Vol. 79 Friday, No. 197 October 10, 2014

Part II

Department of Labor

Occupational Safety and Health Administration 29 CFR Parts 1910, 1915, 1917, et al. Chemical Management and Permissible Exposure Limits (PELs); Proposed Rule

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61384 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

DEPARTMENT OF LABOR faxed to the OSHA Docket Office at Docket: To read or download (202) 693–1648. submissions or other material in the Occupational Safety and Health Mail, hand delivery, express mail, or docket go to: www.regulations.gov or the Administration messenger or courier service: Copies OSHA Docket Office at the address must be submitted in triplicate (3) to the above. All documents in the docket are 29 CFR Parts 1910, 1915, 1917, 1918, OSHA Docket Office, Docket No. listed in the index; however, some and 1926 OSHA–2012–0023, U.S. Department of information (e.g. copyrighted materials) Labor, Room N–2625, 200 Constitution is not publicly available to read or [Docket No. OSHA 2012–0023] Avenue NW., Washington, DC 20210. download through the Web site. All submissions, including copyrighted RIN 1218–AC74 Deliveries (hand, express mail, messenger, and courier service) are material, are available for inspection Chemical Management and accepted during the Department of and copying at the OSHA Docket Office. Permissible Exposure Limits (PELs) Labor and Docket Office’s normal FOR FURTHER INFORMATION CONTACT: business hours, 8:15 a.m. to 4:45 p.m. General information and press inquiries: AGENCY: Occupational Safety and Health (E.T.). Mr. Frank Meilinger, Director, Office of Administration (OSHA), DOL. Instructions: All submissions must Communications, U. S. Department of ACTION: Request for Information (RFI). include the Agency name and the OSHA Labor, Room N–3647, 200 Constitution docket number (i.e. OSHA–2012–0023). Avenue NW., Washington, DC 20210, SUMMARY: OSHA is reviewing its overall Submissions, including any personal telephone (202) 693–1999; email approach to managing chemical information provided, are placed in the [email protected]. Technical exposures in the workplace and seeks public docket without change and may information: Ms. Lyn Penniman, Office stakeholder input about more effective be made available online at: of Physical Hazards, OSHA, Room N– and efficient approaches that addresses www.regulations.gov. OSHA cautions 3718, 200 Constitution Avenue NW., challenges found with the current against the inclusion of personally Washington, DC 20210, telephone (202) regulatory approach. This review identifiable information (e.g., social 693–1950; email [email protected]. involves considering issues related to security number, birth dates). SUPPLEMENTARY INFORMATION: updating permissible exposure limits If you submit scientific or technical Table of Contents (PELs), as well as examining other studies or other results of scientific strategies that could be implemented to research, OSHA requests that you also I. Purpose address workplace conditions where provide the following information II. Legal Requirements for OSHA Standards workers are exposed to chemicals. The where it is available: (1) Identification of A. Significant Risk of a Material notice details the role of past court the funding source(s) and sponsoring Impairment: The Benzene Case decisions on the Agency’s current B. Technological and Economic Feasibility organization(s) of the research; (2) the C. The Substantial Evidence Test approach to chemical management for extent to which the research findings the purpose of informing stakeholders of III. History of OSHA’s Efforts To Establish were reviewed by a potentially affected PELs the legal framework in which the party prior to publication or submission A. Adopting the PELs in 1971 Agency must operate. It then describes to the docket, and identification of any B. The 1989 PELs Update possible modifications of existing such parties; and (3) the nature of any C. The 1989 PELs Update is Vacated processes, along with potential new financial relationships (e.g., consulting D. Revising OSHA’s PELs in the Wake of the Eleventh Circuit Decision sources of data and alternative agreements, expert witness support, or approaches the Agency may consider. IV. Reconsideration of Current Rulemaking research funding) between investigators Processes The Agency is particularly interested in who conducted the research and any information about how it may take A. Considerations for Risk Assessment organization(s) or entities having an Methods advantage of newer approaches, given interest in the rulemaking. If you are 1. Current Quantitative Risk Assessment its legal requirements. This RFI is submitting comments or testimony on Methods Typically Used by OSHA To concerned primarily with chemicals the Agency’s scientific and technical Support 6(b) Single Substance that cause adverse health effects from analyses, OSHA requests that you Rulemaking long-term occupational exposure, and is disclose: (1) The nature of any financial 2. Proposed Tiered Approach to Risk not related to activities being conducted Assessment in Support of Updating PELs relationships you may have with any for Chemical Substances under Executive Order 13650, organization(s) or entities having an Improving Chemical Facility Safety and a. General Description and Rationale of interest in the rulemaking; and (2) the Tiered Approach Security. extent to which your comments or b. Hazard Identification and Dose– DATES: Comments must be submitted by testimony were reviewed by an Response Analysis in the Observed the following dates: interested party prior to its submission. Range Hard copy: must be submitted Disclosure of such information is c. Derivation of Low-End Toxicity (postmarked or sent) by April 8, 2015. intended to promote transparency and Exposure (LETE) Electronic transmission or facsimile: d. Margin of Exposure (MOE) as a Decision scientific integrity of data and technical Tool for Low Dose Extrapolation must be submitted by April 8, 2015. information submitted to the record. e. Extrapolation Below the Observed Range ADDRESSES: Comments may be This request is consistent with 3. Chemical Grouping for Risk Assessment submitted by any of the following Executive Order 13563, issued on a. Background on Chemical Grouping methods: January 18, 2011, which instructs b. Methods of Gap Analysis and Filling Electronically: Submit comments agencies to ensure the objectivity of any i. Read-Across Method electronically at: www.regulations.gov, scientific and technological information ii. Trend Analysis which is the Federal eRulemaking used to support their regulatory actions. iii. QSAR iv. Threshold of Toxicological Concern Portal. Follow the instructions online OSHA emphasizes that all material 4. Use of Systems Biology and Other for making electronic submissions. submitted to the rulemaking record will Emerging Test Data in Risk Assessment Fax: Submissions no longer than 10- be considered by the Agency to develop B. Considerations for Technological pages (including attachments) may be the final rule and supporting analyses. Feasibility

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61385

1. Legal Background of Technological CDR Chemical Data Reporting NORA National Occupational Research Feasibility CFD Computational Fluid Dynamics Agenda (NIOSH) 2. Current Methodology of the COSHH Control of Substances Hazardous to NPRM Notice of Proposed Rulemaking Technological Feasibility Requirement Health (U.K.) (OSHA) 3. Role of Exposure Modeling in CrVI Hexavalent Chromium NRC National Research Council (U.S., Technological Feasibility CSTEE Scientific Committee on Toxicity, private) a. Computational Fluid Dynamics Ecotoxicity and the Environment (E.U.) NTP National Toxicology Program (U.S.) Modeling To Predict Workplace CT Control Technology OECD Organization for Economic Exposures DfE Design for the Environment (EPA) Cooperation and Development (multiple b. The Potential Role of REACH in DHHS Department of Health and Human countries, private) Technological Feasibility Services (U.S.) OEL Occupational Exposure Limit c. Technological Feasibility Analysis With DMEL Derived Minimal Effect Level OPPT Office of Pollution Prevention and a Focus on Industries with Highest DNEL Derived No Effect Level Toxics (EPA) Exposures DOE Washington Department of Ecology OSHA Occupational Safety and Health C. Economic Feasibility for Health DOL Department of Labor (U.S.) Administration Standards ECB European Chemicals Bureau (E.U.) OTA Massachusetts Office of Technical 1. OSHA’s Current Approach to Economic ECHA European Chemicals Agency (E.U.) Assistance and Technology Feasibility EPA Environmental Protection Agency PBT Persistent, Bioaccumulative and Toxic 2. Alternative Approaches to Formulating (U.S.) PBZ Personal Breathing Zone Health Standards that Might Accelerate ES Exposure Scenario PCRARM (EPA) Presidential/Congressional the Economic Feasibility Analysis EU European Union Commission on Risk Assessment and Risk 3. Alternative Analytical Approaches to FDA Food and Drug Administration (U.S.) Management Economic Feasibility in Health GAO Government Accountability Office PEL Permissible Exposure Limits Standards (U.S.) PMN Pre-manufacture Notification (EPA) 4. Approaches to Economic Feasibility GHS Globally Harmonized System for the PNEC Predicted No Effect Concentration Analysis for a Comprehensive PELs Classification and Labeling of Chemicals POD Point of Departure Update HazCom 2012 Revised OSHA Hazard PPE Personal Protective Equipment V. Recent Developments and Potential Communication Standard PPM Parts Per Million Alternative Approaches HCS Hazard Communication Standard QCAT Quick Chemical Assessment Tool A. Sources of Information About Chemical (OSHA) (DOE) Hazards HHE Health Hazard Evaluation (NIOSH) QSAR Quantitative Structure-Activity 1. EPA’s High Production Volume HPV High Production Volume (EPA) Relationship Chemicals HPVIS High Production Volume REACH Registration, Evaluation, 2. EPA’s CompTox and ToxCast Information System (EPA) Authorization and Restriction of Chemicals 3. Production and Use Data Under EPA’s HSE Health and Safety Executive (U.K.) (E.U.) Chemical Data Reporting Rule HTS High Throughput Screening REL Recommended Exposure Level 4. Structure-Activity Data for Chemical IFA Federation of Institutions for Statutory RfC Reference Concentration Grouping Accident Insurance and Prevention RFI Request for Information 5. REACH: Registration, Evaluation, (Germany) SAR Structural Activity Relation Authorization, and Restriction of IMIS Integrated Management Information SBREFA Small Business Regulatory Chemicals in the European Union (EU) System (OSHA) Enforcement Fairness Act (U.S.) B. Non-OEL Approaches to Chemical IPCS World Health Organization SDS Safety Data Sheet Management International Programme on Chemical SEP Special Emphasis Program 1. Informed Substitution Safety SIC Standards Industrial Classification 2. Hazard Communication and the Globally IRIS Integrated Risk Information System SIDS Screening Information Data Set Harmonized System (GHS) (EPA) (OECD) 3. Health Hazard Banding ISTAS Institute of Work, Environment, and STEL Short-term Exposure Limit 4. Occupational Exposure Bands Health (Spain) TLV Threshold Value Limit (ACGIH) 5. Control Banding ITC Interagency Testing Committee (EPA TSCA Toxic Substances Control Act (EPA) 6. Task-based Exposure Assessment and TSCA) TTC Threshold of Toxicological Concern Control Approaches IUR Inventory Update Reporting TWA Time-weighted Average VI. Authority and Signature LETE Low-end Toxicity Exposure vPvB Very Persistent and Very Appendix A: History, Legal Background and LOAEL Lowest Observed Adverse Effect Bioaccumulative Significant Court Decisions Level WEEL Workplace Environmental Exposure Appendix B: 1989 PELs Table LOD Limit of Detection Level (AIHA) List of References by Exhibit Number LTFE Lowest Technologically Feasible Exposure I. Purpose List of Acronyms: Request for MA DEP Massachusetts Department of The purpose of this Request for Information on Chemical Management Environmental Protection Information (RFI) is to present and Permissible Exposure Limits MIBK Methyl isobutyl ketone background information and request MOA Modes of Action ACGIH American Conference of MOE Margin of Exposure comment on a number of technical Governmental Industrial Hygienists MRL Minimal Risk Level issues related to aspects of OSHA’s ADI Allowable Daily Intake NAICS North American Industry rulemaking process for chemical AIHA American Industrial Hygiene Classification System hazards in the workplace. In particular, Association NCGC National Institutes of Health the purpose of the RFI is to: AISI American Iron and Steel Institute Chemical Genomics Center • Review OSHA’s current approach to ANSI American National Standards NIEHS National Institute of Environmental chemical regulation in its historical Institute Health Sciences (U.S.) context; APHA American Public Health Association NIOSH National Institute for Occupational • Describe and explore other possible ATSDR Agency for Toxic Substances Safety and Health (U.S.) approaches that may be relevant to Disease Registry NIST National Institute of Standards and BAuA Federal Institute for Occupational Technology (U.S.) future strategies to reduce and control Safety and Health (Germany) NMCSD Navy Medical Center San Diego exposure to chemicals in the workplace; BMD Benchmark Dose NOAEL No Observed Adverse Effect Level and BMDL Benchmark Dose Low NOES National Occupational Exposure • Inform the public and obtain public BMR Benchmark Response Survey input on the best approaches for the

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61386 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

Agency to advance the development and 2332; Ex. #7). Appendix B to this changing or improving OSHA policies implementation of approaches to reduce Request for Information contains the and procedures regarding the derivation or eliminate harmful chemical table of PELs from the 1989 Air and implementation of PELs, as well as exposures in the 21st century Contaminants Final Rule. The table pursuing new strategies to improve workplace. includes both the PELs originally chemical management in the workplace. By all estimates, the number of adopted by OSHA in 1971 and the PELs The Agency is publishing this notice to chemicals found in workplaces today far established under the 1989 final rule. inform the public of its consideration of exceeds the number which OSHA While the Agency presented analyses of these issues, as well as solicit public regulates, and is growing rapidly. There the risks associated with these input that can be used to inform further is no single source recording all chemicals, as well as the analyses of the deliberations, and the determination of chemicals available in commerce. economic and technological feasibility an appropriate approach. Through its Chemical Data Reporting of the proposed limits for these II. Legal Requirements for OSHA Rule, EPA collects information on chemicals, these analyses were not as Standards chemicals manufactured or imported at detailed as those OSHA would have a single site at 25,000 pounds or greater; prepared for individual rulemakings. In the past, OSHA has received many currently this number exceeds 7,674 The final rule was challenged by both suggestions for updating its PELs, but chemicals (U.S. EPA, 2013a; Ex. #1) industry and labor groups. The 1989 these suggestions often do not take The American Chemistry Council PEL update was vacated by the Eleventh account of the requirements imposed by estimates that approximately 8,300 Circuit Court of Appeals because it the OSH Act, and thus have been of chemicals (or about 10 percent of the found that OSHA had not made limited value to OSHA. OSHA is 87,000 chemicals in the TSCA sufficiently detailed findings that each providing an overview of its legal inventory) are actually in commerce in new PEL would eliminate significant requirements for setting standards in significant amounts (Hogue, 2007; Ex. risk and would be feasible in each order to help commenters responding to #2). By contrast the European Chemicals industry in which the chemical was this RFI to provide suggestions that can Agency database contains 10,203 unique used. (AFL–CIO v. OSHA, 965 F.2d 962 satisfy these requirements. This section substances (as of 9/12/2013) (ECHA, (11th Cir. 1992) (the Air Contaminants summarizes OSHA’s legal requirements, 2013; Ex. #3). Of these, OSHA has case; Ex. #8). This decision is discussed which are discussed in greater detail in occupational exposure limits for only further below and in Appendix A. Appendix A. The next section provides about 470 substances. Most of these are Despite these challenges, health an overview of OSHA’s previous listed as simple limits and appear in professionals and labor and industry attempts to update the PELs. tables (referred to as ‘‘Z-tables’’) in 29 groups have continued to support Section 6(b) of the OSH Act (Ex. #9) CFR 1910.1000, Air Contaminants, addressing PELs which may be outdated provides OSHA with the authority to Subpart Z, Toxic and Hazardous and or inconsistent with the best promulgate health standards. It specifies Substances; Ex. #4. Approximately 30 available current science. The 1989 Air procedures that OSHA must use to have been adopted by OSHA as a part Contaminants rulemaking effort was promulgate, modify, or revoke its of a comprehensive standard, and supported by the American Industrial standards, including publishing the include a number of additional Hygiene Association (AIHA), the proposed rule in the Federal Register, requirements such as regulated areas, air American Conference of Governmental providing interested persons an sampling, medical monitoring, and Industrial Hygienists (ACGIH), and the opportunity to comment, and holding a training However, with few exceptions, American Public Health Association public hearing upon request. However, OSHA’s permissible exposure limits, (APHA), among many other professional much of the labor and analysis that goes (PELs), which specify the amount of a organizations and associations into the final rule starts before the particular chemical substance allowed representing both industry and labor. In publication of the proposal. Section in workplace air, have not been updated an October 2012 survey, members of the 6(b)(5) of the Act specifies: since they were established in 1971 AIHA identified updating OSHA PELs The Secretary, in promulgating standards under expedited procedures available in as their number one policy priority. The dealing with toxic materials or harmful the short period after the OSH Act’s U.S. Chamber of Commerce, in a letter physical agents under this subsection, shall adoption (see 29 CFR 1910.1000; Ex. #4, dated April 8, 2011 to then Deputy set the standard which most adequately 1915.1000; Ex. #5, and 1926.55; Ex. #6). Secretary of Labor, Seth Harris, also assures, to the extent feasible, on the basis of Yet, in many instances, scientific supported updating OSHA’s PELs. the best available evidence, that no employee evidence has accumulated suggesting Much has changed in the world since will suffer material impairment of health or that the current limits are not the OSH Act was signed in 1970. functional capacity even if such employee has regular exposure to the hazard dealt with sufficiently protective. Although OSHA However, workers are essentially by such standard for the period of his has attempted to update its PELs, the covered by the same PELs as they were working life. Development of standards Agency has not been successful, except forty years ago. And while OSHA has under this subsection shall be based upon through the promulgation of a relatively been given no new tools or increased research, demonstrations, experiments, and few substance-specific health standard resources to control workplace such other information as may be rulemakings (e.g., benzene, cadmium, exposures, it has had to conduct appropriate. In addition to the attainment of lead, and asbestos). increasingly complex analyses, which the highest degree of health and safety The most significant effort to update has effectively slowed the process. The protection for the employee, other considerations shall be the latest available the PELs occurred in 1989 when OSHA purpose of this RFI is for OSHA to scientific data in the field, the feasibility of tried to update many of its outdated solicit information as to the best the standards, and experience gained under PELs and to create new PELs for other approach(es) for the Agency to help this and other health and safety laws. substances in a single rulemaking employers and employees devise and Whenever practicable, the standard covering general industry PELs. After implement risk management strategies promulgated shall be expressed in terms of public notice and comment, the Agency to reduce or eliminate chemical objective criteria and of the performance published a general industry rule that exposures in the 21st century workplace desired. lowered PELs for 212 chemicals and environment. This is likely to involve a In general, as this provision has been added new PELs for 164 more (54 FR multi-faceted plan that may include construed by the courts, any workplace

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61387

health standard adopted by OSHA must lessened by a change in practices’’ require industry to meet PELs never meet the following requirements: before it can adopt a new standard. Id. attained anywhere.’’ Id. at 1264–65. (1) The standard must substantially Although the Court declined to Some courts have required OSHA to reduce a significant risk of material establish a set test for determining determine whether a standard is harm. whether a workplace is unsafe, it did technologically feasible on an industry- (2) Compliance with the standard state that a significant risk was one that by-industry basis, Color Pigments must be technically feasible. This means a reasonable person would consider Manufacturers Assoc. v. OSHA, 16 F.3d that the protective measures required by significant and ‘‘take appropriate steps 1157, 1162–63 (11th Cir. 1994; Ex. #13); the standard currently exist, can be to decrease or eliminate.’’ 448 U.S. at AFL–CIO v. OSHA, 965, F.2d 962, 981– brought into existence with available 655. For example, it said, a one in a 82 (11th Cir. 1992) (Air Contaminants; technology, or can be created with 1,000 risk would satisfy the Ex. #8). However, another court has technology that can reasonably be requirement. However, this example upheld technological feasibility findings developed. was merely an illustration, not a hard based on the nature of an activity across (3) Compliance with the standard line rule. The Court made it clear that many industries rather than on an must be economically feasible. This determining whether a risk was industry-by-industry basis, Public means that the standard will not ‘‘significant’’ was not a ‘‘mathematical Citizen Health Research Group v. threaten the industry’s long term straitjacket’’ and did not require the United States Department of Labor, 557 profitability or substantially alter its Agency to calculate the exact F.3d 165,178–79 (3d Cir. 2009; Ex. #14). With respect to economic feasibility, competitive structure. probability of harm. Id. The 1 ppm PEL the courts have stated ‘‘A standard is (4) It must reduce risk of adverse was vacated because OSHA had not feasible if it does not threaten massive health to workers to the extent feasible. made a significant risk finding at the 10 dislocation to . . . or imperil the ppm level. (5) The standard must be supported existence of the industry.’’ Lead I, 647 by substantial evidence in the record, Following the Benzene case, OSHA F.2d at 1265 (Ex. #12). In order to show consistent with prior agency practice or has satisfied the significant risk this, OSHA should ‘‘construct a is supported by some justification for requirement by estimating the risk to reasonable estimate of compliance costs departing from that practice. workers subject to a lifetime of exposure and demonstrate a reasonable likelihood The significant risk, economic and at various possible exposure levels. that these costs will not threaten the technological feasibility, and substantial These estimates have typically been existence or competitive structure of an evidence requirements are of particular based on quantitative risk assessments industry.’’ Id. at 1266. However, ‘‘[T]he relevance in setting PELs, and are in which OSHA, as a general policy, has court probably cannot expect hard and discussed further below. considered an excess risk of one death precise estimates of costs. Nevertheless, per 1000 workers over a 45-year the agency must of course provide a A. Significant Risk of a Material working lifetime as clearly representing Impairment: The Benzene Case reasonable assessment of the likely a significant risk. However, the Benzene range of costs of its standard, and the The significant risk requirement was case does not require OSHA to use such likely effects of those costs on the first articulated in a plurality decision of a benchmark. In the past, OSHA has industry.’’ Id. the Supreme Court in Industrial Union stated that a lower risk of death could While OSHA is not required to show Department, AFL–CIO v. American be considered significant. See, e.g., that all companies within an industry Petroleum Institute, 448 U.S. 607 (1980), Preamble to Formaldehyde Standard, 52 will be able to bear the burden of commonly referred to as the Benzene FR 46168, 46234 (suggesting that risk compliance, at least one court has held case. The petitioners challenged approaching six in a million could be that OSHA is required to show that the OSHA’s rule lowering the PEL for viewed as significant). (Ex. #11) rule is economically feasible on an benzene from 10 ppm to 1 ppm. In B. Technological and Economic industry-by-industry basis. Air support of the new PEL, OSHA found Feasibility Contaminants, 965 F.2d at 982, 986. (Ex. that benzene caused leukemia and that #8) the evidence did not show that there Under section 6(b)(5) of the Act, a was a safe threshold exposure level standard must protect against significant C. The Substantial Evidence Test below which no excess leukemia would risk, ‘‘to the extent feasible, and The ‘‘substantial evidence test’’ is occur; OSHA chose the new PEL of 1 feasibility is understood to have both used by the courts to determine whether ppm as the lowest feasible exposure technological and economic aspects. A OSHA has reached its burden of proof level. The Benzene Court rejected standard is technologically feasible if ‘‘a for policy decisions and factual OSHA’s approach, finding that the OSH typical firm will be able to develop and determinations. ‘‘Substantial evidence’’ Act only required that employers ensure install engineering and work practice is defined as ‘‘such relevant evidence as that their workplaces are safe, that is, controls that can meet the PEL in most a reasonable mind might accept as that their workers are not exposed to operations.’’ United Steelworkers v. adequate to support a conclusion.’’ ‘‘significant risk[s] of harm.’’ 448 U.S. at Marshall, 647 F.2d 1189, 1272 (D.C. Cir. American Textile Mfrs. Inst., Inc. v. 642 (Ex. #10). The Court also made it 1981) (‘‘Lead I’’; Ex. #12). OSHA must Donovan, 452 U.S. 490, 522 (1981; Ex. clear that it is OSHA’s burden to show the existence of ‘‘technology that #15) (quoting Universal Camera Corp. v. establish that a significant risk is is either already in use or has been NLRB, 340 U.S. 474, 477 (1951); Ex. present at the current standard before conceived and is reasonably capable of #16). The substantial evidence test does lowering a PEL, stating that the burden experimental refinement and not require ‘‘scientific certainty’’ before of proof is normally on the proponent. distribution within the standard’s promulgating a health standard (AFL– Thus, the Court held, before deadlines.’’ Id. Where the Agency CIO v. American Petroleum Institute, promulgating a health standard, OSHA presents ‘‘substantial evidence that 448 U.S. 607, 656 (1980); Ex. 10), but is required to make a ‘‘threshold finding companies acting vigorously and in the test does require OSHA to ‘‘identify that a place of employment is unsafe— good faith can develop the technology,’’ relevant factual evidence, to explain the in the sense that significant risks are the Agency is not bound to the logic and the policies underlying any present and can be eliminated or technological status quo, and ‘‘can legislative choice, to state candidly any

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61388 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

assumptions on which it relies, and to Contaminants final rule was only for each individual substance, discussed present its reasons for rejecting intended to update existing PELs or to over 2,000 studies, reviewed and significant contrary evidence and add PELs for substances within addressed all major comments argument.’’ Lead I, 647 F.2d. at 1207. established boundaries. After extensive submitted to the record, and provided a (Ex. #12) review of all available sources of rationale for each new PEL chosen. occupational exposure limits (OELs), OSHA estimated that over 21 million III. History of OSHA’s Efforts To OSHA selected the ACGIH’s 1987–88 employees were potentially exposed to Establish PELs TLVs as the boundaries for identifying hazardous substances in the workplace The history of OSHA’s PELs has three the substances that would be included and over 4.5 million employees were stages. First, OSHA adopted its current in the proposed rule. OSHA proposed exposed to levels above the applicable PELs in 1971, shortly after coming into 212 more protective PELs and new PELs exposure limits. OSHA projected that existence. Second, OSHA attempted to for 164 substances not previously the final rule would result in a potential update its PELs wholesale in 1989, but regulated. In general, rather than reduction of over 55,000 lost workdays that effort was rejected by the Eleventh performing a quantitative risk due to illnesses per year and that annual Circuit Court of Appeals in 1992. Third, assessment for each chemical, the compliance with this final rule would OSHA has made subsequent, smaller agency looked at whether studies prevent an average of 683 fatalities efforts to update certain PELs, but those showed excess effects of concern at annually from exposures to hazardous efforts have never come to fruition. This concentrations lower than allowed substances. history is summarized below, and under the existing standard. Where they C. The 1989 PELs Update Is Vacated by discussed in further detail in Appendix did, OSHA made a significant risk the Court of Appeals A. finding and either set a PEL (where The update to the Air Contaminants A. Adopting the PELs in 1971 none existed previously) or lowered the existing PEL. These new PELs were standard generally received widespread Under section 6(a), OSHA was based on Agency judgment, taking into support from both industry and labor. permitted an initial two-year window account the existing studies and, as However, there was dissatisfaction on after the passage of the OSH Act to appropriate, safety factors. Safety factors the part of some industry adopt ‘‘any national consensus standard (also called uncertainty factors) are representatives and union leaders, who and any established Federal standard’’ applied to the lowest level an effect is brought petitions for review challenging 29 U.S.C 655(6)(a). OSHA used this seen or to a level where no effects are the standard. For example, some authority in 1971 to establish PELs that seen to derive a PEL. industry petitioners argued that OSHA’s were adopted from federal health In order to determine whether the Air use of generic findings, the inclusion of standards originally set by the Contaminants rule was feasible, OSHA so many substances in one rulemaking, Department of Labor through the Walsh- prepared the regulatory impact analysis. and the allegedly insufficient time Healy Act, in which approximately 400 As part of the analysis, OSHA provided for comment by interested occupational exposure limits were performed an industry survey as well as parties created a record inadequate to selected based on ACGIH’s 1968 list of site visits. The survey was the largest support the new set of PELs. In contrast, Threshold Limit Values (TLVs). In survey ever conducted by OSHA and the unions challenged the approach addition, about 25 additional exposure included responses from 5,700 firms in used by OSHA to promulgate the limits recommended by the American industries believed to use chemicals standard and argued that several PELs Standards Association (now called the addressed in the scope of the Air were not protective enough. The unions American National Standards Institute) Contaminants proposal. (Ex. #18) It was also asserted that OSHA’s failure to (ANSI), were adopted as national designed to focus on industry sectors include any ancillary provisions, such consensus standards. that potentially had the highest as exposure monitoring and medical These standards were intended to compliance costs, identified through an surveillance, prevented employers from provide initial protections for workers analysis of existing exposure data at the ensuring the exposure limits were not from what the Congress deemed to be four-digit SIC (Standards Industrial exceeded, and resulted in less- the most dangerous workplace threats. Classification) code level. OSHA protective PELs. Congress found it was ‘‘essential that analyzed the data collected to determine Although only 23 of the 428 PELs such standards be constantly improved whether the updated PELs were both were challenged, the court ultimately and replaced as new knowledge and technologically and economically decided to vacate the entire rulemaking, techniques are developed.’’ S. Rep. 91– feasible for each industry sector finding that ‘‘OSHA [had] not 1282 at 6. (Ex. #17) However, because covered. sufficiently explained or supported its OSHA has been unable to update the For technological feasibility, OSHA threshold determination that exposure PELs, they remain frozen at the levels at found that ‘‘in the overwhelming to these substances at previous levels which they were initially adopted. majority of situations where air posed a significant risk of these material OSHA’s PELs are also largely based on contaminants [were] encountered by health impairments or that the new acute health effects and do not take into workers, compliance [could] be standard eliminates or reduces that risk consideration newer research regarding achieved by applying known to the extent feasible.’’ Air chronic health effects occurring at lower engineering control methods, and work Contaminants 965 F.2d at 986–987; Ex. occupational exposures. practice improvements.’’ 54 FR at 2789; #8 Ex. #7. For economic feasibility, OSHA With respect to significant risk, the B. The 1989 PELs Update assessed the economic impact of the court held that OSHA had failed to In 1989, OSHA published the Air standard on industry profits at the two- ‘‘explain why the studies mandated a Contaminants final rule, which remains digit SIC code level, and found the particular PEL chosen.’’ Id. at 976. the Agency’s most significant attempt at economic impact not to be significant, Specifically, the court stated that OSHA updating the PELs (54 FR 2332). (Ex. #7) and the new standard therefore failed to quantify the risk from Unlike typical substance-specific economically feasible. individual substances and merely rulemakings, where OSHA develops a In the Air Contaminants final rule, provided conclusory statements that the comprehensive standard, the Air OSHA summarized the health evidence new PEL would reduce a significant risk

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61389

of material health effects.’’ Id. at 975. estimates of cost can be extremely (iii) hydrazine, (iv) perchloroethylene, Further, the court rejected OSHA’s misleading in assessing the impact of (v) manganese, (vi) trimellitic argument that it had relied on safety particular standards on individual anhydride, and (vii) chloroprene. factors in setting the new PELs, stating industries’’ the court said, and Quantitative risk assessments were that OSHA had not adequately ‘‘analyzing the economic impact for an performed in-house, and research supported their use. The court observed entire sector could conceal particular (including site visits) was undertaken to that ‘‘the difference between the level industries laboring under special collect detailed data on uses, worker shown by the evidence and the final disabilities and likely to fail as a result exposures, exposure control technology PEL is sometimes substantial.’’ Id. at of enforcement.’’ Id. While OSHA might effectiveness, and economic 978. It said that OSHA had not ‘‘find and explain that certain impacts characteristics of affected industries. indicated ‘‘how the existing evidence and standards do apply to entire sectors The research and analysis were for individual substances was of an industry’’ if ‘‘coupled with a carried out over several years, after inadequate to show the extent of risk for showing that there are no which OSHA decided not to proceed these factors’’ and that the agency had disproportionately affected industries with rulemaking. (Ex. #22) This ‘‘failed to explain the method by which within the group,’’ OSHA had not decision was influenced by findings that its safety factors were determined.’’ Id. explained why its use of such a ‘‘broad (i) prevalence and intensity of worker ‘‘OSHA may use assumptions but only grouping was appropriate.’’ Id. at 982 exposures for some of the substances to the extent that those assumptions n.28, 983. (e.g., carbon disulfide and hydrazine) have some basis in reputable scientific had declined substantially since the D. Revising OSHA’s PELs in the Wake of evidence,’’ the court concluded. Id. at 1989 rule was promulgated; (ii) industry the Eleventh Circuit Decision 978–79. had voluntarily implemented controls to The Eleventh Circuit court also In the wake of the Eleventh Circuit’s reduce the exposure to safe levels; and rejected OSHA’s technological decision, OSHA has generally pursued a (iii) for others, substantial Agency feasibility findings. The Agency had conservative course in satisfying its resources would have been required to made these findings mainly at the two- judicially imposed analytical burdens. fully assess technological and economic digit SIC level, but also at the three- and The set of resulting analytical impacts. four- digit level where appropriate given approaches OSHA has engaged in is In 1997, OSHA held another meeting the processes involved. The court highly resource-intensive and has with industry and labor on the proposed rejected this approach, finding that constrained OSHA’s ability to prioritize PEL development process. Although the OSHA failed to make industry-specific its regulatory efforts based on risk of project did not result in a rulemaking to findings or identify the specific harm to workers. In 1995, OSHA made revise the PELs, OSHA gained valuable technologies capable of meeting the its first attempt following the Air experience in developing useful proposed limit in industry-specific Contaminants ruling to update a smaller approaches for quantifying non-cancer operations. Id. at 981. While OSHA had number of PELs using a more rigorous health risks through collaboration with identified primary air contaminant analysis of risk, workplace exposures, external reviewers in scientific peer control methods: Engineering controls, and technological and economic reviews of its risk analyses. OSHA is administrative controls and work feasibility. (Ex. #20) OSHA and the now examining ways to better address practices and personal protective National Institute for Occupational chemical exposures given current equipment, the agency, ‘‘only provided Safety and Health (NIOSH) conducted resource constraints and regulatory a general description of how the generic preliminary research on health risks limitations. engineering controls might be used in associated with exposure and extent of For readers who are interested in a the given sector.’’ Id. Though noting that occupational exposure. Sixty priority more detailed account of the legislation OSHA need only provide evidence substances were identified for further and court decisions that shaped OSHA’s sufficient to justify a ‘‘general examination and twenty of the sixty current regulatory framework, Appendix presumption of feasibility,’’ the court substances were selected to form a A to this Request for Information, held that this ‘‘does not grant OSHA priority list. Early in 1996, the Agency History, Legal Background and license to make overbroad generalities announced its plans for a stakeholder Significant Court Decisions, provides as to feasibility or to group large meeting, and identified the twenty additional information. Readers may categories of industries together without priority substances, as well as several want to consult Appendix A as they some explanation of why findings for risk-related discussion topics. (Ex. #21) frame responses to the questions posed the group adequately represents the During the meeting, almost all in this Request for Information. different industries in that group.’’ Id. at stakeholders from industry and labor IV. Reconsideration of Current 981–82. agreed that the PELs needed to be Rulemaking Processes The court rejected OSHA’s economic updated; however, not one group feasibility findings for similar reasons. completely supported OSHA’s As reviewed in Section II (Legal As discussed above, OSHA supported suggested approach. Overall, many of Requirements for OSHA Standards) and its economic feasibility findings for the the stakeholders did not support the Section III (History of OSHA’s Efforts to 1989 Air Contaminants rule based development of a list of priority Establish PELs), OSHA has to use the primarily on the results of a survey of chemicals targeted for potential best available evidence to make findings over 5700 businesses, summarizing the regulation and felt there was a lack of of significant risk, substantial projected cost of compliance at the two- transparency in the process for selecting reductions in risk, and technological digit SIC industry sector level. The court the initial chemicals. and economic feasibility under the Act. held that OSHA was required to show In response to stakeholder input and This section reviews how interpretation that the rule was economically feasible OSHA’s research, the agency selected of 6(b)(5) and subsequent case law has on an industry-by industry basis, and seven of the 20 substances discussed at resulted in the methods it uses when that OSHA had not shown that its the stakeholder meeting for detailed developing risk, technical feasibility, analyses at the two-digit SIC industry analysis of risks and feasibility. The and economic findings as well as the sector level were appropriate to meet chemicals selected were: (i) evidence OSHA has used in the past to this burden. Id. at 982. ‘‘[A]verage Glutaraldehyde, (ii) carbon disulfide, make these findings (i.e., OSHA’s use of

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61390 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

formal risk assessment modeling to example, OSHA’s risk assessment for understanding and debate about the evaluate significant risk, and the hexavalent chromium estimated that a health benefits of a new or revised Agency’s use of worker exposure data 45-year occupational exposure at the regulation. However, there are also and exposure control effectiveness data PEL of 5mg/m3 would lead to more than drawbacks to the model-based to evaluate technical feasibility and 10 lung cancer cases per 1000 workers approach, and there are situations costs of compliance). exposed. Because this risk exceeds the where a modeling analysis may not be This section also reviews value of one case of lung cancer per necessary or appropriate for OSHA to developments in science and technology 1000 exposed workers, OSHA found it make the significance of risk and how these new advancements may to be significant. The significance of risk determination to support a new or improve the scientific basis for making determinations of other rules since the revised regulation. Model-based risk findings of significant risk, technical Benzene decision have typically analyses tend to require a great deal of feasibility, and economic feasibility. As followed a similar logic. Agency time and resources. an example, the National Academies of Over the three decades since the In some cases, the model-based Science has released extensive reviews Benzene decision, OSHA has gradually approach is essential to OSHA’s of advances in science, toxicology, and built up a highly rigorous approach to significant risk determination, because risk and exposure assessment and derive quantitative estimates of risk it is not evident prior to a modeling evaluated how the Federal government such as those found in the hexavalent analysis whether there is significant risk can potentially utilize these chromium preamble. First, the Agency at current and technologically-feasible advancements in its decision-making reviews the available exposure-response exposures. In other cases, however, it processes (NRC, 2012; Ex. #23, NRC, data for a chemical of interest. It may be evident from the scientific 2009; Ex. #24, NRC, 2007; Ex. #25). evaluates the available data sets and literature or other readily available While new technologies will advance identifies those best suited for evidence that risk at the existing PEL is the public’s understanding in these quantitative analysis. Using the best clearly significant and that it can be critical areas, the Agency has available data, the Agency then substantially reduced by a more obligations under the OSH Act to make conducts extensive statistical analyses stringent regulation without the need for certain findings under 6(b)(5), as to develop an exposure-response model quantitative estimates extrapolated from discussed above in Section III. How that is able to extrapolate probability of an exposure-response model. In OSHA might utilize these new disease at exposures below the observed addition to reducing significant risk of developments to meet the Agency’s data. Once the model is developed, harm, the OSH Act also directs the evidentiary burden will be discussed in OSHA conducts further analyses to Agency to determine that health this section. evaluate the sensitivity of the model to standards for toxic chemicals are error and uncertainties in the modeling feasible. At times, it is evident without A. Considerations for Risk Assessment inputs and approach. The exposure- extensive analysis that the most Methods response model is used to generate stringent PEL feasible can only reduce, 1. Current Quantitative Risk Assessment estimates of risk associated with a not eliminate, significant risk. In such Methods Typically Used by OSHA To working lifetime of occupational cases, the value of a model-based Support 6(b) Single Substance exposure to the chemical of interest over quantitative risk assessment may not Rulemaking a range of PEL options that often warrant the Agency time and resources include exposure levels below those that model-based risk assessment As discussed in Section III, the considered to be technologically requires. Supreme Court requires OSHA to feasible. The entire risk assessment has In situations described above where determine that a significant risk exists always been subject to peer review, from the PEL may be set at the lowest feasible before adopting an occupational safety choice of data set(s) through generation level, OSHA believes that it can and health standard. While the Court of lifetime risk estimates.When the establish significant risk more did not stipulate a means to distinguish proposed rule is released for comment, efficiently instead of relying on significant from insignificant risks, it it receives additional scrutiny from the probabilistic estimates from dose- broadly described the range of risks scientific community, stakeholders, and response modeling as described above. OSHA might determine to be the general public. The Agency uses the OSHA is exploring a number of more significant: feedback of the peer review panel and flexible, scientifically accepted It is the Agency’s responsibility to public comment at the time of proposal approaches that may streamline the risk determine in the first instance what it to further test and develop the risk assessment process and increase the considers to be a ‘‘significant’’ risk. Some analysis. capacity to address a greater number of risks are plainly acceptable and others are This model-based approach to risk chemicals. plainly unacceptable. If, for example, the assessment has a number of important Question IV.A.1: OSHA seeks input odds are one in a billion that a person will advantages. The quantitative risk on the risk assessment process die from cancer by taking a drink of estimates can be easily compared with described above. When is a model-based chlorinated water, the risk clearly could not be considered significant. On the other hand, the level of 1 in 1000 that the Court analysis necessary or appropriate to if the odds are one in a thousand that regular cited as an example of significant risk. determine significance of risk and to inhalation of gasoline vapors that are 2 Sometimes, the best available data come select a new or revised PEL? When percent benzene will be fatal, a reasonable from worker or animal populations with should simpler approaches be person might well consider the risk exposure levels far above the employed? Are there specific significant and take the appropriate steps to technologically feasible levels for which approaches OSHA should consider decrease or eliminate it. (Benzene, 448 U.S. OSHA must evaluate risk, and a risk using when a model-based analysis is at 655). (Ex. #10), model is used to extrapolate from high not required? To the extent possible, OSHA has interpreted the Court’s to low exposures. When large, high- please provide detailed explanation and example to mean that a 1 in 1000 risk quality exposure-response data sets are examples of situations when a model- of serious illness is significant, and has available, a rigorous quantitative based risk analysis is or is not necessary used this measure to guide its analysis can yield robust and fairly to determine significance of risk and to significance of risk determinations. For precise risk estimates to inform public develop a new standard.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61391

2. Proposed Tiered Approach to Risk the range of feasible exposures is in risk below the observed range for Assessment in Support of Updating close proximity to the exposures where carcinogens. As mentioned earlier, the PELs for Chemical Substances toxicity is observed (i.e., a low MOE) Agency develops appropriate exposure- a. General Description and Rationale of then it may not be necessary to response models (linear or non-linear) Tiered Approach extrapolate exposure-response below that best fit the existing data and are the observed range in order to establish consistent with available information on OSHA is considering a tiered process significant risk. In this situation, OSHA mode of action. The models can be used to exposure-response assessment that would set the PEL at the exposure level to extrapolate risk associated with a may enable the agency to more it determines to be feasible and the working lifetime at occupational efficiently make the significant risk dose-response analysis in the observed exposures below the observed range. findings needed to establish acceptable range should be sufficient to support In some situations, the LETE is further PELs for larger numbers of workplace Agency significant risk findings. The adjusted to calculate worker equivalent chemicals. The approach involves three PEL is set at the lowest feasible level, exposures and to account for how the stages: dose-response analysis in the with the understanding that significant chemical is absorbed, distributed, and observed range, margin of exposure risk of adverse health outcomes remains metabolized, and interacts with target determination, and exposure-response at the new PEL. In the traditional risk tissues in the body. These features and extrapolation (if needed). The process assessment approach described other important issues related to the overlaps with the risk-based previously, OSHA uses quantitative tiered approach to exposure-response methodologies employed by EPA IRIS, exposure-response modeling to estimate assessment are discussed below. OSHA NIOSH, the Agency for Toxic risks below the range of observed believes that there are a number of Substances Disease Registry (ATSDR), exposure, without regard to whether potential advantages to using a tiered the European Union Registration, such exposures are considered to be risk assessment framework including Evaluation, Authorization, and technologically feasible. If the lowest opportunities to rely more heavily on Restriction of Chemicals (REACH) technologically feasible workplace peer-reviewed risk assessments already program, and other organizations that exposures are determined to be far prepared by other Federal agencies. recommend chemical toxicity values or below the LETE (i.e., a high MOE), an b. Hazard Identification and Dose- exposure levels protective of human exposure-response model would be health. The first step is dose-response Response Analysis in the Observed needed to determine significant risk at Range analysis in the observed range. During exposures below the observed range and this step, OSHA analyzes exposures (or to set the appropriate PEL. Hazard identification is the first step doses) and adverse outcomes from If there is a high MOE, then the in the Federal risk assessment human studies or animal bioassays, Agency would move onto the final stage framework as laid out by the National particularly at the lower end of the of the tiered approach, which is Research Council’s ‘red book’ in 1983 exposure range. This involves the exposure-response extrapolation, where (NRC, 1983; Ex. #28). In conducting a derivation of a ‘‘low-end toxicity the dose-response relationship is hazard identification, OSHA evaluates exposure’’ (LETE), which is discussed extrapolated outside the observed range. individual study quality and determines further in section IV.A.2.c. below. Many regulatory agencies, such as EPA, the weight of evidence from The second step is margin of exposure choose to extrapolate outside the epidemiological, experimental, and determination, where LETEs are observed range for non-cancer health supporting data. Study quality favors compared with the range of possible outcomes by applying a series of strong methodology, characterization of exposure limits that OSHA believes to extrapolation factors, also called exposure during critical periods, be feasible for the new or proposed uncertainty factors, to an observed low- adequate sample size/statistical power, standard. Typically, there is a close and end toxicity value, referred to as a point and relevance to the workplace ongoing dialogue between those OSHA of departure (POD). The POD is very population. OSHA gives weight to both technical staff and management similar to the LETE described above. positive and negative studies according responsible for the risk assessment and The distinction between these toxicity to study quality when the Agency their counterparts responsible for the values is discussed later in the evaluates the association between feasibility analyses as the separate subsection. The extrapolation factors are chemical agent and an adverse health determinations are being further explained below. effect. OSHA determines causality based simultaneously developed. Feasibility In many instances, EPA does not use on criteria developed by Bradford Hill analyses, in particular, can take years of the extrapolation factor approach for (Hill, 1965; Ex. #29, Rothman & research, including site visits and cancer effects. Rather, EPA uses dose- Greenland, 1998; Ex. #30). In its review industry surveys. In many of OSHA’s response modeling in the observed of the available evidence, OSHA rulemakings, the lowest feasible PEL range and a linear extrapolation below assesses the chemical’s modes of action can only reduce, not eliminate, the observed range to derive a unit risk (MOA) and the key molecular, significant risk. Thus, OSHA sets many (i.e., risk per unit of exposure). As biological, pathological, and clinical PELs at the lowest feasible level, and described previously, OSHA also uses endpoints that contribute to the health not at a level of occupational exposure dose-response modeling to extrapolate effects of concern. considered to be without significant risk below the observed range for The Mode of Action (MOA) is a risk. This significant risk orientation carcinogens as was done for hexavalent sequence of key events and processes differs from other Federal Agencies, chromium (71 FR 10174–10221; Ex. starting with the interaction of the agent such as EPA and ATSDR that set #26) and methylene chloride (62 FR with a molecular or cellular target(s) environmental exposure levels 1516–1560; Ex. #27). There is a and proceeding through operational and determined to be health protective reasonable body of scientific evidence anatomical changes that result in an without consideration of feasibility. that genotoxic carcinogens, and perhaps adverse health effect(s) of concern. The OSHA is considering using a margin other carcinogenic modes of action, key events are empirically measurable of exposure (MOE) approach to compare display linear, non-threshold behavior molecular or pathological endpoints and the LETE with the range of feasible at very low dose levels. OSHA also uses outcomes in experimental systems. exposure limits. If the MOE indicates dose-response modeling to extrapolate These represent necessary precursor

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61392 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

steps or biologically-based markers study evaluations to support non- MOE to evaluate the need for low dose along the progression to frank illness occupational risk assessments, OSHA extrapolation as described in the next and injury. believes that, in most cases, these section. MOA informs selection of appropriate evaluations can be adapted to the Traditionally, either the Lowest toxicity-related endpoints and models occupational context. Observed Adverse Effect Level (LOAEL) for dose-response analysis. OSHA then Question IV.A.2: If there is no OSHA or No Observed Adverse Effect Levels conducts a dose-response analysis for PEL for a particular substance used in (NOAEL) has served as easily obtainable critical health effects determined to be your facility, does your company/firm LETE descriptors. More recently, the associated with a chemical, provided develop and/or use internal Benchmark Dose (BMD) methodology there are suitable data available. Dose- occupational exposure limits (OELs)? If has increasingly been applied to derive response analysis requires quantitative so, what is the basis and process for an LETE. The BMD approach uses a measures of both exposure and toxicity- establishing the OEL? Do you use an standard set of empirical models to related endpoints. OSHA gives authoritative source, or do you conduct determine the dose associated with a preference to studies with relevant a risk assessment? If so, what sources pre-selected benchmark response (BMR) occupational routes that display a well- and risk assessment approaches are level. An example is the dose associated defined dose-related change in response applied? What criteria do facilities/firms with a 10 percent incidence (i.e., with adequate power to detect effects at consider when deciding which BMD10) and the statistical lower the exposure levels of interest. The authoritative source to use? For confidence limit (i.e., BMDL10). Agency generally prefers high quality example, is rigorous scientific peer Selection of an appropriate BMR epidemiologic studies for dose-response review of the OEL an important factor? considers biologic as well as statistical analysis over experimental animal Is transparency of how the OEL was factors and a lower BMR is typically models, provided there is adequate developed important? applied for clinically serious outcomes exposure information and confounding Question IV.A.3: OSHA is considering (e.g., lung or heart disease) than for less factors are appropriately controlled. greater reliance on peer-reviewed serious adverse effects (e.g., preclinical OSHA may only adopt standards for toxicological evaluations by other loss of neurological or pulmonary exposure to ‘‘toxic materials and Federal agencies, such as NIOSH, EPA, function). In some cases, more harmful physical agents’’ that causes ATSDR, NIEHS and NTP for hazard sophisticated models can be used in the ‘‘material impairment of health and loss identification and dose-response LETE determination, based on of functional capacity even if such analysis in the observed range. What physiologically-based toxicokinetics, employee has regular exposure to the advantages and disadvantages would toxicodynamics, or dosimetry models hazard dealt with by such standard for result from this approach and could it that relate the administered dose to a the period of his working life.’’ OSH Act be used in support of the PEL update more toxicologically relevant dose § 6(b)(5) (Ex. #9) Therefore, its dose- process? metric at a biological target site, if response analysis considers those c. Derivation of Low-End Toxicity sufficient data is available and the biological endpoints and health Exposure (LETE) models are appropriately validated. This outcomes that can lead to adverse is discussed further below. physiological or clinical harm caused by An important aspect of the dose- Question IV.A.4: OSHA is considering continued exposure over a working response analysis is the determination using the Point of Departure (POD) (e.g., lifetime. This includes key molecular of exposures that can result in adverse BMD, LOAEL, NOAEL), commonly and cellular biomarkers established as outcomes of interest. For most studies, employed by other authoritative necessary precursor events along a response rates ranging from 1 to 10 organizations for carrying out non- critical disease pathway. It is important percent represent the low end of the cancer risk assessments as a suitable that the toxicity-related endpoints observed range. Epidemiologic studies descriptor of the Low End Toxicity observed in experimental animals generally are larger and can show a Exposure (LETE) level that represents a selected for dose-response analysis have lower observed response rate than significant risk of harm. Is this an relevance to humans and are not unique animal studies, which typically have appropriate application of the POD by to the test species. fewer test subjects. EPA, ATSDR and EU OSHA? Are there other exposure values In the past, OSHA, for the most part, REACH also derive an estimated dose at that OSHA should consider for its has undertaken an independent the low end of the observed range (i.e., LETE? evaluation of the evidence in its LETE) as part of their dose-response In many situations, the LETE must be identification of hazards and selection assessments. This dose is referred to as adjusted to represent a typical worker of critical studies and toxicity-related the POD (‘point of departure’) because it exposure. The most common endpoints for dose-response analysis. is used as a starting point for low dose adjustments are to correct for the However, other Federal agencies use the extrapolation or the application of standard occupational exposure same risk assessment framework with uncertainty factors as described above to conditions of eight hours a day/five similar hazard identification and dose- derive toxicity values. EPA, ATSDR and days a week and/or respiratory volume response selection procedures. EPA, EU REACH use the POD/extrapolation during work activity. OSHA and NIOSH ATSDR, NIOSH and others have active factor approach to determine Reference have used a standard ventilation rate of risk assessment programs and have Concentrations (RfC), Minimal Risk 10 m3 of air per 8-hour work shift for recently evaluated many chemicals of Levels (MRL) and Derived No Effect a typical worker undergoing light interest to OSHA. These assessments Levels (DNELs), respectively. OSHA physical work activity. undergo scientific peer review and are believes the LETE is an exposure where Allometric scaling (i.e., BW3/4) is subject to public comment. The Agency studies may have demonstrated recommended by some Federal is considering ways to reduce the time significant risk. However, OSHA does authorities when scaling animal doses and resources needed to independently not intend to use the LETE as the point to human equivalents to account for evaluate the available study data by of extrapolation for determining a ‘‘safe’’ toxicokinetic differences in rates of placing greater reliance on the efforts of exposure level in the manner used by absorption, metabolism, and excretion other credible scientific organizations. the aforementioned agencies. OSHA when more specific data is lacking. Although some organizations use their may use the LETE in calculating an Allometric scaling refers to scaling

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61393

physiological rates and quantities to especially from studies in animals or LTFE likely leads to significant risk of mass or volume of one animal species other experimental systems? harm. In this situation, OSHA would set to another animal species. The The worker-adjusted LETE that is the PEL at the exposure level it relationship is generally dependent on derived from dose-response analysis in determines to be feasible and the dose- body weight (BW), often in the form of the observed range should be regarded response analysis in the observed range y=BWa where y is the physiological as a chemical exposure level that leads should be sufficient to support Agency measure and a is the scaling to significant risk of harm. In most significant risk findings. component. Many physiological and cases, the LETE is expected to elicit a There are several factors that OSHA biochemical processes (such as heart toxic response in 1 to 10 percent of the would need to consider in order to find rate, basal metabolic rate, and worker population. This approximates that the MOE is adequate to avoid low- respiration rate have been found to have an excess risk of 10 to 100 cases of dose risk extrapolation. These include a scaling component of 0.75. impairment per 1000 exposed workers the nature of the adverse outcome, the Allometric scaling is most applicable over a duration that is typically less magnitude of the effect, the when the toxicologically relevant dose than a 45-year working life. This degree methodological designs and is a parent compound or stable of risk would exceed the 1 per 1000 experimental models of the selected metabolite whose absorption rate and probability that OSHA historically studies, the exposure metric associated clearance from the target site is regards as a clearly significant risk. with the outcome, and the exposure period over which the outcome was controlled primarily by first order d. Margin of Exposure (MOE) as a studied. OSHA may regard a larger MOE processes. Allometric scaling is less Decision Tool for Low Dose as acceptable to avoid the need for low- well suited for portal-of-entry effects or Extrapolation when toxicity is a consequence of a dose extrapolation for serious clinical As discussed previously, OSHA’s highly reactive compound or metabolite. effects than a less serious subclinical statutory and legal obligations dictate Portal of entry refers to the tissue or outcome. A larger MOE may also be that PELs be set at the level that found acceptable for irreversible health organ of first contact between the eliminates significant risk, if feasible, or biological system and the agent. This is outcomes that continue to progress with if not, at the lowest feasible level. continued exposure and respond poorly nasal, respiratory tract and pulmonary Therefore, Agency risk assessments are tissues for inhalation; skin for dermal to treatment than reversible health directed at determining significant risk outcomes that do not progress with contact, and mouth and digestive tract at these feasible exposures. Because of for oral exposure. further exposure. Health outcomes that the feasibility constraints, low dose relate to cumulative exposures would In the case of respiratory tract effects extrapolation is not always needed to tolerate higher MOEs than similar from inhalation, EPA recommends make the required risk findings. The outcomes unrelated to cumulative adjusting inhalation doses based on OSHA significant risk orientation differs exposure, especially in short-term generic dosimetry modeling that from other Federal Agencies, such as studies. In some instances, an adverse depends on the form of the chemical EPA and ATSDR. The risk-based EPA outcome observed in experimental (e.g., particle of gas) and site of toxicity RfCs and ATSDR MRLs are intended as animals would tolerate higher MOEs (e.g., portal of entry or systemic) (EPA, environmental exposure levels than the same response in a human 1994; Ex. #31). For example, the human determined to be health protective study that more closely resembles the equivalent for a reactive gas that exerts without consideration of feasibility. occupational situation. its toxic effect on the respiratory tract is NIOSH also develops workplace Other Federal agencies apply the scaled based on animal to human exposure limits. These recommended MOE approach as part of the risk differences in ventilation rate and exposure limits (RELs) are based on risk assessment process. EPA has included regional surface area of the respiratory evaluations using human or animal MOE calculations in risk tract. On the other hand, the dosimetry health effects data. The exposure levels characterizations of environmental model adjustment for an insoluble gas that can be achieved by engineering exposure scenarios to assist in risk that exerts its effect in a tissue remote controls and measured by analytical management decisions (EPA, 2005; Ex. from the lung is scaled by species techniques are considered in the #32). The EU has also applied a very differences in the blood: gas partition development of RELs, but the similar Margin of Safety analysis to coefficient. The generic dosimetry recommended levels are often below characterize results of risk assessment models can accommodate specific what OSHA regards as technologically conclusions (ECB, 2003; Ex. #33). In its chemical data, if available. The models feasible. report on the appropriate uses of risk are only intended to account for human- A MOE approach can assist in assessment and risk management in to-animal differences in bioavailability determining the need to extrapolate risk federal regulatory programs, the and further allometric or extrapolation below the observed range. The Presidential Commission on Risk factors may be needed to account for appropriate MOE for use as a decision Assessment and Risk Management species differences in metabolic tool for low dose extrapolation is the recommended MOE as an approach that activation and toxicodynamics (i.e., LETE divided by an estimate of the provides a common metric for target site sensitivity to an equivalent lowest technologically feasible exposure comparing health risks across different delivered dose). (LTFE). A large MOE (i.e., LETE/LTFE toxicities and public health programs Question IV.A.5: Several ratio) means the LTFE is considerably (PCRARM, 1997; Ex. #34). methodologies have been utilized to below exposures observed to cause Question IV.A.6: OSHA is considering adjust critical study exposures to a adverse outcomes along a critical a Margin of Exposure approach that worker equivalent under representative toxicity pathway. This situation would compares the LETE with the Lowest occupational exposure conditions require low-dose risk extrapolation to Technologically Feasible Exposure including standard ventilation rates, determine whether technologically (LTFE) as a decision tool for low dose allometric scaling, and toxicokinetic feasible exposures lead to significant extrapolation. Is this a reasonable means modeling. What are reasonable and risk. A small MOE means the LTFE of determining if further low dose acceptable methods to determine worker estimate is reasonably close to the extrapolation methods are needed to equivalent exposure concentrations, observed toxic exposures indicating the meet agency significant risk findings?

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61394 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

What other approaches should be Contaminants 965 F.2d at 978.( Ex. #8) 3. Chemical Grouping for Risk considered? Since the court ruling, the uncertainty Assessment e. Extrapolation Below the Observed factor approach has undergone OSHA is also considering the use of Range considerable refinement. The scientific one or more chemical grouping considerations for applying individual approaches to expedite the risk The last step in the tiered approach is factors have been carefully articulated extrapolation of risk below the observed assessment process. In certain cases, it by EPA and other scientific authorities range. This low-dose extrapolation may be appropriate to extrapolate data in various guidance materials (EPA, would only be needed if the MOE is about one chemical across a group or sufficiently high to warrant further 2002; Ex. #35, IPCS, 2005; Ex. #36, category of similar chemicals. These dose-response analysis. This situation ECHA, 2012a; Ex. #37). For some factors approaches are discussed below. under certain circumstances, it is being occurs when technologically feasible a. Background on Chemical Grouping exposures are far below the LETE and proposed that standard ‘default’ values quantitative estimates of risk could be can be replaced with ‘data-driven’ The term ‘grouping’ or ‘chemical highly informative in the determination values (EPA, 2011; Ex. #38). However, grouping’ describes the general of significant risk. As described in the type and magnitude of the approach to assessing more than one subsection A.1, OSHA has historically uncertainty factor employed for any chemical at the same time. It can used probabilistic risk modeling to individual substance still requires a include formation of a chemical quantitatively estimate risks at exposure degree of scientific judgment. The category or identification of a chemical levels below the observed range. methodology does not provide analogue (OECD, 2007; Ex. #39). Chemical categories or analogues can be Depending on the nature of the quantitative exposure-specific estimates based on the structural relationship exposure-response data, the Agency has of risk, such as one in a thousand, that between the chemicals being grouped. relied on a wide range of different can readily be compared to the models that have included linear Structure-activity relationships (SAR) significant risk probabilities discussed are relationships between a compound’s relative risk (e.g., hexavalent chromium/ in the Benzene decision. lung cancer), logistic regression (e.g., chemical structure and physicochemical cadmium/kidney dysfunction), and The National Research Council’s properties and its biological effects (e.g., physiologically-based pharmacokinetic Science and Decisions report recently cancer) on living systems. Structurally (e.g., methylene chloride/cancer) advocated a dose-response framework diverse chemicals can sometimes be approaches. that provides quantitative risk estimates grouped for risk analysis based on a Probabilistic risk models can require by applying distributions instead of common mechanism/mode of action or considerable time and resources to ‘single value’ factors (NRC, 2009; Ex. metabolic activation pathway (i.e., construct, parameterize, and statistically #24). The critical extrapolation factors, mechanism/mode of action clustering). verify against appropriate study data, such as species differences in toxic Endpoint information for one chemical especially for a large number of response at equivalent target doses and is used to predict the same endpoint for chemical substances. As mentioned inter-individual variability in the another chemical, which is considered previously, several government human population are defined by to be ‘‘similar’’ in some way (usually on authorities responsible for managing the lognormal distribution with an the basis of structural similarity and similar properties and/or activities). risk to human populations posed by estimated standard deviation. This A chemical category is a group of hazardous chemicals commonly use the allows the human equivalent LETE to be computationally less complex chemicals whose physical-chemical, derived in terms of a median and uncertainty factor approach to human health, environmental, statistical lower confidence bound. The extrapolate dose-response below the toxicological, and/or environmental fate observed range. The uncertainty factors distributional nature of the analysis properties are likely to be similar or account for variability in response facilitates extrapolation in terms of a follow a regular pattern as a result of within the human population, probabilistic projection of average and structural similarity, structural uncertainty with regard to the upper bound risk at specific exposures, relationship, or other characteristic(s). A differences between experimental such as X number of individuals chemical category is selected based on animals and humans, and uncertainty projected to develop disease out of 1000 the hypothesis that the properties of a associated with various other data workers exposed to Z level of a toxic series of chemicals with common inferences made in the assessment. For substance within some confidence level features will show coherent trends in each of these considerations, a Y. The NRC report describes several their physical-chemical properties, and numerical value is assigned and the different conceptual models with case more importantly, in their toxicological point of departure is divided by the examples and extrapolation factor effects (OECD, 2007; Ex. #39). product of all applied uncertainty distribution calculations (NRC, 2009; The use of a category approach means factors. The result is an exposure level Ex. #24). that it is possible to identify chemical considered to be without appreciable properties which are common to at least Question IV.A.7: Can the uncertainty risk. OSHA attempted to apply some members of the category. This factor methodology for extrapolating uncertainty factors in the 1989 Air approach provides a basis for Contaminants Rule to ensure that new below the observed range for non-cancer establishing trends in properties across PELs were set at levels that were effects be successfully adapted by that category and extends the measured sufficiently below exposures observed OSHA to streamline its risk assessment data (e.g., toxicological endpoint) to to cause health effects. The Eleventh process for the purpose of setting similar untested chemicals. Circuit ruled that OSHA had failed to updated PELs? Why or why not? Are In the category approach, not every show how uncertainty factors addressed there advantages and disadvantages to chemical in a group needs to have the extent of risk posed by individual applying extrapolation factor exposure-response data in order to be substances and that similarly, OSHA distributions rather than single evaluated. Rather, the overall data for failed to explain the method it used to uncertainty factor values? Please the category as a whole must prove derive the safety factors. Air explain your reasoning. adequate to support a risk assessment.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61395

The overall data set must allow for an (the source chemical) to predict the been used for determining aquatic assessment of risk for the compounds same endpoint for another chemical (the toxicity or genotoxicity but can be used and adverse outcomes that lack target chemical), which is considered to for evaluating other endpoints as well adequate study. Chemicals may be be ‘‘similar’’ in some way (usually on (OECD, 2007; Ex. #39). grouped for risk assessment based on the basis of structural similarity or on Question IV.A.8: Are QSAR, read- the following: the basis of the same mode or • across, and trend analysis acceptable Common functional group (e.g., mechanisms of action). Read-across methods for developing risk aldehyde, epoxide, ester, specific metal methods have been used to assess assessments for a category of chemicals ion); physicochemical properties and toxicity with similar structural alerts (chemical • Common constituents or chemical in a qualitative or quantitative manner. groupings known to be associated with classes, similar carbon range numbers; The main application for qualitative a particular type of toxic effect, e.g., • Incremental and constant change read-across is in hazard identification. across the category (e.g., a chain-length mutagenicity) or other toxicologically- category); ii. Trend Analysis relevant physiochemical attributes? • The likelihood of common Chemical category members are often Why or why not? Are there other precursors and/or breakdown products, related by a trend (e.g., increasing, suitable approaches? via physical or biological processes, decreasing or constant) for any specific iv. Threshold of Toxicological Concern which result in structurally similar endpoint. The relationship of the (TTC) chemicals (e.g., the metabolic pathway categorical trend could be molecular approach of examining related mass, carbon chain length, or to some The Threshold of Toxicological chemicals such as acid/ester/salt). other physicochemical property. Concern (TTC) refers to the Within a chemical category, data gaps The observation of a trend (increasing, establishment of an exposure level for a may be filled by read-across, trend decreasing or constant) in the group of chemicals below which there analysis and Quantitative Structure- experimental data for a given endpoint would be no appreciable risk to human Activity Relationships (QSARs) and across chemicals can be used as the health. The original concept proposed threshold of toxicological concern. In basis for interpolation and possibly also that a low level of exposure with a some cases, an effect can be present for extrapolation to fill data gaps for negligible risk can be identified for some but not all members of the chemicals with little to no data. many chemicals, including those of category. An example is the glycol Interpolation is the estimation of a value unknown toxicity, based on knowledge ethers, where the lower carbon chain for a member using measured values of their chemical structures. The TTC length members of the category indicate from other members on ‘‘both sides’’ of approach is a form of risk reproductive toxicity but the higher that member within the defined characterization in which uncertainties carbon chain length members of the category spectrum, whereas arising from the use of data on other category do not. In other cases, the extrapolation refers to the estimation of compounds are balanced against the low category may show a consistent trend a value for a member that is near or at level of exposure. The approach was where the resulting potencies lead to the category boundary using measured initially developed by the FDA for different classifications (OECD, 2007; values from internal category members migration of chemicals from consumer Ex. #39). (OECD, 2007; Ex. #39). packaging into food products and used a single threshold value of 1.5mg/day b. Methods of Gap Analysis and Filling iii. QSAR (referred to as the threshold of As a result of grouping chemicals A Quantitative Structure-Activity regulation). based on similarities determined when Relationship (QSAR) is a quantitative The TTC principle extends the employing the various techniques as relationship between a numerical concept used in setting acceptable daily described above, data gap filling in a measure of chemical structure, and/or a allowable intakes (ADIs) by proposing chemical category can be carried out by physicochemical property, and an that a de minimis value can be applying one or more of the following effect/activity. QSARs use mathematical identified for chemicals with little to no procedures: read-across, trend analysis, calculations to make predictions of toxicity data utilizing information from quantitative (Q)SARs and threshold of effects/activities that are either on a structurally related chemicals with toxicological concern (TTC). continuous scale or on a categorical scale. ‘‘Quantitative’’ refers to the nature known toxicities. i. Read-Across Method of the relationship between structurally A decision tree can be developed to The read-across approach uses related chemicals, not the endpoint apply the TTC principle for risk endpoint information for one chemical being predicted. Most often QSARs have assessment decisions:

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61396 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

For OSHA purposes the TTC toxicity data to risk-based decision California’s EPA Office of approach could be adapted to develop making are laid out in landmark reports Environmental Health Hazard an endpoint-specific LETE value for by the National Research Council (NRC, Assessment. The objectives of NexGen chemicals in a specific category where 2009; Ex. #24, NRC, 2007; Ex. #25). A are to pilot the new NRC risk little to no toxicity data exist utilizing collaborative Federal initiative known assessment framework, refine existing source chemicals within the category as ‘‘Tox21’’ has been established bioinformatics systems, and develop where toxicity data is available. between the National Toxicology specific prototype health risk Program (NTP), the EPA Office of assessments. These objectives are 4. Use of Systems Biology and Other Research and Development, the NIH expected to be achieved through an Emerging Test Data in Risk Assessment Chemical Genomics Center (NCGC), and iterative development process that includes discussion with scientists, risk Toxicity testing is undergoing the Food and Drug Administration managers, and stakeholders. transformation from an approach (FDA) to collaborate on development, validation, and translation of innovative Question IV.A.9: How should OSHA primarily based on pathological utilize the new molecular-based toxicity HTS methods to characterize key steps outcomes in experimental animal data, high throughput and computer- in toxicity pathways (NTP, 2013; Ex. studies to a more predictive paradigm based computational approaches being #40). Tox21 has already screened over a that characterizes critical molecular/ generated on many workplace chemicals cellular perturbations in toxicity 1000 compounds in more than 50 and the updated NRC risk-based pathways using in vitro test systems. quantitative HTS assays that have been decision making framework to inform The paradigm shift is being largely made available to the scientific future Agency risk assessments? driven by the technological advances in community through publically molecular systems biology such as the accessible databases (e.g., EPA ACToR, B. Considerations for Technological use of high throughput screening (HTS) NTP CEBS). EPA has launched a Feasibility assays, new computational methods to program, known as ‘‘NexGen’’, to Before adopting a particular predict chemical properties, and implement the NRC vision and advance regulatory alternative, the Agency must computer models able to associate the next generation of risk assessment demonstrate that it is technologically molecular events with a biological (EPA, 2013b; Ex. #41). NexGen is a feasible. As OSHA currently performs it, response. The vision, strategies, and partnership among EPA, NTP, NCGC, a technological feasibility analysis is frameworks for applying the new AND FDA, along with ATSDR and often one of the most resource-intensive

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 EP10OC14.000 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61397

aspects of the rulemaking process. The and engineering control feasibility work environment and to evaluate the Agency must identify all of the studies, effectiveness of engineering and other industries that are potentially affected • Site visits, conducted by OSHA, process control measures. and compile the available information NIOSH, or supporting contractors, Exposure profiles are used to establish on current worker exposure and existing • Information from other the baseline exposure conditions for controls for each industry. On occasion, stakeholders, such as federal and state every job category in affected industries. the best information available for agencies, labor organizations, industry Baseline conditions are developed to technological feasibility analyses comes associations, and consensus standards, allow the Agency to estimate the extent from sparse and incomplete data sets. • Unpublished information, such as to which additional controls will be Rather than rely exclusively on such personal communications, meetings, required to achieve a level specified by variable information, OSHA is and presentations, and a regulatory alternative. • considering the use of exposure OSHA Integrated Management Next, the technological feasibility modeling, such as computational fluid Information System (IMIS) data. analysis describes the additional dynamics (CFD) modeling, for a more With this information, OSHA creates controls necessary to achieve the complete picture of worker exposures profiles that identify the industries regulatory alternatives. OSHA relies on and the potential effectiveness of where exposures occur, what operations its traditional hierarchy of controls different control strategies. lead to exposures, and what engineering when demonstrating the feasibility of Additionally, OSHA is looking at other controls and work practices are being control technology. The traditional implemented to mitigate exposures. A sources of information, such as the hierarchy of controls includes, in order technological feasibility analysis is REACH initiative from the European of preference: Substitution, local typically organized by industry sector or Union, that may help the Agency to exhaust ventilation, dust suppression, group of sectors that performs a unique better characterize industries or jobs process enclosures, work practices, and activity involving similar activities. where there is little to no data on housekeeping. OSHA considers use of OSHA identifies the operations that lead worker exposures and control personal protective equipment, such as to exposures in all of these industries, technologies. respirators, to be is the least effective and eventually determines the method for controlling employee 1. Legal Background of Technological feasibility of a PEL by analyzing exposure, and therefore, personal Feasibility whether the PEL can be achieved in protective equipment is considered only OSHA must demonstrate that a PEL, most operations most of the time, as an for limited situations in which all as well as any ancillary provisions, to aggregate across all industries affected. feasible engineering controls have been the extend they are being adopted, are OSHA has also utilized an application implemented, but do not effectively feasible. In general, OSHA determines approach that evaluates the feasibility of reduce exposure to below the that a regulatory alternative is controls for a specific type of process permissible exposure limit. To identify technologically feasible when it has used across a number of industry what additional controls are feasible, evidence that demonstrates the sectors, such as welding, rather than on the Agency conducts a detailed alternative is achievable in most an industry-by-industry basis. investigation of the controls used in operations most of the time. The Agency OSHA develops detailed descriptions different industries based primarily on must also show that sampling and of how the substance is used in different case studies. analytical methods can measure industries, the work activities during OSHA develops preliminary exposures at the proposed PEL within which workers are exposed, and the conclusions regarding feasibility of an acceptable degree of accuracy. OSHA primary sources of exposure. The regulatory alternatives, by identifying makes these determinations in the Agency also constructs exposure the lowest levels of exposure that are technological feasibility analysis, which profiles for each industry, or by job technologically feasible in workplaces. is made available to the public in the category, based on operations To determine whether an alternative is OSHA rulemaking docket. performed. The Agency classifies feasible throughout the spectrum of workers by job categories within those affected industries, OSHA studies 2. Current Methodology of the industries, based on how similar work whether the regulatory alternative is Technological Feasibility Requirement processes are, and to what extent similar achievable in most operations most of To develop its technological engineering controls can be applied to the time by a typical firm. OSHA may feasibility analysis, the Agency must control exposures in those processes. also determine whether a specific first collect the information about the Each exposure profile contains a list process used across a number of industries that are affected by a of affected job categories, summary different industries can be effectively particular hazard, the sources of statistics for each job category and controlled. exposure, the frequency of the exposure, subcategories (such as the mean, median, and range of exposures), and 3. Role of Exposure Modeling in the number of workers exposed to Technological Feasibility various levels, what control measures or the distribution of worker exposures other efforts are being made to reduce using increments based on the In many situations, the Agency has exposure to the hazard, and what regulatory alternatives. found it difficult to develop sampling and analytical methods are OSHA’s technological feasibility comprehensive exposure profiles and available. analyses for PEL-setting standards have determine additional controls because This information is typically obtained traditionally relied on full-shift, of limitations associated with the from numerous sources including: personal breathing zone (PBZ) samples available exposure data. These • Published literature, to create exposure profiles. A PBZ information gaps could be filled by • OSHA Special Emphasis Program sample is the best sample type to incorporating exposure modeling into (SEP) reports, quantify the inhalation exposure of a the technological feasibility process. • NIOSH reports, such as health worker. Area samples are typically not The limitations associated with the data hazard evaluations (HHE), control used to construct exposure profiles but collected include: technology (CT) assessments, surveys, are useful to characterize how much • Limited number of exposure recommendations for exposure control, airborne contamination is present in a samples: On occasions, an exposure

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61398 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

profile for a job category may be built includes up to 16 different metals phenomena, such as the laminar flow of on a limited number of full-shift whether they are thought to be present a fluid through a cylindrical pipe, these exposure samples, and the Agency has in the sampling environment or not. equations can be solved mathematically. to judge whether the samples available Æ Use of SIC codes in historic IMIS Such solutions describe how a fluid will are representative of the actual exposure data, which do not translate directly move through the specified area, or distribution for that industry. into the NAICS codes currently used in geometry, as a function of time. For • Limit of Detection (LOD) issues: the analyses. more complex physical phenomena, Because only a few exposure samples Æ There is no information in the such as turbulent flow of a fluid through may be available for a job category, the database on the end product being a complex geometry, numerical analysis may include samples reported developed, the action performed to approaches are used to solve the as ‘‘less than’’ values, high LODs, or produce it, or the materials being used governing differential equations. As adjusted LOD values. This causes when the sample is taken. This limits such, CFD modeling uses mathematical inconsistency in the use of LOD samples the interpretation of the data, since an models and numerical methods to and may cause the Agency to under- or analyst is not able to attribute the determine how fluids will behave over-estimate the actual exposure exposure to any particular practice or according to a particular set of variables distribution. process, and cannot recommend and parameters. A mathematical model • Lack of information on controls engineering controls. simulates the physical phenomena associated with data: Information Generally, OSHA has had the most under consideration (i.e. governing regarding working conditions and success using IMIS data to identify and equations of energy, mass, and control strategies associated with collect enforcement case files for further momentum) and, in turn, a numerical exposure samples may not be available. review. Case files from OSHA method solves that model. Overall, CFD This makes it difficult for the Agency to inspections contain more detailed modeling enables scientists and determine the impact of the control information on worker activities and engineers to perform computer strategies for various sources of exposure controls observed at the time simulations in order to make better exposure. Additionally, it is common an exposure sample is taken. Thus, use qualitative and quantitative predictions that the data does not include of case files to a large extent mitigates of fluid flows. information about the exact nature of the limitations of using IMIS data. Some modeling techniques, such as the task performed during the sampling For most health standards, OSHA CFD, allow a user to create a virtual period. Sometimes, samples may not does not have the resources to conduct geometry to simulate actual work exactly correspond to the job category to site visits to obtain the necessary environments using appropriate which OSHA assigns it in the analysis exposure information at firms that are mathematical models and because the job activities performed are representative of all the affected computational methods. The solutions not adequately described. industries. In an effort to develop more predict exposures at any given time and • Limitations of traditional industrial robust exposure profiles, the Agency is in any point in the space of the hygiene sampling: Traditional industrial considering the use of exposure geometry established. A model hygiene practices require a ‘‘before and modeling, such as computational fluid developed with this technique allows after’’ data set to gauge the effectiveness dynamics (CFD) modeling, to the user to evaluate exposures in a of control strategies implemented, and complement the exposure information worker’s personal breathing zone and changes that occur in the working that is already available from literature, identify areas in the work space that environment during the sampling site visits, NIOSH and similar field present high concentrations of the periods. The exact impact of control investigations, and employer-provided contaminant. Because the exposure strategies and environmental conditions data. This technique would potentially concentration can be solved as a cannot be determined easily with only allow OSHA to better estimate function of time, the user can observe one set of samples obtained at a discrete workplace exposures in those how concentration increases or moment in time. It is often the case that environments were data are limited. decreases with time or other changes in OSHA does not have the luxury of Question IV.B.1: OSHA described the model input parameters. This allows ‘‘before and after’’ data sets and must how it obtains information necessary to the user to consider administrative determine how the sample set fits into conduct its industry profiles. Are there controls such as limiting the time of the the exposure profile. additional or better sources of operation, the quantity of material • IMIS data limitations: Since the information on the industries where emitted by the process, or determining Agency may lack exposure data for a exposures are likely, the numbers of how long after an operation a worker particular job category or operation, it workers and current exposure levels can safely enter a previously sometimes relies on IMIS data. OSHA that OSHA could use? contaminated area. In some cases, work does not usually rely on IMIS data in its tasks and processes that are time- a. Computational Fluid Dynamics exposure profiles unless there are no varying can be communicated to the Modeling To Predict Workplace other exposure data available because CFD model through time-varying Exposures the IMIS data can have some significant boundary conditions. limitations, which include the OSHA is considering the use of Models require a defined geometry following: computational fluid dynamics (CFD) to (i.e., work space), and this step in the Æ Insufficient information to model workplace exposure. CFD is a model building may be resource determine if a hazard is present in the discipline of fluid mechanics that uses intensive. To construct geometries of work area in significant amounts as to computer modeling to solve complex complex work environments, OSHA be relevant for an exposure profile. For problems involving fluid flows. Fluid would need to gather the necessary example, an analyst cannot tell from the flow is the physical behavior of fluids, information to model the work information available in the IMIS either liquids or gases, and it is environment. This includes taking database if a sample was targeted for the represented by systems of partial measurements of the work area, hazard in question, or if it was part of differential equations that describe machinery, engineering control a larger metal screening process (if the conservation of energy, mass, and specifications (e.g., exhaust face hazard is a metal), which typically momentum. For some physical velocities, spray systems flow rates),

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61399

and any other objects or activities that advantages of theoretical calculations, than traditional industrial hygiene may affect the air flow in the area of in a general sense, to predict heat sampling for work environments with interest. Moreover, gathering site- transfer and fluid flow processes. Some complex geometries. In these situations, specific information for building CFD of these are: OSHA would have to develop a site visit models can be integrated with • Low Cost: In many current and protocol for gathering dimensions of the traditional industrial hygiene survey future applications, the cost of a work environment of interest. The activities. OSHA is interested in computational method may be lower information to be collected includes the identifying ways to reduce the time and than the corresponding sampling cost. dimensions of the physical space, the money that may be spent recreating As mentioned above, the most resource- ventilation system that affects airflow work environments. One alternative is consuming aspect of solid modeling is patterns, and other details (such as to import facility layouts in an simulating the geometry that resembles location and size of windows, doors, electronic format (such as CAD) into the actual physical space of work and large obstructions). modeling software. If an establishment environments. Despite these limitations, modeling has its facility layout in this format, • Speed: A numerical solution to promises to provide significant then the model designer would not have predict exposures can be obtained very advantages that could help OSHA to take physical measurements and easily in a day. A user could manipulate construct more robust technological recreate the work area by 3–D modeling. different configurations regarding feasibility analyses while reducing the Question IV.B.2: In cases where there worker positioning and engineering considerable amount of resources the is no exposure information available, to controls to find an optimal control Agency already expends on them. In what degree should OSHA rely on strategy. addition to CFD modeling, the Agency modeling results to develop exposure • Complete information: A computer will continue to investigate other profiles and feasible control strategies? solution provides the values of all exposure modeling techniques and their Please explain why or why not. relevant variables throughout the applicability in the rulemaking process. Question IV.B.3: What partnerships domain of interest. These variables Question IV.B.4: Should OSHA use should OSHA seek to obtain cover fluid flow patterns, areas in the only models that have been validated? information required to most efficiently geometry with highest concentrations of If so, what criteria for model validation construct models of work contamination, exposure values at any should be employed? environments? More specifically, how point in the geometry, time profile of Question IV.B.5: What exposure should OSHA select facility layouts to contamination, and exposure results models are you aware of that can be model that are representative of typical based on different control useful for predicting workplace work environments in a particular configurations. Traditional industrial exposures and help OSHA create industry? Note that the considerations hygiene sampling does not allow for this exposure profiles and in what should include variables such as work level of analysis as it measures results circumstances? area dimensions, production volumes based on a particular work environment, At this time, OSHA is primarily and ventilation rates in order to develop and it cannot distinguish how each examining the possibility of models for both large and small scale independent variable (e.g., changes in incorporating CFD models to indoor operations. the workplace during sampling) affects work operations. Most general industry Models must undergo validation and the exposure result. and some construction operations are testing to determine if they provide an • Ability to simulate realistic performed indoors. As the Agency accurate prediction of the physical conditions: A computer solution can conducts more research on the phenomenon under consideration, or in accommodate any environmental applicability of CFD models to predict this case, the concentrations of air condition and the values for all workplace exposures, outdoor models contaminants to which workers could variables that affect the solution can be will also be considered. As such, OSHA be potentially exposed. Sensitivity easily modified to fit a particular is interested in obtaining input from analyses can be used to determine if scenario. parties experienced in these models. model outputs are consistent given Patankar (1980; Ex. #42) also Question IV.B.6: Should OSHA minor changes to grid cell size and time discusses the disadvantages of consider CFD models primarily for step duration. Grid cell size refers to the theoretical predictions to address heat indoor operations, outdoor operations, division of space according to nodes, transfer and fluid flow processes, and or both? What limitations exist with and time step refers to the value they are applicable to exposure these two different types of models? attributed to the time variable to modeling. The solutions obtained Various U.S. federal agencies have numerically solve the equations with depend on the mathematical model used CFD modeling for projects related reference to the nodes. Another method used to simulate the situation, the value to indoor air quality and/or for model evaluation is the comparison of the input parameters, and the occupational health and safety. between the solutions of different numerical method used to obtain a Preliminary research indicates that this models to the same problem in that a solution. As Patankar notes, ‘‘a perfectly CFD modeling work has been performed similarity of findings across multiple satisfactory numerical technique can mostly for academic and research CFD models would provide greater produce worthless results if an purposes. There is little information confidence in the results. Arguably, the inadequate mathematical model is available discussing the use of CFD best performance evaluation is the employed’’. This is why it is imperative modeling for the purposes of litigation comparison of model results to those of that the mathematical model chosen and/or regulatory decision-making. a field experiment that simulates on actually resembles the physical NIOSH has used CFD on a variety of different scales the actual work phenomena under consideration. internal research initiatives that involve environment. The Agency also realizes that even if evaluating and controlling airborne This method of predicting workplace an appropriate mathematical model and exposures. Among other projects, exposures has some potential numerical method are obtained to NIOSH has used CFD modeling to: advantages over traditional industrial describe contamination in a workplace, • Evaluate potential exposure hygiene sampling methods. Patankar the exposure modeling approach may concentrations to hexavalent chromium (1980; Ex. #42) explains some of the prove to be more resource-intensive (CrVI), hexamethylene diisocyanate

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61400 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

(HDI), methyl isobutyl ketone (MIBK), assess outdoor air quality. However decision-makers, while in the U.S., and others with different ventilation there is little information available on OSHA itself is responsible for control configurations during spray EPA projects that have used CFD to generating, researching, and evaluating painting operations at a Navy aircraft evaluate indoor air quality. the relevant information. paint hangar. In this study, NIOSH also As part of the Labs21 program, EPA, As explained in more detail above, tested and validated the predictive in conjunction with the Department of OSHA creates industry profiles to value of CFD modelling against methods Energy, has published a guidance evaluate the technological feasibility of of physical sampling by conducting document for optimization of laboratory a standard. The objective of these workplace air sampling and comparing ventilation rates (EPA & DOE, 2008; Ex profiles is to estimate the number of with model results. The project was #49). The guidance is geared towards workers potentially exposed to performed with assistance from the architects, engineers, and facilities occupational hazards. OSHA relies on Naval Facilities Engineering Command managers, in order to provide information from numerous sources (NAVFAC) and the Navy Medical Center information about technologies and including the U.S. EPA, U.S. DOL, U.S. San Diego (NMCSD) (NIOSH, 2011a; Ex. practices to use in designing, Census Bureau, NIOSH, scientific #43), constructing, and operating safe, publications, and site visits to identify • Study the effectiveness of sustainable, high-performance specific industries where workers are ventilation systems for controlling laboratories. EPA advocates the use of potentially exposed to hazards. Tuberculosis (NIOSH, 2010; Ex. #44), CFD simulations to determine the Acquiring data from these sources is • Evaluate emission controls for mail airflow characteristics of a laboratory straightforward and usually achieved processing and handling facilities space in order to improve ventilation through standard procedures. However, (NIOSH, 2010; Ex. #44), systems and increase safety and energy these sources often contain data gaps or • Better understand the role airflow efficiency. inconclusive information. Thus, new and ventilation play in disease The Building and Fire Research sources of information are needed to fill transmission in commercial aircraft Laboratory of National Institute of existing data gaps and strengthen cabins (NIOSH, 2010; Ex. #44), Standards and Technology (NIST) OSHA’s analyses. • Simulate different air sampling developed a CFD model to simulate the Since similar types of data are methods to better understand how transport of smoke and hot gases during currently being developed and sampling methods can assess exposure a fire in an enclosed space (NIST, 1997; submitted by manufacturers and (NIOSH, 2010; Ex. #44), and Ex. #50). The results of the study and an importers under REACH, this • Help better understand the extensive literature review indicated to information could provide an additional effectiveness of various forms of NIST that CFD can have significant reference source for OSHA to utilize. exposure control technologies in the benefits in the study of indoor air The incorporation of REACH data into manufacturing and transportation, quality and ventilation. The report OSHA’s technological feasibility warehousing, and utilities in the resulting from this study provides a analyses could greatly assist the Agency National Occupational Research Agenda thorough description of CFD and in creating a more exhaustive, thorough, (NORA) Sectors (NIOSH, 2011b; Ex. provides recommendations for future and complete analysis. The information #45). directions in CFD research. developed during the REACH Additionally, NIOSH has also used The Building and Fire Research registration process could help OSHA CFD models in mine safety research: Laboratory of NIST has also used CFD better understand the industries, uses, • NIOSH conducted a CFD study to to model the effects of outdoor gas processes, and products in which a model the potential for spontaneous generator use on the air concentrations chemical of concern is used, gain heating in particular areas of of carbon monoxide inside nearby knowledge about the risk management underground coal mines (Yuan, L. et al., buildings (NIST, 2009; Ex. #51). Using measures and controls currently in 2006; Ex. #46). The purpose of the CONTAM (a mathematical indoor air place, and develop scenarios where study was to provide insights into the quality model), coupled with CFD exposure may be greatest. Exposure optimization of ventilation systems for simulations, the researchers were able to information generated by manufacturers underground coal mines that face both determine factors (e.g., generator in a chemical safety assessment could methane control and spontaneous positioning, wind direction) that be valuable for completing exposure combustion issues. contributed to elevated carbon profiles on chemicals where current • NIOSH looked at the rate of flame monoxide accumulation in the building. references for field sampling analytical spread along combustible materials in a As OSHA continues to explore the data are limited. In addition, utilizing ventilated underground mine entry. option of incorporating CFD modeling information presented in exposure CFD models were used to estimate the into its technological feasibility scenarios that describe the conditions flame spreading rates of a mine fire analyses, the Agency will conduct under which a chemical can be used (Edwards, J. C., and Hwang, C. C., 2006; further research on existing models. safely (i.e., risk management measures Ex. #47). and operating conditions) could provide • NIOSH has also used CFD modeling b. The Potential Role of REACH in insight on currently employed industry to model inert gas injection and oxygen Technological Feasibility control methods and their effectiveness. depletion in sealed areas of Similar to the evaluation of chemical While the benefits of incorporating underground mines (Trevits, M. A., et substances by the European Chemicals REACH data into OSHA’s technological al., 2010; ; Ex. #48). CFD simulations Agency (ECHA) and the European feasibility analyses seems promising, were created to model inert gas Commission before making a decision to challenges such as data access and data injections that aim to eliminate ban or restrict the use of a substance, validity have been identified as explosive atmospheres that form in OSHA must evaluate information on potential drawbacks. Despite provisions sealed mine areas. The CFD model was health effects, exposure levels, and under REACH that require the public able to quantify oxygen depletion and existing controls before setting a new or availability of data and the sharing of gas leakage rates of the sealed area. revised PEL. However, ECHA requires data with other government agencies, EPA has conducted a substantial chemical manufacturers to generate the the European Chemicals Agency, which amount of work using CFD modeling to information evaluated by government maintains the REACH databases, has not

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61401

yet made some of the information in other geographic jurisdictions, e.g., orders that require analysis of the available, including information other states. benefits and costs of a regulation as a generated for and compiled in the Question IV.B.8: To what extent and whole, and in the case of the Regulatory chemical safety assessment. in what circumstances should OSHA Flexibility Act, some estimate of the Additionally, some manufacturers and argue that feasibility for a regulatory economic impacts on small entities. importers may be prohibited from alternative can be established by However, the degree of industry detail sharing the data generated for REACH proving the feasibility of reducing the provided in OSHA’s economic analyses directly with other entities for non- highest exposures to the level proposed is primarily a function of judicial REACH purposes due to agreements by that regulatory alternative? interpretation of the economic made among the members of groups Question IV.B.9: To what extent and feasibility requirements of the OSH Act. organized under REACH to more in what circumstances can OSHA argue The development of the law on efficiently share the information needed that feasibility for a regulatory economic feasibility is discussed in for the registration of a chemical. alternative can be established by the detail in Section III. Below we discuss Question IV.B.7: How can exposure enforcement of a lower PEL [e.g., the potential alternatives to current information in REACH be incorporated 1989 PEL (See Appendix B)] by an methods of economic feasibility into OSHA’s technological feasibility individual state or states? analysis, and then follow with a brief analysis? Question IV.B.10: What are the discussion on how the other analytical appropriate criteria that OSHA should c. Technological Feasibility Analysis requirements OSHA is required to meet use to assess whether control strategies With a Focus on Industries With might be satisfied. implemented in a process from one Highest Exposures As guided by the courts, OSHA industry are applicable to a process develops economic feasibility analyses OSHA’s technological feasibility from another industry (e.g., similarity of that cover every affected industry and analysis is one of the most resource- chemicals, type, extent and duration of process. OSHA has not always taken intensive parts of the rulemaking exposures, similar uses)? this position. For example, in its process. OSHA typically analyzes Question IV.B.11: Regardless of the economic and technological feasibility exposures in all industries and job industries involved, are there criteria analysis of benzene, OSHA examined categories within those industries that that OSHA should use to show that only industries believed to be the worst show potential for exposures and control strategies implemented in a in terms of significant exposure to determine whether a proposed exposure process from one operation are benzene. Since then, however, OSHA limit can be achieved in most operations applicable to a process from another has attempted to cover all affected most of the time. These can range from operation? Please explain. industries in its feasibility analysis. industries that are constantly The Agency realizes that analyses The courts have suggested that the experiencing exposures in most job performed in this manner may have economic feasibility analysis must be categories above an existing PEL or the some implications for smaller firms that reasonably detailed. In the Air regulatory alternatives, to industries may find it harder to implement Contaminants case, the court said: where only a few job categories have resource intensive control strategies shown elevated exposures. OSHA has than larger firms. Additionally, the Indeed, it would seem particularly also utilized an application approach in important not to aggregate disparate control strategies from the most industries when making a showing of which it analyzed exposure associated problematic industries may not be economic feasibility . . . [R]eliance on such with a specific process across a number similar to those that may be needed for tools as average estimates of cost can be of different industries. industries with lower exposures because extremely misleading in assessing the impact The Agency is investigating whether the processes and sources of exposure of particular standards on individual it is appropriate to focus future require different control methods. industries. AFL–CIO v. OSHA, 965 F.2d 962, technological feasibility analyses only Question IV.B.12: How should OSHA 982 (11th Cir. 1992) (‘‘Air Contaminants’’). on job categories that have the highest take into consideration the size of a (Ex. #8) exposures. An analysis performed in business of facility when determining However, the court added: this manner may reduce the amount of technological feasibility? time and money OSHA has to expend to We are not foreclosing the possibility that C. Economic Feasibility in Health OSHA could properly find and explain that prove feasibility. In many cases the certain impacts and standards do apply to control methods applicable for one Standards entire sectors of an industry. Two-digit SICs industry may also be effective in The purpose of this section is (1) to could be appropriate, but only if coupled reducing exposures in other industries. discuss how and why OSHA currently with a showing that there are no By determining the additional conducts its economic feasibility disproportionately affected industries within engineering controls and work practices analysis of health standards, and (2) to the group. Air Contaminants, 965 F.2d at 982 n.28 necessary to reduce the most elevated examine approaches to economic exposures to a level specified by a feasibility that might involve less time In the hexavalent chromium case, regulatory alternative, the Agency could and fewer resources. Public Citizen Health Research Group v. propose that similar control strategies United States Dep’t of Labor, 557 F.3d (wherever applicable) would also be 1. OSHA’s Current Approach to 165, 178 (3d Cir. 2009; Ex. #14), the effective in reducing lesser exposures to Economic Feasibility court recognized that OSHA had the that same level. In other words, by The Agency’s existing approach to flexibility to demonstrate technological making feasibility findings in the most economic feasibility rests directly on feasibility on a process or activity rather problematic industries, OSHA would relevant language in the OSH Act, as than industry-by-industry basis, if the argue that all other industries would interpreted by the courts, requiring processes or activities are sufficiently also be able to comply with a regulatory OSHA to establish that new standards similar from industry to industry. The alternative. A related possibility is for are economically feasible. OSHA also court, however, did not address the OSHA to make a feasibility conducts economic analysis of its question of whether the same flexibility determination based on enforcement regulations in compliance with other applies to economic feasibility. OSHA, activities of the proposed or lower PEL legislation and as a result of executive especially in health standards, has tried

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61402 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

to provide the most detailed analysis of are so small that, in OSHA’s view, no development of standards less resource industries and processes that resources reasonable person could think that the intensive would be to have the permit. For most recent health costs could possibly be expected to standards themselves address health standards, this has meant the use of the threaten the existence or competitive issues in a way that involves less lowest level industry codes for which structure of an industry. Where the costs analysis for any given standard. Health industry data are available, and where are not this small, OSHA conducts a standards can be analyzed faster to the more than one process is used in an variety of further economic analysis, extent that there are fewer processes industry, consideration of each process depending on the economic situation, and/or fewer industries to analyze. It separately. Further, in order to assure nature of the costs, the affected would be less time consuming for that a regulation does not alter the industry, and the economic data OSHA to analyze a health standard for competitive structure of an industry, available. a single process rather than a single OSHA normally analyses three size This basic approach to economic substance that is found in dozens of classes of employer within each feasibility analysis has been used for processes. OSHA already has a variety industry: All establishments, small many health standards, and the of process-oriented standards that firms as defined by SBA, and small approach has generally been successful partially address health hazards in such firms with fewer than twenty employees in assuring that OSHA standards are areas as abrasive blasting, welding, and (always smaller than the SBA economically feasible. In the PELs electroplating. Control banding also definitions). For the typical OSHA rulemaking, where OSHA tried a more represents an approach that, following substance-specific health standard, general approach, the court found the the hazard assessment, examines OSHA analyses each of the controls for level of detail inadequate. Similarly, controls for specific processes. In each of the many processes in which the OSHA has encountered problems when control banding, the hazards are generic, substance might appear, and then of the Agency did not have an adequate but the controls are process specific. each industry in which any process level of detail with respect to the Process-oriented approaches would be might appear, and then of three sizes of exposure profile and the technological most useful for processes widely used in establishment within the industry. feasibility analysis, such as for dry-color a variety of settings—abrasive blasting, Finally, OSHA examines the varying formulators of cadmium pigments. degreasing, welding, etc. Industry-by- levels of exposure and controls within OSHA’s eight lookback studies, industry economic feasibility analysis an industry and develops analyses that conducted under both Sections 610 of for a process-oriented approach would reflect these differences within an the Regulatory Flexibility Act and be enormously simplified by the fact the industry. In terms of the form of the Section 5 of Executive Order 12866, controls and their costs would be very analysis, OSHA has followed the advice have not found any instance in which similar across industries. As a result, of the D.C. Circuit to ‘‘construct a subsequent study showed that a OSHA could develop more detailed and reasonable estimate of compliance costs standard had threatened the existence of more secure cost estimates, with full and demonstrate a reasonable likelihood or brought about massive dislocation opportunities for a variety of affected that these costs will not threaten the within an industry. parties to comment on those estimates. OSHA can reasonably say that it has existence or competitive structure of an This approach might also serve to found a methodology such that the industry.’’ United Steelworkers v. greatly simplify the technological Agency’s determinations of economic Marshall, 647 F.2d 1189, 1272 (D.C. Cir. feasibility analysis. On the other hand, feasibility have both been considered 1980; Ex. #12) (‘‘Lead I’’). since process-oriented standards In response to this guidance, OSHA adequate by the courts and proven to be commonly involve multiple substances, develops detailed estimates of the costs accurate in determining regulations to risk assessment issues might be more of a health standard for each affected be feasible when re-evaluated by complex. industry, and by the three size retrospective analysis. However, the categories of establishment. The result is resulting methodology is extremely A related approach to speeding up at that the economic analyses of health resource intensive and time-consuming least portions of substance specific standards routinely contain a series of because OSHA always has to make health standards might be to regulate a tables showing costs for each industry detailed cost estimates and provide single substance process by process in by multiple size classes of firms within detailed statistical data for every single multiple rulemakings—for example, the industry, and sometimes for more process and industry affected. For this regulate exposures to hexavalent than one process per industry. Each reason, OSHA wants to consider chromium in electroplating, then in entry in these tables is documented by whether there may be methods that can welding, and then painting. By detailed explanations of how the costs short-cut this process and still meet all producing process standards in this were estimated for each industry and of OSHA’s legal requirements. manner, rather than waiting until size class and level of exposure. The remainder of this section analyses of all processes and industries OSHA then makes a determination for examines two kinds of alternative is completed, OSHA could potentially each industry whether or not these costs approaches to accelerating the process address the most severe exposures much are likely to threaten the existence or and reducing the resources needed to more rapidly. This approach could also competitive structure of that industry. produce health standards. One kind of allow OSHA to ignore processes where In order to do this, OSHA first alternative involves formulating health the exposures are likely to be small and constructs a ‘‘screening analysis’’ for standards differently. The second kind the chance of exceeding a PEL minimal. each industry. For the purposes of this involves different kinds of analysis Though this approach might result in screening analysis, OSHA combines its OSHA might perform. portions of a substance-specific estimates on the costs per establishment standard being produced more quickly, of various sizes with statistical data on 2. Alternative Approaches to the approach would probably require the profits and revenues of the affected Formulating Health Standards That more resources for multiple hearings establishment sizes, and then calculates Might Accelerate the Economic and docket analyses. A major costs as a percentage of profits and Feasibility Analysis disadvantage of this approach is that it revenues. For most industries, the costs One approach to simplifying, would result in the possibility that in comparison to revenues and profits speeding up, and making the workers in industries not yet regulated

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61403

would have to endure exposures higher commonplace. Benzidine-based dyes York) are enforcing the 1989 PELs in the than those in regulated industries. have disappeared from the U.S. public sector only. California enforces Another disadvantage might be that the marketplace. However, these cases had its own PELs which in many cases are risk assessment would be subject to no effect on the viability of user substantially lower than OSHA’s. multiple public hearings as each industries or their employment. Situations in which most firms in a state industry or process was regulated. Insulation contractors still install meet a potential requirement of a insulation—it just no longer contains standard are particularly convincing 3. Alternative Analytic Approaches to asbestos. Dyers continue to dye textiles because they show that employers are Economic Feasibility of Health and leather all the colors benzidene- not only able to carry out the Standards based dyes imparted, but without using requirement, but can do so even in A different approach to producing benzidene-based dyes. The chief effect competition with employers who are less resource-intensive and time- has been substitution away from a not required to meet such a consuming economic feasibility substance. This has resulted in serious requirement. analyses would be to re-examine economic impacts on a limited number Nevertheless, OSHA is aware that whether OSHA’s basic approach of of producers of the substance but little some care must be taken with evidence estimating the costs of each process, economic impact on the thousands of that all or most firms in an industry or industry, size class, and possible level users of the substance who simply in an industry within a state meet a of control is really necessary in all cases found a substitute. It would seem that requirement. It is particularly important given how the courts have defined such substitution away from a substance to determine whether those who do not economic feasibility. The key to meeting is not the kind of economic change that meet the requirement might require the legal requirements is to return to the would make a regulation economically fundamentally different controls, have concept of economic feasibility. In the infeasible. different costs, or operate in a different Lead I decision, the court stated: OSHA might be able to place major market in spite of being in the same emphasis on evidence that a significant A standard is feasible if it does not threaten statistical industry. Consider a standard ‘‘massive dislocation’’ to . . . or imperil the portion of an industry is already addressing a specific metal. Most firms existence of the industry. No matter how meeting a standard. Such evidence is an in an industry may find the standard initially frightening the projected . . . costs obvious indication that a standard is easy to meet because they only use the of compliance appear, a court must examine both technologically and economically metal in alloys that call for a very small those costs in relation to the financial health feasible for that industry. After all, the percentage of the metal. However, those and profitability of the industry and the actual fact that a majority of employers firms that use alloys with high likely effect of such costs on unit consumer of all sizes in an industry is meeting a percentages of the metal might be prices. More specifically . . . the practical standard, while remaining viable, question is whether the standard threatens unable to meet the standard. This would should be more convincing than a set of not be apparent looking solely at the competitive stability of an industry. Lead cost estimates in an economic analysis I, 647 F.2d at 1265 (citations omitted). (Ex. aggregate industry data. OSHA should #12) predicting that employers in a given take reasonable steps to determine that industry could meet the standard. As the court recognized, this is a those that did not meet the standard do Actual empirical evidence of a not have important technological or strong criterion. In the real world, proposition is normally considered industries are rarely eliminated or have economic characteristics that are superior to theoretical evidence for a different from those that did. their competitive structure radically proposition. There are several reasons Under this approach, OSHA could altered for reasons related to changes in why many or most employers in an conclude that a standard is feasible their costs, and it is changes in costs industry may already meet a standard— where a state already had such a that courts recognized as the principle these include ease of meeting the standard if it first determines that (1) the reason a regulation might not be standard, industry consensus standards, standard is enforced; (2) employers in economically feasible. Radical changes and concern about liability. in industries tend to come from two Similarly, the fact that a state or other the state in fact meet the standard; and major causes. Most are the result of jurisdiction has already implemented a (3) which of the relevant industries and changes in demand such that the public requirement and that firms within the technologies are represented within that is no longer interested in the product or state are generally following the state. service an industry provides, for such requirement would represent very However, in spite of these caveats, it reasons as technological obsolescence or strong evidence that a requirement is would frequently take OSHA less time the existence of better substitutes. Some economically and technologically and fewer resources to demonstrate that radical changes in industries are the feasible. For example, twenty-two states a standard is technologically and result of foreign competition. However, currently operate their own OSHA economically feasible by showing that foreign competition applies largely, in programs that cover both private sector employers in the industry already meet an OSHA context, to manufacturing, but and State and local government the standard than by the full not to construction, utilities, domestic employees, and five states cover public identification of control technologies, transportation, or most services that employees only. Of the twenty-two exposure levels achieved by those OSHA regulates. states that cover both private and public technologies, the costs of the OSHA is not aware of any instance in sector employees, five states (South technologies, and the economic impacts which an OSHA regulation eliminated Carolina, Minnesota, Tennessee, of these technologies that OSHA now or altered the competitive structure of Vermont and Washington) are still undertakes. an industry—though in some cases, a enforcing the 1989 PELs, and did not As noted above, at one point in the combination of liability-based concerns, revert to the less protective PELs when Lead I decision, the court suggested environmental regulations, and OSHA the Court remanded the Air OSHA develop a ‘‘reasonable estimate of regulation may have radically altered Contaminants rule. (Ex. #8) Michigan is costs.’’ However at another point in this the use of a product. For example, also enforcing the 1989 PELs in general decision the same court clarified: asbestos is not used in many industry, but not in construction. Three [T]he court probably cannot expect hard applications where it was once states (Connecticut, Illinois, and New and precise estimates of costs. Nevertheless,

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61404 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

the agency must of course provide a flexibility analysis or Small Business Cir. 2009; Ex. #14) (‘‘Hexchrome’’) reasonable assessment of the likely range of Regulatory Enforcement Fairness Act (rejecting interpretation that OSH Act costs of its standard, and the likely effects of (SBREFA) Panel is needed can, in most required OSHA to research all those costs on the industry . . . And OSHA cases, be met by focusing on those workplace operations involving can revise any gloomy forecast that estimated sectors and size classes where the most hexavalent chromium exposure to prove costs will imperil an industry by allowing for the industry’s demonstrated ability to pass severe impacts are expected. feasibility, which would ‘‘severely through costs to consumers. Lead I, 647 F.2d Question IV.C.1: Should OSHA hinder OSHA’s ability to regulate at 1266. (Ex. #12) consider greater use of process oriented exposure to common toxins’’); American regulations, such as regulations on Dental Ass’n v. Martin, 984 F.2d 823, OSHA has made little use of the abrasive blasting, welding, or 827 (7th Cir. 1993; Ex. #53) (OSHA not concept of a likely range of costs or of degreasing, as an approach to health required to regulate ‘‘workplace by developing generic approaches to standards? Should such an approach be workplace’’); Assoc. Bldrs & Contrs. Inc. determining a reasonable likelihood that combined with a control banding v. Brock, 862 F.2d 63, 68 (3d Cir. 1988; these costs will not threaten the approach? Ex. #54) (‘‘A requirement that the existence or competitive structure of an Question IV.C.2: Should OSHA Secretary assess risk to workers and industry. consider issuing substance-specific need for disclosure with respect to each OSHA could significantly reduce its standards in segments as the analysis of substance in each industry would resource and time expenditures by a particular process or industry is effectively cripple OSHA’s performance providing ranges of costs, given that the completed rather than waiting until of the duty imposed on it by 29 U.S.C. upper end of the range provides ‘‘a every process and industry using a 655(b)(5); a duty to protect all reasonable likelihood that these costs substance has been thoroughly employees, to the maximum extent will not threaten the existence or analyzed? feasible.’’). competitive structure of an industry.’’ Question IV.C.3: To what extend and Indeed, the requirement that an Such an approach would not only in what circumstances can OSHA argue OSHA standard not threaten ‘‘massive reduce OSHA’s time and effort but also that feasibility for a regulatory dislocation’’ or ‘‘imperil the existence’’ that of the interested public. Too often alternative can be established by the of an industry is an outgrowth of the stakeholders devote significant time and enforcement of a lower PEL (e. g., the idea that OSHA may adopt standards effort questioning cost estimates when 1989 PEL) by an individual state or that may cause marginal firms to go out even the stakeholders’ alternative cost states? of business if they are only able to make estimate would have no effect on 4. Approaches to Economic Feasibility a profit by endangering their employees. whether the costs would threaten the See Industrial Union Dep’t, AFL–CIO v. existence or competitive structure of an Analysis for a Comprehensive PELs Update Hodgson, 499 F.2d 467, 478 (XX Cir. industry. The simple fact is that both 1974; Ex. #55). And the notion that the OSHA and its stakeholders spend far too Following the Eleventh Circuit’s determination must be made on an much time examining the accuracy of direction in the Air Contaminants case industry basis arises from cases in cost estimates even when the highest (956 F.2d at 980–82; Ex. #8) and in which OSHA attempted to do just that; cost estimates considered would have Color Pigments Mfrs. Ass’n v. OSHA, 16 the statute does not require feasibility to little effect on the determination of F.3d 1157, 1161–64 (11th Cir. 1994; Ex. be evaluated in this way. See Lead I, 647 economic feasibility. #13), OSHA has typically performed its F.2d at 1301 (where OSHA attempted to OSHA could also make more effort to economic feasibility analyses on an determine the feasibility of the lead clarify historically the circumstances industry-by-industry basis using the standard on an industry-by-industry under which regulations of any kind lowest level industry codes for which basis, noting that the parties did not have eliminated or altered the industry data are available. While such dispute that feasibility was to be competitive structure of an industry. As an approach best insures that the effect determined in that manner); noted above, OSHA has yet to find an of the standard on small industry Hexchrome, 557 F.3d at 178 (‘‘nothing instance in which OSHA regulations segments will be considered, it is very in 29 U.S.C. 655(b)(5) requires OSHA to eliminated or altered the competitive resource intensive. If OSHA were analyze employee groups by industry, structure of an industry. A more required to use of this approach to nor does the term ‘industry’ even thorough exploration of past address feasibility for a comprehensive appear’’). The approach articulated by experiences with OSHA regulations PELs update, which would require the Air Contaminants court, which might simplify OSHA analyses and addressing the feasibility of new PELs places an affirmative duty on OSHA to make it more empirically based in a for hundreds of chemicals in hundreds establish that proposed standards would variety of situations. of industry segments, it might require not threaten even the smallest industry OSHA believes that it may be able to more resources than the agency would segments before adopting a standard, meet the requirements of Executive have available. creates a heavy analytical burden that is Orders 12866 and 13563 and the There are good reasons to think that not necessarily required by the statute. Regulatory Flexibility Act without the the OSH Act does not require such a As the Lead I court notes, in the case kind of industry-by-industry detail that detailed level of economic analysis to of a standard requiring an employer to OSHA now provides in its economic support a feasibility finding. The adopt only those engineering and analyses. The requirements of executive purpose of the OSH Act is to assure all administrative controls that are feasible, orders for analysis of costs and benefits workers ‘‘safe and healthful working what really is at stake in OSHA’s do not include requirements that they conditions,’’ and therefore it is unlikely feasibility determinations is whether be made available on an industry-by- that Congress intended for OSHA to OSHA has justified creating a industry basis, and OIRA encourages the meet such demanding analytical presumption that the implementation of reporting of ranges as opposed to requirements if it meant that the agency such controls are feasible. 647 F.2d at precise but possibly inaccurate point could not issue a standard addressing 1269–70. Thus, OSHA need not ‘‘prove estimates. OSHA believes that the well-recognized hazards. See, e.g., the standard certainly feasible for all requirements of the executive orders Public Citizen Health Research Group v. firms at all times in all jobs.’’ 647 F.2d and for determining if a regulatory Dep’t of Labor, 557 F.3d 165, 178–79 (3d at 1270. The court recognized that under

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61405

this approach, some employers might The results of this analysis would be consider some application groups for a not be able to comply with a standard, used to build up costs at the industry given chemical as subject to a PELs but noted that the statute offers those level. It is possible that the results of update rulemaking if some other employers several alternatives: such an analysis might be better application groups present feasibility requesting a variance, asserting a characterized in ranges, and of sufficient issues that make them inadvisable feasibility defense in an enforcement precision to establish feasibility at a candidates for a PELs rulemaking? proceeding, or petitioning the agency to level as low as the method that OSHA revise the standard. 647 F.2d at 1270. typically uses. Under this approach, a V. Recent Developments and Potential As noted above, most of OSHA’s determination made in this way would Alternative Approaches current PELs are over 40 years old, and be presumptively sufficient to establish Wide access to information on the are based on science that is even older. feasibility in the absence of contrary Internet and the development of a global It seems unlikely that a statute enacted evidence provided by commenters. If economy has shifted occupational safety to protect workers against chemical such evidence were presented, OSHA and health from a domestic to a global health hazards would preclude OSHA would address it and incorporate it into concern. Countries often struggle with from updating hundreds of those PELs its feasibility analysis supporting the similar experiences and challenges unless it can show that each is feasible final rule. related to exposure to hazardous in each of the smallest industry Question IV.C.4: Should OSHA chemicals, and sharing information and segments in which the chemical is used. consider providing ranges of costs for experiences across borders is a common The question, then, is what level of industries in situations where even the practice. Global data sharing allows for analysis would be sufficient to justify a upper range of the costs would the widespread and rapid dissemination presumption that the standard is obviously not provide a threat to the of available chemical information to feasible, shifting the burden to the existence of competitive structure of an employers, employees, managers, employer as allowed by Lead I. industry? chemical suppliers and importers, risk If OSHA moved forward with a global Question IV.C.5: What peer-reviewed managers, or anyone with access to the PELs update, the Agency might consider economics literature should OSHA Internet. The development of hazard analyzing economic feasibility at a consult when determining whether the assessment tools that take advantage of higher level than it has typically competitive structure of an industry readily available hazard information employed in substance specific health would be altered? Are there any make it possible for employers to standards. In order to do so, OSHA instances where an OSHA standard did implement effective exposure control would need to develop criteria as to threaten the existence or competitive strategies without the need to rely solely what chemicals are suited to be part of structure of an industry? What were on OELs. a PELs rulemaking rather than subject to they and what is the evidence that an a substance-specific rulemaking. For OSHA standard was the origin of the Some of these resources for data and example, if the rulemaking record difficulties? tools that OSHA may use more showed that, for a specific chemical Question IV.C.6: Should OSHA systematically in the future for application group, generally available consider and encourage substitution and hazardous chemical identification exposure controls had not been elimination of substances that cause and/or assessment are addressed in successful in achieving the proposed significant risk in workplaces even if Section V. PEL, then this chemical or at least the such substitution or elimination will A. Sources of Information About application group would be transferred eliminate or alter the competitive Hazardous Chemicals from updated PELs rulemaking to being structure of the industry or industries a candidate for further study and that produce the hazardous substance? In order to design and implement possible inclusion in a substance- Question IV.C.7: Are there other appropriate protective measures to specific rulemaking. The goal under this approaches OSHA could use that would control chemical exposures in the approach would be to develop a provide for more timely and less workplace, employers need reliable reasonable basis for believing that the resource-intensive economic feasibility information about the identities and chemicals and application groups analyses? hazards associated with those remaining in a PELs-update rulemaking Question IV.C.8: In determining the chemicals. OSHA is considering ways in are (1) likely to be economically level of industry detail at which OSHA which recently developed data sources feasible; and (2) subject to relatively should conduct an economic feasibility could be used by the Agency and simple and easily-costed controls that analysis for a comprehensive PELs employers to more effectively manage are likely to be relatively homogenous update, what considerations should chemical hazards in the workplace. across industries. OSHA take into account? What level of Developments in the use of structure— As a result, rather than accumulating detail do you think is sufficient to activity data for grouping chemicals data at the lowest industry level justify the presumption of feasibility for having similar properties, the available regarding exposures and such a standard? Please explain. Environmental Protection Agency’s controls needed for each chemical for Question IV.C.9: Are the High Production Volume (HPV) which a new PEL would be adopted, methodologies suggested above Chemicals, OSHA’s Hazard OSHA could consider a more general appropriate to establish economic Communication standard and the approach. For example, OSHA might feasibility for a comprehensive PELs Globally Harmonized Hazard conduct an economic feasibility analysis update? Why or why not? What other Communication Standard, health hazard at the industry level for which sufficient cost effective methods are available for banding, the European Union’s exposure data are currently available. It OSHA to establish economic feasibility Registration, Evaluation, Authorization, might use a control banding approach in for such a rulemaking? and Restriction of Chemicals (REACH), order to determine the types of controls Question IV.C.10: What factors should are discussed here. OSHA is interested necessary to comply with a new PEL, OSHA consider in determining whether in stakeholders’ comments on how the and validate models to implement each a chemical should be part of an overall Agency may make use of any of these type of control based on variables such PELs update or subject to substance- data sources or other alternative data or as establishment size and process type. specific rulemaking? Should OSHA information sources not discussed here

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61406 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

to better manage workplace chemical from these hazards? OSHA is also conditions, may lead to toxicological exposures. interested to hear from commenters who responses. The results of this research may currently make use of these data in then can be used to suggest the context 1. EPA’s High Production Volume their worker protection programs. in which decision makers can use the Chemicals data. The EPA’s Endocrine Disruptor 2. EPA’s CompTox and ToxCast One potential source of relevant and Screening Program already has begun timely information on chemicals that EPA has also launched an effort to the scientific review process necessary OSHA may make better use of in the prioritize the tens of thousands to begin using ToxCast data to prioritize future is the data on High Production chemicals that are currently in use for the thousands of chemicals that need to Volume chemicals that are being testing and exposure control. Through be tested for potential endocrine-related collected by the EPA and the its computational toxicology (CompTox) activity. Other potential uses include Organization for Economic Cooperation research, the U.S. Environmental prioritizing chemicals that need testing and Development (OECD). The OECD Protection Agency (EPA) is working to under the Toxic Substances Control Act program lists approximately 5,000 figure out how to change the current and informing the Safe Drinking Water chemicals on its list, and OSHA has approach used to evaluate the safety of Act’s contaminant candidate lists. (EPA, determined that 290, or 62 percent of chemicals. CompTox research integrates 2014b; Ex. #60) EPA contributes the the 470 substances with PELs are advances in biology, biotechnology, results of ToxCast to a Federal agency included on the OECD list. chemistry, and computer science to collaboration called Toxicity Testing in Under the HPV program, EPA has identify important biological processes the 21st Century (Tox21). Tox21 pools identified over 2,000 chemicals that are that may be disrupted by the chemicals those results with chemical research, produced in quantities of one million and trace those biological disruptions to data and screening tools from the pounds a year or more in the United a related dose and human exposure. The National Toxicology Program at the States. It would appear that these combined information helps prioritize National Institute of Environmental chemicals are thus economically chemicals based on potential human Health Science, the National Institutes significant in the US, and there are health risks. Using CompTox, thousands of Health’s National Center for likely to be a large number of workers of chemicals can be evaluated for Advancing Translational Sciences and exposed to them. Through the HPV potential risk at a small cost in a very the Food and Drug Administration. Challenge program, EPA encouraged short amount of time. A major part of (EPA, 2014b; Ex. #60) industry to make health and EPA’s CompTox research is the Toxicity Thus far, Tox21 has compiled environmental effects data on these HPV Forecaster (ToxCastTM). ToxCast is a highthroughput screening data on chemicals publicly available. To date, multiyear effort launched in 2007 that nearly 10,000 chemicals. All ToxCast data on the properties of approximately uses automated chemical screening chemical data are publicly available for 900 HPV chemicals has been made technologies, called ‘‘highthroughput anyone to access and use through user- available through the Agency’s High screening assays,’’ to expose living cells friendly Web applications called Production Volume Information System or isolated proteins to chemicals. The interactive Chemical Safety for (HPVIS) (U.S. EPA, 2012a; Ex. #56). For cells or proteins then are screened for Sustainability (iCSS) Dashboards at each HPV chemical, the database changes in biological activity that may http://actor.epa.gov/actor/faces/. includes information on up to 50 suggest potential toxic effects. OSHA could use this publicly endpoints on physical/chemical These innovative methods have the available information on chemical properties, environmental fate and potential to limit the number of required properties and toxicity as a part of the pathways, ecotoxicity, and mammalian animal-based laboratory toxicity tests Agency’s risk assessments that support health effects. EPA has also used this while, quickly and efficiently screening the revision and development of information to generate publicly large numbers of chemicals. The first permissible exposure limits. Tox21 available chemical hazard phase of ToxCast, called ‘‘proof of could also be used by the Agency for characterizations, which provide a concept’’, was completed in 2009, and screening chemicals and prioritizing for concise assessment of the raw technical it evaluated more than 300 well studied risk management. data on HPV chemicals and evaluate the chemicals (primarily pesticides) in more Question V.A.2. How might the quality and completeness of the data than 500 high-throughput screening information on the properties and received from industry (U.S. EPA, assays. Because most of these chemicals toxicity of chemicals generated by 2013d; Ex. #63). already have undergone extensive CompTox, ToxCast, and/or Tox21 be Data on HPV chemicals submitted animal-based toxicity testing, this utilized by employers to identify through the OECD’s program are enables EPA researchers to compare the chemical hazards and protect workers available through its Global Portal to results of the high-throughput assays from these hazards? OSHA is also Information on Chemical Substances, with those of the traditional animal interested to hear from commenters who eChemPortal (OECD, 2013; Ex. #58). In tests. (EPA, 2014a; Ex. #59) may currently make use of these data in addition to searching data collected Completed in 2013, the second phase their worker protection programs. through the EPA HPV and OECD HPV of ToxCast evaluated over 2,000 programs, eChemPortal allows for chemicals from a broad range of sources, 3. Production and Use Data Under simultaneous searching of 26 databases including industrial and consumer EPA’s Chemical Data Reporting Rule for existing publicly available data on products, food additives, and Under the EPA’s Chemical Data the properties of chemicals, including: potentially ‘‘green’’ chemicals that Reporting (CDR) Rule, issued in 2011, physical/chemical properties, could be safer alternatives to existing EPA collects screening-level, exposure- environmental fate and behavior, chemicals. These chemicals were related information on certain chemicals ecotoxicity, and toxicity. evaluated in more than 700 high- included on the Toxic Substances Question V.A.1. How might publicly throughput assays covering a range of Control Act (TSCA) Chemical Substance available information on the properties high-level cell responses and Inventory and makes that information and toxicity of HPV chemicals be approximately 300 signaling pathways. publicly available to the extent possible. utilized by employers to identify ToxCast research is ongoing to The CDR rule amended the TSCA chemical hazards and protect workers determine which assays, under what Inventory Update Reporting (IUR) rule

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61407

and significantly increased the type and chemicals (Russom et al., 2003; Ex. used for new chemical assessments are amount of information covered entities #64). QSARs are mathematical models publically available (U.S. EPA, 2012b; are required to report. The 2012 that are used to predict measures of Ex. #67). submissions included data on more toxicity from physical characteristics of In Europe, internationally agreed- chemicals and with more in-depth the structure of chemicals, known as upon principles for the validation of information on manufacturing molecular descriptors. (Q)SARs were adopted by OECD (including import), industrial Other U.S. and international agencies Member Countries and the Commission processing and use, and consumer and have explored the use of chemical in 2004. In 2007, the Inter-organization commercial use than data collected groupings to regulate chemicals in order Programme for the Sound Management under the IUR in 2006 (U.S. EPA, 2013a; to fulfill their regulatory and statutory of Chemicals, a cooperative agreement Ex. #1). authorities. Under the TSCA Work Plan, among United Nations Environmental The expanded reporting on chemical the EPA announced in 2013 that it Program (UNEP); International Labor production and use information under would begin to assess 20 flame retardant Organization (ILO); Food and the CDR could help OSHA better chemicals and three non-flame retardant Agriculture Organization of the United understand how workers are exposed to chemicals. EPA utilized a structure- Nations (FAO); World Health chemicals and the industries and based approach, grouping eight other Organization (WHO); United Nations occupations where exposures to flame retardants with similar Industrial Development Organization chemicals might occur. characteristics together with the (UNIDO), United Nations Institute for chemicals targeted for full assessment in Training and Research (UNITAR) and 4.Structure-Activity Data for Chemical three groupings. EPA will use the Organization for Economic Co-operation Grouping information from these assessments to and Development (OECD) published Although toxicity testing for better understand the other chemicals in ‘‘Guidance on Grouping of Chemicals’’ chemicals has increased greatly since the group, which currently lack as part of an ongoing monograph series the passage of the Toxic Substances sufficient data for a full risk assessment. on testing chemicals. REACH registrants Control Act (15 U.S.C. 2601–2629; Ex. EPA uses chemical groupings to fill may rely on (Q)SAR data instead of #62) in the United States, and with data gaps in its New Chemical Program. experimental data, provided the similar legislation elsewhere, toxicity EPA’s New Chemical Program, also registrants can provide adequate and data is only publicly available for a under TSCA, requires anyone who plans reliable documentation of the applied fraction of industrial chemicals. Since to manufacture or import a new method and document the validity of the enactment of TSCA and creation of chemical substance into commerce to the model. Validation focuses on the the TSCA Interagency Testing provide EPA with notice before relevance and reliability of a model Committee (U.S. EPA, 2013c; Ex. #57), initiating the activity. This is called a (ECHA, 2008; Ex. #68). the ITC has recommended testing for pre-manufacture notification (PMN). The EU Scientific Committee on hundreds of chemicals, and chemical EPA received approximately 1,500 new Toxicity, Ecotoxicity and the producers have conducted more than chemical notices each year and has Environment (CSTEE) recommended, in 900 tests for these chemicals. However, reviewed more than 45,000 from 1979 their general data requirements for potentially thousands of industrial through 2005 (GAO, 2007; Ex. #65). regulatory submission, that QSAR data chemicals have not been tested. Because TSCA does not require testing may be used as well as animal data. A With the rapidly expanding before submission of a PMN, SARs and chemical category approach based on development of new chemical QSARs are often used to predict the the metal ion has been extensively used substances and mixtures, the need for environmental fate and ecologic effects. for the classification and labeling of toxicity information to inform chemical In addition, the EPA makes predictions metal compounds in the EU. Other safety management and public health concerning chemical identity, physical/ category entries are based on certain decisions in a timely manner has chemical properties, environmental anions of concern such as oxalates and exceeded the capacity of the transport and partitioning, thiocyanates. For these EU government programs to provide those environmental fate, environmental classifications the category approach data. As a result, programs such as the toxicity, engineering releases to the has often been applied to certain Organization for Economic Cooperation environment, and environmental endpoints of particular concern for the and Development’s (OECD) Screening concentrations. The agency uses a compounds under consideration, but Information Data Set (SIDS) and the U.S. variety of methods to make these has not necessarily been applied to all EPA High Production Volume (HPV) predictions that include SARs, nearest- endpoints of each individual compound Challenge programs were designed to analogue analysis, chemical class in the category of substances. encourage the voluntary development of analogy, mechanisms of toxicity, and The Danish EPA has made extensive data. However, even with the creation of chemical industry survey data and the use of QSARs and has developed a these non-statutory programs, collective professional judgment of QSAR database that contains predicted potentially thousands of non-HPV expert scientific staff, in the absence of data on more than 166,000 substances industrial chemicals go untested. empirical data. The agency uses these (OSPAR Commission, 2000; Ex. #69). A Therefore, chemical prioritization for methods to fill data gaps in an recent publication from the Danish EPA screening and testing requires the assessment and to validate submitted reports the use of QSARs for development and validation of standard data in notifications. Predictions are identification of potential persistent, methods to predict the human and also made by the U.S. EPA Office of bioaccumulative and toxic (PBT) and environmental effects and potential fate Pollution Prevention and Toxics (OPPT) very persistent and very of chemicals. Where screening and under TSCA (Zeeman., 1995; Ex. #66). bioaccumulative (vPvB) substances from testing data are sparse, the use of The OPPT has routinely used QSARs to among the HPV and medium- predictive models called structural predict ecologic hazards, fate, and risks production volume chemicals in the EU. activity relations (SARs) or quantitative of new industrial chemicals, as well as OSHA is considering using a structural activity relationships (QSARs) to identify new chemical testing needs, combination of chemical group can extend the use of limited toxicity for more than two decades. OPPT SAR/ approaches to evaluate multiple and safety data for some untested QSARs for physical/chemical properties chemicals with similar attributes

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61408 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

utilizing limited data that can be mammalian toxicity; ecotoxicity; characterization process to determine if extrapolated across categories. The environmental fate; manufacture and the operational conditions cause Agency invites comment on how such use; and risk management measures exposures that require risk management grouping approaches have been used to (ECHA, 2012b; Ex. #71). Non- measures to ensure risks of the evaluate risks to worker populations. confidential information from the substance are controlled. Risk Question V.A.3: Are QSAR, read- technical dossiers is published on the characterization consists of the across, and trend analysis useful and ECHA Web site (ECHA, 2012c; Ex. #72). comparison of exposure values derived acceptable methods for developing Companies manufacturing or from each exposure scenario with their hazard information utilizing multiple importing a chemical in quantities of 10 respective DNEL or an analogous health data sets for a specific group of or more tons per year must also conduct benchmark such as Derived Minimal chemicals? a chemical safety assessment. This Effect Level (DMEL) or Predicted No Question V.A.4: Are there other assessment includes the evaluation of: Effect Concentration (PNEC)), acceptable methods that can be used to (1) Human health hazards; (2) established by the registrant. Where no develop hazard information for multiple physicochemical hazards; (3) health benchmark is available, a chemicals within a group? environmental hazards; and (4) qualitative risk characterization is Question V.A.5: What are the persistent, bioaccumulative and toxic required (ECHA, 2009; Ex. #73). advantages and disadvantages of each (PBT), and very persistent and very Manufacturers and importers are method? bioaccumulative (vPvB) potential required to document the information 5. REACH: Registration, Evaluation, (ECHA, 2012b; Ex. #71). If a substance developed during the chemical safety Authorization, and Restriction of is determined to be hazardous or a PBT/ assessment in a chemical safety report, Chemicals in the European Union (EU) vPvB, registrants must then conduct an which is submitted to ECHA. The report exposure assessment, including the then forms the basis for other REACH Safe chemical management is a development of exposure scenario(s) processes, including substance universal concern. The European Union, (ES) and exposure estimation, and a risk evaluation, authorization, and recognizing the need for a more characterization that includes restriction. integrated approach to chemical development of a health effects ECHA and the EU Member States then management, adopted REACH benchmark, such as the Derived No evaluate the information submitted (Registration, Evaluation, Authorization, Effect Level (DNEL). during the registration process to and Restriction of Chemicals) to address An exposure scenario, the main examine the testing proposals, check the chemicals throughout their life cycle. output of the exposure assessment quality of the registration dossiers, and Although REACH applies to European process, documents a set of operational evaluate whether a substance Union Member States, chemical conditions and risk management constitutes a risk to human health or the manufacturers in other countries measures for a specific use of a environment. Following the evaluation exporting to European countries also substance. A number of exposure process, registrants may be required to have to comply with the REACH estimation models have been developed comply with additional actions to requirements to sell their products in in the EU to help the regulated address concerns (i.e., submit further Europe. community create these exposure information, proceed on restriction or The REACH Regulation (EC) No 1907/ scenarios. Exposure scenarios must also authorization procedures under REACH, 2006 became effective on June 1, 2007, be included in the Safety Data Sheets take actions under other legislation, and relies on the generation and (SDS) in order to communicate this etc.). (ECHA, 2012d; Ex. #74). disclosure of data by manufacturers and information down the supply chain. As the implementation of REACH importers of chemicals in order to When an extended SDS with exposure continues, large amounts of information protect human health and the scenarios is received by a chemical user, will be generated by manufacturers, environment from chemical hazards. the exposure scenarios must be importers, and downstream users The regulation also established the reviewed to determine if they are throughout the registration, European Chemicals Agency (ECHA) to applicable to the use situation in that authorization, and restriction processes. coordinate implementation (EC 1907/ facility. If the exposure scenarios are Some of this information is publicly 2006, 2006; Ex. #70). applicable, the user has 12 months to available on ECHA Web sites, and REACH establishes processes for the implement them. If they are not, the includes toxicological information, Registration, Evaluation, Authorization, user has several options to choose from general exposure control and Restriction of Chemicals. REACH to determine appropriate controls. recommendations, and assessments of requires manufacturers and importers to These options include: (1) User the availability of alternatives. The register their chemicals and establish informing supplier of their use, and user generation and availability of this procedures for collecting and assessing convincing supplier to recognize it as an extensive data on chemicals can assist information on the properties, hazards, ‘‘identified use’’ on suppliers safety OSHA, as well as U.S. employers and potential risks and uses of their assessment; (2) user implementing the workers, to further enhance chemical chemicals. The registration process, suppliers conditions of use described in safety and health management by which began in 2010, is being phased- the exposure scenario of the original/ assisting in the assessment of hazards, in based on the tonnage and hazard current safety assessment; (3) user development of exposure control classification of the substances. For substituting the substance for another recommendations, and selection of existing chemicals, it is set to be substance that is covered in a pre- substitutes to help drive the transition completed in June 2018. existing safety assessment; (4) user to safer chemicals in the workplace. For each chemical manufactured or finding another supplier who does As of July, 2013, the REACH database imported in quantities of 1 ton or more provide an exposure scenario that of registered substances is comprised of per year, companies must register the covers the use of the substance; or (5) more than 9900 substances. The substance by providing a technical prepare a downstream user chemical database provides extensive information dossier to ECHA. The technical dossier safety report. (ECHA, 2012c; Ex. #72). to the public from dossiers prepared by includes information on: Substance After completing the exposure chemical manufacturers, importers, and identity; physicochemical properties; assessment, registrants conduct a risk downstream users. OSHA is interested

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61409

in determining whether some hazards present—OELs established for a neurotoxicant causing symptoms of information developed and submitted few chemicals among the many in the peripheral neuropathy, and hexane- under REACH may be helpful to OSHA workplace environment have acetone blends, which amplify the in its own regulatory initiatives. diminished impact in these situations. neurotoxic effects of n-hexane, thus Information submitted under REACH’s Unlike OELs, which are only useful in resulting in risk-shifting from the requirements to assess chemical risks in protecting workers if regular environment to workers (Wilson et al., workplaces may be useful in developing measurement and assessment of 2007; Ex. #76). task-based exposure control plans, or of compliance is completed, alternative While regulatory processes lacking a use in OSHA’s feasibility analyses. risk management approaches focus more robust assessment of alternatives can OSHA is participating in high-level on determining what types of controls result in substitution that is equally discussions with the EU about the are required to reduce exposures detrimental to human health or the feasibility of sharing these data. without necessarily referring to environment, regulatory efforts that Question V.A.6: OSHA is interested in quantitative assessments of exposure to require planning processes and provide the experiences of companies that have evaluate success. guidance and technical assistance on had to prepare chemical dossiers and An important aspect of risk preferred alternatives can minimize risk submit registration information to the assessment and risk management is trade-offs and protect workers, European Chemicals Agency (ECHA) consideration of safer alternatives, consumers, and the environment. For ECHA. In particular, how might the which can often result in a path forward example, in Massachusetts, facilities approaches be used to support that is less hazardous, technically using specific toxic chemicals in certain occupational exposure assessments and feasible, and economically viable. quantities are required to undertake a development of use-specific risk toxics use reduction planning process. management in the United States? 1. Informed Substitution to Safer Agencies provide various resources to Question V.A.7: To what extent is Chemicals and Processes encourage and facilitate the voluntary information developed under REACH While establishing exposure limits for adoption of alternatives. In the case of used by U.S. businesses to promote hazardous chemicals helps to reduce trichloroethylene, the Massachusetts product stewardship and ensure safe workers’ risk of adverse health effects, Office of Technical Assistance and the use of substances and mixtures by the process is costly, time consuming, Toxics Use Reduction Institute provided product users? and does not drive the development or technical assistance, educational Question V.A.8: Should OSHA pursue adoption of safer alternatives that could workshops, a database of safer efforts to obtain data from ECHA that best protect workers. OSHA recognizes alternatives, and performance companies are required to provide that ultimately, an approach to chemical evaluations of alternatives (Toxics Use under REACH? management that incentivizes and spurs Reduction Institute, 2011a; Ex. #78; B. Non-OEL Approaches to Chemical the transition to safer chemicals, Toxics Use Reduction Institute, 2011b; Management products, and processes in a thoughtful, Ex. #79; Toxics Use Reduction Institute, systematic way will most effectively 2011c; Ex. #80). Through these efforts, OSHA’s PELs and its corresponding ensure safe and healthful conditions for Massachusetts companies reduced the hierarchy of controls have been a major workers. use of trichloroethylene by 77 percent focus in the fields of occupational Informed substitution, the considered since 1990, moving to a number of safer health and industrial hygiene for many transition from hazardous chemicals to alternatives in the process (Toxics Use years. Undoubtedly, occupational safer substances or non-chemical Reduction Institute, 2011d; Ex. #81). exposure limits (OELs), which help alternatives, provides a way of moving These cases demonstrate that the reduce workers’ risk of adverse health toward a more preventative chemical transition to safer chemicals, materials, by establishing precise targets for management framework. products, and processes will be best employers to follow, will always be an facilitated not through restrictions or essential part of controlling chemical a. Substitution in Practice bans of chemicals, but rather through exposures in workplaces. However, Whenever a hazardous chemical is the integration of informed substitution regardless of whether a more effective regulated, there is always the potential and guidance on preferred alternatives process for updating OSHA’s PELs can for the chemical to be replaced with a into regulatory efforts. be established, the rapid development of substitute chemical or redesigned new chemical substances and mixtures product or process that poses new and b. Benefits of a Preference for Primary that will continue to leave workers potentially greater hazards to workers, Prevention Strategies exposed to thousands of unregulated consumers, or the environment or The reduction or elimination of a substances make it impractical to solely results in risk-shifting from one group to hazard at the source, as traditionally rely on OELs. Moreover, for many of the another. Regrettably, this potential has embraced by health and safety chemicals and mixtures that have been been realized in a number of cases. For professionals, is not only the most developed since the PELs were initially example: reliable and effective control approach, promulgated, insufficient hazard • The regulation of methylene but also provides a number of benefits information exists to serve as a basis for chloride by EPA, FDA, and OSHA for workers and businesses. developing OELs. While OELs generally spurred the shift to 1-bromopropane, an Preferring primary prevention focus on a single chemical, workers are unregulated neurotoxicant and possible strategies (i.e. elimination and typically exposed to mixtures or carcinogen, in a variety of applications, substitution) can result in the ‘‘total multiple substances in the workplace. such as refrigeration, metal cleaning, elimination of exposure to hazardous Mixed exposures may also result in and vapor and immersion degreasing chemicals, less reliance on worker synergistic or antagonistic effects that applications, as well as in adhesive compliance or equipment maintenance are rarely considered in developing resins (Kriebel et al., 2011; Ex. #75). for success, elimination of the potential OELs. • Air quality regulations in California for accidental or non-routine Workplace risk assessments, and created a market in the vehicle repair overexposures, prevention of dermal corresponding risk management plans, industry for solvent products exposures, and process and should be based on an evaluation of all formulated with n-hexane, a environmental improvements not

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61410 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

related to worker health’’ (Roelofs et al., consequences, which can result from a comparative chemicals hazard 2003; Ex. #82). precautionary switch away from a assessment tools include the Additionally, making process hazardous chemical without fully GreenScreen (Clean Production Action, improvements designed to reduce or understanding the profile of potential 2012; Ex. #88) and Design for the eliminate workers’ exposures to alternatives, and to enable a course of Environment (DfE) Safer Product hazardous chemicals often results in action based on the best information Labeling Program (U.S. EPA, 2011a; Ex. significant business improvements or that is available or can be estimated. #89). Other existing methods for savings. A 2008 study by the American Informed substitution approaches focus chemical comparison include the Industrial Hygiene Association (AIHA) on identifying alternatives and Column Model (Institut fu¨ r demonstrated the relationship between evaluating their health, safety, and Arbeitsschutz der Deutschen the application of the hierarchy of environmental hazards, potential trade- Gesetzlichen Unfallversicherung, 2011; controls and financial benefits. The offs, and technical and economic Ex. #90) and QuickScan (Netherlands study found that the greatest cost feasibility. Ministry of Infrastructure and the savings and other benefits tended to be Substitution is not limited to Environment, 2002; Ex. #91). Tools and associated with hazard elimination and substitution of one chemical with methods for evaluating performance and the elimination of personal protective another. It can also occur at the cost attributes, while less well equipment (PPE) usage. It also production process or product level. At developed, are also critical for the highlighted the ability of material the product level, substitution may selection of a preferred alternative. substitution to result in very large involve a design change that takes payoffs due to the creation of advantage of the characteristics of new d. Substitution at OSHA efficiencies throughout the business or different materials. A chemical Substitution is not new for OSHA. process (American Industrial Hygiene process design change may eliminate Historically, OSHA attempted to Association, 2008; Ex. #83). For several production steps thereby encourage substitution by setting a ‘‘no example: avoiding or reducing the use of high occupational exposure level’’ for certain • A foundry making automatic diesel hazard chemicals. In some cases, a potential carcinogens where suitable engine blocks enhanced and particular chemistry or the function it substitutes that are less hazardous to aggressively enforced a purchasing serves may be determined to be humans existed for particular uses (45 specification program to eliminate unnecessary. FR 5257–58; Ex. #92). Although this supplied scrap metal contaminated with As implementation of chemical requirement was never fully lead. By eliminating lead from its substitution and product and process implemented, the final rule detailed a supply chain, the company not only changes can be quite complicated, a process for the Agency to analyze the achieved high levels of employee variety of processes, tools, and methods feasibility of substitutes, which required protection, but also enhanced the are critical to achieving informed the consideration of: (1) the safety of the quality of its products and realized substitution. substitute, including the comparative nearly $20 million in savings for the Substitution planning, similar to acute and chronic toxicity of the facility. facility planning for pollution carcinogenic chemical and the • An aircraft manufacturing prevention and source reduction, substitute, and other relevant factors, company, struggling to comply with the establishes practical steps for evaluating such as environmental factors; (2) the OSHA PEL for hexavalent chromium, substitution as a workplace risk technical feasibility of the substitute, transitioned from chromate-based reduction measure. This type of including its relative effectiveness; and primers to non-chromate based primers, planning process supports informed (3) the economic cost of substitution (45 resulting not only in the elimination of substitution by encouraging chemical FR 5258; Ex. #92, 29 CFR 1990.111(k); worker exposure to chromate dusts from users to: Systematically identify Ex. #93, see also 1990.132(b)(6); Ex. #94, rework sanding, but also in quality hazardous chemicals; set goals and 1990.146(k); Ex. #95). improvements of its products, increased priorities for the elimination or OSHA health standards also identify customer satisfaction, productivity reduction of hazardous chemicals; substitution as a preferred exposure gains, avoidance of costly changes to evaluate alternatives; identify preferred control. For example, in the 1989 Air their exhaust ventilation system, and a alternatives; and promote the adoption Contaminants Standard, the Agency savings of $504,694 over the 5-year of identified alternatives. refers to substitution, when properly duration of the project. Alternatives assessment is a process applied, as ‘‘a very effective control of identifying and comparing potential technique’’ and ‘‘the quickest and most c. Informed Substitution chemical and non-chemical alternatives effective means of reducing exposure’’ In order to truly protect workers from that could replace chemicals or (54 FR 2727, 2789; Ex. #7). In addition, chemical hazards, it is important that technologies of concern on the basis of the Agency’s respiratory protection OSHA not only develop health their hazards, performance, and standard mandates the use of accepted standards for hazardous chemicals, but economic viability. A variety of engineering control measures, including also understand alternatives to regulated alternatives assessment processes have the substitution of less toxic materials, chemicals and support a path forward been developed to date (Lavoie et al., as far as feasible, before using that is less hazardous, technically 2010; Ex. #84; Toxics Use Reduction respirators to control occupational feasible, and economically viable. Institute, 2006; Ex. #85; Rossi et al., diseases caused by breathing Informed substitution provides a 2006; Ex. #86; Raphael et al., 2011; Ex. contaminated air (29 CFR 1910.134(a); framework for meeting this goal. #87). Various tools and methods have Ex. #96). Despite this, when complying As previously described, informed been developed to evaluate hazard, with PELs and other health standards in substitution is the considered transition performance, and cost when assessing practice, employers are required to from a potentially hazardous chemical, alternatives. For example, comparative select and implement administrative or material, product, or process to safer chemicals hazard assessments compare engineering controls before using chemical or non-chemical alternatives. potential alternatives based on a variety personal protective equipment, but are The goals of informed substitution are to of hazard endpoints in order to select a not specifically required or encouraged minimize the likelihood of unintended safer alternative. Some examples of to consider elimination or substitution

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61411

before other engineering or In October 2013, OSHA launched an chemicals. For example, the administrative controls. (See 29 CFR effort to encourage employers, workers, Massachusetts Toxics Use Reduction 1910.1000(e); Ex. #97). Thus, and unions to proactively reduce the Act requires entities that use listed substitution may be often overlooked in use of hazardous chemicals in the hazardous chemicals in certain favor of other approaches, such as workplace and achieve chemical use quantities to undertake a planning ventilation and isolation, when that is safer for workers and better for process for reducing the use of those employers are controlling exposures to business. As part of this effort, the chemicals (Massachusetts Department of hazardous chemicals. Agency developed a web toolkit that Environmental Protection, n.d.; Ex. OSHA also considers substitution guides employers and workers in any #77). during the development of PELs. While industry through a seven-step process Existing regulations in the European OSHA does not solely rely on for transitioning to safer chemicals Union place a duty on employers to substitution to make its required (OSHA, 2013a; Ex. #107). Each step replace the use of certain hazardous feasibility findings (62 FR 1494, 1576; contains information, resources, chemicals with safer substitutes, if Ex. #98; 71 FR 10099, 10260; Ex. #99), methods, and tools that will help users technically possible. For example, the Agency, as part of PEL rulemaking eliminate hazardous chemicals or make Directive 2004/37/EC requires the efforts, develops and evaluates informed substitution decisions in the substitution of carcinogens and information about substitution in its workplace by finding a safer chemical, mutagens with less harmful substances technological and economic feasibility material, product, or process. where technically feasible (2004/37/EC, 2004) and Directive 98/24/EC requires analysis, highlighting options available e. Possible Opportunities for Integrating for eliminating or reducing the regulated employers to ensure that risks from Informed Substitution Approaches Into hazardous chemical agents are chemical’s use in various industries and OSHA Activities applications. For example, the eliminated or reduced to a minimum, There are a variety of existing feasibility analysis for methylene preferably by substitution (98/24/EC, regulatory and non-regulatory models chloride describes numerous substitute 1998; Ex. #109). for incorporating informed substitution Other regulations require the use of chemicals and processes, including a into chemical management activities. acceptable substitutes where the uses of detailed table of substitute paint The following are some examples of certain hazardous chemicals are phased- removal methods for 16 applications, entities that have developed and out. This type of approach is currently and evaluates the relative risks for seven utilized informed substitution implemented by U.S. EPA in the context of the more common substitutes for approaches as part of regulatory efforts; of phasing-out ozone depleting methylene chloride (OSHA, 1996; Ex. guidance and policy development; substances. The Clean Air Act requires #100). However, the analysis of education, training, and technical that these substances be replaced by substitutes has varied widely from assistance activities; and data others that reduce risks to human health regulation to regulation. For example, development and research efforts. and the environment. Under the the feasibility analysis for hexavalent Significant New Alternatives Policy i. Models for Regulatory Approaches chromium identifies specific substitute (SNAP) program, EPA identifies and chemicals and processes in many Some regulations and voluntary publishes lists of acceptable and industries, but does not discuss the standards require risk reduction through unacceptable substitutes for ozone- health or safety hazards of the the implementation of a hierarchy of depleting substances (Safe Alternatives substitutes (OSHA, 2006a; Ex. #101), controls that clearly delineates Policy, 2011; Ex. #111). while the feasibility analysis for elimination and substitution as Some chemical management formaldehyde includes only a mention preferred options to be considered and frameworks require the assessment of of the availability of one identified implemented, where feasible, before substitutes before making decisions to substitute for a few industry sectors other controls. For example, the ANSI/ limit or restrict the use of a hazardous (OSHA, 1987; Ex. #102) and the AIHA Z10–2005 standard for chemical. For example, the European feasibility analysis for ethylene oxide Occupational Health and Safety Union REACH Regulation (Registration, does not contain any discussion of Management Systems, a voluntary Evaluation, Authorization and substitutes (OSHA, 1984; Ex. #103). national consensus standard, requires Restriction of Chemicals) requires that OSHA has also included information organizations to implement and an analysis of alternatives, the risks on substitutes in a variety of non- maintain a process for achieving feasible involved in using any alternative, and regulatory documents. New information risk reduction based upon the following the technical and economic feasibility of about available substitutes and preferred order of controls: A. substitution be conducted during substitution trends is included in Elimination; B. Substitution of less applications of authorization for lookback reviews of existing standards hazardous materials, processes, substances of very high concern (EC conducted by the Agency (e.g., lookback operations, or equipment; C. 1907/2006, 2006; Ex. #70). review of the ethylene oxide standard, Engineering controls; D. Warnings; E. Other efforts to spur the transition to lookback review of the methylene Administrative Controls; and F. safer chemicals, products, and processes chloride standard) (OSHA, 2005; Ex. Personal protective equipment (ANSI/ are based on the development of #104; OSHA, 2010; Ex. #105). In some AIHA Z10–2005, 2005; Ex. #108). criteria-based standards for functions or cases, OSHA has also developed European Union Directives 98/24/EC processes that rely on hazardous information on substitution, even where and 2004/37/EC require employers to chemicals. For example, the EPA DfE a PEL has not been established. For eliminate risks by substitution before Safer Product Labeling Program is a example, the OSHA guidance document implementing other types of protection nonregulatory program that recognizes on the best practices for the safe use of and prevention measures (98/24/EC, safe products using established criteria- glutaraldehyde in health care includes 1998; Ex. #109, 2004/37/EC, 2004; Ex. based standards. In order to receive DfE information about drop-in replacements #110). recognition, all chemicals in a and alternative processes available to Some existing laws require firms to formulated product must meet Master reduce or eliminate the use of the undertake planning processes for the Criteria (i.e., toxicological thresholds for chemical (OSHA, 2006b; Ex. #106). reduction of identified hazardous attributes of concern, including: acute

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61412 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

mammalian toxicity; carcinogenicity; comparing the health risks, iv. Models for Data Development genetic toxicity; neurotoxicity; repeated physicochemical risks, and technical Several efforts, at both the federal and dose toxicity; reproductive and suitability of identified alternatives international levels, attempt to support developmental toxicity; respiratory (German Federal Institute for the transition to safer alternatives sensitization; skin sensitization; Occupational Safety and Health, 2008; through research and data development. environmental toxicity and fate; and Ex. #115). For example, EPA, in collaboration with eutrophication), as well as relevant The German Environment Agency has the non-governmental organization functional-class criteria (i.e., additional also developed guidance on sustainable GreenBlue and industry stakeholders, toxicological thresholds for attributes of chemicals. The guide assists jointly developed a database of cleaning concern for surfactants, solvents, direct- manufacturers, formulators, and end product ingredient chemicals release products, fragrances, and users of chemicals in the selection of (surfactants, solvents, fragrances, and chelating and sequestering agents), sustainable chemicals by providing chelating agents) that meet identified established by the EPA (U.S. EPA, criteria to distinguish between environmental and human health 2011a; Ex. #89). sustainable and non-sustainable criteria (GreenBlue, 2012; Ex. #117). In While there are a number of ways in substances (German Environment which OSHA could consider integrating Spain, the Institute of Work, Agency, 2011; Ex. #116). Environment, and Health (ISTAS) has substitution and alternatives assessment OSHA considered developing into its regulatory efforts, the Agency, in developed a database that is a repository guidance on safer substitutes to of information on substitute chemicals. order to promulgate any such standard, accompany individual chemical would need to make the significant risk, The database can be searched for exposure limit standards in its 2010 technological feasibility, and economic chemical substances, uses/products, regulatory review of methylene feasibility findings required under the processes, or sectors to display chloride. Due to the increased use of OSH Act. However, even without information on substitutes and hazards other hazardous substitutes after regulation, it is important to consider associated with those substitutes methylene chloride was regulated in voluntary models for incorporating (ISTAS, 2012; Ex. #118). In addition, the 1998, the Agency considered informed substitution into chemical European Union SUBSPORT project has establishing guidance recommending management activities. begun to create a Substitution Support that firms check the toxicity of Portal, a state-of-the-art resource on ii. Models for Guidance Development alternatives on the EPA and NIOSH Web safer alternatives to the use of hazardous Some entities have developed sites before using a substitute (OSHA, chemicals. The resource is intended to guidance to promote the transition to 2010; Ex. #105). provide not only information on safer alternatives. The European Union, iii. Models for Education, Training, and alternative substances and technologies, in order to support legislative Technical Assistance but also tools and guidance for substitution mandates, developed substance evaluation and substitution guidance on the process of substitution, Other entities have developed management (SUBSPORT, 2012; Ex. including setting goals, identifying outreach, training, and technical #119). priority chemicals, evaluating assistance efforts for substitution Other efforts focus on the completion substitutes, selecting safer alternatives, planning and the assessment of of alternatives assessments for priority and implementing chemical, material, substitutes for regulated chemicals. The chemicals and uses. Currently, EPA’s and process changes. The guidance Massachusetts Toxics Use Reduction Design for the Environment Program, as establishes and describes a seven step Act, which established a number of well as the Massachusetts Toxics Use substitution framework, providing structures to assist businesses, provides Reduction Institute, has conducted workplaces with a systematic process a good example of such efforts. The alternatives assessments for priority for evaluating chemical risk and Massachusetts Office of Technical chemicals and functional uses, making identifying chemicals that could or Assistance and Technology (OTA) this information publicly available in should be substituted (European provides compliance assistance and on- the process (U.S. EPA, 2012c; Ex. #120; Commission, 2012; Ex. #113). The steps site technical support that helps Toxics Use Reduction Institute, 2006; include: Assessing the current level of facilities use less toxic processes and Ex. #85). risk; deciding on risk reduction needs; boost economic performance. The In addition, some research efforts assessing the margins of change; looking Massachusetts Toxics Use Reduction attempt to fill data gaps with regards to for alternatives; checking the Institute provides training, conducts the toxicological properties of existing consequences of a change; deciding on research, and performs alternatives chemicals. While some efforts to change; and deciding on how and when assessments in order to educate conduct toxicity testing for chemicals is to implement change. businesses on the existence of safer taking place at the federal level (U.S. Similarly, the German Federal alternatives and promote the on-the- EPA, 2011b; Ex. #121, U.S. EPA, 2012d; Institute for Occupational Safety and ground adoption of these alternatives. Ex. #122), there have not been Health (BAuA) established guidance to Toxics Use Reduction Planners systematic efforts to conduct targeted support the employer’s duty, as (TURPs), certified by the Massachusetts toxicology studies for specific mandated in the German Hazardous Department of Environmental Protection substitutes of interest. Substances Ordinance, to evaluate (MA DEP), prepare, write and certify the Question V.B.1: To what extent do substitutes to hazardous substances and required toxics use reduction plans and you currently consider elimination and implement substitution where less are continually educated about best substitution for controlling exposures to hazardous alternatives are identified practices in toxics use reduction. Taken chemical hazards? (German Federal Institute for together, these services provide a robust Question V.B.2: What approaches Occupational Safety and Health, 2011; resource for regulated businesses on the would most effectively encourage Ex. #114). The guidance, TRGS 600, transition to safer alternatives businesses to consider substitution and includes a framework for identifying (Massachusetts Department of adopt safer substitutes? and evaluating substitutes and Environmental Protection, n.d.; Ex. Question V.B.3: What options would establishes criteria for assessing and #77). be least burdensome to industry,

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61413

especially small businesses? What comparing the toxicity based on On March 26, 2012, OSHA published options would be most burdensome? nineteen human and environmental major modifications to the HCS. (77 FR Question V.B.4: What information and hazard endpoints, assigning a level of 17574–17896; Ex. #125). These support do businesses need to identify concern of high, moderate, or low for modifications are being phased in over and transition to safer alternatives? each endpoint based on various several years, and will be completely What are the most effective means to established criteria (Clean Production implemented in June 2016. Referred to provide this information and support? Action, 2012; Ex. #88). as HazCom 2012, the revised rule Question V.B.5: How could OSHA A number of robust frameworks have incorporates a new approach to leverage existing data resources to also been developed to assess the assessing the hazards of chemicals, as provide necessary substitution feasibility of adopting alternatives for well as conveying information about information to businesses? hazardous chemicals based on them to employees. The revised rule is v. Effectively Implementing Informed environmental, performance, economic, based on the United Nations’ Globally Substitution Approaches human health, and safety criteria. The Harmonized System for the Massachusetts Toxics Use Reduction Classification and Labeling of Chemicals The goals of informed substitution Institute developed and implemented a (GHS), which established an cannot be achieved without the methodology for assessing alternatives international, harmonized approach to development and application of tools to hazardous chemicals based on hazard communication. and methods for identifying, comparing, performance, technical, financial, The original HCS was a performance- and selecting alternatives. Existing tools environmental, and human health and methods range in complexity, from oriented rule that prescribed broad rules parameters (TURI, 2006; Ex. #85). for hazard communication but allowed quick screening tools to detailed Similarly, the U.S. EPA DfE program has comparative hazard assessment chemical manufacturers and importers also developed and implemented an to determine how the information was methodologies to robust frameworks for alternatives assessment framework to evaluating alternatives based on hazard, conveyed. In contrast, HazCom 2012 is characterize alternatives based on the specification-oriented. Thus, while the performance, and economic feasibility. assessment of chemical hazards as well Illustrative examples, which represent HCS requires chemical manufacturers as the evaluation of availability, and importers to determine the hazards the range of tools available, are functionality, economic, and life cycle described below. of chemicals, and prepare labels and considerations (Lavoie et al., 2010; Ex. safety data sheets (SDSs), HazCom 2012 Some assessment tools provide #84, U.S. EPA, 2012c; Ex. #120). methods for rapid evaluation of goes further by specifying a detailed Although some tools and methods scheme for hazard classification and chemical hazards based on readily exist, as discussed above, further available information. These types of prescribing harmonized hazard research and development in this area is information on labels. In addition, SDSs tools are critical for small and medium- critical for the effective implementation sized businesses, which often lack must follow a set order of information, of informed substitution. and the information to be provided in resources and expertise to evaluate and Question V.B.6: What tools or each section is also specified. compare chemical hazards. In the state methods could be used by OSHA and/ of Washington, the Department of or employers to conduct comparative Hazard classification means that a Ecology (DOE) has developed the Quick hazard assessments? What criteria chemical’s hazards are not only Chemical Assessment Tool (QCAT) to should be considered when comparing identified, they are characterized in allow businesses to identify chemicals chemical hazards? terms of severity of the effect or weight that are not viable alternatives to a Question V.B.7: What tools or of evidence for the effect. Thus, the chemical of concern by assigning an methods could be used by OSHA and/ assessment of the hazard involves appropriate grade for the chemical or employers to evaluate and compare identifying the ‘‘hazard class’’ into based on nine high priority hazard the performance and cost attributes of which a chemical falls (e.g., target organ endpoints (Washington Department of alternatives? What criteria should be toxicity), as well as the ‘‘hazard Ecology, 2012; Ex. #123). Similarly, the considered when evaluating category’’—a further breakdown of the Institute for Occupational Safety and performance and cost? hazardous effect generally based on Health of the German Federation of either numerical cut-offs, or an Institutions for Statutory Accident 2. Hazard Communication and the assessment of the weight of the Insurance and Prevention (IFA) Globally Harmonized System (GHS) evidence. For target organ toxicity, for developed the Column Model as a tool OSHA promulgated its Hazard example, chemicals for which there is for businesses to evaluate chemicals Communication Standard (HCS) (29 human evidence of an effect are likely based on six hazard categories using CFR 1910.1200; Ex. #124) in 1983 to to be classified under Category 1, the information obtained from chemical require employers to obtain and provide most hazardous category, thus safety data sheets (IFA, 2011; Ex. #90). information to their employees on the indicating the highest classification for Other existing tools provide more hazards associated with the chemicals the effect. If the only data available are detailed methodologies for conducting a used in their workplaces. After thirty animal studies, the chemical may fall in comparative hazard assessment, which years of implementation, the HCS has Category 2—still potentially hazardous require greater expertise, data, and resulted in extensive information being to humans, but lower in terms of the resources to complete. The disseminated in American workplaces weight of evidence for the effect. Table- GreenScreen, created by Clean through labels on containers, safety data I illustrates how such a chemical hazard Production Action, provides a sheets (SDSs), and worker training classification may be assigned by hazard methodology for evaluating and programs. class and hazard category

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61414 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

The process of classifying chemicals Once a chemical is placed into a toxicology data for a chemical or other under HazCom 2012 means that all hazard class and hazard category, agent. Health hazard banding presumes chemicals will be fully characterized as HazCom 2012 (and the GHS) specifies it is possible to group chemicals or other to their hazards, as well as degree of the harmonized information that must agents into categories of similar toxicity hazardous effect, using a standardized appear on the label. Referred to as ‘‘label or hazard characteristics. process with objective criteria. Thus, elements,’’ these include a pictogram, Health hazard banding assigns OSHA could use this system to select signal word, hazard statement(s), and chemicals with similar toxicities into certain hazard classes and categories to precautionary statement(s). In addition, hazard groups (or bands. The set priorities. For example, the Agency the label must have a product identifier occupational health professional can could decide to identify substances that and supplier contact information. The use this classification or hazard band, are characterized as Class 1 Carcinogens use of standardized label elements will along with information on worker or as Reproductive Toxicants as its help to ensure consistency and exposures to the substance, to do comprehensibility of the information, priorities. Then chemicals that fall into exposure risk assessment. Hazard which will make HazCom 2012 more those hazard categories could be further banding, along with exposure effective in terms of conveying information, is a useful risk assessment investigated to determine other relevant information to employees and tool, particularly in situations where factors, such as numbers of employees employers. The approach taken in the toxicity data are sparse. Hazard banding exposed, use of the chemical, risk GHS strengthens the protections of the can also aid in the prioritization and assessment, etc. The HazCom 2012 OSHA HCS in several ways, and hazard ranking of chemicals in the information could lead to a more introduces the possibility of the Agency workplace. NIOSH is working with structured and consistent priority using the information generated under OSHA and a variety of stakeholder system than previously attempted HazCom 2012 to help frame a more groups (federal agencies, industry, labor approaches. (Ex. #126) OSHA could also comprehensive approach to ensuring organizations, and professional investigate whether the hazard occupational chemical safety and associations) to develop guidance on categories lend themselves to health. establishing the technical criteria, establishing regulatory provisions for decision logic, and minimum dataset for 3. Health Hazard Banding hazard classes and categories rather the hazard band process. than for individual substances. The ‘‘Health hazard banding’’ can be 4. Occupational Exposure Banding availability of specific hazard defined as a qualitative framework to categorization for chemicals could allow develop occupational hazard NIOSH has proposed an approach, this to be done on a grouping basis— assessments given uncertainties caused occupational exposure banding, which either in regulation, or in guidance. by limitations in the human health or would sort chemicals into five bands (A

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 EP10OC14.001 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61415

through E), with each band representing solved before. Control banding uses the The Control of Substances Hazardous a different hazard level. Chemicals with solutions that experts have developed to Health (COSHH) guidance issued by the lowest toxicity would be grouped in previously to control occupational the Safety Executive (HSE) of the United Band A, while the moist toxic chemicals chemical exposures, and suggests them Kingdom is one model of control would be grouped in Band E. The for other tasks with similar exposure banding (Health and Safety Executive, proposed process includes a three-tiered situations. It focuses resources on 2013; Ex. #129). Under the 2002 COSHH evaluation system based on the exposure controls, and describes how regulation, employers must conduct a availability of toxicological data to strictly a risk needs to be managed. risk assessment to decide how to define a range of concentrations for Control banding is a more prevent employees from being exposed controlling chemical exposures. A Tier comprehensive qualitative risk to hazardous substances in the 1 evaluation relies on hazard codes and characterization and management workplace. COSHH principles first categories from GHS, and intended for strategy that goes further in assigning require that exposure is prevented by chemicals for which little information prescribed control methods to address employers, to the extent possible, by exists. Therefore, a chemical in Band D chemical hazards. It is designed to allow means of: or E in the Tier 1 process is a bad actor employers to evaluate the need for • Changing the way tasks are carried and should be targeted for elimination exposure control in an operation and to out so that exposures aren’t necessary and or substitution. Tier 2 and 3 require identify the appropriate control strategy anymore; professional expertise. Once NIOSH given the severity of the hazard present • Modifying processes to cut out completes their validation work of the and magnitude of exposure. The hazardous by-products or wastes; or three tiers, they plan to develop tools to strength of control banding is that it is • Substituting a non-hazardous or facilitate evaluating hazard data and based on information readily available less hazardous substance for a assigning chemicals to hazard bands as to employers on safety data sheets hazardous substance with new well as educational materials for health (SDSs), without the need for exposure substances (or use the same substance in and safety professionals, managers, and measurements or access to occupational a different form) so that there is less risk workers. (Exs. #127 & #128) health expertise (except in certain to health. circumstances). Control banding If exposures to hazardous substances 5. Control Banding involves not only the grouping of cannot be prevented entirely, then Control banding is a well-established workplace substances into hazard bands COSHH requires employers to approach of using the hazard statements (based on combinations of hazard and adequately control them (Control of from a label and/or safety data sheet exposure information) but also links the Substances Hazardous to Health (SDS) to lead an employer to bands to a suite of control measures, Regulations, 2002; Ex. #130). recommended control measures. This such as general dilution ventilation, Recognizing that many small employers approach has been used successfully in local exhaust ventilation, containment, may not have access to the required a number of countries, particularly in and use of personal protective expertise, and also to reduce the need Europe where such as system of hazard equipment (PPE). for a professional and to promote classification has been in use for some Under control banding, one must consistency in the assessment process, time. HazCom 2012 opens up the consider the chemical’s hazardous the HSE developed an approach to possibility that control banding can be properties, physical properties, and assessment and control of chemical further developed and refined in the exposure potential in order to determine hazards using control banding U.S., either as guidance or regulatory the level of exposure control desired. methodologies spelled out in the 2002 provisions. It is a particularly useful The criteria used for categorizing regulation. This control banding way to provide information for small chemicals include hazard information approach is described in detail in businesses to effectively control such as flammability, reactivity, and the COSHH Essentials. Employers may use chemicals without necessarily going nature of known health effects. These the guidance spelled out in the COSHH through the process of exposure characteristics are associated with Essentials guide to determine the monitoring and other technical defined hazard phrases (e.g., ‘‘Causes appropriate control approach for the approaches to ensuring compliance. It severe skin burns and eye damage’’ or chemical hazard in question. Each also will give employers better ‘‘Causes liver damage,’’ or control approach covers a range of information to conduct risk assessments ‘‘Reproductive hazard’’). These actions that work together to reduce of their own workplaces, and thus select standardized phrases have been familiar exposure: (1) General Ventilation, (2) better control measures. in the EU as ‘‘R-phrases’’ and are found Engineering Controls, (3) Containment, Health hazard banding can be used in on SDSs. and lastly, (4) Special—a scenario where conjunction with control banding to use Different hazard bands exist along a employers should seek expert advice to the information available on the hazard continuum ranging from less hazardous select appropriate control measures. to guide the assessment and chemicals to more hazardous chemicals. The first step outlined under the management of workplace risks. In fact, Once the appropriate hazard group has COSHH Essentials guidance is to health hazard banding is the first step in been determined from the hazard consult the safety data sheet for each the control banding process. Control statements (e.g., ‘‘Hazard Group B’’), chemical in use. Employers must record banding determines a control measure exposure potential is evaluated based on the date of assessment, the name of the (for example dilution ventilation, the quantity in use, volatility (for chemical being assessed, the supplier of engineering controls, containment, etc.) liquids), or particulate nature (for the chemical, and the task(s) for which based on a range or ‘‘band’’ of hazards solids). After evaluating these properties the chemical is used. (such as skin/eye irritant, very toxic, and categorizing the chemical into Step two involves the determination carcinogenic, etc.), and exposures hazard and exposure bands, the of the health hazard. Employers (small, medium, or large exposure). This chemicals are matched, based on their ascertain the hazard by assessing the approach is based on the fact that there band categorization, to the appropriate possible health effects from the hazard are a limited number of control control strategy, with more stringent statements provided on the SDS, the approaches, and that many chemical controls applied for substances that are amount in use, and the dustiness or exposure problems have been met and placed in high-toxicity bands. volatility of the chemical in use.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61416 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

Employers reference the hazard described as ‘‘small’’ (grams or ‘‘low’’, ‘‘medium’’, or ‘‘high’’ volatility statements found on chemical safety milliliters), ‘‘medium’’ (kilograms or based upon the chemical’s boiling point data sheets against a table of COSHH liters), or ‘‘large’’ (tons or cubic meters). and ambient or process operating hazard groups in order to categorize When in doubt, COSHH Essentials temperatures. them into the appropriate hazard group principles encourage employers to err In Step three of the COSHH Essentials (‘‘A’’ through ‘‘E’’, and possibly ‘‘S’’). on the side of the larger quantity in guide, employers identify the Chemicals in Group A tend to be making their determination. appropriate control approach. Tables regarded as less harmful and may, for Additionally, the physical state of example, cause temporary irritation. chemicals effect how likely they are to provided by the COSHH Essentials Chemicals in Group E are the most get into the air and this affects the guide show the control approaches for hazardous and include known control approach to be utilized. For hazard groups ‘‘A’’ through ‘‘E’’ carcinogens. Group S encompasses solids, COSHH Essentials guides according to quantity of chemical in use substances that have special employers to make a determination of and its dustiness/volatility. Table-II considerations for damage caused via either ‘‘Low’’, ‘‘Medium’’, or ‘‘High’’ illustrates how the control approaches contact with the eyes or skin. dustiness based upon visible criteria are assigned. The control approaches Additionally, Step two requires observed during the use of these referred to by number in the table are: employers to make some determinations chemicals. Employers may also use 1) General Ventilation, 2) Engineering about the quantity and physical state of look-up tables provided in the COSHH Control, 3) Containment, and 4) Special. chemicals in use. They must decide if Essentials guide to make a (Health and Safety Executive, 2009; Ex. the amount of chemical in use would be determination of whether liquids have #131).

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4725 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 EP10OC14.002 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61417

Additionally, the COSHH Essentials control banding will provide a higher reduce significant risk of material guide provides detailed control level of control than is necessary. impairment and for technological and guidance sheets for a range of common COSHH Essentials and other control economic feasibility? tasks. Consultation of these task-specific banding concepts developed in Europe Question V.B.10.: Please describe guidance sheets constitutes Step four were based initially on the European your experience in using health hazard under COSHH Essentials. Step five of Union’s pre-GHS classification and and/or control banding to address COSHH Essentials involves the labeling system. Since the European exposures to chemicals in the employer deciding on how best to Union has adopted the GHS in its workplace. implement control measures as classification and labeling rules, these Question V.B.11.: Are additional prescribed. COSHH Essentials risk phrases will no longer be available. studies available that have examined the principles also stress the importance of Control banding approaches are now effectiveness of health hazard and employers reviewing their assessments based on the hazard statements in the control banding strategies in protecting regularly, especially if there is a GHS. OSHA’s adoption of the GHS to workers? significant change in workplace modify the HCS opens up the Question V.B.12.: How can OSHA processes or environment. Employers opportunity to use a control banding most effectively use the concepts of are encouraged to incorporate exposure approach to chemical exposures in health hazard and control banding in level monitoring, health surveillance, American workplaces based on the developing health standards? and relevant training. hazard classification system. This V.B.13.: How might OSHA use A number of European Union nations would be an alternative to focusing on voluntary guidance approaches to assist (e.g., United Kingdom, Germany, PELs that could achieve the goal of risk businesses (particularly small France, Netherlands, Norway, and management for many chemicals and businesses) with implementing the Belgium) and Asian nations (Singapore operations in workplaces. principles of hazard banding in their and Korea) already utilize control OSHA is interested in exploring how chemical safety plans? Could the GHS banding methods comparable to COSHH it might employ these non-OEL chemical classifications be the starting Essential methods for management of a approaches in a regulatory framework to point for a useful voluntary hazard variety of chemical exposures in the address hazardous substances where the banding scheme? What types of workplace. available hazard information does not A number of studies have been yet provide a sufficient basis for the information, tools, or other resources conducted to assess the validity of a Agency’s traditional approach of using could OSHA provide that would be control banding model for control of risk assessment to establish a PEL. most effective to assist businesses, exposure to chemicals. Jones and Nicas OSHA believes that a hazard banding unions, and other safety and health (2006; Ex. #132) reviewed the COSHH approach could allow the Agency to stakeholders with operationalizing Essentials model for hazard-banding in establish specification requirements for hazard banding principles in the vapor degreasing and bag-filling tasks. the control of chemical exposures more workplace? Their study showed that the model did efficiently, offering additional flexibility Question V.B.14.: Should OSHA not identify adequate controls in all to employers, while maintaining the consider greater use of specification scenarios with approximately eighteen safety and health of the workforce. standards or guidance as an approach to percent of cases leaving workers Although health hazard banding and developing health standards? If so, for potentially under-protected. However, control banding show some promise as what kinds of operations are in a similar study, Hashimoto et al. vehicles for providing guidance to specification approaches best suited? (2007; Ex. #133) showed that hazard- occupational health professionals for 6. Task-based Exposure Assessment and banding tended to overestimate the level controlling exposures to workers, their Control Approaches of control and therefore was more use in a regulatory scheme presents protective. In 2011, Lee et al. (Ex. #134) challenges. For example, the agency Job hazard analysis is a safety and found that for a paint manufacturing would need to consider how, if it were health management tool in which facility using mixtures of chemicals to require such approaches, the OSH certain jobs, tasks, processes or with different volatilities, exposure to Act’s requirement that standards that procedures are evaluated for potential the chemicals with higher volatility had reduce significant risk to the extent hazards or risks, and controls are a higher likelihood to exceed the feasible might be satisfied. implemented to protect workers from predicted hazard-band. Lee also OSHA is also interested in exploring injury and illness. Likewise, task-based recommended further research for more the development of voluntary guidelines assessment and control is a system that precise task identification to better for incorporation of control banding into categorizes the task or job activity in enable implementation of task-specific safety and health management programs terms of exposure potential and control measures. in U.S. workplaces. These efforts might requirements for specific actions to NIOSH provides a thorough review include the development and control the exposure are implemented, and critical analysis of the concepts, dissemination of compliance assistance regardless of occupational exposure protective nature, and potential barriers materials (publications, safety and limits. Tasks are isolated from the to implementation of control banding health topic Web pages, computer deconstruction of a larger process that is programs (NIOSH, 2009; Ex. #135). software and smartphone apps, e-Tools) in turn part of an overall operation or NIOSH concluded that control banding as well as consultation services to assist project in an industrial setting. As can be used effectively for performing small businesses. industrial engineering explores the workplace risk assessments and Question V.B.8: How could OSHA use optimization of complex processes or implementing control solutions for the information generated under systems through an evaluation of the many, but not all occupational hazards. HazCom 2012 to pursue means of integrated system of people, equipment, Additionally, NIOSH found that while managing and controlling chemical materials, and other components, the in some situations in which control exposures in an approach other than task-based system attempts to evaluate banding cannot provide the precision substance-by-substance regulation? work activities to define uniform and accuracy necessary to protect Question V.B.9: How could such an exposure scenarios and their variables worker health, and in some cases approach satisfy legal requirements to and establish targeted control strategies.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61418 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

Task-based exposure potential can be hazards in construction (ASSE, 2012; working man and woman in the Nation’’ for defined using readily available data Ex. #139). The standard requires the first time, a legal right to ‘‘safe and including process operating procedures, employers to first identify tasks healthful working conditions.’’ OSH Act task observation and analysis, job involving the use of chemicals and § 2(a); 29 U.S.C. 651. (Ex. #9) Congress recognized that ‘‘the problem of assuring safe activity description, chemical inventory create a hazard communication and healthful workplaces for our men and and toxicity information (hazard inventory for these tasks. Then the women ranks in importance with any that communication), historical exposure employer must determine the hazard engages the national attention today.’’ S. Rep. data, existing exposure databases, level and exposure level, and finally 91–1282 at 2 (1970; Ex. #17). Indeed, when employee surveys, and current exposure develop a control plan based on the establishing the OSH Act, Congress was data. Based on this exposure hazard and exposure classifications. If concerned about protecting workers from assessment, the task is matched with the chemicals used in the task are low known hazards as well as from the numerous specific requirements for exposure hazard and the task is low exposure, new hazards entering the workplace: control. Control specifications can draw then the control plan requires following Occupational diseases which first on a broad inventory of exposure the SDS and label precautions. If, commanded attention at the beginning of the industrial revolution are still undermining controls and administrative tools to however, the task involves greater than the health of workers. . . . Workers in dusty reduce and prevent worker exposure to minimal hazard or exposure, a more trades still contract various respiratory the identified hazardous substances. protective control plan must be diseases. Other materials long in industrial OSHA is interested in exploring task- developed. use are only now being discovered to have based control approaches as a technique However, developing specification toxic effects. In addition, technological for developing specification standards standards governing exposure to health advances and new processes in American for the control of hazardous substances standards for general industry industry have brought numerous new in the workplace as an alternative or operations presents a different hazards to the workplace. S. Rep. 91–1282 at 2. supplement to PELs. Such an approach challenge. Given the diversity in the may offer the advantage of providing nature of industrial operations across a Many of the occupational diseases first discovered during the industrial revolution, employers with specific guidance on range of industry sectors that might be and which later spurred Congress to create how to protect workers from exposure affected by a chemical standard, OSHA OSHA, still pose a significant harm to U.S. and reduce or eliminate the need for is concerned that it will be more workers. While the number of hazardous conducting regular exposure difficult to develop specification chemicals to which workers are exposed has assessments to evaluate the standards for exposure controls that are increased exponentially due to new effectiveness of exposure control specific enough to clearly delineate formulations of chemical mixtures, OSHA strategies. OSHA has developed obligations of employers to protect has not been successful in establishing specification-oriented health standards employees, and yet are general enough standards that adequately protect workers from hazardous chemical exposures, even in the past, in particular, those for lead to provide employers flexibility to from the older, more familiar chemicals. and asbestos in construction. implement controls that are suitable for OSHA’s PELs are mandatory limits for air More recently, OSHA developed a their workplaces and that allow for contaminants above which workers must not control-specification-based approach for future innovation in control be exposed. OSHA PELs generally refer to controlling exposures to crystalline technologies. differing amounts of time during which the silica dust in construction operations Question V.B.15: OSHA requests worker can be exposed: (1) Time weighted (OSHA, 2009; Ex. #136, OSHA, 2013b; comment on whether and how task- averages (TWAs) which establish average Ex. #137). Construction operations are based exposure control approaches limits for eight-hour exposures; (2) short-term particularly amenable to specification limits (STELs) which establish limits for might be effectively used as a regulatory short term exposures; and (3) ceiling limits, standards due to the task-based nature strategy for health standards. which set never-to-be exceeded maximum of the work. The National Institute for VI. Authority and Signature exposure levels. Occupational Safety and Health OSHA’s PELs have existed nearly as long (NIOSH), the Center to Protect Workers’ David Michaels, Ph.D., MPH, as the agency itself. Most of OSHA’s current Rights—a research arm of the Building Assistant Secretary of Labor for PELs were adopted by the agency in 1971. and Construction Trades Department, Occupational Safety and Health, U.S. OSHA currently has PELs for approximately AFL-CIO—has developed and used a Department of Labor, 200 Constitution 470 hazardous substances, which are ‘‘Task-Based Exposure Assessment Avenue NW., Washington, DC 20210, included in the Z-Tables in general industry at 29 CFR part 1910.1000 (Ex. #4) and in Model (T–BEAM)’’ for construction. The directed the preparation of this notice. three maritime subsectors: Part 1915.1000 characteristic elements of T–BEAM are: OSHA is issuing this notice under 29 (Shipyard Employment; Ex. #5); part 1917 (1) an emphasis on the identification, U.S.C. 653, 655, 657; 33 U.S.C. 941; 40 (Marine Terminals; Ex. #140); and part 1918 implementation, and evaluation of U.S.C. 3704 et seq.; Secretary of Labor’s (Longshoring; Ex. #141). Z-Tables that apply engineering and work practice controls; Order 1–2012 (77 FR 3912, 1/25/2012); in construction are found at part 1926.55 (Ex. and (2) use of experienced, specially and 29 CFR Part 1911. #6). There are inconsistencies in the PELs that apply across industry sectors which trained construction workers Signed at Washington, DC, on September (construction safety and health resulted from the regulatory history of each 30, 2014. divergent industry sector. specialists) in the exposure assessment David Michaels, As discussed in further detail below, the process. A task-based approach was Assistant Secretary of Labor for Occupational Agency attempted to update the general used because tasks, or specialized skills, Safety and Health. industry PELs in 1989, but that revision was form the single greatest thread of vacated by judicial decision in 1992. As continuity in the dynamic environment Appendix A: History, Legal such, the 1971 PELs remain the exposure of construction (Susi et al., 2000; Ex. Background, and Significant Court limits with which most U.S. workplaces are #138). Decisions required to comply. The Agency also A new American National Standards promulgates ‘‘comprehensive’’ substance- I. Background specific standards (e.g., lead, methylene Institute Standard (ANSI A10.49) based Since the OSH Act was enacted in 1970, chloride) which, in addition to PELs, require on GHS health hazard categories and OSHA has made significant achievements additional ancillary provisions such as utilizing a task-based approach is also toward improving the health and safety of housekeeping, exposure monitoring, and being developed to address chemical America’s workers. The OSH Act gave ‘‘every medical surveillance.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61419

II. OSHA’s Statutory Authority, Adoption of the exposure limits that apply to construction 1950s and 1960s. In contrast, the ACGIH the PELs in 1971, and the 1989 Attempted were derived from the 1970 ACGIH TLVs and annually reviews chemical substances and Revision certain substance specific Sec. 6(b) standards. updates its list of TLVs®. Where OSHA The industry sector that is referred to today currently has PELs for approximately 470 A. The Purpose of the OSH Act and OSHA’s as ‘‘Maritime’’ has a long and somewhat chemical hazards, the ACGIH recommends Authority To Regulate Hazardous Chemicals confusing history. The Department of Labor TLVs® for more than 700 chemical The OSH Act vests the Secretary of Labor has had some authority since 1958 for the substances and physical agents, with the power to ‘‘promulgate, modify, or maritime industry under the Longshore and approximately 200 of which have been revoke’’ mandatory occupational safety and Harbor Workers Compensation Act (33 U.S.C. updated since 1971. (FACOSH, 2012; Ex. health standards. OSH Act section 6(b), 29 901 et seq.). Specifically authority was #145). U.S.C. 655(b). An ‘‘occupational safety and granted under Public Law 89–742 for the C. Section 6(b) Notice and Comment health standard,’’ as defined by section 3(8) Secretary of Labor to issue regulations to Rulemaking of the OSH Act, is a ‘‘standard which protect the health and safety of requires conditions, or the adoption or use of longshoremen, marine terminal workers, ship Section 6(b) of the OSH Act provides one or more practices, means, methods, repairers, shipbuilders, and ship breakers. OSHA with the authority to promulgate operations, or processes, reasonably Under Section 4(b)(2) of the OSH Act, 33 health standards. OSHA promulgates two necessary or appropriate to provide safe or U.S.C. 941 (Ex. #143) became OSHA main types of health standards: (i) PELs, and healthful employment and places of standards in 1971. (ii) comprehensive standards, which, as the employment.’’ OSH Act section 3(8), 29 At that time, the Shipyard standards were name implies, consist of provisions to protect U.S.C. 652(8). (Ex. #9) in three parts of 29 CFR; part 1915 for ship workers in addition to PELs. Section 6(b)(5) The OSH Act provides three separate repairing, part 1916 for shipbuilding and part imposes specific requirements governing the approaches for promulgating standards. The 1917 for shipbreaking. In 1982 parts 1915, adoption of health standards: first approach, in section 6(a) of the OSH Act, 1916 and 1917 were consolidated into a new [T]he Secretary, in promulgating standards provided OSHA with an initial two-year part 1915, Shipyards. As a consequence of dealing with toxic materials or harmful window in which to adopt standards without their history, the PELs applicable to the new physical agents under this subsection, shall hearing or public comment. Additionally, part 1915, Shipyards, are complex. set the standard which most adequately sections 6(b) and 6(c) provide methods Depending upon the specific operation, assures, to the extent feasible, on the basis of currently available to the agency for either the 1970 TLVs or 1971 PELS the best available evidence, that no employee promulgating health standards. Section 6(b) (originally 1968 TLVs) apply. See §§ 1915.11, will suffer material impairment of health or allows OSHA to create and update standards 1915.12, 1915.32 and 1915.33 (Ex. #144). functional capacity even if such employee through notice and comment rulemaking, Additionally, several of the OSHA single- has regular exposure to the hazard dealt with and section 6(c) provides OSHA with the substance standards apply. by such standard for the period of his authority to set emergency temporary Pursuant to the Longshoremen and Harbor working life. Development of standards standards. OSHA has not successfully Worker Compensation Acts of 1958 under this subsection shall be based upon adopted an emergency temporary standard amendments, in 1960 OSHA issued research, demonstrations, experiments, and for over thirty years, and it is not discussed regulations protecting longshore employees, such other information as may be further here. along with marine terminal employees. These appropriate. In addition to the attainment of regulations were adopted as OSHA standards the highest degree of health and safety B. The Adoption of the PELs Under Section and later recodified. In 1983, OSHA issued protection for the employee, other 6(a) a final standard specifically covering marine considerations shall be the latest available Under section 6(a), OSHA was permitted to terminals (29 CFR part 1917) separately from scientific data in the field, the feasibility of adopt ‘‘any national consensus standard and longshoring. The Marine Terminal Standard the standards, and experience gained under any established Federal standard’’ so long as basically requires that no employee be this and other health and safety laws. the standard ‘‘improved safety or health for exposed to air contaminants over the limits Whenever practicable, the standard specifically designated employees.’’ 29 set in the 1971 Z-Tables. See §§ 1917.2, promulgated shall be expressed in terms of U.S.C. 655(a). The purpose of providing 1917.22, 23, 25. (Ex. #140) objective criteria and of the performance OSHA with this two-year window ‘‘was to Longshoring operations continue to be desired. establish as rapidly as possible national regulated by 29 CFR Part 1918 (Ex. #141). 29 U.S.C. 655(6)(b)(5). (Ex. #9) occupational safety and health standards OSHA has consistently interpreted that the The courts have elaborated on the findings with which industry is familiar.’’ S. Rep. 91– air contaminant exposure limits set forth in OSHA must make before adopting a 6(b)(5) 1282 at 6. When establishing this fast track 1910.1000 (Ex. #4) are applicable pursuant to standard. One such case, Industrial Union to rulemaking, Congress emphasized the 1910.5(c) to longshoring because no Dept., AFL–CIO v. American Petroleum temporary nature of the approach, noting that quantitative exposure limits are set forth for Institute, 448 U.S. 607 (1980) (the Benzene these ‘‘standards may not be as effective or air contaminants, other than carbon case; Ex. #10), has had a major impact on up to date as is desirable, but they will be monoxide. OSHA rulemaking by establishing a useful for immediately providing a As discussed above, the Agency was given threshold requirement that before the agency nationwide minimum level of health and authority to adopt standards to provide can promulgate a health standard it must safety.’’ S. Rep. 91–1282 at 6. (Ex. #17) initial protections for workers from what the show that a significant risk of material Establishing PELs was one of the first Congress deemed to be the most dangerous impairment exists, which can be eliminated actions taken by OSHA. Most of the PELs workplace threats. Congress felt that it was or lessened by a change in practices. contained in the Tables Z–1, Z–2, and Z–3 ‘‘essential that such standards be constantly Additionally, the phrase ‘‘to the extent of 29 CFR 1910.1000 (Ex. #4) for general improved and replaced as new knowledge feasible’’ in section 6(b)(5) has been industry, as well as those in construction and and techniques are developed.’’ S. Rep. 91– interpreted by the courts to require that maritime were adopted during the initial 1282 at 6. (Ex. #17) However, because OSHA OSHA show that a standard is both two-year window under section 6(a). OSHA has been unable to update the PELs, they economically and technologically feasible. adopted approximately 400 occupational remain frozen at the levels at which they American Textile v. Donovan, 452 U.S. 490 exposure limits for general industry that were were initially adopted. OSHA’s PELs are (1981) (the Cotton Dust case; Ex. #15); United based on the American Conference of largely based on acute health effects and do Steelworkers v. Marshall, 647 F.2d 1189, Governmental Industrial Hygienist’s (ACGIH) not take into consideration newer research 1264 (D.C. Cir. 1980) (the Lead I case; Ex. 1968 list of Threshold Value Limits (TLVs). regarding chronic effects occurring at lower #12). These cases will be discussed in greater In addition, about 25 additional exposure occupational exposures. Thus, although there detail in Section III of this Appendix. limits recommended by the American have been radical changes in our Standards Association (presently called the understanding of airborne contaminants, D. 1989 Air Contaminants Standard American National Standards Institute) updates in technology, and changes to In 1989, OSHA published the Air (ANSI), were adopted as national consensus industry practices, OSHA’s PELs are still Contaminants final rule, which remains the standards. 36 FR 10466 (Ex. #142). Currently based on research performed during the Agency’s most significant attempt at

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61420 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

updating the PELs. Unlike typical substance- In reviewing the evidence, OSHA first prepared the regulatory impact analysis in specific rulemakings, where OSHA develops determined whether the studies and analyses two phases. The first phase of its feasibility a comprehensive standard, the Air were valid and of reasonable scientific analyses involved using secondary databases Contaminants final rule was only intended to quality. Second, it determined, based on the to collect information on the chemicals to be update existing PELs and to add new PELs studies, if the published documentation of regulated and the industries in which they for substances not currently regulated. As the REL or TLV would meet OSHA’s legal were used. These databases provided such, the final rule did not include ancillary requirements for setting a PEL. Thus, OSHA information on the toxicity and health effects provisions (e.g. exposure monitoring, reviewed the evidence of significant risk at of exposure to chemicals covered by the medical surveillance, requirements for the existing PEL or, if there was no PEL, at rulemaking, on engineering controls, and on personal protective equipment, or labeling) exposures which might exist in the emergency response procedures. (54 FR 2725; because OSHA determined that these workplace in the absence of any limit. Third, Ex. #7). provisions would delay and unnecessarily OSHA reviewed the studies to determine if Two primary databases were used to complicate the PELs update. Appendix B. to the new PEL would lead to substantial collect information on the nature and extent this Request for Information contains the reduction in significant risk. 54 FR 2372. of employee exposures to the substances table of PELs from the 1989 Air OSHA’s determination of where the new covered by the rule. One database was the Contaminants Final Rule. The table includes PEL should be set was based on its review 1982 NIOSH National Occupational Exposure both PELs originally adopted by OSHA in and analysis of the information found in Survey (NOES), which collected information 1971 and the PELs established under the these sources. OSHA set the new PELs based from 4,500 businesses on the number of 1989 final rule. on a review of the available evidence. 54 FR workers exposed to hazardous substances. In order to determine a starting point for 2402. Safety factors were applied on a case- The second database was OSHA’s Integrated updating the general industry PELs for by-case basis. (54 FR 2365, 2399; Ex. #7). Management Information System (IMIS) chemicals on Tables Z–1, Z–2, and Z–3 of 29 Based on the analysis discussed above, which contains air samples taken since 1979 CFR 1910.1000 (Ex. #4), and for creating new OSHA summarized the health evidence for by OSHA industrial hygienists during PELs for some substances not listed in those each individual substance and determined compliance inspections. OSHA also tables, OSHA analyzed existing databases when and at what level a new limit was consulted industrial hygienists and engineers and lists of occupational exposure limits necessary to substantially reduce a who provided information about the (OELs) to determine the scope of the significant risk of material impairment of exposure controls in use, the number and rulemaking. After extensive review of all health or functional capacity among size of plants that would be impacted by the available sources of OELs, including the American workers. The following example rulemaking, and the estimated costs National Institute for Occupational Safety illustrates the type of analysis that OSHA associated with meeting the new PELs. (54 and Health (NIOSH) Recommended Exposure conducted for each substance: FR 2373, 2725, 2736; Ex. #7). Levels (RELs), the American Conference of OSHA had no former limit for potassium As part of the second phase of its Industrial Hygienists (ACGIH) Threshold hydroxide. A ceiling limit of 2 mg/m(3) was feasibility analyses, OSHA performed an Limit Values (TLVs®), the American proposed by the Agency based on the ACGIH industry survey and site visits. The survey Industrial Hygiene Association (AIHA) recommendation, and NIOSH (Ex. 8–47, was the largest survey ever conducted by Workplace Environmental Exposure Levels Table N1) concurred with this proposal. OSHA and included responses from 5,700 (WEELs), and limits from other countries, OSHA has concluded that this limit is firms in industries believed to use chemicals OSHA ultimately selected the ACGIH’s 1987– necessary to afford workers protection from included in the scope of the Air 88 TLVs to identify the basis for which irritant effects and is establishing the 2-mg/ Contaminants proposal. It was designed to substances and corresponding exposure m(3) ceiling limit for potassium hydroxide in focus on industry sectors that potentially had values that would be included in the the final rule. the highest compliance costs, identified proposed rule. 53 FR 20977. The TLVs were selected as a reference point because of the [One commenter] (Ex. 3–830) commented through an analysis of existing exposure data number of substances they covered, the that there was no basis for establishing an at the four-digit SIC (Standards Industrial availability of written documentation on how occupational limit for potassium hydroxide. Classification) code level. 54 FR 2843. The the TLVs were selected, and the general OSHA disagrees and notes that the irritant survey gathered data on chemicals, acceptance of the TLVs by industrial effects of potassium hydroxide dusts, mists, processes, exposures and controls currently hygienists, other occupational health and aerosols have been documented (ACGIH in use, which ‘‘permitted OSHA to refine the professionals, and industry. (53 FR 20967; 1986/Ex. 1–3, p. 495; Karpov 1971/Ex. 1– Phase I preliminary estimates of technical Ex. #18, 54 FR 2375; Ex. #7) 1115). Although dose-response data are and economic feasibility. Site visits to 90 After determining the scope of hazardous lacking for this substance, it is reasonable to firms were conducted to verify the data chemicals to be included in the rulemaking, expect potassium hydroxide to exhibit collected on chemicals, processes, controls, OSHA began the process of identifying the irritant properties similar to those of sodium and employee exposures.’’ 54 FR 2725; see most appropriate new PELs to be proposed. hydroxide, a structurally related strong also 54 FR 2736–39, 2768, 2843–69. OSHA considered both the ACGIH TLVs and alkali. In its criteria document, NIOSH OSHA analyzed the data collected in the NIOSH RELs as a starting point. (53 FR (1976k/Ex. 1–965) cites a personal phases I and II to determine whether the 20966–67; Ex. #18) When the TLV and REL communication (Lewis 1974), which reported updated PELs were both technologically and were similar, OSHA reviewed both the that short-term exposures (2 to 15 minutes) economically feasible for each industry ACGIH documentation and the NIOSH to 2 mg/m(3) sodium hydroxide caused sector covered. 54 FR 2374. recommendation. Where the TLV and REL ‘‘noticeable’’ but not excessive upper For technological feasibility, OSHA ‘‘differed significantly,’’ OSHA reviewed the respiratory tract irritation. Therefore, OSHA evaluated engineering controls and work studies and reasoning upon which the finds that the 2-mg/m(3) ceiling limit will practices available within industry sectors to NIOSH and ACGIH recommendations were provide workers with an environment that reduce employee exposures to the new PELs. based to determine which was more minimizes respiratory tract irritation, which In general, it found three types of controls appropriate. OSHA presumed that a the Agency considers to be material might be employed to reduce exposures: significant difference did not exist between impairment of health. To reduce these risks, Engineering controls, work practice and the TLV and the REL for a chemical when: OSHA is establishing a ceiling limit of 2 mg/ administrative controls, and personal (a) The TLV and REL values are the same; m(3) for potassium hydroxide. (54 FR 2332 protective equipment. Engineering controls (b) TLV and REL values differ by less than et seq.) included local exhaust ventilation, general 10 percent; OSHA proposed making 212 PELs more ventilation, isolation of the worker and (c) The TLV and REL Time Weighted protective and setting new PELs for 164 enclosure of the source of the emission, and Averages (TWA) are the same, but there are substances not previously regulated by product substitution. Work practice controls differences in the Short Term Exposure Limit OSHA. Substances for which the PEL was included housekeeping, material handling (STEL) or Ceiling (C); or already aligned with a newer TLV were not procedures, leak detection, training, and (d) The TWA in one data base is the same, included. personal hygiene. Personal protective or one-half, the STEL/C in the other data In order to determine whether the Air equipment included respirators, and where base. 53 FR 20977. Contaminants rule was feasible, OSHA the chemicals involved presented skin

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61421

hazards, protective gloves and clothing. 54 Based on the survey, OSHA determined protective enough. The unions also asserted FR 2789–90, 2840. that 74 percent of establishments with that OSHA’s failure to include any ancillary OSHA found that many processes required hazardous chemicals had no exposures in provisions, such as exposure monitoring and to reduce exposure were ‘‘relatively excess of the new PELs and would incur no medical surveillance, prevented employers standardized throughout industry and are costs, 22 percent would incur costs to from ensuring the exposure limits were not used [to control exposures] for a variety of implement additional engineering controls, exceeded and resulted in less-protective substances.’’ 54 FR 2373–74. It ‘‘examined and 4 percent would be required to provide PELs. typical work processes found in a cross personal protective equipment only for Fifteen of the twenty-five lawsuits were section of industries’’ and had industry maintenance workers. 54 FR 2851. OSHA settled; of the remaining suits, nine were experts identify the major processes that had estimated the total compliance cost to be from industry groups challenging seven the potential for hazardous exposures above $788 million per year annualized over ten specific exposure limits, and one was from the new PELs, requiring new controls. For years at a ten percent discount rate. 54 FR the unions challenging 16 substances. each affected industry group, OSHA 2851. OSHA assessed the economic impact of Pursuant to 28 U.S.C. 2112(a), all petitions reviewed the data it had collected to the standard on industry profits on the two- for review were consolidated for disposition ‘‘identify examples of successful application digit SIC level. Assuming industry would not and transferred to the Eleventh Circuit Court of controls to these processes.’’ 54 FR 2790. be able to pass the additional costs on to of Appeals. AFL–CIO v. OSHA, 965, F.2d Based on its review OSHA found that customers, the average change in profits was 962, 981–82 (11th Cir. 1992) (Air ‘‘engineering controls and improved work less than one percent, with the largest change Contaminants). Although only 23 of the new practices [were] available to reduce exposure in SIC 30 (Rubber and Plastics) of 2.3 PELs were challenged, the court ultimately levels in almost all circumstances.’’ 54 FR percent. 54 FR 2885, 2887. Alternatively, decided to vacate the entire rulemaking, 2727. In some cases, it found respirators or assuming that industry could pass on all finding that ‘‘OSHA [had] not sufficiently other protective equipment was necessary. 54 costs associated with the rule to its explained or supported its threshold FR 2727, 2813–15, 2840. For each relevant customers, OSHA determined that for no determination that exposure to these industry sector (which was at the 2, 3, or 4 industry sector would prices increase on substances at previous levels posed a digit SIC code level, depending on the average more than half of a percent. 54 FR significant risk of these material health processes involved). As the court explained 2886, 2887. In neither case was the economic impairments or that the new standard in Air Contaminants, 965 F.2d at 981 (Ex. impact significant, OSHA found, and the new eliminates or reduces that risk to the extent #8): standard was therefore considered by the feasible.’’ Air Contaminants, 965 F.2d at 986– The SIC codes classify by type of activity Agency to be economically feasible. (54 FR 987; Ex. #8. for purposes of promoting uniformity and 2733, 2887; Ex. #7) After publishing the Air Contaminants comparability in the presentation of data. As The Air Contaminants final rule was Final Rule for general industry, OSHA the codes go from two and three digits to four published on January 19, 1989. In the final proposed amending the PELs for the digits, the groupings become progressively rule, OSHA summarized the health evidence maritime and construction industry sectors more specific. For example, SIC Code 28 for each individual substance, discussed over and establishing PELs to cover the agriculture represents ‘‘Chemicals and Allied Products,’’ 2,000 studies, reviewed and addressed all industry sector. OSHA published a Notice of SIC Code 281 represents ‘‘Industrial major comments submitted to the record, and Proposed Rulemaking (NPRM) on June 12, Inorganic Chemicals,’’ and SIC Code 2812 provided a rationale for each new PEL 1992, which included more protective includes only ‘‘Alkalies and Chlorine.’’ chosen. The final rule differed from the exposure limits for approximately 210 OSHA prepared a list of the processes proposal in a number of ways as OSHA substances currently regulated in the identified and the engineering controls and changed many of its preliminary assessments construction and maritime industries and personal protective equipment (PPE) required presented in the proposal based on added new exposure limits for approximately to reach the new PELs. 54 FR 2814–39. In comments submitted to the record. 160 chemicals to protect these workers. (57 almost all cases, the OSHA list showed that Ultimately, the final rule adopted more FR 26002; Ex. #146). The notice also the new PELs could be reached through a protective PELs for 212 previously regulated proposed approximately 220 PELs to cover combination of ventilation and enclosure substances, set new PELs for 164 previously the agriculture industry. OSHA extended the controls. 54 FR 2816–39. OSHA received and unregulated substances, and left unchanged comment period indefinitely while it addressed numerous comments on the an additional 52 substances, for which lower considered possible responses to the Air controls it proposed for use in various PELs were initially proposed. OSHA Contaminants court decision. Once it became industries. 54 FR 2790–2813. OSHA found estimated over 21 million employees were clear that an appeal would not be pursued, that ‘‘in the overwhelming majority of potentially exposed to hazardous substances the Agency halted work on the project. situations where air contaminants [were] in the workplace and over 4.5 million encountered by workers, compliance [could] employees were currently exposed to levels III. Significant Court Decisions Shaping be achieved by applying known engineering above the old PELs or in the absence of a OSHA’s Rulemaking Process and OSHA’s control methods, and work practice PEL. OSHA projected the final rule would Approach to Updating Its Permissible improvements.’’ 54 FR 2789. result in potential reduction of over 55,000 Exposure Limits To assess economic feasibility, OSHA ‘‘made estimates of the costs to reduce lost workdays due to illnesses per year and OSHA’s Air Contaminants final rule is the exposure based on the scale of operations, annual compliance with this final rule would agency’s most significant attempt to move type of process, and degree of exposure prevent an average of 683 fatalities annually away from developing individual, substance- reduction needed’’ based primarily on the from exposures to hazardous substances. 54 specific standards. As discussed above in results of the survey. 54 FR 2373, 2841–51. FR 2725. Section II, this rule attempted to establish or For each survey respondent, OSHA identified The update to the Air Contaminants revise 376 exposure limits for chemicals in the processes employed at the plant and standard generally received wide support a single rulemaking. OSHA’s efforts in made a determination about whether workers from both industry and labor. However, there reducing occupational illnesses and the would be exposed to a chemical in excess of was dissatisfaction on the part of some mortality associated with hazardous a new PEL. 54 FR 2843–47. For those industry representatives and union leaders, chemical exposure has largely been through processes where the new PEL would be who brought petitions for review challenging developing substance specific standards, exceeded, OSHA estimated the cost of the standard. For example, some industry such as Hexavalent Chromium general controls necessary to meet the PEL. 54 FR petitioners argued that OSHA’s use of generic industry (29 CFR 1910.1026; Ex. #26), 2947–51. Process control costs were then findings, the inclusion of so many substances shipyards (29 CFR 1915.1026), and summed by establishment and costs ‘‘for the in one rulemaking, and the allegedly construction (29 CFR 1926.1026) and survey establishment were then weighted (by insufficient time provided for comment by Methylene Chloride (29 CFR 1910.1052; Ex. SIC and size) to represent compliance costs interested parties created a record inadequate #27). These standards, in addition to setting for the universe of affected plants.’’ 54 FR to support the new set of PELs. In contrast, PELs, establish other provisions to help 2851. OSHA received and addressed many the unions challenged the generic approach reduce risk to workers, such as requirements comments on its cost approach and used by OSHA to promulgate the standard to monitor exposure, train workers and assumptions. (54 FR 2854–62; Ex. #7). and argued that several PELs were not conduct medical surveillance, if appropriate.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61422 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

However, due to the associated time and rulemaking used to update or create new change in practices’’ before it can adopt a costs, promulgating comprehensive rules for PELs for 376 chemicals in a single new standard. Benzene, 448 U.S. at 642; Ex. individual chemical hazards is an ineffective rulemaking was permissible under the OSH #10. approach to address all chemical hazard Act. Although the Eleventh Circuit Although the Court declined to establish a exposures because of the sheer number of determined that the Air Contaminants final set test for determining whether a workplace chemicals and mixtures to which workers are rule did not fit within the classic definition is unsafe, it did provide guidance on what exposed on a daily basis. To date, only 30 of a generic rulemaking, the court upheld the constitutes a significant risk. The Court comprehensive individual standards have format used by OSHA to update the PELs. Air stated a significant risk was one that a been successfully published by the Agency to Contaminants, 965 F.2d at 972. The court, in reasonable person would consider significant address hazardous chemicals in the so holding, reasoned ‘‘nothing in the OSH and ‘‘take appropriate steps to decrease or workplace. Act prevented OSHA from addressing eliminate.’’ Benzene, 448 U.S. at 655 (Ex. The courts have had a significant impact multiple substances in a single rulemaking.’’ #10). For example, it said, a one in a 1,000 on OSHA’s rulemaking process by Air Contaminants, 965 F.2d at 972. The court risk would satisfy the requirement. However, articulating specific burdens OSHA must also upheld OSHA’s statutory authority to this example was merely an illustration, not meet before promulgating a standard. It was select the substances and determine the a hard line rule. The Court made it clear that because the Air Contaminants court found parameters of its rules. However, the court determining whether a risk was ‘‘significant’’ that OSHA had failed to meet some of these stated that even though OSHA was permitted was not a ‘‘mathematical straitjacket’’ and burdens that the court vacated OSHA’s to promulgate multi-substance rules, each did not require the Agency to calculate the attempt to update the PELs. This section substance was required to ‘‘stand exact probability of harm. 448 U.S. at 655. discusses the important cases laying out independently, i.e., . . . each PEL must be OSHA was not required to support a OSHA’s burdens under the OSH Act, and supported by substantial evidence in the significant risk finding ‘‘with anything summarizes the reasons the Air record considered as a whole and approaching scientific certainty’’ and was Contaminants court gave for finding that accompanied by adequate explanation.’’ Air free to use ‘‘conservative assumptions’’ in OSHA had not satisfied those burdens. These Contaminants, 965 F.2d at 972; Ex. #8. interpreting the evidence. 448 U.S. at 656. cases influence what steps OSHA may take Still, because OSHA had not made a in the future to update the PELs. C. Significant Risk of a Material Impairment significant risk finding at the 10 ppm level 1. The Benzene Case and Significant Risk (indeed, the Court characterized the evidence A. The Substantial Evidence Test: OSHA’s of leukemia in the record at the 10 ppm level Burden of Proof for Promulgating Health The significant risk requirement was first as ‘‘sketch[y]’’), the Court vacated the new Standards articulated in 1980 in a plurality decision of the Supreme Court in Benzene, 448 U.S. 607. PEL and remanded the matter to OSHA. The test used by the courts to determine The petitioners in Benzene challenged 2. OSHA’s Post-Benzene Approach to whether OSHA has reached its burden of OSHA’s rule lowering its PEL for benzene Significant Risk and Air Contaminants proof is the ‘‘substantial evidence test.’’ This from 10 ppm to 1 ppm. In support of the new test, which applies to policy decisions as In past rulemakings involving hazardous PEL, OSHA found that benzene caused well as factual determinations, is set forth in chemicals, OSHA satisfied its requirement to leukemia and that the evidence did not show section 6(f) of the OSH Act, which states: show that a significant risk of harm is present that there was a safe threshold exposure level ‘‘the determinations of the Secretary shall be by estimating the risk to workers subject to below which no excess leukemia would conclusive if supported by substantial a lifetime of exposure at various possible occur. Applying its policy to treat evidence in the record considered as a exposure levels. These estimates have carcinogens as posing a risk at any level of whole.’’ 29 U.S.C. 655(f). ‘‘Substantial typically been based on quantitative risk exposure where such a threshold could not evidence’’ has been defined as ‘‘such relevant assessments. As a general policy, OSHA has be established, OSHA chose the new PEL of evidence as a reasonable mind might accept considered a lifetime excess risk of one death 1 ppm based on its finding that it was the as adequate to support a conclusion.’’ Cotton or serious illness per 1000 workers associated lowest feasible exposure level. This was Dust, 452 U.S. at 522; Ex. #15 (quoting with occupational exposure over a 45 year because Section 6(b)(5) of the OSH Act Universal Camera Corp. v. NLRB, 340 U.S. working life as clearly representing a requires standards to be set at the most 474, 477 (1951) Ex. #16). significant risk. However, as noted above, protective level that is feasible. See Benzene, Although the substantial evidence test Benzene does not require OSHA to use such 448 U.S. at 633–37; Ex. #10. requires OSHA to show that the record as a a rigid or formulaic criterion. Nevertheless, whole supports the final rule, OSHA is not The Benzene Court rejected OSHA’s OSHA has taken a conservative approach and required to wait for ‘‘scientific certainty’’ approach. First, it found that the OSH Act has used the 1:1,000 example as a useful before promulgating a health standard. did not require employers to ‘‘eliminate all benchmark for determining significant risk. Benzene, 448 U.S. at 656 (Ex. #10). Rather, risks of harm from their workplaces.’’ The This approach has often involved the use of to meet its burden of proof under the OSH Act defines ‘‘occupational safety and the quantitative risk assessment models ‘‘substantial evidence test,’’ the agency need health standard’’ to be standard that require OSHA has employed in developing only ‘‘identify relevant factual evidence, to the adoption of practices which are substance-specific health standards. explain the logic and the policies underlying ‘‘reasonably necessary or appropriate to In the Air Contaminants rule, OSHA any legislative choice, to state candidly any provide safe or healthful employment and departed from this approach. Rather, as noted assumptions on which it relies, and to places of employment’’. OSH Act § 3(8), 29 above, it looked at whether studies showed present its reasons for rejecting significant U.S.C. 652(8); Ex. #9. excess effects of concern at concentrations contrary evidence and argument.’’ Lead I, 647 Relying on this definition, the Court found lower than allowed under OSHA’s existing F.2d. at 1207; Ex. #12. that the Act only required that employers standard. Where they did, OSHA made a ensure that their workplaces are safe, that is, significant risk finding and either set a PEL B. The Air Contaminants Case that their workers are not exposed to (where none existed previously) or lowered OSHA published the Air Contaminants ‘‘significant risk[s] of harm.’’ 448 U.S. at 642. the existing PEL. These new PELs were based final rule on January 19, 1989. As discussed Second, the Court made clear that it is on agency judgment, taking into account the in Section II, the standard adopted more OSHA’s burden to establish that a significant existing studies, and as appropriate, safety protective PELs for 212 previously regulated risk is present at the current standard before factors. Both industry and union petitioners substances, set new PELs for 164 previously lowering a PEL. The burden of proof is challenged aspects of OSHA’s approach to unregulated substances, left unchanged the normally on the proponent, the Court noted, making its significant risk determinations. PELs for 52 substances for which lower limits and there was no indication in the OSH Act The AFL–CIO argued that OSHA’s rule was had been proposed, and raised the PEL for that Congress intended to change this rule. ‘‘systematically under protective,’’ and one substance. 54 FR 2332. The rule was 448 U.S. at 653, 655. Thus, the Court held asserted that 16 of the exposure limits in the challenged by both industry and labor that, before promulgating a health standard, final rule were too high. For example, the groups, which both raised a series of issues OSHA is required to make a ‘‘threshold AFL–CIO argued that OSHA had made a regarding the validity of the final rule. finding that a place of employment is unsafe– policy determination not to lower the PELs The first issue addressed by the court was in the sense that significant risks are present for carbon tetrachloride and vinyl bromide whether OSHA’s ‘‘generic’’ approach to and can be eliminated or lessened by a even though the exposure limits chosen

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61423

would continue to pose a residual risk in some basis in reputable scientific evidence,’’ 1. Technological Feasibility excess of 3.7 deaths per 1,000 workers the court concluded. Air Contaminants, 965 A standard is technologically feasible if ‘‘a exposed over the course of their working F.2d at 978–979. See Section IV. A. for typical firm will be able to develop and lifetime. The court agreed with the AFL–CIO, additional discussion of the use of safety install engineering and work practice finding that OSHA failed to provide adequate factors in risk assessment. controls that can meet the PEL in most evidence to support the higher PEL chosen Ultimately, although the Eleventh Circuit operations.’’ Lead I, 647 F.2d at 1272. by the agency. The court found that some of noted that OSHA ‘‘probably established that Standards are permitted to be ‘‘technology the PELs chosen by the Agency were at levels most or all of the substances involved do forcing,’’ meaning that OSHA can require that would continue to pose a significant risk pose a significant risk at some level,’’ the industries to ‘‘develop new technology’’ or of material health impairment, and court determined that OSHA failed to ‘‘impose a standard which only the most concluded that OSHA’s decision was due to adequately explain or provide evidence to technologically advanced plants in an time and resource constraints, rather than support its conclusion that ‘‘exposure to industry have been able to achieve, even if legitimate considerations, such as feasibility. these substances at previous levels posed a only in some of their operations some of the Air Contaminants, 965 F.2d at 976–77; Ex. significant risk . . . or that the new standard time.’’ Lead I, 647 F.2d at 1264; Ex. #12. #8. eliminates or reduces that risk to the extent Technological feasibility analysis generally Conversely, the American Iron and Steel feasible.’’ Air Contaminants, 965 F.2d at 987. focuses on demonstrating that PELs can be Institute (AISI; Ex. #147) argued that OSHA Therefore, the court vacated the rule and achieved through engineering and work set the PELs for certain substances below the remanded it to the agency. practice controls. However, the concept of level substantiated by the evidence. AISI 3. Material Impairment technological feasibility applies to all aspects argued that OSHA failed to quantify the risk of the standard, including air monitoring, of material health impairment at present Under section 6(b)(5), OSHA must set housekeeping, and respiratory protection exposure levels posed by individual standards to protect employees against requirements. Some courts have required substances and instead relied on assumptions ‘‘material impairment of health or functional OSHA to determine whether a standard is in order to select its updated PELs. The court capacity.’’ This requirement was technologically feasible on an industry-by- agreed with the AISI, finding that although uncontroversial in Benzene, since the effect industry basis, Color Pigments Manufacturers OSHA summarized the studies on health on which OSHA regulated was leukemia. Assoc. v. OSHA, 16 F.3d 1157 (Ex. #13), effects in the final rule, it did not explain However, in Air Contaminants, AISI argued 1162–63 (11th Cir. 1994); Air Contaminants, why the ‘‘studies mandated a particular PEL that not all of the health effects addressed by 965 F.2d at 981–82 (Ex. #8), while another chosen.’’ Air Contaminants, 965 F.2d at 976. OSHA in the final rule were material health court has upheld technological feasibility Specifically, the court stated that OSHA effects. Specifically, AISI stated that the findings based on the nature of an activity failed to quantify the risk from individual category of ‘‘sensory irritation,’’ which OSHA across many industries rather than on a pure substances and merely provided conclusory used as an endpoint to set PELs for 79 industry basis, Public Citizen Health statements that the new PEL would reduce a substances, failed to distinguish between Research Group v. United States Department significant risk of material health effects. Air ‘‘materially impairing sensory irritation and of Labor, 557 F.3d 165,178–79 (3d Cir. 2009; Contaminants, 965 F.2d at 975. the less serious sort.’’ AISI brief at page 24. Ex. #14). OSHA argued to the court that it relied on The court rejected AISI’s argument. It Regardless, OSHA must show the existence safety factors in setting PELs. Safety or accepted OSHA’s explanation that material of ‘‘technology that is either already in use uncertainty factors are used to ensure that impairments may be any health effect, or has been conceived and is reasonably exposure limits for a hazardous substance are permanent or transitory, that seriously capable of experimental refinement and set sufficiently below the levels at which threatens the health or job performance of an distribution within the standard’s adverse effects have been observed to assure employee, and held that, ‘‘OSHA is not deadlines,’’ Lead I, 647 F.2d 1272. Where the adequate protection for all exposed required to state with scientific certainty or agency presents ‘‘substantial evidence that employees. As explained in the 1989 Air precision the exact point at which each type companies acting vigorously and in good Contaminants rule, regulators use safety of sensory or physical irritation becomes a faith can develop the technology,’’ the agency factors in this context to account for material impairment.’’ Air Contaminants, 965 is not bound to the technological status quo, statistical limitations in studies showing no F.2d at 975. ‘‘Section 6(b)(5) of the [OSH] Act and ‘‘can require industry to meet PELs never observed effects, the uncertainties in charges OSHA with addressing all forms of attained anywhere.’’ Lead I, 647 F.2d 1265; extrapolating effects observed in animals to ‘material impairment of health or functional Ex. #12. humans, and variation in human responses. capacity,’’ and not exclusively those causing OSHA usually demonstrates the The size of the proper safety factor is a matter ‘death or serious physical harm’ or ‘grave technological feasibility of a PEL by finding of professional judgment. 54 FR 2397–98 danger’ from exposure to toxic substances, establishments in which the PEL is already The Eleventh Circuit rejected OSHA’s use the court held. Air Contaminants, 965 F.2d being met and identifying the controls in use, of safety factors in the Air Contaminants rule, at 975; Ex. #8. or by arguing that even if the PEL is not however. While noting that the Benzene case currently being met in a given operation, the held that OSHA is permitted ‘‘to use D. Technological and Economic Feasibility PEL could be met with specific additional conservative assumptions in interpreting data Once OSHA makes its threshold finding controls. OSHA is also concerned with . . ., risking error on the side of that a significant risk is present at the current determining whether the conditions under overprotection rather than under protection,’’ PEL or in the absence of a PEL and can be which the PEL can be met in specific plants Benzene, 448 U.S. at 656, the Air reduced or eliminated by a standard, the are generalizable to an industry as whole. Contaminants court found that OSHA had Agency considers feasibility. First, the This approach is very resource-intensive, as not adequately supported the use of safety feasibility requirement that originated in it commonly requires gathering detailed factors in this rule. The court observed that Section 6(b)(5) of the OSH Act requires that information on exposure levels and controls ‘‘the difference between the level shown by the standard be ‘‘technologically feasible,’’ for each affected operation and process in an the evidence and the final PEL is sometimes which generally means an industry has to be industry. OSHA’s inspection databases substantial,’’ and assumed that though ‘‘it is able to develop the technology necessary to usually do not record this information, and not expressly stated, that for each of those comply with the requirements in the consequently OSHA makes site visits for the substances OSHA applied a safety factor to standard. Lead I, 647 F.2d at 1264–65; Ex. specific purpose of determining arrive at the final standard.’’ 965 F.2d at 978. #12. technological feasibility. (See Section IV. of OSHA had not indicated ‘‘how the existing Second, the standard must be this Request for Information for a detailed evidence for individual substances was ‘‘economically feasible,’’ meaning that an discussion of how OSHA determines inadequate to show the extent of risk for industry as a whole must be able to absorb technological feasibility and possible these factors,’’ and ‘‘failed to explain the the impact of the costs associated with alternatives to current methods.) method by which its safety factors were compliance with the standard. Id. at 1265. As noted above, in the Air Contaminants determined.’’ Air Contaminants, 965 F.2d at OSHA has historically made determinations rule, OSHA made its feasibility 978. ‘‘OSHA may use assumptions but only on technological feasibility and economic determination by gathering information on to the extent that those assumptions have feasibility separately. work processes that might expose workers

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61424 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

above the new PELs, and identifying controls provided by the standard. As the Supreme OSHA had failed to meet its burden. The that had been successfully implemented to Court noted, Congress considered the costs of court held that OSHA was required to show reduce the exposure to the new limits. It creating a safe and healthful workplace to be that the rule was economically feasible on an made these findings mainly at the two-digit the cost of doing business. Cotton Dust, 452 industry-by industry basis, and that OSHA SIC level, but also at the three- and four-digit U.S. at 514, 520; Ex. #15. Instead, standards had not shown that its analyses at the two- level where appropriate given the processes are economically feasible if the standard will digit SIC industry sector level were involved. The Air Contaminants court not substantially alter the industry’s appropriate to meet this burden. Air rejected this approach, finding that OSHA competitive structure. Forging Indus. Ass’n v. Contaminants, 965 F.2d at 982. OSHA argued failed to make industry-specific findings or Secretary of Labor, 773 F.2d 1436, 1453 (4th the generic nature of the rulemaking allowed identify the specific technologies capable of Cir. 1985; Ex. #148). In order to make a the agency ‘‘a great latitude in grouping meeting the proposed limit in industry- determination of economic feasibility, OSHA industries in order to estimate ‘average’ specific operations. Air Contaminants, 965 should ‘‘construct a reasonable estimate of costs,’’ and that ‘‘the costs were sufficiently F.2d at 981. While OSHA had identified compliance costs and demonstrate a low per sector to demonstrate feasibility not primary air contaminant control methods: reasonable likelihood that these costs will only for each sector, but each sub-sector.’’ Air engineering controls, administrative controls not threaten the existence or competitive Contaminants, 965 F.2d at 983. However, the and work practices and personal protective structure of an industry,’’ Lead I, 647 F.2d at court found that ‘‘average estimates of cost equipment, the agency, ‘‘only provided a 1272, noting that such analyses will not can be extremely misleading in assessing the general description of how the generic provide absolute certainty: engineering controls might be used in the impact of particular standards on individual [T]he court probably cannot expect hard industries’’ and observed that ‘‘analyzing the given sector.’’ Air Contaminants, 965 F.2d at and precise estimates of costs. Nevertheless, 981. Though noting that OSHA need only economic impact for an entire sector could the agency must of course provide a conceal particular industries laboring under provide evidence sufficient to justify a reasonable assessment of the likely range of special disabilities and likely to fail as a ‘‘general presumption of feasibility,’’ the costs of its standard, and the likely effects of result of enforcement.’’ Air Contaminants, court held that this ‘‘does not grant OSHA those costs on the industry . . . . And OSHA license to make overbroad generalities as to can revise any gloomy forecast that estimated 965 F.2d at 982. The court allowed that feasibility or to group large categories of costs will imperil an industry by allowing for OSHA could ‘‘find and explain that certain industries together without some explanation the industry’s demonstrated ability to pass impacts and standards do apply to entire of why findings for the group adequately through costs to consumers. 647 F.2d at sectors of an industry’’ if ‘‘coupled with a represents the different industries in that 1266–67. showing that there are no disproportionately group.’’ Air Contaminants, 965 F.2d at 981– affected industries within the group.’’ Air Again, courts have required OSHA to 82. Accordingly, the court held that OSHA Contaminants, 965 F.2d at 982 n.28. But in determine whether a standard is failed to establish the technological economically feasible on an industry-by- this case, the court found, OSHA had not feasibility of the new PELs in its final rule. industry basis. See Air Contaminants, 965 explained why its use of such a ‘‘broad Air Contaminants, 965 F.2d at 982. As noted F.2d at 982 (Ex. #8). Both to meet grouping was appropriate.’’ Air below, in a subsequent rulemaking the requirements for any Regulatory Flexibility Contaminants, 965 F.2d at 983; Ex. #8. reviewing court accepted OSHA’s approach Act (5 U.S.C. 603, 604) analysis and to assure Ultimately, the court held that OSHA did of grouping numbers of industries. that standards do not threaten the not sufficiently explain or support its 2. Economic Feasibility competitive structure of an industry, OSHA threshold determination that exposures With respect to economic feasibility, the also analyzes the economic impacts on above the new PELs posed significant risks courts have stated ‘‘A standard is feasible if different size classes within an industry. of material health impairment, or that the it does not threaten ‘‘massive dislocation’’ to However, OSHA is not required to show that new PELs eliminated or reduced the risks to . . . or imperil the existence of the industry.’’ all companies within an industry will be able the extent feasible. Finding that ‘‘OSHA’s United Steelworkers v. Marshall, 647 F.2d to bear the burden of compliance or overall approach to this rulemaking is . . . 1189, 1265 (D.C. Cir. 1980) Lead I,). In order ‘‘guarantee the continued existence of flawed,’’ the court vacated the entire Air to show this, the same court suggested, individual employers.’’ Lead I, 647 F.2d at Contaminant rulemaking, rather than just the OSHA should ‘‘construct a reasonable 1265 (Ex. #12) (quoting Industrial Union 23 chemicals that were contested by union estimate of compliance costs and Dep’t, AFL–CIO v. Hodgson, 499 F.2d 467, and industry representatives. Air demonstrate a reasonable likelihood that 478 (D.C. Cir. 1974) Ex. #55)). Contaminants, 965 F.2d at 987(Ex. #8). these costs will not threaten the existence or As discussed above, OSHA supported its The Eleventh Circuit denied OSHA’s competitive structure of an industry.’’ The economic feasibility findings for the 1989 Air petition for rehearing. No longer having a same court noted, ‘‘[T]he court probably Contaminants rule based primarily on the basis to enforce the 1989 PELs, OSHA cannot expect hard and precise estimates of results of a survey of over 5700 businesses, directed its compliance officers to stop costs. Nevertheless, the agency must of summarizing the projected cost of enforcing the updated limits through a course provide a reasonable assessment of compliance at the two-digit SIC industry memo, which was followed by a Federal the likely range of costs of its standard, and sector level. It found that compliance costs Register Notice on June 30, 1993, revoking the likely effects of those costs on the would average less than one percent of the new limits. 58 FR 35338–35351; (Ex. industry.’’ Lead I, 647 F.2d at 1265; Ex. #12. profits, and, alternatively, that prices would #19). Economic feasibility does not entail a cost- increase by less than one half percent. benefit analysis of the level of protection Nonetheless, the Eleventh Circuit held that Appendix B: 1989 PELs Table TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Acetaldehyde ...... 75–07–0 ...... 100 180 150 270 ...... Acetic acid ...... 64–19–7 ...... 10 25 ...... Acetic anhydride ...... 108–24–7 ...... 5 20 ...... Acetone ...... 67–64–1 ...... 750 1800 1000 24006 ...... Acetonitrile ...... 75–05–8 ...... 40 70 60 105 ...... 2-Acetylamino-fluorine; see 1910.1014 ...... 53–96–3. Acetylene dichloride; see 1,2-Dichloroethylene ...... 540–59–0. Acetylene tetrabromide ...... 79–27–6 ...... 1 14 ...... Acetylsalicylic acid (Aspirin) ...... 50–78–2 ...... 5 ...... Acrolein ...... 107–02–8 ...... 0.1 0.25 0.3 0.8 ...... Acrylamide ...... 79–06–1 ...... 0.03 ...... X

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61425

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Acrylic acid ...... 79–10–7 ...... 10 30 ...... X Acrylonitrile; see 1910.1045 ...... 107–13–1 ...... Aldrin ...... 309–00–2 ...... 0.25 ...... X Allyl alcohol ...... 107–18–6 ...... 2 5 4 10 ...... X Allyl chloride...... 107–05–1 ...... 1 3 2 6 ...... Allyl glycidyl ether (AGE) ...... 106–92–3 ...... 5 22 10 44 ...... Allyl propyl disulfide ...... 2179–59–1 ...... 2 12 3 18 ...... alpha-Alumina ...... 1344–28–1 ...... Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Aluminum (as Al) Metal ...... 7429–90–5. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Pyro powders ...... 5 ...... Welding fumes ...... 5 ...... Soluble salts ...... 2 ...... Alkyls ...... 2 ...... 4-Aminodiphenyl; see 1910.1011 ...... 92–67–1. 2-Aminoethanol; see Ethanolamine ...... 141–43–5. 2-Aminopyridine ...... 504–29–0 ...... 0.5 2 ...... Amitrole ...... 61–82–5 ...... 0.2 ...... Ammonia ...... 7664–41–7 ...... 35 27 ...... Ammonium chloride fume ...... 12125–02–9 ...... 10 ...... 20 ...... Ammonium sulfamate ...... 7773–06–0. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... n-Amyl acetate ...... 628–63–7 ...... 100 525 ...... Sec-Amyl acetate ...... 626–38–0 ...... 125 650 ...... Aniline and homologs ...... 62–53–3 ...... 2 8 ...... X Anisidine (o-, p-isomers) ...... 29191–52–4 ...... 0.5 ...... Antimony and compounds (as Sb) ...... 7440–36–0 ...... 0.5 ...... ANTU (alpha naphthyl-thiourea) ...... 86–88–4 ...... 0.3 ...... Arsenic, organic compounds (as As) ...... 7440–38–2 ...... 0.5 ...... Arsenic, inorganic compounds (as As); see 1910.1018 .... Varies with com- ...... pound. Arsine ...... 7784–42–1 ...... 0.05 0.2 ...... Asbestos; see 1910.1001 ...... Varies ...... Atrazine ...... 1912–24–9 ...... 5 ...... Azinphos-methyl ...... 86–50–0 ...... 0.2 ...... X Barium, soluble compounds ...... 7440–39–3 ...... 0.5 ...... Barium sulfate ...... 7727–43–7. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Benomyl ...... 17804–35–2. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Benzene; see 1910.1028. See Table Z–2 for the limits 71–43–2. applicable in the operations or sectors excluded in 1910.1028. Benzidine; see 1910.1010 ...... 92–87–5. p-Benzoquinone; see Quinone ...... 106–51–4. Benzo(a)pyrene; see Coal tar pitch volatiles Benzoyl peroxide ...... 94–36–0 ...... 5 ...... Benzyl chloride ...... 100–44–7 ...... 1 5 ...... Beryllium and beryllium compounds (as Be) ...... 7440–41–7 ...... 0.002 ...... 1.005 ...... 0.025 ...... Biphenyl; see Diphenyl ...... 92–52–4. Bismuth telluride, undoped ...... 1304–82–1. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Bismuth telluride, Se-doped ...... 1304–82–1 ...... 5 ...... Borates, tetra, sodium salts: Anhydrous ...... 1330–43–4 ...... 10 ...... Decahydrate ...... 1303–96–4 ...... 10 ...... Penta-hydrate ...... 12179–04–3 ...... 10 ...... Boron oxide ...... 1303–86–2. Total dust ...... 10 ...... Respirable Frac- ...... 5 ...... tion. Boron tribromide ...... 10294–33–4 ...... 1 10 ...... Boron trifluoride ...... 7637–07–2 ...... 1 3 ...... Bromacil ...... 314–40–9 ...... 1 10 ...... Bromine ...... 7726–95–6 ...... 0.1 0.7 0.3 2 ...... Bromine pentafluoride ...... 7789–30–2 ...... 0.1 0.7 ...... Bromoform ...... 75–25–2 ...... 0.5 5 ...... X Butadiene (1,3- Butadiene); see 1910.1051 ...... 106–99–0. Butane ...... 106–97–8 ...... 800 1900 ...... Butanethiol; see Butyl mercaptan ...... 109–79–5. 2-Butanone (Methyl ethyl ketone) ...... 78–93–3 ...... 200 590 300 885 ......

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61426 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

2-Butoxyethanol ...... 111–76–2 ...... 25 120 ...... X n-Butyl-acetate ...... 123–86–4 ...... 150 710 200 950 ...... sec-Butyl acetate ...... 105–46–4 ...... 200 950 ...... tert-Butyl acetate ...... 540–88–5 ...... 200 950 ...... Butyl acrylate ...... 141–32–2 ...... 10 55 ...... n-Butyl alcohol ...... 71–36–3 ...... 50 150 X sec-Butyl alcohol ...... 78–92–2 ...... 100 305 ...... tert-Butyl alcohol...... 75–65–0 ...... 100 300 150 450 ...... Butylamine ...... 109–73–9 ...... 5 15 X tert-Butyl Chromate (as CrO3) ...... 1189–85–1 ...... 0.1 X n-Butyl glycidyl ether (BGE) ...... 2426–08–6 ...... 25 135 ...... n-Butyl lactate ...... 138–22–7 ...... 5 25 ...... Butyl mercaptan ...... 109–79–5 ...... 0.5 1.5 ...... o-sec-Butylphenol ...... 89–72–5 ...... 5 30 ...... X p-tert-Butyltoluene ...... 98–51–1 ...... 10 60 20 120 ...... Cadmium (all forms, as Cd); see 1910.1027 See Table 7440–43–9. Z–2 for the limits applicable in the operations or sec- tors excluded in 1910.1027. Calcium carbonate ...... 1317–65–3. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Calcium cyanamide ...... 156–62–7 ...... 0.5 ...... Calcium hydroxide; see particulates not otherwise regu- 1305–62–0 ...... 5 ...... lated. Calcium oxide ...... 1305–78–8 ...... 5 ...... Calcium silicate ...... 1344–95–2 ...... Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Calcium sulfate ...... 7778–18–9. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Camphor, synthetic ...... 76–22–2. Camphor, synthetic ...... 76–22–2 ...... 2 ...... Caprolactam ...... 105–60–2. Dust ...... 1 ...... 3 ...... Vapor ...... 5 20 10 40 ...... Captafol (Difolatan®) ...... 2425–06–1 ...... 0.1 ...... Captan ...... 133–06–2 ...... 5 ...... Carbaryl (Sevin®) ...... 63–25–2 ...... 5 ...... Carbofuran (Furadan®) ...... 1563–66–2 ...... 0.1 ...... Carbon black ...... 1333–86–4 ...... 3.5 ...... Carbon dioxide ...... 124–38–9 ...... 10,000 18,000 30,000 54,000 ...... 0 0 Carbon disulfide ...... 75–15–0 ...... 4 12 12 36 ...... X Carbon monoxide ...... 630–08–0 ...... 35 40 ...... 200 229 ...... Carbon tetrabromide ...... 558–13–4 ...... 0.1 1.4 0.3 4 ...... Carbon tetrachloride ...... 56–23–5 ...... 2 12.6 ...... Carbonyl fluoride ...... 353–50–4 ...... 2 5 5 15 ...... Catechol (Pyrocatechol) ...... 120–80–9 ...... 5 20 ...... X Cellulose ...... 9004–34–6. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Cesium hydroxide ...... 21351–79–1 ...... 2 ...... Chlordane ...... 57–74–9 ...... 0.5 ...... X Chlorinated camphene ...... 8001–35–2 ...... 0.5 ...... 1 ...... X Chlorinated diphenyl oxide ...... 55720–99–5 ...... 0.5 ...... Chlorine ...... 7782–50–5 ...... 0.5 1.5 1 3 ...... Chlorine dioxide...... 10049–04–4 ...... 0.1 0.3 0.3 0.9 ...... Chlorine trifluoride ...... 7790–91–2 ...... 0.1 0.4 ...... Chloro-acetaldehyde ...... 107–20–0 ...... 1 3 ...... alpha-Chloroaceto-phenone (Phenacy1 chloride) ...... 532–27–4 ...... 0.05 0.3 ...... Chloroacetyl chloride ...... 79–04–9 ...... 0.05 0.2 ...... Chlorobenzene ...... 108–90–7 ...... 75 350 ...... o-Chloro-benzylidene malononitrile ...... 2698–41–1 ...... 0.05 0.4 X Chloro-bromomethane ...... 74–97–5 ...... 200 1050 ...... 2-Chloro-1,3-butadiene; see beta-Chloroprene ...... 126–99–8 ...... Chloro-difluoromethane ...... 75–45–6 ...... 1000 3500 ...... Chlorodiphenyl (42% Chlorine) (PCB) ...... 53469–21–9 ...... 1 ...... X Chlorodiphenyl (54% Chlorine) (PCB) ...... 11097–69–1 ...... 0.5 ...... X 1-Chloro,2,3-epoxypropane; see Epichlorohydrin ...... 106–89–8. 2-Chloroethanol; see Ethylene chlorohydrin ...... 107–07–3. Chloroethylene; see Vinyl chloride ...... 75–01–4. Chloroform (Trichloro-methane) ...... 67–66–3 ...... 2 9.78 ...... bis(Chloro-methyl) ether; see 1910.1008 ...... 542–88–1. Chloromethyl methyl ether; see 1910.1006 ...... 107–30–2. 1-Chloro-l-nitropropane ...... 600–25–9 ...... 2 10 ...... Chloropenta-fluoroethane ...... 76–15–3 ...... 1000 6320 ...... Chloropicrin ...... 76–06–2 ...... 0.1 0.7 ......

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61427

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

beta-Chloroprene ...... 126–99–8 ...... 10 35 ...... X o-Chlorostyrene ...... 2039–87–4 ...... 50 285 75 428 ...... o-Chlorotoluene ...... 95–49–8 ...... 50 250 ...... 2-Chloro-6-trichloro-methyl pyridine ...... 1929–82–4. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Chlorpyrifos ...... 2921–88–2 ...... 0.2 ...... X Chromic acid and chromates (as CrO3); see 1910.1026. Varies with com- ...... 0.1 ...... See Table Z–2 for the exposure limit for any operations pound. or sectors where the exposure limit in 1910.1026 is stayed or are otherwise not in effect. Chromium (II) compounds (as Cr) ...... Varies with com- ...... 0.5 ...... pound. Chromium (III) compounds (as Cr) ...... Varies with com- ...... 0.5 ...... pound. Chromium metal and insoluble salts ...... 7440–47–3 ...... 1 ...... Chrysene; see Coal tar pitch volatiles Clopidol ...... 2971–90–6. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Coal dust (less than 5% Si02), quartz, respirable fraction N/A ...... 2 ...... Coal dust (greater than or equal to 5% Si02) respirable N/A ...... 0.1 ...... quartz fraction. Coal tar pitch volatiles (benzene soluble fraction), anthra- 8007–45–2 ...... 0.2 ...... cene, BaP, phenanthrene, acridine, chrysene, pyrene. Cobalt metal, dust, and fume (as Co) ...... 7440–48–4 ...... 0.05 ...... Cobalt carbonyl (as Co) ...... 10210–68–1 ...... 0.1 ...... Cobalt hydrocarbonyl (as Co) ...... 16842–03–8 ...... 0.1 ...... Coke oven emissions; See 1910.1029 Copper ...... 7440–50–8. Fume (as Cu) ...... 0.1 ...... Dusts and mists ...... 1 ...... (as Cu). Cotton dust, raw This 8-hour TWA applies to respirable dust as measured by a vertical elutriator cotton dust or equivalent instrument. The time-weighted average ap- plies to the cotton waste processing operations of waster recycling (sorting, blending, cleaning, and willowing) and garnetting. See also 1910.1043 for cot- ton dust limits applicable to other sectors. Crag herbicide (Sesone) ...... 136–78–7. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Cresol, all isomers ...... 1319–77–3; 95– 5 22 ...... X 48–7; 108–39–4; 106–44–5. Crotonaldehyde ...... 123–73–9; 4170– ...... 2 6 ...... 30–3. Crufomate ...... 106–44–5 ...... 5 ...... Cumene ...... 98–82–8 ...... 50 245 ...... X Cyanamide ...... 420–04–2 ...... 2 ...... Cyanides (as CN) ...... 151–50–0 ...... 5 ...... Cyanogen ...... 460–19–5 ...... 10 20 ...... Cyanogen chloride ...... 506–77–4 ...... 0.3 0.6 ...... Cyclohexane ...... 110–82–7 ...... 300 1050 ...... Cyclohexanol ...... 108–93–0 ...... 50 200 ...... X Cyclohexanone ...... 108–94–1 ...... 25 100 ...... X Cyclohexene ...... 110–83–8 ...... 300 1015 ...... Cyclohexylamine ...... 108–91–8 ...... 10 40 ...... Cyclonite ...... 121–82–4 ...... 1.5 ...... X Cyclopentadiene ...... 542–92–7 ...... 75 200 ...... Cyclopentane ...... 287–92–3 ...... 600 1720 ...... Cyhexatin ...... 13121–70–5 ...... 5 ...... 2,4–D (Dichlorophenoxy-acetic acid) ...... 94–75–7 ...... 10 ...... Decaborane ...... 17702–41–9 ...... 0.05 0.3 0.15 0.9 ...... X Demeton-(Systox®) ...... 8065–48–3 ...... 0.1 ...... X Diborane ...... 19207–45–7 ...... 0.1 0.1 ...... Dichlorodiphenyltri-chloroethane (DDT) ...... 50–29–3 ...... 1 ...... X Dichlorvos (DDVP) ...... 62–73–7 ...... 1 ...... X Diacetone alcohol (4-Hydroxy-4-methyl-2-pentanone) ...... 123–42–2 ...... 50 240 ...... 1,2-Diaminoethane; see Ethylenediamine ...... 107–15–3. Diazinon ...... 333–41–5 ...... 0.1 ...... X Diazomethane ...... 334–88–3 ...... 0.2 0.4 ...... 1,2-Dibromo-3-chloropropane; see 1910.1044 ...... 96–12–8. 2–N-Dibutylamino-ethanol ...... 102–81–8 ...... 2 14 ...... Dibutyl phosphate ...... 107–66–4 ...... 1 5 2 10 ...... Dibutyl phthalate ...... 84–74–2 ...... 5 ...... Dichloro-acetylene ...... 7572–29–4 ...... 0.1 0.4 ......

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61428 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

o-Dichlorobenzene ...... 95–50–1 ...... 50 300 ...... p-Dichlorobenzene ...... 106–46–7 ...... 75 450 110 675 ...... 3,3′-Dichloro-benzidine; see 1910.1007 ...... 91–94–1. Dichlorodifluoro-methane ...... 75–71–8 ...... 1000 4950 ...... 1,3-Dichloro-5,5-dimethyl hydantoin ...... 118–52–5 ...... 0.2 ...... 0.4 ...... 1,1-Dichloroethane ...... 75–34–3 ...... 100 400 ...... 1,2-Dichloroethylene ...... 540–59–0 ...... 200 790 ...... Dichloroethyl ether...... 111–44–4 ...... 5 30 10 60 ...... X Dichloro-methane; see Methylene chloride ...... 75–09–2. Dichloromono-fluoromethane ...... 75–43–4 ...... 10 40 ...... 1,1-Dichloro- 1-nitroethane ...... 594–72–9 ...... 2 10 ...... 1,2-Dichloropropane; see Propylene dichloride ...... 78–87–5. 1,3-Dichloropropene ...... 542–75–6 ...... 1 5 ...... X 2,2-Dichloro-propionic acid ...... 75–99–0 ...... 1 6 ...... Dichloro-tetrafluoroethane ...... 76–14–2 ...... 1000 7000 ...... Dicrotophos ...... 141–66–2 ...... 0.25 ...... X Dicyclo-pentadiene ...... 77–73–6 ...... 5 30 ...... Dicyclo-pentadienyl iron ...... 102–54–5. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Dieldrin ...... 60–57–1 ...... 0.25 ...... X Diethanolamine ...... 111–42–2 ...... 3 15 ...... Diethylamine ...... 109–89–7 ...... 10 30 25 75 ...... 2-Diethylamino-ethanol ...... 100–37–8 ...... 10 50 ...... Diethylene triamine ...... 111–40–0 ...... 1 4 ...... Diethyl ether; see Ethyl ether ...... 60–29–7. Diethyl ketone ...... 96–22–0 ...... 200 705 ...... Diethyl phthalate ...... 84–66–2 ...... 5 ...... Difluorodibromo-methane ...... 75–61–6 ...... 100 860 ...... Diglycidyl ether (DGE) ...... 2238–07–5 ...... 0.1 0.5 ...... Dihydroxy-benzene; see Hydroquinone ...... 123–31–9. Diisobutyl ketone ...... 108–83–8 ...... 25 150 ...... Diisopropylamine ...... 108–18–9 ...... 5 20 ...... X 4-Dimethylamino-azobenzene; see 1910.1015 ...... 60–11–7. Dimethoxy-methane; see Methylal ...... 109–87–5. Dimethyl acetamide ...... 127–19–5 ...... 10 35 ...... X Dimethylamine ...... 124–40–3 ...... 10 18 ...... Dimethylamino-benzene; see Xylidine ...... 1300–73–8. Dimethylaniline (N,N-Dimethylaniline)...... 121–69–7 ...... 5 25 10 50 ...... X Dimethyl-benzene; see Xylene ...... Varies with isomer. Dimethyl-1,2-dibromo-2,2-dichloroethyl phosphate ...... 300–76–5 ...... 3 ...... X Dimethyl-formamide ...... 68–12–2 ...... 10 30 ...... X 2,6-Dimethyl-4-heptanone; see Diisobutyl ketone ...... 108–83–8. 1,1-Dimethyl-hydrazine ...... 57–14–7 ...... 0.5 1 ...... X Dimethyl-phthalate ...... 131–11–3 ...... 5 ...... Dimethyl sulfate ...... 77–78–1 ...... 0.1 0.5 ...... X Dinitolmide (3,5-Dinitro-o-toluamide) ...... 148–01–6 ...... 5 ...... Dinitrobenzene (all isomers) ...... (alpha): 528–29–0 ...... 1 ...... X (meta): 99–65–0. (para-): 100–25–4. Dinitro-o-cresol ...... 534–52–1 ...... 0.2 ...... X Dinitrotoluene ...... 121–14–2 ...... 1.5 ...... X Dioxane (Diethylene dioxide) ...... 123–91–1 ...... 25 90 ...... X Dioxathion (Delnav) ...... 78–34–2 ...... 0.2 ...... X Diphenyl (Biphenyl) ...... 92–52–4 ...... 0.2 1 ...... Diphenylamine ...... 122–39–4 ...... 10 ...... Diphenylmethane diisocyanate; see Methylene bisphenyl 101–68–8. isocyanate. Dipropylene glycol methyl ether ...... 34590–94–8 ...... 100 600 150 900 ...... X Dipropyl ketone ...... 123–19–3 ...... 50 235 ...... Diquat ...... 85–00–7 ...... 0.5 ...... Di-sec octyl phthalate (Di-2-ethylhexyl phthalate) ...... 117–81–7 ...... 5 ...... 10 ...... Disulfiram ...... 97–77–8 ...... 2 ...... Disulfoton ...... 298–04–4 ...... 0.1 ...... X 2,6-Di-tert-butyl-p-cresol ...... 128–37–0 ...... 10 ...... Diuron ...... 330–54–1 ...... 10 ...... Divinyl benzene ...... 108–576 ...... 10 50 ...... Emery ...... 112–62–9. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Endosulfan ...... 115–29–7 ...... 0.1 ...... X Endrin ...... 72–20–8 ...... 0.1 ...... X Epichlorohydrin ...... 106–89–8 ...... 2 8 ...... X EPN ...... 2104–64–5 ...... 0.5 ...... X 1,2-Epoxypropane; see Propylene oxide ...... 75–56–9. 2,3-Epoxy-l-propanol; see Glycidol ...... 556–52–5. Ethanethiol; see Ethyl mercaptan ...... 75–08–1. Ethanolamine ...... 141–43–5 ...... 3 8 6 15 ......

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61429

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Ethion ...... 563–12–2 ...... 0.4 ...... X 2-Ethoxyethanol [In Process of 6(b) Rulemaking] ...... 110–80–5. 2-Ethoxyethyl acetate (Cellosolve acetate) [In Process of 111–15–9. 6(b) Rulemaking]. Ethyl acetate ...... 141–78–6 ...... 400 1400 ...... Ethyl acrylate ...... 140–88–5 ...... 5 20 25 100 ...... X Ethyl alcohol (Ethanol) ...... 64–17–5 ...... 1000 1900 ...... Ethylamine ...... 75–04–7 ...... 10 18 ...... Ethyl amyl ketone (5-Methyl-3-heptanone) ...... 106–68–3 ...... 25 130 ...... Ethyl benzene...... 100–41–4 ...... 100 435 125 545 ...... Ethyl bromide...... 74–96–4 ...... 200 890 250 1110 ...... Ethyl butyl ketone (3-Heptanone) ...... 106–35–4 ...... 50 230 ...... Ethyl chloride ...... 75–00–3 ...... 1000 2600 ...... Ethyl ether...... 60–29–7 ...... 400 1200 500 1500 ...... Ethyl formate ...... 109–94–4 ...... 100 300 ...... Ethyl mercaptan ...... 75–08–1 ...... 0.5 1 ...... Ethyl silicate ...... 78–10–4 ...... 10 85 ...... Ethylene chlorohydrin ...... 107–07–3 ...... 1 3 X Ethylenediamine ...... 107–15–3 ...... 10 25 ...... Ethylene dibromide; see Table Z–2 ...... 106–93–4. Ethylene dichloride ...... 107–06–2 ...... 1 4 2 8 ...... Ethylene glycol ...... 107–21–1 ...... 50 125 ...... Ethylene glycol dinitrate ...... 628–96–6 ...... 0.1 ...... X Ethylene glycol methyl acetate; see Methyl cellosolve ac- 110–49–6. etate. Ethyleneimine; see 1910.1012 ...... 151–56–4. Ethylene oxide; see 1910.1047 ...... 75–21–8. Ethylidene chloride; see 1,1-Dichloroethane ...... 75–34–3. Ethylidene norbornene ...... 16219–75–3 ...... 5 25 ...... N-Ethylmorpholine ...... 100–74–3 ...... 5 23 ...... X Fenamiphos ...... 22224–92–6 ...... 0.1 ...... X Fensulfothion (Dasanit) ...... 115–90–2 ...... 0.1 ...... Fenthion ...... 55–38–9 ...... 0.2 ...... X Ferbam ...... 14484–64–1. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Ferrovanadium dust ...... 12604–58–9 ...... 1 ...... 3 ...... Fluorides (as F) ...... Varies with com- ...... 2.5 ...... pound. Fluorine ...... 7782–41–4 ...... 0.1 0.2 ...... Fluoro-trichloromethane (Trichlorofluoro-methane) ...... 75–69–4 ...... 1000 5600 ...... Fonofos ...... 944–22–9 ...... 0.1 ...... X Formaldehyde; see 1910.1048 ...... 50–00–0. Formamide ...... 75–12–7 ...... 20 30 30 45 ...... Formic acid ...... 64–18–6 ...... 5 9 ...... Furfural ...... 98–01–1 ...... 2 8 ...... X Furfuryl alcohol ...... 98–00–0 ...... 10 40 15 60 ...... X Gasoline ...... 8006–61–9 ...... 300 900 500 1500 ...... Gemanium tetrahydride ...... 7782–65–2 ...... 0.2 0.6 ...... Glutaraldehyde ...... 111–30–8 ...... 0.2 0.8 ...... Glycerin (mist) ...... 56–81–5. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Glycidol ...... 556–52–5 ...... 25 75 ...... Glycol monoethyl ether; see 2-Ethoxyethanol ...... 110–80–5. Grain dust (oat, wheat, barley) ...... N/A ...... 10 ...... Graphite, natural respirable dust ...... 7782–42–5 ...... 2.5 ...... Graphite, synthetic ...... N/A. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Guthion®; see Azinphos methyl ...... 86–50–0. Gypsum ...... 7778–18–9. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Hafnium ...... 7440–58–6 ...... 0.5 ...... Heptachlor ...... 76–44–8 ...... 0.5 ...... X Heptane (n-Heptane)...... 142–82–5 ...... 400 1600 500 2000 ...... Hexachloro-butadiene ...... 87–68–3 ...... 0.02 0.24 ...... Hexachlorocyclo-pentadiene ...... 77–47–4 ...... 0.01 0.1 ...... Hexa-chloroethane ...... 67–72–1 ...... 1 10 ...... X Hexachloro-naphthalene ...... 1335–87–1 ...... 0.2 ...... X Hexafluoro-acetone ...... 684–16–2 ...... 0.1 0.7 ...... X n-Hexane ...... 110–54–3 ...... 50 180 ...... Hexane isomers ...... Varies with com- 500 1800 1000 3600 ...... pound. 2-Hexanone (Methyl n-butyl ketone) ...... 591–78–6 ...... 5 20 ...... Hexone (Methyl isobutyl ketone) ...... 108–10–1 ...... 50 205 75 300 ...... sec-Hexyl acetate ...... 108–84–9 ...... 50 300 ......

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61430 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Hexylene glycol ...... 107–41–5 ...... 25 125 ...... Hydrazine ...... 302–01–2 ...... 0.1 0.1 ...... X Hydrogenated terphenyls ...... 61788–32–7 ...... 0.5 5 ...... Hydrogen bromide ...... 10035–10–6 ...... 3 10 ...... Hydrogen chloride ...... 7647–01–0 ...... 5 7 ...... Hydrogen cyanide ...... 74–90–8 ...... 4.7 5 ...... X Hydrogen fluoride (as F) ...... 7664–39–3 ...... 3 ...... 6 ...... Hydrogen peroxide ...... 7722–84–1 ...... 1 1.4 ...... Hydrogen selenide (as Se) ...... 7783–07–5 ...... 0.05 0.2 ...... Hydrogen sulfide ...... 7783–06–4 ...... 10 14 15 21 ...... Hydroquinone ...... 123–31–9 ...... 2 ...... 2-Hydroxypropyl acrylate ...... 999–61–1 ...... 0.5 3 ...... X Indene ...... 95–13–6 ...... 10 45 ...... Indium and compounds (as In) ...... 7440–74–6 ...... 0.1 ...... Iodine ...... 7553–56–2 ...... 0.1 1 ...... Iodoform ...... 75–47–8 ...... 0.6 10 ...... Iron oxide (dust and fume as Fe) Total particulate ...... 1309–37–1 ...... 10 ...... Iron pentacarbonyl (as Fe) ...... 13463–40–6 ...... 0.1 0.8 0.2 1.6 ...... Iron salts (soluble) (as Fe) ...... Varies with com- ...... 1 ...... pound. Isoamyl acetate ...... 123–92–2 ...... 100 525 ...... Isoamyl alcohol (primary and secondary) ...... 123–51–3 ...... 100 360 125 450 ...... Isobutyl acetate ...... 110–19–0 ...... 150 700 ...... Isobutyl alcohol ...... 78–83–1 ...... 50 150 ...... Isooctyl alcohol ...... 26952–21–6 ...... 50 270 ...... X Isophorone ...... 78–59–1 ...... 4 23 ...... Isophorone diisocyanate ...... 4098–71–9 ...... 0.005 ...... 0.02 ...... X 2-Isopropoxy-ethanol ...... 109–59–1 ...... 25 105 ...... Isopropyl acetate ...... 108–21–4 ...... 250 950 310 1185 ...... Isopropyl alcohol ...... 67–63–0 ...... 400 980 500 1225 ...... Isopropylamine ...... 75–31–0 ...... 5 12 10 24 ...... N-Isopropylaniline ...... 768–52–5 ...... 2 10 ...... X Isopropyl ether ...... 108–20–3 ...... 500 2100 ...... Isopropyl glycidyl ether (IGE) ...... 4016–14–2 ...... 50 240 75 360 ...... Kaolin ...... N/A...... Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Ketene ...... 463–51–4 ...... 0.5 0.9 1.5 3 ...... Lead inorganic (as Pb); see 1910.1025 ...... 7439–92–1. Limestone ...... 1317–65–3. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Lindane ...... 58–89–9 ...... 0.5 ...... X Lithium hydride ...... 7580–67–8 ...... 0.025 ...... L.P.G. (Liquefied petroleum gas) ...... 68476–85–7 ...... 1000 1800 ...... Magnesite ...... 546–93–0. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Magnesium oxide fume, total particulate ...... 1309–48–4. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Malathion ...... 121–75–5. Total dust ...... 10 ...... X Respirable fraction ...... 5 ...... X Maleic anhydride ...... 108–31–6 ...... 0.25 1 ...... Manganese compounds (as Mn) ...... 7439–96–5 ...... 5 ...... Manganese fume (as Mn) ...... 7439–96–5 ...... 1 ...... 3 ...... Manganese cyclopentadienyl tricarbonyl (as Mn) ...... 12079–65–1 ...... 0.1 ...... X Manganese tetroxide (as Mn) ...... 1317–35–7 ...... 1 ...... Marble ...... 1317–65–3. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Mercury (aryl and inorganic) (as Hg) ...... 7439–97–6 ...... 0.1 X Mercury (organo) alkyl compounds (as Hg) ...... 7439–97–6 ...... 0.01 ...... 0.03 ...... X Mercury (vapor) (as Hg) ...... 7439–97–6 ...... 0.05 ...... X Mesityl oxide ...... 141–79–7 ...... 15 60 25 100 ...... Methacrylic acid ...... 79–41–4 ...... 20 70 ...... X Methanethiol; see Methyl mercaptan ...... 74–93–1. Methomyl (Lannate) ...... 16752–77–5 ...... 2.5 ...... Methoxychlor ...... 72–43–5. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... 2-Methoxyethanol; see Methyl cellosolve ...... 109–86–4. 4-Methoxyphenol ...... 150–76–5 ...... 5 ...... Methyl acetate ...... 79–20–9 ...... 200 610 250 760 ...... Methyl acetylene (Propyne) ...... 74–99–7 ...... 1000 1650 ...... Methyl acetylene-propadiene mixture (MAPP) ...... 1000 1800 1250 2250 ...... Methyl acrylate ...... 96–33–3 ...... 10 35 ...... X

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61431

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Methyl-acrylonitrile ...... 126–98–7 ...... 1 3 ...... X Methylal (Dimethoxy-methane) ...... 109–87–5 ...... 1000 3100 ...... Methyl alcohol...... 67–56–1 ...... 200 260 250 325 ...... X Methylamine ...... 74–89–5 ...... 10 12 ...... Methyl amyl alcohol; see Methyl isobutyl carbinol ...... 108–11–2. Methyl n-amyl ketone ...... 110–43–0 ...... 100 465 ...... Methyl bromide ...... 74–83–9 ...... 5 20 ...... X Methyl butyl ketone; see 2-Hexanone ...... 591–78–6. Methyl cellosolve (2-Methoxyethanol) ...... 109–86–4 ...... 25 80 ...... X Methyl cellosolve acetate (2-Methoxyethyl acetate) ...... 110–49–6 ...... 25 120 ...... X Methyl chloride...... 74–87–3 ...... 50 105 100 210 ...... Methyl chloroform (1,1,1-Trichloroethane) ...... 71–55–6 ...... 350 1900 450 2450 ...... Methyl 2-cyanoacrylate ...... 137–05–3 ...... 2 8 4 16 ...... Methyl cyclohexane ...... 108–87–2 ...... 400 1600 ...... Methyl-cyclohexanol ...... 25639–42–3 ...... 50 235 ...... o-Methylcyclo-hexanone ...... 583–60–8 ...... 50 230 75 345 ...... X Methylcyclo-pentadienyl manganese tricarbonyl (as Mn) .. 12108–13–3 ...... 0.2 ...... X Methyl demeton ...... 8022–00–2 ...... 0.5 ...... X 4,4′-Methylene bis(2-chloroaniline) (MBOCA) ...... 101–14–4 ...... 0.02 0.22 ...... X Methylene bis(4-cyclo-hexylisocyanate) ...... 5124–30–1 ...... 0.01 0.11 X Methylene chloride; see 1910.1052 ...... 75–09–2. Methylene-dianiline; see 1910.1050 ...... 101–77–9. Methyl ethyl ketone peroxide (MEKP) ...... 1338–23–4 ...... 0.7 5 ...... Methyl formate ...... 107–31–3 ...... 100 250 150 375 ...... Methyl hydrazine (Monomethyl hydrazine) ...... 60–34–4 ...... 0.2 0.35 X Methyl iodide ...... 74–88–4 ...... 2 10 ...... X Methyl isoamyl ketone ...... 110–12–3 ...... 50 240 ...... Methyl isobutyl carbinol ...... 108–11–2 ...... 25 100 40 165 ...... X Methyl isobutyl ketone; see Hexone ...... 108–10–1. Methyl isocyanate ...... 624–83–9 ...... 0.02 0.05 ...... X Methyl isopropyl ketone ...... 563–80–4 ...... 200 705 ...... Methyl mercaptan ...... 74–93–1 ...... 0.5 1 ...... Methyl methacrylate ...... 80–62–6 ...... 100 410 ...... Methyl parathion ...... 298–00–0 ...... 0.2 ...... X Methyl propyl ketone; see 2-Pentanone ...... 107–87–9. Methyl silicate ...... 681–84–5 ...... 1 6 ...... alpha-Methyl styrene...... 98–83–9 ...... 50 240 100 485 ...... Methylene bisphenyl isocyanate (MDI) ...... 101–68–8 ...... 0.02 0.2 ...... Metribuzin ...... 21087–64–9 ...... 5 ...... Mica; see Silicates ...... N/A. Molybdenum (as Mo) ...... 7439–98–7. Soluble com- ...... 5 ...... pounds. Insoluble com- ...... 10 ...... pounds total dust. Insoluble com- ...... 5 ...... pounds. Respirable fraction Monocrotophos (Azodrin) ...... 6923–22–4 ...... 0.25 ...... Monomethyl aniline ...... 100–61–8 ...... 0.5 2 ...... X Morpholine ...... 110–91–8 ...... 20 70 30 105 ...... X Naphtha (Coal tar) ...... 8030–30–6 ...... 100 400 ...... Naphthalene ...... 91–20–3 ...... 10 50 15 75 ...... alpha-Naphthylamine; see 1910.1004 ...... 134–32–7. beta-Naphthylamine; see 1910.1009 ...... 91–59–8. Nickel carbonyl (as Ni) ...... 13463–39–3 ...... 0.001 0.007 ...... Nickel, metal and insoluble compounds (as Ni) ...... 7440–02–0 ...... 1 ...... Nickel, soluble compounds (as Ni) ...... 7440–02–0 ...... 0.1 ...... Nicotine ...... 54–11–5 ...... 0.5 ...... X Nitric acid ...... 7697–37–2 ...... 2 5 4 10 ...... Nitric oxide ...... 10102–43–9 ...... 25 30 ...... p-Nitroaniline ...... 100–01–6 ...... 3 ...... X Nitrobenzene ...... 98–95–3 ...... 1 5 ...... X p-Nitrochloro-benzene ...... 100–00–5 ...... 1 ...... X 4-Nitrodiphenyl; see 1910.1003 ...... 92–93–3. Nitroethane ...... 79–24–3 ...... 100 310 ...... Nitrogen dioxide ...... 10102–44–0 ...... 1 1.8 ...... Nitrogen trifluoride ...... 7783–54–2 ...... 10 29 ...... Nitroglycerin ...... 55–63–0 ...... 0.11 ...... X Nitromethane ...... 75–52–5 ...... 100 250 ...... 1-Nitropropane ...... 108–03–2 ...... 25 90 ...... 2-Nitropropane ...... 79–46–9 ...... 10 35 ...... N-Nitrosodimethyl-amine; see 1910.1016 ...... 62–75–9. Nitrotoluene ...... o-isomer 88–72–2 2 11 ...... X m-isomer 99–08–1 p-isomer 99–99–0. Nitrotrichloro-methane; see Chloropicrin ...... 76–06–2.

VerDate Sep<11>2014 19:11 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61432 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Nonane ...... 111–84–2 ...... 200 1050 ...... Octachloro-naphthalene ...... 2234–13–1 ...... 0.1 ...... 0.3 ...... X Octane ...... 111–65–9 ...... 300 1450 375 1800 ...... Oil mist, mineral ...... 8012–95–1 ...... 5 ...... Osmium tetroxide (as Os) ...... 20816–12–0 ...... 0.0002 0.002 0.0006 0.006 ...... Oxalic acid ...... 144–62–7 ...... 1 ...... 2 ...... Oxygen difluoride ...... 7783–41–7 ...... 0.05 0.1 ...... Ozone ...... 10028–15–6 ...... 0.1 0.2 0.3 0.6 ...... Paraffin wax fume ...... 8002–74–2 ...... 2 ...... Paraquat, respirable dust ...... 4685–14–7 ...... 0.1 ...... X Parathion ...... 56–38–2 ...... 0.1 ...... X Particulates not otherwise regulated ...... N/A. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Pentaborane ...... 19624–22–7 ...... 0.005 0.01 0.015 0.03 ...... Pentachloro-naphthalene ...... 1321–64–8 ...... 0.5 ...... X Pentachloro-phenol ...... 87–86–5 ...... 0.5 ...... X Pentaerythritol ...... 115–77–5. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Pentane ...... 109–66–0 ...... 600 1800 750 2250 ...... 2-Pentanone (Methyl propyl ketone) ...... 107–87–9 ...... 200 700 250 875 ...... Perchloro-ethylene (Tetrachloro-ethylene) ...... 127–18–4 ...... 25 170 ...... Perchloromethyl mercaptan ...... 594–42–3 ...... 0.1 0.8 ...... Perchloryl fluoride ...... 7616–94–6 ...... 3 14 6 28 ...... Perlite. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Petroleum distillates (Naphtha) ...... 8002–05–9 ...... 400 1600 ...... Phenol ...... 108–95–2 ...... 5 19 ...... X Phenothiazine ...... 92–84–2 ...... 5 ...... X p-Phenylene diamine ...... 106–50–3 ...... 0.1 ...... X Phenyl ether, vapor ...... 101–84–8 ...... 1 7 ...... Phenyl ether-biphenyl mixture, vapor ...... N/A ...... 1 7 ...... Phenylethylene; see Styrene ...... 100–42–5. Phenyl glycidyl ether (PGE) ...... 122–60–1 ...... 1 6 ...... Phenylhydrazine ...... 100–63–0 ...... 5 20 10 45 ...... X Phenyl mercaptan ...... 108–98–5 ...... 0.5 2 ...... Phenylphosphine ...... 638–21–1 ...... 0.05 0.25 ...... Phorate ...... 298–02–2 ...... 0.05 ...... 0.2 ...... X Phosdrin (Mevinphos®) ...... 7786–34–7 ...... 0.01 0.1 0.03 0.3 ...... X Phosgene (Carbonyl chloride) ...... 75–44–5 ...... 0.1 0.4 ...... Phosphine ...... 7803–51–2 ...... 0.3 0.4 1 1 ...... Phosphoric acid ...... 7664–38–2 ...... 1 ...... 3 ...... Phosphorus (yellow) ...... 7723–14–0 ...... 0.1 ...... Phosphorus oxychloride ...... 10025–87–3 ...... 0.1 0.6 ...... Phosphorus pentachloride ...... 10026–13–8 ...... 1 ...... Phosphorus pentasulfide ...... 1314–80–3 ...... 1 ...... 3 ...... Phosphorus trichloride ...... 7719–12–2 ...... 0.2 1.5 0.5 3 ...... Phthalic anhydride ...... 85–44–9 ...... 1 6 ...... m-Phthalodinitrile ...... 626–17–5 ...... 5 ...... Picloram ...... 1918–02–1. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Picric acid ...... 88–89–1 ...... 0.1 ...... X Piperazine dihydrochloride ...... 142–64–3 ...... 5 ...... Pindone (2-Pivalyl- 1,3-indandione) ...... 83–26–1 ...... 0.1 ...... Plaster of Paris ...... 7778–18–9. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Platinum (as Pt) ...... 7440–06–4. Metal ...... 1 ...... Soluble salts ...... 0.002 ...... Portland cement ...... 65997–15–1. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Potassium hydroxide ...... 1310–58–3 ...... 2 ...... Propane ...... 74–98–6 ...... 1000 1800 ...... Propargyl alcohol ...... 107–19–7 ...... 1 2 ...... X beta-Propriolactone; see 1910.1013 ...... 57–57–8. Propionic acid ...... 79–09–4 ...... 10 30 ...... Propoxur (Baygon) ...... 114–26–1 ...... 0.5 ...... n-Propyl acetate ...... 109–60–4 ...... 200 840 250 1050 ...... n-Propyl alcohol ...... 71–23–8 ...... 200 500 250 625 ...... n-Propyl nitrate...... 627–13–4 ...... 25 105 40 170 ...... Propylene dichloride ...... 78–87–5 ...... 75 350 110 510 ...... Propylene glycol dinitrate ...... 6423–43–4 ...... 0.05 0.3 ...... Propylene glycol monomethyl ether ...... 107–98–2 ...... 100 360 150 540 ......

VerDate Sep<11>2014 19:13 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61433

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Propylene imine ...... 75–55–8 ...... 2 5 ...... X Propylene oxide ...... 75–56–9 ...... 20 50 ...... Propyne; see Methyl acetylene ...... 74–99–7. Pyrethrum ...... 8003–34–7 ...... 5 ...... Pyridine ...... 110–86–1 ...... 5 15 ...... Quinone ...... 106–51–4 ...... 0.1 0.4 ...... Resorcinol ...... 108–46–3 ...... 10 45 20 90 ...... Rhodium (as Rh), metal fume and insoluble compounds 7440–16–6 ...... 0.1 ...... Rhodium (as Rh), soluble compounds ...... 7440–16–6 ...... 0.001 ...... Ronnel ...... 299–84–3 ...... 10 ...... Rosin core solder pyrolysis products, as formaldehyde ...... 0.1 ...... Rotenone ...... 83–79–4 ...... 5 ...... Rouge. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Selenium compounds (as Se) ...... 7782–49–2 ...... 0.2 ...... Selenium hexafluoride (as Se) ...... 7783–79–1 ...... 0.05 0.4 ...... Silica, amorphous, precipitated and gel ...... 6 ...... Silica, amorphous, diatomaceous earth, containing less 68855–54–9 ...... 6 ...... than 1% crystalline silica. Silica, crystalline cristobalite respirable dust ...... 14464–46–1 ...... 0.05 ...... Silica, crystalline, quartz, respirable dust ...... 14808–60–7 ...... 0.1 ...... Silica, crystalline tripoli (as quartz), respirable dust ...... 1317–95–9 ...... 0.1 ...... Silica, crystalline tridymite respirable dust ...... 15468–32–3 ...... 0.05 ...... Silica, fused, respirable dust ...... 60676–86–0 ...... 0.1 ......

Silicates (less than 1% crystalline silica)

Mica (respirable dust) ...... 12001–26–2 ...... 3 ...... Soapstone, total dust ...... 6 ...... Soapstone, respirable dust ...... 3 ...... Talc (containing asbestos): Use asbestos limit; see 1910.1001. Talc (containing no asbestos), respirable dust ...... 14807–96–6 ...... 2 ...... Tremolite; asbestiform—see 1910.1001; non- ...... asbestiform—see 57 FR 24310, June 8, 1992. Silicon ...... 7440–21–3. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Silicon carbide ...... 409–21–2. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Silicon tetrahydride ...... 7803–62–5 ...... 5 7 ...... Silver, metal and soluble compounds (as Ag) ...... 7440–22–4 ...... 0.01 ...... Soapstone; see Silicates Sodium azide ...... 26628–22–8. (as HN3) ...... 0.1 ...... X (as NaN3 ) ...... 0.3 X Sodium bisulfite ...... 7631–90–5 ...... 5 ...... Sodium fluoroacetate ...... 62–74–8 ...... 0.05 ...... 0.15 ...... X Sodium hydroxide ...... 1310–73–2 ...... 2 ...... Sodium metabisulfite ...... 7681–57–4 ...... 5 ...... Starch ...... 9005–25–8. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Stibine ...... 7803–52–3 ...... 0.1 0.5 ...... Stoddard solvent ...... 8052–41–3 ...... 100 525 ...... Strychnine ...... 57–24–9 ...... 0.15 ...... Styrene ...... 100–42–5 ...... 50 215 100 425 ...... Subtilisins (Proteolytic enzymes) ...... 1395–21–7 ...... 0. 00006 ...... Sucrose ...... 57–50–1. Total dust ...... 15 ...... Respirable fraction ...... 5 ...... Sulfur dioxide ...... 7446–09–5 ...... 2 5 5 13 ...... Sulfur hexafluoride ...... 2551–62–4 ...... 1000 6000 ...... Sulfuric acid ...... 7664–93–9 ...... 1 ...... Sulfur monochloride ...... 10025–67–9 ...... 1 6 ...... Sulfur pentafluoride ...... 5714–22–7 ...... 0.01 0.1 ...... Sulfur tetrafluoride ...... 7783–60–0 ...... 0.1 0.4 ...... Sulfuryl fluoride ...... 2699–79–8 ...... 5 20 10 40 ...... Sulprofos ...... 35400–43–2 ...... 1 ...... Systox®; see Demeton ...... 8065–48–3. 2,4,5–T ...... 93–76–5 ...... 10 ...... Talc; see Silicates. Tantalum, metal and oxide dust ...... 7440–25–7 ...... 5 ...... TEDP (Sulfotep) ...... 3689–24–5 ...... 0.2 ...... X Tellurium and compounds (as Te) ...... 13494–80–9 ...... 0.1 ...... Tellurium hexafluoride (as Te) ...... 7783–80–4 ...... 0.02 0.2 ......

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61434 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Temephos ...... 3383–96–8. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... TEPP ...... 107–49–3 ...... 0.05 ...... X Terphenyls ...... 26140–60–3 ...... 0.5 5 ...... 1,1,1,2-Tetrachloro-2,2-difluoroethane ...... 76–11–9 ...... 500 4170 ...... 1,1,2,2-Tetrachloro 1,2-difluoroethane ...... 76–12–0 ...... 500 4170 ...... 1,1,2,2-Tetrachloro-ethane ...... 79–34–5 ...... 1 7 ...... X Tetrachoro-ethylene; see Perchloro-ethylene ...... 127–18–4. Tetrachloro-methane; see Carbon tetrachloride ...... 56–23–5. Tetrachloro-naphthalene ...... 1335–88–2 ...... 2 ...... X Tetraethyl lead (as Pb) ...... 78–00–2 ...... 0.075 ...... X Tetrahydrofuran ...... 109–99–9 ...... 200 590 250 735 ...... Tetramethyl lead (as Pb) ...... 75–74–1 ...... 0.075 ...... X Tetramethyl succinonitrile ...... 3333–52–6 ...... 0.5 3 ...... X Tetranitro-methane ...... 509–14–8 ...... 1 8 ...... Tetrasodium pyrophosphate ...... 7722–88–5 ...... 5 ...... Tetryl (2,4,6-Trinitro-phenyl-methyl-nitramine) ...... 479–45–8 ...... 0.1 ...... X Thallium, soluble compounds (as Tl) ...... 7440–28–0 ...... 0.1 ...... X 4,4′-Thiobis (6-tert-Butyl-m-cresol) ...... 96–69–5. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Thioglycolic acid ...... 68–11–1 ...... 1 4 ...... X Thionyl chloride ...... 7719–09–7 ...... 1 5 ...... Thiram ...... 137–26–8 ...... 5 ...... Tin, inorganic compounds (except oxides) (as Sn) ...... 7440–31–5 ...... 2 ...... Tin, organic compounds (as Sn) ...... 7440–31–5 ...... 0.1 ...... X Tin oxide (as Sn) ...... 7440–31–5 ...... 2 ...... Titanium dioxide ...... 13463–67–7. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Toluene ...... 108–88–3 ...... 100 375 150 560 ...... Toluene-2,4-diisocyanate (TDI)...... 584–84–9 ...... 0.005 0.04 0.02 0.15 ...... m-Toluidine ...... 108–44–1 ...... 2 9 ...... X o-Toluidine ...... 95–53–4 ...... 5 22 ...... X p-Toluidine ...... 106–49–0 ...... 2 9 ...... X Toxaphene; see Chlorinated camphene ...... 8001–35–2. Tremolite; see Silicates ...... N/A. Tributyl phosphate ...... 126–73–8 ...... 0.2 2.5 ...... Trichloroacetic acid ...... 76–03–9 ...... 1 7 ...... 1,2,4-Trichloro-benzene ...... 120–82–1 ...... 5 40 ...... 1,1,1-Trichloroethane; see Methyl chloroform ...... 71–55–6. 1,1,2-Trichloroethane ...... 79–00–5 ...... 10 45 ...... X Trichloro-ethylene ...... 79–01–6 ...... 50 270 200 1080 ...... Trichloro-methane; see Chloroform ...... 67–66–3. Trichloro-naphthalene ...... 1321–65–9 ...... 5 ...... X 1,2,3-Trichloropropane ...... 96–18–4 ...... 10 60 ...... 1,1,2-Trichloro-1,2,2-trifluoroethane ...... 76–13–1 ...... 1000 7600 1250 9500 ...... Triethylamine ...... 121–44–8 ...... 10 40 15 60 ...... Trifluorobromo-methane ...... 75–63–8 ...... 1000 6100 ...... Trimellitic anhydride ...... 552–30–7 ...... 0.005 0.04 ...... Trimethylamine ...... 75–50–3 ...... 10 24 15 36 ...... Trimethyl benzene ...... 25551–13–7 ...... 25 125 ...... Trimethyl phosphite ...... 121–45–9 ...... 2 10 ...... 2,4,6-Trinitrophenyl; see Picric acid ...... 88–89–1. 2,4,6-Trinitrophenylmethyl nitramine; see Tetryl ...... 479–45–8. 2,4,6-Trinitrotoluene (TNT) ...... 118–96–1 ...... 0.5 ...... X Triorthocresyl phosphate ...... 78–30–8 ...... 0.1 ...... X Triphenyl amine ...... 603–34–9 ...... 5 ...... Triphenyl phosphate ...... 115–86–6 ...... 3 ...... Tungsten (as W) ...... 7440–33–7. Insoluble com- ...... 5 ...... 10 ...... pounds. Soluble com- ...... 1 ...... 3 ...... pounds. Turpentine ...... 8006–64–2 ...... 100 560 ...... Uranium (as U) ...... 7440–61–1. Soluble com- ...... 0.05 ...... pounds. Insoluble com- ...... 0.2 ...... 0.6 ...... pounds. n-Valeraldehyde ...... 110–62–3 ...... 50 175 ...... Vanadium ...... 1314–62–1. Respirable Dust as ...... 0.05 ...... V205. Fume (as V205) ...... 0.05 ...... Vegetable Oil Mist ...... N/A. Total dust ...... 15 ......

VerDate Sep<11>2014 19:11 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61435

TABLE Z–1–A—LIMITS FOR AIR CONTAMINANTS—Continued [From the vacated 1989 final rule—Ex. #149]

TWA STEL Ceiling Skin Substance Cas No. Designa- ppm mg/m3 ppm mg/m3 ppm mg/m3 tion

Respirable fraction ...... 5 ...... Vinyl acetate ...... 108–05–4 ...... 10 30 20 60 ...... Vinyl benzene; see Styrene ...... 100–42–5. Vinyl bromide ...... 593–60–2 ...... 5 20 ...... Vinyl chloride; see 1910.1017 ...... 75–01–4. Vinyl cyanide; see Acrylonitrile ...... 107–13–1. Vinyl cyclohexene dioxide ...... 106–87–6 ...... 10 60 ...... X Vinylidene chloride (1,1-Dichloro-ethylene) ...... 75–35–4 ...... 1 4 ...... Vinyl toluene ...... 25013–15–4 ...... 100 480 ...... VM & P Naphtha ...... 8032–32–4 ...... 300 1350 400 1800 ...... Warfarin ...... 81–81–2 ...... 0.1 ...... Welding fumes (total particulate)* ...... N/A ...... 5 ...... Wood dust, all soft and hard woods, except Western red N/A ...... 5 ...... 10 ...... cedar. Wood dust, western red cedar ...... N/A ...... 2.5 ...... Xylenes (o-, m-, p-isomers) ...... 1330–20–7 ...... 100 435 150 655 ...... m-Xylene alpha, alpha’ diamine ...... 1477–55–0 ...... 0.1 X Xylidine ...... 1300–73–8 ...... 2 10 ...... X Yttrium ...... 7440–65–5 ...... 1 ...... Zinc chloride fume ...... 7646–85–7 ...... 1 ...... 2 ...... Zinc chromate (as CrO3); see 910.1026. See Table Z–2 Varies with com- for the exposure limit for any operations or sectors pound. where the exposure limit in 1910.1026 is stayed or are otherwise not in effect. Zinc oxide fume ...... 1314–13–2 ...... 5 ...... 10 ...... Zinc oxide ...... 1314–13–2. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Zinc stearate ...... 557–05–1. Total dust ...... 10 ...... Respirable fraction ...... 5 ...... Zirconium compounds (as Zr) ...... 7440–67–7 ...... 5 ...... 10 ...... 1(30 minutes).

References by Exhibit Number Ex. #13: Color Pigments Manufacturers Ex. #25: National Research Council. (2007). Assoc. v. OSHA, 16 F.3d 1157, 1162–63 Toxicity testing in the 21st century: a Ex. #1: U.S. Environmental Protection (11th Cir. 1994). vision and a strategy. Retrieved from: Agency. (2013a). 2012 Chemical Data Ex. #14: Public Citizen Health Research http://www.nap.edu/catalog.php?record_ Reporting Results. Retrieved from: http:// Group v. United States Department of id=11970. _ epa.gov/cdr/pubs/guidance/cdr Labor, 557 F.3d 165 (3d Cir. 2009). Ex. #26: Occupational Exposure to factsheets.html. Ex. #15: American Textile v. Donovan, 452 Hexavalent Chromium, 71 FR 10099 Ex. #2: Hogue, C. (2007). Point/Counterpoint: U.S. 490 (1981) (‘‘Cotton Dust’’). (Feb. 28, 2006). The Future of U.S. Chemical Regulation. Ex. #16: Universal Camera Corp. v. NLRB, Ex. #27: Occupational Exposure to Methylene Chemical and Engineering News, 85(2), 340 U.S. 474 (1951). Chloride, 62 FR 1494 (Jan. 10, 1997). 34–38. Ex. #17: Senate Report (Labor and Pubic Ex. #28: National Research Council. (1983). Ex. #3: European Chemicals Agency. (2013). Welfare Committee) S. REP. 91–1282 Risk assessment in the federal Registered Substances. Retrieved from: (1970). government: managing the process. http://echa.europa.eu/information-on- Ex. #18: Air Contaminants Proposed Rule, 53 Retrieved from: http://www.nap.edu/ FR 20960 (Jun. 7, 1988). chemicals/registered-substances. openbook.php?isbn=0309033497. Ex. #19: Air Contaminants Final Rule, 58 FR Ex. #4: Air Contaminants, Tables Z–1, Z–2, Ex. #29: Hill, A.B. (1965). The environment 35338 (Jun. 30, 1993). and Z–3, 29 CFR 1910.1000 (2012). and disease: association or causation? Ex. #5: Air Contaminants, 29 CFR 1915.1000 Ex. #20: Unified Agenda, The Regulatory Plan, DOL–OSHA, Permissible Exposure Proceedings of the Royal Society of (2012). Limits (PELS) for Air Contaminants, 60 Medicine, 58(5), 295–300. Ex. #6: Gases, vapors, fumes, dusts, and FR 59628 (Nov. 28, 1995). Ex. #30: Rothman, K.J., Greenland, S. Modern mists, 29 CFR 1926.55 (2012). Ex. #21: Notice of Public Meeting on Epidemiology. Philadelphia, Pa.: Ex. #7: Air Contaminants, 54 FR 2332 (Jan. Updating Permissible Exposure Limits Lippincott, 1998. 19, 1989). (PELs) for Air Contaminants, 61 FR 1947 Ex. #31: Environmental Protection Agency— Ex. #8: AFL–CIO v. OSHA, 965 F.2d 962 (Jan. 24, 1996). Integrated Risk Information System (11th Cir. 1992) (‘‘Air Contaminants’’). Ex. #22: Unified Agenda, The Regulatory (1994) Methods for derivation of Ex. #9: Occupational Safety and Health Act Plan, DOL–OSHA, Permissible Exposure inhalation reference concentrations and of 1970, 29 U.S.C. 651, 652(8), 655(a), Limits (PELS) for Air Contaminants, 66 applications of inhalation dosimetry. 655(b)(5), 655(f) (2006). FR 61882 (Dec. 3, 2001). Washington, DC (EPA/600/8–90/066f). Ex. #10: Industrial Union Dept., AFL–CIO v. Ex. #23: National Research Council. (2012). Ex. #32: U.S. Environmental Protection American Petroleum Institute, 448 U.S. Exposure science in the 21st century: a Agency. (2005). Guidelines for 607 (1980) (‘‘Benzene’’). vision and a strategy. Retrieved from: carcinogen risk assessment (EPA/630/P– Ex. #11: Occupational Exposure to http://nap.edu/catalog.php?record_ 03/001F). Formaldehyde Final Rule, 52 FR 46168 id=13507. Ex. #33: European Chemicals Bureau (ECB). (December 4, 1987). Ex. #24: National Research Council. (2009). (2003). Technical guidance on risk Ex. #12: United Steelworkers v. Marshall, 647 Science and decisions: advancing risk assessment. Retrieved from: http:// F.2d 1189 at 1264 (D.C. Cir. 1980) (‘‘Lead assessment. Retrieved from: http://www. publications.jrc.ec.europa.eu/repository/ I’’). nap.edu/catalog.php?record_id=12209. handle/111111111/5619?mode=full.

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61436 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

Ex. #34: Presidential/Congressional Ex. #46: Yuan, L., Smith, A.C., and Brune, Ex. #64: Russom, C.L., Breton, R.L., Walker, Commission on Risk Assessment and J.F. (2006). Computational Fluid J.D., & Bradbury, S.P. (2003). An Risk Management (PCRARM). (1997). Dynamics Study on the Ventilation Flow overview of the use of quantitative Risk assessment and risk management in Paths in Longwall Gobs. Proceedings of structure-activity relationships for regulatory decision-making. Retrieved the 11th U.S./North American Mine ranking and prioritizing large chemical from: http://cfpub.epa.gov/ncea/cfm/ Ventilation Symposium, University Park, inventories for environmental risk pcrarm.cfm. Pennsylvania. assessments. Environmental Toxicology Ex. #35: U.S. Environmental Protection Ex. #47: Edwards, J.C. and Hwang, C.C. and Chemistry, 22(8), 1810–1821. Agency. (2002). A review of the reference (2006). CFD Modeling of Fire Spread Ex. #65: U.S. Government Accountability dose and reference concentration Along Combustibles in a Mine Entry. Office (GAO). (2007). Chemical processes (EPA/630/P–02–002F). Retrieved from: http://www.cdc.gov/ regulation: comparison of U.S. and Ex. #36: International Programme on niosh/mining/UserFiles/works/pdfs/ recently enacted European Union Chemical Safety (IPCS). (2005). cmofs.pdf. approaches to protect against the risks of Chemical-specific adjustment factors for Ex. #48: Trevits, M.A., Yuan, L., Thibou, M., toxic chemicals (GAO–07–825). interspecies differences and human Hatch, G. (2010). Use of CFD Modeling Ex. #66: Zeeman, M. (1995). EPA’s variability: guidance document for use of to Study Inert Gas Injection into a Sealed framework for ecological effects data in dose/concentration-response Mine Area. SME Annual Meeting, assessment. In Office of Technology assessment. Retrieved from: http://www. Phoenix, Arizona. Assessment, Screening and Testing inchem.org/documents/harmproj/ Ex. #49: U.S. Environmental Protection Chemicals in Commerce (pp. 169–178) harmproj/harmproj2.pdf. Agency and U.S. Department of Energy. (OTA–BP–ENV–166). Ex. #37: European Chemicals Agency (2008). Laboratories for the 21st Century: Ex. #67: U.S. Environmental Protection (ECHA). (2012a). Guidance on Best Practice Guide. Agency. (2012b). Ecological Structure information requirements and chemical Ex. #50: National Institute of Standards and Activity Relationships (ECOSAR). safety assessment, chapter R.8: Technology (NIST). (1997). Use of Retrieved from: http://www.epa.gov/ characterization of dose [concentration]- Computational Fluid Dynamics to oppt/newchems/tools/21ecosar.htm. response for human health. Retrieved Analyze Indoor Air Quality Issues Ex. #68: European Chemicals Agency from: http://echa.europa.eu/documents/ (NISTIR 5997). (ECHA). Guidance on information 10162/13632/information_requirements_ Ex. #51: National Institute of Standards and requirements and chemical safety r8_en.pdf. Technology (NIST). (2009). NIST assessment. Chapter R.6: QSARS and Ex. #38: U.S. Environmental Protection Technical Note 1637: Modeling the grouping of chemicals. May 2008 Agency. (2011). Guidance for applying Effects of Outdoor Gasoline Powered Ex. #69: OSPAR Commission. (2000). quantitative data to develop data-derived Generator Use on Indoor Carbon Briefing document of the work of extrapolation factors for interspecies and Monoxide Exposures. DYNAMEC and the DYNAMEC intraspecies extrapolation (EPA/100/J– Ex. #53: American Dental Ass’n v. Martin, Mechanism for the selection and 11/001). Retrieved from: http://www.epa. 984 F.2d 823 (7th Cir. 1993). prioritization of hazardous substances. gov/raf/files/ddef-external-review-draft Ex. #54: Assoc. Bldrs & Contrs. Inc. v. Brock, Retrieved from: http://www.ospar.org/ 05-11-11.pdf. 862 F.2d 63 (3d Cir. 1988). documents/dbase/publications/p00104/ Ex. #39: Organization for Economic Co- Ex. #55: Industrial Union Dep’t, AFL–CIO v. p00104_briefing%20doc%20on%20 operation and Development (OECD). Hodgson, 499 F.2d 467 (D.C. Cir. 1974). dynamec.pdf. (2007). Guidance on grouping of Ex. #56: U.S. Environmental Protection Ex. #70: Regulation of the European chemicals. (ENV/JM/MONO (2007) 28). Agency. (2012a). High Production Parliament and of the Council Retrieved from: http://search.oecd.org/ Volume Information System (HPVIS). Concerning the Registration, Evaluation, officialdocuments/displaydocumentpdf/ Retrieved from: http://www.epa.gov/ Authorisation and Restriction of ?doclanguage=en&cote=env/jm/mono chemrtk/hpvis/index.html. Chemicals (REACH), EC No. 1907/2006 %282007%2928. Ex. #57: U.S. Environmental Protection (2006). Ex. #40: National Toxicology Program (NTP). Agency. (2013c). TSCA Interagency Ex. #71: European Chemicals Agency (2013). High Throughput Screening Testing Committee (ITC). Retrieved from: (ECHA). (2012b). Information Initiative. Retrieved from: http://ntp. http://www.epa.gov/oppt/itc/index.htm. Requirements. Retrieved from: http:// niehs.nih.gov/go/28213. Ex. #58: Organization for Economic echa.europa.eu/web/guest/regulations/ Ex. #41: U.S. Environmental Protection Cooperation and Development (OECD). reach/substance-registration/ Agency. (2013b). NexGen: Advancing the (2013). eChemPortal. Retrieved from: information-requirements. Next Generation of Risk Assessment. http://www.echemportal.org/ Ex. #72: European Chemicals Agency Retrieved from: http://www.epa.gov/risk/ echemportal/index?pageID=0&request_ (ECHA). (2012c). Information on nexgen. locale=en. Chemicals. Retrieved from: http:// Ex. #42: Patankar, S.V., Numerical Heat Ex. #59: U.S. Environmental Protection echa.europa.eu/web/guest/information- Transfer and Fluid Flow. New York: Agency. (2014a). Computational on-chemicals. McGraw-Hill, 1980. Toxicology Research. Retrieved from: Ex. #73: European Chemicals Agency Ex. #43: National Institute for Occupational http://www.epa.gov/ncct/toxcast/. (ECHA). (2009). Guidance in a nutshell: Safety and Health. (2011a). Experimental Ex. #60: U.S. Environmental Protection Chemical Safety Assessment. and Numerical Research on the Agency. (2014). ToxCastTM Advancing Ex. #74: European Chemicals Agency Performance of Exposure Control the next generation of chemical safety (ECHA). (2012d). Evaluation. Retrieved Measures for Aircraft Painting evaluation. Retrieved from: http:// from: http://echa.europa.eu/regulations/ Operations, Part I (EPHB Report No. www.epa.gov/ncct/. reach/evaluation. 329–12a). Ex. #61: REACH Fact Sheet: Safety Data Ex. #75: Kriebel, D., Jacobs, M. M., Ex. #44: National Institute for Occupational Sheets and Exposure Scenarios. Markkanen, P., & Tickner, J. (2011). Safety and Health. (2010). Workplace European Chemicals Agency (ECHA). Lessons learned: Solutions for workplace Safety & Health Topics: Aerosols. (2011). REACH Fact Sheet: Safety Data safety and health. Lowell, MA: Lowell Retrieved from: http://www.cdc.gov/ Sheets and Exposure Scenarios. ECHA– Center for Sustainable Production. niosh/topics/aerosols/internal_ 11–FS–02.1–EN. Retrieved from: http:// research.html. Ex. #62: Toxic Substances Control Act, 15 www.sustainableproduction.org/ Ex. #45: National Institute for Occupational U.S.C. 2601–2629 (2011). downloads/LessonsLearned- Safety and Health. (2011b). NORA Ex. #63: U.S. Environmental Protection FullReport.pdf. Manufacturing Sector Strategic Goals. Agency. (2013d). HPV Chemical Hazard Ex. #76: Wilson, M.P., Hammond, S.K., Retrieved from: http://www.cdc.gov/ Characterizations. Retrieved from: http:// Nicas, M., & Hubbard, A.E. (2007). niosh/programs/manuf/noragoals/ iaspub.epa.gov/oppthpv/hpv_hc_ Worker exposure to volatile organic projects/921Z6KR.html. characterization.get_report?doctype=2. compounds in the vehicle repair

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00054 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules 61437

industry. Journal of Occupational and Ex. #89: U.S. Environmental Protection Management Systems, ANSI/AIHA Z10– Environmental Hygiene, 4, 301–310. Agency. (2011a). DfE’s standard and 2005 (2005). Ex. #77: Massachusetts Department of criteria for safer chemical ingredients. Ex. #109: Council Directive on the Protection Environmental Protection. (n.d.). Toxics Retrieved from: http://www.epa.gov/dfe/ of the Health and Safety of Workers from Use Reduction Act. Retrieved from: pubs/projects/gfcp/index.htm#. the Risks Related to Chemical Agents at http://www.mass.gov/dep/toxics/ Ex. #90: Institut fu¨ r Arbeitsschutz der Work, 98/24/EC (1998). toxicsus.htm. Deutschen Gesetzlichen Ex. #110: Directive of the European Ex. #78: Toxics Use Reduction Institute. Unfallversicherung (IFA). (2011). The Parliament and of the Council on the (2011a). About TUR plans and planning. GHS Column Model: An aid to substitute Protection of Workers from the Risks Retrieved from: http://www.turi.org/Our_ assessment. Berlin, Germany: Deutsche Related to Exposure to Carcinogens or Work/Training/TUR_Planner_Program/ Gesetzliche Unfallversicheung e.V. Mutagens at Work, 2004/37/EC (2004). About_TUR_Plans_and_Planning. (DGUV). Ex. #111: Safe Alternatives Policy, 42 U.S.C. Ex. #79: Toxics Use Reduction Institute. Ex. #91: Netherlands Ministry of 7671K (2011). (2011b). Trichloroethylene and Infrastructure and the Environment. Ex. #113: European Commission. (2012). chlorinated solvents reduction. Retrieved (2002). Implementation strategy on Minimising chemical risk to workers’ from: http://www.turi.org/Our_Work/ management of substances: 2nd progress health and safety through substitution. Green_Cleaning_Lab/How_We_Can_ report. Retrieved from: http:// Retrieved from: https://osha.europa.eu/ Help/Cleaning_Research_Projects/ www.subsport.eu/images/stories/pdf_ en/news/eu-minimising-chemical-risk-to- Trichloroethylene-and-Chlorinated- archive/substitution_tools/15_quick_ workers-health-and-safety-through- Solvents-Reduction. scan_en.pdf. substitution. Ex. #80: Toxics Use Reduction Institute. Ex. #92: Identification, Classification, and Ex. #114: German Federal Institute for (2011c). CleanerSolutions database. Regulation of Potential Occupational Occupational Safety and Health (BAuA), Retrieved from: http://www.turi.org/Our_ Carcinogens, 45 FR 5258 (Jan. 22, 1980). Hazardous Substances Ordinance Work/Green_Cleaning_Lab/Does_It_ Ex. #93: OSHA Cancer Policy, 29 CFR (Gefahrstoffverordnung—GefStoffV) (July Clean/CleanerSolutions_Database. 1990.111(k) (2011). 28, 2011). Ex. #81: Toxics Use Reduction Institute. Ex. #94: OSHA Cancer Policy, 29 CFR Ex. #115: German Federal Institute for (2011d). TCE facts: Use nationally and in 1990.132(b)(6) (2011). Occupational Safety and Health (BAuA), Massachusetts. Retrieved from: http:// Ex. #95: OSHA Cancer Policy, 29 CFR Technical Rule on Hazardous Substances www.turi.org/About/Library/TURI- 1990.146(k) (2011). (TRGS) 600 (Aug. 2008). Publications/Massachusetts_Chemical_ Ex. #96: Respiratory Protection, 29 CFR Ex. #116: German Environment Agency Fact_Sheets/Trichloroethylene_TCE_ 1910.134(a) (2011). (Umweltbundesamt). (2011). Guide on Fact_Sheet/TCE_Facts/Use_Nationally_ Ex. #97: Air Contaminants, 29 CFR sustainable chemicals: A decision tool and_in_Massachusetts. 1910.1000(e) (2011). for substance manufacturers, Ex. #82: Roelofs, C.R., Barbeau, E.M., Ex. #98: Occupational Exposure to Methylene formulators, and end users of chemicals. Ellenbecker, M.J., & Moure-Eraso, R. Chloride, 62 FR 1494 (Jan. 10, 1997). Retrieved from: http:// (2003). Prevention strategies in industrial Ex. #99: Occupational Exposure to www.umweltdaten.de/publikationen/ hygiene: A critical literature review. Hexavalent Chromium, 71 FR 10099 fpdf-l/4169.pdf. AIHA Journal, 64(1), 62–67. (Feb. 28, 2006). Ex. #117: GreenBlue. (2012). CleanGredients. Ex. #83: American Industrial Hygiene Ex. #100: Occupational Safety and Health Retrieved from: http:// Association. (2008). Demonstrating the Administration. (1996). Final economic www.cleangredients.org/home. business value of industrial hygiene: and regulatory flexibility analysis for Ex. #118: Institute of Work, Environment, Methods and findings from the value of OSHA’s standard for occupational and Health (ISTAS). (2012). RISCTOX. the industrial hygiene profession study. exposure to methylene chloride. Retrieved from: http://www.istas.net/ Retrieved from: http://www.aiha.org/ Ex. #101: Occupational Safety and Health risctox/en/. votp_new/pdf/votp_report.pdf. Administration. (2006a). Final economic Ex. #119: SUBSPORT. (2012). Substitution Ex. #84: Lavoie, E.T., Heine, L.G., Holder, H., and regulatory flexibility analysis for Support Portal. Retrieved from: http:// Rossi, M.S., Lee II, R.E., Connor, E.A., OSHA’s final standard for occupational www.subsport.eu/about-the-project. . . . Davies, C.L. (2010). Chemical exposure to hexavalent chromium. Ex. #120: U.S. Environmental Protection alternatives assessment: Enabling Ex. #102: Occupational Safety and Health Agency. (2012c). Alternatives substitution to safer chemicals. Administration. (1987). Regulatory assessments. Retrieved from: http:// Environmental Science & Technology, impact and regulatory flexibility analysis www.epa.gov/dfe/alternative_ 44(24), 9244–9249. of the formaldehyde standard. assessments.html. Ex. #85: Toxics Use Reduction Institute. Ex. #103: Occupational Safety and Health Ex. #121: U.S. Environmental Protection (2006). Five chemicals alternatives Administration. (1984). Regulatory Agency. (2011b). The U.S. assessment study. Retrieved from: impact and regulatory flexibility analysis Environmental Protection Agency’s http://www.turi.org/About/Library/TURI- of the final standard for ethylene oxide. strategic plan for evaluating the toxicity Publications/2006_Five_Chemicals_ Ex. #104: Occupational Safety and Health of chemicals. Retrieved from: http:// Alternatives_Assessment_Study. Administration. (2005). Regulatory www.epa.gov/spc/toxicitytesting/. Ex. #86: Rossi, M., Tickner, J., & Geiser, K. Review of the Occupational Safety and Ex. #122: U.S. Environmental Protection (2006). Alternatives assessment Health Administration’s Ethylene Oxide Agency. (2012d). Overview of National framework of the Lowell Center for Standard [29 CFR 1910.1047]. Research Council toxicity testing Sustainable Production. Lowell, MA: Ex. #105: Occupational Safety and Health strategy. Retrieved from: http:// Lowell Center for Sustainable Administration. (2010). Regulatory www.epa.gov/pesticides/science/nrc- Production. Retrieved from: http:// Review of 29 CFR 1910.1052: Methylene toxtesting.html. www.chemicalspolicy.org/downloads/ chloride. Ex. #123: Washington Department of Ecology. FinalAltsAssess06.pdf. Ex. #106: Occupational Safety and Health (2012). Ecology Quick Chemical Ex. #87: Raphael, D.O. & Geiger, C.A. (2011). Administration. (2006b). Best practices Assessment Tool 1.2 Methodology. Precautionary policies in local for the safe use of glutaraldehyde in Retrieved from: http://www.ecy.wa.gov/ government: Green chemistry and safer health care (OSHA 3254–08N 2006). programs/hwtr/ChemAlternatives/ alternatives. New Solutions, 21(3), 345– Ex. #107: Occupational Safety and Health documents/QCAT2012-03-20final.pdf. 358. Administration. (2013a). Transitioning to Ex. #124: Hazard Communication, 29 CFR Ex. #88: Clean Production Action. (2012). safer chemicals: a toolkit for employers 1910.1200 (2012). GreenScreen for Safer Chemicals v1.2. and workers. Retrieved from: http:// Ex. #125: Hazard Communication, 77 FR Retrieved from: http:// www.osha.gov/dsg/safer_chemicals/. 17574 (Mar. 26, 2012). www.cleanproduction.org/ Ex. #108: American National Standard for Ex. #126: National Safety Council, Greenscreen.v1-2.php. Occupational Health and Safety Fundamentals of Industrial Hygiene

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 61438 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Proposed Rules

(2012) ed. Plog, B.A. and Quinlan, P. J. Comparison with Measurement-based Ex. #141: Safety and Health Regulations for Chapter 31, International Developments Comprehensive Risk Assessment. Longshoring. 29 CFR 1918 (2012). in Occupational Safety and Health, Silk, Journal of Occupational Health, 49, 482– Ex. #142: National Consensus Standards and J. and Brigandi, P. 492. Established Federal Standards, 36 FR Ex. #127: Taylor-McKernan, L. and Seaton M. Ex. #134: Lee, E.G., Slaven, J., Bowen, R.B., 10466 (May 29, 1971). (2014) The Banding Marches On, NIOSH Harper, M. (2011). Evaluation of the Ex. #143: Longshore and Harbor Workers’ Proposes a New Process for Occupational COSHH Essentials Model with a Mixture Compensation, 33 U.S.C. 901–950 Exposure Banding. The Synergist, May, of Organic Chemicals at a Medium-Sized (2006). p. 44–46. Paint Producer. Annals of Occupational Ex. #144: Occupational Safety and Health Ex. #128: Laszcz-Davis, C., Maier, A., Hygiene, 55(1), 16–29. Standards for Shipyard Employment, 29 Perkins, J. (2014) The Hierarchy of OELs, Ex. #135: National Institute for Occupational CFR 1915.11, 1915.12, 1915.32, 1915.33 A New Organizing Principle for Safety and Health (NIOSH). (2009). (2012). Occupational Risk Assessment, The Qualitative risk characterization and Synergist, March, p. 27–30. management of occupational hazards: Ex. #145: Federal Advisory Committee on Ex. #129: Health and Safety Executive. control banding (CB), a literature review Occupational Safety and Health (2013). COSHH Essentials. Retrieved and critical analysis (DHHS (NIOSH) (FACOSH). (2012). Recommendations for from: http://www.hse.gov.uk/coshh/ Publication No. 2009–152). Consideration by the U.S. Secretary of essentials/. Ex. #136: Occupational Safety and Health Labor on the Adoption and Use of Ex. #130: Control of Substances Hazardous to Administration. (2009). Controlling silica Occupational Exposure Limits by Health Regulations, 2002 No. 2677 exposures in construction (OSHA 3362– Federal Agencies. (2002). 05 2009). Ex. #146: Air Contaminants Proposed Rule, Ex. #131: Health and Safety Executive. Ex. #137: Occupational Safety and Health 57 FR 26002 (Jun. 12, 1992). (2009). The technical basis for COSHH Administration. (2013b). Notice of Ex. #147: American Iron and Steel Institute essentials: easy steps to control proposed rulemaking for occupational (AISI). (1990). On Petition for Review of chemicals. Retrieved from: http://coshh- exposure to respirable crystalline silica. Final Rule of Occupational Safety and essentials.org.uk/assets/live/CETB.pdf. Ex. 138: Susi, et. al. (2000). The use of a task- Health Administration: Industry Ex. #132: Jones, R.M., Nicas, M., (2006) based exposure assessment model (T– Petitioners’ Joint Procedural Brief. Evaluation of COSHH Essentials for BEAM) for assessment of metal fume Ex. #148: Forging Indus. Ass’n v. Secretary of vapor degreasing and bag filling exposures during welding and thermal Labor, 773 F.2d 1436, 1453 (4th Cir. operations. Annals of Occupational cutting. Applied Occupational and 1985). Hygiene, 50(2), 137–147. Environmental Hygiene, 15(1): 26–38. Ex. #149: 1989 PELs Table. 54 FR 2332, Ex. #133: Hashimoto, H., Toshiaki, G., Ex. #139: Burg, F. (2012). Standards insider. 2923–2959. Nakachi, N., Suzuki, H., Takebayashi, T., Professional Safety, 57(3), 24–25. Kajiki, S., Mori, K. (2007) Evaluation of Ex. #140: Marine Terminals, 29 CFR 1917.2, [FR Doc. 2014–24009 Filed 10–9–14; 8:45 am] the Control Banding Method— 1917.22, 1917.23, 1917.25 (2012). BILLING CODE 4510–26–P

VerDate Sep<11>2014 17:41 Oct 09, 2014 Jkt 235001 PO 00000 Frm 00056 Fmt 4701 Sfmt 9990 E:\FR\FM\10OCP2.SGM 10OCP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2