergonomic easily be done as part of the overall if it is not currently available. hazards or implement controls to the program evaluation. The Agency will be Thus, OSHA could issue citations and civil extent feasible was similar to the providing information on available penalties to a small employer for failing to approach OSHA uses in many other control technology on its Web site and implement non-existent equipment that ‘‘can standards (Ex. 32–339). The union held updating this information periodically. be developed by improving existing that any incremental abatement process technologies’’ or that is ‘‘on the horizon of Employers should, however, check included in the final standard must other sources of information to ensure technological development.’’ 64 FR at 65823. have as its goal and endpoint the [Ex. 30–3231] that they have not overlooked new elimination of MSD hazards or the hazard controls that are appropriate for The National Solid Wastes reduction of MSD hazards to the extent Management Association (Ex. 32–234) the MSD hazards in their workplaces. feasible. The final compliance endpoint does argued that OSHA’s description of The final rule contains an endpoint not require employers to perform ‘‘technological feasibility’’ would make that would recognize that an employer research and development to extend the compliance with the proposed endpoint is in compliance when he or she has limits of technological feasibility. As virtually impossible: done all that is feasible to reduce MSD explained above, MSD control OSHA asserts that a hazard control hazards. This endpoint is statutorily technology is feasible if the control methodology is technologically feasible even driven. The OSH Act does not give the method is available or adaptable to the if it is not currently available. Thus, OSHA Agency the authority to require controls employer’s specific circumstances. could issue citations and civil penalties to a that are not capable of being done. This Employers are not required to perform small solid waste industry employer for endpoint places a technological and failing to implement non-existent equipment research on MSD control methodology that ‘‘can be developed by improving existing financial limit on how far an employer or develop new technology to abate the technologies’’ or that is ‘‘on the horizon of must go in controlling MSD hazards. MSD hazards in their workplaces. technological development.’’ 64 FR at 65823. As demonstrated by its feasibility e. Comments that the proposed rule [Ex. 32–234] analyses described in Chapter 3 of the would force employers to automate jobs The American Transportation Economic Analysis OSHA believes that out of existence. Some rulemaking Association argued that OSHA could most employers will be able to reach participants argued that the ergonomics conclude that the employer had not one of the other two endpoints (control standard will lead to the elimination of gone far enough to control hazards even MSD hazards or reduce MSD hazards in jobs (see, e.g., Exs. 30–1616, 30–3845, in the absence of continued MSDs (Ex. accordance with or to levels below those 30–3956, 30–4185; Tr. 5701). These 30–4465). In support of this argument, in the hazard identification tools in commenters asserted that employers the Association stated, ‘‘if MSD Appendix D) using existing technology would act to reduce MSD hazards in the symptoms persist, even on an at a cost that is economically feasible. workplace by automating jobs out of occasional basis, an employer must The third endpoint, control MSD existence, shifting jobs overseas, or continue to implement additional hazards to the extent feasible, is not converting full-time jobs to part-time to measures until it has exhausted all technology-forcing in the sense feared reduce exposure (see, e.g., Exs. 30–3845, feasible controls.’’ by some commenters. As discussed 30–3956). Several rulemaking LPA, Inc., and others contrasted the earlier, what is feasible under the participants were concerned about the types of controls OSHA has required standard is determined by the limits of feasibility of automating certain jobs when it cited employers for failing to current technology and knowledge, not (see, e.g., Exs. 30–2208; Tr. 18033). For abate ergonomic hazards under the the potential for future technology. example, the Center for Office general duty clause with the types of Furthermore, OSHA believes that Technology stated: controls the Agency has stated that it many of the comments on the To eliminate the hazard one must automate will accept under the proposed rule corresponding compliance endpoint in the work environment thus eliminating any (see, e.g., Exs. 30–494, 32–208). LPA the proposal were founded on the exposure. Those are not OSHA’s words but argued as follows: impression that the proposed rule those are the examples OSHA gives (Fed. Reg. Page 65832). And in the case of the Once a hazard is identified, an employer would have required employers to office, OSHA suggests that the only way an must implement ‘‘feasible’’ controls to try to eliminate MSDs from the workplace employer of office workers has eliminated eliminate it. A feasible control is one that is subject only to the limits of feasibility the hazard is to use a voice-activated already being used elsewhere in the same job, (see, e.g., Exs. 30–3231, 30–3347, 30– computer to eliminate highly repetitive can be adapted for the job, or ‘‘is on the 3750, 30–4465, 32–211, 32–234). The motions. Here is where OSHA’s definition of horizon of technological development.’’ language of the final rule’s compliance feasible falls apart for the office industry. Is [Footnote omitted] OSHA insists that the endpoint makes it clear that this is not it feasible to have voice recognition for available controls to fix hazards are usually the case. The feasibility compliance computer input when for many applications, neither complex nor costly. Although such given the state of the technology, it is neither controls may be accomplished through endpoint in the final rule supplements effective nor an adequate or available physical changes to the job, changes in work the other two and ensures that no solution? Voice activation technology has practices, or training in proper work employer is required to go beyond the come a long way, however, this technology techniques, [Footnote omitted] the standard limits of feasibility. is not at a point which it can be used for all

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00096 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68357 applications. To use a technology that is still 4. Comments on Whether the Proposed Mike Redman of the National Soft evolving and has limited effectiveness in Compliance Endpoint of Eliminating Drink Association argued the fact that some applications as an endpoint leaves MSD Hazards Is Illusory Because MSDs employees in certain jobs will employers in a never ending cycle with no Cannot Be Eliminated experience MSDs despite the best efforts true solutions. [Ex. 30–2208] of their employers (Tr. 2960). He Some rulemaking participants reasoned that, because the probability of OSHA does not believe that this criticized the final means of an MSD occurring in such jobs is always ergonomics standard will result in the compliance, ‘‘eliminating MSD hazards’’ 100 percent, the employer will not be elimination of a significant number of (see, e.g., Exs. 30–323, 30–1107, 30– able to materially reduce the likelihood jobs through automation or in the 1722, 30–3845; Tr. 8328). For example, that an injury will occur. conversion of full-time jobs to part-time. the US Chamber of Commerce stated Once again, the premise of these Employers use automation to promote that activities that the Agency comments is that the proposed standard efficiency and increase productivity, characterizes as MSD hazards are would have required employers to and reduction of MSD hazards is often ‘‘universal activities of life, both in and eliminate MSDs from the workplace. As a byproduct. The specific concern out of the workplace, that can never be noted earlier, the final rule’s compliance expressed by the Center for Office completely eliminated.’’ The Chamber endpoints stop short of this and provide Technology is unfounded. OSHA also noted that certain risk factors may clearly defined goals. OSHA realizes referred to a voice—activated computer pose MSD hazards to some employees that employers cannot prevent all as an example of a control that would but not to others due to their unique MSDs. In addition, the final rule, like eliminate a repetitive motion hazard but susceptibilities and prior medical the proposal before it, includes a note did not mean to imply that all computer history. Thus, the Chamber concluded, that the occurrence of an MSD is not, in input would henceforth need to be done ‘‘Without knowing how an innumerable and of itself, a violation of the hazard control endpoint. using voice-activation software. list of confounding factors might Appendix D makes clear that is not the coalesce to cause an MSD in a given 5. Comments on Whether Some MSD case. individual, neither OSHA nor an Hazards Are Beyond the Employer’s employer can ever say whether a Control Automation for the sole purpose of significant risk of harm exists and, short Some rulemaking participants, reducing MSD hazards is typically of eliminating the job altogether, it will particularly those representing the unnecessary. Testimony by the United be impossible to say when all possible ambulance service, solid waste, and Auto Workers indicated that, in one of ergonomic ‘‘risks’’ have been moving and storage industries, were their programs covering about 4400 eliminated. [Ex. 30–1722]’’ Other employees and involving over 1000 concerned that employees were exposed rulemaking participants made similar to ergonomic hazards that were out of processes, only one problem job was arguments (see, e.g., Exs. 30–297, 30– fixed by automation (Tr. 14797). In the employer’s control (see, e.g., Ex. 30– 323, 30–2208, 30–3765, 30–3845, 30– 3686, 30–3845; Tr. 8140, 14957, 18030). addition, Mr. David Alexander (Tr. 3934, 30–4185; Tr. 2960, 5342). These For example, Mr. Ron Thackery, 2564), one of OSHA’s expert witnesses commenters said that nonwork-related representing the American Ambulance with extensive experience in factors also cause MSDs and that some Association, testified that not only were ergonomics, testified that most MSDs will continue to occur even after the lifting hazards faced by ambulance ergonomic solutions were low cost: employers control all work-related crews beyond the control of employers In my work, I found that about half of the hazards. For example, the Forum for a but that there were no feasible control projects cost less than $500 and can be done Responsible Ergonomics Standard stated measures that his industry could use to on a standard work order without the need that employers cannot control the meet the compliance endpoint required for detailed justification. Perhaps that is why predisposition of their employees to by the proposed standard (Tr. 15017). we do not hear about many of these low-cost contract MSDs (Ex. 30–3845). The The final rule’s compliance endpoint solutions. Only a third of the projects need Forum asserted that women are recognizes that some aspects of an to cost more than $1,000. In other words, an susceptible to carpal tunnel syndrome employer’s hazard control efforts may ergonomics project is likely to cost, two times for a variety of reasons, including be limited by the availability of feasible out of three, less than $1,000 and usually can because they have smaller wrists and controls. To the extent that the MSD fit within most budgets. [Tr. 2564] greater fluid retention. Similarly, Metz hazards an employee faces are Baking Company stated: ‘‘* * * OSHA’s completely out of the employer’s These control methods do not approach proposal essentially forces companies control, the final rule does not require the cost of automation. Consequently, into the pursuit of continuous efforts to the employer to control them. (For an simple economics will keep most reconfigure their workplaces and analysis of the comments on the employers from automating jobs simply methods of operation down to a level feasibility of controls in various jobs, to control ergonomic hazards. Mr. that is without physical stressors for the see the discussion of technological Alexander also stated that for a single most vulnerable of its employees [Ex. feasibility in the Economic Analysis set of risk factors as many as five to ten 30–323].’’ Some rulemaking participants section later in the preamble.) For different solutions can be developed noted that the standard did not hold example, for paramedics responding to and employers should not be forced to employees accountable for their own an automobile accident, the employer convert full-time jobs to part-time. If behavior on and off the job (see, e.g., would have no control over the weight reduction of exposure time is a control Exs. 30–3355, 30–3723; Tr. 8328). For of the accident victims or their positions an employer selects, rotating employees example, Mr. Perry Ozburn, the at the accident scene. These factors are among different jobs would normally be chairman of the International highly variable and cannot be controlled a cost-effective alternative to the use of Warehouse Logistics Association, by the employer. However, there are part-time workers to replace full-time recounted a case in which his company certain administrative and engineering employees. had to pay benefits to an employee who controls that are available and, to the Mr. Ozburn believed was injured off the extent they can be used, the employer job (Tr. 8328). is required to implement them. For

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00097 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68358 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations example, work rules (with associated permanent controls (i.e., within three years Other rulemaking participants training) can assure that employees during the startup period and within one supported the proposed incremental minimize the risk involved in moving year thereafter) apply, regardless of the abatement process (see, e.g., Exs. 30– accident victims. abatement process an employer chooses to 434, 32–450; Tr. 14854). For example, utilize. [Ex. 32–339] When work rules are used as an Ms. Barbara Fritz testified that she used administrative control of MSD hazards, The International Brotherhood of an incremental process of applying a the employer is obligated to institute an Teamsters stated that the incremental control measure and seeing if it works adequate work rule, train employees in abatement of hazards would be in her efforts to abate ergonomic hazards it, take steps to find violations, and acceptable within a framework of (Tr. 14854). Monsanto Company stated: enforce the rule uniformly. If the continuous ergonomic improvement We agree that using an ‘‘incremental employer has done those things and an that incorporated symptom surveillance, abatement process’’ is a valid method of employee violates that rule without the reaction to ergonomic complaints, active dealing with physical stresses. In some employer’s knowledge, then the risk factor analysis, and continuing instances you implement a potential solution employer will not be cited for that training (Ex. 500–207). The IBT also to a problem and find that once in place violation (see section III.C.8.c(1) of believed, however, that the final additional improvements are either necessary OSHA’s Field Inspection Reference ergonomics standard must specify time or possible. It is also possible that from a Manual, CPL 2.103.). The courts and frames and deadlines for the budgeting standpoint you may not be able to incremental abatement process. implement the full-scale solution until you OSHA Review Commission do can obtain the necessary capital, so you recognize a defense of unpreventable Other rulemaking participants were implement partial solutions until capital is employee misconduct. See, e.g., D.A. also concerned about the lack of a time available. [Ex. 30–434] Collins Constr. Co. v. Secretary of Labor, limit between incremental control steps 117 F.3d 691 (2nd Cir. 1997). Thus, the (see, e.g., Exs. 32–111, 32–210). The NIOSH (Ex. 32–450) also supported fears expressed by Guilford Mills (Ex. United Steelworkers of America the incremental abatement process in 30–2990) and the Oregon Dental suggested that OSHA provide additional the proposed standard: Association (Ex. 32–233) that employers guidance to assist employers in We agree that control of MSD hazards can would be held responsible for determining how long they may wait for be appropriately achieved through the use of unpreventable violations of work rules an injured employee’s condition to the incremental hazard abatement process by their employees is unfounded. improve before implementing additional proposed in Section 1910.922, allowing employers to implement controls in control measures (Ex. 32–111). The 7. Whether the Proposed Incremental increments in order to understand which United Food and Commercial Workers Abatement Process Endpoint is solutions work among all potentially International Union also recommended Appropriate necessary controls, and to implement only that the incremental abatement process those controls that are necessary. We believe The proposed incremental abatement have the same endpoint as the other two that it is essential and standard practice in process (§ 1910.922) would have compliance options (Ex. 32–210). many existing ergonomic programs for the allowed employers to test solutions in a On the other hand, the Integrated routine reassessment of jobs in which initial problem job, so long as they would Waste Services Association urged the control measures fail to reduce the severity result in some hazard reduction and Agency to allow for flexibility in this or occurrence of MSDs. This reassessment wait and see whether an additional should trigger implementation of additional regard, stating: feasible control measures. This process also MSD occurred before trying out further The timing of the incremental abatement allows employers to select the best solutions controls. process will require it to be very specific to to eliminate or materially reduce the MSD This proposed provision drew the situation. Consequently, standardized hazard most efficiently, and to periodically substantial comment on both sides. measures of timeliness would be ineffective check for new controls capable of further Many commenters objected to it as and impractical. The employer should be material reduction of the hazard. [Ex. 32– written because they believed it would permitted to gauge its own unique time frame 450] permit employers to delay for each and every WMSD. [Ex. 32–337] Having considered the views expressed implementing controls that were needed In its post-hearing submission (Ex. by the commenters, OSHA concludes to protect workers. The AFL–CIO 500–218), the AFL–CIO criticized the that it is not necessary to include a recommended changing the provision to provision as allowing an employer to separate provision in the standard on avoid this problem. implement minimal controls for a incremental abatement as the time The AFL–CIO believes that any problem job until a new injury occurs. frames for implementing controls allow incremental abatement process included in According to the AFL–CIO, ‘‘[r]equiring employers to follow an incremental the final standard must have as its goal and employers only to ‘significantly reduce abatement process without a separate endpoint the elimination of MSD hazards or the likelihood that covered MSDs will provision to that effect. The proposed the reduction of MSD hazards to the extent occur,’ and then allowing them to avoid incremental abatement provision feasible. Employers can eliminate or reduce these hazards incrementally, focusing first on further intervention until another injury recognized that the most cost-effective the high duration, high frequency and high occurs is an unacceptable, unprotective approach to reducing or eliminating intensity risk factors identified in the job compliance endpoint that is totally at MSD hazards is at times an incremental analysis. Employee reports of MSDs or odds with the language and purpose of one. Employers may try some basic, symptoms can and should be used to help set the Act.’’ The United Auto Workers inexpensive controls and see how well priorities for action and to help determine expressed similar concerns. ‘‘The plain they work in reducing hazardous which jobs need further attention, but they meaning of ‘incremental abatement’ is exposures before determining whether should not be the endpoint for when and that all feasible controls will not be additional controls are needed. The whether an employer has instituted sufficient implemented in the first instance. proposed incremental abatement controls. The final standard must also set a Instead, the employer is permitted to process was intended to make clear that compliance deadline for implementing all implement some but not all feasible employers are permitted to follow such feasible controls through the incremental controls, and then wait for a second an approach. OSHA has concluded, abatement process. OSHA should make clear employee to be injured before going the however, that it is not necessary to that the same compliance deadlines for rest of the way.’’ (Ex. 32–185). include a separate provision about

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A was the proper way for employers to hazards and is consistent with the practice separate provision on incremental materially reduce risk factors under the under other standards. We recommend that abatement would therefore be incremental abatement process. such a provision be included in the final redundant. In its post-hearing submission, the standard. [Ex. 500–218] Elimination of the incremental AFL–CIO recognized that some OSHA acknowledges that some abatement provision also accommodates employers may have difficulty in employers will have difficulty the concern expressed by the AFL–CIO meeting the proposed rule’s compliance controlling MSD hazards in all problem and UAW that the provision allowed endpoints by the deadlines contained in jobs within the deadlines that would employers to implement minimal the proposal (Ex. 200–218). To remedy have been imposed by the proposed controls and wait until additional MSDs this problem, the AFL–CIO suggested standard—permanent controls would occur before completing abatement. that the final ergonomics standard allow have had to be in place within 3 years Under the final standard, once an employers an additional year to meet after the effective date initially and, if employer has identified a problem job, the compliance endpoint if the the initial compliance deadline has it must now attain one of the employer: passed before an MSD occurs, within 1 compliance endpoints for all employees (1) Has conducted the job hazard year of the incident. To alleviate this in that job within the time frame set out analysis required by the standard, problem, the final ergonomics standard by the standard. Thus, while the final (2) Has identified MSD hazards, gives employers an additional year to (3) Has consulted with employees and standard allows incremental abatement implement permanent controls— their designated representatives, and within its time frames, once a problem permanent controls must be in place (4) Has developed an action plan for job has been identified that the within 4 years after the effective date employer must control, the employer’s eliminating MSD hazards. According to the union, the action plan initially and, if the initial compliance abatement obligation does not depend deadline has passed before an MSD on the occurrence of additional MSDs. should prioritize the control of MSD hazards and provide for measurable occurs, within 2 years after the 7. Whether the Final Ergonomics reductions in exposure to those hazards, employer determines that the job meets Standard Should Allow Employers to and the employer should be required to the Action Trigger. (These deadlines Prioritize the Control of MSD Hazards implement controls in accordance with and the reasoning behind them are Some rulemaking participants were the action plan and evaluate whether explained in more detail in the concerned that the proposed the controls have reduced exposures. summary and explanation for paragraph compliance endpoints limited the The AFL–CIO reasoned that its (x), later in this section of the preamble.) ability to prioritize the control of MSD recommendation, which was consistent OSHA is not, however, providing a hazards (see, e.g., Ex. 30–3813; Tr. 3135, with other OSHA standards, would prioritization requirement in the final 14722). For example, PPG Industries provide employers with sufficient time rule. With the extended deadlines for believed that the incremental abatement to eliminate MSD hazards without the implementation of permanent process outlined in the proposal limited unnecessarily exposing employees to controls, employers will have sufficient the employer’s ability to prioritize injury: time to install all controls necessary to meet the final rule’s compliance hazards (Tr. 3135). The concept of an action plan or Sean Cady, representing Levi Straus endpoint. compliance program to set forth the process Employers are free to prioritize the and Company, testified that the and means by which an employer will proposal did not provide sufficient achieve compliance is an established practice installation of permanent controls guidance for the employer to prioritize under OSHA standards. The majority of within the compliance deadline for jobs for the analysis and control of OSHA’s health standards, including MSD problem jobs. There are many hazards: standards on lead (1910.1025), cadmium ways of assigning priorities to jobs. (1910.1027), arsenic (1910.1018), and Priorities can be assigned on the basis Well I would say first that we’re here today methylene dianaline (MDA) (1910.1050) of risk, severity, cost, or other reasons. to talk about our ergonomic program and contain a requirement for the establishment As long as all required permanent what we’ve learned over the last 10 years of and implementation of a written compliance having a formal program in place. But one of controls are in place by the compliance program. deadline, the Agency does not believe it the concerns that comes to mind is the Similarly, a number of OSHA standards proposal doesn’t seem to provide enough have recognized that in some industries or is necessary or appropriate for the guidance on how an employer should some establishments it may not be possible standard to specify a prioritization prioritize jobs for things like hazard analysis to achieve the control endpoint by the schedule. Consequently, the final rule and job modification and control if more than compliance date established for other contains no requirements on one job is triggered at the same time. [Tr. industries and employers. In these cases, prioritization. 14722] OSHA has on occasion included provisions The United Auto Workers believed to extend the compliance date for the Paragraph (l)—What Kinds of Controls that it is important to prioritize jobs and implementation of controls. Must I Use to Reduce MSD Hazards? hazards for control (Ex. 32–185; Tr. Under the arsenic standard, employers Paragraph (l) of the final rule requires 8102–8104). The UAW suggested that who were unable to achieve compliance with the employer to use feasible the PEL through engineering controls and the employer could use tools such as the work practices by the compliance date of engineering, work practice, or NIOSH Lifting Equation, Snook and December 1, 1979, were required to include administrative controls, or any Ciriello Push-Pull tables, and various in their compliance plan an analysis of the combination of them, to reduce MSD checklists, to identify which job effectiveness of controls, and were required hazards in problem jobs. The standard elements and risk factors are most to install engineering controls, and institute also allows employers to use personal

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In MSDs. routinely observed. addition, the standard requires any PPE When choosing an engineering Administrative controls are work that is provided to be furnished to control to address a particular practices and policies implemented by employees at no cost. ergonomic problem, employers often the employer that are designed to This paragraph of the standard is have many choices, depending on how reduce the magnitude, duration, and/or almost identical to the parallel proposed much they wish to spend, how frequency of employee exposure to risk provision, with one exception. A permanent a solution they seek, how factors by changing the way work is footnote to this paragraph in the extensive a production process change assigned or scheduled. Examples of proposal would have prohibited the use they need, and employee acceptance administrative controls that are used in of back belts/braces and wrist braces/ and preference (see the discussion of the ergonomics context are employee splints as PPE; this footnote has been control approaches in the summary and rotation, job enlargement, and deleted from this paragraph of the final explanation for paragraph (m)). For employer-initiated changes in the pace rule. As explained below, OSHA example, as MacLeod (Ex. 26–1425) of work. believes that evidence in the record points out, an employer whose VDU Administrative controls have been suggests that back belts, in some limited operators are experiencing neck and effective in addressing MSD hazards in applications, may help to reduce MSD shoulder problems has many options a number of cases. For example, one hazards. However, back belts, like other available, including the following: case study cited in the Benefits chapter PPE, may not be used alone if other • Raising the height of the monitor by (Chapter IV of the Final Economic controls are feasible. Wrist splints, wrist putting it on phone books, building a Analysis) describes a lift team approach braces, and back braces, which are post- monitor stand, buying an adjustable that has been effective in reducing injury devices used to speed monitor stand, buying an adjustable work-related back injuries among rehabilitation, are not considered PPE wall-mounted monitor stand, or buying nursing personnel in a long-term care for the purposes of this standard. an adjustable desk-mounted monitor facility for the elderly (Ex. 26–1091). stand; The table of ergonomic program and Paragraph (l)(i)—Feasible Controls • Putting the desk on blocks; or intervention case studies in Section VI Paragraph (l)(i) of the final standard • Providing an adjustable-height desk shows dozens of examples of the mandates the use of feasible controls or workstation. successful use of administrative (engineering, work practice, and Work practice controls involve controls, either alone or in combination administrative controls) or any changes in the way an employee does with other controls. combination of them to control or the job. They are defined by the However, administrative controls reduce MSD hazards in problems jobs. standard as changes in the way an must be used carefully if they are to This paragraph also states that employee performs the physical work provide effective protection to engineering controls, where feasible, are activities of a job that reduce exposure employees. A well-known ergonomics the preferred method of control. This to MSD hazards. Work practice controls book, MacLeod’s ‘‘The Ergonomic paragraph of the final rule is essentially involve procedures and methods for safe Edge,’’ cautions: work. Examples of work practices that unchanged from the proposal. OSHA is * * * job rotation is only beneficial if the allowing employers this flexibility in reduce the potential for exposure to tasks involve different muscle-tendon groups the choice of controls because the ergonomic risk factors are the use of or if the workers are rotated to a rest cycle Agency’s experience and information in neutral positions or postures to perform * * *. Furthermore, job rotation alone does the rulemaking record indicates that tasks (keeping wrists straight, lifting not change the risk factors present in a these control approaches have been close to the body), use of two-person facility. Although job rotation may have effective in contributing to reductions in lifts when mechanical lifts are not beneficial effects, engineering changes the number and severity of workplace available, and the observance of micro- should remain the goal of the ergonomics program (Ex. 26–1425). MSDs. In addition, OSHA believes that breaks as necessary to minimize muscle the broad range of jobs to which the fatigue. In the context of ergonomic OSHA agrees, and paragraph (l)(1) standard will apply, and the great programs, work practice controls are notes, that engineering controls are the variation in workplace conditions essential, both because they reduce preferred method of controlling MSD covered, make compliance flexibility ergonomic stressors in their own right hazards in cases where these controls essential. and because they are critical if are feasible. In contrast to The final standard defines engineering controls are to work administrative and work practice engineering controls as controls that effectively. For example, workers need controls or personal protective physically change the job in a way that to be trained to use a power grip rather equipment (PPE), which traditionally controls or reduces MSD hazards. than a trigger grip if a new tool is to be have occupied lower tiers of the Examples of engineering controls that successful, and they need to know how hierarchy, engineering controls fix the are used to address ergonomic hazards to adjust an ergonomically designed problem once and for all. are workstation modifications, changes chair properly if it is to substantially Many commenters agreed that to the tools or equipment used to do the reduce the risk of neck disorders, engineering controls are generally job, facility redesigns, altering shoulder tendinitis, or another type of superior to other controls, i.e., production processes, and/or changing MSD. Work practices, like learning to administrative controls, work practices, or modifying the materials used. vary job activities during the day (e.g., or personal protective equipment (see, Engineering controls range from very moving from filing to sorting mail to e.g., Exs. 26–1487, 26–1428, 26–1424, simple to complex: from putting blocks using the computer and back again) can 26–2; 26–1426, 26–1425, 26–1408; and under a desk to raise the work surface often reduce the magnitude and 26–3). For example, a recent ergonomics for a taller-than-average worker to duration of exposure to the relevant risk text states: providing a lumbar support pillow or factor sufficiently to make MSDs Ergonomic hazards can be effectively rolled-up towel to a video display unit unlikely. To be effective, the culture at eliminated by introducing engineering

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00100 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68361 controls and applying ergonomic principles clear that engineering controls are preferred, PPE is equipment that is worn by the when developing workstations, tools, or jobs where feasible. Lacking any definition or employee and reduces exposure to risk * * * only engineering controls eliminate guidance of the term ‘‘feasible’’ complicates factors and MSD hazards in the job. the workplace hazards. Other strategies [work understanding or complying with OSHA’s Examples are palm pads and knee pads practices, administrative controls] only intent in this regard. Such ambiguity will minimize the risk of injury (Ex. 26–1408). undoubtedly lead to disagreements between to reduce contact stress, vibration- attenuation gloves, and gloves worn to However, a number of commenters employers and OSHA compliance personnel (Ex. 30–3368). protect against cold temperatures. mistakenly understood OSHA’s The hierarchy of controls, which, as statement in the proposal about the In response, OSHA notes that the discussed above, is widely endorsed by preferred status of engineering controls. hierarchy of controls has been an ergonomists, occupational safety and These commenters understood this established industrial hygiene practice health specialists, and health care statement to mean that administrative or since the 1950s and has been a professionals, accords last place to PPE work practice controls could not be longstanding OSHA policy, as because: used in lieu of engineering controls. evidenced by many of the Agency’s • Its efficacy in practice depends on This was not OSHA’s intent, nor is the standards (e.g., asbestos, § 1910.1001; human behavior (the manager’s, inclusion of this statement in the final benzene, § 1910.1047; cadmium, supervisor’s and worker’s), rule to be interpreted that way. In the § 1910.1027; and methylene chloride, • Studies have shown that the final rule, as in the proposal, OSHA is § 1910.1052). As was stated in the effectiveness of PPE is highly variable permitting any combination of controls proposal, ergonomists endorse the and inconsistent from one worker to the (except PPE) to be used to control hierarchy of controls because they next, MSDs, either alone or in combination. believe that control technologies should • The protection provided cannot be OSHA agrees, as these parties (see, e.g., be selected based on their reliability and measured reliably, Exs. 30–3344, 30–4628) argued, that in efficacy in controlling or reducing the • PPE must be maintained and many cases, the use of administrative or workplace hazard (exposure to risk replaced frequently to maintain its work practice controls alone may factors) giving rise to the MSD. OSHA effectiveness, eliminate the hazard and thus obviate does not agree that ‘‘problematic • It is burdensome for employees to the need for more expensive engineering employee behavior’’ is the cause of wear, because it decreases mobility and controls. For example, the Milliken occupational injuries and illnesses, nor is often uncomfortable, • Company stated: that feasibility will be a concern with It may pose hazards of its own (e.g., this standard, in large part because the the use of vibration-reduction gloves The authorization in [proposed] section 1910.920(a) for employers to use any standard allows such flexibility in may also force workers to increase their combination of engineering, administrative, control approach and requires only that grip strength). and work practice controls is effectively employers implement feasible controls. One author (Ex. 26–1408) notes that: rendered meaningless with the statement that Many groups (see, e.g., Exs. 32–21–1– ‘‘ * * * in most cases, the use of PPE follows, which specifies that engineering 2–19, 20–69, 20–22, 30–4538, 30–3683) focuses attention upon worker controls are the preferred method for commenting on the proposal strongly responses and not the causes of eliminating or materially reducing MSD supported the hierarchy of controls. For ergonomic hazards.* * * PPE does not hazards. This provides too much latitude for example, the American Association of eliminate ergonomic hazards * * * OSHA area directors to issue citations when Safety Engineers stated: [and] must be considered as the last line an employer has used administrative and work practice controls rather than We agree that engineering controls should of defense against ergonomic hazard engineering controls (Ex. 30–3344). be the first option in alleviating WMSDs. exposure.’’ Thus, although the final standard permits PPE to be used as a Other commenters who misinterpreted While this type of approach could be the most expensive from the short-term supplemental control, it cannot be the proposed statement about the perspective, our experience is that relied on as a permanent solution to preference for engineering controls were engineering controls are the most efficient/ MSD hazards unless other feasible concerned that this preference could effective approach in the long-term (Ex. 32– controls are unavailable. greatly increase the costs of compliance 21–1–2–19). In the proposal, OSHA included a if OSHA enforced this provision. For OSHA agrees that the use of engineering note to the proposed section on the example, the Rubber Manufacturers controls is the most effective way of hierarchy of controls that stated that Association emphasized that ‘‘ * * * controlling the MSD hazards. However, back belts/braces and wrist braces/ the hierarchy placing engineering as discussed above, this standard splints were not to be considered PPE controls over other alternatives * * * permits employers to use any for purposes of the standard. This note restricts employers’ discretion to choose combination of controls, except PPE was added to alert employers to the fact less expensive, non-engineered alone, to address MSD hazards in their that back belts and wrist braces, which alternatives’’ (Ex. 500–95). Other workplace. are widely used in U.S. workplaces, groups, such as Pharmteck (Ex. 30– were not to be considered a control to 4122) and Southern States Cooperative Paragraph (l)(2)—Personal Protective reduce ergonomic hazards under the Inc. (Ex. 30–394), argued that ‘‘ * * * a Equipment proposed standard. OSHA pointed out vast percentage of workplace injuries Paragraph (l)(2) of the final standard that these devices were being marketed result not from exposure that might be permits employers to use personal as equipment that could prevent MSDs, limited through engineering solutions, protective equipment (PPE) to although the evidence to support these but from problematic employee supplement engineering, work practice, claims was inconclusive. behavior and safety related decisions.’’ and administrative controls. However, A number of commenters and studies Issues of feasibility were pointed to by personal protective equipment may not in the record (see, e.g., 32–30–1–15, 32– several commenters (see, e.g., Exs. 30– be used alone, i.e., as the sole means of 30–1–6, 32–30–1–7, 32–30–1–29, 32– 3368, 30–4264) such as the National employee protection, unless no other 30–1–14) suggest that OSHA should Soft Drink Association, which stated: controls are feasible. In addition, any allow the use of back belts as PPE on the Although the employer is allowed to use PPE that is provided must be made grounds that these devices have been any combination of controls, OSHA makes available to employees at no cost. shown to reduce workplace injuries. For

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00101 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68362 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations example, Mr. Jeffrey Whitaker the cardiovascular system and * * * were of short duration. Nevertheless, the commented that: that screening for cardiovascular Agency is persuaded that the evidence As safety professionals we realize that back compromise should be conducted before for the effectiveness of back belts, supports alone are not a solution and we occupational belt-wearing.’’ Another although limited, exceeds that available apply the hierarchy of controls in our work study (Alexander et al. 1995) that for other types of equipment that with our customers on a daily basis. We evaluated belt use in nursing, dietary, workers wear that is classified as PPE recommend engineering and work practice and environmental services workers (e.g., palms pads, knee pads). OSHA has controls be used whenever possible but we found no significant differences in the therefore decided not to prohibit the all know of hundreds of workers’ whose jobs number of self-reported back injuries. classification of back belts as PPE for the will never or cannot be changed. These workers need at least a modicum of support The authors concluded that ‘‘This purposes of this standard. Accordingly, when doing their jobs. Back supports are finding supports research [showing] that the note to that effect contained in the used in these situations to provide a basic universal prescription of back belts did proposal does not appear in the final line of defense for vulnerable workers (Ex. not decrease the number of back injuries rule. Permitting back belts to be used as 30–2724). and that there [is] no support for PPE means that employers will be Commenters from Chase Ergonomics uninjured workers wearing back belts to required to provide them to their were of the same opinion: reduce risk of injury.’’ (Ex. 32–30–1–2). workers, if they choose to do so, at no A number of back belt studies in the cost to employees. Further, as with any Back supports should be recognized as an literature report inconclusive results acceptable component of an overall back PPE, back belts used in this manner are (see, e.g., Exs. 32–30–1–22, 32–30–1–8, subject to OSHA’s standard for PPE (29 safety program under the hierarchy of 32–30–1–24, 32–30–1–12). For example, controls. As with any PPE, back supports are CFR 1910.132). not the first intervention option. In many a study by Kraus et al.1996 (Ex. 32–30– OSHA does not believe that the record jobs, however, neither engineering controls 1–12) reported a lower acute back injury in this rulemaking does not support nor work practice or administrative controls rate among belt users than non-users, permitting other devices, such as back are feasible or practicable. In these but cautioned that a number of braces and wrist braces or splints, circumstances, OSHA’s PPE standard allows confounders, such as the inability to which are generally prescribed as part of employers to provide workers with protective evaluate injury status, job lifting a treatment regimen, to be considered equipment that is appropriate for the hazards intensity, or length of employment PPE. These devices are generally present * * * OSHA should clarify that ‘‘may be important confounders or effect employers may use back supports as a prescribed for individuals who have supplement to their overall back injury modifiers that delimit the potential already been injured, and are not prevention program (Ex. 30–3857). effect of back supports.’’ intended to be used in the prevention of However, a number of recent studies injuries. In some cases, they may even However, other organizations and (see, e.g., Exs. 32–30–1–25, 32–30–1–6, commenters cautioned against the use of exacerbate an existing MSD hazard. As 32–30–1–7, 32–30–1–14, 32–30–1–19) explained by the AIHA, wrist splints back belts as PPE. For example, in a contain limited evidence that back belt 1994 report reviewing the available and braces may present serious use can, in certain circumstances, problems: scientific literature on the use of back provide some protection to workers. For belts, NIOSH expressed concern that example, a 1998 study evaluated trunk Wrist splints or braces used to keep the wearing a belt may alter workers’ stiffening during flexion and lateral wrist straight during work are not perceptions of their capacity to lift bending and concluded that ‘‘increased recommended, unless prescribed by a physician for rehabilitation. * * * using a heavy workloads (i.e., belt wearing may spine stability may provide greater foster an increased sense of security, splint to achieve the same end may cause protection against injury following more harm than good since the work which may not be warranted or unexpected or sudden loading’’ (Ex. 32– orientation may require workers to bend their substantiated) (Ex. 15–16). NIOSH does 30–1–6). A 1995 review of the literature wrists. If workers are wearing wrist splints, not recommend the use of back belts as on back belt effectiveness (Ex. 32–30–1– they may have to use more force to work PPE, and neither do a number of 7) concluded: ‘‘Based on our assessment against the brace. This is not only inefficient, professional societies (Exs. 15–15, 15– of the * * * studies reviewed in this it may actually increase the pressure in the 17, 15–33, and 500–41–99). paper, a major finding is that back carpal tunnel area, causing more damage to However, in response to comments supports designed solely for specific the hand and wrist.’’ (Ex. 26–1424). submitted to the record regarding back purposes could be biomechanically, Because these devices are used for belts, OSHA has reviewed the available physiologically, and psychophysically treatment after an injury has occurred scientific literature addressing the effective in relieving the loads on the and because they are not intended to efficacy of back belts in reducing MSDs. lumbar spine for employees engaged in reduce exposure, OSHA finds that it OSHA has conducted an extensive many industrial operations.’’ A study by would be inappropriate to consider back review of the evidence in the record on one of OSHA’s expert witnesses, Dr. braces or wrist braces/splints as PPE the effectiveness of back belts in Stephen Lavender (Ex. 32–30–1–14) that under the final standard. industrial use. The evidence is mixed. evaluated the effect of lifting belts, foot Several studies (see, e.g., Exs. 32–30–1– movement, and lift asymmetry on trunk Paragraph (m)—What Steps Must I Take 21, 32–30–1–22, 32–30–1–2, 32–30–1–8, motions, concluded that the lateral to Reduce MSD Hazards? 33–30–1–16, 32–31–1–23) of back belt bending and twisting motions of the Paragraph (m) of the final rule use showed negative results. For torso are controlled with belt use. establishes the steps employers must example, a 1996 study by Rafacz and OSHA’s review of the voluminous follow to reduce the MSD hazards in McGill (Ex. 32–30–1–21) that record on the back belt issue shows that their jobs. The employer’s obligation to investigated the effectiveness of back back belts may have protective effects in control these hazards is established in belts in 20 healthy male subjects found certain industrial settings, such as paragraph (k); this paragraph (m) sets that belt wearing increased diastolic sudden unexpected loading of the spine out the procedures to be followed and blood pressure during every task (Ex. 32–30–1–14). OSHA is aware that the timelines to be met to achieve the performed by the study subjects. The several of these studies had small necessary hazard reduction. authors concluded that ‘‘wearing an sample sizes (e.g., 10 subjects) (Ex. 32– The procedures in paragraph (m) are abdominal belt may put undue strain on 30–1–6), lacked control groups, and similar to those in proposed § 1910.919,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00102 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68363 although they have been revised in the commenters (see, e.g., Exs. 3–112, 3– taken. OSHA’s experience suggests just final rule to reflect the Action Trigger 164, 30–3765, 30–3748, 500–137, 500– the opposite, i.e., that nothing and to state what employers must do if 220) reported that the employees who disappoints employees more than not the controls they have implemented are are doing the job are usually the best being part of a process that affects their not effectively reducing MSD hazards. source of information on the tasks working conditions so directly. Some The steps specified in paragraph (m) are causing the hazard and ways of solving employers also report that they bring widely recognized as basic procedures the problem. For example, the American their in-house resources (ergonomics in effective control selection and Health Care Association stated: committee members, safety and health problem-solving. For example, the Employers and employees who work in the professionals, ergonomists) into the NIOSH publication, Elements of industry are in the best possible position to process at this stage (see, e.g., Exs. 26– Ergonomic Programs, describes a similar identify risk factors in their workplace and to 1370, 502–17). process (Ex. 26–2). Paragraph (m) also develop prevention methods that concentrate Paragraph (m)(2)—Initial Controls sets the deadlines for the on the significant problems unique to their implementation of initial and particular industry’s environment (Ex. 3– This provision requires employers to permanent controls to reduce MSD 112). identify and implement initial controls hazards. OSHA received very few In many problem jobs, employees and (referred to as ‘‘interim’’ controls in the comments on the proposed control steps their representatives will be able to proposal) to reduce MSD hazards within provision. pinpoint the problem quickly and to 90 days of the time the employer The corresponding provision in the suggest easily adopted controls. In many determines that the job is a problem job. proposal also contained a requirement cases, the solution will become obvious Because the final rule allows employers that employers identify and evaluate at the job hazard analysis stage; many to choose from engineering controls, MSD hazards when they changed, problems also can be addressed with administrative controls, work practice designed, or purchased equipment or simple, off-the-shelf controls. Examples controls, and—as a supplement to these processes in problem jobs. The final rule are: controls—personal protective contains no similar requirement. • Eliminating awkward postures equipment, OSHA believes that OSHA does not believe that a separate (such as bending when leaning across employers will be able to meet this provision is necessary, because the final the workstation to reach a tool) by timetable, which is essential to the rule includes a ‘‘feedback’’ loop putting blocks under a work bench to protection of employees in problem between paragraph (m)(4) of the rule raise the work surface height. jobs. OSHA anticipates that many and paragraphs (m)(1) and (m)(2). OSHA • Eliminating awkward postures of employers, particularly those whose received only one comment on this the neck and reducing stress on the back jobs can be controlled with off-the-shelf proposed provision (Ex. 32–300–1). This by putting packages of copy paper under controls, will simply implement commenter asked whether OSHA a VDT monitor to raise it or taking the permanent controls within 90 days and intended this provision to be similar to VDT off the CPU to lower it. be done with it. Others, however, will the management of change provision in • Reducing awkward postures of the develop a plan and timetable for the Process Safety Management neck by moving the light source or permanent control implementation and standard (29 CFR 1910.119). Since this removing the light bulbs that were may need the full 4 years (2 years after proposed provision has not been carried causing glare on the VDT monitor the standard has been in effect for some forward in the final rule, the issue screen. time) to reach the control levels raised by this commenter is moot. • Reducing force by cleaning thread specified in paragraphs (k)(1) or (k)(2) of from the wheels of a cart that has been the final rule. Paragraph (m)(1)—Ask Employees hard to push. (Many of these controls For these employers, the This paragraph requires employers would qualify for the Quick Fix option implementation of initial controls will who have determined that they have a (see paragraph (o).) generally mean a greater reliance on problem job to ask the employees in the Some commenters (see, e.g., Tr. administrative controls, work practices, problem job, and employee 63354, 9038, 12647), however, were and, in those situations where personal representatives, to recommend measures concerned that consulting with protective equipment is effective, on to reduce the MSD hazard in the job. employees and their representatives PPE, in the period between the 90-day This provision is essentially unchanged could lead to disagreements about the deadline in paragraph (m)(2) and the from the proposal, except that employee controls selected. OSHA’s experience, permanent control compliance deadline representatives are mentioned and comments to the record (see, e.g., in paragraph (m)(3). OSHA recognizes specifically in the regulatory text, which Exs. 3–112, 26–5, 30–3765, 30–3748, that initial controls may not, in all reflects OSHA’s decision to add this 500–137, 500–220, 500–218), do not cases, reach the control levels required language to provisions of the regulatory suggest that this is a problem. Instead, by paragraph (k)(1) or (k)(2) for text where the involvement of employee these commenters point to the value of permanent controls; nevertheless, representatives is particularly employee input. OSHA expects, employers are required to make good important. Several commenters (see, however, that employers will use their faith efforts to address problem jobs e.g., Exs. 32–339–1, 32–182–1) urged management experience and judgment promptly to protect the employees in OSHA to include employee to resolve any disagreement that may them. representatives in this step of the hazard arise. As is the case for all OSHA OSHA expects employers to identification and control process standards, the employer is clearly implement initial controls that will because of the contribution they could responsible for selecting controls and substantially reduce employee exposure make. OSHA agrees and has revised the evaluating their effectiveness. to the risk factors that are contributing text accordingly. Another commenter (Ex. 32–300–1) to the MSD hazard. For example, Asking employees and their argued against involving employees in employers might provide employees representatives for recommendations of the problem-solving and control required to manually carry loads from controls that will reduce MSD hazards identification process on the grounds one point to another with a cart or a is an effective and efficient way of that doing so might disappoint the hand dolly as an initial control, or they solving ergonomic problems. Many employees if their suggestions were not might reduce the weight of the object

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00103 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68364 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations being carried while waiting to install a of initial controls (interim controls) is a 240, 30–133, 30–3122, 30–3284, 32– permanent conveyor system. In other well-established principle of worker 300–1), and OSHA agrees, except that cases, an employer might decide to safety and health protection and is employees in the problem job and their implement a system of employee incorporated in many OSHA standards, representatives must also be involved in rotation while waiting to install new as one commenter noted (Ex. 26–1370). the process, as required by paragraph power tools throughout the plant. Other (m)(1). Paragraph (m)(3)—Permanent Controls examples of controls employers often Employers have many control implement initially and then replace This paragraph requires employers to strategies to choose from when with more permanent controls later are identify and implement permanent identifying permanent controls. The the provision of tools with longer controls that will achieve the hazard controls selected may be any one, or any handles when excessive reaching is reductions required by paragraphs (k)(1) combination of, engineering, work involved, anti-fatigue mats and sit-stand and (k)(2) of the standard. This practice, or administrative controls. stools when excessive standing is the provision is essentially unchanged from These controls may be supplemented by problem, and vibration-reduction gloves the proposal, except that it has been PPE, but PPE may not be used alone while waiting for new power tools with revised to reflect the final rule’s unless other feasible controls are not lower vibration levels to be installed. By objective compliance endpoints and the available (see paragraph (l) of the substantial reduction, OSHA means that function of the action trigger. standard). Among the factors employers the initial controls must reduce the There are many ways employers can consider when selecting controls are: MSD hazard materially by decreasing identify permanent controls in addition • Which control achieves the greatest the magnitude, frequency or duration of to asking employees and their reduction in employee exposure to the the employee’s exposure to the relevant representatives for control ideas. These MSD hazard risk factors. Examples of controls that include: • Which is likely to be accepted and • Asking other establishments in the would not meet the employer’s used by employees company how they have solved a obligations under paragraph (m)(2) • Which takes the least amount of similar problem; many companies with would be decreasing the weight of a time to implement OSHA corporate-wide settlements have package that is manually lifted from 90 • Which achieves a substantial to 85 pounds (because both weights found this approach useful (see, e.g., Ex. 32–185–3). reduction in exposure at the lowest cost. substantially exceed the weight an • These criteria are included as employee should lift alone) or rotating Asking the industry trade associations for suggestions (the food examples only; the standard does not employees into a second job that has the require employers to use these criteria same risk factors (because this would retail industry, for example, worked as a group to reduce package weights (Tr. because OSHA recognizes that not reduce the magnitude or duration of employers will choose those factors to exposure). 4948). • Attending ergonomics conferences consider that are most appropriate to The purpose of paragraph (m)(2) is to and trade shows. their workplace. The following chart ensure that the employer takes steps • Talking to the company’s insurance lists many controls that may be quickly (i.e., no more than 90 days after agent about solutions that have worked appropriate to reduce employee the job is identified as a problem job) to for other companies. exposure to the risk factors that are reduce the exposures of at-risk • Reviewing equipment catalogs (one responsible for MSD hazards, depending employees (i.e., those in jobs that have commenter reported using this approach on the circumstances of a particular identified MSD hazards). Waiting until to identify mechanical alternatives to workplace. This list is illustrative only; permanent controls are installed, which drum handling (Tr. 6981)). it is not exhaustive but is provided may take as long as 4 years, would leave Several commenters stated that merely to show that there are often these employees unprotected and employers are best positioned to choose many different control approaches that increase the likelihood that another their own sources of control information will reduce the magnitude, duration, or MSD incident will occur. The concept and ideas (see, e.g., Exs. 30–434, 30– frequency of risk factor exposure.

Ergonomic risk factors that may be present Examples of controls

Force (Exertions) ...... Use powered tools Change pinch to power grip Use longer handle Use appropriate size handle Use powered lift assist Counterbalance the weight Use lift tables Reduce the weight of the object Ensure that the center of gravity of the tool is over the hand Use a fixture, clamp or jig Provide periodic tool or equipment maintenance

Force (Manual Handling) ...... Lighten the load Use lift assist Use lift table Place package in larger containers that are then mechanically handled Use two-person lift team Rely on gravity to move the object Reduce friction when objects must be pushed or pulled Reposition object closer to the employee Provide pallet or table that can be rotated

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Ergonomic risk factors that may be present Examples of controls

Provide space so that the employee can move closer to the object Reduce the size of the object Slide the object closer before lifting Place objects to be lifted above floor level Use adjustable height tables Force (Manual Handling) ...... Store heavy objects at waist height Put handles on the object Modify the process to eliminate or reduce moves over a significant distance Convey the object (e.g., conveyor, ball casters, air) Use fork lifts, hand dollies, or carts Use appropriate wheels on carts (and maintain the wheels) Provide handles for pushing, pulling or carrying Arrange workstation so that work is done in front of the worker Use conveyors, chutes, slides, or turntables to change direction of the object Provide belt with handholds to assist in moving patients Provide gloves that assist in holding slippery objects Redesign the handling job to avoid movement over poor surfaces Use surface treated with anti-slip material or anti-skid strips Provide footwear that improves friction

Awkward posture ...... Provide workstation adjustability Raise/lower the worker's position Raise/lower the workstation Provide better mechanical advantage, such as with a longer handle Design task for smooth movements Redesign the flow of the workplace layout Reposition object to allow for a neutral posture Train workers to use less stressful postures Provide better access to machinery Rotate pallet or work surface Allow short breaks Position work in front of the worker Use a tool to extend the reach Provide lumbar support for a seated worker Provide workstation adjustability Provide tool holders Provide a strap on the tool handle to allow the hand to relax while maintaining control Provide sit/stand workstations Rotate workers to jobs that do not involve the same posture Provide anti-fatigue mats Provide foot rests

Repetition ...... Use power tools Distribute the work so that less time is spent at repetitious tasks

Contact stress ...... Attach a well-designed handle to the tool Wrap or coat the handle with cushioning and non-slip material Provide a handle that does not press into the palm Wear knee pads or palm pads Use a soft mallet for hand hammering Vibration ...... Use low vibration tools Isolate source of vibration from the worker Maintain tools regularly

The final rule allows employers effective date; this phase-in drops to 2 Paragraph (m)(4)—Track Progress coming into compliance with the years after the standard has been in Paragraph (m)(4) of the final rule standard initially to take up to 4 years, effect for 2 years. For OSHA’s responses requires employers to make sure that the if necessary, to implement permanent to the record on compliance deadlines, controls they have identified and controls; this period is reduced to 2 see the Summary and Explanation for implemented are reducing MSD hazards years for employers who identify paragraph (x). OSHA believes that these and have not unintentionally created problem jobs more than 2 years after the control implementation deadlines will new MSD hazards. This paragraph has standard’s effective date. Several provide smaller employers, and been revised from the proposal to commenters (see, e.g., Exs. 32–339–1, employers with more complex control include additional steps employers 32–185–3, 32–210–2, 30–3815, 32–368– requirements, the time they need to plan must take if they discover that their 1) were concerned with the proposed for, obtain, and implement permanent controls are not achieving the levels compliance deadlines for the controls. required or have introduced new MSD implementation of controls. The final hazards. The proposal, in contrast, rule has extended the permanent control simply required employers to track their deadline to 4 years from the standard’s progress but did not specify what they

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00105 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68366 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations were to do if their controls were not greater certainty that results from the Integrated Waste Services Association working as planned. appropriate use of these tools enhances said: ‘‘While the ‘‘quick fix’’ idea OSHA believes that this paragraph is their ability to protect their employees sounds reasonable, quickly ‘fixing a essential, for several reasons. First, and increase the employer’s confidence problem job’ is unrealistic and illusory’’ unless employers follow up on their that the standard’s control endpoints are (Ex. 30–3853). Some of these control efforts, they will not know being met. commenters said the Quick Fix whether they are protecting their approach would not reduce regulatory employees and are in compliance with Paragraph (o)—May I Use a Quick Fix burdens for employers (see, e.g., Exs. paragraphs (k)(1) or (k)(2) of the rule. Instead of Setting up a Full Program? 30–3853, 30–2988, 30–3815). And the Second, in establishments with many Paragraph (o) of the final rule sets out National Association of Manufacturers problem jobs and a job prioritization alternative provisions that employers (Ex. 30–3815) said that the Quick Fix ‘‘is plan in place, ascertaining the may follow in lieu of setting up a full next to meaningless for an effectiveness of controls is important to ergonomics program. These alternative establishment of any size.’’ ensuring that the employer’s abatement provisions are referred to as the Quick Other commenters were more strategy is an effective one. Third, Fix approach. The Quick Fix option optimistic about the Quick Fix concept, control effectiveness is the basis of any allows employers to control an MSD but said that changes were needed to effective program, and thus plays a hazard quickly and more informally make it more useful for employers. critical role in evaluating the elements without, for example, conducting a Kaiser Permanente, for instance, of the program. For example, an complete job hazard analysis, setting up supported the Quick Fix idea as a evaluation of work practice controls is a training program or a periodic ‘‘practical and cost effective idea’’ in an excellent way of determining program evaluation process. principle, but argued that the proposed whether training in these controls has OSHA has included a Quick Fix provision was too limited and too vague been effective. option in this standard to provide to be workable (Ex. 30–3934). Others This step of the control monitoring compliance flexibility for those said the proposed Quick Fix offered an process requires employers to consult employers who have: ‘‘inappropriately narrow opportunity’’ with employees in the problem job and • Only a few isolated MSD hazards and urged OSHA to allow more their representatives to ensure that the (that is, they have had one prior MSD abatement time and allow more than controls have been effective in reducing incident in any job in which an MSD one Quick Fix in any one job (Ex. 30– the physical difficulties employees incident is reported after the effective 2988, 500–145). Some commenters, associated with the job. The standard date and only 2 prior MSD incidents in however, argued that allowing more does not require employers to use the workplace during the 18 months than one Quick Fix in a job was not quantitative or qualitative measures to before the new MSD incident is protective enough (see, e.g., Ex. 30– evaluate control effectiveness, but many reported), and 2825, 32–182–1). In addition, AFSCME employers use such methods. Examples • MSD hazards that can be identified opposed extending the Quick Fix option of before-and-after approaches used over easily and addressed quickly (that is, this way because it would be a longer (i.e., 6-month) period include: they can fix the job within 90 days after ‘‘encouraging a piecemeal and • Reductions in severity (measured as the MSD incident is determined to meet disjointed approach to ergonomics’’ (Ex. fewer days away from work) 32–182–1). • the Action Trigger). Reductions in the number of OSHA believes that the Quick Fix On the other hand, some commenters symptoms reported in a symptoms option is an efficient mechanism for were concerned that the proposed Quick survey providing ergonomic protection for Fix was not adequately targeted to those • Reductions in workers’ employees, while at the same time workplaces where such an approach compensation costs • reducing regulatory burdens for those would be appropriate. The AFL–CIO Reductions in MSD incidence rates. said: Methods used in shorter-term employers who have only a few isolated evaluations, i.e., those conducted within problems. In our view, the quick fix provisions 30 days, include talking with employees The proposed rule also included a proposed by OSHA are more properly suited Quick Fix provision, which a number of to those workplaces where the number of and their representatives and symptoms jobs with MSD hazards is limited and where surveys. NIOSH (Ex. 26–2) recommends commenters supported (e.g., Exs. 30– 3813, 30–3436, 32–210–1, 30–294, OR there are few MSDs. In those situations, that employers wait at least 2 to 4 weeks focused efforts to identify and correct after control implementation to assess 326, 500–218, Tr. 2134, 13642). For hazards quickly may be the best solutions, the effectiveness of controls, because example, one commenter stated, ‘‘I and a full ergonomics program may not be this period of time is often enough to think that the Quick Fix is an needed (Ex. 32–339–1). outstanding idea that will reduce the allow employees to tell whether the The AFL–CIO and others also burden of this standard for many situation has improved. identified specific high hazard companies’’ (Ex. 30–3436). Portland OSHA believes that the process of workplaces in which the Quick Fix General Electric Company agreed: hazard identification, control selection, would not be appropriate, such as and control evaluation has been greatly We believe that the Quick Fix option is nursing homes, warehouses, automotive facilitated by the fact that the final rule extremely valuable. We operate on a system assembly plants, and meatpacking and identifies objective criteria against of early reporting and effective individual poultry processing plants (Exs. 32–339– which employers can measure the case management, to the benefit of both the 1). employee and the company (Ex. OR 326). extent of the risk factors present and the OSHA has made a number of changes effectiveness of their efforts to control or Some employers said that they had to the Quick Fix provision in this final reduce the hazard. Employers are not implemented types of Quick Fix standard to address these concerns. required to use the hazard identification approaches in their workplaces (see, These changes include: tools referenced in Appendix D–1 or e.g., Exs. OR 326, Tr. 14715–16). • Focusing the Quick Fix more provided in Appendix D–2, but they are A number of commenters maintained carefully on those employers with free to do so. OSHA believes that that the Quick Fix would not be helpful limited MSD problems by specifying employers will generally find that the or would not work. For instance, that it applies where there have been

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Screening Tool) and compliance commenters’ concerns that this Employers must use this process to fix ‘‘endpoint’’ (i.e., the levels in Appendix provision was not clear enough to be the injured employee’s job and all D), workable (see, e.g., Exs. 30–1349, 30– ‘‘same jobs’’ in the establishment. • Ensuring that employees receive 358, 30–595, 30–538, 30–323, 30–1022, Although this process is informal and training in using the implemented 30–1551, 30–3745, 30–3723). flexible, it nonetheless includes those controls so that the Quick Fix is more Third, halving the Quick Fix time basic steps that employers who have likely to be successful, and frame to 18 months should make the Quick Fix or ‘‘quick response’’ • Simplifying the criteria for Quick Fix option available to more processes use (Ex. 32–198–4–27–1). determining whether a Quick Fix has employers because MSDs that occurred This process includes: been successful or has failed. several years ago would not disqualify • Providing prompt MSD Paragraph (o)(1) employers from using the Quick Fix management to the injured employee option. In addition, it makes the Quick (paragraph (o)(2)(i)); Paragraph (o)(1) defines which Fix option more attractive, as Kaiser • Talking with employees to identify employers may avail themselves of the Permanente noted: those tasks they associate with the MSD Quick Fix approach instead of incident (paragraph (o)(2)(ii)); implementing a complete ergonomics [F]or large employers, tracking MSDs to • Observing employees performing program. Employers may use the Quick determine whether another covered MSD is the job to identify the risk factors likely Fix approach if, within the last 18 reported in the same job within 36 months to have caused the MSD incident would be cumbersome (Ex. 30–3934). months: (paragraph (o)(2)(iii)); Organization Resources Counselors, Inc. • No more than 1 prior MSD incident • Asking employees for their ideas for (ORC), agreed: has occurred in the job in which another The proposed requirement that the reducing exposure to the MSD hazards MSD incident is reported, and (paragraph (o)(2)(iv)); • employer establish a full ergonomics program • There have been no more than 2 if another similar MSD occurs in the job Implementing measures within 90 prior MSD incidents in the workplace as within 36 months is too rigid because the days to control or reduce the MSD a whole. hazards (paragraph (o)(2)(v)); occurrence of MSDs is so closely related to • This represents a change from the individual worker characteristics. If the Training employees in using the proposed rule, which would have employer determines that additional feasible controls implemented (paragraph allowed employers to use Quick Fix controls will eliminate the significant risk (o)(2)(vi)); and option in every job in the workplace, from that job for that worker, another quick • Keeping records of the Quick Fix but only for the first MSD incident in fix should be permitted (Ex. 30–3812). (paragraph (o)(2)(vii)). that job. These provisions of the final rule are OSHA believes that the changes in the OSHA estimates that these changes similar to steps in the proposed Quick final rule provide more compliance should allow a large percentage of jobs, Fix, although they have been revised in flexibility, and thus will allow more as high as 25 percent of all jobs meeting some respects to respond to comments employers to take advantage of the the Action Trigger, to be controlled received. using a Quick Fix. (See Chapter V of the Quick Fix option. First, changing the Same Jobs Quick Fix provision to allow employers Final Economic Analysis). Also similar to the proposed rule, to use it 2 times in the same job makes At the same time, limiting the Quick those employers who qualify for and the option available for more jobs. Fix option to employers who have only select the Quick Fix option must fix not Allowing 2 Quick Fixes in one job 2 MSDs in their workplace during the only the injured employee’s job but also recognizes, as Kaiser Permanente prior year and a half also helps to target all other ‘‘same jobs’’ in the pointed out, that the occurrence of a more precisely the provision to those establishment. This requirement applies second MSD in the same job may not workplaces that have only isolated MSD both to employers using the Quick Fix necessarily mean that a previous control problems. OSHA agrees with and to those who must implement measure has not worked, but rather that commenters that where only a few ergonomics programs. Several a different combination of risk factors MSDs are occurring, employers may be commenters objected to requiring may be present (Ex. 30–3934): able to address the problems effectively in an informal way, but that the employers to apply the Quick Fix [T]he conclusion in the proposed rule that beyond the injured employee’s the ‘‘Quick Fix does not work’’ if another occurrence of several MSDs in a workplace in just over a year ‘‘may be individual job (see, e.g., Exs. 30–2208, MSD is reported in the same job within 36 30–2725, 30–3745, Tr. 9183). Some said months * * * wrongly assumes that the indicative of a bigger problem’’ that same fix should work for the same physical requires a more systematic approach to having to fix all same jobs was not work activities and conditions. The fix that adequately address (Ex. 32–210–2). necessary and would impose excessive works for one employee’s condition may not cost. For example, the Center for Office work for another because of that employee’s Although OSHA believes that Technology (Ex. 30–2208) stated: targeting the Quick Fix to workplaces physical characteristics or non-work related The Quick Fix section is worded so that if contributing factors. A second or third MSD with few isolated MSD hazards will one office worker is experiencing discomfort in the same job does not mean the initial likely make the option most useful to and his workstation is changed—the example quick fix did not work, and employers small businesses, larger employers may given is purchasing an adjustable workstation should have the option to apply a quick fix also find the Quick Fix a useful for a VDT operator—all the ‘‘same job’’ to newly reported MSDs (Ex. 30–3934; see mechanism. For example, large employees at that worksite would also have also Exs. 30–2088, 500–215). employers who have ergonomics to get an adjustable workstation when in fact Second, not restricting the 2 MSD programs in some jobs would be free to no other employees may need them. incidents to ones caused by different use the Quick Fix option if an MSD OSHA believes this requirement is risk factors, as the proposed rule would hazard were identified in another job. necessary because it helps to ensure that

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00107 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68368 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations other employees performing the same have determined that an MSD incident opportunity to watch employees physical work activities and exposed to has occurred and the job meets the performing the job (Exs. 30–3436, 26–2, the same MSD hazards are provided Action Trigger. This includes providing Tr. 1038). with protection before they too get hurt. the injured employee with access to an To provide employers with maximum In this sense, the ‘‘same job’’ HCP and work restrictions during the flexibility in complying with this step, requirement helps to make the final rule recovery period, if necessary. Where paragraph (o)(2)(iii) allows employers to more proactive and preventive. OSHA work restrictions are needed, employers select the method of job observation that believes that controlling other same jobs who select the Quick Fix option also works best for the conditions in their will also be cost-effective for employers must provide the work restriction workplace. For example, employers may because it is only a matter of time, in protection (WRP) that this standard simply watch employees perform the jobs meeting the Action Trigger, until requires. (For further discussion of MSD job; videotape the job; or use a simple another MSD incident occurs. management requirements, see checklist, such as the VDT checklist in For several reasons, OSHA does not summary and explanation for Appendix D–2 or checklists similar to believe that the ‘‘same job’’ requirement paragraphs (p), (q), (r), and (s) below.) the one developed by the Dow Chemical will impose an undue burden on 2. Talk With Employees Company (Ex. 32–77–2–1 ). In addition, employers. First, OSHA believes that employers are free to determine in what the number of ‘‘same jobs’’ in the Paragraph (o)(2)(ii) requires that, as order they want to conduct the steps of establishments likely to use the Quick part of the process of identifying the the Quick Fix process. Some Fix option will be small, because OSHA MSD hazards, employers using the commenters said that they observe the believes that many qualifying employers Quick Fix option must at least to talk job first as a way to better focus their will generally be small businesses. with the employees in the job (and their discussions with employees. Second, the final rule allow employers representatives). The purpose of this to limit the Quick Fix to the injured consultation is to ensure that employers 4. Ask Employees for Solutions employee’s job where the employer has ask those who know the most about the Paragraph (o)(2)(iv) specifies that reason to believe that the risk factors in job-those that perform it-for their help employers using the Quick Fix option the job only pose a problem to the in identifying the physical work must ask employees in the problem job injured employee. (See note to activities and job conditions that they for their ideas to fix the job. OSHA has paragraph (j).) Thus, if the case referred believe are mostly likely to be included this step in the Quick Fix to by COT (Ex. 30–2208) meets the associated with the MSD incident. process because time and again requirements described in the note to OSHA believes that including this step employers have said that their paragraph (j), the employer would only in the Quick Fix process will help employees often come up with the best be required to fix that employee’s job. employers more quickly and fully and least expensive solutions to This provision was included in the identify the problem so they will have problems (Tr. 8725, 1160, 9508). For proposed rule, and a number of the chance to fix the problem within the example, PPG stated that: commenters supported it, saying that Quick Fix deadline. such an exception was needed because Many commenters agreed with the We [management] do not have to look over the individual characteristics of one importance of including employees in their shoulders to make sure that they are implementing every—dotting every I. And it worker may require controls that don’t the hazard identification process (see, e.g., Exs. 500–200, 500–215, 30–1100, is a successful program. Essentially, the work for or are not needed by other workers run it (Tr. 3062). workers (see, e.g., Exs. 30–3745, 30– Tr. 3565). The record consistently 358). shows that employers with effective This step also was included in the Finally, even where there are ‘‘same ergonomics programs consult with their proposed Quick Fix. Some commenters jobs’’ that also must be Quick Fixed, employees because employees know asked OSHA to clarify whether OSHA does not believe that the Quick what tasks are contributing to their MSD employers were obligated to implement Fix process will be burdensome for signs and symptoms and because they the recommendations that employees employers. The Quick Fix process is often have the best and least expensive make (Ex. 30–595). The requirement very informal and thus provides ideas for solutions (Exs. 30–1100, 500– that employers ask employees for their employers with great flexibility in 200, 500–215, Tr. 14903, Tr. 3062). recommendations does not limit them to complying with each step in the Quick Talking to other employees who implementing only those solutions Fix process. In addition, the final rule perform the same job as the injured recommended by employees. OSHA allows employers to include a sample of employee also provides employers with expects employers to use their judgment employees, rather than all employees in an opportunity to identify the problems when responding to employee the same jobs, in the hazard with the job more fully, and this, in suggestions and to select controls that identification and solution consultation turn, will help ensure that the right will achieve the reduction in MSD process. OSHA agrees with commenters solutions will be found to address the hazards mandated by the rule. OSHA that allowing employers to rely on a problem. notes that the records shows that sample of the employees who are likely employee suggestions for ergonomic 3. Observe the Job to have the greatest risk factor exposure improvements are often both practical in the job should help reduce burdens Paragraph (o)(2)(iii) specifies that and effective. employers must observe employees for large employers and for employers 5. Implement Controls Within 90 Days with many employees in the same job performing the job to identify the MSD (Ex. 30–2208). hazards that caused the MSD incident. Paragraph (o)(2)(v) of the final rule This step helps to ensure that nothing requires employers, within 90 days, to 1. Provide MSD Management has been overlooked in the discussion implement measures that either: Like employers who must implement with employees. In addition, as several • Control the MSD hazards (i.e., an ergonomics program, employers who commenters have pointed out, often reduce hazards to the extent that they select the Quick Fix option must problems in jobs become readily are no longer reasonably likely to cause provide the injured employee with apparent as soon as the person MSDs requiring days away, work prompt MSD management after they responding to the report has an restrictions or medical treatment), or

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• Reduce the hazards to the levels Appendix B are almost twice as high as changing the way bags move on a indicated in the appropriate hazard those in the Basic Screening Tool. Thus, conveyor), and work schedules (e.g., rest identification tool in Appendix D. the standard does not require employers breaks, job rotation, job enlargement) Employers must put controls into to achieve a ‘‘risk-free environment.’’ (see, e.g., Tr. 2147, 6510). One place within 90 days of the time the Third, the Quick Fix now contains more participant discussed the effectiveness employer determines that the job meets specific criteria for identifying and of these types of Quick Fix adjustments the Action Trigger. Employers are free to controlling hazards so that employers in office environments: use any combination of engineering, more clearly understand when a hazard If you’re looking, say, at the office work practice or administrative controls is present and when they have done environment, the quick fix situation is very to fix the job. As part of the Quick Fix, enough to fix the job. Thus, the final often the one that’s there in any case, because employers must also train employees rule is not requiring employers to take you’re looking at people who need how to use the controls that have been ‘‘technologically or economically’’ improvements to their posture and so on and implemented. infeasible abatement measures. so forth. And very often, the whole work environment is already there to be adjusted. Implement Controls 90-day Control Time Line It just needs a quick-fix, which in this case The proposal would have allowed The final rule continues the proposed is often training and showing people how employers to use the Quick Fix option 90-day time line for implementing they should be adjusting their workstation for only where they could ‘‘eliminate MSD their particular tasks. So very often, in the Quick Fix controls, but now specifies office environment, the quick fix is the only hazards,’’ which was defined as that the time begins to run only after the way to do it. (Tr. 2707) controlling physical work activities and employer has determined that the job in conditions to the extent that an MSD which the MSD incident occurred meets The record also includes information was not reasonably likely to occur, the Action Trigger. Comments on the on a wide variety of inexpensive ‘‘off- which was a higher level of control than proposed 90-day time line were mixed. the-shelf’’ controls and technology that for employers who were implementing Some commenters testified that many can be put into place quickly. Some of full ergonomics programs. Several MSD hazards can be controlled quickly these measures include telephone commenters opposed the proposed (see, e.g., Exs. 30–3813, 30–3436, 32– headsets; foot rests; ‘‘anti-fatigue’’ mats Quick Fix control endpoint, generally 210–2, 30–294, Tr. 13642, Tr. 2134), or other cushioned surfaces; monitor saying that it was either too vague to be while others said that controls, risers; wider grips for hand tools; knife workable or impossible to attain (see, especially engineering controls, could sharpeners; and carts and other e.g., Exs. 30–4290, 30–3812, 30–2208, not be implemented in 90 days (see, e.g., mechanical devices to assist with lifting, Tr. 2998, 8394, 9182). The comment of Exs. 30–3815, 30–240, 31–307, Tr. 4628, pushing, pulling and carrying tasks (Tr. ORC was typical of this opposition: 30–3853, 30–1091, 30–1048). As a 3946). According to David Alexander, a certified professional ergonomist and One fundamental change that must be result, some commenters requested that made to this provision is the revision of the OSHA provide extended abatement time president of Auburn Engineers, one proposed requirement to eliminate MSD for employers who could not implement reason why ‘‘off-the-shelf’’ controls can hazards; the formulation is problematic and Quick Fix within the allotted time frame be implemented so quickly and may be legally impermissible. It is well (Ex. 30–3853). inexpensively is that they do not require established that employers may only be For several reasons, OSHA believes ‘‘custom engineering’’ (Ex. 37–12). In required to take technologically and that the Quick Fix deadline should not addition, Mr. Alexander said that many economically feasible abatement measures. be extended. First, OSHA believes that of these controls can be easily identified The second problem is that employers cannot and purchased by looking at equipment be required to establish a risk-free extending the deadline negates the environment, so that to the extent that the principle underlying the Quick Fix catalogs, calling regular vendors, terms ‘‘eliminate MSD hazards and eliminate concept. Second, OSHA believes that contacting trade associations, and even employee exposure’’ suggest that an controls that take longer than 90 days to searching the Internet (Ex. 37–7). For employer must go beyond reducing the implement indicate that the problem example, he said that the Job significant risk of harm in a particular may be more complex than originally Accommodation Network, a free service instance, these terms must be revised and anticipated, and therefore, may more offered by the President’s Commission clarified (Ex. 30–3812). appropriately be addressed in the on Employment of People with OSHA believes that the changes in context of a comprehensive ergonomics Disabilities, has ‘‘a huge database of this provision address the commenters’ program. specific solutions to accommodation concerns. The final rule’s Action Trigger Third, OSHA does not believe that problems,’’ many of which are also helps to ensure that employers will only extending the 90-day Quick Fix solutions to ergonomics problems, that have to take action in higher-risk jobs. deadline is necessary, because the are available to anyone who calls the As mentioned in the summary and record shows that there are many network’s toll-free number (Ex. 37–12). explanation for paragraph (f), jobs that controls that can be implemented In addition, many other examples of meet the Action Trigger (i.e., exceed the quickly to control or reduce MSD quick and inexpensive fixes are in the exposure levels in the Basic Screening hazards. Many of these are obvious and cost chapter (Chapter V) of the final Tool) are ones that generally pose a risk low-cost fixes that can be made to economic analysis. of MSDs that is three times higher than workstations (e.g., raising or lowering Finally, the fact that employers are those that do not. Second, the control work surface or chair, placing free to Quick Fix hazards using any endpoints employers must meet under equipment directly in front of an combination of engineering, work the Quick Fix option do not require the employee to eliminate extended reaches practice and administrative controls elimination of all risk. For example, or awkward postures, providing a also supports the 90-day time line. employers will be considered in platform or box to stand on as a way to Administrative controls, in particular, compliance with the Quick Fix control eliminate overhead reaching, putting should not take long to implement. And requirement if they reduce exposure reams of copy paper under a monitor as employers would be free to Quick Fix levels to below those in Appendix B of a way to eliminate awkward neck jobs with administrative controls Washington State’s ergonomics rule. postures), tools or equipment (e.g., initially and later substitute engineering The acceptable exposure levels in the servicing of powered hand tools, controls when they become available.

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In addition to requests for more time implemented. OSHA added this before checking up on the job, the to Quick Fix jobs, at least one provision after commenters pointed out injured employee’s condition may commenter urged OSHA to delay the that Quick Fix controls may not be worsen. Retaining the 30-day followup start of the 90-day Quick Fix deadline successful, and therefore employees helps to ensure that employers initiate until after the MSD incident has been may not be protected from MSD further and more comprehensive action confirmed by the employer’s HCP and hazards, if they do not know how to use to prevent the employee from suffering perhaps even an ‘‘independent’’ HCP, those controls correctly (see, e.g., Exs. permanent damage or disability. In any the employee’s medical history has been 32–339–1, Tr. 6985). In fact, a number event, OSHA believes that the evaluated, and diagnostic measures of employees who testified at the availability of various tools and have been conducted (Ex. 30–3853). hearings reported that, although they checklists as well as the final standard’s Paragraph (e) already allows employers had been provided with ergonomically more clearly-defined control endpoints to consult with an HCP in determining appropriate controls (e.g., adjustable will make the control evaluation process whether an MSD incident has occurred. chairs), they had never been taught how easier and quicker. In addition, after that determination is to properly use or adjust the controls 7. Keep Records of the Quick Fix made, employers have another 7 days in (see, e.g., Tr. 8461). which to determine whether exposure Paragraph (o)(2)(vi) specifies that levels in the job exceed the levels in the 6. Check Success of the Controls employers must keep records of their Basic Screening Tool before the 90-day Paragraph (o)(2)(vi) requires Quick Fixes for 3 years, or until control time begins to run. Nonetheless, employers, within 30 days after replaced with updated records. OSHA believes that, in the implementing Quick Fix controls, to Paragraph (v), however, limits the overwhelming number of cases, review the job to determine whether the recordkeeping requirement to employers employers rather than HCP’s will make measures implemented have controlled with 11 or more employees. This the determination about the work- the hazards or reduced them to the provision was included in the proposed relatedness and seriousness of the levels in Appendix D. An analogous rule. While some commenters agreed reported MSD, as they have done for provision also was included in the that such records were necessary (Ex. years in the context of the proposed rule. A number of commenters 30–710), several commenters opposed recordkeeping rule. Therefore, OSHA complained that a 30-day time line for this requirement (see, e.g., Exs. 601–X– does not believe that initiation of the checking the success of the Quick Fix 1, 30–3755, 30–1019, 30–294, 30–3745, control implementation deadline needs controls was too short (see, e.g., Exs. 31– Tr. 2983, Tr. 5758). Some said the to be delayed. 307, 30–240, 30–3815, 30–3853, 30– recordkeeping requirement would be Finally, one commenter asked OSHA 2988, 30–3934, Tr. 4628). For example, burdensome, especially for small to clarify whether the Quick Fix option Kaiser Permanente said: businesses. The Office of Advocacy of could be used in jobs that do not last for the Small Business Administration (Ex. 90 days (Tr. 12179). OSHA is not clear If a person has serious MSD symptoms, the symptoms may not subside in this short time. 601–x–1) submitted the following whether the commenter was referring to Kaiser Permanente recommends that OSHA comment: (1) the same short duration job that is modify the proposed Quick Fix deadline for The Quick Fix option also limits the one repeated (e.g., seasonal work, temp elimination of the MSD hazard to 120 days small business exemption which exists agency work assignments) or (2) one- from the date of implementation of the within the ergonomics program standard time job of short duration (e.g., special hazard controls. proposal. This option states that an employer project). OSHA realizes that where an Likewise, the Tennessee Valley must keep records of the Quick Fix controls MSD occurs toward the end of a short Authority expressed concerns that 30 they implement, when they are implemented duration job that there may be some and the results of any evaluations. [The days might not be long enough to limits on what measures the employer Office of Advocacy of the SBA] strongly evaluate control effectiveness (Ex. 31– may be able to take, that is, the recommends that the language within this 307). employer may not have enough time to option be clarified to indicate that employers fully implement either a Quick Fix or an For several reasons, OSHA believes with less than ten employees do not need to that 30 days provides employers with keep records for any provision in the ergonomics program. Nonetheless, the standard. Without this clarification, the employer must still implement those sufficient time to check up on whether the controls have been successful. In its option is not a real one for small business measures, such as interim controls, that and will have the [effect] of mandating are feasible to implement during the Elements of Ergonomics Programs, compliance with the total rule for employers remaining time. (See summary and NIOSH said that evaluations of control with less than ten employees. effectiveness should be made within 2 explanation for paragraph (m) for Paragraph (v) of the final rule does not discussion of the term ‘‘interim to 4 weeks of control implementation. NIOSH’s concern was not that 30 days require employers with fewer than 11 controls.’’) In addition, where the short employees to keep records, including duration job is repeated on some regular was too short a period of time for conducting post-implementation Quick Fix records. or foreseeable cycle, such as seasonal Other commenters said that the followup, but rather with checking up fish processing, each cycle is, in recordkeeping requirement added on controls too quickly: essence, a serial ‘‘same job.’’ As such, in unnecessary complexity to the Quick order for employers to use the Quick Fix Because some changes to work methods Fix option. For example, Dow Chemical option in these situations, they will be (and the use of different muscle groups) may Company (Ex. 30–3755) stated: required to have controls in place before actually make employees feel sore or tired for the next job cycle begins. a few days, followup should occur no sooner The use of this provision should be such than 1 to 2 weeks after implementation, and that it encourages its use in order to take Control Training a month is preferable. Recognizing this fact advantage of the fact that it exempts an employer out of the full rigors of the As part of the requirement to fix jobs, may help avoid discarding an otherwise good solution (Ex. 26–2). ergonomic program rule. To insist on, for paragraph (o)(2)(v) also requires example, recordkeeping of the quick fix employers to train employees in jobs At the same time, if controls are not controls will be a disincentive to its use and that are Quick Fixed so that they know working and the employer is allowed to thus may defeat its purpose. To require that how to use the controls that have been wait for an extended period of time such documentation be retained for three

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MSD incidents that trigger), First, the Quick Fix option does not occurred more than 18 months • MSD management is no longer include the ‘‘checks and balances’’ of a previously would not be considered in described as being for the purpose of ‘‘to comprehensive program (i.e., determining whether the employer prevent their (the employee’s) condition management leadership, employee could continue to use the Quick Fix from getting worse’’, training, and program evaluation). option in that workplace. • the employer is not required to Second, employers who use this option determine the need for work restrictions will need these records to demonstrate MSD Management and Work Restriction or other actions before consultation with that the Quick Fix process has been Protection a health care provider, successful in controlling the hazards. In Paragraphs (p), (q), (r), and (s) of the • the employer must provide slightly addition, employers themselves need final rule set forth the final rule’s different information to the health care records to be able to demonstrate that requirements for MSD management and provider, • they continue to qualify for using the work restriction protection (WRP). the health care provider is not Quick Fix option. Finally, OSHA These provisions require employers to afforded a right to walk through the believes that keeping the Quick Fix employers workplace, set up a process to manage MSD • records for just 3 years will not pose a incidents when they occur. OSHA’s minor editorial changes to the burden for employers, especially since final rule requires that employers make numbering, language and sequence of these employers will not have to put MSD management available promptly to the requirements to simplify the resources into keeping the other records sections and reduce duplication, and workers in jobs that meet the action • that employers who have full trigger whenever an MSD incident changes to the work restriction ergonomics programs must maintain. occurs; provide this MSD management protection (WRP) requirements reducing WRP payments from 6 months to 3 Paragraphs (o)(3) and (o)(4) at no cost to the employee; provide temporary work restrictions and ‘‘work months, and allowing the use of sick The last two provisions of the Quick restriction protection’’, and provide a leave during the WRP period. These changes reflect OSHA’s review Fix process provide that employers are mechanism for multiple health care and analysis of the many comments and not required to take additional action as professional (HCP) review when health other evidence in the record pertaining long as the job hazards remain care providers disagree about the proper to MSD management, which are controlled or exposures do not exceed course of action the employer should discussed below. OSHA also asked for the levels in Appendix D. As long as take. The discussion of these sections is input on several specific issues in these control levels are maintained, divided into two parts; the first section employers need only provide training in Section XIV of the proposal, Issues on discusses MSD management, and the the use of the controls to new Which OSHA Seeks Comment. The second, worker restriction protection employees who are assigned to Quick comments provided in response to those and multiple HCP review. Fixed jobs. If, however, hazards cannot questions are included in the discussion be reduced to those levels within the MSD Management of the relevant issues below. Quick Fix time frame, or be maintained Under the final rule, employers would Is MSD Management Needed? at those levels, employers must be required to make MSD management implement an ergonomics program in OSHA received many comments on available promptly whenever an MSD that job, i.e., if more than one MSD the proposed MSD management section. incident occurs; provide this MSD incident has already occurred in the job. Many commenters generally supported management at no cost to the employee; However, if this is the first Quick Fix in the inclusion of MSD management and evaluate, manage, and follow-up on that job, the employer would be free to provisions in the standard (see, e.g., Exs. the MSD incident. Specifically, repeat the Quick Fix to see if a second 30–626, 30–651, 30–2387, 30–3033, 30– employers are required by the final rule effort might be more successful. 3034, 30–3035, 30–3258, 30–3259, 30– to: The proposed rule, on the other hand, • 3686, 30–3813, 30–3826, 30–4538, 30– would have adopted a ‘‘wait and see’’ promptly provide effective MSD 3934, 30–4159, 30–4468, 30–4536, 30– approach, requiring employers to management at no cost to the employee, 4538, 30–4547, 30–4549, 30–4562, 30– • implement a full ergonomics program if provide employees with access to a 4627, 30–4776, 30–4777, 30–4800, 31– it turned out that the controls did not health care provider (HCP), 23, 31–31, 31–43, 31–71, 31–92, 31–105, • eliminate the hazards with the deadline provide work restrictions the 31–113, 31–150, 31–156, 31–160, 31– or if another MSD occurred in the job employer or the HCP find necessary, 161, 31–163, 31–186, 31–229, 31–243, • sometime during the following 36 provide the HCP with information 31–259, 31–301, 31–309, 31–342, 31– months. The proposed rule would have about MSD management and the 345, 31–347, 32–182–1, 32–210–2, 32– provided one exception to moving onto employee’s job, 339–1, 32–85–3, 32–111–4, 32–133–1, a full ergonomics program in those cases • obtain a written opinion from the 32–450–1, 30–4468, DC 75, 30–1104, L– where the second MSD incident in the HCP about the MSD, 30–4860, 37–12, 37–28). job was caused by different risk factors. • provide the employee with the Several commenters stated that MSD Several participants commented on HCP’s opinion, and management is an essential component this proposed provision (see, e.g., Exs. • evaluate, manage and follow-up on of an ergonomics program. For example, 30–3813, 30–3815, 30–710, 30–1107, the MSD incident. Lieutenant Colonel Mary Lopez, of the 30–494, 30–4540, Tr. 14985). Most The final rule’s MSD management Department of Defense, reported at the commenters (see, e.g., Exs. 30–3813, 30– provisions are quite similar to the hearing that healthcare management 3815) argued that the 36-month ‘‘wait provisions in the proposed rule. The (i.e., MSD management) is a critical

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00111 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68372 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations element in any ergonomics program (Tr. management for all jobs, rather than medical management of all injuries (Exs. 3221, Ex. 30–3826–14, 500–218). The relying on covered MSDs to trigger 30–3677, 30–3765, 30–4185, 31–79, 31– 3M Company stated that ‘‘The need for action in some jobs, as the proposal did. 321, 500–177–2); effective MSD management is Others recommended using an even • Medical management is addressed universally accepted’’ (Ex. 30–3185). Dr. more proactive, risk-based approach to in other OSHA standards (1910.151 Robert Harrison stated that ‘‘The trigger MSD management, instead of Medical services and first aid.) (Exs. 30– medical and scientific literature and my waiting for an employee report of an 3765); own clinical experience confirm that MSD (see, e.g., Exs. 30–626, 30–2387, • The proposed provisions add MSD management is an essential part of 30–3686). burden on employers (see, e.g., Exs. 30– an ergonomics program’’ (Ex. 37–12). Several commenters supported the 1294, 30–3765, 30–4040, 30–4499, 30– Evidence in the record shows that proposed MSD management provisions 4564, 500–177–2), the cost for medical many companies, through early with reservations/concerns (Ex. 30– assessment of illnesses is too high (see, intervention and the effective 3185, 30–3188, 30–4777). For example, e.g., 30–1026, 30–1302, 30–0295, 30– management of MSDs, have achieved the American Occupational Therapy 1362, 30–0070, 30–0262, 30–0586, 30– substantial reductions in the number Association urged OSHA to ‘‘[p]rovide 0280, 30–3760), and the proposed and severity of MSDs, which have in guidance about the difference between requirements are too prescriptive (Ex. turn, translated into less lost-work time, treatment of a disorder and the 30–400, 30–1294, 500–177–2); fewer lost-workdays, lower costs per management of early symptoms’’ (Ex. • The proposed provisions are case, and fewer workers’ compensation 30–4777). unclear about what the employer is claims (see, e.g., Exs. 3–56; 3–59; 3–73; Other commenters opposed the supposed to do (Ex. 30–3344), fails to 3–95; 3–113; 3–118; 3–147; 3–175; 3– approach to MSD management taken in tell an employer when to provide access 217; 26–23, 26–24, 26–25, 26–26, 30– the proposal (see, e.g., Exs. 30–276, 30– to an HCP (Ex. 32–120–1), or uses vague 3185, 500–20–3, 500–71–84, Tr. 14357, 400, 30–1090, 30–1294, 30–1350, 30– terms (see, e.g., Exs. 30–2987, 30–3364, Tr. 14721, Tr. 17431). Representative of 1357, 30–1370, 30–1722, 30–1727, 30– 30–3677); these comments, Dr. Colin Baigel of the 1989, 30–2037, 30–2208, 30–2216, 30– • The proposed provisions conflict Bristol Myers Squibb Company reported 2435, 30–3032, 30–3167, 30–3200, 30– with workers’ compensation laws (see, at the hearing that ‘‘[o]ne of our keys is 3284, 30–3344, 30–3368, 30–3392, 30– e.g., Exs. 30–300–1, 30–710, 30–1350, early medical intervention with any 3677, 30–3765, 30–3845, 30–3853, 30– 30–1722, 30–2435, 30–2987, 30–3284, sorts [of] symptoms or signs of physical 3867, 30–3956, 30–4040, 3–4046, 30– 30–3745, 30–3765, 30–3845, 30–4026, illness’’ (Tr. 10516). He commented 4185, 30–4470, 30–4499, 30–4564, 30– 30–4564, 30–3677, 30–4499, 31–172, further that, in his company’s program, 4567, 30–4837, 30–4839, 30–4843, 31– 31–180, 31–220, 31–252, 32–206–1); they see and evaluate employees early, 27, 31–77, 31–78, 31–79, 31–125, 31– • The proposed provisions create a modify the workplace, and institute 135, 31–172, 31–180, 31–202, 31–220, preferential system for MSDs and aggressive conservative treatment if 31–225, 31–227, 31–245, 31–246, 31– enforces the notion that ergonomics necessary (Tr. 10516). 247, 31–248, 31–252, 31–253, 31–265, injuries are more important than other North Carolina State University 31–280, 31–283, 31–286, 31–307, 31– injuries (see, e.g., Exs. 30–1294, 30– discussed the consequences of not 319, 31–321, 31–337, 32–120–1, 32– 3765, 30–4470, 30–4843, 31–280, 500– providing prompt MSD management, 300–1, 500–1–127, 500–177–2, 500– 177); stating that ‘‘I know of employees who 208). In a representative comment, PPG • The proposed provisions would were ordered by a non-medical industries recommended that OSHA interfere with existing collective bargaining agreements (see, e.g., Exs. supervisor to get back to work after an Remove these sections completely. These injury—in each case the lack of 30–3284, 30–3765, 32–266–1); are very onerous requirements and the cost • immediate medical care exacerbated estimates of OSHA for these issues do not The proposed provisions would their conditions’’ (Ex. 31–163) begin to approximate the real costs to address a problem that was, in the Several commenters recommended industry to comply with these provisions. opinion of these commenters, largely or that OSHA strengthen the provisions of Further, they do nothing to achieve improved exclusively non-occupational in origin this section to achieve early detection ergonomics in the workplace (Ex. 500–177– (see, e.g., Exs. 30–240, 32–241–4, 30– and a more proactive approach to MSD 2). 3167, 30–3956, 30–3956, 30–4046, 30– management (see, e.g., Exs. 30–626, 30– Some of these commenters objected to 4713, 32–241–4); and 2387, 30–4583, 32–182–1, 32–339–1, L– the proposed MSD management section • The proposed provisions change the 30–4860, 500–71–86, 500–218). Many because it included provisions traditional relationship between suggested that MSD management should protecting the wages and benefits of doctors, patients and employers (Exs. be triggered when an employee reports injured workers (see, e.g., Exs. 30–240, 30–4470) or inappropriately inject the the signs and/or symptoms of MSDs 30–3813, 30–3765, 30–3845, 601–x–1). employer into the employee-patient (see, e.g., Exs. 30–3686, 30–4538, 32– These comments are discussed in detail relationship (Ex. 30–4567). 111–4, 32–182–1, 32–339–1, 32–210–2, below in conjunction with the In a representative comment, the Dow 32–461–1, 32–85–3, L–30–4860). For comments received on the proposed Chemical Company (Ex. 30–3765) stated example, the American Public Health rule’s provisions on work restriction that (1) a management system for work- Association stated that MSD protection. Other commenters objected related injuries already exists through management should be required for all for the following reasons: workers’ compensation laws, (2) the MSDs reported to the employer • The proposed provisions exceed proposal may conflict with some including symptoms of MSDs (Ex. 30– OSHA’s legal authority (see, e.g., Exs. collective bargaining agreements, and 626). The AFL–CIO (Ex. 32–339–1) 30–710, 30–1350, 30–3956, 30–1722, (3) a special work restriction protection argued that, as proposed, the MSD 30–2208, 30–3765, 30–3845, 30–3956, is not warranted for MSDs because of management provided by the proposed 30–4499, 31–319, 32–241–4); their multifactorial nature. The standard would not achieve the goal of • The proposed provisions are Anheuser-Busch Companies, Inc. and early detection and urged OSHA to rely unnecessary (Exs. 30–3677, 30–3765, United Parcel Service, Inc. added ‘‘[t]he on employee reports of persistent signs 30–4185, 500–177–2); employers proposed rule is doomed to fail as a and symptoms to trigger MSD already have systems in place for result of its exclusive focus on

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OSHA has recommended OSHA: recommendations would be likely to reconsidered the issue, and now believe diminish the severity of, and, consequently, [d]elete [the] last sentence of 1910.919 and that any MSD incident is serious enough the disability and suffering associated with, [the] remainder of MSD management, and MSDs. to warrant MSD management. add ‘‘You must make MSD management Several commenters recommended available promptly whenever a covered MSD The final rule’s MSD management that OSHA require an employer to refer occurs. You must provide MSD management provisions are also based on OSHA’s an employee with complaints or signs or at no cost to employees. A health care experience with ergonomics over the symptoms of an MSD to a HCP for professional should be involved in MSD last 15 years. For example, MSD evaluation, management, and follow-up management when necessary’’ (Ex. 30–4628) management provisions were included immediately, rather than ‘‘when (see also Ex. 31–337). in OSHA’s 1990 Ergonomics Program necessary,’’ as proposed (Exs. 30–651, In the final rule, OSHA has decided Management Guidelines for 30–3826, 30–3686, 30–2387, 30–4468, to carry forward the MSD management Meatpacking Plants (Ex. 26–3). In 32–339–1, 32–111–4, 32–182–1, 30– provisions of the proposed rule with addition, MSD management provisions have been included in all of OSHA’s 4538, 32–210–2, 32–461–1, 32–85–3, only minor modifications. The MSD corporate settlement agreements 32–210–2, 32–450–1). For example, the management provisions of the final rule addressing MSD hazards. In a 1999 United Food and Commercial Workers emphasize the prevention of workshop to discuss the experience of (UFCW) argued that having every impairment and disability through companies with corporate wide worker assessed initially by an HCP prompt evaluation and management of settlement agreements, the companies would resolve many issues raised by the MSD incidents, evaluation by a health who were involved stated that ‘‘[q]uality proposal, such as ‘‘when to refer the care provider, provision of needed work healthcare is a must’’ for an ergonomics employee to the HCP,’’ ‘‘follow-up,’’ and restrictions, and appropriate follow-up. program, and ‘‘[g]ood medical ‘‘deciding appropriate work The provisions are included because management allows early reports and restrictions’’ (Ex. 32–210–2). The successful ergonomics programs include American Association of Occupational reduces surgeries’’ (Ex. 26–1420). MSD management, OSHA has had Further, to become a member of OSHA’s Health Nurses (AAOHN) (Ex. 30–2387) successful experience with including commented that ‘‘[e]mployers should Voluntary Protection Program, MSD management as part of an automatically be required to refer employers are required to include ergonomics program agreement with employees with MSD complaints to ‘‘Occupational Heath Care Program’’ employers, and OSHA therefore believes health care professionals for evaluation provisions in their safety and health that MSD management is essential to the and determination about physical programs that address MSDs and their proper functioning of an ergonomics capabilities and work restrictions. Most management, along with other health program. employers are not qualified to make this hazards. determination.’’ The AAOHN also stated The MSD management provisions of There are many reasons why MSD that ‘‘[d]ecisions related to signs and the final rule are based on the many management is essential to the success symptoms of MSD[s] and placement of successful ergonomics programs that of an ergonomics program. As temporary work restrictions should be include policies for the medical mentioned above, MSD management made by a health care professional’’ (Ex. management of MSDs, and the final rule emphasizes the prompt and effective 30–2387). Some commenters stated that contains provisions similar to those in evaluation and management of MSD the phrase ‘‘when necessary’’ was such programs (see, e.g., Exs. 26–2, 32– incidents, with appropriate follow-up unclear, confusing, and vague (Exs. 30– 450–1). The MSD management for the injured employee. When MSD 2987, 30–3782, 30–3826, 30–3845). provisions of the final standard are thus incidents are managed effectively, they Other commenters, however, agreed built on the processes that employers are more likely to be reversible, to with the ‘‘when necessary’’ language, on with effective ergonomics programs are resolve quickly, and not to result in the grounds that it gave the employer using to help employees who have disability or permanent damage. MSD the flexibility to decide when an work-related MSDs. management also helps to reduce the employee needs to be referred to an HCP MSD management is recognized by overall number of MSDs in a given (see, e.g., Exs. 30–3813, 30–4467, 32– employers, HCPs, and occupational establishment because it alerts 300–1). safety and health professionals as an employers to MSD hazards in their jobs OSHA has deleted the ‘‘when essential element of an effective so that they can take action before necessary’’ language from the final rule. ergonomics program (see, e.g., Exs. 26– additional problems occur. An MSD The final rule only applies to specific 1, 26–5, 26–1264, 32–450–1, 30–4468, management process that encourages injuries (those with restrictions, medical 37–12, 37–28). Among employers who early reporting and evaluation of that treatment, or persistent signs and have told OSHA that they have an first MSD helps to ensure that the symptoms) and OSHA finds that these ergonomics program, most reported that analysis and control of the job is injuries should always be followed by their programs include MSD accomplished before a second employee medical management, including access management as a key element (see, e.g., on that job develops an MSD. MSD to an HCP. This change clarifies the Exs. 3–56; 3–59; 3–73; 3–95; 3–113; 3– management thus reduces MSDs final rule and assures prompt medical 118; 3–147; 3–175; 3–217; and Exs. 26– through prevention. In addition, MSD management for employees who need it. 23 through 26–26, 500–71–84). This management helps to prevent future Several commenters recommended approach is also supported by the problems through the development and alternative approaches to MSD scientific literature concerning communication of information about the management. The Pinnacle West Capital ergonomics as evidenced by the occurrence of MSDs to employees.

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Finally, where engineering, design and aid merely require the employer to difficulty lies in getting the injured employee procurement personnel are alerted to ‘‘ensure the ready availability of the treatment they need in a timely manner the occurrence of MSDs, they can help medical personnel for advice and (Ex. 31–301). to implement the best kinds of consultation on matters of plant health’’ OSHA’s responses to the comments ergonomic controls: those that engineer and do not provide sufficient guidance that the MSD management provisions out MSD hazards in the design and for the effective management of MSD exceed OSHA’s legal authority, affect purchase phases and thus prevent MSD incidents. Likewise, simply leaving workers’ compensation, or impact incidents from occurring. MSD management to the discretion of collective bargaining agreements are The final rule does not require the the employer, or including a simple addressed in the section of this employer to provide MSD management reference to provide MSD management preamble dealing with worker removal for all MSDs, but only requires MSD ‘‘when necessary’’ would not provide protection. management for MSD incidents that enough guidance for employers, health Who Provides MSD Management occur to a worker in a job that exceeds care professionals, or workers. At the Services? the action trigger. This helps to assure same time, the final rule’s provisions that MSD management is only required requiring employers to provide access to The preamble to the proposed rule for work-related MSDs, and that non- a health care professional, provide work explained that the proposed ergonomics occupational MSD cases are excluded. restrictions, and generally evaluate, rule would have permitted ‘‘persons in The final rule does not require the manage and follow-up on an MSD the workplace and/or HCPs’’ to provide employer to take any action for non- incident provide the flexibility needed injured employees with evaluation, work-related MSD cases. The only for the variety of MSD cases that management, and follow-up in obligation may be to determine the employers will encounter. An employee connection with the MSD management work-relatedness of an MSD report from who has suffered a severe back injury process (64 FR 65838). The regulatory an employee to make sure that the MSD from lifting a heavy object and is text required that an employer provide is non-occupational, but no other action experiencing agonizing pain and an access to a health care professional for is required. inability to function may need evaluation, management and follow-up Requiring MSD management only for immediate treatment in an emergency ‘‘when necessary’’ (64 FR 66073). MSD incidents, as defined by the final room, while a worker who is Many commenters (see, e.g., Exs. 30– rule, also makes sure that the MSD is a experiencing a gradual worsening of 3826, 30–2387, 32–450–1, 32–210–2, more serious case, and that MSD pain in the wrists may require prompt 30–2806, 30–4468) argued that the management, as well as the other (but not immediate) treatment by a inclusion of individuals without elements of an ergonomics program, are specialist. medical training and experience in the not being required for cases that involve OSHA finds that the arguments that MSD management process was only minor pain or soreness but are the rule changes the traditional inappropriate. For example, the being provided for disorders that need relationship between doctors, patients American Association of Occupational treatment and cases with persistent and employers (Exs. 30–4470) or Health Nurses (AAOHN) strongly signs or symptoms. Requiring MSD inappropriately injects the employer disagreed with the proposal’s use of the management under these circumstances into the employee-doctor relationship phrase ‘‘or other safety and health also makes sense because all of the (Ex. 30–4567) are without merit. professionals as appropriate’’ in the program elements are initiated with the Employers have, for many years, MSD management process on the same implementing mechanism; experienced a relationship with the grounds that assessing, providing requiring MSD management without the medical community in regards to prompt management/treatment to, and other elements of an ergonomics employees work and non-work related following-up individuals with medical program would be inconsistent and injuries and illnesses. Employees problems are clearly activities within ineffective. commonly obtain written notification the scope of health care professionals’ The final rule requires MSD from a physician to explain time off of professional licenses but are not management for all MSD incidents work for personal illness. Employers included in the scope of practice of when the worker’s job exceeds the frequently consult with a health care other safety and health professionals. action trigger. OSHA has eliminated the provider when an employee is injured The AAOHN stated that ‘‘[i]t is phrase ‘‘when necessary’’ so the MSD or becomes ill at work, to determine imperative that the standard not enable management provisions apply to all appropriate time off, restrictions or non-licensed individuals to make health MSD incidents. If an MSD has resulted medical treatment, and the requirements assessments and provide health care in days away from work, restricted of the final rule are not much different. services without a professional license’’ work, or medical treatment, and the Employers also consult with health care (Ex. 30–2387). employee’s job exceed the action trigger, professionals when they contest The National Institute for there is no further reason for delay. workers’ compensation claims, during Occupational Safety and Health MSD management is clearly needed for tort litigation, or when implementing (NIOSH) noted that, although the these MSDs, and the final rule requires reasonable accommodations for disabled institute supports ‘‘[e]mployers’ efforts it. The final rule does not mandate MSD persons as required by the Americans to train employees in the early signs and management for MSDs that do not rise with Disabilities Act (ADA). symptoms of MSDs and to seek HCP to that level. For other incidents, the Finally, OSHA believes these evaluation when appropriate,’’ it employer will have to make a decision requirements are needed to make sure ‘‘recommend[s] that the standard about what MSD management actions that employees get the medical attention preclude non-HCPs and non-licensed are appropriate, but the final rule does they need. As the Thermoquest HCPs from conducting medical not require them. Corporation stated: evaluations.’’ In addition, NIOSH noted OSHA also believes that the final rule that, the institute ‘‘[s]upports OSHA’s [i]f there are no clear guidelines, many strikes the necessary balance between employers may not allow an employee to proposal that permits the MSD being too prescriptive and too vague. seek medical help for various reasons. Also management programs to be The provisions of OSHA’s standard 29 to leave it up to the employee when to see administered by a variety of licensed CFR 1910.151 Medical services and first a physician allow for employee abuses. The HCPs as defined (in the proposal’s

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Evaluating of the program (medical evaluations of The final rule and the proposal define symptomatic workers) be performed by signs and symptoms and determining whether an injury has occurred is the health care professionals as ‘‘physicians licensed HCPs under the supervision of responsibility and within the scope of or other licensed health care HCPs licensed for independent practice practice of licensed health care providers. professionals whose legally permitted (including physicians, and nurse The supervisor and worker relationship is scope of practice (e.g. license, practitioners and physicians’ assistants not a relationship that should involve or registration, or certification) allows in those states where they are so appropriately involves diagnosing physical them to independently provide or be licensed)’’ (Ex. 32–450–1). Other injuries. If the employer erroneously decides delegated the responsibility to provide that a covered MSD has not occurred, commenters (see, e.g., Exs. 30–3826, 32– some or all of the MSD management 210–2, 30–4468, 30–2806) agreed that continuing to perform the hazardous job would result in a delay in evaluation and requirements of this standard.’’ evaluating an employee’s complaint of treatment, and could intensify the injury or Several commenters supported the an MSD or assessing the physical seriously compromise the recovery, proposed definition of ‘‘HCP’’ (see, e.g., capabilities of the employee to return to permitting managers and supervisors to Exs. 3–73, 30–519, 30–2387, 30–2807, work or his or her need to rest the assume these activities, place the employer 30–3745, 30–3748, 30–3813, 30–4567, injured part may require expertise that and/or manager at risk of litigation for 30–4844, 32–85–3, IL–182). For an employer or other safety and health practicing medicine without a license or for example, the Rural/Metro Corporation professional does not have. denying medical attention to an injured (Ex. 30–519) stated that the definition of person (DC 5/8/2000, Tr. 15884). The American College of HCP in the proposal was appropriate Occupational and Environmental The final rule requires the employer because OSHA should not attempt to Medicine (ACOEM) noted that ‘‘[i]f to provide MSD management to decide scopes of practice for HCPs. The MSD signs are to be included as part of employees who have suffered an MSD AAOHN (Ex. 30–2387) stressed that a the triggering event, the employee must incident, if they are employed in a job ‘‘[k]nowledgeable health care be examined by a physician with that rises to the level of the action professional, practicing within their training in medical diagnosis’’ (Ex. 30– trigger, including prompt access to an legal scope of practice, establishes 4468). The ACOEM expressed concern HCP. OSHA agrees with these procedures, or consults with the that ‘‘flexibility’’ in allowing non-HCPs commenters that non HCPs should not employer in the establishment of to evaluate employee reports of signs provide medical services appropriately procedures, to determine what is to be and symptoms ‘‘[w]ould result in reserved to a health care professional. done when an employee reports a MSD employers—who are not likely The final rule does not allow a non-HCP or persistent MSD symptoms.’’ In her qualified—making assessments or to provide medical services, and it was testimony for the AAOHN, Sandy diagnoses. * * * Therefore, ACOEM never OSHA’s intent in the proposal to Winzeler stated: recommends that the determination of a allow a non-HCP to provide medical It is appropriate for OSHA to recognize the recordable MSD be made by a qualified services that are only appropriate to an roles that different health and safety HCP. Oftentimes, an HCP will have been occupational healthcare professional’’ disciplines play in health and safety involved in the MSD case well before programs. * * * Each discipline has a (Ex. 30–4468). the final rule requires MSD unique contribution to make to the program; The United Food and Commercial management, while the employer is in this case, the prevention and management Workers (UFCW) agreed that HCPs, determining the work-relatedness of the of MSDs. It is only through such rather than others, should conduct MSD MSD case, and because the MSD collaboration that we are successful. management, arguing that the OSHA However, it is inappropriate for OSHA to incident, by definition, must involve include language in a standard that would proposal failed to require that an HCP days away from work, restricted work, restrict the practice of any health care make the initial assessment of the medical treatment, or persistent signs/ professional. As you are aware, health care worker’s condition, a crucial element of symptoms before it is covered by the professionals are regulated by the States. The MSD management in the union’s view. MSD management provisions. current language used in the proposal defers UFCW stated that ‘‘[a]ll successful However, there are circumstances to State law in determining whether the programs that we have experience with where an employer may provide a individual can fulfill the requirements under have this core element’’ (Ex. 32–210–2). worker with work restrictions before their licensed scope of practice, and AAOHN The UFCW emphasized this point by supports this. Over half of the States permit consultation with an HCP. In some nurse practitioners to practice independently stating that, in corporate wide cases, the restrictions may be obvious. without any requirement for physician settlement agreements (CWSAs) For example, if an employee injures his supervision or collaboration. This includes between companies and OSHA, ‘‘OSHA or her back, limiting the lifting the the ability to make independent medical and the industry recognized that lay employee is required to perform is a diagnosis. Registered nurses often work in persons were not capable of assessing logical action to take. In other instances, collaborative arrangements with physicians symptomatic employees’’ (Ex. 32–210– the employer may have had experience especially in the occupational health setting. 2). Arguing along similar lines, the with similar MSD cases in the past, and It is impractical to expect that a physician will be on site and available to evaluate every American Association of Orthopaedic the types of restrictions that are needed employee, and in fact, it is usually the Surgeons (AAOS) commented that ‘‘[i]t are familiar to the employer. In the occupational health nurse that is on the front is inappropriate to ask the employee situation where the employer knows line, at the work site, working with and employer to diagnose the what restrictions may be necessary, the employees every day. OSHA should employee’s problem and determine if it final rule requires the employer to recognize the important role that nurses play is or is not related to work and provide such restrictions. Providing and by no means should limit our ability to deserving of further attention from the restrictions even before consultation fully practice within our legally defined employer’’ (Ex. 30–2806). In her with an HCP can provide relief to the scope [DC 3/29/2000, Tr. 5588–5590]. testimony, Mary Foley, President of the employee, reduce the severity of the The American Physical Therapy American Nurses Association (ANA), case, and begin the healing processes at Association (APTA ) also expressed strongly encouraged: an earlier stage. support for ‘‘OSHA’s recognition of

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ACOEM limit employers’ choice of HCPs to Other commenters argued that the recognized the important role of non- specialists, who are often not available ergonomics rule should require HCPs to physicians such as nurses, physician’s in reasonable proximity, which would have specific training (see, e.g., Exs. 30– assistants, and other health care delay prompt evaluation, management, 626, 30–3032, 30–4467, 30–4538, 32– providers, but argued that the healthcare and follow-up and make it much more 339–1, 30–4468, 30–2806, 30–3934, 30– provider must be able to perform four costly (Ex. 3–73, 36–1370, 30–3745, IL– 3745, 30–3937, 32–300–1). For example, basic functions to perform the duties of 182). For example, the American Feed the law firm of Morgan, Lewis and an HCP required by the proposed Industry Association, whose members Bockius argued that HCP’s not ergonomics standard: have facilities in rural areas, expressed specifically trained in musculoskeletal (1) Make independent diagnoses concern that the medical profession in disorders would not be able to make (which is usually limited to physicians, a rural area may not have the expertise accurate diagnoses and that HCPs except in those states where nurse to deal with work-related MSDs, and without MSD specific training ‘‘[m]ight practitioners and physician assistants pointed out that compliance could be a actually irritate conditions or prescribe are licensed for independent practice); problem if the standard stipulated that incorrect treatments, or impose (2) Conduct an appropriate physical the HCP have a specific background (Ex. unwarranted obligations on employers’ exam, 3–73, 30–3745, IL–182). (Ex. 30–4467). The International (3) Order appropriate treatment, and Other commenters opposed the Association of Drilling Contractors (Ex. (4) Be able to relate musculoskeletal proposed definition (see, e.g., Exs. 30– 30–2676) commented that ‘‘According findings to work activities (which 494, 30–991, 30–2208, 30–3004, 30– to a recent medical publication, 82% of requires an understanding of basic 2208, 30–2676, 30–4468, 30–4699, 30– medical school graduates failed a valid epidemiology). 3749, 30–3783, 30–3781, 30–3937, 30– musculoskeletal competency ACOEM further argued that OSHA’s 4025, 30–4467, 30–4538, 30–4843, 32– examination. (The Journal of Bone and definition was questionable because 22–1, 32–339–1, 32–111–4, 32–182–1, Joint Surgery, Vol. 80–1, No. 10, October other federal agencies have refused to 32–210–2, 32–300–1, 32–461–1). Many 1998, pp. 1421–1427)’’ to argue that adopt OSHA’s definition of a ‘‘licensed of these commenters held the opinion ‘‘This startling statistic makes one health care professional’’ used in other that the definition was too broad (see, question how a general physician may standards. AECOM cites as examples, a e.g., Exs. 30–991, 30–2208, 30–3004, properly diagnose a MSD’’ and the NIOSH policy statement on respirator 30–2208, 30–4468, 30–4699, 30–3749, ‘‘[i]nclusion of other fields under its use, as well as the Department of Energy 30–3783, 30–3781, 30–3937, 30–4025, [OSHA’s] definition of HCP is all the (DOE) rule on Beryllium. AECOM also 30–4467, 30–4538, 30–4843, 32–22, 32– more unacceptable’’. However, the cited the variability of state health care 339–1, 32–111–4, 32–182–1, 32–210–2, International Association of Drilling licensing laws as a reason for restricting 32–300–1, 32–461–1). The comments of Contractors did not submit a copy of the the definition, and that state scope of the Combe Inc. company are article into the rulemaking docket, so practice laws were ‘‘never intended to representative: ‘‘[b]y allowing persons OSHA is not able to fully evaluate the be the mechanism to protect a worker who do not even have a medical degree journal article. It appears to be a from a toxic, carcinogenic, or biological to diagnose and treat these disorders, competency examination for a exposure in the workplace’’ [Exhibit 30: the proposed standard creates an specialized medical field, and it is 4699]. environment where the potential for unclear that the examination uses the The National Institute for misdiagnosis and improper treatment same definition of musculoskeletal Occupational Safety and Health efforts is dramatically increased’’ disorder as OSHA’s rule, so OSHA does (NIOSH) [Exhibit 30–3004]. The Center for Office not believe that the article provides Technology pointed out that because the evidence contrary to the final rule’s [s]upports OSHA’s proposal that permits definition is so broad, it could include definition of HCP. MSD management programs to be occupations such as emergency medical Several commenters encouraged administered by a variety of licenced HCPs technicians or licensed vocational OSHA to define the specific * * * However, we recommend that the clinical aspects of the program (medical nurses who would not be the competencies an HCP should acquire to evaluations of symptomatic workers) be appropriate professionals to make be qualified to screen, diagnose and performed by licensed HCPs under the decisions with respect to MSDs [Ex. 30– manage MSD cases (see, e.g., Exs. 30– supervision of HCPs licensed for 2208]. The New Mexico Workers’ 2806, 32–182–1, 32–300–1). For independent practice (including physicians, Compensation Administration argued example, the American Association of and nurse practitioners and physician’s that a massage therapist could render an Orthopaedic Surgeons (Ex. 30–2806) assistants in those states where they are so opinion on MSDs (Ex. 32–22). found OSHA’s proposed definition to be licensed) (Exhibit 32–450–1). A number of commenters incomplete, and suggested the In the final rule, OSHA has carried recommended OSHA limit HCPs to ergonomics rule include a requirement forward the definition from the physicians, nurse practitioners, or to use HCPs who are ‘‘[h]ighly trained proposed rule: physician’s assistants (see, e.g., Exs. 32– and qualified’’ and who are 339–1, 32–111–4, 32–182–1, 30–4538, Physicians or other licensed health care ‘‘[k]nowledgeable in the assessment and professionals whose legally permitted scope 32–210–2, 30–4468, 30–4699, 32–450–1, treatment of MSDs’’ to ensure of practice (e.g. license, registration or 30–2806, 32–300–1). Others advised appropriate evaluation, management certification) allows them to independently that HCPs be limited only to physicians and follow-up of workers’ MSDs. provide or be delegated the responsibility to [Exhibit 30–351, 30–3749, 30–3344]. The American College of provide some or all of the MSD management Several commenters acknowledged Occupational and Environmental requirements of this standard.

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The final rule’s definition of HCP is The definition also relies on the 3284, 30–4301, 30–4467, 30–4564, 30– desirable for several reasons. Perhaps licensing requirements imposed by the 4607, 32–300–1, 32–337–1) In a most important is that the HCP states. As stated in the proposal (FR representative comment, Southern definition provides employers with the 65842), OSHA believes that issues of California Edison argued that: flexibility needed to assure that injured HCP qualifications and scope of practice Since the employer is required to follow employees receive ‘‘prompt and are properly addressed by State law and the HCP’s advice, the employer must be able effective’’ MSD management. Specialists professional organizations. The states to trust the diagnosis. However, not all and occupational physicians are not have been regulating medical practice healthcare providers are qualified by training always readily available, and the rule for quite some time, and appear to be or experience to evaluate, treat and provide allows the employer to consult health doing so effectively, so there is no restrictions for musculoskeletal disorders. If care professionals with these reason to interfere with the licensing the employee is permitted to select the qualifications when needed, but does procedures the states have healthcare provider, as they are allowed by some states’ workers’ compensation laws, not require the employer to seek them implemented. Relying on the state they may not select the provider that will out for each and every case. In some requirements will assure that have the time or experience to work with the rural locations, access to specialized unqualified or inappropriate individuals company in determining appropriate HCP’s may be limited, and even in more do not provide medical services beyond restrictions (Ex. 30–3284). urban settings, it may take significant their training and qualifications, and the Another group of commenters time to get an appointment for an state licensing boards can continue to recommended the opposite, that the employee to see a specialist. If the handle cases where improper treatment employee should be allowed to select employee can see a physician in general is provided or improper actions are the physician (see, e.g. Exs. 30–3033, practice promptly, this may be the better taken. 30–3034, 30–3035, 30–3258, 30–3259, The final standard does not contain option. Likewise, if an employer has an 30–4159, 30–4536, 30–4547, 30–4549, diagnostic or treatment protocols. OSHA occupational health nurse, the nurse can 30–4562, 30–4627, 30–4776, 30–4800, believes this is an area for the health provide services immediately and avoid 31–242). A form letter submitted by a care professions to recommend. Also, delay. number of individual employees made because standards of care change over Each MSD case also requires its own several arguments, including ‘‘[t]he HCP time, it is the responsibility of the level of occupational health services. In must be one of the employee’s choosing, treating health care professional to some cases, a registered nurse or not the employer’s (or insurance select treatments in accordance with physician’s assistant may be able to company’s) choosing. Otherwise, a current acceptable standards of practice. recommend restrictions and biased opinion may result, and the NIOSH supports OSHA’s ‘‘[d]ecision not conservative treatment and resolve the employee’s condition can easily to include particular diagnostic tests, problem. In other cases, the services of worsen’’; that general practitioners ‘‘are treatment protocols, and clinical case a physician or a medical specialist may often the HCPs that are chosen by the definitions in the MSD management be needed to treat the employee. The employer or insurance company to section, or anywhere else in the final rule does not restrict the diagnose work-related injuries under the ergonomic standard. Standards of care employer’s option to obtain more Workers’ comp system. It is common to change over time, evolving with new specialized services, and it is a common underestimate the seriousness and long research, technological innovations, and practice for HCPs to refer cases needing term consequences of MSD injuries, and new therapies. To allow workers to be more specialized care to more qualified consequently, not enough temporary provided with current, state-of-the-art HCPs. OSHA sees no reason why this work restrictions are recommended’’; clinical care, OSHA is correct to leave system will not continue to function as and ‘‘HCPs chosen by someone other diagnostic and therapeutic decisions to well as it has in the past. than the employee may be biased in HCPs and their professional The HCP definition is consistent with favor of the employer or insurance organizations’’ [Ex. 32–450–1]. many of OSHA’s health standards. In its company in order to obtain future most recent health standards (e.g., Who Selects the Health Care referrals’’ (Ex. 30–3332). respiratory protection, methylene Professional The comments from both employers chloride, proposed tuberculosis rule) Some commenters raised the question and employees show a large measure of the Agency has relied on a broad of whether the employer or the distrust for health care professionals definition of HCP, to allow HCPs to employee get to choose the health care selected by either. It is for this reason carry out any of the regulatory professional providing services. The that the final rule includes provisions requirements specified in a given American Apparel Manufacturing for multiple HCP review. It is OSHA’s standard, provided that the medical Association remarked view that, when the employer provides function performed is within their scope access to an HCP under the final rule, of practice, licensure, or certification. OSHA has also failed to address the issue the employer has the right to select the OSHA has not noted any significant of choosing doctors. In some states, patients HCP. However, the employee has a right problems with the definition in have the right to choose their own physicians. In other states, employers choose to a second opinion if he or she employers implementation of these the doctors. Does the employer choose the disagrees with the employer selected standards, the definition appears to be HCP under the proposed federal rule, or HCP, under the provisions of paragraph working as intended, and OSHA’s broad could employees choose a doctor who will (s). A more detailed discussion of HCP definition of HCP published in the diagnose an MSD without real cause and selection is contained in the discussion respiratory protection standard has been expose companies to possible fraudulent of multiple HCP review. upheld in the courts (American Iron and actions? Does the proposed law supercede Steel Institute v. OSHA, 182 F.3d 1261 state laws in those states where the patient ‘‘Prompt’’ MSD Management (11th Cir. 1999)). In addition, may choose? (Ex. 30–4470) The proposal would have required consistency from standard to standard is Several commenters recommended employers to respond promptly to the a desirable feature that makes it easier that OSHA specify in the standard that reports of employees with MSDs, and for employers and workers to the employer has the right to choose the the final rule includes similar language. understand and follow the standards. physician (see, e.g. Exs. 30–3188, 30– Whenever an employee reports an MSD,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00117 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68378 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations the key is to take action quickly to help HCP, and set an appointment for the related MSD incidents. These wages ensure that the MSD does not worsen. employee to see an HCP. would not include production bonuses Many commenters agreed that early In some workplaces, an occupational or other premium payments, but for reporting and prompt response were the health nurse is available to take reports workers who are paid on a piecemeal key to resolving MSD problems quickly of MSDs, and in this case MSD basis, the employer must assure that the and without permanent damage or management begins immediately, so employee would not lose pay by visiting disability [Exs. 30–4468, 32–78–1, 32– promptness is not an issue. In most an HCP. This can easily be 85–3, Tr., p 10516). For example, the cases, however, employers will not have accomplished by paying the worker the American College of Occupational and an on-site HCP, since smaller average piecemeal rate he or she had Environmental Medicine (ACOEM) workplaces make up the overwhelming been earning. remarked that ‘‘[e]mployers should majority of all workplaces. In such OSHA recognizes that MSD ensure that injured employees are cases, OSHA is aware that it may take management imposes costs on provided with ‘prompt access to health a few days to arrange an appointment employers, and these costs are reflected care professionals or other safety and with an HCP. There are circumstances, in the economic analyses for the final health professionals as appropriate.’ The however, where immediate evaluation rule. However, if employees were made early reporting and intervention process by an HCP is warranted. For example, to absorb the costs of MSD management, is important to the effectiveness of a an employee experiencing severe they would be less likely to report MSDs medical management program’’ (Ex. 30– shoulder pain with numbness down her to their employer, which would have a 4468). Other commenters argued that arm, an inability to sleep due to pain, detrimental effect on the overall the first response to any report of MSD and decreased range of motion of the functioning of the rule. arm and shoulder should immediately should be evaluation by a health care Follow-up professional (Exs. 30–651, 30–3826, 30– be referred to an HCP. 3686, 30–2387, 30–3748, 30–4468, 32– Prompt MSD management helps limit The final rule, as did the proposal, 339–1, 32–111–4, 32–182–1, 30–4538, further exposure to the MSD hazard or requires that the employee receive 32–210–2, 32–461–1, 32–85–3, 32–210– hazards associated with the employee’s appropriate follow-up during the 2, 32–450–1). job helps to ensure that the employee’s recovery period. Follow-up is defined as Some commenters stated that condition does not worsen while the the process or protocol the employer, ‘‘promptly’’ was vague and ill defined, employer analyzes the problem job and safety and health professional, or HCP questioning what the term ‘‘promptly’’ makes workplace changes to correct the uses to check up on the condition of meant in the provision directing hazard. employees with covered MSDs when employers to respond to employee they are given temporary work Providing MSD Management at no Cost restrictions or removed from work to reports (see, e.g. Exs. 30–115, 30–2208, to Employees 30–33336, 30–3354, 30–3845, 30–3848, recover. 30–4540). Bruce Cunha RN MS COHN- Both the proposed rule and the final OSHA received very little comment S (Ex. 31–303) stated that ‘‘Five days rule require the employer to provide specific to follow-up. The Southern should be adequate time to start the MSD management at ‘‘no cost to California Edison company stated that management process. If it is enough employees.’’ The requirement to provide the proposed rule: time to arrange a visit with a health care MSD management at no cost drew little [p]laces the responsibility on the employer professional is questionable. Since comment. Some commenters supported to ensure that the employee goes to the HCP OSHA allows the employer to choose the no cost clause (see, e.g., Exs 30– initially and as required thereafter. This the health care provider, it should be 4536, 30–4547, 30–4549, 30–4562, 32– assumes a cooperative employee. The final expected that it may take longer than 5 78–1). Vicorp Restaurants asked OSHA standard should make clear that an employer days to get an appointment.’’ if the employer is required to pay even could not be cited because an employee The final rule requires the employer if the report is ultimately determined to refuses to see the HCP (Ex. 30–3284). to provide ‘‘prompt’’ MSD management. be frivolous, exaggerated, or fraudulent OSHA has included the requirement The term ‘‘prompt,’’ as used in this (Ex. 30–3200). Other commenters for follow-up in the final rule. Follow- paragraph, means as soon as possible or argued that the cost for medical up of injured employees is essential to within a reasonable period of time, assessment of illnesses is too high (see, ensure that MSDs are resolving. Follow- consistent with the apparent severity of e.g., 30–1026, 30–1302, 30–0295, 30– up generally means additional visits to the MSD or with other conditions (e.g., 1362, 30–0070, 30–0262, 30–0586, 30– the HCP to see if the employee is getting accessibility of medical care). OSHA 0280, 30–3760). A few commenters better or is getting worse. This process believes, as the proposal discussed, that suggested that OSHA clarify that ‘‘at no helps to ensure that injured employees employers will almost always be able to cost’’ doesn’t include loss from do not ‘‘slip through the cracks,’’ for provide MSD management within a one production based pay and bonuses (Ex example, by being left in alternative to five day window (64 FR 65840). 30–3354, 30–3848, 30–4530, 30–4799). duty jobs long after they have recovered, Action within this interval will As OSHA explained in the preamble or by being given work restrictions but generally prevent the employee’s (64 FR 65841) the term ‘‘at no cost to failing to follow up to see whether the condition from becoming more severe. employees’’ includes making MSD restrictions helped. If follow-up is not In the final rule, OSHA has provided management available at a reasonable provided, neither the employer nor the clear guidance that prompt is one week. time and place for employees (i.e. HCP will know whether an employee’s Paragraph (x), Table 2. Compliance during working hours) and that the term MSD symptoms are abating or becoming Time Frames states that MSD no cost is interpreted in the same way worse. Where follow-up is not provided management must be initiated within 7 as OSHA’s other health standards. If an or the healing process is not properly calendar days after the employer employee’s MSD report is found to be monitored, injured employees may determines that a job where an fraudulent, then the employer is not never be able to return to their jobs. employee experiences an MSD incident required to pay for MSD management. A The employer need not be fearful of meets the action trigger. OSHA finds fraudulent claim would be one that is citation if the only reason follow-up is that one week is more than enough time found to be non-work-related, and MSD not completed is because the employee to initiate MSD management, select an management is only required for work- refuses to see an HCP. The employer is

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00118 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68379 required to provide access to an HCP, appraisal of the effectiveness of modified having the HCP make the choice of work but is not required to force an employee work programs (Krause 1998). This restrictions. who does not wish to see the HCP to do comprehensive review found that modified EEI recommends that § 1910.931(b) be so. work programs facilitate return to work for deleted. Additionally, the phrase ‘‘temporary temporarily and permanently disable work restrictions’’ should be replaced with Medical Treatment workers. Employees with access to modified ‘‘physical limitations’’ in § 1910.932(b). This would then require only that the HCP During the course of reviewing the work return to work after a disabling injury about twice as often as employees without provide a written recommendation of comments to the proposed ergonomics access to any form of modified duty . . . The physical limitations. Additionally, the standard, OSHA has noticed that some findings from these studies conclusively wording of § 1910.933(a) should be changed commenters believed that the proposed show that early intervention and case to reflect that the employer must take the rule would require the employer to management, including modified/restricted HCP’s physical limitations information and provide medical treatment as part of its duty, will help prevent prolonged disability select the proper temporary work restriction MSD management provisions (see, e.g., (Ex. 37–12). that best addresses the limitations (Ex.32– 300–1). Exs 30–564, 30–1251, 30–2425, 31–353). However, some commenters argued Roy Gibson (Ex. 30–2526) remarked that against restrictions and recommended The Organization Resource Counselors ‘‘Once employees are aware that deleting the work restriction and work suggested that there may be medical treatment is an option open to restriction protection provisions from circumstances where the HCP makes them, they will request treatment.’’ the final rule (see, e.g., Exs. 30–1294, errors and recommends inappropriate Allfirst Bank (Ex. 30–1251) asked ‘‘How 30–3765, 30–3813, 30–3956, 30–3845, restrictions, suggesting OSHA add the can we assure ‘effective’ treatment?’’ 32–300–1). For example, the Edison phrase ‘‘[e]xcept when you determine OSHA wants to make it clear that the Electric Institute argued that providing those recommendations to be clearly erroneous based on review of the final rule does not require the employer work restrictions to provide medical treatment to injured written opinion by a physician or other employees. While specific medical [m]ay conflict with existing collective HCP with specific training and treatment may be appropriate, such as bargaining agreements and current or future experience in diagnosing and managing company philosophies on accommodating MSDs’’ (Ex. 30–3813). medicines, physical therapy, employees on restricted duty when there is chiropractic care, or even surgery, the no work available which they can perform The United Mine Workers of America final rule does not require the employer under the indicated restrictions. This is (UMWA) commented that complete to provide such services. The rule especially true given the current climate of removal from the workplace ‘‘is an requires the employer to provide access mergers, divestitures and competition in the unacceptable response to the problem’’ to an HCP, provide needed restrictions, electric utility industry (Ex. 32–300–1). and that by including this in the provide information to HCP’s and Other commenters asked what an definition of work restriction OSHA employees, and provide WRP, but the employer is to do if there is no ‘‘[h]as tacitly authorized the termination standard does not address the medical alternative work at the establishment of employees who suffer from MSDs.’’ treatment afforded employees. (Exs. 30–2208, 30–3826) or no The UMA goes on to recommend that all Therefore, if an injured employee needs productive work (Ex. 30–240) available such language be deleted from the medical treatment, the employer is not for the employee with the MSD. The standard (Ex. 500–71–86). required to pay for them. Department of Defense stated that it may However, under the final rule, the employer must provide restrictions Temporary Work Restrictions not be possible to provide work within an employee’s work restrictions at some deemed to be necessary by either the The final rule, like the proposal, federal agencies (Ex. 30–3826). employer or the health care requires the employer to provide A number of commenters stated that professional. Both the employer and the temporary work restrictions, where it was inappropriate for an employer to employee whose work has been necessary, to employees with MSDs. determine if an employee needs work restricted need to understand (1) what Work restrictions include any limitation restrictions before the employee is seen jobs or tasks the employee can perform placed on the manner in which an by a HCP (see, e.g., Exs. 30–3033, 30– during the recovery period, (2) whether injured employee performs a job during 3034, 30–3035, 30–3185, 30–3188, 30– the employee is permitted to perform the recovery period, up to and including 3258, 30–3259, 30–3284, 30–3765, 30– these jobs or tasks for the entire complete removal from work. 4046, 30–4159, 30–4536, 30–4547, 30– workshift, and/or (3) whether the Many commenters supported the 4549, 30–4562, 30–4607, 30–4647, 30– employee needs to be removed from requirement of providing temporary 4713, 30–4776, 30–4800, 32–300–1, work entirely in order to recuperate. work restrictions, when necessary (see, 500–163). For example, IBP Inc. argued Employees for whom restrictions have e.g., Exs. 30–3686, 30–3813, 32–339–1, that ‘‘[a]s a rule, [they] are unable to been assigned must be properly 32–111–4, 32–185–3–1, 32–182–1, 30– determine an appropriate work matched with those jobs that involve 4538, 31–353, 32–461–1, 32–198–4, 32– restriction until the medical evaluation work activities that will accommodate 450–1, 37–12). NIOSH described the is completed. As a result, it is the requirements of the restriction and role of work restrictions as the first line impossible to advise the HCP of thus facilitate healing of the injured of defense in addressing MSDs (Ex. 32– available work restrictions’’ (Ex. 30– tissue. If an HCP recommends restricted 450–1) and that ‘‘[c]ompanies should be 4046). The Edison Electric Institute work, employers must follow such able to continue the practice of placing (EEI) argued that: symptomatic workers in temporary restrictions. Thus, in those instances positions until a prompt evaluation by An HCP is better qualified to make an where the employer refers the employee an HCP can be performed * * * ’’ (Ex. initial determination of an employee’s to an HCP, the employer has to follow physical limitations (i.e., lift no more than 10 the temporary work restriction 32–450–1). Dr. Robert Harrison stated pounds, do not stand for more than 4 hours, that: etc.). The employer then is best qualified to recommendations, if any, included in Data from several studies suggest that job determine appropriate work restrictions the HCP’s opinion. If the employer modification is significantly associated with taking into account the physical limitations receives a restricted work improvement in clinical outcome. These described by the HCP. OSHA provides no recommendation they believe to be studies have been summarized in a critical valid reason to complicate the process by inappropriate, the employer may refer

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00119 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68380 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations the employee to an HCP with study (Ex. 600–) suggests that removal removal from the workplace’’ simply specialized training for further from the workplace is assigned by HCPs denotes the provision of time evaluation, but until the employer in only about three percent of all MSD completely off of work (days away from receives a new recommendation for cases. Where appropriate, work work) to allow the employee to restrictions, the employer must follow restrictions that allow the employee to recuperate from the MSD. Of course, the recommendation of the first HCP. continue working (e.g., in an alternative some employees may become The provision of work restrictions to job, or by modifying certain tasks in the completely disabled and have to injured employees is a vital component employee’s job to enable the employee terminate employment. OSHA believes of MSD management. Work restrictions to remain in that job) are preferable that these cases are fairly infrequent, provide necessary time for the injured during the recovery period. These types and the ergonomics programs required tissues to recover. They are often of restrictions allow employees to by final rule should make them even considered one of the most effective remain within the work environment. more so. means of resolving MSDs, especially if Studies indicate that the longer restrictions are provided at the earliest employees are off work, the less likely Written Opinion From the HCP possible stage. If work restrictions are they are to return (Exs. 26–685, 26–919, The final rule, as did the proposal, not provided, it may not be possible for 26–923, 26–924). A case study of a requires the employer to obtain a the employee to recover, and permanent nursing home’s early return to work written opinion from the HCP and damage or disability may result. program ‘‘saved approximately $1 provide a copy to the employee. This For work restrictions to be effective, million in financial losses and improved paragraph also instructs the employer employers must ensure that they fit the injured workers’ morale’’ (Ex. 502–486). that he or she must inform the HCP that functional needs of the injured If employers provide the HCP with the written opinion is not to contain any employee. For example, work accurate and detailed information about medical information not related to restrictions are only effective if they the employees job and, at a minimum, workplace exposure to risk factors, and reduce or eliminate the employee’s informs the HCP that the employer is that the HCP may not communicate exposure to the workplace risk factors willing to accept the employer back into such information to the employer, that caused or contributed to the MSD, the workplace with job restrictions, it is except when authorized by state or or significantly aggravated a pre-existing more likely that the HCP will federal law. Paragraph (q) discussed MSD. To find the right fit, employers recommend restricted activity at work below, then instructs the employer as to may need to examine potential rather than complete removal. the specific items the written opinion alternative duty jobs to ensure that the Employers need to communicate with must contain. employee will still be able to rest the HCPs and supervisors to coordinate the This section of the proposal received affected area while performing the provision of work restrictions. very little comment. A few commenters temporary job. Identifying appropriate Under this provision, employers are supported the written opinion work restrictions may require the not required to provide the employee requirement (Ex. 30–3813, 30–3686). collaboration of different persons such with the alternative job or work The American Nurses Association as HCPs, safety and health personnel, restrictions simply because the supported the proposed requirement for persons involved in managing the employee requests them. Therefore, if a written opinion, remarking that ‘‘The ergonomics program, and the injured an HCP recommends that the employee PLHCP should inform the employee and employee. not perform lifting tasks or not engage the employer, in writing, of the results The final rule’s use of the term ‘‘work in repetitive motions during the of the evaluation, temporary work restrictions’’ includes both restrictions recovery period, the employer is free to restrictions and medical conditions that keep the employee at work, such as provide any form of work restriction resulting from exposure to ergonomic half-days or job modifications, as well that effectuates that work restriction hazards’’ (Ex. 30–3686). as full days away from work. This is in recommendation. For example, if the Other commenters objected to the contrast to OSHA’s recordkeeping rule, recommended work restriction requires requirement for an employer to obtain a which defines restricted work separately fewer repetitive motions, the employer written opinion (see, e.g., Exs. 30–1070, from days away from work. Several of can move the employee to an alternative 30–3231, 30–3336, 30–3347, 30–3392, the commenters failed to recognize this duty job as a way of achieving this 30–3765, 30–4185, 30–4470, 30–4496, important definitional aspect of the restriction. Or the employer might 31–353). Several commenters objected proposal. Because days away from work reduce the number of repetitions to the burden of obtaining a written are included, the employer is not expected to be performed in the opinion from the HCP (see, e.g., Exs. 30– required to invent restricted duty employee’s current job in a number of 3336, 30–4185, 30–4470, 30–4496). assignments that keep the employee at ways: by reducing the amount of time Tyson’s foods believed that the work. If the employer does not have the employee performs repetitive requirement would be particularly restricted work available, restricted motions, by reducing the speed at which onerous because work conflicts with collective the employee performs the tasks, or by bargaining agreements, or the employer eliminating certain repetitive tasks [t]he proposed MSD management simply wishes to do so, the employer during recovery. In the case of lifting provisions also contemplate separate opinions for each MSD case. Under OSHA’s may use days away from work to meet jobs, the work restriction can be as injury and illness recordkeeping the requirement to provide restricted simple as limiting the types or weights requirements, the identical condition may work. Of course, if the employee is sent of objects the employee must move or result in numerous OSHA recordable cases home, he or she must provide WRP lift. * * * requiring a separate written opinion benefits as required by paragraph (r) of The OSH Act prohibits employers for each case has the very real potential to the final rule. from terminating an employee for create a mountain of paperwork for the same Although some covered MSDs could reporting an MSD (or any injury or condition which may repeat itself throughout be at such an advanced stage that days illness). OSHA does not condone the the year. (Ex. 30–4185). away from work are the appropriate inappropriate termination of any Other commenters argued that the treatment, such removal is usually the employee for reporting an MSD (or any employer should not be required to tell recommendation of last resort. A recent other injury or illness). ‘‘Complete the HCP what to provide (see, e.g., Exs

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30–1070, 30–2350, 30–4470, 30–4674, resolve an MSD. These This paragraph also requires an 32–234–2) and believed that if the recommendations may include employer to ensure that the employee HCP’s opinion is incomplete, the temporary work restrictions or the work promptly receives a copy of the opinion employer should not be cited or the employee may do during the sent to the HCP. Several commenters otherwise be held accountable (see, e.g., recovery period as well as the follow-up opposed this provision (Exs. 30–3765, Exs 30–1070, 30–4470, 30–4674). The necessary to ensure that the MSD 30–4185, 30–4567), arguing that 29 CFR American Apparel Manufacturing resolves. It is important that the HCP’s Part 1910.1020 gives better access to Association asked ‘‘If the HCP’s written opinion be provided in writing to the medical info (Exs. 30–4185), that oral opinion fails to include all elements employer or the person(s) at the communication between HCP and stated in [proposed] § 1910.932, should workplace who are responsible for employee is adequate (Exs. 30–4185, the HCP or the employer choosing that carrying out the MSD management 30–4567), that the employer should not HCP be held responsible?’’ (Ex. 30– requirements of the standard. Employers be accountable for communications 4470). The Uniform and Textile Services need to know about the employee’s between the HCP and the employee, Association added ‘‘[e]mployers retain medical condition to ensure that the (Exs. 30–3765, 30–4567), and that the responsibility for the opinions restricted work activity they provide similar problems in the bloodborne content but not the control over it. satisfies the HCP’s recommendations, pathogens standard cause problems (Ex. Employers will have no choice but to and whether the employee requires time 30–4567). In a representative comment, pay whatever fees HCPs impose to away from work. The HCP’s written the American Ambulance Association prepare reports * * *’’ (Ex. 30–3336). opinion is especially important for the stated that: Other commenters stated that HCPs on-site person who is responsible for are reluctant to provide written A similar provision exists in the follow-up. That person needs to Bloodborne Pathogen standard and has been opinions, and that HCPs are too busy to understand the HCP’s plan for follow-up the cause for numerous violations by OSHA provide written documentation (see, to make sure that the plan is inspectors. This proposal will produce the e.g., Exs 30–2350, 30–3231, 32–234–2). implemented effectively. The same consequence. Note that during an On the other hand, Tyson’s Food information is also needed by the safety examination and treatment by a healthcare remarked that the written opinion is not and health personnel who will be professional, the employee and healthcare necessary because HCP’s already keep making workplace corrections. As the professional are present, while the employer written medical records and provide Organization Resource Counselors is not. It is appropriate to assume that the employees with access under the OSHA stated: healthcare provider communicates with the employee, just as healthcare professionals Standard 1910.1020 Access to medical OSHA seems to assume that an HCP will records (Ex. 30–4185). Tyson’s Food (Ex ordinarily communicate with patients. always be designated by the employer to take To interject the employer into the 30–4185) and Johnson & Johnson (Ex. a key role in finding and fixing MSD hazards. communications is ludicrous. To further 30–3347) provided identical comments In fact, in most cases, other professionals will require the physician to produce a written expressing concern about which HCP be designated by the employer to assume this document, that is not produced in the needs to provide an opinion, remarking role. Therefore, they must be provided with ordinary course of business, and to require that: meaningful information regarding the the employer to obtain that document and employee’s capacity to perform various tasks furnish it to the employee is a process fraught [f]or any given MSD complaint, there may (Ex. 30–3813). be a nurse, in-plant physician, physical with error. If OSHA’s intent is to assure that therapist, chiropractor, outside specialist As to the need to obtain a separate employees receive a written document from physician, and outside physician selected by HCP opinion for each recordable MSD, a healthcare provider, then OSHA should the employee, who are all involved in the the final rule does not use a recordable require the healthcare provider to produce treatment of a case * * * It is not clear who MSD as a trigger and the point is no the document and hand it to the employee ‘‘the’’ [emphasis in original] HCP is when longer valid. An HCP opinion is (Ex. 30–4567). there are multiple HCPs involved in a case. required only when an MSD incident It appears that these commenters did OSHA has carried forward the occurs that exceed the action trigger. not realize that the only requirement put provisions that require the employer to Likewise, it is not necessary for each upon the employer is to simply provide obtain a written report from the HCP and every HCP that is involved with the a copy of the written opinion the and provide a copy to the employee. A case to provide a written opinion. A employer receives to the employee. A written report is needed so it is clear to written opinion from the primary separate written report for the employee all parties what needs to be done to treating HCP is needed to provide the is not required. OSHA continues to resolve the employee’s MSD. This employer with the basic information believe that a copy of the written report opinion must be written because oral required by paragraph (q) of the final is essential if the employee is to communication is more susceptible of rule. If the initial is an occupational participate in his or her own protection. misinterpretation. Employers must keep health nurse, and the case is referred It is particularly important for the a record, and the easiest way to do this immediately to a physician, there is no employee to be knowledgeable about is if the opinion is in writing. OSHA need for the occupational health nurse what work restrictions, if any, he or she recognizes that the requirement adds to provide a written opinion, the has been assigned and for how long they burden to the final rule, but believes opinion of the physician will be will apply. Therefore, OSHA has that the need for the requirement adequate. Likewise, it makes no sense included the requirement in the final outweighs the minimal burden imposed. for a physical therapist or some other rule. OSHA does not find the argument that HCP who is strictly providing treatment Confidentiality for Non-Workplace HCP’s will be uncooperative or charge to provide a written opinion. However, Information excessive fees to be persuasive. The if the employer sends the employee to employer has the right to select the a specialist, a written opinion to the Paragraph (p)(5) requires employers to HCP, and if the HCP is uncooperative or employer would be useful to see if the instruct the HCP that any findings, charges excessive fees, the employer is more specialized knowledge of the diagnoses, or information unrelated to free to choose another HCP. specialist HCP changes the need for workplace exposure to risk factors must The written opinion must explain restrictions, results in a different not be included in the written opinion what actions the HCP recommends to diagnosis, etc. or communicated to the employer,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00121 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68382 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations except when authorized by state or OSHA explained the need for this seriously hamper the employer in federal law. The proposed rule kind of privacy protection in the making determinations required by this contained a similar provision. This proposed rule, as follows: final rule, and by the Recordkeeping requirement is intended to encourage The confidentiality provision is necessary rule in 29 C.F.R. Part 1904, about employees to disclose to the HCP all to ensure that employees will be willing to whether reported MSDs are work- information about their health, and their provide complete information about their related (see, e.g. Exs. 30–3004, 30–3061, activities both on and off the job, that medical condition and medical history. 30–3086, 30–3167, 30–3177, 30–3231, could have a bearing on the MSD. Employees will not divulge this type of 30–4334, 30–4564, 30–4674, 30–4713, Full disclosure by employees will personal information if they fear that 30–4843, 30–4844). Combe Inc. argued employers will see it or use it to the that: assist HCPs in evaluating the causal role employee’s disadvantage. For example, of occupational risk factors and in employees may fear that their employment The unreasonable restraints the Proposed determining the nature and duration of status could be jeopardized if employers Standard places on the employer’s ability to appropriate work restrictions. HCP’s know that they have certain kinds of medical obtain information to meaningfully evaluate need this information to recommend conditions, which may be completely the work-relatedness of an employee’s MSD work restrictions and follow-up that fit unrelated to work or exposure to MSD claim further creates an environment of the employee’s capabilities. This hazards, or if they are taking certain kinds of uncertainty and will force the employer into possibly unnecessary or deficient decision- information will also enable the HCP to medication (e.g., seizure medication, an anti depressant). In this sense, the ergonomics making. Section 1910.932(a) of the Proposed inform employees about activities, rule is * * * intended to be consistent with Standard expressly provides that the HCP including non-work activities, that the confidentiality requirements of the must be instructed ‘that any findings, could aggravate the MSD and delay or Americans with Disabilities Act. 64 Fed. Reg. diagnoses or information not related to prevent recovery. It is important for 65844. workplace exposure to MSD hazards must remain confidential and must not be put in employees to know about any changes OSHA recognizes that information they can make to their on-and-off the job the written opinion or communicated to the subject to protection under the final rule employer.’ Thus, if Combe were to receive a activities that will reduce their exposure may, in some circumstances, be single carpal tunnel syndrome complaint to MSD hazards so that they may disclosable under state or other federal from an employee on one of its assembly participate effectively in the recovery law. For example, many state laws lines * * * It would be barred from learning process. An example of an activity that authorize the disclosure of medical whether this employee has any of the non- sometimes must be postponed is a information to employers in connection occupational risk factors the scientific recreational activity that could place literature associates with the development of with workers’ compensation claims. The carpal tunnel syndrome * * * . Because the stress on the injured area of the body agency does not intend the final rule’s during the recovery period. Proposed Standard would prohibit Combe confidentiality requirement to conflict from learning this essential non-occupational Employees will be reluctant with state or federal law authorizing risk factor information or even from learning voluntarily to disclose information disclosure, and has included language if the HCP inquired about this critical data about their health or outside activities if to that effect in paragraph (p)(5). or evaluated it properly, Combe would be confidentiality is not maintained. MSDs The AFL–CIO supported the unable to determine if the new claim is, in may be associated with a variety of confidentiality requirement, noting that fact, the result of non-occupational factors or conditions, including hypertension, it is consistent with similar provisions a deficiency in its heretofore successful diabetes, kidney disorders and ergonomic interventions (Ex. 30–3004, pp. 5– in other OSHA standards and with 6). pregnancy, as well as the use of certain guidelines in the American College of prescription drugs. See Ex. 30–3004 at Occupational and Environmental In a similar vein, the Chamber of p. 5; Ex. 30–3167. However, many Medicine (ACOEM) Code of Ethical Commerce argued: employees would not want this health Conduct (Ex. 500–218, p.117). Other [T]he fact that employers cannot receive information revealed to their employers. comments were also supportive (See, any information related to non-work factors The privacy protection accorded e.g. Exs. 30–3686, 32–185–3–1). necessarily means that they will conclude medical records under state and federal However, a substantial number of that an employee complaint is work-related. After all, if employers are deprived of laws reflects general agreement that commenters were critical of the disclosure of information about a information about possible non work-related provision. These parties argued that causes, what is left for them to consider? person’s health status could result in prohibiting HCPs from disclosing Regardless of the real cause of the embarrassment, stigmatization and information about the contribution of muscluloskeletal complaint, in many cases discrimination in the workplace and non-occupational risk factors will make employers will be forced to conclude that the elsewhere. See Doe v. City of New York, it impossible for employers; (i) to injury is [work-related] because there will 15 F.3d 264, 267 (2d Cir. 1994) determine whether a reported MSD is be—and because there can be—no evidence (‘‘Extension of the right to work-related, (ii) to comply with the of exposures outside the workplace (Ex. 30– 1722, p. 78). confidentiality to personal medical final rule’s requirements to monitor the information recognizes that there are condition of an employee with a work These commenters correctly point out few matters that are quite so personal as restriction to determine whether the that employers must sometimes the status of one’s health, and few MSD is resolving, and to institute consider non-occupational factors, matters the dissemination of which one effective hazard control measures for the including pre-existing medical would prefer to maintain greater control problem job, and (iii) to evaluate a claim conditions, in deciding whether events over.’’) Similarly, information about for workers’ compensation benefits or exposures at work ‘‘caused or employees’ private off-the-job activities arising from the MSD. These arguments, contributed’’ to an MSD. See definition could be embarrassing and harmful if and OSHA’s responses, are discussed of the term Work-related in paragraph disclosed. Therefore, OSHA believes below. (z). However, they misunderstand the that it is important to preserve the MSD management provision in arguing confidentiality of personal information 1. Confidentiality and Work-Relatedness that the confidentiality requirement will revealed by employees to the HCP that Determinations deprive employers of information is not related to workplace exposure to A number of commenters argued that necessary to make work-relatedness MSD risk factors. the confidentiality requirement would determinations. The MSD Management

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00122 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68383 provisions in paragraph (p), including along the path of incremental abatement undermine employer’s efforts to control the confidentiality requirement, apply at great cost and disruption—are not MSD hazards. Under the proposed rule, when an employee has experienced an allowed to even contemplate the employers could have been required to MSD Incident in a job that meets the potential role of such individual institute control measures incrementally Action Trigger. ‘‘MSD Incident’’ is pursuits, activities or conditions’’ (Ex. when MSDs occurred in problem jobs. defined to include only work-related 30–3167). (See also Exs. 30–1722, 30– Commenters correctly pointed out that MSDs meeting certain criteria. See 3211, 30–3231, 32–337–1) if the success of ergonomic paragraph (z). Therefore, the employer OSHA acknowledges that the interventions is to be measured by the must decide that an MSD is work- confidentiality requirement is a occurrence of MSDs in problem jobs, related before it is required to compromise. At the same time, OSHA employer knowledge about non- implement the MSD Management believes that confidentiality is essential occupational factors associated with requirements in paragraph (p). to ensure employees’ willingness to those MSDs assumes greater Moreover, OSHA believes that it will disclose personal health and other significance. rarely be necessary to delve into private information to HCPs, who, in However, the final rule establishes employees’ private lives to make this many cases, make the initial different and more definite criteria for determination. In most cases, employers recommendation about work reducing MSD hazards. As explained in will be able to decide if work is a restrictions. In OSHA’s view, assuring the preamble discussion of paragraph contributing causal factor based on the that HCPs have access to information (k), the final rule sets out concrete steps type of injury and the nature of the necessary to fulfill their central role in that employers may take to reduce MSD employees’ work activities. The final the MSD Management process is of hazards to acceptable levels. When rule will facilitate this process because overriding importance. employers take these steps, the it includes a Basic Screening Tool that OSHA also believes that maintaining occurrence of an MSD in the job does allows employers to determine whether confidentiality in the personal not require further action as long as the risk factors are present in the job at information employees provide to HCPs controls are still in place and levels of concern. In these cases, will not seriously disadvantage functioning and no new hazards have confidentiality protection is necessary employers. The purpose of work arisen. OSHA believes that these to assure full disclosure to HCPs. restriction requirements is to ensure that changes, reflected in paragraph (k), the injured employee’s exposure to address the concerns raised about the 2. Confidentiality and the Employer’s workplace risk factors is reduced or effect of the confidentiality requirement Duty To Follow-Up on the Employee’s eliminated during the recovery period. on the employer’s hazard control Recovery and To Control MSD Hazards The employer must know of the specific obligation. For these reasons, OSHA Some parties argued that the activities or motions to be restricted and concludes that preserving the confidentiality requirement is what jobs, if any, satisfy these confidentiality of information unrelated fundamentally inconsistent with the restrictions. Once the employee has to occupational exposure to risk factors duty imposed on the employer to check been placed in a job that rests the is necessary to effectuate the purposes up on the progress of an employee with affected area, or is removed from work of the standard and will not work an a work restriction to see that the injury entirely to recover, the employer’s undue hardship on employers. is resolving, and to control the MSD compliance obligation is satisfied, even if the employee’s recovery is 3. Confidentiality and Workers’ hazards in problem jobs. The comment Compensation submitted by Layflat Products, Inc. is complicated by non-occupational representative: factors. Thus, the confidentiality Finally, some commenters argued that requirement should not hamper the the restrictions imposed upon HCPs’ OSHA cannot have it both ways. * * * employer’s ability to comply with MSD disclosure of information could Employers should not be forced to undertake workplace accommodations designed, at least Management requirements. preclude employers from evaluating in part, to enable the employee to continue It is true that employers have a workers’ compensation claims arising to work without aggravating an MSD, or to financial interest in ensuring that from MSDs (see, e.g., Ex. 30–4564, 31– provide an opportunity to recover, while at employees do not engage in non-work 324, 31–338). However, the final rule the same time effectively barring employers activities that could prolong the period makes clear that the confidentiality from having any effective means to prevent for which WRP benefits must be paid. requirement does not apply when an employee from continuing to engage in However, the final rule contains disclosure is authorized by state or conduct outside of work which the treating mechanisms to shield employers from federal law. Thus, in a case involving a HCP has concluded and advised the the costs of prolonged WRP. The rule employee will aggravate or prolong the MSD claim for workers’ compensation and, thereby, nullify the remedial efforts provides a procedure for HCPs to inform benefits, the HCP is subject to the which the proposed standard would mandate employees about medical conditions ordinary processes and procedures the employer to take. * * * The preamble to associated with exposures to risk established by the state for obtaining the proposed rule also at least suggests that factors, and any non-work activities that relevant information. Nothing in the the employee’s progress in recovery may could impede their recovery. This final rule is intended to conflict with, or have some bearing on the determination information, conveyed directly by the hamper the operation of, state workers whether a proper ‘‘job fix’’ has been HCP, will go far toward encouraging compensation systems. accomplished (Ex. 30–3061). employees to seek appropriate The NSBU voiced concern that treatment, and to refrain from Providing Information to the HCP ‘‘numerous [health] conditions make potentially harmful outside activities The final rule, like the proposed rule, contributions to musculoskeletal during recovery. The rule also reduces requires the employer to provide complaints. * * * In addition a vast the maximum duration of WRP benefits information about the job and number of outside activities engaged in from six months, as proposed, to ninety workplace conditions to the HCP by employees may contribute equally or calendar days. conducting the assessment. The much more substantially to such OSHA has also addressed the employer must provide the HCP with a complaints. Yet employers—who would concerns of some commenters that the description of the employee’s job and be required to march their workplaces confidentiality requirement could information about the MSD hazards in

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00123 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68384 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations the job and a copy of the ergonomics evaluating and managing the recovery of a summary of the standard, to the health standard. These requirements to provide the injured employee. Many care professional. The final rule simply information to the HCP are slightly stakeholders have told OSHA that they requires the employer to provide a copy different than the proposed rule. The already provide this type of information of the standard. Several commenters final rule does not carry forward the to the treating HCP in order to objected to the proposed requirements proposed requirements to provide a familiarize the provider with the (Exs. 30–3765, 30–4567), arguing that summary of the standard to the HCP, the employee’s job and associated they are not needed for diagnosis or requirement to provide workplace workplace risk factors and ultimately to treatment (Ex. 30–3765), are walkthroughs to the HCP, or the facilitate resolution of the MSD (Exs. burdensome (Ex. 30–4567). The requirement to provide a description of 26–23 through 26–26). American Ambulance Association asked available work restrictions. If the HCP is already on site, he or she what would suffice for a summary of the Many commenters supported the is likely to be familiar with the jobs in standard (Ex. 30–4567). A few proposed provisions pertaining to the the workplace, the MSD hazards commenters suggested that OSHA create information that must be provided to identified in the hazard determination a non-mandatory appendix containing the HCP about the workplace (see, e.g., of the employee’s job, and what jobs or the required summary of the Standard Exs. 30–710, 30–3826, 30–3686, 30– temporary alternative duty may be (Ex. 30–3284, 30–3686, 31–307). Several 4540), whereas others stated that some available. However, HCPs who are not commenters suggested deleting the or all of the provisions in this paragraph routinely on site generally do not have requirement for a summary (Ex. 30– should be deleted (see, e.g., Exs. 30– this workplace-specific information and 2216, 30–3813, 30–3922). For example, 3765, 30–3813, 32–300–1, 30–652). For employers must provide it in these the Organization Resource Counselors example, the Dow Chemical Company cases. It is essential that HCPs charged argued that ‘‘[t]he standard should be suggested that OSHA delete this entire with the responsibility for MSD sufficiently straightforward [so] that the section, because (1) developing job management know or be provided with HCP can understand it without needing descriptions would be burdensome, (2) this information if they are to a special ‘summary’ of the standard’’ gathering the information would create successfully manage the cases of the (Ex. 30–3813). The A.O. Smith a time delay in getting an employee to injured workers. Because employers Corporation suggested that, as an an HCP, and (3) this information would will have tested the injured employees alternative, OSHA could offer training not impact the quality of the care the job against the job hazard screen in to medical providers and certify them injured employee receives (Ex. 30– paragraph (f), the employer will already for this practice area (Ex. 30–2989). 3765). have some idea of the hazards in the OSHA has included the requirement Some commenters thought the employee’s job, and it should not be to provide a copy of the standard to the requirement to provide information to difficult to pass this information on to HCP in order to assure that HCPs know the HCP was redundant with other the HCP. how quickly employers must provide requirements in the proposal or other While some companies routinely keep employees with access to the HCP and existing OSHA regulations (see, e.g., detailed written job descriptions, other that employers must analyze any job in Exs. 30–3813). Others stated that companies (especially small firms) may which an MSD incident is reported. creating and providing this material not have detailed written job Further, the HCP needs to be informed places a burden on employers (see, e.g., descriptions immediately available. It is about the information they are to Exs. 30–2725, 30–4567, 30–4607). not vital that the employer provide the provide in the written report required HCP with an enormously detailed Information About the Employees Job by paragraph (q) of the final rule. OSHA description of the employee’s job. A and the MSD Hazards Within the Job has not included the proposed general description of the employee’s requirement to provide a summary of Both the final rule and the proposal job duties that contains enough detail to the standard to the HCP, finding that the require the employer to provide the HCP help the HCP perform an appropriate summary is a redundant requirement with a description of the employee’s job evaluation and develop an informed that is not needed, since the standard and information about the MSD hazards opinion of the case will suffice. itself is reasonably short and is easily in the job. This provision received very OSHA recognizes that this read. little specific comment. The only requirement places burdens on Descriptions of Available Restrictions specific objection, made by several employers. However, the Agency commenters, was that detailed job believes these burdens are more than The proposed rule would have descriptions are not available (see, e.g., outweighed by the benefits that accrue required employers to provide Exs. 30–2725, 30–3392, 30–3765). from providing the HCP with information on work restrictions that Paragraph (p)(3)(i) of the final rule information about the employees jobs were available during the recovery requires employers to provide a and the MSD hazards in that job. As a period and that were reasonably likely description of the employee’s job and recent journal article stated ‘‘To make to fit the employee’s capabilities during information about the hazards in it. This appropriate recommendations about the recovery period. OSHA believed that information is needed to assist HCPs in return to work, the health care provider providing this information to HCP providing both accurate assessment and should know the physical demand would help facilitate the appropriate effective management of MSDs. Without characteristics of the job the worker is matching of the employee’s physical such information the HCP may not be expected to perform’’ (Ex. 502–284). Of capabilities and limitations with a job able to make an accurate evaluation course, the costs associated with this that would allow an employee to about the causes of the MSD or may not requirement have been included in the adequately rest the injured area while be able to prescribe appropriate economic analyses for the final rule. still remaining productive in other restricted work activity. OSHA believes capacities. Employers with ergonomics that providing HCPs with information Copy of the Standard and a Summary programs have discovered that the more about the results of any job hazard of the Standard detailed information and analysis that has been done in that job The proposed rule would have communication provided to the HCP ensures that the HCP has the most required the employer to provide a copy about available alternative duty jobs, the complete and relevant information for of the ergonomics standard, as well as better the HCP understands the causes

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What Information Must that the HCP to see if available addition, it is more likely that HCPs are the HCP’s Opinion Contain? able to recommend much shorter alternative duty jobs would allow the removal periods when removal is employee to rest the injured area during Paragraph (q) describes the types of combined with restricted work activity the recovery period. OSHA did not information that should be included in as a means of facilitating recovery. intend to require employers to provide the HCP’s written opinion. This A number of commenters argued that HCPs walkthroughs throughout the information includes: (1) the HCP’s the employer cannot determine the need entire facility, and expected that assessment of the employee’s medical for restricted work, before an evaluation workplace walkthroughs could be either condition as related to MSD hazards in by a health care professional. (Exs. 30– informal or formal. Several commenters the employee’s job; (2) any 1091, 30–1671, 30–3033, 30–3034, 30– supported the HCP walkthrough recommended work restrictions, 3035, 30–3185, 30–3188, 30–3258, 30– provisions (see, e.g., Exs. 3–52, 3–107, including, if necessary, removal from 3259, 30–3284, 30–3392, 30–3765, 30– 30–4301, 31–242). The Washington work to allow for recovery, and any 3813, 30–4159, 30–4536, 30–4547, 30– Federation of State Employees Local follow-up needed; (3) a statement that 4549, 30–4562, 30–4607, 30–4647, 30– 1488—AFSCME also recommended that the HCP has informed the employee of 4713, 30–4776, 30–4800, 32–300–1) In a the employer should be required to pay the results of the evaluation, the process representative comment, the Southern for the HCP’s time and travel expenses to be followed to effect recovery, and California Edison company remarked for a walkthrough (Ex. 31–242). The any medical conditions associated with that: Dow Chemical Company said that it was exposures to risk factors; and (4) a not opposed to the proposed provision, statement that the HCP has informed the First, this calls for the employer to employee about work-related or other somehow anticipate the HCP’s diagnoses and and that DOW encourages HCPs to visit evaluation of physical limitations before the their worksites (Exs. 30–3765). Southern activities that could impede recovery employer has even seen the HCP. Second, an California Edison stated that they also from the injury. HCP is better qualified to make an initial did not object to the proposed These four elements to be addressed assessment of an employee’s physical requirement, but recommended that in the HCP’s opinion were included in limitations (i.e., lift no more than 10 pounds, OSHA specify that the employer is the proposal, and OSHA received no do not stand for more than 4 hours, etc.). The under no obligation to pay the HCP for significant comment requiring employer then is best qualified to determine the walkthrough (Ex. 30–3284). discussion in the final rule. OSHA notes appropriate work restrictions taking into A few commenters opposed the that ‘‘work restrictions’’ are defined in account the physical limitations described by paragraph (z) of the final rule as the HCP (Ex. 30–3284). proposed walkthrough rights requirement (Ex. 30–3348, 30–3749, 30– limitations on the employee’s exposure OSHA agrees with these commenters 4713, 30–5674). Freeborn and Peters to risk factors present in the job giving that, for at least some MSD incidents, it argued that the walkthrough rights are rise to the MSD incident, and may is difficult to provide information about not needed (Ex. 30–4713). The Society include limitations on work activities in appropriate restrictions to the HCP, and for Human Resources Management the current job, transfer to an alternative that the HCP is in a better position to stated that the proposed requirement: duty job, or complete removal from tell the employer what restrictions or work to permit recovery. OSHA [w]ould be particularly burdensome for physical restrictions must be smaller employers who rarely have the kind reiterates here the point made in the implemented while the employee is of a relationship with an HCP that such a proposal about the importance of recuperating from an MSD injury. walkthrough would be practical. If OSHA specific work restriction Therefore, this provision has not been chooses to maintain such a requirement, its recommendations. 64 Fed. Reg. 65,845. included in the final rule. However, the application should be limited to larger The HCP should describe in as much employer is required to implement any employers and only for those HCPs whom detail as possible the nature and restrictions he or she finds necessary, the employer expects to use regularly * * * duration of work restrictions so that (Ex. 30–3749). and OSHA believes that there are some employers will have maximum circumstances where the employer can The Puerto Rico Manufacturing flexibility to ensure that employees can implement restrictions before Association remarked that the proposed remain productive while resting the consultation with an HCP. The provision ‘‘[n]eeds to be narrowed, affected area. employer will also benefit from good because it is disruptive to many communications with the HCP about operations * * * ’’ and asked ‘‘[w]hat if Paragraph (r) What Must I do if what types of restricted work may be every employee with a sign or symptom Temporary Work Restrictions or available, and should try to work wanted his own HCP to assess his job?’’ Removal From Work are Needed? cooperatively with the HCP to (Ex. 30–3348). Paragraph (r) describes the actions determine appropriate work. OSHA has decided not to include an required when an MSD incident has HCP walkthrough right in the final rule. occurred in a job with risk factors that Walkthrough Rights for the Health Care While HCP walkthroughs have exceed the action level, and the Professional significant advantages in helping the employer or HCP determines that The proposed rule included a HCP determine appropriate restrictions temporary work restrictions or removal provision that would have required the for injured workers, they are not from work are needed. employer to allow the health care absolutely necessary and could result in Paragraph (r)(1) first makes clear that professional to visit the establishment added burden to employers. As OSHA the employer must either determine the and walk through the establishment if acknowledged in the proposal, there are work restriction or removal himself or the HCP wished to do so (64 FR 66073). other ways HCPs can acquire more in- herself, or comply with the OSHA’s intent was to provide HCPs depth information about the employee’s recommendations of an HCP, either by

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See also Testimony of Dr. percentage of workers with back, upper Paragraphs (r) (2) and (3) require the Evanoff (Tr. 1530–31; 1628); Dr. Herbert extremity and other MSDs file claims for employer to maintain the injured (Tr. 1698–99); Dr. Connell (Tr. 2833); benefits (see e.g., Ex. 37–14, p. 9 [Emily employee’s wages and benefits when Dr. McCunney (Tr. 7649–50); Dr. Spieler, citing, e.g., Morse 2000]; Ex. work restrictions are necessary. Bernacki (Tr. 7687); Dr. Piligian (Tr. 500–203 [Dr. Michael Erdil, citing, e.g., 7883–5); Dr. Frank (Tr. 1388); Dr. Rosenman 2000]; Ex. 32–339–1, Ex. Work Restriction Protection (WRP) Cherniak (Tr. 1234–5). Early detection 500–218; Tr. 2399–2301 [Dr. Boden]). A. Necessity for WRP and intervention also reduces the Physicians and researchers testified ‘‘Work restriction protection’’ or severity of MSDs and the level of that the findings in the literature were ‘‘WRP’’ refers to the requirements in treatment required to address them (see consistent with their experiences (Tr. paragraphs (r)(2) and (3) for maintaining e.g., Exs. 3–23; 3–33; 3–50; 3–56; 3–59; 839–40 [Dr. Armstrong]; Tr. 1021 [Dr. 3–121; 3–124; 3–151; 3–162; 3–179; 3– an injured employee’s employment Punnett]; Tr. 1115 [Dr. Erdil]; Tr. 1886– 184) and reduces the number of days rights, wages and benefits when 87 [Dr. Owen]; Tr. 2399–2401 [Dr. employees must spend on restricted temporary work restrictions are Boden]). Dr. Michael Erdil stated that duty or away from work entirely (see necessary. As explained in the proposed ‘‘my clinical experience as an Ranney 1993, Ex. 26–913; Day 1987, Ex. rule, 64 FR 65848–65852, and in the occupational physician treating 26–914; Oxenburgh 1984, Ex. 26–1367). discussion below, WRP requirements thousands of patients with MSDs is Consequently, the early reporting of are designed to encourage employees to consistent with these studies’ finding MSDs substantially reduces both the report MSDs and their signs and that employees often do not report physical and economic toll of these symptoms as early as possible, and to MSDs they believe to be caused by disorders. work.’’ Tr. 1115. Emily Spieler, an participate actively in MSD The participants in the rulemaking author and lecturer on workers’ management. Early reporting of MSDs had conflicting views on whether, and compensation issues, and a former by employees will contribute to the to what extent, WRP is needed to ensure Commissioner of the West Virginia success of the final rule in several early reporting of MSDs. After a careful Workers’ Compensation Fund, wrote important ways. First, unlike other review of the literature, testimony and that OSHA standards, the rule does not comments on this issue, OSHA finds require employers to monitor their persuasive evidence that, without WRP, [t]he findings regarding under-filing are workplaces for hazards, but rather to employees will be reluctant to report consistent with my own observations evaluate employee reports of MSD signs MSDs and their signs and symptoms at regarding workers’ claims filing behaviors. or symptoms to determine whether an early stage. In the preamble to the Many workers with compensable injuries do further action is necessary. Employee not file claims for benefits. Both my own proposed rule, OSHA discussed a experience and current literature suggest that reports must be evaluated to determine variety of studies in the scientific whether an MSD incident has occurred under filing far exceeds overreporting in literature indicating that MSDs are workers compensation systems. There are in a job with risk factors exceeding the underreported in federal and state serious implications regarding the prevention standard’s action level. If the job has occupational injury and illness and compensation of MSDs that flow from risk factors that exceed the action level, statistics. These studies show that a this. the employer must implement several substantial percentage of work-related Ex. 37–14, p. 10. elements of an ergonomics program, MSDs are not recorded on the OSHA log including job hazard analysis, and must of occupational injuries and illnesses, Workers have given a variety of provide necessary work restrictions and are therefore excluded from the reasons for not reporting MSDs to their (including work removal, if necessary) Bureau of Labor Statistics (BLS) data employers or failing to seek workers’ and MSD management. (see e.g., Exs. 26–28; 26–1258; 26–920; compensation benefits for these This approach depends upon 26–922; 26–1259; 26–1261; 26–1260). disorders (see 64 FR 65849–50; 65980– employees’ willingness voluntarily to They also demonstrate that large 81). Many workers expressed the fear report when they first experience signs numbers of workers with medically that if they report a work-related injury, or symptoms at work. As the agency confirmed MSDs do not file claims for they will lose their job or be transferred noted in the proposed rule, ‘‘[i]f workers’ compensation benefits (see to an alternative job at reduced pay and employees are not willing to come e.g., Exs. 26–1258; 26–1212; 26–920). benefits, or suffer other forms of job forward and report MSDs, serious MSD See also 64 FR 65851–52; 65980–83 and discrimination (see Exs. 3–121; 3–151; hazards in that job will go uncontrolled, Table VII–2. Based on this and other 3–183; 3–184; 3–186). Employees voiced thus potentially placing every employee evidence, OSHA preliminarily these concerns repeatedly during the in that job at increased risk of harm.’’ 64 estimated that at least half of all work- hearing (see Tr. 3602 [Corey FR 65861. Early reporting permits related MSDs are not reflected in the Thompson]; Tr. 5820 [Dave employers to identify problem jobs and BLS statistics. 64 FR 65981. [S]aksewski]; Tr. 5832 [Scott Bean]; Tr. institute corrective measures before Researchers, physicians, and workers 6022 [Dennis Norton]; Tr. 5901–02 other employees in those jobs become themselves supported OSHA’s finding [Victor Henderson]; Tr. 7733–34 [Sandy injured. Thus, timely reporting by that MSDs are underreported at the Brooks]; Tr. 7736–37 [Jeanette Di employees is central to the final rule’s federal and state levels. NIOSH agreed Florio]; Tr. 7545–46 [Penny Siedner]; hazard identification and control that there is a substantial likelihood that Tr. 7998 [Al Close]; Tr. 8013 [Bob mechanisms. the actual number of MSDs exceeds the Zielonka]; Tr. 9561 [Robert Wabol]; Tr. Early reporting is also crucial in BLS estimates, and that this is due in 10,720–21 [Richard Sorokas]; Tr. 12,530 maximizing the standard’s benefits for part to underreporting of the true [Buzz Vsetecka]). Dave [S]aksewski injured employees and in minimizing number of work-related health problems recounted his experience at an costs to employers and employees. The on the OSHA 200 logs (Ex. 32–450–1). automobile assembly plant:

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As I was new in the facility, I received commented on the evidence that lead- Third, payment in apparently compensable many less than desirable jobs. On many of exposed workers would be reluctant to claims for MSDs, and in particular for the assembly jobs my hands or arms ached participate in medical surveillance repetitive stress-related MSDs, may not be at the end of the shift or my back was so sore paid due to controversion, or may be from lifting that I could not do the things on program, as follows: delayed, or may be settled for compensation weekends that I would have enjoyed doing Much of the evidence in the lead below the statutory amounts. and I had normally done in the past. Things proceeding documents the extent to which The result is twofold. First, workers may be like fishing or playing ball went on the back worker participation is adversely affected by discouraged from filing workers’ burner until I felt like I could do them the fear that adverse employment compensation claims or from otherwise without further hurting myself. consequences will result from participation alerting their employers to developing MSDs. I never reported any of these problems to in medical surveillance programs. This Second, workers compensation fails to the medical department because as a problem was emphasized by the testimony of provide employers with adequate incentives probationary employee you just did not many workers and worker representatives. for the prevention of disabling MSDs. complain about anything, even if I was a * * * Evidence concerning the issue of union member. * * * The end result of a worker fear impeding participation, however, Ex. 37–14, p. 10. This evidence complaint from me would have been no was not confined simply to testimony from demonstrates that the potential overtime, maybe a job restriction, or a worker representatives. A wide variety of availability of workers’ compensation disputed compensation claim that I had experts verified the existence of this problem, benefits alone is insufficient to ensure injured myself at home working in the as did several industry representatives. The full and timely reporting of MSDs and garden. evidence suggests that economic their signs and symptoms, and further I can tell you from personal experience that disincentives to worker participation are underscores the need for a requirement people do not report MSDs until they get bad currently a problem in the lead industry. protecting employees’ wages and enough where they can no longer tolerate the 43 FR 54442. job. benefits during periods when work OSHA believes that the two patterns restrictions are necessary. Tr. 5822–23. Autoworker Al Close of employee behavior discussed above— In contrast, OSHA was not convinced agreed, stating ‘‘employees are still the failure to report work related MSDs by those commenters who argued that reluctant to report early symptoms of to employers, and the failure to claim the record does not demonstrate the injury. This is due to intimidation by workers’ compensation benefits for need for WRP. The evidence and middle management and by the fact that these disorders—underscore the need argument presented by these they will get work restrictions or be sent for WRP in the final rule. OSHA’s commenters was not as concrete or home with the loss of pay.’’ Tr. 7998. recordkeeping regulations in Part 1904 specific. They maintained principally Employee representatives from a broad already require employers to inform that: (i) OSHA’s own audits conducted spectrum of industries echoed these employees of the need to report injuries in 1996 and 1997, and statements made sentiments (see e.g., Ex. 32–182–1 and illnesses promptly, and to have a by some OSHA officials and experts, [AFSCME]; Ex. 32–185–3 [UAW]; Exs. clear procedure for reporting. Moreover, demonstrate that employer logs are 32–339–1; 500–218 [AFL–CIO]; 32–198– section 11(c) of the OSH Act protects accurate; (ii) there is no need for WRP 4 [UNITE]). employees who report their injuries because most MSDs require little or no Employers, physicians, and others from acts of discrimination or retaliation time away from work; and (iii) OSHA acknowledged that concerns about by employers. In view of the evidence itself concluded that WRP will not economic loss and retaliation that these provisions do not eliminate rectify underreporting. These arguments influenced employees’ decisions not to underreporting on the OSHA logs, it is are discussed below. report their MSDs or to seek treatment unreasonable to believe that similar In 1998 and 1999, OSHA performed or compensation for them. Peter Meyer, requirements and protections in the audits of employers’ injury and illness Human Resource Director for Sequins final rule, standing alone, will be records. The 1998 audit examined a International testified: sufficient. Indeed, without wage sample group of employers’ 1996 It is true that workers in most situations protection, the standard’s MSD records, while the 1999 audit examined don’t report pain and work-related injuries, management provisions, including records for 1997 (see Ex. 500–168, especially when they are concerned about mandatory work restrictions or work Appendices A and B). A number of their jobs. They are continually concerned removal when recommended by an commenters argued that the results of about the hours that they are going to work HCP, will likely increase the pressure these audits undermined OSHA’s so it makes sense that workers wouldn’t report something that they might think on employees not to inform their finding of widespread underreporting of jeopardizes their jobs. employers of work-related MSDs, and MSDs on employers’ logs (see e.g., Exs. thereby exacerbate an already serious 500–168; 30–3347; 32–78–1; Ex. 30– Tr. 17350. Dr. George Piligian testified problem. 1722; Ex. 30–3956). The AISI’s comment that the most common reason given by The evidence on employees’ is representative: employees for delaying treatment for dissatisfaction with workers’ OSHA went to extensive lengths to perform MSDs was the fear of losing income. He compensation benefits, and avoidance stated, ‘‘[t]his was the biggest obstacle, a statistically significant audit of the of workers’ compensation systems, is accuracy of OSHA 200 recordkeeping. The especially in those that were not high- also relevant. There was substantial results of the official OSHA audits of OSHA paying sectors of the work force. testimony that employees view the 200 logs for 1996 and 1997 are compelling. Therefore, wage replacement, especially workers’ compensation system as OSHA found that, at the 95% threshold of when you first have symptoms, is vital. ineffective and cumbersome to use (see accuracy, the percentage of establishments People will not come forth.’’ (Tr. 7822– e.g., Ex. 500–218 ). Emily Spieler with accurate records [for total recordable cases (TR) and for lost workday cases (LW)] 3). See also Tr. 1115 (Dr. Erdil); Tr. 1724 summarized these problems as follows: (Dr. Robin Herbert). was [for 1996, 87.96% TR and 86.57% LW; This evidence demonstrating that There are several tiers of problems with the for 1997, 91.93% TR and 89.69% LW] * * *. economic concerns are a powerful adequacy of compensation, for both Based on * * * review of the studies cited compensatory and deterrent effects. First, by OSHA [in the proposal], it is clear that motivating factor in workers’ behavior many people do not file claims that, if filed, they do not support OSHA’s allegation of a affecting their health is consistent with might be compensable. Second, in some substantial and widespread underreporting of that adduced in previous OSHA states, many claims involving work-related occupational injuries and illnesses. Rather rulemakings. For example, OSHA MSDs may not be compensable, even if filed. than looking back to limited reviews of

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‘‘ancient history,’’ OSHA is required to look high proportion of MSDs reflected in the occurring—which means that [the] WRP at the best available evidence, which is the records of employees’ private health provision is unnecessary.’’ (Ex. 30– 1996 and 1997 audit reports. They care providers, in confidential 1722, p. 77.). demonstrate an extremely high level of interviews, and in standardized OSHA does not believe that the two accuracy in OSHA 200 recordkeeping from questionnaires and surveys were not propositions cited by the Chamber are samples determined to be representative ***. included in the employers’ logs. NIOSH inconsistent. As discussed above, a reported that: significant factor motivating employees Ex. 500–168, pp. 9–10, 21. The ORC also not to report MSDs is the fear that they pointed to OSHA’s audits: These HHEs compared the OSHA 200 logs with work-related MSDs ascertained via the will be placed in a restricted duty job [t]he [audit] process is centered around following mechanisms: (1) confidential with reduced pay and benefits, and that comprehensively checking both occupational medical interviews; (2) review of employee they may also lose seniority or and nonoccupational injury and illness medical records of private health care ‘‘bidding’’ rights. Thus, employees’ records to identify misreporting and under providers; (3) health surveys utilizing concern about being out of work reporting. Employee interviews are also used standardized MSD symptom questionnaires; altogether is not the only, or necessarily when the compliance staff deems them (4) health surveys defining cases as those the predominant, factor to be considered with work-related symptoms and positive necessary. The results from the audits in evaluating the need for WRP. provide the only statistically reliable insights physical findings conducted by physicians available into the quality of the OSHA data performing physical examinations targeted to Moreover, there is no fundamental and the accuracy of employee reporting and the musculoskeletal systems. We have no tension between OSHA’s conclusion employer recording practices. reason to believe that these HHEs are not that workers’ fear of economic loss is a representative of the likely widespread significant contributing factor to the Ex. 32–78–1 at 27. ORC noted that most under-reporting of work-related MSDs. high level of underreporting observed in of the studies cited by OSHA examine Ex. 32–450–1. Moreover, several of the the literature, and its estimate that most data that is more than a decade old and MSDs will not result in time away from that may not reflect improvements due studies discussed in the proposed rule examine data sources that appear to be work. As discussed further in the to the Agency’s stepped-up Significance of Risk and the Benefits recordkeeping enforcement efforts and different from those considered in OSHA’s audits (see e.g., Exs. 26–28; 26– chapter of the Final Economic Analysis recent guidance on the proper recording supporting this rule, a significant of cumulative trauma disorders (Ex. 32– 1261; 26–1259; 26–1250). For these reasons, OSHA believes that proportion of all MSDs (approximately 78–1, p. 26). ORC and others also noted the recent audits do not undercut the one-third) will result in some lost work that Agency officials, including findings in the literature that time, and certain types of MSDs, such Assistant Secretary Charles Jeffress, widespread underreporting exists. The as carpal tunnel syndrome, require have expressed confidence in the logs are a reasonably accurate reflection nearly a month to recover sufficiently to accuracy of BLS statistics (see e.g., Exs. of those injuries and illnesses actually return to work (median length of time 32–78–1, p. 27; 30–1722, p. 75–76; 30– reported by employees at work.13 OSHA away is 25 days). Therefore, the 3347). believes that many recordable MSDs are prospect of losing work due to an MSD OSHA’s recent recordkeeping audits omitted from OSHA logs and other is a tangible one, and serves as a were designed to measure whether workplace records because employees powerful stimulus to employees. employer records accurately reflect do not inform their supervisors, do not Indeed, the record evinces strong and injuries and illnesses that employees file a claim for workers’ compensation, deeply held beliefs by many employees reported to them. Therefore, the or do not seek treatment from the across industry sectors that reporting auditors examined occupational records employer’s medical staff or health MSDs and their signs and symptoms to identify the work-related injuries and insurance provider. This is apparent not will result in loss of pay and benefits, illnesses that may have occurred to only from the studies examining the or other adverse employment action. employees, including, where available, logs, but also from the evidence on Accordingly, concrete wage and benefit medical records, workers’ compensation employee reporting behavior in the protections are necessary to counter records, insurance records, payroll workers’ compensation field, and the employees’ concerns about reporting records, company safety incident direct testimony of many workers MSDs. reports, first-aid logs, and light duty themselves during the hearing. Some commenters argued that there is rosters (Ex. 500–168–1, Appx. Analysis Considering the record as a whole, no justification for requiring WRP in of Audits on 1996 Employer Injury and OSHA finds that there is reliable, light of OSHA’s preliminary conclusion Illness Recordkeeping, Audit Protocol at persuasive evidence that MSDs are that WRP would not increase the MSD 6, (v)). The audit protocol did not currently underreported in the OSHA reporting rate (see e.g., Exs. 32–211–1, require the auditors to examine non- injury and illness records. p. 9; 32–234–2, p. 27). In the workplace records to determine whether Employer representatives also argued Preliminary Economic Analysis of the employees within the sample group had that OSHA’s estimate in the proposed proposed rule, OSHA explained that it suffered work-related MSDs which were rule that ‘‘most MSDs do not result in was then unable to quantify the not reported because the employees did any days away from work’’ (64 FR incentive effects of WRP on employee not seek treatment from the employer or 65853) undermines the need for WRP reporting of MSDs, and therefore had no the employers’ health insurance, file a (Exs. 32–211–1; 30–1722). The Chamber basis to estimate the costs and benefits worker’s compensation claim, take of Commerce argued that ‘‘[b]oth * * * attributable to increased numbers of leave, or otherwise enter the employer’s propositions cannot be true: either large MSDs reported (64 FR 66001). However, records. Id. By contrast, a number of numbers of employees are refraining the agency ‘‘welcome[d] data and studies in the record examine non- from reporting lost-time injuries to comments on the extent of MSD under workplace records and other sources in avoid significant financial losses, thus reporting, possible increases in the determining that MSDs are not requiring WRP, or few such losses are reporting of MSDs that may occur after accurately reflected in the OSHA logs. employers implement an ergonomics For example, in performing health 13 The audits show that approximately 10% or program, and on the incentive effects of hazard evaluations (HHEs) at several more of injuries and illnesses reported by the proposed standard on employee establishments, NIOSH found that a employees are not recorded in the logs. reporting of MSDs.’’ Id.

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As explained in the Final Economic general matter, broad enough to include cooperation to determine if employee health Analysis, OSHA has identified several [WRP].’’ Id. at 1230. The court also is being impaired by formaldehyde exposure. studies from the economics literature found that OSHA had met its burden of OSHA believes these new [WRP] provisions permitting the Agency to develop a demonstrating that WRP was reasonably will encourage employee participation in the necessary and appropriate by providing standard’s medical surveillance program and methodology that enables it to estimate avoid the problems associated with the impact of WRP on MSD reporting evidence that employees would resist nonspecificity and quick resolution of signs rates. Because wage and benefits cooperating with the medical and symptoms that originally concerned the protection requirements will likely surveillance program in the lead agency. 57 FR 22290, 22293 (May 27, 1992). standard absent assurances that they substantially increase the number of Formaldehyde makes clear that OSHA would have economic protection in the employees who will report MSDs and may not decline to include WRP in their signs and symptoms, WRP is a event of a medical removal. Id. at 1237. OSHA has followed a consistent standards absent specific findings reasonably necessary and appropriate justifying such a ‘‘swerve’’ from past component of the final rule. practice of including WRP provisions in standards when the rulemaking records practice. The rulemaking record here B. Legal Authority for WRP show that the provision is useful or does not support such a ‘‘swerve’; to the contrary, it shows that WRP could serve 1. The OSH Act and Past OSHA Practice necessary to achieve the purposes of the functions strikingly similar to those it Require That OSHA Include WRP In standard. OSHA has included similar serves in the formaldehyde standard. This Standard WRP provisions in numerous other standards. See e.g., 29 CFR 1910.1025 Substantial evidence shows that MSDs It is now well established that (Lead); 29 CFR 1910.1027 (Cadmium); are currently underreported and that a OSHA’s authority to promulgate 29 CFR 1910.1028 (Benzene); 29 CFR significant reason for this occupational safety and health 1910.1050 (Methylenedianiline); 29 CFR underreporting is employees’ fear that standards ‘‘reasonably necessary or 1910.1052 (Methylene Chloride). they will lose income, or even their jobs. appropriate to provide safe or healthful OSHA’s inclusion of WRP in those In order to encourage employees to employment and places of standards was based upon findings that report MSDs, report them at an early employment,’’ 29 U.S.C. § 652(8), absent some wage protection employees stage, and participate in MSD encompasses the authority, in would not participate in the medical management, OSHA must include WRP appropriate cases, to include WRP surveillance provisions of the standards. in this standard. provisions in those standards. Section Despite the legal principles described See e.g., Lead preamble, 43 FR 5440 6(b)(7) provides that a standard should, above, however, a number of (Nov. 21, 1978). ‘‘[w]here appropriate * * * prescribe In 1987, OSHA omitted a WRP rulemaking participants argued that suitable * * * control * * * provision from its formaldehyde OSHA does not have authority to procedures’’ to prevent hazards. 29 standard on the bases that the include WRP in this standard. Their U.S.C. § 655(b)(7), and Section 8(g)(2) of ‘‘nonspecificity of signs and symptoms reasons ranged from factors specific to the OSH Act provides that ‘‘[t]he [made] an accurate diagnosis of this rule to more general assertions that Secretary * * * shall * * * prescribe formaldehyde-induced irritation OSHA never has authority to require such rules and regulations as he may difficult,’’ the symptoms of WRP, and that the cases holding to the deem necessary to carry out his formaldehyde exposure often quickly contrary were wrongly decided. OSHA responsibilities’’ under the statute. 29 resolved, and some employees would responds to these comments below. U.S.C. § 657(g)(2). These provisions give never be able to return to a work Some commenters stated that OSHA OSHA broad authority to require environment that contained any does not have authority to include WRP employers to implement practices, such formaldehyde. 52 FR 46168, 46282 (Dec. (or even provisions for work as WRP, that are reasonably necessary or 4, 1987). On review, however, the D.C. restrictions) in this standard because appropriate to achieve OSHA’s statutory Circuit held that these justifications, there are no ‘‘objective’’ triggers for mission—providing safe or healthful which it characterized as ‘‘feeble’’ or removal. See e.g., Ex. 500–188, p. 87. employment and places of employment. ‘‘vague and obscure,’’ were inadequate These commenters contended that in See 64 FR 65848–53 (Nov. 23, 1999). to justify OSHA’s ‘‘swerve’’ from past every other standard where OSHA has Relying on both this statutory practice. See International Union v. included a WRP provision, OSHA language and the OSH Act’s legislative Pendergrass (Formaldehyde), 878 F.2d established (1) an ‘‘objective’’ exposure history, the D.C. Circuit affirmed a WRP 389, 400 (D.C. Cir. 1989). The court level for removal, and (2) ‘‘objective’’ provision in OSHA’s 1978 lead standard remanded the issue for OSHA’s further medical criteria for removal. In this requiring employers to maintain an consideration. OSHA eventually standard, they argued, employers will employee’s earnings and other rights included a WRP provision in the be forced to remove employees from and benefits during a work removal standard: work based solely on reports of period of up to 18 months. United ‘‘subjective symptoms.’’ Ex. 30–4467, Steelworkers of America v. Marshall On reconsideration, the Agency has pp. 17–18. (Lead), 647 F.2d 1189, 1230 (D.C. Cir. concluded that [WRP] provisions can This argument is based on erroneous 1980), cert. denied, 453 U.S. 913 (1981). contribute to the success of the medical conceptions of the WRP provisions in surveillance programs prescribed in the [Note: In the lead standard, the formaldehyde standard. Unlike some other both OSHA’s earlier standards and this provision at issue was termed medical substance-specific standards, the one. First, other standards frequently removal protection (MRP).] The court formaldehyde standard does not provide for require removal based upon a physician held that (1) the OSH Act gives OSHA periodic medical examination for employees determination that removal is broad authority to include WRP where exposed at or above the action level. Instead, appropriate, even without ‘‘objective’’ necessary or appropriate to protect the medical surveillance is accomplished in the triggers. In the lead standard, for health of workers, and (2) OSHA’s final rule through the completion of annual example, an employee can be removed medical questionnaires, coupled with inclusion of WRP in the lead standard affected employees’ reports of signs and from work when ‘‘a final medical was supported by the rulemaking symptoms and medical examinations where determination results in a medical record. Id. at 1228–40. The court held necessary. This alternative depends on a high finding * * * that the employee has a that ‘‘OSHA’s statutory mandate is, as a degree of employee participation and detected medical condition which

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00129 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68390 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations places the employee at increased risk of ‘‘conditions that exist in the surveillance provisions. OSHA has thus material impairment to health from workplace,’’ Industrial Union Dep’t, found it unnecessary to include WRP in exposure to lead.’’ 29 CFR AFL–CIO v. American Petroleum those standards. OSHA’s past practice 1910.1025(k)(1)(ii). This determination Institute et al.(Benzene), 448 U.S. 607, does not indicate that WRP can only be does not have to be based on objective 642 (1980), OSHA is not precluded from included in section 6(b)(5) standards; tests; rather, it can be based upon a regulating such conditions just because rather, it demonstrates that WRP can physician’s independent judgment. In they may also exist outside the only be included in standards based the Cadmium standard, an employee workplace. Forging Industry Assn. v. upon findings that it is reasonably can be removed based upon ‘‘signs or Secretary of Labor (Noise), 773 F.2d necessary or appropriate. OSHA has symptoms of cadmium-related 1436, 1442 (4th Cir. 1985). OSHA’s made those findings here. dysfunction or disease, or any other Occupational Noise standard, for Some commenters argued that reason deemed medically sufficient by example, establishes certain Congress’ establishment of the National [a] physician.’’ 29 CFR requirements that must be met to Commission on State Workmen’s 1910.1027(11)(i)(A); see also prevent or reduce the incidence of Compensation Laws (National Methylenedianiline 29 CFR hearing impairment, a condition that Commission) in the OSH Act to examine 1910.1050(9)(i)(B)(1) (removal shall can also be caused by exposure to the effectiveness of state workers’ occur ‘‘on each occasion that there is a excessive noise levels outside of work. compensation systems suggests that final medical determination or opinion And OSHA has previously required Congress did not want to ‘‘federalize’’ that the employee has a detected WRP where employees are also exposed workers’ compensation through a medical condition which places the to the hazard at issue outside of the provision such as WRP. Ex. 30–3811, employee at increased risk of material workplace. For example, employees pp. 15–16. But Congress established the impairment to health from exposure to may be exposed to lead, cadmium, National Commission to provide an MDA’’). methylene chloride, and formaldehyde ‘‘objective evaluation of State work[ers’] Second, this standard does not require in varying degrees outside of work. In compensation laws in order to employers to provide WRP to employees this case, OSHA has properly exercised determine if such laws provide an based solely on employee reports of its authority to regulate ergonomic adequate, prompt, and equitable system ‘‘subjective’’ symptoms. The employer hazards in the workplace. The OSH Act of compensation for injury or death makes the determination of whether an thus does not prevent OSHA from arising out of or in the course of employee’s report qualifies as an MSD including WRP in this standard merely employment.’’ See 29 U.S.C. 676. In incident under this standard. See because employees may be exposed to Lead, the D.C. Circuit examined Paragraph (e). Employers can seek some ergonomic risk factors outside of whether Congress’s establishment of the assistance in making these work. National Commission demonstrated a determinations by referring employees OSHA also does not agree that it may legislative hostility to WRP. The court to a health care professional. In the end, not include a WRP provision in a held that it did not. Lead, 647 F.2d at however, it is the employer’s decision. standard that is not promulgated 1235 n.70. Of particular importance to Moreover, this final standard includes pursuant to section 6(b)(5) of the OSH the court was that WRP did not an Action Trigger in paragraph (f). If an Act. Ex. 500–223, pp. 81–82. OSHA’s ‘‘federalize’’ workers’ compensation, employee who has suffered an MSD authority to include WRP in this rather it left the state workers’ incident is not exposed on his or her job standard derives from numerous compensation scheme wholly intact as a to risk factors at levels that exceed those provisions of the OSH Act, including legal matter. Id. Thus, even if Congress on the screening tool in Table 1, the sections 3(8), 6(b)(7), and 8(g)(2). These evinced a hostility to the employer has no WRP obligations. See provisions give OSHA broad authority ‘‘federalization’’ of workers’ Paragraph (f). to implement measures reasonably compensation through the OSH Act, the In any event, neither the OSH Act nor necessary or appropriate to effectuate its WRP provision at issue did not effect any of the court decisions interpreting statutory goal. OSHA’s authority to such ‘‘federalization.’’ Id. OSHA’s authority suggest that OSHA’s include WRP is not granted by section Similarly and as explained in more WRP authority is limited to protecting 6(b)(5) of the OSH Act or limited to detail below, WRP in this standard will workers only against conditions that are standards promulgated pursuant to not affect or supersede workers’ easy to diagnose. On the contrary, the section 6(b)(5). Section 6(b)(5) applies to compensation systems; nor will WRP OSH Act gives OSHA broad authority to toxic materials and harmful physical have a great practical effect on workers’ include provisions in standards that are agents and requires OSHA to ‘‘set the compensation. WRP is not designed to reasonably necessary and appropriate to standard which most adequately ‘‘compensate’’ workers who suffer from effectuate its statutory mandate. OSHA assures, to the extent feasible * * * that MSDs, to provide them with medical has found, based upon substantial no employee will suffer material treatment for their work-related injuries evidence in the rulemaking record, that impairment of health or functional or illnesses, or to determine the extent WRP is necessary to the effectiveness of capacity even if such employee has of their disability, all functions reserved this standard. This finding is not regular exposure to the hazard * * * for to workers’ compensation; WRP is affected by the presence (or absence) of the period of his working life.’’ 29 designed to encourage employees to ‘‘objective’’ baseline tests for certain U.S.C. 655(b)(5). report MSDs early and participate in MSDs or the presence (or absence) of To be sure, OSHA has previously MSD Management. In that sense, WRP ‘‘objective’’ or baseline levels for required WRP only in section 6(b)(5) serves as an administrative control, removal. standards. But the reason for that working to prevent injuries from Some commenters argued that OSHA inclusion was record evidence that becoming disabling and compensable. does not have authority to include WRP absent some wage protection employees NCE et al.also claimed to find in this standard because employees are would not participate in the medical additional evidence that Congress did exposed to some of the hazards at issue surveillance or medical management not intend OSHA to have authority to outside of the workplace. See e.g., Ex. programs of those standards. Non- require WRP in Congress’ refusal to 500–197, p. III–76. But while it is true section 6(b)(5) standards, on the other include the ‘‘Daniels Amendment’’ in that OSHA may only regulate hand, do not include medical the OSH Act. Ex. 500–197, pp. III–73–

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80. The Daniels Amendment would decision, Whirlpool Corp. v. Marshall, WRP is not ‘‘barred’’ by the Executive have required the Secretary of Health, 445 U.S. 1 (1980). Ex. 500–197. OSHA Order. First, there is no ‘‘uncertainty’’ Education, and Welfare to publish an is not convinced by this argument. The with respect to OSHA’s authority to annual list ‘‘of all known or potentially D.C. Circuit did not rely on the include WRP in this standard. As toxic substances and the concentrations Whirlpool decision in holding that the explained above, the OSH Act gives at which such toxicity is known to Daniels Amendment violated OSHA broad authority to include WRP occur,’’ and to determine whether the congressional intent. Rather, the D.C. where necessary or appropriate to levels of toxic substances present in Circuit examined independently the effectuate its statutory mandate. Indeed, individual workplaces posed a hazard to language and history of the Daniels the rulemaking record requires OSHA to employees. It then would have Amendment in reaching its conclusions. include WRP in this standard. Second, prohibited employers from requiring See Lead, 647 F.2d 1233–34 n.69. OSHA has found that ‘‘national action’’ employees to work in areas that had Although the court discussed is necessary to deal with the significant been determined to be hazardous Whirlpool, which it found consistent risk of MSDs in the workplace. As without certain listed protections, with its interpretation of the Daniels shown in great detail in the Risk ‘‘unless such exposed employee may Amendment, its analysis did not rely on Assessment and Significance of Risk absent himself from such risk or harm the Whirlpool decision. Id. sections, the problem of MSDs is for the period necessary to avoid such Furthermore, the D.C. Circuit did not national in scope. See Sections VI and danger without loss of regular misread Whirlpool by noting the context VII below. Under these circumstances, a compensation for such period.’’ See of the Supreme Court’s holding—that national standard to prevent MSDs is Lead, 647 F.2d at 1233. the Daniels Amendment would have appropriate under the OSH Act and In the first place, it is difficult to read allowed employees to unilaterally leave entirely consistent with the federalism significant congressional intent not to work at full pay under certain policies set forth in the Executive Order. grant regulatory authority into the circumstances. Id. Third and finally, OSHA consulted failure of the Congress to enact a with stakeholders, including Commenters also argued that WRP is provision in the Agency’s enabling Act. representatives from State and local barred by the Executive Order on See U.S. Ex. Rel. Stinson v. Prudential governments, on WRP (and the standard Federalism (Executive Order), Insurance, 944 F.2d 1149, 1157 (3d. Cir. in general). Numerous representatives specifically sections 2(i) and 3(b). Ex. 1991); see generally 2A Sutherland from State and local governments 30–3811, pp. 16–18. Section 2(i) of the Statutory Construction § 48.18. This is testified at the hearing. See e.g., 502– especially true when the provision is Executive Order states that ‘‘[t]he 476 (Testimony of The Honorable Eliot not identical to the regulation national government should be Spitzer, New York State Attorney requirement at issue. And the Daniels deferential to the States when taking General; Testimony of National League Amendment has little in common with action that affects the policymaking of Cities). These same commenters and OSHA’s WRP provisions. It would have discretion of the States and should act many others also submitted written provided the grounds for removal from only with the greatest caution where comments on the proposed rule, work based upon informal action by the State or local governments have including comments on WRP. See Secretary of Health, Education, and identified uncertainties regarding the Section XIII for a larger discussion of Welfare. WRP, however, results from constitutional or statutory authority of the participation of State and local OSHA rulemaking involving notice and the national government.’’ Section 3(b) governments in the rulemaking comment procedures. See Lead, 647 provides that ‘‘[n]ational action limiting proceedings. OSHA considered these F.2d at 1233. Further, WRP depends in policymaking discretion of the States comments in developing the final large measure on a health care shall be taken only where there is standard. OSHA also specifically sought professional’s determination that constitutional and statutory authority comment from the public (including removal is appropriate, and the standard for the action and the national activity State and local governments) on also contains a dispute resolution is appropriate in light of the presence of whether the objectives of WRP could be procedure to address disagreements a problem of national significance. attained by other non-regulatory means. among health care professionals. See Where there are significant uncertainties 64 FR 65858 (Nov. 23, 1999). OSHA Paragraph (s). More important, the as to whether national action is considered the various alternatives Daniels Amendment would have authorized or appropriate, agencies suggested; OSHA ultimately concluded, allowed an employee to make an shall consult with appropriate State and however, that those alternatives would individual judgment that the grounds local officials to determine whether be unable to accomplish the objectives for removal applied; employees could Federal objectives can be attained by of WRP (see Chapter VIII, Non- thus effectively remove themselves from other means.’’ 64 FR 43255 (Aug. 10, Regulatory Alternatives, of the Final the workplace. Lead, 647 F.2d at 1233. 1999). The Executive Order sets forth Economic Analysis). Under WRP, however, removal occurs fundamental federalism principles, Finally, representatives of the when certain criteria are met, and may federalism policymaking criteria, and insurance industry also argued that the even occur against an employee’s will. provides for consultation by federal McCarran-Ferguson Act prevents OSHA See Paragraphs (e), (f), and (r). Because agencies with state or local governments from including WRP in this standard. of these differences, the D.C. Circuit when policies are being formulated Ex. 30–3811, pp. 38–39. The McCarran- held in Lead that the Daniels which potentially affects them. [Note: Ferguson Act states, in pertinent part: Amendment ‘‘would probably invite Section XIII of this preamble describes ‘‘No Act of Congress shall be construed controversy and abuse in a way that the Executive Order in more detail and to invalidate, impair, or supersede any [WRP] would not, so the reasons for discusses OSHA’s interactions with law enacted by any State for the purpose which Congress rejected the [Daniels State and local governments in the of regulating the business of insurance, Amendment] may well not apply to development of this rule. It also or which imposes a fee or tax upon such [WRP].’’ Lead, 647 F.2d at 1233–34. contains a certification by the Assistant business, unless such Act specifically Even so, NCE et al.argued that the Secretary that OSHA has complied with relates to the business of insurance.’’ 15 Lead decision was incorrect because it the applicable requirements of the U.S.C. § 1012(b). Congress passed the misinterpreted a 1980 Supreme Court Executive Order.] McCarran-Ferguson Act in reaction to

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00131 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68392 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations the Supreme Court’s decision in United common law or statutory rights, duties, or • Spieler E. Perpetuating Risk? States v. South-Eastern Underwriters liabilities of employers and employees under Workers’ Compensation and the Assn. (South-Eastern), 322 U.S. 533 any law with respect to injuries, diseases, or Persistence of Occupational Injuries, 31 (1944). In South-Eastern, the Supreme death of employees arising out of, or in the Houston Law Rev. 119–264 (1994). Court held that ‘‘insurance transactions course of, employment.’’ 29 U.S.C. 653(b)(4). • Spieler E. Injured Workers, were subject to federal regulation under In the preamble to the proposed rule, Workers’ Compensation, and Work, 95 the Commerce Clause, and that the OSHA explained in detail how the W.Va. Law Rev. 333–467 (1992–93). antitrust laws, in particular, were proposed WRP provision did not violate Professor Spieler stated that WRP applicable to them.’’ SEC v. National section 4(b)(4) of the OSH Act. Section would not alter or affect the legal Securities, Inc., 393 U.S. 453, 457 4(b)(4) of the OSH Act was intended to scheme of state workers’ compensation (1969). The McCarran-Ferguson Act was bar ‘‘workers from asserting a private systems; nor would it ‘‘supersede’’ those an attempt to ‘‘turn back the clock [to cause of action against employers under systems. Specifically, she stated: the time before the Supreme Court OSHA standards,’’ and to prevent any (1) WRP would in no way change the decision], to assure that the activities of party in an employee’s claim under a eligibility criteria for obtaining workers’ insurance companies in dealing with workers’ compensation law or other compensation benefits in the state workers’ their policyholders would remain State law from asserting that an OSHA compensation systems. In fact, she noted that subject to state regulation.’’ Id. at 458– regulation or the OSH Act itself the eligibility criteria for WRP and the 59. preempts any element of State law. eligibility criteria for state workers’ The McCarran-Ferguson Act does not compensation were substantially different. Lead, 647 F.2d at 1235–36. In short, (2) WRP would in no way change the filing prevent OSHA from acting pursuant to section 4(b)(4) prohibits OSHA from requirements for state workers’ compensation its own authority under the OSH Act. legally preempting state workers’ claims. Thus, an employee report of an MSD OSHA derives its authority to issue compensation law. Id. Thus, even if under the standard would not constitute the standards from the OSH Act; OSHA is WRP were to have a ‘‘great practical filing of a workers’ compensation claim. authorized to implement standards effect’’ on state workers’ compensation Every state has its own procedures for filing ‘‘reasonably necessary or appropriate’’ systems, it would not violate section workers’ compensation claims; these would to accomplish its statutory goal. As remain unchanged by WRP. 4(b)(4) so long as it left the state scheme (3) WRP would in no way change the explained in detail above, OSHA is ‘‘wholly intact as a legal matter.’’ Id. at operating well within its statutory benefit payments paid through workers’ 1236 (emphasis in original). compensation systems. Workers’ authority by including WRP in this The rulemaking record confirms that compensation benefits are set by state statute; standard. The McCarran-Ferguson Act WRP in this standard will not change WRP would not affect the payment of those has no bearing on that authority. See the legal scheme of state workers’ benefits. Women in City Government United et al. compensation systems. Professor Emily (4) WRP would in no way change the review and adjudication process governing v. City of New York, 515 F. Supp. 295, Spieler, who is one of the nation’s 303 (S.D.N.Y. 1981) (The McCarran- workers’ compensation claims. ‘‘Because of leading scholars on state workers’ the no-fault principle of the workers’ Ferguson Act was not intended to be compensation systems and their applied ‘‘indiscriminately to subsequent compensation program[], the level of hazard interaction with other federal and state in the workplace and the general treatment federal legislation * * * solely because laws, submitted written comments and of the injured worker is irrelevant to workers’ legislation fails specifically to state that testified at great length on the effects of compensation proceedings. In fact, OSHA it is applicable in circumstances where WRP on state workers’ compensation rules have largely remained outside of insurance interests are implicated.’’). systems. As noted above, Professor workers’ compensation discussions and And, as explained more fully below in Spieler served as the Commissioner of proof. The existence of an ergonomics the discussion of section 4(b)(4) of the standard will not change that.’’ the West Virginia Workers’ OSH Act, WRP will not invalidate, (5) WRP would not cause an increase in Compensation Fund, responsible for impair, or supersede any workers’ workers’ compensation premiums or change setting insurance premium rates, compensation law or system. The the calculation of workers’ compensation premium collection from employers, premium rates. operation of workers’ compensation initial claims review, and adjudication. laws will remain unchanged after the Id. at 15–18; Ex. 500–140, pp. 1–2. She has lectured extensively on standard is promulgated. WRP also will In summary, Professor Spieler stated employment law and public health not supersede workers’ compensation that ‘‘the proposed ergonomics standard issues, and has authored and/or co- systems by encouraging or discouraging [including WRP would] not interfere authored numerous articles on workers’ claims in those systems. The McCarran with, undermine, or federalize workers’ compensation, see Ex. 37–14, Ferguson Act does not prevent OSHA compensation systems or illegally or Curriculum Vitae of Emily A. Spieler, from issuing WRP. inappropriately undermine the including: exclusivity doctrine.’’ Id. at 18. See also 2. Section 4(b)(4) Does Not Prohibit • Spieler E. Is Workers’ Ex. 500–26 (Lynn Marie-Crider). OSHA From Including WRP and Other Compensation the Only Legal Remedy The Attorney General of New York Provisions in This Standard. for Workers Who Are Injured at Work? State, Eliot Spitzer, echoed these same (a). Section 4(b)(4) does not prohibit In Occupational Health: Recognition points with respect to the New York OSHA from including WRP in this and Prevention of Work-Related Disease State workers’ compensation system. standard. and Injury (4th ed. (Lippincott, General Spitzer stated that WRP would The most persistent criticism of WRP is Williams & Wilkins, Levy BS, Wegman, leave New York’s workers’ that Section 4(b)(4) of the OSH Act DW, eds., 2000). compensation system ‘‘wholly intact as forbids OSHA from imposing any type • Spieler E. Dispute Resolution in a legal matter.’’ Ex. DC 75, p. 3. of wage continuation requirement. Workers’ Compensation Managed Care. Specifically, WRP would not affect Section 4(b)(4) provides: Report prepared for Robert Wood workers’ compensation eligibility ‘‘Nothing in this Act shall be construed to Johnson funded project, A Guide to criteria in New York. Id. at 5. Neither supersede or in any manner affect any Evaluating the Effectiveness of Managed would employers in New York State be workmen’s compensation law or to enlarge or Care Programs in Workers’ effectively admitting liability under the diminish or affect in any other manner the Compensation. state system by making certain

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00132 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68393 determinations required by the longer than that period of time, the compensation benefits.’’ Lead, 647 F.2d standard, ‘‘such as whether an employee worker will need to file for workers’ at 1235. Congress obviously did not has a covered MSD, whether that compensation. Currently, 80% of intend section 4(b)(4) to so limit employee should be referred to a workers’ compensation indemnity OSHA’s standard-setting authority. healthcare provider, or whether a WRP benefits are for permanent disability. Id. Instead, section 4(b)(4) is intended to payment should be made.’’ Id. at 6. Ex. 37–14, p. 16. Many of the workers prevent OSHA from affecting or General Spitzer also stated that WRP receiving permanent disability benefits superseding any state workers’ would not affect state workers’ would not be eligible for WRP. compensation law; as the court noted in compensation laws by obstructing the At the same time, OSHA does not Lead, it is intended to ‘‘bar[] workers states’ return-to-work objectives. On the expect that the number of workers’ from asserting a private cause of action contrary, he stated that ‘‘by encouraging compensation claims will rise against employers under OSHA early diagnosis and treatment of covered dramatically with WRP. As Professor standards,’’ and to prevent a worker or injuries * * * WRP would promote, not Spieler stated in her written comments, employer from asserting in a state obstruct, rehabilitation and early return ‘‘the existence of the WRP provision is proceeding ‘‘that any OSHA regulation to work.’’ Id. at 9. Finally, General very unlikely to discourage—or or the OSH Act itself preempts any Spitzer stated that WRP would not encourage—the filing of workers’ element of state law.’’ Id. at 1236. OSHA interfere with the exclusivity doctrine of compensation claims.’’ Id. This has been has shown that WRP does neither. workers’ compensation: ‘‘In my view confirmed by earlier WRP provisions in Furthermore, there are not there is no interference with these other health standards where there has ‘‘numerous’’ factual differences between provisions because WRP is not been no dramatic observable increase or WRP in the lead standard and WRP in providing remedies for injuries. Instead, decrease in the short run in the number this standard. In fact, as explained by reducing the financial risks of workers’ compensation claims filed above, there are a substantial number of associated with reporting injuries, the for conditions covered by WRP and state similarities. To be sure, there may be a income maintenance provisions of WRP workers’ compensation systems. See greater number of workers who qualify would promote early reporting and generally id. at 18; Ex. 500–218, p. 128. for WRP and state workers’ For all of these reasons, WRP does not treatment of the covered injuries and compensation benefits under this violate section 4(b)(4) of the OSH Act. prompt adjustments in workplace standard than under the lead standard. Some commenters argued the opposite, conditions for similarly situated Like the lead standard, however, these however. Some argued that the language workers.’’ Id. at 9–10. In making these numbers will decline after the standard of section 4(b)(4) is unambiguous on its observations, General Spitzer noted that is in place. OSHA predicts that by face: it precludes ‘‘any interference similar WRP provisions in other OSHA encouraging early reporting, employees [with State workers’ compensation standards have not interfered with the will report signs and symptoms of MSDs systems], whether of a legal, economic, functioning of the New York State before they become disabling and public policy, practical or other kind.’’ workers’ compensation system. See Tr. compensable under state workers’ Ex. 30–3811, p. 14. These 3385–3407. compensation systems. Thus, the only Eighteen Attorneys General submitted representatives also argued that the ‘‘effect’’ of WRP will be that fewer post-hearing letters agreeing with the Lead decision was incorrectly decided; employees will become disabled under testimony of General Spitzer that WRP courts today, they argued, would state workers’ compensation systems. would leave state workers’ interpret section 4(b)(4) differently. Id.; As the court correctly noted in Lead, compensation schemes wholly intact as see also Ex. 32–22–1, pp. 34–35; Ex. 30– this is precisely the effect OSHA a legal matter and not ‘‘affect’’ or 4467, p. 17. In addition, some standards are intended to have. Lead, ‘‘supersede’’ state systems in violation commenters argued that numerous of section 4(b)(4). See Ex. 500–48. factual differences exist between WRP 647 F.2d at 1235. There is also no record evidence to in this standard and WRP in the lead Several commenters argued that WRP support the assertion that WRP will standard that make OSHA’s reliance on improperly ‘‘supersedes’’ the exclusive have a significant practical effect on the Lead decision misplaced. See Ex. remedy provisions of state workers’ state workers’ compensation systems. 500–223, pp. 81–82; Ex. 30–4467, pp. compensation laws, essentially giving Injured workers will still have 17–22. One important difference, employees additional ‘‘litigation rights’’ numerous incentives to file for workers’ according to these commenters, was that before the Occupational Safety and compensation. First, neither WRP nor few employees under the lead standard Health Review Commission and the other provisions of the standard require would be eligible for both workers’ federal courts. Ex. 30–3811, pp. 19–22; employers to pay for or provide medical compensation and WRP, whereas many see also Ex. 32–22–1, pp. 11–12. treatment. If a worker is injured on the employees under this standard will be Workers’ compensation systems were job and requires medical treatment, that eligible for both workers’ compensation initially designed to provide the sole worker will need to file for workers’ and WRP. See Ex. 500–223, pp. 84–85. remedy for injuries and illnesses compensation. As noted by Professor OSHA does not believe that section covered by the systems. Of primary Spieler, and consistent with the injury 4(b)(4) can be interpreted to prohibit importance was that employees would data described in Section VII, a large OSHA from having any impact, either no longer be permitted to assert a proportion of MSD claims in workers’ directly or indirectly, on state workers’ negligence claim against employers for compensation systems are for medical compensation systems. Such an injuries arising out of and in the course benefits only. Ex. 37–14, p. 16. Those interpretation would prevent OSHA of employment. Ex. 37–14, p. 12 individuals who are seeking only from enacting any occupational safety (Spieler). ‘‘Notably, workers’ medical treatment through workers’ and health standard, for, as the court compensation continues to bar compensation will not be affected by noted in Lead, ‘‘any health standard that alternative tort-based legal actions WRP. Second, WRP only requires reduces the number of workers who against employers that involve employers to maintain 90% of a become disabled will of course ‘affect’ negligently caused physical injuries removed employee’s gross earnings and and even ‘supersede’ worker’s arising out of and in the course of benefits for up to 90 days. See Paragraph compensation by ensuring that those employment.’’ Id. This has been termed (r)(3). If a worker requires benefits for workers never seek or obtain work[ers’] the ‘‘exclusivity’’ doctrine.

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As explained by Professor Spieler, dates in a citation. 29 U.S.C. 659. WRP need to be removed entirely from work. however, a number of federal and state does not violate the exclusivity doctrine In this respect, this standard (including laws have expanded the rights of of state workers’ compensation systems. WRP) actually promotes the ‘‘return-to- injured workers. WRP also does not conflict with, or work’’ philosophy. ‘‘[A] wide variety of legal rights have frustrate the return-to-work policies of Finally, the record does not show that developed since workers’ compensation laws state workers’ compensation systems. ‘‘return-to-work’’ is a basic philosophy were initially passed. These include federal Ex. 30–3811, pp. 22–24; Ex. 32–22–1, of workers’ compensation. While many employment-based laws (such as OSHA, the pp. 16–18. Most state workers’ representatives of the insurance Americans with Disabilities Act, the Family compensation systems provide industry aggressively argued that it is, Medical Leave Act) that provide additional temporary total disability (TTD) benefits Professor Spieler had a contrary rights to people with work-related health to injured workers in the amount of 66 observation: conditions; state employment-based laws (such as anti-retaliation rights under the 2/3rds of their average weekly wage. ‘‘[I]t is important to note that it is simply public policy exception to the at-will These payments are not taxed. Dr. Leslie incorrect to say that ‘return-to-work’ is one of employment doctrine and disability Boden testified at the informal public the ‘foundational concepts of workers’ discrimination laws); state common law torts hearing that OSHA’s proposed WRP compensation law.’ Until the last 25 years, that provide remedies for employer actions provision was approximately equal to there was absolutely no evidence that return- other than the specific negligence that caused the amount of TTD benefits provided in to-work was a basic component of the the injury (such as fraud); and, in a growing state workers’ compensation systems. workers’ compensation world. Workers who collected benefits under the workers’ minority of states, some expansion of the See Ex. DC–47. The vast majority of definition of intentional actions that remove compensation systems had no right to return injuries from the state exclusivity provisions. workers who receive WRP because they to work; employers had no obligation to All of these legal developments represent an are removed entirely from work, return them to work; and in many cases expansion of workers’ rights when they are therefore, will receive approximately workers who collected benefits were simply injured at work. Id. the same amount of money with WRP as terminated from employment. Recent judicial they would under most state workers’ and legislative developments, combined with Thus, while the ‘‘exclusivity’’ doctrine an expanded understanding that aggressive still exists in workers’ compensation, it compensation systems. Because WRP and TTD benefits are approximately return-to-work efforts can increase exists within the broader framework of productivity and decrease workers’ other Federal and State rights granted equal, WRP is no more repugnant to the compensation costs, has led to a change in workers by Congress and state ‘‘return-to-work’’ philosophy than are the way that this issue is discussed in legislatures. These rights have not been state workers’ compensation systems. workers’ compensation circles.’’ Ex. 500–140, held to violate or contradict in any way Even so, many injured workers p. 3 (internal citations omitted). currently receive supplemental the exclusivity doctrine of state workers’ Commenters also argued that WRP payments above and beyond workers’ compensation systems; ‘‘[t]hey do not ‘‘supersedes’’ state workers’ compensation. Some states specifically change the exclusive nature of workers’ compensation systems by eliminating authorize such a practice. According to compensation for the specific purpose injury requirements and lessening Lynn-Marie Crider, a former member of of shielding employers from common causation requirements. See Ex. 30– the Oregon Workers’ Compensation law tort actions based on negligence.’’ 3811, pp. 24–28; Ex. 32–22–1, pp. 12– Board and an expert in workers’ Id. 13. Neither does WRP. WRP provides compensation: WRP will not directly change, alter, employees some wage protection in ‘‘[T]here is nothing in any workers’ affect, or eliminate the injury order to encourage them to report signs compensation system with which I am requirements or causation requirements and symptoms of MSDs early. ‘‘WRP familiar that forbids workers from receiving of any state workers’ compensation law. does not create any common law tort greater wage replacement payments than are provided for by the workers’ compensation States will continue to operate their remedy for [an] occupational injury.’’ system. Workers may receive supplementary systems in the manner they deem Ex. 500–140, p. 2 (Spieler). WRP does payments from the employer by tapping sick appropriate. WRP will also not not give employees any additional leave benefits, under a disability insurance indirectly coerce states to change or procedural or substantive legal rights; plan, and so forth. These additional alter their injury and causation WRP places a requirement on employers payments are specifically authorized by requirements. As stated by Professor to provide some wage protection to Oregon law. ORS 656.118. So, at least in this Spieler, ‘‘[t]here is no logic to the claim employees when they are placed on state, it would be impossible to argue * * * that any additional payments that a worker that WRP would force complete revision temporary work restrictions. WRP does might receive under the WRP provisions of of state workers’ compensation laws. not give employees a right to file a cause the proposed rule violate an expectation that Workers’ compensation [will] continue of action against an employer for WRP a worker will receive no more than the to process claims exactly as they have benefits; WRP does not give an maximum benefit amount established for always done.’’ Ex. 500–140, p. 3. employee the right to file a cause of temporary disability compensation.’’ Ex. Furthermore, the fact that WRP imposes action against an employer for failure to 500–26, p. 4. (or does not impose) certain pay WRP. To be sure, the OSH Act OSHA is unaware of any commenter requirements on employers that are confers some procedural rights upon who has argued that these supplemental different from workers’ compensation in employees and/or their designated benefits are repugnant to the ‘‘return-to- certain ways does not mean that WRP representatives to participate in OSHA work’’ philosophy of workers’ ‘‘supersedes’’ such systems. In the enforcement proceedings; however, compensation. words of Professor Spieler, these these rights were given employees by Furthermore, current data indicates differences ‘‘underscore the fact that Congress and are very limited. Indeed, that 82% of workers with MSDs are WRP leaves workers’ compensation employees may only question the returned productively to work by HCPs unaffected.’’ Id. Secretary of Labor’s exercise of and only 3% are removed entirely from For the same reasons, OSHA also prosecutorial discretion in an the workplace. See Ex. 500–118. By disagrees with those commenters who enforcement case before the encouraging employees to report signs argued that WRP would ‘‘supersede’’ Occupational Safety and Health Review or symptoms of MSDs early, OSHA state standards in workers’ Commission on the issue of abatement believes that even fewer workers will compensation for determining the

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WRP will not change, ‘‘double recovery.’’ See also Discussion liability under state workers’ compensation alter, or eliminate those state standards. of offset provision below. laws by making certain determinations The mere fact that WRP has a Some commenters argued that WRP required by the WRP such as whether an ‘‘different’’ benefit level and does not violates section 4(b)(4) because it creates employee has a covered MSD, whether that employee should be referred to a health care contain maximum or minimum levels a conflict of interest between employers provider, or whether a WRP payment should does not mean that it ‘‘supersedes’’ or and insurance carriers. See e.g., Tr. be made. None of these determinations ‘‘affects’’ state workers’ compensation 6472–73 (McGowen). would constitute an admission of liability systems; as explained above, it means OSHA is not convinced that WRP will under New York’s Workers’ Compensation just the opposite. create a conflict of interest between scheme.’’ Ex. DC75, pp. 6–7; see also Ex. 37– Some commenters argued that WRP insurance companies and employers. 14, p. 16. Both employers and their insurance would drastically increase the number Indeed, Professor Spieler stated in her carriers have a common interest: of state workers’ compensation claims, written testimony that in the past OSHA reducing injuries and illnesses at work. thus ‘‘affecting’’ state systems in rules ‘‘have largely remained outside of Reducing the incidence of MSDs will violation of section 4(b)(4). See e.g., Tr. workers’ compensation discussions and reduce WRP payments as well as 9786 (Nelson). Other commenters, proof.’’ Ex. 37–14, p. 16. This, of course, workers’ compensation costs. OSHA however, argued just the opposite: makes sense given that the no-fault believes that both employers and because WRP provides ‘‘greater principle of workers’ compensation insurance carriers currently share this benefits’’ to injured workers, workers makes ‘‘the level of the hazard in the will not file workers’ compensation goal and will continue to share this goal workplace and the general treatment of claims, thus ‘‘affecting’’ state workers’ after the standard is promulgated. the injured worker’’ irrelevant to the compensation in violation of section Even if the standard did introduce state proceeding. Id. 4(b)(4). See e.g., Ex. 30–4467, pp. 19–20. some conflict between insurance OSHA has addressed this issue in carriers and employers with respect to Third, OSHA does not anticipate that great detail above. OSHA does not any particular workers’ compensation inclusion of WRP in the standard will believe that claims for workers’ claim, however, OSHA does not believe provide an incentive for state compensation will increase dramatically this violates section 4(b)(4). Once again, administrators to encourage workers to after the standard is promulgated; past section 4(b)(4) prohibits OSHA from ‘‘file’’ for WRP instead of for workers’ experience with other standards that preempting, in whole or in part, the compensation benefits. It is important to include WRP supports this. See Ex. DC– legal scheme of state workers’ reiterate that workers do not file for 75, p. 11. On the other hand, OSHA compensation systems; any potential WRP, as they do under state workers’ does not believe that injured or disabled conflict of interest does not directly or compensation systems. Employers (and workers will stop filing valid workers’ indirectly affect the legal scheme of any in certain circumstances HCPs) make compensation claims. See id. at 11–12. state system. the determination of whether work In order to receive medical benefits or Two commenters suggested WRP restrictions are necessary and thus benefits after 90 days, employees will violates section 4(b)(4) because it will whether WRP is appropriate; this need to file for workers’ compensation. (1) Result in ‘‘blatant forum shopping by determination is not made through an As stated by Professor Spieler, ‘‘the employees and their representatives,’’ employee ‘‘filing.’’ State administrators existence of the WRP provision is very (2) serve as ‘‘res judicata’’ or ‘‘collateral thus could not encourage workers to file unlikely to discourage—or encourage— estoppel’’ in a later state workers’’ for WRP. Furthermore, employees have the filing of workers’ compensation compensation proceeding, (3) create an independent incentive to file for claims.’’ Ex. 37–14, p. 16. incentives for state administrators to workers’ compensation, an incentive Some commenters argued that WRP encourage employees to ‘‘file’’ for WRP unaffected by the actions of state ‘‘affects’’ or ‘‘supersedes’’ state workers’ and not file a state workers’’ administrators—WRP does not pay for compensation systems by providing for compensation claim, and (4) create medical treatment, or for any benefits double recovery for injured workers. See disincentives for states to cover MSDs. after 90 days. And finally, these e.g., Ex. 32–22–1, p. 19–20. These See Exs. 32–300–1, pp. 12–13; 30–3853, commenters did not explain how state commenters specifically argued that pp. 27–28. administrators could actually encourage state systems do not permit the First, OSHA does not understand how individual workers to file for WRP. attachment of state workers’ WRP, a uniform federal requirement, While it is true that in most state compensation payments; thus would encourage ‘‘blatant forum systems workers’ compensation employers would have no mechanism shopping’’ by employees. As shown, administrators become involved at for retrieving from employees payments state requirements for filing of workers’ certain stages of claims proceedings, the made pursuant to WRP. Id. compensation claims will remain determination of whether to initiate a As explained more fully below, WRP unchanged after the standard is workers’ compensation claim is does not provide for double recovery for promulgated. WRP would not give typically made at the plant level, where injured workers. WRP includes a employees any additional rights to file the injury occurred. provision which allows employers to for workers’ compensation claims in Fourth, WRP will not discourage—or reduce their WRP payments when an other forums or allow employees to encourage for that matter—states from employee receives payments from choose in which forums to file workers’ covering MSDs. As Professor Spieler workers’ compensation. It is immaterial compensation claims. stated, ‘‘[t]here is no logic to the claim in this respect whether states permit or Second, WRP will not serve as ‘‘res that WRP would force complete revision prohibit attachment of workers’ judicata’’ or ‘‘collateral estoppel,’’ or of state workers’ compensation laws.’’ compensation payments. WRP does not otherwise be improperly used in any Ex. 500–140, p.3. The decision by a speak to the issue of attachment of these state workers’’ compensation particular state system as to whether a payments. Rather, WRP permits proceeding. The Attorney General of certain injury or illness should be employers to reduce their WRP New York State addressed this issue in covered is a decision made payments by the amount received by the his testimony at the informal public appropriately by state legislatures after employee from other sources. This hearing: consideration of a number of factors.

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Inclusion of WRP in this standard will follow-up provided for by MSD in general, overbroad. Ex. 32–22–1, pp. not independently affect this Management. See Paragraph (r)(4). 27–31. decisionmaking process. Commenters argued in general that OSHA has addressed some of Mr. Some commenters argued that the because WRP is different from state Aurbach’s specific points above. WRP standard violates section 4(b)(4) by workers’ compensation systems (i.e., and other provisions of the standard do denying employees and employers due different standards, different burdens of not require employers to pay for process in making a claim for WRP proof, different compensation rates, medical care, do not create conflicts of under the standard. See e.g., Ex. 32–22– different dates, the presence of a waiting interest between employers and 1, pp. 14–16. period, etc.), it creates a parallel benefits insurance carriers, and do not affect Once again, employees do not make a scheme in violation of section 4(b)(4). state workers’ compensation waiting ‘‘claim’’ for WRP under this standard. In See Ex. 32–22–1, pp. 12–18; Tr. 6466 periods or burdens of proof. OSHA also this respect, WRP is fundamentally (McGowen). does not believe that this standard is different from workers’ compensation. As OSHA explained above, the fact overbroad—OSHA has carefully tailored Under this standard, employers make that differences exist between WRP and this standard to address exposure to the determination as to whether work state workers’ compensation systems ergonomic risk factors at levels shown restrictions are appropriate; if they are, demonstrates that WRP does not violate to cause a significant risk of MSDs. employers must provide WRP. If an section 4(b)(4). WRP is a federal OSHA admits that the standard will employer is cited for failing to provide requirement separate from the place certain requirements upon WRP, the OSH Act provides an requirements and procedures of state employers to ‘‘fix’’ problem jobs, and opportunity for the employer to contest workers’ compensation systems. It is not keep some records of their ergonomics the citation. Employers are thus not intended to replace workers’ programs. Imposing these requirements denied due process with respect to compensation. It is designed instead to on employers, however, does not violate WRP. accomplish very different purposes. section 4(b)(4). Virtually every OSHA standard includes some new That said, OSHA has included a Workers’ compensation is designed to requirements or places some dispute resolution mechanism in the compensate workers after an injury has administrative burdens on employers. final standard that was not included in occurred. WRP is designed to encourage This is not surprising given that the the proposed rule in order to address employees to report signs or symptoms scheme of the statute, manifest in both concerns raised both by employer and of MSDs early, before they become the express language and the legislative employee groups. See Paragraph (s). severe and disabling, and to cooperate history * * * [permits] OSHA to charge Many commenters from both labor and with the standard’s MSD management provisions. As such, it is not surprising to employers the cost of any new means industry asked OSHA to include some it devises to protect workers.’’ Lead, 647 dispute resolution mechanism in the that WRP and state workers’ compensation systems have different F.2d at 1230–31. For example, OSHA standard so that employers and has required employers to install local employees could more efficiently schemes, etc. The fact that WRP operates differently from state workers’ exhaust ventilation in numerous health handle disputes related to work standards, produce and keep medical restrictions. See e.g., Exs. 500–218, p. compensation systems does not mean that it ‘‘supersedes’’ or in any manner surveillance records of employees, 124; 32–300–1, p. 30; Tr. 7654. OSHA provide hazard information to has responded to these comments and ‘‘affects’’ workers’ compensation. In the words of Professor Emily Spieler: employees, etc. These requirements included such a mechanism in the final have never been held to violate section standard. See Discussion below. OSHA ‘‘All of the differences * * * between WRP 4(b)(4). Indeed, if Mr. Aurbach’s notes, however, that it is not aware of and workers’ compensation underscore the interpretation of the second clause of any employee group that alleged that fact that WRP leaves workers’ compensation section 4(b)(4) were accurate, section the proposed standard violated unaffected. This includes the different process of selection of the evaluating health 4(b)(4) would prevent OSHA from constitutional due process by failing to issuing any occupational safety and have a dispute resolution mechanism in care provider (HCP); the different role of the HCP; the different enforcement mechanisms; health standard. Under Mr. Aurbach’s the proposed standard for appealing the different standards for evaluation of interpretation of the second clause of various employer determinations. whether the MSD is covered; the differences section 4(b)(4), if OSHA places any Some commenters argued that the in burdens of proof; and any differences in burdens (such as administrative burdens standard violates section 4(b)(4) because payment levels. The very fact that there will or the requirement to eliminate hazards it does not permit employers to stop be inconsistent outcomes * * * suggests that in dangerous jobs) on employers not paying WRP if it is determined that a WRP will not affect state workers’ already required either by statute or the worker is engaging in practices that compensation programs.’’ Ex. 500–140, p. 3. common law, section 4(b)(4) is violated. delay or prevent his/her recovery. See See also Ex. 500–26, pp. 3–4. This interpretation is not plausible. e.g., Ex. 32–22–1, p. 26. One commenter, Robert Aurbach, Contrary to Mr. Aurbach’s assertion, OSHA believes that these commenters General Counsel of the New Mexico the second clause of section 4(b)(4) must misunderstood the proposed rule; Workers’ Compensation Administration, be read in conjunction with the first OSHA has attempted in this rule to in his capacity as a private citizen clause discussed in detail above. clarify the discussion of MSD argued that WRP violates the second Section 4(b)(4) as a whole prevents Management with respect to employer clause of section 4(b)(4) by (1) Providing OSHA from displacing or preempting obligations to provide WRP. This different requirements for HCP choice, the legal scheme of state workers’ standard expressly provides that (2) eliminating waiting periods, (3) compensation. WRP will do no such employers may condition the payment shifting the burden of proof, (4) thing. Section 4(b)(4) cannot be read to of WRP on employee participation in requiring employers to ‘‘fix’’ problem prevent OSHA from issuing safety and MSD management. This includes the jobs, (5) requiring payment for medical health standards. evaluation and follow-up of employees. care, (6) creating conflicts of interest (b). Section 4(b)(4) does not prohibit Thus, an employer may stop WRP between employer and insurance OSHA from including certain other payments if an employee is not carriers, (7) creating additional provisions in this standard, as some participating in the evaluation and administrative burdens, and (8) being, commenters argued.

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Several commenters argued that the practice of HCPs under workers’ improperly. OSHA’s inclusion of WRP confidentiality provision (Paragraph compensation laws. Those requirements in other standards has never been ruled (p)(2)) of the standard ‘‘supersedes’’ remain the same. ‘‘improper’’ because it somehow created state workers’ compensation systems Commenters argued in general that a ‘‘most-favored injury.’’ because such systems permit the the standard ‘‘supersedes’’ state Furthermore, OSHA disputes that by employer to obtain any information workers’ compensation systems because creating a uniform federal requirement from an HCP related to a workers’ it establishes separate requirements for it is treating employers and employees compensation claim. See e.g., Ex. 32– the provision of medical care with differently in the various states. On the 22–1, pp. 25–26. different cost structures, treatment contrary, WRP applies equally to OSHA admits that the confidentiality guidelines, and regulatory burdens. See employers and employees in general provision in the proposal was not clear. e.g., Ex. 30–3811, pp. 34–38. industry. If, for example, two workers OSHA has changed the language in the This standard does not require the from different states must be removed final rule to clarify it. As explained in employer to pay for or provide medical from work due to the same MSD, they more detail above, if a state workers’ care and/or treatment. MSD both will receive at least 90% of their compensation system requires or even management only requires employers to gross earnings and benefits for up to 90 allows employers to obtain information make an HCP available for evaluation days. WRP creates no inequality. related to a workers’ compensation and follow-up. The standard does not To be sure, inequity currently exists claim, the MSD management provisions establish any cost structures or in state workers’ compensation systems. would not prevent that information treatment guidelines, etc. Indeed, OSHA But as Professor Spieler stated in her from being passed from the HCP to the has expressly declined to include such written comments on the proposed rule, employer in any manner. OSHA thus requirements in the standard. See WRP will not introduce, solve, or affect does not ‘‘supersede’’ or ‘‘affect’’ the Discussion of MSD management above. that inequity: different mechanisms provided by the Finally, many commenters argued that WRP (and other provisions of the ‘‘One final and important point: Some have states for the employer to obtain argued that the proposed standard introduces information from an HCP about a standard) improperly (1) creates a inequity or inequality into the treatment of workers’ compensation claim. ‘‘most-favored injury’’ by providing workers with occupationally-related MSDs. Commenters also argued that the compensation for MSDs at a higher rate * * * But the proposed standard does not standard ‘‘supersedes’’ state workers’ than for other occupational injuries and introduce inequity or inequality into the compensation systems because (1) it illnesses, and (2) treats employers and programs that provide protection for the allows the employer to select the initial employees in different states with affected workers. Serious inequities exist HCP (whereas in numerous states the different compensation systems already. Currently, eligibility criteria for differently. See e.g., Tr. 6435–36 MSDs and payment levels in workers’ employee can select the initial HCP) and compensation programs vary wildly from one (2) it permits certain HCPs to participate (Ewing); 6457 (Situkiendorf). state jurisdiction to another. So do in MSD management, even though those WRP does not result in workers with protections under state-mandated temporary HCPs would not be qualified under state MSDs being compensated at a higher disability programs and under state disability law to examine state workers’ level than workers with other injuries rights laws. Some workers will receive compensation claimants. See e.g., Ex. and illnesses. As stated above, WRP medical treatment, permanent disability 30–3811, pp. 34–37; Ex. 32–22–1, pp. payments are approximately equal to benefits, vocational training, and job 20–26. the amount of TTD payments received placement; others, with equivalent MSDs This standard does not require by workers through workers’ will not. Irrespective of the promulgation of compensation for all occupational the proposed standard, these inequities will employers to select the initial HCP. As persist. They will persist precisely because explained above, this standard requires injuries and illnesses. The standard also state workers’ compensation programs will employers to make an HCP available to includes an offset provision that be unaffected by the promulgation of the injured employees. Employers may prevents an employee from receiving standard.’’ Ex. 37–14, p. 19. choose to satisfy this requirement by both WRP and workers’ compensation. operating within the selection practices See Discussion of offset provision 3. Section 4(b)(1) Does Not Prevent of their state workers’ compensation below. OSHA is thus not creating a OSHA From Applying WRP to Federal systems. (In fact, OSHA anticipates that separate class of injured workers and Employees. most employers will do this.) Thus, if a paying them at a higher rate than The United States Postal Service, as state permits an employee to choose the injured workers receive under workers’ well as certain federal agencies, argued initial HCP, that practice could continue compensation. that section 4(b)(1) of the OSH Act under this standard. OSHA has acted pursuant to its prevents OSHA from applying WRP to Furthermore, the fact that OSHA is statutory authority to issue this standard federal employees because the Federal permitting certain HCPs to participate in to reduce the significant risk of Employees Compensation Act (FECA) MSD management who may not be employees developing MSDs from occupies the field with respect to permitted to examine workers’ workplace exposure to ergonomic risk compensation for work-related injuries. compensation claimants under state factors. The rulemaking record requires Ex. 35–106–1, pp. 14–21. workers’ compensation systems does that OSHA include WRP to effectuate FECA provides compensation to not violate section 4(b)(4). OSHA has the purposes of this standard. WRP is federal employees injured while in the determined, based upon the rulemaking designed to encourage employees to performance of their duties. 5 U.S.C. record, that certain ‘‘HCPs,’’ operating report MSDs early and to participate in 8102. For totally disabled individuals, within their scope of practice, can MSD Management; it is not designed to, FECA pays 66 2/3% of their monthly perform certain functions under MSD nor will it, compensate injured workers pay. 5 U.S.C. 8105(a). In this respect, Management. This is an appropriate at a higher level than injured workers FECA is similar to state workers’ exercise of OSHA’s authority and one receive under state workers’ compensation systems. FECA also has that OSHA has exercised in other compensation. Simply because OSHA certain maximum and minimum levels standards. See 29 CFR 1910.1052(b) has singled out certain injuries and for compensation, as well as a three day (Methylene Chloride). OSHA is not illnesses for regulation, but not others, waiting period. Unlike various state changing the state requirements for does not mean that OSHA has acted systems, however, FECA contains a

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Furthermore, the U.S. 883 (1986). type of non-monetary alternative FECA provides that ‘‘[a]n employee may In this case, FECA is not directed at involves recognition and nominal use annual or sick leave to his credit at all to the working conditions addressed rewards for reporting hazards or the time the disability begins.’’ 5 U.S.C. by this standard. This standard requires presenting useful ideas to improve 8118(c). Like state workers’ employers to implement an ergonomics safety. Although OSHA solicited compensation systems, FECA was program to reduce exposures to comment on the issue, there was no enacted to provide federal employees ergonomic risk factors in the workplace. consensus even among employers that with a quicker and more certain It adopts a comprehensive approach to this type of non-monetary incentives is recovery for work-related injuries. reducing the significant risk of MSDs. an effective substitute for wage FECA does not preempt OSHA under One critical aspect of that approach is protection policies in motivating section 4(b)(1) of the OSH Act from MSD management and WRP. By employees to report. While there is applying WRP to federal employees. encouraging workers to report signs or some evidence non-monetary Section 4(b)(1) of the OSH Act provides, symptoms of MSDs early (even before inducements to reporting hazards can be in pertinent part: they become recordable or effective as part of a well designed Nothing in this Act shall apply to working compensable), WRP prevents serious safety and health program, such conditions of employees with respect to injuries from occurring. It also alerts programs may also involve full or which other Federal agencies * * * exercise employers to the presence of risk factors partial wage protection, sick leave, or statutory authority to prescribe or enforce in a particular job. disability benefits if employees must standards or regulations affecting FECA, one the other hand, does not lose time from work. While many occupational safety or health. 29 U.S.C. attempt to regulate ergonomic hazards 653(b)(1). employers have generous benefits in the workplace to prevent MSDs from policies that would enhance the Section 4(b)(1) ousts OSHA from occurring in the first instance (i.e., effectiveness of non-monetary jurisdiction over working conditions regulate ‘‘working conditions’’ that incentives, many do not (64 FR 65852). over which another agency has cause the injury or illness). In fact, it is Absent persuasive evidence that non- exercised statutory authority. At the not concerned with targeting and monetary incentives for reporting time the OSH Act was passed various reducing occupational hazards at all. hazards, standing alone, can achieve federal agencies had statutory authority FECA is a statute that compensates increased reporting, OSHA sees no basis to prescribe and enforce standards and workers after injury occurs. As such, it to rely on them to the exclusion of WRP. regulations affecting occupational safety has a wholly separate purpose from Another type of incentive plan and health. To avoid duplication of WRP (and, indeed, this standard as a rewards employees with prizes for effort, Congress included section 4(b)(1) whole). To be sure, FECA may in the OSH Act. Thus, section 4(b)(1)’s reporting low numbers of injuries or no indirectly ‘‘affect’’ the occupational injuries. As the preamble discussion of broad purpose is to avoid duplicative safety and health of workers by regulatory burdens without impairing Paragraph (h)(3) makes clear, incentive providing compensation after injury and plans of this type can effectively deter the OSH Act’s primary goal of encouraging temporary work ‘‘assur[ing] so far as possible every reporting because employees may value restrictions; however, it is not targeted the prize more than any health or safety working man and woman in the Nation to the working conditions that cause safe and healthful working conditions.’’ benefit that reporting would produce. MSDs. WRP is not preempted by FECA See, e.g., Tr. 15453, 10992, 7703). 29 U.S.C. 651(2)(b). under section 4(b)(1) of the OSH Act. In order for an agency’s action to Moreover, in plans that reward teams of preempt OSHA under section 4(b)(1), C. Other Considerations employees for low rates of reported injuries, peer pressure exerted by the the agency must formally ‘‘exercise’’ its 1. Non-monetary alternatives statutory authority to regulate group can be an effective deterrent to ‘‘particular working conditions,’’ or Several commenters argued that non- reporting by team members (Tr. 15453, express its view that no action should monetary alternatives can be effective in 11638). occur. See e.g., Baltimore & Ohio R.R. v. increasing reporting of MSDs by For these reasons, OSHA finds that OSHRC, 548 F.2d 1052, 1053–55 (D.C. employees and are preferable to WRP non-monetary incentives would not be Cir. 1976); Southern Pacific Transp. Co. (Exs. 30–4467, p. 23; 32–300–1, p. 24). as effective as WRP in encouraging v. Usery, 539 F.2d 386, 390–92 (5th Cir. The EEI wrote: employees to report MSDs. 1976), cert. denied, 434 U.S. 874 (1977). EEI does not believe that OSHA has 2. Duration and Level of Benefits While courts differ slightly in their sufficiently proven that WRP is the only interpretation of what constitutes effective method to ensure accurate (a). Maximum duration. The proposed ‘‘working conditions’’ for purposes of reporting. OSHA acknowledges that a rule established a maximum duration of section 4(b)(1), all approaches are based properly designed incentive plan can be 6 months for each episode of WRP on the Supreme Court’s definition of successful. OSHA reports that a number of benefits. Several commenters supported that term as limited to an employee’s stakeholders have said that employers use the agency’s preliminary determination various non-monetary incentives to achieve a ‘‘surroundings’’ and the ‘‘ ‘hazards’’’ safer and more healthful workplace. Some of that benefits should be provided for up incident to his work.’’ Southern Pacific these incentives include recognition and to six months if necessary (see e.g., Exs. Transp., 539 F.2d at 390 (quoting and nominal rewards (company caps, plaques) for 500–218, p. 131; 32–185–3, p. 11–10). citing Corning Glass Works v. Brennan, reporting hazards or presenting ideas to fix Other commenters argued that a six- 417 U.S. 188, 202 (1974)). Thus, the problem jobs or reduce severity rates. These month duration is unnecessarily long in courts examine whether the other types of incentives can and do increase light of the data showing that most MSD agency’s exercise of authority is directed employee reporting. cases will recover in far less time (Exs. to the ‘‘particular’’ or ‘‘identical’’ Ex. 32–300–1, p. 24. 30–352; 32–300–1; 30-3344). The EEI

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00138 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68399 recommended reducing the maximum relatively few workers who will require systems could be that some of these duration period to 3 months: more than 3 months to recover from employees would have no protection for Even if OSHA chooses to maintain a WRP their MSDs, a substantial number will several days. Id. In addition, employees provision, it has not shown sufficient be eligible for workers’ compensation who require more than seven days to justification for six months of coverage. benefits to replace a portion of lost recover, but who are not covered by OSHA claims that early recognition, income and to pay for medical workers’ compensation, would face diagnosis and treatment interventions will expenses. substantial financial pressure to return lead to speedier recoveries from MSDs. Given For these reasons, OSHA concludes to work early. For these reasons, OSHA this premise, the six-month WRP period of that a three month maximum time preliminarily concluded that this time is inordinately long and may enhance period for WRP is appropriate. Based on the tendency for an employee with a mild alternative would have a chilling effect MSD case to malinger. OSHA recognizes the estimates discussed above, OSHA on early reporting. Id. within the [proposed rule’s] preamble a believes that the vast majority of OSHA solicited comment on whether median length of disability for all MSDs of workers with lost-time MSDs will the alternatives outlined in the 99 days with many of these cases resolving receive, or be eligible to receive, a proposal, or other alternatives would in significantly less time. Reducing the WRP substantial portion of their wages while effectively encourage early reporting to three months would be consistent with the recovering. OSHA acknowledges that and participation. 64 FR 65858. The anticipated benefits of the proposed rule and there will be some workers who will agency received no evidence that will reduce the cost and complexity of the require more than three months to providing WRP for less than 90 calendar program to employers. recover, and who will not receive days would achieve this purpose. Ex. 32–300–1, p. 23. workers’ compensation or other benefits Accordingly, the final rule requires that OSHA preliminarily estimated that after the first three months. However, WRP be provided for up to 90 calendar while most employees with lost-work- OSHA estimates that this group will days. time MSDs would recover within 3 represent a small proportion of all (b). Interim cutoff points. The final months, over 12% of all lost workday workers with lost-time MSDs. rule permits employers to terminate cases involved more than 3 months The Agency does not believe it is WRP benefits before the expiration of away from work, and that for some appropriate to structure WRP the 90 calendar day maximum period if types of serious MSDs, the typical requirements around this small group of one of the following occurs: (i) the disability duration was more than 3 employees. WRP is intended to provide employee is able to resume the former months (64 FR 65855). OSHA temporary benefits to encourage work activities without endangering his concluded that a six-month maximum employees to report MSDs and to or her recovery, or (ii) an HCP time for WRP was reasonable because it participate in MSD management. As determines, subject to the dispute would allow the majority of workers discussed at length in Section B above, resolution procedure in paragraph (s), with more serious MSDs time to recover WRP is not intended as a federal remedy that the employee can never resume his before losing their benefits. Id. for workers who have suffered work- or her former work activities. In the final rule, OSHA has revised its related MSDs, or as a supplement to As explained in the preceding estimates of the number of days state workers’ compensation systems. discussion, OSHA’s data show that in employees will be out of work due to Based on the record, OSHA believes that most cases, work restrictions will not be MSDs. The agency now estimates that a requirement to provide WRP for up to needed for 3 months because the 90% of all workers who experience lost 3 months will be effective in employee will have recovered in less work-time MSDs will return to work substantially increasing the number of time. The standard permits the within 3 months. In addition, OSHA employees reporting MSDs and their employer to end WRP before 3 months estimates that in approximately 70% of signs or symptoms. While requiring if a determination is made that the cases in which workers’ compensation WRP for up to 6 months or longer would employee is recovered and able to claims for MSDs are filed, benefits will provide a greater degree of economic return to his or her regular job. This is be available to replace up to two-thirds protection to injured workers, it would consistent with the principle that work of the employee’s lost wages. See likely produce little if any additional restrictions or removals are temporary OSHA’s Final Economic Analysis. improvement in reporting. As OSHA and protective in nature, and with While a high percentage of workers with noted in the proposal, the available data OSHA’s practice in other standards MSDs do not currently file claims for indicate that overall, the number of containing benefits similar to WRP (see workers’ compensation benefits, OSHA workers out of work for less than 6 e.g., Lead, 43 FR 54440, Formaldehyde, expects this rate of under-filing to months is not significantly greater than 57 FR 22294). No party opposed the decrease with the implementation of the number of workers out of work for provision that WRP may be ended when WRP, particularly in cases in which the less than 3 months (64 FR 65855). the employee is able to return to his or recovery period exceeds three months. In the proposal, OSHA considered her regular work. Employees will have an incentive to several alternatives that would have Employers may also reduce their pursue benefits since claims-filing will reduced the maximum duration of MRP obligation to provide WRP benefits by not threaten immediate economic harm, benefits to substantially less than 90 addressing the MSD hazards in the job and may be the only avenue to recovery calendar days. OSHA preliminarily at an early date. Once the employer has of medical expenses and extended wage concluded that limiting MRP benefits to controlled the MSD hazards so that the loss. See Emily Spieler, Ex. 37–14, pp. no more than seven days would not employee can resume his/her regular 18–19, and Tr. 3353. Employers will provide the requisite protection to duties without endangering his/her also have a greater incentive to employees to encourage them to report recovery, work restrictions or work encourage employees to file claims, or MSDs early and to participate in MSD removal are no longer necessary. to initiate claims themselves in the management. 64 FR 65856. The agency Controlling the MSD hazards in the job majority of states that permit employer- noted that employees whose injuries do quickly is one way that employers may filed claims, because the final rule not resolve within the WRP coverage limit the number of days that MRP permits an offset against WRP for period would have to rely on workers benefits must be paid. workers’ compensation benefits compensation, and that the effect of the The proposed rule contained no received by employees. Thus, of the waiting periods required by state provision for ending WRP benefits once

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00139 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68400 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations it becomes clear that the employee will physically unable to perform the job. As the earnings of employees removed from not recover sufficiently to return to the noted above, the standard permits the work approximates the portion of these job. Several commenters urged OSHA to employer to end WRP if a determination employees’ wages actually lost due to include such a provision in the final is made that the employee is MSDs. rule (Exs. 500–218; 32–337–1). The permanently unable to return to his 3. Offset Provision AFL–CIO stated: regular job. For these reasons, OSHA [T]he AFL–CIO recommends that OSHA does not believe that an express The final rule permits an employer to include [an additional] WRP cut-off point, limitation on the number of days of reduce its WRP obligation to an consistent with the WRP provisions in other WRP during the year is appropriate. The employee with a work restriction by the standards. An employer should be permitted final rule thus contains safeguards amount that the employee receives in to terminate WRP if and when it is which effectively limit the compensation for lost earnings during determined that the employee is unable to circumstances in which an employee the period of restriction from a publicly return to the job * * *. At this point, could receive WRP benefits at repeated temporary removal no longer serves OSHA’s or employer-funded compensation health protective goal and the worker intervals in a year. program, or receives in income from presumably becomes eligible for workers’ (c). Level of benefits. The final rule employment made possible by virtue of compensation. requires that the employment rights and the employee’s restriction. This benefits of employees be fully provision is designed to ensure that Ex. 500–218. pp. 131, 127. OSHA agrees maintained for the duration of the WRP that a work restriction or work removal employees will not receive more than period. Employers must maintain the current earnings as a result of a work is no longer necessary once it is clear earnings of employees placed in that the employee will not recover restriction (64 FR 65848). restricted work jobs at their pre-WRP Several parties maintained that the sufficiently to be able to return to the level, and must maintain the earnings of job. Accordingly, the final rule permits provision will not achieve its purpose in employees temporarily removed from preventing injured employees from employers to end WRP benefits before work at 90% of their pre-WRP level. The receiving a double recovery because the expiration of three months if a proposed rule contained the same WRP payments will generally be paid determination is made that the requirements as the final for before the employee receives workers’ employee is permanently unable to maintenance of employment rights and compensation benefits and state laws return to his/her regular job. benefits. However, the proposal preclude employers from attaching such Some participants suggested that the required maintenance of either 100% or benefits (Exs. 32–22–1; 30–4467). The final rule should contain a limitation, 90% of ‘‘after-tax earnings,’’ depending General Counsel of the New Mexico similar to that in the FMLA, on the upon whether the employee was Workers’ Compensation Administration maximum number of days of benefits in assigned restricted work or was expressed this view as follows: any year. The Chamber of Commerce temporarily removed. urged this approach, arguing that under Many participants criticized this Whenever the workers’ compensation the proposed structure, an employee provision. Although OSHA intended the system delays benefits for any legitimate could theoretically receive WRP for the provision to mean that the employee’s reason, the worker is paid WRP under the maximum period, return to work for a net earnings should be 90% of the net Proposed Standard, and then later paid for day, and then receive another round of earnings the employee would have the same lost work time by the employer’s workers’ compensation insurer. The MRP benefits. By repeating this cycle, received by working, a number of an employee could receive virtually his employer has no legal mechanism for commenters thought the provision recapturing that portion of the WRP pay that full annual pay and benefits while meant that the employee’s gross WRP was supposed to be offset. Since no state law actually working only a few days during benefits should be equal to 90% of net currently has a provision allowing for the year (Ex. 30–1722, pp. 81–82). earnings. Thus, the AFL–CIO argued reduction of workers’ compensation benefits OSHA does not believe that the that this formulation could result in on the ground that WRP pay was already scenario posited by the Chamber is WRP benefits being taxed twice, and paid for the same injury, the various state realistic. Employers can significantly would be problematic for employers to workers’ compensation laws will need to be reduce the likelihood of having to pay implement (Ex. 500–218, pp. 121–122). revised to make the offset provision for WRP MRP benefits to the same employee on OSHA agrees, and has deleted the work. successive occasions by controlling the reference to ‘‘after-tax earnings.’’ It uses Ex. 32–22–1, pp. 19–20 (emphasis in MSD hazards in their problem jobs the word ‘‘earnings’’ in the final rule. original). effectively. By acting promptly to Earnings generally means gross pay. OSHA does not agree that changes in address MSD hazards, and effectively The AFL–CIO also objected to state laws are needed to effectuate the managing the MSDs that do occur, providing only 90% of pre-WRP wages offset provision. First, contrary to this employers can ensure that, in most to employees temporarily removed from commenter’s assertion, some state laws cases, injured employees will be able to work, arguing that full wage protection already have adequate provision for return to work at full productivity and is necessary to encourage employee employers to recoup wages paid to without the need for further restrictions. reporting and participation (Ex. 500– employees who later qualify for Moreover, while there may be some 218, pp. 122). However, employees who workers’ compensation. For example, unusual instances in which employees remain at home do not incur certain the New York state official charged with will legitimately need work restrictions expenses, such as commuting and child responsibility for the State’s workers’ more than once in a year for the same care expenses, incurred by employees compensation system testified that: job, employers need not allow who must report to work. Therefore, employees to cycle endlessly in and out some reduction from the wages of [t]he offset provision would be effective of WRP. If an employee requires work workers removed from work is even if the workers’ compensation claim took more than six months to resolve because our restrictions on several consecutive appropriate to balance the cost savings system allows for payments of benefits to occasions despite the fact that the MSD that these workers accrue; otherwise employers who have provided other hazards have been controlled to the employees would reap a financial compensation such as sick leave to extent required in the standard, that is benefit from WRP (Ex. 32–22–1; p. 17). employees prior to the award of a strong indication that the employee is OSHA considers that restoring 90% of compensation benefits.

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Tr. 3354 (Eliot Spitzer). Employers are fraud was present in less than 3/10ths of one effective safeguards employers can use also free to structure their employment percent of total claims (Ex. 500–97–1); in to prevent employees from receiving contracts to allow recovery of wages Wisconsin, it was one tenth of one percent WRP benefits to which they are not paid during a period for which workers’ of claims (Ex. DC 78). entitled. Therefore, the potential for compensation benefits are awarded. Ex. 500–218, p. 131. The former fraud is not a basis for eliminating WRP. Nothing in the record shows that Commissioner of the West Virginia Paragraph(s) What Must I Do if the contractual remedies would not be Workers’ Compensation Fund testified Employee Consults His or Her Own effective, or that employers would have that in her experience in administering HCP? greater difficulty in recouping WRP claims, there was little evidence that overpayments than they have in workers prolonged their benefits by Paragraph (s) of the final rule recouping other monies advanced to remaining out of work unnecessarily establishes a procedure for resolving employees (Ex. 500–218, pp. 128–129). (Tr. 1733–34). Other witnesses agreed disagreements among HCPs. The For these reasons, there is no basis to with this assessment (Tr. 3559–60 proposed rule did not contain a conclude that the offset provision will [James Ellenberger], Tr. 11001 comparable provision. be unworkable or ineffective. [Madeline Sherod], Tr. 11102 [Trevor Numerous commenters, including Schnell]). Accordingly, the experience both employer and employee 4. Fraud gained in the worker’s compensation representatives, argued that accurate A number of commenters argued that field does not demonstrate a high medical assessments are critical if the WRP provision will entice large potential for employee abuse of WRP. parties are to have confidence in numbers of employees to attempt to In addition, the final rule contains decisions about work restrictions and secure these benefits fraudulently. features that will reduce the opportunity WRP. A representative of the American These parties were concerned that for fraud in administering WRP. First, College of Occupational and employees will report MSDs that are not work restrictions are required only for Environmental Physicians explained: work-related MSDs and only if the related to work activities, or will [t]he central role that [medical] evaluations exaggerate their MSD symptoms to employee’s job meets certain objective play in triggering requirements of the rule secure work restrictions that are not screening criteria. These requirements make the inclusion of a three-physician necessary or to extend work restrictions are designed to ensure that there is a review in the ergonomic standard longer than needed (Exs. 30–1722; 32– close nexus between the injury and particularly appealing. We recommend that 241–4; 30–4467; 32–234–2; Tr. 6470, significant exposure to ergonomic the standard provide for multiple physician 9847–8, 14215). NCE et al.stated: hazards at work. Moreover, work review to sort out the differences of opinion restrictions are not required unless an and ambiguities in the diagnosis. The key The evidence is clear that the employees HCP or the employer itself has element to triggering implementation of a most likely to complain of musculoskeletal program review should be based again on a discomfort are those who do not like their determined that they are necessary. Thus, even if an employee falsely bona-fide medical diagnosis in light of the jobs. These employees’ subjective complaints corresponding duties. must be taken as given under the proposed reports MSD symptoms, work rule, and cannot be subjected to objective restrictions and WRP are not required Tr. 7654 (Dr. Robert McCunney). The verification. When these workers are given unless the employee’s job meets the AFL-CIO argued that multiple physician the additional incentive of time off at 90 screen and a medical professional review or MPR is necessary to gain the percent pay, or less demanding job tasks at selected by the employer determines trust and participation of employees. It 100 percent of pay, a vast increase in that they are necessary. Therefore, asserted, reported musculoskeletal pain is certain to commenters substantially overstate their [w]orkers have always been concerned follow. case in asserting that subjective about the objectivity and allegiance of Ex. 32–241–4, p. 185. Similarly, the symptoms alone trigger work employer-chosen physicians * * . MPR is Chamber of Commerce argued that, restrictions. important to assure workers that physician based on the extent of workers’ OSHA believes that HCPs, in hostility to WRP will not result in adverse compensation fraud nationwide, ‘‘the particular, will play an important role in consequences when workers step forward only reasonable assumption is that the checking abuse. Health care and report. Without the possibility that a WRP provision will increase such fraud professionals use a variety of techniques colleague will review, and possibly take issue to identify fraud. Nothing in the record with, a decision denying worker transfers or because the dollar amounts at issue are prematurely returning workers to hazardous greater . . . And this problem is likely supports the notion that HCPs are exposures, employer physicians may feel to be especially acute where, as here, frequently duped by false symptoms; to financial pressure from employers to the diagnosis at issue is . . . a loose the contrary, HCPs are adept at minimize WRP participation. evaluating the objectivity of patient collection of poorly defined signs and Ex. 500–218, p. 124. See also Exs. 32– claims. Moreover, data in the record symptoms’’ (Ex. 30–1722, p. 77). 111–4 (USWA); 32–85–3 (CWA). OSHA does not believe that the record shows that most HCPs are far more The EEI voiced concern that if bears out these commenters’ concerns. likely to recommend work restrictions employees are allowed to choose the As a threshold matter, there is than time away from work. (Ex. 500– initial HCP, the person they select may substantial evidence that worker- 118). Further, since 1992, the percentage not have the time or experience to work perpetrated fraud is but a very small of restricted workdays for all with employers in determining part of the overall fraud problem in occupational injuries and illnesses appropriate restrictions. It argued that: workers’ compensation systems (see reported to the BLS has increased by Exs. 500–97; 500–97–1; 500–97–2; 500– 50%, while the percentage of lost [t]he employee’s personal healthcare 97–3; 500–218; 502–254; 502–258). The workdays has decreased by a substantial provider may also not understand that assignment of work hardening and/or AFL-CIO noted that: margin. returning the employee to work on restricted [t]wo states that have devoted significant This is not to suggest that instances of duty as soon as possible are important in the resources to workers compensation fraud fraudulent claims for WRP benefits will recovery process. The employer is much investigation and reporting, California and not occur, or that OSHA condones such more likely to select an HCP that recognizes Wisconsin, have found incidences of worker conduct by employees. Rather, OSHA the need to interface with the health and fraud to be minimal. In California, worker believes that the final rule provides safety staff in developing restrictions

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The following discussion and that it is completed in a timely manner. restriction that is consistent with the responds to public comment received Accordingly, EEI urges that any final opinion of at least one of the HCPs. and explains OSHA’s reasons for standard clearly provide that employers shall Paragraph (s)(5) allows the employer including the requirements in paragraph select the healthcare provider for the WRP and the employee to agree upon an (t) of the final rule. program, at least in the first instance. EEI alternative dispute resolution In the proposal, OSHA included, for would not object if the standard permits an mechanism to use in lieu of the one set each core element of the program, a employee to seek a second opinion. out in the final rule, if it is at least as ‘‘Basic Obligation’’ provision. The Ex. 32–300–1, p. 30. protective of the employee. For purpose of these sections of the The Agency believes that the concerns example, the employer and employee proposal was to summarize the more expressed by all of these commenters may agree in advance that the employee detailed subelements proposed for each are valid. OSHA agrees with the EEI that will see a certain HCP, whose core element. The final rule does not the employer should have the option of recommendation will be binding. The include these basic obligation selecting the HCP to provide the initial standard thus allows employers a degree provisions, because commenters found recommendation on a work restriction. of flexibility in structuring an them confusing and not useful. The final rule requires the employer to alternative dispute resolution process, Comments on specific aspects of the implement an MSD management provided that the employee’s right to a Basic Obligation section are discussed process that includes ‘‘access to an choice in the selection of HCPs is not below, in connection with the HCP.’’ The employer may fulfill this compromised, and the process is individual training requirements of the obligation by arranging for the injured expeditious. These provisions are final rule. employee to visit an HCP selected by similar to the multiple physician review The proposed Basic Obligation the employer. Alternatively, the mechanisms contained in OSHA health section for training provided that any employer may arrange for the employee standards, such as lead and training required by the rule was to be initially to visit an HCP selected by the formaldehyde. OSHA adopts them in provided ‘‘at no cost to employees’’ (see employee. Employers who choose this this final rule because they have proved the Basic Obligation section for option should assure themselves that effective in assuring that all parties have proposed section 1910.923). This the HCP has the appropriate experience confidence in the accuracy and fairness proposed language expressed OSHA’s to work with the employer in of medical determinations about work intention for the employer to bear all of determining work restrictions. restrictions and therefore contribute to the costs associated with OSHA- OSHA also agrees with commenters the overall effectiveness of the rule’s required ergonomics training. For about the need to assure accuracy and medical surveillance (MSD management example, any training materials given to competence in medical assessments. in this rule) provisions. employees must be provided to them Accordingly, paragraph (s)(1) provides free of charge. Further, employees must that if the employer selects the health Paragraph (t). Training be compensated at their regular rate of care professional to make a Training is a critically important pay for time spent receiving training recommendation about a work element of the final ergonomics program during regular work hours, and restriction, the employee may select a standard, as it is of virtually every safety employees cannot be required to forfeit second HCP to review the first HCP’s and health standard (Ex. 26–2). In their regularly scheduled lunch or rest finding. If the employer allows the training for ergonomics programs, the periods to attend training sessions. In employee to select an HCP to make the goal is to enable employees at all levels addition, where training requires initial recommendation on a work of the organization—managers, employees to travel, the employer must restriction, the rule does not provide for supervisors or team leaders, and pay for the cost of travel, including any further review because OSHA expects employees—to: (1) Recognize the signs travel time occurring when the training that, in this situation, both parties will and symptoms of musculoskeletal activities are scheduled outside of the have confidence in the HCP’s findings. disorders (MSDs) so that they can report employee’s normal work hours. On the other hand, if the employee has them early (employees) and respond to The final rule does not contain this seen an HCP on his or her own, before them appropriately (managers, specific proposed language about the the employer has exercised its option to supervisors, and team leaders); (2) costs of training, because that language select an HCP, the employer may refer identify those job tasks that pose an is not necessary for OSHA to impose the employee to a different HCP. In this increased risk to the worker of these costs on the employer. The case, the employee may rely on the developing an MSD; and (3) have the proposed provision merely restated recommendation he or she has already knowledge and skills necessary to OSHA’s longstanding policy, which obtained as the second opinion for participate in the establishment’s requires employers to bear the costs of purposes of the final rule. ergonomics program. The success of complying with safety and health If the second HCP’s determination ergonomics programs depends to a great requirements promulgated under the differs from the first, the employer must extent on the effectiveness of the Act. OSHA finds it reasonable and take reasonable steps to arrange for the training in ergonomics the employer appropriate for employers to bear the two HCPs to discuss and resolve their provides. costs of training because, under the disagreement. This means that the Most comments on the proposed Occupational Safety and Health Act of employer should instruct his HCP to training provisions were supportive, 1970, employers are responsible for contact the employee’s HCP to discuss although many commenters suggested providing a safe and healthful the matter directly. If the two HCPs modifications to the proposed workplace, and training is an integral cannot resolve the conflict quickly, the requirements (see, e.g., Exs. 30–3826, part of this responsibility. It is clear that employer and the employee, through 32–111–4, 32–182–1, 30–3686, 32–198– having employees bear such costs their HCPs, must designate a third HCP 4, 30–3765, 32–339–1, 32–198–4–15, would discourage participation in

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They stated that Several organizations commented on concept. all workers, or all general industry OSHA’s interpretation of the proposed OSHA’s reasoning in including these employees (see, e.g., Exs. 30–3826, 30– ‘‘at no cost to employees’’ language (see, requirements in the final rule is that, 297, 30–4538), or all workers in the e.g., Exs. 30–3813, 30–3686, 32–339–1). once employees in jobs meeting the industry (see, e.g., Ex. 30–3686) should With reference to the preamble to the action trigger have been trained, they be trained. Some stated that, although proposal [64 FR 65833], which will be able to report MSD hazards and all employees should receive training, explained that employees could not be problems early enough to prevent employers should conduct more required to forfeit regularly scheduled problems from becoming worse and to extensive training specifically for those lunch or rest periods to attend training protect other employees in the same job in problem jobs (see, e.g., Ex. 30–4538). sessions, one organization stated that from incurring a similar MSD. Early The thrust of these comments, in OSHA had cited no evidence showing reporting informs employers of the need general, was that the training required that employees receiving training on to address MSD hazards and provide by the standard should be expanded MSDs during ‘‘brown bag’’ lunch MSD management. Trained employees beyond employees in problem jobs (see, sessions or during ‘‘scheduled rest can also participate more effectively in e.g., Exs. 30–3826, 30–3686, 32–182–1, periods’’ would be harmed by this the program and thus better protect 30–3765, 32–198–4, 30–297, 30–4538). practice. This commenter contended themselves by working safely. OSHA For example, Dow Chemical stated, further that OSHA’s interpretation of the also believes that the supervisors (or ‘‘no-cost’’ provision was an intrusion team leaders or lead employees) of Employees having an active role in the prevention of MSD injuries and information into workplace management and employees in these jobs must be trained on how best to recognize and control MSD scheduling, which should be the because they are the personnel to whom hazards is a necessary component of a employer’s exclusive prerogative (Ex. employees report their symptoms and successful program. In fact, Dow encourages 30–3813). In contrast, other the presence of MSD hazards. such training for employees, beyond whether organizations supported the ‘‘no cost to Supervisors are in a position to ensure they are in a ‘‘problem job’’ or not. All work employees’’ requirements of the that employees in such jobs understand activities involve some bodily movement and proposed rule (Ex. 30–3686) and the conditions that may lead to MSDs therefore MSD risks are always present. Dow additionally urged OSHA to limit supports internally a more pro-active sharing and use the work practices and of this type of information rather than training to working hours (Ex. 32–339– procedures established by the employer waiting for an MSD to present itself (Exhibit 1). to control MSD hazards. Also, in many 30–3765). OSHA has no objection to training cases, supervisors are in a position to Expanding the scope of the required during brown bag sessions or breaks, observe MSD hazards first hand and to training to include more employees, and provided that employees are paid for recognize when MSDs are developing in to include employees who have not this time (and, of course, that no laws the workers they supervise. governing break times are contravened OSHA also believes that training is experienced an MSD, would clearly to comply with this provision). Many critical for those individuals who make this program element more employers do have paid lunch hours or establish, administer, and implement proactive, as many commenters urged half-hours and breaks where training the employer’s ergonomics program. (see, e.g., Exs. 30–3826, 32–111–4, 30– can occur without risking non- Because these managers represent the 3686, 32–182–1). Some participants compliance with this provision. employer, it is in the employer’s best argued that the full program, including However, if these time periods belong to interest that program administrators and training, should be implemented employees, i.e., are not periods that are others responsible for implementing the without waiting for workers to report on the clock, they cannot be used for the program be as knowledgeable as injuries (see, e.g., Ex. 32–198–4). Others training required by this standard. possible. Also, as these managers suggested that training be part of new employee orientation (see, e.g., Ex. 500– Who Should be Trained? become more knowledgeable, they will provide better training to their 180–51) be provided when workers are OSHA proposed that employees in employees in the ergonomics program. transferred (Ex. 32–182–1), or be given ‘‘problem’’ jobs (defined in the proposal Of course, as the proposal noted, when the ergonomics program is first as those jobs in which an employee had outside consultants do not have to have implemented or new employees are experienced a covered MSD and employer-provided training because hired (see, e.g., Ex. 32–198–4). One performed activities involving exposure consultants are responsible for commenter stated that the training to risk factors for a substantial amount preparing themselves to perform their requirements of the proposed rule, (or as a ‘‘core element’’ of the work professional duties. unlike the case in other OSHA rules, do shift), their supervisors, and persons The question of who should be not apply to workers who are only involved in the ergonomics program trained was a significant issue in the potentially exposed but instead apply (except for outside consultants) be rulemaking. Commenters offered only to workers who are actually trained initially, periodically as needed, opinions on a variety of issues and exposed (Ex. 32–339–1). and at least every three years. The final represented conflicting viewpoints. The Given the central role of the workers in an rule, at paragraph (t)(1), includes similar major issues with respect to who should effective ergonomics program (e.g., reporting requirements, although the final rule’s be trained under the ergonomics rule symptoms and hazards and making initial and follow-up training were: recommendations about controls), we believe requirements apply only to jobs that • The scope of the training provision, that more regular training is warranted (Ex. 32–339–1). meet the Action Trigger, rather than to • The number of employees to be ‘‘problem jobs,’’ as proposed. In trained, Another comment addressed the addition, while the final rule requires • Whether supervisory employees effect that training only some employees initial and 3-year follow-up training, it should be trained, and might have on employee morale. This does not require ‘‘refresher’’ training at • The training and qualifications of commenter noted that, in some other intervals. The specified initial and trainers. ergonomics pilot training programs,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00143 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68404 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations employees who perceived that they other employees in the establishment employees in a given job to meet the were not going to be included in the with the same job, the final rule’s prevalence or statistically significant program (whether rightly or wrongly) structure is more like that of other tests suggested by these commenters. because they were not trained when OSHA standards (e.g., the hearing Such an approach is clearly others were, felt excluded and were conservation amendment to the unprotective for the many thousands of later less cooperative (Ex. 32–194–4). occupational noise standard, 29 CFR workers in small- or mid-sized OSHA also received comments 1910.95), as some commenters establishments who would not receive recommending that: (1) training be suggested (see, e.g., Ex. 32–339–1). training even in cases where they have limited to employees with MSDs and However, because OSHA has designed experienced an MSD incident. the employees’ supervisors (Ex. 30– the final rule to target those situations OSHA concludes, after a 3813) rather than, as proposed, to all where the problem is most serious, the comprehensive review of the record on employees with the same job as the standard’s training requirements are the issue of who should receive the injured employee; (2) different groups of triggered for a job only when the action training required by the final rule, that employees be given different levels of trigger has been met for that job, and paragraph (t)(1) strikes the right balance training (Ex. 30–240); and (3) the formal not, as some commenters suggested, on inclusiveness. It does this by program apply only to specific when the program is first implemented requiring training for each employee employees in jobs where ergonomic (see, e.g., Exs. 32–198–4). who has experienced an MSD and issues are prevalent (Ex. 30–240). One The Agency does not agree with those works in a job that meets the Action commenter stated that training should commenters who stated that training Trigger, and all other employees be triggered only when a statistically should be required only for injured working in that job. significant percentage of employees in a employees and their supervisors (Ex. The final rule requires the supervisors job have incurred, within the year, 30–3813), or only for employees in jobs or team leaders of these employees to be work-related, HCP-diagnosed MSDs that where ergonomic issues are ‘‘prevalent’’ trained, so that they will encourage resulted in days away from work (Ex. (Ex. 30–240), or only for employees in early reporting, know how to respond to 30–3344). jobs that have caused MSDs in a employee reports, reinforce good work The final rule’s training provisions statistically significant percentage of practices, and be familiar with (paragraph (t)), together with the employees within the prior year (Ex. 30- ergonomic principles and practices. informational requirements in 3344). Restricting the number of Several commenters (Exs. 30–3765, 32– paragraph (d), address many of the employees receiving training in ways 198–4, 30–3859) commented on the issues raised by commenters. First, suggested by these commenters would proposed requirement to train the OSHA has adopted a ‘‘tiered’’ approach be, in OSHA’s view, both inappropriate supervisors of those in higher risk jobs. to training. The Agency agrees that all and insufficiently protective. First, One commenter noted that the term employees should receive orientation or limiting training to injured employees ‘‘supervisor’’ is no longer used in some awareness training (see, e.g., Exs. 30– and their supervisors would eliminate workplaces, which are organized in less 3686, 32–182–1, 32–198–4) but those at one of the standard’s proactive features, traditional management structures (Ex. greater risk must receive more extensive i.e., that other employees holding the 30–3765). This commenter pointed out training (see, e.g., Exs. 30–3686, 32– same job as the injured employee be that some managers may direct more 339–1, 30–240). Paragraph (d) of the trained in the risk factors in that job, the than a hundred employees, and that final rule requires that general signs and symptoms associated with the these employees may be widely awareness information be provided to MSDs caused by those risk factors, and dispersed geographically. In the view of all current employees and new hires. ways to protect themselves from this commenter, the rule should state This new provision also addresses the experiencing an MSD. OSHA believes that employers must train concerns of those commenters (see, e.g., that this provision of the standard will ‘‘knowledgeable resources,’’ rather than Exs. 30–3826, 30–297, 30–4538, 30– contribute substantially to the stipulating that supervisors must be 3686, 32–182–1, 30–3715, 32–198–4) standard’s effectiveness by ensuring that trained. In the final rule (at paragraph who argued that as many employees as all employees in these higher risk jobs (t)(1)(ii)), OSHA states that employers possible should be aware of MSD receive training. A recent study showed are required to train the supervisors or hazards and how to prevent them. The that employers were likely to limit their ‘‘team leaders’’ of employees in jobs that awareness information required by final efforts to control MSD hazards to the meet the Action Trigger. The addition of paragraph (d) also should help to avoid injured worker’s job and not to extend the term ‘‘team leaders’’ conveys the dampening effect on employee preventive practices to other workers in OSHA’s intent, which is to require first- morale noted by one commenter (Ex. the establishment who had the same job level management personnel to be 32–194–4). (The summary and (Ex. 30–651–2). OSHA believes that this trained, whatever their official title may explanation for paragraph (d), above, provision of the standard will ensure be (supervisor, team leader, team provides more detail on the general that all at-risk workers in the same job manager, knowledgeable resource, and information requirements.) will be protected. Absent such a so forth). OSHA is also aware that many Second, training is required by the provision, this preventive effect would workplaces rely on members of an final rule for employees in jobs that be lost. ergonomics committee, joint labor- meet the standard’s Action Trigger. Third, limiting training only to management, or a trained group of OSHA views the occurrence of a work- employees in jobs where ergonomic employees (see, e.g., Ex. 30–115); related MSD and the presence of risk injuries are ‘‘prevalent’’ (Ex. 30–240) or however, the standard does not factor(s) at the level(s) indicated by the where a statistically significant specifically address the training of these Basic Screening Tool as an indication percentage of employees have had an employees. that the job is one that warrants a closer MSD in the last year (Ex. 30–3344) Paragraph (t)(1)(iii) specifies that look. Such a job has the potential to would deny the standard’s training employers also must train ‘‘other expose workers in the job to MSD benefits to all injured and potentially employees involved in setting up and hazards. Because the two-part action exposed workers except those working managing’’ the employer’s ergonomics trigger in paragraph (e) triggers training in very large establishments, since only program. This provision is similar to the for the injured employee and for all such establishments would have enough proposed provision, except that it

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00144 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68405 substitutes ‘‘employees’’ for ‘‘persons’’ 3001, 30–3033, 30–3034, 30–3035, 30– years). In a business such as this, (the proposed term). OSHA has directed 3258, 30–3332, 30–4159–30–4536, 30– ergonomics awareness is likely to be this provision to employees rather than 4546, 30–4547) urged OSHA to require quite high, both because of the amount persons because doing so makes it clear refresher training more frequently than of training going on and because of the that the Agency is not regulating once every three years. job hazard anlysis and control activities individuals operating outside of the Some of the reasons cited by these being conducted. In other words, the employment relationship. commenters for more frequent training initial training and 3-year follow-up Initial and Refresher Training. The included: training requirements will virtually proposed rule required that training be • Many workers experience problems ensure that ergonomics training will be given in accordance with the following in less than a year (Ex. 32–198–4–1/42). a regular part of the program for many • timetable: Training should be required employers. In response to those annually and whenever jobs or commenters who argued that refresher conditions change (Ex. 30–3686). training every three years was • Employers should train every two For employees (1) When a problem job is unnecessary or burdensome, OSHA years at a minimum because many notes that the standard allows in problem defined; employers are already providing jobs and (2) When initially assigned to employers considerable flexibility in the their super- a problem job; training on an annual basis (Ex. 32–198– form that training must take. For visors. (3) Periodically as needed 4). example, although all of the required (e.g., when new hazards Other commenters requested that topics must be addressed in the are identified in a problem OSHA require training less often or refresher training, trainers who observe job or changes are made require training less often in some that trainees ‘‘know the basics’’ are free to a problem job that may situations (see, e.g., Exs. 32–300–1, 30– to spend more of the training time on increase exposure to MSD 3813, 30–3765, 30–327, 30–710, 30– such workplace-specific topics as hazards); and 2725, 30–3284, 30–4046). Some specific (4) At least every 3 years. changes to workstations that have taken reasons given for less frequent retraining place since the last training. For persons in- (1) When they are initially were: volved in assigned to setting up and • There should not be a minimum Some commenters argued that many setting up managing the ergonomics three year retraining provision for workplaces are static rather than and man- program; employees where the reported MSD has dynamic in nature and therefore that aging the (2) Periodically as needed resolved within the three years and no workers in them do not need refresher ergonomics (e.g., when evaluation re- other MSDs (affecting the same part of training (see, e.g., Exs. 30–2835, 30– program. veals significant defi- 3356). OSHA disagrees. MSDs occur in ciencies in the program, the body) have been reported in that job (Ex. 30–3813). workplaces with fixed workstations, in when significant changes • service industry jobs, and in office are made in the Employees will retain knowledge ergonomics program); and about their job’s core functions, like settings; indeed, one of the striking (3) At least every 3 years. how to use controls and work practices characteristics of MSDs is that they properly, even without training (Exs. occur in all general industry sectors (see In the final rule, OSHA has revised 32–300–1, 30–3284). the risk assessment section of this the timetable for initial training to • OSHA should allow employees and preamble, Section V). Whenever MSDs reflect the addition of the Action Trigger supervisors to demonstrate knowledge occur in jobs that meet the action to the standard, and to allow time for retention so that they can be exempt trigger, OSHA believes that workers in the employer to conduct the job from the three year retraining these jobs should be trained initially, screening process and implement the requirement (see, e.g., Exs. 32–300-1, and that they should also receive ergonomic program. Accordingly, 30–327, 30–1671, 30–328). follow-up training at least every three paragraph (t)(4) provides the fillowing • Program administrators should be years. This approach ensures that those timeframes for initial training: When the allowed to bypass portions of initial and workers who are clearly at risk have the employer determines that an employee’s refresher training if they already possess knowledge and skills they need to work job meets the Action Trigger, the background training. This group could as safely in those jobs as possible. The employer has 45 days from that time to include health and safety personnel, approach taken in the final rule—to train employees involved in setting up medically trained personnel, and require refresher training only for and managing the program, and 90 days ergonomists (see, e.g., 32–300–1, 30– employees, and the supervisors of from that time to train each current 327, 30–1671, 30–3284). employees, in jobs that meet the Action employee in that job and their OSHA responds to these comments on Trigger—is also responsive to those supervisor and team leader. Also, if the the appropriate frequency of training as commenters who argued that no such employer assigns a new or current follows. First, OSHA believes that training should be required if the employee to a job that the employer has refresher training every three years for problem has gone away (see, e.g., Ex. already determined meets the Action those in higher-risk jobs is appropriate, 30–3813). OSHA is unsympathetic to Trigger, that employee must be trained given the very broad range and diverse those who believe that employees do prior to starting the job. nature of businesses covered by this not need refresher training because they Paragraph (t)(1) of the final rule also standard. For example, the number of will remember what they need to know requires follow-up training, every three employees in the average business about the ‘‘core functions’’ of their job years, for employees whose jobs meet covered by this standard is 16; such a (see, e.g., Exs. 32–300–1, 30–3284). This the Action Trigger. This requirement business is likely to experience not is not OSHA’s experience, and the differs from the corresponding proposed more than one or two MSDs in a given thousands of fatal and disabling injuries provision, which did not rely upon the year, at most, which means that one or that occur in U.S. workplaces every year Action Trigger concept. two employees will receive initial confirm the fact that workers and their Several commenters (see, e.g., Exs. training every year and one or two will supervisors often do not remember the 32–198–4, 32–198–1/42, 30–3686, 32– need refresher training (once the safe operating procedures in which they 339–1, 30–2116, 30–2825, 30–2847, 30– standard has been in effect for a few were trained.

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OSHA has not adopted the suggestion and resource-intensive. OSHA agrees the program with reducing lost-time of some commenters (see, e.g., Exs. 32– that this is the case; however, injuries by 64% within the first year 300–1, 30–327, 30–1671, 30–328) that ergonomics training is essential for each (Ex. 500–71–61). The record thus employees and supervisors who can employee who experiences an MSD demonstrates that persons with a wide demonstrate that they have retained the incident in a job that meets the Action range of credentials, skills, and information they learned be exempted Trigger, even if that employee is only in experience can effectively train from refresher training. OSHA has not the job for a few weeks or months. employees, supervisors, and managers, done so because refresher training is Employers may also find that training provided that they themselves have only required every three years and the helps to reduce turnover to the extent been well-trained. Agency believes that periodic retraining that ergonomic stress plays a part in Topics for Training. Paragraph (t)(2) is appropriate for all employees in the employees’ decisions to leave of the final rule requires that the program. For the same reasons, the employment. As discussed below, employees identified in paragraph (t)(1) standard does not permit managers and paragraph (t)(5) also allows that if an be trained in the following topics (as supervisors to demonstrate knowledge employee has been trained in a topic appropriate to their responsibilities in and be exempted from refresher required by paragraph (t)(2) within the the ergonomics program): training, as some commenters suggested previous 3 years, the employer need not • The employer’s ergonomics (see, e.g., Exs. 32–300–1, 30–327, 30– provide initial training in that topic. program and their role in it; 1671, 30–3284). However, the final rule OSHA believes that this provision will • The signs and symptoms of MSDs does not use the word ‘‘persons,’’ as the reduce the burden on employers in and ways of reporting them; proposal did, because OSHA agrees high-turnover industries, at least to • The risk factors and MSD hazards with commenters that persons who are some extent. present in the employee’s job, as not employees (e.g., independent or self- The training and qualifications of the identified by the Basic Screening Tool employed ergonomists, safety individuals providing the training and the job hazard analysis; specialists, industrial hygienists, and so required by the final rule was the topic • The employer’s plan and timetable forth) are responsible for their own of several comments (see, e.g., Exs. 32– for addressing the risk factors and training. 111–4, 30–3686, 32–194–4, 32–182–1). hazards identified; To those commenters who argued that These participants stressed the • How to use engineering, work more frequent refresher training should importance of the qualifications of the practice, and administrative controls, or be required because many employers are trainers to effective ergonomics any PPE, that will be used in the job; already doing it (see, e.g., Ex. 32–198– programs, and one commenter (Ex. 32– and 4), OSHA responds that employers are 194–4) expressed concern that, if • How to evaluate the effectiveness of always free to provide more frequent program evaluations were conducted by the control approach adopted to reduce training than OSHA requires. OSHA untrained managers, inadequate the risk factors and MSD hazards. does not agree, as some commenters evaluations could result. With two exceptions, these are the same maintained, that employees will OSHA agrees that the knowledge and training topics (with minor editorial continue to remember the essential skills of those administering ergonomics changes) that OSHA proposed. The two elements of their training, such as how training play a major role in the exceptions are specific training in the to implement controls, without refresher effectiveness of the training. However, requirements of the standard and in the training. Instead, OSHA believes that all the final rule does not specify the importance of early reporting of MSD employees in jobs posing MSD hazards credentials or experience such trainers signs and symptoms. OSHA has not will benefit from the reminders and or program managers must have. included these topics in the list of updating that refresher training Ergonomists, safety professionals, training topics in the final rule because provides. industrial hygienists, and individuals the hazard information provided to OSHA also is not persuaded by who have taken ergonomics courses, employees under paragraph (d) of this arguments (see, e.g., Exs. 30–3765, 30– attended train-the-trainer sessions, and standard already includes this 3813) that program managers should not learned the basics of ergonomics on-the- information. Thus all employers have to be retrained. These personnel, job are currently providing the training covered by the standard will have like employees, will benefit from being presented in existing, effective access to a summary of the standard and renewing their knowledge base and ergonomics programs and have will be aware of the importance of early updating their skills every three years, demonstrated their ability to be effective reporting. particularly since they only receive this trainers. A recent study (Ex. 500–71–64) OSHA believes that training in the training if the employees under their from the International Journal of topics listed in paragraph (t)(2) is an supervision are in jobs that warrant it. Industrial Ergonomics reports that important way to ensure that employees OSHA does agree that training is more trained workers do an exceptional job in at all levels of the organization have the difficult in workplaces with high identifying risk factors and solutions: in information and skills they need to turnover. The Agency believes that the 65 to 85 percent of cases, professional participate effectively in the ergonomics standard may help employers to reduce ergonomists and trained workers program. Only workers trained to turnover, as good ergonomics programs identified the same risk factors when recognize MSD hazards and MSD signs have done in many workplaces (see the they performed job hazard analyses. The and symptoms, to use the controls case study table in Section VI of the authors of this study concluded that implemented to reduce these hazards, preamble). ‘‘users [trained employees] can identify and to evaluate the effectiveness of The difficulties of training short-term rather reliably the risk factors in the these controls, can make the program employees, some of whom may only jobs.’’ work in terms of reducing work-related stay with the host employer for a week Train-the-trainer sessions involving MSDs. or less, were discussed by one employees also have achieved excellent There was substantial disagreement commenter (Ex. 30–240). According to results; for example, a hospital that among those commenters who this comment, training short-term introduced patient handling equipment addressed the content of the proposed employees in a high-turnover and conducted extensive train-the- training requirements. Several felt that environment is both time consuming trainer and employee training credits the list of training topics should be

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00146 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68407 expanded, while others argued that protection. The required topics are implementing the program) and urged some requirements should be deleted. In general, in order to allow the flexibility employers to work closely with health addition, many commenters submitted needed in different workplace care professionals. These commenters data and information showing that situations. This approach is consistent were concerned that, without such training programs can achieve with the training content requirements assistance, managers would be tempted significant results in reducing of other OSHA standards (see, e.g., 29 to buy expensive but ineffective workplace MSD hazards and associated CFR 1910.1018 and 29 CFR 1910.147). ergonomic fixes and purchase products MSDs. The final rule requires training in the that do not address the root cause of the Examples of some of the suggestions employer’s ergonomics program and problem (Exs. 30–614–, 30–898, 30– commenters had for revising the each employee’s role in it; the signs and 4139). proposed training topics included: symptoms of MSDs and ways of Other stakeholders suggested that • OSHA should specifically require reporting them; the risk factors and OSHA train its compliance officers to that employers provide training on the MSD hazards present in the employee’s have, at a minimum, the same level of requirements for medical management, job, as identified by the Basic Screening knowledge as consultants advising Work Restriction Protection, and the Tool and the job hazard analysis; the employers in ergonomics programs (see, standard’s prohibition against employer’s plan for addressing e.g., Exs. 30–1037, 30–3922). These discouraging workers reports (Exs. 32– identified hazards, including the commenters urged the OSHA training 111–4, 32–339–1). employer’s timetable to abate the centers to make ergonomic certification • Work Restriction Protection should hazards identified; training in how to programs and other courses available to be explained during the initial training use the controls in the job, including the public or at least to make employers (Exs. 30–4538, 32–339–1). any personal protective equipment; and aware of sample programs that already • First-line supervisors as well as the how to evaluate the effectiveness of the exist (see, e.g., Exs. 30–1037, 30–3123, program manager should have hazard control approach used. 30–3128). analysis training (Ex. 30–3826). OSHA believes that the required OSHA does have programs in place to • Training should include topics constitute a minimal training help employers with their ergonomics discussions of medical records program and recognizes that many programs. The Agency offers free confidentiality, job hazard analysis employers may choose to administer consultation services through the states. (including ergonomic assessment of more extensive training. OSHA The OSHA consultation program is work stations) and disease and anticipates that many employers will specifically designed for small- and disability related to ergonomic injuries cover such topics in their training medium-size organizations (i.e., (Ex. 30–3686). programs as OSHA’s discrimination employers with 250 employees or fewer • OSHA should include both detailed regulations (Section 11(c) of the Act), per site or 500 per organization). These and more general topics in initial Work Restriction Protection, MSD services are confidential, and training, and job-specific training for management, and multiple HCP review. consultants will not issue citations or employees in problem jobs and their Several of these topics are briefly propose penalties. OSHA also offers off- supervisors (Ex. 32–198–4). addressed in the information on the site services to larger organizations and • Training should cover the standard employees receive in response on-site services on a priority basis if importance of height differences among to the requirements of paragraph (d). resources permit. OSHA staff are employees, the training of lift team OSHA believes that training under available to answer questions from the members, and the importance of paragraph (t) should concentrate public any time during OSHA working labeling packages with their weights primarily on MSDs and MSD hazards hours. In addition, OSHA makes a wide (Exs. 32–461–1, 30–115, 30–4538). that are specific to the employee’s job. range of ergonomics-related materials Other commenters recommended that OSHA has also not included the more available on the Agency’s website, certain subjects be deleted from the detailed topics—package weight www.osha.gov. required training topics. For example, labeling, the importance of height With respect to the training of several commenters suggested that differences among employees, lift team compliance officers and other OSHA training on the specific requirements of training, and so forth—suggested by staff, OSHA’s Training Institute in Des the standard be deleted from the list commenters (see, e.g., Exs. 32–461–1, Plaines, Illinois, provides basic and (see, e.g., Exs. 30–3765, 32–300–1, 30– 30–115, 30–4538). Such topics are advanced ergonomics courses for 240, 30–3284). These commenters were workplace-specific and thus not Federal and State compliance officers, of the opinion that there is no need to appropriate to include in general State consultants, other Federal agency provide in-depth training on the training requirements that will apply to personnel, and private sector employers, standard itself, but that the training all workplaces covered by the standard. employees and their representatives. should instead focus on elements of the Some commenters recommended that Also, the Training Institute has standard only as they specifically apply OSHA expand its training activities by established Training Institute Education to the company’s program. Further, developing outreach training programs Centers, which are nonprofit colleges, these commenters believed that and other compliance assistance universities, and other organizations employees have ample access and materials (see, e.g., Exs. 30–3686, 30– selected after competition for opportunity to familiarize themselves 4538, 32–198–4, 30–3826, 30–614, 30– participation in the program. In with OSHA standards, including access 1037, 30–2806). Some specific addition, OSHA provides funds to to OSHA’s internet homepage (see, e.g., suggestions were that OSHA develop a nonprofit organizations through grants Ex. 330–3765). sample curriculum, including to conduct workplace training. Grants OSHA agrees that the specific audiovisuals (Ex. 30–4538), or that are awarded annually to grant suggestions for additional training OSHA provide a curriculum, instructor recipients, who contribute at least 20% content made by commenters would be materials (and translations), and of the total grant cost. OSHA has already useful to employees. However, the training videos at minimal cost (Ex. 32– trained many of its CSHOs extensively Agency has decided to require only that 198–4). Other comments urged OSHA to in ergonomics, and has made regional employees be trained in those basic establish an ‘‘advice line’’ for program ergonomics coordinators available in the topics that are essential to worker managers (those setting up and regional offices. In addition, OSHA is

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00147 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68408 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations making extensive outreach materials on administered varied widely, from very provision to assure themselves that ergonomics available with the final simple training to comprehensive employees have in fact had the prior standard. efforts. OSHA believes that the training training and have sufficient knowledge Effectiveness of Training. Some program required by the final rule will to work safely. stakeholders submitted data to the do much to increase the level of A number of commenters objected record on the effectiveness of ergonomics knowledge and either to the prior training exemption ergonomics training. Several understanding among employees, their altogether or to the fact that OSHA commenters noted that they had supervisors, and managers. This proposed to permit training given in the developed training programs, had knowledge, in turn, will translate in 3 years prior to the compliance date to coordinated programs through outside practice to fewer MSDs, improved qualify for the portability exemption organizations such as universities, or morale, and greater productivity. There (see, e.g., Exs. 30–3686, 30–2116, 30– were in the process of developing or is evidence in the record that good 2809, 30–2825, 30–2847, 30–3001, 30– testing training programs (see, e.g., Exs. training programs operate in just this 3033, 30–3035, 30–3258, 30–3332, 30– 30–3826, 32–198–4, 32–77–2, 32–185–3, way. For example, a 1997 article in the 4159, 30–4536, 30–4546, 30–4547). 30–1294, 30–3336, Tr. 2776, Tr. 2761, American Journal of Health Promotion OSHA has decided in the final rule to 30–449, 30–2713, 30–3368, 30–3758, [Ex. 500–71–63] reports that ergonomics retain the training exemption as 30–3867, Tr. 3129–3219, Tr. 14969– training programs lasting about an hour proposed, because the Agency believes 15072). Stakeholders described some of and administered to computer operators that employees who have received all of the achievements of these programs described in the article as ‘‘high risk’’ the required training elsewhere do not (see, e.g., Exs. 32–198–4, 32–185–3, 30– led every trainee subsequently to make need to be retrained until their refresher 449, 30–3336, 30–3758, 30–3867, Tr. changes either in their workstations or training date comes up. Although 7982), including their contribution to their work practices. About two-thirds employees who have had prior training the decrease in the rate of MSDs of the trainees made ergonomically are not required to take initial training, observed among their members (Tr. advantageous changes to both. all employees in jobs that meet the 7982) and continued reductions in Another study (Ex. 500–71–59) Action Trigger must receive refresher workers’ compensation costs even in the reports that factory processing line training. face of increases in wages and health workers who were trained in MSD OSHA received several non-specific care costs (Exs. 30–3336, 30–3867, 30– hazard recognition were subsequently comments only tangentially related to 4496). The thrust of these comments is better able to recognize hazards and the proposed training provisions. These that ergonomically aware workers can more willing to report them to their primarily concerned what the help their co-workers and their supervisors. OSHA believes that the commenters perceived as ‘‘vagueness’’ employers to prevent MSDs (Ex. 30– experiences of these companies will be in the proposed language of the 3758). repeated frequently once the final rule’s regulatory text. For example, some Several studies in the record training requirements are implemented. participants believe that employers will demonstrate the benefits of ergonomics Retraining of employees who have not be able to train their employees training. For example, a study by already received training. The proposed because, in their opinion, the standard Parenmark, Engvall, and Malmkvist rule stated that employers do not have isn’t clear about the steps that need to showed that workers receiving training to provide initial training to current be taken (see, e.g., Exs. 32–368–1, 30– had a reduced number of lost workdays employees, new employees and persons 325, 30–494, 30–2846) and assert that due to MSDs compared with untrained involved in setting up and managing the this will make training more difficult controls (Ex. 26-6). The number of days ergonomics program if they have and costly than usual (see, e.g., Exs. 32– lost as a result of arm-neck-shoulder received equivalent training in the 368–1, 30–1668, 30–2846, 30–3781, 30– complaints was reduced by half in the subjects this standard requires within 3593). trained new hires compared with the the last 3 years. However, the proposal In the final rule, OSHA has revised control group (Ex. 26–6, Table 2). stated that employers must provide the proposed standard’s training An AFGE health and safety initial training to such individuals in requirements extensively and has representative referenced an Ergonomic any of the required topics that their clarified areas of overlap and confusion. Workplace Survey conducted by Rani prior training did not cover. The final For example, the basic information Lueder, CPE, for the Social Security rule, at paragraph (t)(5), provides that if requirements in paragraph (d) now Administration in 1997 (Ex. 30–449). an employee has received training in a apply to all covered employers and are The large majority of respondents who required topic within the previous 3 intended to ensure that all employees received the training considered the years, the employer need not provide are familiar with the elements of the training helpful, and the trained initial training to that employee in that OSHA standard, and this topic is no respondents reported consistently lower topic. longer also included in the required rates of discomfort for all body parts, Several commenters supported this training topics. were more willing to report MSD proposed requirement (see, e.g., Exs. Some commenters argued that OSHA discomfort to their supervisors, and 30–3765, 32–300–1, 30–1671, 30–3284). should phase in compliance were more satisfied than untrained Some organizations asked OSHA to requirements for the training provisions workers with their supervisors’ clarify how the Agency expects an because it will take time to develop responses (Ex. 30–499). Also, employer to verify such prior training adequate in-house materials. OSHA is respondents who were trained were (Exs. 30–3826, 32–300–1). OSHA does aware that it takes time to develop more likely to adjust their chairs, not require employers availing training materials, but OSHA is also worktables, and other equipment to themselves of this ‘‘portability of aware that many trade associations and reduce the risk factors present. training’’ provision to have written other organizations, as well as Many commenters at the hearings documentation of the employee’s prior employers, already have such materials. described the training component of training or to require the employee to Further, OSHA is making many their ergonomics programs (see, e.g., Tr. pass an examination (Ex. 30–3826). The outreach materials available at the time 12367–12373, Tr. 7977–7982). The Agency does, however, expect the standard is published and in the extent of the training being employers who wish to benefit from this months thereafter. Consequently, OSHA

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00148 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68409 believes that the time allowed for employees might not understand the work schedules, and dozens of other employers to come into compliance training well enough to ‘‘pass’’ the test items of daily importance to workplace with the rule’s training requirements if CSHOs asked them questions (see, operation and productivity. In other (see paragraph (x)) is appropriate. The e.g., Exs. 30–429, 30–494, 30–1090, 30– words, training is just another form of Agency is phasing in all elements of the 3122, 30–3557, 30–3593, 30–3781). communicating important information final rule; therefore, an employer’s These employers fear that they would be to employees, a process that is going on earliest requirement to train employees vulnerable to citation and penalty in in all U.S. workplaces at the present under this standard will not arise for such a circumstance. Commenters also time. As to the comment about the about a year after the publication date interpreted OSHA’s ‘‘in language the difficulty of complying with the rule in of the final rule. employee understands’’ terminology to workplaces that employ individuals What employers must do to ensure mean that they would have to test with mental disabilities (Ex. 30–3336), that employees understand training. employees to ensure adequate OSHA can only emphasize that the OSHA proposed that employers provide comprehension (see, e.g., Ex. 30–3557). same techniques employers use to ‘‘training and information in language Another commenter specifically transmit other essential workplace that employees understand.’’ The suggested that the final rule require the information to these individuals can be proposal also stated that employers employer to demonstrate that the used to provide the training required by must ‘‘give and receive answers.’’ The employees had understood the training the standard. final rule, at paragraph (t)(3), contains (Ex. 32–339–1). The final rule also does not require essentially the same requirements. Employers were also concerned about employers to test employees’ These requirements provide individual having difficulty finding good understanding or comprehension of the employers with considerable flexibility translations of training materials (see, training given. However, employers are in ways of achieving compliance (e.g., e.g., Exs. 30–4538, 30–240, 30–429, 30– free to do so if they wish, and OSHA is the ‘‘language’’ may be one all trainees 1090, 30–3868). One commenter noted, aware that many employers do evaluate understand rather than the trainee’s however, that training materials in the effectiveness of their training native language, so long as the trainee Spanish could be obtained from the immediately or soon after it is given. understands the language well enough Labor Occupational Safety and Health Thus, although the training paragraph to fully understand the training). Program at the University of California does not require employee testing, Employees have varying educational in Los Angeles (Ex. 30–4538). Some employers who wish to have some way levels, literacy, and language skills, and employers understood the proposed ‘‘in of ensuring that their employees training must be presented in a language language the employee understands’’ understand the training content may and at a level of understanding that terminology as meaning that they would establish any system that works for accounts for these differences in order have to train in each of the languages them. Employers are required by the to meet the intent of the final native to their workforce (see, e.g., Exs. standard to evaluate the training requirement that individuals being 30–240, 30–429, 30–1090, 30–3336, 30– component of their programs when they trained understand the specified 3557), and expressed concern about the do their periodic evaluations to ensure training elements. potential costs of such a requirement effectiveness. The final rule requires that employers (Ex. 30–3868). Some commenters (see, e.g., Exs. 30– provide opportunities for employees to One commenter (Ex. 30–3336) stated 4538, 30–3686, 32–339–1) ask questions and receive answers about that some companies in their industry recommended that the final rule’s the establishment’s ergonomics program had employees on the payroll who training requirements be revised to be and anything covered by the training. spoke 12 different languages; this more consistent with those of other Again, employers have complete commenter understood the proposal as OSHA standards, such as the flexibility in the methods they use to requiring native speakers in each of Bloodborne Pathogens rule (Exs. 32– comply with this requirement. For these languages to be available to 4538, 32–339–1), the Process Safety example, employers could choose to to receive and answer questions on the Management standard (Ex. 32–339–1) or do the training in-house or to use an content of the training and the the Hazardous Waste Operations and outside trainer. Other alternatives ergonomics program. Moreover, this Emergency Response standard (Ex. 30– would be for the employer to have a commenter argued that OSHA’s ‘‘multi- 3686). OSHA believes that the final qualified trainer available by phone, or lingual’’ training requirement presented rule’s requirements, in paragraph (t)(3), through a classroom video-conference. an even greater problem for their that the training be in language the Commenters addressed three issues industry because it had a history of employee understands and that related to the proposed requirement that employing ‘‘mentally challenged’’ employees be permitted to ask questions training be understandable to the individuals (Ex. 30–3336). and receive answers will together employee and that employees have the In response to these comments, OSHA achieve the objective desired by these opportunity to ask questions and receive reiterates that the final rule does not commenters, i.e., assurance that answers about their training. These require employers to present training in employees understand the training issues were: The meaning of the native languages of the employees thoroughly. ‘‘understanding’; the meaning of ‘‘ask working in the establishments. In many Several commenters asked OSHA to questions and receive answers’; and workplaces, although employees many clarify the phrase ‘‘ask questions and whether specific training methods have different ‘‘first’’ languages, they receive answers’’ (see, e.g., Exs. 30– should be included in the rule. understand English or another language 3826, 32–198–4, 30–3686, 30–376). Several commenters asked OSHA to well. The rule merely requires that the These commenters wanted clarification explain what it meant by requiring employer provide the training in a about the methods OSHA requires them training to be provided ‘‘in language the language the employee understands. to use to accomplish this (see, e.g., Exs. employee understands’’ (see, e.g., Exs. OSHA does not believe that this will be 30–3765, 30–3826). Other commenters 30–3826, 32–198–4, 30–3686, 30–3686, difficult, because employers are already recommended that the rule specify that 30–3765, 32–339–1, 30–1091). communicating with their employees employees be permitted to ask questions Commenters were concerned that, about safe working procedures, tool and and receive answers promptly even if despite their best efforts, some equipment care, project requirements, questions occur to them after the

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Suggestions requirement to which they refer. Paragraph (u)—What Must I Do To included: The proposed rule contained • Allow the use of electronic media, Make Sure My Ergonomics Program Is provisions requiring employers with telephone reviews, and videos (see, e.g., Effective? programs to review them periodically to Exs. 30–3826, 30–3765, 30–434, 30– The intent of the provisions of the ensure their effectiveness; identified the 3392). Program Evaluation paragraph of the procedures employers were required to • Require that training be provided in final Ergonomics Program standard is to follow when conducting evaluations; a supportive atmosphere that require employers to evaluate their proposed that evaluations be conducted encourages discussion of concerns with ergonomics program to ensure that it is as often as needed and at least every 3 respect to MSD-related working effective. Good management, as well as years; and proposed that program conditions and encourages common sense, suggest that periodic deficiencies identified during the opportunities for questions (Ex. 30– review of a program’s effectiveness is evaluation be corrected promptly. The 3686). necessary to ensure that the resources final rule’s program evaluation • Require training to be administered being expended on the program are, in provisions have been revised to reflect ‘‘live’’; prohibit written training (Ex. 32– fact, achieving the desired result and comments received, but are generally 198–4). that the program is doing so in an similar to those proposed. A commenter argued for the need for efficient way. Program evaluation is a Paragraph (u)(1) of the final rule live training as follows: tool that can be used to ensure that an provides for the frequency of required Employers often do not know at what level ergonomics program is appropriate for program evaluations. The methods and their employees are reading and the specific MSD hazards in the procedures employers are required to comprehending. Workers are generally employer’s problem jobs and that the use in such evaluations are included in reluctant to share information about their program is achieving desired results. paragraph (u)(1)(i) through (iv). literacy limitation (Sarmiento and Kay, OSHA has long considered program Provision is made for other events that ‘‘Workers Centered Learning,’’ 1990). It is evaluation to be an integral component may trigger program evaluations at more estimated that between 45%–50% of adults of programs implemented to address frequent intervals in paragraph (u)(2). In in America struggle due to some limitations health and safety issues in the in their literacy and/or language proficiency addition, the prompt correction of any (which result in limitation of workplace. For example, the deficiencies identified during the ‘‘understanding’’ or ‘‘reasoning’’), according Ergonomics Program Management evaluation is covered in final rule to ‘‘Adult Literacy in America’’ in Guidelines for Meatpacking Plants paragraph (u)(3). The following publications of the U.S. Department of (‘‘Meatpacking Guidelines’’) recommend discussion presents OSHA’s reasons for Education (1993). In addition, many of those regular program review and evaluation including revised program evaluation functioning at a limited literacy level don’t (Ex. 2–13). These guidelines suggest that provisions in the final rule, and see themselves as having these limitations procedures and mechanisms be summarizes the comments the Agency (Ex. 32–198–4). developed to evaluate the ergonomics received on the proposed program The same commenter recommended program and to monitor progress evaluation requirements. methods such as visual aids, discussion accomplished. Program evaluation is and problem solving, and small group described in the Meatpacking Paragraph (u)(1)—Frequency of Program ‘‘hands-on’’ sessions, and noted that Guidelines as a program component Evaluations workers are more likely to trust the whose use reflects both management OSHA received many comments (see, employers’ programs and develop commitment and employee e.g., Exs. 30–240; 30–1671; 30–3860; confidence if these more oral training involvement. OSHA’s 1989 voluntary 500–71–86; 500–137; 30–3686; 32–210– methodologies are implemented (Ex. Safety and Health Program Management 2; 32–85; Tr. 8982; 30–2116; 30–2809; 32–198–4). Guidelines also recommend regular 30–2825; 30–2847; 30–3258; 30–3035; In response to these comments, OSHA program evaluation as an integral 30–3001; 30–3033; 30–3034; 30–4159; restates the position it has taken program component (Ex. 2–12). Further, 30–4534; 30–4536; 30–4800; 30–4776; consistently in other standards: OSHA’s OSHA’s Voluntary Protection Programs 30–4546; 30–4547; 30–4548; 30–4549; objectives are to require employers to (V.P.P.) and Consultation Program 30–4562; 30–4627; 30–3332; 30–3259; provide basic training in ergonomics, to require periodic evaluations of an 30–4801; 30–3898; 30–4270; 30–4498; ensure that all trained employees employer’s safety and health program, 30–3813 ; 500–33; 30–3745; 30–3765; understand the training, and to permit including that portion of the program 30–3368; 30–4713; 30–4046; 30–4247) employees to ask questions if they need addressing ergonomic issues. on the proposed frequency of ergonomic further information. The Agency does The proposal contained a ‘‘basic program evaluations, as well as on the not dictate the methods that employers obligation’’ section that merely events that should trigger them. A few choose to achieve compliance with summarized the proposed program commenters (see, e.g. Exs. 30–240, 30– these requirements. Properly trained evaluation provisions. The proposed 1671, 30–3860, 500–137) agreed with employees will be sufficiently informed basic obligation section also stated that OSHA’s proposed 3 year time frame, to recognize the signs and symptoms of employers were to evaluate their while others stated that they believed a MSDs and the value of reporting them ergonomics program periodically, and at 3-year interval was too long and that early, to identify MSD hazards in their least every 3 years, ‘‘to ensure that it is program evaluations should take place jobs, to know how to use and evaluate in compliance with this standard.’’ periodically and at least annually (see, the control measures that the employer Because the basic obligation sections of e.g., Exs. 30–3686; 32–210–2; 32–85; implements to reduce those hazards, the proposed standard led to confusion and Tr. 8982).

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As mentioned above, OSHA received and Edison Electric Institute (EEI) (Ex. program must be re-evaluated.’’ In the many comments (see, e.g., Exs. 30–2116; 500–33) asked that the standard’s view of these commenters, every report 30–2809; 30–2825; 30–2847; 30–3258; language be changed to reflect their of an MSD injury or persistent MSD 30–3035; 30–3001; 30–3033; 30–3034; belief that a requirement to evaluate an symptom points to a deficiency in the 30–3686; 30–4159; 30–4534; 30–4536; ergonomics program both periodically ergonomics program that must be 30–4800; 30–4776; 30–4546; 30–4547; and every three years was excessive. evaluated and corrected. OSHA agrees 30–4548; 30–4549; 30–4562; 30–4627; Both commenters agreed that the with these commenters that significant 30–3332; 30–3259; 30–4801; 30–3898; employer was in the best position to changes in workplace conditions, such 30–4270; 30–4498; 31–242; 32–210–2; determine how often the ergonomics as the introduction of a new process; 500–71–86) stating that program program at a particular worksite needs changes in management or supervisory evaluations should take place at least to be evaluated to ensure its personnel, procedures, or policies; or annually. These commenters generally effectiveness. However, in ORC’s words, changes in the form or intensity of argued, in the words of Greg Wyatt, an ‘‘it is not reasonable that the standard employee involvement, can affect the engineer who suffers from a repetitive should require both periodic evaluation functioning of the program substantially stress injury and who offered comments as well as an evaluation every three and thus may necessitate an evaluation as an individual, that ‘‘the ergonomics years.’’ These commenters urged OSHA of particular program elements or of the program should be evaluated regularly to require employers to evaluate their program as a whole. (at least once a year) because it is easier ergonomics programs periodically, However, the Agency has chosen not and more cost effective to fix ‘‘and/or’’ at least every 3 years. to shorten the minimum interval deficiencies early during the Another rulemaking participant, the between program evaluations to once a implementation phase’’ (Ex. 30–3035). National Soft Drink Association (NSDA) year from every three years because In a comment that pertains to all (Ex. 30–368) questioned whether such a requirement would prove to be workplaces, the United Mineworkers of performance of a program evaluation too burdensome if imposed on all of America agreed, ‘‘Routine audits, no every 3 years also would satisfy the industry. Such a frequency would less frequently than once each year, proposed requirement for periodic deprive employers of the flexibility should be performed of the entire evaluations. Because, NSDA believes which was OSHA’s goal in drafting the workplace and problem areas reported that the two provisions are duplicative, program evaluation requirements, given to the appropriate company it recommended that the term the diversity of workplaces covered by representative for immediate action’’ ‘‘periodic’’ be eliminated. The Dow this rule. (Ex. 500–71–86). Chemical Company (Ex. 30–3765) also OSHA also is not persuaded that it The need for evaluations at a opposed the ‘‘at least every 3 years’’ would be appropriate to require minimum frequency of less than 3 years language, on the grounds that industry employers to evaluate their programs was addressed by several commenters should be able to decide if and when every time an MSD incident occurs or (see, e.g., Exs. 30–2116; 30–2809; 30– periodic evaluations should be carried an ergonomic concern is expressed, as 2825; 30–2847; 30–3258; 30–3035; 30– out but agreed that periodic reviews are some commenters urged the Agency to 3001; 30–3033; 30–3034; 30–3686; 30– necessary: * * * review on a periodic do. Such a requirement would 4159; 30–4534; 30–4536; 30–4800; 30– basis is necessary, especially * * * for precipitate constant evaluations for 4776; 30–4546; 30–4547; 30–4548; 30– dynamic workplaces with continuous employers with large workforces, where 4549; 30–4562; 30–4627; 30–3332; 30– turnover, process changes, etc.’’ The the incidence of MSD injuries is often 3259; 30–4801; 30–3898; 30–4270; 30– National Telecommunications Safety high. OSHA does not expect that the 4498; 32–210–2; 32–111–4; 32–229; 30– Panel (Ex. 30–3745) agreed, saying the program mandated by the standard will 4247), who pointed out that workplace proposed rule’s prescribed frequency eliminate MDSs in the workplaces changes that adversely affect the presented particular problems for them covered by the standard; indeed, as the functioning of a particular element of because of their members’ geographic discussion in Section VI of this the program or of the program as a sweep and rapidly changing workplaces preamble makes clear, OSHA is whole can occur in the interval between and that [determining] ‘‘program projecting that, on average, the standard periodic evaluations (or ‘‘regularly evaluation frequency * * * [should be] will prevent about 50% of MSDs in such scheduled’’ evaluations). For example, the sole responsibility of the employer.’’ workplaces. Further, the Agency the United Steelworkers of America A few commenters (see, e.g., Exs. 30– believes that employee concerns about (UOWA) agreed that employers should 4713 and 30–4046) stated that the ergonomics will be addressed regularly evaluate their ergonomics programs at proposal’s requirements for program as a result of the standard’s least every 3 years but asked OSHA to evaluation were excessive: ‘‘* * * a requirements for prompt responses to include in the final rule requirements complete evaluation, as required by the employee concerns and regular that would trigger evaluations at more rule, cannot be realistically performed employer/employee communications frequent intervals as well. ‘‘OSHA ‘periodically,’ as that term is defined.’’ about workers’ concerns. should provide additional specific A number of commenters who have After a review of the evidence in the requirements for the employer to themselves experienced MSDs (see, e.g., record on the frequency of program respond to concerns raised by workers Exs. 30–2116; 30–2809; 30–2825; 30– evaluations, the final rule requires them between evaluations. For example, 2847; 30–3258; 30–3035; 30–3001; 30– when there is reason to believe that the employers should review health and 3033; 30–3034; 30–3686; 30–4159; 30– program is not functioning properly, safety committee minutes to determine 4534; 30–4536; 30–4800; 30–4776; 30– when changes have occurred that may if ergonomic concerns were identified, 4546; 30–4547; 30–4548; 30–4549; 30– have increased employee exposure to [and] then they should verify that those 4562; 30–4627; 30–3332; 30–3259; 30– MSD hazards, and at least once every concerns have been promptly addressed 4801; 30–3898; 30–4270; 30–4498) also three years. The final rule’s or address them at that time’’ (Ex. 32– urged OSHA to require in the final rule requirements are essentially similar to 111–4). that ‘‘every time an employee reports those proposed, although they are From a somewhat different persistent MSD symptoms or an MSD somewhat more specific. OSHA’s perspective, Organization Resources injury, Job Hazard Analysis and Control reasons for retaining provisions for Counselors, Inc. (ORC) (Ex. 30–3813) must be performed, and the ergonomics program evaluation that require such

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By least once every 3 years to ensure that —Are identified hazards being mandating that ergonomics programs they are functioning optimally and controlled? have a certain form, i.e., have specific meeting the needs of the organization —Is the training program providing elements, instead of requiring only that over time. employees with the information they the program be effective, OSHA was, need to actively participate in the according to the Forum, ‘‘elevating form Paragraph (u)(2)—Steps Involved in ergonomics program? over function, divorcing its program Program Evaluation —Are employees using the reporting from [what should be] the goal of In the proposed section titled ‘‘What system? achieving reduced MSD injuries and —Are employees reluctant to report must I do to evaluate my ergonomics focusing instead on ensuring that MSDs or MSD hazards because they program?’’, the proposed rule stated that programs fit a bureaucratic mold that is receive mixed signals from their program evaluation goes beyond a mere administratively simple.’’ In other supervisors or managers about the inspection or audit of problem jobs. The words, the Forum believes that the importance of such reporting? effectiveness of an ergonomics program final rule, at paragraphs (u)(2)(i), (ii), —Is prompt and effective MSD (iii) and (iv ), contains similar should be the sole measure of its management available for employees success in any evaluation. The Forum requirements. For example, the with MSDs? proposed rule would have required stated that the proposed approach to OSHA finds that these questions, program evaluation could lead to ‘‘the employers to consult with employees in which were included in the proposal, problem jobs to assess their views about perverse possibility’’ of an employer continue to be appropriate points for with a program that successfully program effectiveness and identify program evaluations to address. The program deficiencies, paragraph (u)(2)(i) reduces MSDs being cited for a violation comments OSHA received on the of the standard merely because the of the final rule requires employers to proposed requirements for conducting consult with employees, ‘‘or a program failed to include a required evaluations addressed the following program element. representative sample of them,’’ about topics: the vagueness of the proposed program effectiveness and any problems Another commenter (Ex. 31–353) terms used; the inclusion of core questioned how effective a program with the program. Paragraph (u)(2)(iii) elements in the program required by the evaluation could be unless the rule requires employers to evaluate the standard and in the standard’s required the effectiveness of each of the elements of a program to ensure it is requirements for evaluation; the need individual Ergonomic Program elements functioning effectively; this language is for OSHA to specify measures of to be evaluated. ‘‘Without determining essentially unchanged since the effectiveness for employers to rely on; the effectiveness of all the aspects of the proposal. The proposal would have the statement in the basic obligation program, an employer is wasting time required employers to carry out section of the proposed rule that and money, and effort.’’ Similarly, the evaluations to ensure that the program programs should be evaluated to ensure Department of Defense (Tr. 9085–9086) was ‘‘eliminating or materially that they are in compliance with the stated, ‘‘If the evaluation is focused on reducing’’ MSD hazards, while the final standard itself; who should carry out the presence and function or process rule at paragraph (u)(2)(iii) requires the program evaluations; the records to be elements of the program then the employer to assess whether MSD reviewed in a program evaluation; and standard should clarify the essential hazards are being identified and the extent of the recordkeeping required evaluation points for each program ‘‘addressed.’’ The final rule adds, at by this provision of the standard. The element.’’ paragraph (u)(2)(iv), a requirement that comments OSHA received on each of Compliance as a measure of employers use the evaluation as an these topics are discussed below. effectiveness: The Dow Chemical opportunity to assess whether the Vagueness of the rule’s terminology: Company (Exs. 30–3765 and 32–77–2) program as a whole is achieving positive The Center for Office Technology (COT) asked, ‘‘Is the point of program results. OSHA includes examples of complained that some of the terms used evaluation to evaluate compliance with measures of effectiveness, such as in the context of the proposed the standard or the program’s reductions in the number or severity of evaluation section were vague and ‘effectiveness’? Or both?’’ Dow’s MSDs, increases in the number of jobs ‘‘subjective’’ (Ex. 25–710). Specifically, comment referred to a statement in the in which ergonomic hazards have been COT pointed to the proposed basic obligation section of the proposed controlled, reductions in the number of requirement that evaluations be rule to the effect that the program was jobs posing MSD hazards to employees, conducted ‘‘as often as necessary’’ to be evaluated to ensure its compliance or any other measure that demonstrates (defined in the proposal as with the standard. According to Dow, program effectiveness. ‘‘periodically’’) as an example of the ‘‘If OSHA maintains the requirement to An adequate evaluation asks vagueness of the proposal’s language. evaluate ‘effectiveness’ of a program, questions of employers at all levels of COT stated, ‘‘* * * training and then it should indicate the method an the organization to determine whether program evaluation must be conducted employer can use for measuring the required ergonomics program ‘‘as often as necessary’’ and the program ‘effectiveness.’ ’’ A program may have elements have been adequately must be ‘‘appropriate’’ to workplace all of the required elements and thus be implemented and whether they are conditions. How will compliance with in compliance with the rule, but not integrated into a system that effectively these vague, undefined and subjective address all potential MSDs’’ (Ex. 30– addresses MSDs and MSD hazards. requirements be assessed?’’ 3765). The Association of Energy

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Servicing Contractors (Tr. 15624) and Organization Resources Counselors, of the program and their proper others (Ex. 30–3839) agreed with Dow Inc. (ORC) (Ex. 30–3813) voiced a functioning. In response to ORC’s about the need for measurable criteria somewhat different concern regarding comment about the importance of with which to gauge compliance with the need for measures of effectiveness. ensuring that early reporting is present, the standard. ‘‘OSHA expresses particular concern in OSHA agrees that such reporting is Also commenting on this point was the preamble that there is a need to essential to program effectiveness and the Honorable Senator Christopher S. assure that a demonstration of has accordingly built several Bond, Chairman of the United State effectiveness does not mask under mechanisms that will ensure early Senate Committee on Small Business, reporting of MSDs,’’ they wrote. ORC reporting’work restriction protection, who submitted a study (Ex. 30–4334–4) agreed that this was a real concern and multiple HCP review, hazard carried out by the Regulatory Studies suggested that employers should be information and reporting’into the final Program of Mercatus Center at George required to provide evidence that there rule. Mason University, entitled, ‘‘Over is an effective early reporting Who should conduct program Stressing Business: OSHA and mechanism in place as a part of their evaluations?: The preamble to the Ergonomics.’’ The study included the demonstration of program effectiveness. proposal stated that program following statement: ‘‘The draft rule In response to the views of commenters, evaluations may be conducted by those requires employers to evaluate their OSHA notes that the final rule identifies responsible for carrying out the ergonomics program according to both a number of measures of effectiveness, employer’s program, but also noted that activity and outcome measures. Yet in including reductions in the number or evaluations performed by persons who the case of MSDs, neither activity nor severity of MSDs, increases in the are not involved in the day-to-day outcome measures are likely to reflect number of jobs in which ergonomic operation of the program are often even program effectiveness.’’ hazards have been controlled, more valuable because these individuals The final rule does not require reductions in the number of jobs posing bring a fresh perspective to the task. employers to evaluate their programs for MSD hazards to employees, or any other They often can identify program compliance with the standard, as demonstrably appropriate measure of weaknesses that those routinely proposed, because this statement effectiveness, that OSHA believes are involved in program implementation confused commenters and is indicative of program effectiveness. This may fail to see (64 FR 65858–65859). unnecessary. The final rule’s list of measures is not exhaustive; it is OSHA received a number of comments requirements (paragraphs (u)(1)(ii) and meant to be illustrative only. OSHA is addressing who should perform the (iii)) that employers ‘‘evaluate the aware that employers with successful required evaluations (Exs. 30–2809; 30– elements of the program to ensure they programs use other measures, such as 115; 30–2387; 30–3826; 32–339–1; 601– are functioning effectively’’ and ‘‘assess reductions in workers’ compensation x–1587–2). One commenter cautioned whether the program is achieving costs, increases in the number of early that special care must be taken to ensure results’’ will essentially ensure reports of MSD signs and symptoms, continuity within the program when compliance with the standard and and increases in product quality, to outside entities perform successive eliminate the confusion caused by the evaluate the effectiveness of their program evaluations (Ex. 30–2809). This proposed statement. Further, as the Dow ergonomics programs (DOD Tr. 3296– commenter stated, ‘‘It is important to Chemical Company pointed out, 3297; OR Ex. 32–78–1 p.22; AFL–CIO keep records from every evaluation of programs may be effective even if they the ergonomics program so that Ex. 32–339–1–29; Library of Congress do not contain every sub-element of the mistakes are not repeated * * * if a Ex. 32–339–1–33 p.143; Paper, Allied- OSHA standard; this is certainly the different company performs the Industrial, Chemical & Energy Workers case with grand fathered programs that evaluation, lessons learned from the International Union Local 1202 (PACE) were put in place well before OSHA’s previous evaluation may not be Tr.11206; International Paper Ex. 32– standard was promulgated (Exs. 30– recorded * * * It is also important to 61). 3765 and 32–77–2). ensure that all ‘‘action items’’ (issues Measures of program effectiveness: As one rulemaking participant, brought up during previous evaluations) Many commenters asked OSHA to Organization Resources Counselors are resolved and not ignored.’’ identify measures of program (ORC) (Tr. 4147) stated during The American Federation of effectiveness that the Agency believes testimony about the proposed rule, Government Employees (AFGE) (Ex. 30– are appropriate. For example, the Dow ’’* * * there are many different ways 115) suggested that OSHA or some Chemical Company stated, ‘‘If OSHA that companies use to evaluate neutral third party was the appropriate maintains the requirement to evaluate effectiveness. While they might all have entity for evaluating the ergonomics ‘effectiveness’ of a program, then it common elements. . .they apply those program because ‘‘management should should indicate the method an employer elements in very different ways, not have carte blanche to evaluate their can use for measuring ‘effectiveness’. A depending on the circumstances, the own program.’’ Similarly, the American program may have all the required nature of the work, the employees, and Society of Safety Engineers (ASSE) (Ex. elements and thus be in compliance the nature of the workplace.’’ In 601–x–1587–2) commented that the with the rule, but not address all addition, OSHA does not believe that level of expertise needed to perform potential MSDs’’ (Ex. 30–3765). The the ‘‘occurrence of an injury’’ program evaluation/third party audits Oregon Building Industry Association automatically qualifies a program as under this standard is outside that (Ex. 30–562) and others (Exs. 30–368, ‘‘ineffective,’’ in the words of the which many organizations are able to 30–541, 30–627, 30–1697, 30–1717, 30– Oregon Building Industry Association provide. Therefore, ‘‘in order to meet 1355, 30–1545, 30–3783; 31–334: 32– (Ex. 30–562). OSHA recognizes that, the expected need of consultation 210–2) raised the same issue, and the especially in large workplaces in services, OSHA should consider Oregon Association also asked, ‘‘Would industries with many problem jobs, reviewing a system for voluntary third the occurrence of an injury allow the MSDs may continue to occur. The final party audit and evaluations, and work OSHA inspector to automatically rule takes a comprehensive view of with accredited private sector qualify the program as not effective?’’ program effectiveness and emphasizes professional certification bodies, both (Ex. 30–562). the importance of the essential elements public and private recognized registries,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00153 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68414 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations and membership organizations to ensure Records review in the context of numbers alone sometimes can be that consultants have an acceptable program evaluation: OSHA recognizes misleading. However, program level of competence.’’ in the final rule, as it did in the evaluation also must consider the The American Association of preamble to the proposed rule (64 FR accuracy and reliability of the records Occupational Health Nurses (AAOHN) 65859), that the extent of the evaluation under review. For example, it is (Ex. 30–2387) cautioned OSHA about called for by the rule will vary from one essential to be sure that the identified the need to protect employee privacy workplace to another, based on the trends are real and not the product of during the collection and review of characteristics and complexities of the under reporting, loss of interest in the program records for evaluation work environment. However, the basic program, or loss of attention to detail. purposes. The AAOHN pointed out that tools of evaluation remain the same For example, a downward trend in the ‘‘individuals who are not part of the day from workplace to workplace, even number of MSDs or MSD hazards to day operation of the program can though their application may vary. reported may indicate that employees bring a fresh perspective, however in These tools, which are basic to the are being discouraged from reporting or any evaluation, the employer should evaluation of any safety and health that the employees performing job ensure that employees’ privacy is program, include: hazard analysis and control are not protected.’’ For example, the AAOHN —Review of pertinent records, such as doing an effective job because they are noted that a co-worker brought in to those related to MSDs and MSD not adequately trained to do so. evaluate a program must understand the hazards; OSHA received a variety of comments need for confidentiality concerning her —Consultations with affected about records review in the context of or his co-worker’s personal health employees (including managers, program evaluation (Exs. 30–3765, 30– information, if such information is part supervisors, and employees) regarding 276; 30–546; 30–2846; 30–1726). For of the program evaluation. OSHA agrees the ergonomics program and its example, the Dow Chemical Company with the AAOHN that the privacy of problems (if any); and argued that the proposed requirement employee medical and exposure records —Reviews of MSD hazards and problem that employers evaluate different must be protected at all times, including jobs. elements of the program would require them to gather records to support this during a program evaluation. These Examples of the records that are often effort and would thus impose an undue records are required to be handled at all included in such reviews include the burden on certain employers. Dow times in accordance with 29 CFR following: argued, ‘‘depending on the size and 1910.1020, OSHA’s Access to Employee —The OSHA 200 log (if the employer is makeup of the workplace, a review of all Exposure and Medical Records required to keep a log); the proposed records by each standard. —Reports of workers’ compensation workgroup would add undue burden on In response to the views of these claims related to MSDs; each group’’ (Ex. 30–3765). commenters, OSHA notes that the —Reports of job hazard analyses and Texas A and M University (Ex. 30– proposed rule did not specify who was identification of MSD hazards; 276) also found the records review to perform the required program —Employee reports to management of associated with program evaluation evaluations; the final rule also does not MSDs or persistent MSD signs or potentially burdensome. ‘‘Record limit the employer’s choice of program symptoms; keeping is not value-added for the evaluators. OSHA is aware that —Insurance company reports and audits employer or employees. It primarily employers with effective programs rely about ergonomic risk factors or MSD benefits the regulatory overseer.’’ on different individuals, both from hazards; and ElectriCities of North Carolina Inc. (Ex. within and outside their organizations, —Reports about MSD hazards from any 30–546) agreed: ‘‘[These sections] speak to perform this function and that the ergonomic consultants engaged by the of compulsory Record keeping above results of doing so are often excellent employer. and beyond the OSHA 200 log of (see, e.g., Exs. 32–339–1–53, 601–X– Some employers, especially owners of recordable work place injuries and 1711). Some programs, such as the one very small businesses, may have few of illnesses * * *’’. The Manufactured at General Motors, rely on trained these records and will, therefore have to Housing Institute (Ex. 30–2846) noted employees in a Joint Ergonomics Team, rely on other, less formal, methods to that ‘‘Small business is already consisting of union and management assess effectiveness. Small employers overwhelmed with paperwork members, to conduct program generally place more emphasis on requirements and OSHA should avoid evaluations (Ex. 32–339–1–53), while employee interviews and such adding to that burden.’’ other companies, such as Halliburton, approaches as surveys of MSD hazards The University of Wisconsin Inc. (Ex. 601–X–1711) rely on a Board and problem jobs when they perform Extension (Ex. 30–1726) asked OSHA to Certified Professional Ergonomist or ergonomics program evaluations. require that all MSD reporting forms be other outside expert or organization to Records reviews can yield valuable retained by employers for eventual carry out their program evaluation. information on the effectiveness of an program review. ‘‘If a standard reporting OSHA does not agree either with those ergonomics program when comparisons form is required for all employees to commenters who argued that employers are made from year to year and trends report MSD problems, signs and are not choosing appropriate and are identified. For example, if an symptoms, these forms should be qualified program evaluators or that the employer compares the list of MSD retained and made part of the program Agency should narrow the employer’s hazards identified during consecutive review, to follow up each form filed discretion in this regard. OSHA remains program evaluations and finds that the during the program evaluation period.’’ convinced that different approaches are number of hazards has decreased over In response to these concerns about appropriate in different workplaces and time, the employer may conclude that the recordkeeping burden associated that employers are best suited to decide the program’s job hazard analysis and with program evaluation records review, who should conduct the required control activities have been effective. OSHA notes that the final rule does not evaluations. The final rule, therefore, Similarly, a reduction in the number of mandate that employers review specific leaves the selection of evaluators to the MSDs from year to year suggests that the records when conducting their employer. program may be effective, although evaluations. In fact, the final rule does

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00154 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68415 not mandate records review or require MSDs or MSD hazards, the hazard (i) Consult with your employees in the the development of new records of any information and reporting and training program, or a sample of those employees, and kind. This preamble discussion on components of the program are not their representatives about the effectiveness records review simply recognizes that working. If a supervisor is unclear about of the program and any problems with the program; reviewing records already maintained how to reinforce proper work practices, (ii) Review the elements of the program to by the employer for other purposes is the management leadership and training ensure they are functioning effectively; one way of getting the information components of the program are both (iii) Determine whether MSD hazards are needed to evaluate a program. likely to need improvement. Similarly, being identified and addressed; and The Agency believes that employers if managers are not aware of the MSDs (iv) Determine whether the program as a are best able to determine which records and MSD hazards employees are whole is achieving positive results, as in their workplace will provide the most reporting and what corrective actions demonstrated by such indicators as valuable information for evaluation are being taken, the management reductions in the number and severity of purposes. For example, in a very small leadership and training components of MSDs, increases in the number of problem jobs in which MSD hazards have been firm that is not required to keep the the ergonomics program should be OSHA 200 Log, the only records controlled, reductions in the number of jobs improved. Because interviews allow the posing MSD hazards to employees, or any available for review may be employee program evaluator to assess how the other measure that demonstrates program reports of MSD incidents, workers’ elements individually and the program effectiveness. compensation claim information, and as a whole is actually working, there is Paragraph (u)(1)(i) of the final rules records of Quick Fix controls no substitute for direct input from implemented; some workplaces may not requires employers to ‘‘consult with employees in the evaluation process. your employees in the program, or a even have these records. In most Program evaluation also must include workplaces, however, employers will sample of those employees, and their an assessment of MSD hazards and the representatives about the effectiveness wish to review a variety of records to extent to which they are being identify trends, evaluate the functioning of the program and any problems with addressed (paragraph (u)(1)(iii)). This the program.’’ Employee participation in of each program element, and assess the assessment is concerned not only with overall performance of the program. the ergonomics program is critical for identifying MSD hazards but with success, and the involvement of OSHA’s approach is consistent with that identifying how well the ergonomic taken by a number of employers who employees in program evaluation is just program is addressing them. If the one more way that employees can take conduct evaluations of their ergonomics program evaluation identifies jobs that programs, in that it allows employers an active role in the program. The have not been analyzed but exceed the requirement that employers consult the latitude to decide how best to Action Level, the job hazard analysis conduct evaluations of their workplaces. with employees regarding program component of the program needs to be evaluation is not unique to the final The United Technologies Corp. (Ex. 31– improved. In addition, if jobs with 334) agrees that such flexibility is Ergonomics Program standard. OSHA previously identified MSD hazards have recently promulgated a similar important: ‘‘It is important to encourage not been corrected or prioritized for creativity and innovation on the part of provision in the Respiratory Protection correction, the evaluator may conclude final rule (29 CFR 1910.134). employers in meeting the requirements that the job hazard control component * * *’’. This flexibility also means, of Employees in jobs that have been of the program is not effective. Likewise, identified as problem jobs are in the best course, that employers such as The if an MSD hazard is identified and University of Wisconsin Extension (Ex. position to judge whether or not job controlled in a problem job in one part 30–1726) who wish to develop hazard analysis and control measures of the facility but the same job has not standardized MSD reporting forms to are effectively reducing or eliminating been controlled in another part of the use for evaluation and other purposes MSD hazards. Perhaps even more facility, several program components are free to do so. importantly, these employees will be The proposal contained a requirement may need attention: the management most knowledgeable about whether the that program evaluation include leadership component, which may have implemented controls have introduced consultations with employees, and the failed to coordinate and disseminate new, unintended MSD hazards to the final rule also includes such a MSD hazard information throughout the job. By consulting with employees, requirement. Affected front-line facility, the training component, which employers also can have direct feedback employees (or a sample of them), and may have failed to provide the on the effectiveness of other ergonomics their supervisors and managers, must be employees performing the job hazard program elements, such as opportunities included in this process. Consultations analyses with adequate training, and the for employee participation, hazard with employees elicit information on control component, which may have information and reporting, and training. how well the ergonomics program has failed to prioritize jobs appropriately for OSHA is aware that employers been communicated to the people who control. sometimes act in good faith to rely on it the most. Paragraph (u)(1) (i)–(iv) establishes implement ergonomics program Paragraph (u)(2)(ii) of the final rule the steps employers must follow to elements, but that the actual result requires employers to evaluate the evaluate the effectiveness of their experienced by employees can differ elements of their ergonomics programs ergonomics programs. It answers the markedly from the intention. Thus, by to ensure that each of the elements is question, ‘‘What must I do to make sure checking directly with their employees, working properly. If employees cannot my ergonomics program is effective?’’ employers can be sure that their explain what MSD hazards they are This requirement describes the minimal ergonomics program resources are being exposed to in the course of their work, evaluation procedures necessary to effectively invested. do not know what steps their employer assess whether or not an ergonomics Two rulemaking participants is taking to eliminate or control these program is working as intended. commented that the proposed provision hazards, are unclear about the Paragraph (u)(1) of the final rules reads on employee consultation did not procedures they should follow to as follows: require consultations with anyone other protect themselves from these hazards, (1) You must evaluate your ergonomics than employees in problem jobs or or do not understand how to report program at least every three years as follows: allow the employer to select a subset of

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00155 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68416 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations employees with whom to consult. The than a company like Dow to be ergonomics program to be active and Department of Defense (Ex. 30–3826) experienced in program evaluation, meaningful, but this does not mean, as commented that, for some employers, with ideas about the kinds of topics an Morgan, Lewis & Bockius suggest, that such as large companies, branches of the evaluator might find useful when they must be allowed to evaluate ‘‘every military, etc., the requirement to consult consulting with employees. aspect of the program’’ (Ex. 30–4467). with employees could be interpreted to Some rulemaking participants (Exs. Paragraph (u)(1)(ii) of the final mean consultation with tens of 30–494, 30–3745, 30–3723, 32–351–1, standard requires employers to ‘‘review thousands of employees. As a result, 30–4467) argued that employee the elements of the program to ensure DOD requested that the requirement be participation in the evaluation process they are functioning effectively.’’ This changed in the final rule to allow for might be problematic. They evidently requirement is nearly identical to the representative sampling of employees. believe that requiring employers to corresponding provision proposed. In addition, both the DOD (Ex. 30–3826) consult with employees in problem jobs OSHA received a few comments on this and the AFL–CIO (Exs. 32–339–1; 500– could subject the employer to citations. proposed provision (see, e.g., Exs. 30– 218) commented that OSHA had For example, the Forum for a 3031, 30–3813, 30–4334). Tesco Drilling neglected to include employee Responsible Ergonomics Standard (Ex. Technology Inc. (Ex. 30–3031) stated: representatives in the proposed 32–351–1) commented, ‘‘If an employee ‘‘If OSHA does in fact believe that consultation process. The AFL–CIO deems the program ineffective, but the employers are best able to determine suggested (Ex. 32–339–1) that this employer disagrees and implements no evaluation criteria, and that employers provision of the final rule ‘‘should be measures to improve effectiveness, the should be able to define ‘‘functioning modified to provide for consultation proposal appears to grant OSHA properly,’’ why is OSHA proposing this with the employee representative, in discretion to cite the employer for non- cumbersome standard to begin with? If addition to employees in problem jobs. compliance.’’ Morgan, Lewis & Bockius there is no specific evaluation criteria or This modification is consistent with the LLP (Ex. 30–4467) also raised concerns goal in each element, how can a requirement of [the proposed employee about employee participation in compliance officer issue a citation for participation provision] which calls for developing, implementing and noncompliance in any portion of the both employees and employee evaluating the employer’s ergonomics program?’’ Organization Resources representatives to be involved in all program: ‘‘The latter is the most Counselors, Inc. (ORC) (Ex. 30–3813) aspects of the program.’’ troublesome; employers could stated that the phrase ‘‘functioning After reviewing the record on these conceivably receive citations by virtue properly’’ was vague, and comments points, the Agency has revised of a compliance officer’s subjective received from Senator Bond, Chairman paragraph (u)(1)(i) of the final rule to determination that employees were not of the United States Senate Committee reflect the concerns of larger employers allowed to evaluate every aspect of the on Small Business (Ex. 30–4334), agreed and to allow them to consult with program. Moreover, if employees’ with those of ORC: ‘‘For an employer to employees in the program, or ‘‘a sample suggestions for a program are rejected, evaluate its ergonomics program, it is to of those employees’’ about the the employer arguably could be said to ‘‘evaluate the elements of [its] program effectiveness of the program and any have unlawfully limited employee to ensure they are functioning properly; problems with it. In addition, the final participation in the ‘‘development’’ of a and evaluate the program to ensure it is rule states clearly that designated program. (Ex. 30–4467). ‘‘ eliminating or materially reducing MSD employee representatives are to be Three other commenters, the Salt hazards * * * The use of these terms, involved in the consultation process River Project (Ex. 30–710), the and others, throughout the proposed (paragraph (u)(1)(i)). Further, employers Integrated Waste Services Association standard means that employers will be are, of course, free to involve other (Ex. 30–3853), and Southern California left to their own instinct and resources employees in the consultation process if Edison (Ex. 30–3284), argued that the to decide whether they have met the they wish to do so; however, OSHA is proposed provision to consult with obligations and gone far enough.’’ not requiring that employees other than employees during evaluations was too OSHA’s reason for including this those in problem jobs be consulted as open to subjective interpretation: ‘‘The provision in the final rule is that part of the evaluation process. final standard should make clear that evaluations of individual elements and Another concern raised by the Dow the employer is not required to act on their functioning often reveal program Chemical Corp. (Ex. 30–3765) was its a recommendation from employees if deficiencies that are undermining interpretation that OSHA was the employer can document that the program effectiveness but could be attempting in the preamble for this recommendation is without merit’’ (Ex. difficult to detect if the employer only proposed section to mandate the 30–3284). evaluated the program as a whole. For questions employers must ask in In response to these comments, OSHA example, if employees are not reporting conducting an evaluation: ‘‘Dow does notes that, in the Agency’s experience, MSD hazards, it may mean that the not believe that OSHA should mandate employee input is invaluable; management leadership and training the specific questions each employer employees are the best source of components are not working properly. must ask employees during this review, information on how a program is The final rule thus continues to require which it seemingly tries to do in the working in practice. However, that employers evaluate each program preamble at page 65858.’’ Dow went on employers are expected to use their element as well as the program as a to say, ‘‘Scripted questions may not judgment and to assess the value of any whole. How this is done is left to adequately uncover issues or concerns information they receive in the course of employers, because the records, and, from the perspective of the an evaluation, whether from a records methods to be used, and cultures of employee, may sound more like an review or employee consultations. workplaces differ markedly and no one interrogation than a fruitful dialogue.’’ Weighing input from many sources is approach is appropriate for all. The final OSHA does not intend the discussion standard management practice, and the rule does not include specific questions included in the preamble to rule anticipates that employers will effectiveness measures for each element be mandatory. They are presented to continue to use their judgment in these of the program, because these would provide employers, and particularly matters. Further, OSHA intends vary extensively from one workplace to smaller employers who are less likely employee participation in the another. However, as commenters

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00156 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68417 recommended, the final rule does urged OSHA to delete the term For example, Organization Resources include examples of effectiveness ‘‘eliminating or materially’’ from the Counselors (ORC) (Ex. 30–3813) made measures that are useful in evaluating final rule because its use failed to comments that were representative of the effectiveness of programs as a recognize ‘‘that some MSDs may exist those of the above group when it asked whole. epidemiologically in any workplace and OSHA to include a non-mandatory Paragraph (u)(1)(iii) of the final rule that the program [envisioned by the appendix of types of performance requires employers to ‘‘determine standard] is realistic and performance- measures and approaches that OSHA whether MSD hazards are being based.’’ would consider appropriate. In addition identified and addressed.’’ The primary Footwear Industries of America Inc. to the measures of effectiveness purpose of implementing an ergonomics (Ex. 30–4040) commented that the mentioned by OSHA in the proposed program is the identification and control inclusion of the proposed ‘‘eliminating preamble, such as decreases in the of MSD hazards. OSHA expects or materially reducing’’ phrase numbers or rates of MSDs and decreases employers to establish evaluation suggested that ‘‘employers will meet in severity, ORC suggested a few others: criteria to assess the success of their their obligations if they select and ‘‘Measures might include reduced program in meeting this goal. There are implement the controls that a workers’ compensation claims for a wide variety of methods available to reasonable person would anticipate MSDs, use by the employer of periodic employers, ranging from a simple count would achieve a material reduction in symptoms surveys and other indicia of of the number of problem jobs the likelihood of injury. ‘‘ However, effective, early reporting, or controlled to more sophisticated according to this commenter, ‘‘the demonstration that risk factors have analyses, such as year-to-year trend ‘‘reasonable person’’ standard is hardly been reduced and/or tools and analyses. a bright-line test and provides excessive equipment have been modified.’’ Again, OSHA finds that employers are enforcement discretion to OSHA Two other commenters, the American best able to determine the specific inspectors when determining Federation of State, County and evaluation criteria that will most compliance.’’ Municipal Employees (AFSCME) (Ex. effectively tell the story of their efforts OSHA has revised many provisions of 32–182) and the United Steelworkers of to identify and address MSD hazards. the final rule in response to comments America (Ex. 32–11–4), argued that such Commenting on the corresponding received and data submitted to the tools were necessary. They criticized the proposed paragraph, which would have record. One of the more important proposed evaluation provisions in required employers to evaluate their changes is the revision to the language general, because they failed to provide program to ensure it is ‘‘eliminating or of paragraph (k), which tells employers any criteria to aid employers in materially reducing’’ MSD hazards, what they must do to achieve determining if their ergonomics Milliken & Company (Ex. 30–3344) and compliance with the final rule’s control programs were effectively eliminating or others (Exs. 30–3749, 30–4674) argued requirements. The final rule no longer materially reducing MSDs. The that the proposed provision would uses the phrase ‘‘materially reduce,’’ American Association of Occupational require an evaluation to ensure that the and paragraph (u)(1)(iii) therefore has Health Nurses (AAOHN) (Exs. 30–3686, program is eliminating MSD hazards, been revised as well. The language of 30–2387) also urged OSHA to assist when a better measure might be the this provision now requires employers employers by providing standardized extent to which the program is reducing to ‘‘determine whether MSD hazards are evaluation forms. the incidence of MSDs. Nucor being identified and addressed.’’ OSHA OSHA agrees that providing Corporation and Vulcraft-South believes that this language is responsive employers with evaluation tools and Carolina (Exs. 30–3354, 30–3848, 30– to the concerns of those employers who forms would be helpful to employers, 4799, 30–4540, 601–x–1710) asked interpreted the proposed language to employees, and OSHA Compliance OSHA to add ‘‘to the extent feasible’’ to mean that all MSD hazards had to be Officers. In the period between this provision on the grounds that doing eliminated before an ergonomics publication of the final rule and the so ‘‘would keep the proposed regulation program could be judged effective. The compliance dates for program consistent in its requirements final rule, at paragraph (k), makes clear evaluation, the Agency plans, if throughout all elements of an that OSHA will consider an employer to resources permit, to develop and ergonomics program.’’ be in compliance with the standard’s disseminate such materials. The Dow Chemical Co. (Ex. 30–3765) control requirements when it has AM Moving and Storage Association asked OSHA to modify this paragraph in implemented controls meeting any of (Ex. 500–82) argued that the standard as the final rule by adding specific the endpoints identified in that a whole would be infeasible for its language at the end of the paragraph to paragraph. There are clearly many ways member companies: ‘‘if it is not feasible read, ‘‘or maintaining the risks at an to assess whether the program is for movers to implement controls that acceptable level.’’ In Dow’s view, such identifying MSD hazards and dealing would eliminate and materially reduce a change would make it clear that with them appropriately, as discussed MSD hazards, then it is equally instituting the same ‘‘fix’’ across the above, and any method that is impossible for moving and storage board may not eliminate all MSD appropriate and accurate in making this companies to monitor and track the injuries. Dow also was unclear about assessment is acceptable to OSHA. progress of the proposed ergonomics what the Agency meant by ‘‘materially A number of rulemaking participants program.’’ OSHA is not, in this reducing’’ MSD hazards. ( Exs. 32–182, 32–111–4, 30–167, 30– standard, requiring employers to The National Telecommunications 3826, 32–210–2, 32–85–3, 30–3686, 30– implement infeasible controls or to Safety Panel (Ex. 30–3745) expressed 3826, Tr. 9088, Exs. 30–3284, 30–240, reach infeasible hazard control similar concerns about the proposed Tr. 16578, Exs. 32–339–1, 500–218, 31– endpoints. Instead, OSHA is requiring phrase ‘‘eliminating or materially 307, 30–3860, Tr. 8982, Tr. 4372, Exs. employers to take reasonable measures reducing MSD hazards.’’ The Panel 30–1726, 30–1726) commented that to protect their employees from MSD argued that this language was OSHA would clarify the proposed hazards. OSHA expects that moving misleading because, ‘‘some MSDs exist evaluation requirements significantly if companies also will find effective ways epidemiologically in any workplace.’’ it developed guidance materials and of reducing the number and severity of SBC Communications Inc. (Ex. 30–3723) model evaluation tools for employers. their MSD hazards.

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The Union of Needletrades, Industrial OSHA continues to believe, as make sure that the necessary actions and Textile Employees (UNITE) (Ex. 32– explained in the proposal, that the were taken. In a very small workplace, 198–4) argued that the proposed employer is in the best position to of course, such detailed planning would evaluation section would be ineffective. determine how often the ergonomics likely not be necessary. They commented that the proposed program at a particular work site needs Some commenters, including Milliken evaluation requirements overall were to be evaluated to ensure its & Company (Ex. 30–3344) and (Exs. 30– too narrow and ‘‘must be expanded to effectiveness. A site undergoing process 3749; 30–4674), stated that the proposed determine actual effectiveness of the or production changes, for example, or requirement to correct program existing program.’’ OSHA agrees, and one experiencing high turnover, may deficiencies discovered during an has expanded the final rule’s evaluation need more frequent evaluations than evaluation would create a ‘‘needless requirements to include a requirement other, less dynamic, workplaces. second tier of violations on top of the that employers assess their programs Workplaces with these characteristics underlying substantive requirement that using indicators of effectiveness, such as are addressed by final rule paragraph is not being met.’’ Moreover, they reductions in the number, rate, or (u)(2), which requires employers faced argued that, ‘‘the requirement to severity of MSDs. OSHA believes that with changes in operations that are promptly take action to correct the final rule’s combination of likely to increase employee exposure to deficiencies does not provide sufficient qualitative and quantitative approaches evaluate their programs when such latitude for employers to implement to program evaluation will ensure the changes occur. Similarly, an increase in corrections within a time frame that will effectiveness of the programs the number or severity of MSDs in the be reasonable in every case.’’ Tesco implemented to comply with this rule. workplace would suggest that a program Drilling Technologies (Ex. 30–3031) also evaluation is warranted. This situation Paragraph (u)(2)—Program Evaluations expressed concern about an employer’s is one that would be covered by at More Frequent Intervals Triggered by liability once program deficiencies have paragraph (u)(2) of the final rule; such Events been identified. Tesco asked, ‘‘What are an increase clearly suggests that the the criteria by which a compliance Paragraph (u)(2) of the final rule program, or a part of it, has failed to officer can issue a citation under this requires an employer to evaluate the operate properly. In work environments provision. * * * If a citation can not be program, or a relevant part of it, when with a stable workforce and work issued, how can this be enforced? If it the employer has reason to believe that operation, program evaluations cannot be enforced, how can it be a the program, or an element of the conducted once every three years may rule?’’. program, is not functioning as intended; be sufficient. For these workplaces, the In response, OSHA wishes to when operations in the workplace have minimum frequency required by emphasize that its primary goal is to changed in a way that is likely to paragraph (u)(1) may apply. protect employees from MSD hazards, increase employee exposure to As noted in the proposal, current not to hold employers liable for ergonomics risk factors and MSD industry practice as to the appropriate ergonomics program deficiencies. OSHA hazards on the job; and, at a minimum, frequency of ergonomics program expects that even the best programs will once every three years. Thus, the final evaluations in specific environments is find deficiencies in their ergonomics rule retains the minimum 3-year available from other sources. For program at one time or another. OSHA’s evaluation frequency proposed but example, the Meatpacking Guidelines concern is whether or not the employer provides greater specificity than did the (Ex. 2–13) recommend semi-annual has acted on the information obtained proposal about the events that trigger reviews by top management to evaluate during the program evaluation and is evaluation at more frequent intervals. the success of the program in meeting taking steps to correct the problems The proposed language on the its goals and objectives. In addition, a identified. Employers who act in good frequency of program evaluation, which wide range of companies with faith to correct identified program required employers to evaluate their successful ergonomics programs deficiencies clearly will satisfy this programs ‘‘periodically, and at least evaluate these programs at regular requirement. However, employers who every 3 years,’’ was performance-based intervals. rather than specific because of the identify ergonomic program deficiencies diversity of workplaces covered by the Paragraph (u)(3)—Correcting Program through the evaluation process and then rule. OSHA defined periodically in the Deficiencies do not act on this information may not proposal as a process or activity that is Paragraph (u)(3) of the final rule be in compliance with this requirement. ‘‘performed on a regular basis that is requires employers to correct any The final rule does not specify the appropriate for the conditions in the deficiencies identified by the time frame within which identified workplace’’ and ‘‘is conducted as often evaluation. It also requires that program deficiencies must be corrected. as needed, such as when significant employers correct such deficiencies The Agency recognizes that the time changes are made in the workplace that promptly. Deficiencies are findings that needed to correct a program deficiency may result in increased exposure to indicate that the ergonomics program is will vary according to many factors. For MSD hazards.’’ Thus, the proposed not functioning effectively because, for example, the following factors may provision on the frequency of required example, it is not successfully influence an employer’s response time: evaluations was designed to reduce controlling MSD hazards or is not —The nature of the MSD hazard; unnecessary burdens on employers providing needed MSD management. —Previous attempts to correct the whose workplaces, for example, OSHA requires employers to respond to problem; changed little over time, while ensuring deficiencies in the ergonomics program —The complexity of the needed that program evaluations, which are by taking actions such as: identifying controls; essential to program effectiveness, were corrective actions to be taken; assigning —The expense of the needed controls; conducted at some minimal frequency. the responsibility for these corrective —Whether the hazard is a higher or The final rule reflects the same actions to an individual who will be lower priority in the list of identified principles but has been revised to held accountable for the results; setting program deficiencies; and provide the additional specificity a target date for completion of the —The expertise needed to control the requested by commenters. corrective actions; and following up to hazard.

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Some rulemaking participants (Exs. unfairly shift the burden of correcting which mandate certain evaluation steps 30–3853, 30–3765, 30–710, 30–240) program deficiencies to the employer and procedures and establish the commented that OSHA was not clear without considering the employee’s minimal frequencies of periodic about what kind of program deficiencies contribution to such deficiencies. Dow program evaluations. Many employers, needed correction or what ‘‘as quickly argued that the burden of correcting however, such as Kodak, who have had as possible’’ meant. Edison Electric deficiencies should not be placed ergonomics programs for years, are Institute’s (EEI) comment (Ex. 30–3853) completely on the shoulders of the unlikely to need such direction. was representative of the views of those employer. ‘‘Because ergonomics is The Labor Policy Association, Inc. commenters concerned about the time focused on how an individual interacts (LPA) (Ex. 30–494), the Department of frame for correcting deficiencies: EEI with his or her workplace, Dow believes Defense (Tr. 9085–9086) and ( Ex. 30– stated that the proposed requirement to that the employee must have some 3781) cautioned OSHA about the correct ergonomics program deficiencies responsibility for making appropriate difficulties that could arise from doing ‘‘as quickly as possible’’ was vague and changes in their activities.’’ Dow a program evaluation shortly after unenforceable. August Mack suggested that OSHA include an creating a new ergonomics program. Environmental Inc. (Ex. 30–240) stated ‘‘Employee Responsibility’’ section in Specifically, the LPA argued that that, in many cases, the responsibility the final standard that would state that ‘‘newly implemented ergonomics for correcting deficiencies found will be if employees are not following what programs typically experience a spike in transferred to a program administrator, they are supposed to do under the rule, reported MSDs that at some point levels who may be so overwhelmed with other their employers will not be cited for off and begins to drop. However, it can duties, including those of the violating this standard. take as long as four years before the ergonomics program, that he or she may OSHA disagrees with Dow’s views in drop starts to occur. Under the standard, not be able to respond in a reasonable the matter of employee responsibilities. an employer whose reported MSDs were period of time. ‘‘My concern is that a It is the employer, not the employee, increasing would be required to deficiency may be found and assigned who controls the conditions of work. If implement different mechanisms to to the program administrator who will an employee, as Dow’s comment correct the program’s deficiencies. work the problem into his or her overall suggests, is not observing appropriate However, an OSHA compliance officer priority system, so that it can be fixed,’’ work practices, it is the employer’s could view this as evidence of an August Mack posited. ‘‘However, if responsibility to compel compliance. ineffective ergonomics program and inspected in the meantime, OSHA will Employers must manage the conditions launch an in-depth compliance review, find that this is not responsive enough.’’ in their workplace; they must lead by even though the increase in MSDs is a Again, OSHA’s aim in including example, train their employees in the natural outcome of having a new but program evaluation requirements in the use of controls and safe work practices, effective program.’’ Similarly, the DOD final rule and in requiring deficiencies reinforce such practices, and, if argued that time must be allowed to identified through evaluation to be necessary, establish a disciplinary elapse for ergonomics programs to corrected promptly is not to catch system so that employees understand gather data needed for evaluations. employers in violations but to ensure that they must follow safe and healthful OSHA is fully aware that the number that the employer’s ergonomics program practices on the job. However, OSHA of MSDs reported may increase, and is working correctly. If employers have does not believe that employers must be often substantially, in the first year or so identified deficiencies, corrected those the ‘‘insurers’’ of their employees’ after program implementation. The that can be addressed quickly and behavior. If, for example, an employer Agency believes that the examples of easily, prioritized those requiring longer establishes, implements, trains effectiveness measures OSHA includes to correct, and are making reasonable employees in, and enforces safe work in final paragraph (u)(1)(iv) are progress in addressing prioritized practices, and does so in a consistent sufficiently varied to be suitable for deficiencies, they likely will be in manner, the employer will not be liable workplaces with programs at various compliance with these requirements. for an employee’s unforeseeable stages of maturity. The Dow Chemical Company (Ex. 30– violation of its safety rules. Finally, the UFCW (Ex. 32–210–2) 3765) argued that the proposal was In contrast to those commenters who asked OSHA to require employers to unclear as to what program deficiencies found the proposed provisions vague, respond to and, if warranted, address were being addressed. ‘‘Dow simply some commenters found the proposed issues raised by employees during a does not understand whether the evaluation requirements too specific. program evaluation. ‘‘The employer evaluation in this section is the same For example, the Eastman Kodak should be required to take action to evaluation of the program required in Company (Ex. 30–429) argued that only reduce or eliminate hazards uncovered other sections as an employer deals with the proposed basic obligation should be by an evaluation based upon employee identified problems or whether it is an included in the final rule and that the concerns. This type of response and evaluation of the program addressing specific requirements should be deleted: evaluation will only serve to strengthen every element of this regulation. If it is ‘‘We believe . . . [these requirements the entire ergonomics program by the first case, then the section is address] general management practices building confidence among employees redundant and should be removed. If it that should not be mandated but should that they are a valuable source of is the latter case or both, then the be provided in a non-mandatory information and also can be part of the Preamble and section should be appendix.’’ evaluation process.’’ OSHA believes that rewritten to clearly explain this.’’ OSHA OSHA believes that the final rule’s employers will respond to employee is unclear about the meaning of Dow’s provisions provide employers with the concerns during evaluations when they comment, but believes that the final steps to follow to conduct an effective seek inputs from them about the rule’s clear requirements for program and efficient program evaluation. effectiveness of the program. To do evaluation will shed light on the issues Absent such provisions, many otherwise would be inefficient as well of concern to them. employers, particularly smaller ones, as non-responsive. This does not mean, Dow (Ex. 30–3765) also voiced would not know how to conduct an of course, that employers must respond concern that the proposed evaluation evaluation. Accordingly, the final rule to all employee suggestions, as some section seemed, in their opinion, to includes paragraphs (u)(1) and (2), commenters feared (see, e.g., Exs. 30–

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3284, 30–3853, 30–710). Because OSHA rule consistent with that for OSHA’s structure that is increasingly common) believes that such two-way recordkeeping rule (29 CFR Part 1904). would not be required to keep records communication will be encouraged by The following paragraphs discuss the despite several levels of management the final rule’s evaluation provisions, specific requirements of the and more formal methods of the Agency has decided not to mandate recordkeeping provisions of the final communication. such responses in the final rule’s ergonomics rule and the comments The proposed rule’s exemption for program evaluation provisions. OSHA received in response to the very small employers elicited several proposed recordkeeping requirements. comments. These comments addressed Paragraph (v)—What Is My OSHA has carefully evaluated the usefulness of the standard’s small Recordkeeping Obligation? participants’ comments concerning the business recordkeeping exemption and The final recordkeeping provisions records needed for effective ergonomics argued that part time, seasonal, or specify that employers (except those programs to assure that the final leased employees should not be with fewer than 11 employees) must standard only requires employers to included in the count of employees that keep those records essential to any keep those records that are necessary, triggers recordkeeping. In addition, the effective ergonomics program. OSHA i.e., those records that have utility to Department of Navy commented on the observed in the proposal (64 FR 65861) employers, employees, and OSHA. future applicability of the standard to and continues to be convinced that Paragraph (v) of the final rule, entitled federal facilities. occupational injury and illness records ‘‘What is my recordkeeping obligation?’’ Usefulness of the small business are a vital part of an effective establishes which employers must meet recordkeeping exemption. Some ergonomics program in all but the very the rule’s requirements for rulemaking participants (see, e.g., Exs. smallest establishments. Records recordkeeping. This provision requires 30–2493, 3596; Tr. 2982–83, Tr. 8394, provide employers, employees, and employers with more than 10 employees Tr. 15522, Tr. 15565) argued that the consultants with valuable information at any time during the previous calendar proposed small business exemption on conditions in the workplace and can year to keep records of their ergonomics would not be useful to small businesses be used to identify trends over time and program. Employees to be counted because small employers would choose to pinpoint problems. However, OSHA toward this total include part-time and to keep records anyway. For example, also continues to recognize the need to seasonal employees and employees the National Federation of Independent reduce paperwork burdens for all provided through personnel services. Business (Ex. 30–3596, pp. 4–5) stated employers, especially small employers, Under the proposed rule, employers that to the extent that this can be done with fewer than 10 employees would without reducing safety and health have been exempt from having to keep OSHA has touted its paperwork exemption and ‘‘quick fix’’ alternatives to the full protections. OSHA proposed to limit any ergonomics program-related ergonomics program requirements as both the kinds of records employers records. As noted above, the final rule provisions in the ergonomics standard that were required to keep and the increases this size threshold to ‘‘more were revised to appease small business applicability of the standard’s than 10 employees.’’ OSHA’s experience concerns. Although a ‘‘paperwork recordkeeping requirements to very indicates that, because of the absence of exemption’’ may appear to help on its face, small employers. With very few management layers and multi-shift a small-business owner would be ill-advised changes, the final rule contains the work, informal communication may be not to write down and keep records of recordkeeping requirements that were used in very small companies, and everything related to their ergonomics proposed. OSHA believes that the formal recordkeeping systems may not program when faced with the constant possibility of an OSHA inspection. approach to recordkeeping in the final be necessary. A very small rule is consistent with the Paperwork establishment may have a very simple This comment echoes statements made Reduction Act’s emphasis on and informal, but nevertheless effective, by the small entity representatives who minimizing paperwork burdens for ergonomics program that does not need participated in the Small Business small employers whenever possible. written records. Regulatory Enforcement Fairness Act Because larger employers have more OSHA proposed, and the final rule (SBREFA) panel for this rule. These complex workplace organizations, includes part-time and seasonal representatives maintained that they OSHA proposed that larger employers employees and employees provided would choose to keep records even if would be required to keep records of through personnel services when they they were not required by the standard employee reports of MSDs and the count the number of employees they to do so (Ex. 23). In response to these employer’s responses to them; the employed at any time during the small business commenters, OSHA results of job hazard analyses; records of previous year. As explained in the notes that employers are always free to Quick Fix controls; records of controls proposed preamble (64 FR 65861), these keep any records that they wish to implemented in problem jobs; program part-time and temporary employees are maintain, but the final rule does not evaluations; and records of the MSD retained and supervised by the require them to do so. management process. OSHA proposed employer on a daily basis even though Part-time workers should not count to exempt employers with fewer than 10 this may be the case only for a limited toward the total. Some rulemaking employees from the standard’s time. As discussed above, participants (see, e.g., Tr. 3324, Tr. recordkeeping requirements because in establishments with more than 10 5638–39) indicated that the provision these very small workplaces, employees generally should be required describing which employers must keep information can be communicated and to keep records because they are likely records needed to be clarified and retained informally. The final rule to have more than one layer of simplified to state explicitly that requires that employers with management and therefore need to have seasonal, leased, and part-time ergonomics programs keep the same written procedures. In addition, if these employees should be included in the records as those proposed. However, the employees were not counted toward the total count. Other commenters (see, e.g., final rule expands the recordkeeping size threshold for recordkeeping, large Exs. 30–240, 429, 1090) felt that the size threshold from 10 employees to 11 workplaces that operate with few inclusion of temporary, seasonal, and employees. This expansion will make permanent employees but numerous part-time employees in the count of the recordkeeping size threshold for this temporary employees (an organizational employees was burdensome or

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These records are 37, Tr. 5039, Tr. 5334–35, Tr. 5493, Tr. initial health checks are usually not conducted. Personnel service workers could required to be maintained for the length 5638, Tr. 9207–9209, Tr. 12198–99, Tr. have pre-existing conditions that could of the injured employee’s employment 12770, Tr. 12860, Tr. 16486–87, Tr. become aggravated without MSD factors plus 3 years, a retention period 16491, Ex. 500–163) argued that the being present in their workplaces. considerably shorter than that required proposed recordkeeping requirements OSHA’s rationale for including these for other OSHA-mandated medical were excessive, burdensome and records. OSHA health standards, for unnecessary. For example, a commenter employees is that it is the number of example, generally require exposure for Owens Corning (Ex. 500–163, p. 7) employees, not the duration or kind of records to be kept for 30 years and stated that employment relationship they have medical surveillance records to be kept with the employer, that necessitates the The recordkeeping requirements in the for the duration of employment plus 30 keeping of records. The size of the proposed standard are excessive and poorly years, as required by 29 CFR 1910.1020, workforce is the factor that makes layers defined. In addition, the implied OSHA’s access to employee exposure documentation requirements of the proposed of management and more formal and medical records standard. These standard are inconsistent with the methods of communication (and lengthy retention periods are requirements of * * * [the proposed therefore recordkeeping) necessary. In appropriate for many toxic substances rulemaking section], i.e., the real recordkeeping requirements are much more fact, supervising part-time or leased and harmful physical agent standards employees often adds considerable extensive than those specifically required by because of the long latency between this section. complexity to management planning, exposure on the job and the onset of oversight, and recordkeeping. Thus, the disease. However, since the latency OSHA also received numerous pre- final rule uses a workforce of more period for most musculoskeletal and post-hearing form letters to the than10 employees on any day of the disorders is shorter than is the case for effect that the proposed recordkeeping previous calendar year as the size many of the chronic conditions and section was burdensome or unnecessary threshold that triggers compliance with illnesses covered by other OSHA rules, (see, e.g., Exs. 30–2252, 2251, 2360, the rule’s recordkeeping requirements. the Agency believes that a shorter 4226, 4748, 0382, 2973, 2224, 0591, Applicability to federal facilities. In a retention period is appropriate for the 0422, 1126, 4684, 4794, 2246, 0382, comment unique to federal agencies, the ergonomics rule. Also, changes in the 2747, 3331, 2244, 2337, 2888, 3517, U. S. Department of Navy (Ex. 30–3818, workplace, such as equipment or 0176, 2902, 639, 2874, 4624, 3090, 0070, p. 2) recommended that OSHA process changes, often make older 2794, 5104, 4402, 1073, 2999, 2033, ‘‘acknowledge the different ergonomics records irrelevant to current 2097, 2345, 1304, 2908, 4404, 5187, recordkeeping requirements for federal jobs and the present workplace 4718, 2354, 2359, 4269, 4690, 691, 3201, agencies and rewrite * * * [the environment. Employers’ ergonomics 3400, 2866, 0597, 1806, 0912, 4605, standard] to include provisions for the programs continue to evolve, with 2343, 2130, 4422, 1931, 2258, 2998, federal facilities recordkeeping program records of the most recent aspects of 2827, 0378, 2342, 2939, 2298, 4946, of 29 CFR 1960.’’ OSHA has considered that evolution being the most relevant 2787, 3403, 3293, 2938, 2450, 1672, this request, but has decided that a for employee protection. 2995, 4440, 4944, 2317, 4446, 2853, separate provision stating the The proposed recordkeeping 0569, 2877, 2994, 2953, 2096, 3130, applicability of the rule to federal provisions elicited several comments. 1603, 2763, 2885, 3451, 1026, 2884, facility recordkeeping programs is Commenters addressed the following 2924, 4795, 0455, 2336, 0433, 2197, unnecessary because this matter is issues: the potential burden imposed by 1540, 2758, 4796, 2972, 2858, 3294, better addressed in a compliance the recordkeeping requirements; the 4416, 2971, 4798, 4432, 1085, 4657, directive for affected federal agencies. kinds of records employers should keep; 2755, 5098, 3982, 5080, 5057, 5053, Paragraph (v) of the final rule, which the appropriate retention period for 2977, 2979, 5009, 3852, 5070, 2978, corresponds to section 1910.940 of the program-related records; the need to 3970, 4768, 3983, 4806, 2469, 3971, proposed rule, establishes the final permit employees and designated 3935, 5075, 5078, 2974, 2980, 4802, rule’s requirements for keeping the representatives to access the records; 2976, 3005, 2975, 2981, 5026, 3798, records required by the standard. It and electronic recordkeeping. The 2982, 2526, 2285, 3995, 4785; Exs. L30– specifies which records employers must paragraphs below discuss the 4958, 4964, 4967, 5211; Exs. 601–X– keep and how long they must keep comments; OSHA’s responses to the 249, 419, 1298; Exs. 500–1–224, 225, them. OSHA proposed that employers comments follow this discussion. 226, 228, 229, 230, 231, 232, 233, 234, required by the standard to keep records Several rulemaking participants 235, 236, 238, 239, 240, 241, 242, 243, maintain the following: agreed with OSHA’s proposed 244, 245, 246, 247, 249, 250, 251, 252, • Employee reports of MSDs and the recordkeeping requirements (see, e.g., 253, 254, 255, 256, 257, 259, 260, 261, employer’s responses to these reports, Exs. 32–339–1, 182–1; Ex. 500–206; Tr. 262, 263, 264, 265, 266, 267, 268, 269, II The results of job hazard analyses and 3488). Typical of the views of these 270, 271, 272, 273, 273, 274, 275, 276, Quick Fixes, commenters was the comment of the 277, 278, 279, 280, 281, 282, 283, 284, II The controls implemented to reduce AFL–CIO (Tr. 3488) ‘‘The recordkeeping 285, 286, 287, 288, 289, 290, 291, 292, or eliminate MSD hazards, provisions of the rule * * * are 293, 294, 295, 296, 297, 298, 299, 300, II The MSD management process, and necessary for the effective 301, 302, 303, 304, 305, 306, 307, 309, II The results of ergonomics program implementation of the program.’’ 310, 311, 312, 313, 314, 315, 316, 318, evaluations. Recordkeeping requirements are 319, 320, 321, 322, 323, 324, 325, 326, OSHA also proposed that most burdensome. A number of rulemaking 327, 328, 329, 331, 332, 333, 334, 335, ergonomic program records be retained participants (see, e.g., Exs. 30–74, 294, 336, 337, 338, 339, 340, 341, 342, 343,

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344, 345, 346, 347, 348, 349, 350, 351, rulemaking participants (see, e.g., Exs. 30–2809, 3001, 2116, 2825, 2847, 3033, 352, 353, 354, 355, 365, 366, 367, 368, 30–297, 3913, 4538; Exs. 32–85–3, 339– 3034, 3035, 3258, 3332, 4159, 4536, 369, 370, 371, 387, 388, 389, 390, 391, 1, (185–3–1); Tr. 3488) stated that the 4546, 4547, 4548, 4562, 4627, 4776, 392, 393, 394, 395, 396, 398, 399, 400, standard’s record retention periods 4800; Exs. 32–339–1, 185–3; Ex. 500– 401, 402, 403, 405, 406, 407, 408, 409, should be set at five years in the final 218; Tr. 3488) stated that the final rule 410, 411, 412, 414, 415, 416, 417, 418, rule, to be consistent with the retention should explicitly provide for access by 419, 420, 421, 422, 423, 424, 425, 426, period for the Log of Injuries and employees or their designated 427, 428, 429, 430, 431, 432, 433, 434, Illnesses and related records found at 29 representatives to all records required 435, 436, 437, 438, 439, 440, 441, 453, CFR 1904.6. The Dow Company by the standard. Typical of the views of 456, 459). commented that the proposed retention these commenters is the comment of the Some proposed records are not periods were too long, arguing that United Automobile Workers (Ex. 32– required. Some rulemaking participants ‘‘[t]here is no safety or health reason for 185–3–1, p. 7), which stated: questioned the need to keep certain of keeping records beyond their Other matters discussed in this section the records OSHA proposed that usefulness’’ and recommending that job * * * are employee reports and responses, employers retain (see, e.g., Exs. 32– hazard analyses ‘‘should only be kept and control records. First, it should be clear 3004, 30–294, 30–494, 30–2433, 30– while the employer is working through that these are available to affected employees 1294, 30–3356, 30–4628, 500–177–2). solutions to reduce the risk of the and their representatives. These commenters argued that the hazard to an acceptable level.’’ (Ex. 30– Electronic records. The American OSHA Log, medical records, and 3765, p. 116) August Mack Trucking Associations, Inc. (Ex. 30– Environmental Inc. agreed that the program evaluations were all that were 3330) asked OSHA to add the phrase ‘‘in proposed 3-year retention period was needed (Ex. 32–300–1), that Quick Fix paper, photographic, microfilm, appropriate, without providing records were unnecessary (Exs. 30–294, microfiche, CD–ROM, electronic or additional reasons why (Ex. 30–240, p. 30–494, 30–2433), that records of other appropriate format’’ to allow 367). ‘‘preventive’’ or ‘‘voluntary’’ work employers to ‘‘[t]ake advantage of less restrictions should not have to be kept Some rulemaking participants (see, e.g., Ex. 30–3686; 31–353) stated that costly records storage alternatives while (Exs. 30–1294, 30–3356, 30–4628, Ex. ensuring retention of the required 500–177–2), and that employee reports medical records related to employee exposure to ergonomic risk factors records * * *’’ of MSDs or their signs and symptoms Responses to comments received. In were not needed (Ex. 30–2433). should be kept for the duration of employment plus 30 years, as OSHA this section, OSHA specifically The reasons given by these responds to the issues raised by commenters varied. For example, the requires for other records covered by 29 CFR 1910.1020, OSHA’s access to commenters on the proposed Edison Electric Institute (Ex. 32–300–1) recordkeeping provisions. believes that only a few records are employee exposure and medical records standard, while another commenter (Ex. First, some commenters (see, e.g., Exs. needed for effective programs: ‘‘The 30–297, 30–3913, 32–85–3, 32–339–1, current required recordkeeping records 30–525) stated that all of the records required by the standard should be kept Tr. 3488) argued that the ergonomics including the OSHA 200 Log and standard should not have separate medical records along with the program according to the requirements of 29 CFR 1910.1020. Another commenter, the recordkeeping provisions but instead evaluation should be sufficient to that the Agency’s recording and maintain a current and effective National Telecommunications Safety Panel (Ex. 30–3745, p. 16), expressed reporting rule (the ‘‘recordkeeping ergonomics program.’’ The Exxon-Mobil rule’’) (29 CFR Part 1904) should govern Corporation saw no value in keeping concern that the proposed recordkeeping requirements could such requirements. These commenters records of employee reports of MSDs are confused about the purpose of that (Ex. 30–2433, p. 4), stating that potentially conflict with those of 29 CFR 1910.1020 and might raise employee rule, which is to record all occupational The [proposed] standard calls for detailed privacy issues because some of the injuries and illnesses that meet the records of job hazard analyses and hazard records could be ‘‘[p]ersonal and rule’s recordability criteria. Part 1904 control tracking which establishments do not individual in nature (e.g. job hazard does not address the records necessary normally maintain. For example, if a analyses to accommodate individual for an effective safety and health computer monitor is raised 2 inches by use program or the records that must be kept of a monitor block, that action—and any injury or illness)’’ and ‘‘[p]rivacy issues subsequent adjustment to the height—must beyond mere compliance with by employers to comply with the be documented and the document retained. [proposed] 1910.940.’’ Agency’s substance-specific or hazard- Furthermore, most of the records OSHA Many commenters (see, e.g., Exs. 30– specific rules, such as this ergonomics proposes to be maintained are not necessary 2116, 2809, 2825, 2847; 3001, 3033, program rule. It is routine and for an ergonomics program. OSHA should 3034, 3035, 3258, 3259, 3332, 4159, appropriate for rules addressing specific revisit the recordkeeping requirements and 4534, 4536, 4546, 4547, 4548, 4549, hazards, such as the confined spaces remove the requirements for employee 4562, 4627, 4776, 4800, 4801) rule (29 CFR 1910.146), the lockout/ reports and responses, and quick fix controls. maintained that all records other than tagout rule (29 CFR 1910.147), and The Dow Chemical Company (Ex. 30– MSD management records should be many others, to include recordkeeping 3765) saw no value in keeping records kept for 10 years. Representative of requirements geared to those hazards. of job hazard analyses for 3 years: ‘‘Job these comments, Gladys Vereesi argued Accordingly, OSHA has not adopted hazard analyses should only be kept that a 10 year retention period would this suggestion. while the employer is working through allow an ergonomics program to Many commenters (see, e.g., Ex. 30– solutions to reduce the risk of the improve upon past history, that a 3-year 2428, Tr. 9207, Ex. 32–21–1–2) argued hazard to an acceptable level.’’ retention period limited the inputs for that the rule’s recordkeeping The appropriate retention period. The ergonomics program evaluation and that requirements are unnecessarily proposed 3-year retention period also ‘‘[i]mportant lessons learned will be lost burdensome. OSHA disagrees. elicited several comments; commenters (Ex. 30–2116, p. 9). Employers must keep records of their suggested periods ranging from 90 days Access to the records kept. Many program activities for a variety of to more than 30 years. Several rulemaking participants (see, e.g., Exs. reasons: to ensure that the program is

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OSHA stated that management is helping injured must be treated in accordance with the this period would provide sufficient employees to recover as soon as requirements in paragraph (v)(1). The time for employers to review the final possible. OSHA believes that the restriction or removal of a symptomatic rule, get assistance, and prepare to meet records required by the final rule are the employee is thus simply a temporary the initial requirements of the standard minimum necessary for an effective work removal or restriction, as those as it applied to them. program. Simply relying on 200 Logs, terms are used in the final rule. If, on The proposed effective date section medical records, and evaluation records, the other hand, the employer assigns an elicited few comments. Some as the Edison Electric Institute employee to another job before that rulemaking participants (see, e.g., Exs. suggested (Ex. 32–300–1) would mean employee is symptomatic, the 30–3686, 32–85–3, Tr. 13132) agreed that an employer would not have reassignment is simply an with the 60-day effective date. Other records of the controls implemented, the administrative control, i.e., job rotation. commenters (see, e.g., Exs. 30–74, 30– kinds of MSD signs and symptoms Records of work restrictions or removals 3765) felt that 60 days was insufficient. occurring, or the methods used to are required to be kept by the final rule; For example, the Dow Chemical conduct job hazard analysis at the records of routine job reassignments or Company (Ex. 30–3765, p. 118) urged establishment. In this respect, OSHA rotations (i.e., those not done as part of OSHA to change the effective date to agrees with the views of one commenter the employer’s strategy to control or 180 days so that companies with (Tr. 7420) who noted that there is often eliminate MSD hazards) are not. existing programs, like Dow, would a discrepancy between the data on an OSHA agrees with those commenters have sufficient time to review and make establishment’s 200 Log and what is (see, e.g., Exs. 30–2809, 32–339–1, 32– any necessary changes prior to the happening on the floor: ‘‘When you 185–3, 500–218) who pointed out that standard becoming effective. actually review the first report of injury, the proposal failed to provide access to OSHA understands that employers you will conclude that the OSHA 200 records by affected employees and their with existing programs will need time to Log * * * has no report of cumulative designated representatives. The final review their programs, either to trauma and/or repetitive strain injury rule, at paragraph (v)(2) and (v)(3), establish that they qualify for when in fact musculoskeletal disorders corrects this oversight. ‘‘grandfather’’ status under paragraph (c) are at epidemic proportions.’’ OSHA Summary. After a review of the or to modify their programs to match the believes that most employers would rulemaking record, OSHA has decided requirements of the final rule. However, agree that all of the records required by in the final rule to retain the proposed OSHA believes that the 60-day date the final rule will provide information 3-year (or until replaced by an updated before the final rule takes effect, essential to effective ergonomics record) retention periods for most of the together with the additional time programs. required program records. The record, allowed for the implementation of the As to the suggestion (see, e.g., Exs. as discussed above, contains a wide ergonomics program elements, will 30–297, 30–3913, 32–185–3–1) that the range of opinion about the appropriate allow sufficient time for this purpose. retention period be 5 years instead of 3 retention period for these records. Moreover, any further delay would years to coincide with OSHA’s retention OSHA was not convinced to change the unnecessarily deprive employees of periods under the recordkeeping rule, required retention periods either by needed protections against MSDs. OSHA notes that the 3-year retention comments in favor of very short George Nagle, the Corporate Senior period specified in the final rule is retention periods (see, e.g., Ex. 30–3765, Director of Environmental Health and consistent with the frequency of which recommends a 90-day comment Safety for the Bristol-Myers Squibb required program evaluations, where period) or those arguing for a retention Company (Ex. 31–302, p. 1, Tr. 10519– these records will be most useful. period of 30 years or more (see, e.g., Ex. 10521) suggested that a pilot program of However, employers are always free to 30–525). at least one year should be implemented keep their records for longer retention Records of job hazard analyses, in OSHA’s national and regional offices periods if doing so is consistent with or hazard controls implemented, Quick Fix prior to attempting to impose a final beneficial to their management controls put in place, ergonomics ergonomics rule on the regulated practices. Also, even where an employer program evaluations, and MSD community. However, there was is permitted under paragraph (y) of the management records must be kept for insufficient detail in the suggestion to final rule to discontinue the ergonomics the employees and jobs covered by the determine how such a program would program for a job, the employer must employer’s program. Further, as work, or whether such a pilot program still keep the records required to be kept required by paragraph (v)(2), employees strategy would be beneficial to under paragraph (v) for the amount of or their designated representative(s) employees. In addition, there was little time listed in paragraph (v)(4). must be given access to those records or no support in the record for the OSHA agrees that employers may that address their report(s) of MSD implementation of such a pilot program. keep these records electronically, and incidents and the employer’s OSHA believes that a significant paragraph (v)(1) of the final rule makes response(s) to those reports. number of companies have successfully this clear. implemented an ergonomics program Some commenters (see, e.g., Exs. 30– Paragraph (w)—When Does This already; the economic analysis estimates 1294, 30–3356) urged OSHA not to Standard Become Effective? that approximately 20 percent of general require that records of temporary work In paragraph (w) of the final rule, industry companies have done so. removals or work restrictions be kept if which corresponds to § 1910.941 of the Although it does not believe a pilot such removals or restrictions were proposal, OSHA establishes the date program is necessary, OSHA does ‘‘preventive’’ or ‘‘voluntary’’ in nature. when the final rule becomes effective. intend to provide extensive compliance

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00163 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68424 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations outreach to industry when the standard Like the proposal, the final rule proposal do not appear in the final rule is published, and has included useful recognizes that employers need to begin (see the summary and explanation for compliance information in the setting up their ergonomics program paragraph (b)). Appendices to this rule. After reviewing soon after the rule is issued so that they Like the proposal, the final rule does the record on this issue, OSHA has will have an effective process in place not contain different compliance concluded that the 60-day effective date in time to meet the compliance deadlines for small and large employers. is appropriate and sufficient for deadlines. Without phased-in start-up This is the case because OSHA believes employers to read and understand their periods, some employers might wait that the compliance deadlines allow obligations under this final rule. until the last minute to take action. The enough time even for very small final rule’s phased-in compliance employers to obtain information about Compliance Time Frames periods are also designed to ensure that the rule and ways to implement an OSHA’s approach to compliance employees who report MSD signs and ergonomics program. OSHA also deadlines in the proposal differed from symptoms are provided with prompt believes that the final rule’s 4-year that in other OSHA standards. First, intervention (both MSD management phased-in compliance period for OSHA proposed a long start-up period and work restrictions) in order to help controls is adequate for larger employers so that employers would have time to resolve the problem quickly and who might have more complex get assistance before the compliance without permanent damage to the processes, employees, problem jobs, and deadline. Second, even after the employee. The phase-in approach taken controls to implement. compliance deadlines, OSHA proposed by the Agency was supported by Some rulemaking participants (see, to give employers newly covered by the commenters, such as the AFL–CIO, e.g., Exs. 30–3813, 30–3826) stated that standard (e.g., employers whose which stated that ‘‘the overall the compliance dates in the proposal employees develop MSDs after the timeframes for compliance * * * are were logically inconsistent and needed compliance deadlines have expired) more than sufficient’’ (Tr. 3488). to be rewritten. These commenters additional time to set up an ergonomics Finally, the longer start-up periods found this section on phased-in dates program and implement controls. Third, will also allow employers to integrate for program requirements to be difficult OSHA proposed to allow employers to needed job modifications into their to follow and confusing. Some commenters (see, e.g., Exs. 32– discontinue large portions of their regular production schedules or 339–1, 182–1, Tr. 383–384) noted that ergonomics programs if no MSDs were processes. The best way to control MSD under the compliance deadlines set reported for a specified period of time. hazards is often in the design process; allowing additional compliance time forth in the proposal, some employees Paragraph (x)—When Must I Comply allows establishments of all sizes to with MSDs who had already been With the Provisions of the Standard? make needed changes to their processes removed from their job might be returned to the problem job before the In paragraph (x) of the final rule, as part of regular production changes, and perhaps to make those changes at proposal required the employer to which corresponds to proposed implement interim controls. OSHA § 1910.942, OSHA establishes deadlines less cost. The final rule allows an initial period of 4 years for employers to agrees that this could be the case in for compliance with the requirements of some circumstances and has revised the the ergonomics standard. implement permanent controls. The proposal envisioned two levels of final rule accordingly. In the proposed rule, OSHA allowed ergonomics programs: a basic program The compliance time frames in the for start-up times for employers to set for manual handling and manufacturing final rule have been modified as up the ergonomics program and jobs (which included management follows: paragraph (x)(1) gives the implement controls in problem jobs. leadership, employee involvement, employer 9 months after the standard The proposal would have required the hazard information, and employee becomes effective (60 days after employer to implement MSD reporting of MSD signs and symptoms) promulgation) to provide the management promptly when an MSD and a full program for employers whose information required in paragraph (d) to was reported; to set up management employees developed work-related employees. This includes information leadership, employee participation, and MSDs that were covered by the about MSDs and their signs and hazard information and reporting within standard. The full program would have symptoms and how to report MSDs as 1 year of the effective date of the final included all of the elements of the basic well as the kinds of risk factors, jobs and rule; to implement job hazard analysis, program plus job hazard analysis, job work activities associated with MSDs interim controls, and training within 2 controls, training, and program (see preamble discussion for paragraph years of the effective date of the final evaluation. Employers who had (d) for a more complete discussion of rule; and to implement permanent manufacturing or manual handling jobs the information required to be controls and conduct program in their establishments would have had disseminated). evaluation within 3 years of the one year from the effective date of the The rest of the compliance time effective date of the final rule. The rule to comply with the basic program frames are presented in paragraph (x)(2), proposed start-up times thus ranged requirements, and later compliance Table 2. After an employee reports an from 1 to 3 years. deadlines for other requirements of the MSD (or signs or symptoms of an MSD), Based on an evaluation of the full program (job hazard analysis, job the employer must determine whether comments received on the proposed controls, training, and program the MSD is work related, whether it compliance dates, OSHA has revised evaluation, if a covered MSD is requires a work restriction and, where them in the final rule. The compliance reported). appropriate, whether the employee’s job deadlines in the final rule are staggered, OSHA has simplified the scope of the meets the standard’s Action Trigger (see as they were in the proposal, although final rule by eliminating the distinction the preamble discussions for paragraphs some dates fall earlier and some later between manual handling and (e) and (f) for further details on these than they did in the proposal. manufacturing jobs and other jobs. requirements). If an employer Comments received on the proposed Accordingly, the phased-in compliance determines that an MSD incident has dates, and OSHA’s response to the deadlines for manual handling and occurred (i.e., a work-related MSD that comments, are discussed below. manufacturing jobs found in the requires medical treatment beyond first

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If the within 3 years (after a determination required by paragraph (d) given earlier employee’s job meets the Action that a job meets the Action Trigger) and than the training triggered by the Action Trigger, then the employer has 7 days in to promptly correct any deficiencies in Trigger). As noted, the final rule which to initiate MSD management, the program that the evaluation reveals includes some employee awareness which includes access to a Health Care (see preamble discussion of paragraph training for all general industry Professional (HCP), an evaluation of the (u) for further details of this employees; the requirement to provide employee’s condition, any appropriate requirement). this training is the first requirement of work restrictions (including WRP for up Therefore, the effective date section in the standard to go into effect after the to 90 days) (see preamble discussion of the final rule has been modified to avoid effective date. In addition, paragraph paragraphs (p), (q), (r), and (s) for further the unwanted results some commenters (h), management leadership, and details of the employer’s MSD (see, e.g., Exs. 30–3813, 30–3826) paragraph (i), employee participation, management responsibilities). If the pointed out might have occurred under have training components (e.g., employee’s job meets the Action the proposal’s compliance dates. For information on MSDs, information on Trigger, the employer has 30 days in example, these commenters noted that, the ergonomics program and the which to initiate the management an employee with a work-related MSD requirement to provide responsible leadership element of the program could, under the proposal, be returned persons with the information and (assign responsibility for setting up and to a problem job before the employer resources necessary to meet their managing the ergonomics program and was required to implement interim responsibility under the program). communicating with employees about controls for that job. In the final rule, Some rulemaking participants (see, the ergonomics program) and the the employer has a longer period than e.g., Exs. 30–3813, 30–3826) complained employee participation element in the proposal—up to 9 months from that the terms ‘‘permanent’’ and (ensuring that employees have ways to the effective date of the rule—to ‘‘interim’’ controls used in the effective report and receive prompt responses to disseminate information to employees date section were undefined. Definitions reported MSDs and have ways in which about MSDs. After that date the of ‘‘interim’’ and ‘‘permanent’’ controls to be involved in the development and employer must respond promptly to any have been included in the final rule to implementation of the ergonomics reported MSDs by taking steps to further clarify the compliance program) (see preamble discussions for determine if the employee has suffered obligations set forth in the effective date paragraphs (h) and (i) for further details an MSD incident (a determination that section (see paragraphs (k)(1)(i) and of these requirements). the MSD is work-related, is persistent, (m)(2)). Within 45 days of determining that a and requires medical treatment beyond A number of commenters (see, e.g., job meets the Action Trigger, the first aid, days away from work or Exs. 30–3745, 30–3913, Tr. 7745–7746, employer must train employees in restricted work). Once it is determined Tr. 16471) felt that the time periods for setting up and managing the ergonomics that an MSD incident has occurred, the compliance given in the proposal were program (see preamble discussion for employer has 7 days to determine if the inadequate. For example, the National paragraph (t) for further details of this employee’s job meets the Action Telecommunications Safety Panel (Ex. requirement). Also, a job hazard Trigger. If the job meets the Action 30–3745, pp. 16–17) stated: analysis of the problem job must be Trigger, all of the other requirements of Based on previous discussions of initiated within 60 days of a the standard spring from the date of the individual program elements within the determination that the job meets the Action Trigger determination, and proposed rule, the Panel believes it would be Action Trigger (see preamble discussion interim controls would need to be necessary for employers with more than 10 of paragraph (j) for further details of this implemented within 90 days of this worksites and 2500 employees across those requirement). Within 90 days after a determination. Therefore under the final multiple worksites to have two years after a determination that a job meets the rule, an employee on work restriction or rule becomes effective to implement Action Trigger, the employer must WRP would not have to face the ‘‘management leadership’’ and ‘‘hazard implement interim controls and initiate possibility of returning to an ‘‘unfixed’’ information and reporting’’ as defined in the rule, three years to implement ‘‘job hazard training for employees, supervisors and job because the WRP period has expired analysis,’’ ‘‘interim controls,’’ and training, team leaders involved in the ergonomics before the employer has a duty to and four years for ‘‘permanent controls’’ and program (see preamble discussion of implement at least interim controls. ‘‘program evaluation.’’ This reflects the paragraphs (t) and (m)(2) for further Some rulemaking participants (see, distinct probability that most details on these requirements). e.g., Ex. 32–339–1, Tr. 3488–3489) telecommunications companies will Finally, the employer must observed that the compliance deadline maintain a corporate ergonomics program to implement permanent hazard controls for management leadership and ensure consistency of compliance, adequate to fix a problem job (so that any MSD employee participation in the proposal communications and sharing of ‘‘best hazards presented by the job no longer fell due before the deadline for training. practices’’ across all of their workplaces. are likely to cause MSDs that result in Commenters (see, e.g., Ex. 500–218) The National Council of Agricultural work restrictions or medical treatment were concerned that this phase-in Employers (Ex. 30–3781) indicated that beyond first aid) within 2 years of a discrepancy would mean that small employers needed a longer phase- determination that a particular job employees would not be able to fully in period, which would allow them to meets the Action Trigger. The final rule participate in the ergonomics program take advantage of innovations allows the employer up to 4 years (after because they had not had training. undertaken by larger companies. a determination that a job meets the Although the proposal would not have However, this commenter neither stated Action Trigger) for initial prevented employers from training what length of time would be implementation of the permanent employees prior to the 2-year deadline appropriate for small employers nor

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00165 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68426 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations whether more time was needed to OSHA notes that the inability of an date (or 4 years or 5 years after), that comply with all of the provisions of the employer to comply for reasons of employer has 2 years from that date to standard or just the interim and infeasibility can always be raised in the install permanent controls. This two- permanent control provisions. OSHA context of enforcement. The fact that an tiered approach to the requirement to also notes that agricultural employment employer may confront a highly implement permanent controls initially is not covered by this rule (see the unusual situation, such as the one this was adopted to allow employers summary and explanation for paragraph commenter describes, is no reason for sufficient time to deal with a possible (b)). OSHA concludes that the times the implementation dates for all increase in the number of MSD given to comply with the program employers to be extended. Another incidents soon after the standard elements in the final rule are adequate participant stated that the brick-making becomes effective. The Agency believes, for all employers, including small industry would have problems meeting once the standard has been in effect for employers, who will be able to avail the proposed three-year phase-in period several years, there will be fewer MSD themselves of all of the compliance for permanent controls (Tr. 7745–7746) incidents, and that a shorter compliance assistance materials OSHA is because they believe that the only deadline for permanent controls—2 disseminating, the OSHA consultation permanent controls for their ergonomics years—will give these employers program, and other ergonomic resources problems is automation. OSHA notes sufficient time to implement permanent available. that this commenter reported making controls for problem jobs. A number of other comments were substantial progress in reducing its MSD The few employers who may find the received in response to the compliance hazards, but recognizes that feasibility generous compliance times given in the date section of the proposal. One may be an issue for some final rule inadequate also may avail rulemaking participant (Ex. 30–3913) establishments. themselves of the temporary variance argued that training should be phased- The American Industrial Hygiene procedures provided in the in over 5 years rather than the proposed Association (AIHA) (Tr. 16471) noted Occupational Safety and Health Act of 3 years because at present commercially difficulties that might be encountered in 1970. available ergonomic training materials meeting the proposed compliance Many commenters felt that the are of inadequate quality and more time deadlines for the implementation of compliance deadlines were too long would be needed to improve the overall interim or permanent controls by stating (see, e.g., Exs. 30–2039, 30–2116, 30– quality of such training materials. that ‘‘[i]n some cases, substantial 2825, 30–2847, 30–3001, 30–3033, 30– OSHA concludes that a wealth of reductions in hazards may require 3034, 30–3035, 30–3258, 30–3259, 30– material is already available that can reworking an entire material handling 30–3332, 30–3686, 30–4159, 30–4534, assist in meeting the training obligations system for even a production line. These 30–4536, 30–4546, 30–4547, 30–4548, in the final rule. (See Docket 777, e.g., types of changes usually require a stage 30–4549, 30–4562, 30–4627, 30–4776, ‘‘Ergonomics Awareness Manual (Ex. process that may run over three years.’’ 30–4800, 30–4801, 31–242, 31–353, 32– 32–185–3–11);’’ ‘‘Trainer’s Manual Again OSHA understands that controls 85–3, Tr. 11196, 13133). Ergonomics Program (32–111–1–21).’’) can take some time to implement in Typical of comments stating that the In addition even more training materials certain complex cases, and further that deadlines were too long was that of the will become available through OSHA many companies prioritize their jobs for American Nurses Association (ANA) outreach as well as the market for such control. OSHA’s compliance staff is (Ex. 30–3686, p. 22), which criticized materials which the promulgation of trained to address these issues on a the deadlines on the grounds that they this rule will create. Further, the case-by-case basis, and will do so in were so long that they would continue training obligations in the final rule are enforcing this standard as well. to permit opportunities for thousands of implemented over time, and the OSHA has determined that, except in nurses and HCWs (health care workers) materials for them can thus be rare cases, employers will be able to to be injured. Although the immediate developed and implemented piecemeal meet the compliance deadlines in the implementation of effective controls on as program development occurs within final rule. These deadlines are based on jobs with MSD hazards would be ideal, the workplace. a review of the record on the OSHA recognizes that employers will Some participants (see, e.g., Exs. 30– appropriateness of the proposed time need time to find, implement, and 3922, 30–3032, 30–3284, 30–3922, 32– given to implement permanent controls. analyze the effectiveness of controls for 133–1, 32–300–1, L30–5088, 601–x– As a result of that review, OSHA has each job. OSHA has modified the 1711) thought that the deadlines for increased the amount of time employers compliance time frames to address interim or permanent controls were too are allowed to implement permanent comments such as the ANA’s by short. Others (see, e.g., Exs. 30–526, 30– controls initially to 4 years after the significantly shortening the amount of 710, 30–2433) felt that any deadline for final rule goes into effect, and to 2 years time allowed in the final rule for implementing permanent controls was thereafter. This means that the 4-year employers to address jobs that meet the unrealistic, due to the difficulty of period is the maximum time that any Action Trigger. In the final rule, for providing permanent controls. For employer can take to implement example, interim controls must be example, Pinnacle West Capital permanent controls. In other words, the implemented within 90 days of a Corporation (Ex. 30–3032, p. 12) stated: employer has 4 years after the effective determination that a job meets the date to install permanent controls or 2 Action Trigger, as opposed to the 2 * * * due to the heavy regulation of the years after the employer determines that years given in the proposal. Further, the plant modification process by the Nuclear Regulatory Commission in electric utility a job meets the Action Trigger, deadlines in the final rule represent the nuclear plants, it is entirely possible that whichever is later. For example, if an maximum amount of time employers some engineering control implementation employer determines that a job meets will have to comply with the elements could take more than the [proposed] three the Action Trigger 1 year after the of the ergonomics program. Employers year permanent control deadline. This is effective date, that employer will then are encouraged to implement effective particularly true if the modification can only have 3 years to install permanent controls as soon as possible, and OSHA be accomplished during plant outage times. controls. On the other hand, if the believes that many employers will do This commenter did not indicate how employer makes the Action Trigger so, because this approach will benefit often such plants are off line; however, determination 3 years after the effective both employers and employees by

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The The MSD management system required that the standard has been under AHCA stated ‘‘[b]ecause we anticipate by the standard does not in any way development for so long.’’ OSHA that MSDs will be reported early under interfere with workers’ compensation understands that the compliance this proposed standard, we envision (see preamble discussion of paragraph deadlines given are generous, but has that the MSD management component (q)). OSHA included the MSD concluded that some companies will deadline will occur almost immediately management provisions pursuant to its need the extra time to work needed job after the 60-day start-up. This hardly statutory authority under the OSH Act modifications into their regular provides an opportunity for employers (see preamble discussion of paragraph production change schedules. From a to receive assistance on MSD (r)). After reviewing a wide variety of review of the comments on this section, management * * * ’’ In the final rule, opinions as to how long injured OSHA has determined that the final rule the dates in the proposal have been employees should wait before receiving strikes a rational balance between the modified to clarify that, although the MSD management, OSHA has need to respond with due speed to MSD employer has 11 months from the time concluded that MSD management incidents and the benefits of developing the standard is published to disseminate should begin within 7 days after a remedies to problem jobs in an orderly information about MSDs (including determination can be made that an MSD fashion. Substantial evidence in the their signs and symptoms and how to incident, as defined by this standard, record supports the compliance time report them), the employer need not has occurred. Compliance dates are frames adopted in the final rule. respond to the employee reports necessary to effectuate the MSD The Communications Workers of initially until the 11-month period has management provisions included in the America (CWA) (Tr. 13133) supported passed. This initial delay in employer standard, and OSHA believes that the the requirement for prompt responses to response obligations is necessary to time frames included in the final rule reported MSDs, but felt that the permit the employer to develop an for MSD management are appropriate remaining requirements (management ergonomic program in an orderly and supported by the record. leadership and employee participation, fashion. In § 1910.943, OSHA proposed to hazard information and reporting, job Some commenters felt that after the establish different compliance time hazard analysis, training, interim and standard became effective employers frames for those employers who had not permanent controls, and program should be given 5 days to respond to identified a problem job until after some evaluation) should all begin one year MSD reports (see, e.g., Exs. 30–400, 30– or all of the start-up compliance after the effective date of the standard. 4837, 31–3, 31–12, 31–113, 31–31–150, deadlines established in proposed The CWA (Tr. 13133) also stated that 31–160, 31–186, 31–187, 31–192, 31– § 1910.942 had passed. This was hazard information training should be 200, 31–205, 31–243, 31–307, 31–347); because the occurrence of an MSD conducted within 30 days after the others thought that 2 days would be incident is difficult to predict and may identification of a problem job. In the appropriate (Ex. 31–23). These not occur, in some establishments, for final rule, this initial training is required commenters only provided their many years, i.e., long after the before the identification of a problem opinions in this matter, without detail. standard’s initial start-up dates have job. The CWA also suggested that Other periods of time were also run. comprehensive training on MSD recommended for MSD management In proposed § 1910.943, if an hazards, controls, and the employer’s deadlines, such as 1 month (Exs. 31– employer incurred a compliance ergonomics program should be required 125, 31–265 ), again without detailed obligation after the compliance start-up 90 days after the identification of a explanation. The proposal (§ 1910.942) deadline for that obligation had passed, problem job. As noted above, in the had merely required that the employer a different timetable applied. OSHA’s final rule, all of the training provide a ‘‘prompt’’ response. This reasons for this timetable, which was requirements go into effect within 90 requirement has remained essentially shorter than the initial compliance days of a determination that a job meets the same in the final rule but has been timetable, was that employers in later the Action Trigger. Several training included in paragraph (e) rather than in years would not need as long to requirements, such as the dissemination the effective date section (see preamble implement ergonomics programs of MSD awareness information to discussion of paragraph (e) for a more because they could take advantage of employees (paragraph (d)) and the detailed discussion of the MSD response program development and remedies that training of employees involved in requirements). had been developed by other employers setting up the ergonomics program Some commenters (see, e.g., Exs. 31– in the interim. Accordingly, proposed (paragraph (t)) have to be met 27, 31–78, 31–170, 31–180) argued that § 1910.943 gave employers with later substantially sooner. medical treatment deadlines for MSDs incurred compliance obligations some Some commenters agreed that MSD are addressed in state workers’ additional time to comply, but the time management should be provided compensation laws and that OSHA frame between the MSD incident and immediately, or as soon as possible (see, should not interfere with those the remedy was shorter than that e.g., Exs. 30–2387, 30–4538, 31–105, requirements. These commenters proposed for initial compliance when 31–106, 31–129, 31–170, 31–229, 31– misunderstand the rule’s MSD the standard became effective (see 64 FR 276, 31–309, Tr. 13133). Other management provisions. The OSHA rule at 66074). participants (see, e.g., Exs. 30–74, 30– does not require employers to obtain From a review of the rulemaking 2987) felt that the requirement for medical treatment for employees with record, it is clear that many participants prompt response, i.e., as soon as an MSDs; OSHA assumes that MSDs will did not understand proposed § 1910.943 MSD is reported after the effective date, continue to be treated under the or how it would work (see, e.g., Exs. 30– could be disruptive and would result in workers’ compensation system, as they 2116, 30–2809, 30–2825, 30–2847, 30–

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3001, 30–3033, 30–3034, 30–3035, 30– employers covered by the ergonomics ergonomics program, because it gives 3258, 30–3259, 30–3332, 30–3826, 30– standard must comply with the minimal insufficient time for employers to 4159, 30–4534, 30–4536, 30–4546, 30– requirements in paragraph (d) accurately determine if the controls 4547, 30–4548, 30–4549, 30–4562, 30– (informing employees) within 11 implemented have been effective. 4627, 30–4776, 30–4800, 30–4801, Tr. months of the publication of the rule. However, this commenter did not 3236). Additionally, this section of the The remainder of the rule’s obligations suggest what amount of time would be proposed rule elicited a number of and time frames for complying with the appropriate to wait before discontinuing comments, most of which were critical various requirements are incurred after parts of the program. (see, e.g., Exs. 32–85–3, 30–297, 30–424, a determination that an MSD incident On the other hand, some rulemaking 30–434, 30–1090, 30–2433, 30–3120, has occurred in a job that meets the participants (see, e.g., Exs. 30–3471, 30– 30–3171, 30–4537, 32–85–3, 500–145). Action Trigger set forth in paragraph (f). 4185, 30–3868, Tr. 3325–3326) thought However, few commenters provided In view of this altered approach in the that 3 years was too long to wait before detailed reasons for their views. final rule, it is no longer necessary to discontinuing certain aspects of the A few commenters (see, e.g., Exs. 30– provide two separate compliance time program. For example, Tyson’s Foods 4538, 30–3686, 31–353, 32–300–1) frames as was done in the proposal. (Ex. 30–4185, p. 26) stated ‘‘* * * recommended that proposed OSHA has set an unrealistically * * * § 1910.943’s requirement that MSDs be Paragraph (y)—When May I Discontinue low threshold * * * by premising the responded to within 5 days be modified my Ergonomics Program for a Job? obligation to implement engineering to require MSD management Paragraph (y) allows employers to controls on the existence of * * * a ‘‘promptly’’ when an MSD is reported. discontinue most elements of their single reported MSD and then further The American Federation of ergonomics program for a job if the risk requiring employers to continue to Government Employees (Ex. 30–4538, p. factors in that job have been reduced to search for and implement engineering 8) stated: levels below those in the Basic controls until there are no more MSDs OSHA should require medical management Screening Tool (Table 1 of the for at least three years * * *’’ sooner than five days. If an employee standard). The only obligations the Other commenters (see, e.g., Exs. 30– experiencing MSD symptoms continues to employer continues to have for jobs that 3344, 30–3749, 30–4674, Tr. 3325–3326, work in the same job without medical have been controlled to that level are to Ex. 601–x–1710) recommended using attention, his condition could get worse. In maintain the controls that reduce the alternative criteria for discontinuing general, by the time an employee reports a risk factors, continue to provide the elements of the program. For example, problem, she has been experiencing training related to those controls, and Abbott Laboratories (Tr. 3325–3326) symptoms for some time and should not have keep records of the job hazard analysis stated ‘‘clearly the bar for ending the to wait another few days for treatment. and the controls implemented for that full program is too high. We propose Some rulemaking participants (see, job. that OSHA substitute a performance- e.g., Exs. 30–240, 30–526, 30–710, 30– OSHA proposed to allow employers based replacement for the ‘one MSD in 3813, 30–3826, 30–3284, 32–300–1, to discontinue portions of their three years’ criterion.’’ OSHA has 501–6) disagreed with the idea of ergonomics program when no covered considered this suggestion but has providing less time for later-year MSD had been reported in a problem job determined that such a performance- compliance in § 1910.943 than was for 3 years after the problem job was based approach, such as the use of proposed for initial compliance in controlled. Paragraph (y) of the final industry averages, would be too § 1910.942. For example, the rule has the same advantages as the complex to apply and too difficult to Department of Defense (Ex. 30–3826, p. proposed provision, but has been verify during enforcement. 11) stated ‘‘[i]t is not clear why two revised to reflect changes made to the Some commenters (see, e.g., Exs. 30– timetables are provided. It seems design of the final rule. That is, the 2116, 30–2825, 30–2847, 30–3001, 30– capricious to allow some employers up approach taken in the final rule 3035, 30–3258, 30–3259, 30–4159, 30– to three years to fully implement their recognizes the role of the Basic 4534, 30–4536, 30–4546, 30–4547, 30– ergonomics programs, while others will Screening Tool in Table 1, which acts, 4548, 30–4549, 30–4562, 30–4627, 30– have only one year.’’ along with the report of an MSD 4801, 32–85–3, Tr.13134) stated that the Another rulemaking participant (Ex. incident, as a trigger for action under proposed rule would permit employers 32–229–1) observed that the proposed the standard and, in paragraph (y), as to discontinue too many elements of the deadline for training expires after the the mechanism for relieving employers ergonomics program. The deadline for management leadership of most of their obligations under the Communications Workers of America and employee participation, which standard. (Tr.13134), for example, stated that would mean that employees would not Some rulemaking participants (see, management leadership and employee be trained before they are expected to e.g., Exs. 30–526, 30–710, 30–3686, 31– participation, hazard information and participate. In response, OSHA has 242) argued that the 3-year timetable for reporting, awareness training, program shortened the deadline for training for discontinuing elements of the program evaluation, and maintenance of controls employees who are involved in setting should be eliminated. These and the training related to those controls up and managing the ergonomics commenters felt that employers with should be continued to ensure the program in the final rule from the ergonomics programs should be control or prevention of MSDs. proposed 90 days to 45 days after the required to maintain all elements of OSHA has considered the possibility employer has determined that a job their ergonomics program indefinitely. of increasing the number of program meets the Action Trigger. Employee Commenters took issue with the elements employers are allowed to participation has a deadline of 30 days proposed timetable for discontinuing discontinue if they have reduced the after the employer has determined that parts of the program; some thought the MSD hazards in jobs covered by the the job meets the Action Trigger. time period was too short, while others standard to levels below those in the As noted earlier, in the final rule, the argued that it was too long. For screen (Basic Screening Tool in Table events that trigger an employer’s example, one rulemaking participant 1). However, the Agency has decided obligations under this standard have (Ex. 32–185–3) stated that 3 years is too that maintaining the controls that been modified since the proposal. All soon to discontinue parts of the allowed the employer to control the job,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00168 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68429 continuing the training in the use of General Comments on Definitions that they fail to provide sufficient guidance to enable dealers to make practical, cost those controls for employees in these OSHA received many comments on jobs and keeping records of the job effective, and objective determinations (Ex. the definitions for terms used in the 4839). hazard analysis and controls for that job proposed ergonomics program standard. Some commenters were concerned are the minimum requirements needed A great deal of comment focused on the that the terms lacked objective criteria to ensure employee protection. These perceived vagueness of the terms and (see, e.g., Exs. 32–206–1, 30–3765, 30– are the only program requirements the definitions, with commenters raising 1722, 30–4185, 30–3826, 30–4538, 32– employer is required to continue once concerns about their inability to 300–1, 30–3336, 30–2208–1, 30–3853, the risk factors in the job have been understand these terms and, thus, their 30–3749, and 30–3167). Some reduced to levels below the screen. ability to comply appropriately. Others commenters suggested that OSHA Paragraph (y) contains no time period raised concerns about the cost of should use definitions for certain terms and no link to the occurrence of MSD compliance, arguing that they would that had been established by outside incidents, as the proposal did. Instead, spend large sums of money trying to organizations (see, e.g., Exs. 30–3765, both the ‘‘entrance’’ to and ‘‘exit’’ from comply because they were unsure what 30–4499, and 30–3167). Another most program obligations is tied to the the rule meant (see, e.g., Exs. 32–207– commented that there was no consensus extent of the risk factors in the job, as 1, 32–206–1, 30–3765, 30–3845, 30– definition on many of the terms; that indicated by the screen. 3813, 32–368–1, and 30–3853). One experts are not in agreement on the root commenter, Monsanto Corporation (Ex. Paragraph (z)—Definitions cause and true definition of MSDs; and 30–434), recommended moving the that scientists find it difficult to explain Paragraph (z) of the final rule contains definitions to the front of the document why different individuals working on a number of definitions of terms used in for clarity. OSHA has not adopted this the same job will not experience the this final rule. Most of the definitions recommended change, although a Note same symptoms (Ex. 30–3167). Some of are straightforward and self-explanatory. to paragraph (a) of the rule states that the commenters disagreed with the way A general discussion of each of the the definitions for the standard appear the terms were defined or offered terms can be found below; however, in paragraph (z). suggested alternatives (see, e.g., Exs. 30– clarification of many of the terms is OSHA has arranged its discussion of 3765, 30–4185, 30–3826, 30–2208–2, provided in the summary and the comments on definitions so that the 30–1722, 32–111–4, 30–4538, 30–3934, explanation sections for the provisions ‘‘general’’ comments—those that apply 32–198–4, 32–300–1, 30–2208, 30–4499, where the terms are used. OSHA to all definitions—are discussed first, 30–3818, 30–3000, 31–242, 30–4499, believes that describing terms where and the more specific comments—those 30–3867, 30–3818 and 30–434). they are used makes it easier for that pertain to a particular term or The Department of Defense (DoD) (Ex. employers and employees to understand definition—are discussed afterward. 30–3826) suggested that OSHA what OSHA means when it uses them. Additional discussion of some terms eliminate the need for many of the can be found in the summary and The following terms are defined in the definitions, such as those for explanation of the provision where the manufacturing jobs, manual material final rule: ‘‘administrative controls,’’ term is used. ‘‘Assistant Secretary,’’ ‘‘control MSD handling, and several terms used within On the overall issue of the vagueness those definitions, by simply including hazards,’’ ‘‘Director,’’ ‘‘employee of the definitions, commenters said that representative,’’ ‘‘engineering controls,’’ all general industry employers in the terms were unclear or too broadly scope of the standard. OSHA notes that ‘‘follow-up,’’ ‘‘health care professionals defined, which would make it difficult (HCPs),’’ ‘‘job,’’ ‘‘musculoskeletal the scope of the final rule has been for them to implement the standard (see, revised so that it is no longer necessary disorder (MSD),’’ ‘‘MSD hazard,’’ ‘‘MSD e.g., Exs. 30–294, 30–434, 30–1897, 30– to define ‘‘manufacturing jobs’’ and incident,’’ ‘‘MSD signs,’’ ‘‘MSD 3765, 30–2208–2, 30–3845, 30–1722, ‘‘manual handling jobs.’’ (See the symptoms,’’ ‘‘personal protective 30–3813, 30–4185, 30–3739, 30–4006, summary and explanation discussion on equipment,’’ ‘‘problem job,’’ ‘‘risk 30–2705, 30–4038, 601–X–1379, 30– Scope, paragraph (b).) factor,’’ ‘‘work related,’’ ‘‘work 3889, 30–2540, 30–4760, 30–4021, 33– Some commenters argued that the practices,’’ ‘‘work restriction protection 1455, 30–4599, 33–1463, 33–1462, 30– definitions’ vagueness meant that (WRP),’’ ‘‘work restrictions,’’ and ‘‘you.’’ 2751, 30–4982, 30–5009, 30–2598, 30– OSHA’s cost estimates would be Several terms were defined in the 2569, 30–4149, 30–4963, 30–4222, 30– substantially underestimated because proposal (64 FR 65864 and 64 FR 66075) 4023, 30–4224, 30–4060, 30–4063, 30– employers would do ‘‘everything’’ in an but are not defined in the final rule: 2280, 30–3793, 30–4235, 30–2540), 500– attempt to comply (see, e.g., Exs. 32– ‘‘covered MSD,’’ ‘‘eliminate MSD 1–4, 500–1–5, and 500–1–28). 206–1, 32–141–1 and 30–3813). Another hazards,’’ ‘‘ergonomics,’’ ‘‘ergonomic The comments of the National commenter questioned whether the rule design,’’ ‘‘ergonomic risk factors,’’ ‘‘have Automobile Dealers Association are would result in a substantial reduction knowledge,’’ ‘‘manual handling jobs,’’ representative of the comments received in MSDs because it was so unclear (Ex. ‘‘manufacturing jobs,’’ ‘‘materially on the general issue of the vagueness of 32–368–1). Others said that if the reduce MSD hazards,’’ ‘‘MSD the proposed definitions: standard cannot be understood, it is not management,’’ ‘‘no cost to employees,’’ To the extent that the ergonomics rule legally defensible, citing cases such as ‘‘OSHA recordable MSD,’’ remains inexorably tied to the reporting of Kent Nowlin Construction Co. v. ‘‘periodically,’’ ‘‘persistent MSD MSD risks, MSD symptoms, MSDs, OSHA OSHRC, Connally v. General Constr. symptoms,’’ ‘‘physical work activities,’’ recordable MSDs, and covered MSDs, Co., and Diebold Inc. v. Marshall (Exs. and ‘‘resources.’’ These terms are either [automobile] dealers will be forced to closely 30–1897, 32–206–1, 32–368–1 and 30– not being used in the final rule, have scrutinize reported MSD signs and 3336). symptoms, to screen out those that are not been replaced by other terms that are tied to real MSDs, and to avoid identifying In response to these comments, OSHA defined (either in this paragraph or OSHA recordable MSDs. To be sure, has redefined many terms in the final where they first appear), or have such proposed section 1910.145 lists somewhat rule, deleted others, and provided clear meanings that further definition is helpful definitions for each of these terms. greater clarity in several areas that were unnecessary. Nonetheless, these definitions are lacking in particularly singled out for comment

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00169 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68430 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations such as the level of control employers (see, e.g., Ex. 30–3765). In addition, relating to the meaning of this term can must reach. Revised provisions of the there were statements that the term be found in the summary of explanation final rule that provide definite ‘‘eliminate MSD hazards’’ is not really of paragraph (i). compliance endpoints and ‘‘safe different from ‘‘materially reduce MSD Engineering controls are defined in harbors’’ for employers are examples of hazards’’ (see, e.g., Ex. 32–300–1). the final rule as physical changes to a these changes. The issue of ‘‘fair notice’’ Comments on the term ‘‘materially job that reduce MSD hazards. Examples (vagueness) is discussed in the section reduce MSD hazards’’ stated that of engineering controls include: of the preamble entitled ‘‘Other employers would not be able to evaluate changing, modifying, or redesigning Statutory Issues’’. Thus the final rule whether or not material reductions in workstations, tools, facilities, addresses the concerns of employers by risks have occurred and expressed equipment, materials, or processes. providing objective criteria and concern that the term could be The definition of the term establishing clear obligations for interpreted differently by employers, ‘‘engineering controls’’ has been employers to follow. employees, and OSHA inspectors (see, changed from the proposal. In the proposal, OSHA defined engineering Specific Comments on Definitions e.g., Ex. 30–3845). Some commenters also objected to some of the phrases controls as physical changes that Administrative controls are defined as used in the proposal definition of eliminated or materially reduced the changes in the way that work in a job ‘‘materially reduce MSD hazards,’’ such presence of MSD hazards, a term also is assigned or scheduled that reduce the as ‘‘magnitude,’’ ‘‘likelihood,’’ and defined in the proposal. OSHA defined magnitude, frequency, or duration of ‘‘significantly’’ (see, e.g., Exs. 30–1897, the term ‘‘materially reduce MSD exposure to ergonomic risk factors. 30–3765, 30–3866, 32–300–1, 30–4467). hazards’’ to mean ‘‘to reduce the Examples of administrative controls In response to comments in the duration, frequency and/or magnitude include employee rotation, employer- record, OSHA has decided to delete the of exposure to one or more ergonomic designated rest breaks designed to terms ‘‘eliminate MSD hazards’’ and risk factors in a way that is reasonably reduce exposure, broadening or varying ‘‘materially reduce MSD hazards’’ from anticipated to significantly reduce the job tasks (job enlargement), and the final rule. Instead, the Agency has likelihood that covered MSDs will employer-authorized changes in work defined ‘‘control MSD hazards’’ more occur.’’ (See the discussion of these pace. clearly and has additionally provided terms above, in the section on ‘‘Control The definition of the term clear compliance endpoints that MSD hazards.’’) One commenter stated administrative controls is essentially essentially cure the vagueness that the definition of engineering unchanged from the proposal. OSHA objections raised. controls was clear (Ex. 30–3748). received one comment on the definition OSHA also received a comment from The term Follow-up means the (Ex. 30–3748), which noted that the the Department of Defense (Ex. 30– process or protocol an employer or HCP proposed definition was clear. 3826), which recommended that uses (after a work restriction is imposed) The term Control MSD hazards means definitions be developed for ‘‘interim’’ to check on the condition of employees to reduce MSD hazards to the extent and ‘‘permanent controls,’’ stating: who have experienced MSD incidents. that they are no longer reasonably likely The definition of the term ‘‘follow-up’’ to cause MSDs that result in work The timetable in [proposed] § 1910.943 is essentially the same as the proposed restrictions or medical treatment beyond included reference to ‘‘(e) interim controls’’ definition, except that OSHA has first aid. This is a new term in the final and ‘‘(g) permanent controls’’; however, there are no corresponding sections nor definitions removed a sentence from the proposed rule. OSHA has included a definition within section 1910.945 that discusses their definition that explained why ‘‘follow- for this term in the final rule because distinction. At what point does an interim up’’ was necessary. The sentence paragraph (k) of the standard requires control become a permanent control, removed was ‘‘Prompt follow-up helps employers to control MSD hazards. especially when the employer is following to ensure that the MSD is resolving and, Controlling hazards means that the risk the incremental abatement process guidance if it is not, that other measures are factors that were occurring at a contained within 1910.922. * * * According promptly taken.’’ No substantive magnitude, duration, or frequency to some sources, the only permanent control comments on this definition were sufficient to cause an MSD hazard have for ergonomic hazards is an engineering received. Additional discussion relating been reduced to the extent that they are control—administrative and work practice controls can almost always be circumvented to the meaning of this term can be found no longer reasonably likely to cause in the name of convenience, schedule or in the summary and explanation for MSDs that result in work restrictions or production. Unfortunately, in many cases, paragraph (p). medical treatment beyond first aid. there are no feasible engineering controls for Health care professionals (HCPs) are Employers are to use engineering, work identified ergonomic hazards. Therefore, physicians or other licensed health care practice, or administrative controls or permanent controls must be defined, and professionals whose legally permitted personal protective equipment to criteria for determining whether an employer scope of practice (e.g., license, control MSD hazards. has fulfilled the requirement must be registration or certification) allows them The proposed rule contained two identified (Ex. 30–3826). to provide independently or be similar terms—‘‘eliminate MSD The final rule does not use the term delegated the responsibility to provide hazards’’ and ‘‘materially reduce MSD ‘‘interim’’ controls. The terms used in some or all of the MSD management hazards.’’ Commenters alleged that the standard, ‘‘initial controls’’ and requirements of this standard. This these terms were vague and incapable of ‘‘permanent controls,’’ are self- definition is identical to the definition quantification (see, e.g., Exs. 30–1897, explanatory; they are discussed in the in the proposed rule. 32–206–1, 32–368–1, 30–3765, 30–1101 summary and explanation for paragraph One commenter asked OSHA to and 30–2986). Statements in the record (m). clarify the definition to specify which said that the term ‘‘eliminate MSD The term Employee representative occupations (physician, nurse, physical hazards’’ should not be used because it means a person or organization that acts therapist, etc.) were included in the is not possible to eliminate hazards so on behalf of an employee. This term was term ‘‘HCP’’ (Ex. 30–74). Others were of completely that MSDs will no longer not defined in the proposal, but is the opinion that the definition was too occur. There will always be ergonomic included in the final rule for broad (see, e.g., Exs. 30–991, 30–3004, risks, according to these commenters clarification. Additional discussion 30–3934, 30–3937, 30–2208 and 32–22).

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The comments of the Combe Company explanation for paragraphs (p), (q), (r), rule’s definition of a job as the physical are representative: ‘‘[b]y allowing and (s)). activities or tasks that an employee persons who do not even have a medical The American College of performs is responsive to the Navy’s degree to diagnose and treat these Occupational and Environmental concerns. For a discussion of the disorders, the proposed standard creates Medicine (ACOEM) recommended that meaning of tasks in the context of job an environment where the potential for the definition of health care professional hazard analysis, see the summary and misdiagnosis and improper treatment be changed to ‘‘occupational physicians explanation for paragraph (j). In efforts is dramatically increased’’ (Ex. or other licensed occupational health addition, the presence of the Basic 30–3004). In response to these care professionals,’’ to focus on the Screening Tool will enable employers to comments, OSHA notes, first, that the HCP’s training and competencies in identify jobs that are the same, despite, final rule’s MSD management section occupational medicine. OSHA has not for example, differences in job titles. does not require the diagnosis and revised the definition of HCP in this Musculoskeletal disorders (MSDs) is treatment of MSDs; these medical standard, although OSHA believes that defined in the final rule as: aspects of MSDs are left to the workers’ many employers recognize and only rely a disorder of the muscles, nerves, tendons, compensation system, as they always on the expertise of occupational ligaments, joints, cartilage, blood vessels, or have been. The MSD management physicians and nurses. OSHA’s more spinal discs. For purposes of this standard, envisioned by the standard entails the recent standards (see, e.g., the this definition only includes MSDs in the evaluation of an MSD to identify the Respirator standard and the Methylene following areas of the body that have been need for work restrictions and follow- Chloride standard) have used the term associated with exposure to risk factors: ups to ensure that recovery is HCP, and have defined it in the same neck, shoulder, elbow, forearm, wrist, hand, progressing. Second, the Agency is way as in this ergonomics standard; abdomen (hernia only), back, knee, ankle, deferring to the states on the issue of changing it would thus be inconsistent and foot. MSDs may include muscle strains with recent usage. The other issues and tears, ligament sprains, joint and tendon permitted scopes of practice; that is, inflammation, pinched nerves, and spinal different states permit different HCPs to raised by ACOEM—such as the kinds of disc degeneration. MSDs include such perform different healthcare activities, activities encompassed by the term MSD medical conditions as: low back pain, tension and employers are expected to ascertain management—are discussed in the neck syndrome, carpal tunnel syndrome, that the HCPs they rely on to carry out summary and explanation for that rotator cuff syndrome, DeQuervain’s the MSD management responsibilities paragraph (paragraph p). syndrome, trigger finger, tarsal tunnel under the standard are licensed, The American Society of Safety syndrome, sciatica, epicondylitis, tendinitis, registered, or certified to perform these Engineers (ASSE) (see, e.g., Ex. 30–386) Raynaud’s phenomenon, hand-arm vibration functions. asked OSHA to include a definition of syndrome (HAVS), carpet layer’s knee, and Commenters proposed an alternative ‘‘safety professionals’’ in the rule and to herniated spinal disc. Injuries arising from definition of HCP, i.e., that in addition acknowledge the important role of these slips, trips, falls, motor vehicle accidents, or similar accidents are not MSDs. to requiring licensing, OSHA require professionals in ergonomics programs. HCPs to have sufficient training and The preamble to the final rule does so, The definition of ‘‘musculoskeletal experience in diagnosing and treating and specifically mentions the role of disorder (MSD)’’ in the final rule differs MSD injuries/illnesses (see, e.g., Exs. safety professionals, industrial somewhat from the proposed definition. 30–3934 and 30–3937). Another hygienists, and other safety and health The final rule limits the definition to organization pointed out that because professionals in ergonomics program those MSDs involving certain body the definition is so broad, it could implementation. parts: the neck, shoulder, elbow, include occupations such as emergency The term Job is defined in the final forearm, wrist, hand, abdomen (hernia medical technicians or licensed rule to mean the physical work only), back, knee, ankle and foot. This vocational nurses who would not be the activities or tasks that an employee definition, and the purpose paragraph appropriate professionals to make performs. For the purpose of this (paragraph (a)) both also make clear that decisions with respect to MSDs (Ex. 30– standard, OSHA considers jobs to be the this standard does not cover injuries 2208). The New Mexico Workers’ same if they involve the same physical caused by slips, trips, falls, motor Compensation Administration argued work activities or tasks, even if the jobs vehicle accidents, or other similar that under the proposed definition, a that require those activities or tasks accidents (e.g., being caught in moving massage therapist could render an have different titles or job parts). OSHA has made these changes in opinion on MSDs (Ex. 32–22). Again, classifications. OSHA is retaining the response to criticisms that the proposed OSHA is confident that the state scope definition for the term ‘‘job’’ unchanged definition was too broad (see, e.g., Ex. of practice laws that govern HCPs will from that in the proposed rule, except 30–1216, 30–2035, 30–3866, 30–4821, ensure that only appropriate personnel for the addition of the word ‘‘tasks’’. 32–208–1, 32–368–1, 30–3937, 500–1– are permitted to carry out the standard’s Comments on the definition of ‘‘job’’ 116, Tr. 15310). MSD management functions. in the proposal stated that the definition Some commenters raised issues about Some commenters urged OSHA to gave little guidance on how employers the MSDs covered by the standard and limit the term HCP only to physicians were to determine whether jobs were their relationship to psychosocial effects on the grounds that fact finders rely the same (Ex. 30–3784) and that OSHA and non-occupational factors (see, e.g., heavily on treating physician’s opinions should change the word ‘‘job’’ or ‘‘job Exs. 500–1–1116, 30–3211, 30–3866). when litigating causation issues under based’’ to ‘‘task’’ or ‘‘task based’’ (Exs. These comments and issues are the various workers’ compensation laws 30–3765 and 30–3826). The Department discussed in the Health Effects section (see, e.g., Exs. 30–3749, 30–3344 and of the Navy (Ex. 30–3818) also of the preamble, Section V, rather than 30–4674). OSHA’s medical management recommended that OSHA focus on job in this definitions section. provisions are independent of and tasks rather than the job because the Other commenters objected because unrelated to the workers’ compensation term ‘‘job’’ is frequently associated with the acronyms MSD and MSDs are system’s procedures for determining titles and position descriptions. The similar to MSDS, which stands for the medical treatment, or extent-of Department of the Navy also asked Material Safety Data Sheets required by -disability determinations (see the OSHA to define the word ‘‘task’’ in the OSHA’s hazard communication discussion in the summary and final rule. OSHA believes that the final standard, 29 CFR 1910.1200 (see, e.g.,

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Exs. 30–2041 and 30–0522). However, paragraph (e), in which the term ‘‘MSD final rule’s definition is essentially because ‘‘musculoskeletal disorder’’ is incident’’ is used in association with the identical to the definition proposed, the scientifically correct term for these standard’s action trigger. except that the word ‘‘effective’’ before conditions and MSD is the widely MSD signs are objective physical ‘‘protective barrier’’ has been deleted known abbreviation for the term, OSHA findings that an employee may be because the effectiveness of PPE continues to use both ‘‘musculoskeletal developing an MSD. Examples of MSD depends on the circumstances in a disorders’’ and its acronym in the final signs are: decreased range of motion; particular workplace and is therefore rule. deformity; decreased grip strength; and not appropriate for a definition. One Some commenters urged OSHA to loss of muscle function. The final rule’s commenter noted that the definition of add other examples such as thoracic definition is essentially the same as the PPE was clear. Additional discussion outlet syndrome to the list of examples proposed definition, except for minor relating to the meaning of this term can accompanying the definition (see, e.g., editorial revisions made for clarity. be found in the summary and Exs. 30–2825 and 30–3332). The list of Additional discussion of this term explanation of paragraph (l). MSDs included in the final rule is only appears in the summary and Problem job means a job that the a list of examples; OSHA recognizes that explanation for paragraph (d) regarding employer has determined poses an MSD there are many other MSDs, such as the reporting of MSD incidents, hazard to employees in that job. The thoracic outlet syndrome, that could be paragraph (e), the action trigger, and the definition of the term ‘‘problem job’’ has included in this list. Health Effects section of the preamble been changed from the definition in the There was some comment that OSHA (Section V). proposal, which defined a problem job should adopt a definition of MSDs Most of the comments OSHA received as ‘‘* * * a job in which a covered MSD developed by other organizations such on the list of examples of MSD signs is reported. A problem job also includes as NIOSH (see, e.g., Exs. 30–3211 and included in the proposal concerned the any job in the workplace that involves 30–3765). For example, the Dow role of the health care professional the same physical work activities and Chemical Company (Ex. 30–3765) (HCP) and the phrase ‘‘objective conditions as the one in which the recommended that OSHA adopt the physical findings’’ (see, e.g., Exs. 30– covered MSD is reported, even if the NIOSH definition of MSD and the 3818, 30–3826, 30–3934, 30–2993, 30– jobs have different titles or Society for Human Resource 3167, 30–3745, 30–4814 and 30–434). classifications.’’ (See the definition of Management (Exs. OR–364, Tr. 15310– These commenters argued that the rule the term ‘‘job’’ above.) 15311) suggested that OSHA rely on a should be structured so that only an Commenters were concerned that the medical definition of MSD, such as one HCP, not the employer, can determine definition unnecessarily expanded the taken directly from Merck’s Manual. whether a given MSD is associated with scope of the standard (see, e.g., Exs. 32– OSHA’s definition of MSD is, in fact, objective physical findings. The 206–1, 32–368–1, 30–294, 30–2208–1, very similar to NIOSH’s definition, as Newspaper Association of America 30–3284 and 31–336), or requested reflected in the Institute’s publication, objected to the list of signs because clarification of ways an employer could Elements of Ergonomics Programs ‘‘[O]SHA has inexplicably chosen to use to determine when physical work (DHHS, Publication No. 97–117), provide only four examples of MSD activities and conditions were the particularly with respect to the soft signs and leaves employers to guess at ‘‘same’’ (see, e.g., Ex. 30–3765). tissues included and the exclusion of what may constitute objective physical In response, OSHA notes that the accidental injuries. findings’’ (Ex. 30–2986). In response, Agency intends the ‘‘same job’’ MSD hazard means the presence of OSHA notes that employers are always requirements to extend the protections risk factors in the workplace that occur free to involve an HCP in their provided by the standard to employees at a level of magnitude, duration, or determinations. However, OSHA does who are fortunate enough not to have frequency that is reasonably likely to not believe that employers will experienced an MSD incident but who cause MSDs that result in work generally have difficulty deciding are in ‘‘higher-risk’’ jobs, as restrictions or medical treatment beyond whether an MSD sign is related to an demonstrated by the fact that one first aid. The definition of ‘‘MSD employee report because, by definition, employee in the job has already hazard’’ in the final rule differs from the signs are visible indications observable experienced an incident and the job has definition in the proposed rule; it has both by the employee and the employer. been determined to meet the action been revised for clarity, as requested by MSD symptoms are defined in the trigger. The standard’s ‘‘same job’’ some commenters (see, e.g., Ex. 30– final rule as physical indications that an requirements are preventive in nature 2986). Other commenters found the employee may be developing an MSD. and will benefit workers in the job as proposed definition of MSD hazards Examples of MSD symptoms are: pain, well as saving the employer the costs circular (see, e.g., Exs. 30–3344 and 30– numbness, tingling, burning, cramping, associated with the MSDs that are 4674). The revised definition addresses and stiffness. The final rule’s list of averted by fixing the jobs of other this concern, because it focuses on the examples is essentially the same as the employees in the same job. As to the magnitude, frequency, and duration of list in the proposal, except that it is concern about how an employer can identified risk factors and their more clearly written. Most of the know which jobs are the same, OSHA relationship to MSD hazards. comments relating to this term have believes that the Basic Screening Tool MSD incident means an MSD that is already been discussed above under will be useful in cases where deciding work related, requires time away from ‘‘musculoskeletal disorder.’’ Additional which jobs are the same is difficult. work, restricted work, or medical discussion of this term appears in the Risk factor, as used in this standard, treatment beyond first aid, or involves summary and explanation for paragraph means force, awkward posture, MSD signs or MSD symptoms that last (e) on the reporting of MSD incidents. repetition, vibration, and contact stress. 7 or more consecutive days. (See the Personal protective equipment (PPE) The term replaces the term ‘‘ergonomic discussion of the terms MSD signs and is the equipment employees wear that risk factors,’’ which was defined in the MSD symptoms below.) The definition provides a protective barrier between proposed rule. There was considerable of MSD incident is new to the final rule. the employee and an MSD hazard. comment in response to the definition See the summary and explanation Examples of PPE are vibration-reduction of ‘‘ergonomic risk factors’’ in the section describing the provisions of gloves and carpet layer’s knee pads. The proposed rule. Commenters stated that

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A large In the Issues section of the proposal, standard].’’ Other commenters focused number of commenters expressed OSHA asked for comment about the their concern about including concern that they would be unable to appropriate work practices or controls aggravation in the concept of work- quantify the risk factors in a job based employers could use to prevent relatedness on back injuries because on the amount of information provided Computer Vision Syndrome (CVS). In back pain is so common both inside and in the proposal (see, e.g., Exs. 30–1722, response to this inquiry, OSHA received outside the workplace (see, e.g., Exs. 30–3032, 30–3336, 30–3765, 30–3813 several comments (see, e.g., Exs. 30– 30–3784, 30–4185, 31–336 and 30– and 30–3866). 3032, 30–2387, 30–2208). One 3937). The final rule does not rely on an The concerns raised by commenters commenter stated that controlling glare, OSHA recordable injury or illness when have largely been addressed by the final providing adequate lighting, well- defining an MSD incident; the final rule, which limits the number of risk designed software, and regularly rule’s definition specifies what kinds of factors covered by the standard to those shifting the static fixed focal point of the MSDs are included (those involving most often associated with MSDs and eye are all approaches that have been restricted work, for example). OSHA additionally provides clear definitions used to address CVS. Other commenters believes that the increased clarity of the for each risk factor of the magnitude, (see, e.g., Exs. 30–3032, 30–2208) urged final rule will alleviate many of these frequency, or duration at which OSHA not to include CVS in the list of commenters’ concerns. exposure poses a potential risk (the examples of MSDs in the final rule. Work restriction protection (WRP) Basic Screen levels) and the level OSHA agrees that not enough is means the maintenance of the earnings deemed to pose an MSD hazard (e.g., the currently known about CVS and its and other employment rights and levels indicated by the hazard causes for the final rule to focus on it. benefits of employees who are on identification tools in Appendices D–1 Work related means that an exposure temporary work restrictions. Benefits and D–2). in the workplace ‘‘caused or include seniority, insurance programs, Some commenters raised legal issues, contributed’’ to an MSD or retirement benefits, and savings plans. i.e., the alleged vagueness of the term ‘‘significantly aggravated’’ a pre-existing In the proposal, OSHA defined ‘‘work ‘‘risk factors’’ and the lack of precise MSD. ‘‘Work-related’’ was not defined restriction protection’’ to mean: quantitative estimates of the levels at in the proposal. The final rule uses the the maintenance of the earnings and other which each risk factor poses risk (see, term ‘‘work related’’ in the definition of employment rights and benefits of employees e.g., Exs. 32–368–1 and 32–206–1), and an MSD incident. In the proposed rule, who are on temporary work restriction. For the perceived need to establish OSHA used the term ‘‘work relatedness’’ employees who are on restricted work in the definitions of ‘‘covered MSD’’ and activity, WRP includes maintaining 100% of quantitative permissible exposure limits the after-tax earnings employees with for the risk factors (see, e.g., Ex. 30– ‘‘OSHA recordable MSD.’’ A number of commenters objected to covered MSDs were receiving at the time 3784). These issues are discussed at the term ‘‘work-related’’ in the context they were placed on restricted work activity. length in the Other Stautory Issues and For employees who have been removed from of OSHA recordable injuries and the workplace, WRP includes maintaining Legal Authority sections of this illnesses because they believe the term preamble. 90% of the after-tax earnings. Benefits mean is so broad that it often includes non- 100% of the non-wage-and-salary value Work practices are changes in the way work related MSDs (see, e.g., Exs. 500– an employee performs the physical employees were receiving at the time they 188, 30–2489, 31–336, 30–2834, 30– were placed on restricted work activity or work activities of a job that reduce 2986, 30–1722 and 30–1037). For were removed from the workplace. Benefits exposure to MSD hazards. Work example, the Center for Office include seniority, insurance programs, practice controls involve procedures Technology argued that the proposal retirement benefits and savings plans. and methods for safe work. Examples of was designed in a way that would The language beginning with ‘‘For work practice controls for MSD hazards permit a program to be triggered by an employees’’ and ending with ‘‘from the include: episode of weekend overexertion that workplace’’ (outlined in the above (a) Using neutral work postures; interfered with work on Monday (Ex. quote) has been removed from the final (b) Using lifting teams; 30–2208–2), and the International rule’s definition. Additional discussion (c) Taking micro-breaks; and Council of Shopping Centers (Ex. 30– relating to both the meaning of this term (d) Avoiding lifts involving extended 2489) expressed the same concern. and the regulatory requirements on reaches or twisted torso. These commenters are essentially work restriction protection can be found (e) Conditioning or work-hardening objecting to OSHA’s definition of a in the summary and explanation of programs. recordable injury under Part 1904, the paragraph (r). The proposed rule defined work Agency’s recordkeeping rule; that rule Work restrictions are defined as practices in essentially the same way, defines a work-related injury as one limitations, during the recovery period, except that OSHA has added a caused, contributed to, or aggravated by on an employee’s exposure to MSD conditioning or work-hardening an event or exposure in the workplace, hazards. Work restrictions may involve program to the rule in response to without regard to the extent of the limitations on the work activities of the comments in the record (see, e.g., Exs. contribution of work to the injury. employee’s current job (light duty), 30–1902, 30–3686, 32–22, and 32–210, Several participants urged OSHA not transfer to temporary alternative duty and 30–4137, Tr. 8720, Tr. 12472– to include the concept of work jobs, or time away from the workplace 12479). These commenters stated that aggravation of a pre-existing MSD in the to recuperate. For the purposes of this they use these program to protect newly final rule (see, e.g., Exs. 30–629, 30– standard, temporarily reducing an assigned workers during the period 1037, 30–3159, 30–4185 and 31–336). employee’s work requirements in a new when they are first exposed to risk Typical of those comments was one by job in order to reduce muscle soreness

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Paragraph (b) of the of work restriction, even if the employee The final rule makes clear that the final rule provides clear definitions of is removed from his or her regular physical establishment that houses the the standard’s scope and explicitly duties for part of the day. problem job, or to which the injured states that it does not apply to maritime, This definition is a revision of the employee and other employees in the agricultural, railroad, or construction proposed definition. The proposed same job report, limits the program employment. definition of work restriction included activities required by the standard. The Finally, some commenters suggested the sentence: ‘‘To be effective, work standard does not impose corporate- that OSHA define the term recovery restrictions must not expose the injured wide obligations on businesses that period, which was used in the definition employee to the same MSD hazards as have multiple establishments. Instead, of work restriction protection (WRP) were present in the job giving rise to the the standard is job-based in the first (see, e.g., Exs. 30–3749 and 30–3344). covered MSD.’’ This sentence has been instance, i.e., employers are only OSHA has not done so because this term removed from the definition because it required to implement the ergonomics is used in the final rule in its everyday is better suited to the summary and program in those jobs identified as sense, and is therefore clear on its face. explanation for paragraph (r). See the problem jobs. It is establishment-based discussion of the comments received on in the second instance, i.e., employers V. Health Effects Work Restriction Protection in general are only required to include in their above and in the summary and program the problem job (and the In this section, OSHA presents the explanation for paragraph (r). workers in them) within the evidence contained in the rulemaking You means the employer, as defined establishment to which the problem job record that addresses the causal by the Occupational Safety and Health is ‘‘attached.’’ This means that, where relationship between exposure to Act of 1970 (29 U.S.C. 651 et seq.). The the workforce is mobile, the biomechanical risk factors at work and final rule’s definition is identical to the establishment to which the injured an increased risk of developing proposed definition (64 FR 66078). employee reports would be considered musculoskeletal disorders (MSDs). This There were no comments on this the establishment, for the purposes of evidence consists of epidemiological definition. the standard. Since the standard studies of exposed workers in diverse Several terms that were defined in the requires employers to extend the occupational settings, biomechanical proposal are not used in the final rule. standard’s protections to all employees studies describing the relationships They include ‘‘manual handling jobs,’’ in the same job, the employer is between exposure to risk factors and ‘‘manufacturing jobs,’’ and ‘‘have required to ‘‘fix’’ the MSD hazards in associated forces imposed on knowledge.’’ ‘‘MSD management’’ was the workstations or work environments musculoskeletal tissue, studies of tissue also defined separately in the proposal of all employees in the same job who are pathology describing the kinds of tissue but is now discussed in the regulatory located in, or report to, the same alterations that have been seen to result text and summary and explanation for establishment. from such forces, and medical and paragraph (p). For the purposes of the standard, diagnostic information relating to MSDs. Some commenters suggested that OSHA defines an establishment as a In making its findings from this OSHA define new terms, including the single physical location where business evidence, OSHA is relying in part on the term ‘‘employee.’’ The Alliance of is conducted or where services or extensive scientific evidence presented American Insurers (AAI) (Ex. 30–3751) industrial operations are performed. For in the detailed Health Effects objected to the proposal’s cross- activities where employees do not work Appendices to the proposal (64 FR reference to the definition of employee at a single physical location, such as 65865–65926) (Ex. 27–1), located on contained in the OSH Act. The Alliance construction; transportation; OSHA’s webpage at http:// asked OSHA to provide additional communications, electric, gas and www.osha.gov and summarized in this clarification about who is or is not an sanitary services; and similar section. In addition, OSHA’s analysis employee under various types of operations, the establishment is includes results from several other employer/employee relationships, such represented by main or branch offices, studies placed into the rulemaking as employee leasing arrangements. The terminals, stations, etc., that either record after publication of the proposed AAI said: ‘‘how is OSHA to make WRP supervise such activities or are the base rule, as well as comment and testimony determinations? What if one entity is from which personnel carry out these from many distinguished scientific held to be responsible for WRP but the activities. experts. other entity is responsible for workers’ One commenter (Exs. 30–2825 and 30–3332) suggested that OSHA add a This section is divided into the compensation benefits?’’ This issue is following seven parts: discussed in detail in the summary and definition of repetitive motion jobs to explanation for paragraph (r). the final rule. OSHA does not believe • Part A, Description of Biomechanical The DuPont SHE Excellence Center such a definition is necessary because Risk Factors; (Ex. 30–2134) recommended the the final rule contains clear definitions • Part B, Overview of the Health Effects addition of a definition for workplace, of each of the risk factors (see the Basic Evidence; commenting that in the proposed rule: Screening Tool in Table 1). • Part C, Evidence on Neck and Shoulder Several commenters asked OSHA to Disorders; ‘‘There is no definition of workplace clarify the definitions of industries • Part D, Evidence on Upper Extremity incorporated in this section [proposed covered and exempted from the final Disorders; definition of problem job], which creates • more confusion. Is the workplace the specific rule (see, e.g., Exs. 30–1897, 30–3818 Part E, Evidence on Back Disorders; • building the job is located, the same physical and 30–4716). For example, the Part F, Evidence on Lower Extremity site (which might contain several buildings), Honorable James Talent, Chairman of Disorders; and or the entire company with all of its locations the U.S. House of Representatives • Part G, OSHA’s Response to Issues within the U.S. and its territories? Some jobs Committee on Small Business (Ex. 30– Raised in the Rulemaking.

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A. Biomechanical Risk Factors important influence on risk. The include strain gauges, spring scales, and Biomechanical risk factors are the biomechanical risk factors covered in electromyography to measure muscle aspects of a job or task that impose a the final rule are force, repetition, activity. A qualitative assessment of physical stress on tissues of the awkward postures, contact stress, and force is based on direct observation of musculoskeletal system, such as segmental vibration; the basic screening the amount of physical exertion muscles, nerves, tendons, ligaments, tool in the final rule describes criteria required to complete a task, and is joints, cartilage, spinal discs, or (in the for each of these risk factors that usually graded on an ordinal scale (i.e., case of hand-arm vibration syndrome) identifies those jobs where there is a low, medium, high). potential risk of MSDs. Each of these blood vessels of the upper extremities. Repetition To accomplish motion and work, risk factors is described below. muscle, nerves, connective tissue, and Force Repetition refers to the frequency skeleton are affected by a number of with which a task or series of motions Force refers to the amount of physical external and internal physical demands are repeated with little variation in effort that is required to accomplish a causing metabolic and compensatory movement. Although force and/or task or motion. Force also refers to the tissue reactions. External demands can awkward postures can combine with degree of loading to muscles and other include direct pressure on tissues or repetition to increase the risk of MSDs tissues as a result of applying force to tissue friction. Internal responses can over that of repetition alone, perform work. Tasks or motions that include inflammatory responses to acceleration and velocity of repetitive require application of higher force place tissue injury, neurochemical changes, movement are also important higher mechanical loads on muscles, and altered metabolism. The considerations in that they may ‘‘cause tendons, ligaments, and joints (Ex. 26– consequences of these external and damage that would not be predicted by 2). The force required to complete a internal demands associated with work muscle forces or joint angles alone’’ movement increases when other risk activities can include a spectrum of (Washington State CES, p.20, Ex. 500– factors are also involved. For example, symptoms or clinical findings. Although 71–93). more physical effort may be needed to some types of tissue, like skeletal Repetitive motions occur frequently perform tasks when the speed or muscle, have the ability to recover after in manufacturing operations where acceleration of motions increases, when an injury that does not physically production and assembly processes vibration is present, or when the task disrupt the tissue, exceeding tissue have been broken down into small also requires awkward postures. Hand limits may result in permanent damage sequential steps, each performed by tools that require use of pinch grips to a tissue. However, skeletal muscle is different workers. However, it also require more forceful exertions to just one type of tissue that can be applies to many manual handling manipulate the tool than do those that affected; other tissues like tendon, operations, such as warehouse permit use of power grips. operations and baggage handling. ligament, nerve, and cartilage can also Relationships among external loads, Repetition is typically assessed by direct be damaged by exposure to excessive internal tissue loads, and mechanical observation or videotaping of job tasks. physical task factors. These tissues, and physiological responses have also The intensity of exposure is usually unlike skeletal muscle, do not have the been studied extensively, using expressed as a frequency of motion or as same capacity for recover and repair simulation, direct instrumentation, a percent of task cycle time, where a after injury. (Each part of this Health indirect instrumentation, and cycle is a pattern of motions. Effects section briefly summarizes the epidemiological studies. In a report on pathogenesis of MSDs; OSHA’s Health the Research Base of Work-Related Awkward Postures Effects Appendices (Ex. 27–1), Musculoskeletal Disorders prepared by Awkward postures refer to positions developed for the proposed rule, the National Research Council (NRC) in of the body (e.g., limbs, joints, back) that contains detailed discussions of the response to a request from the National deviate significantly from the neutral scientific literature describing the Institutes of Health (NIH) (Ex. 26–37), position while job tasks are being pathogenesis of MSDs). the steering committee provides some The biomechanical risk factors performed. For example, when a rationale for evaluating and controlling addressed by this final rule are person’s arm is hanging straight down biomechanical risk factors, specifically repetition, force, awkward postures, (i.e., perpendicular to the ground) with force: vibration to the upper extremity (i.e., the elbow close to the body, the segmental vibration), and contact stress. • The concept of force can be generalized shoulder is said to be in a neutral In occupations where an increased to encompass numerous ways of measuring position. However, when employees are prevalence or incidence of MSDs has and characterizing external loads. For performing overhead work (e.g., example, force can be measured in terms of been observed, these risk factors the weight of parts, tool reaction force, installing or repairing equipment, frequently occur in combination; the perceived exertion, muscle electrical activity, grasping objects from a high shelf) their level of risk associated with exposure or observer ratings. shoulders are far from the neutral depends on the intensity and duration • Internal loads can be estimated by using position. Other examples include wrists of exposure as well as the amount of external loads. For example, a worker must bent while typing, bending over to grasp recovery time available to the strained bend or stoop to lift something from the floor; or lift an object, twisting the back and tissues for repair. Soft tissues of the a worker will exert more force on a stiff torso while moving heavy objects, and keyboard than a light touch keyboard. musculoskeletal system will develop Understanding these relationships allows squatting. Awkward postures often are tolerance to physical loading if prediction of internal loads. significant contributors to MSDs sufficient recovery time is provided. • Predicted internal loads generally agree because they increase the exertion and Without adequate recovery time, with measured internal and external loads. the muscle force that is required to affected tissues can accumulate damage For example, measurements of muscle loads accomplish the task, and compress soft or become more prone to failure. The during activity using electromyography tissues like nerves, tendons, and blood need for adequate recovery time generally agree with predicted values. vessels. As used in the final rule’s basic between exposure events means that the Force can be assessed qualitatively or screening tool, awkward postures may pattern of exposure also has an quantitatively. Quantitative measures be either static postures held for

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Working at surfaces that are too high results from activities involving either Using vibrating hand tools can also can affect several parts of the body. repeated or continuous contact between contribute to muscle-tendon contractile Employees may have to lift and/or move sensitive body tissue and a hard or forces owing to operators having to use their shoulders, elbows and arms sharp object. The basic screening tool in increased grip force to steady tools (including hands and wrists) into the final rule includes a particular type having high vibration. uncomfortable positions to perform the of contact stress, which is using the Vibration from power tools is not easy job tasks on higher surfaces. For hand or knee as a hammer (e.g., to measure directly without the use of example, employees may have to raise operating a punch press or using the sophisticated measuring equipment. their shoulders or move their elbows out knee to stretch carpet during However, vibration frequency ratings from the side of their body to do a task installation). Thus, although contact are available for many recently designed on a high working surface. Also, they stress is covered in the final rule as a hand tools. may have to bend their heads and necks single risk factor, it is really a Based on the whole of the scientific to see the work they are doing. combination of force and repetition. literature available at the time of the Working surfaces that are too high Mechanical friction (i.e., pressure of a proposal, OSHA also identified usually affect the shoulders. The hard object on soft tissues and tendons) prolonged sitting and standing (a form muscles must apply considerably more causes contact stress, which is increased of static posture) and whole-body contraction force to raise and hold the when tasks require forceful exertion. vibration as risk factors for MSDs; in shoulders and elbows out to the side, The addition of force adds to the friction addition, OSHA identified cold particularly if that position also must be created by the repeated or continuous temperatures as a risk factor modifier maintained for more than a couple of contact between the soft tissues and a because it could require workers to seconds. The shoulder muscles fatigue hard object. It also adds to the irritation increase the force necessary to perform quickly in this position. of tissues and/or to the pressures on their jobs (such as having to grip a tool On the other hand, when surfaces are parts of the body, which can further more tightly) (64 FR 65865–65926) (Ex. too low, employees may have to bend inhibit blood flow and nerve 27–1). The final rule does not explicitly their backs and necks to perform their conduction. include these risk factors. For prolonged tasks while hunched over the working Contact stress commonly affects the standing and sitting, and for cold surface. They may also have to reach soft tissue on the fingers, palms, temperatures, although there is evidence down with their arms and backs to do forearms, thighs, shins and feet. This of an increased risk of MSDs with the tasks. Where working surfaces are contact may create pressure over a small exposure (e.g., see Skov, Ex. 26–674), very low, employees may have to kneel area of the body (e.g., wrist, forearm) the available evidence did not permit or squat, which places very high forces that can inhibit blood flow, tendon and the Agency to provide sufficient on the knees to maintain the position muscle movement and nerve function. guidance to employers and employees and the weight of the body. Working The intensity of exposure to contact on the levels of exposure that warrant surfaces that are too low usually affect stress is usually determined attention. For whole-body vibration, the lower back and occasionally the qualitatively through discussion with there was substantial evidence of a neck. the employee and observation of the job. causal association with low back Working in awkward postures disorders (e.g., see NIOSH 1997); increases the amount of force needed to Segmental Vibration however, heavy equipment and trucks, accomplish an exertion. Awkward Vibration refers to the oscillatory the most common sources of whole- postures create conditions where the motion of a physical body. Segmental, body vibration, are seldom rated for transfer of power from the muscles to or localized vibration, such as vibration vibration frequencies and intensities. In the skeletal system is inefficient. To of the hand and arm, occurs when a addition, measurement of whole-body overcome muscle inefficiency, specific part of the body comes into vibration levels requires special employees must apply more force both contact with vibrating objects such as equipment and training that would be to initiate and complete the motion or powered hand tools (e.g., chain saw, difficult for most employers to obtain. exertion. In general, the more extreme electric drill, chipping hammer) or Therefore, OSHA determined that it was the postures (i.e., the greater the equipment (e.g., wood planer, punch appropriate not to include whole-body postures deviate from neutral positions), press, packaging machine). vibration in the final rule at this time. the more inefficiently the muscles Although using powered hand tools For the biomechanical risk factors of operate and, in turn, the more force is (e.g., electric, hydraulic, pneumatic) force, repetition, awkward postures, needed to complete the task. Thus, may help to reduce risk factors such as segmental vibration, and contact stress, awkward postures make forceful force and repetition over using manual OSHA has concluded that strong exertions even more forceful, from the methods, they can expose employees to evidence exists for a positive standpoint of the muscle, and increase vibration. Vibrating hand tools transmit relationship between exposure to these the amount of recovery time that is vibrations to the operator and, risk factors and an increased risk of needed. depending on the level of the vibration developing MSDs, based on the Awkward postures are assessed in the and duration of exposure, may scientific evidence and testimony workplace by observing joint angles contribute to the occurrence of hand- described in this section of the final during the performance of job tasks. arm vibration syndrome or Raynaud’s rule’s preamble. The risk factors Observed postures can be compared phenomenon (i.e. vibration-induced identified by the Agency as being qualitatively to diagrams of awkward white-finger MSDs) (Ex. 26–2). causally related to the development of postures, such as is done in many job The level of vibration can be the MSDs and that are covered in the final analysis tools, or angles can be result of bad design, poor maintenance, rule are the same risk factors that have

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Burdorf and scientists and physicians during it’s two most current and thorough reviews Sorock reviewed 35 articles that hearing with comments along the lines on this topic are NIOSH’s Critical evaluated risk factors for back disorders of that by Dr. Robert Harrison, from the Review of Epidemiologic Evidence for and concluded that lifting or carrying University of California (Tr. 1649–50): Work-Related Musculoskeletal loads (force), whole-body vibration and The jobs and tasks my patients are Disorders of the Neck, Upper Extremity, frequent bending and twisting (awkward performing are the ones the literature has and Low Back (Bernard, 1997; Ex. 26– postures) were consistently related to identified as high-risk jobs with exposure to 1) and the National Research Council/ work-related low-back disorders (1997; many of the same physical risk factors. In National Academy of Science’s Work- Ex. 500–71–24). In a systematic review fact, my patients are exposed to the identical Related Musculoskeletal Disorders: of 31 studies, Hoogendoorn et al (1997; physical work activities and conditions that Report, Workshop Summary, and Ex. 500–71–32) found strong evidence have been identified by OSHA as causing Workshop Papers (1999; Ex. 26–37). exists for manual materials handling, excessive exposure to force, frequent NIOSH’s review focused on repetition, bending and twisting (awkward repetition, awkward posture, contact stress, force, posture, and vibration when posture), and whole-body vibration as vibration and cold temperatures. evaluating epidemiologic evidence for risk factors for back pain, and moderate The record contains many US and the neck, shoulder, elbow, and hand/ evidence exists for patient handling and international regulations and guidelines wrist. For the low-back, the authors physical work. that reflect the same biomechanical risk looked at the evidence for heavy In their review of the literature on the factors addressed in the final rule; some physical work, lifting and forceful role of physical load factors in carpal are listed below: movements, bending and twisting tunnel syndrome, Viikari-Juntura and • National Research Council. (1999) (awkward postures), whole body Silverstein found an association with Work-Related Musculoskeletal vibration and static work postures. The carpal tunnel syndrome and forceful, Disorders: Report, Workshop Summary, ‘‘work factors’’ identified by the NRC in repetitive work, extreme wrist postures and Workshop Papers. National their report on Work-Related and vibration (1999; Ex. 32–339–1–56). Academy Press. (Ex. 26–37); Musculoskeletal Disorders are the same Other authors (Ariens et al., 2000; Ex. • National Institute for Occupational as the ‘‘biomechanical risk factors’’ 500–71–23) found a relationship Safety and Health. (1997) identified by OSHA. Although terms between neck pain and neck flexion, Musculoskeletal Disorders and may differ depending upon the part of arm force, arm posture, duration of Workplace Factors. Centers for Disease the body being described, it is easy to sitting, twisting or bending of the trunk, Control and Prevention (Ex. 26–1); see the relationship between heavy hand-arm vibration, and workplace • National Institute for Occupational physical work and lifting and the design. Safety and Health. (1998) Elements of concept of force/exertion to the back, for In both written submissions to the Ergonomics Programs, A Primer Based example . record, and in oral testimony, numerous on Workplace Evaluations of The Steering Committee Report for scientific experts confirmed and Musculoskeletal Disorders. (Ex. 26–2); the NRC workshop on ‘‘Examining the substantiated OSHA’s position that • European Agency for Safety and Research Base (for Work-Related sufficient scientific evidence exists, and Health at Work. Work-related neck and MSDs)’’, participants agreed there is is contained in the record, to conclude upper limb musculoskeletal disorders that workplace exposure to the (1999). (Ex.500–71–28); ‘‘enough scientific evidence to confirm that • strain on musculoskeletal tissue increases biomechanical risk factors described Department of Labor and Industries, when humans perform activities that involve above increase the risk for work-related Washington State. (5/25/00) Concise forceful manual exertions, awkward postures, MSDs (Exs. 37–1; 37–2; 37–3; 37–6; 37– Explanatory Statement, WAC 296–62– repetitive or prolonged exertions, exposure to 8; 38–9; 37–10; 37–13; 37–15; 37–16; 051, Ergonomics (Ex. 500–71–93); vibrations and exposure to cold 37–17; 37–18; 37–21; 37–27; 37–28; 26– • Ergonomics for the Prevention of temperatures.’’ 37). Scientists who testified at the Musculoskeletal Disorders, Swedish However, in a separate paper hearings also confirmed that each of National Board of Occupational Safety prepared for the NRC/NAS workshop, these risk factors are linked to an and Health on Ergonomics for the Radwin and Lavender also discuss increased risk of developing an MSD in Prevention of Musculoskeletal ‘‘workplace layout,’’ ‘‘interactions with exposed workers (Dr. Don Chaffin, Disorders. AFS 1998:1; (Ex. 500–71–14); objects,’work scheduling’’ and other University of Michigan, Tr 8254; Dr. • National Codes of Practice for the ‘‘workplace design factors,’’ as factors Nicholas Warren, University of Prevention of Occupational Overuse that these authors, as well as others, Connecticut Health Center, Tr.1084–85; Syndrome-Worksafe Australia have studied in relation to MSDs. Dr. Martin Cherniak, Ergonomics [NOHSC:2013(1994)], (Ex. 500–71–2); Although there is strong agreement on Technology Center of Connecticut, Tr. • National Standard for Manual biomechanical factors associated with 1128; Dr. Richard Wells, University of Handling and National Code of Practice MSDs, the science is still evolving with Waterloo, Tr. 1353–54; Dr. Robert for Manual Handling, Worksafe regard to other types of factors. Thus, Harrison, Tr. 1648; Dr. Amadio, Mayo Australia. 1990 (Ex. 500–71–4); when sources refer to biomechanical Clinic, Tr. 9815, 98; Dr. Eckardt • Occupational Overuse Syndrome: risk factors, all literature reviewed from Johanning, Eastern New York Guidelines for Prevention and the rulemaking record identified the Occupational and Environmental Health Management, Occupational Safety and same basic risk factors, all essentially Center, Tr. 16831–33; Dr. Jim Health Services, Department of Labor, related to force/exertion, repetition, McGlothlin, Purdue University, Dr. New Zealand (Ex. 500–71–12); posture and vibration. Malcolm Pope, Tr. 16808; Dr. Margit • Ergonomics (MSI) Requirements, Literature reviews published in the Bleeker, Tr. 16826). This written and British Columbia, Canada (Ex. 32–339– scientific literature also evaluate these oral testimony from scientific experts 1–6);

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• Regulations and Code of Practice, the proposal (64 FR 65865–65926; Ex. this review was the epidemiology (Manual Handling) Occupational Health 27–1), updates that evidence with more literature, the goal of which is to and Safety Regulations 1988. Victoria, recent information brought to the identify factors that are associated Canada. (Ex. 500–71–17); Agency’s attention during the (positively or negatively) with the • European Communities Council rulemaking process, and presents some development of recurrence of adverse Directive on Manual Handling (Ex. 32– additional information and conclusions medical conditions. This evaluation and 339–1–12); as to the adequacy and quality of the summary of the epidemiologic evidence • American Conference of overall scientific data base used for the focuses chiefly on disorders that affect Governmental Industrial Hygienists, final rule. In developing its review of the neck and the upper extremity, Threshold Limit Value (TLV) the scientific evidence, the Agency has including tension neck syndrome, Committee, Nov. 13, 1999. Notice of relied on almost 200 epidemiological shoulder tendinitis, epicondylitis, Intent to Establish a Threshold Limit studies that describe the prevalence or carpal tunnel syndrome, and hand-arm Value, Hand Activity Level (Ex. 32– incidence of MSDs among workers who vibration syndrome, which have been 339–1–63); have been exposed to biomechanical the most extensive studies in the • American Conference of risk factors. Several of these (see Part G epidemiologic literature. The document Governmental Industrial Hygienists. of the Health Effects sections) also reviews studies that have dealt with 1987. Ergonomic Interventions to simultaneously evaluated the effects of work-related back pain and that address Prevent Musculoskeletal Injuries in biomechanical and psychosocial factors the way work organization and Industry (Ex. DC–386, Tr. 16291–335); in the workplace; these studies • psychosocial factors influence the American Industrial Hygiene generally represent the most recent and relationship between exposure to Association. 1994. Ergonomic Guide best-designed epidemiological studies. physical factors and work-related MSDs. Series (Ex. 32–133–1); In addition to epidemiological • The literature about disorders of the American National Standards studies, OSHA has reviewed a lower extremity is outside the scope of Institute (ANSI) draft Ergonomic considerable amount of information and the NIOSH review, and OSHA has done Standard, Z–365 (1998) (Ex.26–1264). studies that describe the biomechanical its own analysis of that literature. The Furthermore, the vast majority of the aspects of MSD etiology, along with NIOSH work is the most comprehensive many job evaluation tools found in the studies that have been conducted to review of this scientific literature to record and reviewed by the Agency elucidate the physiological responses of date. collectively address these same risk tissues to biomechanical stress. Much of A search strategy of bibliographic factors covered under the final rule (Exs. this information was presented in detail databases identified more than 2,000 26–521, 26–1421, 26–1008, 26–883, 26– in OSHA’s Health Effects Appendices studies. Studies were included if they 500–71–92). Also, studies using specific (Ex. 26–1), prepared at the time of the evaluated exposure so that some interventions to reduce biomechanical final rule. OSHA has since inference could be drawn regarding load address these same risk factors (see supplemented this information with repetition, force, extreme joint posture, section VI, Risk Assessment). additional material contained in the static loading or vibration, and lifting B. Overview of Evidence of Health rulemaking record. tasks. Studies in which exposure was In compiling and evaluating the Effects for Work-Related measured or observed and recorded for scientific evidence for its proposed Musculoskeletal Disorders the body part of concern were ergonomic program standard OSHA considered superior to studies that used A substantial body of scientific made use of the two major reviews of self-reports or occupational/job titles as evidence supports OSHA’s effort to the evidence for work-relatedness of surrogates for exposure. provide workers with ergonomic MSDs available at that time, NIOSH’s Because of the focus on the protection (see the Health Effects ‘‘Musculoskeletal Disorders and epidemiology literature, studies that Appendix of the proposal preamble, and Workplace Factors: A Critical Review of were laboratory-based or that focused on the Health Effects Summary, Risk the Epidemiologic Evidence for Work- MSDs from a biomedical standpoint, Assessment, and Significance of Risk Related Musculoskeletal Disorders of dealt with clinical treatment of MSDs, sections of this preamble, below). This the Neck, Upper Extremity, and Low or had other nonepidemiologic evidence strongly supports two basic Back’’ (Bernard, 1997; Ex. 26–1) and the orientation were eliminated from further conclusions: (1) there is a positive National Research Council/National relationship between exposure to Academy of Sciences’ ‘‘Workshop on consideration for this document. This biomechanical risk factors and Work-Related Musculoskeletal Injuries: strategy yielded over 600 studies for development of work-related The Research Base’’ (Ex. 26–37). inclusion in the detailed review process. musculoskeletal disorders and (2) Because OSHA’s reliance on these two Population-based studies of MSDs, case- ergonomics programs and specific important works generated a control studies, cross-sectional studies, ergonomic interventions can reduce considerable amount of comment and longitudinal cohort studies, and case these risks. Although it is recognized testimony, these two reviews are series were included. that many individual and non- described in detail here. However, The first step in the analytical process biomechanical workplace factors (such throughout this Health Effects section, was to classify the epidemiologic as psychosocial factors) also contribute OSHA has made use of several other studies by the following criteria: to the total risk, exposure to scientific reviews of the literature as • The participation rate was ≥ 70%. This biomechanical factors has been shown well. criterion limits the degree of selection bias in The National Institute for the study. to contribute to the risk independently • from other causal factors; these findings Occupational Safety and Health The health outcome was defined by (NIOSH) conducted a scientific review symptoms and physical examination. This support the appropriateness of criterion reflects the preference of most designing interventions that reduce of hundreds of peer-reviewed studies, reviewers to have health outcomes that are exposures to biomechanical factors as a and evaluated the evidence for work- defined by objective criteria. strategy for reducing risk of MSDs. related musculoskeletal disorders of the • The investigators were blinded to health This section presents an overview of neck, upper extremity, and low back or exposure status when assessing health or the health evidence summarized from (Bernard, 1997; Ex.26–1). The focus of exposure status. This criterion limits

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Studies that between exposure to the specific risk factor having no exposure to high force and used either direct observation or actual and MSD in studies in which chance, bias, repetition.) measurements of exposure were considered and confounding factors could be ruled out Based on the epidemiologic criteria to have a more accurate exposure with reasonable confidence in at least several described above, NIOSH made the classification scheme, whereas studies that studies. following findings: exclusively used job title, interviews, or Evidence of work-relatedness. Some Strong evidence of work-relatedness questionnaire information were assumed to convincing epidemiologic evidence shows a exists for the following associations: have less accurate exposure information. causal relationship when the epidemiologic • criteria of causality for intense or long- High levels of static contraction, During review of the studies, the duration exposure to the specific risk prolonged static loads, extreme working greatest qualitative weight was given to factor(s) and MSD are used. A positive postures involving the neck/shoulder studies that had objective exposure relationship has been observed between muscles and an increased risk for neck/ assessments, high participation rates, exposure to the specific risk factor and MSDs shoulder MSDs; physical examinations, and blinded in studies in which chance, bias, and • Exposure to a combination of risk confounding factors are not the likely factors (e.g., force and repetition, force assessment of health and exposure explanation. status. and posture) and CTS; Insufficient evidence of work-relatedness. • The second step of the analytical The available studies are of insufficient Job tasks that require a combination process was to divide the studies into number, quality, consistence, or statistical of risk factors (e.g., highly repetitious, those with statistically significant power to permit a conclusion regarding the forceful hand/wrist exertions) and presence or absence of a causal association. hand/wrist tendinitis; associations between exposures and • health outcomes and those without Some studies suggest a relationship to High level exposure to hand-arm specific risk factors, but chance, bias, or vibration and vascular symptoms of statistically significant associations. The confounding may explain the association. associations were then examined to hand-arm vibration syndrome; Evidence of no effect of work factors. • Work-related lifting and forceful determine whether they were likely to Adequate studies consistently show that the movements; be substantially influenced by specific workplace risk factor(s) is not related • confounding or other selection bias to development of MSD. Exposure to whole-body vibration (such as survivor bias or other and low-back disorder. The above framework provides an 2. Evidence exists for the following epidemiologic pitfalls that might have a indication of the selection criteria associations: major influence on the interpretation of NIOSH used in identifying studies for • Highly repetitive work and neck the findings). These include the absence inclusion in their review. Studies were and neck/shoulder MSDs, considering of nonrespondent bias and included if the exposed and referent both repetitive neck movements (using comparability of study and comparison populations were well defined, and if frequency and duration of movements) groups. they involved neck, upper-extremity, and repetitive work involving The third step of the analytical and low-back MSDs measured by well- continuous arm or hand movements; process was to review and summarize defined, explicit criteria determined • Forceful exertion and neck MSDs, studies with regard to the epidemiologic before the study. Studies whose primary with ‘‘forceful work’’ involving forceful criteria for causality: strength of outcomes were clinically relevant arm or hand movements, which association, consistency in association, diagnostic entities, generally had less generate loads to the neck/shoulder temporal association, and exposure- misclassification and were likely to area; response relationship. No single involve more severe cases. Studies • Highly repetitive work and epidemiologic study will fulfill all whose primary outcomes were the shoulder MSDs; criteria to answer the question of reporting of symptoms generally had • Repeated or sustained shoulder causality. However, results from more misclassification of health status postures with greater than 60 degree of epidemiologic studies can contribute to and a wider spectrum of severity. flexion or abduction and shoulder the evidence of causality in the Care should be taken when MSDs; relationship between workplace risk interpreting some study results • Highly repetitive work, both alone factors and MSDs. The exposures regarding individual workplace factors and in combination with other factors examined for the neck and upper of repetition, force, extreme or static and carpal tunnel syndrome; extremity were repetition, force, postures, and vibration. As Kilbom • Work involving hand/wrist extreme posture, and segmental (1994; Ex. 26–1352) stated, these factors vibration and CTS; vibration. occur simultaneously or during • Any single factor (repetition, force Using the epidemiologic criteria for alternating tasks within the same work, and posture) and hand/wrist tendinitis; causality as the framework, the evidence and their effects concur and interact. A • Work-related awkward postures and for a relationship between workplace single odds ratio (OR) for an individual low-back disorders. factors and the development of MSDs risk factor may not accurately reflect the 3. Insufficient evidence of work- from epidemiologic studies is classified actual association, as not all of the relatedness exists for the following into one of the following categories: studies derive ORs for simultaneously associations: strong evidence of work-relatedness, occurring factors. Thus these studies • Vibration and neck disorders; evidence of work-relatedness, were not only viewed individually • Force and shoulder MSDs; insufficient evidence of work- (taking into account good epidemiologic • Extreme posture and CTS. relatedness, evidence of no effect of principles) but together for making The NIOSH review (Bernard, 1997; work factors. The amount and type of broader interpretations about Ex. 26–1) is an authoritative, systematic, evidence required for each category is epidemiologic causality. Many critical review of the epidemiologic described below: investigators did not examine each risk evidence regarding work-related risk

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For the limitations in the epidemiologic assessing risk and formulating decisions epidemiology of physical factors, the evidence: about future research or necessary preventive steering committee used a panel format • Temporal contiguity between the measures. to take advantage of a recent review of stressors and onset of effects, as well as In 1998, the National Institutes of this literature, the NIOSH review, amelioration after reduction of stressors, Health asked the National Academy of published in 1997, and previously could not always be established, nor could Sciences/National Research Council discussed here. the clinical course of the observed effects; • (NRC) to assemble a group of experts to Use of this broad approach provided Methods used for the assessment of examine the scientific literature relevant for the examination of evidence from exposures and health outcomes vary, rendering the task or merging and combining to the work-related musculoskeletal both basic and applied science and a wide variety of methodologies, and evidence more challenging than in some disorders of the lower back, neck and other areas of occupational risk assessment; upper extremities. A steering committee considered sources of evidence that • Lack of baseline prevalence and was convened to design a workshop, to extend well beyond the epidemiologic incidence data for the general population. identify leading researchers on the topic literature alone. In determining whether Despite these limitations, the steering to participate, and to prepare a report scientific evidence supports a causal committee reached the following conclusions based on the workshop discussions and claim for risk factors and work-related regarding the epidemiologic evidence: • their own expertise. Additionally, the musculoskeletal disorders, the NAS/ Restricting our focus to those studies steering committee was asked to NRC steering committee considered the involving the highest levels of exposure to address, to the extent possible, a set of following five criteria: biomechanical stressor of the upper extremity, neck, and back and those with the seven questions posed by Congress on • Temporal ordering requires that the cause be present before the effect is sharpest contrast in exposure among the the topic of musculoskeletal disorders. study groups, the positive relationship The steering committee includes experts observed. • between the occurrence of musculoskeletal in orthopedic surgery, occupational Cause and effect covary. For disorders and the conduct of work is clear. medicine, epidemiology, ergonomics, example, when no force is applied to a * * * (T)hose associations identified by the human factors, statistics, and risk tendon, it remains in a relaxed state; in NIOSH review (NIOSH, 1997; Ex 26–1) as analysis (NRC, 1999; Ex. 26–37). Note: the presence of the cause (a force), the having strong evidence are well supported by The steering committee’s report was tendon responds. competent research on heavily exposed • Absence of other plausible populations. published in 1998, and was referred to • in OSHA’s proposal as Ex. 26–37. In the explanations for the observed effect. There is compelling evidence from numerous studies that as the amount of final rule, Ex. 26–37 refers to the final Adequate controlling of confounding factors by the design of the experiment biomechanical stress is reduced, the report, (Work-Related Musculoskeletal prevalence of musculoskeletal disorders at Disorders: Report, Workshop Summary, or observation makes other explanations the affected body region is likewise reduced. for the observed effect less likely. and Workshop Papers, National • This evidence provides further support for Research Council, 1999; Ex. 26–37), Temporal contiguity, amplifies the the relationship between these work which includes the steering committee’s first (temporal ordering). To the extent activities and the occurrence of report, a summary of the proceedings of that the effect follows the cause closely musculoskeletal disorders. • the 2-day workshop (Work-Related in time, the plausibility that other Evidence of a role for biomechanical factors are operative is reduced. stress in the occurrence of musculoskeletal Musculoskeletal Injuries: The Research • Base), and the workshop papers. Congruity between the cause and disorders among populations exposed to low levels of biomechanical stressors remains less The charge to the steering committee, effect, that is the size of the cause is related to the size or magnitude of the definitive, though there are some high- reflected in the focus of the workshop, quality studies suggesting causal associations was to examine the current state of the effect. In its report, the NRC noted that in that should serve as the basis for further scientific research base relevant to the investigation. In cases of low levels of problem of work-related addressing complex research questions, biomechanical stress, the possible musculoskeletal disorders, including such as relationships between risk contribution of other factors to factors that can contribute to such factors and work-related musculoskeletal disorders is important to disorders, and strategies for intervention musculoskeletal disorders, single consider. The report then addresses other to ameliorate or prevent them. The studies rarely, if ever, provide factors, including individual factors (e.g., age, NAS/NRC organized their examination conclusiveness of a causal relationship. prior medical conditions); and organizational Replication and synthesis of evidence and social factors (e.g., job content and of the evidence of factors that demands, job control and social support). potentially contribute to across studies, preferably with studies musculoskeletal disorders: that use a variety of methods (each with The conclusions from the NAS/NRC (1) Biological responses of tissues to different strengths and weaknesses) report (Ex. 26–37) from the biomechanical stressors; strengthens causal associations. In biomechanical literature are presented (2) Biomechanics of work stressors, performing such synthesis, studies that (in brief) in the previous discussion of considering both work and individual most completely satisfy the five criteria ‘‘force’’in Section A. factors, as well as internal loads; specified above should be given greatest In setting forth its conclusions on (3) Epidemiologic perspectives on the weight. Inferential strength is gained by musculoskeletal disorders in the contribution of physical examining the evidence from a variety workplace, NRC/NAS steering (biomechanical) factors; of theoretical perspectives, as well as a committee notes that it has: (4) Non-biomechanical (e.g., variety of research methods. A major supplemented our professional expertise psychological, organizational, social) strength of the NRC/NAS review is that with workshop presentations, commissioned factors; and it takes this broad approach toward papers and other submissions, and

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00180 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68441 discussions with invited workshop whether he agreed with this UPS Agency finds that the body of scientific participants. position, Dr. Robert McCunney, evidence on which OSHA based this and, as a result concluded (in representing the American College of rule is vast and conclusive. This summary): Occupational and Environmental position was supported by many • There is a higher incidence of reported Medicine replied ‘‘I find this statement witnesses and multiple pages of hearing pain, injury, loss of work, and disability incredulous’’ (Tr. 7662). Dr. McCunney testimony, and added to the substantial among individuals who are employed in then continued in his testimony to state base of scientific literature that OSHA occupations where there is a high level of that there is sufficient scientific relied on for the publication of it’s exposure to physical loading than for those literature showing that repetitive motion proposal. And, although there have been employed in occupations with lower levels of activities can lead to MSDs. According critics to OSHA’s actions, they are in exposure. fact, in the vast minority. The science • to Dr. Barbara Silverstein, of the There is a strong biological plausibility Washington State Department of Labor overwhelmingly supports reducing on the relationship between the incidence of biomechanical risk factors in the musculoskeletal disorders and the causative and Industries, scientific researchers exposure factors in high-exposure who hold to the UPS view that there is workplace as an effective approach to occupational settings. no evidence that repetitive movements reducing work-related musculoskeletal • Research clearly demonstrates that causes injury ‘‘are in a minority’’ (Tr. disorders. specific interventions can reduce the 17415). Likewise, in response to the When asked ‘‘whether ACOEM reported rate of musculoskeletal disorders for same question regarding the UPS believes that detection and elimination workers who perform high-risk tasks. of these ergonomic risk factors at work • contention, Dr. Thomas Armstrong Research can (1) provide a better (University of Michigan) defended the can result in a reduction in the number understanding of the mechanisms that scientific evidence that repetitive of these disorders’’ during the hearing, underlie the established relationships Dr. McCunney replied ‘‘Very much so’’ between causal factors and outcomes; (2) movements can result in injury, by replying: (Tr. 7663). consider the influence of multiple factors The following parts of this section (mechanical, work, social, etc.) on symptoms, There are physiological studies looking at injury, reporting, and disability; (3) provide discuss the evidence for the work- repetitive work as it contributes to muscle relatedness of MSDs. Tables V–1 more information about the relationship fatigue and changes in histology of muscle between incremental change in load and tissue. There are epidemiological studies that through V–8 summarize some key incremental biological response as a basis for have looked at the relationship between aspects of the epidemiological studies defining the most efficient interventions; (4) various exposures to repetition and a variety that investigate MSDs, such as the improve the caliber of measurements for risk of musculoskeletal types of disorders. These occupations examined, the factors, outcome variables, and injury data studies from different disciplines all come biomechanical risk factors they were collection systems; and (5) provide better together and support the same conclusion. exposed to, whether exposures were understanding of the clinical course of these disorders. Professional and scientific directly observed or measured during the study, and whether the health The relevant scientific literature has organizations supporting OSHA’s determinations regarding the scientific outcomes were verified by trained been thoroughly and systematically medical personnel during physical evaluated by two highly-reputable and basis underlying the standard include: • American Association of examination. The last column provides independent scientific bodies and their Occupational Health Nurses (Ex. 30– a quantitative (if available) risk measure experts, who used different approaches 2387) or range of risk measures reported in to evaluate the literature from different • American College of Occupational each study that best captures the scientific disciplines (while allowing for and Environmental Medicine (Ex. 30– strength of the association between the some overlap), using causality criteria 4468, Tr. 7637–7690) studied biomechanical risk factor(s) and from two related but different • American Conference of health outcome. Study entries with a frameworks. The NIOSH and NRC/NAS Governmental Industrial Hygienists (Ex. single odds (or prevalence) ratio reviews offer two distinct but consistent DC–386, Tr. 16291–335) examined the relative risk between an sets of conclusions that can be drawn • American Industrial Hygiene exposed group of workers and from the literature on work-related Association (Ex. 32–133–1, Tr. 16464– unexposed referent population. For musculoskeletal disorders. Generally, 72, Tr. 16518–27) most studies, the risk values and both reviews agree that the scientific • American Nurses Association (Ex. confidence intervals were obtained from evidence provides compelling support 30–3686, Tr. 15875–95) tables found in the 1997 NIOSH review for a higher risk of work-related • American Occupational Therapy (Ex. 26–1). For the additional studies musculoskeletal disorders and the loss Association (Ex. 30–4777, Tr. 18095– not reviewed by NIOSH, OSHA of work, and disability among 18121) obtained risk values from the material individuals who are employed in • American Public Health submitted in the docket. occupations where there is a high level Association (Ex. 30–626, Tr. 17649– Many studies reported risk ratios for of exposure to physical loading 17704) multiple exposed groups and/or several (biomechanical factors), and that • American Society of Safety indicators of exposure to biomechanical evidence clearly demonstrates that Engineers (Ex. 32–21–1–2; Tr. 11612) risk factors. In these cases, the range of specific interventions can reduce the • Human Factors and Ergonomics reported risk measures were provided in reported rate of musculoskeletal Society (Ex. 502–472) the summary tables. OSHA did not disorders for workers who perform high- • National Association of Orthopedic include in this range; (1) risks ratios risk tasks. Nurses (Tr. 10578–10588) (high or low) that were inherently In the face of overwhelming evidence • The American Society of Plastic unstable because they were based on that biomechanical/physical risk factors and Reconstructive Surgery (Ex. DC–46, very low numbers of cases; (2) risk in the workplace cause MSDs, some Tr. 1534) ratios that did not reflect differences in critics, such as UPS argue that there is OSHA finds no merit to assertions biomechanical risk factors; and (3) risk not even one study which demonstrates that there is insufficient science on ratios in which the variation in that repetitive motion causes injury (Ex. which to base its proposal and exposure between groups were so small 32–241–4). When asked at the hearing subsequent final rule. Rather, the that a difference in MSD prevalence

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00181 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68442 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations would have been difficult to detect. The one. For greater detail on the scientific (Hunting, et al.199, Ex. 26–1273); 26% 95 percent confidence interval for the evidence summarized here see 64 FR and 18%, in the Danish wood and upper end of the risk range were also 65865–65926). furniture industry respectively recorded on the tables. The lifetime prevalence of neck pain (Christensen, Pedersen, and Sjogaard Some studies on the tables did not is estimated at 40% to 50%, with a 1- 1995, Ex. 26–95). Prevalence of regular report odds (or prevalence) ratios, even year prevalence of about 20% (Takala et discomfort in the posterior neck region though they may have established a al.1982, Ex. 26–1169). Using a was 6.3%, and 9.1% in the upper-back statistically significant association definition of 2 weeks of neck pain, the region, in a group of chicken-processing between biomechanical risk factor and prevalence among men and women aged workers. However, the lifetime health outcome. Often, the association 25 to 74 years in the NHANES Survey prevalence was 36%, the point was expressed as a regression analysis II (1976 to 1980) was 8.2% (Praemer, prevalence was 18%, and 9% had between a particular biomechanical Furner, and Rice 1992, Ex. 26–869). sought medical treatment for discomfort measurement and number of MSD cases. Chronic neck pain is estimated to be (Buckle 1987, Ex. 26–938). Sometimes, the study did not provide a present in up to 9% to 10% of males Many studies of neck pain have risk measure but simply reported the and 12% to 14% of females (Makela et focused on employees working in health MSD prevalence of different groups of al.1991, Ex. 26–980; Revel et al.1994, care. Milerad and Ekenvall (1990, Ex. exposed workers. These study entries Ex. 26–195). Individuals in the 4th to 26–1291) reported cervical symptom were designated with a NR (risk ratio 6th decades of life have the greatest prevalence of 45% of male dentists and not reported). incidence of neck disorders (Makela et 63% of female dentists, rates that were al.1991, Ex. 26–980; Praemer, Furner, 2.6 and 2 times those of male and C. Disorders of the Neck and Shoulder and Rice 1992, Ex. 26–869). female pharmacists, respectively. MSDs of the neck and shoulder that What is known about the course of Twelve-month prevalence of self- have been documented in the scientific neck pain? It is estimated that 90% of reported neck pain was 63.1% in a literature include the clinically well- patients with acute neck pain are group of medical secretaries and defined disorders, such as tendinitis, improved within 2 months (Borenstein, hospital office personnel (Linton and and the less clinically well-defined soft Wiesel, and Boden 1996, Ex. 26–1394). Kamwendo 1989, Ex. 26–978). tissues disorders, such as tension-neck The Quebec Spinal Study (1987, Ex. 26– With regard to work-related cervical syndrome (Gerr 1991, Ex. 26–1208; 494) series of individuals with work- spine disorders, the Quebec Spinal Moore 1992, Ex. 26–984). MSDs of the related spinal disorders suggests that Study (1987, Ex. 26–494) observed an neck and shoulder often involve 74% recover by 7 weeks. A 10-year annual incidence of over 0.1%. tendons, muscles, and bursa; nerves and outcome study of patients with neck However, Bjorksten et al.(1996, Ex. 26– blood vessels may also be affected. pain revealed that 79% had less pain 604) reported a 68%, 3-month Because of the simultaneous and 43% were pain-free. However, 32% prevalence for neck pain in industrial involvement of several regional still experienced moderate or severe workers performing unskilled tasks, structures in neck and shoulder MSDs, pain (Gore et al.1987, Ex. 26–127). With more than double the rate in the general there may be positive signs and/or regard to work-related MSDs, some population. Certain jobs appear to have symptoms in more than one structure. intervention studies have suggested that greater associations with neck pain than For example, strong abduction or workplace modifications may decrease others, with the lifetime prevalence of extension of the upper arm, as well as both symptoms of neck pain and/or neck and shoulder symptoms reaching awkward postures of the neck, can muscle activity as recorded by EMG 81% in machine operators, 73% in ˚ ˚ compress parts of the brachioplexus (Aaras 1994a, Ex. 26–892; Aaras et carpenters, and 57% in office workers under the scalene muscles and other al.1998, Ex. 26–597; Schuldt et al.1987, (Tola et al.1988, Ex. 26–1018). It must anatomical structures. This compression Ex. 26–670). be understood that there may be an can result in nerve and/or blood vessel The extent to which neck pain occurs underestimation of work-relatedness of damage or in eventual damage to the in or affects workers depends to a great neck pain since the onset of pain may, tissues served by these nerves and extent on the terms used to define the at times, be delayed and the work vessels. pain, in terms of intensity and duration, relation uncertain. and on the methods used in determining Tension neck syndrome is a Neck and Upper Back the presence or occurrence (self-report, myofascial (muscle pain) localized in In this section, OSHA summarizes the interview, or physical examination). the shoulder and neck region (Hagberg evidence for an increased risk for Point prevalence of neck pain in a 1984; Ex. 26–1271). Also called musculoskeletal disorders of the neck general U.S. population has been scapulocostal syndrome (Fine and and upper back associated with reported at 10%, matching point Silverstein 1998; Ex. 38–444), these exposure to biomechanical risk factors prevalence reports of workers in an syndromes are often characterized by in the workplace. This region (neck and aeroengineering factory and exceeding a diffuse tenderness over the muscle, upper back) includes the cervical and 4% prevalence reported in a group of rather than the tendon origin, and thoracic spine (spine above the lumbar textile workers (Palmer et al.1998, Ex. activity limitation. The pathophysiology or low back) and supporting structures 26–1529 ). Other estimates found in the is unknown; however, a number of and tissues. The scientific literature literature include 68% for female and mechanism have been proposed, frequently refers to this region as ‘‘Neck 47% for male Swedish industrial including inflammation. Two types of and Neck/Shoulder,’’ or as ‘‘Neck and workers performing unskilled tasks (3- muscle activity may be important in Shoulder’’ or as ‘‘Neck and Upper month prevalence of MSDs in the neck work-related disorders: low-force, Back.’’ With respect to the and in the thoracic back)(Bjorksten et prolonged muscle contractions (e.g., in epidemiologic literature, the studies al.1996, Ex. 26–604). One-year office workers moderate neck flexion NIOSH referred to in it’s ‘‘Neck and prevalence of neck pain or neck and while working on a visual display Neck/Shoulder’’ section are included in upper-back pain was 16% in a group of terminal (VDT) for many hours without this section. A summary of the evidence electricians, excluding neck pain rest breaks); and infrequent or frequent regarding the shoulder only is reviewed associated with traumatic injury, and high-force muscle contractions in the separate section following this 38% with a less restrictive definition (intermittent use of heavy tools) in

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Posterior 1271). electrophysiological evidence of fatigue spondylotic bars, especially if combined Motor nerve control of the working are more common in large muscle with hypertrophy of the ligamentum muscle may be important in sustained groups, such as the neck and shoulder flavum, have the potential to compress static contractions since even if the muscles, when activities are static and the spinal cord, causing symptoms of relative load on the muscle as a whole repetitive rather than dynamic (Sjogaard cervical myelopathy. Anatomically, the is low, the active part of the muscle may 1988, Ex. 26–830). C4 to C5, C5 to C6, and C6 to C7 be working close to it’s maximal Pain arising from cervical spine intervertebral disc spaces are most capacity. Thus, small areas of large skeletal structures may potentially commonly affected by osteoarthritis and muscles such as the trapezius may have originate from many locations, since degenerative disc disease. disturbances in microcirculation that sensory nerve innervation is present in Thoracic outlet syndrome (TOS) is might contribute or cause the ligaments, joint capsules, the anterior defined as a ‘‘neurovascular development of muscle damage (red and posterior longitudinal ligaments, impingement syndrome at different ragged fibers), reduce strength, higher the outer third of the annulus fibrosus, anatomical levels where the brachial levels of fatigue, sensitization of pain and the vertebral body (Bogduk 1982, plexus and subclavian vessels may be receptors in the muscle, and pain at rest Ex. 26–1479; Bogduk et al.1988, Ex. 26– entrapped as they pass through, en route (Armstrong, Buckle and Fine 1993, as 514; Hirsch, Inglemark, and Miller 1963, from the cervical spine to the arm.’’ cited in Fine and Silverstein 1998, Ex. Ex. 26–471). The periosteum of the (Hagberg et al.1995, Ex. 26–432). The 38–444). High levels of tension (strong cervical vertebral body may be a source syndrome involves compression of the contractions) can lead to muscle fiber Z- of pain, although some slowly subclavian artery and the lower trunk of line rupture, muscle pain, and large, progressive lesions may destroy a the brachial plexus, at one or more delayed increases in serum creatine significant amount of bony tissue before locations between the neck and the kinase. These changes are reversible and they are recognized (Borenstein, Wiesel, axilla. Symptoms are experienced in the can be completely repaired, often and Boden 1996, Ex. 26–1394). The upper extremity. Cervical syndrome is leading the muscle to be stronger. It is spinal nerve roots are the source of pain defined as ‘‘compressions of the nerve hypothesized that if damage occurs when there is compression, ischemia, root by a herniated disc or a narrowed daily due to work activity, the muscle and inflammatory or chemical intervertebral foramen’’ (Hagberg et may not be able to repair the damage as mediators that stimulate nociceptors. al.1995, Ex. 26–432). fast as it occurs, leading to chronic Cervical spondylosis refers to Epidemiological Evidence muscle damage or dysfunction. The degenerative changes in the cervical mechanism of this damage at the spine that are apparent on radiological Several muscles act upon the upper cellular level is not understood examination (Hagberg and Wegman spine and shoulder girdle together; (Armstrong, Buckle and Fine, 1993 as 1987, Ex. 26–32). The pathogenesis of Scandanavian studies have often cited in Fine and Silverstein 1998, Ex. cervical spine degenerative disease has combined neck and shoulder MSDs. 38–444). similarities to many other joint Neck pain and MSDs will be discussed Hagberg (1984, Ex. 26–1271; and structures, although there are important here. Those studies that evaluated neck Hagberg and Wegman 1987, as cited in differences. The cervical spine has a and shoulder pain and MSDs together Magnusson and Pope Ex. 38–450) great deal more movement, achieved via will also be included. Studies that described three possible gliding and sliding on adjacent exclusively evaluate pain and MSDs of pathophysiological mechanisms for structures, than the remainder of the the shoulder will be discussed in a occupational muscle-related disorders, spine. And not being subject to subsequent section. Studies that have such as tension neck syndrome. The repetitive and impulsive loading, evaluated objective findings and/or met first is mechanical failure, due to cervical spinal segments do not require diagnostic criteria for specific disorders temporary high local stress involving the strength and stability of the lumbar- have been given greater weight in this eccentric contractions on the shoulders, sacral spine. However, these analysis. such as in workers unaccustomed to the zygoapophyseal joints in the cervical There have been several reviews that work task. The second is local decreased spine have fibrocartilagenous, associate neck disorders work factors, blood flow (ischemia), as seen in meniscus-like structures that are such as repetition, force, static loading, assembly workers whose tasks involved capable of responding with proliferative neck posture, and heavy work (NIOSH dynamic, frequent contractions above 10 changes (Bland 1994, Ex. 26–416 ). As 1997, Ex. 26–1; Grieco, et al.1998, Ex. to 20% of the maximum voluntary with other joints, aging, repetitive 26–627; Hagberg et al.1995, Ex. 26–432; contraction and few rest breaks. Both a motion, and some loading result in Hales and Bernard 1996, Ex. 26–896; reduction in blood flow and pathologic fissuring of the hyaline cartilage Viikari-Juntura 1997, Ex. 26–905; changes were found to be correlated surfaces. Gradually, the hyaline Hagberg and Wegman 1987, Ex. 26–32). with myalgia (muscle pain) and ragged cartilage develops deeper and The majority of neck disorders involve red fibers in 17 patients doing repetitive downward fissuring, larger erosions, soft tissues (muscle and ligament strains assembly work (Larsson et al.1990, Ex. and general thinning. In the cervical and sprains). Outcomes studied and 26–1141). spine, the chondrocytes proliferate in reported are often non-specific, for The third pathophysiologic areas of fibrillation or loosely textured example, neck pain or/or stiffness. Some mechanism for muscle pain (Hagberg matrix (Bland 1994, Ex. 26–416). And studies relied on combination of 1984, Ex. 26–1271) energy metabolism though the matrix may demonstrate symptoms and physical exam disturbance, occurs when energy some attempts at repair, the repair is confirming tenderness in neck muscles demand exceeds production. Long-term generally disorderly. Subchondral bone and tendons upon palpitation and/or static contractions of the muscles result increases in density, followed by localized pain during neck movement. in the prolonged recruitment of limited microfracturing and callus formation. Many others simply relied on self-

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TABLE V±1.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING NECK AND UPPER BACK MUSCULOSKELETAL DISORDERS

Study Job type studies Physical Exposure basis Diagnosis Risk Measure factors (95% CI) 1

Hunting (1981) Ex. 26±1276 ...... VDT operation .... R/P observation ...... physical exam .... OR=9.9 * body posture ...... (3.7±26.9) Veiersted (1994) Ex. 26±1366 ...... chocolate manu- F/R?/P EMG ...... physical exam .... OR=6.7±7.2 * facture. (2.1±25.3) Ohlsson (1995) Ex. 26±868 ...... assembly line ..... R/P neck flexion ...... physical exam .... OR=3.6 * cycle time ...... (1.5±8.8) Bergqvist (1995) Ex. 26±1195 ...... VDT operators ... R/P observation ...... physical exam .... OR=3.6±4.4 * (1.1±17.6) Bergvist (1995) Ex. 26±1196 ...... VDT operators ... R/P observation ...... physical exam .... OR=6.9 * (1.1±42.1) Onishi (1976) Ex. 26±1222 ...... film rolling ...... F?/R/P observation ...... physical exam .... OR=3.8 * EMG ...... (2.1±6.6) Norander (1999) Ex. 38±408 ...... fish processing ... R/P observation ...... physical exam .... OR=3.0 * cycle time ...... (1.5±5.9) Kukkonen (1983) Ex. 26±1138 ...... data entry ...... R?/P posture ...... physical exam .... OR=2.3 * observation ...... (1.1±4.6) Bjelle (1981) Ex. 26±1519 ...... industrial plant .... F/R/P flexion ...... physical exam .... NR * EMG ...... Jonsson (1988) Ex. 26±969; Kilbom (1986) Ex. 500± electronics manu- F/R/P flexor MVC ...... physical exam .... NR * 41±75. facture. flexion ...... Dimberg (1989) Ex. 26±1211 ...... automotive ...... F/R/P observation ...... physical exam .... NR* (p<0.1) Sakakibara (1995) Ex. 26±800 ...... fruit bagging ...... F?/R?/P observation ...... physical exam .... OR=1.5 arm elevation ..... (1.0±2.3) Rosecrance (1994) Ex. 38±203 ...... newspaper work F?/P/R questionnaire ..... symptoms only ... OR=29 * Andersen (1993) Ex. 26±1502 ...... sewing machine F/R/P? job titles ...... physical exam .... OR=6.8 * (1.6±28.5) Baron (1991) Ex. 26±697 ...... grocery checking F/R/P job titles ...... physical exam .... OR=2.0 (0.6±2.7) Bernard (1994) Ex. 26±842 ...... newspaper pub- R?/P observation ...... symptoms only ... OR=1.4 * lishing. (1.0±1.8) Blader (1991) Ex. 26±1215 ...... sewing machine R/P questionnaire ..... physical exam .... NR * Hales (1989) Ex. 2±3±pp ...... poultry proc- F/R job title ...... physical exam .... OR=1.6 essing. (0.4±3.2) Hales (1994) Ex. 26±131 ...... telecommuni- R?/P questionnaire ..... physical exam .... OR=3.8* cation. (1.5±9.4)

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TABLE V±1.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING NECK AND UPPER BACK MUSCULOSKELETAL DISORDERSÐContinued

Study Job type studies Physical Exposure basis Diagnosis Risk Measure factors (95% CI) 1

Hunting (1994) Ex. 26±1273 ...... electrician ...... V/F/R/P questionnaire ..... symptoms only ... OR=1.6 (NR) Kamwendo (1991) Ex. 26±1384 ...... medical secretary R/P questionnaire ..... symptoms only ... OR=1.6* (1.0±2.7) Kiken (1990) Ex. 26±430 ...... poultry proc- F/R job title ...... physical exam .... OR=1.3 essing. (0.2±11) Knave (1985) Ex. 26±753 ...... VDT operation .... R/P questionnaire ..... symptoms only ... OR=1.6 (0.4±3.2) Kuorinka (1979) Ex. 26±639 ...... scissor produc- R/P job title ...... physical exam .... OR=4.1* tion. (2.3±7.5) Luopajarvi (1979) Ex. 26±56 ...... food production .. F/R/P? job title ...... physical exam .... OR=1.6 (0.9±2.7) Schibye (1995) Ex. 26±1463 ...... sewing machine F?/R/P? questionnaire ..... symptoms only ... OR=3.3* (1.4±7.7) Liss (1995) Ex. 26±55 ...... dental hygienist .. F/R/P? questionnaire ..... symptoms only ... OR=1.7* (1.1±2.6) Ohlsson (1989) Ex. 26±1290 ...... auto assembly .... F/R/P? job title ...... symptoms only ... OR=1.9 (0.9±3.7) Andersen (1993) Ex. 26±1451 ...... sewing machine F/R/P? job titles ...... symptoms only ... OR=3.2±4.9* (2.0±12.8) Eckberg (1995) Ex. 26±1193 ...... residents ...... F?/R/P? questionnaire ..... symptoms only ... OR=1.2* (1.0±1.3) Eckberg (1994) Ex. 26±1238 ...... case-control ...... F?/R/P questionnaire ..... symptoms only ... OR=3.6±15.6* (3.2±113) Milerad (1990) Ex. 26±1291 ...... dentist ...... R/P questionnaire ..... symptoms only ... OR=2.1* (1.2±3.1) Punnett (1991) Ex. 26±39 ...... meat processing F/R/P? observation ...... symptoms only ... OR=0.9±1.8 (1.0±3.2) Rossignol (1987) Ex. 26±804 ...... computer oper- R/P questionnaire ..... symptoms only ... OR=1.8±4.6* ation. (1.7±13.2) Viikari-Juntura (1994) Ex. 26±873 ...... machine oper- F/R?/P/V observation ...... symptoms only ... OR=3.0±4.2* ation. (2.0±9.0) Wells (1983) Ex. 26±729 ...... letter carrier ...... F/R?/P job title ...... symptoms only ... OR=2.6 * (1.1±6.2) Aaras (1994) Ex. 26±892 ...... telephone assem- F/R?/P EMG ...... symptoms only ... NR * bly. muscle load ...... Ferguson (1976) Cited in Ex. 26±1 ...... telephone inter- R?/P posture meas- symptoms only ... NR view. ures. Maeda (1982) Ex. 26±1224 ...... machine opera- F?/R?/P? questionnaire ..... symptoms only ... NR * tors. Linton (1989) Ex. 26±729 ...... medical secretary R?/P? questionnaire ..... symptoms only ... NR Linton (1990) Ex. 26±977 ...... multiple indus- F?/R?/P questionnaire ..... symptoms only ... OR=3.5 tries. (2.7±4.5) Sakakibara (1987) Ex. 26±1199 ...... fruit bagging ...... F?/R/P neck/shoulder symptoms only ... OR=1.6 flexion. (0.4±3.2) Welch (1995) Ex. 26±1268 ...... sheet metal proc- F?/R/P questionnaire ..... symptoms only ... OR=7.5 essing. (0.8±68) Yu (1996) Ex. 26±696 ...... VDT operation .... R?/P questionnaire ..... symptoms only ... OR=29 (2.8±291.8) Holmstrom (1992) Ex. 26±36 ...... construction ...... F?/R?/P questionnaire ..... symptoms only ... OR=2.0 * (1.4±2.7) Ryan (1998) Cited in Ex. 26±1 ...... data processing R?/P shoulder flexion .. symptoms only ... NR* Ohara (1976) Cited in Ex. 26±1 ...... cash register ...... F?/R?/P? job title ...... physical exam .... NR Tola (1988) Ex. 26±1018 ...... machine oper- F?/R?/P job title ...... symptoms only ... OR=1.8 * ation. (1.5±2.2) Vihma (1982) Ex. 26±789 ...... sewing machine R/P observation ...... symptoms only ... PRR=1.6 * cycle time ...... (1.1±2.3) Viikari-Juntura (2000) Ex. 500±41±50 ...... forest industry .... P/R? questionnaire ..... symptoms only ... OR=1.4 BothaÈ (1998)Â Ex. 500±212±10 ...... nurses ...... P/F observation ...... symptoms only ... NR * Bjork Csten (1996) Ex. 26±604 ...... metal working ..... R/P questionnaire ..... symptoms only ... NR Ignatius (1993) Ex. 26±1389 ...... typists ...... F/R?/P questionnaire ..... symptoms only ... OR=3.4 * Slov (1996) Ex. 26±674 ...... sales ...... P questionnaire ..... symptoms only ... OR=2.8 * (1.4±5.59) F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear OR=odds ratio; PRR=prevalence rate ratio, NR=not reported; *=p<0.05 1 95% confidence interval expressed for the upper end of the risk measure range

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The odds ratios determined from the between 1979 and 1991) that met their head and arm postures and outcomes of studies ranged from 1.1 to 9.9. Several inclusion criteria. From those studies tension neck syndrome. They did not studies deserve special mention. they found the strength of association find convincing evidence of a Ohlsson et al.(1995, Ex. 26–868) between work and TOS to be generally connection between repetition and compared 82 female industrial workers weak, based on low odds ratios (ORs). cervical radiculopathy. exposed to short-cycle tasks (less than Since all studies were cross-sectional in A recent review of epidemiological 30 seconds) to 64 referents with no design, temporal associations could not studies by Grieco et al.(1998, Ex. 26– exposure to repetitive work. The OR for be confirmed. There seemed to be a 627) concluded that cervical tension neck syndrome was 3.6 (95% CI: consistent association between radiculopathy had not been shown to be 1.5–8.8). repetitive work and TOS across the associated with data entry work, The NIOSH authors concluded that studies. One study demonstrated a dose- dockers’ work, or food production there was ‘‘reasonable evidence’’ for an response relationship between vibration assembly line work. In contrast, tension association between highly repetitive and TOS. The authors also noted an neck syndrome was linked to static work and neck/shoulder MSDs, where association between TOS and age. postures and static loads in several repetitiveness was most often defined in Hagberg et al. (1995, Ex. 26–432) studies on populations of VDT workers, terms of hand activity. They also concluded that the studies typists, and sewing machine operators. determined that there was ‘‘reasonable demonstrated the existence of a Study selection criteria were not evidence’’ for an association between consistent association between discussed in that review. forceful exertion and neck/shoulder repetitive arm movements, manual Several individual studies of workers MSDs, where forceful work was work, and TOS. performing heavy work (including meat conducted by the arms. They concluded In their review, Hagberg et al.(1995, carriers and miners) found increased there was ‘‘strong evidence’’ for an Ex. 26–432) found twelve cross- ORs (most adjusted for age) for cervical association between static loads and sectional studies and one laboratory spondylosis, as did one study of neck/shoulder MSDs, where ‘‘static study of tension neck syndrome dentists. Viikari-Juntura (1997, Ex. 26– load’’ referred to a static load of long (published between 1976 and 1988) that 905) reviewed both epidemiological and duration, high intensity, or extreme met their inclusion criteria. From those experimental studies focused on the amplitude. In many of the situations studies, Hagberg et al.(1995, Ex. 26–432) neck (among other regions). The author under study, workers were exposed to found the strength of association mentioned studies that showed more than one of these physical risk between work and tension neck associations between degenerative factors during the course of their jobs. syndrome to be moderate, based on ORs changes or neck pain and heavy work, The NIOSH review found insufficient from 3 to 7. There seemed to be a repeated impact loading, or static work, evidence of an association between consistent association between work whereas the OR for cervical spondylosis vibration and neck disorders. with VDTs and tension neck syndrome in cotton workers was 0.66 (protective). In an earlier review, Hales and across several studies, including a The relationships between work factors Bernard (1996, Ex. 26–896) concluded determination of an OR for tension neck and cervical spine arthritis have not that neck disorders were associated with syndrome of 2.0 in keyboard operators been clarified due to (1) few studies of work involving repetitive motions, (Hagberg and Wegman 1987, Ex. 26–32). this subject, (2) a lack of universal forceful repetitive work, and There also seemed to be consistent acceptance for the criteria (e.g., constrained or static postures, based on associations between tension neck symptoms, signs, imaging) used to make consistency of association across several syndrome and repetitive work and static this diagnosis, and (3) cervical spine studies. They noted inconsistent head and arm postures. The authors also degenerative changes are common. findings regarding neck disorder and noted that tension neck syndrome was Four additional epidemiological work pace, which, they suggested, may found more commonly in women, but studies that address physical work be due to the many ways work pace can that finding may have been confounded factors and neck and neck/shoulder be quantified. Hales and Bernard also by differences in work. Hagberg et disorders were submitted into the mentioned a consistent association al.(1995, Ex. 26–432) concluded that the OSHA docket following publication of between wearing bifocals, awkward studies demonstrated the existence of a the proposal and have been added to neck postures, and neck disorders. consistent association between Table V–1 (Nordander et. al. 1999, Ex. Hagberg et al. (1995, Ex. 26–432) repetitive work and tension neck 38–408; Viikari-Juntura 2000, Ex. 500– reviewed epidemiological studies for syndrome caused by constrained head 41–50; Botha and Bridger 1998, Ex. 500– evidence of work-relatedness of selected and arm postures. They also noted that 121–10; Rosecrance et al 1994, Ex. 38– musculoskeletal disorders of the neck: tension neck syndrome had a high 203). OSHA found a few additional TOS (neurogenic form), cervical prevalence in both work and reference studies identified in the NIOSH syndrome, and tension neck syndrome. groups. epidemiological review for other MSDs In compiling a list of valid papers for Three cross-sectional studies of that also addressed neck and neck/ their review, the researchers considered cervical radiculopathy (published shoulder and are also included in Table the strength of each study based on between 1979 and 1983) met the criteria V–1 (Dimberg 1989, Ex. 26–1211; minimization of bias (selection bias, of Hagberg et al.They observed that all Ignatious 1993, Ex. 26–1389; Skov 1996, information or misclassification bias, studies showed a low prevalence for Ex. 26–674). Two other submitted confounding or effect modification bias) cervical radiculopathy. Low numbers studies contained some serious and study power. Studies that met their meant wide confidence intervals, which methodological flaws and were not validity criteria were then reviewed for made results difficult to interpret. They included in the table (Leclerc et al., causality (strength of association, concluded that more directed research 1999, 500–118–2; Erikson et al., 1999, demonstration of temporal association, needed to be conducted in this area. 500–118–2). consistency of association among In a review of the epidemiological Nordander et al.1999 (Ex. 38–408) studies, predictive power of exposure evidence for three neck-related MSDs, reported on a cross sectional study of 13 factors, and plausibility. the contributors to Kourinka and Forcier fish processing plants, examining Hagberg et al. found six cross- (1995 Ex. 26–432) report consistent multiple body sites, including the neck sectional studies of TOS (published associations between exposures to static and shoulder. Ninety one male and 165

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00186 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68447 female fish industry workers were movements, but for the combination of and backward, twisting, and handling of compared to men and women with more twisting of the trunk and stress, neck materials.’’ The authors note that ‘‘the varied work. The work was partly paid pain decreased with increasing amounts role of specific occupational risk factors by the work done—piece work. Health of stress. of neck disorders, such as awkward outcome was based on questionnaire Rosecrance (1994, Ex 38–457) postures of the head and neck and static and physical examination. Exposure conducted a cross-sectional study of 906 postures, was not studied because these was assessed by questionnaire, office and production workers from variables were not included in the videotaping of jobs, and the three medium sized newspaper facilities questionnaire.’’ Analyses were observational method using AET to determine the level of symptomatic performed with ‘‘occupation’’ as a crude (Arbeitwissenschaftliche workers and to compare the office and indicator of occupational exposure. Erbehungverfahren zur production workers. A participation rate Female gender, older age, headaches or ¨ Tatigkeitsanalyse) along with the of 72% was reported. A physical exam pain in the head, psychological distress, NIOSH lifting equation. Each work task was given to 105 participants. Exposure and psychosomatic problems were classified according to three factors: was assessed by a self-reported job predictors of neck pain. This study weight of the materials handled (<1, factor survey. The results found that found that there was no significant 1<5, 5<10, 10–25, >25 kg.), cycle time workers who reported repetitive tasks difference in occurrence of neck pain (<5, 5–10, 10–60, >60); and degree of had an odds ratio of 29 (CI not reported, among the different occupations— constrained neck postures (low, high, p=0.01) of missing work due to neck hospital workers, warehouse workers, very high). Neck and shoulder diagnoses symptoms compared to workers who and office workers. This is not among the fish processors was found to did not report repetitive tasks. surprising, as many studies have found be significantly elevated compared to Production workers reported more job increased rates of neck symptoms in the referents (OR=3.5; 95% CI 2.3–5.3). risk factors compared to office workers. these occupational groups. What is There was significantly increased Neck symptoms were the most common lacking in this study, as admitted by the prevalence of shoulder tendinitis found symptom among production workers. authors, is adequate assessment of risk among women fish processors (OR from Faucett and Rempel, 1994 (Ex 38–67) factors known to be associated with 3.4 to 4.65) compared to referents. No carried out a cross-sectional study of neck MSDs. The poor exposure significant effects were found due to 150 video display terminal (VDT) assessment concerning occupational age, leisure time and smoking assessed operators from large metropolitan factors does not detract from the by logistic regression. Job analysis found newspaper. Participation rate was low at relationship of exposure to certain work that several tasks were repetitive, 56%, however, non-respondents had no factors and neck disorders. Because of performed in constrained work difference in age, duration of its failure to address specific work employment, gender, job title, or VDT postures, with fast and continuous wrist factors related to neck disorders, OSHA training. A questionnaire-derived health and hand movements, mostly with does not regard this study as adequate outcome using a body diagram was flexed neck, arms raised and lowered and it was not included in Table V–1. employed. Observational exposure intermittently. Because it involved a assessment was performed on 70 VDT Eriksen et al., 1999 (Ex. 500–118–2) direct assessment of exposure and workstations, completed by trained carried out a community-based 4-year verification of neck injury by a health independent observers working in pairs prospective study of 1429 working professional, OSHA views the study to evaluating work posture, wrist, knee Norwegians who completed a be among the more reliable and leg contact with workstation, questionnaire in 1990, and returned a investigations. display and seat height, angle measures second questionnaire 4 years later. The Viikari-Juntura et al.2000 (Ex. 502–11) of wrist, elbow, shoulder, head, trunk at participation rate was 67% of original recently published findings on a the hip and thigh. Results found that group in 1990; 79.8% of working group longitudinal study of neck pain among 28% met symptom criteria for MSDs of from 1990 responded to 2nd a cohort of 5180 workers in a large forest the upper torso and extremities. Risk of questionnaire in 1994. The health industry enterprise. Participation rate having a MSD increased with a greater outcome was based on the Nordic was only 43% of the originally selected number of daily hours of VDT use. After questionnaire, ‘‘presence of any neck cohort of 7000. Nonrespondents were controlling for the ergonomic factors, pain during the previous 12 months.’’ also followed up—there was no less decision latitude on the job and less Workplace exposure also relied on difference with regard to potential coworker support were found to be questionnaire data. Questions predictors except reporting 1.5 times significantly associated with certain concerned work with hands over difficulties in coming 5 years due to symptoms (numbness). The limitations shoulder-level, static work positions, musculoskeletal health. Four repeated of this study are the low participation repetitive stereotypic movements, heavy questionnaires were used focusing on rate, although the non-responders were lifting, sitting, standing, and high work ‘‘radiating neck pain,’’ categorized as followed up and the non-specific nature pace. The authors note that the healthy (0–7 days), mild pain (8–30 of the health outcome. responders in 1994 were ‘‘less inclined days), and severe pain (>30 days). Leclerc et al., 1999 ( Ex. 500–118–2) to have jobs that required them to spend Validated exposure assessment conducted a longitudinal study to a large amount of time with hands above questionnaires and psychosocial evaluate the effects of prevention shoulder level, jobs that required a large questionnaires were used. There were programs at the workplace aimed at amount of standing, and jobs that several variables related to physical reducing back, neck, and shoulder required a large amount of heavy strenuousness, awkward postures, morbidity among active workers. The lifting.’’ This admission, without repetitive movements, and stress. intervention group (294 workers) and providing further data, makes Results found a statistically significant the referent group (294 workers) were interpretation of results difficult. It is dose-response relationship for neck pain collapsed and analyzed as a whole. impossible to tell whether the study and increasing number of hours working Health outcome was based on two sample reflects the overall original with the hands above the shoulder. The questionnaires. Questions ‘‘focused sample population. By loss of those risk of neck pain also increased with more on the potential risk factors for exposed to heavy lifting or working with increasing amounts of twisting low back pain, such as bending forward hands above shoulder one cannot assess

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00187 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68448 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations whether this would have minor or major workers, mean static trapezius load potential to cause permanent structural impact on the findings. Changes in job decreased from 4.3% to 1.4% of MVC, damage to skeletal muscle (Armstrong et situations after 1990 were also not and in VDT users, MVC declined from al.1993, Ex. 26–1110). Thus, work recorded, which would weaken 2.7% to 1.6%. This was accomplished pacing can reasonably be expected to association between job factors and neck with more accessible tool placement affect muscle function in the neck. pain. In responders without neck pain and support for elevated arms. The Froberg et al.(1979, Ex. 26–117) during the previous 12 months in 1990, median duration for sick leave resulting compared female production workers the ‘‘little influence on own work from MSDs dropped from 23 to 2 days performing piece work vs. salaried situation’’ factor predicted neck pain per person/year. As a result of work. Piece work was associated with during the previous 12 months (odds interventions, including the reduction increased pain in the shoulders, arms, ratio = 2.21; 95% confidence interval, in trapezius loading, the VDT operators and back, accompanied by elevated 1.18 to 4.14) and previous 7 days in also reported less intensity and duration excretion of adrenalin and noradrenalin. 1994 (OR = 2.85; 95% confidence of pain in the neck and shoulder region. Unfortunately, financial incentives in interval, 1.21 to 6.73) after adjustment The study design did not permit the piece workers may encourage workers to for a series of potential confounders. determination of which intervention(s) avoid pacing themselves in an effort to Because of the serious questions with were responsible for the decline in MVC exceed production levels. Brisson et regard to changes in population and sick leave, but it does support the al.(1989, Ex. 26–937) postulated that the exposure over time, OSHA believes the role of workplace ergonomics. biomechanical stressors involved with results are not interpretable and it was While epidemiologic studies piece work performed by female not included in Table V–1. regarding vibration and non-discogenic garment workers in Quebec, and the neck and shoulder pain have been Biomechanical Evidence time pressures imposed by their piece inconclusive, there is some work, combined to account for observed In a series of biomechanical and EMG biomechanical evidence that vibration disability from MSDs. The association studies, Harms-Ringdahl (1986, Ex. 26– may affect muscle activity, and therefore was related to the number of years 1128) demonstrated that considerable could be pathogenic for neck disorders. performing piece work, and was stress is generated in the ligaments and This is a complex area, particularly independent of age, smoking, education, joint capsule of the cervical spine with since the most common shoulder and total length of employment. In extreme neck flexion (more than 45 diagnoses—impingement and rotator addition, some researchers suggest that degrees). The extensor muscle activity is cuff tendinitis—are clinically useful but workers may ignore early warning less than in the neutral position while without very specific pathophysiologic symptoms of work-related MSDs. the load moment (or torque) is 3–4 times meaning. In the following review greater in extreme flexion. (Appendix I, Ex. 27–1), the neck, but not Conclusion Many hand-intensive jobs and tasks the shoulder, is shown to be associated The 1997 NIOSH report concluded require static neck contraction to permit with a vibration-related pathology. The the following with regard to physical accuracy in task performance. Thus, separation of biomechanical, work factors and MSDs of the neck/ significant muscle stress and fatigue physiologically adaptive, and vibration- shoulder region: may occur with maintenance of static specific factors is especially difficult for neck postures required in many office There is strong evidence that working the neck and shoulder. Scapular groups with high levels of static contraction, and assembly workplace settings (Hales stability and posture are the heart of prolonged static loads, or extreme postures and Bernard 1996, Ex. 26–896; Bernard large-muscle activation sequences involving the neck/shoulder muscles are at and Fine 1997, Ex. 26–1; Onishi, Sakai, involving efficient distal muscle group increased risk for neck/shoulder MSDs. and Kogi 1982, Ex. 26–991; Stock 1991, movement (Mackinnon and Novak 1997, Consistently high ORs were found (twelve Ex. 26–1010; Westgaard and Bjorklund Ex. 26–1309). Moreover, static shoulder statistically significant studies with ORs over 1987, Ex. 26–239). In confirmation of posture, important for tool stabilization, 3.0) providing evidence linking tension neck this postulate, several EMG studies have syndrome with static postures and static is an important contributor to early arm loads (Ex 26–1). documented the increase in neck and fatigue (Sjogaard et al.1996, Ex. 26–213). upper back muscle activity from static Finally, the quality of a vibratory OSHA agrees with NIOSH with regard work (Erdelyi et al.1988, Ex. 26–619; stimulus (continuous or discrete) has to the epidemiological evidence for an Onishi, Sakai, and Kogi 1982, Ex. 26– significant impacts on efferent association between neck and neck/ 991; Schuldt et al.1987, Ex. 26–670). recruitment and firing (Maeda et shoulder MSDs and physical risk factors Hidalgo et al., 1992 (Ex. 26–631) al.1996, Ex. 26–562). The combined related to forceful exertion, repetitive reviewed the biomechanical literature of effects of this complexity are not easily motion and awkward posture. Twelve the neck and proposed that prolonged modeled. This is all the more reason out of thirteen well-conducted static contraction of neck muscles be why neck/shoulder symptoms should be epidemiological investigations that limited to force levels at or below 1% carefully scrutinized when a power tool directly observed or measured these of maximum voluntary contraction is part of the exposure background. It factors in the workplace have found a (MVC). may prove difficult in practice to significantly elevated risk of neck/ It has also been shown that workplace distinguish neck/shoulder symptoms shoulder MSDs in exposed workers interventions to mitigate static loading that have their origins in strictly verified by physical exam. This link of neck muscles reduce pain, time out biomechanical processes from vibration- between physical work factors and of work due to musculoskeletal induced injuries. However, there is injury has been established across problems, and EMG measured loading. numerous job areas including VDT ˚ sufficient evidence in support of an Aaraas (1994a, Ex. 26–892; 1994b, Ex. etiology to merit intervention. operation (Hunting 1981, Ex. 26–1276; 26–62) evaluated users of video display As discussed earlier, skeletal muscle electronics manufacture (Kilbom 1986, terminals (VDTs) and assembly workers activity involves oxygen and energy Ex. 500–41–75; Jonsson 1988, Ex. 26– before and after ergonomic interventions consumption and metabolic end- 969) and fish processing (Nordander consisting of changes in the product generation. Repeated damage 1999, Ex 38–408). Several reviews have workstations, tools, and work from overuse without adequate recovery concluded that specific neck disorders, organization alterations. In assembly time for repair therefore has the such as tension neck syndrome, are

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00188 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68449 consistently associated with repetitive contractions is too short, deformation tenocytes within this portion of the work and prolonged static loads and can result in pathologic changes that tendon to repair damage to collagen postures of the neck (Hagberg et al.1995, decrease the tendon’s ultimate strength fibers or their matrix. This impaired Ex. 26–432; Kourinka and Forcier 1995, (Thorson and Szabo 1992, Ex. 26–1171; ability to repair the tendon implies that Ex 26–432; Grieco et al.1998, Ex. 26– Goldstein et al.1987, Ex. 26–953). degenerative changes within this 627). Tendon exhibits additional viscoelastic portion of the tendon will accumulate The epidemiological evidence is properties of relaxation and creep. That over time; therefore, the degree and supported by what is known about the is, when a tendon is subjected to progression of tendon degeneration will biomechanics and pathogenesis of these prolonged elongation and loading, the increase with increasing exposure to neck disorders. It has been consistently magnitude of the tensile force will potential sources of injury, age, or both. shown by EMG that extreme postures gradually decrease (relaxation) and the Potential sources of injury to the and static loads on the neck/shoulder length of the tendon will gradually tendon’s collagen fibers or matrix may increase the internal force on the neck increase (creep) to a level of equilibrium be ischemic, mechanical (impingement), muscles Harms-Ringdahl et al.1986, Ex. (Chaffin and Andersson 1991, Ex. 26– or physiological (contractile load). 26–136; Higado et al.1992, Ex. 26–631). 420; Moore 1992a, Ex. 26–985; Woo et According to the ischemia theory, the Prolonged and frequent stress on these al.1994, Ex. 26–596). During repetitive function and viability of the tenocytes structures leads to muscle fatigue and loading, the tendon exhibits these within the supraspinatus tendon are reduced blood flow. The combination of properties and then recovers if there is compromised because they are in an high oxygen demand and low supply sufficient recovery time. If the time avascular zone; therefore, they are creates ischemia of the surrounding interval between loadings does not unable to sustain the normal structure of tissue and neck pain. Repeated episodes permit restoration, then recovery can be the tendon over one’s lifetime. This lack of stress does not allow adequate incomplete, even if the elastic limit is of maintenance manifests itself as recovery time for repair raising the not exceeded (Goldstein et al.1987, Ex. degenerative changes within the potential for long-term damage to the 26–953). substance of the tendon. The positive neck muscles (Armstrong 1993, Ex. 26– Shoulder tendinitis includes correlation between the prevalence of 1110). OSHA concludes that a supraspinatus and bicipital tendinitis. supraspinatus tendon degeneration and combination physical work-related Bicipital tendinitis results when the tears with age is consistent with this factors, such as repeated movements of tendon of the biceps brachii muscle rubs theory. It is not clear that task variables the upper arm and shoulder, static loads on the lesser tuberosity of the humerus related to work are necessary in this on the neck/shoulder, and extreme bone, which occurs with motion of the pathogenetic model; however, Rothman postures of the neck, are able to cause shoulder (glenohumeral) joint during and Macnab (1970, Ex. 26–499) substantial and serious impairment to overhead arm movements. Persons postulated that shoulder adduction with the neck and shoulder. affected with this disorder experience neutral rotation would subject this pain and tenderness in the shoulder avascular portion of the tendon to Muscoskeletal Disorders of the Shoulder area during shoulder flexion, elbow pressure from the humeral head, thus Much of the evidence that relates extension and forearm supination, or ‘‘wringing out’’ the blood from this physical work factors to shoulder when the elbow and arm are extended already avascular area. If this were true, disorders focuses on shoulder and the forearm is supinated. the duration of shoulder adduction is tendinitis. To understand how force, Supraspinatus tendinitis is also known probably more important than the repetitive motion, and awkward as rotator cuff disorder, subdeltoid number of shoulder adductions. postures lead to tendon injury one must tendinitis, subacromial tendinitis, or Neer (1972, Ex. 26–185) proposed that understand tendon function and repair partial tear of the rotator cuff. Affected the subacromial bursa and mechanisms. As muscles contract, individuals commonly have pain in the supraspinatus tendon were tendons are subjected to mechanical front of the shoulder which is mechanically impinged on the loading and viscoelastic deformation. accentuated when they attempt to raise underside of the anterior aspect of the Tendons must have both tensile the arm away from the body (abduct the acromion process or coracoacromial resistance to loading (to move attached arm), although other movements may ligament as the shoulder approached 80 bones) and elastic properties (to enable also be painful. degrees abduction or flexion when them to move around turns, as in the There are multiple plausible theories internally or externally rotated. Below hand). When collagen bundles are for the pathogenesis of disorders of the 80 degrees flexion or abduction, the placed under tension, they first elongate rotator cuff. For purposes of this review, greater tuberosity of the humerus is without significant increase in stress. it is assumed that supraspinatus tendon generally not in immediate contact with With increased tension, they become tears and calcification represent the acromion process or the stiffer in response to this further endpoints of one pathological process as coracoacromial ligament. Beyond this loading. If the load on these structures opposed to separate and unique degree of elevation, the humeral head is exceeds the elastic limit of the tissue (its endpoints. Mechanisms related to displaced down and away from the ability to recoil to its original disorders of the rotator cuff complex acromion and the ligament, thus configuration), permanent changes with acute onset are excluded from this relieving these structures of this contact occur (Ashton-Miller 1999, Ex. 26–414; discussion (e.g., strains, falls, stress. This contact stress is postulated Moore 1992a, Ex. 26–985; Chaffin and dislocations). to cause disruption of collagen fibers Andersson 1991, Ex. 26–420). During The presence of a watershed or within the tendon mechanically. This subsequent loading of the damaged avascular zone in the supraspinatus mechanism of collagen disruption may tendon, less stiffness is observed. The tendon has been described and (or may not) be combined with the ultimate strength of normal tendon and demonstrated by several investigators phenomenon of impaired healing ligament is about 50% of that of cortical (Moseley and Goldie 1963, Ex. 26–306; related to the avascular zone. The bone (Frankel and Nordin 1980, Ex. 26– Rothman and Parke 1965, Ex. 26–499; critical relationship between this 1125), but structures that have exceeded Rathbun and Macnab 1970, Ex. 26– proposed model of supraspinatus the elastic limit fail at lower limits. In 1376). It is believed that the avascular tendon disease and biomechanical task addition, if recovery time between zone compromises the ability of the variables is the passage of the shoulder

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00189 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68450 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations through the 80 degrees abduction or due to impingement from executing 104). Reduced blood flow and flexion arc. Since this biomechanical butterfly and freestyle strokes. disruption of the transportation of stress occurs in a limited portion of Physical work requires both nutrients and oxygen can produce these arcs, it is anticipated that the mechanical and physiological intramuscular edema (Sjogaard 1988, number of times the shoulder performs responses, for example, muscle force Ex. 26–206). The effect can be this task (per unit time) is more relevant and energy consumption. The compounded in situations where than the duration of time the shoulder mechanical responses include recovery time between static is in this position. Anatomical connective tissue deformation and contractions is insufficient. Eventually, variations in the size and shape of the yielding within the muscle; which a number of changes can result: muscle acromion (particularly type II [curved] increases intramuscular pressure. membrane damage, abnormal calcium and type III [hooked]) as well as Increased intramuscular pressure in homeostasis, an increase in free hypertrophy of tissues related to the turn decreases blood flow through the radicals, a rise in other inflammatory coracoacromial arch are also important muscle (Armstrong et al.1993, Ex. 26– mediators, and degenerative changes factors. (Bigliani et al.1991, Ex. 26–603; 1110). (Sjogaard and Sjogaard 1998, Ex. 26– Fu, Harner, and Klein 1991, Ex. 26– Nerves, vessels, and other soft tissues 1322). may be internally compressed under 464). Epidemiological Evidence conditions of high-force exertions, Posture plays an important role in awkward postures, static postures, and/ In its review of the epidemiologic rotator cuff tendinitis of the shoulder. or high velocity or acceleration of literature on work-related Work with the arm elevated more than movement. For example, strong musculoskeletal disorders of the 60 degrees from the trunk is more abduction or extension of the upper shoulder, NIOSH identified 38 stressful for the supraspinatus than arm, as well as awkward postures of the epidemiologic studies that examined work performed with the arm at the neck, can compress parts of the workplace factors and their relationship trunk. As the arm is raised or abducted brachioplexus under the scalene to shoulder MSDs (Bernard 1997, Ex. the supraspinatus tendon becomes in muscles and other anatomical 26–1). These studies examined the contact with the undersurface of the structures. This compression can result prevalence of shoulder disorders in acromion. They are in closest proximity in nerve and/or blood vessel damage or workers exposed to repeated abduction between 60 and 120 degrees of arm eventual damage to the tissues served by extension or flexion of the shoulder in elevation (Amadio 1995, as cited in Fine these nerves and vessels. combination with strenuous work and Silverstein 1998, Ex.38–444). The Static postures, postures held over a involving heavy loads or elevated arms. precise pathosphysiology of rotator cuff period of time to resist the force of The MSDs were usually shoulder tendinitis is not known. However, the gravity or to stabilize a work piece—are tendinitis or a collection of symptoms role of overhead work, particularly of a particularly stressful to the defined by stiffness, pain, and static nature or very forceful exertions, musculoskeletal system. More precisely, weakness. Table V–2 summarizes some is likely a crucial event (Andersson static postures are usually defined as key aspects of these investigations, such 1995 and Levitz and Iannotti 1995, as requiring isometric muscle force— as the occupations examined, the cited in Fine and Silverstein, 1998, Ex. exertion without accompanying biomechanical risk factors the workers 38–444). Impingement seems important. movement. Even with some movement, were exposed to, whether exposures One suggested histologic pattern is a if the joint does not return to a neutral were directly observed or measured reversible inflammatory infiltrate, with position and continual muscle force is during the study, and whether the increased vascularity and edema within required, the effect can be the same as health outcomes were verified by the rotator cuff tendons, especially the a non-moving posture. Since blood trained medical personnel during supraspinatus tendon. This process, if it vessels generally pass through the physical examination. Sixteen of the becomes chronic, has been postulated as muscles they supply, static contraction studies relied on direct observation or leading to degenerative changes in the of the muscle can reduce blood flow by measurements of exposure and tendons. Eventually, enough as much as 90%. The consequent verification of shoulder injury by degeneration occurs that a minor trauma reduction in oxygen and nutrient supply physical exam. EMG of the forearm causes or seems to cause a partial rotator and waste product clearance results in flexor muscles, frequency of shoulder cuff tear (Fine and Silverstein 1998, Ex. more rapid onset of fatigue and may movements, or angle of shoulder flexion 38–444). predispose muscles and other tissues to were quantitatively measured in some of Another shoulder disorder related to injury. The increased intramuscular these studies. Another 24 studies relied physical work factors is osteoarthritis of pressure exerted on neural tissue may either on job title information or the acromioclavicular joint. result in chronic decrement in nerve questionnaire to obtain exposure Osteoarthritis refers to degenerative function. The viscoelastic ligament and information and/or used self-reported changes in the cervical spine that are tendon tissues can exhibit ‘‘creep’’ over symptoms to define cases of shoulder apparent on radiological examination. A time, possibly reaching failure MSDs. OSHA considers these combination of high exposure to load thresholds beyond which they are investigations to be less reliable. All lifting and high exposure to sports unable to regain resting length. twelve studies with exposure and activities that engage the arm was a risk Chronic reduction of blood flow may medical verification reported factor for shoulder tendinitis, as well as be a mechanism by which static muscle statistically significant associations osteoarthritis of the acromioclavicular contractions lead to MSDs. Several between shoulder disorders and the joint (Stenlund et al.1993, Ex. 26–1459). studies have found that the small, slow physical work factors. The odds ratios Kennedy, Hawkins, and Kristof (1978, motor units in patients with chronic reported in these studies ranged Ex. 26–1135) found that 15% of muscle pain show changes consistent between 1.6 and 46. The wide range in competitive swimmers with repetitive with reduced local oxygen risks probably relates to differences in overhead arm movements had concentrations (Larsson et al.1988, Ex. magnitude of exposure and case significant shoulder disability, primarily 26–1140; Dennett and Fry 1988, Ex. 26– definition among the studies.

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TABLE V±2.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE SHOULDER

Study Job type studied Physical Exposure basis Physical Risk measure factors exam (95% CI) 1

Hughes (1997) Ex. 26±907 ...... Aluminum smelter .... F/R?/P Checklist ...... Yes ...... OR=46 * (3±550) Herberts (1981) Ex. 26±51; (1984) Ex. 26±960 ...... Shipyard welding ..... F/R?/P Observation EMG .... Yes ...... PRR=15±18 * (14±22) Bjelle (1979) Ex. 26±1112 ...... Industry case control F?/R/P Observation ...... Yes ...... OR=10.6 * (2.3±54.9) Frost (1999) Ex. 500±205±4 ...... Slaughter-house ...... F/R/P Observation ...... Yes ...... OR=5.3±7.9 * (2.9±21.2) Onishi (1976) Ex. 26±1222 ...... Multiple jobs ...... F/R/P Observation cycle Yes ...... OR=1.1±6.0 * time. (3.0±12.2) Ohlsson (1995) Ex. 26±868 ...... Assembly line ...... F?/R/P Flexion cycle time .... Yes ...... OR=4.2 * (1.4±13.2) Baron (1991) Ex. 26±967 ...... Grocery checking ..... F/R/P Job titles ...... Yes ...... OR=3.9 * (1.4±11.0) Ohlsson (1994) Ex. 26±1189 ...... Fish processing ...... F/R/P Observation freq./an- Yes ...... OR=3.5 * gles. (1.6±7.2) Nordander (1999) Ex. 38±408 ...... Fish processing ...... F?/R/P Observation ...... Yes ...... OR=3.5 * (2.5±5.3) Punnet (2000) Ex. 500±41±109 ...... Auto workers case/ F/R/P Cycle/flexionlift load Yes ...... OR=1.1±4.0 * control. (1.7±9.4) Chiang (1993) Ex. 26±1117 ...... Fish processing ...... F/R/P? Cycle time EMG ...... Yes ...... OR=1.6±1.8 * (1.2±2.5) Kilbom (1987) Ex. 26±1277; Jonsson (1988) Ex. 26± Electronics manufac- F/R/P MVC, flexion cycle Yes ...... NR * 833. ture. time. Bjelle (1981) Ex. 26±1519 ...... Industrial plant ...... F/R/P Flexion EMG ...... Yes ...... NR * Sakakibara (1995) Ex. 26±800 ...... Fruit bagging ...... F?/R?/P Observation arm ele- Yes ...... NR * vation. Zetterberg (1997) Ex. 26±899 ...... Auto assembly ...... F/P Cycle time tool Yes ...... NR weight. English (1995) Ex. 26±848 ...... Patients case/ con- F/R/P Question- naire ...... Yes ...... OR=2.3 * trol. (NR) Andersen (1993) Ex. 26±1451 ...... Sewing machine ...... F/R/P? Job titles ...... No ...... OR=3.2 * (1.7±7.4) Andersen (1993) Ex. 26±1502 ...... Sewing machine ...... F/R/P? Job titles ...... Yes ...... NR * Stenlund (1992) Ex. 26±733; (1993) Ex. 26±1459 ...... Rockblasting brick- V/F/R? Questionaire ...... Yes ...... OR=0.4±4.0 * laying. (1.8±9.2) Wells (1983) Ex. 26±729 ...... Letter carrier ...... F/R?/P Job title ...... No ...... OR=5.7 * (2.1±17.8) Hoekstra (1994) Ex. 26±725 ...... Video terminal ...... R/P Observation ...... No ...... OR=5.1* (1.7±15.5) Schibye (1995) Ex. 26±1463 ...... Sewing machine ...... F?/R/P? Questionaire ...... No ...... NR Burdorf (1991) Ex. 26±454 ...... Riveting ...... V Tool aceleration ...... No ...... OR=1.5 * (NR) Bergenudd (1988) Ex. 26±1342 ...... Multiple industries .... F/R?/P? Questionnaire ...... No ...... NR Burt (1990) Ex. 26±698 ...... Computer entry ...... R/P Job title ...... No ...... OR=2.6±4.1 * (1.8±9.4) Floodmark (1992) Ex. 26±1209 ...... Vent shaft production F?/R?/P? Job title ...... No ...... OR=2.2 * (1.4±4.4) Hales (1989) Ex. DC±139±D ...... Poultry processing ... F/R Job title ...... Yes ...... OR=0.9±3.8 * (0.6±22.8) Hales (1994) Ex. 26±131 ...... Telecommunication .. R/P Questionnaire ...... Yes ...... NR Ignatius (1993) Ex. 26±1389 ...... Postal work ...... F/R/P Job title ...... No ...... OR=1.8±2.2 * (1.5±3.1) Kiken (1990) Ex. 26±430 ...... Poultry processing ... F/R/P? Job title ...... Yes ...... OR=1.6±4.0 (0.6±29) Kvarnstrom (1983) Ex. 26±1201 ...... Factory/office ...... F/R/P? Questionnaire ...... Yes ...... RR=2.2±5.4 (NR) McCormick (1990) Ex. 26±1334 ...... Textile ...... F/R/P? Job title ...... Yes ...... OR=1.1±1.3 (0.5±3.8) Ohara (1976) Ex. 26±1 ...... Cash register ...... F?/R?/P? Job title ...... Yes ...... OR=1.7±2.2 * (1.4±3.5) Ohlsson (1989) Ex. 26±1290 ...... Auto assembly ...... F/R/P? Job title ...... No ...... OR=2.0±3.4 * (1.6±7.1) Punnett (1985) Ex. 26±995 ...... Garment ...... R/P? Job title ...... Yes ...... OR=2.2 * (1.0±4.9) Rossignol (1987) Ex. 26±804 ...... Computer operation R/P Questionnaire ...... No ...... OR=2.5±4.8 * (1.6±17.2) Sweeney (1994) Cited Ex. 26±1 ...... Sign language inter- R/P? Questionnaire ...... Yes ...... OR=2.5 preter. (0.8±8.2) De Zwart (1997) Ex. 26±617 ...... Various occupations F/R?/P? Questionnaire ...... No ...... OR=1.25±2.5 * (p<0.001)

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TABLE V±2.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE SHOULDERÐ Continued

Study Job type studied Physical Exposure basis Physical Risk measure factors exam (95% CI) 1

LeMasters (1998) Ex. 500±121±44; Bhattacharya Carpenters ...... F/R/P Observation, meas- Only OR=2.3±3.2 * (1997) Ex. 500±121±7; Booth-Jones (1998) Ex. urement. small (1.1±8.9) 500±121±9. subset. Pope (1997) Ex. 32±137±1±4 ...... Various occupations F/R?/P Questionnaire ...... No ...... OR=2.1±5.5 * (1.8±17.4) Botha (1998) Ex. 500±121±10 ...... Nurses ...... F/R?/P Questionnaire, ob- No ...... NR servation. De Joode (1997) Ex. 500±121±72 ...... Ship maintenance .... F/R?/P Strain gauge ...... No ...... RI=1.7±3.9 (NR) F=forceful exertions; R=repetitive motion; P=awkward posture; IR=incidence rate; OR=odds ratio; PRR=prevalence rate ratio; RI=risk index; NR=not reported; ?=presence of risk factor unclear. * p<0.05. 1 95% confidence interval expressed for the upper end of the risk measure range.

The NIOSH noted several well- (p<0.05) for cases with neck/shoulder nonspecific shoulder pain. NIOSH conducted studies that provided disorders than for controls. found insufficient evidence for a evidence of an exposure—response and In a prospective study design, Kilbom positive association between either force temporal relationships. Chiang et et al.(1986, Ex. 500–41–75; 1987, Ex. or vibration and shoulder MSDs because al.(1993, Ex. 26–1117) divided 207 fish 26–1277) assessed the health and the studies that principally examined processing workers into three exposure exposure status of 06 electronics this risk factor relied on self-reported groups based on EMG measurements of manufacturing plant employees over a questionnaires for assessment of forearm flexor muscles and cycle time two year period. The employees were exposure and health outcome. evaluated for maximum voluntary measurements of shoulder movements Twelve studies that address physical isometric contraction (MVC) of the of representative job tasks. Exposure work factors and shoulder MSDs were groups were: (1) Low force, low forearm flexors and shoulder strength. Videotape was used to analyze cycle submitted into the OSHA docket repetition (comparison group); (2) high following publication of the proposal force or high repetition; and (3) high time and working postures and movements. Shoulder MSDs were (Zetterberg et al.Ex. 26–899; De Zwart et force and high repetition. Shoulder al.1997, Ex. 500–121–18; Punnett et girdle pain was the health outcome as determined annually based on interview and physical examination assessing al.2000, Ex. 500–41–109; LeMasters et defined by symptoms and palpable al.Ex. 500–121–9; Bhattacharya et hardenings upon physical examination. tenderness on palpation as well as pain and restriction upon shoulder al.1997, Ex. 500–121–7; Booth-Jones et The results showed a significant al.1998; Ex. 500–121–44; Pope et increasing trend in the prevalence of movement. Symptom severity was also scored. Logistic regression analysis al.1997, Ex. 500–71–42; Frost and shoulder pain from group 1 (10 percent) Anderson 1999, Ex. 500–41–57; Burdorf to group 3 (50 percent). showed significant relationship (p<0.05) between MSDs and percentage of work et al.1997, Ex. 500–71–24; Van Wendel In another cross-sectional study, cycle time with upper arm elevated. The de Joode 1997, Ex. 500–121–72; Botha Ohlsson et al.(1995, Ex. 26–868) number of elevations per hour was a and Bridger 1998, Ex. 500–121–10). compared a group of 82 women who strong predictor for increases in Many of these studies showed that high performed industrial assembly work symptom severity over the study period. physical loads in combination with requiring repetitive arm movements A follow-up investigation also found elevated shoulder positions were with static muscular work of the neck/ that the percent of the work cycle spent associated with increased prevalence of shoulder with a referent group of with the shoulder elevated was shoulder disorders (Ex. 500–121–9; Ex. unexposed women. The frequency, negatively associated with remaining 500–121–7; Ex. 500–121–44; Ex. 500– duration, and critical angles of symptom-free (Jonsson et al.1988, Ex. 41–57; Ex. 500–41–109; Ex. 500–121– movement were measured from 26–833). 18; Ex. 500–121–10; Ex. 500–121–72; videotape and observation. Shoulder NIOSH concluded that there was Ex. 26–899). For example, Frost and MSDs such as tendinitis, evidence for a positive association Anderson (Ex. 500–41–57) found a acromicroclavicular syndrome, and between highly repetitive work and strong significant association (OR>5) frozen shoulder were determined from shoulder MSDs. Only three studies among meat packers who worked symptoms and physical exam. The risk specifically address the health outcome extensively with arm elevation greater of shoulder tendinitis in the exposed of shoulder tendinitis and these studies than 30 degrees more than 10 times per women was significantly greater than involve combined exposure to repetition minute and prevalence of rotor cuff the unexposed women (OR=4.2; 95% CI with awkward shoulder postures or tendinitis compared to those with no 1.4–13.2). The neck and shoulder static shoulder loads. The other six shoulder elevation. The risk increased disorders were also significantly studies with significant positive with cumulative exposure years. (p<0.05) associated with the number associations dealt primarily with Punnett et al.(Ex. 500–41–109) reported and duration of shoulder elevations symptoms. There was evidence for a a significant association between greater than 60 degrees. The study of relationship between repeated or repeated shoulder abduction/flexion Bjelle et al.(1981, Ex. 26–1519) also sustained shoulder posture with greater and shoulder disorders. There was found that the frequency of shoulder than 60 degrees of flexion and evidence of exposure—response with abduction and forward flexion past 60 abduction and shoulders MSDs. This frequency of shoulder movements to 90 degrees was significantly greater holds for both shoulder tendinitis and degrees flexion or abduction. Shoulder

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MSDs were confirmed by physical was observed in all muscle groups of the blood vessels within the tendon examination in both studies. during shoulder-level and overhead are longitudinal extensions of the blood work (p<.05) during the 1-minute trials. vessels in the muscle belly, reduced Biomechanical Evidence Even at waist level, fatigue was perfusion of the intramuscular blood Rohmert (1973, Ex. 26–580) found observed when the upper arm was vessels implies reduced perfusion of the that muscle contractions can be abducted at an angle of 30 degrees. intratendinous blood vessels. If this maintained for prolonged periods if kept Hagberg (1981, Ex. 26–955) measured reduced perfusion is sustained for below 20% of MVC. But other EMG activity and discomfort in the sufficient durations of time, the investigators (Westgaard and Aaras shoulder in a laboratory study of six tenocytes or other tendon components 1984, Ex. 26–1026) found chronic female subjects. Surface electrodes are susceptible to ischemic injury. In deleterious effects of contractions even recorded EMG activity in the terms of biomechanical task variables, if they are lower than 5% of MVC. This descending trapezius, anterior deltoid, experimental data suggest that overhead latter finding is supported by the and biceps brachii while subjects work may cause intramuscular observation that low-level static loading performed repeated flexion of the pressures capable of reducing (such as shoulder loading in keyboard shoulder every 4 seconds to an angle of intramuscular perfusion. Lifting tasks) is associated with shoulder MSDs 90 degrees for a period of 60 minutes. combined with arm elevation (shoulder (Aaras et al.1998, Ex. 26–597). The Heart rate and perceived exertion using load) also contributes to the magnitude supraspinatus muscle, a muscle severely Borg’s scale was also recorded. Hand of supraspinatus muscle activation. constrained by bone and ligamentous load was the independent variable: From a temporal perspective, this tissue, demonstrates increased weights of 0.6 kg, 1.6 kg, and 3.1 kg proposed model is more related to the intramuscular pressure during small were held in the hand (in addition to a duration of the intramuscular pressure amounts of shoulder abduction or no-load treatment). Heart rate and than to its frequency. flexion (Jarvholm et al.1990, Ex. 26– perceived increased over the course of After reviewing the scientific 285). Tichauer (1966, Ex. 26–1172) the trial. Heart rate and perceived were literature, Winkel and Westgaard looked at the impact of arm posture on greater when a load was held in the (1992a, Ex. 26–1163) recommended less trapezius stress. He noted that arm hands. EMG activity in the trapezius than 4 hours of work requiring overhead abduction to 40 degrees increased stress was closely correlated with the external or extended reach postures. For in the upper trapezius muscle eight moment at the shoulder joint. continuous work, they recommended times as much as when the arm was Oberg, Sandsjo, and Kadefors (1994, exposure times of one hour or less, abducted to 20 degrees, and 64 times as Ex. 26–867) measured EMG activity and particularly if the work involved highly much as at a 10 degrees. These study subjective discomfort in the shoulder- repetitive tasks, low worker control, or results suggests the possibility of neck region in a laboratory study of 20 a lack of alternating tasks. When large chronic blood vessel and nerve subjects (10 male, 10 female). Surface forces are also exerted, they compression during static tasks. Other electrodes measured EMG activity in the recommended that the exposure time laboratory evidence for muscle and right trapezius muscle while subjects should be even less. tendon damage in these areas, as well as abducted the arm to a 90 degree angle. Wiker, Chaffin and Langolf (1999; Ex. secondary compression of blood vessels Subjects reported fatigue using the Borg 26–1028) used psychophysical methods and nerves, lends support to the 10-point scale. Each subject was tested to investigate the relationship between connection between work-related static under two conditions: a 5-minute test strength capacity of the shoulder postural requirements and the with no load in the hand and a 2.5 complex and fatigue/discomfort development of these disorders. minute test with a 2-kg load in the hand. induced by sustained awkward arm Biomechanical studies of shoulder At the no-load level, there was no postures in simulated light assembly posture show that muscle activity and change in EMG MPF over the course of work. Awkward shoulder postures subjective fatigue in the shoulder region the trial; however, subjective fatigue (arms above shoulder level) produced increases as a function of shoulder increased. With the 2-kg. load, there was severe discomfort at less than 10% MVC elevation angle and load moment at the a small linear decrease in MPF over the within one hour and were unrelated to shoulder joint. There is also evidence of trial and there was a negative subject strength. These authors localized muscle fatigue based on a shift correlation between MPF and the Borg  recommended elimination of overhead in the MPF of the EMG spectrum. rating = 0.46). The authors concluded Prolonged periods of neck flexion cause that MPF was not a good proxy for work even in light-weight manual increased levels of discomfort and perceived fatigue during low-intensity assembly environments, irrespective of increased EMG activity in the neck static exertions of the shoulder. individual worker strength or extensor muscles. Using EMG, several investigators have anthropometry. Herberts, Kadefors, and Broman demonstrated that the supraspinatus Conclusion (1980, Ex. 26–1129) measured EMG muscle is activated throughout most of activity as a function of static shoulder the range of motion of the shoulder. The 1997 NIOSH report made the posture in a laboratory study using 10 Herberts and Kadefors (1976, Ex. 26– following statement with regard to the male subjects. The primary independent 470) and Herberts et al.(1984), Ex. 26– epidemiological evidence that links variable was posture. Subjects held a 2- 960 postulated that the level of tension physical work factors and shoulder kg load in the hand at waist, shoulder, in the supraspinatus muscle during arm tendinitis: and overhead heights using different elevation (with or without holding an The evidence for specific shoulder combinations of flexion and abduction object in the hands) was sufficiently postures is strongest where there is combined at the shoulder. EMG activity was high to increase intramuscular pressure exposure to several physical factors like measured using wire electrodes in the to a point sufficient to compromise holding a tool while overhead. The strength of the association was positive and consistent anterior and posterior portions of the intramuscular circulation. As reported in six studies that used diagnosed cases of deltoid, the supraspinatus, the by Edwards, Hill, and McDonell (1999; shoulder tendinitis or a combination of infraspinatus, and the upper portion of Ex. 26–1232), intramuscular pressures symptoms and physical findings consistent the trapezius. Localized fatigue (a shift of 20 mm Hg may be sufficient to with tendinitis as the health outcome (Ex. in EMG mean power frequency [MPF]) prevent muscular perfusion. Since many 26–1).

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OSHA agrees with NIOSH with regard back and shoulders. Ms. Flannigan said syndrome and hand-arm vibration to the epidemiological evidence for an that other nurses had been injured doing syndrome. Repeated impact or contact association between shoulder tendinitis similar tasks, but because stress, as well as vibration, have been and a combination of physical risk when people think of newborn ICU, they implicated in the development of factors related to sustained or repeated think of, okay, you’ve got a one-pound baby, hypothenar hammer syndrome. Contact shoulder flexion and abduction, so where are your stressors coming from? stress can, itself, be viewed as a specific particularly when it includes an And they don’t realize that we are combination of repetitive motion and additional static hand load such as responding to alarms in high places, that force applied directly to a localized area working overhead. Fifteen out of sixteen we’re doing awkward postures and reaches, of tissue, in this case the palm. well-conducted epidemiological and we’re pushing heavy equipment, and There are several types of evidence then sometimes we actually lift heavy investigations that directly observed or that continue to support force, equipment which, in my case, gave me a back repetition, awkward posture, and measured these factors in the workplace injury. have found a significantly elevated risk It took Ms. Flannigan eight months of vibration as causative factors for MSDs of shoulder MSDs in exposed workers treatment to recover and she is fearful of re- of the upper extremities. Information on verified by physical exam. This link injury: pathophysiology provides evidence that between physical work factors and I’m fearful of what’s going to happen to me links exposure to risk factors to the injury has been established across as I age. And I’m also fearful of losing my physiological, anatomical, and numerous job areas including assembly ability to work as a nurse. I love my pathological alterations in soft tissues of profession. I wouldn’t trade it. * * * Since line work (Punnett et al.1998, Ex. 38– the upper extremities. This speaks to the I’ve been injured at work, my family really biologic plausibility that work-related 155; Ohlsson et. al. 1995, Ex. 26–868), suffered. I couldn’t bathe my children. I electronics manufacture (Kilbom 1986, couldn’t dress them, couldn’t do the laundry. risk factors contribute to these injuries. Ex. 500–41–75; Jonsson 1988, Ex. 26– My five-year-old buckled my three-year-old There is voluminous epidemiological 969) and fish processing (Nordander et in the car seat if I had to drive. He pushed data that provide evidence of al.1999, Ex 38–408; Chiang et al.1993). the cart at the grocery store—my five-year-old associations between worker exposure pushed the shopping cart. to the identified risk factors and the The epidemiological evidence is Ms. Flannigan stated further : occurrence of upper extremity MSDs. supported by biomechanical studies and I know I’m not the first one hurt at my job, Some of these studies recently have the pathogenesis of these shoulder but what I can’t live with is I won’t be the been reviewed by NIOSH (Bernard and disorders. It has been consistently last unless we start protecting American Fine 1997, Ex. 26–1) and were discussed workers immediately with this ergonomic shown by EMG that fatigue in the by OSHA in the Health Effects shoulder muscles occurs with abduction proposal so we can remove the ergonomic hazards or reduce them in the workplace. Appendicies to the proposed rule (Ex. and flexion of the shoulder. Addition of 27–1). For the final rule, OSHA has a static load or requiring the arm/ American workers deserve a place of employment free from recognized hazards evaluated many additional shoulder motion be performed because when a worker develops an MSD, it’s epidemiologic studies that were entered repeatedly merely increases both muscle not just a lost workday. It can be a life lost into the record by many rulemaking fatigue and perceived discomfort. Over forever to pain and disability. participants. time, these repeated actions stress the D. Disorders of the Upper Extremities Finally, there is biomechanical and tendons in the shoulder causing gradual psychophysical laboratory research that loss of elasticity and strength. Once the This section summarizes the evidence complement and corroborate the damage exceeds the reparative capacity that exposure to physical risk factors at epidemiological evidence. These of the tissue, ischemia sets in and the work contribute to the pathogenesis of approaches are able to directly link tendon becomes inflamed, resulting in a specific musculoskeletal disorders exposure to ergonomic risk factors to chronic tendinitis. The rotator cuff is (MSDs) of the upper extremities. In this biomechanical and subjective particularly vulnerable to this pathology section, the upper extremities of interest measurements of tissue response under since muscles and tendons are already are the elbow, forearm, wrist, and hand. a more controlled set of simulated work somewhat constrained by ligaments and The bulk of the evidence demonstrating conditions. This evidence derives from bone. Severe postures can result in a work-related risk center around five studies reviewed in the Health Effects impingement of nerves and blood MSD classifications; these are Appendices of the Proposed Rule (Ex. vessels further aggravating the injury. epicondylitis, tendinitis of the hand and 27–1) and testimony of the many expert OSHA concludes that sustained or wrist, carpal tunnel syndrome, hand- scientists that appeared at OSHA’s repeated exertions with the arms and arm vibration syndrome, and rulemaking hearing. The evidence for shoulders in awkward postures, such as hypothenar hammer syndrome. There is each specific MSD covered in this raised overhead, can increase the risk of an impressive body of data that address section is discussed in the parts that substantial and serious impairment to the role of three biomechanical risk follow. the shoulder. During OSHA’s hearing on factors in epicondylitis, tendinitis, and it’s proposal, a nurse who injured her carpal tunnel syndrome. These risk Epicondylitis back at work provided compelling factors are force exerted on the muscle, Epicondylitis is a form of tendinitis testimony. Maggie Flannigan, a tendons, and nerves; repetitive motion that affects the forearm extensor muscle- registered nurse with 19 years involving the hands, wrists, and tendon units that extend from the hand experience in various newborn ICUs forearms; and awkward postures of the and wrist to the epicondyle (elbow). The (intensive care units) across the country wrist and arm. Exposure to these factors most common type is lateral told her story for inclusion in OSHA’s often occurs concurrently in epicondylitis (known as ‘‘tennis elbow’’) rulemaking record. Ms. Flannigan occupational settings and the evidence where the fibrous tissue at the bone- reported having back, neck and shows that the risk of injury is greatest tendon junction (usually the extensor shoulder pain for years while working when more than one factor is present. carpi radialis brevis muscle/tendon) on and also after work. Then, while moving There are also studies that relate another the outer elbow is inflamed. This is a 75-pound monitor down from, then biomechanical work factor, vibration believed to be caused by repeated back onto a five-foot high shelf, she from the use of hand-held power tools, microrupture of the tendon from sustained a severe injury to her upper to an increased risk of carpal tunnel overuse of the muscles that control the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00194 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68455 wrists and fingers. Clinical case reports elasticity (probably due to microadhesions of exposures were directly observed or have noted that patients with lateral muscle and tendon sheets), inactivity, loss of measured during the study, and whether epicondylitis were often in occupations strength, and, habitual guarding postures, the health outcomes were verified by which in turn set the stage for overuse, and that involved repetitive, forceful work, so on, in increments. That is why we call trained medical personnel during particularly repeated pronation and these MSDs ‘‘cumulative trauma disorders’’. physical examination. Most of the supination movements with the elbow My work on the pathogenesis of the tennis studies compared the prevalence of fully extended. For example, in one case elbow measured the impact of these epicondylitis in workers with jobs series it was reported that 48 percent of physiological changes, i.e., increased internal known to have highly repetitive, patients with lateral epicondylitis of workload or muscle resistance due to forceful tasks (e.g. meat and fish reduced tissue elasticity leading to unknown origin had occupations that processing) to those engaged in less involved gripping tools with consequent electromyographically detectable recruitment of ever more muscle fibers for the same repetitive, forceful work (e.g. office repetitive supination/pronation of the amount of external workload (which was workers). In some cases, the work also forearm (Sinclair 1965, Ex. 26–736). In held constant in these electromyographic involved awkward hand and wrist a second smaller group of epicondylitis studies of isometric muscle action). This postures. In almost all the studies, patients reported on in the same increased recruitment of more muscle fibers workers were concurrently exposed to a publication, 88 percent worked in jobs makes the patient more vulnerable to combination of 2 or 3 factors. One study with constant gripping or repetitive overexertion at even lower levels of external specifically examined vibration from the movements. physical demands * * * until the patient is unable to even lift a cup. [Ex. 37–15] use of chain saws. Eleven of the studies National surveillance data In a chapter of the Textbook of Clinical based case definition on physical consistently show that the incidence of examination and worker exposure on this injury is greatest in occupations Occupational and Environmental Medicine (1994, Ex. 38–440), Dr. Martin observational analysis. Diagnosis of requiring manually intensive demands Cherniak described the symptoms and epicondylitis was consistent across on the upper extremities in a dynamic disabling nature of epicondylitis: studies and required the presence of work environment, such as mechanics, pain on palpation of the epicondylar butchers, and construction workers. The characteristic symptoms are pain with lifting , gripping, and wrist extension.* * * area and pain at the elbow upon resisted This body of evidence provides ample movement of the wrist. The existence of biological plausibility to the notion that Because grip and extension are so central to many jobs, lateral epicondylitis is a condition work-related risk factors was generally force, repetition, and awkward posture that can be irreconcilably chronic and made based on job/task observation. can contribute to this MSD. The produce major and undesirable changes in Some studies videotaped job tasks and interplay between pathophysiology and life and work, despite its seeming mundane estimated cycle times, static loading on physical work factors is concisely nature. [Ex. 38–440, pp. 384–385] the forearm, and wrist posture in order summarized by Dr. Niklas Krause in his Epidemiological Evidence to qualitatively group workers by written testimony on the proposed ergonomic standard (Ex. 37–15). NIOSH reviewed 18 cross-sectional exposure intensity. Other studies more studies and one cohort study that subjectively evaluated risk factor There always seems to be a mechanical addressed workplace risk factors and exposure by job observation alone. overuse component in MSDs. Tissues react to Seven cross-sectional studies reviewed mechanical stress or overuse or elbow MSDs. Table V–3 summarizes microtraumitization (whatever term is being some key aspects of these investigations, by NIOSH relied strictly on self-reports used) with inflammation leading to edema, such as the occupations examined, the of symptoms or exposure; OSHA swelling, pain, and local repair mechanisms biomechanical risk factors to which considers these investigations to be less that lead to stiffness and reduced muscle workers were exposed, whether reliable.

TABLE V±3.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING EPICONDYLITIS

Study Job type studied Physical Exposure basis Physical Risk Measure factors exam (95% CI) 1

Hughes (1997) Ex. 26±907 ...... Aluminum smelter F/R?/P Checklist ...... Yes ...... OR=37* (3±470) Roquelaure (1996) Ex. 500±41±111 ...... Manufacturing ...... F/R/P Checklist ...... Yes ...... OR=7.7±18.0* (2.2±147) Kurppa (1991) Ex. 26±53 ...... Meat processing ... F/R/P? Observation ...... Yes ...... IR=6.7* (3.3±13.9) Chiang (1993) Ex. 26±1117 ...... Fish processing .... F/R/P? Cycle time EMG ... Yes ...... OR=1.2±6.7* (1.6±32.7) Moore (1994) Ex. 26±1364 ...... Meat processing ... F/R/P Measurement ...... Yes ...... OR=5.5* (1.5±62) Bovenzi (1991) Ex. 26±1433 ...... Forestry ...... V Measurement ...... Yes ...... OR=4.9* (1.3±56) SHARP (1993) Ex. 500±41±116 ...... Poultry processing F/R/P? Measurement ...... Yes ...... NR* (p<0.002) Dimberg (1987) Ex. 26±945 ...... Automotive ...... F/R/P Observation ...... Yes ...... NR* Dimberg (1989) Ex. 26±1211 ...... Automotive ...... F/R/P Observation ...... Yes ...... NR Ritz (1995) Ex. 26±1473 ...... Utilities ...... F/R?/P? Observation ...... Yes ...... OR=1.2±1.7* (1.0±2.7) Luopajarvi (1979) Ex. 26±56 ...... Food production ... F/R/P Measurement ...... Yes ...... OR=2.7 (0.7±15.9) Baron (1991) Ex. 26±697 ...... Grocery checking F/R/P Measurement ...... Yes ...... OR=2.3 (0.5±11) Viikari-Juntura (1991) Ex. 26±1197 ...... Meat processing ... F/R/P? Observation ...... Yes ...... OR=0.88 (0.3±2.8)

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TABLE V±3.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING EPICONDYLITISÐContinued

Study Job type studied Physical Exposure basis Physical Risk Measure factors exam (95% CI) 1

Roto (1984) Ex. 26±666 ...... Meat cutting ...... F/R/P? Job title ...... Yes ...... OR=6.4* (1.0±41) Hoekstra (1994) Ex. 26±725 ...... Video terminal ...... R/P Observation ...... No ...... OR=4.0* (1.2±13) Burt (1990) Ex. 26±698 ...... Computer entry ..... R/P Job title ...... No ...... OR=2.8*) Ex. 26±1.4±5.7) Punnett (1985) Ex. 26±995 ...... Garment ...... R/P? Job title ...... No ...... OR=2.4* (1.2±4.2) Ohlsson (1989) Ex. 26±1290 ...... Assembly line ...... F?/R/P? Job title ...... No ...... OR=1.5±2.8 (0.8±10.7) Andersen (1993) Ex. 26±1451 ...... Sewing machine ... F/R/P? Observation ...... No ...... OR=1.7 (0.9±3.3) McCormack (1990) Ex. 26±1334 ...... Textile ...... F/R/P? Job title ...... Yes ...... OR=0.5±1.2 (0.5±3.4) Bystrom (1995) Ex. 26±897 ...... Auto assembly ...... F/R/P Job title ...... Yes ...... OR=0.7 (0.04±1.7) F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear. IR=incidence rate; OR=odds ratio; NR=not reported. *=p<0.05. 1 95% confidence interval expressed for the upper end of the risk measure range.

Seven of the 11 studies that relied on biomechanical risk factors and the Reanalysis by NIOSH placed the IR at objective exposure assessments and increased incidence of epicondylitis. 5.5 among workers with strenuous jobs medical confirmation of epicondylitis One study evaluated vibration as a versus those with non-strenuous jobs found statistically significant risk factor for epicondylitis and reported after correcting for recurrent cases. associations between exposure to work- a significantly greater prevalence of A few studies reported ORs between related risk factors and risk of epicondylitis (OR = 4.9; 95% CI 1.3–56) 1–3 that were not statistically significant epicondylitis. The most reliable odds in forestry operators using chain saws (Baron et al.1991, Ex. 26–697; ratios (ORs) ranged between 1.0 to 5.5. compared to a comparison group of Luopajarvi et al.1979, Ex. 26–56). The maintenance workers (Bovenzi et Some studies deserve special mention. low risk ratios reported in these studies al.1991, Ex. 26–1433). may reflect the likelihood that the One study was able to divide fish Evidence of exposure-response trends occupations studied (grocery checkers processing workers into a low-force/ in the epicondylitis literature is limited and assembly line food packers) were low-repetition group, a high-force or because of the preponderance of studies associated with relatively low forces high-repetition group, and a high-force that relied on dichotomous comparisons and high-repetition group based on of exposed versus unexposed workers; directed to the forearm extensors observed cycle times and hand forces however, one study found an increase combined with insufficient from electromyography (EMG) (not statistically significant) in repetitiveness, as compared to other jobs recordings of the forearm flexor muscles prevalence with the number of hours that involve higher forces and more (Chiang et al.1993, Ex. 26–1117). An per week working as a grocery checker repetition, such as meat cutters/packers increasing trend was found in (Baron et al.1991, Ex. 26–697). Another where higher prevalence rates of epicondylitis have been found (Moore prevalence of epicondylitis with reported a positive (not statistically and Garg 1994, Ex. 26–1364). In increased exposure intensity (not significant) exposure-response addition, cross-sectional studies are statistically significant). There was a relationship between duration of exposure to gas and waterworks jobs often subject to the ‘‘healthy worker’’ significant difference between males in effect because of the exclusion of the highest exposed group and males in regarded as stressful to the elbow (Ritz 1995, Ex. 26–1473). injured workers who may have left the the lowest exposed group (OR=6.75; workforce at the time a study was 95% CI 1.6–32.7), but this trend was not Some unusually high ORs that were reported by a few studies and contained conducted. This can sometimes lead to observed among female workers in the NIOSH (1997, Ex. 26–1) review an underestimation of prevalence. (OR=1.4; 95% CI 0.3–5.6). A prospective may have been overstated due to bias. Most studies adequately controlled for cohort study grouped meat processing For example, one study of aluminum the important confounder of age but the workers into those engaged in strenuous workers reported an OR of 37 between contribution of non-occupational injury (primarily cutters and packers) and non- elbow/forearm disorders and the to the elbow was often not addressed strenuous work (primarily office work) number of years of forearm twisting; among groups of workers. The large based on repetitive and forceful tasks however, the overall participation rate number of studies reporting a positive (Kurppa et al. 1991, Ex. 26–53). They in the study was only 55 percent, association with exposure make it reported a significantly increased leaving open the possibility of selection unlikely that non-occupational injuries incidence ratio (6.7; 95% CI 3.3–13.9) of bias (Hughs and Silverstein 1997, Ex. were an important confounder. Dr. epicondylitis among workers in 26–53). The cohort study by Kurppa et Cherniak emphasized the importance of strenuous jobs over the 31-month al.(1991, Ex. 26–53) reported an work rather than non-work activities in follow-up period. Because of the epicondylitis incidence rate (IR) of 6.7 the etiology of epicondylitis: ‘‘Its prospective study design, this study for workers performing strenuous tasks popular epithet of tennis elbow provided direct evidence of a temporal but counted recurrences in the same notwithstanding, it is a common relationship between exposure to elbow as if they were new cases. condition among industrial workers and

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Essentially, all epicondylitis based on the existence of age-, gender-, and plant-matched they are describing is localized soreness and/ several studies with quantitative workers selected at random from the or tenderness. The criterion of swelling or measures of load on the hand/forearm same manufacturing population who crepitation and tenderness to palpation along that showed strong ORs (>5) for this risk had no upper limb disorder for the the tendon and pain at the tendon sheath, in factor (Moore and Garg 1994, Ex. 26– previous eight years. Exposure was the peritendinous area, or the muscle/tendon 1364; Chiang et al.1993, Ex. 26–1117). determined by direct observation of two junction during active movement of the NIOSH concluded there was insufficient tendon boils down to focal soreness/ trained assessors using a checklist. RTS tenderness and nothing more specific or evidence of an association between was determined by reviewing the past mysterious than that (Ex. 500–118). epicondylitis and repetition or awkward two years of medical files of the 2,250 posture alone based on an inadequate manufacturing workers. A case of RTS These comments suggest that the two number of studies that examined these was defined as local tenderness 4–5 cm epidemiological studies cited above risk factors as the dominant exposure distal to lateral epicondyle, pain in exclusively rely on a collection of factor, particularly in any quantitative forearm indirectly induced by subjective symptoms indicative of non- specific soreness and discomfort, rather fashion. However, it is clear that, in supination, no peresis or muscle than objective measurement of many of the epidmiological studies of weakness and positive EMG and nerve inflammation and tissue pathology. This epicondylitis, repetition and, in some conduction studies. For 1 kg or greater criticism also applies to virtually all the cases awkward posture, accompanied of hand force, an odds ratio of 18.0 (CI: existing epidemiological studies that exposure to force (see Table V–3). 2.2–147.5, p=0.01) was reported examined epicondylitis since they used Two additional epidemiological compared to those cases exposed to less a similar set of criteria to diagnose this studies that address physical work hand force. For workers with less than MSD. As a result, the commenters factors and elbow disorders were 30-second cycle times, an odds ratio of believe OSHA has not made a sufficient submitted to the OSHA docket 8.7 (CI: 1.2–23.8, p=0.03) was reported following publication of the proposal case that true epicondylitis (as well as compared to those who had longer cycle tenosynovitis) is associated with (Roquelaure et al.1996, Ex. 500–41–111; times. For workers with static hand SHARP 1993, Ex. 500–41–116), which workplace exposure to biomechanical work, an odds ratio of 7.7 (CI: 1.4–42.7, risk factors. are summarized below and included in p=0.02) was reported compared to those Table V–3. Both studies followed an OSHA disagrees with the notion that involved in more dynamic work. This evidence of tissue pathology among adequate study design, directly study demonstrates that an increased observed or measured exposure to exposed workers is required to infer a risk of RTS is associated with exposure causal relationship between exposure to workers, and used physical exam to to force, repetition and static posture of verify the MSD. OSHA, therefore, finds physical risk factors in the workplace the hand. and epicondylitis. The studies of that the studies add substantially to the Two medical experts supplied written evidence that the combination of Luopajarvi et al.(Ex. 26–56) and Kurppa testimony on behalf of UPS indicating et al.(Ex. 26–53) were directed by the forceful exertion, repetitive motion, and that epidemiological evidence to awkward posture increase risk of injury Institute of Occupational Health in support an association between Helsinki, Finland, which developed to the elbow. combined biomechanical factors (e.g. The Safety and Health Assessment systematic methods for screening and force, repetition, awkward posture) and and Research Program (SHARP) of the diagnosing a number of occupational the different types of tendinitis of the Washington State Department of Labor neck, shoulder, and upper limb upper extremities (e.g. elbow and Industries (1993, Ex. 500–41–116) disorders, including lateral and medial (epicondylitis), hand/wrist conducted a cross-sectional study of 104 epicondylitis. The examination (tenosynovitis)) likely are flawed poultry processing workers. procedures and diagnostic criteria have Epicondylitis was assessed by interview because of imprecise case definition. Dr. been published in the peer-reviewed and physical examination. Exposure Peter Nathan wrote: literature (Waris et al.1979, Ex. 26– was assessed by a risk factor checklist There is a startling lack of objective 1218) and they were devised by a team that evaluated repetitiveness, evidence to indicate that actual pathology is of clinicians comprised of occupational forcefulness, mechanical stress, and involved in many of the soft tissue physicians, an orthopedist, physiologist, discomfort complaints that are included and ergonomist. The diagnosis for wrist deviation. The study found the under the umbrella of cumulative trauma prevalence of upper extremity MSD by disorders or musculoskeletal disorders—a lateral epicondylitis (the most common interview was 25% and by physical primary focus of the ergonomic standard. form of epicondylitis) is not simply self- exam and interview was 17%. The * * * Dr. Armstrong refers to a Finnish reported elbow soreness. The tenderness number of repetitive exertions per hour study by Luopajarvi et al.(1979, Ex. 26–56) must be localized over the lateral was significantly predictive of which is one of three valid studies referenced epicondyle and there must be pain epicondylitis (p=0.002). by Dr. Susan Stock in her 1991 meta-analysis associated with resisted extension of the Roquelaure et al.(1996, Ex 500–41– of the literature relating work exposure to wrist and fingers (resistence test). In the conditions of the neck and upper extremities. 111) reported that work characteristics The variable representing tendinitis used by Finnish studies, these signs were of greater than 1 kg of hand force, less Luopajarvi and his colleagues was primarily evaluated by either physicians than 30-second cycle times, and static symptoms confirmed by physical specializing in occupational health or a hand work in workers were associated examination. This does not correspond to the trained physiotherapist. Other potential with radial tunnel syndrome (RTS). RTS classic medical definition of tendinitis, causes unrelated to physical work is a disorder in which the radial nerve which requires objective evidence of true factors, such as fractures, acute trauma, becomes compressed near the elbow inflammation (Ex. 500–118). recreational injuries, infection, arthritis, causing pain and tenderness, similar to Similarly, Dr. Nortin Hadler stated in pre-existing neurological diseases, etc., epicondylitis. Roquelaure used a case- written testimony: were assessed and screened out through

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However, as pronation, or supination with the arm The Finnish criteria are consistent discussed in the Health Effects extended, are at increased risk of with procedures for the assessment, Appendix, there is some evidence developing epicondylitis. diagnosis, and management of elbow suggesting that tensile loading on the complaints recommended by the extensor carpi radialis brevis (ECRB) Tendinitis of the Hand and Wrist American College of Occupational and muscle created by muscular action in Most cases of tendinitis of the hand Environmental Medicine (ACOEM, Ex. combination with elbow extension and and wrist originate as inflammation of 502–240). These guidelines do not call pronation/supination of the forearm the synovial sheath that provides for tissue evidence of inflammation and causes a compressive force at the protection for the tendons. This pathology in diagnosing lateral tendon, ligament, and radial head of the condition is known as tenosynovitis. epicondylitis, but rather depend on elbow. Prolonged contact pressure and/ Inflammation may occur in the flexor expert evaluation of unique signs and or repeated loading is likely to produce tendons on the palmar aspect of the symptoms by a trained clinician upon fraying of the ECRB. The resulting cycle wrist, extensor tendons on the back of physical examination. The food packers of damage/repair leads to clinical and the wrist, or the small separate in the cross-sectional investigation by pathological manifestations of lateral collection of extensor tendons that Luopajarvi et al. (Ex. 26–56) were epicondylitis. controls the extension of the thumb. examined by a physiotherapist specially There are a number of trained at the Finnish Institute of Conclusion pathophysiological outcomes that result Occupational Health. The meat The 1997 NIOSH report concluded from irritation of the tendons. If the processors in the prospective Kurppa et the following with regard to the sheath becomes aggravated, excessive al.(Ex. 26–53) study were primarily relationship between work-related synovial fluid can build up resulting in diagnosed by occupational physicians at physical risk factors and epicondylitis: the plant using the criteria developed by swelling along the affected tendon. There is strong evidence for a relationship Sometimes irritation can occur just the Finnish Institute. The same between exposure to a combination of risk diagnostic approach was also used by proximal to the tendon sheath where factors (e.g. force and repetition, force and there is no synovial fluid. This causes the other key epidemiological studies posture) and epicondylitis. Based on a review that found an association between work- of the epidemiologic studies, especially those a dry rubbing of the tendon called related factors and epicondylitis (Chiang with some quantitative evaluation of the risk peritendinitis crepitans, so named et al.1993, Ex. 26–1117; Moore and Garg factors, the evidence is clear that an exposure because of the discernable creaking 1994, Ex. 26–1364; Bovenzi et al.1991, to a combination of exposures, especially at sensation. There is also a type of Ex. 26–1433). More specialized higher levels (as can be seen in, for example, tenosynovitis, known as stenosing meatpacking or construction work) increases diagnostic tools, such as imaging and tenovanginitis, caused by a constriction the risk for epicondylitis (Ex. 26–1, Emphasis of the tendons at the mouth of the electromyography, are only advised if a in original). prudent course of elbow/forearm rest sheath. If this constriction occurs on the and pain relief do not adequately correct OSHA agrees with NIOSH that there is radial aspect of the wrist involving the the disorder or more serious a reasonably strong body of evidence extensor tendons to the thumb, it is complications are suspected (e.g. showing a relationship between known as De Quervain’s syndrome. If fracture, osteomyelitis, neurological exposure to combinations of the site of injury is the flexor tendons damage). biomechanical risk factors, usually to the fingers, it is known as trigger OSHA finds that the case definition of forceful exertion/repetitive motion or finger. Stenosing tenovanginitis is epicondylitis used by the forceful exertion/repetitive motion/ thought to be the result of compression epidemiological investigators is awkward posture, and an increased risk caused by the thickening of the appropriate for diagnosing this MSD. of epicondylitis. This evidence retinaculum (band of ligaments around The evaluations were administered by emanates from the consistently positive the wrist holding the tendons in place) trained clinicians using specific and associations in epidemiological studies leading to tendon entrapment. standardized criteria that are uniformly of workers from several different One publication in the record accepted by the medical community. industry sectors, especially those described the symptoms and prognosis This was confirmed by testimony from investigations that rely on expert of patients that have trigger finger or numerous physicians during the verification of injury and objective thumb: hearings (AFL–CIO, Ex. 500–218). The determination of exposure. The published clinical guidelines and epidemiological evidence is supported The classic picture [of trigger finger/thumb patients] is painful ‘‘locking’’ of the digit in testimony from the record cited above by the large number of clinical reports flexion whereby the patient has difficulty make clear that the criteria of localized and investigations in the medical and sports literature. There is biological extending the proximal interphalangeal joint. tenderness at a critical bone-tendon Extension can be accomplished passively junction (MSD symptom) combined plausibility that exposure to combinations of risk factors can lead to using the other hand and produces a with pain upon palpation and moderate amount of discomfort and a epicondylitis since forceful and extension/flexion of the wrist during palpable painful ‘‘snap.’’ * * * The repetitive exertion of the forearm physical examination (positive physical prognosis is excellent for a complete recovery finding) are sufficient for the proper muscles and tendons are also consistent barring the occurrence of multiple trigger diagnosis of epicondylitis without the with the pathophysiology of fingers and/or significant osteoarthritis need for further ‘‘objective evidence of epicondylitis. As described in the * * *. In these cases the course is usually true inflammation.’’ NIOSH review of the epidemiological prolonged. Patients tend to question their evidence, there is less evidence that Biomechanical Evidence ability to return to their old jobs and, on exposure to repetition or awkward occasion, any job. In general, workers should There is a very limited amount of posture alone, is associated with an be able to return to heavy work, although it specific study information available in increased risk of epicondylitis. OSHA may take somewhat longer after surgery the Health Effects Appendices for the concludes that workers who perform job because of a tender palmar scar. [Ex. 38–453, proposed rule (Ex. 27–1) that measure tasks requiring repeated forceful pp. 105–106]

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Epidemiological Evidence tendons of the wrist and/or signs of the combined effect of at least two risk crepitation. In some cases, a positive factors. Five studies relied on direct NIOSH (1997, Ex. 26–1) reviewed Finkelstein’s test was used to diagnose observation of job tasks and expert seven cross-sectional studies and one DeQuervain’s syndrome. Because of the judgment to determine exposure cohort study that addressed workplace differences in case definition, it is (Armstrong et. al. 1987, Ex. 26–48; risk factors and MSDs that specifically difficult to compare prevalence rates Luopajarvi et. al. 1979, Ex. 26–56; addressed hand/wrist tendinitis. Table from different studies, although Bystrom et. al. 1995, Ex. 26–897; V–4 summarizes some key aspects of measures of relative risk should be less Kuorinka et. al. 1979, Ex. 26–639; these investigations. In these studies, affected as long as case definitions were Kurppa et. al. 1991, Ex. 26–53). One of tendinitis cases were identified non-differentially applied to exposed these studies quantified force and primarily by physical examination, and unexposed groups (NIOSH 1997, repetitiveness for a subset of workers which usually included localized pain/ Ex. 26–1). tenderness at the tendons upon Exposure assessment was generally performing different jobs and grouped palpation during movement of the restricted to grouping workers in them according to these measurements hand/wrist. However, diagnostic criteria exposed and unexposed categories (Armstrong et. al. 1987, Ex. 26–48). varied across studies depending on the based on the existence of a combination Three studies used less reliable methods types of tenosynovitis of interest. For of excessive force, repetitive motion, of assessing exposure such as self- example, some investigations required and awkward posture. In these studies, reports or general knowledge of job the presence of swelling along the most exposed workers were subjected to tasks.

TABLE V±4.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING HAND/WRIST TENDINITIS

Study Job type studied Physical Exposure basis Physical Risk measure factors exam (95% CI)1

Kurppa (1991) Ex. 26±53 ...... Meat processing ... F/R/P? Observation ...... Yes ...... IR=14±38.5* (11±56) Armstrong (1987) Ex. 26±48 ...... Manufacturing ...... F/R/P? Measurement Yes ...... PRR=4.8±17* EMG. (2.3±126) Moore (2000) Ex. 500±71±41 ...... Pork processing F/ F/R?P Observation ...... Yes ...... PRR=7.0* R?/P. Luopajarvi (1979) Ex. 26±56 ...... Food production ... F/R/P Observation ...... Yes ...... PRR=4.1* (2.6±6.5) Latko (1999) Ex. 38±123 ...... Manufacturing ...... R/F/P? Measurement, Yes ...... OR=3.2* cycle time. (1.3±8.3) Bystrom (1995) Ex. 26±897 ...... Auto assembly ...... F/R/P Forearm load, wrist Yes ...... PRR=2.5* flex. (1.0±6.2) Kuorinka (1979) Ex. 26±639 ...... Scissor production F?/R/P Cycle time, wrist Yes ...... PRR=1.4 flex. (0.8±2.5) Amano (1988) Cited in Ex. 26±1 ...... Shoe assembly ..... F?/R/P Job title ...... Yes ...... PRR=3.7±6.2* (2.7±14) Roto (1984) Ex. 26±666 ...... Meat cutting ...... F/R/P? Job title ...... Yes ...... PRR=3.1* (1.4±6.7) McCormack (1990) Ex. 26±1334 ...... Textile ...... F/R/P? Job title ...... Yes ...... PRR=0.4±3.0* (1.4±6.4) F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear. IR=incidence rate; PRR=prevalence ratios; *=p<0.05. 1 95% confidence interval expressed for the upper end of the risk measure range.

Of the five studies with the most groups and greater than 10 percent in 17.0 (2.3–126.2). The Kourinka et al.(Ex. reliably documented exposure, four unexposed groups. 26–639) study of mostly female scissors reported statistically significant The Armstrong et al.(Ex. 26–48) study makers found a non-statistically increases in the prevalence of hand/ was able to divide industrial workers at significant increase in the prevalence of wrist tendinitis in workers exposed to seven manufacturing plants into a low tenosynovitis (including peritendinitis) physical risk factors (Armstrong et force/low repetition group, a high force/ with an increase in the number of pieces al.1987, Ex. 26–48; Luopajarvi et low repetition group, low force/high handled per year. The PR was 1.4 (95% al.1979, Ex. 26–56; Bystrom et al.1995, repetition group, and a high force/high CI 0.8–2.5) among all exposed workers Ex. 26–897; Kurppa et al.1991, Ex.26– repetition group based on EMG compared to a referent group of 53). In their review, NIOSH (1997, Ex. measurements and observed cycle department store assistants. In this 27–1) chose the prevalence ratio (PR) to times. They found exposure-related study, it is unclear whether cashiers (a represent an estimate of relative risk increases in the prevalence of potentially exposed group) were rather than the more commonly tenosynovitis (including stenosing included in the referent population; if reported OR for hand/wrist tendinitis, tenovanginitis). The high-force/low- so, this would tend to diminish the because the OR can overestimate repetition group and low-force/high- association between exposure and relative risk when prevalence rates repetition group had PRs of 4.8 (95% CI outcome. The results of these two among unexposed groups are high. A 0.6–39.7) and 5.5 (95% CI 0.7–46.3), studies suggest the presence of a few of the studies on work-related respectively, compared to the low-force/ positive exposure-response relationship tendinitis reported prevalence rates low-repetition group, while the high- between exposure to biomechanical risk greater than 25 percent in exposed force/high-repetition group had a PR of

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These biomechanical studies line food packers compared to predict that additional compressive and demonstrate that the increased risk of department store assistants (cashiers frictional forces are exerted on the hand/wrist tendinitis seen among excluded from the unexposed group). tendon when the wrist deviates from a workers exposed to forceful and Bystrom et al.(Ex. 26–897) found a neutral position as the tendon sheaths repetitive hand activities is biologically significant increase in PR (2.5; 95% CI slide against the bones of the carpal plausible and consistent with the 1.0–6.2) of DeQuervain’s syndrome tunnel and flexor retinaculum. These epidemiologic evidence. OSHA among automobile assembly line predictions have been confirmed by therefore concludes that workers workers compared to randomly selected cadaver studies of forces on the tendons, exposed to these risk factors are at subjects (adjusted for potential ligaments, and bones of the hand. A increased risk of developing hand/wrist confounders) from the general laboratory study showed that peak tendinitis. population. The prospective cohort tensile forces in the flexor tendons were Carpal Tunnel Syndrome (CTS) study by Kurppa et al.(Ex. 26–53) found approximately doubled during a a significant increase in the incidence of simulated caulking task with a straight CTS is a disorder that results from tenosynovitis (including peritendinitis wrist and approximately tripled during compression of the median nerve at the and DeQuervain’s syndrome) over a 31- the same task with a flexed wrist (Moore point of passage through the carpal month period in meat processing et al.1991, Ex. 26–183). tunnel, the narrow opening in the hand workers (primarily cutters and packers) When a dynamic component is added consisting of carpal bones of the wrist engaged in strenuous compared to non- to the biomechanical model, it is on the bottom and the carpal ligament strenuous work (primarily office work). predicted that tensile and normal forces on top. The carpal tunnel is a relatively They reported relative risks ranging on the finger flexor tendons increase ‘‘tight’’ compartment filled with flexor from 14.0 to 38.5 for different job rapidly during rapid wrist accelerations. tendons as well as the median nerve categories, but these may be These predictions are supported by a that serve to move and enervate the overestimated since recurrences of preliminary surveillance study that fingers. Forceful contraction of the tendinitis were counted as new cases found wrist acceleration to be flexor tendons in the fingers that occur and case ascertainment was different for substantially higher in jobs with a high during repetitive hand tasks increase the the exposed and referent groups. This rate of upper extremity cumulative pressure within the carpal tunnel (Ex. study does provide evidence of a trauma disorders (Marras and 38–444). Chronic intracarpal pressure temporal relationship between exposure Shoenmarklin 1993, Ex. 26–172). The limits the vascular flow to the median to physical work factors and biomechanical and laboratory evidence nerve and surrounding tissue leading to development of tendinitis. Confounders, provides additional support that swelling of the tendon sheath. The such as gender and age, were adequately biomechanical risk factors, such as epineural edema leads to compression controlled for in the key studies. sustained/repetitive forceful exertions of the median nerve against the carpal Two studies that address physical and flexion/extension of the wrist, can ligament. The ensuing loss of nerve work factors and tenosynovitis were create internal strain on tendons that function initially results in painful submitted to the OSHA docket could result in injury consistent with tingling and numbness in the hand. following publication of the proposal tenosynovitis. After several years, eventually the (Moore 2000, Ex. 26–1364; Latko et tendon tissue can become fibrotic and al.1999, Ex. 38–123). Summary results Conclusion result in muscle weakness, reduced grip of these studies also appear in Table V– The 1997 NIOSH report concluded strength and loss of finger movement. 4. Moore (Ex. 500–71–41) found a the following with regard to the CTS is often accompanied by significant increase in the prevalence of relationship between work-related tenosynovitis, which is not surprising stenosing tenovanginitis as a result of physical risk factors and hand/wrist given their common pathophysiology. jobs requiring repetitive and forceful use tendinitis: ‘‘There is strong evidence CTS is a disabling condition that has of hand tools compared to jobs without that job tasks that require a combination frequently required surgery to provide exposure to this risk factor. Latko et of risk factors (e.g., highly repetitious, the affected individual with relief. For al.(Ex. 38–123) reported a significant forceful hand/wrist exertions) increase example, in Washington State in 1996, linear trend between repetitive work risk for hand/wrist tendinitis’’ (Ex. 26– more than one-third of all CTS workers’ and hand/wrist tendinitis (p<0.01) in a 1). OSHA also finds clear epidemiologic compensation claimants required cross-sectional study of 438 evidence of a relationship between a surgery as part of their treatment (Ex. manufacturing workers. Worker combination of physical risk factors, 500–71–47, P. 12). Histologic studies of exposure to physical work factors were such as repetitive and forceful hand flexor tendon sheaths sampled during directly observed and measured in this activities with a flexed wrist, and carpal tunnel surgery support the above study and tendinitis cases were tenosynovitis. This evidence is from the model since vascular changes consistent confirmed through physical consistently positive associations in the with ischemia and tissue edema are examination by an occupational epidemiological studies described commonly observed (Ex. 26–838). physician in both the Moore and Latko above. There are also laboratory studies National and international studies. that confirm that hand-intensive work, surveillance data have consistently particularly with a bent wrist, produces indicated that the highest rates of CTS Biomechanical Evidence significant load and strain on the flexor occur in occupations and job tasks (meat Static and dynamic biomechanical tendons. The biomechanical evidence is processing, assembly line work, models of the wrist have been used to consistent with the pathophysiology of intensive use of hand and power tools, estimate tensile, normal, and frictional tenosynovitis where sustained and etc.) requiring repeated wrist forces in finger flexor tendons during elevated internal force on the tendon movements, forceful exertions, and

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TABLE V±5.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING CARPAL TUNNEL SYNDROME

Study Job type studied Physical fac- Exposure basis Diagnosis Risk measure tors (95% CI)1

Bovenzi (1991) Ex. 26±1433 ...... Forestry ...... V Measurement ...... Physical exam ...... OR=21* (NR) Roquelaure (1997) Ex. 38±396 ...... Manufacturing ...... F/R/P Measurement ...... Physical exam+NC .. OR=9.0* (2.4±33.4) Silverstein (1987) Ex. 26±34 ...... Manufacturing ...... V/F/R/P Measurement ...... Physical exam ...... OR=1.8± 15.5* (1.7±142) Chatterjee (1992) Ex. 26±942 ...... Rock drilling ...... V Measurement ...... Physical exam+NC .. OR=10.9* (1.0±524) Osorio (1994) Ex. 26±807 ...... Supermarket ...... F/R/P? Observation ...... Physical exam+NC .. OR=6.7±8.3* (2.6±26.4) Barnhart (1991) Ex. 26±1216 ...... Ski manufacture ...... F?/R/P Measurement ...... Physical exam+NC .. OR=1.9±40* (1.0±15.8) Frost (1998) Ex. 38±198 ...... Slaughter house ...... F/R/P Measurements ...... Physical exam+NC .. OR=4.2* (1.8±10.1) Bovenzi (1994) Ex. 26±774 ...... Stone drilling ...... V Measurement ...... Physical exam ...... OR=e.4* (1.4±8.3) Baron (1991) Ex. 26±697 ...... Grocery checking .... F/R/P Measurement ...... Physical exam ...... OR=3.7 (0.7±16.7) Moore (1994) Ex. 26±1364 ...... Meat processing ...... F/R/P Measurement ...... Physical exam+NC .. OR=2.8 (0.2±36.7) Chiang (1990) Ex. 26±1118 ...... Frozen Food Pack- F?/R/P? Measurement ...... Physical exam+NC .. OR=1.9± ing. 11.7* (2.9±46.6) Chiang (1993) Ex. 26±1117 ...... Fish processing ...... F/R/P? Cycle time, EMG ..... Physical exam ...... OR=1.1±1.8* (1.1±2.9) Stetson (1993) Ex. 26±1221 ...... General industry ...... F/R/P Checklist ...... NC only ...... NR* Latko (1999) Ex. 38±123 ...... Manufacturing ...... F/R/P? Measurement ...... Physical exam+NC .. OR=2.3±3.1 (0.9±10.9) Armstrong (1979) Ex. 26±348 ...... Sewing machine use F/R/P EMG, flexion ...... Physical exam ...... OR=1.1±2.0* (1.6±2.5) Nathan (1988) Ex. 26±990 ...... Multiple industries ... F/R/P Observation ...... NC only ...... PRR=1.0± 2.0* (1.1±3.4) Nathan (1992) Ex. 26±989 ...... Multiple industries ... F/R/P Observation ...... NC, symptoms ...... PRR=1.0±1.5 (1.0±2.2) Canon (1981) Ex. 26±1212 ...... Aircraft plant ...... V/R Hand tool measure- Workers' comp ...... OR=2.1±7.0* ment. (3.0±17) English (1995) Ex. 26±848 ...... CTS case/control .... F/R/P Questionnaire ...... Physical exam ...... OR=0.4±1.8* (1.2±2.8)

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TABLE V±5.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING CARPAL TUNNEL SYNDROMEÐContinued

Study Job type studied Physical fac- Exposure basis Diagnosis Risk measure tors (95% CI)1

Feldman (1987) Ex. 26±1210 ...... Electronics plant ...... F?/R/P Cycle time flexion .... Questionnaire ...... OR=2.3* (1.4±4.5) Koskimies (1990) Ex. 26±973 ...... Forestry ...... V Job title ...... Physical exam+NC .. NR* McCormack (1990) Ex. 26±1334 ...... Textile ...... F/R/P? Job title ...... Physical exam ...... OR=0.4±0.9 (0.3±2.9) Morgenstern (1991) Ex. 26±1493 ...... Grocery cashiers ..... F?/R/P Job title ...... Questionnaire ...... OR=1.9 (0.9±3.8) Punnett (1985) Ex. 26±995 ...... Garment ...... F?/R/P? Job title ...... Physical exam ...... OR=2.7* (1.2±7.6) Schottland (1991) Ex. 26±1001 ...... Poultry processing .. F/R/P Job title ...... NC only ...... OR=1.9±2.9* (1.1±7.9) Weislander (1989) Ex. 26±1027 ...... CTS case/control .... V/F/R/P? Questionnaire ...... Physical exam+NC .. OR=1.8±3.3* (1.6±6.8) Liss (1995) Ex. 26±55 ...... Dental hygienist ...... F?/R/P Questionnaire ...... Questionnaire ...... OR=3.7* (1.1±11.9) DeKrom (1990) Ex. 500±41±28 ...... CTS case/control .... F/R?/P Questionnaire ...... Physical exam+NC .. OR=5.4±8.7* (3.1±24.1) Tanaka (1997) Ex. 26±1185 ...... Household survey ... V/P Questionnaire ...... Questionnaire ...... OR=1.8±5.9* (3.4±10.2) Farkkila (1988) Ex. 26±947 ...... Chair saw use ...... V Questionnaire ...... Physical exam+NC .. NR* SHARP (1993) Ex. 500±41±116 ...... Poultry processing .. F/R Measurement ...... Questionnaire ...... NR* (p< 0.0004) Rosecrance (1994) Ex. 38±203 ...... Newspaper work ..... F/P/R/ (pinch) Questionnaire ...... Physical exam ...... NR* Rossignol (1997) Ex. 500±205±24 ...... Manual labor ...... F/R?/P? Questionnaire ...... Surgery for CTS ...... OR=4.1* (1.5±3.2) LeClerc (1998) Ex. 500±41±85 ...... Assembly line ...... R/P? Questionnaire ...... Physical exam+NC .. OR=3.1±6.6* Atroshi (1999) Ex. 38±181 ...... General Population F/P/R/V Questionnaire ...... Physical exam+NC .. OR=1.0±3.0* (1.4±6.8) Gorsche (1999) Ex. 500±121±23 ...... Meat packing ...... V Questionnaire ...... Physical exam ...... NR Katz (1998) Ex. 38±393 ...... CTS case control .... F/R/P Questionnaire ...... Physical exam ...... NR Kerns (2000) Ex. 500±71±34 ...... Pork processing ...... F/R/P Job title ...... NC only ...... NR F=forceful exertions; R=repetitive motion; P=awkward posture; V=vibration; ?=presence of risk factor unclear. NCV=nerve conduction; IR=incidence rate; OR=odds ratio; PRR=prevalence rate ratio; NR=not reported. *=p<0.05. 1 95% confidence interval expressed for the upper end of the risk measure range.

Chiang et al.studied 207 workers from stressed the association between CTS was present in almost the entire study 8 fish processing factories in Taiwan and repetitive movements, although group. (Chiang et al.1993, Ex. 26–1117). Jobs some forceful hand/wrist exertion Barnhardt et al.found ski were divided into three groups based on probably existed in the study group. manufacturing workers with highly level of repetitiveness and force using Stetson et al.studied median NC on repetitive job tasks had a statistically cycle times (upper arm movements, not 103 automotive workers with symptoms elevated OR of 4.0 (95% CI 1.0–15.8) for just wrist) and EMG of the forearm consistent with CTS compared with 137 CTS (defined by physical tests/NC flexor muscles. There was a statistically asymptomatic automotive workers and studies) compared to those workers significant trend in prevalence of CTS an unexposed group of 105 engaged in non-repetitive tasks (defined by physical tests/symptoms) with exposure from low force/ administrative and professional workers (Barnhardt et al.1991, Ex. 26–1216). repetition, high force or high repetition, (Stetson et al.1993, Ex. 26–1221). Exposure was evaluated by and high force/repetition. Force alone, Repetitiveness was evaluated by cycle observational analysis and included but not repetitiveness, significantly times, hand/wrist grip forces were repetitive jobs with sustained flexion, predicted CTS (OR=1.8; 95% CI 1.1– estimated based on weights of handled extension, or ulnar deviation of the 2.9). tools and parts, and wrist deviation was wrists by 45 degrees. The participation Several other epidemiological judged from videotape analysis. Both rate for this study was lower (less than investigations found physical risk symptomatic and asymptomatic workers 70 percent) than most of the other factors to be significantly associated had significantly lower median sensory investigations. Armstrong and Chaffin with prevalence of CTS. In another amplitudes and significantly longer reported that CTS (defined by physical Chiang et al.study of 207 workers from distal latency times than the referent tests/symptoms) was significantly 2 frozen food processing plants, job group. The same NC trends were found associated (OR=2.0; 95% CI 1.6–2.5) tasks were grouped by low and high between automotive workers in jobs with pinch force exertion (combination repetitiveness based on wrist movement requiring grip force greater than 6 of force and deviated wrist posture) in cycle time (Chiang et al.1990, Ex. 26– pounds compared to those requiring less female sewing machine operators 1118). Statistical modeling that than 6 pounds. This grip force variable (Armstrong and Chaffin 1979, Ex. 26– included gender, age, and cold probably combines forceful exertion 348). Because of the case-control study temperatures resulted in an OR of 1.9 with wrist deviation. It was not possible design, it is not clear whether deviated (p<0.05) for CTS (defined by physical to adequately compare repetitive and postures contributed to the development tests/symptoms/NC studies). This study non-repetitive work since this risk factor of CTS or whether the CTS symptoms

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A case control study by exposure to repetitive and forceful wrist Roquelaure et al.1997, Ex. 500–41–111; Chatterjee et al.found a significant motions as judged by an ergonomist and Latko et al.1999, Ex. 38–123; Rossignol difference (OR=10.9; 95% CI 1.0–524) in industrial hygienist (Osorio et al.1994, et al.1997, Ex. 502–420; Leclerc et the prevalence of CTS cases (defined by Ex. 26–807). However, the entire study al.1998, Ex. 500–41–85; Atroshi et NC studies/symptoms) in rock drillers consisted of only 56 workers grouped al.1999, Ex. 38–181; Gorsche et al.1999, compared with controls (Chatterjee et into 3 categories for analysis limiting Ex. 500-121–23; Kearns et al.2000, Ex. al.1982, Ex. 26–942). The rock drillers the power of the study to find a 500–71–34; Katz et al.1998, Ex. 38–393). were exposed to vibration frequencies statistically significant association. All but three of these studies (Ex. 500– between 31.5 and 62 Hertz. The highest Baron et. al. (Ex. 26–697) also studied 121–23; Ex. 500–71–34; Ex. 38–393) relative risks (OR=21.3; p<0.002) for CTS (defined by physical tests/ found significantly increased prevalence CTS (defined by physical tests/ symptoms) in 124 grocery store checkers of CTS among workers exposed to symptoms) were found in forestry and reported an OR of 3.7 (95% CI 0.7– physical risk factors. The three studies workers using chain saws compared to 16.7) compared to 157 non-checkers. that did not find a statistically maintenance workers who did not use Physical examinations were not done on significant association did not rely on power tools (Bovenzi et al.1991, Ex. 26– all workers and the relative risk measure independent assessment or observation 1433). Differences in ambient was based on responses to a of exposure to physical work factors, but temperatures (potential confounder) standardized questionnaire. The instead used job titles or self-reported between outdoor (chain saw operators) exposure level for checkers was survey information to infer exposure. and indoor work (maintenance workers) characterized as having low peak force One of these studies, Gorsche et al.(Ex. may have contributed to the results. and a medium level of repetition; 500–121–23), found an increased Koskimies et al.reported significant therefore, the intensity of exposure to prevalence and incidence of CTS in a correlations between reductions in NC physical risk factors was less than that cross-sectional and longitudinal study velocities in the median and ulnar among workers examined in other of meat packers but it was not nerves and number of years of vibration studies. statistically significant. Kearns et al.(Ex. exposure in forestry workers who used Almost all studies controlled for the 500–71–34), who ascertained cases only chain saws greater than 500 hours in the obvious confounders of age, gender, and by nerve conduction studies and did not previous 3 years (Koskimies et al.1990, predisposing medical conditions by rely on symptoms or clinical evaluation Ex. 26–973). The prevalence of CTS selection of an appropriate referent to diagnose CTS, also failed to find a (defined by physical tests/symptoms) in population, stratification, or use of a statistically significant association. Katz these workers was 20 percent. In multiple logistic regression model. et al.(Ex. 38–393) studied factors another study, Bovenzi et al.reported an Many of the cross-sectional studies associated with long-term disability OR of 3.4 (95% CI 1.4–8.3) for CTS either excluded workers with pre- rather than the development of CTS. (defined by NC studies/symptoms) existing CTS prior to employment or In contrast, three studies that did among stone quarry drillers/carvers excluded recently hired workers from measure or observe exposures and used exposed to hand-transmitted vibration the study. Therefore, it is unlikely that a combination of symptoms, physical when compared to polishers who the reported associations between CTS tests, and nerve conduction velocity performed manual operations and were and exposure to biomechanical risk measurements to diagnose CTS found not exposed to vibration (Bovenzi et al., factors reflected preferential strong associations with exposure to 1994, 26–774). In these four studies, employment of those with CTS (i.e., the repetition and/or force (Exs. 38–198, flexor tendons and the median nerve of requirements for entry into the cohort 500–41–111, 38–123). Another study, the hand were probably subjected to a made it likely that exposure preceded the SHARP study (Ex. 500–41–116) of considerable degree of forceful exertion the onset of CTS). poultry processing workers summarized as well as mechanical injury during use NIOSH (1997, Ex. 27–1) concluded in the hand/wrist tendinitis section of these power tools. Vibration can also that there was epidemiological evidence above, found that the number of forceful cause direct damage to the digital of a positive association between CTS exertions per hour was significantly arteries leading to sensory loss and and highly repetitive work, either alone predictive of CTS (p=0.004). numbness. or in combination with other risk Many studies of CTS contained in the There were three studies that did not factors. They also found evidence of rulemaking docket are not included in find statistically significant association positive associations between forceful Table V–5 either because it was between CTS and exposure to physical work and work involving hand/wrist questionable whether exposure to risk factors, even though each reported vibration and CTS. However, NIOSH physical risk factors occurred or because substantially raised ORs. Moore and concluded there was insufficient the study did not address the Garg found an OR of 2.8 (95% CI 0.2– evidence of an association between CTS relationship between physical risk 36.7) for CTS (defined by NC studies/ and exposure to extreme postures alone factors and CTS (Nathan and Keniston symptoms) among pork processing because of individual variability in 1993, Ex. 351–14; Stallings et al.1997, workers in hazardous jobs compared to work methods and difficulties in Ex 351–20; Franzblau et al.1994, Ex. 38– safe jobs (Moore and Garg 1994, Ex. 26– measuring postural characteristics. 175; Nordstrom et al.1988, Ex. 500–25– 1033). Jobs were categorized based on NIOSH did recognize that there was 9; Zetterberg and Ofverholm 1999, Ex. videotape analysis for estimates of force, strong evidence that exposure to a 500–121–78). Other studies were not repetitition and awkward postures. The combination of physical risk factors included on OSHA’s summary table possible presence of a healthy worker along with non-neutral wrist postures because they used a flawed study design effect (most workers were laid off in the was related to the onset of CTS. or a flawed statistical analysis to year prior to the study) and the short A large number of studies that examine the relationship between latency period (8–32 months) limits addressed physical work factors and exposure to biomechanical risk factors confidence in the relative risk estimate. CTS were submitted into the OSHA and CTS (Malchaive et al.1996, Ex. 500–

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66–5; Homan et al.1999, Ex. 38–172; and interpretation of the results, which affects not only the 1988 baseline study Olafsdotti et al. 2000, Ex 38–288. call their conclusions into doubt. Chief but all future follow-up studies of the One of the above studies is among among these is the failure to adequately same cohort. Because of these several papers published by Dr. Peter justify and validate their grouping and criticisms, OSHA finds that the Nathan Nathan and colleagues, which were rank order of occupational hand use. studies do not convincingly based on two group of workers whom This provides multiple opportunities for demonstrate a lack of association they have followed prospectively (Ex. exposure misclassification and will tend between workplace exposure to 26–990; Ex. 26–988; Ex. 26–989; Ex. 26– to underestimate the association of biomechanical risk factors and CTS. 1294; Ex. 26–517; Ex. 38–437; Ex. 38– exposure with health outcome. This In his written testimony, Dr. Peter 13; Ex. 351–14). Because of the aspect of the study has been criticized Nathan calls into question the case importance of these studies to the by several experts (Ex. 26–1010; Ex. 26– definition for CTS relied upon by OSHA ergonomics rulemaking, they are 952; Tr. 1000). Despite this potential for in their evaluation of the addressed in detail here. In one of the misclassification, there was a significant epidemiological studies (Ex. 32–241–3– earlier studies (Nathan et al.1988, Ex. increase in prevalence between the 13). He testifies that ‘‘there is general 26–990), nerve conduction was assessed lowest (Group I) and higher exposure agreement among experts that classic on 471 randomly chosen individuals groups combined (Groups III, IV, and V) symptoms associated with positive from four industries (steel mill, meat/ in the cross-sectional study (Ex. 26– electrodiagnostic findings for the food packaging, electronics, and plastics 990). Others have also concluded that, median nerve are necessary for a manufacturing). The group was divided methodological shortcomings aside, the diagnosis of CTS’’ but that ‘‘there is no general agreement that symptoms, in the into the following exposure categories: articles by Nathan et al.demonstrate a • Group 1, very low force, low presence of negative electrodiagnostic positive exposure-response relationship repetition; findings is equivalent to CTS.’’ (Id., pg between ‘‘occupational hand activity’’ • Group 2, low force, very high 4). Dr. Nathan then goes on to criticize and slowed conduction of the median repetition; OSHA and NIOSH, in their 1997 review, nerve (Tr. 1519–1522; Tr. 9862). Others • Group 3, moderate force, moderate for accepting studies that use CTS case have testified that alternative exposure repetition; definitions without electrodiagnostic • grouping of the data resulting in less Group 4, high force, moderate confirmation. He argues that repetition; and exposure misclassification would result • longitudinal studies are the only study Group 5, high force, high repetition. in a clear exposure-response design of value for determining No significant difference in median relationship between job group and causation and concludes ‘‘if one nerve sensory latency values was found median nerve latency (Punnett required electrodiagnostic studies for a between Group 1 and Group 2, which testimony, Ex. 37–2; Gerr testimony, 27– valid case definition of CTS, and a differed primarily by the amount of 2). Some who testified at OSHA’s longitudinal design for establishing repetition exposure. There was a informal hearing have also stated that temporal relationships, then only one statistically significantly higher number Dr. Nathan’s articles use statistical [his own] of the 31 studies analyzed by of subjects with median nerve slowing presentation and analysis methods that NIOSH would have met standard in Group 5 compared to Group 1, but obscure the evidence, and that not criteria for establishing causation.’’ (Id., not when compared to Groups 2, 3, or enough data are presented for the reader pg 11). 4. When individual hands were used to to independently evaluate whether the OSHA accepts that specific symptoms base calculations rather than number of authors’ conclusions are justified (Tr. determined during clinical exam in individuals, only Group 3 showed a 1521; Tr. 7850.). Low participation combination with objective evidence of significantly higher prevalence of rates, unusual and inconsistent case median nerve dysfunction through median nerve conduction slowing. definition, and inappropriate statistical electrodiagnostic tests is the most When prevalence ratios were calculated, analysis may also have limited the definitive case definition for CTS at the Groups 3, 4, and 5 had significantly ability to detect increases in CTS present time. This has been supported higher PRs compared to Group 1. prevalence over time in these studies by expert testimony not only from Dr. This same group of workers was with respect to work-related Nathan but Dr. Frederick Gerr (Ex. 37– followed up for five years in a 1992 biomechanical factors. For example, the 2) and Dr. Gary Franklin (Tr. 13363). study (Ex. 26–988) and eleven years in authors reported in the baseline study OSHA also does not dispute lack of a 1998 study (Ex. 38–13). The study that they randomly selected the study agreement among experts on CTS used hands, rather than individuals, as participants (Ex. 26–990). However, diagnosis when symptoms exist in the the basis for analysis. The authors stated they did not report the proportion of presence of normal median nerve that they found no significant difference those who were selected and invited conduction. However, the relevant issue in the prevalence of median nerve that actually participated. Since the 471 is whether clinical symptoms and signs slowing among any of the exposure subjects represented only 26 percent of in the absence of electrodiagnostic groups. The authors claimed to have the total workforce of the participating testing are an invalid CTS case confirmed this finding in a second companies, the representativeness of the ascertainment for the purposes of combined cohort of Japanese and sample is unknown, the ability to evaluating epidemiological evidence to American industrial workers (Ex. 38– generalize from the data is highly determine if work-related physical 437) as well as validated their exposure limited, and the potential for selection factors are associated with the disorder. categories (Ex. 26–1294). They went on bias is substantial. There is no NIOSH addressed the issue in its 1997 to show that slowing of nerve comparative information on participants review and cited studies that found conduction was significantly associated and non-participants with respect to satisfactory correlations between CTS with obesity (Ex. 26–989), body mass demographics, occupational history or diagnosed by nerve conduction and the index (Ex. 26–517), wrist depth/width exposure, or medical history. The lack disorder diagnosed by symptom and a number of other non-occupational of clarifying information is particularly questionnaire and physical examination risk factors (Ex. 351–14). problematic because the direction of the (Ex. 26–1501; Ex. 26–439). It was also However, their research has a number selection bias could be either toward or reported that clinical examination for of flaws in the study design, analysis away from the null value. This problem CTS diagnosis without the benefit of

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On the other hand, different times, we must ask ourselves why. physical risk factors and CTS: clinical exam is expected to miss a In my opinion, after reading these studies and considering all the possible reasons why Based on the epidemiologic studies diagnosis (false negative) when CTS is so many studies show this relationship, the reviewed, especially those with a present about one in six subjects. While most reasonable, plausible, and likely quantitative evaluation of the risk factors, the this degree of sensitivity and specificity explanation is that work really did cause the evidence is clear that exposure to a may not be acceptable when making carpal tunnel syndrome observed in these combination of the job factors studied studies. (Tr. 1525) (repetition, force, posture, etc.) increases the treatment decisions, such as surgery, risk of CTS. This is consistent with the OSHA does not believe it introduces Biomechanical and Psychophysical evidence in the biomedical, physiological, substantial bias for purposes of Evidence and psychosocial literature (Ex. 26–1). evaluating epidemiological evidence. Several clinical and cadaver studies OSHA also finds convincing evidence OSHA does not agree with Dr. confirm that fingertip force, wrist that jobs involving repetitive and Nathan’s assertion that only flexion/extension, repetitive tasks and forceful movements of the hand and longitudinal studies are relevant in combinations of the above are able to wrist are linked to CTS. The evaluating causation. Longitudinal raise carpal tunnel pressure (CTP) in a epidemiological findings are supported prospective cohort studies are indeed dose-dependant manner. Mean CTP was by clinical, biomechanical, and the strongest epidemiological study raised from 5 mm Hg in a neutral wrist psychophysical studies showing that design, especially for establishing position to approximately 100 mm Hg at repetitive tasks involving flexion/ temporal relationships. However, they 60 degree wrist extension and 80 mm extension of the wrist and force to the often require extended periods of time, Hg at 60 degree flexion in a population flexor tendons result in substantial are more costly, and are not as of CTS patients and controls (Weiss et. increases in CTP, reductions in numerous other study designs. Other al. 1995, Ex. 26–236). CTP has been measured exertion, and perceptions of types of epidemiology, such as cross- shown to significantly increase with discomfort. This evidence is clearly sectional and case-control studies, add increasing finger tip force (Rempel et. al. consistent with the pathophysiology of evidence of causality in terms strength 1997, Ex. 26–889) and with clenching a CTS in which elevated CTP can lead to and consistency of association and fist or holding an object in a power grip compression of the median nerve exposure-response. (Seradge et. al. 1995, Ex. 26–325). There resulting in the clinical signs and OSHA has examined the was a two- to three-fold increase in CTP symptoms characteristic of this MSD. epidemiological data base and finds that when performing a repetitive task OSHA finds that the epidemiological even if one restricts the evidence to involving change in wrist posture 20 and biomechanical literature studies that used abnormal median times per minute for 5 minutes (Rempel convincingly demonstrates a causal nerve conduction to establish CTS case et. al. 1994, Ex. 26–1151). The elevated relationship between forceful and ascertainment, there is reasonable CTPs found in these human repetitive exertions to the hand, evidence of association between biomechanical studies are within the especially in combination with a flexed repeated, forceful exertions of the hand range of neuronal pressures shown to wrist, and an increased risk of carpal and CTS. There were eleven studies impair blood flow, axonal transport, and tunnel syndrome. Forceful and either reviewed by NIOSH in their 1997 nerve conduction in experimental repetitive exertion includes vibration review or submitted to the OSHA docket animals. from the use of hand-held power tools. during the rulemaking process that Psychophysical data support the found statistically significant biomechanical findings. They show that Hand-Arm Vibration Syndrome associations between combinations of maximum acceptable weight (MAW) Hand-arm vibration syndrome force, repetitive motion, awkward and torque (MAT) decrease and (HAVS) refers to a collection of signs posture, and segmental vibration and perceived exertion and discomfort and symptoms that occurs when CTS defined by electrodiagnostic increase with the frequency and vibration from a tool is transferred to a criteria (Ex. 38–396; 26–942; 38–198; duration of repetitive wrist motions. worker’s hand or arm. The symptoms 26–1118; 26–1221; 23–1001; 26–1027; The psychophysical method was used to include numbness, blanching of the 500–41–28; 500–41–85; 38–181; 26– determine the preferred weights for one- fingers, pain in response to cold 973). The entire body of epidemiological handed horizontal transfer tasks (e.g. exposure, and reduction in grip studies described in the preceding hand/wrist motion used to move an strength. These manifestations are paragraphs is also supported by object across a supermarket scanner). similar to Raynaud’s phenomenon impressive biomechanical and Frequency and duration of the transfer triggered by cold temperatures. HAVS psychophysical data, discussed in the movement significantly decreased MAW symptoms are believed to be the result following subsection, that shows in an exposure-dependent manner and of both neurological and circulatory sustained force on the flexor tendons increased perceived exertion over an disturbances, probably occurring along with flexion/extension of the eight-hour session (Krawczyk et. al. independently and by unrelated wrist increases carpal tunnel pressure 1992, Ex. 26–974). In another study, mechanisms. Vibration may directly and reduces exertion and perceptions of MAT was reduced over the course of a injure (as opposed to indirect damage discomfort. In his written testimony (Ex. seven-hour trial of repeated flexion and from compression as in CTS) peripheral 37–2), Dr. Fredric Gerr discussed his extension of the wrist (Snook et. al. nerve endings and neuroreceptors evaluation of the epidemiological 1995, Ex. 26–212). The magnitude of causing numbness, tingling and pain in studies that used abnormal nerve MAT reduction correlated with the the fingers. Histopathology of persons conduction to diagnose CTS and made frequency of the task and perceived suffering from HAVS indicate that

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00205 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68466 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations vibration may also directly damage medical personnel during physical Stockholm Taylor-Palmear scale to endothelial cells of the digital arteries examination. Previous investigations grade and stage symptoms. The five resulting in a lack of response to certain were reviewed as part of the 1989 investigations included vibration vasodilators and thickening of the vessel NIOSH criteria document on exposure measurements of exposure on tools used walls. These physiological changes can to HAV (Ex. 26–392). In its 1997 by the study subjects combined with cause vascular constriction and evaluation, NIOSH featured four cross- information on exposure time obtained ischemia of the surrounding sectional studies (Bovenzi et al.1988, by direct interview. musculoskeletal and neural tissue. The Ex. 26–1500; 1994, Ex. 26–1239; 1995, The four cross-sectional studies found clinical outcome is blanching of the Ex. 26–354; Nilsson et al.1989, Ex. 26– statistically significant positive fingers (‘‘white finger’’), loss of feeling, 1148) and one prospective study relationship between exposure to muscle weakness, and weakened grip (Koskimies et al.1992, Ex. 26–1490), vibration and prevalence of HAVS. The strength. which met most of NIOSH’s criteria for high quality. These investigations strength of this association was high Epidemiological Evidence determined HAVS based on medical with reported ORs ranging from 6 to 85. NIOSH reviewed 20 post-1988 exam and did not strictly rely on self- The one prospective study showed epidemiological studies that addressed reported questionnaires. Standard and significant decreases in HAVS workplace risk factors and HAVS. Table relatively uniform diagnostic criteria prevalence with decreasing exposure to V–6 summarizes some key aspects of were used in defining HAVS cases. This vibration over time. All five these investigations, such as the generally included episodes of cold- investigations contributed evidence of occupations examined, the provoked, well-demarcated blanching of exposure-response relationships biomechanical risk factors they were the fingers, occurrence of vibration between HAVS and vibration exposed to, whether exposures were white finger attacks after employment acceleration or duration of exposure. directly observed or measured during and following use of power tools, and One study also documented a the study, and whether the health abnormal digital artery response to cold relationship between exposure and outcomes were verified by trained provocation. All studies used the symptom severity.

TABLE V±6.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING HAND-ARM VIBRATION

Study Job type studied Physical Exposure basis Diagnosis Risk measure Factors (95% CI)1

Nilsson (1989) Ex. 26±1148 ...... Pulp mill machin- V Tool acceleration Physical exam .... OR=14±85 * ing. (15±486) Bovenzi (1995) Ex. 26±354 ...... Forestry ...... V Chain saw accel- Cold provocation OR=6.2±32 * eration. (11±93) Bovenzi (1994) Ex. 26±1239 ...... Stone drilling ...... V Tool acceleration Physical exam .... OR=9.3 * (4.9±17.8) Bovenzi (1988) Ex. 26±1500 ...... Stone cutting ...... V Tool acceleration Physical exam .... OR=6.1 * (2.0±19.6) Brubaker (1987) Ex. 26±762 ...... Forestry ...... V Chain saw accel- Symptoms ische- NR eration. mia. Koskimies (1992) Ex. 26±1490 ...... Forestry ...... V Chain saw accel- Physical exam .... NR eration. Brubaker (1983) Ex. 26±763 ...... Forestry ...... V Questionnaire ..... Symptoms ische- NR mia. Dimberg (1991) Ex. 26±1395 ...... Aircraft machin- V Questionnaire ..... Questionnaire ..... NR ing. Krivekas (1994) Cited in Ex. 26±1 ...... Forestry ...... V Questionnaire ..... Pyhsical exam .... OR=3.4±6.5 * (2.4±17.5) Letz (1992) Ex. 26±384 ...... Ship-yard ...... V Tool acceleration Questionnaire ..... OR=5.0±40.6 * (11±176) McKenna (1993) Ex. 26±745 ...... Machine riveting V Questionnaire ..... Cold provocation OR=24 * (3.1±510) Mirbod (1992) Ex. 26±1492 ...... Forestry ...... V Chain saw accel- Physical exam .... NR eration. Mirbod (1997) Ex. 500±121±49 ...... Motorcyclists ...... V Handlebar accel- Questionnarie ..... NR * eration. Mirbod (1999) Ex. 500±121±48 ...... Metal grinding .... V Job title ...... Physical tests ..... NR * Mirbod (1994) Ex. 26±1491 ...... Multiple indus- V Tool acceleration Questionnarie ..... OR=3.8 * tries. (2.1±6.8) Musson (1989) Ex. 26±743 ...... Power tool use ... V Tool acceleration Questionnaire ..... NR Nagata (1993) Ex. 26±1494 ...... Chain saw oper- V Job title ...... Physical exam .... OR=7.1 * ation. (2.5±19.9) Saito (1987) Ex. 26±1440 ...... Chain saw oper- V job title ...... Cold provocation NR ation. Palmer (1998) Ex. 500±121±56 ...... Pavement break- V estimated tool ac- Physical exam OR=2.2±2.6* ing. celeration. cold test. (1.4±4.8) Palmer (2000) Ex. 500±121±57 ...... Multiple indus- V Questionnaire ..... Questionnaire ..... PRR=1.5±2.2* tries. (1.9±2.4) Lindsell (1999) Ex. 500±205±13 ...... Dockyard work ... V Job title ...... Cold provo- NR * cations. McGeoh (2000) Ex. 500±41±96 ...... Welding ...... V Questionnaire ..... Questionnaire ..... NR * Shinev (1992) Ex. 26±836 ...... Polishing ...... V Tool acceleration Physical exam .... NR

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TABLE V±6.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING HAND-ARM VIBRATIONÐContinued

Study Job type studied Physical Exposure basis Diagnosis Risk measure Factors (95% CI)1

Starck (1990) Ex. 26±1510 ...... Machining ...... V Tool acceleration Questionnaire ..... NR Virokannas (1995) Ex. 26±891 ...... Railway ...... V Questionnaire ..... Questionnaire ..... NR Miyashita (1992) Ex. 26±1223 ...... Construction ...... V Questionnaire ..... Questionnaire ..... OR=0.5 (0.1±11.8) V=vibration; OR=odds ratio; NR=not reported. * =p<0.05. 1 95% confidence interval expressed for the upper end of the risk measure range.

Bovenzi et al.found a significantly et al.1992, Ex. 26–1490). Their analysis al.1998, Ex 500–121–56; McGeoch and greater prevalence of HAVS in a group showed a monotonic decrease in Gilmour 2000, Ex. 500–42–96; These are of 222 active forestry workers engaged prevalence from 40 percent in 1972 to summarized in Table V–6. Studies that in chain saw work as compared to 6 percent in 1990. In a subcohort of 57 either measured tool acceleration or randomly chosen shipyard workers workers followed prospectively, HAVS based HAVS on a combination of unexposed to hand vibration (Bovenzi et cases decreased from 35 percent in 1975 symptoms and medical tests found a al.1995, Ex. 26–354). The reported OR to 6 percent in 1986. Over the same time significant association between was 11.8 (95% CI 4.5–31.1) for all period, modifications in chain saws segmental vibration exposure and this forestry workers and 6.3 (95% CI 2.3– used by the workers resulted in a MSD (Ex. 500–121–49; Ex. 500–121–56 17.1) for workers only using ‘‘anti- reduction vibration acceleration from 14 Ex. 500–121–48). vibration’’ saws. The study found a m/s2 to 2 m/s2. While it is likely that the Conclusion nearly linear dose-response between decline in HAVS is due to changes in HAVS prevalence and both vibration the vibration acceleration, exposures The 1997 NIOSH report concluded acceleration and years of exposure. and outcomes were never linked for the following with regard to the Vibration exposure was determined individual workers. relationship between work-related from questionnaire reports on frequency The 1989 NIOSH criteria document physical risk factors and HAVS: of chain saw work and direct (Ex. 26–392) provides some The 20 epidemiological studies show measurement of vibration produced by epidemiological evidence for an strong evidence of a positive association 30 different saws. exposure-response relationship and between high level exposure to hand-arm In two earlier studies, Bovenzi et temporal association between HAVS vibration and vascular symptoms of hand- al.examined HAVS in stone quarry and vibration exposure. NIOSH arm vibration syndrome (HAVS). These drillers and carvers exposed to vibration analyzed HAV acceleration levels and studies are of workers with high levels of exposures such as forestry workers, stone from hand-held power tools along with prevalence of HAV-related vascular cutters or carvers, shipyard workers, or an unexposed referent group. The first symptoms from 23 cross-sectional platers. These workers were typically investigation found a statistically studies and found the two variables exposed to HAV acceleration levels of 5 to 36 significant HAVS prevalence (OR=6.1; linearly correlated (R=0.67; p<0.01). m/s2 * * * There is substantial evidence that 95% CI 2.0–19.6) in 75 drillers/cutters Many of these earlier studies as intensity and duration of exposure to compared to unexposed mill workers determined latency between vibration vibrating tools increase, the risk of (Bovenzi et al.1988, Ex. 26–1500). There exposure and onset of HAVS symptoms developing HAVS increases. [Ex. 27–1, was a significant association between providing some evidence of a temporal Emphasis in original] the level of vibration acceleration and relationship. Unfortunately these data OSHA agrees with the NIOSH severity of symptoms. In a much larger may be subject to recall bias since the statements that intensity and duration of study of 570 quarry drillers/carvers and mean latency was about six years and exposure to vibrating tools is linked to 258 polishers/machine operators not onset of symptomatology was often self- the risk of developing HAVS. Most of using power tools, an OR of 9.3 (95% CI reported. the epidemiological studies show a 4.9–17.8) was reported (Bovenzi et Most studies accounted for potential strong and consistent association al.1994, Ex. 26–1239). HAVS prevalence age-related effects by stratification of the between high-level exposure to HAV showed a significant increasing trend analysis or through the use of multiple and HAVS symptomatology. The data with estimates of lifetime vibration logistic regression. These studies also indicate there are strong exposure- exposure. controlled for non-occupational response relationships between the In the Nilsson study, HAVS was disorders that involve symptoms similar magnitude and duration of exposure examined in 89 platers and 61 office to HAVS, such as idiopathic Raynaud’s and HAVS prevalence and severity. workers from a pulp mill machine phenomena, peripheral neuropathy, Some studies indicate temporal manufacturing plant (Nilsson et al.1989, alcohol-related illness, etc. According to correlation between the chronic use of Ex. 26–1148). Prevalence of HAVS NIOSH (1997, Ex. 26–1), it does not vibrating power tools and the onset of (OR=85; 95% CI 15–486) was much appear that these potential confounders the disorder. A causal association greater for platers with current exposure account for the fairly strong and between vibration and HAVS is to vibration than unexposed office consistent association between HAVS consistent with clinical evidence workers. There was a clear dose- and vibration. showing that vibration damages nerve response between HAVS and years of Four studies that address vibration tissue and blood vessels in the fingers exposure. and HAVS were submitted into the leading to symptoms characteristic of Koskimies et al.investigated HAVS in OSHA docket following publication of this MSD. Therefore, OSHA concludes a group of 124 forestry workers from the proposal (Mirbod et al.1999, Ex that workers exposed to segmental 1972 to 1990 using a series of ten cross- 500–121–48; Mirbod et al.1997; Ex 500– vibration exposure, such as from long- sectional studies over time (Koskimies 121–49; Ex 500–205–21; Palmer et term use of hand held power tools, are

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The occluded blood Hypothenar hammer syndrome (HHS) directly to a specific anatomical region. vessels that develop in the palmar is a collection of vascular and Other studies have reported HHS in region of the hand as a result of the neurological signs and symptoms that workers repeatedly exposed to high- blunt trauma created by these have been related to repeated trauma to frequency mechanical stress to the palm occupational risk factors have been the hand. HHS is associated with from occupational use of hand-held cited in numerous case studies. The striking or pushing hard objects with the vibrating tools (Nilsson et al.1989 Ex. pathophysiology that links the initial hypothenar region of the hand using the 26–1148; Kaji et al.1993 Ex. 500–41–70). damage with tissue ischemia and the hook of the hamate bone as an anvil. At Thus, HHS is clearly another example of characteristic symptoms that define this location, the palmar blood vessels a work-related injury that occurs as a HHS are also well established in the of the ulnar artery and the sensory result of combined exposure to medical literature. Although limited in branch of the ulnar nerve lie virtually biomechanical risk factors (e.g. terms of numbers and design, the unprotected near the surface of the skin repetition, force, vibration) associated epidemiological findings are consistent and become trapped between ‘‘the with other MSDs of the upper with the clinical evidence and provide hammer’’ (i.e. the hard object) and ‘‘the extremities. support for a causal association between anvil’’ (i.e. the hamate bone). As a repeated and forceful contact stress to Epidemiological Evidence result, the blood vessels and nerves are the hand and this disorder. OSHA especially vulnerable to injury by Besides the case studies mentioned concludes that workers exposed to external mechanical stress. The repeated above, there were two cross-sectional repeated and forceful impact between blunt trauma can lead to ulnar artery studies in the rulemaking docket that the hypothenar region of the hand and spasm, aneurysm formation, and/or investigated HHS among workers (Little hard objects, such as hand hammering thrombosis. These lesions cause arterial and Ferguson 1972 Ex. 500–41–89; Kaji while on the job, or frequent exposure occlusion, vascular insufficiency, and et al.1993 (Ex. 500–41–70 ). Little and to mechanical stress from use of hand- post-traumatic ischemia of the Ferguson examined 79 male vehicle held power tools, are at increased risk surrounding tissue. The damage to maintenance workers from Australia for of developing hypothenar hammer neural tissue and reduced blood flow to HHS who self-reported daily use of the syndrome. the fingers are responsible for the most hand as a hammer and 48 employees in frequently reported symptoms of pain, the same shops who did not report E. Disorders of the Low Back numbness, cold feeling, discoloration habitual hand hammering. HHS was Low-back pain has long been and stiffness of the affected digits. A identified by both a positive Allen and associated with the performance of diagnosis can be made based on Doppler test. The Doppler test charted heavy physical work (Hales and Bernard symptoms and a physical examination blood flow from the radial artery and 1996, Ex. 26–896; Klein, Jensen, and test of the radial and ulnar arterial blood had shown good correlation with ulnar Sanderson 1984, Ex. 26–972; Rowe supply to the hand, termed the Allen artery occlusion as measured by 1969, Ex. 26–318; 1971, Ex. 26–319). test. This test measures reflow time arteriography. The prevalence of HHS Studies have demonstrated that back through the arteries following was 14 percent (11 out of 79) in the disorder rates vary substantially by compression. Reflow time is exposed workers and 0 percent in the industry, occupation and by job within substantially delayed in patients that referent population. The mean duration given industries or facilities (see Bigos suffer ulnar artery occlusion. More of employment (29.9 years) was et al.1986a, Ex. 26–871; Riihimaki et recently, arteriography has been used to significantly greater (p<0.02) in subjects al.1989a, Ex. 26–58; Schibye et al 1995, confirm diagnosis of HHS. If elimination with HHS than in men exposed to Ex. 26–1463; Skovron et al.1994, Ex. of the contact stress fails to resolve repeated trauma without the disorder 26–795). Recently, a NIOSH review symptoms, vascular reconstructive (mean duration of 18.7 years). (Bernard and Fine 1997, Ex. 26–1) surgery is often performed (Ex. 500–41– Kaji et al.used arteriography to concluded that several work-related 29). examine the hands of 330 Japanese factors are associated with low-back There are four case studies of hospital workers that used vibrating tools in disorders. The National Academy of or surgery clinic patients with HHS in mining, forestry, and several other Sciences (NAS 1999, Ex. 26–37) also the OSHA docket that have consistently industries. They found a 7.3 percent (24 concluded that there is an association implicated occupational exposure to cases) prevalence of HHS among the between certain work factors and low- repeated palmar trauma as a critical risk workers. The injured subjects were back disorders. This section summarizes factor (Conn et al.1970 Ex. 26–821; predominantly coal miners, rock drillers and discusses the evidence that physical Vayssairet et al.1987 Ex. 500–41–47; and forestry workers that reportedly work-related risk factors contribute to DeMonoco et al.1999 Ex 500–41–39; used air and jack hammers or chain the pathogenesis of specific disorders of Ferris et al.2000 Ex. 500–41–33). These saws. All suffered from HAVS as well as the back. The risk factors are (1) heavy studies report on 58 patients altogether. HHS. The mean duration of vibration physical work, (2) lifting and forceful In almost every case, the individuals exposure was 19.4 years (range 5 to 30 movement, (3) bending, twisting and suffering from the disorder reported a years). There was no unexposed referent awkward posture, (4) static work history of repetitive blunt trauma to the group and no direct observation or postures, and (5) whole body vibration. hand related to their jobs. Occupations measurements of vibration exposure in Exposure to several factors often occurs such as carpenter, metal worker, the study. concurrently in occupational settings machinist, and mechanic were most and the evidence indicates that the risk often cited. More infrequently, the HHS Conclusion of injury is greatest when more than one patients were engaged in hobbies in There is clear evidence that repeated factor is present, reinforcing the concept which the hand was exposed to frequent and forceful impact between the that these MSDs are both multi factorial impact, such as karate and wood hypothenar region of the hand and hard in etiology and that the joint effects of working. It should be noted that use of objects, such as hand hammering while these risk factors can be synergistic. The

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00208 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68469 terms ‘‘back disorder’’ or ‘‘back MSDs’’ Laboratory studies are controlled 420; Williams, McCulloch, and Young are used to encompass all adverse scientific investigations of how humans 1990, Ex. 26–1563; Wiesel et al.1996, health outcomes related to the back. respond when exposed to specific Ex. 26–1394). This discussion of the There are several types of evidence ergonomic risk factors (e.g., forceful anatomy of the low back region is that interrelate to support the five risk exertions, awkward work postures, high followed by a summary of the factors stated above as causative factors repetition, etc.) during simulated work occupational epidemiology literature on for MSDs of the back. Information on activities. Responses include both the low back. This section is followed pathophysiology provides evidence that objective biomechanical/physiological by a discussion of the biomechanical links risk factors to the physiological, measurements, such as the and laboratory research literature on anatomical, and pathological alterations electromyographic (EMG) activity of a stressors on the back. in soft tissues of the back. This speaks working muscle, and subjective The epidemiology literature is to the biologic plausibility that work- psychophysical measurements, such as examined, to the extent possible, by related risk factors contribute to these ratings of perceived exertion. Most of grouping by specific work-related stress injuries. There is also a large volume of the studies cited were performed in true factor. The biomechanical and epidemiological data that provides laboratory settings. A few studies were laboratory section discusses specific evidence of an association between performed in operational workplaces stressors separately for soft tissue worker exposure to the identified risk modified as necessary to collect data disorders, disc disorders, and arthritis/ factors and the occurrence of MSDs of under carefully controlled conditions. spondylosis. In the conclusion section the back. Finally, there is biomechanical Because of ethical issues related to the OSHA makes a determination of and psychophysical laboratory research protection and safety of human subjects, causality based on the consistency and that provides much corroboration and laboratory studies are designed to keep strength of the epidemiology evidence adds to the plausibility and coherence exposures to risk factors at levels below and the coherence with the arguments for a causal association the threshold of injury. As a result, biomechanical and laboratory evidence. determination. these studies are generally incapable of OSHA makes a determination of Epidemiologic and laboratory-based ‘‘proving’’ a relationship between causality on each occupational risk research methods have both been used exposure and injury. Despite this factor examined, where possible; to evaluate the significance of various limitation, laboratory studies provide however, the final determination of risk factors associated with work-related important scientific insights as to how work-related back MSDs is based on the musculoskeletal disorders (MSDs). the body responds to ergonomic totality of the evidence, not on each Epidemiologic studies are designed to stresses. Combined with factor separately. OSHA believes that look for significant associations between pathophysiological models of determining causal associations exposure to ergonomic risk factors and musculoskeletal injury mechanisms and between individual work-related risk selected health outcomes (ranging from epidemiological findings of positive factors and MSDs is helpful, both in medically diagnosed disease entities to relationships between exposure to making a final determination of subjective reports of pain or discomfort) ergonomic risk factors and causality and in determining ways to in selected populations of workers. musculoskeletal injury, laboratory abate risk. However, in discussing the NIOSH (Bernard and Fine, 1997, Ex. 26– studies are an essential element in epidemiology evidence it becomes clear 1) performed a comprehensive review of understanding the causes and that work often involves simultaneous the occupational epidemiology back prevention of work-related overexertion exposure to multiple risk factors, even MSD literature and after carefully injuries. though in any particular situation selecting those highest quality studies, Biomechanical models simulate and/ exposure to one risk factor may performed an assessment of the 42 or predict how the musculoskeletal predominate. studies by type of work-related risk system responds to work factors such as Anatomy of the Low Back factor. This evaluation draws from the external loads placed on the hands, NIOSH assessment and appends it with work posture, and movement dynamics. The lumbar spine is required to additional and more recent studies These models can be used to estimate redistribute forces related to both added to the record. musculoskeletal stresses in the absence intrinsic weight bearing and extrinsic Although epidemiologic studies of a human experiment. load carrying. It is composed of five provide important insights into To understand the mechanisms by vertebral bodies separated by understanding the causes of MSDs, which work causes or contributes to the intervertebral discs acting as shock these studies are sometimes criticized genesis or expression of low-back pain, absorbers and stabilizers, as well as the due to their inability to precisely it is first necessary to comprehend basic posterior vertebral ring composed of measure exposures to risk factors and low-back anatomy and potential sources pedicles, laminae, spinous and the associated biomechanical and/or of pain. The majority of low-back transverse processes, and facet joints physiological responses to these disorders involve soft tissues (muscle that enclose and protect the spinal cord exposures. Biomechanical models and and ligament) or the three-disc complex and spinal nerve roots. The lumbar laboratory studies do not replace (the intervertebral disc and two facets). vertebrae are numbered from the upper epidemiological studies. However, these The latter may involve degenerative disc (cephalad) or first lumbar vertebra (L1) approaches provide important disease, disc herniation or osteoarthritic to the lower (caudad) or fifth lumbar complementary information toward conditions. To understand how the vertebra (L5). Lumbar vertebrae are understanding the complex process of performance of work causes lumbar disc larger and wider than those in the dorsal how exposures to ergonomic risk factors disease, a review of lumbar anatomy, and cervical spine, with the fifth result in physiological responses that disc biochemistry, and disc vertebra generally the largest. This may ultimately lead to work-related biomechanics is presented here. With affords a larger surface area for the injuries and illnesses. Presented here is this foundation, pathogenic models are intervertebral disc and for load a summary of laboratory studies and better appreciated. Several references distribution. Disc anatomy and function biomechanical models of work factors are available for additional information will be discussed further in this section. associated with increased risk of low- (Bogduk and Twomey 1991, Ex. 26–720; At the lower end of the lumbar spine is back injuries and disorders. Chaffin and Andersson 1991, Ex. 26– the sacrum, a large, triangular bone

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These ganglia are encountered measures may be defined in terms of These joints help permit motion and in or close to the intervertebral bear some of the compressive load in severity and also whether the foramina. Axons of the nerve roots information was based on self-reports addition to helping maintain stability of consist of collagen tissue called the the spine against torsion and shear. (interview or questionnaire) or objective endoneurium. This is covered by a thin criteria, e.g., lumbar disc pathology. Facet joints are synovial, and they root sheath that separates the Because there are numerous contain nerve innervations in the endoneurium from a small amount of conditions in the low back which may synovial lining. cerebrospinal fluid, and the epineurium cause low back pain, regardless of their Anterior and posterior longitudinal and perineurium covering. Blood flow relationship to work factors, and, in ligaments attach to the superior and derives from segmental arteries that most cases the cause(s) cannot be inferior margins of the lumbar vertebrae, divide into three branches when determined with any degree of clinical and are innervated by pain fibers. The approaching the intervertebral foramen. ligamentum flavum is a non-innervated certainty, the most common form of Nociceptors are present in facet back disorder is ‘‘non-specific structure that runs down the vertebral synovium and outer layers of annulus ring, and may hypertrophy after injury. symptoms,’’ which often cannot be (or extension of the posterior diagnosed. Therefore, in its review of This may become significant when a longitudinal ligament). hypertrophied ligament infolds during the epidemiologic evidence for work- spinal extension in an individual with There are several important muscles relatedness of low-back musculoskeletal disc bulging and facet arthropathy, of the low back. The psoas muscles are disorders NIOSH (Bernard 1997; Ex. 26– thereby creating relative spinal stenosis. major spinal flexors that originate at the 1) included subjectively-defined health The interspinous ligament, also non- anterior vertebral borders and combine outcomes (e.g., ‘‘back pain’’) because innervated, runs down the posterior with the iliacus from the crest of the they comprise such a large subset of the margins of the spinous processes, pelvic ilium and insert on the pelvis total. From a total of 42 studies, 24 posterior projections from the vertebral and lesser trochanter of the hip. investigations defined the health ring. Posteriorly, the erector spinae muscles outcome only by report of symptoms on In adults, the spinal cord terminates attach to the spinous processes and questionnaire or interview, 2 used sick as the conus medullaris at about the laminae down to the sacrum to act as leaves and medical disability level of the first lumbar vertebra in the major spinal extensors. The retirements and 6 used injury/illness upper lumbar spine. Branching off from interspinales muscles run between the reports. The NIOSH review of the conus is a bundle of lumbosacral five spinous processes of the lumbar epidemiologic studies of low-back nerve roots that resemble a horse’s tail, spine and contribute to extension. disorders examined the following called the cauda equina. These nerve Several other coactivating muscles assist potential risk factors related to physical roots pass through the lumbar and sacral in spinal stabilization and rotation. The aspects of the workplace: (1) Heavy portions of the spinal canal surrounded rectus abdominis extends from the physical work (HPW, work that has high by the vertebrae, intervertebral discs, lower border of the rib cage to the pelvis energy demands or requires some pedicles, laminae, facet joints, and and assist in flexion and maintenance of measure of physical strength, jobs that spinal ligaments and eventually emerge lordosis. The obliques and transversus impose large compressive forces on the as individual nerve roots through the are coactivators, and contribute to the spine), (2) lifting and forceful intervertebral foramina. The neural generation of increased intraabdominal movements (LFM), (3) bending and foramen is bordered by the transverse pressure, which some feel helps twisting (BT, awkward postures), (4) processes of adjacent vertebrae, and the decrease compressive loading on the static work postures (SWP), and (5) spinal nerve root takes its name from spine. External moments imposed on whole-body vibration (WBV). These the adjacent (cephalad) vertebrae. The the lumbar spine during lifting are physical risk factors almost always spinal cord is covered by the thecal sac, proportional to the weight and distance appear in workplaces in combinations composed of meningeal tissue and of the load from the spine and the with other work-related risk factors, as cerebrospinal fluid. weight and location of the individual’s well as a myriad of personal, Nerve roots in the lumbosacral spine body segments. This results in a state of psychosocial and other factors. include ventral (motor) and dorsal equilibrium where the external However, to the extent possible the (sensory) components. Ventral roots moments are counteracted by internal review seeks to examine the physical contain motor axons sending signals to moments, primarily created by muscle factors separately. Furthermore, since distal areas and control various skeletal contractions of flexors balancing this ergonomics rule does not contain muscle motor functions. Dorsal roots extensors with additional stabilization provisions relating to WBV, this last comprise primarily sensory axons from co-activators. Ligaments provide portion of the NIOSH review will be receiving signals from distal areas or passive resistance or restorative moment substantively omitted from this analysis. dermatomes. Thus, symptoms and signs to muscles. It is not clear, however, Table V–7 contains a listing of both the of nerve root compression will vary under what lifting conditions the higher quality back studies used in the with the location of the compressive ligaments play a significant NIOSH 1997 (Ex. 26–1) review and lesion. As the intrathecal nerve roots biomechanical role. additional back studies in the record.

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TABLE V±7.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE BACK

Study/exhibit number Job type studied Physical fac- Exposure basis Physical Risk measure tors exam. (95% CI)1

Punnett, 1991 Ex. 26±39 ...... Auto assembly ..... HPW/BT Observation Yes ...... OR=2.2±8.1* LFM measurement. (1.4±4.4) Astrand, 1987 Ex. 26±527 ...... Pulp mill ...... HPW Questionnaire job Yes ...... OR=2.3* title. Bigos, 1991 Ex. 26±1242 ...... Aircraft assembly HPW Observation ques- No ...... NR* tionnaire. Burdorf, 1991 Ex. 26±454 ...... Concrete fabrica- HPW/BT Observation No ...... OR=2.8* tion. LFM measurement. (1.3±6.0) Clemmer, 1991 Ex. 26±1345 ...... Offshore drilling ... HPW Questionnaire job No ...... OR=2.2±4.3* title. Hildebrandt, 1995 Ex. 26±1516 ...... Population based HPW Questionnaire job No ...... OR=1.2* title. (1.33±1.55) Heliovaara, 1991 Ex. 26±959 ...... Population based HPW/LFM Questionnaire job Yes ...... OR=1.9±2.5* title. (1.4±4.7) Hildebrandt, 1996 Ex. 26±770 ...... Steel maintenance HPW Questionnaire job No ...... NR title. Johansson, 1994 Ex. 26±1132 ...... Metal workers ...... HPW/BT Questionnaire job No ...... PRR=1.76 LFM title. (1.25±2.47) Leigh, 1989 Ex. 26±750 ...... Population based HPW Questionnaire job No ...... OR=1.5* title. (1.1±2.2) Masset, 1994 Ex. 26±1470 ...... Steel workers ...... HPW/BT Questionnaire job No ...... NR title. Partridge, 1968 Ex. 26±1, pg. 6±81 ...... Dock workers ...... HPW Questionnaire job Yes ...... OR=1.2 title. Riihimaki, 1989 Ex. 26±998 ...... Concrete workers HPW/BT Questionnaire job No ...... OR/1.0±1.5* title. Riihimaki, 1994 Ex. 26±1188 ...... Heavy equipment BT Questionnaire job No ...... NR operators. title. Ryden, 1989 Ex. 26±809 ...... Hospital employ- HPW/BT Questionnaire job No ...... OR=2.2* ees. title. (1.25±4.15) Svensson, 1989 Ex. 26±732 ...... Population based HPW/BT Questionnaire job No ...... OR=1.2* LFM title. Videman, 1990 Ex. 26±1023 ...... Hospital patients .. HPW/SWP Questionnaire job autopsy .. OR=2.8±24.6* LFM title. (1.5±409) Bergenudd, 1988 Ex. 26±1342 ...... Population based HPW Questionnaire job No...... OR=1.8* title. (1.2±2.7) Burdorf, 1990 Ex. 26±1518 ...... Crane operators .. HPW/SWP Questionnaire job No ...... OR=0.5±4.0 LFM title. (0.8±21.2) Chaffin, 1973 Ex. 26±876 ...... Electronics LFM Job title ...... No ...... OR=5.0* manufact.. Holmstrom, 1992 Ex. 26±36 ...... Manual handling .. LFM/BT Questionnaire job Yes ...... OR=1.3* for BT SWP title. (1.1±1.5) Huang, 1988 Ex. 26±1204 ...... School lunch LFM Observation No ...... NR workers. measurement. Kelsey, 1975 Ex. 26±1134 ...... Case/control her- LFM/SWP Questionnaire job No ...... NR niated lumbar title. disc. Kelsey, 1984 Ex. 26±752 ...... Case/control LFM/BT Questionnaire job Yes ...... OR=3.1* prolapsed lum- title. (1.3±7.5) bar disc. Knibbe, 1996 Ex. 26±766 ...... Nurses ...... LFM Questionnaire job No ...... OR=1.3 title. Magora, 1972, 1973 Ex. 26±1513 ...... 8 occupations ...... LFM/BT Observation No ...... OR=1.0±1.7* measurement. (1.3±2.1) Liles, 1984 Ex. 26±33 ...... Manual handling .. LFM Measurement ...... No ...... OR=4.5* (1.02±19.9) Marras, 1995 Ex. 26±14±12 ...... Manufacturing LFM/BT/ Observation No ...... OR=10.7* workers. HPW measurement. (4.9±23.6) Toroptsova, 1995 Ex. 26±1, pg. 6±92 ...... Machine builders LFM/BT/ Questionnaire job Yes ...... OR=1.4*±1.7* SWP title. Undeutsch, 1982 Ex. 26±731 ...... Airport baggage LFM Questionnaire job Yes ...... NR handlers. title. Walsh, 1989 Ex. 26±1437 ...... Population based LFM/SWP Questionnaire job No ...... OR=1.5±2.0* title. (1.1±3.7) Skov, 1996 Ex. 26±674 ...... Saleworkers ...... SWP Questionnaire job No ...... OR=2.5* title. (1.2±4.9) Mandel, 1987 Ex. 500±41±92 ...... Hospital nurses ... LFM Questionnaire ...... No ...... OR=1.4* Thorbjornsson, 1998 Ex. 500±119±7 ...... Random selection HPW Questionnaire ...... Yes ...... OR=1.4* from 2500 med- (1.0±2.0) ical exams.

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TABLE V±7.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE BACKÐ Continued

Study/exhibit number Job type studied Physical fac- Exposure basis Physical Risk measure tors exam. (95% CI)1

Kuh, 1993 Ex. 500±41±80 ...... Population based LFM Job title ...... No ...... RR=1.3* (1.0±1.7) Smedley, 1995 Ex. 500±41±40 ...... Hospital nurses ... LFM Questionnaire ...... No ...... OR=1.3±1.8* (1.3±2.5) Venning, 1987 Ex. 500±41±49 ...... Nurses ...... LFM Questionnaire job No ...... OR=1.7±4.3* title. Xu, 1997 Ex. 500±119±9 ...... Population based BT/HPW Questionnaire ...... No ...... OR=1.3±1.7* (1.51±1.93) Stobbe, 1988 Ex. 500±41±45 ...... Hospital nurses, LFM Questionnaire ...... No ...... OR=1.0±2.7* LPNs, attend- ants. Park, 1997 Ex. 500±41±104 ...... Population based HPW/LFM/ Questionnaire ...... No ...... OR=1.88* BT (1.64±2.15) for HPW Latza, 2000 Ex. 500±41±83 ...... Population based HPW/BT/ Questionnaire ...... No ...... OR=1.77±1.89* SWP/LFM Latza, 2000 Ex. 500±119±6 ...... Laying sandstone HPW/LFm Questionnaire ...... Yes ...... PR=1.8±2.6* (1.1±6.5) for hours/shift Kerr, in press Ex. 500±39 ...... Automotive work- LFM/BT Measurement ...... No ...... OR=1.7±2.0* ers. (1.22±3.59) for biomechanical factors Krause, 1998 Ex. 500±87±2 ...... Transit vehicle HPW Questionnaire Yes ...... OR=3.04* workers. records. (1.85±5.00) MacFarlane, 1997 Ex. 500±41±91 ...... Population based LFM Questionnaire ...... Yes ...... OR=1.1±2.5* (1.5±4.1) Waters, 1999 Ex. 500±41±54 ...... Lifting case/con- LFM Questionnaire No ...... OR=2.45* trol. measurement. (1.29±4.85) Wang, 1998 Ex. 500±41±52 ...... Manual handling .. LFM Measurement ...... No ...... Significant cor- relation p<0.01 Van Poppel, 1998 Ex. 500±121±71 ...... Airline baggage HPW Questionnaire ...... No ...... NR handlers. Vingard, 2000 Ex. 500±41±51 ...... Population based HPW/LFM/ Questionnaire ...... No ...... RR=1.4±2.9* BT (1.2±6.8) Luoma, 1998, (2000) Exs. 500±71±39, (38) ...... Not by identifiable risk factor but Job title ...... Yes ...... OR=2.0±8.1* by titleÐoffice carpenter ma- (2.4±21.1) chine driver SHARP, 1993 Ex. 30±7 ...... Data entry ...... SWP Questionnaire ...... No ...... NR* (p<0.05) Larese, 1994 Ex. 38±130 ...... Hospital nurses ... LFM Measurement ...... Yes ...... OR=1.9±2.4* Myers, 1999 Ex. 500±119±10 ...... Case/control mu- HPW/BT/ Questionnaire No ...... OR=1.6±2.0* nicipal workers. LFM measurement (1.13±3.67) for job title. BT HPW=heavy physical work; LFM=lifting or forceful movements; BT=bending and twisting or other awkward postures; SWP=static work postures IR=incidence rate; OR=odds ratio; RR=relative risk; NR=not reported; *=p<0.05 1 95% confidence limits expressed for the upper end of the risk measure range.

Heavy Physical Work eighteen found statistically significant al. 1991, Ex. 26–1241), while two The NIOSH summary reviewed the positive associations. The relative risk showed statistically significant eighteen higher quality studies which estimates for these significant increases (Clemmer et al. 1991, Ex. 26– address the association between HPW associations generally ranged from 1.1 1345; Bergenudd et al. 1988 Ex. 26– and LBP (Ex. 26–1, pgs. 6–4 to 6–13). Of to 4.3, although one study of cadavers 1342). Two cross sectional studies also these eighteen, 14 were cross-sectional, found a significant OR=12.1 (95% C.I. considered temporal relationships by 3 were prospective) and one was a case- 1.4—107) for the risk of osteophytosis including in the analysis only those control (Ryden et al. 1989, Ex. 26–801). among those in the HPW category. MSD-free when starting their current Study populations included individuals OSHA notes that if there were no true jobs, and both showed positive working in health care, office work, associations only one of these eighteen associations (Burdorf et al. 1991, Ex. manufacturing and construction, and all studies should have shown a 26–454; Burdorf and Zondervan 1990, with different physical work statistically significant result. Ex. 26–1518). Thus, these results are requirements. Despite the fact that the With regard to temporality, this is consistent with a positive finding for studies assessed different groups of usually most easily studied with a temporality. workers, defined disorders and assessed cohort study design. Of these three OSHA also notes that the Bureau of exposures in many ways, nine of these studies, one had no association (Bigos et Labor Statistics Annual Survey of

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Injuries and Illnesses as well as other department. Cases were defined from were controlled for in the regression health interview surveys have found reports from the city Occupational models. Results found that 17.6% of elevated LBP rates and MSDs in typical Medicine Clinic, and were those who workers reported back pain every day HPW associated occupations, (female) had been assigned restricted work or for one or more weeks during a 12 nursing aides, orderlies and attendants; had lost work time due to back injury. month period; 26.9% of these reports personal care; and air transportation Further information was gathered from were attributed to repeated activities workers (see the risk assessment in questionnaire about work history, work (RA) at work; 17% to RA and injury, section VI of this preamble). While characteristics, work injuries, back pain, and 8.2% to injury at work. The survey statistics may not be definitive in psychosocial behaviors, and majority of back pain found in blue themselves, they show a pattern of demographics. Exposure was assessed collar workers (OR=1.38, 95% C.I. consistency with the results from the by questionnaire and measurement; the 1.22—1.54), was attributed to work; epidemiology studies discussed above. strenuousness of each worker’s job whereas the majority of BP in white- OSHA notes that these types of classified as light, medium, or heavy collar workers was not attributed to population-based studies can be less according to weight capacity, frequency work conditions. A higher proportion of reliable than other epidemiology and duration of sitting-standing- workers with work-related back pain designs due to generally less knowledge walking. Analyses screened for 2-way, caused by injury or RA had pain in the about individual exposures. 3-way and 4-way interactions. The lower back extending to lower body Since OSHA’s Ergonomics proposal variables examined included a work parts, had missed work more than 5 was published, several other studies on movement index, which combined days, and had changed jobs than had HPW and LBP have been put into the twisting, extended reaching, and workers with non-work related back record. Several are discussed below: stooping. Factor analysis was used to pain. Other significant variables were The Vingard et al., 2000 (Ex. 500–41– determine the important psychosocial ‘‘strenuous physical activities at work 114) population-based case-referent factors from the Job Content more than 4 hours per day [HPW]’’ study suggests that prolonged exposure Questionnaire. There was no difference (OR=1.88, 95% C.I. 1.64—2.15), to many years of heavy work and in the prevalence among the cases and ‘‘repetitive movements more than 4 forward bending (cumulative exposure) controls regarding physical work hours per day’’ (OR=2.4, 95% C.I. 2.1— increases the risk of LBP. The Latza et demands (light, medium, and heavy), 2.77) and current smoking (OR=1.57, al., 2000 (Ex. 38–424) prospective study, nor twisting or extended reach. 95% C.I. 1.39—1.76), BMI greater than after adjusting for trade, found However, because the cases and controls 28 kg/m2 (OR=1.35, 95% C.I. 1.2—1.52) exposure-response relationships for were matched on job department and/or and age 35–59 (OR=1.31, 95% C.I. 1.2— hours per shift laying sandstone job title, the design provided little 1.46). The strength of this study is the (PR=1.8, 95% C.I. 0.7—4.7, for 0 to <2 ability to examine those job factors. This rigorousness used by the National hours; PR=2.6, 95% C.I. 1.1—6.5, for ≥ would also preclude any conclusions Center for Health Statistics in their 2 hours; trend test p=0.03), and stone pertaining to the relative strength study design and analysis. A weakness load (PR=1.8, 95% C.I. 0.4—9.5, for between psychosocial and physical is that it is based on questionnaire data. intermediate level; PR=4.0, 95% C.I. factors. Although the authors noted that 0.8—19.8 for high level; trend test Thorbjornsson et al, (1998, Ex. 500– their ‘‘findings underscore the p=0.03). The Krause et al. 1998 study 119–7) used data collected over 24 years importance of adopting a model that (Ex. 38–272) found that cable car crews for its cohort study. 252 women and 232 does not focus entirely on physical performing the heaviest physical labor men were randomly selected from 2500 factors in relation to the multifactorial had a three-fold increased risk of spinal for medical examination (a 62% problem of back injury,’’ their study injury compared with bus driver participation rate). In 1969 these (OR=3.04, 95% C.I. 1.85—5.00). This design did not allow them to focus subjects had a questionnaire-based five year prospective study of 1,871 adequately on the physical factors. This interview and an examination. LBP was transit vehicle operation also found both study focused on the psychosocial defined as pain, aching, or stiffness in physical workload and psychosocial job aspects of the acute back pain but did the lower back in the past 12 months. factors independently predict spinal not adequately address work factors. There was a follow-up a re-examination injury in transit vehicle operators. Park et al. (1997, Ex. 500–41–104) in 1993. Exposure assessment was based OSHA has also considered three other carried out a cross-sectional study using on a questionnaire from 1969 using a studies available since the proposal on data from the National Health Interview dichotomous scale for 11 work factors HPW. Two of these three studies found Survey Occupational Health (e.g., high mental load (hectic work, at least one statistically significant Supplement, 1988. In this survey, exhaustion at end of day), poor association between LBP and HPW 30,074 randomly selected employed supervisor social support, monotonous while the third suffered from persons were asked about back pain work, full time work; night or shift methodological problems. Myers et al. occurring every day for a week or more work, overtime work, high physical load (1999, Ex. 500–119–10) carried out a in the previous 12 months. The (40 kg for women, 60 kg for men or case-control study of 274 workers with response rate was 87%. Causes of back physical exhaustion at end of day), symptoms and signs of low back pain pain were classified into 3 groups: (1) severe vibrations, and non-working from four municipal departments (a Injury and/or repeated activities that conditions, using a dichotomous scale. 73% participation rate). The stated occurred at work; (2) injury and/or (Insufficient or unsatisfactory leisure purpose was to identify factors, both repeated activities that occurred outside time, few or unsatisfactory social physical work characteristics and work; and (3) other reasons (illness, contacts, additional domestic psychosocial factors, associated with diseases, unknown). Self-reported work workload). Risk factors for back pain acute low back injury. Two randomly activities included repeated activities during 1972–1992 included: for women, selected controls were chosen, one with lifting, pushing, pulling, bending, unsatisfactory leisure time (OR=1.5, matched according to work tasks, which twisting, or reaching. Occupation was 95% C.I. 1.1—2.0); for men, 1972–1993: the authors stated ‘‘could be used to coded according to the 1980 classified high physical load (OR=1.4, 95% examine importance of non-ergonomic Index of Industries and Occupations of C.I.1.0—2.0), vibrations (OR=1.4, 95% factors’’ and one matched by the U.S. Bureau of Census. Confounders C.I. 1.0—2.2), and unsatisfactory leisure

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00213 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68474 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations time (OR=1.5, 95% C.I. 1.1—2.0). Since OSHA’s Ergonomics proposal cared for double the number of patients Cumulative incidence ratios for 1972– was published, several other studies on compared to the oncology nurses. 1993, adjusted for age, and earlier back LFM have been put into the record. Calculating crude odds ratios showed pain were 38% for women and 43% for Some are more recent, and these are that general nurses had an OR=1.9 (95% men. discussed first, while several older C.I. 1.32—2.76) for LBP and an OR=2.4 studies, not part of the original review, (95% C.I. 1.35—4.27) for back pain sick Lifting and Forceful Movements (LFM) are also discussed below. leave compared to the oncology nurses. The NIOSH summary reviewed the 18 With respect to the more recent The authors used the Mantel-Haenzel higher quality studies that address the studies, published since 1996, the chi-square statistics to control for age association between LFM and LBP (Ex. studies of LFM and LBP in a wide and for occupation among the two 26–1, pgs. 6–13 to 6–21). Of the eighteen variety of industries provide substantial groups, but multivariate analysis to studies, 13 were cross-sectional, two additional evidence that repetitive control for both factors simultaneously were prospective, and three were case- lifting is associated with low back was not done. The authors concluded control designs. Only the one case- disorders. that ‘‘comparison between the two control study of back pain in auto There are a limited number of hospitals suggests factors associated workers (Punnett et al. 1991, Ex. 26–39) negative studies which provide little with the disorders: work tasks and fulfilled all four of their quality evidence to weaken the overall particularly nurses/patients ratio are evaluation criteria. Besides auto conclusion from the much large number more important than age and length of workers, among the study groups which of positive studies. Other reportedly exposure.’’ The authors did not present showed increased risks to workers with negative studies of lifting and low back the data from which they drew these high lifting or manual materials disorders have limitations. For example, conclusions. handling (MMH) demands were nursing Feyer, Herbison et al. (2000, Ex. 26– Stobbe et al. (1988, Ex. 500–41–45) aides, baggage handlers, workers in 1499) conducted a prospective study of carried out a retrospective study of three manufacturing and electronics, crane low back pain among nursing students, hospital groups at a major medical operators, and concrete fabricators, but there was no evaluation of the center including 143 licensed practical although several studies focused more physical demands of jobs and there was nurses, 252 nurses aides, and 20 a 1/3 dropout from the study. on the actual stresses within the job attendants. Two groups were identified, In addition to the more recent studies, rather than job title. In all 10 of the one exposed to frequent patient lifting, six older studies, not in the proposal, eighteen studies showed at least some one not. Health outcome was defined as also discussed the relationship between back injuries, including both lost-time statistically significant associations LFM and LBP. Mandel and Lohman between LFM and LBP, with the and non-lost-time injuries. Lifting (1987, Ex. 500–41–92) showed an frequency was determined through significant risk estimates generally increased risk of back pain with lifting ranging from 1.2 to 5.2 (Ex. 26–1, pg. 6– interviews with the nursing director, the more than10 patients per week head nurse, and nursing supervisors. 41). For the most part, higher ORs were (OR=1.39, 95% C.I. 1.05—1.84) in a High frequency lifting was defined as an observed in high-exposure populations. cross-sectional study in which 428 average of more than 5 patient lifts per The highest risk estimate (OR=10.7) was registered nurses in a Midwestern shift. Low frequency lifting (control from a group of workers in a cross- hospital participated (rate was 65%). group) was defined as average of less sectional study by Marras et al., (1993, Fifteen percent of the nurses had than two patient lifts per shift. Nursing Ex. 26–170; 1995, Ex. 26–171). The reported experiencing LBP for the first personnel with estimated exposures of MMH workers with this highest OR had time during the study year, with most 3–5 patient lifts per shift were excluded. the highest combination of exposure episodes occurring in younger workers. Lifting frequency (OR=2.7, p=0.009), measures relating to five specific risk However, while intensive care unit and length of employment ( p=0.0085) factors associated with lifting, twisting, nurses lifted significantly more patients, remained significant in the logistic frequency, angle, and force, again LBP was not associated with work area. regression model, while occupation did strongly suggesting synergism among The most significant associations were not. The authors used a survivor type the risk factors. The 5 studies reviewed having LBP prior to the study year and conditional analysis which assumed for this chapter which showed no having pain in another part of the spine. that when a person with a back injury association between lifting and back The limitations of this study are its report resumed work, the future disorder used subjective measurements participation rate and both its exposure probability of injury was the same as if of exposure, had poorly described assessment and health outcome there had been no previous injury. This exposure assessment methodology, or definition. However, despite these assumption has not been supported in showed little differentiation within the limitations, it provides support for other studies. study group. patient lifting as a risk factor for LBP in Kuh et al. (1993, Ex. 500–41–80) in With regard to temporality, both the nurses. their longitudinal study of 3262 same prospective studies which assessed Larese and Fiorto (1994, Ex. 38–130) age Great Britain natives (born the first exposures prior to identification of in a cross-sectional study compared 425 week, 1946), looked at risk factors for MSDs, had positive association. Also, of general nursing staff from an urban LBP, mainly the association with stature the four (three cross-sectional and one hospital to 198 oncology nurses and height, but also lifting. The study case-control) studies which attempted to (participation rate: 91.4%). LBP cases population had been followed every 2 address temporality, three found were based on clinical examination or years in childhood, and every 5 years as positive relationships between lifting X-ray findings. Exposure measurements adults. Participation rate for this study and LBP. OSHA also notes that of the included the analysis of working was only 60.8%. Exposure was assessed eight studies which examined exposure- conditions, which revealed both groups using job title and occupational response relationships in some manner, of nurses had to do frequent and heavy histories. A matrix assigned jobs to three six found positive associations, lifting, lowering, and pushing-pulling. levels of lifting—low, intermediate and including Punnett et al., 1991, (Ex. 26– Differences were found when analyzing high. The interaction of height and 39) while two others did not (Ex. 26–1, the number of patients assisted by the occupational lifting as a risk factor for pg. 6–20). different nursing groups: the staff nurses LBP was investigated for men. The onset

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00214 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68475 of back pain symptoms was significantly Smedley et al. (1995, Ex. 500–41–40) about non-musculoskeletal symptoms, more common in men whose jobs were conducted a cross-sectional survey of included in the questionnaire, were likely to involve heavy lifting (RR=1.3, 2,405 nurses using a self-administered designed to investigate whether 95% C.I. 1.0—1.7). The main questionnaire to investigate the risk psychological factors that influence occupations of heavy lifting associated factors associated with low back pain. reporting of other symptoms also affect with LBP were farming and The response rate was sixty-nine reporting of LBP. After adjustment for construction. There was discussion of percent. Among those who responded to age, height and non-musculoskeletal reporting bias, recall bias, lack of direct the survey, 1616 were women. Due to symptoms, significant associations were information about lifting at work. The the low number of male respondents, found for: frequency of manually this study focused on female workers. weakness of this study is using ‘‘job moving patients around on the bed; Low back pain was defined as pain title’’ as surrogate for exposure, but a manually transferring patients between lasting for longer than a day in an area bias here is likely to mask true bed and chair; and manually lifting between the twelfth rib and the gluteal associations. folds (indicated on a chart). Questions patients from the floor.

Frequency OR 95% C.I. Factors controlled

Manual Movement of Patients on Bed

5±9 moves ...... 1.5 1.1±2.2 Age/height. 5±9 moves ...... 1.6 1.1±2.3 Age/height/non-musculoskeletal symptoms. 10+ moves ...... 1.7 1.2±2.3 Age/height. 10+ moves ...... 1.7 1.2±2.4 Age/height/non-musculoskeletal symptoms.

Manual transfer of patients between bed and chair

5±9 moves ...... 1.7 1.2±2.3 Age/height. 5±9 moves ...... 1.8 1.3±2.5 Age/height/non-musculoskeletal symptoms. 10+ moves ...... 1.5 1.1±2.1 Age/height. 10+ moves ...... 1.5 1.1±2.1 Age/height/non-musculoskeletal symptoms.

Evaluation of the task of manually elevated when a forward stepping at least one statistically significant lifting patients from the floor resulted in model of logistic regression was association between LFM and LBP. similar significantly elevated risks applied. The observed adjusted odds When considered with the 10 studies regardless of whether age and height ratios were: 4.26 for service areas where originally reviewed by NIOSH which alone or all three factors, i.e., age, lifting occurs most often as compared found statistically significant height, non-musculoskeletal symptoms, with areas where lifting occurs least; associations, this epidemiology data were controlled for (OR=1.3, 95% 2.19 for daily lifters as compared with base provides strong evidence for a C.I.1.0—1.6). In this study, nurses who light, occasional, and nonlifters; 1.77 for causal association between LFM and often report non-musculoskeletal nursing aides as compared with LBP. symptoms, such as low mood or stress, registered nurses and supervisory Bending and Twisting/Awkward were significantly more likely to report personnel; and 1.73 for individuals who Postures (BT) low back pain. For example, frequent have previously reported back injury as low mood was strongly associated with compared with those who have not The NIOSH summary reviewed the 12 subsequent back pain (OR=3.2, 95% reported previous injury. No other higher quality studies which addressed C.I.. 2.2—4.8). Specific manual handling factors, including age, physical activity, the association between BT and LBP tasks were associated with an increased availability of lifting aids, height and (Ex. 26–1 pgs. 6–21 to 6–26). Of the risk of back pain while no such weight, and instruction in back care and twelve, nine also examined the effects of association was found in this study lifting procedures, were significantly occupational lifting, although for all but among nurses using mechanized patient associated with reporting of back injury. the Marras et al., (1993, Ex. 26–170; transfer (with hoists). The influence of service area is not 1995, Ex. 26–171) analysis discussed A study of personal and job-related easily explained. The authors chose to above the presented comparisons for factors that may affect the incidence of define service area as a work activity. LFM and BT are different. As with the back injuries among 5,649 nurses was With an attitudinal measurement, job analysis for BT above, only the Punnett conducted by Venning et al. (1987, Ex. satisfaction may have also proven to be et al., 1991 case-control study fulfilled 500–41–49). A ‘‘back complaint’’ was a significant factor. The question would all four of the quality evaluation criteria. defined as any work-related injury or then be one of temporality and Nine studies were cross-sectional, two complaint of discomfort in the back and association between those factors. It is were case-control and one was reported through an employee health clear, however, that service area prospective. Of the twelve studies seven office. Nurses were surveyed by assignment is a major risk factor. When reported statistically significant questionnaire and then observed for a two employees who are similar in job associations, with the significant risk 12-month study period. As annual category and history of back injury are estimates generally ranging from 1.2 to injury rate of 4.9% was observed. Four assigned to different service areas, the 3.5. However, two of these ORs were factors were found to be highly risk of back injury is dependent on that higher; in addition to the previously statistically significant (p<0.01) ward assignment. mentioned OR of 10.7 in the Marras et predictors of back injury. Risk estimates In summary, seven of the eight new al. (Exs. 26–170, 26–171) study, Punnett for all four factors (service area, lifting, studies, and all six of the older studies et al., 1991, (Ex. 26–39) using a job category, and previously reported (all of nurses and nursing assistants who multivariate analysis that adjusted for back injury), remained significantly did more frequent patient lifting), found covariates, found a statistically

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00215 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68476 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations significant OR=8.09 (95% C.I. 1.4–44) The third recent study, Xu et al., reviews also examines psychosocial for time in a non-neutral position for (1997, Ex. 500–119–9), examined factors (Ex. 500–71–24). These are auto workers. Several studies suggested bending and twisting, as well as discussed below. that both lifting and awkward postures physically hard work in the Danish The Burdorf and Sorock (1997, Ex. were important co-contributors to risk of population in a cross-sectional survey 500–71–24) review assessed the low back disorder. conducted in 1990. A random sample of epidemiologic evidence of occupational With regard to temporality and 5,185 workers with similar sex, age, and risk factors for back disorders. They exposure-response, three studies—one occupational distributions as in the included only those published studies prospective, one case-control, and one Danish population was selected, with a that clearly described exposure cross-sectional—attempted designs and response rate of 89.3%. The health measures, had quantitative estimates of analysis to investigate temporality. Only outcome was defined as symptoms of risk for work-related factors, and did not the case-control study of Punnett et al., back pain in the past 12 months, have evidence of a serious 1991 (Ex. 26–39) found a strong assessed by structured interview, and methodological problem. In all they association between exposure to included conditions of pain, ache, included thirty-five articles, which they awkward postures and back pain. The discomfort localized in the lower back, assessed for associations with physical Riihimaki et al., 1994 (Ex. 26–1188) regardless of intensity and severity. factors at work, psychosocial factors at prospective study comparing heavy Occupational exposure information work, and individual factors. Of the 19 equipment operators with office workers included duration of daily exposure, cited studies reporting on associations found a three year prevalence ratio for vibrations affecting the whole body, between back disorders and lifting or LBP of 1.4 (95% C.I. 1.0–1.9) (Ex. 26– physically hard work, frequently carrying of loads (LFM), sixteen were 1, 6–86). For exposure-response twisting or bending, sitting down, positive. The risk estimates ranged from relationships between posture and low standing up, walking a lot, working with 1.12 to 3.07, with attributable fractions back disorder, five of the six studies hands raised, concentration demands, estimated between 11% and 54%. Nine which attempted such an analysis found repetition, and lifting heavy loads. The out of ten studies reported positive significant relationships between some psychosocial factor ‘‘concentration associations with frequent bending or incremental index of LBP and exposures demands’’ was also included in the twisting of the trunk (BT), three of relating to awkward postures. model. Confounders controlled for which reported exposure-response Since OSHA’s Ergonomics proposal included gender, age group, educational relationships. Seven studies examined was published, three other recent level, and duration of employment. heavy physical load (HPW); six of these studies on BT and LBP have been put There was a significant dose-response demonstrated increased risks of 1.54 to into the record. These are discussed trend towards the greater prevalence of 2.58; however the one large longitudinal below: LBP with a greater proportion of the day study did not demonstrate an With respect to the two most recent exposed to the risk factors, for two association between physical load and studies, both Latza et al., 2000, (Ex. 38– physical factors—physically hard work the incidence of back injury claims 424) and Vingard et al., 2000 (Ex. 502– (OR=1.28, 95% C.I. 1.08–1.52), and during the study period (Ex. 26–1242). 410) have been discussed above, in both frequent twisting or bending (OR=1.71, For static work postures (SWP), seven the HPW and LFM sections. The Latza 95% C.I. 1.51–1.93). Concentration studies were considered and three of et al. study, in a logistic regression demands and standing up were also these had positive associations, The analysis controlling for several significantly positively associated with authors found some evidence of an covariables, found that risk factors for the occurrence of low back pain. The association between the psychosocial LBP included working in a bent results indicate that the associations of factors of job dissatisfaction and low job position, for men, with an OR =1.89 risk factors with LBP were stronger decision latitude and back pain, but the (95% C.I. 1.03–3.46). This OR was among those required to work for 37 or evidence was not consistent across greater than those, computed in the more hours/wk. The authors addressed different studies and study designs. The same regression analysis, for carrying issues of recall and participation bias. review found that age, smoking habit, heavy loads, OR=1.47 (95% C.I. 0.97– In summary, the statistically and education may be important 2.24), and heavy physical work OR=1.77 significant associations of BT and LBP confounders, while the individual (95% C.I.1.06–2.93). For the Vingard et seen in seven of the 12 NIOSH reviewed characteristics of gender, height, weight, al. study, there were statistically studies and in all three of the more exercise or sport, and marital status significant associations for both men recent studies, provide by strong were consistently not associated with and women when related to both heavy evidence that the associations observed back disorders. The finding that exercise and cumulative exposures. When the are real. or sport, the one physical individual combined physical exposures of characteristic examined, was not Recent Epidemiology Reviews of Work- ‘‘heavily exposed to forward bending’’ associated with back disorders provides Related Low Back Disorders and ‘‘manual handling over the last ten supporting evidence that the physical years’’ were added to current exposures, Since the NIOSH 1997 review, there work-related risk factor findings are real the estimated RRs in men was 2.8 (95% have been three published reviews and are not confounded by leisure time C.I. 1.1–7.5) and in women 2.9 (95% C.I. which bear on the epidemiology of the physical factors. 1.2–6.8). Multiple logistic analyses work-related risk factors for back pain In making their causality adjusting for a wide range of variables discussed above. The first is the NAS determination, Burdorf and Sorock including age, social support at work report, discussed elsewhere in this acknowledged that the majority of cross- and outside work, low back pain earlier, Health Effects section, which reviews sectional design studies in the data base and negative life events, did not identify and affirms the appropriateness of the precluded a firm determination of the many physical or psychosocial factors methodology and the conclusions of the temporal and specificity criteria of the as significant predictors. However, for NIOSH 1997 review (Exs. 26–37). The Hill criteria; they also expressed some ‘‘forward bending greater than one other two are recently published concern that ‘‘the state of the art does hour’’ the RR in men was 1.8 (95% C.I. reviews relating specifically to risk not allow unequivocal conclusions 1.1–3.1), and in women 1.2 (95% CI factors, especially physical stress about the contribution of specific work- 0.7–1.8). factors, for back pain. One of these related risk factors to the incidence of

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00216 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68477 back disorders.’’ (Ex. 500–71–24, pg. found for standing, walking, sitting, work before the age of 20. Also, based 253). Nevertheless, they concluded that: sports, and total leisure time physical on a job scale rating of 1 to 4 to Despite these methodological concerns, the activity. aggregate every job title and associated available literature has presented persuasive OSHA finds that the consistency of task descriptions during a subject’s evidence for several risk factors for work- findings in the NIOSH 1997 (Ex. 26–1) lifetime work history, the mean absolute related back disorders. Various studies with and the two other recent reviews, all job scale difference in these 115 twin clear differences in design, methodology, and using different study selection and pairs was 0.9. For mean hours working populations have consistently produced evaluation criteria, provides in bending/twisting positions the comparable findings for MMH, frequent BT, confirmation of OSHA’s emphasis on absolute mean difference within the 115 heavy physical load and WBV. With regard NIOSH’s methodology and conclusions pairs was 1.6 hours. This means that to MMH, sufficient biomechanical and for work-related causes of back pain. physiological evidence is available to support this study had little statistical power to the biological plausibility of lifting as a risk The assessment on physical load factors show differences among physical work factor for back disorders. The results on was insensitive to slight changes in the factors, after adjusting for genetic lifting do not distinguish between the effect assessment of findings and the factors, since only discordant pair of infrequent lifting of heavy loads and methodological quality of the studies. results factor into an individual frequent lifting of light loads. The studies Burdorf and Sorock (Ex. 500–71–24), in matched analysis. among nurses indicate that a single lift of a their review, also commented that The authors examined the patient is associated with an increased risk comparable findings were consistently associations between the several of back pain or back disability [cite to Exs. found for heavy physical work, lifting, exposure factors and disc degeneration 500–41–92, 500–41–70, and 500–41–49]. twisting and bending, and whole body scores using both univariate and This finding is consistent with vibration at work in various studies multivariate analyses, and both biomechanical evaluations that predict high compression forces on the lower back during with clear differences in design, observational and digital summary patient lifting [cite to Ex. 38–141]. Frequent methodology, and populations. scores for disc degeneration for both upper and lower bask disc degeneration BT of the trunk was consistently related to Dr. Tapio Videman’s Testimony on scores. In the univariate analyses, which back disorders in various studies. In one Twin Back Studies case-referent study with detailed exposure apparently did not factor in the twins assessment, a clear dose-response Dr. Tapio Videman, DrMedSci, matched pair design, only the heavier relationship was shown [cite to Ex. 26–39]. University of Helsinki, testified that a physical work job code score and mean The findings for heavy physical load weakness with the OSHA proposal was total occupational lifting per day were demonstrate that this is an important work- that in the studies OSHA examined, the significantly adversely associated with related risk factor. Several community-based role of genetic factors was not taken into disc degeneration score, and then only studies have presented dose-response account in studies estimating the effect gradients [cite to Exs. 29–959, and others]. for the high back discs. Most other The strength of the gradients is difficult to of work-related stress factors (Tr. increased physical activity and smoking assess since self reports have been applied to 16996). To make this point, Dr. scores were also associated with rank exposure to physical load on ordinal Videman presented a slide in his increased disc degeneration scores, but scales. A second problem is that this testimony (Tr. 16997) that referred to a the associations were not statistically particular risk factor probably includes MMH published paper he had co-authored on significant. Increased mean time sitting and frequent BT. Hence, in epidemiologic the determinants of lumbar disc at work was associated with less disc surveys, heavy physical load might be a degeneration in a retrospective cohort degeneration for both high and low surrogate measure for other risk factors rather study (Ex. 26–71). The study design back, but only the high back scores than a separate risk factor (Ex. 500–71–24, attempted to control for the role of showed statistical significance. pg. 253). genetics by comparing disc degeneration To attempt to control for the genetic Finally the review concludes: scores between identical twins with effect, the authors also used multiple This review concludes that there is a clear different exposure factors thought to be regression methods in an attempt to relationship between back disorders and associated with back pain. Among the explain the observation summary disc physical load, that is, between back disorders factors examined in the paper were scores. Their results found that, for the and MMH, frequent BT, HPW, and WBV. occupational workload, leisure time upper back, only the mean job code and * * * the evidence presented indicates that physical activities, measures of aerobic age were jointly statistically significant, preventive measure reducing the exposure to exercise and other sports participation, with no other specific environmental or these risk factors will decrease the occupational driving, and smoking. behavioral factors contributing occurrence of back disorders. The study consisted of 115 pairs of significantly. For the lower back, heavy Hoogendoorn et al. (1999, Ex. 500– identical twins selected from the leisure time physical loading was the 71–32) conducted systematic reviews of Finnish Twin cohort, who were among only specific environmental factor of the literature for physical load as risk the most discordant pairs in terms of the statistical importance; this one variable factors for back pain. A rating system exposure factors mentioned above. The explained 2% of the variance in the was used to assess the evidence based objective was to study whether multiple regression model. on methodological quality and differences in exposure factors In an attempt to consider the amount consistency of the findings; under this correlated with the disc degeneration contributed by the genetic component in scheme cross-sectional studies were scores, controlling for genetic factors. the study design, the authors inserted excluded based on the authors’ quality Both observational and digital summary 114 co-twin (indicator) variables in the criteria. The review of studies scores for disc degeneration, based on model and recalculated the estimates. addressing physical load examined 28 an MRI examination, were obtained for They found that together, these 114 cohort and 3 case-referent studies. For both the upper and lower back regions. variables, ‘‘those of familial aggregation, physical load, the review found that Occupational and leisure physical reflecting primary genetic and shared strong evidence exists for work-related activity responses were derived via early environmental influences * * * MMH, BT, and whole-body vibration as personal interviews. explained nearly 75% of the variability risk factors for back pain. Moderate An important feature of the study in disc degeneration score in the upper evidence exists for patient handling design is that of the 115 pairs of twins region and nearly 50% in the lower (LFM) and HPW, and no evidence was only 23 pairs were discordant for heavy lumbar region (id., pg. 2608). The

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00217 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68478 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations authors concluded, as did Dr. Videman variables will explain most of the The Bigos et al., 1991 Back Study in his testimony, that these ‘‘findings variation in the multiple regression suggest that disc degeneration may be model. OSHA concludes that Dr. Bigos et al.published several papers explained primarily by genetic and early Videman’s conclusion on the on a study (see, e.g., Exs. 500–121–8, environmental influences and importance of genetic factors in his 38–280, 26–1241) that assesses the role unidentified factors. * * * If disc studies is a function of his analysis and of work perceptions and psychosocial factors in predicting the report of back degenerative changes are associated his study design. This type of matched- pain disability. The study group was a with symptomatic conditions, these control study is designed to control for cohort of aircraft assembly workers at studies findings suggest a need to genetic effects, not to study them. rethink future research and prevention the Boeing Company in Everett, strategies in this area.’’ (id., pgs. 2610– OSHA also notes that in Dr. Washington who volunteered to 2611). Videman’s smoking study with 20 twin participate. This longitudinal study Dr. Videman and associates made matched-pairs and a mean discordance ultimately analyzed 1326 out of a cohort similar findings on the importance of between siblings of 32 pack years, ‘‘a of 4027 aircraft assembly workers (33% genetic factors in disc degeneration in a very huge difference’’ (Tr. 16994), the of the original solicited population) for study comparing 20 pairs of twins with disc degeneration difference was the final models. discordant smoking status (Ex. 32–241– statistically significant at all of the The health outcome studied was 3–89; Tr. 16994–16995). Using the same measured disc levels. Controlling for ‘‘back pain disability lasting longer than type of multivariate methodology, with genetic traits was undoubtedly 3 months,’’ and the authors used three one variable for smoking and 18 important, as suggested by the statistical notification systems—reporting to the variables for co-twin status, they significance of the 18 covariables (Ex. company medical department, filing an concluded, ‘‘Whereas smoking status 32–241–3–89, pg. 1666). incident report, or filing an industrial and age explained 0 to 15% of the In the hearings, Dr. Videman was insurance claim. The study did not variability on the various degenerative questioned by Ms. Seminario about a investigate the actual presence of back findings in the discs, 26% to 72% of the study he co-authored that concluded, symptoms or specific back disorders. At variability was explained with the ‘‘environmental factors [including the beginning of the study, subjects addition of a variable[s] representing co- physical work factors] account for more answered a series of questionnaires twin status. These findings are than 80 percent of the [etiology] of which addressed demographics, compatible with a marked genetic sciatica and more than 90 percent in the psychosocial factors, and cardiovascular influence and warrant further case of patients admitted to the risks, as well as a take-home investigation.’’ (Ex. 32–241–3–89). hospital.’’ (Tr. 17054, see also Dr. questionnaire including the 566 In his testimony at the hearings, Dr. question Minnesota Multiphasic Videman emphasized the relative Videman’s response to a similar question by Ms. Butterfield, Tr. 17128). Personality Inventory (MMPI), the importance of genetic factors over Health Locus of Control Questionnaire, physical work factors, ‘‘(W)e could Although Dr. Videman acknowledged the correctness of this statement, he and a modified Work Adaptation, conclude that, from a blood sample, I Partnership, Growth, Affection, and can predict MRI [disc] changes better appeared to contradict these findings by explaining that ‘‘all the data from that Resolve (APGAR) survey (modified from than having a lifetime work history the Family APGAR survey). Other about another interview.’’ (Tr. 16998). study was based on questionnaire data, information included previous medical OSHA has considered Dr. Videman’s so the reliability of the diagnosis is history, previous back discomfort or testimony and publications and unclear.’’ (Tr. 17129). OSHA notes, disagrees with his conclusions about the however, that in the actual paper the problem, back injury claims in the previous 10 years, and work relative importance of physical work authors note that ‘‘the cumulative age- perceptions. Subjects were also given a factors and genetics in the prediction of specific incidences of sciatica [were] physical examination to assess physical MRI disc changes. Although the agency based on both the questionnaire and the attributes including anthropometry, agrees that the discordant identical twin hospital discharge records,’’ and that the lifting strength, aerobic capacity, and study design is useful to control for results are in ‘‘accord with the results of genetic and early environmental factors, sagittal flexibility. A back examination a previous Finnish study.’’ (Ex. 502– including reflexes, girths, sciatic other factors in the design are at least as 227, pg. 397). Furthermore, the authors important. As was seen in the first study tension, and posture was performed. noted that the hospital discharge Thus, each subject provided individual discussed above (Ex. 26–71), in a diagnoses are given by doctors based on matched control study the amount of responses to questions concerning these the WHO manual of the International physical and psychosocial factors. discordance in the exposure variables Statistical Classification of Diseases (id., within the twin pairs will determine the 394). The authors also cited studies on In contrast to the above factors, which power of the study to detect an effect. the reliability of the nationwide hospital were collected for each worker individually, workplace exposure For example, with little discordance in discharge registry (id., 394). exposure variables and few discordant assessment was limited to all jobs that pairs, the study has little ability to Thus, because that Dr. Videman’s employed more than 19 workers and detect a true effect. In fact OSHA conclusions about the relative was not performed on individual believes that in such a situation importance of genetics and physical workers. These jobs were analyzed for degenerative disc summary scores work factors in back disorders were tasks that were heavy and tiring tasks in between twins should be very similar. based on the questionable methodology terms of maximum loads on the spine, To carry this example further in that used in the two twin studies discussed based on some unspecified first study, which involved the 115 twin above, and because Dr. Videman’s biomechanical mathematic model. Any pairs with little co-twin difference in testimony on another study which worker in a job with fewer than 19 the exposure variables, it is not contradicted those conclusions was not people did not get physically measured; surprising that adding 114 co-twin supportable, OSHA is unable to give also, the authors did not measure variables to the analysis, it is absolutely much weight to Dr. Videman’s workers’ cumulative loads. As with the no wonder that in total these 114 testimony on this issue. psychosocial factors, workplace

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00218 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68479 exposure was also measured only at (n=1451) on their modified APGAR and Growth, Affection, and Resolve initial recruitment. MMPI packets, with the 1,569 subjects (APGAR) survey score. The authors Subjects were followed for slightly who did complete the forms. The added two additional untested items to more than four years, during which 279 difference in injury report rates was not the family APGAR: (1) ‘‘I enjoy the tasks subjects reported back problems. After statistically significant, which suggests involved in my job,’’ and (2) ‘‘please analyzing the data to determine which that this final study group may be check the column that indicates how factors could best predict these reports, representative of the total. well you get along with your closest the authors concluded: OSHA also notes that no individual immediate supervisor.’’ (Ex. 26–1242, Other than a history of current or recent exposure measurements were carried pg. 2). Results found the strongest back problem, the factors found to be most out, although extensive individual statistically significant relationship predictive of subsequent reports in a psychosocial and psychological between back disability and statement multivariate model were work perceptions measurements were done. Workplace (1) ‘‘I enjoy the tasks involved in my and certain psychological responses. * * * exposure assessment was limited to jobs job.’’ (id., pg. 3). However, this single Subjects who stated that they ‘‘hardly ever’’ that employed more than 19 workers, initial response from a single point in enjoyed their job tasks were 2.5 times more and there was no accounting for time, rather than from more reliable likely to report a back injury (p=0.0001) than individual inter- or intra-variability. repeated measures over time, was used subjects who ‘‘almost always’’ enjoyed their Because the exposure data represented to explain the outcome over a four-year job tasks. These findings emphasize the the ‘‘exposure’’ of a group of workers period. importance of adopting a broader approach to the multifaceted problem of back complaints rather than the measured exposure of OSHA also has some concerns about in industry, and help explain why past individual workers, the authors would a potential bias due to subjects who prevention efforts focusing on purely not be able to determine the were excluded from strength testing if physical factors have been unsuccessful. contribution of physical factors to the current back symptoms were present at observed outcome in as robust a fashion the time of testing, or had caused them OSHA notes that one major problem as they would the contributions of to miss work in the previous six with the interpretation by other medical history, psychological surveys, months. This strongly influences the researchers of these results in the physical exam, or job satisfaction ability to draw from the study Boeing studies is that within the Boeing survey, which were all recorded as conclusions that are related to this studies, ‘‘physical variables’’ include individual exposure data. The authors variable, i.e., eliminating the back pain only those physical attribute variables did not report nor provide information subjects from the study population that deal with anthropometry, back on the analysis of the exposure data. creates a healthy worker effect, which examination indices, and physical There was no report on the data would bias results toward the null. capabilities (e.g. flexibility, lifting collected on biomechanical loads of the For the final predictive model, strength, aerobic capacity) (Ex. 38–280, spine. They also did not report nor involving 33% of the original solicited Table 1, pg. 25). It is under the provide information on the data population, the percentage of the overall ‘‘nonphysical variables’’ that the authors collected on the workers’ perceived variability explained by the model was included workplace factors—duration of physical exertion in their jobs. 2.2% for job satisfaction, 1.9 for employment, job classification code, Dr. Bigos, in his testimony to OSHA psychological factors, 1.2% for physical and measured peak spinal loading—as during the hearings, stated that the examination factors, and 3.3% for well as psychological and psychosocial Schultz model (the only biomechanical medical history; the sum of these factors. Other researchers include model related directly to human individual components was 8.6%; 7% workplace factors (e.g., measured peak intradiscal measurements) was applied combined (Ex. 38–280, pg.29). This spinal loading and physical workload) to the evaluation of mechanical stress means that 93% of the variability was as physical variables. Thus, when Bigos on the Boeing subjects, and it found no unexplained by this model for et al.conclude in their study that none significant relationship between predicting industrial back pain reports of the physical variables was important mechanical stress on the subjects and (back disability > 3 months). in predicting back pain reports (back the report of back problems or disability In sum, with the qualifications disability > 3 months)—they are not (Tr. 6725–6727). OSHA is addressing discussed above, OSHA acknowledges referring to the same types of work- back pain in its final standard, and the importance of the Bigos et related physical risk factors—lifting/ intradiscal measurement changes, al.prospective study on the role of forceful movements, bending/twisting obtained from the Schultz model, are psychosocial factors in reports of back and awkward postures, heavy physical not directly relevant to the existence of injuries. OSHA used this study in its work, or static work postures—that back pain or back disability. weight of evidence determination for OSHA refers to in its standard. Bigos et OSHA also notes that this study did HPW as a risk factor for LBP, and found al.did not directly address these factors not address heavy lifting, or even jobs no association. However, OSHA in their study. at the moderate or high end of HPW concludes that physical risk factors OSHA also notes that the overall exposure. Bigos et al.report, ‘‘the study were not as well determined in this participation rate for this study was low, was done in a diverse, highly study as were the psychosocial risk which makes representativeness an sophisticated manufacturing industry factors, making their relative issue, especially for the 25% of the where job tasks do not tend to be contributions difficult to assess. group that initially chose not to extremely stressful for the back.’’ (Ex. Furthermore, the lack of truly HPW, participate. The longitudinal study 500–121–8, pg.5). As Bigos et al.(1991, according to the authors, among these ultimately analyzed 1326 out of a cohort Ex. 26–41) state, ‘‘our study may not be workers would further limit the ability of 4027 aircraft assembly workers (33% representative of workers with to study this physical risk factor. Thus, of original solicited population) for the extremely physically demanding jobs, OSHA concludes that although this final models. In an attempt to determine where virtually no one remains active study found a significant relationship whether the voluntary aspect of the until retirement age.’’ between psychosocial factors and LBP, study would create a bias, the authors OSHA also has concerns about the this study lacked the ability to compared the reported injury rates for interpretation of the results of the concurrently study the relative those who returned incomplete data ‘‘Work’’ Adaptation, Partnership, contribution of the physical work-

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00219 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68480 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations related risk factors of interest to OSHA. Specific Low-Back Disorders 26–420). In addition, during In Section G5 OSHA provides Low-back pain symptoms are caused unsupported sitting, the lumbar spine additional discussion of both the Bigos by a variety of injuries and disorders. flattens, and the use of lumbar supports et al.study and psychosocial risk factors. Although the underlying cause of back and back rests can reduce the loss of normal lordosis (Andersson et al.1979, Biomechanical Factors and Laboratory pain cannot be determined definitively Experiments in up to 90% of patients, work-related Ex. 26–1553). cases are believed to result from the Using a back rest inclination of 110 For a distilled summary of the degrees and a 4 cm lumbar support, the literature describing laboratory following mechanisms: muscle or ligamentous (soft tissue) injury; authors were able to demonstrate that experiments and biomechanical models lumbar posture could be similar to of risk factors associated with low back herniation of the intervertebral disc with irritation of adjacent nerve roots; normal standing posture. Maintenance pain in table format, see Table II–1 in of adequate seated posture has further the health effects appendices to the and degenerative changes (arthritis/ spondylosis) in the intervertebral discs implications for the intervertebral disc, proposed rule (Ex. 27–1). with lower intervertebral disc pressures There is some debate as to the exact (Deyo, Rainville, and Kent 1992, Ex. 26– noted during supported sitting as etiology of low-back pain, and some 365). Evidence for work-relatedness for opposed to unsupported sitting authorities suggest that it is possible to low-back disorders of these three (Andersson et al.1974, Ex. 26–346). make a precise diagnosis in perhaps sources of etiology is summarized Inadequate seating can contribute to the only 20% of patients presenting with below. development of low-back pain. acute low-back pain (Frymoyer 1988, Soft Tissue/Mechanical Low-Back Individuals who sit in chairs that are too Ex. 26–118; Nachemson 1976, Ex. 26– Disorders high and have their feet unsupported 1147; White and Gordon 1982, Ex. 26– 1160). Proposed etiologies for low-back As noted earlier, the exact etiology of experience elevated pressure on the pain that have been advanced include low-back pain is unknown in many back of their thighs (Akerblom 1969, Ex. the roles of nerve compression, tissue cases, and therefore, there is a lack of 26–522; Bush 1969, Ex. 26–455; ischemia, sensitization of nerve endings, universal agreement on the contribution Schoberth 1962, as cited in Chaffin and inflammatory mediators, spinal of muscle and ligament sprains and Andersson 1991, Ex. 26–420). Burandt instability, and other postulates strains to work-related low-back and Grandlean (1963, Ex. 26–1569) (Frymoyer 1988, Ex. 26–118; disorders. In part, the difficulty in observed the tendency of subjects in Nachemson 1992, Ex. 26–490). The diagnosis relates to the inability to high seat pans to slide forward in their majority of cases of work-related low- easily palpate deep low-back muscles, seats to support their feet, negating the back pain are attributed to mechanical the lack of imaging information on low- benefit of a back rest. causes, such as muscle and ligament back muscle disorders, and the absence Dynamic Loading strains and sprains and disc herniations. of surgical pathologic specimens to Degenerative disc or facet disease, evaluate. Dynamic loading of the lumbar spine spinal stenosis, spondylolisthesis and However, in addition to an has other implications for muscle and compression fractures have also been understanding of muscle anatomy, ligament. Stresses induced in the low attributed, at least in part, to work. consideration of muscle function (static back during manual materials handling Additionally, back disorder is and dynamic loading), and repair relate to the load weight and the multifactorial in origin and may be mechanisms contribute to characteristics of the lift. As a result of associated with both occupational and understanding the role of muscle and their anatomic positions, large spinal nonwork-related factors and ligament sprains and strains in work- movements are created from relatively characteristics (Bernard 1997; Ex. 26–1). related low-back disorders. small degrees of muscle shortening. One additional difficulty in Unfortunately, this results in the Static Loading evaluating the etiology of low-back pain generation of relatively large muscle and is that roughly 50% to 60% of patients In evaluating the pathogenesis of soft- joint forces, with potential for tissue reporting an episode of work-related tissue low-back disorders, there are overloading and injury. This could be low-back pain note an insidious onset of considerations related to static and particularly important during excessive pain rather than a single, point-in-time dynamic work activities. Simple or rapid movement (Andersson and event with immediate low-back pain maintenance of posture requires Marras 1996, Ex. 26–412), or at the point (Bergquist-Ullman and Larsson 1977, balancing of counteracting mechanical of muscle fatigue. Ex. 26–933). This study also found that forces about the spine. Static loading A study by Hukins et al.(1990, Ex. 26– cases with an insidious onset affects muscle and connective tissue. 143) revealed that greater forces are experienced prolonged recovery. Part of During static trunk flexion, low-back exerted on ligaments as the speed of the explanation for this may lie in the extensor muscles must progressively motion increases. In addition, elastic absence of nociceptors in the disc itself increase their activity to maintain trunk limits of the ligaments and disc may be and the facet joints (except for the flexion (Schultz et al.1982, Ex. 26–581). exceeded (Adams and Dolan 1981, Ex. synovial lining) (Pope et al.1991, Ex. Using myoelectric measurements, 26–1348). Bush-Joseph et al.(1988, Ex. 502–502). These load-bearing structures Andersson et al.(1974, Ex. 26–346) 26–939) evaluated the effect of the may, therefore, become injured without ascertained that activity of the erector speed of lifting on the external load immediate recognition (e.g., sudden spinae progressively decreased as the moment. Subjects were asked to lift at pain), and the eventual manifestation of angle of the back rest advanced from 10 slow, medium, and high speeds. There low-back pain may only occur after a degrees of forward inclination to was a direct linear correlation between series of point-in-time events have backward inclination. This results from increasing speed of lifting and increased sufficiently injured these spinal a partial reduction of the lumbar spine peak moment. Furthermore, a study by structures to the point where load imposed by the upper body as the Marras and Mirka (1992, Ex. 26–982) nociceptors become irritated (e.g., in the load is transmitted to the back rest revealed that muscles must generate a outer one-third annulus or facet (Andersson and Marras 1996, Ex. 26– higher percentage of electromyographic synovium). 412; Chaffin and Andersson 1991, Ex. (EMG) maximal activity to maintain a

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00220 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68481 constant muscle force as the speed of and demands associated with dynamic degrees, sagittal extension velocity at 0 trunk velocity increases with bending. lifting may better assess the risk of degrees, sagittal extension acceleration Both lifting frequency and load developing a low-back disorder from at 0 degrees, continuous velocity, weight affect back muscle work manual materials handling. The authors continuous acceleration, lateral right capacity, in part related to fatigue. Using analyzed 400 lifting jobs in 48 range of motion at 0 degrees). EMG assessments, Kim and Chung industries using a triaxial goniometer In the next phase, the eight highly (1995, Ex. 26–858) observed that lifting (Lumbar Motion Monitor or LMM) that reliable trunk motion characteristics at 10% of maximum voluntary isometric was worn by working subjects. A evaluated in the healthy subjects were strength (MVIS) at a rate of 6 times a combination of five trunk motion and compared with measurements in minute was more fatiguing than lifting workplace factors was able to subjects with chronic low-back pain (96 at 20% MVIS at a rate of 3 times per reasonably predict jobs posing high risk males and 75 females) who were minute. for low-back disorders (Marras et recruited for study from secondary and Frequent loading of the lumbar spine al.1995, Ex. 26–1412). These factors tertiary referral practices. These with moderate to heavy weights can also include the lift frequency, load moment, individuals had been symptomatic for at cause general physical fatigue with trunk sagittal range of motion, trunk least 7 weeks and had been sufficiently elevation in heart rate and energy lateral velocity and trunk twist studied, including with appropriate expenditure. Uncoordinated muscle acceleration (Marras et al.1995, Ex. 26– imaging studies, to permit accurate activation that could result from local 1412). A recent NIOSH Health Hazard Quebec classification. Dynamic trunk and systemic fatigue could then place Evaluation provided additional motion characteristics were normalized other tissues at increased risk with verification that the LMM has predictive for age and sex, and using quantitative continued lifting (Garg 1986, Ex. 26– capacity equal to the NIOSH Lifting discriminant analysis, the 510 subjects 121). Equation in job analysis (NIOSH 1993, were correctly classified in 94% of cases as being either healthy or having Postural Issues Ex. 26–521), with perhaps greater ease of administration. chronic low-back pain(stage-one Additional postural factors during analysis). lifting significantly affect muscle Recently, Marras et al.(1990, Ex. 26– In a stage-two analysis, nine variables function and risk of injury. Skeletal 1523; 1993, Ex. 26–170; 1995, Ex. 26– (the eight previously mentioned and muscle is more likely to rupture during 171) studied the trunk angular motion continuous position) correctly classified eccentric contraction (Friden and Lieber characteristics of normal and chronic 80% of subjects into one of eleven 1994, Ex. 26–546), a factor involved in low-back pain subjects. Used in a groups (normal, low-back pain alone, many manual materials-handling tasks. clinical setting, the LMM appears to low-back pain with proximal or distal In addition, muscle length affects the have good ability to accurately radiation, disc herniation with high or amount of force that muscle can distinguish between normal individuals low pain scores, spondylolisthesis, generate, with maximal force produced and those with chronic low-back pain or spinal stenosis, postoperative, when muscles are at their resting structural disease. The authors used nonorganic components, other) via lengths (Andersson and Marras 1996, anatomic and pain categories previously modified classification using splines. It Ex. 26–412; Chaffin and Andersson selected by the Quebec Task Force was also noted that trunk range-of- 1991, Ex. 26–420). Therefore, lifting in Study on Spinal Disorders (1987, Ex. motion parameters commonly used to positions where skeletal muscles are 26–494). Normative trunk motion values quantify impairment had poor ability to elongated or shortened can increase the for age and gender were derived in a discriminate normal vs. chronic low- risk of injury to these tissues. study of 339 males and females from back pain, nor was it useful in Using EMG evaluation of muscle ages 20 to 70 years who had never classification. Furthermore, a function during lateral flexion of the experienced significant low-back pain. characteristic pattern of recovery from lumbar spine, Andersson, Ortengren, While wearing the LMM, subjects low-back pain was noted, with and Herberts (1977, Ex. 26–1570) performed trunk flexion and extension normalization occurring first in range of demonstrated increased activity on the in five symmetric and asymmetric motion followed by velocity and later side contralateral to bending. Other motion planes (0 degrees, 15 degrees acceleration of dynamic trunk motion. It researchers have determined that and 30 degrees right and left) while was opined that the LMM’s ability to asymmetric loading in lateral flexion trunk angular position, velocity, and quantify unloaded free-dynamic motion and axial rotation causes high levels of acceleration were recorded with the and account for the co-activation of antagonistic activity in abdominal and LMM. In a repeatability study, 20 additional structures (e.g., internal and back extensors. This is associated with healthy normal subjects who had never external obliques, lattissimus dorsi) increased myoelectric activity on the experienced a low-back disorder were affecting erector spinae function was in side of spine contralateral to the load, tested with the LMM once a week for 5 part responsible for its enhanced although there is still significant activity weeks. No statistically significant discriminating ability compared to on the ipsilateral side (Astrand 1987, differences were observed among the alternate imaging techniques. Ex. 26–527; Kelsey 1975, Ex. 26–1134; trunk motion characteristics between Disc Disorders/Disorders of the Three- Magora 1970, Ex. 26–297; Merriam et the five weekly test sessions using Joint Complex (Disc and Two Facets) al.1983, Ex. 26–299). Andersson (1977, multivariate analysis of variance. and the Nerve Root Ex. 26–449) noted that increased Correlation coefficients were computed intervertebral disc pressure and to select reliable trunk motion variables The three-joint complex refers to the intraabdominal pressure occurs when to be used in the next phase of the intervertebral disc and two facet joints. the trunk is loaded in lateral flexion and study. Correlations varied as a function This complex permits the spine to axial rotation, with rotation being the of the angle of asymmetry and measured absorb compression and resist torsion greater factor. variables, with motion characteristics in and shear, while permitting translation the zero plane demonstrating correlation and rotation of the spine. Epidemiologic Muscle Velocity and Acceleration coefficients of 0.88 to 0.96 (number of evidence suggests that work exposures Marras (Ex. 26–1412) has indicated conditions performed, twisting range of involving heavy lifting or manual that several trunk muscle characteristics motion, sagittal range of motion at 0 materials handling are associated with

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00221 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68482 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations low-back disorders, including disc below 6 kN. Adams and Hutton (1982, with different mechanical behavior of disorders (Bernard and Fine 1997, Ex. Ex. 26–1379) studied cadaver discs from the disc. 26–1). male subjects aged 22 to 46 years. The Eventually radial tears result in the Excessive or repeated spinal loading authors determined that most specimens development of degenerative disc and inadequate rest periods to permit could withstand an average of 10 kN on disease and/or bulging. As a result of repair mechanisms to function may be single loading prior to failure, usually at this damage, the capacity of the lumbar associated with biomechanical stresses the end plate. In contrast, Bartelink intervertebral discs to tolerate further that damage intervertebral disc cartilage (1957, Ex. 26–349) noted that discs were compressive loads during lifting is endplates. This may then disturb fractured from forces ranging between altered. When these smaller tears extend metabolic transport, hastening the 1.6 and 6.7 kN, with a mean of 3.1 kN. and form complete annular tears, the development of degenerative disc The wide inter-individual variation in nucleous pulposis can protrude (disc disease and disc herniation with tissue tolerance makes it difficult to herniation) (Farfan et al. 1970, Ex. 26– secondary nerve root compression or assign a single value of compressive 113). Over time, sclerosis of cartilage inflammation. force against which to engineer jobs to endplates and altered disc loading can Rowe (1971, Ex. 26–319) opined that prevent lumbar disc. facilitate the development of facet up to 70% to 80% of recurring, chronic When mechanical failure occurs, it is arthropathy, osteophytic change, low-back pain will eventually be generally through the cartilage stenosis, or instability. Disc diagnosed as discogenic. Discogenic endplates (Adams and Hutton 1982, Ex. degeneration in combination with facet pain can include clear and consistent 26–1379; Armstrong 1985, Ex. 26–1070; arthropathy may also lead to foraminal symptoms and signs expected with Brinckmann el al., 1988, Ex. 26–1318; narrowing with resultant nerve lumbar disc herniation and specific Erdil, Dickerson, and Chaffin 1994, Ex. compression and radicular pain. These nerve root pathology, as well as chronic 26–424) Disc height, spinal position, observations are consistent with a low-back pain associated with increased and frequency of bending appear to be cumulative trauma theory that could pressure in the intervertebral disc or risk factors. Creep results in loss of disc account for some types of low-back degenerative disc disease. In patients height, increased contact between load- injuries and is supported by the with lumbar disc herniations, bearing surfaces of the facet joints, research and opinions of other approximately 90% to 95% occur at the diminished capacity to dissipate forces, authorities (Erdil, Dickerson, and lower three intervertebral disc spaces and decreased ability of the spinal Chaffin 1994, Ex. 26–424; Pope et al. (lumbar 3⁄4 disc or lumbar 4th nerve column to tolerate loading (Kazarian 1991, Ex. 502–502; Yong-Hing and root, lumbar 4⁄5 disc or lumbar 5th nerve 1975, Ex. 26–379). Adams and Hutton Kirkaldy-Willis 1983, Ex. 26–405). root, lumbosacral L5/Sl or sacral 1st (1982, Ex. 26–1379) observed maximal nerve root) (Deyo, Rainville, and Kent single loading tolerances of up to 10 kN; While many individuals with 1992, Ex. 26–365). Increased however, when the spines were flexed degenerative disc disease are compressive and torsional forces forward, 40% of discs prolapsed at an asymptomatic, individuals with greater transmitted to the lower levels of the average of only 5.4 kN. Repeated lumbar degrees of degeneration are at risk for lumbar spine probably account for this spine loading can cause tissue fatigue low-back pain. In one study (Vanharanta observation. Peak incidence of lumbar with fracture at lower loads than the et al. 1987, Ex. 26–225) 90% of subjects disc herniation occurs in adults during spine would tolerate for non-repetitive with severe disc degeneration the working years from ages 30 to 55 loading. Adams and Hutton (1985, Ex. experienced pain during discography, (Spangfort 1972, Ex. 26–502). The onset 26–1315) determined that when while only 23% of those without disc of symptoms may be acute, subacute, or repetitive loading was simulated, degeneration reported pain. chronic, and the relationship to a single previously healthy discs failed at an Arthritis/Spondylosis lifting incident may not always be average of 3.8 kN. obvious (Berquist-Ullman and Larsson These studies support the clinical Several studies have suggested a 1977, Ex. 26–933). Symptoms and observation that the intervertebral disc relationship between lumbar physical findings depend on the is especially vulnerable when loaded in degenerative disease and work activities location of the disc herniation and the the flexed position or when subjected to (e.g., heavy work, repetitive lifting, and degree of nerve compression. repetitive loading. This becomes more vibration). This association has come An understanding of disc significant when workers with lower from both radiographic and pathological biochemistry and biomechanics assists tissue tolerance from prior injury, evaluations in association with work in the understanding of the degenerative disc disease, or age lift at histories. One difficulty in these pathogenesis of work-related lumbar high rates for prolonged periods. evaluations is the observation that disc disorders. For ethical reasons the Armstrong (1985, Ex. 22–877) noted lumbar spine x-ray changes are majority of observations on spinal that small microtears most often occur common, occurring in about 40% of all tolerance have been derived from in the region of the posterior elements low-back x-rays (Rowe 1983, Ex. 26– cadaver spines. However, in vitro and in of the annulus fibrosus and cartilage 699). However, the relationship of many vivo comparisons appear to validate end plates. As noted, these are the areas x-ray changes with symptoms of low- these conclusions. There is a wide subject to the greatest spinal back pain is unclear (Andersson 1981, biologic variation in human disc and compressive forces (Gracovetsky and Ex. 26–1480; Himmelstein et al. 1988, end plate tolerances (Brinckmann et al., Farfan 1986, Ex. 26–128; Hickey and Ex. 26–962; Magora and Schwartz 1976, 1988, Ex. 26–1318) related to age, Hukins 1980, Ex. 26–708; Pope et Ex. 26–389; Rowe 1963, Ex. 26–317; gender, genetics, prior injuries, and al.1991, Ex. 26–1296). With repeated 1969, Ex. 26–318). Videman, Nurminen, other factors. The maximum axial lumbar spinal stresses and/or injuries, and Troup (1990, Ex. 26–1023) noted an compressive force tolerated by the progressive microfractures in cartilage increase in vertebral osteophytosis in human cadaver lumbar spine has been end plates and annular fibers (annulus autopsy specimens from workers who measured by Brinckmann et al., 1988 fibrosus) may develop in the performed heavy work. Of interest is (Ex. 26–1318) to range from 2.1 to 8.8 intervertebral discs (initially toward the that the heavier work exposures also kN (210 to 880 kg), with 30% fracturing center of vertebral bodies). This causes were observed in association with at forces below 4 kN and 63% fracturing altered metabolism and fluid transfer increased rates of low-back disability.

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Riihimaki et al. (1991, Ex. 26–966) this juncture with symptoms and signs However, OSHA considers that each performed a radiographic study of the or radiculopathy. factor, by itself, can increase the risk of lumbar spine in concrete workers and In the next phase, the posterior joint back disorder. house painters. Lateral lumbar x-rays capsule and annulus fibrosus develops F. Disorders of the Lower Extremities were obtained in 216 concrete laxity and instability. The intervertebral reinforcement workers and 201 house disc progresses to grade 2 or 3 Work-related disorders of the lower painters aged 25 to 54 years. Disc space degenerative disease. It may be possible extremities have not received the same narrowing was noted 10 years earlier to detect instability on dynamic x-rays. scrutiny as those of the upper and spondylophytes 5 years earlier in Subperiosteal bone formation, extremities and back. However, existing the concrete workers. Risk ratios for the calcification of the ligaments, and information from pathophysiology, univariate effect of occupation on disc capsular fibers manifest as peripheral epidemiological studies, and space narrowing was 1.8, and for osteophytes and traction spurs (Dupuis biomechanical investigations implicate spondylophytes it was 1.6. Potential 1987, Ex. 26–1299) in an attempt to physical work factors related to cofounders such as age, prior back stabilize the motion complex (MacNab repetitive, forceful exertion and accidents, body mass index, and 1977, Ex. 26–1367). If laxity awkward posture to these disorders, smoking had minimal effect. The predominates over repair processes, the especially osteoarthritis of the knee and authors concluded that heavy physical degenerative spondylolisthesis (facet hip. As more completely described in work with materials handling and laxity) or retrolisthesis (disc laxity) may Health Effects Appendix III.D (Ex. 27– postural loading enhances the occur (Dupuis et al. 1985, Ex. 26–108). 1), osteoarthritis is considered a degenerative process of the lumbar In the final phase, there is fibrosis of disorder of the movable joints spine. the posterior facet joints, loss of disc characterized by the disintegration of Wickstrom, Nummi, and Nurminen material (grade 3 or 4 degenerative disc the articular cartilage that covers the (1978, Ex. 26–1161) evaluated degree of disease), and progressive osteophyte end of the bones. The articular cartilage lumbar flexion, presence of pain, and x- formation (Wedge 1983, Ex. 26–1035). and subchondral bone that lies just ray findings of degenerative disc disease This increases the load-bearing surface beneath the cartilage provide opposing in 295 concrete reinforcement workers of the three-disc complex, although it structures and surfaces that are matched aged 19 to 64 years. These workers decreases motion and results in in such a way as to allow transmission commonly perform work involving increased stiffness. The repair process of joint loads at the lowest and most spinal loading in stooped postures. may create narrowing of the central uniform pressures, (Meisel 1984, Ex. Radiographic evidence of degenerative canal (central spinal stenosis) from facet 26–1562). disc disease was noted in two-thirds of arthropathy, disc bulging, and The arthrosis process is thought to the 110 individuals with restricted hypertrophy of the ligamentum flavum. begin with disruption at the thin surface flexion and in one-third of those Lateral stenosis may also result from overlying the load-bearing cartilage (n=185) with normal flexion. facet arthropathy and osteophyte Kirkaldy-Willis (1983, Ex. 26–431) formation adjacent to the (Meisel, 1984, Ex. 26–1562). This described a pathophysiologic spectrum neuroforamina. Spinal stenosis is a disruption results in progressive erosion of changes that lead to the development diagnostic entity that has only recently of the cartilage layer and a joint surface of lumbar spine degenerative disease. In been described. A few patients have less able to withstand normal loads and the first phase, there are early and mild congenitally small spinal canals; forces. Continual loading on the joint changes in the posterior complex, with however, most present with this type of then disrupts the process of bone/ facet synovitis, joint effusion, capsular acquired spinal stenosis secondary to cartilage repair and regeneration, stretch, and thickening. Inflamed longstanding degenerative disease. Most leading to formation of marginal bone in synovium may become entrapped in the patients first become symptomatic after the shape of spurs (osteophytes). The joint between the cartilage surfaces and 50 years of age (Turner et al. 1992, Ex. degenerative process continues until the initiate cartilage damage. Meanwhile, 26–1455). By virtue of its long-term cartilage has been completely destroyed; the intervertebral disc develops some degenerative nature, spinal stenosis is there is bone-on-bone contact, and the circumferential tears in the annulus not often considered a work-related structural integrity of the joint is lost. fibrosus. Tears in the periphery have at disorder; however, patients with spinal The clinical manifestations are joint least some potential to heal because of stenosis may present with co-existing stiffening, pain and loss of movement the proximity to vascularity, but these lumbar disc herniation or other (Meisel 1984, Ex. 26–1562). deeper tears lack this ability by virtue of degenerative changes that have been It is well recognized that acute trauma their distance from blood flow or exacerbated by work factors. can trigger osteoarthritis, but there is metabolic diffusion. As these also evidence that less substantial, but Conclusions circumferential tears enlarge, they repetitive, forces to the joints can lead develop into large radial tears. As a OSHA finds convincing evidence to microfractures of the articular result, the nucleus pulposus begins to from the confluence of many cartilage and subchondral bone. The lose proteoglycan and exhibits investigation on biomechanical models, disruption in structural integrity results structural changes with grade 1 or 2 laboratory research and epidemiology in the onset of the degenerative changes degenerative disc disease. Loss of water studies that work related risk factors described above (Radin et al., 1994, Ex. and disc height as well as a decline in including (1) heavy physical work, (2) 26–578). This process has been observed annular resistance can cause increased lifting and forceful movements, (3) in animals subjected to repetitive compression forces on the facets. bending, twisting and awkward impact loading of one or more limbs Individuals may be asymptomatic or positions, and (4) static work positions (Moskowitz, 1992, Ex. 26–1547). have vague low-back pain. However, are causally linked to low back Damage to the joints in these animals due to the lack of nociceptors in the disc disorders and pain. Work often involves involve fibrillation and splitting of the and facet joints (except the synovium), several of these risk factors concurrently cartilage, evidence of chondrocyte a significant degree of degenerative and there is evidence that the first three activity as bone remodeling occurs, disease may occur before pain develops. of these factors may act together in a progressive erosion of the cartilaginous Lumbar disc herniation may occur at synergistic way to increase the risk. layer, and formation of osteophytes.

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Other MSDs of the lower extremity greater than 25 kg (which places an verified by medical tests, whether that may be caused by physical work- additional load on the lower evidence provided of an exposure- related factors include bursitis and extremities) resulted in an even stronger response or other temporal relationship tarsal tunnel syndrome. Joint overuse association (OR≥5) with this knee between the risk factor and outcome; may lead to bursitis, an inflammation of disorder. Other epidemiological studies and the measure of relative risk used a fluid-filled sac or sac-like cavity that associated occupations such as along with the results of this measure. serves to reduce friction in a joint (Ex. construction work, farming, firefighting, In addition to the evidence previously 502–317). Repetitive use of the foot may laundry/dry cleaning, and manual labor, reviewed, Table V–8 includes five be related to tarsal tunnel syndrome, a with knee osteoarthritis (Anderson and additional studies submitted to the nerve entrapment syndrome of the Felson, 1988, Ex.26–926; Vinguard et docket that address physical work lower extremity analogous to carpal al., 1991, Ex. 26–1500). factors and disorders of the lower joints, tunnel syndrome in the wrists (Day Three case-control studies reported primarily the knee (Ex. 500–41–114; Ex. 1996, Ex. 26–615). In addition to acute and repetitive positive associations between MSDs of 500–121–44; Ex. 500–41–69; Ex. 502– trauma, MSDs of the lower extremities the hip and work tasks involving 317; Ex. 500–41–68; Ex. 500–121–18. have been linked with congenital biomechanical factors (Coggon et al., Three of the studies examined the abnormalities, underlying genetic or 1998, Ex. 26–1285; Croft et al., 1992, Ex. prevalence of knee disorders among metabolic disorders, and chronic 26–1503; Vinguard et al., 1997, Ex. 26– carpet- and floorlayers who spend a conditions, such as cancer, diabetes and 1617). One study found that jobs substantial amount of time working in collagen-vascular disease (Felson 1994, requiring lifting over 25 kg more than knee straining postures. Kivimaki (1992, Ex. 26–544; Meisel 1984, Ex. 26–1562). ten times in an average week for more Ex. 500–41–78) compared 96 floor- and than 20 years raised the odds of carpetlayers to 72 painters with regard Epidemiological Evidence developing hip osteoarthritis (Ex. 26– to disorders of the knee. An analysis of Epidemiological evidence of an 1285). Farmers, mail carriers, videotaped work tasks indicated that association between workplace factors firefighters, and meat processors were floor- and carpetlayers assume a and MSDs of the lower extremities was occupations reported to be significantly kneeling posture in their job 42% of discussed in Health Effects Appendix I. associated with hip osteoarthritis in a their work time, compared to 3% of A summary of the risk factors is registry-based cohort study (Ex. 26– work time by painters. Ultrasonographic presented in Table C–1 (for 400). Repetitive kneeling, squatting, and examination indicated changes in the osteoarthritis of the knee) and Table C– lifting are all activities involving the prepatellar or superficial infrapatellar 3 (for the hip). Several work-related biomechanical risk factors of repetition, bursa in 49% of the carpet and floor activities, such as squatting and forceful exertion, and awkward postures layers compared to 7% of painters. On kneeling for more than 30 minutes per of the lower joints. Table V–8 a symptom questionnaire, the floor- and day, were significantly associated summarizes some key aspects of these carpetlayers reported a significantly (OR≥3) with osteoarthritis of the knee in investigations, including: Occupations greater prevalence of bursitis in front of a population-based case-control study examined; biomechanical risk factors the knee cap, knee pain in a kneeling (Cooper et al., 1994, Ex. 26–460). This involved; whether or not exposures posture, sudden and intense swelling of study also showed that a combination of were directly observed during the study, the knee, aspirations of the knee, and these activities along with lifting loads whether the health outcomes were injections to the knee than painters.

TABLE V±8.ÐSUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MSDSOFTHELOWER EXTREMITIES

Physical Diagnosis/body Risk meas- Study Job type studied factors Exposure basis part Other attributes ure (95% CI)1

Kivimaki (1992) Ex. 500±41± carpet laying; floor F/R/P observation ques- questionnaire NR* 78. laying. tionnaire. ultrasound/knee. Jensen (1997) Ex. 500±41±69 carpet laying; car- F/R/P questionnaire ob- questionnaire radi- exposure response OR=1.5±6.4* pentry. servation. ology/knee. (3.2±8.9) Tanaka (1986) Ex. 502±317 .. floor laying; tile F/R/P questionnaire ...... questionnaire knee exposure response PRR=1.1± setting. 5.0* (3.2±7.8) Sandmark (2000) Ex. 500± prosthetic knee pa- F/R/P questionnaire ...... surgery/knee ...... exposure response OR=0.7±3.2* 41±114. tients. (2.0±5.2) Cooper (1994) Ex. 26±460 .... general population F/R/P questionnaire ...... questionnaire X- OR=0.8±6.9* ray/knee. (1.8±26.4) Anderson (1988) Ex. 26±926 general population F?/R/P job title question- questionnaire X- OR=0.8±3.5* naire. ray/knee. (1.2±10.5) Vingard (1991) Ex. 26±1400 .. various occupa- F/R?/P? job title ...... hospitalization RR=0.6±3.8* tions. knee or hip. (1,2±12.1) Coggon (1998) Ex. 26±1285 patients case/con- F/R/P? questionnaire ...... hip replacement .... OR=1.0±2.1* trol. (1.1±3.9) Croft (1992) Ex. 26±1503 ...... patients case/con- F/R?/P? questionnaire job joint measurement/ OR=0.8±2.5 trol. title. hip. (1.1±5.7) Vingard (1997) Ex. 26±1617 .. patients case/con- F/R/P? questionnaire ...... hip replacement .... RR=0.8±2.3* trol. (1.5±3.6) De Zwart (1997) Ex. 500± Various occupa- F/R/P job title ...... questionnaire temporal relation- NR* 121±18. tions. lower limbs. ship. F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear; RR=relative risk; OR=odds ratio; PRR=prevalence rate ratio *=p<0.05

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1 95% confidence interval expressed for the upper end of the risk measure range.

Jensen et al. (1997, Ex. 500–41–69) also reported bursitis (11%) and knee kneeling (OR=2.1, 95% CI: 1.4–3.3), and conducted a larger cross-sectional study aspirations (31%) in excess of those jumping (OR=2.7, 95% CI: 1.7–4.1) were of knee disorders among current and reported by millwrights and bricklayers. significantly associated with former floor- and carpetlayers (N=133), In this study questionnaire responses osteoarthritis of the knee. Individuals carpenters (N=506), and compositors were compared to responses given by a who had spent ten or more years in an (N=327). Based on telephone interviews representative sample of white males to occupation considered to involve high and video recording of work activities, standardized questions about symptoms physical load on the knee were also the authors determined that floor- and of knee disease. When compared to more likely to undergo knee carpetlayers spent 56% of their working sample, floorlayers, tilesetters, and replacement due to osteoarthritis than time in knee-straining postures. millwright and bricklayers all reported those who had not worked in such Carpenters were reported to have spent a higher age-adjusted prevalence for occupations (men, OR: 2.5, 95% CI 1.7– 25% of their working time in such each of the seven symptoms than the 3.6; women, OR: 2.5, 95% CI: 1.6–3.9). postures, while compositors did not sample. This result suggests that the The analysis controlled for confounders spend any working time in knee- relative risk of knee disorders in the such as age, body mass index, smoking, straining positions. highly exposed groups may be and sports activities. Response to a questionnaire revealed understated when millwrights and The findings of Sandmark et al. (Ex. that carpenters experienced a bricklayers are the reference group since 500–41–114), Jensen et al. (Ex. 500–41– significantly increased frequency of they may, themselves, be at increased 69) and Tanaka et al. (Ex. 502–317) knee complaints within the last 12 risk relative to the general population. indicate an exposure—response months (OR=3.8, 95% CI: 2.7–5.5), Physical examination that included relationship between the frequency of within the last seven days (OR=3.6, 95% radiological tests of a subset of the work involving strain to the knees and CI: 2.3–5.8), and for more than 30 days workers was performed to validate the osteoarthritis, bursitis and other signs of over the preceding 12 months (OR=2.5, questionnaire. The questionnaire was injury to this joint. 95% CI: 1.6–3.9) when compared to reported to show low sensitivity (38– In a longitudinal survey study, de compositors. Floor- and carpetlayers, 44%), but moderate specificity (82– Zwart et al. (1997) (Ex. 500–121–18) the highest exposed group, also reported 89%), for both bursitis and arthritis. investigated changes in musculoskeletal a significantly increased frequency of Other studies examined the complaints among workers performing knee complaints within the last 12 relationship between lower limb MSDs mentally demanding work (N=4686) and months (OR=6.4, 95% CI: 4.0–10.1), and physical work factors in more heavy physical work (N=7324). Job within the last seven days (OR=5.7, 95% diverse occupational settings. Using a demands were determined by CI: 3.3–10.1), and for more than 30 days case-control study design, Sandmark et occupational title. Mentally demanding over the preceding 12 months (OR=5.3, al. (2000, Ex. 500–41–114) compared work was described as sedentary, while 95% CI: 3.1–8.9) when compared to individuals who had received prosthetic heavy physical work involved tasks compositors; the odds ratios reported for knee replacements due to osteoarthritis such as lifting heavy objects, handling floor- and carpetlayers were uniformly to control subjects to examine the heavy tools, and stooping in higher than those reported for relationship between lifetime physical combination with standing or walking. carpenters. Age, weight, body mass load from work and the risk of knee The subject groups were stratified by index, smoking, and sports activities osteoarthritis. A total of 625 individuals age (20–9, 30–9, 40–9, 50–9 years old). were reported to have had no significant who had received prosthetic knee The occurrence of musculoskeletal effect on the incidence of knee replacements due to osteoarthritis, and complaints were compared between two complaints. Among 50 floor- and who were between the ages of 55 and 70 surveys having a mean interval of carpetlayers, 51 carpenters, and 49 at the time of surgery were compared to approximately four years. No physical compositors who had radiological 548 age- and gender-matched examination or examination of medical examinations of their knees, an individuals randomly selected from the records was performed. increased prevalence of osteoarthritis population of the same geographical The incidence of musculoskeletal was found in floor- and carpetlayers area who had not reported osteoarthritis complaints of the lower limbs on the (14%) when compared to carpenters or other dysfunction of the knee. second survey was higher among those (8%) and compositors (6%). Through telephone interview and who had not reported complaints on the A third cross-sectional study written questionnaire, the subjects first survey for all age groups. However, involving floorlayers by Tanaka et al. provided information on workloads the incidence was only statistically (1986, Ex. 502–317), and also reported from occupational and non- significant for the youngest three age by Thun et al. (1987, Ex. 26–60), occupational activities, personal groups. The authors concluded that examined the relationship between characteristics, and general health younger and middle-aged employees work activities involving strain on the status. The duration and frequency of develop musculoskeletal complaints as knees and the development of knee activities (e.g., kneeling, sitting, number a result of exposure to heavy physical disorders. Floorlayers (N=112) and of stairs climbed) were computed for work, and that a healthy worker effect tilesetters (N=42) who reported frequent each individual. Subjects were then served to mask this effect for the oldest kneeling in a survey questionnaire were divided into three exposure groups: No age group. Because of its prospective compared to a group millwrights, or low exposure comprising the lower design, this investigation provides a bricklayers, and decorators (N=243) who quartile; medium exposure comprising temporal link between MSDs of the did not commonly kneel. the middle two quartiles; and high lower extremities and heavy physical The floorlayers reported more exposure consisting of the top quartile. work. frequent bursitis of the knee (20% vs. Analysis of the data revealed that, Lemasters et al. (1998) (Ex. 500–121– 6%) and more needle aspirations of among men, lifting at work (OR=3.0, 44) examined the prevalence and risk knee fluid (32% vs. 6%) than the 95% CI: 1.6–5.5), squatting or knee factors for work-related MSDs among millwrights and bricklayers. Tilesetters bending (OR=2.9, 95% CI: 1.7–4.9), carpenters. (N=522) who completed a

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Self-reports were or temporal relationship between Generally, as duration of employment compared to timed video recordings for physical risk factor and health outcome. increased, the prevalence of symptoms 39 carpenters and 33 floorlayers. The Therefore, it is biologically plaucible increased. An adjusted logistic carpenters and floorlayers were that repetitive impact loading on the regression analysis showed that videotaped while working and, then joints is consistent with the duration of employment in carpentry for immediately afterwards were requested degenerative pathophysiology of at least 20 years was significantly to estimate the amount of time spent in osteoarthritis. OSHA concludes that the associated with work-related MSDs of knee-straining postures. A close evidence reviewed in this section the knees (OR: 3.5, 95% CI: 1.3–9.2). association was reported between the demonstrates that workers who perform Carpenters who indicated they felt observed and self-reported durations job tasks requiring repeated forceful exhausted at the end of day experienced (Spearman’s correlation coefficient: flexion of the knee or other joints of the significant increases of work-related 0.88). While this report provides lower extremities are at increased risk of MSDs of the knees (OR: 1.8, 95% CI: evidence that immediate self-reports are serious musculoskeletal impairment 1.1–3.1). Having minimal influence over largely accurate, recall bias associated such as osteoarthritis. their work schedule was also reported to with self-reports of historical work activities remains a concern. G. OSHA’s Response to Health Effects be a risk factor for work-related MSDs Issues Raised in the Rulemaking of the knees (OR: 2.3, 95% CI:1.2–4.1). Biomechanical Evidence A subset of the subject group received 1. Comments on OSHA’s Use of the Bhattacharya et al. (1985, Ex. 502– NIOSH (1997) and NAS (1999) Reviews a physical examination including 270) examined the biomechanical forces examination of the knees. The authors associated with different working Several commenters (Ex. 30–1722; Ex. concluded that reported disorders, postures involved in carpet installation 500–109; Ex. 32–368–1; Ex. 32–241–4; including those of the knee, were when using a knee kicker. The knee Ex. 500–197) criticized OSHA’s reliance significantly associated with positive kicker is a device consisting of a plate on the 1997 NIOSH review (Ex. 26–1) findings upon physical examination. with a set of teeth in one end that grips and the 1999 NAS report (Ex. 26–37) of An examination of the reliability of the carpet while an installer kicks the the evidence for work-related MSDs. questionnaire responses was performed padded end with a knee to stretch the First, the commenters considered the by Booth-Jones et al. (1998) (Ex. 500– carpet. A job analysis indicated that methodology used by NIOSH to evaluate 121–9). Ten percent of the subjects carpet installers spend approximately the epidemiological evidence that work- examined by Lemasters et al. (1998) (Ex. 75% of their time in a kneeling position, related factors were associated with 500–121–44) were subsequently and use the knee kicker an average of MSDs to be seriously flawed. Second, randomly selected and administered the 141 times per hour. Postures were they accused OSHA of ignoring obvious original questionnaire for a second time. reported to require near-maximum knee limitations of the NIOSH review and All positive responses were categorized flexion. Knee-flexion angles at impact then misrepresenting its conclusions. as ‘‘yes’’ answers and all other averaged about 58°, while normal daily Finally, the commenters claimed that responses were categorized as ‘‘no’’ activities involve less flexion (e.g., the NAS workshop report did not responses. Comparison of the results of sitting, 87°; tying shoe laces, 74°; support the OSHA position with regard the first and second administrations of walking upstairs, 97°). Workers to biomechanical risk factors and MSDs. the test indicated that the responses performing the heaviest of the knee A more detailed description of each were largely consistent, with overall kicks produced peak impact forces assertion will follow along with OSHA’s agreement reported to be 85.6%. This averaging over 3000 newtons, response. result provides a strong indication that equivalent to approximately four times The criticisms of the NIOSH the questionnaire responses examined their body weight. The authors methodology were aimed at nearly every by Lemasters et al. (1998, Ex. 500–121– suggested that the biomechanical level of evaluation. It was said that 9) are a reliable representation of the demands of installing carpet may be NIOSH exercised a ‘‘publication bias in recollections of the subjects examined. responsible for the high incidence of favor of positive studies’’ in its study A significant concern when knee disorders among these workers. selection (Ex. 500–197, pg. I–146). It evaluating studies in which exposure was said that the NIOSH criteria used to measurements and health outcome are Conclusion assess study quality ‘‘emphasize[d] based on self-reports is the possibility of OSHA concludes that strong evidence biased and unreliable methodology at recall bias. Among the studies is available showing that steoarthritis of the expense of sound scientific pertaining to the lower extremities that the knee and other MSDs of the lower approaches.’’ (Ex. 32–241–4, pg. 109). It are described here, those of Sandmark et extremities can result from exposure to was said that there was ‘‘no indication al. (Ex. 500–41–114), Jensen et al. (Ex. the combined physical work-related of any systematic method for assigning 500–41–69), Tanaka et al. (Ex. 502–317), factors of repetition, force, and awkward weight,’’ (Id. pg. 109), and that the and Lemasters et al. (Ex. 500–121–44) posture. This evidence comes from the weighting could not be ‘‘replicated and, each depend to a greater or lesser extent consistently positive associations in therefore fails to satisfy one of the most upon the accuracy of self-reported epidemiological studies of carpet- and basic tenets of scientific inquiry.’’ (Ex. exposures to ergonomic risk factors. floorlayers who spend considerable 23–109, pg. 23). It was said that NIOSH Such self-reports have been criticized as amounts of time in knee-straining ‘‘failed to adequately consider other being unreliable (Exs. 30–276, 500–118). postures. Biomechanical evidence confounding factors in their analysis’’ Evidence submitted to the docket indicates knee flexion and impact forces (Ex. 32–368–1, pg. 40). Finally, it was regarding the studies discussed above, can be substantial during installation of said that NIOSH was ‘‘forced to draw its while not eliminating concerns about carpet. Other occupational activities conclusions from a larger body of

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It did not use a weight of the biomechanical factors and MSDs when tendinitis, and epicondylitis are significantly evidence approach. For example, there is no there existed convincing evidence from higher in jobs that involve repetitive motions, explanation of how studies which met several studies for a causal relationship localized stress, awkward positions, NIOSH’s criteria standards were regarded using the epidemiologic criteria, and for vibrations, and forceful exertions. differently than studies which did not. In which chance, bias, and confounding Dr. Robert McCunney (Tr. 17566–67) essence, NIOSH put the 2000 studies into a OSHA’s conclusion that there is an black box, and out popped 600. Then the 600 factors were not the likely explanation. OSHA believes that NIOSH clearly did epidemiological evidence of an association went into another black box, and out popped between many work factors and certain the conclusions (Ex. 32–368–1, pg. 36–37). not use a ‘‘flawed’’ methodology and their evaluation process represents a MSDs is consistent with the literature that OSHA strongly disagrees that the I’ve read and my clinical experience as an systematic weight of evidence approach approach used by NIOSH to evaluate the occupational medicine physician treating that relies on an unbiased set of sound epidemiological studies was flawed or thousands of patients with MSDs over the and reliable scientific principles. that the conclusions in the 1997 review past 20 years. NIOSH concluded there was evidence Dr. Michael Erdil (Tr. 1112) are weakly supported by the evidence. that MSDs of the neck, shoulder, upper We have, first of all, lots of epidemiological In the first chapter of its report, NIOSH extremities, and back that have been describes, in detail, where it retrieved studies that show physical factors are subjected to epidemiological involved in MSDs. We have actually no information on epidemiological studies, investigation were associated with at how studies were selected for more epidemiological study that shows, that least some biomechanical factors or proves there is no physical factor involved. detailed review, the procedure used to combination of factors. In several Dr. Niklas Krause (Tr. 1367) analyze the overall strength of work- instances, the evidence was judged to be Some commenters thought that OSHA relatedness, the six criteria (strength of strong. For most MSDs, there were association, consistency, temporality, situations in which the epidemiological misrepresented the findings from the exposure-response, coherence, and role evidence was judged insufficient for NIOSH review in order to support its of confounders) employed to evaluate certain biomechanical factors in own conclusions that exposure to work- the evidence of causality, and the four isolation (e.g. CTS and extreme posture; related biomechanical factors increase categories to classify the evidence. The epicondylitis and repetitive motion). the risk of serious musculoskeletal 600 studies reviewed by NIOSH [out of However, these factors were usually impairment. It was claimed that OSHA more than 2,000 identified in initial found to be associated with the MSD had seriously overstated the NIOSH database searches] were published or when present in combination with other conclusions as ‘‘having established accepted for publication in the scientific biomechanical factors (e.g. strong causation’’ (Ex. 32–241–4, pg. 98) literature or government reports that evidence of posture/force combination between biomechanical factors and had undergone peer review and were and CTS; strong evidence of repetition/ MSDs regardless of the length and widely available. These had to meet force and epicondylitis). For several intensity of exposure, instead of the true some minimum requirement in terms of MSDs, OSHA found that the strength NIOSH goal of drawing conclusions defined study groups, measurable health and consistency of the associations about the evidence of an association outcomes, identifiable exposures related between biomechanical factors and between risk factor and health outcome to physical factors, and adequate study MSDs was even stronger, if the under conditions of prolonged design. The NIOSH selection strategy evaluation was restricted to studies exposure. Commenters argued that was a common screening approach that where exposure was directly observed OSHA ignored the restricted scope of has been successfully employed by or measured and the health outcome the NIOSH analysis that was limited to OSHA and many other groups. There was confirmed by physical exam or ‘‘certain objectively defined MSDs’’ and was no bias toward the selection of medical tests (see Health Effects Section ‘‘examined only certain very specific positive studies; rather NIOSH selected V). It is important to note that the stressors of highly repetitive and those only studies that met the above NIOSH analysis focused primarily on forceful work, lifting and forceful criteria. OSHA believes that the NIOSH the epidemiological evidence. OSHA movements, awkward and prolonged selection process captured the best believes these conclusions were sustained postures and exposure to epidemiological studies available at the reasonable and based on the selected vibration.’’ (Ex. 500–109, pg. 24). On the time on which to evaluate the evidence evaluation criteria. other hand, it was claimed that OSHA for a causal association between work- Since the evaluation process involved used the NIOSH findings to ‘‘support related risk factors and MSDs. expert judgment, weighting of causal inferences for all other MSDs NIOSH analyzed the reviewed studies individual studies cannot be precisely * * * which include not only those in terms of well-accepted ‘‘replicated’’ in the same way as a MSDs studied by NIOSH but also epidemiological principles, such as scientific measurement, however, DeQuervain’s disease, trigger finger, participation rate, blinded study design, substantial evidence in the rulemaking Raynaud’s syndrome and tarsal tunnel exposure method, and case definition record supports NIOSH’s conclusions. syndrome’’ and ‘‘attempts to broaden and gave greater weight in its evaluation There were a number of written the NIOSH exposure associations to process to those that minimized submissions and oral testimony from include not only the factors that NIOSH selection and observation bias and scientific experts supporting the studied, but also a wide range of other confirmed the existence of exposure and position that sufficient evidence exists so-called ergonomic risk factors health outcome by qualified experts. that biomechanical factors can increase including among others, contact stress NIOSH applied the highly-regarded the risk of MSDs (e.g., Exs. 30–3805, 32– and cold temperatures.’’ (Ex. 30–1722, Bradford Hill criteria (see six criteria 57, Tr. 9819, 16317, 17358, 17687). pg. 43).

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OSHA does not agree that the findings However, it is a nerve impingement OSHA concludes that ‘‘In sum, although not of the 1997 NIOSH review have been disorder analogous to CTS in the wrist. all of the epidemiological studies reviewed misrepresented in any way. The Agency Like the carpal tunnel, the tarsal tunnel demonstrate significant associations, the has not stated that the epidemiological is a relatively ‘‘tight’’ compartment overwhelming majority justify a conclusion evidence established that MSDs are that the risk factors noted in this section, filled with flexor tendons and the tibial with effects adjusted by the four modifying caused by exposure to work-related nerve that may be susceptible to factors, cause or exacerbate work-related biomechanical factors. Epidemiological compression in response to increases in MSDs.’’ Thus the data justify the conclusion studies rarely, if ever, prove causation. intra-tarsal pressure as a result of that these factors cause or exacerbate work- They are designed to identify repeated flexion/extension of the ankle. related MSDs (Ex. 32–450–1, pg. 7–8) associations between two study In the Final Rule, OSHA does not The commenters also claimed that variables. Depending on the strength broaden the set of biomechanical risk OSHA misrepresented the findings of and consistency of the associations and factors associated with MSDs beyond the NAS workshop and that the whether the association shows aspects the four (force, repetition, posture, and conclusions in their 1999 report of temporality and exposure-response, vibration) supported by the 1997 NIOSH ‘‘simply do not support OSHA’s broad epidemiological data can provide review (contact stress, which is covered conclusions linking physical work- evidence of a causal relationship. OSHA by the standard, is a particular related factors to musculoskeletal has stated that there is convincing combination of force and repetition). complaints.’’ (Ex. 32–241–4, pg. 117). scientific evidence that biomechanical Although OSHA believes that evidence They allege numerous inadequacies of factors, usually in combination, increase exists that cold temperatures can the workshop, such as the fact that the the risk of several specific MSDs. These aggravate some MSDs, this participants included ‘‘only a few conclusions are often based, not on environmental factor principally scientists who seriously questioned epidemiological studies alone, but also operates to modify exposure to some of OSHA’s ergonomic hypothesis’’ (Ex. 32– on the pathophysiology of the disorder the biomechanical factors listed above 368–1, pg. 33). Despite this, the and biomechanical and psychophysical and is not regarded as a primary risk workshop participants supposedly research that are able to link ergonomic factor. OSHA included contact stress in seriously questioned the NIOSH study risk factors to biomechanical and the final rule’s Basic Screening Tool and, unlike OSHA, ‘‘admitted that the subjective measurements under a more because there is reasonable evidence evidence of a link between MSDs and controlled set of simulated work that repeated impact, such as hand physical risk factors at the workplace is conditions. hammering, increases the risk of the inconclusive at best,’’ (Ex. 32–241–1, pg. In general, the conclusions drawn by MSD known as hypothenar hammer 118). This led one NAS panelist, Dr. OSHA based on the entire body of syndrome (see Part D of the Health Howard Sandler, to state ‘‘that the scientific evidence track closely with Effects section). In addition, repetitive NIOSH approach to their review of the those of NIOSH. OSHA does not stretch knee hammering has been shown to be evidence was sufficiently flawed to the NIOSH findings ‘‘far beyond the associated with a high risk of bursitis make the conclusions questionable.’’ breaking point’’ to support causal (‘‘carpet layers knee’’) (see Part F of (Ex. 32–241–4, p. 112). Presumably the inferences of the existence of vast Health Effects section). The final rule NAS report ‘‘actually undermines numbers of MSDs that are not examined makes clear that it is prolonged and OSHA’s decision to limit its analysis to by the epidemiological studies (Ex. 30– regular exposure to a combination of physical, work-related factors’’ since it 1722, pg. 44). For example, biomechanical work factors that cites ‘‘individual, organizational, and DeQuervain’s disease and trigger finger presents the greatest potential hazard. are forms of hand tendinitis specifically It should also be noted that workplace social factors * * * which are possible examined in epidemiological studies intervention is not required by the influences on physiological pathways (Ex. 26–48; Ex. 26–53; Ex. 26–897) ergonomic standard unless there is an that lead from soft tissue to impairment relied on by NIOSH to conclude MSD incident that the employer has and disability.’’ (Ex. 32–241–4, p. 118 ). evidence of an association between determined to be work-related and there The argument for the OSHA repetition, force, and awkward posture is evidence of exposure to the misrepresentation of the NAS report is and hand/wrist tendinitis. In fact, biomechanical risk factors defined by summarized as follows: NIOSH states in its review that the OSHA basic screening tool. This In sum, the [NAS] Steering Committee ‘‘DeQuervain’s disease and other action trigger serves to limit the number advised against doing exactly what OSHA tenosynovitis of the hand, wrist, and of stressors and disorders that require does in its analysis—focusing exclusively on forearm have been associated for action under the OSHA rule. physical work-related factors: ‘‘Non- decades with repetitive and forceful For the above reasons, OSHA finds biomechanical factors must [emphasis added] be considered if understanding of the hand activities as one of the possible that its conclusions with regard to work- causal factors.’’ (Ex. 26–1, pg. 5b–8). relationship between biomechanical work related biomechanical factors and risk of factors and MSDs is to expand and inform in The other two MSDs cited as not MSDs do not misrepresent, but are being supported by NIOSH findings are the design of workplace interventions to entirely consistent with, the findings in reduce or prevent such disorders.’’ (Ex. 32– Raynaud’s phenomenon and tarsal the 1997 NIOSH review. This view was 241–4, p.120). tunnel syndrome (TTS). Raynaud’s confirmed by written testimony from phenomenon refers to blanching of one OSHA does not believe the NAS the Director of NIOSH, Linda or several fingers and is a characteristic report seriously questions findings of Rosenstock: sign of vascular damage that occurs in the NIOSH review or undermines the Hand-Arm Vibration Syndrome (HAVS) OSHA builds on the evidence of the OSHA position on the evidence that due to segmental vibration (Ex. 502–18). association between workplace risk factors exposure to biomechanical factors NIOSH concluded that there was strong and the development of MSDs provided in increases the risk of MSDs. Regarding the 1997 NIOSH review and strengthens the the epidemiological evidence, the NAS evidence of a positive association evidence with the supporting data provided between segmental vibration and the by laboratory and psychophysical studies Steering Committee Report states: vascular symptoms of HAVS. TTS is an * * * NIOSH concurs with OSHA’s Restricting our focus to those studies MSD of the foot and, therefore, was not conclusion from the discussion of the involving the highest levels of exposure to addressed in the NIOSH review. evidence from the epidemiological studies. biomechanical stressor of the upper

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00228 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68489 extremity, neck, and back and those with the ergonomic hypothesis that OSHA is MSDs in exposed individuals; there is sharpest contrast in exposure among the espousing. This is not because the NAS strong biological plausibility that relates study groups, the positive relationship selection process excluded those with these disorders to biomechanical risk between the occurrence of musculoskeletal disorders and the conduct of work is clear. other views, as implied by the factors; and interventions that reduce The relevant studies have not precisely commenters. The NAS prides itself on exposure to those factors have been determined the causal mechanical factors and is regarded world-wide as an demonstrated to reduce the incidence of involved nor the full clinical spectrum of the organization that renders impartial and the MSDs. reported MSDs (which are often lumped unbiased expert judgment on scientific In summary, the methodology used by together nonspecifically as MSDs of a body issues. The reason for the NAS NIOSH to arrive at its findings that there region); nonetheless, those associations participants’ support is simply that most is evidence of an association between a identified by the NIOSH review as having ergonomic experts around the world strong evidence are well supported by number of work-related physical risk competent research on heavily exposed agree there is clear evidence that factors and MSDs of the neck, upper populations (Ex. 26–37, pg 15–16). biomechanical work factors increase the extremity, and back is not a flawed There is compelling evidence from risk of MSDs. ‘‘black box,’’ but a scientifically sound numerous studies that as the amount of OSHA is aware that one member of approach based on well-accepted biomechanical stress is reduced, the the six person panel addressing physical epidemiological principles. By NIOSH’s prevalence of musculoskeletal disorders at factors and epidemiology, Dr. Howard own testimony, OSHA’s conclusions the affected body region is likewise reduced. Sandler, was critical of NIOSH’s This evidence provides further support for regarding biomechanical factors and the the relationship between these work methodology and findings. OSHA does risk of MSDs in the workplace reinforce activities and the occurrence of not agree with Dr. Sandler’s statements, and do not misrepresent the 1997 musculoskeletal disorders (Ex. 26–37. p 16). and neither did the majority of the other NIOSH findings. Finally, the panel members. In the NAS workshop OSHA believes these NAS conclusions in the 1999 NAS report are summary, the consensus of the panel conclusions are not ‘‘inconclusive at supportive of both the NIOSH analysis was that NIOSH had not overlooked any best’’ but as the commenters claims, and the OSHA position. In addition, to important body of epidemiological instead clearly support those the NIOSH and NAS, the European evidence. The panelists generally agreed associations between work-related Agency for Safety and Health at Work that the NIOSH analysis resulted in the biomechanical factors and MSDs (Ex. 500–71–28) and Washington State identified in the NIOSH review where review on of high quality studies. With (Ex. 500–71–93) have evaluated the evidence is strong, namely the exception of Dr. Sandler, the scientific evidence and also reached combinations of forceful exertions, panelists unanimously agreed that a similar conclusions regarding the repetitive motions, awkward postures, reassessment of the epidemiological evidence linking work-related vibration and heavy lifting. The above literature would not alter the biomechanical factors with the biomechanical exposures are the same conclusions drawn by NIOSH regarding development of MSDs. ones that the OSHA standard seeks to the work-relatedness of MSDs. Finally, it is important to note that in 2. Issues Relating to Causal Inference in reduce. Epidemiology The NAS Steering Committee did evaluating all the evidence, not just the point out some limitations to the epidemiology, the NAS Steering Several commenters to the Proposal epidemiological evidence, particularly Committee made the following argued that OSHA had failed to show that ‘‘it was difficult to make strong conclusions: causality between exposure to causal inferences on the basis of Thus, while there are many points about workplace factors and MSDs; one group evidence from any individual study.’’ which we would like to know more, there is of comments emphasized that the types (Ex. 26–37, p. 15; emphasis added). little to shake our confidence in the thrust of of studies used by NIOSH and OSHA to They acknowledged that ‘‘the our conclusions, which draw on converging evaluate causality of the various MSD occurrence of MSDs among populations results from many disciplines, using many risk factors were inadequate for that methods: exposed to low levels of biomechanical • purpose because of the studies design There is a higher incidence of reported (see, e.g., Ex. 32–241–4, pg 86–91). stressors was less definite. * * * In case pain, injury, loss of work, and disability of low levels of biomechanical stress, among individuals who are employed in Specific comments were: the possible contribution of other factors occupations where there is a high exposure Only repeated longitudinal prospective to MSDs is important to consider.’’ (Ex. to physical loading than for those employed studies can establish causation; OSHA relies 26–37, p. 16). OSHA agrees with these in occupations with lower level of exposure. instead on methodologies prone to error and statements and has not ignored the • There is a strong biological plausibility bias. * * * Cross-sectional studies, upon contribution of individual, between the incidence of MSDs and the which OSHA heavily relies, are incapable of organizational, and psychosocial factors causative exposure factors in high exposure providing evidence of cause and effect, occupational settings. because correlation does not establish in the etiology of MSDs. The Health • Research clearly demonstrates that causation (Id. pg. 86). Case-control studies Effects section of the rule emphasizes specific interventions can reduce the are highly prone to bias. Prospective cohort the multifactorial nature of MSDs. reported rate of MSDs for workers who studies are the best method of studying Substantial evidence in the rulemaking perform high risk tasks. No single etiology, * * * retrospective studies [are record, however, demonstrates that intervention is universally effective. prone to] the hazards of * * * ‘‘recall bias.’’ biomechanical risk factor show strong Successful interventions require attention to (Id. pg. 87). * * * In the case of associations with elevated MSD risk individual, organizational, and job musculoskeletal pain, which OSHA [has] when other non-work-related factors are characteristics, tailoring the corrective linked to ‘‘awkward postures’’ and other controlled for. Thus, OSHA does not actions to those characteristics (Ex. 26–37) biomechanical exposures, recall bias [in any OSHA believes the above NAS retrospective design] can be extreme. * * * believe that the existence of other risk Cross-sectional studies are necessarily factors should prevent actions that conclusions support, not undermine, retrospective and prone to recall bias. (Id. pg. reduce exposures to those work-related the premise that there is convincing 87). [Cross-sectional studies] are useful for biomechanical stressors. evidence that exposure to work-related observing patterns and correlations, but can OSHA agrees that the majority of the physical factors increases the risk of only generate hypotheses. A review seeking NAS participants supported the MSDs. There is a higher incidence of evidence of causation must exclude all cross-

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00229 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68490 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations sectional studies, because their methodology directly assessed to any great degree. (Ex. 32– exposure and disease, where you had a body is inadequate to test a hypothesis. (Id. pg. 88) 241–3–7, pg. 3). of cross-sectional studies that had accurate With respect to case-control study OSHA has carefully considered these exposure assessment and accurate health outcomes; in that setting, we believe that you designs, the comments continued: comments on the criteria and may well infer causality, particularly if you [C]ase-control studies generally measure methodology for selecting and see, in studies with a wide range of exposure, exposure to various hypothesized risk factors combining studies for a weight-of- a dose-response relationship (Tr. 2095). retrospectively, and consequently are prone evidence approach to evaluating to a number of biases, particularly in the causality and has concluded that Second, OSHA has considered the recall of exposure to suspected risk factors. OSHA’s approach and the approach NAS review of the NIOSH criteria for * * * Case-control studies are most suitable used in the NIOSH report (Ex. 26–1) are study inclusion and weighting (Ex. 26– for examining rare diseases * * * scientifically sound. First, with respect 37). In the NAS review seven Musculoskeletal complaints are hardly ‘‘ epidemiologists specializing in rare,’’ of course, making OSHA’s reliance on to the NIOSH methodology, OSHA notes that NIOSH did prioritize studies by ergonomics were asked about the retrospective studies particularly NIOSH assessment’s selection and unwarranted and puzzling (Id. pg. 89). type of design and did discuss each design’s inherent capabilities, weighting of studies. Each provided With respect to combining studies for a weaknesses, and potential biases (Ex. individual comments (Id., pgs. 152– total weight-of-evidence assessment, 26–1, App. A). NIOSH also included in 174). In general they concurred with the critics were somewhat divided. Some its criteria for evaluating the weight of NIOSH approach. Dr. Frederick Gerr, noted that: a study the study’s population, health Associate Professor, Rollins School of [In order to do a proper assessment] only outcome, and exposure: ‘‘the greatest Public Health, Emory University, prospective cohort studies reliably establish qualitative weight was given to studies thought that NIOSH had included all etiology, that is, valid scientific evidence of that had objective exposure important epidemiological evidence in cause and effect. (Id. pg. 89). * * * Adequate assessments, high participation rates, its review (Id., pg. 159), an opinion science, however, requires more than mere shared by Dr. Laura Punnett, Professor, association. It demands clinically accepted, physical examinations, and blinded assessment of health and exposure University of Massachusetts, Lowell rigorously controlled studies. (Ex. 32–241–3– (Id., pg. 162), Dr. Alfred Franzblau, 1, pg.3), status.’’ (Ex. 26–1, pg. 1–9 and 1–10). NIOSH then evaluated the data base Associate Professor of Occupational while others, including Dr. Stanley of studies using guidelines to assess Medicine, University of Michigan Bigos, felt that case-control studies causal inference made famous by School of Public Health (Id., pg. 155), could also be used: Bradford Hill (Ex. 26–726). These and Dr. David Wegman, Professor, To infer causal relationships, one would consisted of (1) strength of association; University of Massachusetts Lowell (Id., look for consistent findings in a number of (2) consistency of association; (3) pg. 172). With respect to the four criteria case-control and prospective cohort studies, specificity of association; (4) NIOSH chose to use to further as well as other supporting scientific qualitatively weight each study, some of information. Bradford Hill published an temporality; (5) exposure-response relationship; and (6) coherence of the NAS participants found that these influential set of guidelines for causal ‘‘criteria for identifying studies of inference. (Ex. 32–241–3–4, pg. 9). evidence (a combination of consistency with other information and biological relatively greater methodological rigor However, another commenter plausibility). These guidelines are are reasonable and appropriate’’ (Id., pg. cautioned about drawing conclusions endorsed in the Reference Manual On 159), and ‘‘that the studies most heavily for a group of studies: Scientific Evidence (Federal Judicial relied on by NIOSH in its assessment of It should be noted that weaknesses of Center, 2000) that assists federal judges workplace factors and MSDs are of good individual studies cannot be overcome by in interpreting scientific reasoning as it quality.’’ (Id., pg. 156); and ‘‘[t]he synthesizing a large number of studies with pertains to litigation and is held up by quality of the studies that were most different weaknesses that suggest the same heavily weighted was generally quite conclusion. (Ex. 32–241–4, pg. 89). Gibson, Dunn & Crutcher as an authoritative source. The Manual states high because they met the multiple Still another commenter, Dr. Lloyd the following about the application of criteria set out by NIOSH for weighting. Fisher, noted a methodology using a the Hill criteria: (Id., pg. 172). One panelist, however, Dr. statistical approach for combining Howard Sandler (in a study co-authored studies. This methodology is termed There is no formula or algorithm that can with non-panelist Dr. Richard Blume), be used to assess whether a causal inference thought that this weighting method was meta-analysis: is appropriate based on these guidelines. One The process for properly formally or more factors may be absent even when a neither fully explained nor tested and synthesizing information from multiple true causal relationship exists. Similarly, the validated. (Id., pg.168). Dr. Sandler was studies of the same thing is described in a existence of some factors does not ensure that scheduled to appear at the OSHA textbook I coauthored. Requirements for a a causal relationship exists. Drawing causal hearing as an expert for Keller/Heckman valid meta-analysis include that (1) all inferences after finding an association and but never did so. studies in the area be considered, without considering these factors requires judgment Because of the NIOSH assessment’s ‘‘publication bias’’ based on treatment effect and searching analysis, based on biology, of use of cross-sectional studies, the indicated in the studies; (2) a careful why a factor or factors may be absent despite comments of Dr. Alfred Franzblau in assessment of study quality should be a causal relationship and vice versa. While discussing NIOSH’s weighting of cross- performed; and (3) study results should the drawing of causal inferences is informed reflect a homogeneity of results. This was not by scientific expertise, it is not a sectional studies should be noted: attempted where possible in the material that determination that is made using scientific What some researchers have done is to I reviewed. methodology. (pg. 375) perform cross-sectional studies among Perhaps the most notable example of meta- NIOSH witness Dr. Larry Fine stated in workers (and jobs) that are known to have analysis discussed by OSHA is [the NIOSH been stable for some minimum period of time report]. However, it is not clear that the his testimony: (e.g., six months or one year). This type of NIOSH report satisfies any of the three Again, it’s always hard to talk in cross-sectional design overcomes some of the conditions. Some relevant studies (such as generalizations, but in a situation where you shortcomings of cross-sectional studies the Boeing back-injury study) are not have evidence of a biologically plausible relative to prospective studies, and serves to included. The quality of the studies is not explanation for the relationship between greatly strengthen the confidence one can

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00230 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68491 have in the conclusion. Many of the studies inference, you would not have medicine. (Tr. within occupations with higher versus that were most heavily weighted in the 1411). lower risk factors can be made in the NIOSH assessment fall into this category (Ex. When questioned about the cross- various studies in a basic weight-of- 26–37, pg. 156). sectional design’s inability to establish evidence approach. However, a rigorous Dr. David Wegman provided the temporality, a key factor for determining meta-analytic approach for a combined following summary comments: causality, Dr. Krause further stated that risk estimate is much more problematic There is no ‘‘correct’’ way to carry out a in his studies this was not the case: because of the many factors being studied and the different response literature review particularly with as large a To give you an example, in our cross- scope as the one undertaken by NIOSH. The sectional studies of the bus drivers, we measures. authors of the NIOSH report are to be measured the years of occupational driving. In addressing NIOSH’s reliance on a commended for developing a methodology These years clearly occurred before they said qualitative evaluation of the that is reasonable, understandable, clearly to us I have back pain now. I have no doubt epidemiology rather than a formal meta- presented, open and conservative. It is hard that these risk factors are [temporal], in a analysis, Dr. David Wegman, Professor, to imagine a more effective way to [temporal] relationship or coming before the University of Massachusetts Lowell, summarize this literature (Ex. 26–37, pg. back pain. And so this study qualifies for stated in his review for the NAS: 173). causal inference as a cross sectional study. I would not disregard this. (Tr. 1411). Meta-analysis is not appropriate when the Third, several witnesses and question under study is as broad as the one commenters on OSHA’s ergonomics The AFL–CIO post-hearing comments NIOSH addressed. In my judgement [another proposal also addressed the use of provide their analysis of the OSHA writer] * * * provides the answer which, in multiple types of epidemiological record with respect to the evidence for his words is: ‘‘I question whether studies to determine causality. Dr. John causality (Ex. 500–218). In discussing quantitative methods can ever be as Frank, Professor of Public Health the types of studies that can be used to thoroughgoing, probing and informative as Sciences, University of Toronto, stated determine causality, they stated: qualitative methods’’ [Ex. 26–37]. in his testimony: The record evidence clearly establishes The NAS Panel’s Steering Committee The best design cannot be read from a that cross-sectional and case-control studies concluded, with respect to the findings cookbook which automatically requires there have been and can be used to identify causal of the seven epidemiology experts on to be a rank ordering of study design qualities relationships between exposures to risk the NAS panel about combining studies for all circumstances. Prospective studies can factors and adverse health outcomes. In fact, for an overall risk estimate: actually make some mistakes that are the record demonstrates that cross-sectional Methods used for the assessment of overcome in well designed case-control and case-control studies have been used with exposures and health outcomes vary [among studies (Tr. 1472). great success to infer causal relationships studies], rendering the task of merging and addressing some of our nation’s most combining evidence more challenging than Dr. Laura Punnett, Professor, important public health issues, such as University of Massachusetts Lowell, in in some other areas of risk assessment. But smoking and lung disease, which have led to this variability does provide the benefit of support of the conclusions of the NIOSH life-saving intervention measures in the multiple perspective on a common set of report pointed out that: absence of prospective studies. The record problems [Ex. 26–37]. also does contain prospective Almost all of the studies considered in the epidemiological studies which have In summary, OSHA finds no support review have been published in the peer- confirmed findings from cross-sectional and for Dr. Fisher’s comment that NIOSH reviewed scientific literature, meaning that case-control studies that exposure to they had already been through the standard erred by not performing a proper meta- biomechanical/physical factors in the scientific quality control process prior to analysis. Neither Dr. Fisher nor anyone workplace cause MSDs among exposed else has provided any specific evidence their publication and review by NIOSH. (Tr. workers. 864). to support his contention that a meta- (Id., pg. 30) In a statement that contradicts the analysis approach would be appropriate view of several witnesses stating that In summary, with respect to the in this case. Instead, OSHA concurs medicine must rely on randomized selection, use, and weighting of studies with the National Academy of Science’s clinical trials (RCT) for determining of multiple designs to make a conclusion that a formal meta-analysis causality (e.g., see Ex. 32–241–3–4, pg. determination of the causality between would not be the best methodology in 7–10), Dr. Niklas Krause, of the Public work-related stress factors and MSDs, this case. Gibson, Dunn & Crutcher also claimed Health Institute, discussed the necessity OSHA concludes that the NIOSH that OSHA did not properly evaluate the of doing a careful evaluation of all the approach is sound. With respect to Dr. Fisher’s comment epidemiological evidence according to evidence: that a formal methodology for the Reference Manual On Scientific So there are design problems in any study. combining study results to derive a Evidence (Ex. 500–197). Gibson, Dunn & And there is no gold standard, not even the weighted estimate of effect is a meta- Crutcher cited the following alleged randomized control trial is the gold standard analysis and that NIOSH did not weakness: that OSHA characterized the as some people say. Epidemiologists say it. It is not the gold standard. You have to use perform a proper meta-analysis, OSHA epidemiological evidence as proving all the available evidence. It is a careful agrees that NIOSH’s analysis was not cause while the Manual makes clear that evaluation of all the methodological features that of a formal meta-analysis. However, epidemiological studies address from measurement to control group to the neither Dr. Fisher nor anyone else has association not causation, and that timing and going through criteria that are provided a formal meta-analysis of the OSHA relied on studies of ‘‘employee’s important for causation as laid down by Hill epidemiological literature to the record. recollection of the details of past job and others. There is a discussion among us, Furthermore, OSHA notes that a duties * * * and measures such as job you know, [about] which are the most necessary criteria for combining studies titles coupled with the assumption that important ones. But I think we all agree in a successful meta-analysis is that job duties were consistent across all job * * * we have established temporality in another way than doing a longitudinal study. only studies measuring similar factors titles.’’ (Id., pg. I–55). The Manual And it can be established. We have repeated and estimating very similar effects criticizes studies that rely on the that. Then, all study designs are equally should be analyzed together. OSHA’s memory of subjects and states a important. (Tr. 1476). * * * If you disregard review of the database has determined preference for measurement of all the cross-sectional studies for causal that comparisons both between and exposure. The Manual says that the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00231 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68492 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations outcome or health effect being studied the thirteen studies found statistically although not every individual study did must be clearly defined, yet OSHA significant associations between so. Pathology information that relied on ‘‘studies that examine epicondylitis and exposure to work- epicondylitis is caused by microrupture subjective memories regarding an related physical factors (see, e.g., Exs. of the tendons resulting from overuse of individual’s experience with or personal 26–907; 500–41–131; 26–53; 26–1117; the forearm muscles, and the well- tolerance for pain.’’ (Id., pg. I–56). While 26–1364; 26–1433; 500–41–116; 26–945; established connection between NIOSH found that many studies ‘‘did 26–1473). Six of the studies reported epicondylitis and racquet sports (i.e., not take into account [confounding] odds ratios or other risk measures of five tennis elbow) establish the biological factors beyond job duties and produced or greater (Exs. 26–907; 500–41–111; plausibility of the relationship. odds or risk ratios that were not 26–43; 26–1117; 26–1364; 26–1433). The evidence briefly described above statistically significant’’ (Id., pg. I–57), One study found that the rate of led OSHA to conclude that workers that OSHA ‘‘just picked the ones that repetitive exertions is highly predictive perform job tasks requiring repeated purport to show results favoring its (p=0.002) of epicondylitis (Ex. 500–41– forceful movements, especially flexion, hypothesis’’ and ‘‘routinely relied on 116). Two studies reported odds ratios pronation, or supination with the arm studies reporting associations or odds greater than ten (Exs. 26–907; 500–41– extended, are at increased risk of ratios well below 9–10 and indeed often 111). This is a much different pattern of substantial and serious musculoskeletal below 2.’’ (Id., pg. I–59). According to risk ratios than that presented by impairment to the elbow. In its analysis Gibson, Dunn & Crutcher, the Manual Gibson, Dunn & Crutcher, which claims of the epidemiological literature, NIOSH ‘‘indicates that where risk ratios are that odds ratios are well below 9–10 and also concluded there was strong significantly below nine or ten there is often around 2. evidence for a relationship between a probability that unmeasured factors The Manual does not state risk ratios exposure to a combination of work- are the true causes of the effect or below 10 may indicate that confounding related physical factors and disease being studied.’’ (Id., pg. I–58). factors are responsible for the epicondylitis (Ex. 26–1, pg 4–1 to 4–48). Gibson, Dunn & Crutcher association, as implied by Gibson, Dunn It should be noted that these OSHA and mischaracterized the nature of the & Crutcher. The Manual states ‘‘a NIOSH conclusions do not, in fact, epidemiological studies on which relative risk of 10 * * * is so high that speak of causation as purported by OSHA relied, the criteria used by OSHA it is extremely difficult to imagine any Gibson, Dunn & Crutcher; both OSHA’s to evaluate those studies, and the bias or confounding factor that might and NIOSH’s conclusions are careful to conclusions OSHA drew from those account for it.’’ (pg. 376). The Manual conform to the language of the Manual. studies. They also misconstrue a key goes on to say that ‘‘although lower In Section V on health effects, OSHA section of the Manual. OSHA did not relative risks can (emphasis added) evaluates the epidemiological evidence simply rely on epidemiological studies reflect causality, the epidemiologist will for MSDs of the upper extremity, in which exposures were assumed but scrutinize such associations more shoulder, neck, back, and lower never measured and in which the health closely because there is a greater chance extremity, be focusing primarily on the outcome was simply self-reported that they are the result of uncontrolled most reliable studies. This usually memories of pain. For each MSD, OSHA confounding or bias.’’ (Pg 377). means studies where exposures to relied primarily on a subset of studies The Manual also discusses the Hill physical work factors are directly in which exposure to work-related criteria previously cited. OSHA has observed or measured, not assumed biomechanical factors was directly evaluated the epidemiological evidence based on job title, and the MSDs have observed or measured and for which the against these criteria. As mentioned been confirmed by a combination of health outcome was clearly defined by above, the large number of studies symptoms, physical exam, and medical a combination of symptoms and reporting significant associations and tests as appropriate. In addition to the physical exam. This meets the Manual’s risk ratios above five speaks to the evidence for epicondylitis cited above: preference for objective and uniform strength of the association and the • Thirteen studies examined neck exposure measures and case definition. replicatibility of the findings for MSDs and neck/shoulder MSDs using physical It is also compatible with the 1997 of the elbow. As further explained in the exam and direct observation of NIOSH analysis, which quite properly Health Effects section, there was one exposure. All but one found significant give the greatest weight to studies that prospective cohort study of meat cutters associations between biomechanical risk involved objective exposure that provided evidence of a temporal factors and health outcome. At least assessments and physical examinations relationship between repetitive, forceful three studies reported odds ratios in their evaluation of the evidence (Ex. exertions of the forearm/elbow and greater than five (see Table V–1). 26–1, pg. 1–10). epicondylitis (Ex. 26–53). In addition, • Seventeen studies examined For example, in the case of several cross-sectional studies indicated shoulder MSDs (mostly tendinitis) using epicondylitis and other elbow MSDs, an exposure-response relationship physical exam and direct observation of thirteen epidemiological studies based between the intensity or duration of exposure. All but one found significant case definition on physical examination repetitive exertions and the prevalence associations between biomechanical risk and worker exposure determined by of MSDs (Exs. 500–41–116; 500–41–111; factors and health outcome. At least six observational analysis (see Table V–3). 26–1117; 26–697; 26–1473). Two studies reported odds ratios greater than In these studies, the diagnosis of studies reported ORs between 1 and 3 five (see Table V–2). epicondylitis was consistent and that were not statistically significant, • Seven studies examined hand/wrist required both pain on palpation of the probably because the workers were tendinitis using physical exam and epicondylar area and pain at the elbow exposed to relatively low force directed direct observation of exposure. All but with resisted movement of the wrist. at the forearm (Exs. 26–56; 26–697). one found significant associations Exposures relied on videotaped analysis Another study that did not find an between biomechanical risk factors and of job tasks to group exposed and association may have misclassified health outcome. At least four studies unexposed workers, sometimes with exposure, according to NIOSH (Ex. 26– reported odds ratios greater than five quantitative estimates of cycle times (for 1211). As a group, OSHA found that the (Table V–4). repetition), static loading on the forearm studies relied on generally controlled • Seventeen studies examined carpal (for force), and wrist posture. Nine of for important confounders and bias, tunnel syndrome using physical exam

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At least five studies reported OSHA presented results of several that it would be more difficult for many odds ratios greater than five. studies that evaluated exposure- or most forms of bias or confounding to • Six studies examined hand/arm response trends; since publication of the produce an artifactual exposure- vibration syndrome using physical exam proposal, OSHA has identified many response relationship than to bias a and vibration measurements. Four more studies that provide evidence that, simple association such as an odds found significant associations between as the level (intensity, frequency or ratio. However, it is not a sine qua non, vibration and health outcome; all of duration) of exposure increases, so does in that an epidemiologic study can which reported odds ratios greater than the risk of MSDs. OSHA summarizes provide valuable information even if five. this evidence in this section of the both exposure and outcome are OSHA has carefully evaluated the preamble. Based on these studies, represented only as dichotomous collective data base of studies for each OSHA finds that there is substantial variables (i.e., exposed versus MSD category using the criteria for evidence for a positive relationship unexposed), nor does it make causality cited in the Manual (pg. 374– between duration and intensity of unnecessary consideration of 378). OSHA used the epidemiological exposure to biomechanical risk factors methodologic issues that must be data, biomechanical research studies, and the risk of developing MSDs, and addressed when evaluating a given and information addressing biological that this evidence strengthens the causal study. Furthermore, the lack of an plausibility to draw its overall relationship between exposure and risk. exposure-response relationship is not conclusions with regard to the evidence One of the key criteria for necessarily evidence against a causal that the work-related biomechanical demonstrating a causal relationship is effect. factors were responsible for the evidence that the prevalence or The studies cited in this section observed increase in the risk of health incidence of a health outcome increases utilized a wide range of exposure impairment. OSHA finds this evidence with an increase in the level of exposure measures, including worker self-reports, compelling and points to the need to to a hazardous condition. In observation, and direct measurement. take action to provide workers with occupational epidemiological studies, As several authors have noted, even necessary protection. OSHA does not an exposure-response relationship is though exposure units and scaling vary, believe that it is appropriate to wait for demonstrated when there is a statistical there is an overall consistency between ‘‘proof of causation’’ since scientific association between the prevalence or self-reports and other, presumably more evidence cannot ever establish incidence of the health outcome in at objective, measures in these studies causation beyond any doubt. As Sir least three groups of workers each with (e.g., Booth-Jones et al., 1998: Ex. 500– Bradford Hill wrote over 35 years ago: a varying degree of exposure (e.g., no 121–9; Jensen et al., 2000: Ex. 500–41– exposure, low exposure, high exposure). 68; Neumann et al., 1999: Ex. 38–85; All scientific work is incomplete—whether When exposure response relationships Pope et al., 1998: Ex. 500–71–67). This it is observational or experimental. All scientific work is liable to be upset or are based on groups of workers, the suggests that worker perception modified by advancing knowledge. That does exposure variable is represented as an provides a useful guide to the not confer upon us a freedom to ignore the ordinal variable. Alternatively, identification of jobs involving high knowledge we already have or to postpone statistical analysis can be performed on exposures to physical risk factors, and the action that it appears to demand at a give data for individual members of study that, in general, the jobs that will be time (Ex. 26–726). cohorts to derive statistical functions identified as potentially hazardous by 3. Evidence for Exposure Response that reflect the exposure-response workers’ own evaluations will generally Relationships relationship; in this case, the exposure correspond to those that would be variable is represented as a continuous identified as potentially hazardous by Several submissions, such as those variable. For this section, studies were other measures. The results of studies submitted by the U.S. Chamber of included if the risk between that have examined exposure-response Commerce and experts testifying on musculoskeletal disorders and exposure relationships are summarized in Tables behalf of United Parcel Service (Exs. 30– to one or more biomechanical risk V–9 through V–13, and are summarized 1722, 32–241–3–19, 32–241–3–13, 30– factors were examined using either of briefly below. 4184, 30–1552), claimed that there is no these two approaches. In the studies Work Pace and Repetition epidemiologic evidence of exposure- compiled here, the most common response (or ‘‘dose-response’’) presentations of exposure response There is substantial evidence of an relationships between MSDs and the relationships are when the prevalence, exposure-response relationship for physical ergonomic stressors addressed incidence, odds ratio, or risk ratio for an MSDs of the neck and shoulders. For by the OSHA standard. In their joint MSD increases from one exposure example, in a case-control study of the written testimony on the proposed rule, category to the next. Typically these are general population in Sweden, the odds Kellie Truppa and Dr. Michael Vender, accompanied by confidence intervals or of neck/shoulder disorders increased for example, stated: a test of linear trend, as measures of markedly with work pace levels from While it may seem very intuitive that statistical stability. In other studies, the slow to medium to rushed, as well as decreasing reported ergonomic stressors exposure-response relationship may be with hours per day of performing would decrease disorders, there is no expressed in the form of a statistically repetitive precision movements at work scientific study that has demonstrated a significant linear regression coefficient, (Ekberg et al., 1994: Ex. 26–1238 ). decrease in the incidence of true disease or (partial) correlation coefficient, Ohlsson et al.found positive directly attributable to actual ergonomic associations with both the number of changes. Unlike other risk factors to health showing that, as exposure increases so (e.g.—smoking) there is no concept of does the prevalence or risk. items handled per hour in repetitive threshold exposure or dose-response in An exposure-response relationship, assembly work and the number of years relating ergonomic risk exposure to the when present, is considered to employed in such work, especially development of disease. Therefore, there can strengthen the evidence of a causal among younger employees (Ohlsson et

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TABLE V±9.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO REPETITIVE MANUAL WORK

Health outcome/body region Measure of repetitiveness (unit) affected Measure of effect Reference

Neck and Shoulder

Years sewing machine operator (4 Neck/Shoulder ...... Odds Ratio [unadj] Andersen et al.(1993: Ex. 26± categories). 0 (control: 1.0 1451). 0±7: 2.3 (0.5±11.0) 8±15: 6.8 (1.6±28.5) >15: 16.7 (4.1±67.5) Years sewing machine operator (4 Chronic neck pain ...... Odds Ratio [adj] Andersen et al.(1993: Ex. 26± categories). 0 (control): 1.0 1502). 0±7: 1.9 (1.3±2.9) 8±15: 3.8 (2.3±6.4) >15: 5.0 (2.9±8.7) Years sewing machine operator (4 Chronic should pain ...... Odds Ratio [adj] Andersen et al.(1993: Ex. 26± categories). 0 (control): 1.0 1502). 0±7: 1.4 (0.9±2.4) 8±15: 3.9 (2.3±6.5) >15: 10.3 (5.9±17.9) Years sewing machine operator (4 Chronic neck and/or shoulder Odds Ratio [adj] Andersen et al.(1993: Ex. 26± categories). pain. 0 (control): 1.0 1502). 0±7: 1.8 (1.2±2.6) 8±15: 4.3 (2.6±6.9) >15: 8.0 (4.7±13.8) Data entry at video display unit Neck (cervical diagnoses) ...... Odds Ratio [adj] Bergqvist et al.(1995: Ex. 26± (hours/week). 5±20 hr/wk: 1.2 (0.4±4.3) 1195, 500±165±25). ≥20 hr/wk: 1.7 (0.7±4.3) Data entry at video display unit ...... Neck/shoulder ...... Odds Ratio [adj] Bergqvist et al.(1995: Ex. 26± Data entry: 1.4 (0.7±2.9) 1195, 500±165±25). Data entry plus limited rest breaks: 4.8 (1.3±18.1) Typing speed ...... Neck ...... Prevalence [unadj] (test of trend): Burt et al.(1990: Ex. 26±698). Slow: 10% Moderate: 14% Fast: 25% (p<0.001) Percentage of time typing ...... Neck ...... Odds Ratio [adj] Burt et al.(1990: Ex. 26±698). <20: 1.0 20±39: 2.0 (1.0±7.7) 40±59: 2.6 (1.4±5.0) 60±79: 2.2 (1.0±4.7) 80±100: 2.8 (1.4±5.4) Typing speed ...... Shoulder ...... Odds Ratio [adj] Burt et al.(1990: Ex. 26±698). Slow: 1.0 Moderate: 2.6(1.1±5.9) Fast: 4.1 (1.8±9.4)) Percentage of time typing ...... Shoulder ...... Prevalence [unadj] (test of trend): Burt et al.(1990: Ex. 26±698). 0±19: 6% 20±39: 10% 40±59: 13% 60±79: 11% 80±100: 15% (p=.10) Repetitive precision movements Neck/Shoulder ...... Odds Ratio [adj] Ekberg et al.(1994: Ex. 26±1238). (hours/day) (3 categories). Low: 1.0 Medium: 3.8 (0.7±20) High: 15.6 (2.2±113) Work pace (3 categories) ...... Neck/Shoulder ...... Odds Ratio [adj] Ekberg et al.(1994: Ex. 26±1238) Low: 1.0 Medium: 7.6 (1.6±36) Rushed: 10.7 (2.2±52) Hour per day of video display ter- Neck, shoulder, upper back Odds Ratio [unadj] per hour 1.4 Faucett et al.(1994: Ex. 38±256) minal (VDT) use. (``upper torso''). (1.0±2.0) Monotonous working movements Neck (in white collar workers) ...... Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± (duration of repetitive move- 0.38 (p < 0.05) 1331) ments, static stress and sitting). Monotonous working movements Shoulder (in white collar workers) Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± (duration of repetitive move- 0.32 (p < 0.05) 1331) ments, static stress and sitting).

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TABLE V±9.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO REPETITIVE MANUAL WORKÐContinued

Health outcome/body region Measure of repetitiveness (unit) affected Measure of effect Reference

Monotonous working movements Shoulder (in blue collar workers) Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± (duration of precision move- 0.15 (p < 0.05) 1331) ments, repetitive movements, and static and stress). Years employed in repetitive as- Neck ...... Increasing odds (graphical pres- Ohlsson et al.(1989: Ex. 25± sembly work. entation only) 1290) Shoulder ...... Increasing odds (p=0.03); below 35 years of age, p=0.01 Work pace (items/hour) (4 cat- Shoulder ...... Odds Ratio [adj] Ohlsson et al. (1989: Ex. 26± egories). < 100: 1.0 1290) 100±199: est 8.0 (p=0.0006) 200±700: est 9.0 (p=0.0006) > 700: est 2.0 (p-value not given) Hours per day of VDT use (4 cat- Neck ...... Prevalence [unadj] (test of trend): Rossignol et al.(1987: Ex. 26± egories). 0 hr: 7% 804) 0.5±3 hr: 7% 4±6 hr: 12% ≥7 hr: 19% (p<0.00001) Odds Ratio [adj] 0 hr: 1.0 0.5±3 hr: 1.8 (0.5±6.8) 4±6 hr: 4.0 (1.1±14.8) ≥7 hr: 4.6 (1.7±13.2) Hours per day of VDT use (4 cat- Shoulder ...... Prevalence [unadj] (test of trend): Rossignol et al.(1987: Ex. 26± egories). 0 hr: 6% 804) 0.5±3 hr: 5% 4±6 hr: 10% ≥7 hr: 16% (p=< 0.00001) Odds Ratio [adj] 0 hr: 1.0 0.5±3 hr: 2.5 (0.7±10.8) 4±6 hr: 4.0 (1.0±16.9) ≥7 hr: 4.8 (1.6±17.2) Sewing machine operation (years of Neck ...... Odds Ratio [unadj] Schibye et al.(1995: Ex. 26±1463) employment). < 8 yrs: 1.0 8±14 yrs: 1.1 (0.4±2.6) ≥15 yrs: 2.1 (0.8±5.6

Shoulder ...... < 8 yrs: 1.0 15 yrs: 4.3 (1.5±12.5) 8±14 yrs: 1.3 (0.5±3.4) ≥

Arm and Elbow

Data entry at video display unit Arm/hand ...... Odds Ratio [unadj] Bergqvist et al.(1995: Exs. 26± (hours/week). 5±20 hr/wk: 1.6 (0.6±4.5) 1195, 500±165±25) ≥ 20 hr/wk: 1.8 (0.8±3.9) Percentage of time typing ...... Elbow/forearm ...... Odds Ratio [adj] Burt et al.(1990: Ex. 26±698) 20±39%: 1.2 (0.6±22.5) 40±59%: 1.7 (0.8±3.5) 60±79%: 1.9 (0.9±4.3) 80±100%: 2.8 (1.4±5.7) Typing speed ...... Elbow/forearm ...... Prevalence [unadj] (test of trend): Burt et al.(1990: Ex. 26±698) Slow: 7% Moderate: 11% Fast: 13% (p=0.02) Hours per day of VDT use ...... Arm ...... Prevelance [unadj] (test of trend): Rossignol et al.(1987: Ex. 26± 0 hr: 4% 804) 0.5±3 hr: 2% 4±6 hr: 4% ≥7 hr: 7% (p=0.01)

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TABLE V±9.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO REPETITIVE MANUAL WORKÐContinued

Health outcome/body region Measure of repetitiveness (unit) affected Measure of effect Reference

Hand and Wrist

Typing at video display unit (hours/ Hand/wrist ...... Odds Ratio [adj] Bernard et al.(1994: Ex. 500± day). 0±<2 hr: 1.0 165±21) 2±<4 hr: 1.3 (0.6±1.8) 4±<6 hr: 1.3 (0.8±2.2) 6±≥8 hr: 2.1 (1.3±3.6) ´8 hr: 3.3 (1.2±8.9) Typing speed ...... Hand/wrist ...... Odds Ratio [adj] Burt et al.(1990: Ex. 26±698) Slow: 0.9 (0.3±2.3) Moderate: 1.3 (0.6±3.1) Fast: 2.5 (1.0±5.6) Percentage of time typing ...... Hand/wrist ...... Prevalence [unadj] (test of trend): Burt et al.(1990: Ex. 26±698) 0±19: 13% 20±39: 23% 40±59: 27% 60±79: 30% 80±100: 24% (p<0.01) Hours per day of video display ter- Hand and arm ...... Odds Ratio [unadj] per hour Faucett et al.(1994: Ex. 38±256) minal (VDT) use. 1.5 (1.1±2.0) Repetition rating (1 unit on 0±10 Odds Ratio [adj]: Latko et al.(1999: Ex. 38±171) scale). Dominant wrist/hand/fingers ...... 1.17 (1.06±1.29) Tendinitis (distal upper extremity) 1.23 (1.04±1.46) Carpal tunnel syndrome ...... 1.16 (1.00±1.34) Cycle length (seconds), in work Carpal tunnel syndrome ...... Odds Ratio [adj] Leclerc et al.(1998: Ex. 500±205± performed 4±8 hours per day. ≥1 min: 1.0 11) 30±59 s: 1.03 (0.56±1.89) 10±29 s: 1.33 (0.75±2.37) <10 s: 1.90 (1.04±3.48) Years employed in repetitive as- Hand ...... Increasing odds (p=0.002) Ohlsson et al.(1989:Ex. 26±1290) sembly work. Repetitive wrist motions (years of Carpal tunnel syndrome ...... Odds Ratio [unadj] Wieslander et al.(1989: Ex. 26± exposure). <1 yr: 1.0 1027) 1±20 yrs: 2.3 (0.7±7.9) >20 yrs: 9.6 (2.8±33.0)

Multiple Body Regions

Piece-rate wage system (years of Musculo- skeletal diseases ...... Odds Ratio [adj] Brisson et al.(1989: Ex. 26±937) employment). 0±4 yrs: 1.0 5±9 yrs: 4.3 (0.5±35.9) 10±14 yrs: 10.0(1.0±79.3) 15±19 yrs. 8.0 (0.8±76.8) ≥20 yrs: 11.4 (0.9±137.1) Hours per week of video display Upper extremity and back ...... Mean hours per week [unadj] Knave et al.(1985: Ex. 26±753) terminal use. 30 in cases, 27 in non-cases (p<0.05) Percentage of recovery time per Upper extremity...... Linear regression coefficient Moore et al.(1994: Ex. 26±1033) work cycle. [unadj]: Ln(% recovery): 0.6 (r2=0.49, p<0.001) Hours per day at keyboard ...... Hand, wrist, forearm and/or elbow Prevalence [unadj] (test of trend): Oxenburgh (1987: Ex. 26±1367) 3 hr: 21% 4 hr: 24% 6 hr: 45% 6 hr: 50% >6 hr: 86%(p<0.00001) Keyboarding speed ...... Upper extremity ...... Prevalence [unadj] (test of trend): Polanyi et al.(1997): Ex. 500±41± <40 wpm: 17% 106) 40±60 wp,: 22% >60 wpm: 29% (p=0.025) Daily time keyboarding (hours per Upper extremity ...... Means (test of difference) [unadj]: Polanyi et al.(1997: Ex. 500±41± day). Cases 3.9 hours/day, controls 3.2 106) hours/day (p<0.001) Note: adj = adjusted for other covariate(s) unadj = not adjusted for other covariates

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TABLE V±10.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO FORCEFUL MANUAL EXERTION

Health outcome/body region af- Measure of manual force (unit) fected Measure of effect Reference

Neck and Shoulder

Grocery checking: hours per week Shoulder ...... Odds Ration [unadj] Baron et al.(1991: Ex. 26±697) of checking work. <20: 1 20±25: 1 >25: 3.6 (p<0.05) Forearm rotation while exerting very Shoulder ...... Odds Ration [adj] per unit: Hughes et al.(1997: Ex. 26±907) high forces (Frequency of expo- sure * Years of exposure). Interview ...... 92 (7.3±±) Examination ...... 46 (3.8±550) Light materials handling [factor Shoulder (in white collar workers) Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± formed from frequency and dura- 0.18 (p < 0.05) 1331) tion of materials handling 0.5±<1 kg and 1±5 kg]. Years of carpentry work (<10, 10 to Shoulder ...... Odds Ration [adj] Lemasters et al.(1998: Ex. 500± <20, 20+ years). 10±<20 yr: 2.3 (1.0±5.4) 121±44) 20+ yr: 3.2 (1.1±8.9) Load lifted (cumulative exposure, in Shoulder: acromio-clavicular os- Odds Ratio [adj] (per category) Stenlund et al.(1992: Ex. 26±733) 3 categories: 0±709; 710±25,999; teoarthritis. Right side: 1.55 (1.03±2.34) and >25,999 kg). Left side: 2.55 (1.50±4.35) Load lifted (cumulative exposure, in Shoulder tendinitis ...... Odds Ratio [adj] (per category) Stenlund et al.(1993: Ex. 502± 3 categories: 0±709; 710±25,999; Right side: 1.02 (0.59±1.76) 462 and >25,999 kg). Left side: 1.81 (0.95±3.44)

Arm and Elbow

Grocery checking: hours per week Elbow ...... Elbows Odds Ratio [unadj] Baron et al.(1991: Ex. 26±697) of checking work. <20: 1 20±25: 1.4 >25: 2.8 (p<0.05) Forearm rotation while exerting very Elbow/forearm: ...... Odds Ratio [adj] per unit: Huges et al.(1997: Ex. 26±907) high forces (Frequency of expo- Interview ...... 4 (0.2±4) sure * Years of exposure). Examination ...... 37.0 (3.0±470) Strenuous exertions (years of high Epicondylitis ...... Odds Ratio [adj] Ritz (1995: Ex. 26±1473) exposure). 0 yr: 1.0 1±14 yr: 1.8(0.6±5.9) 15±38 yr: 3.3 (0.9±12.5)

Hand and Wrist

Hand forces (finger flexor muscles Carpal tunnel syndrome ...... Average force (test of difference Armstrong et al.(1979: Ex. 500± on electromyography). in means): 41±8) Cases: 4.3 ″ 3.5 kp Noncases: 3.8 ″ 3.2 kp (p<0.05) Grocery checking (years of expo- Hand/wrist ...... Odds Ratio [adj] Baron et al.(1991: Ex. 26±697) sure). 0±5: 1 5±10: 2 10+: 6 (p<0.05) Grocery checking (years of expo- Carpal tunnel syndrome ...... Odds Ratio [adj] Baron et al.(1991: Ex. 26±697) sure). 0±5: 1 5±10: 4 10+: 15 (p<0.05) Grocery checking (hours per week Carpal tunnel syndrome ...... Odds Ratio [adj] Baron et al.(1991: Ex. 26±697) of exposure). <20: 1 20±25: 2.3 >25: 4.8 (p<0.05) Forearm rotation while exerting very Hand/wrist: ...... Odds Ratio [adj] per unit Hughes et al.(1997: Ex. 26±907) high forces (Frequency of expo- Interview ...... 17.0 (2.9±106) sure * Years of exposure). Examination ...... 9.3 (1.0±90) Years of carpentry work (<10, 10 to Hand and wrist ...... Odds Ratio [adj] Lemasters et al.(1998: Ex. 500± <20, 20+ years). 10¥lt;20 yr: 2.4(1.1±5.3) 121±44) 20+yr: 3.1(1.1±8.4) Biomechanical index from direct Carpal tunnel syndrome ...... Linear regression [unadj] Loslever et al.(1993: Ex. 26±161) measurements of force and pos- Flexion 0.017(r=0.62) ture. Extension: 0.035(r=0.26)

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TABLE V±10.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO FORCEFUL MANUAL EXERTIONÐContinued

Health outcome/body region af- Measure of manual force (unit) fected Measure of effect Reference

Mean relative finger flexor force (by Wrist ...... Linear regression coefficient [adj]: Malchaire et al.(1996: Ex. 26± EMG)/45±90 minute work sam- Mean relative deviation angle 1473) pling period. (p<0.05) Mean relative EMG signal (p<0.05) Seniority (years employed) (p<0.05) Manual force (as % MVC, in 5 cat- Upper extremity ...... Linear regression [unadj]: Moore et al.(1994: Ex. 26±1033) egories). Ln (Force: 2.0 (r2=0.49, p<0.001) Forceful wrist motions (3 cat- Carpal tunnel syndrome By his- Prevalence [unadj] (test of trend) Osorio et al.(1994: Ex. 26±807) egories: low, medium, high). tory. Low: 0% Medium: 10% High: 63% (p=0.00006) By nerve conduction velocity ...... Low: 0% Medium: 7% High: 33% (p=0.02) Forceful wrist motions (years ex- Carpal tunnel syndrome...... Linear regression [adj], p<0.05 Osorio et al.(1994: Ex. 26±807) posed). for: Right median nerve conduction velocity Grip >6 lb. per hand (3 categories Hand/wrist ...... Prevalence [unadj] (test of trend) Stetson et al.(1993: Ex. 26±1221) of frequency). None: 41% Some: 40% Frequent: 65% (p=0.30) High load on wrist (years of expo- Carpal tunnel syndrome ...... Odds Ratio [unadj] Wieslander et al.(1989: Ex. 26± sure). <1 yr: 1.0 1027) 1±20 yr: 2.1 (0.8±5.2) >20 yr: 6.6 (1.4±14.7)

Back

Frequency of lifting per shift ...... Low back ...... Prevalence [unadj] Arad et al.(1986: Ex. 500±41±7) 0/shift: 29% 1±5/shift: 33% 6±10/shift: 49% 11±20/shift: 55% >20/shift: 54% Frequency of lifting >11.3 kg (times Prolapsed lumbar disc ...... Odds Ratio [adj] (test of trend): Kelsey et al.(1984: Ex. 500±41± per day). 0: 1.0 73) <5: 1.6 (0.4±6.1) 5±25: 2.7 (0.8±9.2) >25: 4.9 (0.5±47.6) (p=0.02) Frequency of lifting >11.3 kg (times Prolapsed lumbar disc ...... Odds Ratio [adj] (test of trend): Kelsey et al.(1984: Ex. 500±41± per day). 0: 1.0 73) <5: 1.2 (0.7±2.0) 5±25: 1.3 (0.7±2.5) >25: 3.5 (1.5±8.5) (p=0.01) Frequency of carrying 11.3 kg Prolapsed lumbar disc ...... Odds Ratio [adj] (test of trend): Kelsey et al.(1984: Ex. 500±41± (times per day). 0: 1.0 73) <5: 1.0 (0.6±1.9) 5±25: 2.1 (1.0±4.3) >25: 2.7 (1.2±5.8) (p=0.004) Lifting 11.3 kg while twisting ...... Prolapsed lumbar disc ...... Odds Ratio [adj] (test of trend): Kelsey et al.(1984: Ex. 500±41± Never or rare: 1.0 73) Moderate: 2.5 (0.9±6.8) Often: 3.1 (1.3±7.5) (p=0.002) Load on spine (12 continuous bio- Low back ...... Odds Ratio [adj] for inter-quartile Kerr et al.(2000: Ex. 500±41±74) mechanical variables: peak and spreads: daily integraetd load). Peak lumbar shear (N): 1.7 (1.0±2.9) Cumulative lumbar disc compres- sion (N s/shift): 2.0 (1.2±3.6) Peak hand force (N): 1.9 (1.2± 3.1) Index of stone load (weight*hours/ Low back ...... Odds Ratio [adj]: Latza et al.(2000: Ex. 500±19±6) day). None: 1.0 Intermediate: 1.8 (0.3±9.3) High: 4.0 (0.8±19.8)

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TABLE V±10.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO FORCEFUL MANUAL EXERTIONÐContinued

Health outcome/body region af- Measure of manual force (unit) fected Measure of effect Reference

Lifting demands index (``Job Sever- Back ...... Injury incidence rate, disabling in- Liles et al.(1984: Exs. 26±33, ity Index''). jury incidence, and severity rate 500±41±88) increased with JSI (graphical presentations) Dynamic trunk motions (31 contin- Low back...... Odds Ratio [adj] for combined Marras et al.(1993: Ex. 500±41± uous biomechanical. weighted means of 5 variables: 94) 10.7 (4.9±23.6) Load on spine (12 continuous bio- Low back ...... Higher load in cases vs controls, Norman et al.(1998: Ex. 38±84) mechanical variables: peak and by each variable (all p-values daily integrated load). <0.04). Odds ratios [adj] com- puted both for full observed ranges of exposure and more conservatively for inter-quartile spreads: Peak shear (N) 1.5 (1.0±2.4) Peak trunk velocity (deg/sec) 1.6 (1.1±2.5) Integrated moment (MN m s) 1.4 (1.0±2.0) Usual hand force (N) 1.7 (1.2± 2.6) Transfer a patient on canvas and Low back ...... Odds Ratio [adj] Smedley et al.(1995: Ex. 500±41± poles (frequency/average working 0: 1.0 40) shift). 1±4: 1.0 (0.8±1.3) ≥5: 1.3 (0.8±2.1) Manually transfer patient between Low back ...... Odds Ratio [adj] Smedley et al.(1995: Ex. 500±41± bed and chair (frequency/shift). 0: 1.0 40) 1±4: 1.4 (1.1±1.9) 5±9: 1.8 (1.3±2.5) ≥10: 1.5 (1.1±2.1) Manually move patient around on Low back ...... Odds Ratio [adj] Smedley et al.(1995: Ex. 500±41± bed (frequency/shift). 0: 1.0 40) 1±4: 1.2 (0.8±1.7) 5±9: 1.6 (1.1±2.3) ≥10: 1.7 (1.2±2.4) Manually transfer patient between Low back ...... Odds Ratio [adj] Smedley et al.(1997: Ex. 500± bed and chair (frequency/shift). 0: 1.0 205±25) 1±4: 1.3 (0.9±1.7) 5±9: 1.6 (1.1±2.3) ≥10: 1.6 (1.1±2.3) Transfer patient between bed and Low back ...... Odds Ratio [adj] Smedley et al.(1997: Ex. 500± chair with hoist (frequency/shift). 0: 1.0 205±25) 1±4: 1.5 (1.0±2.0) ≥5: 1.6 (0.8±3.0) Manually move patient around on Low back ...... Odds Ratio [adj] Smedley et al.(1997: Ex. 500± bed (frequency/shift). 0: 1.0 205±25) 1±4: 1.3 (0.8±1.9) 5±9: 1.5 (1.0±2.3) ≥10: 1.7 (1.1±2.5) Lift patient in or out of bath with Low back ...... Odds Ratio [adj] Smedley et al.(1997: Ex. 500± hoist (frequency/shift). 0: 1.0 205±25) 1±4: 1.4 (1.0±1.9) ≥5: 2.1 (1.2±3.6) Frequent vs. infrequent lifting in pa- Back ...... Length of time at work without Stobbe et al.(1988: Ex. 500±41± tient care. back injury longer for those 45) with infrequent lifting demands (p<0.01 in survival analysis) Lifting frequency (4 categories of Back ...... Odds Ratio [adj] Venning et al.(1987: Ex. 500±41± hospital service area, from 1, lift- Area IV: 1.0 49) ing most, to IV, lifting least). Area III: 1.26 (p>0.05) Area II: 1.73 (p>0.05) Area I: 4.26 (p<0.01)

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TABLE V±10.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO FORCEFUL MANUAL EXERTIONÐContinued

Health outcome/body region af- Measure of manual force (unit) fected Measure of effect Reference

NIOSH Lifting Equation Lifting Low back (severity rating, range Mean severity (standard devi- Wang et al.1998 (1998: Ex. 500± Index (LI) (4 categories). 0±5). ation): 41±52) LI:<1: 0.18 (0.15) 1≤LI ≤3: 3.57 (0.86) LI>3: 4.07 (0.73) RWL*=0: 3.86 (0.75) ANOVA (α=0.05) *Recommended Weight Limit NIOSH Lifting Equation Lifting Low back ...... Odds Ratio [unadj] Waters et al.(1999: Ex. 500±121± Index (LI). 0: 1.0 76) 0

Lower Extremity or Multiple Body Regions

Strength demand of job (3 cat- Knee (radiographic osteoarthritis) Odds Ratio [adj] Anderson et al.(1988: Ex. 26± egories: none, some, much). Men, ages 55±64: 1.9 (0.9±4.0) 926) Women, ages 55±64: 3.1 (1.0± 9.4) Kneeling, squatting or stair-climb- Knee osteoarthritis ...... Odds Ratio [adj] Cooper et al.(1994: Ex. 500±41± ing, with and without heavy lifting. Neither kneeling nor lifting: 1.0 27) Kneeling/squatting: 2.5 (1.1±5.5) Kneeling and lifting: 5.4 (1.4± 21.0) Maximum compressive force (lb.) ``Overexertion incidents'' by clinic Incidence rate (per 200,000 Herrin et al.(1986: Ex. 26±961) on L5/S1 lumbar disc. visit. hours): <1000 lb: 65 1000±1500 lb: 150 >1500 lb: 208 Index of physically strenuous load .. Overall MSD morbidity: ...... Linear regression coefficient [adj]: Leino et al.(1995: Ex. 32±241±3± Symptoms ...... 0.127 (p=0.002) 54) Findings ...... 0.091 (p=0.026) Years of carpentry work (<10, 10 to Knee ...... Odds Ratio [adj] Lemasters et al.(1998: Ex. 500± <20, 20+ years). 10±<20 yr: 1.9 (0.9±4.1) 121±44) ≥20 yr: 3.5 (1.3±9.2) Lifting at work (kilograms per day) Knee ...... Odds Ratio [adj] Sandmark et al.(2000: Ex. 500± Men: ...... Medium: 2.5 (1.5±4.4) 41±114) Women: ...... High: 3.0 (1.6±5.5) Medium: 1.2 (0.7±1.9) High: 1.7 (1.0±2.9)

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TABLE V±11.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTURE

Health outcome/body region af- Measure of posture fected Measure of effect Reference

Neck and Shoulder

Height of video display unit key- Neck/shoulder ...... Linear regression coefficient Bergqvist et al.(1995: Ex. 500± board relative to elbow height [unadj] 0.18 (¥0.03, 0.40) 165±24) (centimeters). Duration of shoulder flexion or ab- Shoulder/neck ...... Ratio for cases vs. controls: Bjelle et al.(1981: Ex. 26±1519) duction >60 degrees (hours/day). Right: 2.0 (p <0.005) Left: 2.4 (p <0.025) Frequency of shoulder flexion or Shoulder/neck ...... Ratio for cases vs. controls: Bjelle et al.(1981: Ex. 26±1519) abduction >60 degrees (times/ Right: 2.0 (p <0.001) day). Left: 2.2 (p <0.005) Arms lifted (hours per day, 3 cat- Neck/shoulder ...... Odds Ratio [adj] Ekberg et al.(1994: Ex. 26±1238) egories). Low: 1.0 Medium: 2.4 (0.8±7.1) High: 4.8 (1.3±18) Elbow flexed >1 time/minute (per Shoulder ...... Odds Ratio [adj] English et al.(1995: Ex. 26±848) hour/day). 1.10 (0.98±1.23) Head rotation...... Neck, shoulder, upper back R-squared [adj] Faucett et al.(1994: Ex. 38±256) (``upper torso''). Pain: 0.11 (p<0.01) Stiffness: 0.18 (p<0.01) Keyboard height relative to elbow .. Neck, shoulder, upper back R-squared [adj] Faucett et al.(1994: Ex. 38±256) (``upper torso''). Pain: 0.05 (p<0.05) Stiffness: 0.06 (p<0.05) Years of exposure to repetitive Shoulder impingement syndrome Increasing prevalence ratio [adj] Frost et al.(1999: Ex. 38±97) shoulder flexion (angle ≥30 de- with cumulative exposure non- grees, 600 times/hour) with high linear trend, p=0.002 for quad- forces. ratic term È Hands above shoulder level (hours Neck/shoulder pain with impair- Prevalence Ratio [adj] Holmstrom et al (1992: Ex. 500± per day). ment. <1 Hr. 1.1 (0.8±1.5) 41±64) 1±4 hr. 1.5 (1.2±1.9) >4 hr. 2.0 (1.4±2.7) È Stooping (hours per day) ...... Neck/shoulder pain with impair- Prevalence Ratio [adj] Holmstrom et al (1992: Ex. 500± ment. <1 Hr. 1.0 (0.8±1.3) 41±64) 1±4 hr. 1.4 (1.1±1.8) >4 hr. 1.5 (1.1±2.1) Bent work postures [factor=duration Neck (in white collar workers) ...... Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± of precision movements and 0.20 (p<0.05) 1331) head bent foward; frequency and duration of trunk forward flexion (20°±60°)]. Twisted work postures Neck (in white collar workers) ...... Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± [factor=duration of trunk rotation 0.23 (p<0.05) 1331) (>45°) and head rotation (>45°)]. Extreme work postures Shoulder (in blue collar workers) Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± [factor=frequency and duration of 0.14 (p<0.05) 1331) trunk forward flexion (>60°); fre- quency of trunk forward flexion (20°±60°); and duration of head rotation (>45°), trunk rotation (>45°), and work with hands above shoulders]. Twisted work postures Shoulder (in white collar workers) Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± [factor=duration of trunk rotation 0.16 (p<0.05) 1331) (>45°) and head rotation (>45°)]. Percentage of work cycle with Cervicobrachial (neck to hand) .... Odds Ratio [adj] Jonsson et al.(1988: Ex. 26±969) shoulder elevated. 1.04 (p<0.05) Neck flexion (percentage of work Neck ...... Regression coefficient p-value Kilbom et al.(1986: Ex. 500±41± cycle). [adj] 75) p<0.01 Shoulder elevated (percentage of Regression coefficient p-value Kilbom et al.(1986: Ex. 500±41± work cycle). [adj] 75) Neck ...... p<0.05 Shoulder ...... p<0.05 Neck flexion (movements per hour) Neck/shoulder ...... Ratio of median for cases vs. Ohlsson et al.(1995: Ex. 26±868) controls [unadj] Total movements: 1.3 (p=0.008) Flexions ≥30°: 1.3 (p=0.02)

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TABLE V±11.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTUREÐContinued

Health outcome/body region af- Measure of posture fected Measure of effect Reference

Frequency of shoulder flexion or Neck/shoulder ...... Median elevation >30° (% of time) Ohlsson et al.(1995: Ex. 26±868) abduction. [unadj]: Cases=16, controls=9 (p=0.05) Median elevation >30° (move- ments per hour) [unadj]: Cases=60, controls=9 (p=0.004) Median abduction ≥60° (% of time) [unadj]: Cases=1, controls=0 (p=0.04) Median elevation ≥60° (move- ments per hour) [unadj]: Cases=47, controls=0 (p=0.04) Shoulder flexion or abduction >90 Left shoulder ...... Odds Ratio [unadj] (test of trend) Punnett et al.(2000: Ex. 500±41± degrees (duration, as percentage Right shoulder ...... >0%±<10%: 2.5 109 of work cycle). Either shoulder ...... ≥10%: 5.1 (p=0.0001) >0%±<10%: 1.7 ≥10%: 2.8 (p=0.002) Ratio of mean duration in cases vs. controls [unadj]: 2.6 (p=0.003) Odds Ratio (95% CI) per 10% in- crement [adj]: 1.4 (1.1±1.8) Twisted or bent postures (4 cat- Neck/shoulder ...... Odds Ratio [adj] Tola et al.(1988: Ex 26±1018) egories). Little: 1.0 Moderate: 1.2 (1.0±1.5) Rather much: 1.6 (1.4±1.9) Very much: 1.8 (1.5±2.2) Twisting of trunk (hours/day) (4 cat- Neck ...... Odds Ratio [adj]: Viikari-Juntura et al.(2000: Ex. egories). Not at all: 1.0 500±41±50) Little: 1.3 (0.7±2.4) Moderately: 1.9 (1.1±3.5) Much: 2.3 (1.2±4.3) Working with hand above shoulder Neck ...... Odds Ratio [adj]: Viikari-Juntura et al.(2000: Ex. level (hours/day) (3 categories). <0.5 1.0 500±41±50) 0.5±1: 1.2 (1.0±1.3) >1: 1.4 (1.3±1.6) Twisting or bending of trunk at work Neck ...... Odds Ratio [unadj]: Viikari-Juntura et al.(1994: Ex. (3 categories). Very or rather little: 1.0 26±873) Moderate: 1.7 (0.9±9±3.2) Rather or very much: 1.9 (1.2± 3.2)

Hand and Wrist

Wrist bending or twisting (per 2 Carpal tunnel syndrome ...... Odds Ratio [unadj] Blanc at al. (1996); Ex. 26±42 hours/day). 1.5 (1.2±1.7) 500±41±16) Wrist flexion (hours/week) (hours Carpal tunnel syndrome ...... Odds Ratio [unadj] De Krom et al.(1990: Ex. 26±102) truncated at 40). 0: 1.0 1±7: 1.5 (1.3±1.9) 8±19: 3.0 (1.8±4.9) 20±40: 8.7 (3.1±24.1) Wrist extension (hours/week) (hours Carpal tunnel syndrome ...... Odds Ratio [unadj] De Krom et al.(1990: Ex. 26±102) truncated at 40). 0: 1.0 1±7: 1.4 (1.0±1.9) 8±19: 2.3 (1.0±5.2) 20±40: 5.4 (1.1±27.4) Shoulder rotation with arm ele- Odds Ratio [adj] English et al.(1995: Ex. 26±848) vated, >1 time/minute (per hour/ day). Wrist/forearm ...... 1.6 (1.2±2.3) Carpal tunnel syndrome ...... 1.8 (1.2±2.8) Shoulder rotation with elbow flexed, Finger ...... Odds Ratio [adj] English et al.(1995: Ex. 26±848) >1 time/minute (per hour/day). 5.1 (2.0±12.8) Wrist flexion or extension (per 20 Thumb ...... Odds Ratio [adj] English et al.(1995: Ex. 26±848) repetitions/min). 1.4 (1.1±1.8) È Ulnar abduction (degrees of ``typ- Forearm ...... Increasing percentage of opera- Hunting et al.(1981: Ex. 26±1276) ical'' work posture). tors w/medical findings vs. angle of ulnar abudction (graphical presentation only)

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TABLE V±11.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTUREÐContinued

Health outcome/body region af- Measure of posture fected Measure of effect Reference

Relative angle of wrist ulnar or ra- Wrist ...... Linear regression coefficient [adj]: Malchaire et al.(1996: Ex. 26± dial deviation/45±90 minute work Mean relative deviation angle 1473) sampling period. (p<0.05) Mean relative EMG signal (p<0.05) Seniority (years employed) (p<0.05) Wrist bending or twisting (mean Carpal tunnel syndrome ...... Odds Ratio [adj] Nordstrom et al.(1997: Ex. 26± hours/day) (5 categories). 0: 1.0 900) 0.25±1.75: 1.34(0.64±2.80) 2±3: 1.23(0.60±2.53) 3.5±6: 2.33 (1.24±4.36) 7±16: 2.47 (1.38±4.43) quad- ratic dose-response effect in al- ternative model, p=0.03 Wrist deviation (3 categories of fre- Hand/wrist ...... Prevalence [unadj] (test of trend) Stetson et al.(1993: Ex. 26±1221) quency). None: 35% Some: 43% Frequent: 45% (p=0.43)

Back

Postural load (index of frequency Low back pain ...... Odds Ratio [adj] (test for trend) Bovenzi et al.(1994: Ex. 26±774) and/or duration of 4 postures, in 4 categories). Lifetime ...... Mild: 1.0 Moderate: 1.3(0.8±2.4) Hard: 1.7(1.0±3.0) Very hard: 3.6(2.0±6.5) (p=0.001) 12 month pervalence: ...... Moderate: 1.8 (1.1±3.2) Hard: 2.2(1.3±3.8) Very hard: 4.6 (2.6±8.0) (p=0.0001) È Hands above should level (hours Low back (severe pain with im- Prevalence Ratio [adj]: Holmstrom et al.(1992: Ex. 500± per day). pairment). <1 hr: 1.1 0.8±1.5) 41±65) 1±4: 1.5 (1.2±2.0) >4 hr: 1.6 (1.0±2.6) È Stopping (hours per day) ...... Low back (severe pain with im- Prevalence Ratio [adj]: Holmstrom et al.(1992: Ex. 500± pairment). <1 hr: 1.3 (0.9±1.8) 41±65) 1±4 hr: 1.9 (1.4±2.6) >4 hr: 2.6 (1.7±3.8) È Kneeling (hours per day) ...... Low back (severe pain with im- Prevalence Ratio [adj]: Holmstrom et al.(1992: Ex. 500± pairment). <1 hr: 2.4 (1.7±3.3) 41±65) 1±4 hr: 2.6 (1.9±3.5) >4 hr: 3.5 (2.4±4.9) Extreme work postures [factor Low back (in blue collar workers) Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± formed from frequency and dura- 0.16 (p<0.05) 1331) tion of trunk forward flexionn (>60°); frequency of trunk forward flexion (20°±60°); and duration of head rotation (>45°), trunk rota- tion (>45°), and work with hands above shoulders]. Monotonuous working movements Low back (in white collar workers Partial correlation coefficient [adj] Johansson et al.(1994: Ex. 26± [factor formed from duration of 0.22 (p<0.05) 1331) repetitive movements, static stress, and sitting]. Driving (hours/week) ...... Low back ...... Odds Ratio [adj] for prevalence: Pietri et al.(1992: Ex. 29±309) <10: 1.0 10±14: 1.5 (1.0±2.4) 15±19: 1.2 (0.8±1.9) 20±24: 2.0 (1.3±3.1) ≥ 25 2.1 (1.3±3.4)

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TABLE V±11.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTUREÐContinued

Health outcome/body region af- Measure of posture fected Measure of effect Reference

Driving (hours/week) ...... Low back ...... Odds Ratio [adj] for 1 year cumu- Pietri et al.(1992: Ex. 38±309) lative incidence: <10: 1.0 10±14: 4.0 (1.1±14.3) 15±19: 4.8 (1.4.8±16.4) 20±24: 3.3 (0.9±12.0) ≥ 25 3.7 (0.9±14.0) Percentage of work cycle in trunk Low back ...... Odds Ratio [unadj] (test of trend) Punnett et al.(1991: Ex. 26±1289) flexion (3 categories). Mild flexion: 0%: 1.0 1±10%: 4.2 ≥10%: 6.1 (p=0.014) Severe flexion: 0%: 1.0 0±10%: 4.4 ≥10%: 8.9 (p=0.003) Percentage of work cycle in non- Back ...... Odds Ratio [adj] Punnett et al.(1991: Ex. 26±1289) neutral trunk posture (mild flex- 8.09 (1.5±44.0) ion, severe flexion, twist or lateral bend). Ê Twisted or bent postures (4 cat- Low back ...... Odds Ratio [adj] Riihimaki et al. (1989: Ex. 26±58) egories). Rather or very little: 1.0 Moderate: 1.3 (1.0±1.7) Rather much: 1.5 (1.2±1.9) Very much: 1.5 (1.2±1.9) Ê Forward bending (minutes per day) Low back ...... Odds Ratio [adj]: Vingard et al.(2000: Ex. 500±41± Men 51) 1±59 min: 1.6 (1.1±2.5) ≥60 min: 1.8 (1.1±3.1) Women 1±59 min: 1.1 (0.8±1.6) ≥60 min: 1.2 (0.7±1.8) Repeated bending, twisting, and Back ...... Odds Ratio [unadj] Wild (Ex. 26±1106; 26±1107) reaching at work (hours per day. 0 hr: 1.0 >0±<2 hr: 5.8 2+±<4 hr: 8.4 4+±<6 hr: 10.4 6+ hr: 14.1 Odds Ratio [adj] per hour of re- peated bending, twisting and reaching: 1.09 (1.06, 1.13) Frequent twisting or bending ...... Low back ...... Odds Ratio [unadj] (test of trend): Xu et al.(1997: Ex. 500±71±53) No or seldom: 1.0 1/4 of the time: 1.8 1/2 of the time: 1.9 3/4 of the time: 2.0 All of the time: 2.0 (p<0.001)

Lower Extremity

Knee-bending demand of job (3 Knee: radiographic osteoarthritis Odds Ratio [adj] Anderson et al.(1988: Ex. 26± categories: none, some, much). Men, ages 55±64: 2.5 (1.2±5.0) 926) Women, ages 55±64: 3.5 (1.2± 10.5) Kneeling and/or squatting (Floor- Knee ...... Odds Ratio [unadj] Kirkeskov Jensen et al.[Jensen, and carpetlayers 56%, carpenters Compositors: 1.0 1977#1975] 25%, compositors 0% of working Carpenters: 3.9 (2.7±5.5) time). Floor- and carpetlayers: 6.4 (4.0±10.1) Standing (hours per day) ...... Knee ...... Odds Ratio [adj] Sandmark et al.(2000: Ex. 500± 41±114) Men ...... Medium: 1.5 (0.9±2.4) High: 1.7 (1.0±2.9) Women ...... Medium: 1.2 (0.7±1.9) High: 1.6 (1.0±2.8) Squatting or knee bending (number Knee ...... Odds Ratio [adj] Sandmark et al.(2000: Ex. 500± per day). 41±114) Men ...... Medium: 1.3 (0.8±2.2) High: 2.9 (1.7±4.9)

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TABLE V±11.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTUREÐContinued

Health outcome/body region af- Measure of posture fected Measure of effect Reference

Kneeling (minutes per day) ...... Knee ...... Odds Ratio [adj] Sandmark et al.(2000: Ex. 500± 41±114) Men ...... Medium: 1.4 (0.9±2.2) High: 2.1 (1.4±3.3) Jumping (number per day) ...... Knee ...... Odds Radio [adj] Snadmark et al.(2000: Ex. 500± 41±114) Men ...... Medium: (0.9±2.4) High: 2.7 )1.7±4.1) Ê Jumping (number) ...... Hip ...... Odds Ratio [adj] Vingard et al.(1977: Ex. 26±1617) Medium: 1.0 (0.5±2.0) High: 2.1 (1.1±4.2) Ê Stairs climbed (flights) ...... Hip ...... Odds Ratio [adj] Vingard et al.(1997: Ex. 26±1616) Medium: 1.3 (0.8±2.0) High: 2.1 (1.2±3.6)

TABLE V±12.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO SEGMENTAL VIBRATION, BY BODY REGION AFFECTED.

Health outcome/body region af- Measure of vibration exposure (unit) fected Measure of effect Reference

Vibration exposure (energy equiva- Upper extremity ...... Odds Ratio [adj] Bovenzi et al.(1991: Ex. 500±41± lent frequency-weighted accelera- <7.5 m/sec 2 2.7 18) tion) for 4 hours/day. >7.5 m/sec 2 14.1 (p<0.005) Daily vibration exposure (energy Upper extremity ...... Odds Ratio [adj] per unit Bovenzi et al.(1991: Ex. 500±41± equivalent frequency-weighted ac- 1.29 (p<0.5) 18) celeration). Daily vibration exposure (energy Upper extremity muscle-tendon syn- Odds Ratio [adj] per unit Bovenzi et al.(1991: Ex. 500±41± equivalent frequency-weighted ac- drome. 1.42 (p<0.5) 18) celeration). Daily vibration exposure (energy Carpal tunnel syndrome ...... Odds Ratio [adj] per unit Bovenzi et al.(1991: Ex. 500±41± equivalent frequency-weighted ac- 1.73 (p<0.5) 18) celeration). Lifetime dose (5 categories of accel- Hand-arm vibration syndrome ...... Odds Ratio [adj] per unit Bovenzi et al.(1991: Ex. 500±41± eration 2 years). 0: 1.0 17) 0±19: 4.1 (1.1±16.4) 19±20: 4.7 (1.3±16.1) 20±21: 9.4 (3.1±28.4) >21: 34.3 (11.9±99.0) Riveting (years) ...... Wrist ...... Odds Ratio [adj] per year Burdorf et al.(1991: Ex. 500±41±21) 1.12 (p<0.05) Riveting (years) ...... Hand-arm vibration syndrome ...... Odds Ratio [adj] per year Burdorf et al.(1991: Ex. 500±41±21) 1.07 (p<0.05) Power tool usage ...... Forearm-hand (right) ...... Median values for Fransson Hall et al.(1996: Ex. 500± workstations with high vs. 41±56) low symptom prevalence [unadj] Holding time: 12 sec. vs 6 secs. (p<0.05) Total duration: 21 sec. vs 15 secs. (p<0.05) Years of exposure to vibration (chain Vibration-induced white finger ...... Positive association with Futatsuka et al.(1985: Ex. 26±1430) saw use). duration of exposure Higher prevalence and ear- lier onset of symptoms with earlier first exposure (higher acceleration lev- els) (all data presented graphically)

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TABLE V±12.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE TO SEGMENTAL VIBRATION, BY BODY REGION AFFECTED.ÐContinued

Health outcome/body region af- Measure of vibration exposure (unit) fected Measure of effect Reference

Cumulative hours of exposure to vi- Median and ulnar motor and sen- Correlation coefficient Koskimies et al.[Koskimies, 1990 bration. sory nerve function. [unadj] #1983] R median motor NCV: 0.274 (p=0.01) L median motor NCV: 0.123 (p>0.05) R ulnar motor NCV: 0.259 (p=0.05) L ulnar motor NCV: 0.389 (p>0.001) R median distal latency: 0.172 (p=0.05) L median distal latency: 0.214 Cumulative exposure to vibration (log Hand-arm vibration syndrome: ...... Odds Ratio [adj] per com- Letz et al.(1992: Ex. 26±384) hours). mon log unit Vascular ...... 2.9 (1.7±5.0) Sensorineural ...... 1.8 (1.2±2.9) Tool use (years) ...... Hand-arm vibration syndrome Odds ratio [adj] per year McGeoch et al.(2000: Ex. 500±41± (Stockholm workshop scales):. 96) Neurological stage ≥ 1 ...... 1.09 (p<0.05) Vascular stage ≥ 1 ...... 1.10 (p<0.05) Years of exposure to vibration ...... Hand-arm vibration syndrome ...... Odds ratio [adj] per year Nilsson et al. (1989: Ex. 26±1148) 1.11 (1.05±1.17) Years of exposure to vibration ...... Median nerve latency at carpal tun- Odds ratio [adj] per year Nilsson et al.(1994: Ex. 26±1190) nel. Right: 1.12 (1.02±1.23) Left: 1.09 (1.00±1.20) Cumulative vibration exposure (3 cat- Shoulder: osteoarthritis of the Odds Ratio [adj] (per cat- Stenlund et al.(1992: Ex. 26±733) egories: 0±8999; 9000±255,199; acromioclavicular joint. egory) and >255,199 energy-weighted Right side: 1.3 (0.9±1.8) hours). Left side: 1.8 (1.2±2.6) Cumulative vibration exposure (3 cat- Shoulder tendinitis ...... Odds Ratio [adj] (per cat- Stenlund et al.(1993: Ex. 502±462) egories: 0±8999; 9000±255,199; egory) and >255,199 energy-weighted Right side: 1.7 (1.1±2.6) hours). Left side: 1.8 (1.1±3.1)

TABLE V±13.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MSDS WITH COMBINATION OF EXPOSURES (e.g., REPETITION, FORCE AND POSTURE), BY TYPE OF EXPOSURE AND BODY REGION AFFECTED.

Health outcome/body region af- Exposure factors fected Measure of effect Reference È È Index of physical stress at work Neck ...... Odds Ratio [adj] Makela et al.(1991: Ex. 26±980) (sum of 6 items). Age 30±64 years: 1.26 (1.18± 1.33) Age ≥ 65 years: 1.12 (1.00± 1.26) Index of mechanical workload (sum Elbow: epicondylitis ...... Odds ratio [adj]: Ono et al.(1998: Ex. 500±66±4) of 6 items). Model 2: 1.5 (1.0±2.3) Model 3: 1.7 (1.2±2.6) Repetition; force (4 categories: LF Hand/wrist: tendinitis ...... Prevalence Rate Ratio [unadj] Armstrong et al.(1987: Ex. 26±48) = low force; LR = low repetition; LF LR: 1.0 HF = high force; HR = high rep- HF LR: 4.8 (0.6±39.7) etition. LF HR: 5.5 (0.7±46.3) HF HR: 17.0 (2.3±126.2) Work at video display unit, with and Arm/hand ...... Odds Ratio [adj] Bergqvist et al.(1995: Ex. 26± without specific job features. Data entry: 1.5 (0.7±3.4) 1195 500±165±25) Data entry plus keyboard too low: 2.8 (0.9±8.6) ≥ 20 hr/week: 0.5 (0.2±1.4) ≥ 20 hr/week plus limited rest breaks, no lower arm support: 4.6 (1.2±17.9) Work at video display unit, with and Arm/hand ...... Odds Ratio [adj] Bergqvist et al.(1995: Ex. 500± without specific job features. Limited rest breaks, plus no lower 165±24) arm support, vs. one or neither: 10.1 (2.4±43.2)

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TABLE V±13.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MSDS WITH COMBINATION OF EXPOSURES (e.g., REPETITION, FORCE AND POSTURE), BY TYPE OF EXPOSURE AND BODY REGION AFFECTED.ÐContinued

Health outcome/body region af- Exposure factors fected Measure of effect Reference

Force and repetition of hand activi- Hand: Median nerve sensory con- Test of positive linear trend: Nathan et al.(1988: Ex. 26±990) ties (5 classes, from very light/ duction velocity. p < 0.01 low to very heavy/high). Force and repetition of hand activi- Hand: Median nerve sensory con- Linear regression coefficient [adj]: Nathan et al.(1992: Ex. 26±988) ties (5 classes, from very light/ duction velocity. Class of hand activity: 0.011 (p < low to very heavy/high). 0.05) Index of physical risk factors (sum Hand: Radial tunnel syndrome .... P <0.001, test for trend Roquelaure et al.(1996: Ex. 500± of 3 items: force; 1 kg, cycle time 41±111) < 30 sec, static hand work). Index of physical risk factors (sum Hand: Carpal tunnel syndrome .... Odds ratio [adj] Roquelaure et al.(1997: Ex. 38± of 5 occupational items plus par- ≤ 2 factors: 1.0 396) ity ≥ 3). 3 factors: 5.6 (1.6±24.5) 4 factors: 93.7 (13.4±93.8) ≥ 5 factors: 90.0 (8.0±366.5) Repetition; force (4 categories: LF Hand/wrist ...... Odds Ratio [adj] Silverstein et al.(1986: Ex. 26± = low force; LR = low repetition; LF LR: 1.0 1404) HF = high force; HR = high rep- HF LR: 5.2 etition). LF HR: 3.3 HF HR: 29.1 (p < 0.05) Repetition; force (4 categories: LF Hand: Carpal tunnel syndrome .... Odds Ratio [adj] Silverstein et al.(1987: Ex. 26±34) = low force; LR = low repetition; LF LR: 1.0 HF = high force; HR = high rep- HF LR: 1.8 etition). LF HR: 2.7 HF HR: 15.5 (p < 0.001) Repetitiveness and forceful exer- Test of positive linear trend: Chiang et al.(1993: Ex. 26±1117) tions of the upper limbs (Group I = neither, Group II = either, Group III = both). Neck symptoms ...... p = 0.04 Shoulder symptoms ...... p = 0.000 Shoulder girdle diagnosis ...... p = 0.000 Elbow symptoms ...... p = 0.11 Epicondylitis ...... p = 0.14 Wrist symptoms ...... p = 0.03 Hand symptoms ...... p = 0.04 Carpal tunnel syndrome ...... p = 0.02 Index of ergonomic stressors (sum Upper extremity (neck, shoulder/ Prevalence ratio [adj] Punnett (1998: Ex. 26±38) of 9 items, range 0±25). upper arm, elbow/forearm, and/ 0±6: 1.0 or hand/wrist). 7±12: 2.0 (1.2±3.4) 13±18: 2.6 (1.6±4.3) 19±25: 2.8 (1.6±4.8) Shoulder/upper arm ...... 0±6: 1.0 7±12: 2.6 (1.1±6.2) 13±18: 3.6 (1.6±8.3) 19±25: 3.3 (1.3±8.3) Wrist/hand ...... 0±6: 1.0 7±12: 1.9 (1.0±3.8) 13±18: 2.4 (1.3±4.7) 19±25: 2.3 (1.1±4.7) È Index of occupational physical Low back ...... Odds Ratio [adj]: Heliovaara et al.(1991: Ex. 26± stress (sum of 5 items, range 0± 0: 1.0 959) 5). 1: 1.2 (0.9±1.6) Lifting >11.3 kg while twisting 2: 1.7 (1.3±2.1) Low back: Prolapsed lumbar 3: 2.1 (1.6±2.7) disc Odds Ratio [adj]: 4: 3.2 (2.3±4.5) Knees bent: 2.7 (0.9±7.9) 5: 2.5 (1.4±4.7) Knees straight: 6.1 (1.3±27.9) Kelsey et al.(1984: Ex. 500±41± 73) Lifting > 11.3 kg while twisting ...... Low back: Prolapsed lumbar disc Odds Ratio [adj] Kelsey et al.(1984: Ex. 500±41± Knees bent: 2.7 (0.9±7.9) 73) Knees straight: 6.1 (1.3±27.9) Physical exposure index (sum of 3 Low back ...... Odds Ratio [adj]: Liira et al.(1996: Ex. 26±748) items, range 0±3. 0: 1.0 1: 1.41 (1.02±1.94) 2: 2.45 (1.63±3.68) 3: 3.18 (1.72±5.81) Ê Forward bending and manual mate- Low back ...... Odds Ratio [adj]: Vingard et al.(2000: Ex. 500±41± rials handling (MMH) (highly ex- 51) posed now, 5 and 10 years ago).

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TABLE V±13.ÐEVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MSDS WITH COMBINATION OF EXPOSURES (e.g., REPETITION, FORCE AND POSTURE), BY TYPE OF EXPOSURE AND BODY REGION AFFECTED.ÐContinued

Health outcome/body region af- Exposure factors fected Measure of effect Reference

Men Forward bending: 1.8 (1.0±3.3) MMH: 2.0 (1.0±4.3) Bending and MMH: 2.8 (1.1± 7.5) Women Forward bending: 1.5 (0.8±2.6) MMH: 1.1 (0.6±2.1) Bending and MMH: 2.9 (1.2± 6.8) Kneeling, squatting or stair-climb- Knee osteoarthritis ...... Odds Ratio [adj]: Cooper et al.(1994: Ex. 500±41± ing, with and without heavy lifting. Neither kneeling nor lifting: 1.0 27) Kneeling/squatting: 2.5 (1.1±5.5) Kneeling and lifting: 5.4 (1.4± 21.0) Kneeling, with (floor layers) and Knee: bursitis ...... Prevalence ratio [adj]: Thun et al.(1987: Ex. 26±60) without (tile/terrazzo setters) use Floor layers: 3.2 (1.9±5.4) of knee kicker. Tile setters: 1.8 (0.8±3.9)

In a cross-sectional study of trend with years of exposure (p<0.001). Wieslander et al., 1989: Ex. 26–1027). newspaper workers, the risk of both These findings are compatible with Moore et al., (Moore et al., 1994: Ex. 26– neck and shoulder disorders increased those of Brisson et al., (Brisson et al., 1033) showed that the risk of reported with typing speed and with percentage 1989: Ex. 26–937), who examined long- upper extremity disorders decreased of time working at the keyboard (Burt et term musculoskeletal disability in with the percentage of recovery time in al., 1990: Ex. 26–698). Similarly, several general, and specifically that due to each work cycle. investigators have shown exposure- arthritic and back disorders, including Force response relationships for neck and regular pain in the lower back, upper shoulder disorders among video display back/neck, shoulders, hands/wrists/ Forceful manual exertions have been unit operators with the number of hours elbows, or knees/ankles. The risk of characterized by different investigators per day (or week) of VDU work long-term disability, both overall and for with a variety of metrics, some of them (Bergqvist et al., 1995: Exs. 26–1195, musculoskeletal disorders, increased involving the combination of at least 500–165–25; Faucett et al., 1994: Ex. with years of piece-rate garment work. two of object weight, frequency of 38–256; Rossignol et al., 1987: Ex. 26– Elbow and forearm disorders are handling, and duration of exposure. 804). typically less prevalent, so there are These various approaches have yielded Two different studies of sewing fewer opportunities to evaluate evidence of the risk of shoulder machine operators in the garment exposure-response relationships with disorders increasing with exposure in industry have shown increasing adequate statistical power. Nevertheless, white collar, construction, and prevalence of neck and shoulder several studies of VDU operators have manufacturing jobs (Hughes et al., 1997: disorders with cumulative years of shown such associations with speed or Ex. 26–907; Johansson et al., 1994: Ex. exposure to repetitive work (Andersen daily duration of VDU work (Bergqvist 26–1331; Stenlund et al., 1993: Ex. 502– et al., 1993: Ex. 26–1451; Andersen et et al., 1995: Ex. 26–1195, 500–165–25; 462), and similar evidence for elbow al., 1993: Ex. 26–1502; Schibye et al., Burt et al., 1990: Ex. 26–698; Rossignol disorders, even though limited by the 1995: Ex. 26–1463). (Note that Andersen et al., 1987: Ex. 26–804). smaller numbers of cases mentioned 1993a (Andersen et al., 1993: Ex. 26– Intensity and duration of VDU work above (Hughes et al., 1997: Ex. 26–907; 1451) computed both crude and have shown similar exposure-response Ritz, 1995: Ex. 26–1473). adjusted odds ratios, and the latter relationships with disorders of the hand Among grocery store workers, grocery estimates were higher. However, in the and wrist region, including carpal checking has been identified as a job adjusted model, each of the potential tunnel syndrome (Bernard et al., 1994: requiring forceful exertions. In two confounders had little association with Ex. 500–165–21; Burt et al., 1990: Ex. different studies, the risk of shoulder, the risk of neck/shoulder syndromes, so 26–698; Faucett et al., 1994: Ex. 38– elbow, and wrist/hand disorders, this model was deemed overly 256), as well as with cases that include including CTS, was associated with the conservative and statistically inefficient, both proximal and distal regions of the level of forcefulness required by each and the unadjusted ORs are shown in upper extremity (Knave et al., 1985: Ex. employee’s job, the number of hours of the table.) Andersen et al., (Andersen et 26–753; Oxenburgh, 1987: Ex. 26–1367; checking work per week, and the al., 1993: Ex. 26–1502) also computed Polanyi et al., 1997: Ex. 500–41–106). cumulative number of years of checking chi-square tests of trend with exposure In the manufacturing sector, there is (Baron et al., 1991: Ex. 26–697; Osorio for specific diagnoses. The following also evidence that the risk of hand and et al., 1994: Ex. 26–807). Note that had a positive trend with years of wrist disorders increases with work Osorio et al. defined three categories of exposure: cervicobrachial fibromyalgia pace and repetitiveness (Latko et al., exposure, but there were no CTS cases (p<<0.001); rotator cuff syndrome 1999: Ex. 38–171; Leclerc et al., 1998: in the low exposure group, so in (p<0.01); and cervical syndrome Ex. 500–41–85) and with cumulative multivariate modeling only the odds (p<0.001). The probability of having no years of exposure to repetitive manual ratio for low/medium vs. high exposure MSD symptoms showed a negative work (Ohlsson et al., 1989: Ex. 26–1290; could be calculated. These dichotomous

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However, 7 of the increasing risk of shoulder disorders electromyography, as well as for simpler covariates in the model had little with the observed proportion of the estimates of force based on object association with LBP, so this model was work cycle in which the included angle weight and on self-report. In particular, deemed overly conservative and the at the shoulder was at least 90 degrees these showed trends in risk of CTS that unadjusted ORs were selected as (Punnett et al., 2000: Ex. 500–41–109). are compatible with the experimental summary measures of the study results.) This association was not confounded by evidence, as summarized recently by Studies of other, related health gender or other demographic or medical Viikari-Juntura and Silverstein (Viikari- outcomes, including knee arthritis and history factors. Juntura et al., 1999: Ex. 500–121–73). ‘‘overexertion incidents’’ of any body Viikari-Juntura et al. (Viikari-Juntura There is a particularly large number of part, provide compatible findings et al., 2000: Ex. 500–41–50) carried out studies demonstrating that the risk of regarding the effects of strenuous work. a longitudinal study with four repeated back disorders, including prolapsed In addition, Krause et al. (Krause et al., questionnaires among 5180 workers in a lumbar disc, increases with the 1997: Ex. 26–1281) found that disability large forest industry enterprise. The frequency or duration of manual retirement was increasingly frequent authors used a modified Nordic material handling, with load weights, from jobs with heavy physical demands questionnaire (Kuorinka et al., 1987: Ex. and with other indicators of physically and also showed an exposure-response 38–204) for the health outcome of ‘‘ strenuous work including but not trend with an index of repetitive strain radiating neck pain’’ and validated limited to lifting and carrying tasks. that included lifting demands, muscle exposure assessment and psychosocial Again, exposure has been variously effort, and non-neutral postures. The questionnaires. There was a statistically characterized on the basis of cases of disability retirement were due significant dose-response relationship observation, self-report, and bio- to any medical condition; however, a for radiating neck pain with the instrumentation measures and/or large proportion was caused by frequency of ‘‘twisting movements of combined into indices. The volume of musculoskeletal conditions (see Table 2 the trunk during a work day’’ (ORs from evidence is extremely impressive and of (Krause et al., 1997: Ex. 26–1281)). 1.0 to 2.3), as well as a dose-response demonstrates that such exposure- relationship for hands above the Posture response relationships have been found shoulder. These estimates were adjusted in nursing and other health care work, Studies of the effect of non-neutral for body mass index and high mental in construction, in manufacturing, and postures also include a wide range of stress. in the wide range of jobs encountered in exposure measures, including estimated English et al. conducted a study of the general population. For example, frequency or duration of specified patients in the general population Venning et al. (Venning et al., 1987: Ex. postures, as well as tasks that imply seeking medical care for upper 500–41–49 ) published a prospective specific postural demands (e.g., driving extremity disorders (English et al., 1995: study of a closed cohort, which showed as an indicator of highly constrained Ex. 26–848 ). Conditions affecting the the predictive value of work area static sitting) and workstation wrist and hand showed exposure- classified a priori in terms of lifting characteristics that directly influence response relationships with several demands. Kerr, Norman, and colleagues posture (e.g., VDU keyboard too high). different shoulder and wrist postures (Kerr et al., Ex. 500–41–74 ; Norman et Since the anatomic segments of the (Table 3b). The degree of ulnar al., 1998: Ex. 38–84 ) compared cases to body form a kinematic chain, non- deviation has been reported to be controls on 12 continuous neutral postures may affect not only the associated with the risk of forearm and ¨ biomechanical variables, representing same joint region but also other joints wrist disorders (Hunting et al., 1981: Ex. both peak and daily integrated load on along that chain. For example, if the 26–1276; Malchaire et al., 1996: Ex. 26– the spine. There was a higher load in work layout requires the trunk to be 1473). Several authors have found that the cases by each variable (all p-values twisted while the eyes are facing the risk of carpal tunnel syndrome < 0.04). There was a moderate amount forward, the neck will also be twisted increases with the number of hours per of correlation among these variables, so and health effects may be found all day or week in which the wrist is flexed the final regression model was reduced along the spine. Work with the arms or extended (Blanc et al., 1996: Exs. 26– to four, with adjustment for elevated may alter wrist posture or 42, 500–41–16; de Krom et al., 1990: Ex. demographic and psychosocial factors. impose a biomechanical disadvantage 26–102; Nordstrom et al., 1997: Ex. 26– The odds ratios, computed both for full on the arm muscles; it will increase the 900). observed ranges of exposure and more torque exerted by an object held in the In studies of back disorders, a number conservatively for inter-quartile spreads, hands, which in turn increases the of investigators have reported exposure- showed that several dimensions of load compressive forces experienced in the response relationships with trunk on the lumbar spine made independent lumbar spine (Chaffin et al., 1991: Ex. forward flexion, lateral bending, and contributions to risk of back disorders. 26–420). rotation. These studies address non- It is of particular interest that three There are a very large number of neutral postures in both seated and different studies (Marras et al., 1993: Ex. studies showing that neck and shoulder standing work, and they cover a range 500–41–94 ; Wang et al., 1998: Ex. 500– disorders exhibit an exposure-response of industries and occupations from 41–52; Waters et al., 1999: Ex. 500–121– relationship with arm and neck tractor driving to construction to 76) showed such a relationship when postures, especially arm elevation to automobile assembly. Similar data for lifting demands were characterized form an included angle of at least 30° the U.S. general population were using the NIOSH lifting index (Waters et flexion or abduction. Both Bergqvist et obtained from analysis of the National al., 1993: Ex. 26–521). (It should be al. (Bergqvist et al., 1995: Ex. 500–165– Health Interview Study (Exs. 26–1106, noted that Waters et al. (Waters et al., 24 ) and Faucett et al. (Faucett et al., 26–1107). There is also evidence of

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(Pietri et al., was not conclusive regarding exposure requiring either exposure alone 1992: Ex. 38–309), the odds ratios for to segmental vibration, it does suggest (Armstrong et al., 1987: Ex. 26–48; both prevalence and one-year an exposure-response trend between Silverstein et al., 1986: Ex. 26–1404; cumulative incidence of low back pain segmental vibration and CTS. Silverstein et al., 1987: Ex. 26–34). showed increases with hours of driving In an historical cohort, Futatsuka et (Numerous examples of other additive per week in multivariate models al. (Futatsuka et al., 1985: Ex. 26–1430) or multiplicative effects between adjusted for age, gender, comfortable car found a positive association between the physical ergonomic exposures have seat (y/n), carrying loads (y/n), standing prevalence of ‘‘vibration-induced white been listed in Tables V–9 through V– (y/n), tobacco consumption, and finger’’ and the duration of exposure to 13). Thus, the exposure-response curve psychosomatic factors. vibration (chain saw use). In addition, for each exposure should ideally be With regard to disorders affecting the there was an interaction with year of described as a function of the level of lower extremity, knee-bending, first exposure: higher prevalences and each other exposure that might also be kneeling, squatting, jumping from one earlier onset of symptoms were present in the same job. This represents level to another, and stair-climbing are observed among workers with earlier an enormous number of combinations of all found in these studies. In a series of first exposure, when the acceleration exposure, of which only some have been Danish studies, direct observations levels were higher (all data presented studied epidemiologically to date. Given showed that the average proportion of graphically). One study team found the available exposure-response time that was spent kneeling and/or similar associations for the risk of relationships, plus evidence that squatting by workers in three different shoulder disorders (Stenlund et al., exposures interact with each other, the trades (Jensen et al., 1997: Ex. 500–41– 1993: Ex. 502–462; Stenlund et al., decision not to attempt quantitative risk 69). The prevalence of knee disorders 1992: Ex. 26–733). assessment calculations at this time is among the same three trades increased Several statements contained in readily justifiable. However, this does proportionately to the exposure submissions by the Chamber of not at all imply that the evidence for prevalences. Anderson and Felson Commerce and others cited OSHA’s exposure-response relationships is utilized the U.S. Department of Labor statement in the preamble to the insufficient to conclude that there is a Dictionary of Occupational Titles and proposal that it had not constructed causal relationship between exposure to characterized each occupation on the ‘‘generalized quantitative exposure- risk factors and the risk of MSDs. basis of the proportion of job titles response relationships’’ for standard- within it that required knee-bending setting (64 Fed. Reg. at 65927), and that Another argument made in the (0%, up to 50%, more than 50%) the Agency’s reluctance to set testimony cited above is that if an (Anderson et al., 1988: Ex. 26–926). permissible exposure levels for risk exposure-response relationship existed, Among subjects aged 55 to 64 years, factors provided evidence of a lack of it would necessarily be linear or there was a two to three-fold increase in exposure-response relationship in the monotonic, and that it would risk of radiographic osteoarthritis with epidemiologic literature (e.g., Chamber necessarily provide an exposure level each category of knee-bending, adjusted of Commerce, Ex. 30–1722, p. 46 and that could be used to differentiate for gender, race, education, and body Ex. 500–188, pp. 10–11; United Parcel between background risk of MSDs and mass index. These odds ratios represent Service, Ex. 500–197, pp. I–61 to I–62). an elevated risk (United Parcel Service, the increase in risk across the three Such arguments confuse exposure- Ex. 500–197, pp. I–62 to I–67). This categories, i.e., from no to some and response relationships as evidence of a assertion is false. An exposure-response from some to much knee-bending. causal relationship with the last stage of relationship need not take the form of a quantitative risk assessment, namely straight line through all data points; it Vibration computation of a permissible exposure may conceivably be better described as Segmental vibration exposure to the level. a logistic curve, or as a step-function, or distal upper extremity, especially It is critical to distinguish between as any other of a variety of mathematical through holding and operating power these points. Exposure-response functions. As one example, the analyses tools, is another area of research where relationships have been demonstrated in presented by Frost et al. (Frost et al., exposure-response relationships have the epidemiologic literature, using a 1999: Ex. 38–97) clearly show a non- been reported by numerous authors. variety of exposure metrics and for a linear exposure-response trend with Some studies have shown the variety of health outcomes, and a cumulative exposure to repetitive and association with years of exposure, and number of reviewers have cited this loaded shoulder flexion. Two among others combined work history with evidence in concluding that there are many other illustrations of non-linear, direct measurements of frequency and causal relationships (eg., Armstrong et positive exposure-response acceleration to construct biologically al., 1993: Ex. 26–1110; Bernard, 1997: relationships can be found in Liles et informed cumulative exposure indices. Ex.26–1; Burdorf et al., 1997: Ex. 500– al., 1984 (Liles et al., 1984: Ex. 26–33 Most of the evidence concerns 121–13; Hagberg et al., 1992: Ex. 8–1; 500–41–88), where the authors neurological and circulatory impairment Hales et al., 1996: Ex. 26–896; Viikari- suggested that their graphs provided of the hand and wrist. Three different Juntura et al., 1999: Ex. 500–121–73). At evidence of exposure thresholds, and investigations reported an odds ratio of the same time, although the indicted Moore et al., 1994 (Moore et al., 1994: about 1.1 for each year of occupational exposures and their associations with Ex. 26–1033), where a log-log exposure to hand-arm vibration, which MSDs are qualitatively similar across transformation improved the fit of the represents a doubling of risk about every many studies, the variations in model. A non-linear relationship, for 7 years. In addition to those studies measurement approaches results in very example, accommodates the likelihood shown in Table 4a, Nordstrom et al. limited numbers of studies with any that some physical activity is beneficial (Nordstrom et al., 1997: Ex. 26–900) single exposure metric. More and that only at more extreme levels do

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00250 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68511 adverse health effects occur, a point Juntura et al., 1999: Ex. 500–121–73). determine the reliability. However, from advanced by several in their testimony OSHA finds that it is reasonable to a description in the paper of the to the docket (e.g., United Parcel conclude, as these experts have done, blindness with which the survey was Service, Ex. 500–197, pp. I–68; Vender that there is a need for continuing study administered, OSHA believes that such attachment to UPS post-hearing of those relationships and interactions, an imperfect exposure measurement comments, Ex. 500–118, page 17). Dr. while at the same time, that it is instrument would yield non-differential Hadler opined that ‘‘whenever a appropriate to implement the scientific exposure misclassification. Such non- relationship between exposure and knowledge in hand in order to reduce differential misclassification would bias effect is not linear (not monotonic), you the risk of work-related MSDs. both the ORs and the slope toward a can be sure there are confounders, In the preamble to the proposed rule finding of no increasing trend. The fact * * *.’’ (Hadler attachment to UPS (64 FR 65768), OSHA presented the the deKrom et al. study found post-hearing comments, Ex. 500–118, results of several studies that provided statistically significant ORs for each page 4). He offered no evidence in evidence for positive trends between incremental number of weekly hours of support of this assertion, and in fact exposure to biomechanical risk factors activities with extended or flexed wrist there is no requirement in epidemiology and the prevalence or incidence of separately, plus finding a statistically that the relationship must either be MSDs. Three commenters critiqued significant exposure-response trend for linear or monotonic. OSHA has relied twelve of these studies, claiming a both duration variables, despite the on non-linear dose-response variety of design or methodological negative bias, provides strong evidence relationships in other health standard flaws in the studies, computational that the effect is real. This finding is rulemakings (see Formaldehyde, 54 errors in the studies, or that OSHA further strengthened by the final FR46168, Cadmium 57 FR 42101). misused some of the data (Exs. 30–276, analysis of de Krom et al. which used Second, most exposure-response 500–79, 32–241–4). The comments are a multiple regression model relationships do not indicate a single those of Dr. Steven Moore, Professor, simultaneously containing both exposure level that unambiguously Environmental and Occupational duration of ‘‘flex’’ and ‘‘extended’’ wrist differentiates risk from no risk. This is Health, Texas A&M University (Ex. 30– activities as variables, with both especially true if exposure is treated as 276), Marathon Ashland Petroleum LLC variables found to be statistically continuous and the relationship fits a (Ex. 500–79), and Gibson, Dunn & significant for duration-of-exposure- straight line through the origin, in Crutcher (Ex. 32–241–4). Marathon response trends (Ex. 500–41–28, pg. which case each small increment in Ashland Petroleum LLC includes Dr. 1108). The finding of joint statistical exposure increases the probability of an Moore’s comments as an Appendix. significance of collinear variables when adverse health outcome and, Gibson, Dunn & Crutcher summarize the simultaneously modeled increases extrapolated downward, there may be critiques of several experts, whose confidence in the significance of the no discernable point without excess risk statements are attached to their separate variables. above the zero exposure level. Note that comment. OSHA responds to all these OSHA also responds to the criticism in this regard U.P.S. criticized OSHA for comments below. that ‘‘in a conclusion that would the assumption that, in fact, UPS had Dr. Moore and Gibson, Dunn & devastate OSHA’s attempt to redesign made: ‘‘OSHA has falsely assumed that Crutcher criticized the study on risk the American office, [deKrom et al.] any increment of human muscle usage factors for CTS by deKrom et al., (1990, found no significant risk of CTS related is harmful, * * *.’’ (United Parcel Ex. 500–41–28). They claim that the to typing.’’OSHA notes that of the 156 Service, Ex. 500–197, pp. I–68). study does not account for psychosocial cases of CTS, only 12 cases reported any On the other hand, when exposures factors and that it is methodologically work-related typing at all. In a case- have been categorized and are ordinally flawed in relying on self-reported control study such as this with only 12 associated with risk of disease, it can be information about duration of exposure, cases exposed to typing, the statistical argued that the first exposure level rendering the results meaningless. With ability to determine a significant result where an elevated risk is observed respect to the lack of analysis on is very small. Either a different study above baseline represents an psychosocial factors, OSHA recruitment procedure or a much larger appropriate point for a permissible acknowledges that this case-control sample size would be required. With exposure level (at least until subsequent study, with cases mostly of hospital respect to another criticism by Gibson, studies clarify whether there is still outpatients and controls from the Dunn & Crutcher on the apparently excess morbidity occurring below that general population, did not examine or spurious finding of an association of level). This type of approach was taken control for psychosocial factors. CTS with varicosis in men, the authors recently by the American Conference of However, OSHA finds nothing in the reported this result of their analysis for Governmental Industrial Hygienists design and analysis of this study that the scientific world to contemplate, but (2000), which used essentially the same would invalidate the statistically found it inconsistent with that of other epidemiologic evidence available to significant positive associations among authors (Ex. 32–241–4). OSHA—with its variety of exposure work related physical factors and CTS Dr. Moore also criticizes OSHA’s use metrics—to determine the proposed that the study did find. The authors of the MSD prevalence study by new Threshold Limit Value for concluded that activities with a flexed Luopajarvi et al., (1979, Ex. 26–56) used occupational hand activity level (see wrist or with an extended wrist as part of the agency’s determination of Exs. 38–162, DC–387). (exposure-related increased ORs) were causality for hand/wrist tendinitis. Dr. Several authors have called attention risk factors for CTS. Dr. Moore criticized Moore claims the study’s poor exposure to the complexity of the process of the duration analysis used to estimate assessment and lack of statistical utilizing exposure-response data for exposure-response as a function of time, comparisons provide poor support. In quantitative risk assessment in the claiming that the survey questionnaire response, OSHA notes that the same multi-dimensional domain of physical instrument for collecting exposure exposure assessment methods were ergonomics (e.g., Armstrong et al., 1993: information was unreliable. OSHA used in the study comparisons between Ex. 26–1110; Burdorf et al., 1997: Ex. responds that with little information the assembly-line packers and the shop 500–121–13; Frank et al., 1996: Ex. 502– about the survey questionnaire in the assistants, so that the differences should 407; Kilbom, 1999: Ex. 38–406; Viikari- published paper, the agency cannot be unaffected. OSHA also notes that

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00251 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68512 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations these comparison showed that the include the findings of a second study, were not controlled for in this investigation. assembly-line packers had a highly Armstrong et al., (1987, Ex. 500–41–4) (Ex. 26–1404). statistically significant (p<0.001) in NIOSH’s evaluation on the effect of OSHA concludes that NIOSH was increased prevalence of (1) syndromes posture for hand/wrist tendinitis. Dr. correct in not considering the found in the neck, shoulders and Moore claims that NIOSH rated the Armstrong et al. (Ex. 500–41–4) and elbows; and (2) muscle-tendon Armstrong et al. study as high quality Silverstein et al.1986 and 1987, (Exs. syndromes in the hands (p<0.001). The for other physical risk factors (i.e. force 26–1404, 26–34) study further for most common neck syndrome in this and repetition, for which the study posture with this particular study group. study was tension neck and the most found highly statistically significant Gibson, Dunn & Crutcher also criticize common shoulder disorder was humeral associations) but didn’t include the OSHA’s omission that the Armstrong et tendinitis. For hands, Luopajarvi et al. study at all in the discussion of the al., study ‘‘found no significant noted the prevalence of tenosynovitis/ effect of posture. Armstrong et al. association between * * * vibration peritendinitis at 53% in the assembly- reported no significant associations for and [hand/wrist tendinitis] (Ex.32–241– line packers, but only 14% in the shop- differences in posture ‘‘comparing the 4, pg. 140). OSHA responds that the assistants (who endured prolonged percentage of the time spent in various Armstrong et al., 1987, (Ex. 500–41–4) standing, but otherwise physically light postures between jobs in which there publication provided less information work). For the assembly-line packers the were workers with tendinitis and those about vibration in the study group than authors noted especially the repetitive in which there were no workers with it did about posture, and that apparently motions at a high speed, and fingers and tendinitis’’ (Ex. 500–41–4). Dr. Moore it was not a well studied factor in this hands constantly used at the pace of the claims that this omission by NIOSH and group. machine, up to 25,000 cycles per OSHA is an error in evaluation and that Dr. Moore also criticizes the ‘‘NIOSH workday. For these packers the authors this error ‘‘would likely have a material and OSHA reviews [for] inappropriately also noted difficult static muscle work, impact on the conclusion’’ (Ex. 30–276). generaliz[ing] results of some studies extreme work positions of the hands, beyond the constructs used to measure and difficult lifting. OSHA believes that OSHA has considered Dr. Moore’s claim about NIOSH’s evaluation of the or categorize MSD risk factor [i.e., force this study provides a good comparison and repetitiveness]’’ (Ex. 30–276, pg. 2– between similar demographic groups, Armstrong et al. study and has 3), singling out Armstrong et al. (Ex. and that it provides good evidence that concluded that while Dr. Moore is 500–41–4) and Silverstein et al., 1987, work-related physical stress factors were correct in his claim that Armstrong et al. (Ex. 26–34). OSHA has considered this causing shoulder and upper extremities found no associations with the posture comment and disagrees with Dr. Moore. injuries. variable stated above, there is simply Dr. Moore also claims that errors in not enough detail in the publication to Most authors define risk factors slightly the evaluations of two other studies are weight that study highly with regard to differently and the NIOSH analysis had materially related to the NIOSH’s and the posture variable. With this study to categorize the slightly different OSHA’s conclusions (Ex. 30–276, pg. 2). group Armstrong et al. found a highly definitions into categories. OSHA With respect to the study by Kuorinka statistically significant odds ratio of 29.4 believes this categorization does not and Koskinen, he criticizes NIOSH for (p<0.001) for high force/high detract from either the NIOSH analysis not specifically mentioning the ‘‘non- repetitiveness hand/wrist motion or the ability to generalize that force and positive’’ finding of no evidence of compared with a low force/low repetitiveness are etiologically related to association of with time spent in repetitiveness motion group. These hand/wrist tendinitis. In fact, OSHA deviated wrist postures per day. OSHA groups appeared well defined and well believes that the different studies’ responds that the Kuorinka and studied with respect to force and abilities to detect significant Koskinen study did not specifically repetitiveness, with 652 workers associations using different definitions mention peritendinitis and divided fairly evenly among the four actually make the overall results more tenosynovitis in its analysis, only the groups increasing the statistical power generalizable. total complex of muscle-tendon to detect an effect if one exists. Gibson, Dunn & Crutcher, also syndrome. Their definition of muscle- However, no detail is given for the criticize the Silverstein et al., 1986 tendon syndrome used in this study posture analysis, only a short paragraph study of hand wrist cumulative trauma came from an accompanying article they result (Ex. 500–41–4). To study this disorders (CTDs, Ex. 26–1404, and by coauthored in the same journal (see Ex. same highly force- and repetitiveness- implication Exs. 26–34 and 500–41–4) 26–1218); the definition included stressed group for the effect of posture for being methodologically flawed, syndromes of the shoulder and elbow, differences on hand/wrist tendinitis, specifically citing recall bias and along with the wrist and hands. Every (and CTS, see Silverstein et al., 1987, observer bias as leading to an one of the seventeen (out of 93) manual Ex. 26–34, and comment in Ex. 32–241– overestimation of the associations workers with muscle-tendon syndrome 4, pg.143) would appear to be quite between risk factors and health effect also had tension neck syndrome, but difficult, considering the proven effect (Ex. 32–241–4, pg. 142–143). They also none was specifically identified as of force and repetitiveness as risk factors cite the study’s cross-sectional design, having either peritendinitis or in this worker group. Silverstein et al. the omission of a number of jobs from tenosynovitis (Ex. 26–639). While Dr. (1986) studying essentially the same the investigation, and lack of analysis Moore is correct that Kuorinka and group, discussed postures, stating: on non-biomechanical factors as serious flaws. Koskinen found no correlation between (W)rist postures required on a job are often the number of signs in the wrist and the determined by the height of the work station OSHA has considered this criticism of deviation load of the wrist joint (1979, with respect to the location of the worker. the methodology, but disagrees with the Ex. 26–639). OSHA finds too few details * * * to test this hypothesis the job of each characterization that a cross-sectional in the analysis for any conclusions with worker in a job would have to have been design cannot establish causation. In respect to peritendinitis and videotaped and analyzed. This was not done another section of this preamble, OSHA tenosynovitis. in this investigation. * * * Awkward discusses the value of all the studies Dr. Moore also criticizes the NIOSH postures (wrist deviation, flexion, together in forming a database to 1997 (Ex. 26–1) review for its failure to hyperextension, and finger pinching) * * * determine causality. OSHA also notes

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(Ex. 26– The findings in this investigation may also retrospective in recalling exposures and 33, pgs. 690–691). have underestimated the prevalence of hand pre-existing conditions. OSHA Gibson, Dunn & Crutcher also criticize wrist CTDs in several ways. Firstly, subject acknowledges the limitations of such as the study by Snook et al., (1978, Ex. 26– selection was limited to active workers. those design. However, OSHA considers the 35) on three preventive approaches to away from the job with CTDs at the time of design, conduct, and analysis of this low back injury. The study is criticized evaluation (potentially severe cases) would study quite persuasive—in terms of as being methodologically flawed in that not have been available for study. Secondly, strength of association, temporality, and it is a cross-sectional study which looks the one year seniority criteria for subject exposure-response—in the overall solely at biomechanical risk factors, and selection excluded those who might have had determination of causality of BT and cannot establish causation. However, CTDs and transferred before one year as well LBP; see OSHA’s section on back Gibson, Dunn & Crutcher also quote as those with CTDs but not on the job for at several portions of the article that it least one year. The finding that hand wrist disorders in this preamble. The authors CTDs were negatively associated with age in their publication conclude: wants OSHA to recognize: (1) that most and years on the job support the argument of Back disorders were associated with mild cases of industrial back injury have no selection/survival bias in the study trunk flexion (OR=4.9 (p5% C.I. 1.4–17.4), known cause, and recovery occurs population [which would underestimate the severe trunk flexion (OR=5.7, 95% C.I. 1.6– before any cause is ever found, (2) some effect] (Ex. 26–1404, pg. 784). 20.4), and trunk twist or lateral bend workers never suffer from low back pain (OR=5.0, 95% C.I. 1.6–21.4). the risk regardless of their type of work, and Gibson, Dunn & Crutcher criticize the increased with exposure to multiple postures study of shoulder pain in shipyard others seem to get it in spite of what and increasing duration of exposure. (Ex. 26– they do; and (3) ‘‘low back injuries are workers (welders and steel plate- 39, pg. 337). workers) by Herberts et al., 1984, (Ex. usually not serious; four out of five Gibson, Dunn & Crutcher also criticize 26–51), for methodological flaws, workers suffering from low back injuries Dr. Punnett’s more recent study (1998, including cross-sectional design, and return to the job within three weeks.’’ Ex. 26–38) of upper extremity disorders (Ex.32–241–4). OSHA responds that this the lack of demographic matching in vehicle manufacturing, as being Snook et al., case-series study of 191 between the exposed and control methodologically flawed in that it is a low back injuries is of limited groups. (Ex. 32–241–4, pg. 142). They cross-sectional design and does not usefulness in determining causality, but also criticized OSHA for not recognizing include an analysis of the relative it does suggest that low back injury is what Herberts et al. did, have ‘‘chronic importance of psychosocial factors. associated with excessive manual shoulder pain is * * * common in OSHA has considered this comment and handling tasks. OSHA also people not necessarily active in arduous disagrees. Even though this study is acknowledges the general apparent physical work.’’ (Ex. 26–51, pg. 167). cross-sectional, OSHA considers it well- truthfulness of statement (2), by Snook OSHA responds that the Agency does conducted and analyzed. Using a et al., but can find no reference for it in recognize that people other than those primary exposure score relating to the article. Statement (1) of Snook et al., in HPW have shoulder pain; that responses to psychophysical exposure references a 1970 published article and recognition allows researchers, OSHA items, Punnett found both statistically a 1971 editorial. There is more recent and other analysts to compare the significant PRs and significant science available. Statement (3) cites prevalence of shoulder pain in workers exposure-response relationships for one 1966 study as its reference. doing HPW to that in workers not so both (1) shoulder and upper arm Gibson, Dunn & Crutcher also criticize engaged, in order to estimate the disorders and (2) wrist and hand a study by (1992, Ex. 26–36) on low contribution from HPW. Herberts et al. disorders. The results were consistent back and neck/shoulder pain in also did this and concluded that when the analyses were done both for construction workers. They claim that ‘‘Rotator cuff tendinitis constitutes a the symptom cases and the physical the study is methodologically flawed in major problem in people with arduous examination cases. The authors that it is cross-sectional in design, occupations, i.e., shipyard welders concluded that ‘‘musculoskeletal limiting its ability to show causality. At (PR=18.3%), and steel plate-workers disorders of the upper extremities were the same time they criticize OSHA for (PR=16.2%).’’ By contrast, of the 57 strongly associated with exposure to failing to discuss the study’s findings of clerks in the comparison group only one combined ergonomic stressors.’’ (Ex. positive associations between LBP and (1.7%) reported this disorder. Of this 32–241–4) Gibson, Dunn & Crutcher both psychosocial factors and age, as highly statistically significant also criticize OSHA’s use of the well as the finding(s) of no significant difference, Herberts et al., note: prospective study by Liles and association between sitting posture and Since the clerks are on an average older Deivanayagam, 1984 (Ex. 26–33) on job LBP (and severe LBP). OSHA responds than the other two groups, there would be a severity index (JSI) for the evaluation that with respect to sitting (>4 hours) higher likelihood of age-induced tendinitis in and control of lifting injury of the back. posture and the Holmstrom et al. (Ex. this [clerks] group. However, the hypothesis The JSI is a function of lifting frequency 26–36) finding of no significant is that those with a high physical workload of task, maximum required weight of association with either LBP or severe have tendinitis to a greater extent than lift, adjusted capacity of the individual, LBP, both NIOSH (Ex. 26–1, pg. 6–47) normal. (Ex. 26–51). and total lifting frequency. Criticism of and OSHA (see Table on back studies Gibson, Dunn & Crutcher also criticize the study focuses on a potential bias considered) do consider the finding of OSHA’s use of the Punnett et al., 1991 which Gibson, Dunn & Crutcher call a this study as ‘‘no association’’ for SWP (Ex. 26–39) study of back disorders and ‘‘nocebo effect’’, a bias due to and LBP. With respect to specific nonneutral trunk postures in automobile differential reporting of pain symptoms psychosocial factors being significant in assembly workers. The study is by the subjects, knowing that their this analysis, OSHA concurs. However, criticized as methodologically flawed in symptoms are being monitored. OSHA the discussion of psychosocial factors

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00253 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68514 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations by Holmstrom et al. fails to mention of Work-Related Musculoskeletal 1979, Ex. 26–1489). Once in their whether or not the multiple regression Disorders,’’ stating that: working years (age 25 to 65), however, model used also found the physical risk The multifactorial nature of MSDs requires the prevalence is relatively consistent factors simultaneously statistically a discussion of individual factors that have (Guo et al. 1995, Ex. 26–1274; Biering- significant with these data, which been studied to determine their association Sorenson 1983, Ex. 26–843). would suggest that physical and with or influence on the incidence and Musculoskeletal impairments are among psychosocial factors are independent prevalence of work-related MSDs. These the most prevalent and symptomatic risk factors (Ex. 26–36, pg. 667). factors include age (Guo et al., 1995; Biering- health problems of middle and old age. Sorensen et al., 1983; English et al., 1995; Nonetheless, age groups with the 4. Comments on the Role of Individual Ohlsson et al., 1994); gender (Hales et al., highest rates of compensable back pain and Non-Work Factors 1994; Johansson, 1994; Chiang et al., 1993; Armstrong et al., 1987a); anthropometry and strains are the 20–24 age group for In their posthearing testimony, (Werner et al., 1994; Nathan et al., 1993; men, and the 30–34 age group for Gibson, Dunn and Crutcher assert that: Heliovaara, 1987); physical activity women. NIOSH acknowledges that age-related In developing its unfounded assertion that (Holmstrom, Lindell, and Moritz, 1992; biomechanical workplace factors play a Baron et al., 1991; Craig et al., 1998); strength degenerative disorders may result in predominant role in the development of (Chaffin and Park, 1973; Chaffin et al., 1977; decreases in musculoskeletal function, MSDs, OSHA has also ignored a great Troup, Martin, and Lloyd, 1981); cigarette and loss of tissue strength with age may number of scientifically valid studies smoking (Finkelstein, 1995; Owen and also increase the probability or severity establishing that non-work-related factors, Damron, 1984; Svensson and Andersson, of soft tissue damage. NIOSH also notes such as genetic predisposition, age, general 1983; Kelsey, Golden, and Mundt, 1990; that: health, smoking, social activities, and Hildebrandt, 1987); and alcohol, caffeine, Another problem is that advancing age and psychosocial factors exert a greater influence and vitamins (Nathan et al., 1996, Keiston et increasing number of years on the job are than biomechanical factors on the al., 1997). In addition, psychosocial factors usually correlated. Age is a true confounder development of MSDs (Ex. 500–118). have been associated with upper-extremity and back disorders (Ex. 27–1, p. I–1). with years of employment, so that these Other commenters also expressed factors must be adjusted for when OSHA has stated elsewhere that it determining relationship with work. Many of concern about the role of non-work relied on two major reviews of the factors in the etiology of MSDs (e.g., the epidemiologic studies that looked at evidence for work-relatedness of MSDs populations with a wide age variance have Exs. 30–1722, 60–2037, 30–4184, 30– available at that time, NIOSH’s controlled for age by statistical methods. 3077, 30–1352, 30–4130, 30–3922, 30– ‘‘Musculoskeletal Disorders and However, 3114, 30–3354). Workplace Factors: A Critical Review of While some commenters tended to the Epidemiologic Evidence for Work- Several studies found age to be an important lump individual factors along with factor associated with MSDs (Guo et al. 1995; Related Musculoskeletal Disorders of Biering-Sorenson 1983; English et al. 1995; psychosocial factors, these two types of the Neck, Upper Extremity, and Low Ohlsson et al. 1994; Riihimaki et al. 1989a; factors are clearly separate and distinct. Back’’ (Bernard, 1997; Ex. 26–1) and the Toomingas et al. 1991) others have not OSHA has separated its discussion of National Research Council/National (Herberts et al, 1981; Punnett et al. 1985). individual factors from that of Academy of Sciences’ ‘‘Workshop on [Ex. 26–1] psychosocial factors, and has fully Work-Related Musculoskeletal Injuries: Riihimaki et al. (1989, Ex. 26–58) addressed comments on psychosocial The Research Base’’ (Ex. 26–37). OSHA found a significant relationship between factors later in this part of the Health believes that it was appropriate to place sciatica and age in machine operators, Effects section. In this section OSHA great weight on these two sources, as carpenters, and sedentary workers. Age presents it’s response to comments in they are comprehensive reviews of was also a strong risk factor for neck and the record on individual factors, recent peer-reviewed scientific literature shoulder symptoms in these same sometimes called ‘‘personal’’ factors. conducted by highly-reputable and groups of workers (Riihimaki et al. The factors that are discussed in the independent groups of scientists expert 1989, Ex. 26–58). literature include age, susceptibility, in their respective fields. When a study does not find a either by genetic predisposition or To the extent that the studies relationship between an increased risk medical conditions, and other factors reviewed by NIOSH considered for MSDs and aging, lack of an observed that may be thought of as those that exposure to nonoccupational physical relationship may be due to ‘‘survivor modify the capacity of individuals to activities, such as nonoccupational VDT bias.’’ If workers who have health perform work. use, hobbies, second jobs, and problems leave their jobs, or change jobs The above post-hearing comment (Ex. household activities that might increase to one with less exposure, the remaining 500–18) makes two claims: risk for MSDs, NIOSH included this population includes only those workers (1) that OSHA ignored an entire body information in its review, and whose health has not been adversely of literature relevant to this rulemaking, acknowledges that: affected at their jobs. As an example, in and a number of factors can influence a person’s a study of female plastics assembly (2) that had OSHA not ignored this response to risk factors for MSDs in the workers, Ohlsson et al. (1989, Ex. 26– body of literature, it would have come workplace and elsewhere. Among these are 1290) reported that the degree of to an opposite conclusion than that the following: age, gender, smoking, physical increase in the odds of neck and reached by OSHA, i.e., that these factors activity, strength, anthropometry. shoulder pain with the duration of ‘‘exert a greater influence’’ presumably The literature, as reviewed by NIOSH employment depended on the age of the than biomechanical risk factors, on the (NIOSH, 1997; Ex. 26–1): on each of worker. For the younger subjects, the development of MSDs. these individual factors is summarized odds increased significantly as the OSHA, in fact, did not ignore the here: duration of employment increased, but literature on individual factors. On the Age: The prevalence of MSDs for the older ones no statistical change contrary, OSHA introduced the increases as people enter their working was found with length of employment. appendices to the proposed Health years. By the age of 35, most people The older women who had been Effects section with a discussion of have had their first episode of back pain employed for shorter periods of time ‘‘Individual Factors and Epidemiology (Guo et al. 1995, Ex. 26–1474; Chaffin had more reported symptoms than the

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00254 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68515 younger ones, while older workers with concluded that the lack of workplace Ex. 26–882) evaluated the effects of longer employment times reported accommodation to the range of workers’ tobacco, caffeine, and alcohol on the fewer symptoms than younger workers. height and reach may, in part, account prevalence of median entrapment Ohlsson et al. (1989, Ex. 26–1290) for the apparent gender differences. neuropathy at the wrist, CTS symptoms, interviewed 76 former assembly workers The fact that more women are and CTS confirmed by nerve conduction and found that 26% reported pain as the employed in hand-intensive jobs and studies among industrial workers cause of leaving work. This finding industries may account for the greater (nonclaimants and working patients supports the likely role of a survivor number of reported work-related MSDs referred for upper-extremity symptoms) bias in this study, the effect of which is among women. Bystrom et al. (1995, Ex. who volunteered for the study. Nathan to underestimate the true risk of 26–897) reported that men were more et al. (1996, Ex. 26–882) stated that developing MSDs, in this case in the likely to have de Quervain’s disease greater use of tobacco combined with older workers. than women; they attributed this to greater consumption of caffeinated Some studies report observing an more frequent use of hand tools. beverages and alcohol abuse was increased risk for MSDs with age, others The reporting bias may exist because associated with more median nerve do not. Where the effects of age have women may be more likely to report slowing, more specific hand/wrist been controlled for in studies, thus pain and seek medical treatment than symptoms, and more eliminating the influence of ‘‘age’’ in the men (Armstrong et al., 1993; Hales et electrophysiologically confirmed CTS. equation, the physical risk factors al., 1994). Some studies have reported However, the effects explained only a discussed here have been consistently that workplace risk factors account for small portion of the total risk. shown to be associated with the increased prevalence of MSDs among Toomingas et al. (1991, Ex. 26–1019) development of MSDs in exposed women more than personal factors (e.g., found no associations between multiple populations. This means that, regardless Armstrong et al. 1987, Ex. 26–1110; health outcomes (including tension of whether or not age plays a role in the McCormack et al. 1990, Ex. 26–1334). In neck syndrome, rotator cuff tendinitis, development of a particular MSD in a a recent evaluation of Ontario workers’ CTS, or problems in the neck/scapula or particular population, the influence of compensation claims for repetitive shoulder/upper arm) and nicotine habits physical risk factors is independent. strain injury (RSI), Asbury et al. (1995, among platers, assemblers, and white Gender Some studies have found a Ex. 26–250) reported a relative risk (RR) collar workers. In a case/referent study, higher prevalence of some MSDs in for female to male claims ranging from Wieslander et al. (1989, Ex. 26–1027) women (Bernard et al. 1994, Ex. 26–842; 1.3 to 1.6 across industries. Within five found that smoking or using snuff was Hales et al. 1994, Ex. 26–131; Johansson different broad occupational categories, not related to CTS among men operated 1994, Ex. 26–1331; Chiang et al. 1993, females were approximately 2 to 5 times on for CTS. Ex. 26–1117). A male-to-female ratio of as likely to have a lost-time RSI claim. Several papers have presented 1:3 was described for carpal tunnel No information on gender differences in evidence that a positive smoking history syndrome (CTS) in a population study hand-intensive jobs was reported. Many is associated with low-back pain, in which occupation was not evaluated researchers have noted that men and sciatica, or intervertebral herniated disc (Stevens et al. 1988, Ex. 26–1009). women tend to be employed in different (Finkelstein 1995, Ex. 26–369; However, in the Silverstein et al. (1985, jobs. Frymoyer, Pope, and Clements 1983, Ex. Ex. 26–1173) study of CTS among Smoking. In the Viikari-Juntura et al. 26–950; Svensson et al. 1983, Ex. 26– industrial workers, no gender difference (1994, Ex. 26–873) prospective study of 1158; Kelsey et al. 1984, Ex. 26–152); could be seen after controlling for work machine operators, carpenters, and whereas other papers have found a exposure. Franklin et al. (1991, Ex. 26– office workers, current smoking (OR: negative relationship (Kelsey, Golden, 948) found no gender difference in 1.9; 95% CI: 1.0–3.5), was among the and Mundt 1990, Ex. 26–52; Riihimaki workers’ compensation claims for CTS. predictors for change from ‘‘no neck et al. 1989, Ex. 26–997). Boshuizen et al. Burt, Hornung, and Fine (1990, Ex. 26– trouble’’ to ‘‘severe neck trouble.’’ In a (1993, Ex. 26–81) found a relationship 698) found no gender difference in study of Finnish adults aged 30 to 64 between smoking and back pain only in reporting of neck or upper-extremity (Makela et al. 1991, Ex. 26–980), neck those occupations that required physical MSD symptoms among newspaper pain was found to be significantly exertion. In their study, smoking was employees using video display associated with current smoking (OR: more clearly related to pain in the terminals (VDTs). Nathan et al. (1988, 1.3; 95% CI: 1.0–1.61) when the logistic extremities than to pain in the neck or Ex. 26–990; 1992, Ex. 26–988) found no model was adjusted for age and gender. the back. Deyo and Bass (1989, Ex. 26– gender differences for CTS. In contrast, However, when the model included 105) observed that the prevalence of Hagberg and Wegman (1987, Ex. 26–32) mental and physical stress at work, back pain increased with the number of reported that neck and shoulder obesity, and parity, then smoking (OR: pack-years of cigarette smoking and muscular pain is more common among 1.25; 95% CI: 0.99–1.57) was no longer with the heaviest smoking level. females than males, both in the general statistically significant (Makela et al. Heliovaara et al. (1991, Ex. 26–959) only population and among industrial 1991, Ex. 26–980). With univariate observed a relationship in men and workers. analysis, Holmstrom (1992, Ex. 26–36) women older than 50 years. Two studies Whether the gender difference seen found a prevalence rate ratio (PRR) of did not find a relationship between with some MSDs is due to physiological 1.2 (95% CI: 1.1–1.3) for neck/shoulder sciatica and smoking among concrete differences or differences in exposure is trouble in ‘‘current’’ smokers vs. people reinforcement workers and house unclear. One laboratory study, Lindman who ‘‘never’’ smoked. But using painters (Heliovaara et al. 1991, Ex. 26– et al. (1991, Ex. 26–976), found that multiple logistic regression, when age, 959; Riihimaki et al. 1989, Ex. 26–997). women have more type I muscle fibers individual, and employment factors Several explanations for the in the trapezius muscle than men, and were in the model, only ‘‘never relationship with smoking have been have hypothesized that myofascial pain smoked’’ contributed significantly to postulated. One hypothesis is that back originates in these type I muscle fibers. neck/shoulder trouble. pain is caused by coughing from Ulin et al. (1993, Ex. 26–223) noted that While investigating reasons for higher smoking. Coughing increases the significant gender differences in work compensation claims for CTS in certain abdominal pressure and intradiscal posture were related to stature and employee groups, Nathan et al. (1996, pressure and puts strain on the spine. A

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00255 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68516 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations few studies have observed this two studies of nurses (Videman et al. to be diagnosed with CTS. These relationship (Deyo and Bass 1989, Ex. 1989, Ex. 26–1155; Mostardi et al. 1992, researchers developed a multiple linear- 26–105; Frymoyer et al. 1980, Ex. 26– Ex. 26–986), lifting strength was not a regression CTS model (with the 707; Troup et al. 1987, Ex. 26–1307). reliable predictor of back pain. difference between median and ulnar The other mechanisms proposed When examined together, these sensory latencies as the dependent include nicotine-induced diminished studies reveal the following: the studies variable). The regression highlighted blood flow to vulnerable tissues that found a significant relationship BMI as the most influential variable, but (Frymoyer, Pope, and Clements 1983, between strength and back pain used still only accounted for 5% of the Ex. 26–950), and smoking-induced more thorough job assessment analysis variance in the model. In Nathan’s diminished mineral content of bone and focused on manual lifting jobs. (1994, Ex. 26–517) logistic model, BMI causing microfractures (Svensson et al. However, these studies only followed accounted for 8.6% of the total risk; 1983, Ex. 26–1158). Similar associations workers for periods of 1 year, and however, this analysis used both hands with diminished blood flow to whether this same relationship would from each study subject as separate vulnerable tissues have been found hold over a much longer working period observations, although they are not between smoking and Raynaud’s remains unclear. The studies that did independent of each other. Falck and disease. not find a relationship, although they Aarnio (1983, Ex. 26–1122) found no Strength. Some epidemiologic support followed workers for longer periods of difference in BMI among 17 butchers exists for the relationship between back time, did not include precise with (53%) and without (47%) CTS. injury and a mismatch of physical measurements of exposure level for each Vessey, Villard-Mackintosh, and Yeates strength and job tasks. Chaffin and Park worker, so they could not assess the (1990, Ex. 26–229) found that the risk (1973, Ex. 26–1115) found a sharp strength capabilities that were important for CTS among obese women was increase in back injury rates in subjects in the jobs. double that for slender women. performing jobs requiring strength that Anthropometry. Weight, height, body Nordstrom et al. (1997, Ex. 26–900), was greater than or equal to their mass index (BMI) (a ratio of weight to in a study of risk factors for CTS in a isometric strength-test values. The risk height squared), and obesity have all general population, concluded that BMI been identified in studies as potential was 3 times greater in the weaker is one factor that seems to have a causal risk factors for certain MSDs, especially subjects. In a second longitudinal study, relation to CTS. These researchers found CTS and lumbar disc herniation. Chaffin et al. (1977, Ex. 26–1111) that for each increase of one unit of Obesity seems to play a small but evaluated the risk of back injuries and BMI, about 6 pounds for the average- significant role in the occurrence of CTS strength and found the risk to be 3 times sized adult, risk of CTS increases by (see Section B.4.a). Anthropometric data greater in the subjects without lower 8%. Werner et al. (1997, Ex. 26–718), in are conflicting, but in general indicate static strength. Keyserling, Herrin, and a study at five different worksites (four Chaffin (1980, Ex. 26–970) strength- that there is no strong correlation industrial, one clerical), concluded that tested subjects, biomechanically between stature, body weight, body obesity (BMI > 29), industrial work, and analyzed jobs, and assigned subjects to build, and low-back pain. age were independent risk factors for either stressed or non-stressed jobs. Few studies examining median mononeuropathies. Their study, Following medical records for a year, anthropometric risk factors in which did not define specific work- they found that job matching based on relationship to CTS have been related exposures, showed no strength criteria appeared to be occupational epidemiologic studies; significant interaction between work beneficial. In another prospective study, most have used hospital-based activity and obesity. However, the Troup, Martin, and Lloyd (1981, Ex. 26– populations that may differ authors caution interpretation of the 1456) found that reduced strength of substantially from working populations. back flexor muscles was a consistent Nathan et al. (1988, Ex. 26–990; 1992, data and urge more investigation. It has predictor of recurrent or persistent back Ex. 26–989; 1994, Ex. 26–517) have been suggested that relationship of CTS pain, but this association was not found published several papers about a single with BMI involves increased fatty tissue for first-time occurrence of back pain. industrial population and have reported within the carpal canal or increased Other studies have not found the an association between CTS and obesity; hydrostatic pressure throughout the same relationship with physical however, the methods employed in their carpal canal in obese persons compared strength. Two prospective studies of studies have been questioned in a with slender persons (Werner 1994, Ex. low-back pain reports (or claims) of number of subsequent publications 26–237). large populations of blue collar workers (Gerr and Letz 1992, Ex. 26–384; Two other anthropometric risk ´ (Battie et al. 1989, Ex. 26–72; Leino, Mackinnon et al. 1997, Ex. 26–1309; factors, carpal tunnel size and wrist Aro, and Hasan 1987, Ex. 26–1142) Stock 1991, Ex. 26–1010; Werner et al. size, have been suggested as risk factors failed to demonstrate that stronger 1994, Ex. 26–237). Several investigators for CTS; however, some studies have (defined by isometric lifting strength) have reported that their industrial study linked both small and large canal areas workers are at lower risk for low-back subjects with CTS were shorter and to CTS (Bleecker et al. 1985, Ex. 26–934; pain claims or episodes. One study heavier than the general population Winn and Habes 1990, Ex. 26–1029). followed workers for 10 years after (Cannon et al. 1981, Ex. 26–1212; Dieck Schierhout et al. (1995, Ex. 26–403) strength testing and the other followed and Kelsey 1985, Ex. 26–944; Falck and found that short stature was workers for a few years. Neither of these Aarnio 1983, Ex. 26–1122; Nathan et al. significantly associated with pain in the studies included precise measurement 1992, Ex. 26–989; Werner et al. 1994, neck and shoulder but not in the of exposure level for each worker, so the Ex. 26–237; Wieslander et al. 1989, Ex. forearm, hand and wrist, or back, among authors could not estimate the degree of 26–1027). workers in 11 factories. Height was not mismatch between workers’ strength Werner et al. (1994, Ex. 26–237) a factor for neck, shoulder, or hand and ´ and task demands. Battie compared studied a clinical population requiring wrist MSDs among newspaper workers with back pain with other electrodiagnostic evaluation of the right employees (Bernard et al. 1994, Ex. 26– workers on the same job (by isometric upper extremity, patients classified as 842). Kvarnstrom (1983, Ex. 26–1201) strength testing) and did not find that obese (BMI > 29) were 2.5 times more found no relationship between neck/ workers with back pain were weaker. In likely than slender patients (BMI < 20) shoulder MSDs and body height in a

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Swedish engineering company with own capacity. The capacity to perform opponents have argued, only clouds this more than 11,000 workers. work varies with gender and age, among issue by blaming the victims. [Ex. 500–218] Examples exist where biomechanical workers, and for any individual over On this same subject, Dr. Frederick Gerr, or physical risk factors have been time. The relationship between Emory University (Tr. 1525–26): labeled as individual factors. During the Some will argue that personal factors, such biomechanical risk factors, both inside as gender and body weight, are the cause of hearing for this rulemaking, Dr. Niklas and outside the workplace, these these disorders among American workers, Krause mentioned two of these individual as well as other factors and rather than ergonomics hazards in the examples, the first refers to people in the resulting risk of injury to the worker workplace. The fact that personal the military who drive tanks, and found is complex, but not unique to this characteristics can increase the risk for these that tall people have more back pain OSHA standard. disorders in no way undermines the evidence than short people. A very logical For each of the ‘‘individual factors’’ that work has been clearly shown to increase explanation for the observation of discussed here, some studies report their risk as well. increased back pain was provided by Dr. observing an increased risk for MSDs, The blame-the-victim approach to these Krause: disorders is both scientifically and ethically others do not. What they have in bankrupt. Virtually all occupational illnesses, Well, if you have ever entered a tank, you common, is their ability to effect the including asthma, cancer, skin disease, know that it is not constructed for very tall capacity of individuals independently peripheral and central nervous system people. There is not much room in there. [Tr. from biomechanical risk factors. In other disorders, and many others, have causes that 1378] words, in those studies where the effects extend outside of the workplace. This fact And a second example, also provided by of age, gender, smoking, etc. have been does not lessen the added burden of disease Dr. Krause: controlled for, the physical risk factors that occupational exposures produce. And we have actually found in our bus discussed here have been consistently drivers, too, and we measured. We had their shown to be associated with the Non-Work Leisure Activities height and their weight. We found that an ergonomic evaluation of the bus fleet showed development of MSDs in exposed The commenters (e.g., Exs. 30–2493, that the buses that are running in San populations. This means that, regardless 31–324, 30–3368, 30–605, 30–3783, Tr. Francisco were constructed for people—that of whether or not age plays a role in the 5073) also raise the issue of the is what the ergonomics Professor Thompson development of a particular MSD in a relationship of ‘‘non-work’’ to the from Sanford found out when he looked at particular population, the influence of development of MSDs. By this, OSHA them—were constructed for people in the biomechanical risk factors is assumes the reference is to those upper 10 percent of the North American independent from other associated activities such as nonoccupational VDT population. factors. Furthermore, it has been use, hobbies, second jobs, and You can imagine if you hire small people, demonstrated repeatedly, that reducing Asians and women for example, into that household activities, activities that may work force and put them on this bus that the these biomechanical factors in the result in additional exposure to fit is bad. And actually, what we see is that workplace results in reductions in the biomechanical factors similar to that the over the years, the percentage of small incidence of work-related MSDs. individual is experiencing at the drivers drops on that work force rapidly. The AFL/CIO found that the record workplace. If this assumption is correct, When they enter, when people take the job, provides some additional evidence that then ‘‘non-work’’ may actually refer to there is about 6 percent of drivers who are individuals may vary in their exposure to the same types of physical/ small, defined as * * * the lower half of the susceptibility to developing certain biomechanical factors that may be population. * * * After one to five years, work-related MSDs, such as carpal additive to similar workplace exposure. only 2.9 percent of these small people are in tunnel syndrome, based on individual the workforce. After six to ten years, only 1.3 And, while it is true that the physical/ percent. And after eleven to fifteen years, factors including age, body weight and biomechanical risk factors which only 0.4 percent. This is a statistically gender (Ex. 26–1, Ex. 26–37, Ex. 500– increase the risk of MSDs at work can significant trend. And it clearly shows you 71–93). They also found that other also be found outside of work and may that people based on their smallness and evidence in the record indicates that for lead to MSDs (Ex. 500–71–93). misfit probably had to leave the occupation. back and neck pain or disorders, for However, according to Dr. Nicholas [Tr. 1378–1380] example, no association with age, Warren from the University of When used to determine whether a gender, height or weight has been Connecticut (Tr. 1077–78): correlation exists between stature, body established (Ex. 500–71–24, Tr. 1332). It is very seldom the case that home risk weight, body build and low back pain, The AFL/CIO point out that: factors are encountered with the same anthropometric data are conflicting, but Obviously the underlying principle of intensity or the same duration as they are in general indicate that there is no ergonomics is to fit the job to the worker, and encountered in the workplace. strong correlation. Obesity seems to play so personal physical characteristics do come On the same subject , the AFL/CIO (Ex. into play when evaluating certain MSD risk 500–218) notes: a small but significant role in the ′ ″ occurrence of CTS. factors. A worker who is 5 2 may have a Opponents of the standard, while arguing much longer reach to an assembly line than that there is no evidence that physical factors Genetics. Another type of factor that her 6′0″ co-worker. But other than as relevant at work cause MSDs, also simultaneously affects an individual’s capacity is to evaluating exposure to known risk factors, argue that it is non-work leisure physical genetic make-up. While the term personal characteristics and differences in activities which cause MSDs and that an ‘‘genetic susceptibility’’ is often heard; susceptibility are irrelevant to this OSHA standard cannot regulate adverse in reality both the amount of genetic rulemaking. This regulation, and all other health conditions and exposures to risk information involved in the response OSHA standards, are designed to regulate factors which are partially, primarily or and the variability of possible responses risks that are found in the workplace that exclusively the result of non-work activities are vast and for the most part, not yet may result in the development of an adverse (Ex. 32–241–4). understood. The little bit of work done outcome (MSDs) in workers who are exposed For most musculoskeletal disorder cases, to risk factors which have been demonstrated ‘‘workplace factors are the predominant risk in this area was done by Videman, and to cause MSDs. The ergonomics regulation is and it is upon these risks, obviously, that the is covered in a brief discussion in the consistent with OSHA’s responsibility to OSHA proposed rule focuses (Tr.1079). Other section on the low back. regulate hazards which are present in the evidence in the record confirms that there is A worker’s ability to respond to work workplace. To shift the focus toward little or no impact on the development of factors may be modified by his or her personal characteristics, as some industry MSDs related to the back from non-work

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00257 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68518 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations participation in sports, exercise, and leisure Dunn & Crutcher (Exs. 32–241–4, 500– focus on additional conceptualizations time physical activity (Ex. 500–71–24, Ex. 197), and several research and medical of psychosocial exposures, including job 500–71–32, Ex. 502–510). scientists who testified on behalf of UPS security, monotony, and job satisfaction The AFL/CIO also states: (Exs. 32–241–3–2, 32–241–3–3, 32–241– (for example, Krause, 1998, Ex. 38–242, Thus the record evidence suggests that the 3–5, 32–241–3–8, 32–241–3-12), Bigos, 1991b Ex. 26–1242). Psychosocial non-work exposures to risk factors rarely, if ever, occur at the same frequency, duration criticized the proposed rule for its factors reflecting these external aspects or magnitude as workplace exposures. Even failure to take into account the of the work environment have been the where workers are exposed to non-work risk contribution of psychosocial risk factors subject of investigation in nearly all of factors off the job, it is important to point out to MSD causation and exacerbation, the studies and literature reviews that this standard is designed only to believing that psychosocial factors play discussed in this section. decrease exposures to biomechanic risk a significantly greater role than do As is the case with biomechanical risk factors occurring at the workplace. An biomechanical risk factors in the factors, proposed exposure-outcome analogy may be drawn to the risks of development of MSDs and the relationships for psychosocial factors incurring hearing loss from excessive disabilities associated with them. are multifactoral, i.e., several of these exposure to noise. Exposure to noise at levels Much of the scientific literature that factors may be in play in any given and durations which can cause or contribute to noise-induced hearing loss can and do addresses the etiology of MSDs has situation, and may combine and interact occur both at the workplace as well as in examined aspects of the social and in complex ways that are difficult to non-work situations. While these work and psychological environment that may study and understand (Bongers et al., non-work exposures and risks of developing have a causal or moderating role in MSD 1993, Ex. 26–1292, Bernard, 1997, Ex. hearing loss exist, OSHA’s noise standard is development and exacerbation. In this 26–1 Warren et al., 2000a, b, Exs. 38– confined exclusively to addressing excessive part of the Health Effects section, OSHA 75, 38–73). It is unlikely that these noise exposures in the workplace. [Ex. 500– first discusses what is meant in the psychosocial workplace risk factors 218] literature by the term ‘‘psychosocial occur and act in isolation of And from Dr. Nicholas Warren, University factors.’’ Following this discussion, biomechanical risk factors (Tr. 868–869, of Connecticut (Tr. 1078–79): OSHA summarizes the expert testimony 1264, 5942–5943, NIOSH 1997 (Ex. 26– When I work with an individual with, for instance, carpal tunnel syndrome, carrying of witnesses and rulemaking 1), NAS 1999 (Ex. 26–37)). out forceful, repetitive tasks over most of a participants who have evaluated the A growing body of literature also nominal 40 hour work week and then often body of psychosocial literature as it identifies aspects of organizational into another 10 hours of voluntary overtime, relates to the work-related risk of MSDs. structure, technology, policy, and it’s painful to hear an insurer gleefully Finally, OSHA presents its own culture as potential contributors to inform me that this person bowls in a league literature review, summarizing specific occupational disease and characterizes on Saturday night. It is equally painful to studies contained in the rulemaking them as organizational risk factors hear the worker blame him or herself by docket that have examined and (Shannon, et al., 1996, Ex. 26–1368, saying, ‘‘That’s probably because I knit,’’ compared the roles of biomechanical 1997, Ex. 26–1369, Warren, 1997, Ex. when, in fact, a clear objective assessment of and psychosocial factors in the etiology 38–72, Warren et al., 2000a, Ex. 38–75). the workplace risk factors reveals that these Organizational risk factors are proposed are much more important in the etiology of of MSDs, and summarizes several his or her disease. literature reviews that have been as the underlying bases of work design published on this topic. in the company; through their effect on OSHA concludes that, in general, work organization, they determine each individual’s capacity is affected Definition of Psychosocial Factors levels of both psychosocial and differently by many factors including The study of psychosocial factors as it biomechanical risk factors experienced some of those presented here: age, applies to the study of work-related by employees. It is this common set of gender, smoking, physical activity, MSDs is surrounded by a measure of roots that results in the strong co- strength, anthropometry, genetic factors confusion because there are several very variation of psychosocial and and activities outside the workplace. different definitions of ‘‘psychosocial’’ biomechanical risk factors noted below. This is also true in the more specific used in common and in technical The second concept of psychosocial case of the development of work-related parlance. Lack of clarity and consensus factors that has been used in the MSDs. However, it is important to in defining psychosocial factors was literature relates to the internal remember that exposure to addressed by some researchers at the characteristics of the worker’s biomechanical factors in the workplace public hearing (Tr. 867–868, 1306, psychological makeup that affect how is independent of those factors that each 17443). There are three general concepts he/she appraises, processes and reacts individual brings to the workplace, i.e., of psychosocial factors that apply. Most to external biomechanical and when the influence of individual factors researchers who have examined the role psychosocial factors, and thus is controlled for in studies, effects due of psychosocial factors in the etiology of moderates how these external factors are to exposure to biomechanical factors are MSDs have emphasized the external experienced internally. There are still observed . It is also true that in the aspects of the psychological and social studies demonstrating that individual vast majority of cases, where exposure work environment that cause the worker psychological factors can increase to biomechanical exposures is high, the to experience ‘‘stress’’, a condition of susceptibility to MSD development and effects due to biomechanical exposures chronic or prolonged arousal of the affect MSD recognition and reporting are far greater than those associated human ‘‘flight or fight’’ mechanisms (Linton, 2000, Ex. 502–413, NAS, 1999 with these types of individual factors. that has been linked to a wide variety Ex. 26–37). Emerging research sugg of negative health outcomes, including influence care-seeking and disability 5. Role of Psychosocial Factors in the MSDs. The primary aspects of the than initial onset of disease (Linton, Etiology of MSDs psychosocial work environment include 1992, 2000, Ex. 502–413 ests that The role of psychosocial factors in the level of psychological job demands, internal psychological factors more etiology of MSDs was a subject of much level of worker control over the job strongly, Waddell & Burton, 2000, Ex. debate during the rulemaking. Many process, and level of social support DC–151–A). Some researchers and participants, in particular the Chamber received from co-workers, supervisors physicians combine internal and of Commerce (Ex. 500–188), Gibson, and the organization. Some researchers external psychological factors in their

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00258 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68519 definition of psychosocial factors; for (Section VI) of this preamble). Thus, it significant than, biomechanical factors. (Ex. example, Dr. Raymond Bellamy, an is highly unlikely that an individual 500–188, p. 41) orthopedic surgeon testifying on behalf with psychological tendencies towards In addition, several research and of UPS et al., included such factors as negative reactions at work or tendencies medical scientists testifying on behalf of dislike of job, recent poor performance to seek out care-givers would UPS et al. stated in written or oral evaluation, depression and anxiety, preferentially select themselves into comment that the scientific literature hypochondriasis, and desire for physically demanding jobs. It is also strongly supported that psychosocial narcotics in his description of impossible to imagine how prospects for factors play a dominant role in the psychosocial factors (Ex. 32–241–3–3). secondary gain would be differentially etiology of MSDs (Exs. 32–241–3–2,32– Dr. Arthur Barsky, also testifying on distributed into occupations or industry 241–3–3, 32–241–3–5, 32–241-3–8, 32– behalf of UPS et al., stated that sectors that involve highly physical 241–3–12). For example, psychosocial factors (his use of the term work. Dr. Alf Nachemson concluded a conflates external factors and internal Consequently, this part of the Health review of the literature by stating that psychological factors) ‘‘exacerbate, Effects section focuses on the large perpetuate, and maintain these * * * [t]he research indicates that number of studies that have psychosocial factors are not simply an [musculoskeletal] symptoms and simultaneously examined the roles of overlay but rather an integral part of the pain amplify the disability they engender’’ biomechanical risk factors along with disability process that includes emotional, (post-testimony comments, p.1, Ex. 500– psychosocial factors that relate to cognitive and behavioral aspects * * * 118–1). Thus, it is not always clear in external aspects of the psychological [T]here was strong evidence of the highest the literature or in the testimony and social work environment. These level that psychosocial variables generally contained in the record when the term studies generally represent the most have more impact than biomedical or ‘‘psychosocial factors’’ is being used to biomechanical factors on pain disability.’’ recent studies of work-related MSDs in (Ex. 32–241–3–12, p. 13) refer to external psychological or social the literature. workplace factors, internal Dr. Norton Hadler stated in written psychological makeup of the worker, or Discussion of Testimony on the comment that Psychosocial Literature both. Associations between disabling regional The third concept of psychosocial Based on these studies, the Chamber musculoskeletal symptoms and psychosocial factors relates to aspects of the legal, of Commerce (Ex. 500–188) and Gibson, variables overwhelm and explain away any insurance and medical environment that Dunn & Crutcher representing UPS, and all associations with biomechanical influence a worker’s tendency to Anheuser-Busch, the National Coalition exposures. (Ex.32–241–3–8, p. 18) identify a particular constellation of on Ergonomics, and others (e.g., Exs. Taking a more moderate symptoms as a disease. At its most 32–231–4, 500–197, 32,435, 30–3346, interpretation of the literature, Dr. extreme, this definition is used to claim Tr. 3655) were critical of OSHA Arthur Barsky agreed that MSDs are not that workers make up and fake disease, emphasizing the role of biomechanical entirely a psychosocial problem; for ‘‘secondary gain’’. A broader risk factors over psychosocial factors in however, he felt that ignoring them in interpretation is the argument that these its scientific literature review. For designing intervention programs can aspects of legal and medical recognition example, in their post-hearing brief, make the problem worse (Ex. 500–118– and possible financial gain may subtly, Gibson, Dunn & Crutcher commented 1, p. 1). At the public hearing, he even unconsciously influence a worker’s honest identification of that explained that symptoms as a disease and The science has shown that where * * * [workers’] symptoms really are better predisposition to report it. psychosocial factors in particular are understood as a social communication, as a Although individual psychological considered, they generally overwhelm the kind of non-verbal way of responding to factors or medical/legal factors may weak and inconsistent associations between difficulties in the workplace—job affect MSD perception and reporting to biomechanical exposures and the reporting of dissatisfaction, role conflicts, insecurity MSDs. Yet the*** [A]gency dismissed around the job, a whole variety of a degree, it is unlikely that they play a the validity of psychosocial factors in psychosocial work conditions—and to hear major causal role in the etiology of cavalier fashion***[Ex. 500–197, p. I– these as a biomedical complaint is to totally MSDs. This is because the increased 33] miss the point***What really concerns prevalence and incidence of MSDs seen me, is***[that complaints of MSD among workers who are highly exposed Similarly, the Chamber of Commerce symptoms are] a kind of social to biomechanical risk factors cannot be stated that ‘‘The Agency has egregiously communication***a metaphor for life adequately explained primarily by ignored each and every one of these stress, for psychosocial distress***and psychological factors given the present indisputably relevant factors***’’ the response that too often is made to a state of the evidence. As the discussion (Ex. 500–188), and explained the symptom like that, is [an inappropriate] in this Health Effects section has necessity for OSHA to evaluate the role referral to orthopedics. Tr. 17043–17044] demonstrated, the epidemiological, of psychosocial factors in the Dr. Barsky illustrated his point with an laboratory, psychophysical, and workplace: example of a widowed mother of two intervention literature demonstrating * * * [D]etermining why individuals feel worked two jobs and visited the quantifiable links between the need to report and/or to seek medical emergency room of a hospital biomechanical exposures and MSD care for such complaints is a complex complaining of tired feet [Tr. 17043– outcomes is overwhelming. Many problem involving not only the physical 17044], and viewed the proposed studies have demonstrated substantial exposures, but psychosocial factors such as ergonomics standard as an differences in MSD incidence and job satisfaction, ability to control the work inappropriate response to such an prevalence between companies and environment, interpersonal relationships at ‘‘interpersonal communication’’ (Tr. work, and the like***And, in the vast industry sectors that correlate strongly majority of studies that have assessed 17044). with the presence of physical risk whether biomechanical workplace factors Other scientists testifying on behalf of factors (for example, Franklin et al., and psychosocial factors cause the UPS echoed the conclusions reached 1991, Ex. 26–948, NAS, 1999, Ex. 26–37, musculoskeletal complaints, psychosocial by Dr. Nachemson in his literature see also the Risk Assessment section factors are just as significant, or more review and Dr. Bigos, who referred to

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00259 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68520 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations his groups Boeing study (Ex. 26–1241, medical or scientific literature that which he participated also found an 26–1242,26–1393) in contending that [would] substantiate that statement’’ (Tr. association between MSDs and exposure low back pain (LBP) is primarily a 1538). Both also strongly disagreed (Tr. to biomechanical risk factors psychosocial phenomenon (Exs. 32– 1538–1539) with Dr. Hadler’s statement independent from psychosocial factors. 241–3–2, 32–241–3–5). Other in his written testimony that When asked about the significance of commenters also remarked on the psychosocial factors ‘‘overwhelm and that finding, Dr. Frank responded importance of psychosocial factors in explain away any and all associations The importance particularly for the the development of MSDs (e.g., Exs. 32– with biomechanical factors’’ (Ex.32– proposed standard or any public health 435, 30–3346, 30–3086, 30–536, 30– 241–3–8, p. 18). efforts to reduce biomechanical hazards at 4046, 30–1070, Tr. 3655). Several other researchers and medical work is that[,]***acting on Many of OSHA’s scientific witnesses scientists appearing at the hearing on biomechanical risk factors will bring risk disputed these interpretations of the their own behalf disagreed with the UPS reductions according to our understanding of psychosocial literature, stating that the witnesses assessments that psychosocial the multifactorial causal process even if we factors predominate in the etiology of are unable***at the present time to literature is not in conflict with the conclusively act to reduce psychosocial causal relationship that has been MSDs (Tr. 2838, 2840, 7857–7858, 9504, factors***[Tr. 1365–1366] demonstrated between exposure to 9880). Dr. George Piligian of the Mt. biomechanical risk factors and Sinai Center for Occupational and Dr. Frank also drew a parallel with successful efforts to control cholesterol development of MSDs, and that Environmental Medicine, when asked blood levels to reduce heart disease psychosocial factors had generally less whether it was appropriate for OSHA to incidence, despite ‘‘two dozen or more’’ of an influence than biomechanical emphasize the role of biomechanical other risk factors that contribute to heart factors in these studies (Tr. 842, 874, factors in its proposed rule given the disease because high cholesterol levels 1087, 1206, 1364, 1537–1540). For evidence on psychosocial factors, are independently associated with an example, Dr. Thomas Armstrong responded with an analogy: increased risk of heart disease (Tr. testified that * * * [Suppose] a person is thirsty and has 1365–1366). * * * [M]ore than a critical mass of come from the desert, and if you have only In the preamble to the proposed rule, half a glass of water to offer that epidemiological literature shows that OSHA’s focus on identification and biomechanical factors are important person[.]***Someone argued and said***I don’t think we should give this control of biomechanical risk factors in predictors of the occurrence of the workplace was based on two musculoskeletal disorders and the elevated person that half a glass of water until it’s risk of harm. full***I would venture to say that the considerations. First, OSHA In studies where we have included both person who is thirsty would probably beg preliminarily concluded that there was psychosocial and physical risk factors, the you to give them that half a glass of water, substantial evidence of a clearly physical factors come out as the strongest then, go back and fill it ***. demonstrated causal relationship predictor. [Tr. 842] We are doing what we can with the knowledge we have rather than using the between exposure to physical risk Dr. Laura Punnett testified that argument, which I find actually factors and MSD outcomes (64 FR ‘‘* * * the impact of physical counterintuitive***that we must have 65926), and that most researchers who exposures at work is beyond that every single thing that we know of in place studied the etiology of MSDs placed explained by demographics, medical before we proceed. [Tr. 7857–7859] emphasis on biomechanical risk factors. history, psychosocial features of the Some of OSHA’s expert witnesses Second, research into role of work environment or other factors’’ (Tr. who are actively engaged in research on psychosocial risk factors in the etiology 874). Similarly, Dr. Nicholas Warren work-related MSDs testified that an of MSDs was considered to be a less testified that in studies that have important finding from the more recent mature field than that addressing the measured both biomechanical and literature is that biomechanical risk role of biomechanical risk factors, psychosocial factors factors have been shown to be characterized by emerging methodology, as pointed out by Dr. Martin Cherniak * * * we almost always find that both associated with MSDs independently contributed. If you control for psychosocial from psychosocial factors (Tr. 1327– at the hearing (Tr. 1307), and sometimes risk factors[,] which well-designed studies 1328, 1331–1332, 1335, 1343, 1365, by inconsistent results. Thus, most allow you to do, you’ll find a strong 1412). Dr. Niklas Krause, in testifying on interventions designed to address work- contribution from biomechanical risk factors his own prospective study of public related MSDs focused on and that it generally, not in all workplaces, transit operators and low back disorders biomechanical, rather than psychosocial but in most workplaces, is a larger effect than (Ex. 500–87–2), stated that factors. that of the psychosocial risk factors. [Tr. The 1997 NIOSH review (Ex. 26–1) on 1087] The main result***is that both which OSHA relied heavily, examined biomechanical and psychosocial job factors When asked whether he would agree were independently associated with spinal psychosocial risk factors that might with Gibson, Dunn & Crutcher’s disorders***[I]ndependent positive dose contribute directly and indirectly to statement in their pre-hearing response relationships were also found for musculoskeletal illness and injury. The submission that ‘‘a majority of medical ergonomic problems***I conclude from review noted that the results from the experts who study the causes of MSDs this new high quality evidence [referring to literature were not entirely consistent, believe most chronic workplace pain is the Loisel et al.(Ex. 38–28) randomized trial and that a lack of consensus on standard caused by psychosocial issues’’ (Ex. 32– study] and the literature that has been measurements and procedures might be already collated by OSHA [in its preamble to 241–4, p. 36), both Dr. Bradley Evanoff the proposed rule and Health Effects one reason for lack of consistency. and Dr. Fred Gerr disagreed. Dr. Evanoff Appendices (Ex. 27–1) that high-quality Perceptions of intensified workload, believed the opposite was true, that ‘‘the epidemiological studies confirm that monotonous work, low job control, low majority of people studying work- physical work place factors cause MSDs job clarity, and low social support were related musculoskeletal independently from individual worker associated with MSDs in some studies. disorders***feel that physical characteristics and psychosocial job NIOSH found that these associations, exposures are a very strong risk factor’’ factors***[Tr. 1331–1335]. despite the variance in methods used to Tr. 1358). Dr. Gerr stated that he was Dr. John Frank testified that the Kerr et assess these factors, were significant in ‘‘aware of absolutely no basis in the al. case-control study (Ex. 38–82) in the better studies; however, the size of

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Further, the going to be low, your discomfort level is low, In his testimony, Dr. Frank (Tr. 1343– underlying mechanisms are still not your attitude is bad, and you may be one of 1345, 1397–1398) discussed the reasons the silent sufferers. * * * When * * * we nearly as well understood as those take our risk factor checklist out and we for this inconsistency, relating it to the developed for biomechanical verify that, yes, these postures are awkward field being in the embryonic stage of associations (Tr. 1344–1345, NAS, 1999, postures and when you add that along with understanding psychosocial effects, and Ex. 26–37). Similarly, understanding the forces and the exertions that you’re using to imperfect measurement instruments. and evaluating psychosocial that that’s a possibility it sure could cause He pointed out that the Institute for interventions is also in its infancy, pain. It’s no wonder the morale becomes low. Work and Health study discussed below making it difficult to design appropriate And they [biomechanical and psychosocial (Kerr et al., 2000, Ex. 38–82) did not interventions. factors] do intertwine. But the pain is usually confirm findings of Bigos et al. (1991a, the cause of [low morale], in my opinion, None of the studies cited by either from what I see. [Tr. 5942–5943] b, Exs. 26–1241, 26–1242, 1992, Ex. 26– proponents or opponents of an 1393) or Krause (1998, Ex. 500–87–2) ergonomics standard can demonstrate These underlying sources of that low job satisfaction contributed to that any of the risk factors measured, biomechanical and psychosocial risk. In contrast, Dr. Frank (Tr. 1344) whether biomechanical, psychosocial, exposures can themselves be seen as a noted that, in newer studies that personal, or demographic, can single exposure category known as simultaneously assessed the effect of completely explain an increased organizational exposure (Warren, 1997, physical and psychosocial factors, prevalence or incidence of MSD Ex. 38–72, Warren et al., 2000a, b, Exs. biomechanical loads make a consistent outcomes. (In other words, the 38–75, 38–73, Shannon et al., 1996, and generally stronger contribution to combined contribution of all factors to 1997, Exs. 26–1368, 26–1369), which, as Dr. Warren described, recognizes that MSD outcomes. statistical models never comes close to ‘‘the way work is organized will have an Although psychosocial exposure explaining 100 percent of the variance effect on the levels of both assessment has grown rapidly in the last between exposure groups in the biomechanical and psychosocial work decade and is characterized by outcome measure; there are always stresses’’ (Tr. 1264). continually improving methodological other, unmeasured factors involved.) Dr. developments, it is still a relatively Tapio Videman (Ex. 32–241–3–20), Dr. Summary of Primary Literature on young field. Measurement Arthur Barsky (Ex. 500–118–1) and most Biomechanical and Psychosocial methodologies are not well other researchers agreed that a simple Factors standardized; this was addressed by Dr. biomechanical model of tissue wear and OSHA’s review of the literature Barbera Silverstein, who testified that tear is not sufficient by itself to explain there was no consensus on the kinds of presented below shows that most of the disease development in humans, which best studies available suggest that MSDs psychosocial issues that should be is characterized by complicated studied or how they could be assessed are the result of a complicated interactions with external combination of biomechanical and ‘‘with the same rigor that has environmental factors and individual been***looked at [for] physical psychosocial factors, with the characteristics. In fact, testimony at the prevalence or incidence of MSDs being load factors’’ (Tr. 17444). hearing (Tr. 868, 1264, 5942–5943) In addition, less is known about the generally more strongly associated with made it clear that considering causal relationship between biomechanical risk factors. Given the psychosocial and biomechanical factors psychosocial factors and MSDs. Many present state of research into MSD to be separate kinds of exposures is a studies performed so far have been cross etiology, there can be little doubt that a somewhat artificial distinction in that sectional, thus making it difficult to multifactoral model, incorporating both the two classes of stressors are strongly evaluate the temporal nature of the biomechanical and psychosocial risk linked, both resulting from core aspects association (i.e., whether psychosocial factors, would best explain the of the organization: its technology, factors preceded the MSD or whether differences in MSD prevalence or culture and work organization. the presence of a disorder led to incidence seen among various groups of For example, Dr. Punnett testified that negative psychosocial outcomes). Dr. workers. Nevertheless, from the Punnett addressed this issue in her There is also a recognized overlap between testimony presented above and the testimony: some characteristics of physical and review of the literature that follows, psychosocial work environment. OSHA concludes that biomechanical * * * [S]ince psychosocial factors may be A repetitive, monotonous job on a machine risk factors contribute independently perceived and reported differently by the paced assembly line can be described equally worker after the development of from psychosocial factors to MSD well by the ergonomist as consisting of etiology, that the association between musculoskeletal disorders, the reported stereotyped repetitive motion patterns with associations are particularly difficult to rigid pacing and few rest breaks or as having the risk of MSDs and exposure to interpret with respect to***[etiology]. poor psychological job content with few biomechanical risk factors has been The occurrence of a work-related opportunities to make decisions, work observed to be generally stronger than musculoskeletal disorder***may itself collaboratively with co-workers, utilize for psychosocial factors, and that, cause psychosocial strain. And that strain existing skills or learn new ones. consequently, it is reasonable to design may also subsequently slow or interfere with And I suggest that the worker performing the recovery process without necessarily interventions that focus on exposures to that job would be hard pressed to make a having been involved in the initial etiology. biomechanical risk factors to reduce the In this context, we should note that distinction between the physical and the risk of MSDs in exposed workers. associations with cross- psychosocial characteristics of that job. [Tr. Because the scientific literature sectional***[studies] with physical 868–869] summarized in this section addresses exposures are far less ambiguous. [Tr. 869– Ms. Sue Rahula, an ergonomist the relative strength of association 870] technician with United Auto Workers, between MSD risk and two broad As a result, associations found described how biomechanical exposure categories of workplace factors, and between psychosocial exposures and and the presence of an MSD can affect because of the potential for interacting MSD outcomes are, relative to worker morale, which can be reflected or modifying effects between biomechanical associations, less in negative psychosocial outcomes: biomechanical and psychosocial factors,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00261 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68522 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations it becomes particularly important to psychosocial factors, the use of a modeling method in many studies) consider certain elements of prospective study design that follows cannot assess the contribution of an epidemiological study design to ensure groups of workers over time becomes exposure if its magnitude or intensity is that study results are appropriately particularly important to evaluate the essentially the same in all study interpreted. These design considerations temporal relationships between participants. include the following: exposure to biomechanical risk factors, Assess both stressor categories at the Best study design. Epidemiological psychosocial factors, development of same individual or group level. Studies studies can be of three general designs: MSDs. that assess both categories of exposure, cross-sectional, case-control, and In addition, as was the case with the but at different levels of analysis (i.e., prospective (longitudinal) cohort. Dr. biomechanical literature reviewed in the level of the individual worker versus Stanley Bigos presented a earlier parts of the Health Effects groups of workers), will generally not comprehensive review of the advantages section, determination of exposure and find an effect for the variables measured and disadvantages of each study design health outcome by objective means, at a higher (group) level of aggregation; (Ex. 32–241–3–4, pps. 7–9). OSHA also such as direct observation or this was addressed by Dr. Frank in his addressed general issues regarding measurement of exposure and medical testimony (Tr. 1364–1365). For example, study design and causal inference in a assessment of health status, is preferable the Boeing study (Bigos, et al., 1991a, b, previous part of this Health Effects over sole reliance on worker self-reports Exs. 26–1241, 26–1242, 1992 Ex. 26– section. All researchers agree that because objective measures rule out the 1393) assessed psychological and prospective studies can most possibility of reporting bias (e.g., the emotional variables at the individual persuasively establish causality, with possibility that a worker’s disease status level and biomechanical variables at the cross-sectional studies presenting the might influence the self-report of group level. This error also reflects most potential problems in this area. In exposure). This design consideration violation of the preceding two criteria the absence of any other information, points to another difficulty in studying since measurement at the group level prospective studies are generally the role of psychosocial factors in that reduces both precision in the preferable. However, several factors may they can only be assessed by biomechanical exposure measure recommend against this design: in administering questionnaires or (compared to measuring exposure at the particular, the high cost of these studies interviews. individual level) and variance in and the dynamic nature of the modern Simultaneous assessment. It is biomechanical exposure between obvious that to accurately assess the workplace, which may change job groups. When one variable is aggregated relative contribution of biomechanical classifications (and hence workers’ or represented at the group level, as in and psychosocial risk factors to MSD exposures) over the follow-up period of the Bigos measurement of causation and exacerbation, both classes the study. biomechanical risk, the variations in Although cross-sectional studies of exposure must be measured. exposure within each group are lost; identify associations and cannot by Address collinearity. Levels of both internal variance within each group is themselves permit a definite attribution biomechanical and psychosocial risk reduced to zero. of a causal relationship, it is still factors are in large part the result of the possible to draw inferences when one way work is organized, the technology The studies summarized below relied causal direction (i.e., exposure precedes and sector of the company, and the on assessment of both biomechanical disease) is much more plausible than organizational policies and culture that and psychosocial factors in the the alternative explanation (i.e., disease drive work organization. Thus the two workplace. Thus, in accordance with precedes exposure). As Dr. Gerr noted in classes of stressor are generally highly the second criteria described above, his testimony (Tr. 1525) the many cross- correlated in a workplace (Tr. 868–869, studies were excluded if they did not sectional studies showing an association 1264, 5942–5943). Concurrent analysis assess one class of stressor or did not between carpal tunnel syndrome and of exposure-outcome associations must include both classes in multivariate physical workplace factors strongly be very careful to avoid modeling analysis. Such studies are useless for the indicate that exposure to these problems that arise from collinearity. exploration of combined biomechanical workplace factors causes disease. This Assess both stressor categories with and psychosocial effects. conclusion arises in part because it is equal precision. Some studies assess The majority of the studies below illogical to postulate that the presence of both categories of exposure, but assess demonstrate at least equal, and often CTS would cause exposure to physical one with more precision or detail than stronger, associations with factors (i.e., workers select themselves the other. The category characterized in biomechanical stressors than with into physically harmful jobs on the basis more detail presents fewer opportunities psychosocial. This fact, combined with of disease status). Dr Gerr testified that for non-differential exposure the independent effects of both stressor this would be ‘‘like saying cancer causes misclassification (which biases results classes, as discussed above, is sufficient smoking. It’s as wrong as it is silly to towards a lower effect) and will thus to support OSHA’s focus on hear’’ (Tr. 1525). However, for show artificially elevated relative biomechanical risk factors in the final psychosocial factors such as poor job associations with outcome. Dr. Wells rule. However, relative magnitude of the satisfaction or low supervisory support, stated that a factor measured with poor associations for biomechanical and it is more difficult to logically infer or precision in an epidemiological study psychosocial risk factors should only be exclude a temporal relationship will often not appear as a risk factor in seen as a qualitative indicator of relative between a psychosocial factor and an statistical modeling (Tr. 1355). strength of association with MSD MSD; this was described by Dr. Punnett Ensure adequate variance in all prevalence or incidence. Actual in her testimony (Tr. 869). That is, it measures. Studies that assess both quantitative effect sizes may not be cannot be known whether having poor categories of exposure, but with little comparable within or between studies job satisfaction preceded development variance between exposure groups in for a number of reasons, including: of the MSD or whether the presence of one or the other category of exposure • Use of different measurement the MSD is causing a worker to become will generally not find effects associated scales; less satisfied with their job. Thus, in with that category or measure. • Use of different analytical strategies evaluating the causal nature of Regression analysis (a standard to categorize risk levels; and

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• Use of different outcome measures the follow-up period by questionnaire, hypothesized that psychosocial in different studies. and data on sick leave attributed to back exposures have less effect if the physical Table V–14. summarizes the key pain and other MSDs (doctor diagnosis load is high, it is interesting that features of the design of each study as if over 3 days) was obtained from psychosocial stress was predictive of well as the range of measures of company records. The exposure LBP in white-collar workers, while none association for biomechanical and assessment at baseline plus physician of the 4 psychosocial exposures were psychosocial factors. diagnosis at follow-up made this design significantly predictive in blue-collar ¨ Wickstrom & Pentti 1998 (Ex. 500– capable of strongly implying causal workers. However, sick leave was 121–77). This 2-year prospective study status to both physical and psychosocial predicted for blue-collar workers by of 117 white-collar and 189 blue-collar risk factors. As predictors of self- both biomechanical exposures (RRs: workers in two metal industry facilities reported LBP, 3 physical exposures 1.72–2.04) and psychosocial (RRs 1.58– assessed both biomechanical and were predictive for both white collar 1.99). In general, this study supports the psychosocial exposures (4 items each) at (RRs: 2.82–6.19) and blue-collar workers interpretation that MSDs are caused by baseline, using equivalent levels of (RRs: 2.49–3.67). Since other authors both classes of risk factor, with detail. Back pain was assessed twice in (Marras, 2000, Ex. 500–121–46) have biomechanical showing stronger effects.

TABLE V±14.ÐSTUDIES ASSESSING BOTH BIOMECHANICAL AND PHYSICAL RISK FACTORS

Number of Study Exposure Outcome Study Reference subjects type measure measure design Results: outcome and effect

Association with Biomechanical Factors Stronger than with Psychosocial Factors (or effect size not reported) È Wickstrom & Pentti 306 3 1 ...... 1, 2, 3 ...... all LBP & sick leave due to LBP; Physical RR: (1998). 1.97±6.19; Psychosocial RR: 1.58±1.59. Bergqvist et al.(1995) ... 260 1 2 ...... 3 ...... all UE/LBP sympt./MD diag.; Physical OR: 3.1±7.4; Psychosocial OR: 2.1±7.4. Kerr et al.(2000) ...... 381 2 3 ...... 1 ...... all Reporting of LBP; Physical OR: 1.7±3.0; Psy- chosocial OR: 1.6±2.6. Koehoorn et al.(1999) ... 4020 3 2 ...... 2 ...... a, c MSD symptoms & claims; Physical RR: 1.41± 4.65; Psychosocial RR: 0.45±2.78. Krause et al.(1998) ...... 1449 3 1, 2 ...... 2 ...... b, c Spinal injury through WC; Physical OR: 3.04 (driving cable car); 0.37 (part-time driving: 20±30 hrs); Psychosocial OR: 1.50±1.56. Latko et al.(1997, 1999) 352 1 2 ...... 1, 3 ...... all Symptoms, MD Dx of CTS; Physical OR (high repetition vs. low rep.): 2.32±3.23; Psycho- social OR: n.s. Latza et al.(2000) ...... 230 3 1 ...... 1 ...... all Self-reported LBP; Physical PR: 1.8±4.0; Psy- chosocial PR: n.s. Leclerc et al.(1998) ...... 1210 1 1 ...... 3 ...... all CTS by signs or NCV; Physical OR: 1.90±2.24; Psychosocial OR: 1.59±2.24. Linton (1990) ...... 22,180 3 1 ...... 1 ...... all Neck & LBP symptoms Univariate ORs; Phys- ical: 0.86±2.95; Psychosocial: 1.15±2.60; Combined ORs: 2.42±3.65. Ono et al.(1998) ...... 575 1 1 ...... 3 ...... all Epicondylitis, MD Dx; Physical OR: 1.7; Psy- chosocial OR: 1.2. Videman et al.(1989) .... 199 3 2 ...... 1 ...... b, c Incidence of back injury; Low skill OR: 37±156 (if also 3 hrs. strenuous working postures) Bernard et al.(1992, 973 1 1, 2 ...... 1 ...... all UE symptoms; Physical OR: 1.4±2.5; Psycho- 1994). social OR: 1.4±1.7. Faucett & Rempell 150 1 2 ...... 1 ...... all UE symptom severity, (effect measured by R 2 (1994). change): Physical: 0.11±0.15; Psychosocial: 0.03±.12. Heliovaara (1987) ...... * 592 3 1 (occ.) .... 3 ...... none Hospital Admission for disc herniation/sciatica; Occupational RR: 2.2±3.0; Psychic Distress: NR. Ê Josephson & Vangard, 269 2 1 ...... 1 ...... all LBP medical visit; Physical OR: 2.3±8.7; Psy- 1998. chosocial OR: n.s. Svensson & Andersson 940 ** 1 1 ...... 2 ...... all LBP sickness absence; Heavy Lifting (effect (1981). NR); Reduced overtime/monotonous work (effect NR). È Thorbjornsson et 484 2 1 ...... 1 ...... all LBP med. visit or absence; Physical OR: 1.7± al.(2000). 2.2; Psychosocial OR: n.s.; Interaction OR: 3.1±3.7. Ê Vingard et al.(2000) ...... 2118 3 1 ...... 1 ...... a, b Care-seeking for LBP; Physical RR: 1.8±2.9; Psychosocial RR: 1.5±1.6. Warren et al.(2000a) .... 845 2 1 ...... 1 ...... all NIOSH MSD case def.; Physical OR: 1.89± 2.13; Psychosocial OR: 1.56±1.69. Waters et al.(1999) ...... 284 1 1, 2 ...... 1 ...... all Prevalence of LBP; Lifting Index OR: 1.04± 2.20; Satisfaction OR: 4.57±7.65. Burt et al.(1990) ...... 834 1 1 ...... 1 ...... all UE Symptoms; Physical OR: 2.0±4.1; Dis- satisfaction OR: 1.9±2.3.

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TABLE V±14.ÐSTUDIES ASSESSING BOTH BIOMECHANICAL AND PHYSICAL RISK FACTORSÐContinued

Number of Study Exposure Outcome Study Reference subjects type measure measure design Results: outcome and effect

Lemasters et al.(1998) 522 1 1 ...... 3 ...... c Pain, all body parts, self-report and MD Dx; Physical OR: 2.3±3.5; Psychosocial OR: 1.6± 2.9. Scov et al.(1996) ...... 1306 1 1 ...... 1 ...... all UE and low back symptoms; Physical OR: 1.64±2.80; Psychosocial OR: 1.43±2.04. Warren et al.(2000b) .... 7712 1 1 ...... 1 ...... all MSD symptoms & pain; Physical β: 0.06±0.16; Psychosocial β: 0.04±0.12. Hales et al.(1992, 1994) 533 1 1 ...... 1 ...... a, b UE MSD symptoms; Physical OR: 1.1±3.8; Psy- chosocial OR: 1.1±3.5. Hoekstra et al.(1994) .... 108 1 1 ...... 1 ...... a, b MSD symptoms; Physical OR: 3.5±5.1; High Control: OR 0.6. Houtman et al.(1994) .... 5865 1 1 ...... 1 ...... b, c Complaints: muscle/joint & back; chronic back problems; Physical OR: 1.36±1.62; Psycho- social OR: 1.20±1.35.

Association with Psychosocial Factors Stronger than with Biomechanical

Viikari-Juntura & 5179 3 1 ...... 1 ...... all Radiating neck pain; Physical OR: 1.2±2.3; Riihimaki (2000). Psychosocial OR: 1.1±6.1. Waters et al.(1999) ...... 284 1 1, 2 ...... 1 ...... all Prevalence of LBP; Lifting Index OR: 1.04± 2.20; Satisfaction OR: 4.57±7.65. Elberg et al.(1995) ...... 637 1 1 ...... 1 ...... all Neck & shoulder symptoms; Physical OR: 1.2; Psychosocial OR: 1.2±1.3. Sauter (1984)...... 333 1 1 ...... 1 ...... all Somatic complaints; Physical β: 0.16±0.21; Psychosocial β: 0.19±0.26. Warren et al.(submitted) 7712 1 1 ...... 1 ...... all LBP, absenteeism; Physical OR: 1.45±1.88; Psychosocial OR: 1.32±2.27.

Biomechanical Effect Not Significant È Leino & Hanninen 902 3 1 ...... 1, 3 ...... b, c Back/limb symp. & MD Dx; Physical β: n.s.; (1995). Psychosocial β: .110±.146. Bigos et al.(1991a) ...... 3020 3 1, 2 ...... 2 ...... none Reporting back injury; Physical RR: n.s.; Psy- chosocial RR: 1.34±1.70. Svensson & Andersson 1746 1 1 ...... 1 ...... all Low back pain; Physical n.s.; effect NR; Fa- (1989). tigue, dissatisfaction, worry; sig., but effect NR. n.s.: not significant NR: controlled for factor, but effect not reported Table only notes statistically significant effects (p<0.05) Key: Study Type: 1ÐCross sectional 2ÐCase-control/Referent 3ÐCohort/Prospective Exposure Measure: 1ÐWorker self-report 2ÐObservation of job 3ÐInstrumentation Outcome Measure: 1ÐWorker self-report 2ÐObservation/record 3ÐClinical findings Study Design aÐBiomechanical and psychosocial factors studies with equal precision bÐBiomechanical and psychosocial factors assessed at same individual or group level cÐAdequate variance between groups in all measures * case 2140 con. ** retro. outcome

Bergqvist, Wolgast, Nilsson, Voss 1995 peer contacts (ORs 2.1–4.5) had problems in each body location showed (Ex. 26–1195). hese investigators found independent associations. Although the a different pattern of personal, a number of upper extremity diagnoses study was cross-sectional, confidence in psychosocial and biomechanical to be consistently associated with study findings is improved by the stressor associations. standard biomechanical risk factors detailed physical examination used to Faucett and Rempel 1994 (Ex. 38–67). (especially postural stressors, ORs 2.2– determine outcome and the broad array his study of 150 newspaper editorial 4.4, and lack of rest breaks, ORs 2.7– of exposure measures (including work found that upper extremity pain 7.4); some personal factors (especially individual factors, non-work risks, work and numbness symptoms in VDT age and presence of children at home), organizational factors and workers were related primarily to task flexibility (OR 3.2) and quality of biomechanical factors). Muscle postural variables (R2 changes 0.11–

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0.15), with smaller additions to model 38–82), performed in concert with the psychosocial data and thus subject to R2s from psychological demands, Ontario Universities Back Pain Study greater non-differential misclassification decision latitude, and employee (OUBPS) group, is a case-control study and consequent dilution of effect in relationship with the supervisor (R2 reviewed in detail by John Frank (Ex. statistical modeling. Psychosocial changes 0.03–0.12). The effects of 37–27). Subjects reported levels of stressors demonstrated, on average, postural variables on upper torso pain physical demands (including perceived higher ORs than the surrogate physical and stiffness were greater than those for exertion) as well as psychosocial factors. measure of hours spent driving. This is pain and numbness (R2 changes 0.19– In addition, videotape analysis and an example of the fourth study design 0.32), while psychosocial effects were biomechanical modeling provided criterion discussed above: the factor reduced (R2 changes 0.01–0.08). quantifiable estimates of actual spinal measured in greater detail has a greater Interaction terms between keyboard loading. These biomechanical measures likelihood of showing stronger height and psychosocial variables added acted independently to substantially associations in the modeling. The fact to the model R2s (R2 changes 0.04–0.15), increase risk of workers reporting new that a biomechanical effect still emerged suggesting that the effect of cases of LBP, after controlling for in the modeling strongly suggests that if biomechanical variables can be individual and psychosocial factors. In physical exposures were measured in modified by psychosocial variables. In final models, the biomechanical risk the same detail as psychosocial this study, biomechanical stressors were factors demonstrated ORs of 1.7–3.0, exposures, they would have clearly the dominant factor, but the size while psychosocial risks were demonstrated a larger effect in of the effect for interaction terms may associated with ORs of 1.6–2.6. This modeling; however, it cannot be known have meaning for the mechanism of study improved on earlier study designs whether the resulting size of the effect psychosocial action as being an effect by directly measuring forces on back for biomechanical factors would have modifier. during job performance. The case- surpassed that for psychosocial factors. NIOSH Health Hazard Evaluations control study also matched controls by For cable car operators, biomechanical (Exs. 26–439, 26–842, 26–725). Three actual job, allowing analysis of the factors were more strongly associated cross-sectional NIOSH studies, at the degree to which job exposures with back cases than were psychosocial L.A. Times (Bernard, Sauter, Petersen, influenced self-reported LBP. factors. Fine, & Hales, 1992, Ex. 500–165–20, Compression, peak shear force, peak In his written comments, Dr. Nortin 1994, Ex. 26–439), Newsday (Burt, et al., hand force were associated with Hadler (Ex. 32–241–3–8) demonstrated a 1990, Ex. 26–842) and two Social doubled risk of LBP reporting. These basic misunderstanding of the research Security Administration teleservice findings are consistent with much of the by taking the Krause studies to task for centers (Hoekstra et al., 1994, Ex. 26– other epidemiological data reviewed in showing a biomechanical effect only for 725) found associations of this section. Thus this study strengthens cable car drivers. The data did show biomechanical risk factors (in particular, confidence in the results of other that only cable car drivers’ injury rate duration of VDU work) with MSD studies that rely on less detailed was significantly elevated when symptoms, while also finding exposure assessment and/or self- compared to diesel bus drivers. independent associations of these reported exposures and outcomes. However, the pooled data for all drivers symptoms with several psychosocial showed a highly significant increase factors. Another NIOSH HHE at U.S. Krause et al.1997 (Ex. 38–267), 1997 (2.7 times) in injury rate between West Communications (Hales et al. 1992 (Ex. 38–266), 1998 (Ex. 500–87–2). (Ex. 26–727), 1994 (Ex. 26–131) did not Niklas Krause and colleagues, studying drivers who worked 20–30 hrs per week find associations between symptoms a cohort of San Francisco drivers, compared to those who worked 31–40, and physical workplace characteristics examined relationships between suggesting a significant effect related to other than use of bifocal glasses (OR biomechanical and psychosocial biomechanical factors. Hours-per-week- 3.8), because the standardized exposures and neck and shoulder driven was the study’s surrogate workstations presented virtually no outcomes. The cross-sectional analyses measure for exposure to physical risk variance in biomechanical measures. (Krause et al., 1997a, Ex. 38–267, 1997b factors. Thus, psychosocial factors were Ex. 38–266) determined that both Latko et al.1997 (Ex. 38–122), 1999 dominant in the models, although work biomechanical and psychosocial job (Ex. 38–123). These researchers pressure (OR 1.1–1.2), workload surges factors were separately and performed a cross-sectional study with (OR 1.2) and information processing simultaneously associated with non- some of the most detailed exposure demands (OR 1.2) probably represent a disabling neck and back pain. The 5- assessments to be found in the combination of physical and year longitudinal follow-up of this literature. The study, described psychosocial exposures. See Table V– cohort (Krause et al., 1998, Ex. 500–87– elsewhere in the testimony (Franzblau, 14. for strength of association estimated 2) found that workers’ compensation Ex. 37–3, Armstrong, Ex. 37–21) by multivariate logistic regression cases of spinal injury were predicted by measured a wide variety of models in all these studies. a combination of biomechanical demographic, personal, and exposure Kerr, et al.2000 (Ex. 38–82). (measured by hours driving) and variables, including 13 psychosocial Researchers at the Institute of Work and psychosocial risk factors at baseline. parameters. It is distinguished by Health (IWH) have carried out several (See Krause testimony, Ex. 37–15). The precise measurement of exposure well-designed studies measuring both physical risk factors addressed by this variables and several levels of outcome biomechanical and psychosocial measure of hours spent driving included measurement objectivity, ranging from stressor levels in detail. These studies prolonged sitting, twisting/bending, symptom reports, through physical demonstrate the independent vibration, and use of foot pedal (Krause findings, to nerve conduction velocity contributions of biomechanical, testimony, Tr. 1376, Ex. 37–15). (NCV) results. The contribution of the psychosocial and organizational factors Although all measures were gathered at psychosocial variables did not reach to models explaining back injury and the same (individual) level, the significance in the final modeling, accidents (Shannon et al., 1996, 1997, surrogate measure for biomechanical strongly implying that the effect of Exs. 26–1368, 26–1369). The most exposure (hours spent driving) was a biomechanical factors predominates in recent IWH study (Kerr, et al., 2000, Ex. more generalized measure than the these 3 manufacturing plants (testimony

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These results were, in same level and degree of detail. the revised NIOSH lifting equation) to fact, marginally significant. Moreover, if Warren et al.2000 (Ex. 38–75). Warren prevalence of low back pain. a more conservative definition of CTS and colleagues from the University of Measurements used to calculate the LI was used, (i.e., 0.8ms threshold plus Connecticut Health Center carried out a were collected on a sample of workers positive hand diagram report), the separate study of the Connecticut over a 2–4 day period by trained association was significant (Franzblau working population, using a random- observers. Workers also completed a testimony, Ex. 37–21). In addition, Dr. digit-dialing study design. This cross- self-administered questionnaire that Hadler failed to note either the wide sectional study is one of the few to included psychosocial items. In range of significant associations found randomly sample workers with multivariate modeling, increasing for repetition, symptom reports and unreported cases of MSD (using the values of the LI were associated with tendinitis as indicated by physical exam NHIS definition; Tanaka et al.1995 (Ex. increases in period prevalence of LBP findings, and that these associations did 26-59)). Psychosocial and over the last 12 months, with an demonstrate a positive exposure- biomechanical variables were assessed exposure-response relationship that response relationship. at equal levels of detail. Logistic reversed at the highest LI (>3). The Warren 1997 (Ex. 38–72), Warren et regression analysis found case status to authors noted that this drop in negative al.2000 (Ex. 38–73). Nicholas Warren be associated with a broad mix of outcomes in the highest exposure and colleagues at the University of psychosocial and biomechanical category is seen in other studies and Massachusettes at Lowell and at TNO, stressors, with biomechanical exposures seems to indicate a ‘‘healthy worker’’ or the Netherlands, performed analyses on showing somewhat higher odds ratios. survivor effect (representing the the Dutch Monitor data set, collected Significant psychosocial ORs ranged departure of workers with pain or high from a broad sample of companies and from 1.56–1.69, while biomechanical risk of back injury from highly stressful industry sectors in 1993—a cross- jobs). Psychosocial factors of demands, ORs were between 1.89 and 2.13. sectional study. The data set contained control and social support did not enter Stressors were measured at equivalent completed questionnaires from 7,717 significantly into these models, perhaps levels of detail and demonstrated Workers in 528 companies that assessed because they were entered as independent effects for psychosocial in detail both workplace exposure to continuous, not categorized, variables. and biomechanical exposures. biomechanical and psychosocial risk However, a four-category measure of factors and a variety of musculoskeletal Koehoorn, 1999 (Ex. 500–40). This decreasing work satisfaction showed a and stress outcomes, as well as reports doctoral thesis used a retrospective significant exposure-response of extended sick leave. Controlling for cohort design to follow 4020 health care relationship with LBP. This high-quality gender, education and tenure on the job, workers from an acute-care hospital study, which relied on independent the multivariate linear analyses found over a 4-year follow-up period, measurement of physical job roughly equal contributions of both assessing outcomes of musculoskeletal characteristics, demonstrated the stressor classes to the pain and MSD symptoms and claims. Results varied by combined contribution of physical and symptom reports, with physical factors body location. In multivariate models some psychosocial stressors to having a somewhat larger magnitude of explaining upper body symptoms, a prevalence of LBP, with physical effects effect (standardized regression biomechanical index showed risk ratios predominating in multivariate coefficients of 0.06–0.16) than of 1.41–1.84, while psychosocial modeling. psychosocial (0.04–0.12). Logistic variables showed RRs ranging from Leclerc et al. 1998 (Ex. 500–41–85). modeling of low back pain and 0.45–2.78. For lower-body symptoms, This cross-sectional study of 1210 absenteeism outcomes found similar RRs for biomechanical risk factors workers in 3 industry sectors results, with biomechanical ORs of ranged from 2.12–4.65; psychosocial incorporated a sophisticated mixture of 1.35–1.88 and psychosocial ORs of variables generally did not reach individual measurement of both 1.32–1.64, excluding social support. statistical significance. Outcomes of physical and psychosocial factors, However, low social support did compensation claims related to these combined with group-level assessment demonstrate the highest OR (2.27) in the two body areas showed similar ranges of of cycle time and autonomy. Given the model explaining low back pain. The effect. In subcohorts analyzed for study design principles outlined above, study was cross-sectional and thus departmental sicktime and overtime, the effects of these group-level factors could not definitively evaluate temporal increased sick time was associated with may thus be underestimated. With this associations. However its large size and symptoms and claims, but increased caveat, the research still demonstrated a wide range of companies and sectors overtime was not. The study design combined contribution to physician- allowed precise separation of assessed detailed biomechanical factors diagnosed CTS for cycle times less than biomechanical and psychosocial by observation, but only by 10 seconds (OR 1.90) and psychological exposure-outcome associations, without occupational title, while psychosocial ‘‘problems’’ (OR 1.41). Other physical collinearity problems. factors were assessed by individual and psychosocial factors dropped out of Dr. Alf Nachemson criticized this questionnaire. Thus, the relative this model. In a final model study (post-hearing comments, Ex. 500– strength of association may have been incorporating the presence of just-in- 118–1), confusing it with a completely underestimated for biomechanical time production organization at the different study of a different database stressors. This large, carefully designed plant, this factor replaced cycle time, submitted to Spine. The results of this cohort study provides evidence for a with an OR of 2.24. Other physical and study are reported in a doctoral thesis multifactoral model of MSD causation, psychosocial risk factors were (Warren, 1997, Ex. 38–72) and an article with physical factors being more associated with marginal significance.

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The work organization variable of just- small. Overall, the MUSIC study abdominal strength, respectively). The in-time production is probably a provides well-designed and detailed authors emphasized that ergonomic surrogate for a combination of increased evidence that physical and psychosocial interventions must be coupled with biomechanical and psychosocial risk. exposure combine in the etiology of training and describe the training as This study thus demonstrates the LBP, with the physical stressors resulting in biomechanically less combined contribution of both types of demonstrating stronger effects. stressful lifting choices by nurses. They risk. This study also found that industry Houtman et al.1994 (Ex. 26–1230). concluded that training is an effective sector did not enter significantly into This paper reported a cross-sectional intervention and ‘‘the biomechanical the model when both physical and analysis of pooled 1977–1986 results and ergonomic components of training psychosocial risk factors were more from the National Work and Living in patient-handling appear to be Condition Survey in the Netherlands. precisely measured at the individual inescapable’’¨ (Ex. 26–1155). level. The study asked one question on work Thorbjornsson et al. 2000 (Ex. 500– Latza et al.2000 (Ex. 38–424). This pace, four on intellectual discretion, and 71–49). This retrospective nested case prospective study of construction one on physical load. The items were all control study examined a cohort of 484 workers in Hamburg took detailed assessed at the same level of precision subjects from the general population, observational measurements of (dichotomous, yes/no) and at the same examined first in 1969 and again, 24 biomechanical stressors associated with analytical level, but the greater detail in years later, in 1993. Exposure a wide variety of construction tasks. Of intellectual discretion assessment may information was collected the 571 workers who filled out baseline have biased the estimated effects of that retrospectively for the 24-year period questionnaires, 285 individuals free of particular construct upwards. and the 12 months previous to the 1993 LBP were selected; 230 were followed Multivariate logistic regression models interview. Outcomes measured were up after 3 years. The physical stressors were constructed to explain variance in LBP that resulted either in a medical at baseline predicted subsequent 1-year 3 musculoskeletal outcomes: back visit or sick leave more than 7 days. The prevalence of LBP (PRs: 1.8–4.0), while complaints, muscle/joint complaints, study identified a small number of psychosocial stressors did not enter and chronic back problems. Work pace physical factors (heavy physical work, significantly into the models. This is was consistently associated with these sedentary work) and psychosocial somewhat surprising since, although the outcomes (ORs 1.21–1.29) as was heavy factors (poor social relations and physical stressors were evaluated in physical load (ORs 1.36–1.62). Of the overtime work) associated with LBP, as detail, they were measured at the job intellectual discretion items, only one, well as high load outside of work. Most level, while psychosocial factors were monotonous work, was consistently importantly, the research demonstrated measured at the individual level. As associated with musculoskeletal significant ORs for a wide variety of noted above, this usually results in an symptoms (ORs 1.29–1.35), but when all interaction terms between workplace underestimate of the physical stressor four items were combined, the scale biomechanical and psychosocial risk contribution relative to psychosocial demonstrated the strongest association factors (ORs: 2.2–3.5). In final modeling factors.˚ of the study with chronic back pain (OR incorporating the interaction terms, Vingard et al.2000, MUSIC study (Ex. 2.10). Thus, in addition to providing individual psychosocial effects became 500–41–51). The Swedish MUSIC more evidence for independent non-significant, but an interaction project has consistently demonstrated association of physical and psychosocial between poor social relations and combined associations of biomechanical stressors with musculoskeletal overtime work showed an OR of 3.1–3.7 and psychosocial stressors with back, outcomes, the study supports the for men, depending on LBP onset time. neck and shoulder, and other disorders. hypothesis that psychosocial stressors The finding of significant interactions This study assessed prospectively the have their strongest effect with duration between biomechanical and individual and combined effects of of pain, not its inception. psychosocial factors suggests that physical and psychosocial exposures on Videman et al.1989 (Ex. 26–1155). control of biomechanical risk factors in subjects’ seeking care for LBP over a 5- This study is difficult to interpret, but the workplace should reduce not only year period. Gender stratification is included because of its relevance to the effects associated with reduced significance levels but interventions. The researchers biomechanical risk factors, but the demonstrated somewhat different dichotomized graduating nursing effects of their interaction with exposure-outcome associations for students by skill level. Half the students psychosocial exposures. males and females. For men, forward had received traditional lifting training; bending and manual material handling half had received advanced, Boeing Study. (Bigos et al.1991 (Ex. 26– time, when compared to levels 5 and 10 biomechanically-oriented training. Skill 1241), 1991 (Ex. 26–1242), 1992 (Ex. 26– years ago, were significantly predictive assessment was performed through 1393)). (RR 1.8 and 2.0 respectively) with a video analysis of standardized tasks, not These studies were discussed earlier in combined exposure having a RR of 2.8. by simple assignment to trained or the Health Effects section. In addition, This combined exposure was also untrained groups. Nurses were also several witnesses who appeared at the significant for females (RR of 2.3). For dichotomized by hours/day in strenuous public hearings (Frank, Krause, others, both genders, a combination of physical postures (<3 hrs/day, >=3 hrs/day). In e.g. Exs. 37–27, 37–15) have explored stressors including metabolic stress was addition, the study collected extensive the methodological problems with this also a risk factor. Although included in anthropometric, strength and study, which explain its finding that the these multivariate models, most psychological measures. Incidence of only significant predictor of back pain psychosocial stressors did not enter back injury was assessed at a 1-year reporting found was job dissatisfaction. significantly (exceptions were low work follow-up. The results seem to confuse In sum, the study assessed physical satisfaction and low skill use for males, training level and activity level, but a factors at the group level (although the RRs of 1.6 and 1.5, respectively). A combination of >3 hours/day of articles never make clear the exact subset of the study sample reflecting a strenuous activity and low skill level methodology), while assessing combination of high physical load and significantly predicted self-reported psychosocial and psychological high psychosocial load showed much incidence of back injury (ORs of 37 or variables at the individual level. higher RRs, but the sample size was 156, further stratified by high and low Assessed at the group level, the variance

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00267 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68528 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations in predictive physical factors was and psychosocial effects for three greater precision, the psychosocial drastically reduced. For instance, Dr. reasons. First, the study only reports the factors. Bigos stated (Bigos et al., 1991b, Ex. 26– p-value range of the significant The authors noted that their physical 1242, testimony, Tr. 6908) that no-one associations and does not report effect load measure did enter into the cross- was required to lift over 20 lbs., and no- size, thus making it impossible to tell if sectional models at baseline, along with one actually lifted more than 50. physical exposures were of near more psychosocial exposures (work However, the analysis had no way to significance and to compare relative content, overstrain) and occupation. It assign actual lifting frequency or strength of association. Second, it is not was surprising to find that physical load compressive forces at the individual at all clear whether variables of (a slightly more precise measure of level. It is difficult to determine whether dissatisfaction and worry/tension biomechanical exposures than even the poor characterization of represent a psychological exposure or exposure) dropped out of final models physical load approached statistical an outcome, resulting from an while occupation class remained. Both significance because the authors elected underlying combination of physical and physical load and occupation in this simply not to report results that were psychosocial/psychological workplace study represent biomechanical not significantly associated with factors, or from underlying symptoms exposures assessed at a much less outcomes (testimony, Tr. 6786). In (see, Linton, 2000, Ex. 26–642). Most precise level than the psychosocial addition to this measurement problem, importantly, it is clearly a mistake to measures. This study, though psychosocial and psychological factors label ‘‘fatigue’’ a psychosocial variable. provocative, cannot provide useful were measured with much greater In fact, fatigue represents an integrated information about the relative strength precision. As noted above, these measure of all stressors, physical and of effect. assessment differences virtually ensure psychosocial, encountered by the the primacy of the better-measured worker and may well be weighted Summary of Literature Reviews factors, in this case the psychosocial towards the obvious biomechanical Several reviews have been published factors, in statistical modeling. stressors. As such, it is not surprising that have evaluated the literature In addition, the factors entered in the that this measure might capture dealing with work-related MSDs; many Boeing study models explained only an variance from the individual physical of these reviews included evaluations of extremely small percentage of variance exposures tested in the study. (Recall studies that concurrently examined the in the outcome; job satisfaction how the combined index of effects from exposure to both explained 2.2 percent and psychological psychosocial exposures in the Houtman biomechanical risk factors and variables explained 1.9 percent. All of et al.study, (1994, Ex. 26–1230) had the psychosocial risk factors. In this section, the psychological, physical exam and highest ORs in the study, while the OSHA summarizes the reviews medical history variables assessed in the individual items composing the index contained in the rulemaking docket. study combine to explain only 8.6 had much lower ORs.) As confirmation, Burdorf & Sorock 1997 (Ex. 502–232). percent of the variance (Bigos et al., it is interesting to note that these These authors reviewed 35 studies that 1992, Ex. 26–1393). Thus, 91.4 percent authors’ earlier research (1983, Ex. 26– collected quantitative information on of the variance in reporting of back pain 1158), which assessed a similar set of exposures and back disorder outcomes. is not explained by the combination of exposures but did not include the poorly measured physical risk factors Eight of these studies assessed fatigue item, did demonstrate a psychosocial and biomechanical risk and the more detailed psycho-emotional contribution from a physical stressor factors. This suggests relatively poor factors simultaneously. Of these, six (high degree of lifting). Thus, this characterization of overall exposure. found positive associations of back research appears to be unable to The flaws noted above also pertain to disorders with a combination of the psychological factor assessment in accurately separate the contribution of physical and psychosocial exposures this study. Psychological factors were physical and psychosocial/ and two identified several of the psychological factors to LBP. physical factors to be significantly measured at a much finer level of detail ¨ than physical factors, which were Leino and Hanninen 1995 (Ex. 38–76). associated, while the psychosocial measured at the group level. Overall This paper reported the results of a factor measured (job dissatisfaction) did explanatory power of any of these prospective study begun in 1973, in not show a significant association. measures was poor. As a minor point, 2653 industrial workers, including The analysis identified lifting or specific to the psychological managerial and office positions. Nine carrying loads, whole-body vibration, assessment, the study used non- hundred two of these participants were and frequent bending and twisting to be standard and out-of-date instruments reexamined after 10 years. Outcomes the biomechanical risk factors having (Cherniack testimony, Tr. 1150). were self-reported musculoskeletal consistent associations with work- symptoms and evaluations by related back disorders. Unlike some Svensson and Andersson 1989 (Ex. ¨ 26–732). This study evaluated the physiotherapists. At follow-up, both other studies (e.g., Leino & Hanninen, association of a number of physical and self-reported symptoms and medical 1995, Ex 38–76), height and weight (as psychosocial and psychological findings were predicted by one well as gender, exercise and marital variables with incidence (retrospective) psychosocial scale (social relations, OR status) were consistently not associated and prevalence of LBP in women. Both 2.63–3.41) and occupational class (OR with back disorders in these studies. physical and psychosocial/ 2.67–3.73). The only factor that partly The review identified low job decision psychological variables showed captures physical load in this model is latitude and job dissatisfaction as univariate associations with the occupational class. A single, 4-level possibly important predictors of MSDs, outcome, but multivariate analysis measure of physical load was also but the evidence was not consistent found associations only with 3 entered into the equation. However, this across studies with different designs. ‘‘psychological’’ variables: measure is much less precise than the Although the majority of these eight dissatisfaction with the work 6-question scale (each item with 5 studies acknowledged the importance of environment, worry/tension at the end levels) assessing social relations. This psychosocial factors, the generalization of the day, and fatigue. The analysis is unequal precision would bias the results that emerges from them is that not helpful to the separation of physical towards the exposures measured with biomechanical factors were more

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Thus, the review’s results are extremity symptoms and findings in This article was one of the earliest consistent with the multifactoral model computer users (classified by neck/ reviews of the evidence for an of MSD etiology (including shoulder, arm/elbow, and hand/wrist). association between psychosocial biomechanical, psychosocial, The authors found strong, consistent factors and MSD outcomes. The authors psychological and personal variables). evidence linking MSD development looked at 29 cross-sectional and 3 Despite the care with which the with biomechanical factors (hours/day longitudinal studies addressing work- studies were selected and analyzed, and cumulative years of exposure, related psychosocial factors. Of these, however, the review did not identify the intensive or repetitive data entry, and 22 measured physical load, and the type of biomechanical exposures non-neutral postures due to poor authors of this review did not think that assessed in the studies or the level at workstation design), while controlling the physical load assessment was of a which they were studied. Instead, it for work organizational and high enough quality to specifically simply noted that 18 studies controlled psychosocial factors in 7 of the 72 assign relative association effects to for miscellaneous confounding factors, papers included in the analysis. The physical and psychosocial factors. Thus, one of which was ‘‘workplace factors’’. work organizational factors included in this review is included to demonstrate No indication was given as to the nature 3 papers (repetitive work, work pressure how far the field has moved since 1993. of these factors and which of these 18 and insufficient rest breaks represent a Subsequent reviews and studies studies addressed ‘‘workplace factors’’. combination of physical and addressed in this section show that Given the age of some of the papers, psychosocial risks. In 4 papers, this research in the intervening 7 years has controlling for other factors (instead of review found suggestive but moved towards more accurate simultaneously assessing their effect) is inconsistent associations (making characterization of biomechanical and understandable, but it renders the generalization impossible) between psychosocial loads and defining their review useless in contributing to the MSD symptoms and the psychosocial associations with MSD outcomes. central debate concerning relative National Academy of Sciences, 1999 factors of low decision latitude, low contribution of biomechanical and social support, job insecurity and job (Ex. 26–37). The NAS study (cited by psychosocial factors (i.e., both external dissatisfaction (Bergqvist et al., 1995, Armstrong, Exs. 37–21, 37–1, 37–9 and psychological and social workplace Ex. 26–1195, Faucett & Rempell, 1994, others, Ex. 37–15, testimony) was factors and internal psychological Ex. 38–67, Kamwendo et al., 1991, Ex. discussed in OSHA’s preamble to the factors). To further compromise the 26–1384, Hoekstra et al., 1994, Ex. 26– proposed rule and is described in part utility of this review, the studies 725). The authors also noted the B of this Health Effects section. It evaluated in this review included difficulty of using job dissatisfaction as reviewed a number of studies that found several that measured physical exposure a predictor for MSDs since it could strong evidence for biomechanical at the wrong analytical level (e.g., Bigos easily be either a cause or consequence contribution to MSD etiology, et al., 1991, Exs. 26–1241, 26–1242) or of an MSD. controlling for psychosocial factors. ¨ at a reduced level of detail (e.g., Leino Lagerstrom et al. 1998 (Ex. 38–102). In Linton, 2000 (Ex. 26–642). This paper ¨ this review of studies relating to low is a careful literature review of studies & Hanninen, 1995, Ex. 38–76, Viikari- back problems in nursing, 42 articles addressing the association between Juntura et al., 1991, Ex. 26–1219), passed the inclusion criteria: 21 cross- psychological factors and back and neck compared to the psychological factors. sectional, 10 prospective, and 11 pain. The author concentrated on This review, although a significant intervention (also prospective). One of individual psychological measures (i.e., contribution to the literature overall, the reviewers’ quality criteria was that internal psychological factors) but also provides no useful information the studies include both physical and included some external psychosocial concerning relative contribution of psychosocial exposure information. The factors. Since many of the studies also physical and psychological factors to authors noted that a problem in many of assessed outcomes of disability and time MSDs. the studies was the assessment of to return-to-work (RTW), the author was Nachemson 1999 (Ex. 32–241–3–31). physical stressor information at an able to provide evidence for his This article is a comprehensive review aggregate or group level, while suggestion that psychological factors of the studies purporting to demonstrate psychosocial exposures were assessed at may play a greater role in these long- that physical workplace factors are the individual level. As noted above, term outcomes. irrelevant to the development of back this non-comparability would tend to The findings of this review are pain, injury and disability. Instead, the underestimate biomechanical effect in strengthened by its assessment of only studies implicate personal biology and relationship to psychosocial effect. Still, prospective studies. This might allow an psychological factors, stress and the authors conclude from their review interpretation that the positive psychosocial factors in the workplace, that biomechanical and psychosocial relationship found between various and the monetary incentives of the exposures generally combine in their psychological factors and the outcomes compensation system. Some of these associations with or (in prospective of pain, disability, RTW time, etc. might studies have been addressed above (e.g., studies) effects on back disorder represent a causal connection. However, Bigos, 1991b, Ex. 26–1242). In general, outcomes. Looking at well-designed there are two important caveats. Dr. Dr. Nachemson’s claim that these factors studies with dual exposure Linton noted that longitudinal contribute to low back disorders is measurement, the authors report that relationships of this sort may still mask credible. Very few of the researchers ‘‘[t]o our knowledge there are no studies reverse causal connections. The studies cited above would deny their that show that work organizational or generally cannot determine whether contribution. What is emphatically not psychosocial factors, as such, cause low- some psychological ‘‘predictor’’ credible is the claim that physical back problems.’’ They do acknowledge variables and the outcome variables are factors are thus not implicated.

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There are 3 primary problems with collecting a wide variety of studies noting the high prevalence of LBP in this claim. First, many of the studies addressing the complex issues of low non-dynamic jobs, and even in the cited in the article have not assessed the back pain, disability, and management, unemployed, is, of course, related to the role of physical factors at all or have does not demonstrate that physical well-established research findings that assessed them at levels of analysis or workplace factors are not involved in sedentary and constrained postures are detail that make examination of their the etiology of LBP. Nor does it also physical risk factors for back contribution impossible. The results of demonstrate that workplace disorders (Putz-Anderson, 1991, Ex. 26– these errors have been discussed above. interventions directed towards 1255, Hoogendoorn et al., 1999, Ex. 38– These studies overestimate the role of reduction of biomechanical risk factors 81, Burdorf & Sorock, 1997 Ex. 502– non-physical risks and thus cannot would be ineffective. His citation of the 232). address the question or relative effects Daltroy (Daltroy et al., 1997, Ex. 38–57) More importantly, the studies used to of biomechanical and psychosocial training intervention in the postal provide ‘‘strong evidence’’ for various exposures in the workplace. service, for example, is not a refutation conclusions are sometimes categorized Second, the basic conceptual gap in of the central causal role of as being of high quality when, in fact, the Nachemson review is a failure to biomechanical exposures in the etiology they violate some of the important acknowledge and address the of back injury. Rather, it is emblematic epidemiological design criteria cited implications and mechanism of of the general failure of ‘‘back schools’’, above. In particular, in making a case for multifactoral causation. There is a broad when introduced in the absence of primarily psychosocial causation, the literature of well-designed studies, both measures directed towards control of authors used studies that measured epidemiological and laboratory physical risk factors. Dr. Nachemson, biomechanical exposures inadequately (reviewed above and in earlier parts of himself, states in this review: ‘‘[I]t is (e.g., Bigos et al., 1991b, Ex. 26–1242, the Health Effects section) obvious that certain types of lifts and and others reviewed above) or studies demonstrating that psychosocial and working positions should be avoided that did not include both biomechanical psychological factors can add to the and this in particular applies to twisted and psychosocial factors in statistical effects of physical exposures or even lifts.’’ Ideally, this review will advance modeling (Macfarlane et al., 1997, Ex. potentiate them (interaction or effect the development of more effective 500–41–91, Papageorgiou et al., 1997, modification) (see Linton, 1990, Ex. 26– intervention techniques that address the Ex. 32–241–3–41). Several reviews are 977, for a clear example). Dr. combination of risk factors presented by cited that, on closer examination, are Nachemson’s reluctance to consider Dr. Nachemson. only modest in their assessment of both such effects is represented by his Waddell & Burton 2000 (Ex. DC–151– psychosocial and biomechanical risk ¨ citation of the Valfors et al. (1985, Ex. A). This thorough review of contribution, noting the problems with 26–685) examination of LBP. This study management protocols for LBP includes study design and, especially, the reported that physical risk factors evaluation of epidemiological and relatively few studies that assessed both (poorly characterized by a clinical studies addressing etiology of exposures adequately and at equal physiotherapist and a physician) were LBP. Because the review and levels of precision (Burdorf & Sorock, similar in workplaces of controls and recommendations focus primarily on 1997, Ex. 500–232, Bongers et al., 1993, low back cases, while reporting case/ medical management issues, it is not Ex. 26–1292, Davis & Heaney, 2000). control differences in psychosocial work surprising that it concentrates on the Conclusions environment (again, poorly psychosocial factors involved in pain ¨ characterized). Valfors thus attributed perception, sickness absence, disability Based on the rulemaking testimony, the back injuries in the case group to the and return-to work. Most of the studies scientific studies, and literature reviews psychosocial factors. The logical fallacy, addressed above acknowledge the considered in this section, OSHA of course, is to assume that this importance of psychosocial factors in concludes that the evidence contained difference removes physical exposures medical management issues, not only in the record supports a combined from a causal role. The more logical for LBP but also for other contribution of biomechanical and explanation, especially in light of all the musculoskeletal disorders. The psychosocial risk factors to the onset, evidence for multifactoral etiology evidence reviewed above corresponds development and prolongation of MSDs. presented in this section, is that the with these authors’ conclusions that low Biomechanical contributions to the combination of physical exposures and job satisfaction, ‘‘unsatisfactory etiology of work-related MSDs have psychosocial exposures presented psychosocial aspects of work’’ and been demonstrated to be more increased risk. A level of physical risk individual psychosocial findings are consistent than psychosocial factors that is acceptable in a psychosocially risk factors for onset of LBP, health care across different study populations, and benign work environment can combine use and work loss, but the size of that most well-designed studies reported with elevated levels of psychosocial risk association is small to modest (strong stronger associations between exposure to cause disorders. evidence). The authors also noted that to biomechanical risk factors and an Finally, many of the studies cited in physical demands of work (manual increased MSD prevalence or incidence this article confuse cause with effect. To materials handling, lifting, bending, than has been observed for psychosocial continue with Dr. Nachemson’s citation, factors. However, it is not possible to ¨ twisting, and whole body vibration) can Valfors concluded that the measured be associated with onset of LBP, determine the relative strength of differences in work satisfaction were the increased LBP reports, symptom association between biomechanical and cause of the low back pain episodes, aggravation, and back ‘‘injury’’ psychosocial factors with any precision when it is just as likely that the LBP (authors’’ quotes). However, they find because of differences in measurement itself affected patients assessment of that the association ‘‘appears to be’’ techniques used in the various studies their work satisfaction (see Linton, weaker than those of individual, non- to assess biomechanical and 2000, Ex. 26–642). occupational and unidentified factors psychosocial factors, and because of the These three errors, together or (strong evidence). different ways in which psychosocial individually, characterize many of the The authors make an elementary error factors are defined by various studies in the Nachemson article. In in ascribing potential LBP causation investigators. Most importantly is the sum, this review, while useful in only to dynamic back activities. Their finding by several investigators that

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Bellamy and Vendor, above (testimony) by [‘‘]and nobody cares[’’], you know that Findings from published literature are addressed by the reality of this close there’s a psychological problem in that reviews of studies that conform to the correlation between stressor types. workpalce. So I think that, yes, * * * a epidemiologic design principles The intervention literature control of a biomechanical risk factor with no discussed above are consistent with the demonstrates that the very fact of a change in a psychosocial environment would Agency’s conclusions. Four reviews company’s undertaking even a limited reduce the chance of injury, but that it would (Burdorf, Ex. 502–232, Punnett, 38–13, probably also change the psychosocial program to control biomechanical environment to a small degree. [Tr. 1265] Lagerstrom, Ex. 38–102, NAS, Ex. 26– exposures is, de facto, also a 37) reported that biomechanical risk psychosocial intervention. If workers Dr. Rosecrance (Tr. 2319–20) presented factors generally showed stronger and/ report MSD symptoms and the company a specific example. He noted that the or more consistent associations with responds with workplace alterations, biomechanical intervention in his study elevated MSD prevalence or incidence medical intervention, training, and the of the Cedar Rapids Gazette resulted not than did psychosocial factors. other program elements in the final rule, only in reductions of MSDs, but also Three reviews reached an opposite this response often represents a improvements in the company social conclusion (Linton, Ex. 26–642, reduction in excessive psychological structure. Nachemson, Ex. 32–241–3–31, Waddell, demands, an increased sense of control, Mr. Dave Alexander believed that the DC–151–A); however, these reviews and an improvement in the social employee participation provision of the relied more heavily on studies where support structure of the workplace. In proposed standard would address biomechanical factors were not Sweden, Kvarnstrom (1992, Ex. 38–69) psychosocial issues: evaluated at all, were evaluated in jobs found that changes in the physical work having little variance in physical load, * * * the opportunity for worker characteristics, combined with changes or were evaluated at different analytical participation in the form of contributing in the psychosocial work environment levels or with less precision, or than information, suggesting solutions, having a (increased variety, decision-making psychosocial factors. All of these design mechanism to report problems would, in fact, latitude, and individual control over the tie in with the psychosocial issues that flaws bias results towards increased work situation) in a small department of would be important in the workplace. [Tr. psychosocial effects in modeling. It is 2713–2714] on the basis of these reviews and the a large, multi-national company greatly underlying studies that the Chamber of reduced the high rate of absenteeism Similarly, Dr. Silverstein testified that Commerce, Gibson, Dunn & Crutcher, and turnover due to musculoskeletal providing workers with basic and several of their scientific witnesses disease. In the United States, Smith and information on MSDs and employee base their conclusion that psychosocial Zehel (1992, Ex. 38–70) reported that involvement in the ergonomics program factors outweigh the importance of employee focus groups identified the increases the decision latitude for biomechanical factors in the etiology of need for physically-oriented engineering workers [Tr. 17445]. MSDs. Accordingly, OSHA is not changes as well as psychosocial changes These studies and testimony indicate persuaded by these arguments, and in a meat-processing plant; the that the basic precepts of management finds the preponderance of evidence combined intervention resulted in commitment and employee supports a multifactorial model of MSD decreased physical symptoms for part of participation contained in the final rule, causation involving both biomechanical the work force. Worker participation in while forming the administrative and psychosocial factors acting problem identification and solution infrastructure of an ergonomics program independently on risk. development is a central feature of focused on physical risk abatement, has Moreover, testimony and evidence many successful approaches to work the potential to have positive effects on presented above suggests that environment change and is at the core the psychosocial characteristics of the biomechanical and psychosocial risk of the proposed rule. For example, work environment. factors are, to a degree, inextricable Pasmore & Friedlander (1982, Ex. 38– 6. Final Rule’s Consistency With (Punnett, testimony, Tr. 868, Kerr et al., 71), addressing an outbreak of upper Medical Guidelines 2000, Ex. 38–82). The degree of extremity disorders in a United States influence each exerts on MSD risk is in electronic assembly facility, designed an Several commenters questioned large part determined by company intervention in which the employees whether the program elements of characteristics and work organization, determined the data to be collected and OSHA’s final rule were consistent with and their very separation is somewhat solutions based on these data. While existing medical practice guidelines, artificial. The final rule’s focus on this level of employee involvement primarily with respect to diagnosing reducing exposures to biomechanical focused on reducing biomechanical risk and treating low back pain, but also risk factors reflects the intervention factors, it also increased employee diagnosing and treating other MSDs. For strategy that has been emphasized in the participation and task control and example, when referring to the Agency literature and implemented by many altered role relationships within the for Health Care Policy and Research sophisticated companies. Simply less is organization. (AHCPR) low back pain guidelines, known about how to intervene A number of witnesses testified at the Gibson, Dunn and Crutcher stated that effectively on psychosocial factors. hearing that ergonomic programs the review of evidence published with However, this does not mean that designed to address biomechanicla the guidelines biomechanical intervention will have no factors have positive effects on contradicts OSHA’s ergonomic hypothesis effect on psychosocial factors in the psychosocial factors that have been that work causes physical injury, contradicts wortkplace. Because of the correlation implicated in MSD etiology. Dr. Warren OSHA’s view that ‘‘ergonomic’’ interventions and interactions between biomechanical explained why this is the case: can alleviate workplace pain, and contradicts

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OSHA’s prescription for rest as a response to ergonomics in return to work decision based recommendations on the back pain. [Ex. 500–118] making by stating that: ‘‘Several management of acute low back pain to OSHA disagrees with these ergonomic guidelines on lifting and clinicians. The Royal College guidelines commenters. In reviewing the record, materials-handling tasks are available to do not purport to relate to, nor were OSHA finds that the final rule is help the clinician provide ranges of they focused on, the same purpose as consistent with the medical literature, activity alterations at work.’’ (Ex. 32– OSHA’s proposal, that is to reduce including the AHCPR guidelines, the 241–3–93) MSDs and control MSD hazards in the American College of Occupational and Finally, the AHCPR guidelines (Ex. workplace. These guidelines do not Environmental Medicine (ACOEM) 32–241–3–93) do not suggest that contain information on evidence based Occupational Medicine Practice patients with acute low back pain conclusions on ergonomics or low back Guidelines (Ex. 38–234), The Royal immediately return to work involving pain prevention. Several elements of the College of General Practitioners’ Clinical physical factors that may stress the proposal are supported by the Royal Guidelines for the Management of Acute spine. Rather they advise appropriate College guidelines (Ex. 32–241–3–38). Low Back Pain (Royal College activity modification to assist in the For example, under Initial Assessment guidelines) (Waddell et al. 1999; Ex. 32- recovery process. AHCPR guidelines Methods, they recommend: ‘‘The 241–3–38), the Faculty of Occupational Activity Recommendations panel patient’s age, the duration and Medicine’s Occupational Health findings and recommendations state: (1) description of symptoms, the impact of Guidelines for the Management of Low ‘‘Patients with acute low back problems symptoms on activity and work, and the Back Pain at Work (British guidelines) may be more comfortable if they response to previous therapy are (Ex. 500–118–2), and other evidence- temporarily limit or avoid specific important in the care of back problems.’’ based medical practice. activities known to increase mechanical Under Information to Patients, the The first assertion, that the AHCPR stress on the spine, especially prolonged guidelines state: ‘‘About 10% of patients guidelines ‘‘contradict[ ] OSHA’s unsupported sitting, heavy lifting, and will have some persisting symptoms a ergonomic hypothesis that work causes bending or twisting the back while year later, but most of them can manage physical injury’’ is incorrect for several lifting. (Strength of Evidence = D.);’’ and to continue with most normal activities. reasons. The AHCPR guidelines (2) ‘‘Activity recommendations for the Patients who return to normal activities acknowledge that employed patient with acute low back feel healthier, use less analgesics and symptoms need to consider the patient’s are less distressed than those who limit * * * several studies have identified an age and general health, and the physical their activities.’’ The Royal College increased incidence of low back problems demands of required job tasks. (Strength among individuals whose work involves guidelines suggest that most workers heavy or repetitive lifting, exposure to total of Evidence = D.)’’ As to the duration of can manage with most normal activities, body vibration (from vehicles or industrial activity modification, the AHCPR but do not suggest that this includes machinery), asymmetric postures, and guidelines demonstrate an extremely physical tasks that cause very postures sustained for long periods of time. understanding of the impact that the significant mechanical loading to the [Ex. 32–241–3–93] physical demands of work have on lumbar spine and are associated with The guidelines also recognize that recovery and modified activity. The elevated risks of low back pain. guidelines state that ‘‘The nature and Similarly, the purpose and findings of Other biomechanical research suggests that duration of limitations will depend on the British occupational health low back certain postures and activities increase the mechanical stress on the spine. It is not clear the clinical status of the patient and the pain guidelines (Ex. 500–118–2) have whether these mechanical stresses are the physical requirements of the job.’’ also been misrepresented (e.g., Ex. 32– cause of low back problems. However, once Several other components of the final 241–3–20). The British guidelines state: symptoms are present, mechanical stresses rule are supported by AHCPR ‘‘These guidelines represent the main correlate with worsening of symptoms. recommendations, including the use of recommendations and evidence Prolonged sitting and postures that involve job hazard analysis and medical statements derived from a detailed bending and twisting have been shown to management involving communication Evidence Review and developed by a increase the mechanical stress on the spine with the HCP. Pertinent AHCPR multidisciplinary group of practitioners. according to pressure measurements in guidelines statements are as follows: (1) They concern the clinical management lumbar intervertebral discs. Heavy lifting also ‘‘In recommending activity of workers affected by non-specific low appears to increase mechanical stress on the modifications for patients who work, spine, but this stress can be reduced if the back pain, including advice on lifted object is held close to the body rather the clinician may find it helpful to placement, rehabilitation and measures than at arm’s length. [Ex. 32–241–3–93] obtain from the employer a description for prevention.’’ The British guidelines of the physical demands of required job further clarify that they were not These conclusions are clearly consistent tasks,’’ and (2) ‘‘The panel recommends intended to disseminate information with the conclusions of the Health that clinicians help patients establish regarding workplace health and safety, Effects section of the final rule that activity goals, in consultation with their job design, and ergonomics when they biomechanical factors are associated employer when applicable.’’ state: ‘‘They focus on actions to be taken with low back pain. It must be recalled As with the AHCPR guidelines (Ex. to assist the individual and do not that the AHCPR guidelines were 32–241–3–93), the commenters cited specifically cover legal issues, health * * * intended to provide primary care above did not accurately represent the and safety management, job design and clinicians with information and findings of the Royal College guidelines ergonomics.’’ Again, this is a different recommended strategies for the assessment (Ex. 32–241–3–38) and British focus than the proposal, and and treatment of acute low back problems in guidelines (Ex. 500–118–2) in criticizing conclusions should be interpreted in adults. [Ex. 32–241–3–93] OSHA’s proposal. They also failed to that light. Under evidence review They were not intended to provide a acknowledge evidence and methods, the British guidelines state: comprehensive review of work-related recommendations from these reports In view of the occupational health focus of low back pain, ergonomics or low back that are consistent with the final rule. the guidelines and the present review, the pain prevention. There are few The Royal College guidelines (Ex. 32– following areas were excluded from the references to ergonomics, and the 241–3–38) were developed for the review, except where they impact directly on guidelines promotes the utility of purpose of disseminating evidence- the guideline recommendations: chronic

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GWYNN: Doctor, you believe, do you preface. In reviewing challenges for the authors advise the ‘‘need to be directed not, that lifting and bending while lifting and review the authors state: ‘‘The need for at both physical and psychosocial twisting while lifting can aggravate low back everyone to recognize that work is only factors.’’ If physical work is not harmful pain? one contributor to back pain but that and it does not contribute to low back DR. BIGOS: I believe that it can bring on back pain whatever its cause can, if pain, then why would the authors symptoms in people who have had prior back poorly managed, have a devastating advise addressing the physical task problems. And perhaps, it could bring on effect on a person’s ability to work.’’ factors of work in prevention efforts? symptoms of people who haven’t, depending upon the condition they are in. [Tr. 6916] The review goes on to classify evidence Similarly, if physical characteristics of based literature recommendations using work are not significant issues for Along other lines, some commenters the following classification scenarios: workers who return to work after raised issues with OSHA’s inclusion of ***Strong evidence—provided by developing a low back disorder, then symptoms in the definition of an MSD. generally consistent findings in why do the authors state the following? Gibson, Dunn and Crutcher stated that: multiple, high quality scientific studies. **Moderate evidence—provided by There is a pragmatic argument that These sensations that the agency treats as generally consistent findings in fewer, individuals at highest risk of LBP should not tantamount to musculoskeletal injury are be placed in jobs that impose the greatest ubiquitous in the general population and do smaller or lower quality scientific physical demands. The basic concern is that not warrant interference by the agency. [Ex. studies. workers with physically (or psychologically) 500–118] *Limited or contradictory evidence— demanding work report rather more low back provided by one scientific study or symptoms, have more work-related back OSHA does not agree with this inconsistent findings in multiple ‘‘injuries’’ and lose more time off work with argument. OSHA is not attempting to scientific studies. LBP. Even if physical demands of work may regulate common symptoms. Rather, —No scientific evidence—based on be a relatively modest factor in the primary OSHA has proposed strategies to modify clinical studies, theoretical causation of LBP (see Background above), physical workplace factors that are considerations and/or clinical people who have LBP (for whatever cause) do associated with the development of consensus. have more difficulty managing physically MSDs, when the physical factors at Several British guidelines (Ex. 500– demanding work (T3: (Muller et al.1999) T2: work are present in frequency, intensity, (Waddell 1998)). It may be argued, therefore, 118–2) findings are consistent with the that avoiding putting people at highest risk and/or duration likely to be responsible final rule. With respect to the of recurrent LBP and sickness absence into for causing observed MSDs. As required relationship of physical work factors more physically demanding work would be in the final rule, the employer’s and work-related low back pain, the in the interests of the individual worker, the responsibility is that it must evaluate guidelines report the following evidence employer and the total societal burden of employee reports of MSD signs and based findings: There is strong evidence LBP. [Ex. 500–118–2] symptoms to determine whether an that Similarly, the ACOEM guidelines (Ex. MSD incident has occurred. The Physical demands of work (manual materials 38–234) agree with the observation that evaluation may include an evaluation handling, lifting, bending, twisting, and specific physical work factors are by an HCP to determine the nature of whole body vibration) can be associated with associated with certain work-related the condition and assist the employer in increased reports of back symptoms, MSDs. evaluating the work-relatedness of the aggravation of symptoms and ‘‘injuries.’’ [Ex. One of the criticisms raised by a MSD. Many employers presently act in 500–118–2] commenter was the limited reference to a very similar manner when an These guidelines therefore acknowledge the Cochrane Collaboration Back employee reports a potential problem. potential for physical work factors to Review Group in low back sections of The employer may perform an accident precipitate low back pain episodes, and the Health Effects section of the or incident investigation, offer recognize some evidence of a preamble to the proposed rule. temporary modified duty, correct the cumulative effect of spinal loading. In However, as a significant contributor to problem, and/or refer the employee to a addition, management of work-related this effort, Dr. Nachemson clarified that HCP for evaluation. low back pain, as noted in the AHCPR neither work-related back pain nor Gibson, Dunn, and Crutcher also low back pain guidelines, may ergonomics were the focus of these suggested that paying attention to reasonably include elements similar to reviews (Tr. 6779). subjective complaints would lead to those in the OSHA final rule, such as Although Dr. Nachemson questioned inaccurate diagnoses. They state that: * * * temporarily limit[ing] or avoid[ing] OSHA’s findings of the relationship of One of the challenges presented by MSDs specific activities known to increase work to the development of work- is that, in order to diagnose an affliction (in mechanical stress on the spine, especially related low back disorders, he an effort to determine what response is prolonged unsupported sitting, heavy lifting, contradicts this in the chapter he required to comply with the proposed and bending or twisting the back while authored for the International Society standard), an employer or the employer’s lifting. [Ex. 32–241–3–93] for the Study of the Lumbar Spine, physician must rely principally, if not solely, In summary, the British guidelines (Ex. entitled ‘‘Future of Low Back Pain’’ on subjective reports of pain from employees. 500–118–2) state that there is moderate (Wiesel et al. 1996, Ex. 26–1620). The [Ex. 500–118] evidence that ‘‘From an organisational chapter has a table compiled on the These assertions are incorrect, and are perspective, the temporary provision of effects of external load on low back not consistent with medical literature lighter or modified duties facilitates structures. The table lists extreme and opinion. A worker’s medical return to work and reduces time off loading activity, several hours of hard history, including subjective reports like work.’’ training, extreme body position, as pain, is a key element that has been

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[Ex. 26–1620] A few key questions on the medical history review by Dr. Stanley Bigos, expert The authors go on to propose a can help ensure that a serious underlying witness for UPS and Anheuser-Busch classification system for low back pain condition, such as cancer or spinal infection, and others. The following quotes are (Pynsent-Fairbank-Hall Classification of will not be missed * * * Symptoms of excerpted from the guidelines: Extraspinal Pain), which is primarily sciatica (leg pain) or neurogenic claudication A focused medical history, work history, based upon patient symptoms. The (walking limitations due to leg pain) suggest and physical examination are generally possible neurologic involvement. Pain acknowledgment of the importance of sufficient to assess the worker with a symptoms in this text is of particular radiating below the knee is more likely to complaint of an apparently job related indicate a true radiculopathy than pain disorder. [Ex. 502–240] interest to OSHA due to the fact that radiating only to the posterior thigh. A two principal expert witnesses who history of persistent numbness or weakness In this assessment, certain patient testified on behalf of UPS and others in the leg(s) further increases the likelihood responses and findings raise the that symptoms are not meaningful, Dr. of neurologic involvement. The articles suspicion of serious underlying medical Stanley Bigos and Dr. Alf Nachemson, indicate that cauda equina syndrome can be conditions. are members of The International ruled out with a medical history that The patient’s description of the mechanism Society for the Study of The Lumbar ascertains the absence of bladder dysfunction of injury (so far as is known), his or her Spine, the organization that published (usually urinary retention or overflow presenting symptoms, the duration of incontinence), saddle anesthesia, and the above text. symptoms, exacerbating factors, and the The classification of low back pain unilateral or bilateral leg pain and weakness. history of previous episodes will help define [Ex. 32–241–3–93] the problem. [Ex. 502–240] primarily upon patient symptoms is The AHCPR guidelines go on to clarify similar to the approach used by the In Chapter 14, the ACOEM guidelines Quebec Task Force (1987; Ex. 26–494). that the examination is used to confirm state: clinical impressions derived from the Dr. Nachemson also served as a member medical history, including pain Thorough medical and work histories and of the task force for this publication. a focused physical examination are sufficient characteristics: The Quebec classification included 11 for the initial assessment of the worker with categories, with 1–4, 8, 9 and 10 based The physical examination supplements the a complaint of potentially work-related low upon symptoms. back symptoms. [Ex. 502–240] information obtained in the medical history The American Medical Association, in seeking an underlying serious condition or These statements from clinical in its Guides to the Evaluation of possible neurologic compromise. [Ex. 32– medicine practice guidelines provide 241–3–93] Permanent Impairment, 4th edition, (Ex. further support for the use of symptoms 38–246) also include symptoms in The AHCPR low back pain guidelines as a trigger in the final rule. The practice classifying impairment. In particular, also indicate that ‘‘The physical guidelines make use of the patient Table 72 in that publication contains a examination is less useful than the history and reports of symptoms and Diagnosis Related Estimate for history in searching for underlying take a consistent approach to the Lumbosacral Category II: Minor serious conditions.’’ Thus OSHA’s physical examination referent to Impairment (5% whole person approach to the use of employee patients with low back pain. impairment). The guidance used by the symptoms is similar to the AHCPR This approach is consistent with the AMA for this is ‘‘The clinical history rigorous analysis of the literature on one medical text brought to OSHA’s and examination findings are acute low back pain evaluation and attention. The International Society for compatible with a specific injury or treatment that concluded that symptoms the Study of The Lumbar Spine illness. The findings include significant and history give important information publishes a text entitled ‘‘The Lumbar intermittent or continuous muscle to diagnose and manage adults with Spine’’ (Wiesel, et al. 1996; Ex. 26– guarding that has been observed and acute low back pain. 1620). In Chapter 3 on clinical documented by a physician, Both the Royal College and British evaluation of low back pain by Jeremy nonuniform loss of range of motion, or guidelines support the role of history, Fairbank and Hamilton Hall (History nonverifiable radicular complaints. including symptoms, in the diagnosis taking and physical examination: There is no objective sign of and management of low back pain. The Identification of syndromes of back radiculopathy and no loss of structural British guidelines state: pain), the authors state: integrity.’’ There is similar guidance for The patient’s age, the duration and Conventional western medical therapy is the cervical spine. description of symptoms, the impact of practiced on the basis of a diagnosis that is Guidelines for diagnosis and symptoms on activity and work, and the made from a synthesis of information treatment of low back pain that have response to previous therapy are important in acquired from the patient’s history, physical been published in the United States the care of back problems. (B: Moderate examination, and special investigations. Back include the AHCPR guidelines (Ex. 32– research based evidence). [Ex. 500–118–2] pain is a common presenting symptom, and 241–3–93) and the ACOEM guidelines The guidelines confirm AHCPR its diagnosis should be approached in the same manner as that of any other symptom. (Ex. 38–234). These will be addressed in recommendations by indicating: [Ex. 26–1620] the discussion on rest and activity to The initial clinical history can identify ‘red They further state that follow in this section. flags’ of possible serious pathology. Such It must also be recognized that low inquiries are especially important in patients A detailed history obtained from the back pain is not the only potentially over age 55. (B: Moderate research based patient is essential for making a diagnosis, covered MSD, and other potential MSDs evidence). [Ex. 500–118–2] assessing disability, and dictating management. Time spent listening to the may present as symptoms only. For OSHA’s approach, in particular the patient is not wasted. Back pain has a wide example, it is clear that patients with acknowledgment of worker symptoms, variety of causes, and many of these can be CTS may have symptoms of numbness parallels this literature based analysis. revealed during history taking. [Ex. 26–1620] without any physical findings (Erdil and

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Dickerson 1997, Ex. 502–18; Katz et al. There is overwhelming evidence that the method of treatment even of tissues that have 1991, Ex. 38–101; Moore 1992, Ex. 26– number of reported cases of repetitive motion sustained traumatic injury or age-related 985). Of significance, commonly disorders is rapidly growing. These disorders degeneration. Properly conditioned; a utilized physical signs to clinically have become an extremely costly public traumatically injured joint may be restored to health issue. Although some individuals full function by the protection of muscles diagnose carpal tunnel syndrome, such believe that the underlying issue may be stronger than before the injury. [Ex. 32–241– as the Tinel’s test and Phalen’s sign, do improper reporting or false claims of a 3–4] not have as high a sensitivity or medical problem, the organizers and most of specificity as the Hand Diagram (Katz the participants believe that for the vast Dr. Bigos’ statement that ‘‘repetitive and Stirrat 1990; Ex. 500–121–33), a majority of cases, there is an underlying motion that fatigues musculoskeletal symptom based tool. Clearly, utilizing physiologic insult to one or more of the tissues is medically prescribed, to the symptoms to identify possible cases of various tissues involved. point of being the preferred method of carpal tunnel syndrome and other MSDs The text goes on to cover treatment even of tissues that have is consistent with the knowledge based epidemiologic evidence; sustained traumatic injury or age-related upon reviewing the medical literature. pathophysiology of biomechanical degeneration,’’ while having elements of validity, again fails to look at the Dr. Malcolm Jayson argued that loads, connective tissue, muscle and nerve. Chapters on rehabilitation of the various work-related MSDs as well as * * * if a person has pain in the knee, the wrist, elbow and shoulder all indicate the stage and severity of the condition. most effective form of treatment is knee that time limited periods of rest may be There is supporting literature and exercises. When we rehabilitate back consensus, including clinical practice problems we prescribe[] exercises with a indicated for acute MSDs. The book is progressive regime to increase physical the result of a workshop organized by guidelines (e.g. ACOEM; Ex. 38–234) capacity. There is now overwhelming the National Institute of Arthritis and that recommend periods of splinting evidence that exercise is good for back Musculoskeletal and Skin Disease, NIH. and rest for MSDs like acute tendonitis problems and damaged joints and rest is Co-sponsors included NIOSH, CDC, or stenosing tenosynovitis, harmful. [Ex. 32–241–3–9] Orthopedic Research and Education DeQuervain’s disease and carpal and cubital tunnel syndromes. A However, nowhere does OSHA state Foundation, the National Center for comparison could be made to a patient that all exercise is harmful, nor does it Medical Rehabilitation Research, and who experiences an acute myocardial support rest as the treatment for MSDs. others. One expert witness Dr. Stanley infarction with muscle damage. In this With regard to work factors like Bigos, who testified on behalf of one scenario, rehabilitation often includes repetition, it is important to recognize industry group organized in opposition carefully controlled exercise appropriate that biomechanical factors that are to OSHA’s proposed standard in to the stage of recovery and level of present in a sufficient intensity, general, is a member of AAOS. function of the remaining heart muscle. duration, and/or frequency to cause or In June 1998, Clinical Orthopedics It would not be reasonable to presume contribute to an MSD are addressed. In and Related Research (Exs. 26–1310, that a patient one day after a significant these circumstances, OSHA 26–1322, 26-1316) covered Cumulative myocardial would be improved if forced recommends modification of exposure Trauma Disorders of the Upper to run a marathon. Neither would a to these factors. It is clear that, when Extremity through a joint sponsorship of worker benefit from intensive and excessive, repetition and other cited the Association of Bone and Joint uncontrolled exercise after the onset of work factors can cause MSDs. Several Surgeons, the Academic Orthopedic an acute MSD with significant studies were presented in the Health Society, the Hip Society, the inflammation, degeneration and loss of Effects Section of the final rule to Musculoskeletal Tumor Society, and the function. demonstrate the pathogenic Knee Society. This text again covered The same commenters stated that mechanisms through which physical sections regarding the effects of physical OSHA’s use of the term ‘‘rest’’ in the work factors can be responsible for work factors (i.e. repetition) on nerve, proposal implied that OSHA causing or contributing to certain MSDs muscle, joints, and certain clinical recommends or promotes bed rest for identified in the epidemiologic review. conditions. Similarly, the National Academy of workers with MSDs. This statement is Unfairly, this statement simplifies Sciences, in 1999, (Ex. 26–37) published incorrect and fails to recognize the physical factors in work settings as the results of a workshop they purpose and application of the standard. solely characterized by repetition, sponsored on work-related MSDs. While This standard is not intended as a without considering the frequency, there was some variance in opinions guideline for the medical treatment of duration, and periodicity of the about the contribution of physical work MSDs. Medical treatment is left to the repetitive activities. In addition, it factors to MSDs, there was agreement licensed health care provider, utilizing ignores other factors that have potential among most that physical work factors sound medical judgement, and evidence to cause MSDs in the workplace, such contribute to MSDs. ‘‘MSDs are based literature and clinical practice as excessive force, awkward posture, multifactorial, with work and guidelines. contact stress, and vibration. Also biomechanical aspects of work being What OSHA did intend when it used neglected is the observation that important contributors.’’ The NAS the term ‘‘rest’’ was appropriate activity combinations of factors like force, reviewers also explained the concepts modification. The standard supports posture, etc. with repetition, may behind temporary rest or activity return to work where there are effective compound the effect of repetition on modification for injured tissues. controls of biomechanical factors musculoskeletal tissues. Finally, the Contrary to the view of NAS, Dr. causing or contributing to the MSD. The statement does not differentiate types of Stanley Bigos provided the following preamble to the proposal stated: tissue affected and whether the tissue is comment: healthy or damaged. Although some covered MSDs are at such an advanced state that complete removal In the preface to The American Contrary to ergonomists’ beliefs, usage is a prerequisite to health—using the body, even from the work environment is the Academy of Orthopedic Surgeons’ book vigorously using the body, is not intrinsically appropriate treatment, it should usually be entitled ‘‘Repetitive Motion Disorders of harmful. That is why repetitive motion that the recommendation of last resort. Where the Upper Extremity’’ (Gordon et al. fatigues musculoskeletal tissues is medically appropriate, work restrictions that allow the 1995; Ex. 26–1399), the editor states: prescribed, to the point of being the preferred employee to continue working (e.g., in an

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00275 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68536 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations alternate job, or by modifying certain tasks in understanding of the impact that the However, comparisons of workers the employee’s job to enable the employee to physical demands of work have on with young and highly skilled athletes remain in that job) are preferable during the recovery and modified activity. They is not appropriate. This is pointed out recovery period. state that ‘‘The nature and duration of by the ISSLS text on the Lumbar Spine Dr. Stanley Bigos argued that the limitations will depend on the clinical (Wiesel et al.1996; Ex. 26–1620). The proposed ergonomics rule was at odds status of the patient and the physical following quote is from the chapter on with the recommendations of the requirements of the job.’’ biomechanics: AHCPR guidelines, in that the proposed While the AHCPR guidelines (Ex. 32– Comparison of athletic exercises with rule recommended rest, reduced work, 241–3–93) did not find evidence that industrial labor is complicated because, in and inactivity in response to pain, while bed rest was beneficial for the majority the athletic field, (1) one deals with young, the AHCPR guidelines recommend of individuals with acute low back pain, healthy subjects; (2) there is a selection of increased activity and conditioning (Ex. the panel did acknowledge that, in some individuals for the specific tasks; (3) the 32–241–4). circumstances, bed rest may be required specific task is always accompanied by The AHCPR guidelines (Ex. 32–241– for select patients with acute low back remedial exercises. In industrial labor, one is pain (‘‘The majority of low back patients dealing with the average population. There is 3–93) do recommend that adults with almost no selection of the individuals, and acute low back pain maintain activity. will not require bed rest. Bed rest for 2 there are many monotonous tasks that are not However, the guidelines do not suggest to 4 days may be an option for patients interrupted by remedial exercise. [Ex. 26– that patients with acute low back pain with severe initial symptoms of 1620] primarily leg pain.’’) immediately return to work involving Dr. Michael Vender explained his Program elements in OSHA’s proposal physical task factors that may stress the belief that soft tissue has almost are also consistent with the British spine. Rather they advise appropriate limitless capacity to recover from injury. activity modification to assist in the guidelines, that state that there is recovery process. AHCPR guidelines moderate evidence that We cannot explain the natural process of Activity Recommendations panel aging and gradual deterioration of all body From an organisational perspective, the parts by the concept of cumulative trauma. findings and recommendations state: temporary provision of lighter or modified The most basic flaw in this logic revolves ‘‘Patients with acute low back problems duties facilitates return to work and reduces around the comparison of the human body to may be more comfortable if they time off work. [Ex. 500–118–2] a piece of metal [as reflected in the temporarily limit or avoid specific Some commenters appeared to biomechanical model espoused by activities known to increase mechanical confuse the concepts relevant to the ergonomists). [Unlike metal], the body, when stress on the spine, especially prolonged practice of sports medicine with stressed or even injured, has the ability to unsupported sitting, heavy lifting, and concepts relevant to the prevention of heal and recover.—When one repeatedly bending or twisting the back while bends a piece of plastic, it becomes MSDS in workers. For example, Gibson, permanently deformed. When one repeatedly lifting. (Strength of Evidence = D.);’’ Dunn & Crutcher state exercises a muscle, it becomes stronger and and, ‘‘Activity recommendations for the Increase in physical activity (compared to more functional. [Ex. 32–241–3–19] employed patient with acute low back past activity level) is a guiding principle in This belief is in contrast to the symptoms need to consider the patient’s musculoskeletal rehabilitation, and has been age and general health, and the physical opinion of the NAS workshop (1999) the primary intervention and treatment in (Ex. 26–37) noted above, and fails to demands of required job tasks. (Strength many musculoskeletal disorders. These of Evidence=D.)’’ treatment protocols include many of the recognize concepts of muscle The AHCPR guidelines acknowledge physical stresses that OSHA recommends disruption, tendon and ligament that avoiding. [Ex. 500–118] viscoelastic deformation and creep discussed in the Health Effects This again is an overly simplistic several studies have identified an increased Preamble. incidence of low back problems among statement, since there are differences in individuals whose work involves heavy or the intensity, duration, and/or 7. Additional Criticisms of repetitive lifting, exposure to total body frequency of guided rehabilitation of an Epidemiological Studies Raised by vibration (from vehicles or industrial injury that is tailored to the individual’s Commenters machinery), asymmetric postures, and type of injury, severity of the condition, Gibson, Dunn & Crutcher in their postures sustained for long periods of time.’’ stage of rehabilitation and the [Ex. 32–241–3–93] post-hearing comments (Ex. 500–118, individual’s conditioning, as opposed to Section B, pgs. 65–81) supply critiques The guidelines also recognized that intensity, duration, and/or frequency of of additional ‘‘studies on which OSHA Other biomechanical research suggests that physical job factors that are based upon relies or may rely in support of the certain postures and activities increase the delivery of goods or services and have proposed rule.’’ (id., pg. 65). OSHA’s mechanical stress on the spine. It is not clear no bearing upon individual capabilities response to these critiques is given whether these mechanical stresses are the or injuries. Dr. Tapio Videman, another below. cause of low back problems. However, once expert witness for the UPS attempted to Gibson Dunn & Crutcher criticize the symptoms are present, mechanical stresses explain the importance of physical study by Latza et al. (2000, Ex. 38–424) correlate with worsening of symptoms. activity as follows: Prolonged sitting and postures that involve that examined occupational risk factors bending and twisting have been shown to Sports medicine—and much of modem of low back pain among construction increase the mechanical stress on the spine mainstream medicine—views physical workers. Among their criticisms, Gibson according to pressure measurements in loading as a means of increasing fitness, Dunn & Crutcher argue that the authors lumbar intervertebral discs. Heavy lifting also strength, and function, and is part of most drew causal inferences from a study that appears to increase mechanical stress on the related intervention today. Why would is only an exploratory analysis. Further, spine, but this stress can be reduced if the physical loading be harmful in work but beneficial in leisure time? * * * Physical they claim that the researchers were lifted object is held close to the body rather vague in their methods and did not than at arm’s length.’’ [Ex. 32–241–3–93] activity can promote physical adaptation to loading, and restore and maintain functional come up with a single promising As to the duration of activity capacity. This may explain why there is some association. modification, the AHCPR guidelines evidence of the benefits of exercise for spinal OSHA disagrees with these criticisms. (Ex. 32–241–3–93) demonstrate an disorders. [32–241–30–20] First, the study as a whole cannot be

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The (Ex. 500–118 pg 71) also claim that, ‘‘By preservation of cartilage, which is good. ‘‘exploratory approach’’ reported by the its very nature, a surveillance study They question whether the Stenlund et authors refers not to the study as a perturbs the experience of discomfort.’’ al. (1992) paper is detecting a ‘‘bad’’ whole but rather to a detailed analysis However, this type of physiological outcome. Gibson Dunn & Crutcher also of the data to identify potential risk biasing factor would appear to have criticize the 1993 Stenlund et al. paper factors that might be used to predict low only a minimal or no effect on the end for using shoulder tendinitis as an back pain. The authors describe a results since the rate of occurrence of adverse effect measure, arguing that detailed process for focusing on factors tenosynovitis or peritendinitis and shoulder tendinitis is subject to overt most likely to have caused the observed epicondylitis, for both men and women, reporting and recording bias. They reports of low back pain. Second, OSHA was shown typically to be an order of conclude that these types of outcome disagrees that the authors were vague in magnitude higher for strenuous measures are not appropriate to be used their methods. Various aspects of the compared to non-strenuous meat in epidemiological studies. study, such as the selection of study processing jobs (Ex. 26–53, pg. 34). With regard to the 1992 Stenlund et subjects, data collection, and data Gibson Dunn & Crutcher correctly al. study, the critics are comparing analysis, were described in clear enough point out (Ex. 500–118, pg. 72–73) that minimal changes commonly observed detail that would allow the reader to the utility of participatory ergonomics with habitual usage of a joint such as assess the results reported. Finally, the was not evaluated in the Roquelaure et the knee (e.g., increased preservation of authors noted that causality cannot be al. (1997, Ex. 38–96) study. However, cartilage) to severe osteoarthrosis, from established with this study. However, OSHA used this study only to show an heavy manual work and vibration, of a the purpose of the study was to identify association between stress variables and joint, in this case the shoulder. In the possible risk factors for low back pain carpal tunnel syndrome (CTS). The role Stenlund study, radiographs were among these workers that might aid in of participatory ergonomics in reducing classified into 5 grades of osteoarthrosis the identification of hazardous CTS was not alluded to by OSHA. (0 = normal; 1= minimal changes; 2 = components in the work that can guide Gibson Dunn & Crutcher correctly moderate changes, more severe changes effective primary intervention. In this point out (Ex. 500–118, pg. 73) that in to cartilage and bone structure begins to regard, the authors report positive the Viikari-Juntura et al. (1994, Ex. 26– be affected; 3 = severe osteoarthrosis, associations that show that certain 873) study what is defined as severity of and 4 = totally destroyed joint). Those occupational risk factors can be neck trouble is in fact the frequency of classifying the radiographs were blinded predictive of low back pain. self-reported symptoms (pain, ache, as to exposure. The authors did not find Gibson, Dunn & Crutcher criticize a stiffness or numbness). As a result, significant differences in lower grade study by Punnett et al. ‘‘A comparison Gibson Dunn & Crutcher believe the changes. However, they did observe that of Approaches to Modeling the possibility exists that the subject’s among rock blasters and bricklayers Relationship between Ergonomic statements concerning severe neck who had exposure to heavy load and Exposures and Upper Extremity trouble could be misleading. OSHA vibration compared to foremen who did Disorders’’ (2000, Ex. 500–71–43). This used the Viikari-Juntura et al. study to not, there was a significant increase in is a methodology study concerning only show an association between neck grade 2 and 3 osteoarthrosis. Therefore, approaches for combining independent symptoms and stress factors. OSHA did OSHA believes that Gibson Dunn & and dependent variables for the purpose not comment on the severity of the Crutcher are actually confusing two of exposure-response analysis. This symptoms. different health outcomes in their study uses the information on upper Gibson Dunn & Crutcher note (Ex. criticism. The study by Stenlund et al. extremity disorders in vehicle 500–118, pgs. 73–74) that the authors of (1992) would support the hypothesis manufacturing found in an earlier the Kearns et al. (2000, Ex. 500–71–34) that normal habitual use of the shoulder Punnett et al. (1998, Ex. 26–38) study), study did not intend that the results of might cause increased preservation of which these same commenters criticized the study on the prolongation of median the cartilage. However, shoulder joints previously (Ex. 32–241–4, pg. 144). motor and sensory nerve latency be exposed to heavy loads and vibrations OSHA has responded to those criticisms generalized beyond the effects of work such as those examined in the study elsewhere in this preamble. related to pork processing. OSHA agrees show radiographic evidence of severe Gibson, Dunn & Crutcher have two that the study supplies limited osteoarthrosis. main criticisms of the Kurppa et al., information about the relationship With regard to the 1993 Stenlund et (1991, Ex. 26–53) study concerning the between workplace physical factors and al. study, the authors noted the potential incidence of tenosynovitis or CTS. for misclassification when using peritendinitis and epicondylitis in a tendinitis as a measure of outcome. meat-processing factory. The Stenlund et al.studies, Exs. 26–733 and They agree that in some epidemiological commenters claim that the diagnostic 26–1479 studies, clinical diagnosis of tendinitis definition of the response tenosynovitis Gibson Dunn & Crutcher (Ex. 500–118 may not be an appropriate measure of or peritendinitis (agreed to by the plant pg. 70–71) have criticized the 1992 prevalence in the population, since physician), ‘‘boils down to focal study by Stenlund et al. (Ex. 26–733) of some individuals with tendinitis may soreness/tenderness and nothing more osteoarthrosis and the 1993 Stenlund et not see a physician for their symptoms, specific or mysterious than that.’’ (Ex. al. (Ex. 26–1459) of shoulder tendinitis. thus creating a selection bias. However, 500–118, pg. 71). In response, OSHA First, the 1992 Stenlund et al. study is the authors assert that this type of bias notes that, in order to be included as a criticized for its conclusion that is overcome in their study by the use of response in the study, the condition radiographic evidence of osteophytes a cross sectional study design. In order needed to be severe enough in each case (spurs) in the acromioclavicular joint is to further lessen the potential for to qualify for sick leave (Ex. 26–53, pg. a predictor of osteoarthrosis causing misclassification, the authors also

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The effect of this negative of this study, the agency believes that that persons experiencing pain in their bias, however, would underestimate the these sources of bias have been taken shoulder in the last year and who on risk ratios. In an attempt to understand into consideration in this study to such examination have pronounced pain the underlying etiology of this disc an extent that the observed increased reaction to palpation and contraction, degeneration, the authors did additional risk ratios can be accepted with some have probably had a disorder in the analyses looking at different segments of confidence. In addition, OSHA believes muscle attachment or tendon, that in the lumbar region and different that these observed risk ratios are more clinical practice would have been degenerative spinal changes (e.g. disc than barely significant and, when classified as tendinitis. OSHA believes space narrowing, spondylophytes, and viewed in the context of other positive that, with proper study design and endplate sclerosis). In some of these epidemiological evidence, contribute to control for misclassification, as was sub-analyses for certain lumbar regions, the weight of evidence and the strength done in the Stenlund study, clinically there was no statistically significant of the agency’s overall health effects diagnosed shoulder tendinitis is an effect. Overall, however, the authors assessment. adequate measure of effect. Thus, the found a significant association between Gibson Dunn & Crutcher also criticize Stenlund et al., 1993 study can be used work and disc degeneration while four other epidemiology studies OSHA with other studies in the record to form controlling for confounders. Therefore, relied on in contributing to the strength a reliable weight of evidence on which OSHA does find these results of the agency’s overall health effects to base the agency’s health effects compelling and generally supportive of assessment: two studies by Silverstein et conclusions. its health effects assessment. al. (Exs. 26–34 and 26–1404), a study by Gibson Dunn & Crutcher criticized the Gibson Dunn & Crutcher also Venning et al. (Ex. 500–41–49), and a 1994 study of sciatic pain among men criticized the 1990 study on study by Punnett et al. (Ex. 26–39). in machine operating, dynamic physical degenerative disc disease among OSHA responds to criticisms of these 4 work and sedentary work by Riihimaki concrete workers and house painters by studies in on Section G:3-Exposure- et al. (1994, Ex. 26–1188). They claim Response. Riihimaki et al. (Ex. 502–455). They that the associations observed in this argue that the results of this study are study are ‘‘barely significant’’ (Ex. 500– VI. Risk Assessment ‘‘not compelling’’ because the authors 197, pg. 69) and are no more significant A. Introduction found insignificant risk ratios and, thus, than the associations observed with are very likely to be influenced by physical exercise. In addition, they state The United States Supreme Court, in unmeasured variables. OSHA finds this that the observed increases are the Benzene decision (Industrial Union argument unconvincing for the negatively influenced by workers’ self Department, AFL-CIO v. American following reasons. Number one, the reporting of tasks, ‘‘an inadequate Petroleum Institute, 448 U.S. 607 authors did, in fact, find a statistically definition of sciatica’’ and recall bias. (1980)), has ruled that the OSH Act significant risk of detectable OSHA is unsure as to what these requires, prior to the issuance of a new degenerative changes in the lumbar critics mean by ‘‘barely’’ significant. The standard, that a determination be made spine among concrete workers (38%) authors reported a statistically that there exists a significant risk of compared to house painters (26%). significant increase in sciatic pain material impairment and that issuance (Relative Risk=1.4, (CI 1.1–1.8; p<0.01)) among machine operators and of the new standard will substantially In this study, concrete reinforcement carpenters compared to office workers. reduce that risk. The Court stated that workers were compared to house For machine operators the relative risk ‘‘before he can promulgate any painters. The authors noted that the =1.6 (95% CI 1.2–2.2) and for carpenters permanent health or safety standard, the load on the back is distinctly different was 1.7 (95% CI 1.3–2.4). This statistical Secretary is required to make a among concrete workers compared to significance remained even after threshold finding that a place of house painters. The authors also note controlling for a variety of risk factors employment is unsafe in the sense that that in Finland, persons in these trades (e.g., age, seniority, education, physical significant risks are present and can be have very similar socio-economic status exercise, smoking, car driving, and prior eliminated or lessened by a change in and lifestyles, thus making it more back accidents). Adjusted relative risks practices’’ (448 U.S. 642). The Court likely that the detected difference were 1.4 and 1.5. also stated that ‘‘the Act does limit the between these groups is due to The authors do acknowledge that the Secretary’s power to require the occupational exposures rather than reporting of symptoms of sciatica can be elimination of significant risks’’ (448 other factors. Moreover, as a part of the subjective, as can a worker’s perception U.S. 644). study design the concrete reinforcement of physical task. In order to minimize In the Cotton Dust case (American workers and house painters were this type of bias, they used explicit Textile Manufacturers Institute v. matched by age, earlier back accidents, descriptions of symptoms and tasks to Donovan, 452 U.S. 490 (1981)), the height, body mass index and smoking. ensure uniform understanding of the Court reaffirmed the position it had These covariates were included in a concepts. The authors also recognize the previously taken in the Benzene mutivariate logistic regression to potential of recall bias to negatively decision that a risk assessment is not perform the statistical analysis to influence the results. However, they only appropriate but required to identify control for possible confounding factors note that this misclassification also significant health risks in workers and likely to affect disc degeneration. After depends not only on the recall error but to determine if a new standard will controlling for these factors, the authors also the incidence rate of the symptoms. reduce those risks. Although the Court still reported statistically significant They conclude that the recall error bias did not require OSHA to perform a effects. In addition, the authors noted in the observed risk ratios is small if ‘‘by quantitative risk assessment in every that workers, to be included in the the end of follow-up’’ the rate of case, the Court implied, and OSHA as

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In general, workers in the the Health Effects section of this the strength of the evidence for a causal exposed groups were exposed to preamble (Section V) demonstrates a relationship between several types of biomechanical risk factors on a nearly causal relationship between exposure to MSDs and the workplace risk factors of daily basis, and were usually exposed workplace risk factors and work-related force, repetitive motion, awkward for most of each work shift. However, as musculoskeletal disorders. As discussed posture, and vibration. More than 600 shown by OSHA’s summary of in that section, the major workplace risk peer-reviewed studies were critically exposure-response data in the Health factors include exposure to repetitive reviewed, making this one of the largest Effects section (Section V), many of motion, force, awkward postures, human data bases ever built to examine these epidemiological studies placed contact stress, and segmental vibration. work-related adverse health outcomes. workers in the exposed group even if The Health Effects section also NIOSH found that for most they were exposed for only about one- demonstrates that the risk associated combinations of MSDs and risk factors, quarter to one-half of the work shift. with occupational exposure to these risk the evidence in humans that a causal Later in this section, OSHA defines factors increases with frequent or relationship existed between workplace ‘‘higher-risk’’ workers as those who are prolonged exposure to these risk factors, exposure to risk factors and the exposed in excess of the final rule’s job and that the risk is increased when development of MSDs was either screening criteria, which generally workers are exposed to more than one ‘‘sufficient’’ or ‘‘strong.’’ For a few MSD/ reflects those workers as having two or risk factor in a job. risk factor combinations, there was more hours per shift of exposure to OSHA has determined that there is insufficient evidence of a causal biomechanical risk factors. Since the NIOSH and NAS reports, substantial evidence that exposure to relationship, but in no case did NIOSH many additional epidemiological these biomechanical stressors at work determine that there was evidence for studies have been published and are can cause or contribute to the the absence of a relationship between contained in the rulemaking record. development of MSDs and that exposure to workplace risk factors and These studies have been reviewed by reductions in these stressors can reduce the development of MSDs. NIOSH OSHA in detail in the Health Effects the number and severity of these work- concluded that ‘‘ * * * a substantial body of credible epidemiologic research section, and their results add to the related MSDs. The underlying evidence already substantial weight of evidence falls into three broad categories: provides strong evidence of an association between MSDs and certain originally evaluated by NIOSH and Studies of groups of workers showing a work-related physical factors when NAS. OSHA is not alone in its relationship between exposure to determination that the epidemiological biomechanical risk factors in the workplace there are high levels of exposure and especially in combination with data base for ergonomics convincingly and an increased incidence or prevalence of establishes a causal relationship MSDs; exposure to more than one physical between workplace exposure to risk Biomechanical studies that show that factor * * *’’ (NIOSH 1997, ES p. xiv, adverse tissue reactions and damage can Ex. 26-1). factors and MSDs. Many experts who occur when tissues are subjected to high A similar conclusion was reached by provided testimony in the record and forces and/or a high number of repetitive the experts participating in a workshop appeared at OSHA’s informal hearing movements, which occur when workers are conducted by the National Academy of agreed that sufficient epidemiological substantially exposed to biomechanical risk Sciences/National Research Council evidence exists to conclude that factors; and (NRC) (Ex. 26–37). For the NRC report, biomechanical factors at work cause or Scientific and case studies that contribute to MSDs. These experts demonstrate that workplace interventions a panel of experts critically reviewed the methods used to select and evaluate included researchers, medical designed to reduce exposures to professionals, and ergonomists (Exs. 37– biomechanical risk factors are effective in the human studies relied on in the 1997 1, 37–2, 37–9, 37–10, 37–13, 37–10, 37– reducing the internal forces imposed upon NIOSH study (Ex. 26–1). The 1999 NRC tissues and the incidence and severity of report concluded as follows: 15, 37–16, 37–17, 37–18, 37–21, 37–27; MSDs. Tr. 843, Tr. 1048; Tr. 1112, Tr. 1103– [the association between MSDs and exposure 1103, Tr. 1367, Tr. 9808–9809, Tr. In the Health Effects section of this to risk factors at work that have been] 16802, Tr. 17566–17567, Tr. 8261, Tr. preamble, OSHA summarizes data and identified by the NIOSH review * * * as 2834, Tr. 9297, Tr. 16145, Tr. 1959– having strong evidence are well supported by findings from more than 170 1960, Tr. 17358, Tr. 13330–13331, Tr. epidemiological studies of the incidence competent research on heavily exposed populations. 3412). or prevalence of MSDs in groups of There is a higher incidence of reported That exposure to workplace risk workers who are exposed to physical pain, injury, loss of work, and disability factors can cause or contribute to MSDs risk factors in their jobs. In most of these among individuals who are employed in is made more plausible by the growing studies, the MSD prevalence of a group occupations where there is a high level of body of studies of biomechanical effects, of exposed workers is compared to that exposure to physical loading than for those also summarized in the Health Effects in another worker group that is not employed in occupations with lower levels of section (Section V of this preamble), exposed to the risk factors of interest. If exposure. (Ex. 26–37) that are designed to explore how tissues the exposed group shows a higher MSD In this context, NAS’s use of the react to mechanical stress and how prevalence than does the reference phrases ‘‘heavily exposed’’ and ‘‘high those reactions are related to disease group, the study provides evidence of level of exposure’’ does not refer to any processes. OSHA presented detailed an association between exposure and an specific quantitatively defined level of scientific information on the increased risk of developing MSDs, exposure to biomechanical risk factors, biomechanics and pathophysiology of particularly if the study is of good but simply reflects that, in the MSDs in its Health Effects Appendicies, quality and adequately controlled for epidemiological studies, groups of prepared at the time of the proposed potentially confounding factors (such as workers who were considered to be rule (Ex. 27–1); the discussion below age and gender) and biases. ‘‘exposed’’ to biomechanical risk factors briefly summarizes the information

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The importance of poor job exposure-response relationships have Muscles, ligaments, tendons, and content is difficult to evaluate, since not been observed or cannot be defined tendon sheaths can become inflamed this factor can coexist with in specific circumstances; in fact, there with repetitive or prolonged loading, biomechanical factors (for example, are many cases in which the risk of cartilage can deteriorate when subjected excessive workload can result in a MSDs has been quantitatively related to to abnormal loads, and nerves can worker needing to increase repetitive the degree and intensity of exposure. In exhibit dysfunction and eventually movement and/or force). Social factors the Health Effects section of this permanent damage if compressed or refer to a lack of social support from preamble (Section V), OSHA describes subjected to extended tension. Other management and supervisors, which scientific studies that demonstrate a studies have shown that the kinds of can lead to psychological stress and positive association between the risk factors present in many industrial dissatisfaction with work, both magnitude and/or duration of exposure occupations can impose internal forces associated with an increased prevalence to workplace risk factors and the on soft musculoskeletal tissue sufficient of MSDs. However, after evaluating the prevalence of MSDs, including upper to cause the kinds of physiologic nature of psychosocial factors and their extremity disorders and back injuries. responses described above. The role in contributing to the risk of MSDs, OSHA concludes that these studies relationships between external and OSHA has determined that, although provide compelling evidence of the internal loads have been demonstrated psychosocial factors appear, at least in work-relatedness of MSDs, since a using both biomechanical models and some studies, to have some relationship finding of positive exposure-response direct measurement and observation in to the observed increases in the trends is one of the key findings the workplace (see Section V, Health incidence of MSDs among workers necessary to establish a causal Effects). exposed to risk factors, their effect is relationship between exposure and Finally, evidence of the work- independent of that of biomechanical disease. relatedness of MSDs comes from several factors and is generally not as predictive Using data on the incidence of work- studies and case reports that document of MSD risk as are biomechanical related MSDs, risk can be quantified the effectiveness of ergonomic factors. The evidence reviewed by the using a population-based approach interventions in reducing exposures to Agency suggests that psychosocial similar to the one used by OSHA to risk factors and the successes of factors may have a greater influence in individual companies’ ergonomics quantify the risk of Hepatitis B among determining the length of disability workers with frequent occupational programs in reducing the incidence or following development of an MSD than prevalence of MSDs and the severity of exposure to blood and other potentially do biomechanical factors, but have infectious material (56 FR 64004). For MSDs among their workers. After shown weaker associations with the this final ergonomics program rule, reviewing intervention studies, prevalence or incidence of MSDs than OSHA uses a similar approach in its including both field and laboratory have biomechanical factors (see Section final risk assessment. In this assessment, studies, the NRC (1998, Ex. 26–37) V.G.5 of the Health Effects Section for OSHA relies on data from the Bureau of concluded that a discussion of the literature dealing Labor Statistics (BLS) to estimate the with psychosocial effects). OSHA’s * * * specific interventions can reduce the annual incidence of work-related MSDs finding is in accord with that of the reported rate of musculoskeletal disorders for in different industry sectors and workers who perform high-risk tasks. No NAS review (1999, Ex. 26–37). known single intervention is universally OSHA believes that the human occupations, by type of injury and type effective. Successful interventions require epidemiologic studies, the of exposure. A description of these data attention to individual, organizational, and biomechanical and physiological and OSHA’s analytical approach are job characteristics, tailoring the corrective studies, and the studies of the described in part B below, and the action to those characteristics. effectiveness of workplace ergonomic results of this analysis appear in part C. The scientific evidence and case studies interventions together constitute a Having quantified the risk, it is demonstrating that ergonomic compelling body of evidence that important to determine the extent to interventions reduce excessive tissue demonstrates that exposure to risk which the standard is likely to reduce loads and the associated tissue factors at work is a major factor in the that risk. In the case of this ergonomics pathology, and reduce MSD incidence development of MSDs, and that program standard there is abundant and severity, are summarized later in reducing or eliminating exposures to evidence of the effectiveness of this section). these risk factors will reduce the ergonomic programs. This evidence In addition to biomechanical risk number and severity of these MSDs. comes from a variety of published factors present at work, the risk of The epidemiological data base that studies, articles, and unpublished data developing an MSD is also influenced describes the associations between that describe the reductions in risk by individual, organizational, and social exposure to workplace risk factors and ergonomics programs have actually factors. Factors that affect individual increased prevalence or incidence of achieved in the workplace. Most susceptibility include age, general MSDs is vast. The nature of the hazard commonly, this evidence is expressed in conditioning, and pre existing medical and of the available data require OSHA terms of reductions in injury rates and conditions. Although some of these to perform a different type of risk decreases in the numbers of lost individual factors have been identified assessment than it performs to assess workdays caused by MSDs. OSHA’s in human studies as being statistically occupational risks from chemical discussion of these data appears in part significant predictors of disease, they exposures. There are many reasons for D, below. The Agency presents the are generally much weaker predictors this, in particular the complex results of its risk analysis in parts C and than are biomechanical factors of force, interactions among different kinds of D; comments on the preliminary risk

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For this analysis, OSHA is interested illnesses that are associated with the final rule. These risk factors are in capturing only those injuries and exposure to the risk factors addressed in repetitive motion, excessive force,

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MSDs caused by segmental vibration whole-body vibration in both event separate out those vibration-induced are thus included with those caused by categories, which makes it difficult to injuries and illnesses related only to

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According including tendinitis and bursitis, which classified under these two categories generally occur over time as a result of to Gibson, Dunn and Crutcher (Ex. 500– (excluding injuries involving the eyes) repetitive activity should be coded in 197): had occurred in 1996 (see BLS Table Musculoskeletal System and Connective OSHA states that back cases are ‘‘injuries’’ R32 for 1996, available at http:// Tissue Diseases and Disorders, major group that are ‘‘usually triggered by an www.bls.gov/oshc_d96.htm). Because it 17. (Ex. 26–1372) instantaneous event’’ for purposes of OSHA is not possible to identify the number of Based on this definition, Gibson, Dunn, 200 recording, [but] converts them into ‘‘illnesses’’ that develop ‘‘gradually over injuries associated with segmental & Crutcher conclude that cases vibration, OSHA has included in its time’’ for purposes of its MSD statistics classified as sprains, strains, and tears * * * The bottom line is that OSHA has no analysis only those MSDs related to the represent single-incident traumatic three event codes of overexertion, reliable data regarding the causes of back injuries and ‘‘are not MSDs’’ (Ex. 500– pain and back injuries. OSHA allows repetitive motion, and the subcategory 197, p. I–166). employers to ‘‘generalize’’ about back pain of bodily reaction described above. The To further support their view that for purposes of OSHA 200 recording injury/illness and event codes used by strains, sprains, and tears reflect acute precisely because its causes are often OSHA in the Risk Assessment and injury events and not cumulative indeterminate. Significance of Risk sections for the trauma, Gibson, Dunn, & Crutcher note OSHA has carefully considered these final rule are the same as those used to that most of the strain, sprain, and tear comments and finds them unpersuasive. support these analyses of the proposed injuries described in OSHA’s It is necessary and appropriate to rule. OSHA’s decision not to include preliminary risk assessment were include these BLS categories to arrive at vibration-induced injuries and illnesses associated with overexertion, which is an accurate estimate of the risk posed by in the universe of MSDs means that the defined by the BLS as follows: the biomechanical risk factors addressed risks estimated in the final Risk Overexertion applies to cases, usually non- in this standard. Assessment section, and the estimates First and foremost, OSHA is issuing in the Significance of Risk section, are impact, in which the injury or illness resulted from excessive physical effort its final ergonomics program standard understated. directed at an outside source of injury or because of substantial evidence that OSHA received numerous comments illness * * * Free bodily motions that do not workers who are regularly exposed to on its selection of injury/illness and involve an outside source of injury or illness biomechanical risk factors are at an exposure event codes from those used in are classified either in major group 21, Bodily increased risk of MSDs and the pain and the BLS classification system. In Reaction, or in major group 23, Repetitive disabilities associated with them. particular, several commenters objected Motion. (Ex. 26–1372) Whether these injuries and illnesses to OSHA’s inclusion of injuries Thus, Gibson, Dunn, and Crutcher argue come about because of an acute event or categorized as ‘‘strains, sprains, and that because of pathology that develops over tears,’’ because, in their view, such Clearly, nothing in this definition suggests a longer term is not germane to the issue injuries reflect acute injury events, that overexertion injuries develop gradually of whether workers who are regularly while OSHA’s ergonomics program over time. To the contrary, this definition exposed need protection. The sole standard was intended to address expressly excludes injuries that result from consideration is that increased exposure injuries that arise from cumulative repetitive motion. There is simply no to biomechanical risk factors increases damage through long-term exposure to evidence that sprains, strains, and tears the risk to the worker. For example, a risk factors. These commenters include, associated with overexertion meet the worker whose job involves heavy lifting among others, the Chamber of definition of an MSD. (Ex. 500–197, p. I–167) on a regular basis is at an elevated risk Commerce (Ex. 30–1722), the American Similarly, the Chamber of Commerce of suffering a low back disorder. Such Iron and Steel Institute (Exs. 30–3951, stated: ‘‘It is not difficult to imagine that a disorder may arise either because 32–206), Gibson, Dunn, & Crutcher on many, if not most of these injuries repeated lifting is causing cumulative behalf of numerous clients (Exs. 500– * * * may well have occurred as the wear resulting in degenerative changes 197, 32–241), the National Coalition on result of a single instantaneous event.’’ to the disc, or because the stress Ergonomics (Ex. 32–368), the American (Ex. 30–1722) imposed on the spine during lifting can Forest & Paper Association (Ex. 30– Gibson, Dunn & Crutcher (Ex. 500– overcome the capacity of the disc to 3865), the AEI-Brookings Joint Center 197), AISI (Exs. 32–206, 30–3951), the withstand compression, resulting in (Ex. 30–3911), Edison Electric Institute American Forest & Paper Association acute structural failure (see Section V.E (Ex. 32–300–1), the Center for Office (Ex. 30–3865), the American Meat on the health evidence for low-back Technology (Ex. 30–2208), Integrated Institute (Ex. 30–3677), and the Hon. disorders). Although a worker who lifts Waste Services Association (Ex. 30– David M. McIntosh of the U.S. House of heavy loads infrequently may be at risk 3853), Organization Resources Representatives (Ex. 30–542) all from acute failure, the worker who lifts Counselors (Ex. 30–3813), the American objected to the inclusion of cases from frequently as part of their regular job is Meat Institute (Ex. 30–3677), Guilford BLS category 0972 (back pain, hurt at greater risk via either mechanism. Mills (Tr. pp. 11519–11520, 11566– back) in the universe of MSDs on the Furthermore, there is substantial 11567), the Puerto Rico Manufacturers grounds that these are traumatic injuries evidence in the record that many of the Association (Ex. 30–3348), and the as well. To support this position, injuries coded as strains, sprains, and National Paint and Coatings Association Gibson, Dunn, & Crutcher pointed to tears in fact develop gradually over (Ex. 30–4340). In support of their views, OSHA’s Record Keeping Guidelines for time. Several commenters believed that these commenters point to the BLS’s Occupational Illnesses and Injuries, it was appropriate for OSHA to include definition of ‘‘strains, sprains, and commonly known as the ‘‘Blue Book.’’ statistics on strains, sprains, and tears in tears,’’ which appeared on Table VI–1 of These guidelines instruct employers its assessment of MSD risks. For the preamble to the proposal (64 FR how to record occupational injuries and example, the AFL-CIO, in their post- 65928—65929) and reads as follows: illnesses on their OSHA 200 logs. hearing brief, stated that

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The industry is just plain wrong on this Some rulemaking participants As described by the AFL–CIO point [that back injuries are traumatic provided evidence to the record submission and Dr. Frank Mirer’s injuries]. The BLS survey is based on documenting that back disorders were testimony, all back disorders are employer reports of injuries. To simplify frequently recorded as strains and classified as injuries rather than recording, OSHA recording criteria sprains without regard to the nature of illnesses, under OSHA’s recordkeeping specifically specify that back injuries, one major source of MSDs, should be recorded as the exposure or events associated with rules; as a result, back disorders are injuries, even if they result from chronic each case. For example, the post-hearing commonly classified as strains and exposure conditions. Disorders related to submission of the United Food and sprains, regardless of whether the repeated trauma, including carpal tunnel Commercial Workers Union (UFCW) disorder arose from an acute, traumatic syndrome are to be recorded as illnesses. (Ex. 500–133), which contained copies event or from cumulative damage * * * Thus, it is OSHA’s recording criteria of OSHA–200 logs (Ex. 500–133–2), caused by prolonged exposure to risk and BLSs coding rules and definitions that reported finding MSDs categorized as factors. Evidence in the record indicates result in many MSDs, particularly back strains and sprains, back pain, hurt that most cases of back pain arising from injuries, being classified as sprains, strains, back, carpal tunnel syndrome, hernia, exposure to risk factors of the type and tears. This category includes injuries that may result from a single exposure and those and disorders associated with repeated covered by the final rule do not develop that result from repeated activities. OSHA trauma. According to the UFCW, retail suddenly but are instead cases involving has limited the types of strains, sprains, and stores primarily categorized such MSDs gradual onset, which makes it difficult tears that are covered [in its risk assessment] as sprains and strains, back pain and to identify or relate the back pain to a to those * * * associated with] exposures hurt backs, and injuries, and seldom single precipitating event. OSHA’s that are covered by the rule (e.g., classified MSDs as illnesses. In contrast, witness, Dr. Stover Snook, testified that overexertion, repetition). (Ex. 500–218, p. the UFCW stated that meatpacking 13–14) I am of the view and most scientists are of industry logs more often accurately the view that that is not typically how low Testimony from Dr. Frank Mirer of the record MSDs as illness, reflecting the back pain develops through traumatic things United Auto Workers, who is also a greater experience this industry has in like playing football on a weekend. It usually dealing with ergonomic issues. A review develops gradually and insidiously, most of member of the BLS Labor Research it, not all of it, but most of it does. (Tr. 884) Advisory Committee, explained why of OSHA 200 logs submitted by the MSDs of the back are frequently Teamsters (Ex. 500–146) also shows that In a study of back braces, Walsh and recorded as sprains and strains: disorders that are clearly recognized as Schwartz (Ex. 30–3857–7) also MSDs, such as carpal tunnel syndrome characterized the nature of work-related You have to understand the reality of this and tendinitis, are nevertheless often back disorders as being of gradual onset: BLS database, which is derived from [the] recorded by employers as injuries, OSHA 101 form submitted by management Most back injuries are not the result of a medical departments to OSHA or to the BLS. which in turn would be described in the single traumatic incident but rather a Now when a worker goes up to the medical BLS statistics as strains and sprains. compilation of minor traumatic events department * * * all they know is they hurt. Other rulemaking participants occurring during normal working conditions And most of them see a nurse and their described the use of sprain and strain for reasons that are seldom obvious to the disorder is just thrown into a bin. Back injury categories for ergonomic injuries individual worker. Successive injuries result conditions are all injuries. They come as in other injury classification systems. In in more severe impairment and increase the strain and sprain * * *. [W]e have acute describing the province of Victoria’s probability of long-term disability * * *. In flare ups, just as a back injury is a chronic fact, improper body mechanics and condition and has an acute flare up. So (Australia) 1999 ergonomics regulation, unhealthy work habits may take their toll on standard practice in the industry * * * is which combined Victoria’s earlier a daily basis. In recent years, there has [that] cases [considered to be] of ergo interest manual handling and occupational evolved a body of evidence that suggests that * * * [include] sprain and strain injuries overuse syndrome (OOS) regulations, the etiology of most but not all back pain is that are not accompanied by a fall or some Mr. David C. Caple, Director, David due to insidious and chronic deterioration of other traumatic [event] * * *. (Tr. 5896– Caple & Associates Pty Ltd., testified the intervertebral disc, facet joints, and 5897) that both repetitive injuries and back ligaments in the back caused by injuries were combined under one biomechanical wear and tear. (Ex. 30–3857– When asked whether strains and sprains generic sprain and strain category by 7, p. 245) due to overexertion or repetition were that regulation (Tr. 2723–2724). The OSHA’s analysis of the biomechanical likely to be related to the risk factors Ford Motor Company’s injury and pathological literature dealing with covered by the standard, both Dr. classification system also combines work-related back pain leads to Rosecrance and Mr. Alexander agreed. strain and sprain injuries with conclusions that are consistent with Dr. Rosecrance testified that injuries cumulative trauma disorders and other these characterizations (see Section V, classified as sprains or strains are disorders of interest to the company’s Health Effects). appropriately considered MSDs, ergonomics committee (Tr. 5826). When Because back disorders are recorded depending on the events leading to the asked whether sprains and strains are as injuries, notwithstanding the injury: included within the category of mechanistic evidence described above * * * I look at an MSD * * * as a disorder repetitive motion disorders under that characterizes most back disorders affecting muscles, tendons, ligaments, bone, Oregon’s workers’ compensation law, as being of chronic onset, practicing connective tissue. And certainly in my Mr. Goodman replied that they are often ergonomists believe that it is important definition of MSD, a sprain would meet that classified in that category, depending on to investigate the underlying events because a sprain is a tear to a ligament * * * the events leading to the injury. He associated with recorded cases of strain [It] perhaps [might] be a traumatic one or explained that Oregon’s law defines an or sprain to determine whether the from an acute injury like a slip or a trip injury as ‘‘sudden and unexpected in injury is related to excessive exposure to * * *. When we review, let’s say, the OSHA 200 Log and there is a strain or sprain on onset’; thus, strains and sprains would ergonomic risk factors. This practice there, I will ask * * * what was the cause be considered repetitive motion was described in the testimony of Dr. of that sprain or strain? Was the strain from disorders if the onset was slow and John Rosecrance, Assistant Professor, repetitive use or was it a strain from an acute insidious rather than sudden (Tr. University of Iowa and Mr. David type of injury? 13694). Alexander, President of Auburn

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Engineers, Inc. and reflects an employees who are exposed to workplace risk factors and the relative understanding that the classification of workplace risk factors that are risk of developing an MSD (see the back disorders as strains and sprains associated with the development of Health Effects section of this preamble). often does not mirror the true nature of MSDs, for several reasons. First, the BLS These studies show that the prevalence these disorders. data include only those lost workday of MSDs among exposed employees is OSHA’s final risk assessment (like its (LWD) cases that resulted in at least 1 often 2- or 3-fold higher, and can be as proposed assessment) relies on statistics day spent away from work, and thus do much as 10 to 20 times higher, as the for strains and sprains that are not capture either non-lost workday prevalence among workers who are not associated only with overexertion (i.e., MSD cases nor MSD cases that resulted so exposed. lifting/lowering, pushing/pulling, in the employee being temporarily In the next part of the Final Risk holding/carrying), repetitive motion, reassigned to another job. Second, some Assessment, OSHA presents two and bodily reaction (i.e., awkward LWD MSDs reported to the BLS by alternative approaches to quantifying postures). Thus, OSHA’s treatment of employers are likely to have been coded risks posed to workers who are exposed the BLS data exclude strains and sprains in BLS injury categories that are to biomechanical risk factors on the job. that were determined by ergonomists or excluded from OSHA’s categories of The first approach is the same as that health care professionals to arise from overexertion, repetition, and bodily used in the Preliminary Risk accidents, such as slips or falls. Based reaction (bending, climbing, crawling, Assessment presented in with the on the evidence and testimony reviewed reaching, twisting); for example, injuries proposed rule. In that approach, above, strains and sprain injuries due to segmental vibration are included OSHA’s estimates of the risk are based captured by the BLS system and in BLS event categories other than those on the numbers and incidence of MSDs classified under these three exposure included by OSHA in its analysis, and, reported by BLS (based on OSHA’s event codes properly reflect as pointed out by the UAW (Ex. 32– definition of MSDs) by industry sector musculoskeletal disorders that arise as a 185), the non-specific BLS injury and by occupation. OSHA’s second result of exposure to the risk factors categories of ‘‘other’’ and ‘‘multiple approach responds to a number of covered in the final rule. Further, as injuries’’ are also likely to contain comments made in the record that the described below in part C of the risk MSDs. Agency’s Preliminary Risk Assessment assessment, OSHA has refined its Finally, the incidence of MSDs did not (1) properly subtract out MSD analysis, based on data in the record, to reported by the BLS is the reported cases that occurred among employees estimate the number and incidence of incidence of MSDs occurring among all who were not heavily exposed to MSDs occurring among those workers workers in the industries surveyed (on physical risk factors, and (2) did not who are exposed to risk factors at levels a full-time-equivalent basis); that is, the properly account for background risk that meet the final rule’s screen; OSHA incidence for each industry sector is (i.e., that part of the risk that could not believes that this refinement will ensure calculated by BLS as the number of be attributed to workplace exposure or that the Agency is accurately stating the MSD cases reported in 1996 divided by that occurs among the general risks posed to employees covered by the the total number of full-time equivalent population). To address these final rule. employees in that industry sector in The United Auto Workers (Ex. 32– 1996. Expressing the incidence in this comments, the Agency was able to use 185), argued that OSHA was way has the effect of diluting the data that became available in the record underinclusive, not overinclusive, in its estimated incidence of disorders that are to more precisely characterize the MSD choice of the BLS categories that actually occurring among exposed risk in the subset of employees who are represent MSDs. In addition to the six employees, i.e., those who routinely are the most heavily exposed to risk factors categories chosen by OSHA, the UAW exposed to workplace risk factors that covered in the final rule, and to account argued that OSHA should have included have been associated with the for background risk. OSHA’s underlying a substantial fraction of the injuries and development of work-related MSDs. The rationale is explained fully in part C illnesses categorized as ‘‘other’’ and risk to exposed employees is below. ‘‘multiple injuries’’ as well. OSHA substantially higher than the risk C. Results agrees that these injury categories reflected by the BLS estimates of MSD contain MSDs that are relevant to incidence, because most of the injuries Table VI–3 provides the BLS OSHA’s risk analysis. However, since reported to the BLS will in fact have estimates of the number of injuries and data are not available to describe the occurred among that subset of workers illnesses reported nationwide by proportion of the injuries classified whose jobs expose them to these risk employers for 1996, by nature of injury under these categories that are, in fact, factors (that is, if the incidence were and type of workplace exposure, for all MSDs, the Agency has not included calculated using the much smaller injury and exposure event categories them in its revised risk assessment. This denominator that reflects the number of determined by OSHA to represent the decision also means that the risks exposed employees, the resulting MSDs covered by the standard. Overall, presented by OSHA in its Risk incidence estimate would be higher). OSHA estimates that there were a total Assessment section and estimated in the Evidence that workers exposed to of 647,344 lost workday MSDs that Significance of Risk section are workplace risk factors are at occurred in 1996, as derived from understated. substantially higher risk than other employer reports of thoseTable VI–3 As explained by OSHA in its workers in their industry comes from here illnesses and injuries. These preliminary risk assessment for the the large data base of formal scientific disorders represent about 34.4 percent proposed rule, risk estimates based on studies of exposed worker populations of the 1.88 million LWD injuries and the BLS data understate the true risk of that have demonstrated a positive illnesses reported by employers in 1996 incurring a work-related MSD posed to relationship between exposure to (BLS press release 97–453, 12/17/97).

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TABLE VI±3.ÐESTIMATES OF THE NUMBER OF LOST WORKDAY MUSCULOSKELETAL DISORDERS (MSDS) IN 1996, BY NATURE OF INJURY AND TYPE OF WORKPLACE EXPOSURE

Type of workplace exposure Nature of injury BLS Code Total for all Overexertion Repetition Subtotal Bodily Subtotal exposures (O and R) Reaction a

Total for all lost work- day injuries ...... 526,594 73,796 600,390 79,475 679,865 Musculoskeletal Dis- orders: Sprains, Strains, Tears ...... 021 819,658 424,290 12,872 437,162 66,068 503,230 Back Pain, Hurt Back ...... 0972 52,046 28,046 861 28,907 4,646 33,553 Soreness, Hurt, ex- cept back ...... 0973 73,542 17,984 5,811 23,795 2,896 26,691 Carpal tunnel syn- drome ...... 1241 29,937 ...... 29,809 29,809 ...... 29,809 Hernia ...... 153 29,624 25,819 322 26,141 670 26,811 Musculoskeletal and connective system diseases and disorders .... 17 35,238 7,761 18,278 26,039 1,211 27,250

Total Number of MSDs ...... 1,040,045 503,900 67,953 571,853 75,491 647,344 a Data from BLS included only those injuries reporeted to have been associated with ``Bending, climbing, crawling, reaching, twisting.'' Source: BLS-reported estimates for BLS nature-of-injury codes 021, 0972, 0973, 1241, 153, and 17, and for BLS exposure events of overexertion, repeti- tion, and bodily reaction (1996).

For 1998, the BLS estimated that there evidence and testimony presented in sprain, strain, and tear injuries (379,615) were 592,500 MSDs that occurred part B above, however, OSHA has are comprised of injuries due to lifting throughout U.S. industry, representing determined that it is appropriate to /lowering, pushing/pulling, holding/ an 8.5-percent decline from 1996 (‘‘Lost- include strains, sprains, and tears that carrying, or throwing, all of which are Worktime Injuries and Illnesses: are associated with the exposure events activities involving force. For the Characteristics and Resulting Time of overexertion, repetitive motion, and remaining 11 percent of the BLS-coded Away From Work, 1998,’’ U.S. Bureau bodily reaction in the universe of sprain, strain, and tear injuries, the of Labor Statistics, available at http:// relevant MSDs because these injuries exact nature of the overexertion www.bls.gov/news.release/ arise from exposure to relevant risk exposure was either not reported by the osh2.nr0.htm). This decline is factors. Furthermore, OSHA believes employer or did not fall into any other consistent with the pattern seen from that, when MSDs result from exposure exposure classification under the BLS 1992–1996, when both MSD and overall to the biomechanical risk factors system. Of the 379,615 injuries for injury rates declined. For the final risk covered in the final rule, it is not which the nature of the overexertion assessment, OSHA has continued to use important to make any distinction exposure was reported, the majority (88 1996 BLS data in order to be consistent between whether those injuries arose percent) affected body parts that are with the economic analysis, which uses from acute or chronic events. The consistent with the kinds of injuries 1996 as a base year throughout. For purpose of the standard is to reduce the addressed by the final standard, such as example, 1996 is the base year from risk of MSDs resulting from exposure to the upper extremities, neck and which data are used to estimate risk factors, regardless of the duration of shoulder, lower extremities, and back. numbers of establishments and the exposure preceding to those injuries Fifty-two percent of these injuries employees, revenues, profits, and costs and illnesses. represent back injuries due to lifting or associated with the final rule. As further evidence of the lowering. Only a small proportion (12 About 66 percent of the estimated appropriateness of including strain, percent) of sprain, strain, and tear number of MSDs reported to the BLS in sprain, and tear injuries in the risk injuries reported by the BLS in 1996 1996 were categorized by BLS coders as assessment, OSHA presented BLS data affected body parts that are not relevant ‘‘sprains, strains, and tears’’ due to in the preliminary risk assessment that to MSDs. Therefore, OSHA is confident overexertion. As discussed in part B provides additional information on the that the vast majority of BLS-coded above, OSHA received many comments nature of the injuries and the exposure sprain, strain, and tear injuries are on the use of BLS data on injuries events associated with those injuries [64 appropriately included in the estimated classified by the BLS as sprains, strains, FR 65931]; these data are reproduced in number of MSDs for 1996, and that the and tears; these commenters objected to Table VI–4. For this analysis, OSHA judgment of the OSHA expert panel in including these injuries in the risk obtained from the BLS a breakout of the selecting appropriate BLS injury and assessment on the grounds that injuries estimated number of injuries, by body event categories for Table VI–4 here the classified as strains, sprains, and tears part and by type of overexertion event. risk analysis is confirmed by this reflect acute injuries that cannot be This breakout appears in Table VI–4 and additional breakout and review of the considered MSDs. Based on the shows that about 89 percent of these BLS data.

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The data summarized above have industry sector and by occupation code. with estimates of the incidence of been broken out by the BLS both by In addition, the BLS provided OSHA MSDs, as defined above by injury type

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Of the Census Employment and in the industry sector of interest).1 For experiencing an MSD. In addition, Earnings (1996). Occupations having the example, the estimated incidence of OSHA’s approach also assumes that highest incidence include: MSDs in 1996 for SIC 80, Health each worker within a given industry Driver—sales workers (42.2 cases/ Services, is 13.847 lost workday cases sector (defined by 2-digit SIC) has the 1,000 workers); per 1,000 workers. The probability that same risk. For the same reasons as a worker in SIC 80 will not experience discussed above, a relatively small Machine feeders and offbearers (34.6 an MSD in any given year is calculated number of workers will, in fact, cases/1,000); as 1-.013847, or 0.9862 (almost 99 experience injury rates far in excess of Public transportation attendants (32.1 percent). Over 45 years, the probability the average, while a comparatively large cases/1,000); that a worker will never experience a number will experience injury rates Nursing aides, orderlies, and work-related MSD is (.9862)45, or 0.534 below the average. At this time, data are attendants (31.6 cases/1,000); (i.e., 53 percent). Therefore, the not available that would allow OSHA to Punching and stamping machine probability that a worker in SIC 80 will determine the lifetime MSD risks for operators (30.4 cases/1,000 workers); experience at least one work-related subpopulations of workers within each Laborers, except construction (29.1 MSD is 1–0.534, or 0.466 (i.e., 466 per industry sector, i.e., those cases/1,000); 1,000 workers). subpopulations with higher than Sawing machine operators (18.9 Alternatively, lifetime risk could be average or lower than average risks, cases/1,000); defined as the expected number of respectively. work-related MSDs an employee Another meaning or interpretation of Furnace, kiln, and oven operators, entering an industry will experience expected value may be more intuitive: except food (18.0 cases/1,000); over a working lifetime in that industry. The expected value is the total number Grinding, abrading, polishing Unlike a probability, the expected value of MSDs that may be expected to occur machine operators (17.9 cases/1,000); in such cases can exceed 1. (That is in a cohort of 1000 workers all of whom Health aides, except nurses (16.9 why, in the table below, one industry is enter an industry sector at the same time cases/1,000; and identified in which an individual who and all of whom work for 45 years in the Licensed practical nurses (16.5 cases/ works for 45 years can expect to industry. The expected value of the 1,000). experience, on average, more than one number of MSDs occurring among these Of the 225 occupations for which BLS work-related MSD during that time.) 1,000 workers over 45 years of provided estimates of the numbers of The expected value represents the employment is calculated as the annual employer-reported MSDs and total experience of the ‘‘average’’ individual, MSD incidence multiplied by 45. For employment, the annual incidence of a measure that reflects the aggregate example, the estimated incidence of MSDs was 1 LWD case or more per experience of many individuals. work-related MSDs in 1996 for SIC 80 1 1,000 workers per year for 178 (79 Both approaches taken by OSHA to (Health Services) is 13.847 cases per percent) of the occupations. The data estimate lifetime risk assume that the 1,000 workers, or a frequency of described above reflect the annual risk to a worker is independent from 0.01387. The expected value of the incidence of MSDs estimated to have one year to the next, i.e., that a worker’s number of work-related MSDs predicted occurred in 1996 within general injury experience in any one year does to occur among those 1,000 workers industry sectors and within occupations not modify his or her risk in any over 45 years is estimated to be within this sector. subsequent year. Although this is a (0.01387*45), or 0.623 (623 per 1,000 reasonable assumption for the purpose workers). Past risk assessments conducted by of estimating an average lifetime risk, it Table VI–7 presents OSHA’s estimates OSHA in other health standards is likely to be the case that the risk will of the lifetime risk of experiencing rulemakings have typically estimated be higher for workers who have had an work-related MSDs, by industry sector. the lifetime risk to workers based on the MSD and continue to be exposed since Based on the probability approach, the assumption that they are exposed to the musculoskeletal tissue has already been estimated probability of experiencing at hazard in question for a full 45-year damaged. Among workers who have not least one work-related MSD during a working lifetime. These past risk experienced symptoms of an MSD, the working lifetime ranges from 24 per assessments dealt primarily with risk to any individual worker in 1,000 to 813 per 1,000, depending on chronic, fatal diseases such as cancer. subsequent years depends on the the industry sector. Based on the Unlike the impairments of health amount of tissue damage sustained from expected value approach, the expected caused by many other OSHA-regulated exposure to risk factors and that number of work-related MSDs that will hazards, however, MSDs are not fatal, worker’s individual ability to repair or occur in a cohort of workers all entering although they are often debilitating. resist continued injury to the point of an industry at the same time ranges Moreover, a worker can experience from 24 per 1,000 to 1646 per 1,000, more than one work-related MSD over a 1 OSHA used two simplifying assumptions when since this approach recognizes that it is working lifetime. As a result, the calculating the probability of experiencing no work- possible for a worker to experience more lifetime risk associated with exposure to related MSDs in a working lifetime: (1) Employment than one work-related MSD in a risk factors on the job can be expressed in an industry was used as a surrogate for exposure working lifetime. in a number of ways. One way of doing to ergonomic hazards in that industry. (2) The probability of experiencing a work-related MSD in Several rulemaking participants this is to define lifetime risk as the any given industry was treated as if it were criticized OSHA’s preliminary risk probability that a worker will identical for workers in that industry who had assessment on the grounds that the experience at least one work-related never previously experienced a work-related MSD Agency’s risk estimates made no musculoskeletal disorder during his or and those who had previously experienced a work- related MSD. allowance or correction for background her working lifetime (45 years). This 1 In written comments (Ex.32–185–3), the UAW risk. These participants (see, for 45 probability is calculated as 1–(p), expressed a strong preference for estimating the example, Exs. 32–206, 500–223, Tr. where p is the probability that a worker lifetime risk as the probability that a worker will pp.10248–9, Exs. 30–3865, 30–3356, 32– will not experience a work-related MSD experience at least one MSD in a working lifetime rather than as an estimate of the lifetime risk 368, 30–4185, 30–3813, 30–1722, 500– in any given year (i.e., p is one minus expressed as the expected number of MSDs a 221) argued that MSD risks for specific the estimated MSD incidence for 1996 worker will experience in a working lifetime. industries and occupations based on

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BLS data should be compared to the general population. When excess risk is population is the non-work-related rate, background rate of MSD risk in the calculated by comparing a population of and then subtracting this rate from the general population to calculate the concern (in this case the employed BLS-based rate, would yield estimates of excess risk associated with work. Some population) to a reference population the work-related, or excess, risk to of these stakeholders asserted that, (e.g., the general population), the proper workers only if the BLS data truly because OSHA has not done so, the approach is to compare the total represented all MSDs occurring among Agency’s estimates here represent only incidence in the population of concern workers (both on the job and off the job). the average MSD risk posed to a worker to the total incidence in the reference This is clearly not the case, since the in a particular industry or occupation by population (see Rothman and BLS data are designed only to capture exposure to ‘‘all of life’s activities.’’ Greenland, Ex. 38–240). That is, to those injuries that are work-related; the OSHA does not agree; the BLS data estimate the excess risk of MSDs among BLS system does not capture those reflect only cases that employers have workers using the approach suggested MSDs that occur among workers that are deemed to be work-related. It would be by these commenters, one must have unrelated to work. Therefore, adjusting inappropriate to adjust the MSD rates data that describes the incidence of all the BLS data by subtracting out MSD estimated on the basis of the BLS data MSDs, both work-and non-work-related, rates for the general population would by subtracting from these rates the MSD in the working population. Assuming not yield meaningful estimates of the rates that have been reported in the that the MSD rate for the general excess MSD risk to workers.

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Some commenters (see, e.g., Ex. 30– 46–28, 30–4564, 30–3865, 30–4185, 30– screening out some of the background 3813, Tr. 4102–4108, Exs. 30–3356, 30– 3368, 30–1897) argued that, despite risk, the BLS data are still overinclusive.

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They pointed out that under the employees in jobs that would not be studies reviewed in the Health Effects applicable OSHA and BLS guidelines, a covered by the OSHA standard. That is, section. It is for this reason that OSHA case is considered ‘‘work-related’’ if an some of the MSDs being captured by the believes that the risk estimates event or exposure in the workplace BLS’s annual survey reflect injuries to presented in the first analysis above, made any contribution to the injury or workers who are not in jobs that meet which relied on the BLS-reported illness, regardless of the extent of that the action trigger, e.g., those who may incidence estimates by industry and contribution. For example, Frank White be exposed to risk factors only occupation, understate the true risk of ORC testified that infrequently or those whose exposures among the workers who are more highly ORC [and others] question OSHA’s ability were not of sufficient duration. OSHA exposed to physical risk factors (while to make quantitative determinations of does not intend the final ergonomics overstating it for workers who are not workplace risks based on data that do not program standard to apply to these highly exposed to risk factors). allow OSHA to differentiate between the kinds of jobs. Instead, OSHA intends the OSHA’s second approach to respective contributions of workplace and standard to apply to those jobs where estimating work-related MSD risks takes non-workplace factors. In the face of OSHA’s MSDs have occurred and the employee’s account of this risk differential between own acknowledgment of the special exposure to risk factors was of sufficient more highly exposed (i.e., higher-risk) difficulties associated with establishing MSD workers and lesser-exposed (i.e., lesser- causation compared ‘‘to more traditional duration, magnitude, and frequency to workplace exposures and disorders,’’ the use have contributed to the injury. This risk) workers to estimate more precisely of data that inherently include conditions concept is reflected in the final rule in the risk among those workers who caused by both work and non-work the form of the Basic Screening Tool, would most benefit from an ergonomics exposures to determine workplace risk is which explicitly identifies those program. In addition, the risk among the unacceptable. The result, once again, is an exposure conditions that must be higher-risk workers is estimated in two overreaching by OSHA—this time in its forms. One assumes that all of the risk estimation of the true workplace risk—that present on the job, along with an employee’s report of an MSD incident, among the higher-risk workers can be has the effect of permeating, and effectively attributed to their exposure to invalidating, the entire proposal. (Tr. 4102) before the employer is obligated to implement the program. Employers biomechanical risk factors, i.e., all of the OSHA interprets Mr. White’s comment have no obligation to establish an risk is work-related. OSHA believes this as saying that, although strictly non- ergonomics program under the final rule is reasonable because the data used to work-related MSDs are not captured by if employees are not exposed to risk make these estimates are the BLS data, the BLS system, some proportion of factors at least at the level(s) reflected in which represents MSDs reported by cases in the system nevertheless the Basic Screening Tool. Thus, OSHA employers to be work-related. The represent MSDs that occur among second form assumes that, despite the workers who are not regularly exposed adjusted, as an alternate analysis, its estimates of risk based on the BLS data fact that the data derive from reports of to risk factors, or whose exposures arise work-related injuries, only part of the from tasks that are not ‘‘core elements’’ to include only that portion of the risk that will be addressed by an ergonomics risk can be attributed to workplace of the job (using the language contained exposure to physical risk factors in the proposed rule). In other words, program developed under the final rule, i.e., that portion of the risk that is because of the presence of some although there may be some ‘‘background’’ risk among the higher- contribution from work to these cases, occurring among employees who are exposed to risk factors at least to the risk workers. This background risk exposure to risk factors on the job are represents MSDs that are not work- extent reflected in the final rule’s no greater that those encountered during related and are attributed to some screening tool. OSHA is thus estimating non-work activities. unknown non-work exposure to risk the risk of MSDs occurring among In this risk assessment for the final factors. OSHA believes that making employees who would be covered in an ergonomics program standard, OSHA such an adjustment to the estimated risk ergonomics program, i.e., those who are has relied on BLS injury and illness data among higher-risk workers leads to an more highly exposed to biomechanical in much the same way it does when overly conservative estimate of risk risk factors. evaluating the risks associated with among workers whose jobs will be safety hazards. Because the statistics As explained by OSHA above, the screened in under the final rule; relied upon by OSHA reflect work- BLS-reported incidence of MSDs reflects however, the Agency is nevertheless related injuries and illnesses reported the number of MSDs reported per 1,000 making this adjustment in response to by employers and determined by OSHA full-time equivalent workers employed addresses the concerns of those to have been associated with exposure in industry. This incidence figure commenters who argued that OSHA to the risk factors addressed by the final distributes the MSDs evenly across all should take account of the rule, there is no ‘‘background’’ number workers in an industry sector or ‘‘background’’ incidence of MSDs. of injuries and illnesses in the OSHA occupation. However, as demonstrated The first step in OSHA’s second data in the sense that BLS data are by the scientific evidence presented in approach to estimating work-related capturing non-work-related injuries. In the Health Effects section (Section V), MSD risks is to estimate the incidence other words, the total number of MSDs OSHA has determined that the work- of MSDs for higher-risk and for lesser- that occur in the workforce are either related risk of MSDs increases with the risk workers. OSHA considers the work-related or non-work-related; BLS intensity and/or duration of exposure. higher-risk workers to be those workers counts the first and the second Because of this, MSDs are not, in fact, who are exposed to risk factors at levels represents background. Thus, OSHA evenly distributed across all workers, that meet the final rule’s basic screening does not agree with these commenters but are concentrated among the tool; all other workers are considered that it is necessary to adjust the BLS proportion of workers who are the more lower-risk in the sense that they are data per se to account for such highly exposed to biomechanical risk exposed to risk factors at levels below background risk. factors. Thus, the incidence of MSDs the final rule’s screen. However, OSHA does recognize that among the more highly exposed workers To accomplish this analysis, OSHA some fraction of the number of MSDs is greater than that among the lesser- relied on data contained in the record estimated from the BLS data represents exposed workers; this has been shown from Washington State’s industry-wide injuries and illnesses occurring among in the almost 200 epidemiological survey of workplace exposure to

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Assuming that there is a three-fold workers compared with lower-risk higher-risk employees is estimated for higher risk of MSDs among higher-risk workers, the incidence of MSDs among

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TABLE VI±9.ÐSUMMARY OF RISK RATIOS IN THE EPIDEMIOLOGICAL LITERATURE FOR MSDS REVIEWED BY OSHA, AND ESTIMATED FRACTION OF MSDS ATTRIBUTABLE TO WORKPLACE EXPOSURE

Body part affected/disorder Neck or neck/ Only Elbow Carpal tunnel Hand/wrist Hand/arm Back Lower shoulder shoulder syndrome tendinitis vibration extremity

Number of Stud- ies Included .. 42 32 18 30 10 12 44 9

Risk Ratios a

Median ...... 2.7 3.3 2.8 3.2 3.7 6.6 1.85 2.2 Average ...... 4.5 5.2 5.5 4.4 6.5 12.6 2.66 2.4

Estimated Percent of MSDs Attributable to Exposure to Risk Factors b

Median ...... 63.0 69.5 63.6 68.5 72.6 84.8 45.9 53.5 Average ...... 77.6 80.6 81.9 77.5 84.6 92.1 62.4 58.9 a Risk ratios include odds ratios, prevalence rate ratios, and incidence ratios. b Proportion of disorders among exposed workers that is attributable to their exposure at work; calculated as (RR±1)/RR, where RR is the me- dian or average risk ratio derived from each group of epidemiological studies. Source: Data presented in Tables V±1 through V±6 of the Health Effects section (Section V).

The MSD incidence among lower-risk estimate the lower bound, OSHA of MSDs per worker (i.e., the expected employees in each industry sector is estimated the excess risk among higher- value) were calculated assuming a 45- estimated as the ratio of the number of risk workers from the general formula year working life. Table VI–10 presents MSDs that occurred in 1996 among that the Agency has used in previous OSHA’s estimates of the lifetime risk of lower-risk employees to the estimated risk assessments to estimate excess risk. experiencing work-related MSDs, by number of lower-risk employees in each The general formula for estimating industry sector; lifetime risks were industry sector (see formula in Table excess risk is calculated based on both the upper- and VI–8). lower-bound estimates of the MSD PP− The portion of the risk for higher-risk d 0 incidence among higher-risk employees − employees that can be attributed 1 P0 (i.e., those exposed to risk factors at levels meeting the final rule’s screen). directly to workplace exposure to risk where Pd is the probability of injury or factors (i.e., that portion of the risk that illness among workers exposed to a Based on the probability approach, the estimated probability that a higher-risk is potentially preventable) lies between hazard and P0 is the background risk two extremes, the upper and the lower that occurs among persons who are not worker will experience at least one work-related MSD during a working bound of the range of estimated risks. exposed to the hazard. In this case, P0 OSHA estimated the upper bound of the represents the estimated MSD incidence lifetime ranges from 33 per 1,000 range to be equal to the MSD incidence among workers who are either not workers to 926 per 1,000 workers, among higher-risk employees; this exposed to risk factors at work or who depending on the industry sector. Based bound assumes that the BLS data are exposed to risk factors below the on the expected value approach, the includes no cases reflecting background level meeting the final rule’s screen. expected number of work-related MSDs risk, since all of the MSD cases in the As with the first risk assessment that will occur in a cohort of higher-risk BLS data are work-related. The lower approach discussed above, OSHA also workers all entering an industry at the bound, on the other hand, assumes that estimated the lifetime risk of same time ranges from 34 per 1,000 the MSD incidence among lower-risk experiencing a LWD MSD to workers workers to 2,530 per 1,000 workers, employees is entirely attributable to who work in jobs that meet the final since this approach recognizes that it is background, i.e., that work did not rule’s basic screening tool. Estimates possible for a worker to experience more contribute in any of the MSD cases representing the risk of experiencing at than one work-related MSD in a reported among lower-risk workers. To least one MSD and the average number working lifetime.

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Several rulemaking participants preliminary risk assessment and the estimate the magnitude of MSD risks to commented on the results of OSHA’s approaches taken by the Agency to employees.

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In their post-hearing submissions estimated MSD rates in the working used in occupational epidemiology. It (Exs. 500–221, 500–223), Keller & population, based on the BLS data, and cannot represent the rate of CTS among Heckman presented an alternative risk estimated MSD rates in the general persons without workplace exposure analysis that they believe could be used population, based on community because the CTS cases in the Maizlish to compare work-related risks to the medical records for the rate of CTS in study were drawn from the entire background risk of MSDs. Citing the Rochester, Minnesota. As explained in Rochester population, which included work of Maizlish et al. (Ex. 26–1186), part B above, the BLS injury and illness both workers and non-workers. they stated that the background risk of survey is not designed to capture all For these reasons, OSHA finds the carpal tunnel syndrome (CTS) is 1.05 injuries and illnesses that occur among analysis provided by Keller & Heckman cases per 1,000 person-years; this workers; it is only designed to capture both methodologically flawed and estimate is based on an analysis of those that employers have determined unconvincing. The Agency believes that medical records in Rochester, to be work-related. In contrast, the its own risk analysis, which is based on Minnesota, between 1961 and 1980 Rochester study on which Keller & estimates of the numbers of higher-risk (Stevens et al., Ex. 26–1009). Using Heckman’s analysis rests involved all and lower-risk workers and on the OSHA’s estimates from the preliminary cases of CTS that occurred in the extensive epidemiological data risk assessment of the total number of community, regardless of whether those presented in Section V of this preamble, MSDs in U.S. industry for each of the cases were work-related or not. These appropriately takes account of that six injury categories selected by OSHA, two statistics are not comparable in any portion of the MSD rate among workers Keller & Heckman estimated a meaningful way. To make a meaningful that is attributable to their workplace background incidence for each of the six comparison, one would need to have exposures. injury types based on the ratio of the data that permit estimates to be made of Keller & Heckman (Exs. 500–221, number of LWD cases for each injury the total MSD rate in the U.S. workforce, 500–223) also claim that the ‘‘aggregate type to the number of LWD CTS cases. not just the work-related component. risk (workplace and non-workplace risk For example, since OSHA’s estimates of Second, Keller & Heckman assume combined)’’ of a U.S. worker the number of LWD strains, sprains, and that the ratio between the number of one experiencing an LWD MSD due to tears is 16.88 times higher than the type of MSD to that of another will anything that might be defined as a number of LWD CTS cases, Keller & mirror the ratio of the incidence rates harmful physical agent would be no Heckman estimated that the background for the two types of MSDs in the general more than 0.7 per 1,000 workers per rate of LWD strain, sprain, and tear population. However, the ratio between year. They arrive at this rate by dividing injuries in the U.S. population is 17.72 the number of cases of two medical the 1996 number of BLS MSD cases cases per 1,000 people per year (i.e., conditions can be equal to the ratio of caused by repetition by total private industry employment. This estimate 16.88 × 1.05). Across all six injury types, the incidences of those conditions only ignores the LWD cases attributed in the Keller & Heckman estimated the if the cases of both medical conditions BLS data to overexertion or to awkward background rate for all LWD MSDs to be are drawn from the same population. postures (i.e., ‘‘bending, climbing, 22.83 cases per 1,000 persons per year Clearly, the population from which the crawling, reaching, twisting’’), both of for the U.S. population. They also BLS data are drawn differs from the which are exposure event codes that estimated the MSD rate across the U.S. general U.S. population in many ways. OSHA has determined to be highly workforce to be 6.55 LWD MSD cases Consequently, OSHA believes that it is not possible to reliably estimate the relevant for assessing MSD risks to per person-year, by dividing the total background rate of any type of MSD in workers. Second, Keller & Heckman estimated number of MSDs in 1996 the general population from the ratio characterize their aggregate risk rate as (647,344) by private industry between two MSD types seen in the reflecting both workplace and non- employment for 1996 (98,772,900 working population, and therefore the workplace contributions to MSD risk. workers). From this analysis, Keller & assumption made by Keller & Heckman Since the rate Keller & Heckman use is Heckman concluded that there is no in conducting their analysis is not derived from BLS data, which reflects significant excess risk of MSDs in supportable. work-related cases exclusively, OSHA private industry, since the estimated Third, Keller & Heckman’s analysis does not agree with this background rate of MSDs in the general interprets the rate of CTS in the characterization. population is about 3.5 times higher Rochester, Minnesota, population as the The National Coalition on Ergonomics than the rate that they estimated for the ‘‘background’’ rate of CTS. However, the (Ex. 32–368) and the American Iron and U.S. workforce. They presented similar study by Stevens et al. (Ex. 26–1009) Steel Institute (Ex. 32–206) objected to estimates of MSD rates for selected made no effort to evaluate the work- the fact that OSHA did not modify its industry sectors at the 3-digit SIC level relatedness of the CTS cases identified risk estimates from the BLS data by and concluded that (1) only 10 of the from the medical records, nor was there reducing them to account for MSDs that hundreds of industry sectors covered by any mention of the investigators occurred in jobs that would not pass the the ergonomics program rule have an collecting work histories or assessing screening criteria in § 1920.902 of the MSD incidence that exceeds their the work status of the cases identified. proposal. In the final ergonomics estimated background rate of MSDs, and The Maizlish study (Ex. 26–1186) cited program rule, OSHA has modified its (2) that there is no excess risk of work- by Keller & Heckman was a study of a screening criteria from the performance- related MSDs in either SIC 204 (Grain California surveillance system for work- oriented language contained in the Mill Products), SIC 206 (Sugar and related CTS, in which the Rochester proposal to be more specific in terms of Confectionary Products), or SIC 331 CTS rate was used as a reference point the kinds and durations of exposures to (Steel Works, Blast Furnaces, and for the purpose of identifying ‘‘epidemic risk factors that warrant further hazard Rolling Mills). clusters’’ of CTS (defined as a rate twice analysis by the employer. Employers are OSHA believes that the analysis that of the Rochester CTS rate). not expected to conduct job hazard conducted by Keller & Heckman is Although the authors of this study refer analysis or provide medical seriously flawed in a number of to the Rochester CTS rate as a management of MSDs for employees in respects. First, Keller & Heckman make ‘‘background’’ rate, their rate is clearly jobs where the exposures to risk factors an improper comparison between not a background rate as that term is are below those in the final rule’s action

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Thus, related, accurate reports of the medical OSHA’s final risk assessment reflects • The cases reported are only those diagnoses of work-related MSDs would the excess MSD risks among the more that were serious enough to involve at result in higher risk estimates than those highly exposed portion of the worker least one day away from work, in OSHA’s analysis. population covered by the standard. • The cases reported do not include The Edison Electric Institute (Ex. 32– The Center for Office Technology other types of work-related MSD cases 300–1) and Southern California Edison (COT) (Ex. 30–2208) and the Puerto Rico that rarely, if ever, come to the attention (Ex. 30–3284) take OSHA’s statement in Manufacturing Association (Ex. 30– of the employer, and the preliminary risk assessment that 3348) took issue with OSHA’s • The cases reported do not account BLS data ‘‘are not easy to use for risk statements in the preliminary risk for the extended or permanent disability assessment purposes’’ to mean that assessment and significance of risk that results in employee termination. these data are weak. This is not the case nor is it what OSHA meant by this analysis for the proposed rule that the In addition, NIOSH points out that some statement. OSHA’s statement that the BLS data understate risk. For example, workers with MSD episodes that may BLS data are not easy to use for risk COT commented that represent lost workday cases are assessment referred to the fact that the * * * BLS in their reports state that there is reassigned to minimal work activities in BLS injury and illness classification ‘‘95% confidence that the ‘true’ incidence order to avoid recording the case as one system does not contain a single injury/ rate falls within the confidence interval involving lost workdays. For these illness category that contains data on all * * * and has an estimated relative standard reasons, NIOSH agrees that there is a error of about 0.9 percent.’’ BLS does not relevant MSDs. This fact required the substantial likelihood of under- state that their estimates of injury and Agency to select injury/illness illnesses reflect under reporting. Assistant reporting in the BLS system and that the categories and appropriate exposure Secretary Charles Jeffress is also on the BLS estimates represent a lower bound event categories to represent the kinds record supporting the accuracy of the BLS of the true risks of work-related MSDs. of disorders addressed by the final rule. data and is quoted * * * as saying ‘‘90% of NIOSH agrees with OSHA that the true As discussed above, OSHA has employers keep accurate records 95% of the incidence of work-related MSDs is time, or better.’’ (Ex. 2208, p. 19) determined both that the BLS data are greater than indicated by the BLS the best available data for evaluating However, OSHA did not base its estimates. MSD risks to workers and that OSHA’s preliminary determination that work- In its pre-hearing comments (Ex. 32– reliance on these data is appropriate. In related MSDs are seriously 368), the National Coalition on addition, these two stakeholders underreported on the precision (or lack Ergonomics objected to the use of BLS characterize the employment estimates thereof) of the BLS survey. The BLS data in risk assessment on the grounds from the U.S. Bureau of the Census as statement referred to in COT’s comment that the data reflect reports by workers ‘‘another questionable data source’’ simply reflects the fact that the BLS to employers rather than medical without providing any justification for estimates of work-related injuries and diagnoses. The BLS data relied on by this characterization. They also stated illnesses in the United States are based OSHA in this risk assessment is lost- that combining these data to calculate on a sampling of OSHA 200 logs, not the work-day data, which employers MSD rates by occupation ‘‘compounds logs of all employers. Consequently, the provide to the BLS along with sufficient the flaw.’’ In fact, both the BLS and estimates generated from the sample of information about each injury or illness Bureau of Census population data have logs have some uncertainty associated to permit detailed classification of each been used by the Agency to analyze the with them, which is characterized by a injury and illness. Thus, the data relied impact of its rules for several years, are 95% confidence interval around the on by OSHA do not represent ‘‘reports used extensively by other researchers estimate. The stated precision of the by workers to employers’’ but cases that both within and outside the federal survey data provided by the BLS does employers have determined to be work government, and represent state-of-the- not address issues related to the related and for which they provided art programs for conducting and accuracy of the logs that are sampled, detailed descriptions of the nature of the analyzing nationwide surveys of just the precision of the estimates events associated with each case. working populations. OSHA knows of generated from the sampled logs. Further, the Coalition’s comment no other data sources that could provide OSHA’s determination that MSDs are implies that MSD rates would be much more reliable information on seriously underreported on OSHA logs lower if they were based on medical occupations and workplace injuries and is based on the findings of several diagnoses rather than employer reports. illness in the United States. scientific studies and other data that However, evidence in the rulemaking Jesse McDaniel, a Certified Safety compared MSD rates from logs to those record shows that the opposite result is Professional from August Mack Inc. (Ex. from medical insurance records, records more likely; several investigators have 30–240), commented on OSHA’s use of of sick leave, or other sources of data actually compared MSD rates from the the BLS data and the preliminary risk independent from the OSHA logs; these OSHA logs with the rates reflected in assessment. First, Mr. McDaniel stated studies were reviewed in Table VII–2 of other sources of data that report the that injuries that do not involve lost the preamble to OSHA’s proposed rule results of medical evaluations of injuries workdays, restricted work, or medical (64 FR 65982), and in Table VII–1 and and illnesses, such as medical insurance treatment (or diagnosis in the case of an OSHA’s discussion of the Significance records, compensation claims, medical illness) are not recordable cases under of Risk (Section VII) in this preamble. case records, and medical absence OSHA’s recordkeeping rules; he According to NIOSH (Ex. 32–450), records (Exs. 26–28, 26–920, 26–1261, believes that OSHA was therefore OSHA’s discussion of the limitations on 26–1259, 26–1260). These studies, incorrect in stating in the preliminary the use of BLS data in the risk reviewed in the Significance of Risk risk assessment that the BLS data assessment section of the preamble is section of the preamble (Section VII), understate the true MSD risk to workers

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00307 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68568 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations because it excludes cases that do not Second, OSHA compiled a large hazards is strong. Likewise, NIOSH’s involve days away from work. In other database of published and unpublished experience in evaluating the risks of MSDs in words, Mr. McDaniel appears to believe data from case studies that describe the a variety of workplaces and our review of that cases not counted as LWD MSDs in effect of implementing ergonomic information from a variety of sizes of industries has generally shown that using the BLS system are not recordable, and programs on workplace MSD injury ergonomic programs is an effective way to that OSHA’s claim that the data rates. Finally, OSHA used the findings prevent or reduce work-related MSDs. understate the true risk is not from the epidemiological studies (Ex. 32–450–1, pp. 8–10) warranted. OSHA does not agree it was contained in the NIOSH (1997, Ex. 26– incorrect in making this statement. The 1) review to estimate the potential Many expert witnesses also testified data relied on by OSHA for both its effectiveness of ergonomics programs. that, from their experience, ergonomic preliminary and final risk assessment Since publication of the proposal, a programs are effective in reducing MSD comes from the detailed employer substantial number of additional risks. For example, Dr. Snook testified survey data, which requires employers scientific and ergonomic case studies on the effectiveness of ergonomic to provide descriptions of work-related were entered into the record; OSHA has programs for reducing the disability injuries and illnesses only for those relied on these to revise its effectiveness from back pain: cases involving days away from work, analysis. The additional information Now, this is what we know about i.e., the employer is not required to and data entered into the record confirm ergonomics and low back disorders. First of provide detailed information on other OSHA’s preliminary determination in all, we know that in heavy manual handling kinds of recordable injuries and illness the proposal that ergonomic programs jobs, there is an increased disability from low back pain, as measured in lost work days and not involving days away from work. and interventions are effective both in Therefore, OSHA’s estimates of LWD restricted duty. reducing those forces on the The second thing that we know is that MSD rates based on the BLS data do not musculoskeletal tissue that have been there have been several guidelines developed include the other kinds of recordable associated with the development of to help identify the high risk manual MSDs referred to by Mr. McDaniel. He tissue pathology, and in reducing the handling jobs. also believes that OSHA inflated its risk incidence of MSDs. In this section, Third, that when these jobs are designed estimates by reporting MSD rates per OSHA summarizes these studies and according to the guidelines, the disability 1,000 workers rather than on a per-100- evidence and analyzes the data from from low back pain decreases. worker basis, which is the convention And finally, employers who have used these studies to estimate the overall ergonomics programs to identify and control used by BLS in reporting injury rates by reduction in MSD rates that is likely to industry sector and occupation. OSHA high-risk jobs have found them to be cost occur when employers implement effective. used the risk per 1,000 worker metric ergonomic programs like the program I also believe it is important to because OSHA’s significant risk range is required by this standard. acknowledge what we do not know. We bounded by the Supreme Court’s The record contains much testimony simply do not know the * * * [etiology] or guidance in the Benzene decision, as from scientific experts that ergonomic the cause of most low back pain. explained in the preliminary risk programs designed to reduce Some have suggested that this lack of assessment. Mr. McDaniel also provided biomechanical load are effective in knowledge must constitute a stopping point. examples that he believes suggest Others, however, have demonstrated that this reducing MSD risk. In its pre-hearing is not a stopping point, that implementing OSHA’s estimated LWD MSD rates testimony, NIOSH agreed with OSHA’s exceed the BLS-estimated total injury ergonomic intervention[s] and programs to preliminary conclusion that ergonomic reduce physical loads does reduce the case rates for some industry sectors and programs are effective: disability from low back pain. occupations. However, since the BLS (Tr. 846–847) case rates are reported per 100 full-time- * * * [T]here are numerous companies which have reported success in using equivalent employees, and OSHA Dr. Cherniak testified that the volume of ergonomic programs as a cost-effective way published ergonomics literature itself is presents its risk estimates to prevent or reduce work-related MSDs, and conventionally in terms of cases per reduce lost time by workers with MSDs. indicative of the success of ergonomics 1,000 employees, OSHA’s rates, as they Some of these companies also report interventions: appear in this risk assessment, must first increases in productivity and workplace The extensive literature review included in be divided by 10 to be comparable to the morale. The studies—in part summarized in this [OSHA’s proposed] standard and BLS injury case rates. When this OSHA’s preamble, reviewed by the NAS explosion of the ergonomics literature in adjustment is made, the comparisons panel—illustrate that interventions, industrial countries are testaments to the made by Mr. McDaniel show that including redesign of tools, machines, and seriousness of MSDs, but also to the OSHA’s estimated MSD rates are below work stations, can reduce workplace hazards effectiveness of responsive intervention. I and the resulting MSDs. * * * the BLS’s total injury case rates. would say that medical fields that lack The effectiveness of ergonomics programs components of prevention and therapeutics D. Analysis of Ergonomic Program was a resounding message echoed by labor, do not usually generate expanding literature. Effectiveness industry, business, universities, health care, They generally lead to dead ends. and professional societies at two conferences (Tr. 1134–1135) In the preliminary risk assessment, co-organized by NIOSH and OSHA to OSHA evaluated information and data stimulate an exchange of information about Many other rulemaking participants that described the effectiveness of preventing work-related MSDs. * * * The provided testimony that ergonomics ergonomic interventions and programs conferences, attended by over 1,700 people, programs reduce disease. Dr. Barbara similar to those of the proposed featured workshops and presentations by Silverstein, Research Director for the ergonomics program standard [64 FR industry, labor, and government Safety and Health Assessment and 65943–65975]. These data were drawn representatives sharing their successful Research Team, Washington State from three sources. First, OSHA ergonomics programs and how they have Department of Labor and Industries, reduced lost work time and cut costs due to searched for and evaluated studies that injuries and illnesses in a variety of testified that ‘‘Reducing exposure to investigated the effect of ergonomic industries and workplaces. * * * hazardous loads does reduce interventions on reducing exposures to NIOSH believes that the evidence in the musculoskeletal disorder prevalence, workplace risk factors. These included scientific literature showing the success of an incidence, and severity.’’ (Tr. 17357) both field and laboratory studies. ergonomics program approach to workplace Both Drs. Bernacki and McCunney,

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Dr. Punnett: Well, that I think leads us 7690–7693) Sherri Gibson, representing fairly directly to the inference that reducing Because of the independent physical work load all other things being the American Industrial Hygiene relationship between biomechanical and Association, testified that ‘‘We know the equal will reduce the magnitude and/or other risk factors in the etiology of severity of musculoskeletal disorders. * * * controls and ergonomic programs work, MSDs, a change in worker exposure to That is that the effect is not confounded by we’ve seen it time and time again.’’ (Tr. biomechanical risk factors would be those other factors. And therefore, we can 16466) Under questioning by OSHA, expected to lead to a corresponding anticipate a benefit proportional to the Mr. Fernandez, a practicing ergonomist, change in worker risk of MSDs. One of increase that has been identified with current stated that, although some ergonomic exposures. the basic principles of public health is Q: Does this mean that an OSHA standard interventions may require more than that reducing exposure to a substance, one attempt and some ‘‘tweaking,’’ in aimed at reducing exposure to MSD hazards agent, or force that has been [i.e., biomechanical factors] is likely to his experience he has never seen a case demonstrated to be harmful to health prevent work-related MSDs? in which an ergonomic intervention or will reduce the risk of harm; this Dr. Punnett: I believe so, yes. program was ultimately unsuccessful. principle has been the scientific (Tr. 5427) Table VI–8 presented summary rationale behind all of OSHA’s statistics from the epidemiological In the preliminary risk assessment substance-specific health standards. studies that OSHA selected for the that accompanied the proposed rule, Accordingly, OSHA finds that the strong Health Effects section; these studies OSHA relied, in part, on the large body evidence in the scientific literature include those contained in the 1997 of epidemiological data showing relating exposure to biomechanical risk NIOSH review (Ex. 26–1) as well as consistent associations between factors to an increased risk of MSDs is, additional studies in the record. The exposure to biomechanical factors at by itself, sufficient evidence for Agency statistics presented in Table VI–8 work and an increased prevalence or action that will reduce the exposure of include the range in risk ratios reported incidence of MSDs. Although these workers to biomechanical factors in the in these studies, grouped by type of studies were not designed specifically to workplace. OSHA’s determination is disorder studied, as well as the median determine or measure the effectiveness supported by the testimony of its and mean of the distribution of these of ergonomic interventions in working witnesses. In his written testimony, Dr. risk ratios. The risk measures in the populations studied, OSHA finds that Wells stated that the epidemiological epidemiological studies include odds they nonetheless provide highly useful studies involving biomechanical risk ratios, prevalence rate ratios, and (for a information on the potential for factors have found strong and consistent few studies) incidence ratios, and ergonomic interventions to reduce relationships between those risk factors approximate the relative risk of injuries and illnesses; these studies and MSDs, and therefore that reducing musculoskeletal disorders in an exposed provide this information because they exposures to these risk factors is a worker population compared with that describe the relationship between reasonable strategy for preventing MSDs in a referent group. Although the risk exposure to the biomechanical risk (Ex. 37–18). Similarly, Dr. Frank ratios reported in epidemiological factors addressed in this final commented that the epidemiological studies cannot be used directly to ergonomics program rule and the risk to evidence and the results of other measure the effectiveness of ergonomics workers of developing MSDs. The investigations on the biology of low programs, they do provide information Health Effects section (Section V of the back pain strongly suggest that on that part of the MSD incidence seen preamble) summarizes the results of reductions in forces exerted on the in workers that can be attributed more than 170 epidemiological studies spine will substantially reduce directly to their exposure to overall, more than 60 of which disability (Ex. 37–27). During biomechanical risk factors; this portion demonstrate that increased MSD risk is questioning at the public hearing, Dr. of the MSD incidence is termed the related to increased duration and/or Frank explained: attributable, or etiologic fraction, and is magnitude of exposure to biomechanical * * * [A]cting on biomechanical risk factors also the fraction of the MSD incidence risk factors. Other biomechanical and will bring risk reductions according to our seen in worker populations that is biological data reviewed in the Health understanding of the multifactorial causal potentially preventable. Effects section provide evidence that process even if we are unable, for example, The concept of an attributable or excessive force imposed on at the present time to conclusively act to etiologic fraction is standard in musculoskeletal tissue, absent sufficient reduce psychosocial factors because we still epidemiology, and the concept has been repair and recovery time, is associated understand them poorly. used previously to estimate the with tissue damage that is consistent Q: So that given that as a conclusion, then attributable fraction of several types of with the kinds of disorders seen in the in your opinion does that mean that an MSDs in working populations. Hagberg working populations studied; thus, this OSHA standard aimed at reducing exposure and Wegman (1987, Ex. 26–32) supporting evidence is consistent with to biomechanical factors in the work place is reviewed the epidemiological literature the general model that excessive likely to reduce lost time disability for low and selected 21 studies in which back pain? biomechanical loading increases the risk diagnoses of neck and shoulder Dr. Frank: That is what every of developing MSDs. At the public epidemiologist who understands these disorders were made from physical or hearings, OSHA presented much expert methods would say. laboratory examinations. Odds ratio scientific testimony that this general measures from studies describing model is supported by high-quality Dr. Punnett also explained the similar disorders were pooled across scientific evidence. Although there is importance of findings that studies for common occupations that evidence that other factors, including biomechanical risk factors act involved exposures to workplace risk individual and non-biomechanical independently from other factors and factors, and the authors computed the

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MSD risk by computing the etiological As discussed above, OSHA has These 34 studies together represent fraction in the exposed population; the determined that the strength of the the best available direct evidence that etiologic fraction was computed only epidemiological, biomechanical, and practical application of the principles from those odds ratios that were biological data reviewed in the Health and methods of ergonomics in the statistically significantly higher than 1. Effects section is sufficient to justify the workplace results in reduced employee Hagberg and Wegman (1987, Ex. 26–32) promulgation of an ergonomics program exposure to hazards and in a reduced found that the etiological fraction standard to reduce the significant risks incidence of work-related ranged from 40 to 99 percent, depending of MSDs posed to workers who are musculoskeletal disorders. These on the specific type of upper extremity exposed to biomechanical risk factors studies evaluated the effect of disorder. This study thus provides on the job. Nevertheless, the record ergonomic interventions on risk factor evidence that the potential for contains a substantial body of scientific exposure, health outcomes, or both. Of ergonomic interventions to reduce MSD evidence and case reports that these studies, 22 reported that, after the incidence among workers is quite high, demonstrate directly that ergonomic ergonomic intervention, exposure was provided that such interventions reduce programs designed to reduce exposures reduced, as measured by the magnitude worker exposures to biomechanical risk to biomechanical risk factors do reduce of external stressors (i.e., reductions in factors. the incidence of MSDs in exposed repetitions or improved postures) or OSHA’s own summary of the risk workers. Some of this evidence was reduced tissue loading; 12 of these ratios reported in the epidemiological reviewed in the preliminary risk studies also documented reduced MSD database, both in the preliminary and assessment for the proposed rule; rates as measured by injury records or final risk assessments, is consistent with however, since publication of the employee symptom reports. OSHA the findings of Hagberg and Wegman proposal, many additional studies and believes that the 12 studies that (Ex. 26–32). The distribution of risk case reports have been made available measured both exposure and outcome ratios reported in the epidemiology in the record. The remainder of this part effects are particularly strong, and their studies relied on by OSHA in the Health of OSHA’s final risk assessment reviews findings particularly significant, Effects section of the preamble indicate these studies and reports. because they provide direct evidence of that, based on the median of the Intervention studies that employ a relationship between reductions in distribution, between 46 percent (back formal scientific methods are exposure to biomechanical risk factors disorders) and 88 percent (hand-arm particularly compelling and merit and reductions in the incidence of MSD vibration syndrome (HAVS)) of the special attention. Unfortunately, cases or symptoms, findings that are MSDs experienced by workers who have intervention studies for ergonomics consistent with the model derived from substantial exposure to biomechanical programs are infrequently conducted the epidemiological data, which posits risk factors (i.e., those workers who because they are complex and that biomechanical risk factors are comprised the exposed cohorts in these scientifically challenging because of the associated with an increased MSD risk studies) can be attributed to their lack of control that investigators independent of other contributing exposure to risk factors, and are generally have over workplace factors. Ten of the intervention studies therefore potentially preventable by conditions. Thirty-four reports of documented outcome measures alone reducing exposure to the biomechanical ergonomic interventions in workplaces and found that injury rates or symptom risk factors that caused them. For upper were identified in the rulemaking record reports declined following ergonomic extremity disorders (excluding HAVS), and are summarized in Table VI–11. interventions. Two studies (Bernacki, neck disorders, and shoulder disorders, Each of these 34 reports was 1999, Ex. 38–34; Bohr, 1997, Ex. 38–64) the attributable fractions based on the characterized by: also reported improved recognition of median of the risk ratios is between 55 • A clearly described intervention, potentially hazardous jobs among the and 65 percent. The mean of the • Measurable exposure or health participants in the ergonomics programs distribution suggests a somewhat higher effects endpoints studied.

TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONS

Health effects out- Study Population Intervention Analytic method Exposure outcome come

Aaras (1994) Ex. 502± 420 female tele- Reduce postural load: Longitudinal survival Decreased postural Reduction in mean 252; Westgaard communication as- individual adjust- analysis (1967± load intensity and sick leave from 22 (1985) Ex. 26±787; sembly workers. ment of workstation 1984). Exposure duration on days to 1.8 days, Westgaard (1984) height and angle, evaluated by trapezius, reduce Reduced turnover Ex. 26±1026. increased legroom, trapezius static load in hand, re- from 30.1% to suspending hand load via EMG, pos- duced shoulder an- 7.6%, Increased tools, arm supports, tural angles Out- gles. productivity. limit vertical dimen- come: signs & sions; Design work symptoms, sick to reduce postural leave due to load- fixity. related MSDs. Sur- vival analysis.

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TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONSÐContinued

Health effects out- Study Population Intervention Analytic method Exposure outcome come

Aaras (1997) Ex. 26± 20 VDU workers ...... Forearm support, Laboratory study Trapezius load signifi- 63. screen sight angle using open, ran- cantly lower with change. domized Graeco- forearm support Latin squared trial (both duration and with five test condi- intensity) with both tions using key- sitting and stand- board and then ing. No significant using mouse, differences with 15 measurements in- versus 30 degrees cluded descending sightline. m. trapezius and erector spinae lumbalis at L3 EMG and inclinometer. Aaras (1998) Ex. 26± Male VDU workers, 1 new lighting ...... Serial interventions in Reduced trapezius Reduced trapezius 597. 50 per group. 2 new workplace 2 intervention load in intervention pain, in intervention design to support groups, 1 control groups after fore- groups, no change forearms. group, Load meas- arm support and in forearm pain (ap- 3 optical exams and ured via EMG and optometric correc- peared to be asso- corrections. observation, con- tions, Reduced ciated with in- trolled for psycho- glare problems in creased mouse social factors at intervention groups. use, no change in work and home. back pain). Head- aches reduced after lighting change, borderline improvement with optometry, Visual discomfort im- proved with both lighting and optom- etry Bernacki (1999) (Ex. University employees, Implementation of a Longitudinal follow-up Ergonomic assess- Incidence rate de- 38±34). 1992±1998. program with early of employees re- ments (2041), ini- creased 80% (6.5 diagnosis and treat- porting to the med- tially with those in 1992 to 1.3/1000 ment, ergonomic ical department with UEMSDs for in 1998), surgery assessment and after policy to in- job modifications. trend also de- correction: wrist clude medical By 1994, signifi- creased. supports, document workup and ergo- cantly more as- holders, foot rests, nomic assessments sessments on jobs headsets, alternate for UEMSDs start- believed to be risky keyboards, glare ing in 1992. OSHA prior to injury. screens, chairs, etc. 200 logs. Bohr (1997) Ex. 38±64 600 employees in Used participatory One year longitudinal 14 problems identified not assessed. three departments worker-manage- evaluation of the and potential solu- in a large metro- ment ergonomics ability of ergonomic tions considered or politan medical teams to identify teams to identify identified. center. risks and control problems and de- strategies. sign solutions. Brission 1999 Ex. 38± 627 university em- Ergonomic training to Six month longitudinal Greater decreases in Greater decrease in 92. ployees working 5 identify postural comparison of pos- the prevalence of the prevalence of or more hours per stressors and make tural stressors and three postural musculoskelatal week with a video changes in equip- injury statistics in stressors in the ex- disorders by both display unit. ment and work ac- randomly assigned perimental group questionnaire and tivities. experimental than the control physical exam in (n=284) and control group. experimental group (n=343) groups. subjects under 40 years of age than in the control group.

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TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONSÐContinued

Health effects out- Study Population Intervention Analytic method Exposure outcome come

Cook (1999) Ex. 38± 20 meatpackers ...... Clamp rather than RMS EMG measure- Left wrist and finger 205. hand to hold hog ments if biceps, ex- flexor muscle effort head while chis- trinsic finger and was significantly re- eling. Modified han- wrist flexor muscles duced in chiseling dle and tool bal- after calibration. operation (hand ance for ham trim- Workers random- holding eliminated). ming, Air knife to ized order of trials Right wrist and fin- cut casings rather between old and ger flexor muscle than pulling casings new method by effort significantly by hand. each worker for 30 reduced in ham minutes (multiple trimming. Casing A±B±A±B research pulling task showed design). no significant re- duction in muscle effort. Drury & Wick (1984) Shoe manufacturing Ergonomics program Pre-post study de- Prototype implemen- Body area discomfort Ex. 26±1244; Wick workers. including employee sign. Observational tation showed pro- eliminated (except (1987) Ex. 26±1058. training and in- analysis of posture, ductivity increased forearm). Two year volvement in devel- force, frequency or remained un- follow-up of orna- oping controls, sys- every half hour for changed, awkward ment job (Wick) tematic process of week pre and post wrist motions de- showed no addi- task analysis, de- intervention, pos- creased, postural tional injuries re- sign, testing, imple- tural discomfort stress ratings de- ported. mentation and survey, perform- creased. measurement. Tilt- ance measures ed work surfaces, Data for 5 jobs pre- arm & foot rests, sented. adjustable chair, pneumatic pedal, pallet leveller. Evanoff (1999) Ex. 100±110 orderlies in Used a participatory Two year longitudinal Not reported ...... Decreased OSHA re- 38±32. a 1,200 bed urban worker-manage- evaluation of pre cordable injury and hospital. ment ergonomics and post interven- lost workday rates committee to de- tion injury rates and (relative risk = 0.64 sign and implement self reports of for all injuries and changes in training symptoms. 0.4 for lost time in- and work practices juries among order- for lifting. lies, adjusted for rates among other hospital staff. Sta- tistically significant reductions in re- ports of various systems. Garg (1999) ...... Seven nursing homes Used Participatory One year longitudinal Not reported ...... For injuries from pa- and one hospital, employee-manage- comparison of pre tient transfers: 62% employing 57±136 ment advisory and post interven- decrease in the nursing personnel teams to implement tion injury statistics. number of injuries, each. ``zero-lift programs''. 86% decrease in lost workdays, 64% decrease in re- stricted workdays, 84% decrease in workers' com- pensation costs.

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TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONSÐContinued

Health effects out- Study Population Intervention Analytic method Exposure outcome come

Garg & Owen (1992) 57 nursing assistants Walking belts and Pre-post study de- Significant reduced Back injury incidence Ex.±1093 (1994) Ex. in 2 nursing home mechanical hoists, sign: observed perceived exertion rate decreased 502±481; Owen & units. shower chairs. transfer techniques, with mechanical from 83 to 42 per Garg (1994) Ex. 26± rate of perceived and belt transfers 100 FTEs, Severity 1415. exertion, OSHA compared to man- rate decreased 200 logs 4 years ual transfers. Me- from 634 days to 0 prior to intervention chanical lifts with days per 100 FTEs and 4 months post scales and shower [Note: short follow- intervention. chairs reduced the up time reduces number of transfers strength of the required per patient. study. There was an increased in in- jury/severity rate in the first phase of the intervention on one unit, but none of thee injuries were related to resident transfers] Harms-Ringdahl Ex. 71 Electronic circuit Suspended arms sup- Pre-post intervention Not reported ...... 31 subjects per-3 26±630. board assembly port to reduce neck design. Symptoms months post shoul- workers. and shoulder mus- (VAS) 12 months der symptoms de- cle static loading. and one week prior creased from 62% to intervention, and to 45%, for neck 3 months (n=31) decreased from and monthly ratings 57% to 55%. Mean for 1.5 years post end of shift VAS in intervention (n=71). 1.5 year follow-up decreased from 46mm to 24mm, and for neck 41mm to 19mm. 93% of subjects using the balancers after 1.5 years. [Note: paired analysis was not used at 1.5 years]. Jones (1997) Ex. 32± 12,000 employees in Comprehensive cor- Five year longitudinal Not reported ...... 46% and 20% de- 339±1±29. 13 poultry proc- porate-wide evaluation of work- crease in UEMSD essing plants. ergonomics pro- ers' compensation incidence rate and gram, including rates and costs and severity rate, re- management com- overall program as- spectively. 50% mitment, ergonomic sessment scores.. and 36% decrease committees, risk in lifting claims inci- factor checklists, dence rate and se- job analysis, med- verity rate respec- ical management, tively. education and training, and job modification. Kadefors (1996) ...... Auto assembly work- Increase task varia- Comparsion of fac- Reduced time in awk- Not described; small ers in the assembly bility, increase tories with and ward postures in sample size in pre- versus parallel as- cycle time, increase without parallel as- each assembly full production sembly. standing upright. sembly and tilting step when using phase limits conclu- car capacity using tilting device, lower sions. observational anal- muscle load with tilt ysis and EMG. assembly, reduced discomfort. Loisel, (1997) Ex. 38± 130 employees from Either occupational Population based ran- Not reported ...... The occupational and 28. various workplaces, (including ergo- domized clinical the combined inter- absent from work nomic) or clinical trail with three vention groups re- for more than four intervention, sepa- intervention groups turned to regular weeks with back rately and in com- and one control work 1.5 and 2.4 pain. bination. group. times faster than those in the usual care intervention group or the clinical intervention group.

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TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONSÐContinued

Health effects out- Study Population Intervention Analytic method Exposure outcome come

Marklin & Wilzbacker Electric utility ware- (a) Raise location of Pre-post intervention Reduced lifting index Not reported. (1999). house workers. heavy objects from assessment of ex- (a&b), Increased below knee to thigh posure in jobs with percentage of pop- height. historically high in- ulation capable (c (b) Replace heavy jury rates using & d), Reduction in oak gate with light- NIOSH lifting equa- probability of back er pine gate. tion, 3D Static injury reduced (e & (c) Modify tool with Strength Prediction f), Reduction in extension and bet- Program, Lumbar perceived exertion ter drill bit. Motion Monitor and (g). (d) Maintenance of Perceived Exertion. pulling system. (e) Height adjustable lift table for han- dling meter readers. (f) Semiautomated pallet wrap ma- chine. (g) Power tool for opening line clamps. McKenzie (1985) ...... 6,600 Telecommuni- Ergonomics program Pre-post program de- Not reported ...... Dramatic decrease in cations manufac- with taskforce, sign using OSHA number of cases, turing workers. training for engi- 200 logs for repet- lost and restricted neers and super- itive trauma dis- days. Authors at- visors, improved order cases, lost tribute much of the workstation and and restricted days. improvement in lost tools, medical man- Program was im- and restricted days agement of re- plemented in 1981. to better medical stricted workers. management. Melhorn (1996) Ex. 212 rivet gun employ- Random assignment Longitudinal evalua- Decreased risk asso- Not assessed. 38±19. ees. to various combina- tion of risk factors ciated with ergo- tions of posture among eight expo- nomic posture training, exercise sure groups com- training. Vibration training and rivet pared with controls. dampening rivet gun types. guns associated with decreased risk among new hires and increased risk among previous hires. Melhorn (1999) Ex. 3152 newly hired Comprehensive pro- Prospective cohort Not reported...... Increased recordable 38±131. sheet metal me- gram of education, evaluation with pre case incident rate chanics. job placement, and post interven- and hours worked modifications and tion comparisons. per employee. De- medical manage- creased lost time ment designed for case incident rate, employees based lost time severity on individualized rate, and workers' risk assessments. compensation costs per employee. Ben- efit to cost ratio of 16.5/1.0. Meyers et al.(1999) .... 194 Wine grape har- Substitute smaller Participatory Reduced tub weight Results not reported. vest workers in 3 tubs to lower ergonomics inter- from 57 to 47 vineyards. weight to below 50 vention study ad- pounds. pounds. dressing load weight and hand coupling. Used checklist to identify tasks and lumbar motion monitor and NIOSH Lifting Equation to assess physical load, symptoms ques- tionnaires and OSHA logs to as- sess health.

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TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONSÐContinued

Health effects out- Study Population Intervention Analytic method Exposure outcome come

Miller (1971) Ex. 26± Surgeons and scrub Added larger surface Pre-post testing of Reduced fatigue and Not applicable. 1250. nurses. area to handle of extensors and required recovery surgical forceps to flexors with EMG time. increase stability over 35 procedures and decrease load by six surgeons. on fingers. Moore (1994) Ex. 38± 5 engine assembly Participatory Pre-post case study Carrying tasks not full UECTD Incidence 339±1±35. workers. ergonomics ap- of one job. OSHA eliminated, manual rate decreased proach: eliminate 200 log incidence hammering elimi- 78%, 82% de- carrying 11.6±14.7 data (39 months nated Reduction in crease in restricted kg parts, eliminate pre, 30 months RPE. or lost day rates. high impact use of post), Borg scale, brass head ham- satisfaction, psy- mers. chological demands. Moore & Garg, (1996) 930 pork slaughtering Two departmental Quasi-experimental Exertions per minute, Not assessed. Ex. 38±24; Moore & plant employees. ergonomics teams design, using post hand/wrist posture Garg, (1997) Ex. used to analyze intervention com- and strain index 26±21. jobs and develop parisons of non- scores improved for ergonomics inter- equivalent groups. leaf lard pulling job. ventions. Biomechanical stresses to the low- back, shoulders and guts hand eliminated on gut snatch job. Percent exertion per cycle, exertions per minute, and hand/ wrist postures im- proved on rib pull job. Parenmark (1993) ...... Tool and Equipment Engineering and or- Pre-post design. Fol- Not reported...... Sick leave decreased manufacturing. ganizational im- low-up 18 months 5%. provements in de- after production Turnover decreased sign of new factory: started in new fac- 25%. adjustable work tory, emg bio- heights, work tech- feedback to keep nique training, job load below 15±20% enlargement, work MVC. Sick leave pace decrease and turnover rate 25%, work organi- were outcome zation, flexible work measures. hours, wage sys- tem, rehabilitation. Rooney et al.(1992) 400 shoe and canvas Total quality manage- Pre and post inter- 373 job modifications, Annual lost time inci- Ex. 26±1056. luggage manufac- ment program, vention job analysis. 85 of which dent rate reduced turing employees. using an achieved more than from 14.9 to 3.3 ergonomics team 25% reduction in per 200,000 hours ``to closely follow force, repetition or during four-year the proposed postural stress. study period. Not OSHA ergonomics analyzed for spe- guidelines''. cific associations with job modifica- tions. Rosecrance & Cook 455 Newspaper em- Continuous improve- Pre and post inter- At least one interven- Not assessed at 4±6 (2000) Ex. 38±253. ployees. ment process, vention question- tion completed in months post inter- using an naires and non- eleven of twelve of- vention. ergonomics com- structured inter- fice and production mittee to manage a views. areas, including en- five step problem gineering and ad- solving method. ministrative changes to problem jobs with static pos- tures, repetitive tasks and non-ad- justable workstations.

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TABLE VI±11.ÐSUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONSÐContinued

Health effects out- Study Population Intervention Analytic method Exposure outcome come

St. Vincent (1998) Ex. 2 electrical product Participatory Pre-post design. 78% of solutions re- Not reported. 500±71±64. manufacturing ergonomics proc- Video analysis of duced risk factors plants. ess: 7 jobs with 50 posture, force, du- (postural load, solutions imple- ration, frequency, forces applied), mented: improving impacts. 14% had no ob- material feed, repo- servable effect, 8% sitioning of mate- could not be evalu- rials, change in ated. work station dimen- sions, change in product jigs, tool changes, job en- largement, handling aids. Shi (1993) Ex. 26± County government One year Back injury Pre-post randomized Not reported ...... Nonsignificant fre- 1099. workers. prevention pro- intervention groups quent back pain gram: Individual (n=4, 77% partici- prevalence de- health risk assess- pation) and control creased in interven- ment at year 1 and groups (2) with tion groups where- year 2 in interven- similar demo- as overall preva- tion group (fitness, graphics. Meas- lence significantly job demands, satis- ures: Satisfaction, decreased. Signifi- faction, demo- HRA scores, symp- cant increase in job graphics), training, toms prevalence, satisfaction. Signifi- ergonomic improve- workers compensa- cant decrease in ments (lifting de- tion rates. HRA risk status vices, gait belts, (not recorded for improved seating, control groups). minimizing trans- WC costs per claim port). increased in control groups but de- creased in all inter- vention groups. Re- turn on investment =179%. Partici- pants believed ergonomic interven- tions contributed the most. No at- tempt to separate effects of ergonomics im- provements from individual health promotion behavior in design or anal- ysis.

Three individual studies are design with pre-and post-intervention the study. The authors reported a particularly persuasive (Melhorn et comparisons. Potential confounders benefit to cost ratio of 16.5/1.0 for this al.1999, Loisel et al.1997, Brisson et al. considered included hours worked per program. 1999). Melhorn et al. (1999) reported the employee, average number of employees Brisson et al. (1999) conducted a results of a 5-step MSD prevention and new hires, and rates in otherwise longitudinal comparison of postural program based on OSHA and NIOSH comparable plants without programs. stressors and injuries in randomly ergonomics guidelines and The authors compared outcome data for assigned experimental (n=284) and implemented in a large aircraft several years pre- and post-program control (n=343) groups of university manufacturing facility. This implementation. Although the employees keying five or more hours comprehensive program included recordable case incidence rate and the per week at a video display unit. The education, risk factor analysis, job hours worked per employee increased experimental group received ergonomic placement (including transitional (or moderately in the period studied, there training in the identification of postural ‘‘restricted’’) work), job modifications was a substantial decrease in the lost stressors and in making changes in and medical management designed for time case incident rate, lost time equipment and work activities. employees based on individualized risk severity rate, and workers’ Measurements were taken two weeks assessments. The authors followed a compensation costs per employee. prior and six months post intervention. group of 3,152 newly hired sheet metal Workers’ compensation costs did not Symptoms questionnaires and mechanics, using a prospective cohort decrease in comparison facilities during standardized physical examinations

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There reviews (Linton and Van Tulder, 2000, limit research in this area as technology were significantly greater decreases in and Lincoln et al., 2000) that concluded and markets change to more flexible the prevalence of three postural that the intervention literature provides niche market demands and as there is stressors (twisted neck, height of visual little or no evidence of the effectiveness an increase in temporary workers target, broken hand-wrist line) in the of ergonomics programs. OSHA finds limiting long-term follow-up of experimental group after the training these reviews unconvincing for the outcomes. This real-world phenomenon than in the control group. There was following reasons: is not unique to the study of work- also a greater decrease in the prevalence Linton and Van Tulder (2000, related musculoskeletal disorders. Frank of musculoskeletal disorders as reported Attachment to Ex. 500–118) identified et al.1996 [Ex. 38–207] pointed out that both in questionnaires and in physical 900 articles about the prevention of most of the study design factors that examinations in the experimental group musculoskeletal problems. They then produce the most convincing evidence subjects under 40 years of age than in restricted their evaluation to 20 studies are outside the control of the researchers the control group. Symptom prevalence of randomized controlled trial design in occupational settings; such design decreased from 29% to 13% in the and 8 studies of non-randomized trial factors include stable working experimental group for those less than design, each of which was designed to populations and processes; 40 years of age. The prevalence of study ways of preventing long-term randomization of intervention groups; physical findings decreased from 18.8% neck or back problems in subjects not and the need for long-term follow-up, to 2.9% for those under 40 in the seeking treatment; the methods used in which is made difficult during experimental group compared to a these studies included back school economic downturns, product or decrease from 18.3 to 10.8% in the training, exercise programs, etc. None of process changes, or during labor- reference group. There were no the studies involved workstation management problems. In most cases, significant differences between the modifications, changes in controls or quasi-experimental designs, such as experimental and control groups in work practices, or administrative those reviewed by OSHA in Table VI– hours of VDU use, psychosocial work controls. Not surprisingly, the authors 10, which use either concurrent factors, smoking, leisure time, or body concluded that there is no evidence of comparison groups or historical control mass index. The differences between the good quality on the effectiveness of groups, present the best available younger and older workers appeared to ergonomics interventions. OSHA gives evidence of the effectiveness of be related to the duration of symptoms this study little weight because the engineering or administrative controls with older workers having longer authors made an arbitrary decision that in reducing occupational risks studies have no validity unless they are duration. (Zwerling et al., 1997, Ex. 500–71–65, ‘‘controlled trials’’ (the authors do not Loisel et al. (1997) used a population- Goldenhar & Shulte, 1994, Ex. 26–126). define the term). The authors also based, randomized clinical trial design OSHA discusses the need for and use of exclude from consideration any studies to evaluate 4 return-to work (RTW) randomized or controlled clinical trials of upper or lower extremity problems approaches for workers with acute back in ergonomics research later in this and any studies involving subjects who problems who were absent from work section in response to comments that sought treatment. Their sweeping for more than 4 weeks. These included were made to the record. occupational intervention (including conclusion goes far beyond what is ergonomics), clinical intervention, supportable, based on the very small In addition to the scientific studies, combined intervention or usual care. group of 28 studies that meet their the record contains a large number of One hundred thirty employees from 40 inclusion criteria. case reports documenting the different workplaces were followed for Lincoln et al. 2000 [Ex. 500–118nn] experiences of employers and 1 year. Survival analysis was used to assessed the intervention literature occupational health professionals who estimate return to work time. The related to work-related carpal tunnel have implemented ergonomics occupational (ergonomics) intervention syndrome (CTS). Twenty-four studies programs. OSHA reviewed several of group and the combined intervention met their inclusion criteria, which these in its preliminary risk assessment; group returned to work 1.5 and 2.4 included having a comparison group; however, since publication of the times faster, respectively, than the usual implementing engineering, proposal, many additional case reports care group or the clinical intervention administrative, personal or multiple have become available. Generally, these group. component interventions; and reports, which are listed in Appendix OSHA finds that this additional body describing outcome measures related to VI–B, involve case studies of individual of scientific intervention studies, taken CTS or upper extremity MSDs. companies that have instituted together with the other data presented Although these authors found that programs that include some or all of the in the preliminary-final risk multiple component programs were elements of the ergonomics program assessments, provides strong evidence suggestive of positive effect, the authors required by the standard; these reports that ergonomics programs are effective concluded that lack of randomization describe the results of ergonomic in reducing MSD risks to workers. These and lack of control for confounding interventions in a wide variety of studies have documented that weakened the conclusions to be drawn industry sectors, including reductions in exposure to from these studies. OSHA does not manufacturing establishments, service biomechanical risk factors, as well as agree that this conclusion undermines establishments, health care facilities, as reductions in the rates of MSD cases and the findings drawn from the many well as in other workplaces where jobs symptoms, follow implementation of intervention studies reviewed by OSHA. routinely involve manual handling. ergonomic interventions. These findings As noted above, randomization of Overall, OSHA identified over 300 case are consistent with the epidemiological engineering controls in intervention studies that quantified the reduction in and biomechanical evidence presented studies is particularly problematic MSD incidence following in the Health Effects section that because very few employers are willing implementation of ergonomic programs demonstrate the role of biomechanical to permit investigators to dictate which and interventions; of these, 262

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For primary care clinicians with and non-lost workday) injuries and all MSDs (i.e., lost workday and non-lost information and recommended illnesses, and 81 values for lost workday workday MSDs), these case studies strategies for the assessment and injuries and illnesses. These case reported a median 67-percent reduction treatment of acute low back problems in studies do not reflect a ‘‘quasi- in injury rates (mean effectiveness was adults.’’ The word ‘‘ergonomic’’ appears experimental’’ study design because 64 percent). The median and mean four times. Twice, this term is used to they do not use control groups and there reductions for lost workday MSDs only describe back school programs included is generally no evaluation of workplace were somewhat higher, at 75 percent in the analysis. One citation simply exposures by an independent and 71 percent, respectively. Although points to a review of safe lifting. The investigator; instead, a company’s or the effectiveness of individual final citation notes: ‘‘Several ergonomic establishment’s MSD rate experience is ergonomics programs varied widely guidelines on lifting and materials- evaluated before and after among the establishments described in handling tasks are available to help the implementation of an ergonomics these case studies, most interventions clinician provide ranges of activity program or intervention. Thus, the (about 87 percent of the case studies) alterations at work.’’ Thus even the outcome measure used in these studies achieved at least a 30 percent reduction AHCPR panel felt it beneficial to reflects the measure that is probably in MSD injury rates, 61 percent of the employ ergonomic guidelines on lifting most often used by employers who wish case studies reduced MSD rates by half and materials handling in establishing to evaluate whether their programs are or more, and several achieved the total safe levels of work activity for patients effective. Documenting changes in MSD elimination of lost workday MSDs (see with acute low back pain. The section rates before and after implementation of Appendix VI–B). on prevention consists of a total of two an ergonomics program is, in fact, one paragraphs and 195 words, including a E. OSHA’s Response to Comments on of the methods listed in the final rule by just three citations, two of which are the Program Effectiveness Evidence which employers may evaluate the opinion papers rather than research effectiveness of their ergonomics Gibson, Dunn & Crutcher (Exs. 32– studies. Therefore, the published programs. 241–4, 500–197) raised several issues AHCPR low back pain guidelines do To characterize the experiences of regarding OSHA’s analysis in the not, and do not purport to, have a focus employers and safety and health proposed rule of the effectiveness of on non-acute low back pain, work- professionals in implementing these ergonomics programs. These issues were related low back pain, ergonomics or programs, OSHA determined the range, • The lack of evidence that ergonomic prevention of low back pain. Citing the median, and mean reduction in MSD interventions will reduce low back pain, AHCPR guidlines as evidence that case rates for the overall data set, using as evidenced by a comprehensive ergonomics interventions are not the same approach as was used in the literature evaluation conducted to effective in reducing the risk of low preliminary risk assessment. From each develop the Agency for Health Care back disorders is inconsistent with the of these case studies, OSHA calculated Policy and Research (AHCPR) medical cited purpose and scope of the the effectiveness of the standard (e.g., guidelines for acute low back pain; document itself. Therefore, OSHA is not employee involvement and training, • The necessity of conducting persuaded by this argument that the implementation of engineering or work randomized controlled trials to guidelines ‘‘failed to find evidentiary practice controls). These case studies of determine whether ergonomics support for the use of ergomonic ergonomic interventions measure programs will, in fact, be effective; intervention to treat back pain injury effectiveness as the percent reduction in • complaints;’’ indeed, they would hardly either lost workday or total number of OSHA’s reliance on the have done so because they did not look MSDs prior to and after implementation epidemiological data in making for such evidence. of the program. That is, effectiveness inferences about the effectiveness of was calculated as the ratio ergonomics programs; and Regarding the second issue, Gibson, • Criticisms of individual case Dunn & Crutcher (Exs. 32–241–4, 500– − studies relied upon by OSHA to ()NBABNN/ 197) asserted that randomized demonstrate program effectiveness. controlled trials (RCT) and controlled where NB represents the number or In their post-hearing comments, from clinical trials (CCT) are the only study incidence of MSD cases prior to Gibson, Dunn & Crutcher (Ex. 500–118) designs that can demonstrate whether implementation of the ergonomic stated that ‘‘After conducting an ergonomics interventions are effective. intervention, and N represents the A exhaustive study, Dr. Bigos’ panel, They stated that: number or incidence after the under the auspices of the AHCPR, 1 The fact that there is no RCT supporting intervention . ‘failed to find evidentiary support for the proposed standard is a major weakness in OSHA’s estimate of the overall the use of ergonomic interventions to effectiveness of ergonomics programs is OSHA’s position * * *. [W]ithout RCT, treat back pain injury complaints.’ ’’ expressed as the median and mean OSHA cannot show that the alleged risks at However, in the Executive Summary for reduction in MSD injury rates contained issue will be alleviated by particular the AHCPR low back pain guidelines, in this data set; Appendix VI–3 to this solutions contained in its proposed rule. [Ex. the purpose of the effort was clarified as 500–197, pp. I–104 to I–105] follows: ‘‘The Agency for Health Care 1 Note that, by this definition, the presence of background MSD cases (non-work-related cases) Policy and Research (AHCPR) convened They also quote the statements of two of will decrease the apparent effectiveness of a 23-member, multidisciplinary, private- their witnesses, Dr. Bigos and Dr. ergonomic interventions since the interventions sector panel to develop a guideline for Fisher. Dr. Stanley Bigos, Orthopedic would presumably not have any effect on the the evaluation and treatment of acute background rate of MSDs in the working population Surgeon and Professor in the University (i.e., both NB and NA might contain background low back problems in adults.’’ of Washington Department of MSD cases). (Emphasis added) Orthopaedics, called prospective RCTs:

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* * * the gold standard for evaluating the pharmaceuticals, or for a comparison of For all of these reasons, OSHA efficacy of interventions in medicine. * * * the effectiveness of different treatments believes that sufficient RCT intervention This is a widely accepted standard across for diseases and medical conditions, the studies could not be practically medicine, and across science. * * * The conducted within a reasonable time strength of the RCT is that both known and study of interventions in ergonomics unknown risk factors are balanced across covers many more and different factors. frame to justify delaying regulatory treatment groups, so that any differences in Thus, any ergonomics RCT or CCT action. Therefore, OSHA disagrees with outcomes are more likely to be attributable to would require far more complex the arguments of the Coalition and its specific interventions (Ex. 500–197, pg. I– statistical designsand require many witnesses that OSHA should wait to 104). more subjects. Another major difference issue its final rule until RCT studies can Dr. Lloyd Fisher, Professor Emeritus is that intervention studies, unlike be conducted. in the Department of Biostatistics, typical medical or pharmaceutical In estimating risk and risk reduction University of Washington, likewise efficacy studies, would start with in this section, OSHA, as it has in all of claimed that because there have been no healthy groups and then test for its past rulemaking efforts, relies on the RCTs on interventions in ergonomics, differences in subsequent risk or well-founded public health concept ‘‘We have no evidence that these rules incidence of MSD. A pharmaceutical that, if risk factors can be identified that are going to work. They might work. study equivalent, for example, would be contribute to the etiology of disease, it They might be harmful.’’ (Fisher Tr. a trial to test a drug that would prevent is reasonable to act to reduce exposure 6740). A third witness, Dr. Shekelle, a specific cancer or chronic disease, not to those risk factors to reduce the risk stated: just treat it. Such medical RCT of disease. OSHA’s logic and rationale prevention trials would require a less in this rulemaking are similar to the To my knowledge there is not a single well complex statistical design than a good position taken by Dr. John Frank, conducted randomized clinical trial of any ergonomic intervention, i.e., prevention, Professor, Public Health Sciences, intervention designed to modify any of the University of Toronto (Ex. 500–64). ergonomic factors proposed in the OSHA study; yet even are such a trial would be prohibitively expensive when the Under the heading ‘‘Standard Public document that has proven to have a Health Practice Regarding Hazard beneficial effect on disability due to back disease incidence is fairly low, (because pain. (Ex. 500–197, pg. I–104). many subjects would be required), and Control’’, Dr. Frank poisted three this expense would increase as the conditions as the basis for deciding Controlled clinical trials are used whether to implement ergonomic principally in medicine to test the required follow-up time and effort increased. abatement policies: efficacy of alternative treatments on • ‘‘Is there ‘reasonable cause’ * * * patients. In a typical design, one group As an example of the expense of an RCT ergonomic study, Dr. Frank, to believe that exposure to the putative of patients that has been diagnosed with hazard truly does lead to measurable a specific disease or disorder is given considering a simpler prospective design than required would be required adverse health effects?’’; the usual medical care and one or more • ‘‘Is there reasonable cause to believe for an ergonomic intervention study, in other groups of patients with the same that feasible hazard abatement/control his testimony related his attempt to disease or disorder are given alternative intervention * * * e.g. ergonomic job study physical loads on the back as an treatments. The response of the test modification/design * * * actually independent risk factor for workplace group(s) to the new treatment is reduce exposure to the hazard?’’ and compared with the response in the lower back pain, controlling for several • ‘‘Is there reasonable cause to believe control group to determine whether the individual characteristics of the worker: that no significant harmful new treatment(s) were more or less And in a nutshell, we decided that the key consequences of implementing such an effective than the standard for thing was, and it is very expensive to do this, intervention will occur * * *?’’ (Ex. treatment. In a randomized trial design, to actually measure the physical loads on the 500–64) the patients are randomly assigned to back. * * * It costs us about $2,000 U.S. Regarding the first question, whether dollars per subject. And we did well over 300 the various test or control groups; in a subjects to simply use a case-control design the evidence supports causal association controlled, non-randomized clinical (emphasis added). * * * you cannot afford to between exposure to the hazard and trial, assignment of patients to the do those measurements on the 5,000 workers, workplace MSDs, OSHA has concluded various groups is not made using a give or take a few thousand that you need to in its Health Effects section (Section V) purely randomized procedure. The follow if you are going to use a cohort or that there is substantial evidence that randomized trial is considered overall to prospective design to see who subsequently exposure to biomechanical risk factors be the superior design since it has the develops back pain (Tr. 1341). at work—repetitive motion, forceful greatest likelihood of controlling for In addition to the expense of RCT exertion such as heavy lifting, non- both known and unknown confounders, intervention studies, conducting such neutral body postures, contact stress, increasing the ability to attribute any studies over a period of time sufficient and segmental vibration—all contribute observed differences in treatment to make valid conclusions, often means to the risk of MSDs. OSHA has followed responses between the groups to the that unforeseen changes in conditions the weight-of-evidence approach for treatments themselves. occur, invalidating the original study evaluating the best available body of OSHA has carefully considered these design. This is especially true when scientific evidence on ergonomics, comments that RCT studies in dealing which are often characterized by especially the large amount of ergonomics are necessary to determine workplaces with changing conditions epidemiologic data, and finds that the the effectiveness of interventions in and workers who can self select on job evidence, as judged by the (Sir Austin reducing risk (and the related argument or life style condition changes. For these Bradford) Hill criteria, used by the that such a high standard of scientific reasons, and also because the number of scientific community for over forty evidence is necessary before prevention industry sectors and variety of work years, is convincing. Like Dr. Frank, procedures should be required). conditions is so large, the results from OSHA especially notes the consistency Although the Agency agrees with Dr. the few carefully designed ergonomic in findings across epidemiologic studies Bigos that RCT and CCT are the RCTs that could be conducted over the and the consistency between the appropriate statistical designs for trials next 5 to 10 years would be difficult to epidemiological studies and the on the safety and efficacy of generalize to U.S. industry as a whole. accumulated scientific knowledge on

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The Health question posed by Dr. Frank, whether that ergonomic interventions will result Effects section (Section V) also contains there is reasonable cause to believe that in deconditioning of the workforce and sufficient evidence on exposure- feasible hazard abatement and control a resulting increase in the risk of MSDs. response to further confirm these interventions (e.g., ergonomic job OSHA discussed this issue in detail in findings. modification/design) will actually the Health Effects section (Section V of Dr. Laura Punnett, an epidemiologist reduce exposure to the hazard. As with the preamble) and rejected this and ergonomist, and member of the its other rules, OSHA finds that, having argument. In brief, OSHA finds that its panel that reviewed the epidemiologic identified specific biomechanical risk final ergonomics program standard is evidence on work-related MSD for the factors that contribute to the etiology of consistent with current medical practice National Academy of Sciences, agrees MSDs, procedures to reduce exposure to and guidelines, will not encourage an with OSHA’s findings: those factors will reduce risks. This is unhealthy level of inactivity in lieu of the underlying principle that has In summary, the epidemiologic evidence returning to a safe level of work that links physical and ergonomic exposures goverened all of OSHA’s prior health following an injury, and is therefore at work with the risk of MSD is extensive and rulemakings, and it is also the principle unlikely to harm workers by includes a sufficient number of providing the foundation for public discouraging conditioning. methodologically strong studies to health interventions. Moreover, as the Finally, several commenters [implement] primary prevention activities. In discussion earlier in this part of the Risk presented arguments that it would be the light of the experimental literature, the Assessment demonstrates, OSHA has unethical to withhold interventions. epidemiology is certainly most plausibly accumulated substantial evidence, both The ethical arguments was summarized interpreted [as] showing a causal effect of scientific in nature and less formal, occupational physical stressors on MSD by Dr. Frank: among people with exposures on the job reflecting employers experiences with ergonomic programs, and showing that There is also the moral impropriety of (Punnett, Tr. 874). randomizing [for RCT studies] a set of ergonomic interventions do reduce Having found that MSDs are causally communities or set of workplaces to not have exposures to biomechanical risk factors a putative hazard abated (Ex. 500–64). related to multiple biomechanical risk and do reduce the prevalence and factors, OSHA rejects the arguments of incidence of MSDs. Dr. Punnett also testified that controlled the commenters that OSHA should With respect to the types of studies trials are inappropriate in the context of conduct RCTs in order to determine needed to estimate risk and risk protecting the public from exposures to whether or which specific interventions reduction, OSHA notes that potential hazardous agents. When asked whether will reduce MSD risk. OSHA believes risk reduction is estimated in many of controlled trials are the only that other types of approaches can be the Agency’s past rules by extrapolation scientifically rigorous method for used; in particular, OSHA believes that of study results using mathematical determining causal relationships the analogy between ergonomice dose-response models. None of these between exposure to risk factors and the interventions to address the risk and risk reduction estimations risk of MSDs, she replied: multifactoral nature of ergonomic risk relied on RCT. Several of these You know, I really find that quite an factors and interventions for the estimates were derived from modeling extraordinary concept. * * * I could hardly multiple risk factors associated with the studies with retrospective cohort imagine that OSHA would have ever been development of coronary heart disease designs. In these studies, it was held to putting subjects in an exposure (CHD, e.g., blood pressure, weight, common in the course of the cohort’s chamber and exposing them to coke smoking, and cholesterol) is time frame that ‘‘interventions’’ emissions or benzene vapors or cotton dust to see whether they developed cancer or lung appropriate. For CHD, risks and risk occurred, in the industrial hygiene reductions were estimated for these disease. And the whole idea that this would sense, to reduce exposures to the be the kind of evidence that would need to factors long before there were any putative chemical agent. However, in be provided in order for OSHA to take results from controlled prospective these studies information about the preventive action, truly it is astounding to trials (Frank, Tr. 1340). OSHA notes the exact interventions or exactly which me. And there are lots of examples. I mean, post-hearing comments of Anheuser- cohort members these interventions I showed international criteria documents, Busch Inc. and United Parcel Service affected is usually very limited, and the the European Union taking action on Inc. comparison which included Dr. studies could hardly be considered physical ergonomic exposures without ever a Michael Vender’s and Dr. Arthur ‘‘controlled.’’ Furthermore, all estimates mention of such a thing as a randomized Barsky’s objections to Dr. Frank’s of for risk reduction required extrapolation clinical trial in this area. [Tr. 1001–1002] CHD and back pain. Dr. Vender states beyond the range of observation, for OSHA considers this ethical argument that, unlike coronary heart disease, back which there were no ‘‘interventions.’’ to be valid in that the Agency does not pain is ‘‘a subjective experience and can This methodology is based on the desire to delay hazard abatement in originate from many sources that are not logical rationale that if causes or risk order to conduct an RCT, the result of readily identified or measurable, factors for adverse health effects are which may or may not be generalized to including muscle, ligament, joint and established, a reduction in exposures to worker populations overall. This is disc.’’ (Ex. 500–118, Tab Kn pg. 21). these factors will lead to a reduction in especially the case because the Agency OSHA finds Dr. Vender’s argument the adverse effects. already has a sound methodology for irrelevant, however, since the relevant With regard to Dr. Frank’s third measuring the extent of current risk and connection in Dr. Frank’s analogy is that question, whether there is reasonable the potential that reduction in risk in the case of CHD the medical and cause to believe that no significant associated with implementation of the public health communities harmful consequences of implementing standard.

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Gibson, Dunn & Crutcher in their post programs, in both the Preliminary and measures of statistical significance.’’(Ex. hearing comments criticized OSHA for Final Risk Assessments, is to estimate 500–118, p. II–33). In short, according to using epidemiology studies to assess the the proportion of disease occurring Gibson, Dunn & Crutcher, OSHA work-relatedness of MSDs and as a among workers exposed to risk factors agglomerated studies of all qualities and source of information and data to that can actually be attributed to their all significance levels, studies estimate the effectiveness of ergonomics exposure. This approach does not reflect measuring different risk factors, using programs (Ex. 500–118, pp. II–25 to II– a risk of ‘‘zero,’’ as Gibson, Dunn & different levels of exposure, and 36). Part of Gibson, Dunn & Crutcher’s Crutcher suggest. Instead, this approach different types of control groups. ‘‘The criticism relates to their claim that ‘‘a explicitly recognizes that only some result, in the end, is a mathematically statistical level of ‘risk association’ from portion of the disease prevalence meaningless number whose content an epidemiologic study cannot translate observed in a population of exposed dependes primarily on happenstance.’’ into a measure of effectiveness for workers will be affected by intervening (Ex. 500–118, pg. II–33). OSHA’s proposed program.’’ (Ex. 500– to reduce the hazardous exposure. The OSHA believes that there is a good 118, p. II–27). They provided three risk ratios from epidemiological studies rationale for applying this methodology reasons to support this claim. First, they are precisely the kind of data that are to estimate median or mean risk ratios claim, even assuming that OSHA’s risk used to estimate the attributable fraction from the epidemiological data base by ratio estimates for the work-related of disease in an exposed population weighing each risk ratio equally (64 FR MSDs are correct (which they do not (e.g., see Hagberg and Wegman Ex. 26– 65950–65951, see Table VI–9). OSHA concede), that by changing the job 32). For example, if an epidemiological believes that the use of epidemiological conditions: study reports that the rate of disease in data and such unweighted median and there will still be some level of force or an exposed population is twice as high mean risk ratio estimates, separately for repetition, some movement from completely as that seen in an unexposed each body part, using the neutral posture * * * that presumably could population, (e.g., an OR of 4), then the epidemiological data is fair and cause ‘contact stress.’ * * * In changing a job attributable fraction can be estimated to appropriate, for several reasons. First, to address one ‘risk factor,’ moreover, an be 0.75, or 75 percent. This means that the epidemiological data, which is entirely different concern might be created. drawn largely from the 1997 NIOSH * * * Yet OSHA’s approach would measure the rate of disease in the exposed population can be reduced by up to 75 review (Ex. 26–1), is an unbiased the effect as if it were the difference between screened review of the published the ‘‘risk’’ from the old job and zero. That percent in response to an intervention. assumption is simply wrong. (id. II–29). The actual result achieved in an literature, with the result that only higher quality studies are selected. Second, they claim that intervention may be less, depending on the effectiveness of the specific Second, estimating risk ratios by body ‘‘ ‘deconditioning’ from a reduction in part agglomerates studies that reflect physical activity may play a very intervention employed. These commenters’ third reason is that, similar background rates; this should significant role in increasing the risk of provide a more even distribution of risk MSDs. * * * An epidemiologic study because the epidemiology studies are limited and cannot control for enough ratio estimates than would be the case that focuses solely on alleged ‘risk if all of the studies were grouped factors’ in the existing job, however, risk factors, the risk ratio estimates from these studies overstate the risk due to together. provides no mechanism for taking this Third, including all risk ratios by the studied risk factor and cannot be into account, or any other change in the body part is reasonable, even though generally applied to intervention risk nature of a job as altered after an some studies estimated risks for more reduction estimates. However, it is not intervention.’’ (Ex. 500–118, p. II–29). than one body part and may therefore be The third reason is that ‘‘the ‘risk ratios’ always the case that study biases lead to included in analyses of more than one yielded by epidemiologic studies an overestimate of the risk. Risk ratio body part. Often when more than one control only for factors that each author estimates may overestimate or body part is included in the same study, was able to identify and analyze. * * * underestimate the true risk, depending the risk estimates are based on different In the real world, * * * [with many on the study design, the subgroups of workers. In OSHA’s final other factors to be considered] the ‘risk interrelationship of the risk factors risk assessment any one study is ratios’ attributable to job factors, after involved, and the comparison of the included for each body part only once. fully accounting for all these other exposed and control groups. For Finally, OSHA addresses the criticism variables, would be far lower than those example, errors in exposure assessment of combining unweighted odds ratios reflected in the epidemiologic that arise because of the use of from many different high-quality evidence.’’ (Ex. 500–118, p. II–30). imprecise measures to characterize studies, even though NIOSH may have OSHA notes that all of the ‘‘real world’’ exposure (such as job title) leads to ranked studies according to their quality complications pointed to by these exposure misclassification, which criteria. OSHA believes that, in this commenters are also pertinent to RCF. usually results in an underestimate of case, unweighted or equal-weighted OSHA disagrees with all three of risk, or even the observed absence of an means and unweighted medians are Gibson, Crutcher & Dunn’s arguments association where one actually exists. appropriate and fair. Most important, that ergonomic risk factor epidemiology Gibson, Crutcher & Dunn further this methodology gives the same weight studies may not be used for risk argue that, ‘‘even if the epidemiologic to high-quality studies that show no reduction estimates. Gibson, Crutcher & evidence has some application, OSHA’s association as to those that do, instead Dunn argue that reducing one stress review of it for benefit purposes was of focusing on the highest risk estimate. factor will either lead to increased risk fatally flawed.’’ (id., pg. II–31). They OSHA believes this is fair because the due to exposure to another stress factor offer several reasons for this opinion; large variety of study designs, work (reason one), or, contradictorily, lead to their primary reason is that OSHA took situations, and specific disorders increased risk because the body is an unweighted median or mean risk of addressed in these studies will be more ‘‘deconditioned’’ and, therefore, more ‘‘every ‘risk ratio’ it could find in a representative of the varied nature of susceptible to injury (reason two). NIOSH table, even in situations where working conditions across the country. OSHA’s approach for estimating the the majority of study ratios—all but On the other hand, if OSHA were to potential effectiveness of ergonomics eight in one case—did not even satisfy weight risk ratios by some quality

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When I was going around a representative of the broad mix of proposed rule, OSHA did not claim that workplace, there were no restrictions placed workplaces covered in the final rule. the case studies it relied on represented on me to say, ‘‘Oh, don’t talk to the workers,’’ Consequently, given OSHA’s objective ‘‘scientific’’ studies, but instead simply or anything like that * * * I have no reason to quantitatively characterize the work- characterized them as sources of ‘‘* * * to believe that people were not telling me just the facts that were there. [Tr. 2714–2715] related risk of MSDs and the potential data on the success of ergonomics effectiveness of ergonomic programs and workplace interventions, The approach taken by Dr. Oxenburgh interventions, using the best available * * * [which are in turn] supported by is often relied on by regulatory agencies data, OSHA finds that its approach that data from [other] scientific studies [i.e., (e.g., OSHA and the EPA), academic makes use of all of the epidemiological epidemiological studies and researchers, and other investigators; it data judged by the Agency to be of experimental laboratory studies in the involves having individuals with reasonable quality is preferable to record] indicating the potential for professional expertise (in Dr. relying only on a small subset of those successful ergonomics programs’’ (Ex. Oxenburgh’s case, in ergonomics and data. 28–1, p. IV–4). The 24 case studies from productivity measurement) talk to In both their pre- and post-hearing Dr. Oxenburgh’s book that OSHA used involved individuals, take notes, inspect submissions (Exs. 32–241–4, 500–197), as a source of effectiveness data provide equipment and facilities, and evaluate Gibson, Dunn & Crutcher raised several precisely this kind of information, and what has been observed. For example, criticisms of some of the specific case OSHA does not find that the absence of in conducting research to obtain data for studies relied on by OSHA in the a formal study design diminishes the the economic and technological preliminary risk assessment (these case utility of these data in describing the feasibility analyses to support its studies were summarized in Appendix beneficial effects that ergonomic standards, OSHA conducts many site VI–B of the preamble to the proposed interventions have had on MSD rates in visits to gather data on control standard, 64 FR 65965–65975). In actual workplaces. In fact, real-world technologies and work practices, worker addressing each of these specific effectiveness studies, almost by exposures, costs of exposure controls, comments below, OSHA first identifies definition, describe what happens in a and economic data. In more than 20 the case study or studies being particular workplace environment when years of experience, the Agency has addressed in the comment, quotes or interventions of the kind required by the never had reason to conclude that the information collected in this way is not summarizes the comment, and follows standard are put into effect. OSHA did reliable. In fact, site visits and onsite that with a response to the comment. not in the proposal and does not in the interviews generally provide much more final rule claim that these studies do Group of 24 Case Studies From M. detailed and accurate information than more than report what employers have Oxenburgh, Increasing Productivity and can be obtained in written form alone. done and the results they have. Profit Through Health & Safety (Ex. 26– OSHA believes that this is why Dr. 1041). Comment: In his testimony, Dr. Oxenburgh ‘‘relied as little as possible Comment: Methodology that Dr. Oxenburgh stated that he relied as little on people’s * * * written data’’ (Tr. Oxenburgh used is biased because he as possible on written data (citing Tr. 2648): he understands that the answers only obtained claims of reported 2648), and preferred to accept what he to specific questions and to follow-up success. ‘‘Oxenburgh confirmed that he was told on site by the people involved questions are far more revealing than was looking to write a book * * * to in implementing and working with the the information in paper records. OSHA demonstrate ‘the effectiveness * * * intervention (Exs. 500–197, p. II–11, 32– finds that the information and data from an injury reduction perspective’ of 241–4, p. 215). Dr. Oxenburgh did not collected by Dr. Oxenburgh and ergonomic interventions [citing Tr. use a methodology that involved to contained in his book are fair and 2646]. Having ‘made known what [he] verification of his claims (Ex. 500–197, accurate reports on the effectiveness of was looking for,’ [citing Tr. 2647] he pp. II–11). Oxenburgh was willing to ergonomic interventions, and the obtained only reports of success.’’ (Ex. accept employer accounts without Agency does not agree with Gibson, 500–197, p II–10) ‘‘* * * [T]reatise independent verification (Ex. 32–241–4, Dunn & Crutcher’s insinuation that the * * * unabashedly describes itself as an p. 231). Dr. Oxenburgh’s sources were data are unreliable. Further, Gibson, assemblage of ergonomic ‘success health and safety professionals who had Dunn & Crutcher provide no evidence stories’ designed ‘to make believers’ out much to gain and nothing to lose by that the information in Dr. Oxenburgh’s of management [citing p. 2 of Ex. 26– making exaggerated claims of benefits book is exaggerated or was 1041].’’ (Ex. 32–241–4, p. 215). (Exs. 32–241–4, p. 231; 500–197, p. II– misrepresented by safety and health OSHA’s Response: The introduction 12). professionals intent on promoting their to Dr. Oxenburgh’s book was written by OSHA’s Response: To obtain reputations and careers. OSHA therefore Dr. Stover Snook, who used the quoted information from establishments, Dr. rejects this argument as specious. phrases ‘‘success stories’’ and ‘‘to make Oxenburgh visited facilities to conduct Comment: Each case study in Dr. believers.’’ Dr. Oxenburgh actually personal interviews and perform Oxenburgh’s book describes ‘‘health, objected to terms such as ‘‘making inspections of the interventions safety and productivity gains’’ in broad believers’’ and ‘‘success stories,’’ firsthand (Tr. 2648). Although Dr. generalities and rarely provides any because, as he stated at the hearings, he Oxenburgh did inspect some documents quantitative statistics (Ex. 32–241–4, p. compiled ‘‘a series of case studies which on the site visits, he sometimes obtained 215) illustrate the concept of health and written documentation after the visit OSHA’s Response: OSHA relied only safety and productivity running ‘‘* * * by which time [plant contacts] on the 24 case studies from Dr. together’’ (Tr. 2643, ln. 11–13). Gibson, would have looked up their Oxenburgh’s book that did in fact report Dunn & Crutcher criticize Dr. information.’’ (Tr. 2649) At the informal quantitative changes in the number or Oxenburgh’s publication as part of their hearing, Dr. Oxenburgh testified that the rate of MSDs; these quantitative data are

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00322 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68583 reflected in Appendix VI–B in both the through ergonomic interventions.’’ (Exs. two to four years prior to program preliminary and final risk assessments. 500–197, p. II–13, 32–241–4, p. 226). implementation and draw comparisons Comment: ‘‘Oxenburgh holds a OSHA’s Response: Although the from that single statistical quirk’’ (Exs. doctorate in biochemistry but, after 15 ‘‘robot’’ case study is an unusual case 500–197, p. II–14, 32–241–4, p. 227). (because employers generally years in this field, saw a career OSHA’s Response: NIOSH initiated opportunity during the early stages of mechanize jobs but only rarely automate them), it is an example of an this Health Hazard Evaluation in 1990 the infamous Australian repetitive strain and followed up in 1993; the purpose of injury epidemic of the early 1980’s and engineering approach that eliminated a the evaluation was to identify jobs switched disciplines with no further job that had previously caused associated with upper-extremity and academic training.’’ (Ex. 32–241–4, p. musculoskeletal injuries among an 214) ‘‘Primarily * * * Oxenburgh extraordinary high percentage of back MSDs in the flywheel milling described his expertise as being based workers (60 to 80 percent of the department, and to make on various consulting activities he workforce that performed these recommendations to reduce MSDs in undertook after becoming ‘‘interested in functions) (Tr. 2654). The engineering that department. The MSD incidence ergonomics’’ and ‘‘join[ing] the control (i.e., the robot) was rates per 100 workers for the study Ergonomics Society of Australia [citing implemented after facility personnel period, as presented in Table 8 of the Tr. 2700].’’ (Ex. 500–197, p. II–12) determined that other options (e.g., job report (Ex. 26–1080), were 27.6 (1989), OSHA’s Response: Gibson, Dunn, & rotation, increased rest breaks, and 11.5 (1990), 18.7 (1991), 13.4 (1992), Crutcher impugn Dr. Oxenburgh’s complete workstation redesign) would and 12.5 (1993) (Ex. 26–1080). These professional experience and training but not prevent the injuries (Tr. 2654–2655, data do not appear to support Gibson, fail to acknowledge that Dr. Oxenburgh Ex. 26–1041, pp. 156–158). In his Dunn & Crutcher’s claim of a ‘‘general has in fact worked in the field of testimony, Mr. Caple also discussed upward trend in MSDs during the study occupational health and safety since situations in which robots are used in period.’’ Gibson, Dunn & Crutcher chocolate making and in the automotive 1976 (Tr. 2700) and has practiced in the described the incidence rate of 27.6 for industry (Tr. 2624–2625). However, field of ergonomics for 20 years, since 1989 as a ‘‘statistical quirk’’ because it both Dr. Oxenburgh’s and Mr. Caple’s he joined the Ergonomics Society of testimony confirm that robotics are used is substantially higher than the Australia and became a committee rarely to control MSD risks. However, incidence rates for 1987 (11.8), 1988 member of the New South Wales because of the unusual nature of the (8.9), and 1990 (11.5) (Ex. 32–241–4, p. division (Ex. 37–24, Tr. 2700). Dr. control approach in this case study (i.e., 227). The case study indicates, however, Oxenburgh also served for several years robotics), OSHA has deleted it from the that this increased rate was associated as a founder and co-ordinator of the case study data set and is not relying on with hiring a nurse between 1988 and Economics and Ergonomics specialist it in its effectiveness analysis. 1989 who ‘‘brought new vigilance to the group of the International Ergonomics Comment: ‘‘It is surely no coincidence reporting of musculoskeletal disorders’’ Association. Over the past 12 years, Dr. that 9 of the 24 Oxenburgh case studies (Ex. 26–1080, p. 12), suggesting that the Oxenburgh has been an expert witness invoked by OSHA cite General Motors lower rates reported for 1987 and 1988 in more than 700 common law injury as the source of information. At the time reflect the underreporting, rather than claims, in which capacity he has * * * General Motors was facing a low incidence, of MSDs. Further, the appeared about half the time on behalf major 5(a)(1) ergonomics citation, of the employer and half the time in case study suggested that the MSD backed up by considerable pressure incidence for 1990, which was support of the plaintiff. Dr. Oxenburgh from its union on the subject of has also been the principal author on a substantially lower than that for 1989 or ergonomics * * * [GM] had every 1991, may have decreased because of a number of research studies, including incentive to look for outlets to publicize several seminal works on the sudden 20-percent increase in the that it was committed to ergonomics department’s workforce: new workers quantifiable effects of early reporting and was achieving results.’’ (Ex. 32– may have under-reported and medical management (see, for 241–4, p. 231) example, Exs. 38–188, 26–1405, Winkle OSHA’s Response: Gibson, Dunn & musculoskeletal problems, or it is and Oxenburgh (1990) cited in Ex. 37– Crutcher imply that the information and possible that the disorders did not 24, Oxenburgh (1997) cited in Ex. 37– data taken from these 9 case studies are become symptomatic until the following 24, Oxenburgh (1994) cited in Ex. 37– unreliable because GM was willing to year (Ex, 26–1080, pp. 12–13). For these 24). OSHA made Dr. Oxenburgh fabricate or distort information to reasons, OSHA does not agree that the available to testify at the informal public promote its ergonomics activities. MSD rate for 1989, which is taken as the hearing because of the importance of his OSHA does not believe that General base year for comparison with post- work on ergonomics and productivity, Motors operates in this way, and the intervention years, is necessarily a and finds Gibson, Dunn, & Crutcher’s Agency notes that Gibson, Dunn & statistical aberration, but rather that the characterization of Dr. Oxenburgh’s Crutcher provide no evidence of any lower MSD rates for the surrounding qualifications both inaccurate and kind to support their allegations that years may reflect underreporting of unjustified. these 9 case studies are anything other MSDs and abrupt increases in the Comment: Regarding the robot case than factual accounts of ergonomic workforce of the establishment. study contained in Dr. Oxenburgh’s interventions. Accordingly, OSHA is not However, because of the concern raised book, Dr. Oxenburgh admitted that this persuaded by this comment. about the representativeness of the is a very unusual case (Tr. 2655) and Harley-Davidson Case Study injury rate for 1989, OSHA is basing its that the workers are no longer estimate of program effectiveness from performing that job at all (Tr. 2653). (McGlothlin and Baron, Ex. 26–1080) this study on the injury rate for 1991, Consequently, there is no ‘‘compelling Comment: The case study documents which represents the first year in which justification for including it in a case a general upward trend in MSDs during study compilation to broadly represent the study period. ‘‘The only way a interventions were planned and ways in which employers purportedly decrease in injury rates could be implemented. can achieve ‘100%’ effectiveness claimed was to pick an aberrational year

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Telecommunications (Video Display Comment: ‘‘Tadano also explains at consisted of a combination of education, Terminal (VDT) operator) Case Study length that CTDs ‘have a multifactorial training, physical fitness activities, and (Tadano, Ex. 26–1337) etiology’ and that it is often not possible ergonomic improvements. The author to attribute trends to any single acknowledged that it was not possible Comment: ‘‘OSHA attributed intervention. She concludes: rule out a Hawthorne effect bias in the significance to a ‘40.8’ percent reduction In the current study, so many factors were results. However, although the author in ‘Total MSDs’ allegedly achieved by changed * * * that success or improvement was aware of the potential for some an ergonomics program * * * [T]his cannot be attributed to any single factor. Also confounding, he made several reduction took place after a very the data were limited, in that the sample size observations about the effectiveness of substantial increase in MSD reports was small and the duration of time measured the back injury intervention program during the preceding period. The article was limited.’’ [Citing Ex. 26–1377, p. 70] studied: suggests that this claimed reduction Yet, OSHA does exactly what Tadano The results of the study lend support to the may have arisen from ‘a certain operator warns it no[t] to do ‘‘it attributes the widely held belief that health promotion in hysteria about * * * catching entire * * * success or improvement the workplace can significantly reduce [repetitive motion sickness], * * * * * * described in the article to the employee health risks. * * * [T]he study possibly connected to sentiments, * * * single factor * * * of ergonomic offers suggestive evidence for the initial fueled by union activities, that interventions in the workplace’’ (Ex. 32– benefits of a back injury prevention program. ‘management was * * * not doing 241–4, p. 218–219). Whether such interventions will continue to enough * * * to curb this epidemic’’ ’ OSHA’s Response: Gibson, Dunn & reap benefits in future years depends, to a (citing Ex. 30–1337, p. 69). The reported Crutcher omitted an important part of large extent, on a favorable work the excerpt they quote from the Tadano environment and the maintenance and reduction, therefore, might have nothing continuation of positive behavioral changes to do with the effectiveness of the study. The excerpt should read that (emphasis added) (Ex. 26–1099, pp. 209– ergonomics program and more to do ‘‘* * * so many factors were changed 210). with the statistical effect of ‘‘regression (i.e., worker methods, work-station to the mean’’ (Ex. 500–197, pp. II–17– design, addition of exercises, and mini- I response to general comments in the 18). breaks) that success or improvement record that the case studies OSHA used cannot be attributed to any single to indicate program effectiveness are OSHA’s Response: This case study factor.’’ The factors mentioned by seriously biased, OSHA does not describes an ergonomic intervention Tadano all relate to the ergonomic dispute that these case studies, like all implemented by a telecommunications interventions described in the study, such reports and investigations, may establishment to address an increase in and all would be considered appropriate reflect some bias; no study can the rate of upper-extremity MSDs among engineering, administrative, and eliminate all biases or potential VDT operators. There is nothing in the medical management interventions confounders. However, the large case study that supports Gibson, Dunn under the final rule. Thus, OSHA did number of case studies accumulated by & Crutcher’s contention that the not attribute the reduction in the MSD the Agency makes it highly unlikely that observed decline in the number of rate inappropriately, Gibson, Dunn & any single unaccounted for confounder, upper extremity MSD cases and their Crutcher imply; instead, OSHA, as well such as the Hawthorne effect, could associated medical costs was due to as the author of the study, attribute the explain the consistent results reported ‘‘regression to the mean’’ following an post-intervention reduction in MSD rate in these studies as well as the effect unusual increase in MSD rates, nor is to the collective effect of all of the OSHA postulates: that ergonomic there any suggestion by the author that components of the ergonomic interventions work. ‘‘operator hysteria’’ was solely or even intervention. primarily responsible for the increase in Malcolm Pope Case Study of the MSD rate prior to instituting the Leiyu Shi Study (Ex. 26–1099) Telecommunications Workers (Ex. 26– 1073) intervention. When reports of MSDs Comment: Although this study is a began to increase, the article stated that randomized study, there are serious Comment: As an example of an the ‘‘* * * medical department staff flaws including small size and lack of ‘‘emphatic disclaimer’’ OSHA’s critics was especially concerned, as they were sufficient study period to eliminate claim the authors of the technical aware that a similar department of a Hawthorne effect or other variables as articles made and OSHA ignored Pope company branch in an adjacent state potential explanations (Tr. 6823; Ex. 32– explains in his article [which was used had been faced with [repetitive motion 241–3–7, p.15). The author admits that by OSHA in its effectiveness analysis] syndrome] in ‘epidemic proportions’.’’ ‘‘* * * his analysis ‘contains a number that ‘‘there are other factors involved (Ex. 26–1337, p. 69) The article also of limitations,’ including the need for * * * [in low back pain] such as stated that ‘‘* * * the job was further examination and empirical abnormal anatomy, the physical fitness considered stressful and monotonous by testing to establish ‘the reliability and of the individual, changes related to age many operators,’’ and that ‘‘* * * [the] validity’ of the methodology he used and previous injury.’’ (Ex. 32–241–4, p. labor management relationship had and the very real possibility of ‘a 219, citing Ex. 26–1073, p. 450). previously been good.’’ (Ex. 32–1337, p. Hawthorne effect among the OSHA’s Response: The Pope paper 69) The author clearly attributed the participating units’ because employees discusses the etiology of work-related decline in MSD cases following the knowing they are being studied react low back pain and approaches for ergonomic intervention to the unusually and their reported behavior reducing back injury rates. Part of this intervention itself, and reported that change may be more a result of their report presents a case study of an ‘‘* * * these results indicate the value enthusiasm rather than that of an injury ergonomic intervention in a of a positive approach to prevention of prevention program.’’ [citing Ex. 26– telecommunications manufacturing this occupational group [of disorders].’’ 1099, p. 210] (Ex. 32–241–4, p. 219). facility. In discussing the etiology of low (Ex. 26–1337, p. 70) Therefore, OSHA OSHA’s Response: The Leigu Shi back pain, Pope stated, almost as an finds that it is appropriate to rely on this study is a randomized trial of a back aside, that other factors may be case study as part of its data set of injury prevention program implemented involved; however, in discussing the ergonomic interventions. among county employees; the program etiology of low back pain, Pope

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Comment: The group is too small to subjected to loads that are too high for OSHA’s Response: This study was a support statistically valid conclusions. too long a period of time without an formal investigation of sick leave and Baseline of four compensation claims, opportunity for repair to occur’’ (Ex. 26– medical records to evaluate the not necessarily attributable to MSDs (Ex. 1073, p. 450). In addition, he notes that effectiveness of ergonomic 32–241–4, p. 220, see footnote 805). ‘‘[l]ow back pain has, in most cases [of improvements made in 1975 in a OSHA’s Response: This case study of over-exertion injuries reported], telecommunications parts a mid-sized ice cream manufacturer occurred due to a mechanical overload manufacturing plant. Although the (230 workers in summer, 60 in winter) to one of the tissues of the back’’ (i.e., authors stated that ‘‘* * * one should clearly identifies the four workers’ lifting to much, too far, too long, etc.) not conclude that the work station is the compensation cases as involving ‘‘soft (Ex. 26–1073, p. 450). Dr. Pope major causal factor for any individual tissue’’ (Ex. 26–1100, p. 52). All of these concluded the section of his paper on case of [MSD]’’ (emphasis added), there claims occurred after the installation of etiology by stating that ‘‘The key issue is no question that the investigators six new workstations, whereas in the for those involved in the prevention of believed that reducing exposures to preceding seven years (before the occupational injuries is to use biomechanical load was responsible for workstations were installed) there had epidemiologic information so that the reducing the sick leave associated with been no such claims. In addition to the relationships between load, repetition MSDs: decrease in the number of claims after rate and exposure can be identified.’’ There is no doubt that there has been an the intervention, the implementation of (Ex. 26–1073, p. 450) unusually high rate of musculoskeletal ergonomic changes resulted in a Dr. Pope then described the case illness among the workers * * * in general. decrease in absenteeism from ten to four study that exemplifies his approach (Ex. * * * It is also clear that the work situations percent, an increase in productivity of 26–1073, p. 453, abstract). The results of have been strenuous, with the strain mainly as much as 55 percent, and an overall the case study showed that, within one affecting a limited number of muscles in the shoulder and neck region * * *. [I]t is very increase in morale (Ex. 26–1100). Thus year of implementing an ergonomics unlikely that those employed at the [work OSHA finds it appropriate to include program that included engineering station] * * * have a sufficiently different this study in its database. changes, the incidence rate of life situation to other women of the same age significant repetitive trauma disorders to explain the group differences in sick leave Cattle Feed Processing Case Study (Ex. decreased from 1.1 cases per 100,000 due to musculo-skeletal disorders. The work 26–1046) working hours to 0.26 cases/100,000 load and, specifically, the strain on shoulder Comment: Group is too small to working hours and lost work days and neck muscles, must therefore be considered a major causal factor in the support statistically valid conclusions. decreased from 1,000 to 129 (i.e., an development of musculo-skeletal disorders Purportedly scientific article making almost eightfold decrease in lost work among [the] workers [Emphasis added]. claims based solely on the experience of days). Dr. Pope concluded his paper as [Ex.26–1026, p. 174] two cattle feed processing employees follows: Thus, based on the specific without any attempt to explore the An ergonomic approach, soundly based on conclusions reached by the authors of etiology of the reports (ex. 32–241–4, p. biomechanical principles, will be effective in this study, OSHA finds that it 220, see footnote 805). reducing such injuries if the correct appropriate to include this study among OSHA’s Response: This study management approach is taken. [Ex. 26–1073, describes a case in which a processing p. 454] the data base of case studies that describe the effectiveness of ergonomics plant began producing experimental Based on Dr. Pope’s discussion of the programs. cattle feed in a manual operation. etiology of low back pain and the According to the article, the operation conclusions that accompany the case Meatpacking Case Study (Ex. 26–1043) ‘‘was apparently initiated without either study, OSHA does not agree that the Comment: Group is too small to pre-run trials or consideration of reference to ‘‘other factors’’ cited by support statistically valid conclusions. occupational health and safety issues’’ Gibson, Dunn & Crutcher represent an Baseline of four reported injuries at (Ex. 26–1046, p. 27). The injuries ‘‘emphatic disclaimer’’ of the case meatpacking operation (Ex. 32–241–4, sustained by the two employees were study’s findings. p. 220, see footnote 805). shown to have been a direct result of OSHA’s Response: This article these specific workplace activities; Westgaard and Aaras Study of a describes the comprehensive between two and four weeks after Telecommunications Manufacturer (Ex. ergonomics program implemented by a beginning these specific workplace 26–1026) major meatpacking company. Although activities, both of the workers sustained Comment: The authors note in this the program was implemented for ‘‘all irreversible back injuries. After paper that ‘‘musculo-skeletal illness plant locations’’ of the company, the engineering controls were implemented, may also develop as a result of other article reports quantitative results only there were no incidents of reported back factors than work load, for instance as for the bacon department. Although the pain during three subsequent trials of a complication because of other number of MSD cases is small, Gibson, the redesigned process. The author illnesses, due to general defects of the Dunn & Crutcher fail to mention that the reported that ‘‘* * * [h]ad such musculo-skeletal system, due to muscle reduction experienced by the countermeasures been implemented spasms as a consequence of problems of department was a decrease from four immediately, the irreversible injury a psychological nature, or to strenuous CTDs in one month to none in the six would have been prevented’’ (Ex. 26– leisure time activities [;t]hus, one months following the implementation of 1046, p. 28). Again, OHSA finds this should not conclude that the work the program (Ex. 26–1043, pp.138 & study is appropriately included.

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Hand Tool Operations Case Study (Ex. predicting long-term effects from the homes and other health care industry 26–1070) employer’s newly implemented sectors (see Appendix VI–2 in this Comment: Group is too small to ergonomics program, it also stated the section of the preamble). These other support statistically valid conclusions: following: studies also report reduced MSD rates ‘‘the data are inadequate for rigorous that are attributed to ergonomic [I]t appears that [worker CTD interventions, many of them similar to statistical evaluation’’ (Ex. 32–241–4, p. compensation] claims have declined 220, see footnote 805, citing Ex. 26– those investigated by Garg and Owen somewhat, but the program has not really (i.e., use of mechanical devices for 1070, p. 678). been in place long enough to be able to verify OSHA’s Response: This was a formal a trend * * * It does look promising, patient lifting, modifying showers and toilets for easier access). Therefore, study of OSHA log and medical records however, particularly in terms of the number OSHA does not agree that it is at a telecommunications manufacturing of CTD claims, which have fallen even while inappropriate to include the Garg and facility during the implementation of a total employment has risen, and perhaps the average cost per claim. Owen case study in the database, program to introduce redesigned hand On a division-wide basis, members of the despite the authors’ caution. tools and provide employee training on company CTD committee think that, as a ergonomics; one of OSHA’s expert result of the CTD strategy implementation, Couch, Summary of Six Case Studies witnesses, Dr. Thomas Armstrong, was the numbers of CTD-related injuries and (Ex. 26–1086) a co-author of this study. The plant- illnesses have decreased, the associated costs Comment: The importance of non- wide incidence rate of OSHA reportable of claims (workers’ compensation and work factors such as gender and age are repetitive trauma disorders prior to the medical) have decreased, employee mentioned as potential contributors. complaints have been reduced, and employee implementation of engineering and ‘‘The above examples of the cost administrative ergonomic controls was morale has improved (Ex. 26–1176, pp. 12– 13). benefits of ergonomics are quite positive 2.2 cases per 200,000 workhours and and indicate that ergonomics does seem 1,000 lost workdays. In addition, Thus, it is clear that this employer to reap monetary rewards as well as incidence rates were as high as 4.6 representative attributed the observed improve worker well being. However, percent in some areas of the facility and decline in MSDs directly to there are many factors that have not work restrictions were impeding the implementation of the program, and been accounted for or controlled in balance of production lines. Four OSHA therefore finds it appropriate to these reports; these factors, such as departments accounted for 68 percent of include it in the data set being relied on changes in the economy that reduce job all repetitive trauma injuries, and 48 by the Agency to evaluate the turnover or changes in production percent of all repetitive trauma injuries effectiveness of ergonomic technology and product lines that may occurred among assemblers (Ex. 26– interventions. eliminate high risk jobs or leave only 1070, pp. 674, 676–677). Garg and Owen Study of Ergonomic the survivors in remaining jobs, may After the implementation of controls, Interventions in a Nursing Home (Ex. also contribute to the apparent payback. repetitive trauma disorders decreased to 26–1093) Because ergonomic case studies such as 0.53 per 200,000 workhours and only these are done ‘in the field,’ it is very 129 lost workdays. The authors stated Comment: Group is too small to difficult to hold these independent or that the contribution of the control support statistically valid conclusions. external variables constant’’ (Ex. 32– program to the reduction in MSDs seen ‘‘[L]arge-scale studies in different 241–4, p. 220, see footnote 805, citing in the facility ‘‘cannot be statistically nursing homes are necessary to confirm Ex. 26–1086). tested using the available medical data,’’ the * * * findings’’ in the article (Ex. OSHA’s Response: OSHA recognizes but emphasized that they believe the 32–241–4, p. 220, see footnote 805, that the case studies contained in control program was ‘‘an important citing Ex. 26–1093). Appendix VI–2 are, because of their factor in this reduction’’ (Ex. 26–1070, OSHA’s Response: The study was real-world rather than laboratory nature, p. 677) and stated that the program conducted in two units of a nursing unable to control for a number of factors ‘‘appears very promising’’ (Ex. 26–1070, home which employed 57 nursing that could affect injury and illness p. 678). Based on the authors own assistants. As a result of the controls outcomes; some of these factors are conclusions, OSHA finds that the implemented, the incidence rate for mentioned in the Couch article (Ex. 26– reported reduction in MSDs in this back injury decreased from 83 per 1086) and in Gibson, Dunn & Crutcher’s plant are apprpriately attributed to the 2,000,000 work-hours to 47 per comment. However, OSHA is not basing ergonomic interventions described. 2,000,000 work-hours. The authors its finding that ergonomic interventions concluded that ‘‘an appropriate are effective on any single study or a Material Handling at Grocery (OSHA ergonomic intervention program offers few case studies. Instead, OSHA has Site Visit) (Ex. 26–1176) great promise in reducing physical identified more than 200 case studies Comment: Group is too small to stress and risk of low-back pain to from the record, all of which document support statistically valid conclusions. nursing personnel.’’ OSHA agrees that, reductions in MSD numbers or rates ‘‘From these data, it is not certain that as the authors stated in their article, the following implementation of ergonomic costs associated with CTDs, the severity specific findings of this one study may interventions. These case studies reflect of CTDs (as represented by cost per not reflect the results achieved in other a wide variety of industry sectors, claim), or the impact of CTDs on total establishments that implement similar workplace conditions, labor market medical claims have changed ergonomic measures. Garg and Owen conditions, and technologies. significantly for the long term’’ (Ex. 32– explain that implementing such Nevertheless, despite the presence of 241–4, p. 220, see footnote 805, citing measures requires consideration of confounding or modifying factors such Ex. 26–1176). staffing levels, training, workload, and as those mentioned in the Couch article, OSHA’s Response: This case study administrative support (Ex. 26–1093). all of these studies attributed the resulted from an OSHA-sponsored site However, the study by Garg and Owen observed reductions in MSD rates visit to a retail grocery establishment. is only one of several case studies used primarily to the ergonomic Although the site visit report by OSHA to examine the effectiveness interventions described. Because such a acknowledges its limitations in of ergonomics programs in nursing large number of case studies yields such

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The article studies. ergonomics program the elimination of does not claim, as the comment hand MSDs from a pre-intervention contends, that ‘‘ergonomic remedies Automobile Cable Manufacturer (OSHA level of 51 MSDs in 1976. ‘‘The claim were unsuccessful.’’ Instead, the article Site Visit) (Ex. 26–1181) is false: the exhibit makes no reference stated that several attempts were made Comment: OSHA’s estimate of the to elimination of hand MSDs, and the to develop a ‘‘safety program’’ that was reduction in the number of MSDs pre- underlying data tables confirm the not further described (Ex. 26–1059, p. and post-intervention are based on existence of continuing injury reports. 52). If engineering solutions to address numbers of illness cases, lost workday Moreover, ergonomic interventions were MSDs were implemented, they were not cases, and lost work days in 1991 and not even proposed at the plant until discussed in the article; instead, the 1993. However, the statistics for 1993 1977, a year in which MSDs dropped to article reported that ‘‘because of the represent only the first 9 months of the a level (20) more consistent with the expense of workstation redesign in this year. Further, the establishment lower rates existent prior to this year.’’ very old facility, almost all human- reported an increase in the total number (Ex. 32–241–4, p. 220). factors engineering measures were also OSHA’s Response: Tables 3 and 4 of of injuries, which must include some deemed to be impractical’’ (Ex. 26–1059, Ex. 26–1090 (p. 430) provide data on the MSDs, from 46 in 1991 to 65 in the first p. 52). Therefore, no claim can be made numbers of hand MSDs from 1972 to 9 months of 1993. OSHA cannot base its as to the success of an ergonomic 1984 in this food packaging facility. The effectiveness estimate solely on the intervention based on engineering at incidence of hand MSDs increased reduction in illness cases reported (Ex. this facility. The comment states that steadily from 1972 to a high of 51 cases 32–241–4, p. 222). the program implemented was actually in 1976 and 20 in 1977; between 1979 ‘‘ ‘a behavioral management program’ OSHA’s Response: The site visit and 1984, the table reported between 0 designed to improve worker attitudes report clearly states in a footnote to the to 1 MSDs occurring annually, and morale.’’ Behavior management is ‘‘1993’’ column which of the data indicating that the problem had been defined in the article as ‘‘simply the ‘‘covers [the] period from January to virtually eliminated. OSHA has revised management of people in the work place September 1993’’ (Ex. 26–1181, p. 10). the entry for this case study in in such a way that they interact with the If the statistics for 1993 are extrapolated Appendix VI–2 to report the study’s environment in the most safe and to cover a full year, based on the findings more precisely. With reference efficient manner’’ (Ex. 26–1059, pp. 51– experience of the first 9 months, to the second part of Gibson, Dunn & 52). The training ‘‘attempted to educate declines in lost workday cases and Crutcher’s comment, OSHA did not rely employees on the causes and effects of illnesses are still apparent: lost workday on the hand MSD statistics for its [cumulative trauma disorders] * * * cases decline from 48 (1991) to 36 overall measure of program and the state workers’ compensation (1993) (a 25-percent reduction); the effectiveness, but on data presented in system.’’ (Ex. 26–1059, p. 53) The final number of lost workdays decline from Table 5 of the article, which reported rule requires employers to provide 1,287 (1991) to 367 (1993); and the the number of MSDs of the neck and similar information to all employees on number of illnesses decline from 47 upper extremity in 1977 and 1981 and the causes and characteristics of MSDs. (1991) to 23 (1993) (a 51-percent reflect an overall reduction in the The program at the facility also reduction). Although the report clearly number of MSD of 47 percent. Thus, encouraged employee participation, indicates that the number of total OSHA is using 1977 as the baseline another important component of the injuries increased from 1991 to 1993, year, the year in which ergonomics final rule. OSHA does not agree with the the report also states that ‘‘[t]he facility interventions were being proposed. comment that the case study believes that their ergonomics program demonstrates that psychosocial factors has contributed to decreases in the Footwear Assembly Case Study (Ex. 26– 1059) are more important that biomechanical following: number of overall illnesses, factors; OSHA’s review of the scientific number and costs of worker’s Comment: OSHA attributes a 62- evidence on the role of psychosocial compensation claims, number of work percent decline in MSDs over a 2-year factors is presented in the Health Effects days and lost workday cases, medical period to an ergonomics training section (Section V of the preamble), (i.e., non-compensated disability) cost, program. However, the article explains where the Agency finds that, although and turnover’’ (Ex. 26–1181, p. 9). These that ergonomic remedies were psychosocial factors play a role in the claims are supported by the data unsuccessful and the ergonomics etiology of work-related MSDs, they do presented in the report. No reason was training program ‘‘* * * was actually a not outweigh the significance of given for the increase in the total ‘behavioral management’ program exposure to biomechanical factors in the number of injuries from 1991 to 1993, designed to improve worker attitudes workplace and are independent of nor was there any evidence in the report and morale’’ (Ex. 32–241–4, p. 225). biomechanical efferts. to suggest that the rise in total number This case study is consistent with of injuries was attributed to an increase evidence that ‘‘reports of pain are rooted Sewing and Cutting Operations Case in the number of MSDs. It is apparent, in psychosocial factors rather than Study (Ex. 26–1060) however, from the report that the workplace ‘hazards,’ [and that] the Comment: This is an article written by employer would have been likely to attitude adjustment strategy apparently an OSHA area office employee about an classify some MSDs as injuries rather achieved what ergonomics could not.’’ inspection of a sewing facility. ‘‘The than illnesses. Therefore, OSHA has [Ex. 32–224–4, pp. 225–226] article actually reports, however, that revised its analysis for the final rule to OSHA’s Response: This article there was a steady decline in reported reflect that lost workday cases declined describes a training program CTD rates beginning long before any by 25 percent, and is not relying on the implemented at a footwear ergonomic interventions: 26% in 1987,

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18% in 1988, and 15% in 1989’’ [citing attribution of the reduction in MSDs to ‘‘The statement only reflects the Ex. 26–1060, p. 1]. The article does not the ergonomics program, when the subjective judgement of Dr. Oxenburgh identify exactly when ergonomic reduction occurred prior to program about ‘risk’; he provides no actual data controls were implemented, but it does implementation, and its use of total concerning actual injury experience state that rates continued to decline to injury rates as if they were MSDs are after the change.’’ (Ex. 32–241–4, p. 225) 14.6% in 1990 and 6.8% in 1991, but ‘‘blatant distortions of the truth.’’ (Ex. Further, the numbers are too small for increased to 11% in 1992. The article 32–241–4, p. 224) statistical analysis, and ‘‘Oxenburgh’s also noted that ‘‘there was an increase OSHA’s Response: This case study is unverified hunch about risk has no initially reported’’ after ergonomics a site visit report of a poultry place in a statistical analysis.’’ (Ex. 32– controls were implemented, which slaughtering and processing plant. The 241–4, p. 225) could only refer to the jump from 6.8% injury rate history of this plant was as OSHA’s Response: This case study to 11%. Since no statistics are given for follows: 14.0 in 1987, 10.5 in 1988, 10.5 describes a sugar cube packing years after 1992, these data would in 1989, 7.5 in 1990, and 7.0 in 1991 operation in which 5 employees used a suggest, if anything, that ergonomic (Ex. 26–1174, p. 17). The comment by tool to pack cubes tightly into boxes. controls reversed a previous trend of Gibson, Dunn & Crutcher suggests that Because of the hand posture and declining injury reports at this plant, the reduction in injury rate that pressure required to operate the tool, prompting a 62% increase from 6.8% to occurred in 1990 occurred prior to injuries to the hand and upper limbs 11%.’’ (emphasis in original) [Ex. 32– implemetation of most of the occurred in about 1 out of 4 operators 241–4, p. 223] ergonomics program. However, the site (i.e., 25 percent of workers). After OSHA’s Response: This article reports visit report states clearly that $410,000 implementing an engineering and on an OSHA inspection conducted at a in capital cost was incurred for marketing solution that allowed the sewing facility in October of 1989. Since engineering controls in 1990, compared cubed sugar to be packed loosely into the inspection, at least through 1992, to $242,500 in 1991, indicating that bags, productivity increased to the point the company had been working under most engineering improvements to where only 2 workers were required for an abatement plan that required the address MSDs were made in 1990 (Ex. the packing operation. The complete facility to develop and implement a 26–1174, pp. 9–10). Therefore, OSHA quote partially cited by Gibson, Dunn & comprehensive ergonomics program does not agree that the 1990 injury rate Crutcher from the case study reads as ‘‘from the ground up’’ (Ex. 26–1060, p. reflects a time when most of the follows: ‘‘The risk of serious strain 3). In 1992, the year in which the MSD program had not yet been implemented. injuries to the hands and upper limbs rate increased over that of 1991, the Further, the first drop in injury rate, has virtually been eliminated and has report stated that there were ‘‘fewer which occurred in 1988, can be at least led to considerable savings in sickness incidents reported [overall],’’ which partly attributed to the large increase in absence and workers compensation.’’ suggests that employment in the plant employment in 1988 (from 950 workers Although no statistics are presented, had fallen since 1991 (there had in 1987 to 1,350 workers in 1988) (Ex. previously been about 100 workers at 26–1174, p. 17). Because of the change this is significant because it this plant). There were also no surgeries in employment in 1988, OSHA used the demonstrates a clear benefit from the reported in 1992, compared to 13 injury rates from both 1987 and 1988 as change to the process. Rather than reported between 1987 and 1989 (Ex. baseline years to calculate the percent representing an ‘‘unverifiable hunch,’’ 26–1060, p. 2). The report concludes reduction in injury rate pre- and post- as Gibson, Dunn & Crutcher suggest, that the ‘‘lost workday injury rate has implementation (i.e., OSHA used an OSHA finds it logical to conclude from been effectively reduced,’’ and noted average baseline rate of 12 injuries per Dr. Oxenburgh’s statement that no that the number of employee complaints year). Additional evidence that the drop serious injuries occurred among the two of MSD symptoms had fallen from 34 in in injury rate in 1990–1991 can be remaining operators because the change 1991 to 14 in 1992 (Ex. 26–1060, p. 6). attributed to the ergonomics program eliminated the forceful repetitive Therefore, OSHA does not agree with comes from other statistics provided by motion (i.e., pressing the sugar cubes the analysis of this report by Gibson, the facility that show drops in both together) responsible for the prior Dunn & Crutcher, which suggests that worker absenteeism and turnover in injuries. the ergonomics program led to an 1990–1991 compared with earlier years; Computer Manufacturer Case Study (Ex. increase in the rate of MSDs. in contrast, there was no drop in 26–1068) absenteeism or turnover rates to Poultry Processing Case Study (Ex. 26– accompany the drop in injury rate seen Comment: OSHA attributes a 41- 1174) from 1987 to 1988 (Ex. 26–1174, p 17). percent reduction in upper-extremity Comment: ‘‘OSHA claims that Therefore, OSHA finds that the decline disorders in 1994–1995 and a further ‘ergonomic solutions’ at a poultry plant in injury rate seen in the 1990–1991 50-percent reduction in 1995–1996 to an decreased recordable injuries and time period is most likely to have been ergonomics program. However, the illnesses * * * from 10–14/100 workers the result of the ergonomic program was implemented in 1991, after (1988–89) to 7/100 workers (1991). improvements made in 1990 and 1991 a year (1990) in which the company’s * * * [T]he only two notable dips in at this factility. upper-limb disorder rate was 0.5 per recordable injury rate—which includes 100 workers. This rate increased to a all injuries and not just MSDs— Packaging Sugar Cubes Case Study (Ex. high of 2.5 cases per 100 workers in occurred between 1987 and 1988, when 26–1041, Case 41) 1994, after which they drop in 1995 and the rate declined from 14.0 to 10.5, and Comment: OSHA attributes a 100- 1996. ‘‘Thus, the reported declines in between 1989 and 1990, when there was percent reduction of MSDs at a sugar 1995 and 1996 brought the company a further drop from 10.5 to 7.5. The first cube packing operation, where the down to approximately a 0.7 rate—a 40- occurrence took place before author of the study, Dr. Oxenburgh, percent increase over the experience it ergonomics began, and the second stated that ‘‘the risk of serious strain had during the last year before occurrence took place before the injuries to the hands and upper limbs ergonomic interventions were majority of the program was rolled out.’’ has been virtually eliminated’’ (citing introduced.’’ (Ex. 32–241–4, p. 226, (Ex. 32–241–4, p. 224) OSHA’s Ex. 26–1041, p. 230, emphasis added). emphasis in original)

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OSHA’s Response: Although this year in which their MSD rate was 5.2 cases at an aircraft parts manufacturer computer manufacturer did implement cases per 100 workers), and first began ‘‘based solely on data referring to an ergonomics program in the early to implement controls in 1991 (Ex. 26– specific diagnosis of CTS, ignoring 1990s, according to the case study, the 1183, p. 2). OSHA used 1990, the first information * * * clearly stating that program began ‘‘with a reactive year prior to implementation of the total ‘number of reportable approach, addressing individuals.’’ This ergonomic controls, as the base year in ergonomic injuries and illnesses [not isolated approach could be a reason its effectiveness analysis. The company just CTS] has actually increased since why an immediate reduction in upper- continued to implement controls in the ergonomics program began.’ ’’ (Ex. limb disorders was not realized. In 1992 and 1993. Since injury statistics 32–241–4, p. 232, citing Ex. 26–1179, p. addition, ‘‘[p]art of the increase in the were only available for the first 3 15, emphasis in original) number of CDT cases per year [from months of 1993, OSHA believed that a OSHA’s Response: This case study is 1990 through 1994] can be attributed to reliable injury rate could not be a report of a site visit conducted at an the company’s rapid growth, which determined for that year. OSHA does aircraft parts manufacturing facility. A more than doubled during that period.’’ not agree that the statistics available for formal ergonomics program was The trend was not reversed until the the first quarter of 1993 show that the initiated in 1988, but did not have company, beginning in 1993, ‘‘spent at MSD rate was increasing because it ‘‘solid commitment from upper least two days a week performing reflected too short a period. management and * * * [was] not evaluations, held mandatory ergonomic Consequently, there are no data readily accepted by the workforce.’’ (Ex. training classes for high risk groups available in the report to permit an 26–1179, p. 1) In 1991, the facility including technical publications, assessment of the effect of ergonomic implemented a redesigned program order[ed] administration and customer interventions implemented in 1992 or following an OSHA citation, ‘‘which technical phone support, and created 1993 at this facility. OSHA attributed [the program] proved to be very and distributed a 16-page ergonomics the decline in MSD rates from 1990 to successful since it had the support of brochure.’’ Additionally, with the 1992 to the improvements made in upper management and relied on hourly growth in 1994 and 1995, the company 1991, based on the report’s finding that employees working together to identify purchased new furniture ‘‘allowing ‘‘[t]he facility believes that their and implement solutions to ergonomic employees a greater range of postures ergonomics program has contributed to problems.’’ (Ex. 26–1179, p. 1) The and flexibility.’’ It was this expanded a general decrease in the plant’s annual facility reported that the percentage of and comprehensive approach that led to incidence rate for ergonomic-related total recordable injuries represented by the 41 percent drop in reportable upper- injuries and illnesses.’’ OSHA believes ergonomics cases rose from 13.5 percent limb disorders from 1994 to 1995 and that this is an appropriate interpretation in 1991 to 20 percent in 1992 (i.e., MSDs the further decrease of 50 percent in of this study. (Ex. 26–1183, p. 10) represented a larger proportion of all reportable CDT cases from 1995 to 1996 injuries and illnesses in 1992 than in Vehicle Seat Assembly Case Study (Ex. (Ex. 1068, pp. 7–8). Therefore, OSHA 1991). This does not necessarily mean 26–1076) finds that the decline experienced in that the number or rate of MSDs MSD rates beginning in 1995 is Comment: This case study reported increased during this period, as Gibson, consistent with the company’s that the number of tendinitis and carpal Dunn & Crutcher claim. In fact, facility implementation of ergonomic tunnel syndrome cases had dropped 93 representatives stated that ‘‘the actual improvements that consisted of and 96 percent, respectively, but OSHA number of [MSD] cases is at least appropriate education and training of its ignored information that the broader holding steady.’’ (Ex. 26–1179, p. 15) workers, as well as workstation category of ‘‘strains and sprains’’ However, because the site visit report modifications. increased over the same period. makes clear that there were MSD cases OSHA’s Response: This is a case that occurred in the facility in addition Medical Device Manufacturer Case study of an automobile seat to the CTS cases used by OSHA to Study (Ex. 26–1183) manufacturer that began experiencing calculate program effectivness, and Comment: OSHA apparently problems with MSDs shortly after because the report provides no statistics attributes a 29-percent reduction in beginning full production. The ‘‘slight’’ or other details on the number or rate MSD rates from 1990 (2.1 cases per 100 increase in sprains and strains reported of these cases, OSHA is no longer workers) to 1992 (1.5 cases per 100 by the case study occurred during a time relying on this case study in its workers) to an ergonomics program (Ex. when the numbers of tendinitis and effectiveness analysis for the final rule. 32–241–4, p.228, footnote 857). carpal tunnel syndrome cases dropped However, ‘‘the corporation did not begin dramatically. According to the Office Furniture Manufacturing Case to address ergonomic issues until 1991, manufacturing manager, the increase in Study (Ex. 26–1102) did not formalize the program until strains and sprains ‘‘reflected the Comment: OSHA claimed a 67- 1993, and did not conduct training or employees reporting the discomfort and percent reduction in MSD rate, implement the vast majority of its pain [of MSDs] earlier.’’ (Ex. 26–1076, p. apparently from a ‘‘passing reference to workplace modifications until 1992 or 66) Because the increase in strain and a claimed reduction in ‘‘incidence 1993. The result was a very substantial sprain reports was described as ‘‘slight’’ rate’* * * (‘‘incidence of what is not increase in ‘ergonomics incidence rate’ by the manufacturing manager (Ex. 26– specificed)’’ (Ex. 32–241–4, p. 232). to 2.8 [per 100 workers] in the first three 1076, p. 66), OSHA finds that the much However, the information presented in months of 1993 from * * * pre- larger decreases in the numbers of OSHA’s Appendix VI–2 shows a intervention levels.’’ (Ex. 32–241–4, p. tendinitis and CTS cases fairly reflect reduction only from 21 per 100 workers 228) the results achieved by the company’s in 1989 to 19 per 100 workers in 1991– OSHA’s Response: This case study is ergonomics program. 1992, a change of only 9 percent ‘‘that a site visit report to a manufacturer that is of dubious statistical significance’’ produced suction canisters used to Aircraft Parts Manufacturer Case Study (Ex. 32–241–4, p. 232). collect blood during surgical (Ex. 26–1179) OSHA’s Response: In OSHA’s final procedures. The company began to Comment: OSHA attributes a analysis of the effectiveness of address ergonomic issues in 1989 (a reduction of 96.2 percent in total MSD ergonomics programs, OSHA is basing

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Regarding the comment on Comment: ‘‘[OSHA] * * * recites two statistical significance, it was not Materials Handling, Electrical Utility (Ex. 26–1085) examples from self-interested company OSHA’s intent to limit its analysis of officials claiming ‘50%’ and ‘100%’ case studies only to those studies where Comment: OSHA attributes 100- reductions in ‘total MSDs’, while the reported change in MSD rate could percent effectiveness to an ergonomics ignoring a lengthy description in the be shown to be statistically significant, program based on a ‘‘passing reference’’ same article of scientifically primarily because most of the case in the case study to eliminating 9 documented experience at a different studies lacked information to perform injuries just by getting in and out of company showing that ‘job tests of statistical significance. OSHA vehicles. The article explains elsewhere improvements’ cannot be expected to believes it important to base its analysis that the total program is in its ‘infancy translate to any reduction in ‘the on all of the experiences reported in the stage’ and the overall asserted effect so number of back injury claims filed’.’’ set of case studies, however large or far has been to reduce lost-time injuries (Ex. 32–241–4, p. 234, citing Ex. 26– small the result attributed to ergonomics from more than one per 100 employees 1078, p. 30) interventions, and not to limit its to 0.42, only part of which is allegedly OSHA’s Response: The ‘‘scientifically analysis to the small group of case documented experience’’ referred to by studies for which tests of significance attributable to ergonomics.’’ (Ex. 32– 241–4, pp. 233–234) Gibson, Dunn & Crutcher is a short could be performed. article by Dr. Stanley Bigos, University OSHA’s Response: This case study is of Washington Department of Freight Truck Terminal Operations Case a published article describing the Study (Ex. 26–1177) Orthopaedics, describing his results ergonomics program at a major utility from the Boeing study and the role of Comment: OSHA assumes a 46- company. OSHA based its measure of psychosocial factors in low back percent decline based on a table that intervention effectiveness on the results disability. OSHA discusses both the shows 13 MSDs occurred in 1989 and 7 of two specific interventions discussed Boeing study and psychosocial factors at in 1991, ‘‘but it overlooks further in the article. These are not ‘‘passing length in the Health Effects section information in adjacent sections of the references’’ but are examples of the (Section V) of this preamble. report indicating that there have been earliest interventions implemented by ‘‘no changes’’ in overall * * * [MSD] the company: UPS Case Study (Ex. 26–1084) incidence’’ and that there has been no ‘‘Downsizing water and ice kegs from 10 to Comment: Steven Thompson, who co- decrease in MSD-related disabilities (Ex. five gallons and lowering their placement on authored a UPS report, ‘‘does not 32–241–4, p. 233) trucks is one way we profited from believe that it would be legitimate to OSHA’s Response: This case study is ergonomic thinking right away * * * Since cite the article as evidence that a site visit report for a truck terminal making the change, we’ve had no injuries ergonomic interventions pursuant to operation. The site visit report was associated with lifting water kegs’ (Ex. 26– OSHA’s proposal would have the effect prepared in July, 1992 and contained a 1085, p. 25). that OSHA claims’’ because, among table that reported numbers of MSDs ‘‘[t]hrough the use of ergonomics, ‘we have other things, the article did not attempt occurring in 1989 through 1991. reduced sprain injuries in several of our to link the observed reduction in OSHA’s analysis of ergonomics operations areas.[’] For example, he says, ‘we reported MSD cases to any particular intervention effectiveness was based on went from nine injuries last year from just cause or to account for the Hawthorne these numbers. Although the report getting in and out of trucks and vehicles, to effect (Ex. 32–241–4, p. 217). stated that no decline in MSD-related zero this year’’ (Ex. 26–1085, p. 25) OSHA’s Response: This case study is disabilities had been seen, it also stated a published report of the results of an that the program had been recently The article also makes clear that the ergonomics program that provided implemented (in 1990) and ‘‘its ergonomics program is in its ‘infancy adjustable sit-stand workstations to UPS effectiveness may not yet be apparent’’ stage’ on the corporate-wide level, i.e., employees using computer stations to (Ex. 26–1177). A follow-up telephone that not all problems have been perform a variety of tasks. Benchmark interview was conducted in January, addressed at the time the article was data collected prior to introducing the 1994, at which time the employer published. For example, the article sit-stand workstations included indicated subjectively that there were makes reference to workers who work at production levels, absenteeism, survey no changes in MSD incidence. However, bill processing machines for extended results on operator comfort, and injury the employer also reported that the periods of time and are at risk of and illness rates. The study reported company ‘‘had no hard data to back that developing carpal tunnel syndrome. that injury and illness rates declined by up,’’ and that no information was Because the program had not yet been more than 50 percent in the year after available to track changes in workers’ fully implemented, OSHA did not base introducing the new workstations, and compensation claims related to the its effectiveness measure on corporate- that there were no costs associated with ergonomics program (Ex. 26–1177, pp. wide injury statistics (the company the remaining injuries. In addition, the 5–7 & 5–8). Therefore, it is clear that the reported that total lost-time injuries study reported an average reduction of employer had not been evaluating the declined from more than 1 per 100 62 percent in symptoms of discomfort. performance of their program after 1991, workers to 0.42 per 100 workers) (Ex. There was no change in production and therefore no conclusions can be 26–1085, p. 27), but instead based it on level or absenteeism, which the authors reached regarding the effectiveness of the proven effectiveness of the specific believed may be partly explained by the program after 1991, the last year in interventions discussed in the case poor weather at the beginning [winter] which OSHA was able to obtain data on study. After considering this comment of the follow-up year. In an attachment MSD injuries. OSHA finds that the and reviewing the case study, OSHA to Gibson, Dunn & Crutcher’s quotes cited by Gibson, Dunn & finds that this is still a reasonable submission, Mr. Thompson of the UPS, Crutcher are not convincing in approach and therefore has continued to one of the co-authors of the study, stated establishing that the ergonomics include this study in its database. that the article in question ‘‘did not

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00330 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68591 engage in the type of individual cause- Carl Zipfel, Seton Company piece of equipment that removes brick and-effect analysis that would be Comment: ‘‘Carl Zipfel, Director of from the kiln required employees to necessary to link the observed reduction Environmental Compliance and Safety stand on top of the cars and bend below in reported MSD cases to the sit-stand for Seton Company, a supplier of knee level to lift bricks and place them workstation as opposed to other non- automotive interior leather, testified into trays. Employees suggested and ergonomic factors.’’ Mr. Thompson about his company’s efforts to help implemented an approach that identifies several factors relating to the employees who were stretching leather prevented the need to bend below knee moving of the office location to a new hides over a table and began to level but still required workers to lift building from an ‘‘old crowded complain about shoulder problems. bricks at waist height using an extended building.’’ ‘‘The new building had better Seton Company tried every measure that reach (Tr. 7787–7788). In this example, lighting, ventilation, temperature OSHA could expect. * * * After all of Mr. Willoughby commented without control, windows, modular doors, and these efforts no improvements were providing evidence, that ‘‘what we have an overall open environment.’’ observed.’’ (Ex. 500–197, p. II–20) accomplished [from eliminating the According to Mr. Thompson’s OSHA’s Response: In his testimony at deep bend] is going to be offset by the statement, the authors of the report ‘‘did the informal hearing, Mr. Zipfel fact of extending the arms’’ (Tr. 7788). not account for the Hawthorne effect in provided the following information, On the other hand, Mr. Willoughby light of these factors’’ and other factors, which explains why no improvements provided two examples of job fixes that some of which are often, in fact, were observed: he believed were worthwhile: one considered engineering and • Under questioning, Mr. Zipfel involved using pallets to package brick administrative ergonomic changes. agreed that Seton had no ergonomics in smaller increments for easier In the original article, published as program that would either meet the handling, and the other used metal part of the Proceedings of the Human definition of an existing program under strapping bands and magnetic lifts to Factors and Ergonomics Society 38th the grandfather clause or that would reduce the need for manual handling Annual Meeting, the authors, Nerhood meet the requirements for an (Tr. 7790–7791). Regarding Boral’s and Thompson, do discuss moving ergonomics program in the standard as overall ergonomics program, Mr. employees to a new building to provide proposed (Tr. 3051–3052). Willoughby testified that he developed a better working environment and • Although Seton has investigated a written program a few years ago, but providing adjustable sit-stand incidents of MSD symptoms, the it has not been fully implemented; as workstations for those employees ‘‘with company has no one trained to do a job part of their overall safety and health the heaviest risk of discomfort’’ (Ex. 26– hazard analysis (Tr. 3066). program, Boral currently provides 1084, p. 668). The authors also • Mr. Zipfel stated that Liberty information on MSDs, trains employees acknowledge the possibility of a Mutual and Penn State analyzed jobs in recognizing potential hazards, and Hawthorne effect being a ‘‘contributing and prepared reports for Seton regarding has safety and health committees at its factor to any production changes’’ (Ex. the leather stretching problem, but he facilities, some of which actively 26–1084, p. 671, emphasis added) never discussed what remedies were inspect the workplace and propose because ‘‘the study cycle was too short recommended in those reports or improvements (Tr. 7785–7786). Because to hypothesize long term results [on whether Seton tried to implement any of of the continued exposure of employees production]’’ (Ex. 26–1084, p. 668); the suggested remedies (Tr. 3059). to risk factors in jobs that had been however, nowhere in the article do the There is no evidence in Mr. Zipfel’s automated, and Mr. Willoughby’s authors indicate that the Hawthorne testimony that indicates that Seton had testimony about the value of some of the effect was or could have been implemented engineering or interventions implemented by Boral, responsible for the observed drop in administrative controls to address the OSHA does not agree that the injury rate or operator discomfort. problem at the leather stretching station; experience of Boral Bricks represents a Despite the non-ergonomic changes in thus, OSHA does not agree that Seton failed ergonomics effort. the work environment associated with ‘‘tried every measure that OSHA could Mary Banks, Social Security the new building, the authors concluded expect,’’ and finds Mr. Zipfel’s Administration that ‘‘[t]he commitment from all groups testimony unpersuasive evidence for the involved was the key to the successful failure of ergonomics interventions. Comment: Ms. Banks, a key operator implementation of the ergonomics who was diagnosed with DeQuervain’s program and installation of the new Robert Willoughby, Boral Bricks syndrome in 1998, testified that her adjustable sit-stand workstations’’ (Ex. Comment: After implementing Boral’s symptoms have not improved at all and 26–1084, p. 671, emphasis added). insurance company’s suggestion of have gotten progressively worse in the Thus, in the original study, the authors automating certain jobs in some of his year since she was provided with a new attribute the reduction in operator facilities, the ‘‘injury rates are not workstation. (Ex. 500–197, pp. II–21 discomfort and injury rate to the significantly better than [at] the plants citing Tr. 10664). ergonomic intervention. Because of the that [have ] more manual [jobs]’’ (Ex. OSHA’s Response: Ms. Banks strong conclusion made in the original 500–197, pp. II–20 to II–21, citing Tr. described the new furniture as ‘‘too study, OSHA finds it appropriate to 7776). little, too late’’ for her (Tr. 10690). Her retain this study in its data set. OSHA’s Response: Mr. Willoughby testimony indicated that her condition In their post-hearing brief, Gibson, stated that Boral’s insurance company was quite severe: Dunn & Crutcher describe the testimony recommended the automation of two of several witnesses as examples of jobs: setting green, unfired brick on kiln This impairment is devastating at times. I ergonomic interventions that failed (Ex. cars and hand packaging the finished feel pain most of the time. It is difficult for me to pick up anything that weighs more 500–197, pp. II–20 to II–23). The product (Tr. 7745–7746). It is clear from than three pounds. It is hard to reach in back following summarizes these examples Mr. Willoughby’s description that the of me, to clap my hands even in church. It and OSHA’s response to Gibson, Dunn automated equipment has contributed is difficult to open an envelope. I cannot pick & Crutcher’s interpretation of the significantly to reduction in exposure to up my grandbaby without fear of dropping testimony. risk factors. For example, one automated him. (Tr. 10666–10667)

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In addition, Ms. Banks was also Dr. Charles Roadman for American mean we should not keep trying to do diagnosed with tendinitis (Tr. 10667), Health Care Association that’’ (Tr. 4448). In general, Dr. and used only able to use her right hand Comment: ‘‘Dr. Roadman testified, Roadman has positive things to say to key at the time of the hearing (Tr. however, that ‘everything that we have about ergonomic programs. He discusses 10695). She concluded her testimony by tried has not decreased the incidents of favorably programs that the AHCA stating that, if the ergonomics program [carpal tunnel syndrome]’’’ (Ex. 500– created with the assistance of OSHA (Tr. had been in place, she would not have 197, p. II–21 citing Tr. 4448). 4355–6). He also stated that ergonomic developed her condition (Tr. 10667). OSHA’s Response: Dr. Roadman was programs ‘‘can be very positive if all the OSHA does not find that the lack of not discussing programs that members factors are in place and you have good improvement in Ms. Banks serious of the American Health Care cooperation * * * between labor and upper-extremity disorder after she was Association (AHCA) had instituted to management and the assessment issued a new workstation (details of handle carpal tunnel syndrome, but was process. Yes, they can be very successful’’ (Tr. 4436). which were not described during her referring to an Air Force program he had testimony) constitutes adequate instituted years before when he had From the examples above, OSHA is evidence that properly designed been Surgeon General of the Air Force not convinced that the testimony cited (Tr. at 4448). Although he felt that the by Gibson, Dunn & Crutcher computer and VDT workstations are interventions he had seen tried with demonstrate that ergonomic ineffective in reducing the risk of computer users did not seem interventions are ineffective, as a developing MSDs among healthy qualitatively to reduce the incidence of general matter. workers. CTS, he also stated that ‘‘that doesn’t BILLING CODE 4510±26±P

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BILLING CODE 4510±26±C

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VII. Significance of Risk degrees of material harm—not just death threatened, even though those effects may be or serious physical harm—and may act transitory. * * * Overall, we find that In this section of the preamble, OSHA OSHA’s determinations of what constitute conducts several analyses and presents with a ‘‘pronounced bias towards worker safety.’’ Building & Constr. ‘material impairments’ are adequately data and information to demonstrate, explained and supported in the record.’’ Id. first, that musculoskeletal disorders Trades Dep’t., AFL–CIO v. Brock, 838 at 975 (emphasis added). (MSDs) constitute material harm under F.2d 1258, 1266 (D.C. Cir. 1988). Injuries or illnesses that affect a the Occupational Safety and Health Act The OSH Act also permits OSHA to worker’s job performance, result in lost (OSH Act or Act). This discussion regulate a hazard to prevent the signs or workdays or restricted work, and/or demonstrates that MSDs are painful, symptoms of an injury or illness from result in medical treatment beyond first often disabling injuries and illnesses becoming more severe and disabling. aid constitute material harm under the that cause lost work time, require See Lead, 647 F.2d at 1252 (‘‘We OSH Act. See PELs, 965 F.2d at 974–75. medical treatment, involve restricted conclude that if OSHA could find on the This was confirmed by the 11th Circuit work, and, all too often, result in basis of substantial evidence that Court of Appeals in its review of surgical interventions. preventing subclinical effects of lead The Agency then demonstrates the OSHA’s Air Contaminants Standard. In disease would help prevent the true significance of the risk of incurring this the Air Contaminants standard, OSHA clinical phase of lead disease, the material harm in the industries and set permissible exposure limits for over statute empowered it to set a blood-lead occupations covered by the scope of the 400 substances to prevent the onset of level goal to prevent these effects.’’). ergonomics standard. As OSHA’s certain health effects, including sensory The OSH Act does not require OSHA to analysis shows, over a working lifetime, irritation (i.e., stinging, itching, and wait until an injury or illness becomes workers in jobs that meet the final rule’s burning of the eyes, tearing (or so severe that employees become exposure screen face risks ranging lacrimation), a burning sensation in the disabled before it has authority to roughly from 33 cases per 1,000 workers nasal passages, rhinitis (nasal regulate. Such an approach would turn to 926 cases per 1,000 workers, risks inflammation), cough, sputum the OSH Act from a statute designed to that are clearly significant by any production, chest pain, wheezing, and prevent injuries and illnesses from reasonable measure. Even on an annual dyspnea). Id. OSHA found that in occurring to one that reacts to injuries rather than lifetime basis, many of the certain circumstances these effects were and illnesses that have already workers who would be covered by the fleeting; however, substantial evidence occurred. This was not Congress’ intent standard are at great risk: nursing aides in the rulemaking record suggested that when it tasked OSHA with ‘‘assuring as and truck drivers, for example, can these effects could be quite serious at far as possible every working man and expect to suffer between 32 and 42 lost- times and could affect a person’s ability woman in the Nation safe and healthful workday musculoskeletal disorders for to perform at work: working conditions.’’ 29 U.S.C. every 1,000 workers in every year that ‘‘OSHA concludes that exposure limits are 651(2)(b). they work. Again, that risks of this needed for those substances for which PELs Based on the evidence discussed in magnitude are significant within the are being established in this rulemaking to this and other sections of the preamble, protect against sensory irritant effects that as well as all other evidence gathered by meaning of the Act is not disputable. result in objective signs of irritation, such as Parts A and B below thus demonstrate coughing, wheezing, conjunctivitis, and OSHA and placed in the public docket unequivocally that the first two tests tearing. Such levels of mucous membrane of this rulemaking, OSHA has OSHA must meet before it can irritation may require medical treatment, concluded that MSDs as defined by this regulate—that the hazard regulated by adversely affect the well-being of employees, standard constitute material harm under the standard constitutes material harm and place the affected individuals at risk the OSH Act. OSHA recognizes that and that the risk posed to workers from increased absorption of the substance these disorders are not life-threatening covered by the standard is significant, as and decreased resistance to infection. and that some of these disorders may be Exposing workers repeatedly to irritants at reversible, particularly if early that term has been defined in OSHA levels that cause subjective irritant effects case law—have been met. OSHA’s may cause workers to become inured to the intervention is provided. Nonetheless, response to comments received on its irritant warning properties of these evidence in the record shows that these disorders are debilitating (Brisson et al. significance of risk analysis in the substances and thus increase the risk of ˚ proposed rule appear in Part C. overexposure.’’ 54 FR 2444–45 (Jan. 19, 1989, Ex. 26–47; Vingard et al. 1991, Ex. 1989). 26–44; Berg et al. 1988, Ex. 26–46; Liss A. Material Harm Industry representatives challenged et al. 1992, Ex. 26–55; Webster and The OSH Act requires OSHA to make OSHA’s determination that these health Snook 1994, Ex. 26–33; Binder and a threshold finding that a significant effects constituted ‘‘material Hazleman 1983, Ex. 26–45; Boshuizen et risk of material harm exists in the impairment’’ within the meaning of al. 1990, Ex. 26–40; Blanc et al. 1996, workplace before issuing an section 6(b)(5) of the OSH Act. Id. While Ex. 26–42; Liberty Mutual Research occupational safety or health standard. OSHA conceded that minor irritation Center for Safety and Health, 1998, Ex. See Benzene, 448 U.S. 607, 642; 58 FR would not, by itself, constitute ‘‘material 26–54). These disorders cause persistent 16612, 16614 (Mar. 30, 1993). What impairment,’’ it concluded that sensory and severe pain, lost worktime, constitutes ‘‘material harm’’ in any irritation that resulted in medical reduction or loss of the worker’s normal particular case is, at bottom, a policy treatment or affected job performance functional capacity both in work tasks determination, for ‘‘OSHA is not would constitute such impairment. and in other of life’s major activities, required to state with scientific certainty PELs, 965 F.2d at 974. The court agreed loss of productivity, and significant or precision the exact point at which with this finding: medical expenses. Where preventive each type of [harm] becomes [material].’’ action or early medical intervention is See AFL–CIO v. OSHA (PELs), 965 F.2d ‘‘We interpret this explanation as not provided, these disorders can result indicating that OSHA finds that although 962 (11th Cir. 1992). As long as its minor irritation may not be a material in permanent damage to determination is reasonable, OSHA is impairment, there is a level at which such musculoskeletal tissues, causing such entitled to deference; however, OSHA irritation becomes so severe that employee disabilities as the inability to use one’s must be cognizant of all forms and health and job performance are seriously hands to perform even the minimal

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Contrary to the consideration to potentially of Labor Statistics (BLS) data for 1996, allegations of some commenters, see confounding factors. Ex. 500–188. But which show that the median number of e.g., Ex. 30–3865; 500–187, this OSHA is not relying on this testimony lost workdays (LWD) per recordable standard does not trigger employer to demonstrate that work causes MSDs lost-time MSD is higher than the median obligations based solely upon employee or that this particular standard will across all lost workday injuries (see reports of ‘‘aches and pains.’’ An reduce the incidence of MSDs, as the Figure VII–1). For example, the median employer is only required to respond to Chamber incorrectly suggested. Other number of lost workdays for cases an employee report of an MSD when it: evidence and data (described above) in classified by BLS as carpal tunnel (1) Results in one or more lost the rulemaking record demonstrates syndrome, tendinitis or tenosynovitis, workdays, one or more days of restricted this. The testimony of injured workers, or musculoskeletal and connective work, medical treatment beyond first however, is particularly probative in tissue disorders, is 25, 9, and 10 days, aid, or (2) includes signs or symptoms demonstrating how MSDs significantly respectively. More than one-half of all of an MSD that persist for 7 or more affect peoples’ lives. For this, statistics, carpal tunnel LWD cases and one-third consecutive days, and (3) the employer epidemiological data, and other of musculoskeletal and connective is exposed to risk factors at the levels evidence are not alone sufficient. The tissue disorder LWD cases result in described in the Basic Screening Tool, testimony of these workers puts a more than 20 lost workdays, compared which are associated with increased human face on the pain and suffering to less than one-fourth of all LWD risk. MSDs that result in days away from experienced everyday by workers who injuries. Among workers who received work, restricted duty, or medical suffer from these injuries. It also compensation awards in 1994 for upper- treatment beyond first aid clearly convincingly demonstrates that MSDs extremity disorders, the average length constitute material harm under the OSH are not everyday ‘‘aches and pains’’ of disability was 87 days, with 6.8 Act, as described above. See PELs, 965 experienced by all, but serious, percent of the claims covering one-year F.2d at 974–75. Moreover, it is clear that disabling conditions. or more of disability (Liberty Mutual OSHA may trigger employer action Research Center for Safety and Health, upon employee reports of signs or MSDs of most kinds are also 1998, Ex. 26–54). symptoms of MSDs that persist for recognized as compensable under Finally, several individual studies seven or more consecutive days. There virtually all State workers’ provide additional evidence is substantial evidence in the compensation plans, and these demonstrating the disabling nature of rulemaking record that persistent signs disorders imposed nearly $20 billion in MSDs. A study of female sewing or symptoms of MSDs will progress and medical costs and industry payments on machine operators showed an increased become more severe and disabling if the U.S. economy in 1994 (see the prevalence of disability among both they are not treated and the employee Economic Analysis section of this retired and active workers compared to remains in the job unabated. See (Tr. preamble). Under workers’ national rates of disability (Brisson et 7660, 7884, see also (Ex. 32–450–1). compensation, however, employees are al., 1989, Ex. 26–47). Operators who had OSHA need not wait for signs and reimbursed only where their work- left their jobs had a greater rate of severe symptoms of MSDs to become disabling related injury or disorder requires disability when compared to workers to act; rather, OSHA may ‘‘act to ‘reduce medical treatment and/or results in lost who had left other types of employment. the risk’ of serious material impairment workdays. Moreover, payments for lost Vingard et al.(1991, Ex. 26-44) found an [at some point in the future].’’ See Lead, wages are not provided unless the increased risk of early retirement among 647 F.2d at 1253. employee’s injury or disorder results in workers exposed to heavy or medium The pain associated with these a certain number of lost workdays (the work loads due to disorders of the lower workers is not the normal muscle number varies across the States and back, neck/shoulder, hip, or knee. An soreness associated with job break-in or ranges from one to seven days). elevated incidence of long-term conditioning, or temporary muscle According to evidence presented in the absenteeism and disability due to strain due to doing new or unusual Economic Analysis, a significant intervertebral disc disorders was found tasks. Instead, the pain is severe and number of musculoskeletal disorder among tractor drivers, with the persistent. Many employees must be workers’ compensation claims result in incidence appearing to increase with placed on medication to alleviate or at lost workdays. For example, according whole-body vibration dose and duration least reduce the intensity of their pain. to a study by Webster and Snook (1994, (Boshuizen et al.1990, Ex. 26–40). An The pain of MSDs may also continue or Ex. 26–33) based on workers’ analysis of data from the National may even manifest after the employee is compensation data from Liberty Mutual Health Interview Survey showed that removed from exposure at the end of the Insurance Company, the largest repetitive bending of the hand or wrist workshift (Ex. 26-1263). In addition, the underwriter of workers’ compensation on the job was significantly associated pain usually increases if exposure to the insurance in the country, more than 45 with the frequency of self-reported ergonomic risk factors continues (Ex. percent of all low back pain cases carpal tunnel syndrome (CTS), and that 26–1263). OSHA believes that this type involved indemnity payments for lost work-related disability was common of severe and persistent pain, and the workdays. This study also indicated among the 544 subjects reporting CTS. tissue damage underlying this pain, that, on average, more than 65 percent The persistence of symptoms associated clearly constitutes material harm under of the workers’ compensation costs for with MSDs is illustrated by two other the OSH Act. musculoskeletal disorders represented studies. Berg et al.(1988, Ex. 26–46) The Chamber of Commerce argued indemnity payments for lost workdays. studied the prevalence of MSD that OSHA should not rely on the Overall, work-related low back pain symptoms among 327 retired shipyard testimony of injured workers to accounts for 15 percent of all Liberty workers who had been engaged in heavy

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In Supreme Court in Benzene held that the analysis appropriate to the available another study, Binder and Hazleman OSH Act requires a threshold finding evidence and need not attempt to fit the (1983, Ex. 26–45) followed the health that a significant risk of material harm evidence to a preselected analytical status of 125 patients with lateral exists and that the standard being method. epicondylitis over a 1- to 5-year period promulgated will substantially reduce There is no need, in the case of after initial presentation of the disorder. that risk. See Benzene, 448 U.S. 607, musculoskeletal disorders, for OSHA to Over the follow-up period, 40 percent of 642; see also 58 FR 16612, 16614 (Mar. engage in risk modeling, low-dose the patients continued to have 30, 1993). In so holding, the plurality extrapolation, or other techniques of projecting theoretical risk to identify the discomfort that affected some daily noted that ‘‘precise quantification of magnitude of the risk confronting activities. risks is * * * impossible’’ given the workers exposed to ergonomic risk imperfect state of scientific knowledge. OSHA has promulgated standards factors. The evidence of significant risk Benzene, 448 U.S. at 652. Thus, while where the adverse health effects is apparent in the annual toll reported ‘‘it is OSHA’s responsibility to associated with exposure to substances by the Bureau of Labor Statistics, the determine, in the first instance, what it or conditions are serious but not vast amount of medical and indemnity considers to be a ‘‘significant’’ risk, necessarily life-threatening, such as payments being made to injured * * * the requirement that a health effects that interfere with normal workers and others every year (nearly ‘‘significant’’ risk be identified is not a daily life or job performance, or that $20 billion in direct costs and as much require substantial medical mathematical straitjacket * * * [and] as $60 billion more in indirect costs), intervention. See Cotton Dust (29 CFR the Agency has no duty to calculate the and the lost production to the U.S. 1910.1046), Occupational Noise exact probability of harm.’’ Id. at 655. economy imposed by these disorders. Exposure (29 CFR 1910.95), Indeed, ‘‘there are a number of ways in Similarly, there is no need for OSHA to Occupational Exposure to Lead (29 CFR which the Agency can make a rational turn to complex theoretical projections 1910.1025), Occupational Exposure to judgment about the relative significance of reductions in risk to demonstrate that Formaldehyde (29 CFR 1910.1048). For of the risks associated with exposure the standard will substantially reduce example, in promulgating the Hearing * * *.,’’ id. at 656–57, and ‘‘so long as this significant risk. Ergonomics Conservation Amendment, OSHA they are supported by a body of programs work in practice. The determined that ‘‘* * * material reputable scientific thought, the Agency evidence is there in the form of impairment of hearing is directly related is free to use conservative assumptions hundreds of epidemiological analyses, to people’s ability to understand speech in interpreting the data * * *, risking meta-analyses, and case studies as it is spoken in everyday social error on the side of overprotection reporting the effectiveness of ergonomic conditions * * *.’’ (46 FR 46236), rather than underprotection.’’ Id. at 656. programs in reducing risk. The including being able to understand Since Benzene, OSHA has adopted a following discussion, and the analyses variety of methods for determining what speech in noisy environments. In the presented below, demonstrate the constitutes a significant risk. See e.g., Formaldehyde standard, OSHA based significance of the risk confronting Asarco, Inc. v. OSHA, 746 F.2d 483, its permissible exposure limit (PEL) and workers in the industries and 490–95 (9th Cir. 1984); Public Citizen ancillary provisions, in part, on occupations targeted in the standard Health Research Group v. Tyson, 796 evidence that employees were at and make the case for the standard’s F.2d 1479 (D.C. Cir. 1986). With respect significant risk of developing sensory effectiveness. to section 6(b)(5) standards, OSHA has irritation (e.g., burning and tearing of In this rulemaking there are, as often utilized scientifically-based the eyes, severe irritation of the nose mentioned above, extensive data on the mathematical modeling techniques to and throat) and skin diseases at the adverse effects on the human determine risk at certain levels of existing PEL, and that these effects were musculoskeletal system of exposure to exposure. This modeling permits OSHA sufficiently severe to interfere with the workplace risk factors such as repetitive to ‘‘extrapolate [risk] * * * into areas motions; awkward postures; and the use employee’s ability to perform job where experimental [or observational] functions (52 FR 46168, 46234–37). of excessive force. As described in the data do not exist.’’ Public Citizen, 796 Health Effects and Quantitative Risk This standard is similar to these other F.2d at 1496. With respect to non- Assessment sections of this preamble, OSHA standards in this respect. MSDs section 6(b)(5) standards, however, studies and national statistics are also result in material harm by causing OSHA has not needed to engage in available to demonstrate the high temporary or permanent physical quantitative modeling techniques to incidence and prevalence of work- damage to the body. Such damage can determine significant risk because it related musculoskeletal disorders include severe inflammation of joints typically has observational data that occurring or existing among workers and tissues; reduced conduction quantifies the risk faced by workers to exposed to ergonomic risk factors. velocity in peripheral nerves; partial or particular hazards. In the Electric Power Estimates of the risk of harm total loss of strength in an extremity; Generation rulemaking, for example, confronting exposed workers can be tearing of muscles and tendons; OSHA found that the generation, based directly on the rates of work- numbness; decreased range of motion; transmission, and distribution of related musculoskeletal disorders arthritis; and pain. When this damage electric power and the non-use or currently being reported, and BLS occurs, employees are unable to perform misuse of appropriate electrical survey data can be used to demonstrate their jobs at all or at normal protective equipment resulted in 86 the degree to which work-related performance levels without fatalities and 12,977 injuries annually musculoskeletal disorders have experiencing pain or causing further and that the standard would prevent 61 occurred across nearly all major damage. Accordingly, OSHA concludes fatalities and 1,634 injuries annually. industrial sectors and in numerous that MSDs as defined by this standard Thus, the OSH Act does not require occupations. constitute material harm under the OSH OSHA to construct dose-response The data discussed in the Act. relationships or other models for every Quantitative Risk Assessment and

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Health Effects sections of the preamble part of that risk is attributable to MSD injuries reported by employers as demonstrate that the risk of work- exposure (i.e., the rest of the risk is lost workday injuries. MSDs that force related musculoskeletal disorders background). The results are presented an employee to be temporarily assigned constitutes a significant risk under the by 2-digit SIC industry group in Table to alternate duty, as well as those work- OSH Act. For example, OSHA estimates, VI–9 of the Risk Assessment. The related MSDs not reported to employers based on the 1996 BLS data, that more probability of experiencing at least one by employees or not recorded by than 590,998 lost-workday (LWD) LWD MSD during a working lifetime employers, are not included in these musculoskeletal disorders occurred ranges from 33 per 1,000 workers risk estimates. among workers in industries that are (lower-bound estimate in SIC 62, Evidence of Underreporting within the scope of the final rule, and Security and Commodity Brokers, that were recorded and reported by Dealers, Exchanges, and Services) to 926 There is also evidence that the actual employers in 1996 (see Table VI–8 of per 1,000 workers (upper-bound risks attributable to occupational the Risk Assessment). The estimated estimate in SIC 45, Air Transportation). exposure to ergonomic risk factors may annual incidence of employer-reported The expected number of MSDs that will be much higher than is indicated by the MSDs (both upper-and lower-bound occur in a cohort of workers all entering BLS statistics. Many peer-reviewed estimates), defined as the number of an industry at the same time and studies have been published in the MSDs occurring in a given year per working for 45 years ranges from 34 per scientific literature in the last 18 years 1,000 workers employed in jobs that 1,000 workers to 2,530 per 1,000, that document the underreporting of meet the final rule’s exposure screen in depending on the industry sector, since MSDs on OSHA Logs (McCurdy et al., each industry sector exceeded 1 LWD it is possible for a worker to experience 1999, Ex. 2–2; Silverstein et al., 1997, case per 1,000 workers for all but 3 of more than one MSD in a working Ex. 26–28 ; Pransky et al., 1999, Ex. 26– the 2-digit SIC general industry groups lifetime. 922; Park et al., 1992, Ex. 26–1259; Park in 1996; the incidence exceeded 10 The estimates of lifetime risk et al., 1996, Ex. 26–1261; Nelson et al., LWD cases per 1,000 workers in 15 of presented above are based on an 1992, Ex. 26–1260). Table VII–1 these industry sectors (see Table VI–5 in assumption that workers in jobs that summarizes these studies. These studies the Quantitative Risk Assessment meet the final rule’s screen are at three- document extensive and widespread section of the preamble). Further, OSHA fold higher risk than are workers in jobs underreporting on the OSHA Log of estimates that the annual incidence of that do not meet the screen. As occupational injuries and illnesses in employer-reported LWD MSDs reached explained in the final Risk Assessment, general (McCurdy et al., 1999, Ex. 2–2) 1 case or more per 1,000 workers for 79 this assumption is well-supported by and of MSDs in particular (Silverstein et percent of all of the occupational groups the data base of almost 200 al., 1997, Ex. 26–28; Fine et al., 1986, for which BLS estimated the numbers of epidemiological studies reviewed by the Ex. 26–920; Pransky et al., 1999, Ex. 26– MSDs and employees. For 36 of these Agency and found to be of acceptable 922; Park et al., 1992, Ex. 26–1259; Park occupations, the estimated annual quality (see Section V, Health Effects). et al., 1996, Ex. 26–1261; Nelson et al., incidence of LWD MSDs exceeded 10 However, this assumption is not critical 1992, Ex. 26–1260). Underreporting on cases per 1,000 workers (Table VI–6 in to the Agency’s determination that the the Log is directly related to OSHA’s the final Risk Assessment). For some risks to workers exposed to significant risk finding, because high risk occupations, such as practical biomechanical risk factors at the level of incidents that are not reported on the nurses, nursing aides and attendants, the final rule’s screen are highly Log but should have been would laborers, public transportation significant. In its final risk assessment, downwardly bias the BLS annual survey attendants, and truck drivers, annual OSHA presented another analysis that is numbers on which OSHA’s risk incidence rates are on the order of 32 to identical to that presented as part of the estimates depend. 42 LWD MSD cases per 1,000 workers proposed rule. That analysis relies on Since OSHA published the proposed per year. These extremely high BLS-provided estimates of the incidence rule, several commenters have provided incidence rates, however, are of MSDs that is calculated across the additional information and comment, underestimates of the true incidence of entire working population; that is, the either through the submission of written MSDs, because they are based only on BLS-provided incidence figures do not comments and additional studies on lost workday cases. OSHA estimates recognize any difference in incidence of underreporting to the docket, or through that the number of MSDs that do not MSDs that occur between higher-risk testimony at the hearing. NIOSH result in lost workdays is about twice and lower-risk workers. Even under that provided seven health hazard that of LWD MSDs. assumption, which minimizes the evaluations (HETAs), as described in the In the final Risk Assessment, OSHA estimate of the risk to highly exposed NIOSH pre-hearing comments (Ex. 32– also estimated the probability that an workers, OSHA’s estimates of lifetime 450–1), that document extensive and employee will suffer at least one risk are unambiguously significant. widespread underreporting on the musculoskeletal disorder due to Estimates of the probability of OSHA Log of occupational injuries and workplace risk factors over a 45-year experiencing at least one MSD over 45 illnesses (NIOSH HETA# 88–344–2092, working lifetime as both an upper-and years range from 24 to 813 per 1,000 1991 (Ex. 32–450–1); NIOSH HETA# lower-bound estimate. The upper-bound workers, and the average number of 90–273–2130, 1991 (Ex. 32–450–1–13); estimate represents the lifetime risk to MSDs predicted to occur over 45 years NIOSH HETA# 92–331, 1993 (Ex. 32– an employee who works in job that ranges from 24 to 1,646 per 1,000 450–1); NIOSH HETA# 95–0294–2594, meets the final rule’s exposure screen, workers (see Table VI–7 in the final Risk 1996 (Ex. 32–450–1–22); NIOSH HETA# and assumes that all of the risk is Assessment). 97–0276–2724, 1999 (Ex. 32–450–1–2); attributable to his or her workplace Although these data indicate that the NIOSH HETA# 96–0101–2476, 1997 exposure to physical risk factors. The risk of experiencing an MSD is clearly (Ex. 32–450–1–26); NIOSH HETA# 98– lower-bound estimate represents the significant, OSHA believes that these 0085–2715, 1998 (Ex. 32–450–1–10). lifetime risk to an employee in a job that data seriously understate the true risk. These new studies have been meets the screen, but assumes that only First, the BLS data capture only those incorporated into Table VII–1.

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TABLE VII±I.ÐSUMMARY OF UNDERREPORTING STUDIES

Study Measure of underreporting Extent of underreporting observed Additional detail

McCurdy, Schenker, and Samuels, Percentage of cases meeting 40% of all reportable cases not 10 manufacturing facilities in 6 Am. J. Public Health. 81:85 OSHA reporting criteria not re- recorded; for illnesses, 56% not states from semiconductor in- (1991) Ex. 2±2. corded on OSHA Log. recorded. dustry with approx. 50,000 em- ployees; 24% cases met OSHA recording criteria. NIOSH. Health Hazard Evaluation Failure to report lost workdays Not quantified; ``several'' employ- Winding and taping department of Report, HETA 93±0233±2498, and restricted work on OSHA ees had surgeries for WMSDs an instrument transformer man- (1995) Ex. 26±1255. 200 Log. in 5-year period and 1¤3 of em- ufacturer; 27 employees in de- ployee were on restricted work, partment. but no LWDIs reported on Log over 5-year period. NIOSH. Health Hazard Evaluation Percent of medically confirmed 5 employees reported to NIOSH News department of large metro- Report, HETA 93±0860±2438, WMSD cases not recorded on that they had been diagnoses politan TV-news station; video (1994) Ex. 26±1256. OSHA Log or not reported to with carpal tunnel syndrome tape editor and other employ- employer. (CTS); of these, 2 did not re- ees. port their illness to the em- ployer. 1 of the 5 reported cases were not reported on log. Silverstein, Stetson, Keyserling, Incidence (per 100 workers Plant/year; OSHA 200 Log; Self- Four automobile manufacturing and Fine Am. J. Ind. Med. 31:600 years) of work-related MSDs, report: plants. 713 out of 948 workers (1997) Ex. 26±28. reported on OSHA 200 logs Plant 1: ...... selected for the study com- compared with cases that re- 1986: 1.0; 30.9 ...... pleted the questionnaire. ceived medical treatment, as 1987; 2.7; ...... identified by self-administered 1988; 6.9; ...... questionnaire. Plant 2: ...... 1986: 0.9; 40.9 ...... 1987; 11.9 ...... 1988; 21.4. Plant 3: ...... 1986: 20.3; 47.8 ...... 1987; 14.6 ...... 1988; 19.43. Plant 4: ...... 1986: 0.7; 24.5 ...... 1987; 2.1 ...... 1988; 9.9.. Fine, Silverstein, Armstrong, Ander- Incidence (per 100 worker-years) Plant; 200; OSHA WC, MAR, Data from two large automobile son, and Sugano, JOM. 28:674 of upper-extremity MSDs re- MCR: manufacturing plants (total em- (1986) Ex. 26±920. ported on OSHA 200 logs com- B; 0.03; 0.29; 3.04; 2.03 ...... ployment not reported). pared with workers' compensa- C: 0.15; 0.45; 1.85; 13.98 ...... tion (WC), medical absence records (MAR) and medical case records (MCR). Pransky, Snyder, Dembe, and Percent of workers reporting mus- Work-related Symptom; % report- Questionnaire administered to Himmelstein, Ergonomics. 42:171 culoskeletal symptoms caused ing; % on Log:. 110 packers, of whom 98 re- (1999) Ex. 26±922. or aggravated by work, com- Hand/Wrist; 86%; 6% sponded. Plant produces vari- pared to OSHA Log entries. Arm; 33%; 1% ety of childrens' products. Neck; 21%; 0 Back/legs; 28%; 2% 9% of workers reported that symptoms resulted in lost work days over the past year. 6% re- ported they were formally as- signed light-duty work by plant nurse. 15% reported symptoms resulted in information light- duty work arranged by co-work- ers.. Park, Krebs, and Mirer JOEM. Number of claims made in a sick- Only 7 of an estimated 47 (15%) Study of an automotive assembly 38:1111 (1996) Ex. 26±1261. ness and accident (S&A) dis- S&A upper extremity LWD and stamping complex employ- ability (sick leave) system com- cases in 1992 were recorded ing 10,000 workers. pared to lost-work-day (LWD) on the OSHA Log. For LWD injuries and illnesses recorded back injuries, 27 of an esti- in OSHA log. mated 36 (75%) S&A cases were recorded.

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TABLE VII±I.ÐSUMMARY OF UNDERREPORTING STUDIESÐContinued

Study Measure of underreporting Extent of underreporting observed Additional detail

Park, Nelson, Silverstein, and Medical insurance claims linked From 1984 to 1987, OSHA logs Conclusion based on authors' Mirer, JOM. 34:731. (1992) Ex. to work histories compared to failed to record between 20 and own unpublished data from in- 26±1259. OSHA logs. 80 percent of occupational surance records of five auto- MSDs.. motive manufacturing plants. These records identified 11,577 MSD health claims made by 3,204 workers. Nelson, Park, Silverstein, and Medical insurance claims linked From 1985 through 1986, OSHA Mirer, Am. J. Public Health. to work histories compared to logs identified 59 hand/wrist 82:1550 (1992) Ex. 26±1260. OSHA logs.. MSD cases compared to 150 cases identified in health insur- ance records. For all MSDs from 1984 through 1987, only 9% of cases identified through insurance claims were recorded on OSHA logs (the authors cite data from Parks et al.(1992) in- dicating that about half of the upper extremity MSD cases from insurance claims are at- tributable to work. NIOSH Health Hazard Evaluation Percentage of workers with work- 40% of supermarket checkers W±R MSD's not brought to the Report, HETA 88±344±2092 related (W±R) upper extremity with WR UE MSD did not seek attention of a health care pro- (1991) Ex. 32±450±1. (UE) MSDs not seeking med- medical care. fessional (HSP) will not be re- ical care. W±R UE MSD cases corded on the OSHA 200 logs. defined by NIOSH standardized symptom questionnaires and positive physical findings from physician-conducted physical examinations. NIOSH Health Hazard Evaluation Percentage of workers with W±R 85% of employees with W±R UE Jewelry manufacturing employees Report, HETA 90±273±2130 UE MSD not seeking medical MSD symptoms were not eval- exposed to repetitive, forceful, (1991) Ex. 32±450±1±13. care and whether they were re- uated by a HSP. and awkward postures during corded on the OSHA 200 logs. A small fraction of those with W± job tasks (MSD hazards). W±R UE MSD defined by R UE MSD were recorded on NIOSH standardized symptom the OSHA logs. questionnaires. NIOSH Health Hazard Evaluation Evaluation to determine compli- Large numbers of symptomatic Red meatpacking plant employ- Report, HETA 92±331 (close-out ance with OSHA corporate set- workers evaluated by HAPS ees exposed to MSD hazards. letter) (1993) Ex. 32±450±1. tlement agreement. Review of and prescribed a temporary job BLS requires cases involving plant's health clinic algorithm to transfer. HSP deemed these as employees with W±R symp- evaluate and treat symptomatic ``preventive'' job transfers and toms assigned a job transfer to workers. did not record these on the be record onto the logs. OSHA 200 logs. NIOSH Health Hazard Evaluation Percentage of workers with W±R 75% of employees with W±R UE Research technicians conducting Report, HETA 95±0294±2594 UE MSD not seeking medical MSD did not seek medical care. pipetting operations with MSD (1996) Ex. 32±450±1±22. care and whether they wer re- A small fraction of those with W± hazards. corded on the OSHA 200 logs. R UE MSD were recorded onto W±R UE MSD defined by the OSHA 200 logs. NIOSH standardized symptom questionnaires. NIOSH Health Hazard Evaluation Employee health records and em- 23% of employees with W±R UE Truck frame assumably employ- Report, HETA 96±0101±2476 ployee interviews compared MSD not recorded onto the ees exposed to MSD hazards. (1997) Ex. 32±450±1±26. with the plant's OSHA 200 logs. OSHA 200 logs. Same method used to determined The number of actual lost or re- Under-reporting the lost or re- the accuracy of the number of stricted work days significantly stricted workdays gives the im- lost and restricted workdays re- under-reported. pression of a less serious dis- corded. order. NIOSH Health Hazard Evaluation Clinic employee report of injury ill- Many entries listed on the Clinic Fiberglass manufacturing plant Report, HETA 97±0276±2724 ness forms compared with the Employee Report of Injury/Ill- employees exposed to MSD (1999) Ex. 32±450±1±2. plant's OSHA 200 logs. ness forms and many cases hazards. Employee health records com- from individual employee health pared with the plant's OSHA records were not recorded on 200 logs.. the OSHA 200 logs. NIOSH Health Hazard Evaluation Comparison of workers reporting Several discrepancies between Casket manufacturing employees Report, HETA 98±0085±2715 MS symptoms on a body map these two lists. Employees exposed to MSD hazards. (1998) Ex. 32±450±1±10. diagram with the OSHA 200 probably not reporting all W±R logs. symptoms to employer.

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As stated by NIOSH (Ex. 32–450–1), OSHA’s Data Initiative) of employer reporter. And I was afraid I would never be these HETAs compared the OSHA 200 injury and illness records indicates a made full-time if my employer knew the job Logs with work-related MSDs ‘‘satisfactory’’ level of reporting; and (3) was injuring me (Tr. 7318–9).’’ ascertained via the following factors such as aging and off-the-job NIOSH also agrees that the BLS data mechanisms: (1) Confidential medical risks affect the onset of MSDs and underestimate the true magnitude of the interviews; (2) review of employee complicate the accurate reporting of occupational injury and illness problem medical records of private health care work-related MSDs. In response, OSHA for two reasons: (1) Approximately one- providers; (3) health surveys utilizing notes that many of the reports and third of industries are not included in standardized MSD symptom studies it is relying on as evidence of the BLS annual survey, and (2) questionnaires; and (4) health surveys underreporting are recent (late 80’s and underreporting of the true number of defining cases as those with work- 90’s) and that in this section of the work-related health problems on the related symptoms and positive physical preamble (Significance of Risk), OSHA OSHA 200 Logs occurs. NIOSH stated findings conducted by physicians is relying only on those studies that that while it is widely accepted that performing physical examinations report underreporting on the Log (and occupational disease is underestimated targeted to the musculoskeletal systems. thus may affect the BLS survey results). in the U.S., the OSHA 200 Logs are the In one HETA, NIOSH estimated the OSHA believes that ORC’s argument major data source used by BLS to extent of the underreporting of that establishing the work-relatedness of determine the extent of occupational recordable cases of MSDs on OSHA MSDs may make them difficult for disease in the United States. OSHA is Logs as 23 percent of cases among a employees to report accurately only persuaded by the evidence in the record group of truck frame workers (Ex. 32– reinforces OSHA’s point: that they are that work-related MSDs are currently 450–1–26). In other studies, NIOSH underreported on the Log. Finally, being substantially underreported on quantatively characterized the extent of although OSHA agrees that OSHA’s OSHA Logs. OSHA believes that the the underreporting in these HETAs as Data Initiative audits show a relatively number of lost-time, work-related MSDs ranging from ‘‘a small fraction’’ for accurate level of Log reporting, it is quantified in the Agency’s risk jewelry workers and research important to note that they do show that assessment on the basis of the BLS data technicians to ‘‘many not reported’’ for lost-time injuries are underreported by is understated by at least a factor of two. fiberglass manufacturers to ‘‘large close to 15%. Other Evidence Risks are Significant numbers not reported’’ for red In response to OSHA’s request in the meatpacking plants; for a group of proposal for specific information on the In addition to the BLS data, supermarket checkers, NIOSH underreporting or overreporting of epidemiologic studies comparing the quantitatively estimated that the MSDs, the AFL–CIO submitted prevalence or incidence of MSDs in underreporting amounted to 40% of all additional studies to the docket exposed populations with the cases. NIOSH states that there is no supporting the underreporting of work- prevalence or incidence in referent reason to believe that these HHEs are related MSDs (Ex. 500–218). groups with lesser or no such exposure not representative of the widespread Representatives from the AFL–CIO also document the elevated risk underreporting believed to be associated support OSHA’s statements in the confronting employees exposed to with work-related MSDs. NIOSH proposed rule to the effect that the BLS workplace risk factors. These studies suggested that OSHA include these survey understates the true magnitude also identify the types of workplace risk HETAs in the final standard, to of the MSD problem by a factor of two factors associated with the development strengthen the evidence of MSD (64 FR 65981). The AFL–CIO states that of work-related musculoskeletal underreporting. the record demonstrates that MSDs are disorders, as well as the duration of The rulemaking record thus contains indeed significantly underreported, thus exposures found to be associated with convincing evidence that MSDs are supporting OSHA’s determination on these disorders. This information often underreported; this evidence this point (see Ex. 32–339–1 at pp. 3– further supports the occupational origin includes the new peer-reviewed studies 4). Further, at the hearings several of the reported disorders. submitted by several rulemaking physicians and researchers confirmed For example, the odds of having an participants. OSHA finds this evidence that there is significant underreporting. upper extremity disorder like carpal persuasive and has incorporated this (See, e.g., Dr. Armstrong, Tr. 839–40; Dr. tunnel syndrome or tendinitis/ information into this final standard, as Punnett, Tr. 1021; Dr. Erdil, Tr. 1115; peritendinitis of the shoulder or wrist appropriate. Dr. Owen, Tr. 1886–87; Dr. Boden, Tr. are 5–30 times greater among workers Some commenters agreed that OSHA 2399–2401.) Similarly, numerous exposed to combinations of risk factors was correct in its assumptions about workers explained that workplace such as high force, repetition and underreporting (see, e.g., Exs. 32–339– injuries often go unreported to awkward postures (e.g., overhead work) 1–34, –36 and –43, Tr. 3588, Tr. 4306– employers (Tr. 3588, 3602, 3612–13, then among either unexposed workers 07, 4308, 6336, 7362, 7522, as reported 4510–11, 4587–89, 4595–97, 5601, 5820, or workers who are exposed to a single in AFL–CIO, Ex. 500–218). Other 5861, 6068–69, 6381, 7546–7550, 7377– risk factor (e.g., Luopajarvi et al., 1979, commenters, however, questioned the 78, 7382–83, 7384–88, 7510–12, 7704). Ex. 26–56; Armstrong et al.,1987, Ex. accuracy of OSHA’s estimates of the The AFL–CIO submitted testimony from 26–48; Silverstein et al., 1987, Ex. 26– extent of MSD underreporting (see, e.g., Nancy Foley, a journalist from 34; deKrom et al., 1990, Ex. 26–41; Exs. 500–197, 30–3845, 30–3813). Massachusetts, concerning her fears and Herberts et al., 1984, Ex. 26–51). The For example, Organizational how that led her not to report her injury, odds of experiencing a low back Resources Counselors, Inc. (Ex. 30– as follows: disorder increased 3–8 fold among those 3813) disagreed with OSHA’s workers exposed to frequent or forceful preliminary finding that MSDs are ‘‘In 1993, I began having pain in my neck manual handling, awkward trunk underreported on the grounds that: (1) and weakness in my hands. I did not seek postures (such as severe forward medical attention until 1995 when the pain The studies comparing workers’ had spread into my left shoulder and left arm flexion), or to whole body vibration compensation data with OSHA Logs are making it difficult for me to sit through the (Liles et al., 1984, Ex. 26–33; Kelsey et more than a decade old; (2) OSHA’s work day. Fear prevented me from seeking al., 1990, Ex. 26–52; Punnett et al., own audits (done in connection with medical attention sooner. I was a part-time 1991, Ex. 26–39; Wikstrom et al., 1994,

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Ex. 26–61; Tanaka et al., 1995, Ex. 26– identify risk factors and implementation the MSD hazards present. The OSH 59). Hip and knee disorders are of controls to reduce exposures to these Act’s requirement are met if OSHA associated with heavy physical work risk factors, can be very effective in determines that employees are being and awkward postures, such as kneeling reducing those forces responsible for subjected to a significant risk of material and squatting, or using the knee as a musculoskeletal disease and injury; this impairment of health or functional kicker. Thun et al. (1987, Ex. 26–60) has been shown in studies that have capacity by the risk factors being reported an increased risk of bursitis in quantitatively examined the impact of targeted and that the standard being carpet-layers that was 5 times higher ergonomic interventions on exposures promulgated will reduce that risk than that of the unexposed workers. In to risk factors, as well as studies and substantially. OSHA has done that here. a review of 4 studies, Hagberg and reports that have documented actual Using the best available evidence, Wegman (1987, Ex. 26–32) estimated the reductions in injury prevalence OSHA has found that employees are work-attributable fraction of shoulder following the implementation of currently exposed to a significant risk of tendinitis in the exposed population to ergonomics programs. Several of the material harm from the risk factors of be 90%. In a review of 15 cross- standard’s provisions, such as MSD force, repetition, awkward posture, sectional and 6 case control studies of management and training, will provide contact stress, and vibration. The BLS carpal tunnel syndrome, Hagberg et additional protection against the data used by OSHA to calculate al.(1992, Ex. 26–50) estimated the work- significant risk that will remain after significant risk included Nature of attributable fraction in the population controls are implemented in problem Exposure Event Codes corresponding to exposed to high force, high repetition, jobs. these risk factors: vibration or awkward wrist/hand • Repetitive motion: This category C. OSHA’s Response to Additional postures to be 50–90%. Olsen et reflects the risk factor of repetition; Comments al.(1994, Ex. 26–57) estimated that 40% however, such exposure is often of the cases of coxarthrosis Several commenters argued that combined with force and/or posture. (osteoarthrosis of the hip) seen in the OSHA must quantify separately the risk • Overexertion: This category reflects exposed working population was due to posed by each hazard it is regulating the risk factor of force; however, such heavy physical workload. Thus, in (i.e., force, awkward posture, vibration, exposure is often combined with general, strong and consistent repetition, and contact stress), and must repetition and/or posture. • associations have been identified in the do so in every industry below the two- Bodily reaction: This category epidemiologic literature, primarily in digit SIC code level, in every reflects the risk factor of posture; cross-sectional and case control studies, occupational category, and in every job however, such exposure is often but also in prospective studies (e.g., covered by the standard. See e.g., Ex. combined with force or repetition. Kurppa et al., 1991, Ex. 26–53; 30–4499; Ex. 500–197; Ex. 500–187; While the BLS data did not directly Riihimaki et al., 1994 Ex. 26–58; Felson 500–223. include numbers reflecting exposures to et al., 1991, Ex. 26–49). Exposure- In the Risk Assessment and Health the risk factors of vibration and contact response relationships have been Effects sections of this preamble, OSHA stress, OSHA believes that some of the identified in a number of studies, explained in detail its reasons for MSDs included in the data may also although precise quantitative modeling addressing these risk factors together in have involved exposure to these is not yet available. one standard. Substantial evidence in hazards. Other evidence in the Based on the various data and studies the rulemaking record demonstrates that rulemaking record also convincingly discussed in the Quantitative Risk these factors work together to pose a shows that employees exposed to these Assessment and Health Effects sections significant risk of material harm to two risk factors experience a significant of the preamble, OSHA finds that employees. In most of the cohorts risk of material harm. A number of workers exposed to workplace risk studied in the epidemiological literature epidemiological studies in the factors are at significant risk of examining these risk factors, the rulemaking record demonstrate that developing work-related employees studied were exposed to exposure to vibration at even low levels musculoskeletal disorders, which are combinations of the risk factors causes a number of serious conditions, harmful and often disabling conditions. regulated; rarely would one of the risk including hand-arm vibration This is particularly true for workers who factors be studied in isolation. In syndrome. See the discussion of are exposed to a combination of risk addition, substantial evidence in the vibration in the Health Effects section; factors over most of the workshift. rulemaking record indicates that see also Ex. 26–392. Indeed, NIOSH The data indicate that this rule would, ergonomic interventions are most specifically found this in its 1997 if promulgated, cause employers to effective when they examine an review of the epidemiological literature. implement, for their problem jobs, employee’s exposure to all of the risk See Ex. 26–1. There is also substantial interventions that would reduce the factors at issue at one time. The tools evidence in the rulemaking record that exposure of at-risk workers to workplace used to assess exposure to ergonomic contact stress as defined by this risk factors, and thus would risk factors are designed to account for standard can cause a significant risk of substantially reduce significant risk. interactions between risk factors. For material harm. As discussed fully in the Specifically, the requirements to example, the NIOSH lifting equation Health Effects section, the scientific conduct job analyses and implement considers how forces applied by the literature strongly shows that contact controls where exposure to risk factors worker (weight), the workers’ posture, stress causes such conditions as is high (i.e., for jobs meeting the Action and lift frequency all interact to increase hypoththermal hammer syndrome and Trigger and/or identified as having MSD risk. Indeed, it would be inappropriate carpet layers’ knee. Thus, there is no hazards) would help to ensure that for OSHA to quantify the risk posed by question that workers are currently employees are exposed to fewer risk each risk factor alone. Such an approach exposed to a significant risk of material factors over time, or to a combination of would not provide an accurate harm from the risk factors of force, risk factors for a lesser amount of time, representation of the MSD hazard a repetition, vibration, awkward posture, than is now the case. A large body of particular employee faces when doing a and contact stress. data demonstrates that workplace certain job; indeed, such an approach OSHA is also not required to conduct interventions, such as job analysis to would provide an inaccurate picture of its significant risk analysis at a detailed

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00499 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68760 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations industry level, or by occupational Several commenters argued that (Real estate). Even in SIC code 62 category or job. Where a standard because MSDs are not fatal, OSHA (Security and Commodity Brokers, requires employers to act only when the should deviate from its past practice of Dealers, Exchanges, and Services), the hazards being regulated are present in considering as ‘‘significant’’ a ‘‘one in a SIC code with the lowest risk, 24 out of their workplace, OSHA has no duty to thousand’’ risk that a worker will 1,000 workers are likely to suffer at least disaggregate risk in this manner. See develop an MSD over a working one MSD during a working lifetime. International Union, United Auto lifetime. See e.g., Ex. 500–223. These risk levels are extremely high by Workers v. OSHA (LO/TO II), 37 F.3d As noted above, a plurality of the any measure or formulation and are 665, 670 (D.C. Cir. 1994). This was Supreme Court in Benzene held that, clearly ‘‘significant’’ under the OSH Act. recently confirmed by the D.C. Circuit although ‘‘it is OSHA’s responsibility to Further, the serious and often disabling in its review of OSHA’s Lockout/Tagout determine, in the first instance, what it nature of these disorders is attested to standard. In the Lockout/Tagout considers to be a ‘‘significant’’ risk, by the fact that their severity (measured rulemaking, OSHA found that workers * * * the requirement that a by median number of days away) is performing certain operations across ‘‘significant’’ risk be identified is not a greater than median for all other injuries general industry were exposed to a mathematical straitjacket * * * [and] and illnesses combined. significant risk of material harm from the Agency has no duty to calculate the Some commenters argued that the the hazard of energy unexpectedly being exact probability of harm.’’ Id. at 655. standard is improperly structured to released from certain powered While the Court noted OSHA’s broad reduce all risk, even insignificant risk. industrial equipment. Id. at 667. Certain discretion to formulate what level of See Exs. 30–4185; 30–3951. OSHA industry challengers argued that OSHA risk it considers to be significant, the agrees that this standard will was under a duty to disaggregate the Court also provided guidance to OSHA substantially reduce the significant risk risk faced by workers by SIC code, as to what a reasonable person might of material harm faced by workers from particularly since, they contended, there consider a significant risk of material exposure to ergonomic risk factors. was zero risk in certain SIC codes. The harm: OSHA estimates that the standard will reduce the number of lost workday court held that the OSH Act placed no ‘‘Some risks are plainly acceptable and such duty on OSHA: ‘‘If, as OSHA others are plainly unacceptable. If, for MSDs currently reported to the BLS by asserts * * * the regulation applies example, the odds are one in a billion that approximately 50%. This amounts to simply to machines that pose a a person will die from cancer by taking a approximately 300,000 MSDs a year and significant risk and to workers subjected drink of chlorinated water, the risk clearly constitutes a substantial reduction in to that risk, we see no reason why could not be considered significant. On the the number of MSDs experienced by other hand, if the odds are one in a thousand OSHA should be concerned with workers every year across general that regular inhalation of gasoline vapors that industry. This standard is not designed industry classifications that appear are 2 percent benzene will be fatal, a essentially irrelevant to its task.’’ LO/TO to reduce ‘‘insignificant’’ risk, however. reasonable person might well consider the OSHA has made some changes to the II, 37 F.3d at 670 (emphasis added). See risk significant and take the appropriate steps also Associated Builders and to decrease or eliminate it.’’ Id. at 655. standard (from the proposed rule) to ensure that employers are not required Contractors, Inc. v. OSHA, 862 F.2d 63, In past standards, OSHA has applied 68 (3d Cir. 1988) (‘‘A requirement that to act when the risk posed to their that guidance, noting that a risk of one employees from the risk factors at issue the Secretary assess risk to workers and in a thousand of dying from an need for disclosure with respect to each is below certain levels. occupational exposure is significant. First, OSHA has included a screen in substance in each industry would However, OSHA has never quantified the standard that will ensure that effectively cripple OSHA’s performance the lowest level of risk of death that it employers are not required to act in the of the duty imposed on it * * *’’); considers significant, beyond absence of ‘‘significant risk.’’ OSHA American Dental Ass’n v. Martin, 984 acknowledging that the level must be established the screen based on F.2d 823, 827 (7th Cir. 1993) (‘‘[T]he higher than one in a billion. Thus it is substantial evidence in the rulemaking agency [is not] required to proceed not true that OSHA takes the position record showing substantial excess risk workplace by workplace, which in the that a risk of dying is necessarily of developing MSDs above the hazard case of bloodborne pathogens would insignificant if it is less than one in a levels in the screen. If employees are require it to promulgate hundreds of thousand. exposed to the risk factors at issue thousands of separate rules.’’). OSHA has only infrequently below the levels indicated by the screen, Like OSHA’s Lockout/Tagout rule, quantified the risks of nonlethal harm employers have no obligations to this standard is not ‘‘industry-based.’’ from workplace exposures. It analyze their jobs, implement controls, An employer is required to respond to recognizes, however, that a reasonable or train their workers. an employee report of signs or person might well be willing to accept Second, OSHA has not included the symptoms of an MSD only when the a greater risk of injury than of death, proposed incremental abatement employer determines that an ‘‘MSD and that there may be cases where even process in the final standard. As incident’’ has occurred and the a risk of one in a thousand of some explained more thoroughly in section employee’s job is one that contains risk types of injuries occurring is IV, above, the incremental abatement factors that exceed the standard’s insignificant. OSHA need not determine process would have allowed employers screen. OSHA is not triggering industry whether this is such a case, however, to incrementally implement controls to wide obligations; rather, it is triggering because, throughout general industry, certain jobs to materially reduce MSD obligations on employers where there the working lifetime risk of developing hazards. If continued exposure to are ergonomic hazards present at certain an MSD is extraordinarily high. OSHA certain hazards in the job prevented an levels in jobs in their workplace. Under has found working lifetime risks to be injured employee from recovering, the these circumstances OSHA is not as high as 835 per thousand employer was required to implement required to disaggregate risk by three or (Transportation by air), 486 per additional feasible controls. Although four digit SIC code, or by occupational thousand (Local and suburban transit this approach mirrored what many category, or by jobs potentially covered and interurban highway passenger employers were currently doing in their by the standard. transportation), and 206 per thousand ergonomics programs, it was highly

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00500 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68761 criticized during the rulemaking exposure to risks not covered by this maintaining awkward postures of the process. One criticism was that it standard are not included in the Risk neck, wrists, arms, trunk, and lower- effectively required employers to Assessment. In addition, for the final extremities; and lifting, lowering, continue to implement controls when standard OSHA has conducted a pushing, carrying, and pulling loads of the risk posed by a certain job was no second, alternative analysis that excessive weight. Depending on the longer ‘‘significant.’’ Although OSHA eliminated from the risk assessment specific combinations of risk factors does not agree that the process placed MSDs caused by exposure to risk factors encountered in the workplace, requirements on employers to act where at levels below the screen. See Risk musculoskeletal disorders identified as there was no significant risk, OSHA has Assessment discussion. This additional being work-related include carpal nonetheless eliminated the requirement analysis confirms OSHA’s conclusions tunnel syndrome (hand, wrist), trigger from the final standard in order to, as to the risk faced by workers exposed finger (hand), De Quervains’ disease among other tings, avoid any to the risk factors at issue and implication that employers must abate demonstrates that the risk of developing (wrist), tendinitis (hand, wrist, hazards that are not significant. MSDs for workers exposed to risk shoulder, ankle), epicondylitis (elbow), Some commenters argued that OSHA factors at levels meeting the screen is rotator cuff tendinitis (shoulder and improperly relied on the BLS data for its alarmingly high and, without question, neck), sciatica (lower back), significant risk analysis because the data significant. osteoarthritis (hip, knee), bursitis (knee), include injuries and illnesses that are One commenter argued that OSHA and tarsal tunnel syndrome (foot). only 1% caused by work. See Ex. 32– has improperly considered ‘‘significant’’ The evidentiary base on which OSHA 78. These commenters miss the point risks that represent incident rates much relies in making these conclusions is about OSHA’s significant risk analysis. lower than those being targeted in the described fully in the Health Effects The appropriate question to be asked is Agency’s new enforcement plan. Tr. section of the preamble. This evidence whether the BLS data accurately reflect 10439 (NCR Corporation). The OSH Act is comprised of several hundred cross- the risk faced by workers exposed to the and past OSHA practice provide the sectional, case-control, prospective, and risk factors being regulated and whether framework within which OSHA must case series reports of working the standard will substantially reduce make its significant risk finding. Acting that risk. As explained above, the BLS within this framework and on the best populations in a variety of industrial data represent the best available available evidence, OSHA has found settings. Supplementing these reports is evidence on the magnitude of the MSD that a significant risk of material harm a large body of scientific literature that problem in the United States today, and currently exists for workers exposed to provides data on the mechanisms by thus on the significant risk faced by the hazards regulated and that the which exposure to these risk factors workers from exposure to the ergonomic standard will substantially reduce that causes musculoskeletal disorders; these risk factors at issue. The BLS survey is risk. OSHA’s enforcement strategy, on data demonstrate the biological a comprehensive one; it collects the other hand, is based on entirely plausibility of the relationship between workplace injury and illness data from different principles. Because OSHA has exposure to workplace risk factors and about 165,000 private industry a limited enforcement budget, OSHA an elevated risk of MSD injury and establishments. For the survey, selected targets its enforcement activities to illness. employers are required to provide industries where the risk of harm is MSDs have been recognized as statistics on the total number of injuries particularly severe. OSHA engages in compensable under virtually all State and illnesses recorded on the OSHA comprehensive data collection in order workers’ compensation plans, Form 200, as well as information to determine where certain industries describing the nature and causes of their fall within this prioritization scheme. demonstrating that exposure to work- lost workday injuries and illnesses. The OSHA’s most recent enforcement related risk factors is already widely information is provided in sufficient initiative focuses on relatively large recognized as a cause of detail to permit BLS to systematically workplaces whose past experience musculoskeletal disorders. Taken code each reported case and develop shows that hazards are likely to be together, OSHA believes that the estimates of the numbers and incidence present. The principles used to support scientific and other evidence described of each specific type of LWD injury and OSHA’s enforcement efforts are very in the preamble to this rule constitute illness for the United States as a whole, different from the principles OSHA an evidentiary base of unusual depth by industry sector and by occupation. must abide by in setting occupational and quality. The data provided reflect the employer’s safety and health standards. For this Accordingly, OSHA concludes that understanding of which cases are work- reason, it is entirely appropriate for musculoskeletal disorders associated related under current U.S. Department OSHA to apply different standards for with workplace exposure to workplace of Labor recordkeeping guidelines. determining significant risk and risk factors constitute material harm OSHA is thus confident that the targeting its enforcement activities. under the OSH Act. Further, as reported cases of MSDs included in the D. Conclusions significant risk analysis accurately demonstrated by the evidence discussed reflect injuries caused by work. OSHA concludes, based on the in Section B above, the data available to OSHA has also taken a number of evidence discussed above and the Agency demonstrate clearly that additional steps to ensure that the risk elsewhere in the record, that the workers in the occupations and assessment and the significant risk scientific data are sufficient to industries covered by the ergonomics analysis have a tight nexus with the risk demonstrate that exposure to work- program standard are at significant risk factors being regulated and the structure related risk factors is associated with the of experiencing a work-related MSD of the standard. As stated, OSHA only development of musculoskeletal over their working lifetime; for many included Nature of Exposure Event disorders of the upper extremities, back, occupations and industries, they are at categories in its risk assessment that and lower extremities. Risk factors significant risk of experiencing a work- corresponded to the risk factors targeted identified from this body of literature related MSD even in a single year of by the standard. Thus, the MSDs include repetitive motions; use of work in their job. experienced by workers as a result of excessive force; segmental vibration;

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VIII. Summary of the Final Economic Fairness Act (SBREFA) Panel convened excessive force, perform too many lifts Analysis and Regulatory Flexibility for this standard. and carries, and repeat similar motions Analysis The Final Economic Analysis too often. Many studies cited in the contains the following chapters: Health Effects section of the preamble A. Introduction Chapter I, Introduction (Section V) to the final standard OSHA’s Final Economic and Chapter II, Industrial Profile demonstrate the presence of these risk Regulatory Flexibility Analysis (Ex. 900) Chapter III, Technological Feasibility factors in the workplace, and many addresses issues related to the costs, Chapter IV, Benefits biomechanical studies show the effects benefits, technological and economic Chapter V, Costs of Compliance on the soft tissues of the body of these feasibility, and economic impacts Chapter VI, Economic Feasibility external forces: tissue damage, (including small business impacts) of Chapter VII, Economic Impacts and pathophysiology, and outright disease. the Agency’s ergonomics program rule. Final Regulatory Flexibility Analysis Market mechanisms have been The analysis also evaluates regulatory Chapter VIII, Assessment of Non- inadequate to address these risks (see and non-regulatory alternatives to this Regulatory Alternatives. the discussion in Chapter VIII of this rule. B. Introduction and Industrial Profile economic analysis). Although many This rule is a significant rule under (Chapters I and II) firms, and particularly larger firms, have Executive Order 12866 and has been addressed ergonomic risk factors and Data from the Bureau of Labor substantially reduced their MSD rates, reviewed by the Office of Information Statistics (BLS) Annual Survey of and Regulatory Affairs in the Office of many firms have not. Approximately 60 Occupational Injuries and Illnesses for percent of all general industry Management and Budget, as required by 1996 shows that 626,000 U.S. workers the executive order. In addition, this employees continue to work in across all industries experienced establishments that have not yet economic analysis meets the musculoskeletal disorders serious requirements of both Executive Order addressed ergonomic risk factors, enough to require time away from work despite the widespread presence of 12866 and the Regulatory Flexibility Act for recuperation in that year (Ex. 26– (as amended in 1996). The complete MSD hazards. 1413). In addition to these lost workday Because these characteristics of work Final Economic and Regulatory MSDs, OSHA estimates that, on average Flexibility Analysis has been entered are not unique to the United States, across all of general industry, about two countries of every size and on every into the rulemaking docket as Ex. 900. times as many non-lost workday cases This Final Economic and Regulatory continent are also experiencing involving work-related MSDs occur significant numbers of musculoskeletal Flexibility Analysis presents OSHA’s every year in U.S. workplaces. full economic analysis and disorders among their workforces. Many In some general industry sectors, lost of these countries—ranging from the methodology, as well as responses to workday MSD rates reached 37 cases comments in the record on the United Kingdom and Sweden to per 1,000 full-time equivalent (FTE) Pakistan, Ecuador, and South Africa— Preliminary Economic and Regulatory workers in 1996, and in many others, Flexibility Analysis. The remainder of have already established regulatory annual incidence rates were greater than requirements designed to address some this section of the Preamble summarizes 10 per 1,000 FTE (Ex. 26–1413). If these or all of the workplace risk factors the results of that analysis. annual risks are converted into working giving rise to these disorders. A table The purpose of this Final Economic lifetime risks (assuming a 45-year summarizing the ergonomics rules and and Regulatory Flexibility Analysis is working lifetime), the risks of guidelines issued by other countries and to: experiencing a lost workday MSD faced • organizations can be found in Chapter I Identify the establishments and by general industry employees over the of this Final Economic Analysis. industries potentially affected by the course of their working life, based on The standard OSHA is issuing today rule; OSHA’s most conservative estimates, applies to general industry employers • Estimate the benefits of the rule in range from 24 to 813 per 1,000 workers, and will also affect state and local terms of the reduction in depending on the particular industry in government entities or agencies in musculoskeletal disorders (MSDs) which the worker is employed (see the OSHA’s State-plan States, except that employers will achieve by coming into Significance of Risk section of this the following industries are exempt compliance with the ergonomics preamble). By any reasonable definition, from the scope of the final standard: program standard and some of the direct these risks of material impairment are agriculture; maritime; and construction. cost savings associated with those significant. Another indicator of the In addition, the standard does not apply reductions; significance of work-related MSDs to the to railroad operations. • Evaluate the costs, economic economy is the fact that employers The final ergonomics rule is a impacts and small business impacts annually pay out, in direct workers’ program standard, i.e., one that requires establishments in the regulated compensation costs, between $15–$18 employers whose employees experience community will incur to establish billion, or about 1 dollar of every 3 MSDs in jobs determined to be higher ergonomics programs to achieve workers’ compensation dollars, for risk jobs to implement a program that compliance with the standard; MSD-related claims. includes the elements of any sound • Assess the economic feasibility of The extensive evidence available safety and health (ergonomics) program. the rule for affected industries; clearly demonstrates that ergonomic risk These include management leadership • Evaluate the principal regulatory factors—such as repetitive motion, and employee participation, job hazard and non-regulatory alternatives to the force, awkward posture, and vibration— analysis to identify musculoskeletal final rule that OSHA has considered; are present in all types of general hazards, the implementation of controls • Present the Final Regulatory industry workplaces, including small, to reduce the hazards identified, Flexibility analysis for the ergonomics medium, and large workplaces. In training for employees and their program rule; and today’s workplace, the pace of work, the supervisors or team leaders in jobs that • Respond to the findings and specialization of work, and continued have MSD hazards, management of recommendations made to OSHA by the reliance on unassisted manual handling musculoskeletal disorders when they Small Business Regulatory Enforcement require many workers to apply occur, and regular evaluation of the

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This is the case a hazard is found—hazard control and compliance obligations of employers as because a report of an MSD or MSD program evaluation. much as possible, consistent with signs and symptoms is the trigger to The final rule provides employers employee protection; and to permit further action by the employer. Once an with several different hazard employers to adapt the required employee has reported an MSD, or its identification tools that they may use to program and its elements to the signs or symptoms, to the employer, the determine whether a job that meets the conditions and circumstances of their employer must determine whether the screen does in fact pose an MSD hazard particular workplaces. Among the MSD (or signs or symptoms) meet the to employees in that job. These tools standard’s flexible provisions are the standard’s definition of an MSD appear in two appendices (Appendices following: incident. An MSD incident is defined by D–1 and D–2) to the standard. OSHA • The programmatic design of the the standard as a work-related MSD or believes that a number of jobs that meet standard itself, which requires MSD sign or symptom that involves the screen will subsequently be shown, employers to establish a basic persistent signs or symptoms (those by a job hazard analysis, not to present framework with widely agreed-upon lasting for 7 or more consecutive days a hazard to employees. For example, elements but leaves employers free to since the time they were reported to the some jobs will have an ergonomic risk provide many of the establishment- employer), or that requires medical factor, or a combination of risk factors, specific details; treatment beyond first aid, one or more at levels that meet the screen; however, • A two-step action trigger, which days of restricted work, or one or more use of one of the hazard identification requires the employer to take action days away from work. If the employee’s tools in Appendix D, such as the Rapid only if an employee has experienced an report of an MSD is determined by the Upper Limb Assessment (RULA), may MSD incident (one involving medical employer to be an MSD incident, the show that the risk factors present in the treatment beyond first aid, days away employer must then move to the second job are within the ‘‘acceptable’’ zone on from work or on restricted work, or prong of the standard’s action trigger: a that tool. The final rule permits employers to signs or symptoms lasting 7 days or review of the employee’s job to use a variety of hazard identification longer) and that employee’s job is determine whether it involves tools, which are included in appendices determined to involve heightened ergonomic risk factors (repetition, force, to the standard. Employers may also exposure to ergonomic risk factors; vibration, awkward postures, or contact stress) for durations that meet those choose to rely for hazard identification • A Quick Fix provision, which specified by the Basic Screening Tool in on the services of a safety and health allows employers whose employees Table 1 of the standard for that risk professional trained and experienced in have experienced only a few MSDs to factor. If the relevant risk factors in the ergonomics; in addition, they may fix the problem job without having to employee’s job do not meet the screen choose to use any other reasonable implement the entire program; in Table 1, the employer is not required method that is appropriate to the job • Provisions that specify that the to take further action. In other words, and addresses the relevant risk factors. employer is only required to implement unless both parts of the action trigger If the job hazard analysis identifies MSD a program for those jobs meet the action are met (the occurrence of an MSD hazards in the injured employee’s job, trigger, and then only to implement the incident and the presence, in that the employer must then identify and program in that establishment; employee’s job, of risk factor(s) meeting implement controls to reduce these • A provision permitting employers the screen), no ergonomics program is hazards. to use a variety of methods to conduct triggered. The standard also permits employers job hazard analysis; OSHA believes that the action trigger • great flexibility in meeting their A provision permitting employers in the final rule is a highly effective obligations to control MSD hazards in to demonstrate that they have met their targeting device because OSHA’s data jobs that have been identified as posing hazard control obligations in any one of show that only about 37 percent of all MSD hazards to employees. Employers a variety of ways; general industry jobs will meet the • may fulfill their obligations by: A ‘‘grandfather’’ clause that permits screen, but that about two-thirds of all • Controlling MSD hazards (defined employers with effective existing lost workday MSDs reported to the BLS as reducing the hazards to the extent programs that contain the basic annually occur in those jobs. Put they are no longer reasonably likely to elements of ergonomics programs and another way, the risk that an employee cause MSDs that result in work that have been evaluated and shown to will incur an MSD is about three times restrictions, or medical treatment be effective before the standard’s greater in a job with risk factors that beyond first aid); or effective date to continue to implement meet the screen than in jobs that do not • Reducing MSD hazards in their programs rather than the program have such risk factors. accordance with or to the levels required by the standard; The standard requires employers who indicated by one of the hazard • Provisions stating that an have jobs that meet the action trigger to identification tools used by the employer’s obligation to maintain its implement an ergonomics program for employer in the job hazard analysis; or ergonomics program ceases for that job and for all employees in the • Reducing MSD hazards to the employees and jobs once the job has same job within the establishment.1 The extent feasible. been controlled to levels below the program consists of the following Employers who control their problem screen. elements: management leadership, jobs to one of these ‘‘endpoints’’ will be OSHA believes that the flexibility considered to be in compliance with the afforded by the final rule will facilitate 1 Employers qualifying for and choosing to use standard’s hazard control requirements. compliance by employers of all sizes the Quick Fix provision of the standard do not have OSHA believes that the range of control to implement a program but may instead implement and provide their employees with the controls and follow other procedures to address the obligation endpoints permitted by the protections they need against the risk factors in that job alone. standard will ensure that employers will

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BILLING CODE 4510±26±C one of the levels specified in paragraph of time the average worker in Group A C. Technological Feasibility (Chapter III) (k)(1)(i) or (k)(1)(ii) is feasible in the lost, either to days away or alternate majority of workplaces, hazard duty, was 124.9 days; in Group B, this Chapter 3 of the economic analysis for reduction to those levels may not be figure decreased by 72%, to 34.9 days. the final ergonomics rule illustrates the feasible under certain workplace The final standard (and therefore this technological feasibility of controlling conditions at certain times. economic analysis) is structured in such MSD hazards in problem jobs in a way that the number of jobs fixed in accordance with the rule. The analysis D. Benefits Analysis (Chapter IV) any given year depends on the number presented in this chapter demonstrates In its analysis of both the benefits and of MSD incidents reported that involve that controlling MSD hazards is feasible costs of the final standard, OSHA has workers in jobs that need to be in the industry sectors included in the estimated MSD rates based on BLS data. controlled, and the number of workers scope of the rule. However, as discussed in Chapter IV of OSHA has approached the analysis of OSHA estimates hold jobs that involve the Final Economic Analysis, there is the same physical work activities as the technological feasibility for the final extensive evidence that MSDs are rule from four perspectives. The four job giving rise to the reported MSD. For underreported to the BLS. OSHA purposes of estimating the number of analyses for technological feasibility are: estimates that there is at least one • Risk factor analysis—This analysis jobs that will require control under the unreported MSD for every MSD final standard, OSHA used answers to a demonstrates the variety of methods reported to BLS on OSHA logs. available for controlling the five risk Washington state survey indicative of However, the final standard creates how many workers would be above the factors covered by the rule. Information incentives for employees to report MSDs compliance endpoint given in Appendix drawn from the rulemaking record by providing work restriction protection D–1 (Ex. 500–41–3). This survey demonstrates how risk factors can be to employees. The final standard can showed that 37 percent of all workers controlled and how these controls can also be triggered by reports of persistent will be exposed at levels that meet the achieve compliance with one or more of symptoms. To account for these screen, and thus that their jobs will the final rule’s compliance endpoints. differences, OSHA estimates that MSD require job hazard analysis, medical • Ergonomic program analysis—This incidents will be reported at a rate 50 management and work restriction analysis demonstrates the feasibility of percent higher than current MSD rates protection. The survey also showed that implementing effective ergonomics based on BLS data. programs by identifying cases in the Most of the benefits of the final 33 percent of workers will be above the rulemaking record where effective standard will be generated when levels indicated by the hazard programs, that have program elements employers fix their problem jobs and identification tools in Appendix D–1, similar to or the same as those required thus reduce the number of covered and thus will require hazard controls. by the final rule, have already been MSDs these jobs cause. Hazard Combining this data allowed OSHA to implemented. information, MSD management and estimate the number of jobs that would • Model job analysis—This analysis work restriction protection will also be controlled and the resulting demonstrates how the risk factors generate benefits because they will reduction in the number of MSDs inherent in model jobs that represent ensure that MSDs are identified and projected as a result of the standard. the highest rates of lost workday MSDs treated early in their development, thus OSHA estimates that employers will be according to BLS data can be controlled preventing progression of the MSD to a required to fix almost 7 million jobs in in accordance with the final rule’s serious long-term disability. However, the first year the standard is in place, compliance endpoints. This analysis OSHA has not found ways to calculate and a diminishing number every year also presents a model job analysis for the benefits of early detection, although thereafter. Over ten years, video display terminal (VDT) the Agency is aware that early reporting approximately 18 million jobs will be workstations. and medical management have fixed. OSHA estimates that fixing these • Industry-by-industry analysis—This substantial benefits that are similar to jobs will reduce the number of MSD analysis demonstrates the broad those associated with preventive incidents caused by these jobs by 50 applicability of the available control medicine in general. For example, percent per year (based on the methods to virtually all of the covered Oxenburgh et al. (1985) compared two effectiveness rate reported in the Risk industries, as described by 3-digit SIC groups of VDU operators (Ex. 26–1041). Assessment section of this preamble) for codes. In Group A, which did not report early the next ten years (the time horizon of Each of these analyses was performed or receive medical management early, this analysis). In the first 10 years, the based on information contained in the 22% of cases were at the second or third final standard is therefore projected to rulemaking record. These analyses stage by the time they sought medical avert approximately 2.3 million demonstrate that compliance with the attention, compared with 8% at these currently reported MSDs and an final rule including paragraphs (k)(1)(i) stages in Group B, which had been additional 2.3 million MSDs not and (k)(1)(ii) is technologically feasible made aware of the need to report early currently reported, for a total of 4.6 for most processes in most workplaces and the value of prompt medical million MSDs averted. These estimates most of the time. management. The mean period of reflect changes from the estimates in the Finally, controlling MSD hazards in absence for Group A workers was 33.9 Preliminary Economic Analysis, which accordance with the final rule can be days; only 25% of this group continued are mainly the result of the inclusion of accomplished (that is, is feasible) to work (i.e., at alternate duty) the screen and clearly defined because paragraph (k)(1)(iii) of the rule throughout the period of recuperation. compliance endpoints in the standard, states that employer is only required to In Group B, however, the mean period but are also the result of including reduce hazards to the extent feasible. of absence from work was only 3.4 days, unreported MSDs in the analysis of OSHA expects that employers will and fully 80% of this group remained in benefits. These changes to the standard implement feasible controls in the alternate duty throughout. The mean make the rule substantially more cost context of their own individual number of alternate duty days was 91 effective then the proposal would have workplace. This provision recognizes days for Group A workers and 31.5 days been, because they reduce the number that, while controlling MSD hazards to for those in Group B. The total amount of jobs to be fixed by 40 percent.

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OSHA estimates that the direct cost The cost analysis does not account for among industries in terms of wage rates, savings associated with each currently any changes in the economy over time, turnover, baseline rates of compliance, reported MSD, including the savings in or for possible adjustments in the and the MSD rate for the industry. To lost productivity, lost tax payments, and demand and supply of goods, changes facilitate analysis of the impacts of the administrative costs for workers’ in production methods, investment final rule on small businesses, costs compensation claims, are $27,700 and effects, or macroeconomic effects of the were calculated separately for each of $7,000 per MSD not currently reported standard. Taking account of all of these three size classes of establishments. The (1996 dollars). (The difference in the effects could increase or decrease the Final Regulatory Flexibility Analysis dollar values assigned to these two cost or benefit estimates presented here, (Section VIII. H. of this Preamble) categories of MSDs is attributable to the although the macroeconomic effects of provides a detailed summary of OSHA’s fact that OSHA assumes that the any rule whose costs are less than 0.05 unit cost estimates for each element of currently unreported MSDs are much percent of GNP are likely to be minimal. less severe than those being reported.) OSHA believes that its approach, i.e., of the standard. These direct cost savings do not determining the benefits and costs of the OSHA estimates that the annualized attribute a value or assign a monetary standard for industry as it is today, is costs to society of the final standard will cost to the pain and suffering of injured the least speculative and least be $3.9 billion per year. (All costs are or ill workers, losses to their families, or controversial way of presenting the expressed as 1996 dollars and losses of the worker’s ability to benefits and costs of the final standard. annualized using a 7 percent discount contribute at home, and are thus OSHA relied on responses to a 1993 rate and a 10-year annualization period.) conservative estimates of these savings. ergonomics survey (see Chapter V of the Table VIII–2 shows the costs of the final Based on this estimate of the direct cost Final Economic Analysis) of thousands ergonomics standard, by major savings associated with each reported of general industry employers to provision of the standard. Costs are MSD avoided, the annualized benefits estimate the extent to which considered in two parts: costs to society (using a discount rate of 7%) accruing establishments within the scope of the and costs to employers. This distinction in the first ten years the standard is in standard already have implemented is necessary because the costs associated effect are estimated to be $9.1 billion ergonomics programs involving the with the standard’s work restriction control of jobs. This current industry per year. protection provisions represent a cost to baseline was taken into account in employers, but not to society as a whole. E. Costs of Compliance (Chapter V) calculating industry-by-industry and This chapter presents OSHA’s size-of-establishment cost estimates, i.e., Table VIII–2 shows that the total estimates of the costs employers would any costs employers have already estimated costs to society for the private incur to comply with the ergonomics incurred, and any benefits they have sector are $3.4 billion per year, while program rule. The costs reported are already accrued, to voluntarily estimated costs for all affected parties, annualized costs measured in real 1996 implement such programs have not been including state and local governments, dollars over the first 10 years the rule is attributed to the final rule. are $3.9 billion per year. Estimated costs in effect. To calculate annualized costs, Costs were calculated separately at to employers in the private sector as a non-recurring costs have been the three-digit SIC code level for all whole are $4 billion per year, and to all annualized using a discount rate of 7 industries. These industry-by-industry affected sectors are $4.5 billion per year. percent for an estimated life of 10 years. cost estimates account for differences BILLING CODE 4510±26±P

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The programmatic elements of the reported a weighted average controls since the proposal. OSHA standard have annualized costs of $2.2 productivity improvement of 7 percent believes, after a review of the comments billion. In addition, the provision per ergonomic intervention. The cost and cost estimates in the record and an requiring employers to control jobs that estimates presented in this Final analysis of the controls needed to have been found to have MSD hazards, Economic Analysis differ appreciably achieve the final rule’s endpoint, that its has costs of $1.3 billion per year. Four from those presented in the Preliminary initial costs-of-control estimates are of the industries covered by the Economic Analysis. These changes are reasonable. standard have costs of more than $100 described in greater detail in Chapter V F. Economic Feasibility (Chapter VI) million per year: hospitals (SIC 806); of this final analysis, but the most eating and drinking places (SIC 581); important changes and the reasons for The OSH Act requires the Agency to trucking and courier services (SIC 421) them are the following: set standards that are feasible, both and grocery stores (SIC 541). • The inclusion of a clearly defined technologically and economically. To Estimates of the costs of job controls action trigger in the final standard has demonstrate that a standard is feasible, are presented as net costs, because served to significantly reduce the costs the courts have held that OSHA must OSHA has taken the benefits employers of the standard. In the preliminary ‘‘construct a reasonable estimate of often accrue from productivity economic analysis, OSHA assumed that compliance costs and demonstrate a improvements associated with job all MSDs in jobs that had not yet been reasonable likelihood that these costs controls as offsets to the costs of job fixed would require job controls and will not threaten the existence or control. OSHA estimates that the labor other actions as appropriate. Under the competitive structure of an industry’’ savings (productivity improvements) final rule (and thus in this final [United Steelworkers of America, AFL– provided by the job controls the analysis), many reports of MSDs will CIO–CLC v. Marshall (the ‘‘Lead’’ standard will require will amount to not trigger further action because they decision)], 647 F2d 1189 (DC Cir. 1980). approximately $700 million per year in would not meet the standard’s screen. OSHA’s analysis of economic annualized savings.2 OSHA believes Thus the screen serves to significantly feasibility was conducted on an that many ergonomic interventions reduce the costs of the standard. establishment basis. For each affected improve productivity, either because • In order to ensure that the economic industry, estimates of per-establishment they reduce employee fatigue and analysis reflects the costs associated annualized compliance costs were relieve muscle pain (which means that with implementing ergonomics compared with per-establishment the employee will do more work in less programs in practice, the costs for most estimates of revenues and per- time), or because they involve program elements have been revised establishment estimates of profits, using automating portions of jobs in ways that upward to account for the extensive two worst-case assumptions about the can be expected to improve comments in the record on the ability of employers to pass the costs of productivity. In addition to such direct experience of firms that have compliance through to their customers: effects on productivity, ergonomic implemented ergonomics programs. On The no cost passthrough assumption interventions frequently offset the the other hand, the estimated costs to and the full cost passthrough employers’ cost for controls by : general industry employers in assumption. Based on the results of • Reducing absenteeism because a establishments that do not have MSDs these comparisons, which define the worker is less likely to take time off to have been reduced, since the final universe of potential impacts of the recover from muscle soreness, fatigue, standard, unlike the proposal, no longer ergonomics program standard, OSHA etc.; has a requirement for all establishments then assessed the final standard’s • Reducing turnover, particularly with manufacturing or manual handling economic feasibility for establishments since new hires are more likely to find jobs to have a basic program. in all covered industries. an ergonomically designed job within • Work restriction protection (WRP) OSHA assumed that the their physical capacity; costs are substantially reduced overall, establishments falling within the scope • Improving product quality because although the per-case costs have been of the final standard had the same fewer errors are made when processes increased. The overall decrease in WRP average sales and profits as other are more mechanized and demand less costs is a result of the reduced length of establishments in their industries. This physical effort. WRP coverage (from 6 to 3 months) and assumption is reasonable because there These positive productivity impacts the effects of the screen; WRP will only is no evidence suggesting that the are attested to by the experience of be paid under the final rule to workers financial characteristics of those firms many employers (see the productivity in jobs that meet the action trigger. In whose employees experience MSD tables in Chapter V of the Final addition, OSHA agrees with comments incidents are different from firms that Economic Analysis). OSHA’s 1993 in the record pointing out that OSHA’s do not have such incidents among their ergonomics survey of general industry preliminary WRP cost estimates did not workforce. Absent such evidence, employers found that 30 percent of accurately reflect the full costs to the OSHA relied on the best available those employers who had implemented employer of WRP wage replacement, financial data (those from the Bureau of ergonomics controls reported that their and the final WRP costs have been the Census (Ex. 28–6) and Robert Morris ergonomics programs had had adjusted accordingly. Associates (Ex. 502–69)), used measurable positive impacts on • OSHA’s cost estimates in the final commonly accepted methodology to productivity. On average, these rule also take account of the increase in calculate industry averages, and based employers (including the few employers the number of MSDs the Agency its analysis of the significance of the who reported that their controls had believes will be reported to employers projected economic impacts and the negative impacts on productivity) as a result of the encouragement to feasibility of compliance on these data. report provided by WRP and the For this Final Economic Analysis, 2 OSHA estimated productivity impacts by inclusion of persistent signs and OSHA averaged profit data for the four determining the average percentage reduction from symptoms in the standard’s definition of years 1995 to 1998 rather than using a gross costs caused by productivity in a set of examples of ergonomic interventions. Please see the an MSD incident. single year’s data. Because industry Final Economic Analysis, particularly Tables V–17 OSHA has not significantly changed profit can show major year-to-year through V–19, for details. its estimates of the unit costs of job variance, this modification assures that

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G. Economic Impacts to conduct a Final Regulatory Flexibility However, OSHA analysis in Chapter Analysis if, in any affected sector, the VII of the Final Economic Analysis To identify possible economic impact of the annualized compliance shows that some small entities and very impacts, OSHA compared annualized costs exceeds 1 percent of revenues or small entities in the most affected class, costs to revenues and profits for all 5 percent of profits for a substantial those finding MSD hazards, would have covered establishments, for small number of small entities. As Table VIII– compliance costs exceeding 5 percent of entities defined as small using Small 4 shows, in no 3-digit industry do the profits. Business Administration (SBA) size expected costs of compliance exceed 1 OSHA prepared an Initial Regulatory criteria, and for all small entities with Flexibility Analysis as a follow up to 1–19 employees (Ex. 28–3). Costs were percent of revenues. However, the impact of the compliance costs exceeds convening a Small Business Regulatory annualized over ten years, including the Enforcement Fairness Act (SBREFA) costs of controlling all of the MSDs 5 percent of profits for 1 industry, SIC 315, leather gloves and mittens. Panel (the report of the Panel is in the projected to occur in the facility over docket of this rulemaking as Ex. 23). that time period. Focusing on very small Based on the finding that in some OSHA analyzed the impacts of the establishments, Table VIII–5 shows that industries the most affected small final standard’s annualized compliance no 3-digit industry has estimated costs entities would have compliance costs costs on small entities in each 3-digit that exceed one percent of average exceeding 5 percent of profits, OSHA SIC industry. The results of this analysis revenues. The table also shows that in prepared a Final Regulatory Flexibility are shown in Tables VIII–4 and VIII–5. no industry do impacts on profits Analysis, a summary of which is OSHA’s procedures call for the agency exceed 5 percent. presented in the next section.

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BILLING CODE 4510±26±C

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H. Summary of the Final Regulatory to ergonomic risk factors on the job standard on large and small employers. Flexibility Analysis leads to MSDs of the upper extremities, ‘‘Smaller businesses unlike large The Regulatory Flexibility Act, as back, and lower extremities. Every year, corporations do not maintain positions amended in 1996, requires that a Final nearly 600,000 MSDs that are serious for health and safety officers * * * Regulatory Flexibility Analysis (FRFA) enough to cause time off work are many small businesses will be forced to contain the following elements: 3 reported to the Bureau of Labor obtain consultations and assistance from (1) a succinct statement of the need Statistics by employers, and evidence an outside firm’’ (Tr. pp. 9195–9196). Or for, and objectives of, the rule; suggests that an even larger number of that small businesses ‘‘do not have (2) a summary of significant issues non-lost worktime MSDs occur every means to hire’’ experts such as raised by public comments on the Initial year. The purpose of this standard is to ergonomists, engineers, and doctors (Tr. Regulatory Flexibility Analysis (IRFA), a reduce the number and severity of pp. 9258–9259), a statement that was summary of the assessment of the MSDs caused by exposure to risk factors repeated by many commenters from Agency of the issues, and a statement of in the workplace. small businesses. Many small any changes made in the proposal as a 2. Significant issues raised by public businesses also stated that the result of the comments; comments on the Initial Regulatory complexity of the standard and (3) a description and estimate of the Flexibility Analysis (IRFA), an specialized skills necessary for job number of small entities affected by the assessment of the issues, and changes hazard analysis or job controls would final standard, where possible; made in the proposal as a result of the make compliance difficult. ‘‘The vast (4) a description of the reporting, comments. Relatively few commenters majority of small businesses * * * lack recordkeeping, and other compliance provided comment on the Initial the safety and health expertise requirements of the rule, including an Regulatory Flexibility Analysis. necessary to interpret the complex estimate of the classes of small entities However commenters did raise many standard’’ (Ex. 30–4843). Other which will be subject to the issues relevant to the regulatory commenters found the standard and requirements, and the type of flexibility analysis. Some of the ergonomics too technical, too complex, professional skills necessary for the principal issues raised by public or beyond their abilities (e.g., Exs. 30– preparation of the report or record; and comments that have special relevance to 4334, 30–1545, Tr. pp. 12770–12771, (5) a description of the steps the regulatory flexibility analysis, and 15564–15566). OSHA agrees that the Agency has taken to minimize the OSHA’s responses to them, are standard may have greater impacts on significant economic impact on small summarized in the remainder of this small businesses than on large entities consistent with the stated section. businesses. However, as Chapter VII of objectives of the applicable statutes, Many commenters referred to an the final economic analysis including a statement of the factual, estimate attributed to SBA that the costs demonstrates, the standard is of complying with the proposal would policy, and legal reasons for selecting economically feasible even for very be 2.5 to 15 times higher than the the alternative adopted in the final rule small businesses and will reduce Agency’s estimate (see, e.g., Tr. pp. and why each one of the other significant risk to small entity 7767–7768, pp. 5730–5731, pp. 16005– significant alternatives to the rule employees. Furthermore, in the long 16006, p. 9975, pp. 15668–15669, 30– considered by the Agency which affect run, the standard will lead to significant 2047. 30–3811, 30–2056, 30–238, 31– the impact of the small entities was reductions in the costs of workers’ 326, 31–326, 30–2058). While OSHA rejected. compensation and other injury related does not agree with that estimate, OSHA In addition, a Final Regulatory costs for many small employers. Flexibility Analysis must contain a has revised the rule in a variety of ways In terms of the regulatory approach of description of any significant to make it less costly to small the proposal, some small business alternatives to the proposed rule that businesses. The introduction of a two commenters urged the Agency to accomplish the stated objectives of the part action trigger will have the effect of provide a specification type of standard. applicable statute (in this case the OSH significantly decreasing the number of ‘‘Small businesses * * * often cannot Act) and that minimize any significant jobs small businesses will need to deal with that type of flexibility economic impact of the proposed rule address through a full ergonomics [referring to controlling hazards] and so on small entities. This section program or a quick fix. OSHA has also prefer certainty’’ (Tr. pp. 6202–6206). summarizes OSHA’s Final Regulatory increased its estimates of many of the ‘‘What OSHA failed to do in the Flexibility Analysis. The full analysis, unit costs for activities required in proposed standard is give the specific including responses to comments on the response to comments from businesses steps that a small business owner must IRFA and a discussion of alternatives, is of all sizes and SBA. Many small businesses were take to prevent MSDs. The proposed provided as part of the Final Economic concerned about would be the necessity standard only gives small businesses a and Regulatory Flexibility Analysis, of hiring consultants or ergonomic process for how they should develop which is Ex. 900 in the Docket. their own solutions to the MSD 1. Description of the Reasons for experts (which the standard does not problem’’ (Ex. 30–1897). ‘‘Small Agency Action. OSHA is issuing a final require) (see, e.g., Exs. 30–2993, Tr. p. businesses prefer certainty which rule Ergonomics Program Standard to 15586, Exs. 30–3849, 30–3166, 30–4334, [sic] unfortunately does not provide’’ address the significant risk of employee 30–3167, 30–2993, Tr. pp. 14934, 30– (Tr. pp. 6202–6206). In developing the exposure to ergonomic risk factors in 3231, Tr. pp. 16935–16936). OSHA has final rule, OSHA has tried to retain the general industry workplaces. Exposure increased its estimate of the time that managers will need to understand how flexibility that will reduce costs to many 3 The Regulatory Flexibility Act states that a to implement ergonomics programs, but small employers, while adding clarity to Regulatory Flexibility Analysis need not contain all continues to believe that, with adequate many provisions. Particularly the use of of the above elements in toto if these elements are training, ergonomic consultants will be the screen as part of the action trigger presented elsewhere in the documentation and needed for only 15 percent of all and the optional safe harbors for analysis of the rule. The Regulatory Flexibility Analysis should, however, summarize where these problem jobs. determining compliance should elements can be found elsewhere in the rulemaking Some commenters were concerned significantly simplify compliance for record. about the differing impact of the final the small employer.

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3. An estimate of the number of small very small entities (i.e., those employing preparation of the report or record. entities affected by the final standard. fewer than 20 employees). Table VII–6 summarizes the compliance OSHA estimates that there are 4.75 4. Reporting, recordkeeping, and requirements of the rule, which types of million small establishments in general other compliance requirements of the small entities they apply to, the industry affected by the rule. The final rule, including an estimate of the expected burden requirements, and the standard covers an estimated 4.2 million classes of small entities which will be types of professional skills needed. subject to the requirements and the type BILLING CODE 4510±26±P of professional skills necessary for the

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BILLING CODE 4510±26±C

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5. Steps the Agency has taken to achieve the goal of employee protection. that have voluntarily elected to adopt an minimize the significant economic These revisions will help all employers, OSHA State Plan. Consequently, the impact on small entities. The final including small employers. final standard does not meet the standard contains many elements that definition of a ‘‘Federal Alternatives to the Proposed Standard will reduce burden on small entities as intergovernmental mandate’’ (Section compared with the proposal. The scope In the Final Regulatory Flexibility 421(5) of UMRA (2 U.S.C. 658(5)). of the standard is simplified. All Analysis, OSHA considered alternatives This final rule was proposed under employers must provide basic with respect to voluntary action, Section 6(b) of the OSH Act. The final information to employees, and there are alternative scope provisions, alternative ergonomic program standard will no special obligations for employers trigger provisions, alternative work prevent 4.6 million MSDs over the next with employees engaged in restriction protection provisions and 10 years. The final ergonomics program manufacturing or manual handling other approaches to the rule making standard will lead to $558 million per operations. Employers will need less such as exempting small or low hazard year in costs on state, local or tribal time and effort to determine how they employers. SBA’s Office of Advocacy governments. OSHA pays 50 percent of are affected by the scope of the rule. In (Ex. 601–X–1) urged OSHA to consider State plan costs but does not provide the appendices to the standard, OSHA exempting low hazard industries, and funding for state, local or tribal has provided material that employers exempting small firms from WRP. governments to comply with its rules. can use to meet this requirement, OSHA believes that the new two part OSHA does not anticipate any further reducing the burden of the rule. action trigger is a superior means of disproportionate budgetary effects upon The Agency has also kept an MSD focusing the rule’s obligation on high any particular region of the nation or trigger mechanism, and has added a hazard work situations, while particular state, local, or tribal screen. Employers do not need to do maintaining employee protection. The governments, or urban or rural or other anything beyond provide information to action trigger serves to assure that types of communities. Chapters V and employees unless an MSD incident in a employers do not need to try to fix low VI of the economic analysis provide job that meets the screen. The addition hazard jobs. Further, this approach does detailed analyses of the costs and of the screen serves both to simplify this in a way that assures that even impacts of the final rule on particular decisionmaking for small employers and small firms in high hazard industries segments of the private sector. OSHA to target the rule toward high risk jobs. will not need to fix their low hazard has analyzed the economic impacts of For employees in jobs meeting the jobs, while workers in the occasional the rule on the affected industries and action trigger, employers must provide a high hazard job in a low hazard industry found that compliance costs are, on quick fix or initiate an ergonomics receive the protection they need. average, only 0.05 percent of sales, and program. In addition, the employer need Exempting small businesses from WRP that few, if any, facility closures or job not control the job unless MSD hazards would remove needed protections for losses are anticipated in the affected are found during the job hazard employees in small businesses. The industries. As a result, impacts on the analysis. Employers may meet their job Agency’s analysis found that those national economy would be too small to hazard analysis and control obligations alternatives that significantly alleviated be measurable by economic models. in any one of a variety of ways. The the impact on small businesses more The anticipated benefits and costs of addition of clearer compliance than OSHA’s final standard did not this final standard are addressed in the endpoints will reduce employer provide adequate protection to worker Summary of the Final Economic uncertainty about whether they are in health and safety. Many of the Analysis (Section VIII of this preamble), compliance with the rule. Finally, an alternatives to specific provisions, such above, and in the Final Economic employer can cease having a program at as WRP, are also discussed in the Analysis (Ex. 900). In addition, pursuant any time the risks in the job are lowered Preamble in the sections describing to Section 205 of the UMRA (2 U.S.C. so that the job no longer meets the these provisions. 1535), having considered a reasonable number of alternatives as outlined in screen. IX. Unfunded Mandates Establishments with fewer than 11 this preamble and in the economic employees do not have to keep records. OSHA reviewed the final ergonomics analysis (Ex. 900), the Agency has Where a job hazard analysis or job program standard in accordance with concluded that the final standard is the controls are necessary, employers do not the Unfunded Mandates Reform Act of most cost-effective alternative for have to hire a professional ergonomic 1995 (UMRA) (2 U.S.C. 1501 et seq.). As implementation of OSHA’s statutory consultant. The Agency will also supply discussed above in the Summary of the objective of substantially reducing or compliance guides for small businesses Final Economic Analysis (Section VIII eliminating a significant risk of material and a Web-based expert system to guide of the preamble), OSHA estimates that impairment. This is discussed at length employers through the applicability of compliance with the final ergonomics in the economic analysis (Ex. 900) and the final standard. The Agency has program standard will require the in the Summary and Explanation provided flexibility in choosing controls expenditure of approximately $4.0 (Section IV of this preamble) for the to reduce MSD hazards, including billion each year by employers in the various provisions of the final administrative controls along with private sector. Therefore, the final ergonomics program standard. engineering and work-practice controls. ergonomics program standard X. Environmental Impact Statement Finally, the Agency is permitting establishes a federal private sector existing ergonomic programs to be mandate and is a significant regulatory Pursuant to the National grandfathered and considered in action, within the meaning of Section Environmental Policy Act, the compliance with the standard as long as 202 of UMRA (2 U.S.C. 1532). OSHA Department of Labor has issued the existing program meets the has included this statement to address regulations to determine when an requirements in paragraph (c). the anticipated effects of the final environmental impact statement is The principal reasons that the Agency ergonomics program standard pursuant required in a rulemaking proceeding. has made its revisions for the final to Section 202. Section 29 CFR § 11.10(a)(3) states: standard are to make the final standard OSHA standards do not apply to state Preparation of an environmental impact less costly, more cost-effective, and still and local governments, except in states statement will always be required for

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Mechanization and automation in those industries are likely ‘‘forceful lifting/lowering;’’ ‘‘problem In the preamble to the proposed rule, to produce greater efficiencies and job;’’ ‘‘common sense determination;’’ the Agency stated that no environmental lower costs as well as reducing the risks ‘‘ergonomic risk factors;’’ ‘‘OSHA impact statement would be required for and costs of employee injuries. OSHA recordable MSD;’’ ‘‘reasonably likely to this rule because it does not meet the disagrees with the commenter’s cause or contribute to the type of MSD criteria set forth in 29 CFR § 11.10(a)(3), assertion that recycling would be reported;’’ ‘‘cold temperatures;’’ as stated above. OSHA received one abandoned on a large scale as a result ‘‘dynamic motion;’’ ‘‘awkward posture;’’ comment disagreeing with this of OSHA’s standard on ergonomics ‘‘static posture;’’ and ‘‘reduce to the determination. The commenter (Ex. programs; by necessity or law, most extent feasible.’’ E.g., Ex. 32–368–1 at p. 500–221) suggested that employer local jurisdictions in the U.S. have now 126 & Ex. 500–197 at pp. III–3–18 compliance activities associated with committed themselves to recycling. (NCE); Ex. 32–206–1 at pp. 13–14 the proposed Ergonomics Program OSHA believes the claims of adverse (American Iron & Steel Institute); Ex. Standard would have the potential to environmental effects asserted by the 32–241–4 at pp. 166–80 (Anheuser- cause enormous environmental impacts. commenter are highly speculative, and Busch and United Parcel Service). The commenter also suggested that the fail to make a plausible case that the Some of the same commenters, as proposed standard would increase the final Ergonomics Program Standard will well as others, object to what they demand for electricity by encouraging significantly affect the human characterize as the proposal’s ‘‘one size workplace automation; increase the environment. Moreover, none of the fits all’’ approach. E.g., Ex. 30–3845 at consumption of natural resources by impacts predicted by the commenter p. 37 (Forum for a Responsible encouraging employers to use greater takes into account any of the Ergonomics Standard); Ex. 32–368–1 at numbers of smaller product containers; environmental benefits that might result p. 72 (NCE); Ex. 30–3077 at p. 1 and impair air quality by encouraging from ergonomics-related job (National Tooling and Machining delivery vehicles to remain at idle while modifications, such as productivity Association); Ex. 30–2993 at p. 2 (Small employees manually move smaller loads increases and waste reduction. Business Legislative Council). They per trip. Finally, the commenter Accordingly, OSHA concludes that the believe it is inadvisable for OSHA to asserted that the proposed standard final rule will not result in significant issue a standard that applies to a wide would encourage automation of trash environmental impacts and, therefore, variety of different industries because collection and waste disposal an environmental impact statement is conditions pertinent to ergonomics vary operations, and would discourage not required. widely among industries. recycling. The reason OSHA included general OSHA notes that the final standard XI. Additional Statutory Issues language, such as the phrases the requires employers to control problem 1. Fair Notice commenters contend are too vague, in jobs by modifying the conditions under the proposed standard was to avoid the which the work is performed, including Numerous commenters contend that very ‘‘one size fits all’’ approach to such changes as workstation various terms used in the proposed which some of the same commenters modification, redesign of tools, and job standard are unduly vague and fail to and many others object. Because of the rotation. The final standard also provide fair notice of what the standard numerous variables that can result in requires employers to develop requires. For example, the American work-related MSDs, OSHA drafted the ergonomic programs that involve such Iron & Steel Institute asserts that the proposed rule in flexible, performance- elements as assessment of problem jobs, proposal ‘‘is not written in language that oriented language to enable employers modification of jobs to reduce MSD can reasonably be understood by those to develop ergonomics programs hazards, employee training, and MSD who must comply with it.’’ Ex. 32–206– tailored to their workplaces, rather than management. 1. Morgan, Lewis & Bockius believes attempting to prescribe, for example, the Ergonomics-related job modifications that several provisions of the proposal specific manner in which employers typically result in greater production ‘‘are unworkably vague in their current should control an MSD hazard. As a efficiencies without the need for state.’’ Ex. 30–4467 at p. 6. Organization result, the proposal used a number of additional natural resources or the Resources Counselors, Inc. (ORC) states general phrases to allow employers the increased discharge of pollutants. As that the proposal contains an ‘‘excess of maximum amount of flexibility several ergonomists testified at the complex terms and definitions.’’ Ex. 32– consistent with the standard’s goal of hearings (David Alexander, Tr. Pp 78–1 at p. 5. Similar objections were reducing MSDs. 2142–53, 2369–72 and Dennis Mitchell, raised by the Edison Electric Institute In response to the numerous Tr. Pp 2366–68) ergonomic (Ex. 32–300–1 at p. 6); the Integrated comments that criticized the proposed modifications typically involve Waste Service Association (Ex. 22–337– standard as being unduly vague, OSHA mechanization (e.g. the use of carts, 1 at p. 8); the National Coalition on has made a number of changes to the shelves, adjustable workstations, etc.) Ergonomics (Ex. 32–368–1 at pp. 126– final standard that are designed to give and only rarely involve automation (the 29); the Chamber of Commerce (Ex. 30– additional guidance as to what the replacement of people by machines.) 1722 at pp. 24–25 & Ex. 500–188 at pp. standard requires of employers. Some of Automation is a rarely-used approach 66–69); the Forum for a Responsible the complaints most frequently voiced unless the employer considers that Ergonomics Standard (Ex. 30–3845 at in the comments—that employer process efficiency will be improved. pp. 26–29); and numerous others. obligations are not defined with The likelihood is that updated, more Among the phrases in the proposal the sufficient clarity—are addressed by (1) energy-efficient production equipment commenters assert were overly vague changing the scope of the standard to no will actually lead to a decrease, not an are ‘‘eliminate or materially reduce the longer require employers to determine increase, in energy consumption. In the MSD hazards;’’ ‘‘significant amount of whether their employees are engaged in trash collection and recycling the employee’s worktime;’’ ‘‘repeated ‘‘manual handling’’ or manufacturing;

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(2) including an objective Action Trigger 2. OSHA’s Past Enforcement Efforts Pepperidge Farm held that the for determining whether an employer In the NPRM, OSHA noted that it had company’s employees were exposed to must fix a job in which an employee has gained experience over the years in recognized lifting and repetitive motion reported a MSD incident; and (3) addressing ergonomic issues through a hazards. In Dayton Tire, OSHA received establishing compliance endpoints that variety of means, including an adverse decision from the will enable employers to tell with enforcement, consultation, training and administrative law judge and decided certainty whether they have taken education, compliance assistance, the the case did not present a proper vehicle sufficient steps to fix a problem job. As Voluntary Protection Programs, and for appeal. The final order in Dayton a result of these changes, certain phrases issuance of voluntary guidelines. 64 FR Tire is therefore an unreviewed that commenters claimed were too at 65774. In the area of enforcement, the administrative law judge’s decision and vague, such as ‘‘significant amount of agency had successfully issued over 550 lacks precedential value. United States the employee’s worktime,’’ ‘‘core ergonomics citations under the OSH v. Sturm, Ruger & Co., 84 F.3d 1, 5 n. 4 (1st Cir.1996); Matter of Establishment element of the job,’’ and ‘‘forceful Act’s General Duty Clause, section Inspection of Cerro Copper Prods. Co., lifting/lowering’’ are no longer used. 5(a)(1). Id. Almost all of these citations, 752 F.2d 280, 284 (7th Cir. 1985); Leone The changes to the final rule, and the the agency observed, had led to the Constr., 3 O.S.H. Cas. (BNA) 1979, 1981 reasons for them, are discussed in the implementation of ergonomics programs Summary and Explanation section of (Rev. Comm’n 1976). by the cited employers, included some The Chamber contends that the this preamble. Although the final rule corporate-wide programs developed contains greater specificity than the ‘‘unfavorable’’ decisions in these three pursuant to settlement agreements. Id. cases undermine the scientific basis for proposal, OSHA believes that the final The Chamber of Commerce criticizes ergonomics regulation and hence for rule still gives employers sufficient OSHA for not mentioning cases where, this rule. To the contrary, OSHA flexibility to develop ergonomics in the Chamber’s words, OSHA’s programs that are suited to the believes that the decisions in Beverly enforcement efforts ‘‘abjectly failed.’’ and Pepperidge Farm support both the particular characteristics of their Ex. 30–1722 at p. 7. The Chamber states workplaces. need for and the scientific basis of this that OSHA lost the ‘‘only three rule. They demonstrate that, even under OSHA believes that this final rule enforcement actions that were actually the heavy burden of proof OSHA bears provides fair notice to employers of tried to completion,’’ citing Pepperidge in general duty clause litigation, the their obligations. On its face, it provides Farm, 17 O.S.H. Cas. (BNA) 1993 (Rev. preponderance of the credible evidence persons of ordinary intelligence a Comm’n, 1997); Dayton Tire, Division of shows that workplace exposures cause reasonable opportunity to understand Bridgestone/Firestone, Inc., 1998 WL MSDs, that employers recognize this, the conduct it prohibits or requires. See 99288 (ALJ, 1998); and Beverly Enters., and that serious injuries result from Hill v. Colorado, 120 S.Ct 2480, 2498 1994 WL 693958 (ALJ, 1995), review these exposures. (2000). Moreover, in addition to the directed (Nov. 9, 1995), decided by the The Chamber also cites testimony of language of the standard and the further Commission (Oct. 27, 2000). Ex. 30– OSHA witnesses in these cases, along guidance provided by this preamble, 1722 at pp. 7–8. See also Ex. 500–197 with deposition testimony from Hudson other sources will be available to help at Ex. III–C, E. Scalia, OSHA’s Foods, a case that was ultimately employers determine their compliance Ergonomics Litigation Record Three settled, to attempt to show that experts obligations. OSHA intends to make Strikes and It’s Out, cato inst. No. 391. engaged by OSHA cannot state with compliance assistance conveniently These cases, the Chamber contends, certainty the degree of risk caused by available to the public, both through its ‘‘demonstrate the futility of exposure to different levels of website (www.osha.gov) and through promulgating a mandatory ergonomics ergonomic stressors (Ex. 30–1722 at pp. printed publications. Among the program standard, and underscore 26–27, 47); that OSHA compliance compliance assistance materials will be OSHA’s failure to understand the state officers are unqualified to evaluate the a small entity compliance guide, as of the scientific evidence and its legal health risk from ergonomic stressors required by the Small Business authority.’’ Ex. 30–1722 at p. 10. (Ex. 30–1722 at pp. 28, 64); that experts Regulatory Enforcement Fairness Act of Similarly, the NCE asserts that litigation are unable to define with precision 1996, specifically designed to inform of ergonomics citations under the terms such as ‘‘awkward posture,’’ small businesses of their obligations general duty clause demonstrates ‘‘high force,’’ and ‘‘long periods of under the rule in language that is OSHA’s inability to garner sufficient standing’’ (Ex. 30–1722 at pp. 64–69); readily understandable. Employers and scientific evidence to support an that two OSHA expert witnesses in employees will also be able to look to ergonomics rule. Ex. 32–368–1 at p. 14. Dayton Tire did not offer consistent guidelines that have proven successful Contrary to the Chamber’s definitions of the stressors in certain in averting MSDs in specific industries, contentions, OSHA has not ‘‘lost’’ the jobs (Ex. 30–1722 at p. 69); and that such as the red meat guidelines. Ex. 2– only three ergonomics cases tried to OSHA experts were unable to testify to 13. OSHA-funded consultation services completion. In the case of Beverly the effectiveness of abatement measures through state agencies will be available Enters., the ‘‘loss’’ to which the (Ex. 30–1722 at pp. 72–73). to qualifying employers who request it. Chamber refers was an adverse The Chamber’s reliance on selected And personnel in OSHA’s national and administrative law judge’s decision that testimony in these cases does not field offices will be available to answer was under review by the Commission undermine the scientific basis for this questions about the standard. OSHA when the Chamber submitted its final rule. First, as the Commission also encourages trade associations and comments. The Commission has since, decisions in Beverly and Pepperidge other business organizations to in a decision issued on October 27, Farm show, the evidence in those cases disseminate information, such as case 2000, reversed the administrative law supports OSHA’s decision to address studies of successful ergonomic judge’s decision and held that the ergonomic hazards in this final rule. interventions by employers in their company’s practices for lifting patients Second, even if reasonable experts differ industries, that will help facilitate in its nursing homes exposed its nursing over the nature of ergonomic risks or compliance with the standard by their assistants to a serious recognized cannot precisely quantify those risks, members. hazard. The Commission decision in OSHA is not precluded from issuing a

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Over a three- its duty under the general duty clause OSHA may use conservative year period, 28 employees engaged in with respect to the repetitive motion assumptions in interpreting the repetitive motion tasks had undergone hazards. Id. at 2040–41. evidence and risk error on the side of 42 separate surgical procedures, Beverly Enterprises overprotection rather than including 32 carpal tunnel releases. Id. underprotection. Id. See also American at 2015. Based on this evidence and on In Beverly Enterprises, OSHRC No. Dental Ass’n v. Martin, 984 F.2d 823, testimony about the rate of carpal tunnel 91–3344 et al., (Rev. Comm’n, Oct. 27, 827 (7th Cir.), cert. denied, 510 U.S. 859 syndrome in the general population, the 2000), the nursing assistants (NA’s) the (1993) (‘‘OSHA was required neither to Commission found that the incidence of company employed in its nursing quantify the risk to workers health nor carpal tunnel injury caused by repetitive homes were required to lift patients to establish the existence of significant motions performed at the plant was manually and, in many cases, without risk to a scientific certainty.’’). ‘‘substantially in excess of that found in assistance. Those employees suffered a Certainly, the record of this rulemaking other populations, including other disproportionate number of cases of contains conflicting evidence on the populations of workers.’’ Id. at 2029. lower back pain (LBP), which was often issues the Chamber raises, such as the The Commission relied on expert so severe that the employee would be relationship between ergonomic testimony, evidence of biological off work for long periods of time, in stressors and MSDs. However, given the plausibility, and epidemiological some cases six months to over a year. high number of MSDs workers have studies, to find that the high rate of Slip. op. at 16. The administrative law been suffering and continue to suffer, MSDs suffered by the employees was judge concluded that OSHA had not OSHA does not believe that the lack of caused by their work on the assembly proven that the cases of LBP were a consensus among knowledgeable line. Id. at 2028–29. The Commission caused by Beverly’s lifting practices. experts justifies further delay in the also held that the employer recognized The ALJ therefore vacated the citation issuance of a rule that is needed to the hazard posed by the repetitive for lack of proof of a hazard. protect workers against such ailments. motions because the company’s own The Commission reversed the ALJ’s In addition, there is a substantial body medical staff attributed the cause of decision. The Commission extensively of scientific evidence to support the employee disorders to the tasks examined the evidence showing that the promulgation of an ergonomics performed at the facility. Id. at 2030. nurses aides were exposed to the risk of standard. And, the Commission held that the contracting LBP from their lifting upper extremity musculoskeletal Because the Chamber and other activities. The evidence included: (1) disorders resulting in surgery, disability, The high rate of lost-time cases of LBP rulemaking participants have argued and restricted work suffered by that Pepperidge Farm and Beverly suffered by Beverly’s NA’s; (2) evidence employees from their assembly line of biomechanical modeling, which undermine the basis for this rule, a brief tasks ‘‘clearly involved serious physical discussion of those cases is appropriate. evaluated the compressive force harm.’’ Id. at 2032. The actual hazard imposed by lifts of various weights and Pepperidge Farm posed to employees from the highly body positions on the lower back and repetitive work, as opposed to a calculated the percentage of the working In Pepperidge Farm, the Commission potential hazard, was thus not ‘‘benign,’’ population that could safely perform held that the employer willfully as claimed by one writer. Ex. 500–197 such lifts; (3) the NIOSH lifting violated the OSH Act in requiring its at p.12. equation, a formula developed for employees to perform hazardous lifts, Finally, the Commission accepted NIOSH for determining a safe level of which caused them to suffer high rates OSHA’s position that Pepperidge Farm lift based on data compiled by various of serious MSDs. The administrative law was required to follow a process of researchers on the biomechanical, judge found that the employer’s manual abatement to eliminate or materially epidemiological, psychophysical, and lifting tasks, which required the lifting reduce the hazard. 17 O.S.H. Cas. (BNA) physiological bases for LBP; and (4) of objects weighing up to 165 pounds, at 2034–35. The Commission agreed epidemiological studies showing a were hazardous, that the company with OSHA on the core components of correlation between patient lifting and recognized the hazard, and that feasible such a process—‘‘accurate record LBP in populations of health care means of abating the hazard existed. 17 keeping, medical treatment for injured workers. The Commission concluded: O.S.H. Cas. (BNA) at 2003. The employees, workplace analysis to assess employer did not dispute before the the potential hazard and steps to abate We find on the scientific evidence Commission the ALJ’s findings that the it, education and training of workers presented that manual lifting of residents is lifting tasks were hazardous and that a known and recognized risk factor for LBP. and management, and further actions, to Considering also the evidence showing that abatement was feasible, but argued that the extent feasible, to materially reduce the frequency and manner in which Beverly’s it did not recognize the hazard. The the hazard.’’ Id. at 2034. Under this NA’s performed their assigned tasks exposed Commission rejected the argument, process, the employer would determine them to compressive forces in excess of finding that Pepperidge Farm ‘‘precisely what particular mix of limits well-established and accepted in the recognized the hazard based on engineering and administrative controls scientific community, and that Beverly’s recommendations by its worker’s most efficiently reduces the [hazard].’’ working conditions resulted in numerous compensation carrier and its own Id. at 2033. The Commission found that lost-time incidents and prevented Beverly’s corporate ergonomist. Id. at 2003–07. NA’s from performing their usual daily Pepperidge Farm had in fact followed activities, we conclude that the manual Thus, Pepperidge Farm illustrates, as such a process by implementing a lifting of residents was shown on this record OSHA has found in this rulemaking, number of engineering and to be a hazardous work practice and that that repetitive lifting of heavy objects is administrative controls and taking the Beverly controls the methods used to perform hazardous and that feasible means that other process steps recommended by the lifting.

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Slip op. at 52. agreements are highly significant. While The Chamber of Commerce asserts The Commission further found that avoidance of the time and expense of that a settlement agreement with Beverly recognized the hazard. Among litigation undoubtedly entered into Hudson Foods is an example of a case other evidence, the Commission noted those employers’ decisions to settle, that the employer settled despite that Beverly had adopted a ‘‘Lift with they nevertheless agreed to put forth palpable weaknesses in OSHA’s Care’’ program, which referred to the substantial efforts to reduce or eliminate evidence. Ex. 30–1722 at pp. 11–12. The NIOSH limits for safe lifting and taught the hazards for which they had been Chamber suggests that OSHA settled for its NA’s how to lift patients in a way cited. For many, the agreements went little to get out of litigation that was not that would reduce the likelihood both of far beyond the cited locations to other going well. In fact, OSHA had injury to the resident and back injury to corporate facilities not visited by OSHA developed strong evidence to support the NA. Id. at 53, 59–60. In addition, and, therefore, far beyond any the citations and was fully prepared to Beverly knew its NA’s were suffering abatement orders OSHA might have go to trial if necessary. See generally high rates of LBP from its workers’ obtained in litigation. OSHA’s Reply to Hudson Foods. Inc.’s compensation claims; that failure to use Those agreements and resulting Motion to Exclude Expert Testimony, correct lifting techniques is one cause of efforts were clearly successful. As noted Secretary v. Hudson Foods, Inc., dated back injury; and that its nursing homes in the proposed rule preamble, OSHA April 30, 1999 (OSHRC Docket No. 98– did not have enough mechanical hoists held a workshop in March 1999, in 0079)(Ex. 502–26). However, OSHA was to ensure that such equipment was which ten companies described their willing to settle because the settlement available when necessary. Id. at 54–55. experience under their settlement secured all of its objectives. Hudson, Finally, the Commission relied on agreement and with their ergonomics which was purchased by Tyson Foods, testimony showing that experts familiar programs. All the companies that Inc. after OSHA’s inspection, but before with the nursing home industry reported results to OSHA showed a the settlement, withdrew its notice of perceive lifts such as those performed substantially lower severity rate for contest to the ergonomic allegations by Beverly to be hazardous. Id. at 62. MSD’s since implementing the programs contained in the citations, paid a total The Commission found that the defined in their agreements. Ex. 26– penalty of $200,000 for all citations, hazard was likely to cause serious 1420. Most companies reported lower and, most importantly, agreed to physical harm. ‘‘LBP has a substantial workers’ compensation costs, as well as implement the comprehensive, existing and significant effect on the affected higher productivity and product quality. Tyson Foods ergonomics program that employees’’ ability to perform their Id. Only five of the 13 companies the parties anticipated would abate the normal activities and effectively involved in these agreements violations. Ex. 502–42, pp. 3–5, Exhibits disables employees for periods of time consistently reported the number of ‘‘A’’ and B’’. With this hazard which are extensive in some instances. MSD cases or MSD case rates, and all recognition and gain in employee safety We conclude that in view of the five showed a significant decline in the and health, continued litigation over a debilitating effect on employees and the number of lost workdays. None of the larger penalty was pointless. The potential duration of the disability, LBP companies that reported severity exculpatory language cited by the is properly considered serious physical statistics showed an increase in lost Chamber was acceptable in light of the harm.’’ Id. at 68. workdays as a result of the ergonomics intervening purchase of Hudson by The parties disputed before the program. Tyson Foods, which had not caused the Commission whether OSHA had proven The success of OSHA enforcement cited conditions and had displayed the feasibility and likely utility of coupled with settlements requiring good faith through its own abatement measures. Since the comprehensive ergonomics programs implementation of a comprehensive administrative law judge had not made was confirmed by the United Food and ergonomics program. Ex. 30–4137, p. 1. factual findings on that issue, the Commercial Workers International Commission remanded the case for such Union. The union recognized that ‘‘[t]he OSHA’s Red Meat Guidelines findings. Id. at 72–73. majority of our successful programs in In addition to OSHA’s enforcement the meatpacking and poultry industries efforts, many knowledgeable witnesses Settlements of General Duty Clause were propelled by OSHA enforcement. agreed that the agency’s Ergonomics Citations Ergonomic settlement agreement and Program Management Guidelines for The Chamber of Commerce takes corporate-wide settlement agreements Meatpacking Plants (‘‘Red Meat issue with OSHA’s claim in the NPRM (CWSAs) * * * demonstrate industry Guidelines’’) (Ex. 2–13) have resulted in (64 Fed. Reg. at 65774) that the recognition of the existence of MSD implementation of successful workplace settlement agreements that resolved hazards and the elements of a program programs addressing ergonomic most of the contested General Duty to prevent worker injuries arising from hazards. For example, in contrasting Clause citations showed the success of exposure to these hazards.’’ Ex. 32–210– OSHA’s proposal to the Red Meat OSHA’s enforcement efforts and the 2, p. 5. The UFCW gave a number of Guidelines, IBP Inc.’’s Bob Wing efficacy of ergonomics programs. Ex. examples illustrating the efficacy of acknowledged that the Guidelines had 30–1722 at pp. 10–12. The Chamber these agreements and resulting been successful. Ex. 30–4046, p. 1. says that employers settle ergonomic programs. One was that of IBP’s Dakota Similarly, the American Meat Institute citations to avoid the prospect of City meatpacking plant, which (‘‘AMI’’), the main representative for the expensive litigation, and that OSHA implemented a comprehensive program U.S. Meat Industry, including 276 meat therefore cannot conclude that ‘‘those as a result of citations and subsequent packers and processors, operating 559 employers ergonomics programs will in settlement agreement. Cost savings facilities, acknowledged that the fact reduce injury in the workplace, and attributed to the program ‘‘* * * were industry worked with OSHA on the Red that, in the absence of OSHA’s realized in the following areas: Meat Guidelines and has been using interventions, the employees in [employee] turnover was down them for nearly ten years. Ex. 30–3677, question would have been without significantly . * * *; [MSD] incidence p. 1. The AMI notes that the Red Meat protection.’’ Id. at 10–11. OSHA dropped dramatically; surgeries fell; Guidelines work and that the industry continues to believe, contrary to the [and] worker’s compensation costs were has made substantial progress in Chamber’s assertion, that the settlement reduced significantly.’’ Id. at 9. addressing ergonomic issues since

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In order to compliance costs compared to noted that upon publication of the prove an employer violated section enforcement of ergonomics protection Guidelines, industry began to respond 5(a)(1), OSHA must prove that a under section 5(a)(1). It has frequently both from the standpoint of technology, recognized hazard that is likely to cause been observed that reliance on as well as ergonomic programs. Ex. 32– death or serious physical harm exists in standards is preferable to enforcement 210–2, pp. 25–26. The success of the the employer’s workplace. Nelson Tree under section 5(a)(1) because standards Guidelines led to use and acceptance in Srvs v. OSHRC, 60 F.3d 1207, 1209 (6th spell out employer duties more other industries. The poultry industry Cir. 1995). OSHA must also specify a specifically than does section 5(a)(1). appears to have secured substantial means by which the employer can E.g., St. Joe Minerals Corp. v. OSHRC, reductions in chronic MSD’s from eliminate or materially reduce the 647 F.2d 840, 846 n.13 (8th Cir. 1981); adherence to the principles in the hazard and demonstrate the feasibility B & B Insulation, Inc. v. OSHRC, 583 document (Ex. 30–3375, p. 1). and likely utility of those means. Id. F.2d 1364, 1371 & n.12 (5th Cir. 1978). OSHA can not, however, ‘‘demand’’ that That is true of this final rule. For Enforcement Actions and Compliance example, unlike section 5(a)(1), this rule Costs an employer abate a 5(a)(1) violation in any particular way. The employer is not establishes safe harbors that will enable Some commenters (e.g., Anheuser- limited to using the means listed in the employers to know with a high degree Busch and United Parcel Service, Ex. citation to eliminate or materially of certainty when they have fulfilled 32–241–4 at pp. 259–266 and the reduce the hazard but is free to use any their compliance obligations. By National Coalition on Ergonomics et al., means that accomplishes that goal. See providing better notice of employer Ex. 500–197 at pp. II–79–84) contend OSHA Field Inspection Reference duties than does section 5(a)(1), the that OSHA’s compliance cost estimates Manual, Ch. A.4.f(2) (‘‘the employer is standard will promote the efficient use ignore the way the agency has enforced not limited to the abatement methods of employer resources and thereby help ergonomic requirements under section suggested by OSHA.’’); Marshall v. B.W. minimize costs. 5(a)(1). The commenters assert that Harrison Lumber Co., 569 F.2d 1303, OSHA’s estimated costs of compliance 3. Cost-effectiveness. 1308 (5th Cir. 1978). An employer will with the ergonomics standard are far All OSH Act standards must be cost generally have more detailed knowledge lower than the costs of the controls effective. Cotton Dust, 453 U.S. at 514 of its operations and processes than OSHA has ‘‘demanded’’ in 5(a)(1) n. 32. A standard is cost-effective if the OSHA will gain during a relatively brief enforcement actions. protective measures it requires are the This argument lacks a factual inspection of the workplace and may least costly of the available alternatives foundation because it is unsupported by therefore be able to devise methods of that achieve the same level of any evidence of the abatement costs eliminating ergonomics hazards that are protection. Id.; Lockout/Tagout II, 37 associated with the section 5(a)(1) more cost effective than those proposed F.3d at 668. ergonomics citations. In any event, by OSHA. As a result, the costs OSHA has taken a number of steps to OSHA does not believe those costs are associated with the means of abatement ensure that this final rule is cost- extravagant. In many cases, the listed in a citation, even if those costs effective. First, the rule allows abatement measures sought by OSHA were quantified in this record, may well employers with problem jobs to use any were already being used by similarly- be higher than those the employer will combination of engineering, situated employers. In Hudson Foods, as actually incur. administrative, and work practice discussed above, the settlement For additional reasons as well, the controls to control the MSD hazards. agreement simply required Hudson to costs associated with section 5(a)(1) Therefore, from the entire range of adopt the ergonomics program of its citations cannot be used to calculate the controls that would be potentially new owner, Tyson Foods. In Pepperidge costs of this standard. The employers effective in an employer’s workplace, Farm, abatement of the lifting violations who have been cited for 5(a)(1) the employer is able to select those that found by the Commission required the ergonomics violations are not are the least costly. company to do no more than its own representative of the universe of The standard also ensures the cost- corporate ergonomist had employers who will have compliance effective use of employer resources by recommended. 17 O.S.H. Cas. (BNA) at duties under the standard. As noted focusing employers’ compliance 2004–06. Similarly, the process for above, to sustain a 5(a)(1) citation, resources where they will do the most abating the repetitive motion hazards OSHA must be able to prove not only good: on those jobs that are that Pepperidge Farm had already been that a hazard is present but that the demonstrably causing MSDs. It requires following was found by the Commission hazard is one that is recognized by the all covered employers to provide basic to meet its duty to implement a feasible employer or its industry and is likely to information about MSDs to its means of abatement. Id. at 2039–41. cause death or serious physical harm. employees, but only those employers Thus, the citations in Pepperidge Farm Because of this heavy burden of proof, whose employees experience MSD did not require the employer to take OSHA has only issued 5(a)(1) citations incidents in jobs that meet the additional steps beyond those it was for ergonomic violations to a relatively standard’s Action Trigger have already taking. small number of employers, and those additional duties. In this regard, the Moreover, these arguments reflect a employers have been cited because their final standard is more cost-effective fundamental misunderstanding of the employees had been suffering unusually than the proposal, which would have significance of abatement requirements high rates of work-related MSDs. And required all employers engaged in in 5(a)(1) citations and on a mistaken because the employers cited under manufacturing and manual handling to belief that employers who received 5(a)(1) had particularly severe implement ergonomics programs.

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The Quick Fix option in the final rule 4. Alleged Conflict With Other Federal and to give the employees the also adds to the rule’s cost-effectiveness Statutes opportunity to ask questions about the by allowing employers to fix problem A number of commenters contend ergonomics program. Paragraph (u) jobs without incurring the additional that portions of the standard conflict requires employers to consult with costs of setting up an entire ergonomics with other federal laws, in particular the employees and their representatives program. The Quick Fix option is National Labor Relations Act (NLRA), about the effectiveness of the program available for those jobs that can be fixed 29 U.S.C. 141 et seq., the Americans and any problems with it. quickly and completely once the job is with Disabilities Act (ADA), 42 U.S.C. Some commenters contend that the identified as a problem job. 12101 et seq., the Family and Medical requirement for employee participation Leave Act (FMLA), 29 U.S.C. 2601 et in an ergonomics program, to the extent The extended compliance dates in the it applies in nonunion workplaces, seq., Title VII of the Civil Rights Act of standard will also help minimize would conflict with section 8(a)(2) of 1964, 42 U.S.C. s 2000e et seq., and the employers’ compliance costs. Employers the NLRA, which prohibits employers Age Discrimination in Employment Act are given 11 months from the date of the from dominating or interfering with a (ADEA), 29 U.S.C. 621 et seq. The standard’s publication to provide their labor organization. Ex. 32–368–1 at pp. preamble to the proposed standard employees with the basic information 124–26 (National Coalition on discussed in some detail the standard’s the standard requires. Employers will Ergonomics); Ex. 32–234–2 at pp. 29–30 consistency with the NLRA and the thereby have sufficient time to first (National Solid Waste Management ADA, see 64 FR at 65,794–65,795 become familiar with the standard Association); Ex. 30–3845 at p. 36 (NLRA), 66,058–66,059 (ADA), and, as themselves and then have time to (Forum for a Responsible Ergonomics provide the required information to discussed below, the comments do not Standard). The National Coalition on their employees. alter OSHA’s conclusion that there is no Ergonomics (NCE) states that because conflict with those statutes. The the standard requires that employers Employers are given up to four years proposed preamble did not address the from the standard’s effective date to provide ways for employees to be FMLA, Title VII, or the ADEA, but there involved in developing, implementing, complete the implementation of too we conclude there is no conflict, as permanent controls for problem jobs. and evaluating ergonomics programs, discussed below. the standard is an ‘‘open invitation’’ to This extended time frame will promote a. National Labor Relations Act— violate Section 8(a)(2). Ex. 32–368–1 at cost-effectiveness in several ways. First, NLRA’s prohibition on employer- it will give employers sufficient time to p 126. NCE also asserts that requiring dominated labor organizations in employers to respond to employee learn about the range of available nonunion workplaces. Various controls, both from the compliance reports of MSD symptoms would provisions of the standard require require conduct violating Section assistance OSHA plans to make employers to convey information to available and from other sources. Many 8(a)(2). Id. their employees and obtain information These arguments are without merit. employers will thereby be able to from their employees. Paragraph (i), implement ‘‘off-the-shelf’’ controls, Nothing in the standard requires governing employee participation, creation of any sort of employee which will be less costly than if the requires that employees: (1) Have ways employer needs to develop controls on organization or committee, let alone one to promptly report MSDs, their signs that violates the NLRA. Section 8(a)(2) its own or hire an outside expert to and symptoms, and MSD hazards in the recommend controls. Second, the of the NLRA does not restrict the ability workplace; (2) receive prompt responses of nonunion employers to deal with extended compliance period will enable to their reports of MSD signs and an employer to adopt an incremental employees as individuals, and such symptoms and MSD hazards; (3) have employers can comply fully with the abatement approach that may, in turn, ready access to the standard and to result in less expensive controls than if standard’s employee participation information about MSDs, MSD signs provisions by doing so. Contrary to the employer had to commit itself to a and symptoms, and the employer’s NCE’s contention, the requirement that control strategy immediately. For ergonomics program; and (4) have ways employers respond to employee reports example, an employer can first try a to be involved in developing, of MSD symptoms does not violate the low-cost control and, if it works, would implementing and evaluating the NLRA. Even before the passage of the not need to consider higher-cost ergonomics program. Paragraph (j) OSH Act, it was common for employees controls. Third, the extended time frame requires an employer analyzing a to report injuries to employers, and for will enable employers who have more problem job to talk with affected responsible employers to respond to than one problem job to control the employees and their representatives those reports by correcting workplace highest risk jobs first while still giving about the tasks they perform that relate hazards. See Taft Broadcasting Co., them sufficient time to control their to MSDs. Paragraph (m) provides that an Kings Island Div., 13 O.S.H. Cas. (BNA) other problem jobs. This will enable employer required to control a problem 1137, 1140 (Rev. Comm’n 1987), aff’d, such an employer to avert more MSDs job must ask employees and their 849 F.2d 990 (6th Cir. 1988). It has at an earlier time and thereby minimize representatives for recommendations never been suggested that such actions its costs for MSD management and about reducing the MSD hazards and violate the NLRA, and they clearly do worker removal protection. consult with employees and their not. Finally, OSHA is permitting those representatives about the effectiveness Moreover, nonunion employers can employers who already have of the controls the employer use a variety of other means to comply implemented ergonomics programs implements. Paragraph (o) provides that with the employee participation meeting certain criteria to continue an employer who chooses the Quick Fix provisions of the standard without those programs rather than establish option must ask employees and their running afoul of section 8(a)(2)’s new programs under this final rule. representatives for recommendations proscription against dominating or Those employers whose current about reducing the MSD hazards. interfering with the formation or programs qualify for ‘‘grandfathering’’ Paragraph (t) requires the employer to administration of any labor will therefore not incur any new costs train employees in the aspects of the organization. A ‘‘labor organization’’ as a result of this final rule. ergonomics program that affect them under the NLRA is ‘‘any organization of

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Ex. 30–1722 at p. 82. employment, or conditions of work.’’ 29 Protections, Committee on Education The NCE and others say that unionized U.S.C. § 152(5). A critical component of and the Workforce in the House of employers would be forced into direct this definition is that the organization or Representatives). In addition, the dealing with represented employees and committee ‘‘deal[] with’’ an employer. preamble noted that employers can will thereby violate section 8(a)(5). Ex. Such ‘‘dealing’’ occurs if there is a provide mechanisms for individual 500–197 at pp. III–53–61. Similarly, the ‘‘bilateral process’’ that entails a pattern employees to report problems and make Edison Electric Institute (EEI) reads the or practice by which a group of recommendations, or can assign safety proposed standard as requiring employees makes proposals to responsibilities to employees as part of employers to deal with individual management and management responds their job descriptions, without employees regarding their working to those proposals by acceptance or implicating Section 8(a)(2). Id. conditions and contends that this rejection by word or deed. EFCO Corp., The NCE questions whether ‘‘brain- requirement ‘‘creates the seeds of 327 N.L.R.B. No. 71 (Dec. 31, 1998), storming’’ groups or ‘‘information- conflict with the exclusive bargaining aff’d, EFCO Corp. v. NLRB, 2000 WL gathering’’ committees would actually authority of recognized unions under 623436 (4th Cir. 2000) (unpublished); fall outside the scope of Sections 2(5) Section 9(a) of the [NLRA].’’ Ex. 32– Electromation, Inc., 309 N.L.R.B. 990 and 8(a)(2). Ex. 32–368–1 at p. 126. 300–1 at p. 9. The Integrated Waste (1992). However, if there are only These types of entities are specifically Services Association (ISWA) makes a isolated instances in which a group mentioned in NLRA case law as ones similar argument. Ex. 22–7–1 at pp. 16– makes ad hoc proposals to management, that would pass muster. See E.I. du 17. EEI and ISWA urge OSHA to make the element of dealing is lacking. E.I. du Pont, 311 N.L.R.B. at 894, cited in Ex. clear in the final rule that where Pont de Nemours & Co., 311 N.L.R.B. 26–23, pp. 11–12; see also EFCO Corp., employees are represented by a certified 893, 894 (1993). 327 N.L.R.B. No. 71, slip op. 5 (‘‘[a] bargaining representative, employers In its preamble to the proposed rule, significant portion of the purposes and will satisfy the employee involvement OSHA carefully explained that the functions of the Safety Committee, such provisions of the standard by dealing in requirement that employees have ways as the reporting and correction of safety good faith with the union. Ex. 32–300– of being involved in the ergonomics problems, would not contribute to a 1 at p. 11 (EEI); Ex. 22–337–1 at p.17 program can be satisfied by measures finding that it is a labor organization’’); (ISWA). that fall short of the employer- id. (employee suggestion screening As discussed elsewhere in this dominated committees and other committee did not ‘‘deal with’’ preamble, employee participation in an employee organizations that violate employer because it merely reviewed ergonomics program is a vital Section 8(a)(2). In general, the agency and forwarded suggestions without component of an effective program. emphasized that the ‘‘nature, form, and formulating proposals or presenting OSHA further believes that unions, extent of how employers must provide them to management). Nor does the fact where they exist, must be involved in employees with opportunities to that the proposed preamble elsewhere the program and has therefore provided participate will vary among refers to an ‘‘ergonomics committee’’ or that ‘‘representatives’’ of employees be workplaces,’’ depending upon a variety a ‘‘labor-management CTD committee’’ afforded the opportunity to participate of factors, including ‘‘[t]he presence or as effective components of an in job hazard analyses, absence of a union.’’ 64 FR at 65,800. In ergonomics program suggest that the recommendations for controls, and particular, it explained that OSHA has agency is being ‘‘disingenuous,’’ as NCE program evaluation. Cf. OSHA Field been careful to structure the ‘‘employee charges. Ex. 32–368–1 at p. 125 n. 228. Inspection Reference Manual, Ch. II, participation requirements so that they The general reference to an ‘‘ergonomics Sec. A.3.f (where employees are are entirely consonant with the case law committee’’ does not suggest that represented by a recognized union, the based on the NLRA.’’ 64 FR at 65,795. OSHA, contrary to its express highest ranking on-site union official or Thus, the agency explained that the statements, requires employers to union employee representative proposed rule does not ‘‘mandate any institute employee committees that designates who will represent particular method ‘‘ such as employee violate Section 8(a)(2), and the reference employees during a walkaround committees ‘‘ for ensuring employee to a joint-labor management committee inspection); OSHA Instruction CPL 2– participation,’’ and that this ‘‘leaves is consistent with OSHA’s statement 2.45A (Sept. 13, 1994), Process Safety employers free to involve employees in that a permissible mechanism for Management of Highly Hazardous the program in ways that do not violate employee participation in unionized Chemicals—Compliance Guidelines and the NLRA but will further meaningful workplaces, consistent with the Enforcement Procedures, Appendix B employee participation.’’ Id. proposed standard and the NLRA, is a (‘‘employee representative’’ under Moreover, OSHA has already ‘‘joint labor-management committee employee participation provision of explained that there are various established in compliance with the process safety management standard, 29 permissible ways to meet the NLRA by bargaining between the C.F.R. 1910.119(c), refers to recognized requirement that employees be involved employer and the union representing union). Thus, rather than bypassing in developing, implementing, and the employees.’’ 64 FR at 65,795. unions, the standard provides that they evaluating ergonomics programs. The Impact on collective bargaining play an important role. preamble to the proposed standard agreements in unionized workplaces. As For example, the employer must, pointed to certain methods of obtaining to unionized settings, the Chamber of under paragraph (m), ask the employee input through employee Commerce contends that the proposed ‘‘employees and their representatives’’ group activity—a brainstorming group, rule would force employers to run afoul for recommendations about how to best an information-gathering committee, or of the NLRA and the Railway Labor Act eliminate or control MSD hazards. The

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That The possibility that existing collective and health matters, and will eagerly deal language is intended to encompass the bargaining agreements address with employers over ergonomics. The record entire range of workplaces, including ergonomics does not, as the Chamber of reflects extensive union-management efforts nonunion workplaces, unionized to tackle ergonomic hazards. Thus, the notion Commerce suggests, place employers in that the employer’s bargaining obligation workplaces in which all of the an untenable position. If such employees in problem jobs are stands in the way of OSHA compliance does collectively bargained programs meet not reflect reality. Ex. 500–218 at p. 162. represented by the union, and the standard as adopted or qualify under The National Coalition on Ergonomics workplaces in which some of the the standard’s grandfather clause, they employees in problem jobs are argues that imposition of some of the will not need to be altered. If they controls suggested by OSHA could represented by the union and some are conflict with the standard, the not. In workplaces in which all violate seniority and line of progression employer’s statutory obligation to employees in a problem job are within provisions in collective bargaining comply with the standard takes priority the bargaining unit, employers may, as agreements. Ex. 32–368–1 at p. 81. The over the agreement. Murphy Oil, 286 EEI and ISWA suggest, fulfill their NCE is apparently referring to the NLRB at 1042 (employer ‘‘was not only obligations under the provisions that standard’s inclusion of employee within its rights, but also legally bound require the involvement of ‘‘employees rotation in the definition of to adopt a rule that complied with and their representatives’’ by dealing in ‘‘administrative controls.’’ The NCE also Federal law.’’); Standard Candy Co., 147 good faith with the union. The employer claims that employees being rotated into NLRB 1070, 1073 (1964) (employer was and union may agree on any mechanism other jobs may not be qualified to legally obligated to raise wages to new for employee participation that is perform those jobs and that job rotation federally-mandated minimum wage consistent with the standard. can create a greater hazard by subjecting without bargaining with union). employees to the risk of new MSD risk Some commenters note that To the extent the employer has factors they were not exposed to in their ergonomic provisions have been prior jobs. Id. incorporated into collective bargaining discretion in the means by which it achieves compliance, and the means These objections are unpersuasive. agreements and assert that employers First, many workplaces are not covered may be forced to violate these involve a mandatory subject of bargaining, the employer would be by collective bargaining agreements that agreements to comply with the rule. Ex. contain seniority or line of progression 30–1722 at p. 82 (Chamber of required to bargain with the union regarding the means of compliance. limitations. In those workplaces, the Commerce); Ex. 500–197 at p. III–62 concerns raised by NCE are totally United Steelworkers, 647 F.2d at 1236 (National Coalition on Ergonomics and absent. Second, the standard does not (‘‘[w]hen an issue related to earnings others). The duty to bargain with require any employer to use job rotation. protection not wholly covered by OSHA recognized unions over safety and To the contrary, it specifically states regulation arises between labor and health matters does not excuse that engineering controls, where management, it will remain a mandatory employers from complying with OSH feasible, are to be preferred over Act standards. Employers and unions subject of collective bargaining’’); see administrative controls, including job cannot bargain away an obligation Watsonville Newspapers, LLC, 327 rotation. However, to give employers under the Act. See Trans World Airlines N.L.R.B. No. 160, slip op. 2–3 (Mar. 24, maximum flexibility, the standard gives v. Hardison, 432 U.S. 63, 79 (1977) 1999); Dickerson-Chapman, Inc., 313 employers the option of using (‘‘neither a collective-bargaining N.L.R.B. 907, 942 (1994) (although administrative controls. As a result, contract nor a seniority system may be employer must comply with OSH Act those employers who can use job employed to violate the statute.’’); standard requiring daily inspections of rotation safely and effectively are free to Alexander v. Gardner Denver Co., 415 open excavations by a ‘‘competent do so, while those who believe job U.S. 36, 51 (1974) (notwithstanding person,’’ employer must bargain with rotation would lead to contractual or contrary provision of collective union about who would be so safety problems can address ergonomic bargaining agreement, employee has designated); Hanes Corp., 260 N.L.R.B. hazards in other ways. right to court hearing on race 557, 561–562 & n.12 (1982) (where b. Americans with Disabilities Act. discrimination claim under Title VII). OSHA standard required use of The ADA is an anti-discrimination See generally United Steelworkers v. respirators but gave employer discretion statute that prohibits discrimination by Marshall, 647 F.2d 1189, 1236 (D.C. Cir. with respect to choice of respirator, covered employers against ‘‘qualified 1980), cert. denied, 453 U.S. 913 (1981) employer could require use of respirator individual[s] with a disability,’’ that is, (‘‘[i]n passing a massive worker health without bargaining, but could not persons ‘‘with a disability who, with or and safety statute, Congress certainly unilaterally determine which approved without reasonable accommodation, can knew it was laying a basis for agency respirator would be used). Nothing in perform the essential functions of the regulations that would replace or the ergonomics program standard employment position that such obviate worker safety provisions of forecloses employers from bargaining individual holds or desires.’’ 42 U.S.C. many collective bargaining with unions about discretionary aspects 12111(8), 12112(a). Under the ADA, agreements’’), cert. denied, 453 U.S. 913 of the standard that are mandatory employers must reasonably (1981); see also Murphy Oil USA, Inc., subjects of bargaining under the NLRA. accommodate disabled workers. 286 NLRB 1039, 1042 (1987) (employer To the contrary, OSHA has repeatedly However, if there is no reasonable can unilaterally adopt work rule emphasized the importance of involving accommodation that would permit a required by OSHA standard without employee representatives in all aspects disabled employee to work for the bargaining with union); Louisiana of the ergonomics program. As the AFL– employer, the employer is free to Chem. Ass’n v. Bingham, 550 F. Supp. CIO points out: discharge the employee under the ADA.

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Commenters argue that the proposed business hardship, which is defined as the incidence of MSDs. The standard standard improperly requires employers ‘‘an action requiring significant should therefore lessen the number of to take steps beyond those required by difficulty or expense, when considered occasions on which employers would the ADA in that the standard’s in light of’’ certain statutory factors. Id. need to raise defenses under the ADA, requirement that employers control §§ 12111(10), 12112(b)(5)(A). such as that the accommodation ergonomics hazards requires steps As OSHA explained in the preamble involves an undue hardship or that the beyond ADA’s requirement for to the proposed standard, the disabled person is a direct threat, see 42 reasonable accommodation. Ex. 32–368– ergonomics standard and the ADA are U.S.C. 12113(b), to the health or safety 1 at p. 118 (NCE); Ex. 30–1722 at p. 81 complementary in purpose. 64 FR at of others that cannot be eliminated by (Chamber of Commerce). These 66,058–66,059. The standard the reasonable accommodation. 64 FR at comments are fundamentally implements measures in problem jobs 66,060. This salutary effect does not misguided. that would reduce the likelihood of establish a conflict with the ADA and In the preamble to the proposed rule those jobs causing or aggravating MSDs provides no ADA-based reason for not OSHA explained its authority under the (a category that includes impairments implementing the standard. OSH Act for promulgating this standard. that may be disabilities under the ADA, NCE argues that a provision in the In order to achieve the Act’s purpose of although it also includes impairments proposal (proposed section assuring ‘‘safe and healthful’’ that do not rise to the level of an ADA- 1910.132(a)(2)) conflicts with the ADA workplaces, 29 U.S.C. 651(b), the covered disability). These measures will by requiring employers to keep Secretary of Labor is authorized to not only prevent MSDs within the confidential certain information promulgate health and safety standards, meaning of the ergonomics standard, pertaining to an employee’s medical id. § 655(b), which may require but also make it easier for persons with condition that the employer could, ‘‘conditions, or the adoption or use of existing impairments (including ADA- under limited circumstances, release one or more practices, means, methods, covered disabilities) to work in those under the ADA. Ex. 32–368–1 at operations, or processes, reasonably jobs. Accordingly, the standard pp.119–20. The proposed provision necessary or appropriate to provide safe comports well with the ADA’s goal of would have required confidentiality ‘‘to or healthful employment and places of reducing barriers to the employment of the extent permitted and required by employment.’’ Id. § 652(8). Pursuant to individuals with disabilities. law,’’ avoiding any possible conflict Notwithstanding this complementary this authority, see 64 FR at 65,774– with another statute’s disclosure purpose, the NCE and the Chamber of 65,775, OSHA has determined, based on requirement. The provision has been the best available evidence, that the Commerce argue that the standard deleted from the final standard because, various components of the ergonomics impermissibly conflicts with the ADA as NCE notes, it is superfluous. Ex. 32– standard are reasonably necessary and because it may require employers to 368–1 at p.120. appropriate to provide adequate make changes to jobs it is not required protection from hazards that are to make under the ADA. Ex. 32–368–1 NCE also objects to a provision in the reasonably likely to cause or contribute at p. 118 (NCE); Ex. 30–1722 at p. 81 proposed standard providing that the to work-related MSDs. It is on the basis (Chamber). This contention is meritless. employer instruct the health care of this authority that OSHA is requiring As noted, the ergonomics standard is provider (HCP) that diagnoses unrelated employers to take such actions as squarely based on OSHA’s authority to to workplace exposure to MSD must analyzing jobs to identify MSD hazards, promulgate health and safety standards. remain confidential and must not be implementing measures to control such Moreover, although the NCE and the included in the opinion communicated hazards, and removing a disincentive to Chamber suggest that the ADA prohibits to the employer. Ex. 32–368–1 at p.119. reporting MSDs by providing economic OSHA from requiring changes to jobs This provision has been carried over protection for workers who are placed beyond the reasonable accommodations into the final standard (with the on temporary work restrictions or required under the ADA, nothing in the addition of an exception as discussed removed from work because of MSDs ADA even remotely supports this below). Although NCE appears to related to their jobs. See generally 64 FR proposition. 29 C.F.R. pt. 1630 app. at contend that this provision also at 65,838–65,861. Nothing in the ADA 354 (‘‘nothing in [EEOC ADA conflicts with the ADA’s confidentiality limits OSHA’s authority under the OSH regulations] prohibits employers * * * exceptions, it offers no cogent reason Act to issue standards that are from providing accommodations beyond why this is so. OSHA continues to reasonably necessary and appropriate to those required by th[e]’’ regulations). believe, as it explained in the preamble protect worker health and safety. Similarly, nothing in the ergonomics to the proposed standard, that a The ADA’s definition of disability is standard conflicts with the ADA. The provision protecting the confidentiality not keyed to impairments that are standard does not purport to authorize of medical conditions that are not occupational in origin, but more discrimination that is prohibited by the workplace-related is needed to protect generally encompasses impairments ADA; nor does it purport to eliminate employees’ privacy and, for that reason, (whatever their origin) that substantially any defenses that an employer may have has been a routine feature of OSHA limit (or are regarded as limiting) an to an ADA action. NCE’s charge that health standards for many years. 64 FR individual’s major life activities. 42 OSHA is attempting to eliminate at 65,844. Such a confidentiality U.S.C. §§ 12111(10), 12112(b)(5)(A). defenses under the ADA is based on a provision is reasonably necessary to Reasonable accommodations to such misunderstanding of the thrust of the encourage employee reporting of MSD impairments may include ‘‘job pertinent agency statements in the hazards because employees could be restructuring, part-time or modified preamble to the proposed standard. Ex. deterred from such reporting if they work schedules, reassignment to a 32–368–1 at p. 121; see 64 FR at 66,059– knew information about their medical vacant position, acquisition or 66,060. OSHA explained that the condition would be improperly modification of equipment or devices’’ ergonomics standard, by requiring disclosed. Thus, the agency clearly has and other similar accommodations. Id. employers to control problem jobs, the authority to adopt such a provision. § 12111(9)(B). Employers are not ultimately should make it easier for Moreover, OSHA has added language to required, however, to provide employers to hire persons with MSD- the provision clarifying that it is subject accommodations that would pose undue related disabilities and should lessen to an exception: the information may be

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We note, however, that in the standard may require employers to alter would make Congressional policies scenario with which NCE seems most jobs to a greater extent than does the embodied in the FMLA irrelevant for concerned—the employee who is on ADA’s reasonable accommodation OSHA’s preferred class of employees,’’ paid WRP-leave—it is highly unlikely requirement, persons with non-MSD Ex. 30–1722 at p. 82. The NCE similarly that there will be a bona fide dispute disabilities may claim that the employer contends that ‘‘OSHA cannot supersede about whether the employee has a has engaged in disparate treatment by the requirements of another federal serious health condition that has providing more extensive statute without express statutory rendered him or her unable to perform accommodations for MSD disabilities authority,’’ Ex. 32–368–1 at p. 124. the functions of the job. See 29 CFR than non-MSD disabilities. Ex. 32–368– Similar arguments are made by the 825.114(a)(2) (serious health condition 1 at p. 119. Even assuming that National Solid Wastes Management includes condition that causes more allegations of differing degrees of Association (Ex. 32–234–2 at p. 28); and than three consecutive calendar days of accommodation for different disabilities Paul, Hastings, Janofsky & Walker LLP incapacity and involves either two visits states a viable claim of disparate (Ex. 32–211–1 at pp. 10–11); to a HCP or one visit followed by a treatment under the ADA, the employer As with the ADA, there is nothing in regimen of continuing treatment under would have a defense to such a claim. the FMLA or its implementing the HCP’s supervision), 825.115. In EEOC regulation, 29 CFR 1630.15(e), regulations that suggests any restriction other words, it is implausible that an recognizes that ‘‘[i]t may be a defense to on OSHA’s authority to regulate employee on paid WRP-leave would a charge of discrimination under this workplace safety and health. Nor is resist the employer’s designation of the part that a challenged action is required there anything in the ergonomics leave as FMLA-leave on the ground that or necessitated by another Federal law standard that would cause an employer he or she does not have a serious health or regulation.’’ The employer’s to violate the FMLA. There is thus no condition. obligation to comply with the FMLA-based obstacle to adoption of the NCE also contends that compliance ergonomics standard would constitute a standard. Moreover, the FMLA requires with the proposed standard could legitimate, nondiscriminatory reason employers to accommodate employees’ subject employers to discrimination explaining the difference between its need for time off to care for their own claims under the FMLA because treatment of disabilities also covered or their family’s health. The ergonomics workers covered by the standard may under the ergonomics standard and its rule will prevent many incipient MSDs receive WRP consisting of paid leave, treatment of other disabilities. See from progressing to the type of serious while other workers with serious health generally id. pt. 1630, app. at 369 health conditions that might justify conditions who are unable to perform (necessity of compliance with federal leave under the FMLA and will thereby their job are entitled only to unpaid law or regulation a defense, where not reduce the need for employees to invoke leave under the FMLA. NCE 123–124. a pretext for discrimination). the FMLA’s protections. Thus, as with The FMLA’s anti-discrimination OSHA emphasizes that this final the ADA, the ergonomics standard provision, however, does not sweep so standard does not limit an employer’s works in concert with, not against, the broadly. It prohibits interference with obligation to comply with the ADA. If purposes of the FMLA. the exercise of rights under that statute, an HCP advises the employer, pursuant The NCE raises some questions about 29 U.S.C. 2615(a)(1), and proscribes to paragraph (r)(2)(ii) of the standard, the interplay between the FMLA and the discrimination against an individual for that an employee with a MSD can never standard’s work restriction protection having engaged in activity such as resume his or her former work activities, (WRP) provisions. Ex. 32–368–1 at p. opposing unlawful practices under the any obligations the employer has toward 123. NCE asks, for example, whether an statute, filing charges, or giving that employee under the ADA would employee could receive six months of information or testifying in connection remain in effect. WRP payments while removed from with FMLA proceedings or inquiries. 29 c. Family and Medical Leave Act. work and then obtain an additional 12 U.S.C. 2615(a)(2), (b). An employer who Under the FMLA, an ‘‘eligible weeks of unpaid leave under the FMLA. has placed employees on paid WRP- employee’’ is entitled to take up to a FMLA regulations provide that an leave under the ergonomics standard total of 12 work weeks of unpaid leave employer may in specified has not, by that action, interfered with for the birth of a child and to care for circumstances designate paid leave as other employees’ FMLA rights. Nor such child, for the placement of a child FMLA leave. 29 CFR 825.208. Nothing would its reason for not giving similar for adoption or foster care, to care for a in the ergonomics standard precludes an paid leave to those other employees— spouse or an immediate family member employer from designating WRP-leave that the employees were outside the with a serious health condition, or when as FMLA leave if the limited scope of the WRP provisions of the he or she is unable to work because of circumstances under which paid leave ergonomics standard—constitute a basis a serious health condition. See 29 U.S.C. may be designated as FMLA leave are of prohibited discrimination under the 2612(a)(1). In response to the proposed met. FMLA (such as retaliation for protected standard, the Chamber of Commerce NCE also contends that the ergonomic activities). and the NCE pointed out that, while the standard’s provisions regarding d. Title VII of the Civil Rights Act of FMLA only requires employers to opinions of health care providers (HCPs) 1964 and the ADEA. Title VII prohibits provide 12 weeks of unpaid leave to conflict with FMLA regulations employment practices and devices that employees with serious health regarding medical certifications for the discriminate on the basis of race, color, conditions, the proposed standard’s existence of a serious health condition. religion, sex, or national origin. The provisions for work restriction Ex. 32–368–1 at p. 123; citing 29 U.S.C. ADEA prohibits employment protection provided that an employee 2613. See also 29 CFR 825.305–825.308. discrimination on the basis of age. The

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Forum for a Responsible Ergonomics employers believe they can gain some days), during which the public could Standard contends that women and benefit by hiring only young, male comment and submit evidence on all older workers are more susceptible to workers, Title VII and the ADEA aspects of the proposed standard. OSHA MSDs than younger persons and that the prohibit them from doing so on the basis also scheduled a nine week informal ergonomics standard will therefore that it will make compliance with the public hearing, for interested parties to encourage employers to violate these standard easier. testify on the proposed standard. statutes by hiring a young, male- Finally, OSHA established a 90 day XII. Procedural Issues dominated workforce. Ex. 30–3845 at post-hearing comment period. The post- pp. 36–37. I. Introduction hearing comment period gave hearing These anti-discrimination statutes OSHA began seeking public participants 45 additional days to were adopted to combat the attitudes participation in this rulemaking when it submit data and evidence, and 90 prevalent among many employers that published an Advance Notice of additional days to submit comments for older workers, or female workers, or Proposed Rulemaking (ANPR) in August consideration by OSHA. In sum, those minority workers, were not as qualified 1992. The Agency received more than individuals who participated in the to do a job as well as young, white 250 comments in direct response to that informal public hearing had 216 days males. Through their enactment, (more than seven months) after Congress prohibited employers from notice. See Comments in Ex. 3. The next year OSHA conducted an extensive publication of the proposed rule to relying on such outdated stereotypes submit data and evidence to the rather than making hiring decisions on survey of employers to obtain information on the extent of existing rulemaking record for OSHA’s the basis of a worker’s individual consideration, and 261 days (nearly capabilities. See Hazen Paper Co. v. ergonomics programs and practices in general industry. In 1994–1995, and nine months) after publication of the Biggins, 507 U.S. 604, 610 (1993) proposed rule to submit briefs and (‘‘Congress promulgation of the ADEA again in 1998 and 1999, OSHA held a series of ‘‘stakeholder meetings’’ across arguments to the rulemaking record. was prompted by its concern that older Although these procedures exceed the workers were being deprived of the country where interested members of the public discussed with legal requirements for OSHA employment on the basis of inaccurate rulemaking and are consistent with the and stigmatizing stereotypes.’’); Los representatives of OSHA their experiences and opinions relating to procedures used in past Agency Angeles Dept. of Water & Power v. rulemakings, a number of participants, Manhart, 435 U.S. 702, 707 n. 13 (1978) ergonomics and ergonomic programs. See Ex. 26–1370. In some cases, OSHA primarily employer groups, have (‘‘In forbidding employers to attacked them as inadequate. A major discriminate against individuals even shared early drafts of regulatory text under consideration with theme of these attacks is that the issues because of their sex, Congress intended in this rulemaking are unprecedentedly to strike at the entire spectrum of participants in these meetings. In developing the proposed standard, complex, and that OSHA therefore disparate treatment of men and women should have provided extraordinary resulting from sex stereotypes.’’). OSHA took account of all the information it had obtained during this comment periods and other In particular, these statutes preclude opportunities to challenge its discriminatory hiring decisions based period: the ANPR comments; the survey responses; and the stakeholders’ views preliminary conclusions. OSHA on perceived gender or age-based recognizes that the size of the record on susceptibility to a safety or health risk and experience, as well as its own enforcement experience and some issues could have posed inherent in the job. In UAW v. Johnson challenges, although by no means Controls, Inc., 499 U.S. 187 (1991), the information gleaned from a insurmountable ones, to rulemaking Supreme Court held that an employer’s comprehensive review of the relevant participants. OSHA responded to these ‘‘fetal protection policy’’ violated Title literature. In response to this input, challenges by making adjustments to the VII. Under that policy, the employer OSHA revised its regulatory approach rulemaking schedule and to the refused to assign women to jobs substantially from that reflected in its procedures used in earlier rulemakings involving lead exposure unless the early drafts of a standard. In February in order to provide interested parties women could show they were unable to 1999, as part of the review process with easier access to rulemaking become pregnant. The employer required by the Small Business materials (including extending Docket claimed that this policy was justified Regulatory Enforcement Fairness Act Office hours), and to ensure that the because lead in a pregnant woman’s (SBREFA), 5 U.S.C. § 601 et seq., OSHA bloodstream could potentially harm the released to the public a draft proposed rulemaking proceeded in a fair and fetus. The Supreme Court held that the Ergonomics Program standard (SBREFA orderly manner. employer’s concern that women who draft) that reflected much of the II. The Adequacy of the Rulemaking were or might become pregnant would regulatory approach of the proposal. Process be particularly susceptible to a health The SBREFA draft was also made risk from lead exposure was not a valid available on OSHA’s website. OSHA A. Length of the Pre-Hearing Comment reason to allow them to exclude such received a large amount of feedback on Period women from jobs for which they were this draft from the small entity OSHA published its proposed qualified. representatives participating in the Ergonomics Program standard on The rulemaking record shows that SBREFA process, and OSHA made a November 23, 1999. 64 FR 65768 (Nov. workers of both sexes and all ages suffer number of alterations to the draft based 23, 1999); see also 64 FR 73448 (Dec. 30, MSDs when exposed to high levels of on that feedback. See Ex. 23. 1999) (publication of corrections the risk factors addressed by this As described in detail below, OSHA’s notice). In the Federal Register notice, standard. OSHA therefore does not official Notice of Proposed Rulemaking OSHA established a 70 day pre-hearing believe that the rulemaking record provided the public with additional comment period to submit written supports the commenters’ claim that opportunities to participate in the comments and evidence on the this standard will provide any incentive rulemaking. Specifically, OSHA proposed standard. Id. These materials to employers to violate Title VII and the established a 70 day pre-hearing were required to be postmarked by ADEA. However, even if some comment period (later extended to 100 February 1, 2000. Id.

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OSHA received a number of requests Numerous other OSHA rulemakings nine weeks of informal public hearings to extend the pre-hearing comment have also included pre-hearing and a 90 day post-hearing comment period and delay the informal public comment periods of similar length. For period on the proposed rule. Thus, hearing. See e.g., Letters in Ex. 33. In example: those parties who filed Notices of Intent response to these requests, OSHA • Tuberculosis—123 day pre-hearing to Appear at the hearing had a total of extended the pre-hearing comment comment period. 63 FR 5905 (Feb. 5, 261 days (nearly nine months) from the period an additional 30 days, until 1998). date the proposal was issued to the end March 2, 2000, and delayed the start of • Butadiene—91 day pre-hearing of the post-hearing comment period to the informal public hearing by 20 days, comment period. 55 FR 42406 (Oct. 19, comment on the proposed rule. OSHA until March 13, 2000. 65 FR 4795 (Feb. 1990). believes that this period of time was 1, 2000). This schedule gave interested • Bloodborne Pathogens—76 day pre- more than adequate to allow interested parties a total of 100 days to submit pre- hearing comment period. 54 FR 23042 parties an opportunity to review the hearing comments on the proposed (May 30, 1989). record and submit meaningful standard. OSHA also notified • Hazard Communication—60 day comments. participants of a number of innovations pre-hearing comment period. 48 FR In addition, OSHA’s procedures in its filing and docket access 53280 (Nov. 25, 1983). typically provide that only parties who procedures, so that parties would have Most significantly, it is clear that the participated in an OSHA rulemaking as little difficulty as possible in 100 day comment period provided the hearing may file post-hearing reviewing the record and filing public with an adequate opportunity to submissions. But in this rule OSHA comments in the time allowed. See Ex. comment on the proposed rule. The permitted trade associations or other DC–423. For example, OSHA placed comprehensive and detailed nature of groups who were eligible to file such copies of the proposed rule, the full many of the pre-hearing comments comments to attach to their own Health Effects section, and the full OSHA received is itself compelling submissions comments from their Preliminary Economic Analysis on its evidence of this fact. For example: members who were not eligible to file webpage and on CD–ROM. OSHA • The National Coalition on on their own. Many interested parties mailed a CD–ROM free of charge to all Ergonomics (NCE) submitted a 156 page (e.g., members of the National individuals who had participated in comment, as well as attachments of 321 Association of Manufacturers) who did earlier stakeholder meetings and to any pages. Ex. 30–3956. not file a Notice of Intent to Appear, other interested party upon request. • The U.S. Chamber of Commerce therefore, were able to submit post- The 100-day pre-hearing comment (Chamber) submitted a 95 page hearing submissions through their trade period was more than three times as comment, as well as attachments of 524 association or other group. See e.g., long as that required by the OSH Act. pages. Ex. 30–1722. Letters in Ex. 500–1. The OSH Act only requires OSHA to • Anheuser-Busch, Inc. and United Moreover, many interested parties give interested parties 30 days to Parcel Service, Inc. (UPS) submitted a were familiar with the overall structure comment on a proposed standard. 29 299 page comment, as well as of the proposed rule before it was U.S.C. 655(2). OSHA’s procedural attachments of 2007 pages. These published on November 23, 1999. regulations also state that a proposed attachments consisted of additional OSHA posted the SBREFA draft, which rule must provide interested persons comment and evidence prepared by 23 was similar to the proposed rule in with 30 days in which to submit expert witnesses. Ex. 32–241. many respects, on its website in ‘‘written data, views, and arguments, • The Union of Needletrades and February, 1999. Many interested parties, which shall be available for public Industrial Textile Employees (UNITE) including small business owners, inspection and copying.’’ 29 CFR submitted a 70 page comment, as well commented on the draft rule. See Ex. 23. 1911.11(b)(3). See also Executive Order as attachments of 1078 pages. Ex. 32– In addition, OSHA had engaged 12866, 58 FR 51735 (Sept. 30, 1993) 198–4. interested parties in discussions on (encouraging administrative agencies to • The United Food and Commercial ergonomics issues for quite some time provide a minimum 60 day pre-hearing Workers Union (UFCW) submitted a 179 before publication of the proposed rule. comment period). The 100 day pre- page comment, as well as attachments of See Discussion in Part II above. Many hearing comment period provided here 2218 pages. Ex. 32–210–2. parties who commented on the was more than adequate to meet all of Although some of these submissions proposed rule and participated in the these requirements. came from parties complaining that the informal public hearing were very This comment period is also comment period was inadequate, the familiar with the issues relevant to the consistent with past OSHA practice in comments listed above, as well as many rulemaking long before the pre-hearing rulemakings of this magnitude. In the others, demonstrated a thorough comment period began. Air Contaminants Rulemaking, OSHA mastery of the proposal and preamble, For these reasons, OSHA does not proposed to lower the permissible as well as extensive familiarity with agree with those commenters who exposure limits for over 400 hazardous OSHA’s Preliminary Economic complained that 100 days was an substances, 54 FR 2332 (Jan. 19, 1989), Analysis, its Health Effects discussion, inadequate amount of time to analyze an enormous undertaking by any and much of the material in the record. the rulemaking record fully and to measure. The Eleventh Circuit See e.g., Exs. 30–1722; 30–3956; 32–241. submit meaningful comments on the subsequently rejected a challenge to the And a number of comments were proposal. A couple of commenters went 47 day pre-hearing comment period submitted early, including the so far as to claim that the 100 day pre- OSHA afforded in that rulemaking. Chamber’s 619 page comment, which hearing comment period violated AFL–CIO v. OSHA, 965 F.2d 962, 969 was submitted on February 16, 2000, a parties’ due process rights. Ex. 30–3956, n.8 (11th Cir. 1992) (Air Contaminants) full two weeks before the due date. See p. 141; 30–3865, pp. 33–4. The (‘‘[W]e are unpersuaded that the time Ex. 30–1722. American Iron and Steel Institute (AISI) period allowed in this rulemaking was Moreover, the pre-hearing comment suggested that the OSH Act required so insufficient as to prevent interested period represented only one aspect of OSHA to give a 30 day pre-hearing parties from commenting on the the public participation opportunities in comment period for each hazard at issue proposed rule.’’). this rulemaking. OSHA also scheduled in the rulemaking (i.e., force, repetition,

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00570 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68831 awkward posture, static posture, contact responsibilities. These types of conflicts an informal public hearing to provide stress, cold temperatures, and do not prevent interested parties from interested parties another opportunity to vibration); thus, AISI argued that OSHA submitting meaningful comments on comment on the proposed standard. 64 was obligated to set a 210 day pre- any particular proposed rule. FR 65768 (Nov. 23, 1999). Participants hearing comment period. Ex. 500–223, Finally, the extension of the pre- in the hearing could present testimony p. 94. Many commenters noted as well hearing comment period was not and ask questions of OSHA and other that a number of holidays occurred granted too late. OSHA originally public witnesses. OSHA scheduled the during the pre-hearing comment period, believed that the 70 day pre-hearing informal public hearing for three cities: and that these, as well as Year 2000 comment period established in the Washington, DC; Portland, OR; and computer issues, made review and proposal was sufficient to allow Chicago, IL. Id. at 65769. The hearing preparation of comments particularly interested parties to comment was originally scheduled to begin on difficult. See e.g., Ex. 30–3865, p. 34; meaningfully on the proposed standard. February 22, 2000, and OSHA required Letters in Exhibit 33. Finally, a number (The 70 day period was more than twice participants to file Notices of Intent to of commenters stated that OSHA’s grant as long as that required by the OSH Act, Appear by January 24, 2000. Id. at of a 30 day extension of time from 70 and longer than the 60 day minimum 65768. When OSHA extended the pre- days to 100 days was not meaningful period recommended by Executive hearing comment period, it also delayed because it was not granted until January Order 12866). OSHA seriously the start of the hearing until March 13, 27, 2000, a few days before pre-hearing considered the requests it received to 2000, 11 days after the close of the pre- comments were originally scheduled to extend the initial 70 day pre-hearing hearing written comment period. 65 FR be filed. See e.g., Exs. 500–188, p. 6 n.3; comment period, however, and 4795 (Feb. 1, 2000). In addition, because 500–109; 30–3956, p. 142. ultimately decided to grant the 30 day it received more than 400 Notices of No party’s due process rights were extension. Intent to Appear at the hearing, OSHA violated by the 100 day pre-hearing OSHA granted the extension on added an additional 7 days to the comment period. As shown above, the January 27, 2000, a few days before hearing in Washington, DC and comment period was more than written comments were originally Portland, OR, in order to accommodate adequate for interested parties to review scheduled to be filed. In addition to all members of the public who sought to the record and submit pre-hearing publishing notice of the extension in the testify. See 65 FR 11948 (Mar. 7, 2000); comments. Nor does the OSH Act Federal Register on February 1, 2000, 65 FR 19702 (Apr. 12, 2000). require OSHA to provide a 30 day pre- 65 FR 4795 (Feb. 1, 2000), OSHA issued On February 25, 2000, the Assistant hearing comment period for each risk a press release to inform the public that Secretary issued special hearing factor at issue. As explained above, the the comment period had been extended procedures to ensure that the hearing OSH Act provides for a minimum 30 and placed the press release on its web- proceeded in a fair, orderly, and timely day comment period for each ‘‘proposed page. See http://www.osha.gov/media/ manner. 65 FR 11948 (Mar. 7, 2000). In rule promulgating * * * an oshnews/jan00/national-20000127.html. doing so, the Assistant Secretary acted occupational safety or health standard.’’ Some commenters thanked OSHA for pursuant to Section 1911.4 of OSHA’s 29 U.S.C. 655(b)(2) (emphasis added). granting the extension. See Exs. 32–21– procedural regulations governing The OSH Act does not place a 1, p.9; 500–1–26; 30–4496, p. 1. The 30 informal public hearings, which allows requirement upon OSHA to provide day extension was useful in allowing the Assistant Secretary, upon reasonable additional time for comment depending interested parties additional time to notice, to specify additional or upon the number or types of hazards review the record and comment on the alternative hearing procedures for good being regulated. See Air Contaminants, proposed rule. cause. 29 CFR 1911.4. OSHA published 965 F.2d at 969 n.8. In fact, OSHA often grants extensions the Hearing Procedures in the Federal Furthermore, the occurrence of of comment periods near the end of the Register, mailed them to every hearing holidays during the pre-hearing original period. For example, in the participant, and placed them on its web- comment period did not substantially Butadiene rulemaking, OSHA granted page. The Assistant Secretary and the affect the ability of parties to review the an extension on the final day of the Chief Administrative Law Judge also record and comment on the proposed original pre-hearing comment period. 55 met with interested members of the rule. In fact, holidays accounted for only FR 42406 (Oct. 19, 1990). Similarly, in public to describe and answer questions five days of the pre-hearing comment the tuberculosis rulemaking, OSHA about the conduct of the hearing. period. Similarly, OSHA does not granted an extension a mere 12 days Representatives of the U.S. Chamber of believe that Year 2000 computer before the close of the original pre- Commerce, United Parcel Service, Inc., conversion issues substantially affected hearing comment period. 63 FR 5905 the National Coalition on Ergonomics, stakeholders’ ability to comment on the (Feb. 5, 1998). Indeed, often it is only and the AFL–CIO attended this meeting. proposed standard. Employers and other The Hearing Procedures described the toward the end of any filing period that parties always devote resources to nature of the informal public hearing, as a need to extend becomes clear. It different areas of their enterprises at well as the procedural rules governing would hardly be logical to permit different times of the year. For example, the hearing. Id. The Hearing Procedures when industry and labor are engaged in Agencies to respond to this need only if gave the locations and scheduled times collective bargaining negotiations, they did so several weeks before the for the different hearing sites; they also employers and labor unions (including close of the original comment period. permitted the presiding Administrative safety and health representatives) must B. There Was Adequate Opportunity for Law Judge to extend the hearing past the devote additional resources (including Participants To Prepare for and scheduled closing time for any time and money) to the negotiations. Participate in the Informal Public particular day ‘‘to assure orderly The time and resources devoted to these Hearing development of the record.’’ Id. negotiations certainly ‘‘conflict’’ with The Hearing Procedures emphasized other priorities of both parties. Yet both 1. The Hearing Procedures and the that the hearing was a legislative-type parties to the negotiations are able to Hearing Schedule hearing, not an adjudicative one. Id. continue to function during this period In the November 23, 1999 Federal Thus, neither the rules of evidence nor and to carry out their other Register notice, OSHA also scheduled other procedural rules governing

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As OSHA made changes to however, was designed to ‘‘facilitate the The schedule organized the public the hearing schedule, OSHA posted the development of a clear, accurate and witnesses into panels, and allotted each changes on its web page and often complete record, while assuring fairness witness an amount of time to testify announced them at the beginning or end and due process.’’ Id. ‘‘The intent is to based upon the time the witness had of a hearing day. See e.g., Tr. pp. 7161; provide an opportunity for effective oral requested. Id. The Hearing Procedures 7567; 13121; 13531. presentation by interested persons, and established the following format for The informal public hearing began on to avoid procedures which might questioning of the public witnesses: March 13, 2000 in Washington, DC and unduly impede or protract the each public witness on a panel would ended on May 15, 2000. OSHA’s rulemaking process * * * ’’ Id. at present testimony; after all of the Director of the Safety Standards 11947–48. witnesses on the panel presented, the Program Directorate (Director) made a The Procedures also described the panel as a group would answer short statement at the beginning of the conduct of the rulemaking hearing. questions from members of the public hearing. For the rest of the first two days First, a panel of OSHA representatives and OSHA. 65 FR 11948–49 (Mar. 7, of the hearing, a panel of representatives would be available to answer questions 2000). The Hearing Procedures, from OSHA and the Solicitor of Labor on the proposed standard for two full however, also gave the presiding (OSHA panel), headed by the Director, days, on March 13 and 14, 2000. Id. at Administrative Law Judge authority to answered questions on ergonomics 11948. The Hearing Procedures allocate the time for questioning of generally and on the proposed standard explained the process for handling the witnesses in a different manner, as he specifically. In total, the OSHA panel questioning of the OSHA panel, to deemed appropriate. Id. at 11949. This answered questions for approximately assure that the questioning time was provided a fair and orderly process for 16 hours. See Tr. pp. 1–5–819. distributed in a fair and equitable questioning the public witnesses while As established in the Hearing manner. Id. They also prescribed the allowing flexibility to accommodate Procedures, OSHA allowed each manner of questioning of OSHA’s expert participants’ desire for more or less member of the public who filed a Notice witnesses and a panel of witnesses from questioning of certain witnesses. See of Intent to Appear to question the the National Institute of Occupational e.g., Tr. pp. 9043; 9378–79; 13345. OSHA panel. In order to accommodate Safety and Health (NIOSH). Id. After OSHA published the initial the large number of individuals who The Hearing Procedures directed schedule, a substantial number of wished to question the OSHA panel, the public participants to use their oral participants requested that OSHA alter Hearing Procedures provided that the presentations to summarize and clarify the hearing schedule. OSHA questioning occur in ‘‘rounds.’’ In total, their written submissions rather than to accommodated these individuals to the there were four rounds of questioning of read those submissions into the record. extent possible. Some examples of the Id. The Procedures provided that the the OSHA panel; thus, questioners were accommodations made for various Administrative Law Judge should able to question at four different times hearing participants included: over the two days. The amount of time allocate time for questioning of public • witnesses as appropriate; however, the American College of Occupational allotted for questioners in each round and Environmental Medicine was the following: procedures required that the ‘‘testimony • and questioning of all witnesses —Rescheduled from 4/13/2000 to 5/11/ Round 1— Ten minutes per 2000. questioner. Tr. p. 1–27. scheduled for each day [be] completed • • that day.’’ Id. The Procedures further American Iron and Steel Institute— Round 2— 20 minutes per encouraged participants having similar Rescheduled from 4/07/2000 to 4/18/ questioner. Tr. p. 1–244. • interests to ‘‘designate one 2000. Round 3— 20 minutes per • representative [to] conduct the American Society of Safety questioner. Tr. p. 615. • questioning on their behalf.’’ Id. Engineers—Rescheduled from 5/09/ Round 4— 15 minutes per Finally, the Hearing Procedures 2000 to 4/21/2000. questioner. Tr. p. 771. established a 45 day post-hearing period • International Order of the Golden Thus, each member of the public had in which participants could submit Rule—Rescheduled from 4/07/2000 to up to one hour and five minutes to additional information and data to the 4/12/2000. question the OSHA panel. record, and a 90-day post-hearing period • Levi-Strauss—Rescheduled from 4/ After the first two days of the hearing, in which they could submit briefs and 18/2000 to 5/04/2000. 28 OSHA expert witnesses testified arguments on the proposed standard. Id. • National Automobile Dealers about various aspects of ergonomics, Along with the Hearing Procedures, Association—Rescheduled from 4/13/ MSDs, and other issues raised by the OSHA distributed a schedule for 2000 to 4/14/2000. proposed rule. Ex. 502–476. A panel of witness testimony at the informal public • Association for Suppliers of representatives from NIOSH also hearing. See Ex. 502–476. OSHA sent Printing, Publishing, and Converting testified about the causes and the initial schedule for the Washington, Technologies—Rescheduled from 3/31/ prevention of ergonomic injuries. Id. DC and Chicago, IL locations to hearing 2000 to 5/09/2000. The OSHA expert witnesses were participants on February 26, 2000 (with • Screenprinting and Graphic grouped into subject-matter panels. the Hearing Procedures), and posted it Imaging Association International— Generally, each expert provided on the OSHA web page. OSHA sent the Rescheduled from 3/22/2000 to 4/12/ affirmative testimony for about 15 schedule for the Portland, OR location 2000. minutes (45 minutes per panel), and the to the Portland participants on March 8, • UniSea Inc.—Rescheduled from 4/ panel answered questions for about two 2000, and also posted it on the OSHA 27/2000 to 5/02/2000. hours. In some instances, panels web page. The schedules listed the dates • Three UPS expert witnesses— answered questions for approximately and times for the testimony of the expert Rescheduled from 4/2000 to 5/10/2000. three hours. See e.g., Ex. 502–476,

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Testimony of Wednesday, March 15, allotted time among industry, labor, and Attachments to Ex. 30–1722. OSHA 2000; March 20, 2000; March 21, 2000. OSHA). therefore disagrees with those During the first two days of testimony OSHA scheduled appearance times commenters who stated that 11 days by OSHA’s experts, the questioning for all of the more than 400 parties who was insufficient to review the comments followed the same format as the filed Notices of Intent to Appear at the and testimony submitted, or to prepare questioning of the OSHA panel. After hearing. Id. More than 100 of these for questioning of all of the witnesses the first two days of testimony, parties, however, canceled their who were scheduled to appear over the however, the Administrative Law Judge scheduled testimony. Many of these nine weeks of hearings. See Exs. 500– altered the allocation of time so that parties did not notify OSHA of their 188, p. 6; 500–197, p. IV–5; 30–3956, p. employer representatives collectively, cancellations, or did so at the last 142. and labor representatives collectively, minute, so that OSHA was often not The conduct of the hearing was also were each given approximately 40% of able to adjust the schedule to allow consistent with the OSH Act and the time to ask questions, and OSHA more time for other witnesses. See e.g., OSHA’s procedural regulations. was assigned approximately the Tr. pp. 3138; 9379; 12036–12041. Although this legislative type hearing is remaining 20%. Questioners who did informal, OSHA’s procedural 2. Adequacy of the Procedures not represent either employers or labor regulations provide for more than the were allotted proportional amounts of A number of participants complained bare essentials of informal rulemaking time from industry and labor’s time. Tr. that the 11 days between the end of the and include: (1) An ALJ to preside at the pp. 1774–75; 1780–1790. comment period and the beginning of hearing; (2) ‘‘an opportunity for cross- OSHA’s expert witnesses testified the hearing was too short to allow them examination on crucial issues,’’ and (3) from Wednesday, March 15, 2000, to participate meaningfully in the a verbatim transcript of the hearing. 29 through Tuesday morning, March 21, rulemaking. See Exs. 500–188, p. 6; CFR 1911.15(b) (emphasis added). 2000. See Ex. 502–476. In order to 500–197, p. IV–5; 30–3956, p. 142. Indeed, OSHA rulemakings differ from maximize the public’s time to question OSHA disagrees. There is no statutory the rulemakings of other federal these experts, OSHA encouraged the requirement that OSHA allow any agencies in that members of the public witnesses to shorten their affirmative particular amount of time between the can question OSHA’s expert witnesses presentations, and ceded some of its close of the comment period and the and each other. The procedural own time for questioning to industry public hearing. OSHA’s own procedural regulations also permit the Assistant and labor. See Tr. pp. 1791; 1816; 2087; regulations, however, require a 10 day Secretary for OSHA, upon reasonable 2496; 2287–88. period between the close of the pre- notice, to ‘‘prescribe additional or A panel of NIOSH experts also hearing comment period and the alternative procedural requirements: testified during the first week of the hearing. 29 CFR 1911.11(b)(4). The 11- • In order to expedite the conduct of hearing, on Friday, March 17, 2000. See day period OSHA provided in this the proceeding; Ex. 502–476. NIOSH was scheduled to rulemaking was consistent with those • In order to provide greater appear for 41⁄2 hours, and the public regulations. protection to interested persons questioners, including both labor and During this period, OSHA made whenever it is found necessary or industry representatives, had been unprecedented efforts to assist appropriate to do so; or allocated 31⁄2 hours for questioning. See participants in preparing for the • For any other good cause which Ex. 502–476. However, the questioners hearing. OSHA extended its Docket may be consistent with the applicable used only 2 hours and forty-five Office hours and established a separate laws.’’ minutes of this time. See Tr. p. 2125. ergonomics reading room. See Ex. DC– See 29 CFR 1911.4. Public witnesses testified during the 423. It also made Docket Office staff Here, as it frequently does, OSHA remainder of the nine weeks of the available to help individuals locate scheduled the informal public hearing informal public hearing. After a panel of materials quickly and efficiently. when it published the proposed rule on public witnesses presented testimony, Interested parties were able to review November 23, 1999. The informal public the witnesses were available for the materials submitted to the hearing complied with OSHA’s questioning by members of the public rulemaking record as soon as they were procedural regulations: (1) An and OSHA. See Ex. 502–476. The received by OSHA. Administrative Law Judge presided over Administrative Law Judge presiding After the schedule for the it; (2) interested parties were given an over the hearing on any particular day Washington, DC and Chicago, IL hearing opportunity to cross-examine witnesses exercised discretion in terms of how the locations was issued on February 26, on crucial issues; (3) OSHA provided testimony and questioning of the public hearing participants could use it to transcripts of the proceedings; and (4) witnesses would proceed. On a few utilize their own preparation period OSHA designed procedures that occasions the presiding Administrative most effectively. And hearing effectuated the stated intent of OSHA Law Judge admitted into the rulemaking participants had no need to read each informal hearings, i.e., ‘‘to provide an record evidence and testimony that others’ comments to prepare for their opportunity for effective oral were not submitted in accordance with own questioning of the OSHA panel. presentation by interested persons the hearing procedures. See Tr. pp. Parties had more than 100 days to which can be carried out with 1095–97; 7168–73. Such allowances by prepare for this process. In addition, expedition. * * *’’ 29 CFR the Presiding Officer were appropriate many hearing participants were already 1911.15(a)(3). under the hearing procedures in order to familiar with the NIOSH and OSHA Due to the large number of ensure a clear, complete, and accurate expert witnesses and with the substance individuals who filed Notices of Intent rulemaking record. With respect to the of their testimony. One of the to Appear, the Assistant Secretary also allocation of time for questioning of the participants who complained repeatedly had ‘‘good cause’’ to issue special public witnesses, in the vast majority of that there was inadequate time to hearing procedures to ensure that the instances the questioning proceeded in prepare for the public hearing had, in hearing proceeded in a fair and orderly a similar format to that established fact, cross-examined some of the expert manner. The Assistant Secretary issued during the questioning of OSHA’s witnesses on similar issues in earlier the Hearing Procedures on February 25, expert witnesses (i.e., dividing the OSHA enforcement litigation. See 2000, giving hearing participants

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00573 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68834 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations reasonable notice. OSHA mailed the hearing procedures used in past OSHA deviated from its past practice and set Hearing Procedures the very next day to rulemakings. aside two full days for the panel to all individuals who had filed Notices of For these reasons, OSHA does not answer questions on the proposal. See Intent to Appear, published them in the agree with those commenters who stated Ex. 502–476. Federal Register, and posted them on that the informal public hearing was not Furthermore, in order to ensure that the OSHA web page. In addition, the adequate to provide interested parties the questioning was evenly distributed Assistant Secretary and the Chief an opportunity to present additional among the participants, OSHA set up a Administrative Law Judge held a evidence, and to cross-examine public format for the questioning. OSHA meeting with interested parties on witnesses and OSHA on crucial issues. established several ‘‘rounds’’ of March 7, 2000, in order to discuss the See Exs. 500–188, pp. 6–10; 500–197, questioning. Although there were a large procedures and answer any questions pp. IV–11–14. On the contrary, OSHA number of individuals who wished to from the participants. believes that the process struck an question OSHA during the first two The conduct of the informal hearing appropriate balance: it gave interested rounds, only a few had remaining was also consistent with that of other parties the opportunity to present questions in rounds three and four. In OSHA rulemakings. For example, in the testimony, to question OSHA, and to fact, by the final round of questioning Tuberculosis rulemaking, the Pre- question other members of the public, only three questioners (representing hearing Guidelines signed by the while ensuring that the proceedings Boral Bricks, NCE, and the Chamber) Administrative Law Judge laid out the would proceed in an orderly manner. asked questions of OSHA. Tr. pp. 771– following similar parameters: Specific objections included the 819. Those parties who utilized their • The purpose of the hearing was for complaints of some participants that full time in every round had over one information gathering and clarification; they did not have enough time to hour total to question OSHA. OSHA the hearing was not an adjudicative one question the OSHA panel and that believes that this schedule provided but rather an informal administrative OSHA did not disclose who would be adequate time for interested parties to proceeding. representing it on the panel until the question the Agency, while not unduly • Each hearing day would end when day the informal public hearing began. protracting the rulemaking process. See e.g., Tr. pp. 1–42–43. A few of these Finally, OSHA did not prejudice any the scheduled testimony and questions commenters, United Parcel Service, Inc., member of the public by waiting until for the day had been completed. the National Coalition on Ergonomics, the day of the hearing to disclose the • Because written submissions were and the U.S. Chamber of Commerce, members of the OSHA panel. The made a part of the rulemaking record, requested that the OSHA panel return purpose of the first two days of the public witnesses ‘‘should’’ use their oral for additional questioning at the end of informal public hearing was to allow testimony to summarize and clarify the informal public hearing. Ex. DC– interested parties an opportunity to their written submissions. • 424. Before the Assistant Secretary question OSHA about its proposed rule; Questioning of public witnesses could respond to that request, however, the purpose was not to provide an should be limited to 15 minutes, but the it was modified (and presumably opportunity to question individuals presiding Administrative Law Judge withdrawn) on April 11, 2000. Id.; see about their views of the proposed rule. could alter the schedule as appropriate also Tr. pp. 17956–58. The panel members were made to allow more time for questioning of a In any event, OSHA believes that the available to answer questions about the particular witness. hearing participants had more than an • proposed rule on behalf of OSHA. They If the hearing were to fall adequate opportunity to question the did not appear to express personal significantly behind schedule, the OSHA panel on the proposed rule. The opinions about ergonomics or the presiding Administrative Law Judge OSHA panel answered questions for proposed standard. Thus, there is no could further restrict the questioning or approximately 16 hours; those validity to the implication that order further consolidation of the participants who questioned the panel questioners should have had additional questioning. for each round had over one hour to time to prepare for the kind of • Participants having similar interests question the panel. credibility-based cross examination that should, if possible, designate one Like other administrative agencies, would be appropriate in adversarial representative to conduct the OSHA explains its reasons for issuing a litigation. See e.g., Tr. pp. 539–41. questioning on their behalf. proposed rule in the preamble to the Some participants also objected • If an organization were represented proposal and other supporting during the hearing that there was not by more than one questioner, only one documentation. OSHA is not required enough time to question the person should question a witness on a by any law or regulation to explain its government’s expert witnesses. Tr. pp. particular topic area. rationale further at the informal public 936–941; 1438–1444. The Chamber, for • Questions should be brief and hearing. OSHA, however, generally example, complained that OSHA only should be designed to clarify a spends some time at the beginning of gave ‘‘industry as a whole under two presentation or elicit information within rulemaking hearings answering a few hours of cross-examination’’ to question the competence or expertise of the questions from participants. In the past, the NIOSH panel. Ex. 500–188, p. 7 witness. OSHA usually made a panel available (emphasis in original). • A tentative 120 day post-hearing for a few hours at the beginning of the Once again, OSHA believes that the comment period was established. hearing. For example, in both the amount of time allotted for questioning Docket H–371, Ex. 24; See also Pre- Tuberculosis and Access to Employee its expert witnesses was reasonable and hearing Guidelines for Hearing on Exposure to Medical Records hearings, provided interested parties adequate Employer Payment for Personal the OSHA panel answered questions for time to ask questions, clarify Protective Equipment, Docket S–042, a couple of hours at the beginning of the presentations, and elicit new Ex. 17 (including same); Mintz, OSHA: hearings. See Docket H–022B, Ex. 171A; information, while not unduly History, Law, and Policy 66–7 (BNA Docket H–371, Ex. 25A. Recognizing protracting the rulemaking process. 1984). As is clear from the above, OSHA that there were a number of parties who Each panel was available for did not deviate meaningfully in the wished to question the Agency more questioning for over two hours (and on ergonomics rulemaking hearing from the extensively in this case, however, OSHA many occasions for over three hours).

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See Ex. 502–476. This amount of time e.g., Tr. pp. 16851–52. First, as OSHA ability to ‘‘cross-examine’’ certain was longer than that provided for stated in its Hearing Procedures, public witnesses was improperly curtailed questioning of most other members of witnesses were asked to summarize misunderstood the nature and purpose the public, and OSHA believes it was their written submissions. See 65 FR of OSHA’s informal rulemaking sufficient to allow members of the 11948–49 (Mar. 7, 2000). Because hearings. public to question the experts on written submissions were already part It is clear that the public witnesses ‘‘crucial issues.’’ of the rulemaking record and available had adequate time to question each OSHA also encouraged its expert for all to review beforehand, there was other. The schedule typically allowed a witnesses to provide only brief oral no reason for participants also to read panel of witnesses to be questioned for presentations. Some of them gave only those submissions into the record. one hour. In other words, for every hour short opening statements. See e.g., Tr. Second, OSHA established the of testimony, OSHA allowed an hour of pp. 2361–65, 2366–69, 2369–72; see amount of time for public testimony questioning. Consistent with its also Tr. pp. 1816 (Industry questioner based on the amount of time witnesses decision to allow much more time for thanking panel of OSHA expert requested in their Notices of Intent to questioning of the government expert witnesses for abbreviating testimony). Appear. Witnesses who requested only witnesses, OSHA also allowed for On other occasions, OSHA ceded the 10 minutes to testify were typically greater questioning of public witnesses Agency’s time to the public for scheduled for the entire amount of time who were particularly well-known in questioning. See e.g., Tr. pp. 2087; 2496; they requested in their Notice. If the field of ergonomics. 2287–88. Contrary to the arguments of individuals requested 15 minutes, • Dr. Don Chaffin, a Professor of Industrial UPS and NCE that the procedures were OSHA typically scheduled them for 10 Engineering at the University of Michigan, somehow designed to ‘‘minimize time minutes of affirmative testimony. If they former Director of its Center for Ergonomic available for industry questioning,’’ Ex. requested 20 minutes, OSHA typically Studies, and author of numerous articles on 500–197. p. IV–13, OSHA’s efforts in scheduled them for 15 minutes. For ergonomics (See Ex. 500–5), appeared on a fact increased the amount of time for witnesses who requested longer periods panel by himself and had only a short public questioning of the expert of time, OSHA scheduled time for affirmative presentation; OSHA ceded its witnesses. affirmative testimony based upon the own questioning time to allow for more questions from the public. Tr. p. 8264. Third, the Administrative Law Judge number of topics to be addressed by a • Dr. Gary Franklin, a physician who treats changed the questioning format after the hearing participant. Thus, UPS filed patients with MSDs and has written second day of testimony by the Notices of Intent to Appear for over 20 extensively on ergonomics and MSDs, government experts in order to allow individuals and requested varying appeared on a panel by himself and only questioning to proceed more efficiently. amounts of time to cover a wide range gave a short affirmative presentation; the To ensure an even distribution of of subject areas. Ex. 32–241–1. OSHA amount of time available for questioning by industry representative was significantly questioning, the Administrative Law allotted these witnesses 21⁄2 days (22 Judge divided the time available for hours and forty-five minutes), a increased by the presiding Administrative Law Judge. See Tr. pp. 13340–13415. questioning among the three broad significant amount of time by any • Dr. Barbara Silverstein, Director of the categories of questioners—labor, measure, to present their testimony and Safety and Health Assessment and Research industry, and OSHA. The Hearing respond to questions. Ex. 502–476. Program in Washington State and author of Procedures issued by the Assistant OSHA believes that the amount of time numerous articles on ergonomics and MSDs, Secretary gave the Administrative Law given the public witnesses to testify met appeared on a panel with one other Judge this authority; in fact, the the goal of allowing interested parties to individual and had only a short affirmative Procedures envisioned the exercise of summarize their main points, while not presentation; members of the public had one this authority in just such a situation. ‘‘unduly protracting’’ the rulemaking hour to question the two witnesses. See Ex. 502–476. See 65 FR 11948 (Mar. 7, 2000). OSHA process. believes that this revision in format Nonetheless, some participants Second, OSHA repeatedly ceded to allowed all interested participants an objected throughout the hearing that the public its own questioning time to even greater opportunity to question there was not enough time to question allow for more questioning by public OSHA’s expert witnesses. public witnesses. See Tr. pp. 8265; participants. See e.g., Tr. pp. 8264; Finally, OSHA finds completely 3500; 6062. NCE et al., for example, 10546; 17602–03. The Administrative unfounded the allegation made stated that OSHA improperly Law Judges also often adjusted the repeatedly by some commenters ‘‘suspended the rules that allow for schedule to allow more time for (including the Chamber) that there was [cross-examination]’’ and asked leading questioning of witnesses when insufficient time to question the NIOSH questions of certain witnesses in a interested members of the public had panel. See e.g., Ex. 500–188, p. 7. OSHA manner that did not develop the remaining questions. See e.g., Tr. pp. allotted an entire afternoon, 31⁄2 hours, rulemaking record. Ex. 500–197, p. IV– 8263–66; 13345; 13366; 13380; 13415. for questioning of the NIOSH panel. (In 11, 15–16. The time available for questioning total, OSHA scheduled NIOSH for a 41⁄2 OSHA did not suspend any rules could have been substantially increased hour block of time to present its allowing for cross-examination. In fact, had more scheduled witnesses notified testimony and respond to questions.) In as described in detail above, the hearing OSHA in advance of their intent not to fact, the hearing was recessed early on procedures expressly provided for cross- appear. As stated above, over 100 that day because there were no examination. The hearing was not a witnesses canceled their appearances questions left for the NIOSH panel to trial, however, and no OSHA procedural (amounting to approximately one week answer. See Tr. p. 2125. The time regulation gives the public unlimited of scheduled hearing time), often with allotted for questioning of the NIOSH time to question witnesses. The public’s no advance notice. This included many panel was more than adequate; if desire to question witnesses must be of the same parties who objected most anything, OSHA scheduled too much balanced against the primary function of vigorously to the length of the time for the questioning of this panel. the hearing: to assist OSHA in gathering questioning time and would have been OSHA also believes that all interested evidence that will help the Agency expected to be most anxious to assist parties had an adequate opportunity to determine whether and how to regulate. OSHA in increasing that time. See e.g., present their affirmative testimony. See Those parties who complained that their Tr. pp. 3138; 12036–12041. For

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Tr. p. would be a large amount of material approximately two days during the 936. Second, on May 3, 2000, OSHA submitted to the docket during this hearing where no testimony or placed on its web page unofficial copies rulemaking, the Agency implemented questioning occurred. See Ex. 502–476. of the hearing transcripts. Third, on May special procedures to ensure timely and Similarly: 30, 2000, OSHA made the official convenient access to the docket. For • Keller & Heckman LLP requested 40 transcripts available on its web-page. example, OSHA made the proposed rule minutes to testify and canceled its OSHA placed paper copies of the and preamble, the Preliminary appearance. See Exs. 32–215; 32–215–1. official transcripts in the Docket Office Economic Analysis, and the full Health • Fed Ex Corporation and its a few days later. Effects sections available on its web subsidiaries requested 100 minutes to There is no statutory, regulatory, or page and on CD–ROM. In fact, OSHA testify and canceled their appearances. other authority requiring that OSHA go mailed a CD–ROM containing this See Exs. 32–203; 32–205; 32–208; 32– to such lengths to provide copies of the information free of charge to all parties 209; 32–208–2. transcripts to the public. OSHA’s who participated in the stakeholder • NCE’s economic task force procedural regulations state only that meetings OSHA held before issuance of requested 130 minutes to testify and transcripts ‘‘shall be available to any the proposed rule and to any other canceled its appearance. See Ex. 32– interested person upon such terms as interested party upon request. 375; Tr. pp. 12036–41. the presiding officer may provide.’’ See OSHA also extended its Docket Office 29 CFR 1911.15(b)(3). OSHA’s efforts to hours by 3 hours a day, and designated • The Rubber Manufacturers make the transcripts available certainly an area in the Docket Office as an Association requested 45 minutes to exceeded what is required by its ‘‘ergonomics reading room,’’ where testify and canceled its appearance. See procedural regulations and was more parties could review docket submissions Ex. 32–242; Tr. p. 3138. than adequate to allow parties to review as soon as they were received by the All of these entities, or representatives transcripts of the proceedings promptly Agency. Ex. DC–423. In addition, OSHA of these entities, objected to the amount and in a meaningful way. moved people from other positions in of time allotted for cross-examination of the Agency to process public comments witnesses. See Ex. 500–197 section IV; C. Availability of Record Material in the and scan the material into the computer Tr. p. 2303. Docket database as quickly as possible. These NCE et al.contended that OSHA When it issued the proposal, OSHA steps, which exceeded any legal further reduced the time for the public placed in the rulemaking docket a large obligations and went far beyond questioning of witnesses by using its amount of material and evidence. OSHA’s own past practice, were more own questioning time ineffectively. Ex. Throughout the rulemaking, OSHA than adequate to ensure interested 500–197, IV–14–15. But many received additional evidence, both from parties a meaningful opportunity to participants in the hearing complained rulemaking participants and through its comment on the proposed rule. that others asked irrelevant questions, own efforts. This entire body of Although an administrative agency wasted time, and otherwise failed to evidence forms the basis for the engaged in rulemaking must make develop the record efficiently. The issuance of this final standard, and ‘‘critical factual material * * * used to AFL–CIO pointed to an exchange in OSHA took unprecedented steps to support the agency’s position’’ available which a UPS lawyer spent several ensure that all of it was available for to the public for review in a rulemaking transcript pages attempting, public inspection. proceeding, Air Transport Ass’n. v. unsuccessfully, to elicit a particular The OSHA Docket Office (Docket FAA, 169 F.3d 1, 7 (D.C. Cir. 1999), response from an AFL–CIO witness. Ex. Office) provides a number of ways to agencies generally are not required to 500–218, pp. 168–170. But this merely review and access materials submitted. make the material ‘‘available’’ in any highlights that one participant in a First and foremost, the Docket Office particular format, so long as the public rulemaking may believe that certain maintains hard copies of all documents has an opportunity to review the questions are of relevance, while submitted to the rulemaking record and material during the rulemaking. another participant may think precisely places them on a central shelf in the There can be no question that OSHA the opposite. OSHA designed the Docket Office reading room. Any made the material ‘‘available’’ here informal public hearing to give both interested party can view and copy within the meaning of this requirement. itself and the hearing participants the these documents, consistent with With only a few exceptions, OSHA opportunity to question members of the applicable copyright laws. Docket Office placed all documents cited in the public in a manner each believed would staff are always available to help preamble to the Proposal in the Docket best develop the rulemaking record. interested parties find and obtain Office by November 23, 1999—the date OSHA believes that it did this rulemaking materials. Until recently, the proposal was published. OSHA also effectively throughout the informal this method was the only way to access scanned the documents into a computer hearing. an OSHA rulemaking docket. database to allow interested parties to The same participants also Recently, however, OSHA has been view, search, and print copies of the complained that ‘‘OSHA withheld the exploring methods of using technology documents more efficiently. Docket hearing transcript from the rulemaking’s to make access to its dockets even more Office staff were available to help participants’’ and that the ‘‘transcripts convenient. For example, OSHA began interested parties in searching the were not provided until the hearings a process of scanning all materials into computer database and locating were ended.’’ Ex. 500–197, p. IV–17; see an electronic database. This permits particular documents. See Ex. 30–3956, also Ex. 500–109. However, OSHA did interested parties to view documents in p. 133 (‘‘[T]he Docket Office staff were not withhold the transcripts from the the database, search for documents extraordinarily helpful in attempting to

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But OSHA did not design docket was available to OSHA staff OSHA used this information to estimate the the database to serve as the primary through its intranet. economic impact of the proposed rule on mechanism for reviewing the • The copying fee of 15 cents a page various industries, as well as small rulemaking record; it is an additional was excessive. businesses. When OSHA recognized that convenience for the public. • OSHA relied on a NIOSH review of these data had inadvertently not been placed In fact the computer database for 2000 studies in supporting the proposed in the docket, it immediately placed in the viewing, searching, and printing the rule; ‘‘the 2000 studies were not’’ in the docket a hard copy of the web page where record is relatively new technology in docket. interested parties could access the material • One economic document appeared (on December 23, 1999). On February 1, the context of OSHA’s rulemakings. 2000, OSHA placed hard copies of the data Similarly, OSHA has not previously to be named differently in the (127 pages) in the docket. See Ex. 28–6–1. made documents available on CD–ROM Preliminary Economic Analysis than in • RMA data—These data provide net and the web page. Extending the hours the preamble. return on sales information by industry SIC • the Docket Office was open to allow the The Docket Index was incomplete code and are available in many public public greater access to the rulemaking at certain times during the pre-hearing libraries. OSHA used this information to record was also not commonplace in comment period. estimate the economic impact of the • Only the cover pages of some proposed rule on various industries. Due to earlier rulemakings; the Agency also copyright concerns, OSHA originally did not does not typically dedicate a special documents were in the docket, as compared to the entire document. place this information in the docket. OSHA area of the Docket Office to serve as a later obtained permission to include these reading room. Thus, in numerous earlier Ex. 30–3956, pp. 134–37. data in the docket; once it obtained this rulemakings, interested parties reviewed Many of these allegations are not permission, OSHA placed the information in and copied (as necessary) the paper accurate, and those that are represent the docket (on February 18, 2000). See Ex. copies of documents submitted to the the minor and harmless complications 28–10. • record of a particular rulemaking. The of managing any large record. It is not IRS data—These data also provide net true that ‘‘numerous’’ documents, return on sales information by industry and extraordinary efforts made in this case are available on the IRS web page. OSHA not only exceeded any applicable legal including the Preliminary Economic Analysis, were not available for public only used these data for a handful of industry requirements, they were an appropriate sectors for which the RMA data were not response to the comments of some inspection by November 23, 1999. The available. When OSHA recognized that these parties that the number of issues Preliminary Economic Analysis was data had inadvertently not been placed in the involved in the rulemaking required stamped as received in the Docket docket, it immediately placed the material in additional accommodations. See e.g., Office at 9:55 a.m. on November 23, the docket (on January 31, 2000). See Ex. 28– Ex. 500–223, p. 94. 1999. As such, it was available for 9. For these reasons, OSHA does not inspection and copying at that time. To OSHA also did not rely upon data that agree with those commenters who the extent interested parties had it did not place in the rulemaking contended that underlying record difficulty locating or obtaining the record. The commenters who raised this material was not available to interested Preliminary Economic Analysis, Docket issue did not identify precisely what parties for their review. NCE, for Office staff were available to assist data they were referring to, see Exs. 30– example, alleged that ‘‘numerous them. 3716, p.5; 30–3736, p. 10, but it may documents were missing or unavailable OSHA also disputes the allegation have been the same material that was because they had been sent out for that Exhibits 28–3, 28–4, and 28–5 were requested in a number of Freedom of photocopying, including the 1100 page missing on November 23, 1999. In fact, Information Act (FOIA) requests filed by Preliminary Economic and Regulatory the record indicates that Exhibits 28–3 some hearing participants. See e.g., Ex. Flexibility analysis and approximately and 28–4 were entered into the 503. Some of these requests were for 500 pages of associated materials offered computer database on November 23, information that was in the rulemaking in support of the Agency’s 1999 and thus were certainly available docket, and others were for information conclusions,’’ Ex. 30–3956, p. 133, and for viewing at that time. Exhibit 28–5 is that was not part of the rulemaking that Exhibits 28–3, 28–4, 28–5, and 28– a number without an exhibit; there is no record, because OSHA had not relied on 6 were not available for review on such document and ‘‘Exhibit 28–5’’ was it in the proposed rule. November 23, 1999. Ex. 30–3956, not cited or relied upon by OSHA in the OSHA responded to the requests for Appendix IV. NCE also made a number preamble to the proposed rule, or in the information in a timely manner. See Ex. of other attacks on the integrity of the Preliminary Economic Analysis. 500–23–1, p. 8. To the extent the OSHA does not know which other record and on OSHA’s provision of information was available, OSHA documents NCE and other commenters, access to it: provided it to the requesters, and, as • OSHA generally relied upon see 30–3815, p. 4; 30–3956, pp. 133, appropriate, placed the FOIA requests additional underlying data that it did 135; 30–3819, p. 3, claim were and responses in the docket. See Ex. not make available to the public. ‘‘unavailable.’’ After the proposed rule 503. OSHA is not, however, aware of • There was only one high speed was published, however, OSHA any information it relied upon that it printer for use in the OSHA docket discovered that a few documents cited did not place in the docket. To be sure, office, and that printer takes in the proposed rule had been OSHA receives data and information approximately two hours to print 800 inadvertently omitted from the material from a number of different sources pages. placed in the docket by November 23, when preparing a proposed rule. But all • The Docket Office only stays open 1999. These documents included the data that were relevant to the for 6 hours a day. following: promulgation of the proposed rule and • The computer systems and printers • Firm Size Data Provided by the Bureau were relied upon by OSHA in the were not operating perfectly—there of the Census (Exhibit 28–6)—These data rulemaking were placed in the record.

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The allegation that ‘‘2000 studies’’ material in the docket. As stated earlier, impede participants’ ability to view the relied upon by NIOSH in its literature OSHA is required to make critical material in the rulemaking. review were not in the docket on material available for public inspection The fact that the Docket Office was November 23, 1999 is also factually during the rulemaking proceeding. open for 6 hours a day during the inaccurate and of questionable OSHA is generally not required to make prehearing comment period also did not relevance. NIOSH did not rely on 2000 such material available in any particular deny any party an adequate opportunity studies in its literature review. As form or manner. In this case, OSHA to review the record. Particularly with described more fully in Section V above, made the relevant material available in the technological assistance described NIOSH originally examined 2000 hard copy format for review and above, OSHA believes that interested studies in preparing its literature review copying (as appropriate) in the Docket parties could adequately review the but chose to use only about one-third of Office reading room. OSHA is aware of record and comment on the proposed them, based on certain methodological no commenter who has suggested that rule in the time allotted. And as also criteria NIOSH established for the study. any of the material in the docket was discussed above, the quality and Ultimately, NIOSH included about 600 not available in hard copy form or that comprehensiveness of the pre-hearing studies in its literature review. Many of any of the copying machines were not submissions, including NCE’s own 156 these studies were in the rulemaking functioning during the comment period. page submission, belie any suggestion docket. For example, a quick check by Indeed, one commenter expressly noted that the parties were impeded in their OSHA located the following studies in that there were ‘‘no particular ability to comment. Even so, when the the rulemaking record: difficulties’’ in requesting, reviewing, hearing began OSHA extended the • Aaras A. [1994]. Relationship and copying documents in the Docket Office hours to allow the public between trapezius load and the rulemaking record. Ex. 500–218, p. 165. even more time to review the comments incidence of musculoskeletal illness in And as explained, OSHA never and evidence received into the the neck and shoulder. Int. J. Ind. intended its computer database to serve rulemaking record. Docket Office hours Ergonomics 14(4):341–348. Ex. 26–892. were extended on March 13, 2000; the • as the sole method for interested parties Armstrong T. et al. [1987a]. to use to review the record. OSHA Docket Office continued these extended Ergonomic considerations in hand and intended the database to be an hours until September 1, 2000, well wrist tendinitis. J. Hand. Sur. additional tool to facilitate this review, after the rulemaking record closed. 12A(5):830–837. Ex. 26–48. Certainly, the $0.15 a page fee the for those participants who prefer • Bigos S. et al. [1986b]. Back injuries Docket Office charges for copying and electronic access. OSHA does not in industry: a retrospective study. III. printing did not deny interested parties believe that the occasional technical Employee-related factors. Spine 11:252– an opportunity to review the record. failure of this additional tool deprived 256. Ex. 26–871. OSHA is authorized to charge this any party of an opportunity to review • Dehlin O. [1977]. Back symptoms nominal fee in order to recoup some of relevant material. and psychological perception of work: a the costs of paper and toner, etc. See 29 study among nursing aides in a geriatric Similarly, interested parties were not CFR 70.40(d)(2). But OSHA does not hospital. Scand. J. Rehabil. Med. 9:61– denied meaningful review because charge any fee for interested parties to 65. Ex. 26–820. OSHA did not produce the entire docket enter the Docket Office and review Even though a few of the studies electronically or on a zip file. First, as documents submitted to the record, so examined by NIOSH may not have been described above, OSHA provided a the fee did not prevent any interested in the docket, however, the public number of documents to interested party from viewing any document. would not have been deprived of an parties on its web page and on CD– The fact that one particular economic adequate opportunity to review the ROM, including the full Health Effects document was improperly named in the information OSHA relied upon in the section as well as the entire Preliminary Preliminary Economic Analysis also did proposed rule, because OSHA relied Economic Analysis. Second, OSHA not deprive parties of an adequate upon the NIOSH literature review in made the information in the docket review of the record. Certainly, OSHA discussing the epidemiological evidence available electronically on its computer took pains to ensure that all documents supporting the proposed standard. The database. Providing the entire docket on were accurately cited in the preamble to NIOSH literature review was in the a zip file would have been the proposed rule, as well as in the docket and available for review by administratively difficult, expensive, computer database. It is precisely November 23, 1999. Ex. 26–1. OSHA’s and time consuming, particularly since because human error may occur from use of, and reliance upon, its research the docket was constantly growing, with time to time, however, that Docket arm in this manner was expressly new submissions being received by Office staff are available to answer contemplated by Congress when it Docket Office staff daily. questions from interested parties, as created NIOSH in the OSH Act. See 29 Third, providing the record in such a well as to make inquiries of OSHA if U.S.C. § 671. Furthermore, OSHA is not way would raise copyright issues for parties are having difficulty locating obligated to place in the docket every some of the material in the record. certain documents. The specific underlying study used by any researcher Finally, and as mentioned previously, document referred to by NCE, Exhibit in reviewing the scientific literature OSHA is not required to provide the 28–7—Tabulations from OSHA’s 1993 about any particular subject. Cf. Cable & material in the record as an electronic Ergonomics Survey, was inadvertently Wireless P.L.C. v. FCC, 166 F.3d 1224, or zip file. OSHA is, of course, titled Description of Cost Estimates of 1234 (D.C. Cir. 1999) (FCC did not continually investigating new ways to Ergonomic Controls Under Draft OSHA unreasonably rely upon published study provide interested members of the Ergonomics Standard in both the even though underlying data for the public with access to the rulemaking Preliminary Economic Analysis and the study was not available to the FCC or record. However, there is surely no due Summary of the Preliminary Economic the public). process requirement that OSHA provide Analysis (Summary) in the Preamble. It is also not true that printer failures access to the document in any particular OSHA corrected the error in the and other computer problems prevented form, and OSHA’s decision not to Summary in a corrections notice interested parties from reviewing and provide an additional form of electronic published December 30, 1999. See 64 commenting meaningfully on any access did not violate due process or FR 73448–58 (Dec. 30, 1999). OSHA,

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Twenty-eight consultants in their rulemaking review and comment upon the material experts prepared pre-hearing comments, activities. See e.g., BASF Wyandotte in the Exhibit. testified during the informal public Corp. v. Costle, 598 F.2d 637, 640–41 (1st Cir. 1979) (EPA retained outside OSHA also believes that the Docket hearing, answered questions at the consultants to analyze pesticide Index was never ‘‘incomplete.’’ By its hearing, and submitted post-hearing industry in preparation of regulation); very nature, the Docket Index is an comments and data. These experts cf. National Small Shipments Traffic unfinished and ever-growing document. testified on a wide range of issues including the work-relatedness of Conf., Inc. v. I.C.C., 725 F.2d 1442, 1449 Interested parties are continually (D.C. Cir. 1984) (ICC retained consultant sending documents to OSHA to place in MSDs, the diagnosis of MSDs, the implementation of engineering controls to evaluate various methodological the record. When the Docket Office criticisms of rulemaking record). As receives a document, it is processed and in workplaces, and the costs of ergonomic programs. See Testimony in explained in A Guide to Federal Agency placed into the record. Part of the Rulemaking published by the ABA: processing involves entering the Ex. 37. OSHA’s use of expert witnesses document into the computer database in this way is expressly authorized by Agencies sometimes use the services of the OSH Act, is consistent with past outside consultants in developing rules or and generating the Docket Index. Thus, supporting analyses, particularly in the Docket Index is constantly growing practice, and is consistent with the practice of other administrative rulemakings involving questions of science as new information is submitted to the or technology as to which the agency needs record. This does not mean, however, agencies. added expertise. The tasks consultants are Section 7(c)(2) of the OSH Act states: that the Docket Index is ‘‘incomplete’’ at asked to perform vary, but they include ‘‘In carrying out his responsibilities any particular time. testifying as witnesses, conducting research, under this Act, the Secretary [of Labor] summarizing and evaluating data in the Docket Office staff processed is authorized to * * * (2) employ record, and helping draft portions of the final rulemaking documents as soon as experts and consultants or organizations rule and its rationale. Lubbers, A Guide to possible upon receipt. Indeed, OSHA thereof as authorized by Section 3109 of Federal Agency Rulemaking 243 (ABA 1998). moved people from other positions Title 5.’’ 29 U.S.C. § 656(2). The OSH Clearly, therefore, those commenters within the agency to expedite this Act does not limit the purposes for who claimed that it was improper, per process. OSHA does not believe that its which OSHA may obtain expert se, for OSHA to contract with expert processing of documents into the record assistance, and assuring that it has witnesses to participate in the and onto a Docket Index deprived any appropriate expertise during rulemaking rulemaking process were wrong. See interested party an adequate proceedings falls squarely within this e.g., Exs. 500–43, pp. 1–2; 500–201, p. opportunity to review the record or to authorization. In United Steelworkers of 2. OSHA has also considered the more comment meaningfully on the proposed America v. Marshall (Lead), 647 F.2d specific objections that: (1) OSHA did standard. 1189 (D.C. Cir. 1980), the U.S. Court of not disclose to the public that it had Finally, in a few cases, due to Appeals for the District of Columbia contracted with the expert witnesses to copyright concerns, OSHA placed only Circuit upheld OSHA’s authority under participate in the rulemaking the cover pages and tables of contents of the OSH Act to employ experts to proceedings; (2) the expert witnesses published documents into the docket. prepare written comments, submit had a financial interest in the These documents were generally relevant data, and present testimony rulemaking and therefore their available to interested parties upon during rulemaking proceedings. The testimony was tainted; (3) OSHA request; they were also often publicly court stated: ‘‘The OSH[] Act empowers coached the witnesses; (4) the expert available. See e.g., Tr. p. 2640 (Hearing the agency to employ expert consultants witnesses provided additional detailed participant complaining that only cover * * * and OSHA might have possessed critiques of other public commenters that power even without express page of book in the record, but that were not placed in the rulemaking statutory authority * * * .’’ Id. at 1217. admitting he was able to obtain copy of record; and (5) OSHA improperly used The court also noted that it would be the book). Once again, Docket Office the expert witnesses to review and absurd to require OSHA and other analyze the public comments and staff were available to answer any agencies to ‘‘hire enormous regular hearing testimony. See Exs. 500–188, questions from interested parties and to staffs versed in all conceivable pp. 7–10; 500–197, pp. IV–1925. help locate materials that might technological issues, rather than use First, the rulemaking record is replete otherwise be difficult to find. OSHA their appropriations to hire specific with evidence that OSHA’s use of expert does not believe that this practice consultants for specific problems.’’ Id. witnesses and consultants was disclosed deprived interested parties of their right OSHA has historically used experts to to the public and was clearly known to to review the record. testify at public hearings about parts of the parties who cross-examined OSHA’s As the above discussion proposed rules that fall within their experts at the public hearings. OSHA demonstrates, OSHA undertook areas of expertise. Some earlier OSHA notified interested members of the extraordinary measures to provide rulemakings that involved OSHA expert public of its expert witnesses in several interested members of the public access witnesses included: the Lead ways: (1) OSHA clearly listed its expert to the rulemaking record. These efforts rulemaking (1980); the Hazard witnesses as ‘‘OSHA Witnesses’’ on the ensured that all participants had an Communication rulemaking (1983); the hearing schedule that was sent to opportunity to examine the underlying Ethylene Oxide rulemaking (1984); the hearing participants and placed on the information and comment meaningfully Benzene rulemaking (1987); and the OSHA webpage, see Ex. 502–476; (2) on the proposed rule. Methylene Chloride rulemaking (1997). OSHA placed the witnesses’ testimony

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See Tr. pp. 1–142; 1–189; believe; in fact, some criticized aspects reduce the significant risk of MSDs. 1–205; 1–206; 1–229; 1–230; 719. of the proposed rule with which they OSHA’s use of experts in helping to Indeed, it was clear to the parties who disagreed. See e.g., Testimony of Les make that determination was not cross-examined OSHA’s experts that Boden, Tr. pp. 1683–34 (‘‘Even though improper or inappropriate. OSHA’s experts were paid witnesses. I happen to be here at the request of E. Supplemental Hearing on the For example, when an attorney OSHA, I think it’s clear that OSHA Economic Impact of the Proposed representing UPS questioned OSHA should reword the language that Standard on the United States Postal witness Maurice Oxenburgh, he describes WRP so that people like Service, State and Local Governments, referenced the ‘‘Expert Witness myself, when they first read it, won’t and Railroads Cont[r]act for Dr. Maurice Oxenburgh.’’ think that it means that the worker is Tr. pp. 2637; see also Tr. p. 1440. supposed to be paid 90 percent of their After OSHA published the proposed Second, OSHA’s expert witnesses had after tax earnings * * * .’’); Testimony standard on November 23, 1999, it no financial interest, and therefore no of Laura Punnett, Tr. p. 1011 (‘‘I would realized that it had failed to include in conflict of interest, in the outcome of prefer to see a standard which is based its Preliminary Economic Analysis and the ergonomics rulemaking. The basis on exposure levels * * * and which Initial Regulatory Flexibility Analysis for this objection, raised by NCE et al., does not require the occurrence of an assessment of the economic impact appears to be that, because many of the disorders before a program goes into of the proposed standard on the United expert witnesses were well-known place.’’). States Postal Service, State and local ergonomics experts, they would benefit Fourth, OSHA’s expert witnesses did governments, and railroads. Once OSHA financially from an ergonomics not prepare any detailed written recognized the omission, it conducted a standard, presumably because they critiques of public witnesses during the supplemental analysis of the economic would be hired more often to address rulemaking process that OSHA could impact of the proposed standard on ergonomic issues. According to this have, but did not place in the these groups (supplemental analysis) theory, the witnesses testified that there rulemaking record. The commenter who and published the analysis in the was a need for a standard on ergonomics made this allegation, the Chamber, gave Federal Register. See 65 FR 33263 (May in order to receive this future, no support for it, but rather summarily 23, 2000). speculative economic benefit. See e.g., stated: ‘‘the Chamber understands that In order to allow interested parties an Ex. 500–197, p. IV–19. many of these supposed experts have opportunity to comment on the In fact, however, OSHA hired these apparently prepared detailed critiques supplemental analysis, which consisted witnesses precisely because their of the public comments the Agency only of 2 Federal Register pages (with experience with ergonomics provided received, which have never been a 10 page Technical Appendix), OSHA them with relevant expertise. And their released to the public, much less established a 30 day pre-hearing testimony shows clearly why most of subjected to rebuttal or cross- comment period, scheduled an informal them supported promulgation of this examination.’’ Ex. 500–188, p. 8 public hearing on the supplemental standard: they have participated in the (emphasis added). This allegation is not analysis, and established a 34 day post- implementation of ergonomics programs true. As detailed above, OSHA placed in hearing comment period. 65 FR 33263 similar to those required by this the docket all of the information it (May 23, 2000). The post-hearing standard, and have observed the success relied upon in promulgating the comment period for the supplemental of those programs in reducing MSD standard. analysis closed the same day as the rates, increasing productivity and Fifth and finally, OSHA did not post-hearing comment period for the efficiency, and decreasing workers’ improperly involve expert witnesses in rest of the proposed standard. Id. compensation costs. In other words, the preparation of the proposed and The hearing took place on July 7, 2000 they believe that a program standard is final rule, and in the review and in Atlanta, GA, and 8 parties filed necessary because they have seen analysis of the public comments and Notices of Intent to Appear. See Exs. programs work to reduce injuries among hearing transcripts. It is true that OSHA 701; 702. The hearing was scheduled to workers and save money for their hired some experts to help in preparing begin at 9:00 a.m. and conclude by the employers. See e.g., Exs. 37–7; 37–25; the proposed and final rule and in end of the day. 65 FR 37322, 37323 37–20. evaluating the rulemaking record; (June 14, 2000). An OSHA panel was Third, there is no basis for the claim however, such use of experts is not available for questioning on the that OSHA improperly ‘‘coached’’ the improper. As described above, it is supplemental analysis from 9:15 a.m. expert witnesses. One of the witnesses’’ expressly authorized by the OSH Act until 12:00 p.m. A representative of UPS functions was to help the public and has been upheld by the D.C. Circuit questioned the panel for more than two understand the scientific and technical Court of Appeals. Lead, 647 F.2d at hours, and the presiding Administrative research on which OSHA based its 1216 (OSHA properly hired experts ‘‘to Law Judge permitted one person who proposal. OSHA worked with its experts summarize and evaluate data in the had not filed a Notice of Intent to to be sure that they were prepared to record, prepare record data for computer Appear to question OSHA for about 10 explain clearly and succinctly, the processing, and help draft portions of minutes. See Tr. pp. 18153–55; 18218. reasoning and assumptions on which the Preamble and the final standard.’’). A representative of the railroad industry OSHA relied in developing the In the end, OSHA must weigh the was the only party to present testimony proposed standard. Indeed, OSHA evidence and determine whether a at the afternoon session—the others believes that it had a responsibility to standard is appropriate and how that having canceled their appearances—and prepare its expert witnesses to present standard should be designed to the hearing concluded early. See Tr. pp. the scientific and technical assumptions substantially reduce a significant risk of 18217–81.

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OSHA’s issuance of the supplemental prepare for the informal public hearing. deprive any member of the public the analysis and procedures for comment on In fact, the information supplied by the opportunity to comment on relevant the analysis were consistent with railroad industry was largely evidence. Past OSHA rulemakings have applicable law. As described in detail responsible for OSHA’s decision to included post-hearing comment periods above, the OSH Act and OSHA’s reserve for possible future rulemaking of similar length. For example: procedural regulations require that the issue of the applicability of the final • Powered Industrial Trucks—90 day OSHA provide at least 30 days for rule to the railroad industry. See post-hearing comment period. 63 FR interested parties to comment on a Discussion in Part IV, Paragraph (b) 66237 (Dec. 1, 1998). proposed rule. 29 U.S.C. 655(2); 29 CFR above. • Cadmium—90 day post-hearing 1911.11(b)(3). OSHA gave interested comment period. 57 FR 42101 (Sept. 14, F. The Post-Hearing Comment Period parties such an amount of time to 1992). submit pre-hearing comments on the As stated above, the Hearing • Process Safety Management—90 supplemental analysis. Procedures established a 90 day post- day post-hearing comment period. 57 OSHA’s procedures for seeking hearing comment period for the FR 6356 (Feb. 24, 1992). comment were also adequate to allow rulemaking. 65 FR 11948, 11949 (Mar. 7, • Hazard Communication—93 day interested parties an opportunity to 2000). During the first 45 days of the post-hearing comment period. 48 FR meaningfully comment on the period (until June 26, 2000), hearing 53280 (Nov. 25, 1983). supplemental analysis. The participants could submit additional Indeed, in the Air Contaminants supplemental analysis was based in data and evidence to the rulemaking rulemaking the Secretary of Labor large measure on the original record. Id. Hearing participants had established a 77 day post-hearing Preliminary Economic Analysis until August 10, 2000 to submit post- comment period, a shorter period than published on November 23, 1999. Id. at hearing briefs and arguments. that provided here. 53 FR 34708 (Sept. 33264. Interested parties, therefore, Furthermore, trade associations or other 7, 1988). As described in more detail were familiar with the methodology groups who filed Notices of Intent to above, the time allotted for comment in employed by OSHA in the supplemental Appear were permitted to attach to their that rulemaking was challenged in the analysis before it was published on May post-hearing submissions comments 11th Circuit Court of Appeals, which 23, 2000. Indeed, virtually all of the from their members who had not held that those comment periods did parties who filed a Notice of Intent to participated in the informal public not deprive individuals of the Appear at the informal public hearing hearing. See e.g., Ex. 500–1. Numerous opportunity to comment meaningfully. on the supplemental analysis (or who hearing participants availed themselves Air Contaminants, 965 F.2d at 969 n.8. submitted written comments on the of the post-hearing comment period. For Here, too, OSHA believes that the 90 supplemental analysis) also filed example: day post-hearing comment period was written comments on the November 23, • NCE et al. submitted 906 pages of more than adequate to allow interested 1999 proposal. See e.g., Comments of new information and data and parties an opportunity to submit the United States Postal Service, Ex. 35– submitted a 565 page brief. See Exs. additional data and argument on the 106; Comments of the Association of 500–118; 500–197. proposed rule. As stated above, parties American Railroads, Ex. 30–3750; • The Chamber submitted 22 pages of who participated in the informal public Comments of UPS, Ex. 32–241–4. new information and data and hearing had 216 days, including the 90 Because it was based on the earlier submitted a 107 page brief. See Exs. day post-hearing comment period, from Preliminary Economic Analysis, the 500–109; 500–188. the date OSHA published the proposed supplemental analysis was not a large, • The AFL–CIO submitted 2072 pages rule to submit data and evidence to the complicated document. See e.g., Ex. 28– of new information and data and rulemaking record for OSHA’s 15 (Technical Appendix). Interested submitted a 178 page brief. See Exs. consideration. They had 261 days from parties did not need to review numerous 500–71; 500–97; 500–218. the date OSHA published the proposed additional documents to prepare written • The American Iron and Steel rule to submit briefs and arguments to comments. In addition, the industries Institute submitted 186 pages of new the rulemaking record. OSHA believes analyzed in the supplemental analysis information and data and submitted a that this gave interested parties more represented only a small fraction of the 129 page brief. See Exs. 500–168; 500– than enough time to review the record, total industries affected by the proposed 223. comment on the evidence submitted, rule. OSHA and its expert witnesses also and comment on the proposed rule. OSHA therefore disagrees with those participated in the post-hearing In addition, the participation of commenters who contended that, by comment period. OSHA submitted new OSHA and its expert witnesses in the setting a 30 day pre-hearing comment evidence and data it had obtained since post-hearing comment period was not period and by failing to provide a publication of the proposal to the docket improper. See Ex. 803–2. First, the bifurcated post-hearing comment period by June 26, 2000. See Ex. 502. Some of Hearing Procedures did not preclude (i.e., the first part of the period for OSHA’s expert witnesses also submitted OSHA and its expert witnesses from submission of additional data and new data, information, and argument at participating in the post-hearing evidence and the second part for post- this time. See e.g., 500–38; 500–134; comment period. See 803–2. In past hearing briefs and argument), OSHA did 500–84. A few expert witnesses also rulemakings, OSHA and its expert not provide for adequate comment on submitted argument after June 26, 2000. witnesses have participated fully in the supplemental analysis. OSHA gave See e.g., 500–167. These arguments post-hearing comment periods by interested parties more than 60 days to were postmarked on or before August submitting data, evidence, and comment on the supplemental analysis 10, 2000, in accordance with the argument. See e.g., Docket S775 (Steel (including the pre-hearing and post- Hearing Procedures. 65 FR 11948, 11949 Erection); Docket H225 (Formaldehyde); hearing comment period); OSHA (Mar. 7, 2000). Docket S048 (Logging); Docket H049 believes this period of time was more The 90 day post-hearing comment (Respiratory Protection). For OSHA and than adequate to allow interested parties period and OSHA’s participation in it its expert witnesses not to submit to review the relevant record material, were consistent with Agency practice in additional data and information it submit written comments and data, and past OSHA rulemakings, and did not becomes aware of in the post-hearing

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00581 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68842 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations comment period would be negligent, hearing participants did not have an health plans approved under Section 18 given OSHA’s mandate to consider the opportunity to comment upon it during of the OSH Act would be able to ‘‘best available evidence’’ in the post-hearing comment period. See develop their own comparable State promulgating a standard. It would also 65 FR 11948, 11949 (Mar. 7, 2000). standards to deal with any special give rise to the charge that OSHA was OSHA is thus under no obligation to problems. relying in the final standard on non- consider it in promulgating the final In short, there is a clear national record evidence. rule. Even so, OSHA has examined the problem related to occupational safety Second, in accordance with the information and data carefully and and health for employees exposed to Hearing Procedures, OSHA and its given it appropriate consideration MSD hazards in the workplace. Any expert witnesses submitted all new data (consistent with the fact that it has not rule pertaining to ergonomics developed and evidence by June 26, 2000. been subject to rebuttal by other hearing by States that have elected to participate Although some of the material was not participants). under Section 18 of the OSH Act would scanned into the computer database For these reasons, OSHA does not not be preempted by this final rule if the until later, all of the information was agree with those commenters who have State rule is determined by Federal available after June 26, 2000, in hard implied that the post-hearing comment OSHA to be ‘‘at least as effective’’ as the copy form in the Docket Office. OSHA period was too brief or that OSHA and Federal rule. California has already even prepared a finding aid to help its expert witnesses improperly promulgated a final ergonomics interested members of the public locate participated in the post-hearing standard, and so has Washington. The and review the information submitted. comment period. See e.g., Exs. 803–2; State of North Carolina has proposed Thus, interested members of the public 500–197, p. IV–9. one. Because the ergonomics program had an opportunity to review and XIII. Federalism standard may preempt State rules that comment on all new data and evidence are not ‘‘at least as effective’’ as the submitted by OSHA and its expert OSHA has reviewed the final Federal rule, OSHA has determined that witnesses. OSHA admits that a handful ergonomics program rule in accordance it has ‘‘federalism implications’’ as of its expert witnesses, like many other with the Executive Order on Federalism defined in Executive Order 13132. The Hearing Participants, submitted post- (Executive Order 13132, 64 FR 43255, order requires consultation with State hearing argument on August 10, 2000. August 10, 1999). This Order requires and local governments for regulations See e.g., Exs. 500–167; 500–187; 500– that agencies, to the extent possible, that have federalism implications. 173. As explained above, this was refrain from limiting state policy In the course of OSHA’s development permitted under the Hearing options, consult with States prior to of this final standard for ergonomics, Procedures. 65 FR 11948, 11949 (Mar. 7, taking any actions that would restrict OSHA solicited and received a great 2000). OSHA does not believe that these state policy options, and take such deal of participation from submissions constituted new actions only when there is clear representatives of state, county and information or data, as some constitutional authority and the municipal governments. Some commenters suggested. See 803–2. presence of a problem of national scope. representatives participated by Rather, these submissions interpreted The Order provides for preemption of attending one or more stakeholder and analyzed evidence and data that State law only if there is a clear meetings held by OSHA in the early were already a part of the rulemaking Congressional intent for the agency to stages of the rulemaking effort. Others do so. Any such preemption is to be record. In any events, OSHA has not participated by submitting written limited to the extent possible. relied in the final standard on comment or testifying at the public Section 18 of the Occupational Safety comments from its expert witnesses hearing. Below is a listing of those who submitted after June 26, 2000. and Health Act (OSH Act) expresses Congress’ clear intent to preempt State participated in the rulemaking process. OSHA acknowledges that NIOSH Representatives of the following state, laws with respect to which Federal submitted a handful of new studies to county, and municipal entities attended OSHA has promulgated occupational the rulemaking record after the June 26, one or more of the OSHA-sponsored safety or health standards. Under the 2000 deadline. Because of this, OSHA stakeholder meetings addressing the OSH Act a State can avoid preemption has not relied upon these studies in Ergonomic Program Standard: promulgating this final rule; OSHA has only if it submits, and obtains Federal also not relied upon the conclusions approval of, a plan for the development The City of Greensboro, N.C.; the Virginia NIOSH reached in its post-hearing brief of such standards and their State Department of Labor and Industry; the State of Hawaii Department of Labor; the as evidence in the final standard, even enforcement. Occupational safety and Washington State Department of Labor and though OSHA believes that NIOSH’s health standards developed by such Industries; Iowa OSHA; the Maryland post-hearing brief represents argument, State Plan States must, among other Occupational Safety and Health not new data and evidence. OSHA has things, be at least as effective as the Administration; the New York State considered, however, the numerous Federal standards in providing safe and Department of Labor; the North Carolina studies NIOSH submitted in accordance healthful employment and places of Safety and Health Program, and Utah OSHA. with the Hearing Procedures on June 26, employment. Representatives of the following state, 2000. See Ex. 500–121. In short, OSHA Since many work-related MSDs are county, and municipal entities were is not relying in this standard on any reported every year in every State and invited to attend one or more of the information that interested parties did since MSD hazards are present in OSHA-sponsored stakeholder meetings not have an opportunity to comment workplaces in every state of the Union, addressing the Ergonomic Program upon. the risk of work-related MSD disorders Standard, but elected not to send a Finally, OSHA notes that some is clearly a national problem. The representative: Hearing Participants submitted new Federal final ergonomics program evidence and data to the rulemaking standard is written so that employees in Cal/OSHA Consultation Services; California OSHA; the City of Casper, record on August 10, 2000. See e.g., Ex. every State would be protected by the Wyoming; The City of Mt. Airy, North 500–219. This new data and evidence standard. To the extent that there are Carolina; the City of Portland, Oregon, was not submitted in accordance with any State or regional peculiarities, Bureau of Risk Management; the North the Hearing Procedures and other States with occupational safety and Carolina Department of Labor; the North

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Carolina League of Municipalities; the Ohio 30–637 and 500–18); Gilbert Public Schools Pennsylvania Department of Labor and Bureau of Workers’ Compensation; Oregon (Ex. 30–691); Elsinore Valley Municipal Industry (Ex. L–30–4932); Attorney General OSHA; the State of Kansas Consultation Water District (Ex. 30–693); District of of Missouri (Ex. L–30–5216); Nevada City Program, and the Texas Workers Columbia Water and Sewer Authority (Ex. School District (Ex. 31–23); City of Ridgecrest Compensation Insurance Fund. 30–702); Bullhead City Schools (Ex. 30–704); (Ex. 31–135); City of De Pere (Ex. 31–137); Representatives of the following state, Mukilteo Water District (Exs. 30–714 and 30– Sonoma County Water Agency (Ex. 31–146); 982); City of Tampa Water Department (Ex. Denver Public Schools (Ex. 31–180); Porter county, and municipal entities provided 30–869); the Industrial Commission of Hills Presbyterian Village (Exs. 31–209 and comments to the public rulemaking Arizona (Ex. 30–877); Valley County Water 30–220); Stark County Department of Human docket for the proposed Ergonomic District (Ex. 30–880); Plainview Water Services (Ex. 31–213); San Diego City Program Standard (Docket S–777): District (Ex. 30–900); Lake Hemet Municipal Schools (Ex. 31–234); Fairfax County Butler Rural Elec Cooperative Inc. (Exs. Water District (Ex. 30–902); Jordan Valley Government Risk Management Division (Ex. 30–182 and 30–239); North Park Public Water Conservancy District (Ex. 30–916); City 31–306); Lewis County Public Health (Ex. Water District (Ex. 30–212); City of Garner of David City and David City Utilities (Ex. 31–308); Washington State Farm Bureau (Ex. (Ex. 30–219); Colchester Public Works (Ex. 30–1002); Bellevue Department of Public 31–312); Indiana Association of Cities and 30–247); Appomattox River Water Authority Works (Ex. 30–1003); City of Nooksack (Ex. Towns, for Richmond Indiana (Ex. 31–328); (Ex. 30–248); South Island Public Services 30–1009); Multnomah County Department of State of New Mexico Workers Compensation District (Exs. 30–252; 30–281; and 30–354); Support Services (Ex. 30–1018); Kentucky Admin (Exs. 500–13–1 thru 500–13–5); Des Moines Water Works (Exs. 30–254 and Labor Cabinet (Ex. 30–1024); Olivehain Washington Department of Labor and 30–279); Mishawaka Utilities (Exs. 30–255 Municipal Water District (Ex. 30–1039); Industry (Exs. 500–20–1 thru 500–20–8); and 30–278); Public Works Department (Ex. Oregon Department of Consumer and Oregon Department of Consumer and 30–257); Saginaw Midland Municipal Water Business Services (Ex. 30–1110); North Park Business Services (Ex. 500–28–1); Supply Corp (Ex. 30–258); Board of Public Public Water District (Ex. 30–1114); Board of Washington State Department of Labor and Utilities (Ex. 30–261); City of Nashville (Ex. Public Utilities (Ex. 30–1116); Village of Industry (Exs. 500–41–1 thru 500–41–120); 30–270); Stroudsburg Municipal Authority Morrisville Water and Light Department (Ex. State of Oregon Department of Consumer and (Ex. 30–271); City of Laurel (Ex. 30–272); City 30–1118); Pennsylvania Farm Bur (Exs. 30– Business Services (Ex. 500–71–22); of Drain (Ex. 30–273); McCormick Comm of 1121; 30–1202; and 30–1204); Owatonna Washington State Department of Labor and Public Works (Ex. 30–274); Ilion Water Public Utilities (Ex. 30–1124); City of Industry (Ex. 500–86); Oregon Department of Comm Municipal Building (Ex. 30–275); Monona (Ex. 30–1125); Consumers Insurance and Finance (Ex. 500–141–1); Rural Lorain County Water Authority (Ex. Pennsylvania Water Co (Ex. 30–1127); Rock Oregon Workers Compensation Department 30–285); Winchester Municipal Utilities (Ex. Rapids Utilities (Ex. 30–1128); Warminster (Ex. 500–141–2); Oregon Department of 30–286); Ohio Rural Elec Cooperatives Inc. Municipal Authority (Ex. 30–1130); June Insurance and Finance (Ex. 500–141–3); New (Ex. 30–297); St. Louis County Water Co (Ex. Lake Public Utility District (Ex. 30–1140); Mexico Workers Compensation 30–302); City of East Jordan (Ex. 30–304); City Hall, City of Canyonville (Ex. 30–1206); Administration (Ex. 500–184–1); City of Clarksdale Public Utilities (Ex. 30–305); Central New York Water Authority (Ex. 30– Portland Environmental Services (Ex. 501–4); Westmont Water Department (Ex. 30–342); 1212); Sanitary District No. 4 Town of Washington State (Ex. 502–67); Alaska Bucks County Water and Sewer Authority Brookfield (Ex. 30–1247); Nevada Irrigation Department of Labor (Ex. 502–98); California (Ex. 30–343); Town of Hillsborough (Ex. 30– District (Ex. 30–1262); City of Boerne (Ex. Department of Labor (Ex. 502–104); 347); Department of Water Supply (Ex. 30– 30–1265); Blacksburg Christainsburg VPI California Office of Occupational Safety and 356); the City of Portsmouth (Ex. 30–357); Water Authority (Ex. 30–1272); Casitas Health (Ex. 502–106); California Department Cedar Rapids Water Department (Ex. 30– Municipal Water District (Ex. 30–1275); of Industrial Relations (Ex. 502–220); 366); State of Maine Comm on Labor (Ex. 30– Jennings North West Regional Utilities (Ex. Pittsburgh County Memorial Hospital (Ex. 376); City of Elko (Ex. 30–377); Arizona 30–1310); Ypsilanti Comm Utilities 502–285); Allouez Water Department (Ex. School Alliance (Ex. 30–382); New Jersey AM Authority (Ex. 30–1329); Mammoth Comm 600–X–15); Goshen Water and Sewer Plant Water Co (Ex. 30–402); Fayette County Water District (Ex. 30–1376); City of Elko (Ex. 600–X–16); Stevens Point Water and Hospital (Ex. 30–420); Mohave Union High City Hall (Ex. 30–1413); Charter Township of Sewage Treatment Department (Ex. 600–X– School District Number 30 (Ex. 30–433); Independence (Ex. 30–1415); Town of Oyster 18); City of George West (Ex. 600–X–19); Cartwright School District Number 83 (Ex. Bay, N.Y. (Ex. 30–1447); Clear Creek Pennsylvania AM Water Company (Ex. 600– 30–439); City of Murfreesboro (Ex. 30–440); Community Services District (Ex. 30–1471); X–20); City of Cuyahoga Falls (Ex. 600–X– Gurnee Public Works (Ex. 30–450); City of Washington Suburban Sanitary Commission 21); Water and Light Department (Ex. 600–X– David City (Ex. 30–482); Cartwright School (Ex. 30–1508); Contra Costa Water District 22); Mars Hill Utility District (Ex. 600–X–23); District Number 83 (Ex. 30–492); Tualatin (Ex. 30–1526); Bona Vista Water Marshall County Board of Public Utilities Valley Water District (Ex. 30–495); United Improvement District (Ex. 30–1527); (Ex. 600–X–24); The City of North Myrtle Water Conservation District (Ex. 30–500); Stanislaus County (Ex. 30–1531); Alaska Beach (Ex. 600–X–25); Niagara County Water Shoshone Municipal Pipeline (Ex. 30–501); Municipal League (Ex. 30–1536); Long Beach District (Ex. 600–X–26); Old Hickory Utility South Fulton (Ex. 30–504); City of Hood Public Transportation Co. (Ex. 30–1539); District of Davidson County (Ex. 600–X–27); River (Ex. 30–505); Municipal Authority of Municipal Association of South Carolina (Ex. Bella Vista Water District (Ex. 600–X–28); the Township of Robinson (Ex. 30–507); City 30–1583); Salem County Utilities Authority Columbus Water Works (Ex. 600–X–29); Dept of Petersburg (Ex. 30–508); Town of (Ex. 30–1714); Texas Department of Criminal of Engineering and Public Works (Exs. 600– Greensboro (Ex. 30–510); Thermalito Justice (Ex. 30–1847); Western Governors X–31 and 600–X–67); North Carolina General Irrigation District (Ex. 30–512); McCloud Association (Ex. 30–2036); State of Kansas Assembly (Ex. 601–X–391); New Jersey State Comm Services District (Ex. 30–513); State of Department of Human Resources (Ex. 30– League of Municipalities (Ex. 601–X–444); Kansas Department of Human Resources (Ex. 2041); Public Hospital District No. 1 of Pend the Commonwealth of Massachusetts (Ex. 30–522); Salt River Project (Ex. 30–526); HI Oreille County (Exs. 30–2731 and 30–4103); 601–X–630); Florida House of Desert District Water (Ex. 30–549); Clear Oregon Department of Consumer and Representatives (Exs. 601–X–712 and 601–X– Creek Comm Services District (Ex. 30–553); Business Services (Ex. 30–3022); Point 838); Texas House of Representatives (Ex. Cucamonga County Water District (Ex. 30– Lookout Village (Ex. 30–3073); Oswego 601–X–946); State of Tennessee (Ex. 601–X– 558); Ramona Municipal Water District (Ex. County Ambulance (Ex. 30–3186); Louisville 980); Utah State Senate (Ex. 601–X–1013); 30–578); Clackamas River Water (Ex. 30– Water Company (Ex. 30–3187); Richmond West Virginia Municipal League (Ex. 601–X– 579); State University of New York (Ex. 30– Ambulance Authority (Ex. 30–3311); New 1125); Rhode Island League of Cities and 584); Kyrene School District (Ex. 30–590); York Department of Labor (Ex. 30–3731); Towns (Ex. 601–X–1133); New Jersey State Arizona School Alliance (Ex. 30–591); Elizabethtown Water Company (Ex. 30– League of Municipalities (Ex. 601–X–1134); Pennsylvania State Representative (Ex. 30– 3739); PIMA County Risk Management and the City of Portland Oregon (Ex. 601–X– 599); The Arlington Chamber (Ex. 30–600); Department (Ex. 30–3968); New York State 1494). Anchorage Water and Wastewater Utility (Ex. Thruway Authority (Ex. 30–4057); Montana In addition, representatives of the 30–622); Multnomah County Oregon (Exs. State Fund (Ex. 30–4847); Commonwealth of following state, county, and municipal

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00583 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 68844 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations entities gave oral testimony at the Representation by governmental League, and the Long Beach Public informal public hearings on the entities has been greater for this rule Transportation Company (See, e.g., Exs. proposed Ergonomic Program Standard: than for any other OSHA rule. OSHA 30–254; 30–1110; 30–1536; 30–1539;), The New York State Attorney General; the has benefitted from the information and among many others, expressed concerns National League of Cities; the Montgomery data provided by these representatives regarding the effect of the rule on County (Ohio) Administration; the State of at stakeholder meetings held during the Workers’ Compensation Systems and New Mexico Worker’s Compensation years the standard was under suggested that workers’ comp is an area Administration; the State of California development, and the Agency has best left to the states to address. Some Department of Health and Human Services; carefully reviewed and considered the commenters questioned whether OSHA the City of Portland, Oregon; the Multnomah oral testimony and written submissions had the authority to address issues County, Oregon Government; the Oregon of the participants. Many of their related to workers’ compensation Workers’ Compensation Division and the comments are addressed throughout the systems and questioned whether State of Washington Department of Labor and Industries. preamble to the final rule, others are OSHA’s cost estimates included the cost discussed below. to be expended by ‘‘every company in Representatives of the following state, An examination of the comments the nation in renegotiate their workers county, and municipal entities provided revealed that many commenters shared compensation premium costs with written comments at the informal public similar concerns and views on how to insurance companies for these WRP hearing on the proposed Ergonomic remedy those concerns. OSHA received payments?’’ (Ex. 30–254). Issues raised Program Standard: hundreds of comments, for example, by commenters about workers’ The Wisconsin Department of Industry and expressing concern that the proposed compensation and its relation, or lack of Labor (Ex. DC–78); the New Jersey standard lacked clarity. Over 80 of these it, to OSHA’s work restriction Department of Health and Senior Services comments were identical, raising protections, are responded to in the (Ex. DC–109A); Montgomery County, Ohio concerns about coverage, costs and how summary and explanation for paragraph (Ex. Il–169); the New Mexico Workers’ to comply. For example, many (r). Compensation Administration (Ex. Il–222); commenters said: The Pennsylvania Farm Bureau (Ex. the City of Portland, Oregon (Ex. Or–324); the 30–1121) said the proposal raised Oregon Department of Consumer and * * * The lack of specificity throws OSHA’s estimates of range of impact and cost concerns for farm employers even Business Services (Ex. Or–350–1); the State though OSHA did not propose to apply of Oregon Board of Dentistry (Ex OR–351–9); to employers into serious question. It also the National League of Cities (Ex. DC–371) leaves employers attempting to comply in the rule to agriculture. One concern and the Washington State Department of good faith at risk of non-compliance. Based cited by this commenter was that Labor and Industry (Exs. DC 417, 417–1 and on these concerns, I therefore, request that farmers would be affected by higher 417–2). OSHA review its proposed ergonomics costs passed on to them by suppliers standard and provide clarification about both and others directly impacted by the OSHA’s ergonomics rulemaking what kind of work and what types of workers rule. Another concern expressed by the are covered by it. process has thus involved hundreds of Bureau was the extent to which representatives from every level of Commenters asked that OSHA clarify agricultural operations were exempt government. Many State governments its exemption of construction work. from the rule. The Bureau cited various (e.g., Maine, Washington, Oregon, OSHA has responded in depth to these OSHA interpretations and language Kansas, Arizona. Kentucky, concerns in the summary and used to clarify when general industry Pennsylvania, New York, Nevada, explanation of the rule (see the and agricultural standards applied as Texas, Montana, Missouri, New Mexico, discussion for paragraph (b), Does this the reason for their concern. The Alaska, California, Indiana, North standard apply to me?) Other Pennsylvania Farm Bureau stated that Caroline, Massachusetts, Florida, commenters asked for clarification as to OSHA should exclude agriculture from Tennessee, Utah and local and the application of the rule to the the coverage of the proposed standard. municipal governments (e.g., Nashville, agricultural industry, inmates in penal Similar concerns on this issue were TN; Portsmouth, VA; Petersburg, AK; institutions, the manufacturing raised by the Pennsylvania Farm Greensboro, NC; Multnomah County, industry, the ambulance industry, and Bureau, the New York Farm Bureau, the OR; District of Columbia, Blackburn- the solid waste management industry. North Carolina Farm Bureau Federation, Christainsburg, VA; Ypsilanti, MI; Long These issues are also addressed in the and others (See e.g., Ex. 30–1201; 30– Beach, CA; Denver, CO; Richmond, IN; summary and explanation for paragraph 1418; 30–1421) as well as individual Montgomery County, OH) participated (b). Some of the specific comments are farmers (See e.g., Ex. 30–1202 and 30– either by appearing in person at the discussed in greater detail below. 1204). OSHA notes that the final hearings or submitting written Some commenters complained the Ergonomic Program Standard does not comments. Municipal and State entities proposal was too long; the comment apply to agricultural operations. A full represented included, water districts, period too short and then questioned and complete discussion of this issue school districts, electrical utilities, the science used by OSHA, suggesting can be found in the summary and public works departments, municipal that OSHA table its work until the explanation for paragraph (b), Does this authorities, hospitals and long-term care National Academy of Sciences standard apply to me? facilities, labor commissions, human completes its second literature review. Some commenters (Exs. 30–1536 and resource departments, universities, (Exs.30–1018; 30–1536; and 30–1847). 30–1583) who are members of the legislative bodies, industrial Comments addressing procedural issues National League of Cities (NLC) noted commissions, workers’ compensation are discussed in the Procedural Issues that the NLC does not support the administrations, public transportation section of the preamble; those on the application of the federal ergonomics systems, emergency medical services, science supporting this rule are standards to municipal governments. public highway authorities, emergency reviewed in the Health Effects section They cited their inability to obtain medical services, public highway (Section V). funding and their lack of technical authorities, state insurance funds, The Des Moines Water Works, the resources to put an ergonomic program public health departments, and Oregon Department of Consumer and together as reasons for the objection. environmental services. Business Services, the Alaska Municipal OSHA will provide considerable

VerDate 112000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00584 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68845 compliance assistance to the regulated The Long Beach Public Virginia, Virgin Islands, Washington, community that may help NLC members Transportation Company (Ex. 30–1539) Wyoming. Until such time as a state or reduce expenditures and develop stated their agreement with the territorial standard is promulgated, solutions. These materials will be listed fundamental concepts proposed by Federal OSHA will provide interim on OSHA’s website at www.osha.gov. OSHA, but expressed some opposition enforcement assistance, as appropriate. The Salem County Utilities Authority regarding the classification of MSDs and XV. OMB Review Under the Paperwork (Ex. 30–1714) registered their support the standard’s potential impact on Reduction Act of 1995 for the position of the National Solid workers compensation laws. Long Beach Wastes Management Association’s Transportation encouraged OSHA ‘‘to This final ergonomics program (NSWMA) request that the solid waste provide education to promote even standard contains collections of management industry be exempt from more voluntary employer ergonomic information (paperwork) that are subject the ergonomic program standard. This programs to address the issues of to review by the Office of Management commenter listed a number of reasons MSDs.’’ The concluding comment of and Budget (OMB) under the Paperwork similar to those set out by OSHA in the this entity was that ‘‘The Standard, as Reduction Act of 1995 (PRA’95), 44 proposed rule as the basis for the proposed, however would place an U.S.C. 3501 et seq. and its regulation at exemption of the construction, maritime economic and regulatory burden on 5 CFR § 1320. PRA’95 defines collection and agricultural industries. OSHA’s employers, would treat injured of information to mean, ‘‘the obtaining, response to NSWMA’s concerns are employees inequitably and would causing to be obtained, soliciting, or addressed in connection with paragraph jeopardize voluntary systems already in requiring the disclosure to third parties (b) of the summary and explanation. place to address this issue.’’ This view or the public of facts or opinions by or The Texas Department of Criminal was also expressed by many for an agency regardless of form or Justice (TDCJ) (Ex. 30–1847) requested commenters from state, county and format.’’ [44 U.S.C. § 3502(3)(A)]. OSHA an exemption for correctional worker municipal governments. In response, submitted an Information Collection positions and asked for clarification of OSHA notes that employers and entities Request (ICR) for OMB approval when the applicability of the rule to prisoners covered by the rule can anticipate to the proposed rule for the ergonomic assigned to manufacturing positions. reap substantial benefits from their program standard was published on Like other commenters, TDCJ expressed programs (see the discussion of the November 23, 1999. OMB did not concern about the number of new staff results achieved by others in the final approve the ergonomic program’s that would be needed, in their view, to economic analysis). information collection provisions at that comply with the ergonomics program The Richmond Ambulance Authority time, but instructed the Agency that standard. (RAA) (Ex. 30–3311) stated that they future ICR submissions should use the The Butler Rural Electric Cooperative, ‘‘applaud and support OSHA’s effort to OMB control number 1218–0245. OSHA Inc. (Ex. 30–182) acknowledged the address ergonomic concerns in the has submitted a final ICR estimating the importance of an ergonomics program workplace.’’ This commenter then listed paperwork burden hours and costs, to and provided details on the work a few areas of concern and noted that OMB as required by 5 CFR § 1320.11(h) already done by Butler; however, they the exemption criteria for industries for approval. Public comments believe that the OSHA ergonomics with special compliance issues clearly regarding paperwork issues are program standard is not necessary apply to the ambulance industry. The addressed in the Summary and because OSHA could continue to rely RAA said that ‘‘compliance efforts by Explanation, and Cost and Benefit on the General Duty Clause to do the members of the ambulance industry chapters of the final standard. job. In addition, Butler raised some would be extremely costly’’ and urged The following section provides concerns about the Work Restriction OSHA to exclude back pain from the information on the collections of Protection provisions of the proposal, kinds of MSDs covered. information contained in the final which they believe will encourage OSHA is grateful to the many state, ergonomics program standard, as fraud. Again, these are areas of concern local, municipal, other government required by 5 CFR § 1320.5(a)(1)(iv) and that have been raised by other entities who have participated actively § 1320.8(d)(2) . It describes the commenters and are discussed at length in this rulemaking. All the concerns collections of information, the need for in the summary and explanation section raised by these commenters have been and proposed use of the information, for paragraph (r). considered, and many changes to the and the covered employers who will be The Stanislaus County (CA) Risk rule have been made based on the required to collect and maintain Management Division (Ex. 30–1531) comments and suggestions provided by information under the standard. The suggested that more specific guidance these participants. section also discusses the required time was needed to help employers comply periods for collecting and maintaining XIV. State Plans States with the standard. They supported the this information, and provides an grandfather clause, stating that The 23 states and 2 territories which estimate of the annual cost and ‘‘Stanislaus County has saved millions operate their own Federally-approved reporting burden. (Reporting burden of dollars over the last six years with the occupational safety and health plans includes the time for reviewing implementation of our injury and loss must adopt a comparable standard instructions, gathering and maintaining prevention program. One of these within six months of the publication the data needed, and completing and programs includes ergonomics.’’ They date of a final standard. These States reviewing the collection of information.) support the grandfather clause because include: Alaska, Arizona, California, Title: The ergonomics program they believe ‘‘There should be some Connecticut (for State and local standard, 29 CFR § 1910.900. incentive for those employers who are government employees only), Hawaii, Description: The final ergonomics already making a good faith effort, with Indiana, Iowa, Kentucky, Maryland, program standard addresses the programs in place, to be rewarded, and Michigan, Minnesota, Nevada, New significant risk of work-related MSDs we would encourage you to keep the Mexico, New York (for State and local confronting employees in various jobs grandfather clause.’’ In response, OSHA government employees only), North in general industry workplaces. The notes that the final rule contains a Carolina, Oregon, Puerto Rico, South standard’s information collection grandfather clause (see paragraph (c)). Carolina, Tennessee, Utah, Vermont, requirements are essential components

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List of Subjects in 29 CFR Part 1910 will use some of the information in their Employers must provide employees, enforcement of the standard. their representatives, OSHA, and Ergonomics program, Health, Summary of the Collections of NIOSH access to the above records, Musculoskeletal disorders, Information: The final ergonomics except the HCP opinions, for Occupational safety and health, standard requires employers to do the examination and copying in accordance reporting and recordkeeping following: familiarize themselves with with the procedures and time periods requirements. the final standard; provide basic provided in 29 CFR 1910.1020(e)(1), Signed at Washington, DC, this 6th day of ergonomic information to their (e)(2)(ii), (e)(3) and (f). Employers must November 2000. employees; receive employees’ reports provide the HCP opinion to employees, Charles N. Jeffress, of musculoskeletal disorders (MSDs) or to anyone having the specific written MSD signs or symptoms; and determine Assistant Secretary of Labor for Occupational consent of the employee, to OSHA, and Safety and Health. if a reported MSD is work-related and if to NIOSH upon request for examination the employee’s job meets the standard’s and copying in accordance with the XVII. The Standard Action Trigger. If an employee’s job procedures and time periods provided The Occupational Safety and Health meets the standard’s Action Trigger, the in 29 CFR 1910.1020(e)(1), (e)(2)(ii), Administration is amending Part 1910 employer will incur additional (e)(3) and (f). paperwork requirements in complying Respondents: Employers in general of title 29 of the Code of Federal with the ergonomics program industry. The standard does not apply Regulations as follows: requirement or the quick fix option. to employment covered by the following PART 1910Ð[AMENDED] MSD management is triggered when OSHA standards, or to employment the employee experiences a work- such as office management and support New Subpart W of 29 CFR Part 1910 related MSD that meets the Action services directly related to that is added to read as follows: Trigger and requires medical treatment employment: (i) OSHA construction Subpart WÐProgram Standards beyond first aid, or involves MSD signs standards in Part 1926; (ii) OSHA’s or MSD symptoms that last for 7 or more maritime standards in Part 1915, 1917, Sec. 1910.900 Ergonomics program standard. consecutive days after the employee or 1918; or OSHA’s agriculture first reports them to the employer. The standards in Part 1928. The standard Subpart WÐProgram Standards employer must provide that employee also does not apply to railroad with access to a health care professional operations or to employment such as (HCP). When the employee consults Authority: Secs. 4, 6, and 8, Occupational office management and support services Safety and Health Act, 29 U.S.C. 653, 655, with an HCP, the employer must obtain directly related to the operation of a 657, Secretary of Labor’s Order No. 3–2000 a written opinion from the HCP and railroad. (65 FR 50017); and 29 CFR Part 1911. provide a copy of that opinion to the Frequency of Response: All employers employee. The employer must provide must provide basic ergonomic § 1910.900 Ergonomics Program Standard. the HCP with a description of the information to current and new (a) What is the purpose of this employee’s job and information about employees. The frequency of other standard? The purpose of this standard the physical work activities, risk factors, paperwork requirements is determined is to reduce the number and severity of and MSD hazards in the job; a copy of by whether the employer has an musculoskeletal disorders (MSDs) this standard; and a list of items that the employee who has experienced an MSD caused by exposure to risk factors in the HCP’s written opinion must contain, incident, and whether the employee’s workplace. This standard does not including temporary work restrictions, job meets the standard’s Action Trigger. address injuries caused by slips, trips, if necessary. Average Time Per Response: Time per falls, vehicle accidents, or similar Paperwork requirements for response varies, from minimal accidents. employers to develop and implement recordkeeping requirements for a quick the ergonomic program include: Note to paragraph (a): Definitions of terms fix situation, to establishing and used in this standard are in paragraph (z) of management leadership, employee implementing a complete ergonomics this section. participation in the employer’s program. ergonomic program, job hazard analysis, Total Burden Hours: Approximately (b) Does this standard apply to all hazard control measures, and evaluation 36.5 million hours. employers? This standard covers all of the ergonomic program. Estimated Costs (Operating and employers covered by the Act with the Employers with 10 or more Maintenance): $61 million (purchasing following exceptions: employees, including part-time services). This standard does not apply to employees, must keep written or employment covered by the following electronic records of the following: (i) XVI. Authority and Signature OSHA standards, or to employment Employee reports of MSDs, their signs This document was prepared under such as office management and support and symptoms and MSD hazards, (ii) the direction of Charles N. Jeffress, services directly related to that Employer’s response to employee Assistant Secretary of Labor for employment: reports; (iii) Job Hazard Analysis; (iv) Occupational Safety and Health, U.S. (i) OSHA’s construction standards in Hazard control measures, (v) Quick fix Department of Labor for Occupational Part 1926 of this chapter; process, (vi) Ergonomics program Safety and Health, U.S. Department of (ii) OSHA’s maritime standards in evaluations, and (vii) Records of work Labor, 200 Constitution Avenue, NW, Part 1915, 1917, or 1918 of this chapter; restrictions and the HCP written Washington, DC 20210. or opinions. Employers must keep all This final standard is issued pursuant (iii) OSHA’s agriculture standards in records, except the HCP written to sections 4, 6, and 8 Occupational Part 1928 of this chapter.

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(2) This standard does not apply to your workplace; and the methods you employees within 14 days of hiring. You railroad operations or to employment are taking to control them; and must post the information in a such as office management and support (v) Program evaluation, as conspicuous place in the workplace services directly related to the operation demonstrated by regular reviews of the (e.g., employee bulletin board or, if all of a railroad. elements of the program and of the employees have access, electronic (c) How does this standard apply if I effectiveness of the program as a whole, posting). already have an ergonomics program in using such measures as reductions in Note to paragraph (d): You may use the place when the OSHA ergonomics the number and severity of MSDs, information sheet in non-mandatory program standard becomes effective? increases in the number of jobs in which Appendix A to this section to comply with (1) You may continue to implement MSD hazards have been controlled, or paragraphs (d)(1) of this section and the your program instead of complying with reductions in the number of jobs posing summary sheet in non-mandatory Appendix paragraphs (d) through (y) of this MSD hazards to employees; and the B to this section to comply with paragraph section, provided that your program is correction of identified deficiencies in (d)(2) of this section. written, complies with the requirements the program. At least one review of the (e) What must I do when an employee of paragraph (c) of this section, has been elements and effectiveness of the reports an MSD or the signs or implemented before November 14, 2000, program must have taken place prior to symptoms of an MSD? and contains the following program January 16, 2001. (1) You must promptly determine elements: (2) By January 16, 2002, you must whether the reported MSD or MSD signs (i) Management leadership, as have implemented a policy that or symptoms qualify as an MSD demonstrated by an effective MSD provides MSD management as specified incident. You may request the reporting system and prompt responses in paragraphs (p), (q), (r), and (s) of this assistance of a Health Care Professional to reports, clear program section. (HCP) in making this determination. A (3) An employer who has policies or responsibilities, and regular report is considered to be an MSD procedures that discourage employees communication with employees about incident in the following two cases: the program; from participating in the program or reporting the signs or symptoms of (i) The MSD is work-related and (ii) Employee participation, as requires days away from work, demonstrated by the early reporting of MSDs or the presence of MSD hazards in the workplace does not qualify for restricted work, or medical treatment MSDs and active involvement by beyond first aid; or employees and their representatives in grandfather status under paragraph (c) (ii) The MSD signs or symptoms are the implementation, evaluation, and of this section. work-related and last for 7 consecutive future development of your program; (d) If the standard applies to me, what days after the employee reports them to (iii) Job hazard analysis and control, initial action must I take? you. as demonstrated by a process that (1) You must provide each current identifies, analyzes, and uses feasible and each new employee basic (2) If the employee has experienced engineering, work practice, and information about: an MSD incident, you must determine administrative controls to control MSD (i) Common musculoskeletal whether the job meets the standard’s hazards or to reduce MSD hazards to the disorders (MSDs) and their signs and Action Trigger. See paragraph (f) of this levels below those in the hazard symptoms; section. (ii) The importance of reporting MSDs identification tools in Appendix D to (3) If the employee has not and their signs and symptoms early and this section or to the extent feasible, and experienced an MSD incident, you do the consequences of failing to report evaluates controls to assure that they are not need to take further action. them early; effective; (f) How do I determine whether the (iii) How to report MSDs and their employee’s job meets the Action Note to paragraph (c)(1)(iii): Personal signs and symptoms in your workplace; Trigger? protective equipment (PPE) may be used to (iv) The kinds of risk factors, jobs and (1) A job meets the Action Trigger if: supplement engineering, work practice, and work activities associated with MSD administrative controls, but you may only hazards; and (i) An MSD incident has occurred in use PPE alone where other controls are not (v) A short description of the that job; and feasible. Where PPE is used, you must requirements of OSHA’s ergonomics (ii) The employee’s job routinely provide it at no cost to employees. program standard. involves, on one or more days a week, (iv) Training of managers, supervisors, (2) You must make available to the exposure to one or more relevant risk and employees (at no cost to these employee a summary of the factors at the levels described in the employees) in your ergonomics program requirements of this standard. Basic Screening Tool in Table W–1. and their role in it; the recognition of (3) You must provide the information (2) If the employee’s job does not meet MSD signs and symptoms; the in written form or, if all employees have the Action Trigger, you do not need to importance of early reporting; the access, in electronic form. You must take further action. identification of MSD hazards in jobs in provide the information to new BILLING CODE 4510±26±P

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BILLING CODE 4510±26±C

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(g) What actions must I take if the (4) Have ways to be involved in the additional feasible controls that would employee’s job meets the Action development, implementation, and control or reduce MSD hazards; and Trigger? For the employee’s job and all evaluation of your ergonomics program. (C) If such controls exist, implement jobs in the establishment that are the (j) What must I do to determine them until you have reduced the MSD same as that job, you must either: whether a job that meets the Action hazards in accordance with paragraphs (1) Comply with the Quick Fix option Trigger poses an MSD hazard to (k)(1)(i) or (k)(1)(ii) of this section. in paragraph (o) of this section, or employees in that job? (2) If a work-related MSD occurs in a (2) Develop and implement an (1) You must conduct a job hazard job whose hazard(s) you have reduced ergonomics program that includes the analysis for that job. You may rely on to the levels specified in paragraph following elements: an analysis previously conducted in (k)(1) of this section, you must: (i) Management leadership as accordance with this section to the (i) Ensure that appropriate controls specified in paragraph (h) of this extent it is still relevant. are still in place, are functioning, and section; (2) Your job hazard analysis must are being used properly, and (ii) Employee participation as include all employees who perform the (ii) Determine whether new MSD specified in paragraph (i) of this section; same job, or a sample of employees in hazards exist and, if so, take steps to (iii) MSD management as specified by that job who have the greatest exposure reduce the hazards as specified in paragraphs (p), (q), (r), and (s) of this to the relevant risk factors, and include paragraph (m) of this section. section; the following steps: Note to paragraph (k): The occurrence of (iv) Job hazard analysis as specified (i) Talk with those employees and an MSD in a problem job is not in itself a by paragraph (j) of this section; their representatives about the tasks the violation of this standard. (v) Hazard reduction and control employees perform that may relate to (l) What kinds of controls must I use measures as specified in paragraphs (k), MSDs; and to reduce MSD hazards? (l), and (m) of this section, and (ii) Observe the employees performing (1) For each problem job, you must evaluations as specified in paragraph (u) the job to identify the risk factors in the use feasible engineering, work practice of this section, if the job hazard analysis job and to evaluate the magnitude, or administrative controls, or any determines that the job presents an MSD frequency, and duration of exposure to combination of them, to reduce MSD hazard; those risk factors. hazards in the job. Where feasible, (vi) Training as specified in paragraph (3) You must use one or more of the engineering controls are the preferred (t) of this section. following methods or tools to conduct method of control. (h) What must I do to demonstrate this analysis: (2) You may use personal protective management leadership? You must: (i) One or more of the hazard equipment (PPE) to supplement (1) Assign and communicate identification tools listed in Appendix engineering, work practice or responsibilities for setting up and D–1 to this section, if the tools are administrative controls, but you may managing the ergonomics program; relevant to the risk factors being use PPE alone only where other controls (2) Provide designated persons with addressed; are not feasible. Where you use PPE, the authority, resources, and (ii) The occupation-specific hazard you must provide it at no cost to information necessary to meet their identification tool in Appendix D–2 to employees. responsibilities; this section; (m) What steps must I take to reduce (3) Ensure that your policies and (iii) A job hazard analysis conducted MSD hazards? You must: practices encourage and do not by a professional trained in ergonomics; (1) Ask employees in the problem job discourage: or and their representatives to recommend (i) The early reporting of MSDs, their (iv) Any other reasonable method that measures to reduce MSD hazards; signs and symptoms, and MSD hazards; is appropriate to the job and relevant to (2) Identify and implement initial and the risk factors being addressed. controls within 90 days after you (ii) Employee participation in the (4) If you determine that there is an determine that the job meets the Action ergonomics program; MSD hazard in the job, the job will be Trigger. Initial controls mean controls (4) Communicate periodically with termed a ‘‘problem job.’’ that substantially reduce the exposures employees about the ergonomics Note to paragraph (j): If you determine that even if they do not reach the levels program and their concerns about the MSD hazards pose a risk only to the specified in paragraph (k)(1) of this MSDs. employee who reported the MSD, you may section. (i) What must I do to ensure employee limit your job controls, training and (3) Identify and implement permanent participation in my program? You must evaluation to that individual employee’s job. controls that meet the levels specified in ensure that employees and their (k) What is my obligation to reduce paragraph (k)(1) of this section within 2 representatives: MSD hazards in a problem job? years after you determine that a job (1) Have ways to promptly report (1) You must: meets the Action Trigger, except that MSDs, MSD signs and symptoms, and (i) Control MSD hazards; or initial compliance can take up to MSD hazards in your workplace; (ii) Reduce MSD hazards in January 18, 2005 whichever is later. (2) Receive prompt responses to their accordance with or to levels below those (4) Track your progress and ensure reports of MSDs, MSD signs and in the hazard identification tools in that your controls are working as symptoms, and MSD hazards; Appendix D to this section; or intended and have not created new (3) Are provided with a summary of (iii) If you cannot reduce MSD MSD hazards. This includes consulting the requirements of this standard, as hazards in accordance with paragraphs with employees in problem jobs and specified in paragraph (d)(2) of this (k)(1)(i) or (k)(1)(ii) of this section, you their representatives. If the controls are section, and have ready access to a copy must do the following: not effective or have created new MSD of this standard and to information (A) Reduce MSD hazards to the extent hazards, you must use the process in about MSDs, MSD signs and symptoms, feasible; paragraphs (m)(1) and (m)(2) of this MSD hazards, and your ergonomics (B) At least every 3 years, assess the section to identify additional control program; and job and determine whether there are measures that are appropriate and

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(ii) Any necessary work restrictions, duty job in accordance with paragraph (1) You may use a Quick Fix for a job including time off work to recover; (r)(1) of this section, you must provide if your employees have experienced no (iii) Work restriction protection; and that employee with Work Restriction more than one MSD incident in that job, (iv) Evaluation and follow-up of the Protection, which maintains the and there have been no more than two MSD incident. employee’s employment rights and MSD incidents in your establishment, in (2) You must obtain a written opinion benefits, and 100% of his or her the preceding 18 months. from the HCP for each evaluation earnings, until the earliest of the (2) To use a Quick Fix, you must: conducted under this standard, and following three events occurs: (i) Provide the MSD management provide a copy to the employee. You (i) The employee is able to resume the required by paragraphs (p), (q), (r), and must instruct the HCP that the opinion former work activities without (s) of this section, as appropriate, to the may not include any findings or endangering his or her recovery; or employee promptly after you determine information that is not related to (ii) An HCP determines, subject to the that the employee’s job meets the Action workplace exposure to risk factors, and determination review provisions in Trigger; that the HCP may not communicate paragraph (s) of this section, that the (ii) Talk with employees in the job such information to the employer, employee can never resume his or her and their representatives about the tasks except when authorized to do so by former work activities; or the employees perform that may relate State or Federal law. (iii) 90 calendar days have passed. to the MSD incident; and (3) Whenever an employee consults (3) Whenever an employee must take (iii) Observe employees performing an HCP for MSD management, you must time off from work in accordance with the job to identify which risk factors are provide the HCP with the following: paragraph (r)(1) of this section, you likely to have caused the MSD incident; (i) A description of the employee’s job must provide that employee with Work (iv) Ask the employee(s) performing and information about the physical Restriction Protection, which maintains the job and their representatives to work activities, risk factors and MSD the employee’s employment rights and recommend measures to reduce hazards in the job; benefits and at least 90% of his or her exposure to the MSD hazards identified; (ii) A copy of this standard; and earnings until the earliest of the (iii) A list of information that the (v) Within 90 days of your following three events occurs: determination that the job meets the HCP’s opinion must contain. (i) The employee is able to return to Action Trigger in paragraph (e) of this Note to paragraph (p): MSD management the former job without endangering his section, implement controls in the job in under this standard does not include medical or her recovery; accordance with paragraph (l) of this treatment, emergency or post-treatment (ii) An HCP determines, subject to the section that control the MSD hazards or procedures. determination review provisions in reduce MSD hazards in accordance with (q) What information must the HCP’s paragraph (s) of this section, that the or to levels below those in the hazard opinion contain? The HCP’s opinion employee can never return to the former identification tools in Appendix D to must contain: job; or this section, and train the employee(s) (1) The HCP’s assessment of the (iii) 90 calendar days have passed. in the use of these controls; employee’s medical condition as related (4) You may condition the provision (vi) Within 30 days after you to the physical work activities, risk of WRP on the employee’s participation implement the controls, review the job factors and MSD hazards in the in the MSD management that this to determine whether you have reduced employee’s job; standard requires. the MSD hazards to the levels specified (2) Any recommended work (5) Your obligation to provide WRP in paragraph (o)(2)(v) of this section; restrictions, including, if necessary, benefits to a temporarily restricted or and time off work to recover, and any removed employee is reduced to the (vii) Keep a record of the Quick Fix follow-up needed; extent that the employee receives process for each job to which it is (3) A statement that the HCP has compensation for earnings lost during applied. You must keep the record for informed the employee of the results of the work restriction period from either 3 years. the evaluation, the process to be a publicly or an employer-funded (3) If you determine that you have followed to effect recovery, and any compensation or insurance program, or reduced the MSD hazards to the levels medical conditions associated with receives income from employment made specified in paragraph (o)(2)(v) of this exposure to physical work activities, possible by virtue of the employee’s section, you need take no further action risk factors and MSD hazards in the work restriction. except to maintain controls, the training employee’s job; and Note to paragraph (r): The employer may related to those controls, and (4) A statement that the HCP has fulfill the obligation to provide work recordkeeping. informed the employee about work- restriction protection benefits for employees (4) If you have not reduced MSD related or other activities that could temporarily removed from work by allowing hazards to the levels specified in impede recovery from the injury. the employees to take sick leave or other paragraph (o)(2)(v) of this section, you (r) What must I do if temporary work similar paid leave (e.g., short-term disability must implement an ergonomics restrictions are needed? leave), provided that such leave maintains program, as specified in paragraph (g) of (1) If an employee experiences an the worker’s benefits and employment rights this section. MSD incident in a job that meets the and provides at least 90% of the employee’s (p) What MSD management process Action Trigger, you must provide the earnings. must I implement for an employee who employee with any temporary work (s) What must I do if the employee experiences an MSD incident in a job restrictions or time off work that the consults his or her own HCP? that meets the Action Trigger? HCP determines to be necessary, or if no (1) If you select an HCP to make a (1) You must provide the employee HCP was consulted, that you determine determination about temporary work with prompt and effective MSD to be necessary. restrictions or work removal, the

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If the employee has (i) Relevant topics in paragraph (t)(2) in itself mean that the program is ineffective. previously seen an HCP on his or her of this section; (v) What is my recordkeeping own, at his or her own expense, and (ii) How to set up, manage, and obligation? received a different recommendation, he evaluate an ergonomics program; (1) If you have 11 or more employees, or she may rely upon that as the second (iii) How to identify and analyze MSD including part-time or temporary opinion; hazards and select and evaluate employees, you must keep written or (2) If your HCP and the employee’s measures to reduce the hazards. electronic records of the following: HCP disagree, you must, within 5 (4) You must provide initial training (i) Employee reports of MSDs, MSD business days after receipt of the second to: signs and symptoms, and MSD hazards, HCP’s opinion, take reasonable steps to (i) Each employee involved in setting (ii) Your response to such reports, arrange for the two HCPs to discuss and up and managing your ergonomics (iii) Job hazard analyses, resolve their disagreement; program within 45 days after you have (iv) Hazard control measures, (3) If the two HCPs are unable to determined that the employee’s job (v) Quick fix process, (vi) Ergonomics program evaluations, resolve their disagreement quickly, you meets the Action Trigger; (ii) Each current employee, supervisor and and the employee, through your (vii) Work restrictions, time off of respective HCPs, must, within 5 and team leader within 90 days after you determine that the employee’s job work, and HCP opinions. business days after receipt of the second (2) You must provide all records meets the Action Trigger; HCP’s opinion, designate a third HCP to required by this standard, other than the (iii) Each new employee or current review the determinations of the two HCP opinions, upon request, for employee prior to starting a job that you HCPs, at no cost to the employee; examination and copying, to employees, have already determined meets the (4) You must act consistently with the their representatives, the Assistant Action Trigger; determination of the third HCP, unless Secretary and the Director in accordance (5) You do not have to provide initial you and the employee reach an with the procedures and time periods training in a topic that this standard agreement that is consistent with the provided in § 1910.1020(e)(1), (e)(2)(i), requires to an employee who has determination of at least one of the (e)(3), and (f). HCPs; received training in that topic within (3) You must provide the HCP (5) You and the employee or the the previous 3 years. opinion required by this standard, upon (6) You must provide the training employee’s representative may agree on request, for examination and copying, to the use of any expeditious alternative required by paragraph (t) of this section the employee who is the subject of the dispute resolution mechanism that is at in language that the employee opinion, to anyone having the specific least as protective of the employee as understands. You must also give the written consent of the employee, and to the review procedures in paragraph (s) employee an opportunity to ask the Assistant Secretary and the Director of this section. questions about your ergonomics in accordance with the procedures and (t) What training must I provide to program and the content of the training time periods provided in employees in my establishment? and receive answers to those questions. § 1910.1020(e)(1), (e)(2)(ii), (e)(3), and (1) You must provide initial training, (u) What must I do to make sure my (f). and follow-up training every 3 years, ergonomics program is effective? (4) You must keep all records for 3 for: (1) You must evaluate your years or until replaced by updated (i) Each employee in a job that meets ergonomics program at least every 3 records, whichever comes first, except the Action Trigger; years as follows: the HCP’s opinion, which you must (ii) Each of their supervisors or team (i) Consult with your employees in keep for the duration of the employee’s leaders; and the program, or a sample of those employment plus 3 years. (iii) Other employees involved in employees, and their representatives (5) You do not have to retain the HCP setting up and managing your about the effectiveness of the program opinion beyond the term of an ergonomics program. and any problems with the program; employee’s employment if the employee (2) The training required for each (ii) Review the elements of the has worked for less than one year and employee and each of their supervisors program to ensure they are functioning if you provide the employee with the or team leaders must address the effectively; records at the end of his or her following topics, as appropriate: (iii) Determine whether MSD hazards employment. (i) The requirements of the standard; are being identified and addressed; and (w) When does this standard become (ii) Your ergonomics program and the (iv) Determine whether the program is effective? This standard becomes employee’s role in it; achieving positive results, as effective January 16, 2001. (iii) The signs and symptoms of MSDs demonstrated by such indicators as (x) When must I comply with the and ways of reporting them; reductions in the number and severity provisions of the standard? (iv) The risk factors and any MSD of MSDs, increases in the number of (1) You must provide the information hazards in the employee’s job, as problem jobs in which MSD hazards in paragraph (d) of this section to your identified by the Basic Screening Tool have been controlled, reductions in the employees by October 15, 2001. After in Table W–1 and the job hazard number of jobs posing MSD hazards to that date you must respond to employee analysis; employees, or any other measure that reports of MSDs and signs and (v) Your plan and timetable for demonstrates program effectiveness. symptoms of MSDs. addressing the MSD hazards identified; (2) You must also evaluate your (2) You must meet the time frames (vi) The controls used to address MSD program, or a relevant part of it, when shown in Table W–2 for the other hazards; and you have reason to believe that the requirements of this section, when you (vii) Their role in evaluating the program is not functioning properly. have determined that an employee has effectiveness of controls . (3) If your evaluation reveals experienced an MSD incident, in (3) The training for each employee deficiencies in your program, you must accordance with paragraph (e) of this involved in setting up and managing the promptly correct the deficiencies. section.

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TABLE W±2.ÐCOMPLIANCE TIME FRAMES

Requirements and related recordkeeping Time frames

Paragraph (e), (f): Determination of Action Trigger ...... Within 7 calendar days after you determine that the employee has ex- perienced an MSD incident.

Paragraphs (p), (q), (r), (s): MSD Management ...... Initiate within 7 calendar days after you determine that a job meets the Action Trigger.

Paragraphs (h) & (i): Management Leadership and Employee Participa- Initiate within 30 calendar days after you determine that a job meets tion. the Action Trigger.

Paragraph (t)(4)(i): Train Employees involved in setting up and man- Within 45 calendar days after you determine that a job meets the Ac- aging your ergonomics program. tion Trigger.

Paragraph (j): Job Hazard Analysis ...... Initiate within 60 calendar days after you determine that a job meets the Action Trigger.

Paragraph (m)(2): Implement Initial Controls ...... Within 90 calendar days after you determine that a job meets the Ac- tion Trigger

Paragraph (t)(5)(ii): Train current employees, supervisors or team lead- Within 90 calendar days after you determine that the employee's job ers. meets the Action Trigger.

Paragraph (m)(3): Implement Permanent Controls ...... Within 2 years after you determine that a job meets the Action Trigger, except that initial compliance can take up to January 18, 2005 whichever is later.

Paragraph (u): Program Evaluation ...... Within 3 years after you determine that a job meets the Action Trigger.

Note to paragraph (x): Refer to paragraph Health and Human Services, or been associated with exposure to risk (o) of this section for Quick Fix timeframes. designated representative. factors: neck, shoulder, elbow, forearm, (y) When may I discontinue my Employee representative means, wrist, hand, abdomen (hernia only), ergonomics program for a job? You may where appropriate, a recognized or back, knee, ankle, and foot. MSDs may discontinue your ergonomics program certified collective bargaining agent. include muscle strains and tears, for a job, except for maintaining controls Engineering controls are physical ligament sprains, joint and tendon and training related to those controls, if changes to a job that reduce MSD inflammation, pinched nerves, and you have reduced exposure to the risk hazards. Examples of engineering spinal disc degeneration. MSDs include factors in that job to levels below those controls include changing or such medical conditions as: low back redesigning workstations, tools, described in the Basic Screening Tool in pain, tension neck syndrome, carpal facilities, equipment, materials, or Table W–1. tunnel syndrome, rotator cuff syndrome, processes. (z) Definitions. The following DeQuervain’s syndrome, trigger finger, Follow-up means the process or tarsal tunnel syndrome, sciatica, definitions apply to this standard: protocol an employer or HCP uses to Administrative controls are changes epicondylitis, tendinitis, Raynaud’s check on the condition of an employee phenomenon, hand-arm vibration in the way that work in a job is assigned after a work restriction is imposed on or scheduled that reduce the magnitude, syndrome (HAVS), carpet layer’s knee, that employee. and herniated spinal disc. Injuries frequency or duration of exposure to Health care professionals (HCPs) are ergonomic risk factors. Examples of arising from slips, trips, falls, motor physicians or other licensed health care vehicle accidents, or similar accidents administrative controls for MSD hazards professionals whose legally permitted include: are not considered MSDs for the scope of practice (e.g., license, purposes of this standard. (1) Employee rotation; registration or certification) allows them MSD hazard means the presence of (2) Job task enlargement; to provide independently or to be risk factors in the job that occur at a (3) Alternative tasks; delegated the responsibility to carry out magnitude, duration, or frequency that (4) Employer-authorized changes in some or all of the MSD management is reasonably likely to cause MSDs that work pace. requirements of this standard. result in work restrictions or medical Assistant Secretary means the Job means the physical work activities treatment beyond first aid. Assistant Secretary of Labor for or tasks that an employee performs. This MSD incident means an MSD that is Occupational Safety and Health, or standard considers jobs to be the same work-related, and requires medical designated representative. if they involve the same physical work treatment beyond first aid, or MSD signs Control MSD Hazards: means to activities or tasks, even if the jobs have or MSD symptoms that last for 7 or more reduce MSD hazards to the extent that different titles or classifications. consecutive days after the employee they are no longer reasonably likely to Musculoskeletal disorder (MSD) is a reports them to you. cause MSDs that result in work disorder of the muscles, nerves, MSD signs are objective physical restrictions or medical treatment beyond tendons, ligaments, joints, cartilage, findings that an employee may be first aid. blood vessels, or spinal discs. For developing an MSD. Examples of MSD Director means the Director of the purposes of this standard, this signs are: National Institute for Occupational definition only includes MSDs in the (1) Decreased range of motion; Safety and Health, U.S. Department of following areas of the body that have (2) Deformity;

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(3) Decreased grip strength; and hazards. Work practice controls involve of this standard, temporarily reducing (4) Loss of muscle function. procedures and methods for safe work. an employee’s work requirements in a MSD symptoms are physical Examples of work practice controls for new job in order to reduce muscle indications that an employee may be MSD hazards include: soreness resulting from the use of developing an MSD. For purposes of (1) Use of neutral postures to perform muscles in an unfamiliar way is not a this Standard, MSD symptoms do not tasks (straight wrists, lifting close to the work restriction. The day an employee include discomfort. Examples of MSD body); first reports an MSD is not considered symptoms are: (2) Use of two-person lift teams; a day away from work, or a day of work (1) Pain; (3) Observance of micro-breaks. restriction, even if the employee is (2) Numbness; Work-related means that an exposure removed from his or her regular duties (3) Tingling; in the workplace caused or contributed for part of the day. (4) Burning; to an MSD or significantly aggravated a (5) Cramping; and pre-existing MSD. You means the employer as defined (6) Stiffness. Work restriction protection (WRP) by the Occupational Safety and Health Personal protective equipment (PPE) means the maintenance of the earnings Act of 1970 (29 U.S.C. 651 et seq.) is equipment employees wear that and other employment rights and Appendices to § 1910.900 provides a protective barrier between benefits of employees who are on the employee and an MSD hazard. temporary work restrictions. Benefits Non-Mandatory Appendix A to § 1910.900: Examples of PPE are vibration-reduction include seniority and participation in What You Need To Know About gloves and carpet layer’s knee pads. insurance programs, retirement benefits Musculoskeletal Disorders (MSDs) Problem job means a job that the and savings plans. Non-Mandatory Appendix B to § 1910.900: Work restrictions are limitations, Summary of the OSHA Ergonomics employer has determined poses an MSD Program Standard hazard to employees in that job. during the recovery period, on an Appendix C to § 1910.900 [Reserved] Risk factor means, for the purpose of employee’s exposure to MSD hazards. Appendix D to § 1910.900: Hazard this standard: force, awkward posture, Work restrictions may involve Identification Tools repetition, vibration, and contact stress. limitations on the work activities of the Appendix D–1 to § 1910.900: Ergonomics Job Work practice controls are changes in employee’s current job (light duty), Hazard Analysis Tools (Mandatory) the way an employee performs the transfer to temporary alternative duty Appendix D–2 to § 1910.900: VDT physical work activities of a job that jobs, or temporary removal from the Workstation Checklist reduce or control exposure to MSD workplace to recover. For the purposes Appendix E: Ergonomics Rule Flow Chart

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BILLING CODE 4510±26±C

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Non-Mandatory Appendix B to § 1910. program and provide supervisors with disabled to ever return to the job, 900: Summary of the OSHA Ergonomics the responsibility and resources to run whichever comes first. Program Standard the program. The employer must also F. Second Opinion: The standard also 1. Why did OSHA issue an assure that policies encourage and do contains a process permitting the Ergonomics Program Standard? not discourage employee participation employee to use his or her own HCP as OSHA has issued an ergonomics in the program, or the reporting of well as the employer’s HCP to standard to reduce musculoskeletal MSDs, MSD signs and symptoms, and determine whether work restrictions are disorders (MSDs) developed by workers MSD hazards. required. A third HCP may be chosen by whose jobs involve repetitive motions, Employees and their representatives the employee and the employer if the force, awkward postures, contact stress must have ways to report MSDs, MSD first two disagree. and vibration. The principle behind signs and symptoms and MSD hazards G. Program Evaluation: The employer ergonomics is that by fitting the job to in the workplace, and receive prompt must evaluate the ergonomics program the worker through adjusting a responses to those reports. Employees to make sure it is effective. The workstation, rotating between jobs or must also be given the opportunity to employer must ask employees what they using mechanical assists, MSDs can be participate in the development, think of it, check to see if hazards are reduced and ultimately eliminated. implementation, and evaluation of the being addressed, and make any 2. Who is covered by the standard? ergonomics program. necessary changes. All general industry employers are B. Job Hazard Analysis and Control: If H. Recordkeeping: Employers with 11 required to abide by the rule. The a job meets the Action Trigger, the or more employees, including part-time standard does not apply to employers employer must conduct a job hazard employees, must keep written or whose primary operations are covered analysis to determine whether MSD electronic records of employee reports by OSHA’s construction, maritime or hazards exist in the job. If hazards are of MSDs, MSD signs and symptoms and agricultural standards, or employers found, the employer must implement MSD hazards, responses to such reports, who operate a railroad. control measures to reduce the hazards. job hazard analyses, hazard control 3. What does the rule require Employees must be involved in the measures, ergonomics program employers to do? identification and control of hazards. evaluations, and records of work The rule requires employers to inform C. Training: The employer must restrictions and the HCP’s written workers about common MSDs, MSD provide training to employees in jobs opinions. Employees and their signs and symptoms and the importance that meet the Action Trigger, their representatives must be provided access of early reporting. When a worker supervisors or team leaders and other to these records. reports signs or symptoms of an MSD, employees involved in setting up and I. Dates: Employers must begin to the employer must determine whether managing your ergonomics program. distribute information, and receive and the injury meets the definition of an D. MSD Management: Employees respond to employee reports by October MSD incident—a work-related MSD that 15, 2001. Employers must implement requires medical treatment beyond first must be provided, at no cost, with prompt access to a Health Care permanent controls by November 14, aid, assignment to a light duty job or 2004 or two years following temporary removal from work to Professional (HCP), evaluation and follow-up of an MSD incident, and any determination that a job meets the recover, or work-related MSD signs or Action Trigger, whichever comes later. MSD symptoms that last for seven or temporary work restrictions that the employer or the HCP determine to be Initial controls must be implemented more consecutive days. within 90 days after the employer If it is an MSD Incident, the employer necessary. Temporary work restrictions determines that the job meets the Action must check the job, using a Basic include limitations on the work Trigger. Other obligations are triggered Screening Tool to determine whether activities of the employee in his or her by the employer’s determination that the job exposes the worker to risk current job, transfer of the employee to the job has met the Action Trigger. factors that could trigger MSD problems. a temporary alternative duty job, or The rule provides a Basic Screening temporary removal from work. 5. Flexibility features of the Tool that identifies risk factors that E. Work Restriction Protection: Ergonomics Program Standard: could lead to MSD hazards. If the risk Employers must provide Work A. Employers whose workers have factors on the job meet the levels of Restriction Protection (WRP) to experienced a few isolated MSDs may exposure in the Basic Screening Tool, employees who receive temporary work be able to use the ‘‘Quick Fix’’ option then the job will have met the restrictions. This means maintaining to reduce hazards and avoid standard’s Action Trigger. 100% of earnings and full benefits for implementing many parts of the 4. What happens when the worker’s employees who receive limitations on program. job meets the standard’s Action Trigger? the work activities in their current job B. Employers who already have If the job meets the Action Trigger, the or transfer to a temporary alternative ergonomics programs may be able to employer must implement the following duty job, and 90% of earnings and full ‘‘grandfather’’ existing programs. program elements: benefits to employees who are removed C. The employer may discontinue A. Management Leadership and from work. WRP is good for 90 days, or parts of the program under certain Employee Participation: The employer until the employee is able to safely conditions. must set up an MSD reporting and return to the job, or until an HCP The full OSHA Ergonomics Standard response system and an ergonomics determines that the employee is too can be found at http://www.osha.gov.

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Appendix C to § 1910.900 [Reserved] Appendix D–1 to § 1910.900: job hazard analysis (paragraph (j)(3)) Appendix D to § 1910.900: Hazard Ergonomics Job Hazard Analysis Tools and reduce MSD hazards (paragraphs (k) Identification Tools (Mandatory) and (m)). This mandatory appendix contains important information about Appendix D to § 1910.900 contains Paragraph (j)(3)(i) of the OSHA these tools. A description of each of hazard identification tools. This Ergonomics Program Standard allows these tools is also contained in the appendix consists of Appendix D–1, employers to use any of the job hazard Summary and Explanation of paragraph Ergonomics Job Hazard Analysis Tools, analysis tools in this appendix, where and Appendix D–2, VDT Workstation appropriate to the risk factors in the job, (j) in the preamble to this standard. Checklist. to fulfill their obligations to conduct a BILLING CODE 4510±26±P

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[FR Doc. 00–28854 Filed 11–13–00; 8:45 am] BILLING CODE 4510±26±C

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Reader Aids Federal Register Vol. 65, No. 220 Tuesday, November 14, 2000

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING NOVEMBER

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202±523±5227 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since the revision date of each title. Laws 523±5227 3 CFR 8 CFR 103...... 67616 Presidential Documents Proclamations: 7370...... 67247 214...... 67616 523±5227 Executive orders and proclamations 7371...... 67605 The United States Government Manual 523±5227 9 CFR Executive Orders: 12866 (See EO 78...... 68065 Other Services 13175) ...... 67249 93...... 67617 Electronic and on-line services (voice) 523±4534 12988 (See EO 94...... 65728 Privacy Act Compilation 523±3187 13175) ...... 67249 97...... 65729 Public Laws Update Service (numbers, dates, etc.) 523±6641 13084 (Revoked by Proposed Rules: TTY for the deaf-and-hard-of-hearing 523±5229 EO 13175)...... 67249 130...... 67657 13067 (See Notice of October 31, 2000)...... 66163 10 CFR ELECTRONIC RESEARCH 13132 (See EO Proposed Rules: World Wide Web 13175) ...... 67244 35...... 65793 13174...... 65705 430...... 66514 Full text of the daily Federal Register, CFR and other 13175...... 67249 publications: Administrative Orders: 11 CFR http://www.access.gpo.gov/nara Memorandums: Proposed Rules: 100...... 66936 Federal Register information and research tools, including Public Memorandums of April 102...... 66936 Inspection List, indexes, and links to GPO Access: 29, 1994 (See EO 13175) ...... 67249 104...... 66936 http://www.nara.gov/fedreg October 31, 2000...... 66599 12 CFR E-mail Notices: October 31, 2000...... 66163 Proposed Rules: PENS (Public Law Electronic Notification Service) is an E-mail November 9, 2000...... 68061 3...... 66193 service for notification of recently enacted Public Laws. To November 9, 2000...... 68063 208...... 66193 subscribe, send E-mail to Presidential Determinations: 225...... 66193 [email protected] No. 2001±03 of 325...... 66193 516...... 66118 with the text message: October 28, 2000 ...... 66843 517...... 66118 subscribe PUBLAWS-L your name 5 CFR 543...... 66118 Use [email protected] only to subscribe or unsubscribe to 1209...... 67607 544...... 66116, 66118 PENS. We cannot respond to specific inquiries. 545...... 66118 7 CFR 550...... 66118 Reference questions. Send questions and comments about the 52...... 66485 552...... 66116 Federal Register system to: 250...... 65707 555...... 66118 [email protected] 251...... 65707 559...... 66118 The Federal Register staff cannot interpret specific documents or 301...... 66487 560...... 66118 regulations. 718...... 65718 562...... 66118 905...... 66601 563...... 66118 929...... 65707 563b...... 66118 FEDERAL REGISTER PAGES AND DATE, NOVEMBER 931...... 65253 563f...... 66118 65253±65704...... 1 944...... 66601 565...... 66118 947...... 66489 567...... 66118, 66193 65705±66164...... 2 966...... 66492 574...... 66118 66165±66482...... 3 1411...... 65709 575...... 66118 66483±66600...... 6 1421...... 65709 584...... 66118 66601±66922...... 7 1424...... 67608 66923±67248...... 8 1427...... 65709, 65718 13 CFR 67249±67604...... 9 1434...... 65709 Proposed Rules: 67605±68064...... 13 1439...... 65709 124...... 66938 68065±68870...... 14 1447...... 65709 1464...... 65718 14 CFR 1469...... 65718 25...... 66165 Proposed Rules: 39 ...... 65255, 65257, 65258, 868...... 66189 65730, 65731, 66495, 66497, 923...... 67584 66588, 66604, 66607, 66611, 927...... 66935 66612, 66615, 66617, 66923, 929...... 65788 66925, 66927, 68065, 68067, 1930...... 65790 68069, 68071, 68072, 68074, 1944...... 65790 68076, 68077

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71 ...... 65731, 66168, 66169, 1313...... 67796 685 ...... 65616, 65624, 65632, 150...... 67136 67253, 67254, 67255, 67256, 65678 151...... 67136 67257, 67624, 67626 24 CFR 690...... 65632, 65662 153...... 67136 97...... 65732, 65734 888...... 66887 692...... 65606 Proposed Rules: Proposed Rules: Proposed Rules: 46 CFR 39 ...... 65798, 65800, 65803, 100...... 67666 75...... 66200 25...... 66941 65805, 66197, 66657, 67311, 1003...... 66592 350...... 66200 27...... 66941 67315, 67663 71...... 67318, 67664 26 CFR 36 CFR Proposed Rules: 4...... 65808 1...... 66500 217...... 67514 15 CFR Proposed Rules: 219...... 67514 47 CFR 6...... 65260 1...... 67318 740...... 66169 37 CFR 0...... 66184, 66934 774...... 66169 27 CFR 1...... 66502 1...... 66934 Proposed Rules: Proposed Rules: 19...... 66184 Ch. VII...... 66514 9...... 66518 38 CFR 63...... 67651 285...... 66659 55...... 67669 17...... 65906, 66636 64...... 66934 73 ...... 65271, 66643, 67282, 16 CFR 21...... 67265 28 CFR 67283, 67289, 67652, 67653, 2...... 67258 Proposed Rules: 39 CFR 67654, 67655, 68082 4...... 67258 552...... 67670 Proposed Rules: 74...... 67289 305...... 65736 111...... 65274 76...... 66643, 68082 Proposed Rules: 29 CFR 90...... 66643 1026...... 66515 1910...... 68262 40 CFR Proposed Rules: 17 CFR Proposed Rules: 9...... 67267 20...... 66215 1956...... 67672 52 ...... 66175, 67629, 68078 32...... 67675 1...... 66618 63...... 67268 36...... 67320 230...... 65736 30 CFR 81...... 67629 42...... 66215 240...... 65736 62...... 66929 132...... 66502, 67638 43...... 67675 Proposed Rules: 920...... 66929 148...... 67068 54...... 67322 4...... 66663 931...... 65770 180...... 66178, 67272 61...... 66215 18 CFR 938...... 66170 261...... 67068 63...... 66215 946...... 65779 268...... 67068 64...... 66215, 67675 37...... 65262 271...... 67068 73 ...... 66950, 66951, 67331, 157...... 65752 31 CFR 300...... 65271, 67280 67675, 67688, 67689, 67690, 382...... 65757 306...... 66174 302...... 67068 67691, 67692 19 CFR 355...... 65700 Proposed Rules: 10 ...... 65769, 67260, 67261 356...... 66174 52 ...... 65818, 66602, 67319, 48 CFR 12...... 65769 358...... 65700 67675, 68111, 68114 Proposed Rules: 18...... 65769 Proposed Rules: 63...... 66672 2...... 65698, 66920 24...... 65769 205...... 66671 81...... 67675 4...... 65698 111...... 65769 300...... 67319 12...... 66920 113...... 65769 32 CFR 761...... 65654 32...... 66920 114...... 65769 736...... 67628 41 CFR 47...... 66920 125...... 65769 52...... 66920 134...... 65769 33 CFR 60±1...... 68022 60±2...... 68022 145...... 65769 100...... 67264 49 CFR 162...... 65769 117 ...... 66932, 66933, 67629 101±2...... 66588 571...... 67693, 68107 171...... 65769 151...... 67136 42 CFR 578...... 68108 172...... 65769 165 ...... 65782, 65783, 65786 592...... 68108 Proposed Rules: Proposed Rules: 63...... 66511 10...... 66588 117...... 66939 410...... 65376 151...... 65808 414...... 65376 50 CFR 20 CFR 153...... 65808 419...... 67798 18...... 67304 335...... 66498 164...... 66941 Proposed Rules: 300...... 67305 349...... 66499 165...... 65814 412...... 66303 600...... 66655 655...... 67628 413...... 66303 648...... 65787 34 CFR 660 ...... 65698, 66186, 66655, 21 CFR 44 CFR 100...... 68050 67310 179...... 67477 104...... 68050 65...... 66181 679 ...... 65698, 67305, 67310 524...... 66619 106...... 68050 Proposed Rules: Proposed Rules: 558 ...... 65270, 66620, 66621 110...... 68050 67...... 66203 17 ...... 65287, 66808, 67345, 600...... 66621, 67477 600...... 65662 67335, 67343, 67796 606...... 66621, 67477 668...... 65632, 65662 45 CFR 224...... 66221 808...... 66636 674...... 65612, 65678 1628...... 66637 226...... 66221 820...... 66636 675...... 65662 600...... 67708, 67709 Proposed Rules: 682 ...... 65616, 65678, 65632, 46 CFR 648 ...... 65818, 66222, 66960 314...... 66675 65678 30...... 67136 679...... 66223

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REMINDERS Artificially dwarfed plants in Alaska; fisheries of comments due by 11-20- The items in this list were growing media from Exclusive Economic 00; published 11-9-00 editorially compiled as an aid China; comments due by ZoneÐ Maryland and Virginia; to Federal Register users. 11-20-00; published 9-20- North Pacific Groundfish comments due by 11-20- Inclusion or exclusion from 00 Observer Program; 00; published 11-9-00 this list has no legal AGRICULTURE extension; comments Virginia; comments due by significance. DEPARTMENT due by 11-20-00; 11-20-00; published 10- Federal Crop Insurance published 11-3-00 19-00 Corporation Caribbean, Gulf, and South Pesticides; tolerances in food, RULES GOING INTO Crop insurance regulations: Atlantic fisheriesÐ animal feeds, and raw EFFECT NOVEMBER 14, Rice crop; comments due Gulf of Mexico and South agricultural commodities: 2000 by 11-20-00; published 9- Atlantic coastal Mefenoxam; comments due 20-00 migratory pelagic by 11-24-00; published 9- There are no Rules going AGRICULTURE resources; comments 25-00 into effect today. DEPARTMENT due by 11-24-00; Water pollution control: Food and Nutrition Service published 10-25-00 National Pollutant Discharge COMMENTS DUE NEXT Child nutrition programs: West Coast States and Elimination SystemÐ WEEK Special milk, summer food Western Pacific South Dakota; sludge service, and child and fisheriesÐ management (biosolids) AGRICULTURE adult care food programs, Pacific Coast groundfish; program modification DEPARTMENT and free and reduced comments due by 11- application; comments Agricultural Marketing price meals and free milk 20-00; published 10-6- due by 11-20-00; Service in schoolsÐ 00 published 10-5-00 Children's eligibility Blueberries, cultivated; Pacific Coast groundfish; Water supply: information; disclosure; promotion, research, and comments due by 11- National primary drinking comments due by 11- information order; name 21-00; published 9-22- water regulationsÐ 22-00; published 7-25- change from blueberry 00 00 Arsenic; maximum promotion, research, and Pacific Coast groundfish; contaminant level; AGRICULTURE information order; comments comments due by 11- comments due by 11- DEPARTMENT due by 11-20-00; published 22-00; published 11-7- 20-00; published 10-20- 9-21-00 Food Safety and Inspection 00 00 Service Pork Promotion, Research, Pacific Coast groundfish; Arsenic; maximum and Consumer Information: Meat and poultry inspection: comments due by 11- contaminant level; Program referendum; Recall information; sharing 22-00; published 0-0- 0 correction; comments conduct procedures; with State and other Pacific Coast groundfish; due by 11-20-00; comments due by 11-20- Federal agencies; comments due by 11- published 10-27-00 00; published 10-19-00 comments due by 11-20- 24-00; published 11-9- 00; published 9-19-00 FEDERAL Walnuts grown inÐ 00 COMMUNICATIONS California; comments due by COMMERCE DEPARTMENT Western Pacific pelagic COMMISSION Economic Analysis Bureau 11-22-00; published 10- fisheries; comments due Common carrier services: 23-00 International services surveys: by 11-20-00; published Federal-State Joint Board BE-11; annual survey of AGRICULTURE 10-19-00 on Universal ServiceÐ DEPARTMENT U.S. direct investment DEFENSE DEPARTMENT abroad; comments due by Jurisdictional separations; Animal and Plant Health Acquisition regulations: recommended decision; Inspection Service 11-20-00; published 9-21- 00 Overseas use of purchase comments due by 11- Animal welfare: 24-00; published 11-9- BE-577; direct transactions card in contingency, 00 Inspection, licensing, and of U.S. reporter with humanitarian, or procurement of animals; foreign affiliate; comments peacekeeping operations; Wireless telecommunications comments due by 11-20- due by 11-20-00; comments due by 11-20- servicesÐ 00; published 10-19-00 published 9-21-00 00; published 9-20-00 911 Act implementation; Exportation and importation of BE-82; annual survey of ENERGY DEPARTMENT N11 codes and other animals and animal financial services Acquisition regulations: abbreviated dialing products: arrangements use; transactions between U.S. Contractor legal Hog cholera; disease status compatibility with 911 financial services management changeÐ emergency calling providers and unaffiliated requirements; comments systems; comments due East Anglia; comments foreign persons; due by 11-24-00; by 11-20-00; published due by 11-20-00; comments due by 11-20- published 10-25-00 published 9-20-00 00; published 9-21-00 9-19-00 ENVIRONMENTAL Interstate transportation of BE-93; annual survey of Compatibility with 911 and PROTECTION AGENCY animals and animal products royalties, license fees, enhanced 911 (quarantine): and other receipts and Air quality implementation emergency calling Equine viral arteritis payments for intangible plans; approval and systems; comments due regulatory program for rights between U.S. and promulgation; various by 11-20-00; published horses; comments due by unaffiliated foreign States: 9-19-00 11-20-00; published 9-20- persons; comments due Colorado and Utah; Digital television stations; table 00 by 11-20-00; published 9- comments due by 11-24- of assignments: Swine; interstate movement 21-00 00; published 10-24-00 Arkansas; comments due by within production system; COMMERCE DEPARTMENT Connecticut; comments due 11-24-00; published 10-5- comments due by 11-20- National Oceanic and by 11-20-00; published 00 00; published 9-21-00 Atmospheric Administration 10-19-00 Florida; comments due by Plant-related quarantine, Fishery conservation and District of Columbia, 11-24-00; published 10-5- foreign: management: Maryland, and Virginia; 00

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North Carolina; comments applications and research by 11-20-00; published 9- TREASURY DEPARTMENT due by 11-24-00; and development contract 21-00 Comptroller of the Currency published 10-5-00 projects; scientific peer NATIONAL AERONAUTICS Community bank-focused South Dakota; comments review; comments due by AND SPACE regulation review; lending due by 11-24-00; 11-20-00; published 9-21- ADMINISTRATION limits pilot program; published 10-5-00 00 Acquisition regulations: comments due by 11-21-00; Radio stations; table of INTERIOR DEPARTMENT Priorities and allocations published 9-22-00 assignments: Fish and Wildlife Service system; comments due by TREASURY DEPARTMENT 11-20-00; published 9-20- South Dakota and Wyoming; Endangered and threatened Privacy Act; implementation; 00 comments due by 11-20- species: comments due by 11-24-00; 00; published 10-12-00 Critical habitat NUCLEAR REGULATORY published 10-25-00 FEDERAL HOUSING designationsÐ COMMISSION Radiation protection standards: FINANCE BOARD California red-legged frog; New dosimetry technology; LIST OF PUBLIC LAWS Federal home loan bank comments due by 11- licensee use of personnel system: 20-00; published 10-19- dosimeters requiring This is a continuing list of Capital structure 00 requirements; comments processing by accredited public bills from the current Mexican spotted owl; processors; comments session of Congress which due by 11-20-00; comments due by 11- published 9-26-00 due by 11-24-00; have become Federal laws. It 20-00; published 10-20- published 10-24-00 may be used in conjunction HEALTH AND HUMAN 00 with ``P L U S'' (Public Laws SERVICES DEPARTMENT TENNESSEE VALLEY Peninsular bighorn sheep; AUTHORITY Update Service) on 202±523± Food and Drug comments due by 11- Tennessee River system; 6641. This list is also Administration 20-00; published 10-19- construction approval and available online at http:// Food for human consumption: 00 regulation of structures: www.nara.gov/fedreg. Food labelingÐ Riverside fairy shrimp; Residential related use on The text of laws is not comments due by 11- Foods processed with TVA-controlled residential published in the Federal 20-00; published 9-21- alternative nonthermal access shoreline and TVA Register but may be ordered 00 technologies; use of flowage easement in ``slip law'' (individual term ``fresh''; comments Wintering piping plovers; shoreline; comments due pamphlet) form from the due by 11-20-00; comments due by 11- by 11-20-00; published 9- Superintendent of Documents, published 9-20-00 24-00; published 10-27- 20-00 U.S. Government Printing Plant sterol/stanol esters 00 TRANSPORTATION Office, Washington, DC 20402 and coronary heart Migratory bird hunting: DEPARTMENT (phone, 202±512±1808). The disease; health claims; Tin shot; temporary approval Federal Aviation text will also be made comments due by 11- as nontoxic for waterfowl Administration available on the Internet from 22-00; published 9-8-00 and coots hunting; Airworthiness directives: GPO Access at http:// Human drugs: comments due by 11-24- Agusta S.p.A.; comments www.access.gpo.gov/nara/ Cold, cough, allergy, 00; published 9-25-00 due by 11-21-00; index.html. Some laws may not yet be available. bronchodilator, and INTERIOR DEPARTMENT published 9-22-00 antiasthmatic products Surface Mining Reclamation Airbus; comments due by H.R. 1651/P.L. 106±450 (OTC)Ð 11-24-00; published 10- and Enforcement Office To amend the Fishermen's Antihistamine products; 25-00 Permanent program and Protective Act of 1967 to administrative record Boeing; comments due by abandoned mine land extend the period during reopening; comments 11-20-00; published 10-5- reclamation plan which reimbursement may be due by 11-24-00; 00 published 8-25-00 submissions: provided to owners of United British Aerospace; States fishing vessels for Medical devices: New Mexico; comments due comments due by 11-20- by 11-22-00; published costs incurred when such a Physical medicine devicesÐ 00; published 10-20-00 10-23-00 vessel is seized and detained Ionotophoresis device; Eurocopter Deutschland by a foreign country, and for identification revision; JUSTICE DEPARTMENT GMBH; comments due by other purposes. (Nov. 7, 2000; comments due by 11- Drug Enforcement 11-20-00; published 9-20- 114 Stat. 1941) Administration 00 20-00; published 8-22- H.R. 2442/P.L. 106±451 00 Records, reports, and exports Industrie Aeronautiche e Wartime Violation of Italian HEALTH AND HUMAN of listed chemicals: Meccaniche; comments due by 11-24-00; American Civil Liberties Act SERVICES DEPARTMENT Red phosphorus, white (Nov. 7, 2000; 114 Stat. 1947) phosphorus, and published 10-19-00 Inspector General Office, H.R. 4831/P.L. 106±452 Health and Human Services hypophosphorous acid McDonnell Douglas; Department (and its salts); comments comments due by 11-20- To redesignate the facility of 00; published 10-4-00 the United States Postal Medicare and State health due by 11-24-00; Pratt & Whitney; comments Service located at 2339 North care programs; fraud and published 9-25-00 due by 11-20-00; California Avenue in Chicago, abuse: JUSTICE DEPARTMENT published 9-20-00 Illinois, as the ``Roberto Revisions and technical Prisons Bureau Airworthiness standards: Clemente Post Office''. (Nov. corrections; comments Inmate control, custody, care, Special conditionsÐ 7, 2000; 114 Stat. 1950) due by 11-20-00; etc.: published 10-20-00 Canadair Model CL-600- H.R. 4853/P.L. 106±453 Drug abuse treatment 2B19 series airplanes; To redesignate the facility of HEALTH AND HUMAN programs; participation comments due by 11- the United States Postal SERVICES DEPARTMENT requirements; comments 22-00; published 10-23- Service located at 1568 South National Institutes of Health due by 11-20-00; 00 Green Road in South Euclid, Grants: published 9-20-00 Class E airspace; comments Ohio, as the ``Arnold C. National Institutes of Health; Inmate drug testing due by 11-20-00; published D'Amico Station''. (Nov. 7, research grant programs; comments due 9-18-00 2000; 114 Stat. 1951)

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H.R. 5229/P.L. 106±454 S. 1211/P.L. 106±459 S. 1586/P.L. 106±462 To designate the facility of the Indian Land Consolidation Act United States Postal Service To amend the Colorado River Amendments of 2000 (Nov. 7, Public Laws Electronic located at 219 South Church Basin Salinity Control Act to 2000; 114 Stat. 1991) Notification Service authorize additional measures Street in Odum, Georgia, as S. 2300/P.L. 106±463 (PENS) the ``Ruth Harris Coleman to carry out the control of Coal Market Competition Act Post Office Building''. (Nov. 7, salinity upstream of Imperial of 2000 (Nov. 7, 2000; 114 2000; 114 Stat. 1952) Dam in a cost-effective PENS is a free electronic mail manner. (Nov. 7, 2000; 114 Stat. 2010) S. 501/P.L. 106±455 notification service of newly Stat. 1987) Glacier Bay National Park S. 2719/P.L. 106±464 enacted public laws. To Native American Business subscribe, go to http:// Resource Management Act of S. 1218/P.L. 106±460 2000 (Nov. 7, 2000; 114 Stat. Development, Trade hydra.gsa.gov/archives/ publaws-l.html or send E-mail 1953) To direct the Secretary of the Promotion, and Tourism Act of to [email protected] Interior to issue to the 2000 (Nov. 7, 2000; 114 Stat. S. 503/P.L. 106±456 with the following text Landusky School District, 2012) Spanish Peaks Wilderness Act message: of 2000 (Nov. 7, 2000; 114 without consideration, a patent S. 2950/P.L. 106±465 Stat. 1955) for the surface and mineral Sand Creek Massacre SUBSCRIBE PUBLAWS-L S. 835/P.L. 106±457 estates of certain lots, and for National Historic Site Your Name. Estuaries and Clean Waters other purposes. (Nov. 7, 2000; Establishment Act of 2000 114 Stat. 1988) (Nov. 7, 2000; 114 Stat. 2019) Note: This service is strictly Act of 2000 (Nov. 7, 2000; for E-mail notification of new 114 Stat. 1957) S. 3022/P.L. 106±466 S. 1275/P.L. 106±461 laws. The text of laws is not S. 1088/P.L. 106±458 Nampa and Meridian available through this service. Arizona National Forest Hoover Dam Miscellaneous Conveyance Act (Nov. 7, PENS cannot respond to Improvement Act of 2000 Sales Act (Nov. 7, 2000; 114 2000; 114 Stat. 2024) specific inquiries sent to this (Nov. 7, 2000; 114 Stat. 1983) Stat. 1989) Last List November 9, 2000 address.

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