Pages 6647±6944 Vol. 60 2±3±95 No. 23 federal register February 3,1995 Friday issue. Dallas, TX,seeannouncementontheinsidecoverofthis For informationonbriefingsinWashington,DC,and Briefings onHowToUsetheFederalRegister 1 II Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995
SUBSCRIPTIONS AND COPIES
PUBLIC Subscriptions: Paper or fiche 202–512–1800 FEDERAL REGISTER Published daily, Monday through Friday, Assistance with public subscriptions 512–1806 (not published on Saturdays, Sundays, or on official holidays), by Online: the Office of the Federal Register, National Archives and Records Telnet swais.access.gpo.gov, login as newuser 2 III Contents Federal Register Vol. 60, No. 23 Friday, February 3, 1995 Agriculture Department PROPOSED RULES See Food and Consumer Service Postsecondary education: See Food Safety and Inspection Service Student assistance general provisions— See Forest Service Men’s and women’s intercollegiate athletic programs; Equity in Athletics Disclosure Act implementation, Antitrust Division 6940–6944 NOTICES NOTICES Competitive impact statements and proposed consent Agency information collection activities under OMB judgments: review, 6703–6705 New England Fish Exchange et al., 6733–6734 Grants and cooperative agreements; availability, etc.: Postsecondary education— Army Department Federal work-study programs, 6705–6706 Special education and rehabilitative services: NOTICES Blind vending facilities under Randolph-Sheppard Act— Meetings: Arbitration panel decisions, 6706–6707 Armament Retooling and Manufacturing Support Public/ Private Task Force, 6703 Employment and Training Administration NOTICES Blind or Severely Disabled, Committee for Purchase From Adjustment assistance: People Who Are AEG Transportation Systems, Inc., 6734 See Committee for Purchase From People Who Are Blind or Exxon Co., U.S.A., 6734–6735 Severely Disabled M.C.M. Coats Inc., 6735 Marathon Oil Co., 6735 Coast Guard Miles Chemical Laboratories, 6735 RULES Uarco, Inc., et al., 6735–6736 Drawbridge operations: Unocal, 6736–6737 Florida, 6658–6660 PROPOSED RULES Employment Standards Administration Commercial vessels, U.S. Flag; alternate compliance for See Wage and Hour Division inspection and certification, 6687–6689 NOTICES Minimum wages for Federal and federally-assisted Commerce Department construction; general wage determination decisions, See Export Administration Bureau 6737 See International Trade Administration See Minority Business Development Agency Energy Department See National Institute of Standards and Technology See Federal Energy Regulatory Commission See National Oceanic and Atmospheric Administration NOTICES Atomic energy agreements; subsequent arrangements, 6709– Committee for Purchase From People Who Are Blind or 6710 Severely Disabled Environmental Protection Agency NOTICES RULES Procurement list; additions and deletions, 6701–6702 Hazardous waste: Chicago, IL, waste-to-energy facilities; Resource Commodity Futures Trading Commission Conservation and Recovery Act Subtitle C NOTICES jurisdiction for municipal waste combustion ash, Contract market proposals: 6666–6670 Chicago Mercantile Exchange— PROPOSED RULES Mexican peso futures, 6703 Air quality implementation plans; approval and Meetings; Sunshine Act, 6770 promulgation; various States: Illinois, 6687 Consumer Product Safety Commission NOTICES NOTICES Environmental statements; availability, etc.: Meetings; Sunshine Act, 6770 Agency statements— Comment availability, 6710 Defense Department Weekly receipts, 6710 See Army Department Federal agency environmental justice strategies; availability, 6710–6711 Education Department RULES Export Administration Bureau Institutions of higher education, hospitals, and other non- NOTICES profit organizations and direct grant programs; Export privileges, actions affecting: reporting and recordkeeping requirements, 6660 Teledyne Industries, Inc., 6696–6697 IV Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Contents Federal Aviation Administration Fish and Wildlife Service RULES RULES Airworthiness directives: Endangered and threatened species: Beech, 6652–6654 Tiburon paintbrush, etc. (12 plants from California), Pratt & Whitney, 6654–6657 6671–6685 Class E airspace, 6657 PROPOSED RULES Food and Consumer Service Class E airspace, 6686–6687 NOTICES NOTICES Food distribution programs: Airport rates and charges; policy statement, 6906–6918 Nutrition program for elderly; assistance level, 6691–6692 Federal Communications Commission Food and Drug Administration RULES PROPOSED RULES Radio stations; table of assignments: Human drugs: Alabama et al., 6670–6671 Vaginal contraceptive products (OTC), 6892–6903 PROPOSED RULES NOTICES Radio stations; table of assignments: GRAS or prior-sanctioned ingredients: American Samoa, 6689 American Dairy Products Institute, 6713 Washington, 6689–6690 Human drugs: NOTICES New drug applications— Agency information collection activities under OMB Vaginal contraceptive products (OTC); guidance review, 6711–6712 document for manufacturers; availability, 6713– Meetings; Sunshine Act, 6770–6771 6714 Public safety radio communications plans: New York Metropolitan Area, 6712 Food Safety and Inspection Service PROPOSED RULES Federal Deposit Insurance Corporation Meat and poultry inspection: Pathogen reduction; hazard analysis and critical control NOTICES point (HACCP) systems, 6774–6889 Meetings; Sunshine Act, 6771 Forest Service Federal Emergency Management Agency NOTICES NOTICES Environmental statements; availability, etc.: Hotel and Motel Fire Safety Act; national master list, 6932– Kootenai National Forest, MT, 6692–6695 6937 Tahoe National Forest, CA, 6695–6696 Federal Energy Regulatory Commission Health and Human Services Department RULES See Food and Drug Administration Natural gas companies (Natural Gas Act): See Health Care Financing Administration Project cost limits under blanket certificates, 6657–6658 See Health Resources and Services Administration NOTICES See National Institutes of Health Environmental statements; availability, etc.: See Public Health Service Grand River Dam Authority, 6707 See Substance Abuse and Mental Health Services Public Utility District No. 2 of Grant County, WA, 6707 Administration Natural Gas Policy Act: State jurisdictional agencies tight formation Health Care Financing Administration recommendations; preliminary findings— NOTICES Oklahoma Corporation Commission, 6707–6708 Agency information collection activities under OMB Applications, hearings, determinations, etc.: review, 6714–6715 AIG Trading Corp., 6708 Columbia Gas Transmission Corp., 6708 Health Resources and Services Administration Columbia Gulf Transmission Co., 6708–6709 NOTICES Destec Power Services, Inc., 6709 Grants and cooperative agreements; availability, etc.: Williams Natural Gas Co., 6709 Geriatric education centers; correction, 6715 Maternal and child health services— Federal set-aside program; research and training grants, Federal Highway Administration 6715–6719 NOTICES Minority health professions education centers of Environmental statements; notice of intent: excellence, 6719 Jefferson and Shelby Counties, AL, 6766–6767 Meetings; advisory committees: March, 6719–6720 Federal Reserve System NOTICES Housing and Urban Development Department Meetings; Sunshine Act, 6771 NOTICES Applications, hearings, determinations, etc.: Grant and cooperative agreement awards: ESB Bancorp, Inc., et al., 6712 Public and Indian housing— Regions Financial Corp., 6712–6713 Family investment centers program, 6725–6728 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Contents V Grants and cooperative agreements; availability, etc.: National Institutes of Health Facilities to assist homeless— NOTICES Excess and surplus Federal property, 6723–6725 Meetings: Research Grants Division special emphasis panels, 6720 Immigration and Naturalization Service RULES National Oceanic and Atmospheric Administration Immigration: NOTICES Administrative naturalization, 6647–6652 Meetings: Pacific Fishery Management Council, 6701 Interior Department See Fish and Wildlife Service National Park Service See Land Management Bureau NOTICES See National Park Service Environmental statements; availability, etc.: Pictured Rocks National Lakeshore, MI, 6731–6732 International Trade Administration NOTICES National Science Foundation Antidumping duty orders and findings: NOTICES Intent to revoke, 6697–6698 Privacy Act: Systems of records, 6738 International Trade Commission Nuclear Regulatory Commission NOTICES Import investigations: NOTICES General agreement on trade in services; examination of Petitions; Director’s decisions: major trading partners’ schedules of commitments, Pressurized water reactors, 6739 6732 Applications, hearings, determinations, etc.: Advanced Medical Systems, Inc., 6741 Justice Department Illinois Power Co., 6739–6741 See Antitrust Division Public Health Service See Immigration and Naturalization Service See Food and Drug Administration NOTICES See Health Resources and Services Administration Pollution control; consent judgments: See National Institutes of Health Massachusetts, Executive Office for Administration and See Substance Abuse and Mental Health Services Finance, et al., 6732–6733 Administration Privacy Act: NOTICES Systems of records, 6733 Agency information collection activities under OMB review, 6720–6722 Labor Department See Employment and Training Administration Research and Special Programs Administration See Employment Standards Administration NOTICES See Wage and Hour Division Pipeline safety: User fees, 6767–6768 Land Management Bureau NOTICES Securities and Exchange Commission Environmental statements; availability, etc.: NOTICES Lake County, OR; perlite mining operation, 6728–6729 Meetings; Sunshine Act, 6771–6772 Realty actions; sales, leases, etc.: Self-regulatory organizations; proposed rule changes: Idaho, 6729–6730 Midwest Securities Trust Co., 6741–6743 Nevada, 6730–6731 New York Stock Exchange, Inc., et al., 6743–6744 Survey plat filings: Applications, hearings, determinations, etc.: Idaho, 6731 G.T. Global Growth Series et al., 6744–6747 Health-Mor Inc., 6747–6748 Minority Business Development Agency NuMed Home Health Care, Inc., 6748 NOTICES Public utility holding company filings, 6748–6749 Business development center program applications: State Mutual Life Assurance Co. of America et al., 6749– Minnesota, 6698 6751 National Credit Union Administration Substance Abuse and Mental Health Services NOTICES Administration Meetings; Sunshine Act, 6771 NOTICES Federal agency urine drug testing; certified laboratories National Institute of Standards and Technology meeting minimum standards, list, 6722–6723 NOTICES Information processing standards, Federal: Transportation Department SQL environments, 6698–6700 See Coast Guard Meetings: See Federal Aviation Administration National Voluntary Conformity Assessment Systems See Federal Highway Administration Evaluation (NVCASE) Program, 6700–6701 See Research and Special Programs Administration VI Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Contents RULES Separate Parts In This Issue Procedural regulations: Airport fees; air carrier and foreign air carrier fee Part II increases or newly established fees; determination of Department of Agriculture, Food Safety and Inspection reasonableness, 6919–6930 Service, 6774–6889 NOTICES Airport rates and charges; policy statement, 6906–6918 Part III Grants and cooperative agreements; availability, etc.: Department of Health and Human Services, Food and Drug Regional liaison outreach and services program, 6751– Administration, 6892–6903 6766 Privacy Act: Part IV Systems of records, 6766 Department of Transportation, Federal Aviation Administration, 6906–6930 Treasury Department NOTICES Part V Organization, functions, and authority delegations: Federal Emergency Management Agency, 6932–6934 Freedom of Information Offices; mailing addresses, 6768 Privacy Act: Part VI Systems of records, 6768–6769 Federal Emergency Management Agency, 6936–6937 Part VII United States Enrichment Corporation NOTICES Department of Education, 6940±6944 Meetings; Sunshine Act, 6772 Veterans Affairs Department Reader Aids RULES Additional information, including a list of public laws, Adjudication; pensions, compensation, dependency, etc.: telephone numbers, and finding aids, appears in the Reader Undiagnosed illnesses compensation, 6660–6666 Aids section at the end of this issue. Wage and Hour Division Electronic Bulletin Board RULES Free Electronic Bulletin Board service for Public Law Family and Medical Leave Act; implementation numbers, Federal Register finding aids, and a list of Deferral, 6658 documents on public inspection is available on 202–275– 1538 or 275–0920. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Contents VII CFR PARTS AFFECTED IN THIS ISSUE A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue. 8 CFR Proposed Rules: 103...... 6647 52...... 6687 292...... 6647 46 CFR 299...... 6647 310...... 6647 Proposed Rules: 312...... 6647 Ch. I ...... 6687 313...... 6647 47 CFR 315...... 6647 73...... 6670 316...... 6647 316a...... 6647 Proposed Rules: 319...... 6647 73 (2 documents) ...... 6689 322...... 6647 50 CFR 324...... 6647 17...... 6671 325...... 6647 327...... 6647 328...... 6647 329...... 6647 330...... 6647 331...... 6647 332...... 6647 332a...... 6647 332b...... 6647 332c ...... 6647 332d...... 6647 333...... 6647 334...... 6647 334a...... 6647 335...... 6647 335a...... 6647 335c ...... 6647 336...... 6647 337...... 6647 338...... 6647 339...... 6647 340...... 6647 343b...... 6647 344...... 6647 499...... 6647 9 CFR Proposed Rules: 308...... 6774 310...... 6774 318...... 6774 320...... 6774 325...... 6774 326...... 6774 327...... 6774 381...... 6774 14 CFR 39 (2 documents) ...... 6652, 6654 71...... 6657 302...... 6919 Proposed Rules: 71...... 6686 18 CFR 157...... 6657 21 CFR Proposed Rules: 310...... 6892 29 CFR 825...... 6658 33 CFR 117...... 6658 34 CFR 74...... 6660 75...... 6660 Proposed Rules: 668...... 6940 38 CFR 3...... 6660 40 CFR 270...... 6666 6647 Rules and Regulations Federal Register Vol. 60, No. 23 Friday, February 3, 1995 This section of the FEDERAL REGISTER naturalization. Title IV of the The Technical Amendments clarified contains regulatory documents having general Immigration Act of 1990 (Pub. L. 101– and revised some changes made by applicability and legal effect, most of which 649) (IMMACT), effective October 1, IMMACT in several areas relating to the are keyed to and codified in the Code of 1991, transferred jurisdiction over administrative naturalization process. Federal Regulations, which is published under Most notably, a federal or state court 50 titles pursuant to 44 U.S.C. 1510. naturalization from the judiciary to the Attorney General, subject to judicial now may elect to exercise exclusive The Code of Federal Regulations is sold by review, and redefined the naturalization jurisdiction to administer the oath of the Superintendent of Documents. Prices of process as an administrative proceeding. allegiance to applicants for new books are listed in the first FEDERAL On October 7, 1991, the Service naturalization under certain REGISTER issue of each week. published in the Federal Register an circumstances. Also added by the interim rule to implement the Technical Amendments is the procedures governing administrative requirement that the Attorney General DEPARTMENT OF JUSTICE naturalization. 56 FR 50475. Before a rather than a court, promptly prepare a naturalization certificate for each person Immigration and Naturalization Service final rule could be drafted, however, Congress enacted the Miscellaneous and to be administered the oath of allegiance 8 CFR Parts 103, 292, 299, 310, 312, Technical Immigration and by a court, and then transmit that 313, 315, 316, 316a, 319, 322, 324, 325, Naturalization Amendments of 1991 certificate to the court having 327, 328, 329, 330, 331, 332, 332a, 332b, (Pub. L. 102–232) (Technical jurisdiction to administer the oath. This 332c, 332d, 333, 334, 334a, 335, 335a, Amendments), effective January 11, process reduces administrative costs to 335c, 336, 337, 338, 339, 340, 343b, 344, 1992, which significantly changed the courts while maintaining and 499 several statutory provisions relating to naturalization as a source of court administrative naturalization. The revenue and also ensures that a [INS No. 1435±92: AG Order No. 1946±95] Service then published a second interim certificate of naturalization prepared by RIN 1115±AC58 rule in the Federal Register on the Service can be delivered to the September 24, 1993, at 58 FR 49905, to applicant at the time of the Administrative Naturalization implement the changes brought about administration of the oath, regardless of by the Technical Amendments. That whether the oath administration AGENCY: Immigration and Naturalization ceremony is judicial or administrative. Service, Justice. second interim rule also incorporated changes based on public comments The Technical Amendments also ACTION: Final rule. received on the first interim rule. This provide a means by which an applicant facing special circumstances may SUMMARY: This rule establishes rule adopts as final both the first interim participate in an oath administration procedures implementing an rule (October 7, 1991) and the ceremony without having to wait until administrative naturalization process as subsequent changes in the second the date of the next public ceremony. provided for by recent changes in the interim rule (September 24, 1993). This The court now has discretion to immigration laws. The rule streamlines final rule also includes changes based consider special circumstances in the administrative naturalization on public comment, and some minor determining whether to administer the process since the courts are now changes resulting from the Service’s oath immediately in a private judicial removed from routing decisions experience in working with the two ceremony, or to refer the person to the approving applicants for naturalization. interim rules. Attorney General for immediate As a result of this rule, applications for As noted above in the two previous administrative naturalization. naturalization will be processed to interim rules, IMMACT amended the completion within the immigration and naturalization process so that the Comments on the Interim Rule Naturalization Service (the Service), judiciary no longer holds exclusive Published on September 24, 1993 with the role of the courts limited to jurisdiction over naturalization The Service received six comments administration of the oath of allegiance applications. It is now the responsibility from the public in response to the in some circumstances, and judicial of the Service not only to receive September 24, 1993, interim rule. These review of administrative denials. applications for naturalization and to comments covered 14 specific areas. EFFECTIVE DATE: February 3, 1995. conduct examinations to determine Only one of the comments addressed FOR FURTHER INFORMATION CONTACT: statutory eligibility for citizenship, but issues arising under the Technical William Tollifson, Adjudications also to render formal determinations on Amendments provisions for exclusive Officer, Naturalization and Special applications for naturalization, to jurisdiction of the courts in Projects Branch, Adjudications Division, provide for administrative review of administering the oath of allegiance. Immigration and Naturalization Service, such determinations, and to issue The remaining comments related to room 3214, 425 I Street, NW., naturalization certificates. The issues addressed in both interim rules. Washington, DC 20536, telephone: (202) judiciary’s participation in the The discussion that follows summarizes 514–5014. naturalization process is limited to the issues raised in the comments, SUPPLEMENTARTY INFORMATION: This rule administering the oath of allegiance and provides the Service’s position on these finalizes two previous interim rules renunciation for persons whom the issues, and explains the revisions published by the Immigration and Service determines to be admissible to adopted. Naturalization Service to implement citizenship and to reviewing Two of the commenters focused on procedures for administrative administrative denials. standardized testing of knowledge of the 6648 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations United States government and history requirements listed in 8 CFR 312.3. The purposes and residence as used in other and English literacy, covered in 8 CFR Service points out that such a provision Service regulations. part 312. These two commenters, already exists in § 312.3(b). Under that One commenter asserted that the Educational Testing Services and provision, applicants must still provision in § 316.10 specifying that a Comprehensive Adult Student demonstrate spoken English skills at the conviction for an aggravated felony be a Assessment System, felt that time of the naturalization interview. permanent bar to naturalization only if § 312.3(a)(1) as written did not clearly One commenter requested the conviction occurred after November provide that a standardized test of clarification of the changes made by the 29, 1990, contradicts a General Counsel knowledge of United States government second interim rule to § 312.4. legal opinion dated February 22, 1991 and history and English literacy could Specifically, the commenter note the (on file with the Office of General be taken even after the submission of an requirement that the Service provide an Counsel, INS). The legal opinion application for naturalization, so long as applicant with another interpreter in a discusses when a conviction can be the results were presented as part of the timely manner when it disqualifies the classified as an aggravated felony. interview process. Both commenters applicant’s own interpreter. The However, as the legal opinion also provided suggested language. While the commenter was concerned that this discusses, section 509 of IMMACT, Service agrees that the original language language could be misconstrued as which replaces ‘‘murder’’ with needs clarification, the commenters’ requiring the Service to obtain an ‘‘aggravated felony’’ in section 101(f)(8) suggested language was not accepted interpreter on the same day as the of the Act, is applicable only to because it effectively would restrict the disqualification. The commenter convictions occurring on or after taking of the test to the period before the pointed out that such a requirement November 29, 1990. Accordingly, an applicant’s first interview. Instead, the would generate a significant cost to the applicant is permanently barred from Service has modified § 312.3(a)(1) to Service and also could lead to violations showing good moral character, and reflect that the standardized test may be of the Service’s contractual obligations hence from eligibility for naturalization, taken and passed up until the date of with interpreter firms. The Service has by a conviction for an aggravated felony any examination on the application clarified this section to reflect that an only when the conviction occurred on under 8 CFR part 335, including a retest interview may be rescheduled within a or after that date. As noted in the on the § 312 requirement. The wording reasonable time period so long as such supplementary information in the first sentence also has been rescheduling does not cause undue accompanying the second interim rule, changed from ‘‘submits an application’’ delay in the adjudication of the however, nothing in the regulations to ‘‘files an application’’ to bring the application. prevents the Service from using a pre- language into conformity with all other The same commenter also noted the November 29, 1990, aggravated felony references to receipt of applications by removal of the term ‘‘terrorist’’ from the conviction as an impediment to the Service. definition of ‘‘subversive’’ found in establishing good moral character under One of these commenters also § 313.1. As we explained when we § 316.10(b) (2) or (3). suggested that the Service include published the second interim rule, One commenter suggested that the specific language in § 312.3(a)(3) to terrorists are not specifically included provision in § 335.2(a) allowing for the reflect that an applicant’s inability to among the classes of persons ineligible presence of an applicant’s attorney or speak English will not be construed as for naturalization under section 313 of representative at the examination evidence of fraud in the taking of the the Act. We note, however, that should refer only to § 292.3, rather than standardized test. In response to the first although section 313 of the Act does not to the filing of an appearance in interim rule, the Service received a expressly prohibit the naturalization of accordance with part 292 generally. similar request to set forth the exact persons who engage in terrorist activity However, the broader reference to part level of proof required to invalidate test as defined in section 212(a)(3)(B) of the 292 was designed to encompass § 292.3 results on the basis of fraud. In this rule, Act, such persons will be closely as well as the other guidelines for the Service has certified that the scrutinized for lack of good morale representation before the Service listed inability to speak English may not be character. in that part. That commenter also used as the sole ground upon which to Also noted by that commenter were asserted that the Service seems to have invalidate test results. However, it the changes made by the second interim expanded the legal representative’s should be noted that an applicant’s rule in § 316.5(c)(1)(i) regarding the term participation in the in the naturalization inability to speak English at the used to describe the interruption of process. As explained in the interview may provide the officer with continuity of residence. The commenter supplementary information a reason to scrutinize more closely the took issue with the use of the phrase accompanying the second interim rule, circumstances surrounding the ‘‘continuity of residence,’’ suggesting prior to the change to administrative administration of the test. Moreover, that ‘‘continuous residence’’ would be a naturalization, all applicants were while the Service may not invalidate more appropriate term, as the Service subject to a preliminary investigation, test results as fraudulent solely because uses that term throughout its regulations where limited representation was an applicant is unable to speak English and particularly in 8 CFR part 245a. It allowed, and to a preliminary at the interview, the Service is not should be noted, however, that examination and final hearing, where precluded from denying an application § 316.5(c)(l)(i) implements section full representation was allowed. As on the grounds that the applicant is 316(b) of the Act, which refers to applicants are now subject to only one unable to speak English. residence as required for admission to examination, the rights to representation The same commenter also requested citizenship, as opposed to residence in at that examination have been expanded inclusion of a specific provision stating other immigration contexts. Moreover, to be consistent with all other that persons who have satisfied the section 316(b) of the Act uses the term adjudications before the Service. educational requirements set forth in ‘‘continuity of residence.’’ Accordingly, One commenter requested that the section 312 of the Immigration and § 316.5(c)(1)(i) adheres to the design of Service provide further guidance in Nationality Act (the Act) during the the statute by using the Act’s § 335.2 to adjudications officers legalization program under section terminology and by distinguishing concerning the conduct of 245A of the Act have met the between residence for naturalization naturalization examinations, as Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6649 discrepancies sometimes exist in the for in § 337.2(c). The commenter lawful admission for permanent level of difficulty of questions asked of requested assurance that when further residence. In order to bring the applicants. Although we recognize the questioning is warranted after review of regulation into conformity with the need to provide guidelines for the completed form, the applicant will statute, the Service has inserted the adjudications officers, such guidelines be given the opportunity to respond to phrase ‘‘for permanent residence’’ at the are more properly provided in the an officer’s questions in a quiet, private end of § 316.2(a)(3). Service’s Operations Instructions. setting so as to allow for a meaningful At § 316.5(c)(2), the Service clarified That commenter also suggested that exchange with the officer. The Service language regarding relinquishment of the Service amend § 335.6 to allow believes that completion of the Form N– permanent resident status by aliens who applicants to make verbal requests for 445 is a necessary part of the claim nonresident alien status for rescheduling of missed interviews at the naturalization process. Although income tax purposes. The rebuttable field office. For reasons of Service adjudications officers will be presumption of relinquishment of administrative efficiency, the Service provided with guidance on the lawful permanent resident status must require that all requests be treatment of applicants whose answers extends not only to persons who submitted in writing. However, the warrant further investigation, such ‘‘voluntarily’’ claim nonresident alien written request need not take any guidelines are provided more properly status for income tax purposes, but also specific form, but rather may be a brief, in the Services Operations Instructions. to persons who fail to file income tax informal notation for the adjudications That commenter also had concerns returns based on their claims to officer to insert in the applicant’s file. that the procedure for requesting nonresident alien status. One commenter questioned the expedited administration of the oath of At § 329.4, the Service had referred portion of § 335.7 that allows the allegiance set forth in § 337.3(c) may erroneously to an inappropriate section Service to deny applications on the cause undue delay, because the Service of the regulations. This citation has been merits where applicants fail to explain would be required in some cases to first corrected in § 329.4(b), which formerly adequately absences from appearances pass upon the merits of each request referred to ‘‘§ 329.2(a), (c)(1), or (c)(2)’’ required after their initial examinations and then send a recommendation to the and now reads ‘‘§ 329.2 (a), (b), or or to provide the Service with court. The Service has addressed this (c)(2).’’ additional requested evidence. The concern by revising § 337.3(c) to At § 339.2, the Service added a commenter suggested that dismissal is eliminate the recommendation process. provision to clarify the purpose of the more appropriate than denial in cases The commenter also expressed concern courts’ submission of monthly reports where the Service does not have over the requirement that requests for prepared on Form N–4. As approved in sufficient evidence upon which to make expedition be in writing, and suggested a notice published on October 25, 1993, a determination. Section 335(e) of the that the Service implement a more at 58 FR 55084, 55085, Form N–4, in Act provides that, where the applicant flexible approach. While the Service addition to serving its recordkeeping fails to prosecute an application, the recognizes the need to provide the purpose, will be treated by the Service Service may either decide the public with an efficient process, the as a billing document submitted by the application on the merits or dismiss it Service is concerned that many courts. Use of Form N–4 in this manner for lack of prosecution. The Service applicants, especially those without will enable the Service to process more agrees with the commenter that cases legal representation, may have difficulty efficiently requests for reimbursement may be more appropriately ‘‘dismissed’’ in communicating with judges or clerks from courts for performance of oath than adjudicated on the merits where no of court to request expedited administration ceremonies. The added record exists. The Service therefore has ceremonies. The Service, therefore, has paragraph also explains that made a distinction between cases where revised § 337.3(c) to provide that reimbursements for state courts will be the applicant has not appeared for the applicants seeking expedited determined under the same standards examination, provided for in § 335.6, ceremonies may submit their requests to set for the Federal courts. and cases where the applicant has either the court or to the Service. already appeared for an examination but The same commenter also suggested Regulatory Flexibility Act the Service requires further testimony or that the Service attempt to reallocate its The Attorney General, in accordance documentary evidence to support the resources to rectify discrepancies in with the Regulatory Flexibility Act (5 application, provided for in § 335.7. waiting times for adjudications. While U.S.C. 605(b)), has reviewed this This rule further clarifies the Service’s this regulation is not the proper forum regulation and, by approving it, certifies position that when the applicant fails to in which to address such concerns, the that the rule will not have a significant appear for the examination, leaving the Service assures the commenter that it is economic impact on a substantial Service without sufficient evidence working constantly to improve the number of small entities. upon which to render a determination, efficiency of the administrative the case will be dismissed for lack of naturalization process. Executive Order 12866 prosecution after the passage of one year This regulation has been drafted and from the date the application was Service Initiated Changes reviewed in accordance with Executive closed. However, when the applicant As a result of working under the Order 12866, § 1(b). The Attorney appears for examination but the Service interim rules since 1991, the Service General has determined that this rule is requests additional testimony or discovered some errors or areas where not a significant regulatory action under documentation, and the applicant then further clarification is needed. Executive Order 12866, § 3(f), and fails to prosecute the application, the At § 316.2(a)(3), which lists one of the accordingly this rule has not been Service will adjudicate the case on the requirements for naturalization, the rule reviewed by the Office of Management merits, as sufficient evidence should stated only that the applicant must have and Budget. exist to render a decision. resided continuously in the United One commenter expressed concern States for 5 years after lawful admission. Executive Order 12612 over the process for reviewing Section 316(a) of the Act, however, This regulation will not have completed Forms N–445 prior to the requires that the applicant has resided substantial direct effects on the States, oath administration ceremony, provided in the United States for 5 years after on the relationship between the 6650 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations National Government and the States, or 8 CFR Part 322 8 CFR Part 334a on the distribution of power and Citizenship and naturalization, Citizenship and naturalization, responsibilities among the various Infants and children, Reporting and Reporting and recordkeeping levels of government. Therefore, in recordkeeping requirements. requirements. accordance with section 6 of Executive Order 12612, it is determined that this 8 CFR Part 324 8 CFR Part 335 rule does not have sufficient federalism Citizenship and naturalization, Administrative practice and implications to warrant the preparation Reporting and recordkeeping procedure, Authority delegations of a Federalism Assessment. requirements, Women. (Government agencies), Citizenship and Executive Order 12606 naturalization, Reporting and 8 CFR Part 325 recordkeeping requirements. The Attorney General has reviewed Citizenship and naturalization, 8 CFR Part 335a this rule under Executive Order 12606 Reporting and recordkeeping and has determined that this rule will requirements. Citizenship and naturalization. not have an impact on family formation, maintenance, or general well-being. 8 CFR Part 327 8 CFR Part 335c List of Subjects Citizenship and naturalization, Citizenship and naturalization. Military personnel, Reporting and 8 CFR Part 336 8 CFR Part 103 recordkeeping requirements. Citizenship and naturalization, Administrative practice and 8 CFR Part 328 procedure, Archives and records, Courts, Hearing and appeal procedures, Authority delegations (Government Citizenship and naturalization, Reporting and recordkeeping agencies), Fees, Forms, Freedom of Military personnel, Reporting and requirements. information, Privacy, Reporting and recordkeeping requirements. 8 CFR Part 337 recordkeeping requirements, Surety 8 CFR Part 329 bonds. Citizenship and naturalization. Citizenship and naturalization, 8 CFR Part 338 8 CFR Part 292 Military personnel, Reporting and Administrative practice and recordkeeping requirements, Veterans. Citizenship and naturalization, Reporting and recordkeeping procedure, Hearing and appeal 8 CFR Part 330 procedures, Immigration. requirements. Citizenship and naturalization, 8 CFR Part 339 8 CFR Part 299 Reporting and recordkeeping Citizenship and naturalization, Citizenship and naturalization, requirements, Seamen. Courts, Reporting and recordkeeping Immigration and Nationality Act, 8 CFR Part 331 requirements. Reporting and recordkeeping requirements. Aliens, Citizenship and 8 CFR Part 340 naturalization. 8 CFR Part 310 Citizenship and naturalization, Law 8 CFR Part 332 enforcement. Citizenship and naturalization, Citizenship and naturalization, Courts. 8 CFR Part 343b Education, Reporting and recordkeeping 8 CFR Part 312 requirements. Citizenship and naturalization, Reporting and recordkeeping Citizenship and naturalization, 8 CFR Part 332a requirements. Education. Citizenship and naturalization, 8 CFR Part 344 8 CFR Part 313 Courts. Citizenship and naturalization, Citizenship and naturalization. 8 CFR Part 332b Courts. 8 CFR Part 315 Citizenship and naturalization, 8 CFR Part 499 Education. Armed forces, Citizenship and Citizenship and naturalization, naturalization, Selective service system, 8 CFR Part 332c Reporting and Recordkeeping Treaties. Citizenship and naturalization. requirements. 8 CFR Part 316 Accordingly, the interim rule 8 CFR Part 332d published at 56 FR 50475 on October 7, Citizenship and naturalization, Authority delegations (Government 1991, amdnding 8 CFR parts 103, 299, International organizations, Reporting agencies), Citizenship and 310, 312, 313, 315, 316, 316a, 319, 322, and recordkeeping requirements. naturalization. 324, 325, 327, 328, 329, 330, 331, 332, 332a, 332b, 332c, 332d, 333, 334, 334a 8 CFR Part 316a 8 CFR Part 333 335, 335a, 335c, 336, 337, 338, 339, 340, Citizenship and naturalization, Citizenship and naturalization. 343b, 344, and 499, and the interim rule Immigration, Residence. published at 58 FR 49905 on September 8 CFR Part 334 8 CFR Part 319 24, 1993, amending 8 CFR parts 292, Administrative practice and 299, 310, 312, 313, 316, 322, 329, 334, Citizenship and naturalization. procedure, Citizenship and 335, 336, 337, 338, 339, 343b, and 499, Reporting and recordkeeping naturalization, Courts, Reporting and are adopted as a final rule with the requirements. recordkeeping requirements. following changes: Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6651 PART 312ÐEDUCATIONAL manner. If rescheduling of the interview § 329.4 Application and evidence. REQUIREMENTS FOR is required, then a new date shall be set * * * * * NATURALIZATION as soon as practicable so as not to delay (b) Evidence. The applicant’s unduly the adjudication of the eligibility for naturalization under 1. The authority citation for part 312 application. The officer who disqualifies § 329.2(a), (b), or (c)(2) shall be continues to read as follows: an interpreter shall make a written established only by the certification of Authority: 8 U.S.C. 1103, 1423, 1443, 1447, record of the reason(s) for the executive department under which 1448. disqualification as part of the record of the applicant served or is serving. 2. Section 312.3 is amended by: the application. a. Revising paragraph (a)(1); and by PART 335ÐEXAMINATION ON PART 316ÐGENERAL b. Revising paragraph (a)(3), to read as APPLICATION FOR NATURALIZATION REQUIREMENTS FOR follows: NATURALIZATION 9. The authority citation for part 335 § 312.3 Standardized citizenship testing. continues to read as follows: 4. The authority citation for part 316 (a)(1) An applicant for naturalization Authority: 8 U.S.C. 1103, 1443, 1447. continues to read as follows: may satisfy the reading and writing 10. In § 335.6, a new paragraph (c) is requirements of § 312.1 and the Authority: 8 U.S.C. 1103, 1181, 1182, 1443, added to read as follows: knowledge requirements of § 312.2 by 1447; 8 CFR 2.1. passing, within one (1) year preceding 5. Section 316.2 is amended by § 335.6 Failure to appear for examination. the date on which he or she files an revising paragraph (a)(3) to read as * * * * * application for naturalization, or at any follows: (c) If the applicant does not request time subsequent to filing an application reopening of an administratively closed but prior to a final determination on the § 316.2 Eligibility. application within one year from the application, a standardized citizenship (a) * * * date the application was closed, the test given by an entity authorized by the (3) Has resided continuously within Service will consider that application to Service to conduct such a test. the United States, as defined under have been abandoned, and shall dismiss * * * * * § 316.5, for a period of at least five years the application without further notice to (3) An applicant who passes a after having been lawfully admitted for the applicant. standardized citizenship test as permanent residence; 11. Section 335.7 is amended by provided in paragraph (a)(1) of this revising the last sentence to read as * * * * * follows: section for naturalization shall not be 6. Section 316.5 is amended by reexamined at the Service naturalization revising paragraph (c)(2) to read as § 335.7 Failure to prosecute application interview on his or her ability to read follows: after initial examination. and write English or on his or her ** * In the event that the applicant knowledge of the history and form of § 316.5 Residence in the United States. fails to respond within 30 days of the government of the United States, unless * * * * * date of notification, the Service shall the examining officer has reasonable (c) * * * adjudicate the application on the merits cause to believe, subsequent to (2) Claim of nonresident alien status pursuant to § 336.1 of this chapter. verification of the applicant’s test for income tax purposes after lawful results with the authorized testing admission as a permanent resident. An PART 337ÐOATH OF ALLEGIANCE entity, that the applicant’s test results applicant who is a lawfully admitted were obtained English may not be the 12. The authority citation for part 337 permanent resident of the United States, continues to read as follows: sole reason for finding that the test but who voluntarily claims nonresident results were obtained through fraud or alien status to qualify for special Authority: 8 U.S.C. 1103, 1443, 1448. misrepresentation. The Applicant’s exemptions from income tax liability, or 13. Section 337.3 is amended by inability to speak English may not be fails to file either federal or state income revising paragraph (c) to read as follows: the sole reason for finding that the test tax returns because he or she considers results were botained through fraud or § 337.3 Expedited administration of oath of himself or herself to be a nonresident allegiance. misrepresentation. A written record of alien, raises a rebuttable presumption the officer’s determination shall be that the applicant has relinquished the * * * * * made in the record of the application privileges of permanent resident status (c) All requests for expedited including the response from the testing in the United States. administration of the oath of allegiance entity concerning the applicant’s test. shall be made in writing to either the * * * * * * * * * * court or the Service. Such requests shall 3. Section 312.4 is revised to read as PART 329ÐSPECIAL CLASSES OF contain sufficient information to follows: PERSONS WHO MAY BE substantiate the claim of special circumstances to permit either the court § 312.4 Selection of interpreter. NATURALIZED: NATURALIZATION BASED UPON ACTIVE DUTY SERVICE or the Service to properly exercise the An interpreter to be used under IN THE UNITED STATES ARMED discretionary authority to grant the § 312.2 may be selected either by the FORCES DURING SPECIFIED relief sought. The court or the Service applicant or by the Service. However, PERIODS OF HOSTILITIES may seek verification of the validity of the Service reserves the right to the information provided in the request. disqualify an interpreter provided by 7. The authority citation for part 329 If the applicant submits a written the applicant in order to ensure the continues to read as follows: request to the Service but is awaiting an integrity of the examination. Where the oath administration ceremony by a court Authority: 8 U.S.C. 1103, 1440, 1443. Service disqualifies an interpreter, the pursuant to § 337.8, the Service Service must provide another 8. Section 329.4 is amended by promptly shall provide the court with a interpreter for the applicant in a timely revising paragraph (b) to read as follows: copy of the request without reaching a 6652 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations decision on whether to grant or deny the Federal Aviation Administration (FAA) (SB) No. 2255, Revision V, dated request. has received several reports of these October 1993. improved design trusses cracking in Interested persons have been afforded PART 339ÐFUNCTIONS AND DUTIES Area A (as specified in the service an opportunity to participate in the OF CLERKS OF COURT REGARDING information) of the engine truss. This making of this amendment. Due NATURALIZATION PROCEEDINGS action retains the currently required consideration has been given to the two repetitive inspections, but shortens the comments received. 14. The authority citation for part 339 One commenter concurs with the continues to read as follows: repetitive inspection interval in Area A and eliminates the inspection- proposal as written. Authority: 8 U.S.C. 1103, 1433, 1448. terminating replacement option; and The other commenter concurs with 15. Section 339.2 is amended by also incorporates the Beech Models the actions specified in the proposal, adding a new paragraph (e) to read as 1900C and 1900D airplanes that have but states that the engine trusses on the follows: engine trusses of this same type design Beech Model 1900 airplanes are hard to installed at manufacture. The actions identify. This commenter states that § 339.2 Monthly reports. specified by this AD are intended to Beechcraft 1900 Airliner Communique * * * * * prevent failure of the engine truss No. 27, dated February 1993, presents (e) Use of reports for accounting assembly caused by a cracked engine information that helps identify the older purposes. Form N–4 shall be used by truss. engine trusses, and recommends that the FAA reference this document in the state and federal courts as a monthly DATES: Effective March 25, 1995. billing document, submitted to the proposal. The FAA concurs that the The incorporation by reference of Service for reimbursement in Beech Model 1900 airplane engine certain publications listed in the accordance with section 344(f)(1) of the trusses are hard to identify, and that regulations is approved by the Director Act. The Service shall use the Beechcraft 1900 Airliner Communique of the Federal Register as of March 25, information submitted on this form to No. 27, dated February 1993, helps 1995. calculate costs incurred by courts in identify these trusses. A NOTE has been performing their naturalization ADDRESSES: Service information that added in the proposal that references functions. State and federal courts will applies to this AD may be obtained from this service communique as a document be reimbursed pursuant to terms set the Beech Aircraft Corporation, P.O. Box that could be used in identifying engine forth in annual agreements entered into 85, Wichita, Kansas 67201–0085. This trusses. In addition, Beech has revised SB between the Service and the information may also be examined at 2255 to the Revision VI level (dated Administrative Office of United States the FAA, Central Region, Office of the August 1994). This document revises Courts. Assistant Chief Counsel, Room 1558, 601 E. 12th Street, Kansas City, Missouri the inspection schedule for airplanes Dated: January 26, 1995. 64106; or at the Office of the Federal having engine truss part number 129– Janet Reno, Register, 800 North Capitol Street NW., 910032–79. Implementation of this Attorney General. suite 700, Washington, DC. schedule would be a reduction from that [FR Doc. 95–2645 Filed 2–2–95; 8:45 am] already proposed. The FAA has FOR FURTHER INFORMATION CONTACT: Mr. BILLING CODE 4410±10±M determined that this SB should be Steven E. Potter, Wichita Aircraft incorporated into the proposal. Certification Office, FAA, 1801 Airport After careful review of all available Road, Mid-Continent Airport, Wichita, information including the comments DEPARTMENT OF TRANSPORTATION Kansas 67209; telephone (316) 946– referenced above, the FAA has 4124; facsimile (316) 946–4407. Federal Aviation Administration determined that air safety and the SUPPLEMENTARY INFORMATION: A public interest require the adoption of 14 CFR Part 39 proposal to amend part 39 of the Federal the rule as proposed except for the Aviation Regulations (14 CFR part 39) to addition of the NOTE, the incorporation [Docket No. 93±CE±41±AD; Amendment 39± include an AD that would apply to of Beech SB No. 2255, Revision VI, 9136; AD 95±02±18] Beech Model 1900 and certain Model dated August 1994, and minor editorial Airworthiness Directives; Beech 1900C airplanes was published in the corrections. The FAA has determined Aircraft Corporation Models 1900, Federal Register on December 1, 1993 that this minor addition, the SB 1900C, and 1900D Airplanes (58 FR 63305). The action proposed to incorporation, and the editorial supersede AD 92–06–09 with a new AD corrections will not change the meaning AGENCY: Federal Aviation that would (1) retain the repetitive of the AD or add any additional burden Administration, DOT. inspection requirements of AD 92–06– upon the public than was already ACTION: Final rule. 09, extend the applicability to include proposed. Beech Models 1900C and 1900D The FAA estimates that 279 airplanes SUMMARY: This amendment supersedes airplanes that have a part number 129– in the U.S. registry will be affected by Airworthiness Directive (AD) 92–06–09, 910032–79 engine truss installed, and this AD, that it will take approximately which currently requires repetitively shorten the repetitive inspection 16 workhours per airplane to inspecting the engine trusses for cracks interval of Area A (as specified in the accomplish the required inspection on Beech Aircraft Corporation (Beech) service information) of the engine truss (one-time in all applicable areas), and Model 1900 and certain Model 1900C to 100 hours TIS; and (2) eliminate the that the average labor rate is airplanes, repairing or replacing any option of terminating the repetitive approximately $60 an hour. Based on cracked engine truss, and installing inspections on the Beech Model 1900 these figures, the total cost impact of the reinforcement doublers. That AD also and 1900C airplanes if an improved AD on U.S. operators is estimated to be provides the option of installing an design engine truss, 129–910032–79, is $267,840. The only additional cost engine truss of improved design as installed. The inspections were impact on U.S. operators by the required terminating action for the repetitive proposed to be accomplished in action over that which is currently inspections. Since issuing that AD, the accordance with Beech Service Bulletin required by AD 92–06–09 is the Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6653 required inspections on 77 Beech substantial number of small entities and by adding a new AD to read as Models 1900C and 1900D airplanes or under the criteria of the Regulatory follows: × × $73,920 (16 workhours $60 77 Flexibility Act. A copy of the final 95–02–18 Beech Aircraft Corporation: airplanes). These figures are based on evaluation prepared for this action is Amendment 39–9136; Docket No. 93– the assumption that no affected airplane contained in the Rules Docket. A copy CE–41–AD. Supersedes AD 92–06–09, owner/operator has accomplished the of it may be obtained by contacting the Amendment 39–8189. required initial inspection, and do not Rules Docket at the location provided Applicability: Models 1900, 1900C, and account for the cost of repetitive under the caption ADDRESSES. 1900D airplanes (all serial numbers), inspections. The FAA has no way of List of Subjects in 14 CFR Part 39 certificated in any category. determining the number of repetitive Compliance: Required as indicated in the inspections each owner/operator would Air transportation, Aircraft, Aviation body of this AD, unless already incur. safety, Incorporation by reference, accomplished. Safety. To prevent failure of the engine truss The regulations adopted herein will assembly caused by a cracked engine truss, not have substantial direct effects on the Adoption of the Amendment accomplish the following: States, on the relationship between the Accordingly, pursuant to the (a) For Models 1900 and 1900C airplanes national government and the States, or authority delegated to me by the with either engine truss part number (P/N) on the distribution of power and Administrator, the Federal Aviation 114–910025–1 or P/N 118–910025–1 responsibilities among the various Administration amends part 39 of the installed that is not equipped with levels of government. Therefore, in reinforcement doublers at the engine firewall Federal Aviation Regulations (14 CFR attachment bosses, upon the accumulation of accordance with Executive Order 12612, part 39) as follows: it is determined that this final rule does 1,400 hours TIS or within the next 100 hours TIS after the effective date of this AD, not have sufficient federalism PART 39ÐAIRWORTHINESS whichever occurs later, install reinforcement implications to warrant the preparation DIRECTIVES doublers in accordance with the of a Federalism Assessment. 1. The authority citation for part 39 ACCOMPLISHMENT INSTRUCTIONS For the reasons discussed above, I continues to read as follows: section of Beech Service Bulletin (SB) No. certify that this action (1) is not a 2255, Revision VI, dated August 1994. ‘‘significant regulatory action’’ under Authority: 49 U.S.C. App. 1354(a), 1421 (b) For all affected airplanes having engine and 1423; 49 U.S.C. 106(g); and 14 CFR Executive Order 12866; (2) is not a truss P/N 129–910032–79 installed, initially 11.89. and repetitively inspect the engine truss for ‘‘significant rule’’ under DOT cracks at the weld joints in accordance with § 39.13 [Amended] Regulatory Policies and Procedures (44 the ACCOMPLISHMENT INSTRUCTIONS FR 11034, February 26, 1979); and (3) 2. Section 39.13 is amended by section of Beech SB 2255, Revision VI, dated will not have a significant economic removing AD 92–06–09, Amendment August 1994, at the times specified in the impact, positive or negative, on a 39–8189 (57 FR 8060, March 6, 1992), following chart: Area specified in figure Models 1 of Beech SB No. Initial inspection Repetitive inspection 2255, Rev. VI 1900 and 1900C ...... A ...... Upon accumulating 1,400 hours TIS* ...... Every 100 hours TIS. 1900 and 1900C ...... B and C ...... Upon accumulating 3,200 hours TIS* ...... Every 100 hours TIS. 1900D ...... A ...... Upon accumulating 3,200 hours TIS* ...... Every 450 hours TIS. 1900D ...... B and C ...... Upon accumulating 3,200 hours TIS* ...... Every 3,000 hours TIS. * Or within the next 100 hours TIS after the effective date of this AD, whichever occurs later. (c) For all Models 1900 and 1900C Area speci- (d) If any cracks are found during the airplanes having engine truss P/N 118– fied in fig- inspections required by paragraphs (b) 9100–25–37, P/N 118–910025–121, P/N ure 1 of Repetitive in- and (c) of this AD, prior to further flight, Beech SB Initial inspection spection 114–910025–1 or P/N 118–910025–1, N. 2255, repair the crack or replace the engine initially and repetitively inspect the Rev. VI truss with one of the applicable truss engine truss for cracks at the weld joints part numbers specified in the following in accordance with the B ...... Upon accumu- Every 600 table, and reinspect the truss at the lating 1,400 hours TIS. ACCOMPLISHMENT INSTRUCTIONS hours TIS*. times previously specified: section of Beech Service Bulletin (SB) C ...... Upon accumu- Every 3,000 2255, Revision VI, dated August 1994, at lating 1,400 hours TIS. Truss part No. Models Instructions the times specified in the following hours TIS*. chart: * Or within the next 100 hours TIS after the 118±910025± 1900 and Applicable effective date of this AD, whichever occurs 37 (service- 1900C. Mainte- Area speci- later. able truss). nance fied in fig- Manual. ure 1 of Repetitive in- Note 1: Beechcraft 1900 Airliner Initial inspection 118±910025± 1900 and Applicable Beech SB spection Communique No. 27, dated February 1993, N. 2255, 121 (serv- 1900C. Mainte- Rev. VI provides information for identifying engine iceable nance trusses on Beech Model 1900 airplanes. truss). Manual. A ...... Upon accumu- Every 100 Copies of this document may be obtained 129±910032± 1900, 1900C Beech Kit lating 1,400 hours TIS. from the Wichita Aircraft Certification Office 79. and 1900D. 114±9036± hours TIS*. (ACO) at the address specified in paragraph 1 or 114± (f) of this AD. 9036±3. 6654 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations Note 2: Installation of an improved design applicable to certain Pratt & Whitney 11, 1994), applicable to Pratt & Whitney engine truss, P/N 129–910032–79, on any of (PW) JT8D series turbofan engines, that (PW) JT8D series turbofan engines, to the affected airplanes does not eliminate the currently requires initial and repetitive require inspection of the Number 7 fuel repetitive inspection requirement of this AD. inspections of the Number 7 fuel nozzle nozzle and support assembly for Note 3: Compliance with a previous and support assembly, replacement of evidence of fuel leakage and burning revision level of the service bulletin referenced in this AD fulfills the applicable the Number 7 fuel nozzle and support until replacement of the Number 7 fuel requirements of this AD and is considered assembly with a more leak-resistant nozzle and support assembly with an ‘‘unless already accomplished’’. configuration, and replacement of improved sealing configuration. That (e) Special flight permits may be issued in aluminum oil pressure and scavenge AD also requires replacement of the accordance with §§ 21.197 and 21.199 of the tube fittings with steel fittings. This aluminum oil tube fittings with steel Federal Aviation Regulations (14 CFR 21.197 amendment adds a requirement fittings. That action was prompted by and 21.199) to operate the airplane to a incorporated in a new revision of a PW two reports of uncontained engine fires location where the requirements of this AD Alert Service Bulletin (ASB) that was on Pratt & Whitney (PW) JT8D series can be accomplished. omitted from the existing AD to replace engines due to fuel leakage from the (f) An alternative method of compliance or an additional aluminum oil scavenge Number 7 fuel nozzle and support adjustment of the initial or repetitive line bolt with a steel bolt. This assembly, ignition of that fuel, melting compliance times that provides an equivalent of aluminum oil pressure and scavenge level of safety may be approved by the amendment also makes a correction to Manager, Wichita ACO, FAA, 1801 Airport a note in the compliance section to tube fittings that are in the proximity of Road, Mid-Continent Airport, Wichita, apply only to PW JT8D–200 series the Number 7 nozzle, and augmentation Kansas 67209. The request shall be engines. This amendment is prompted of that fire with the liberated oil. The forwarded through an appropriate FAA by the need to make these corrections. resulting fire burned through the engine Maintenance Inspector, who may add The actions specified by this AD are diffuser case and fan ducts, causing an comments and then send it to the Manager, intended to prevent fuel leakage from aircraft engine cowl fire. That condition, Wichita ACO. the Number 7 fuel nozzle and support if not corrected, could result in fuel Note 4: Information concerning the assembly, ignition of that leaking fuel, leakage from the Number 7 fuel nozzle existence of approved alternative methods of and liberation of oil from melted oil line and support assembly, ignition of that compliance with this AD, if any, may be fittings, which can result in an leaking fuel, and liberation of oil from obtained from the Wichita ACO. uncontained engine fire and damage to melted oil line fittings, which can result (g) The inspections and replacement (if the aircraft. in an uncontained engine fire and necessary) required by this AD shall be done damage to the aircraft. in accordance with Beech Service Bulletin DATES: Effective February 21, 1995. The incorporation by reference of Since the issuance of that AD, the No. 2255, Revision VI, dated August 1994. FAA noted the omission of the This incorporation by reference was certain publications listed in the approved by the Director of the Federal regulations is approved by the Director requirement to replace an additional Register in accordance with 5 U.S.C. 552(a) of the Federal Register as of February aluminum oil scavenge line bolt with a and 1 CFR part 51. Copies may be obtained 21, 1995. steel bolt. This additional requirement from the Beech Aircraft Corporation, P.O. Comments for inclusion in the Rules is incorporated in Revision 2 to PW Box 85, Wichita, Kansas 67201–0085. Copies Docket must be received on or before Alert Service Bulletin (ASB) No. A6170, may be inspected at the FAA, Central Region, April 4, 1995. dated October 20, 1994. Also, the FAA Office of the Assistant Chief Counsel, Room was alerted of an error in the ADDRESSES: Submit comments in 1558, 601 E. 12th Street, Kansas City, compliance section where the incorrect triplicate to the Federal Aviation Missouri, or at the Office of the Federal engine series was specified. In Administration (FAA), New England Register, 800 North Capitol Street NW., suite paragraph (b)(2)(iv), the reference to ‘‘all 700, Washington, DC. Region, Office of the Assistant Chief other JT8D engines’’ should read ‘‘JT8D– (h) This amendment (39–9136) supersedes Counsel, Attention: Rules Docket No. 200 series engines.’’ In addition, PW has AD 92–06–09, Amendment 39–8189. 94–ANE–40, 12 New England Executive (i) This amendment (39–9136) becomes issued Revision 2 to ASB No. A6169, Park, Burlington, MA 01803–5299. dated October 26, 1994, which differs effective on March 25, 1995. The service information referenced in from Revision 1, cited in the current Issued in Kansas City, Missouri, on January this AD may be obtained from Pratt & AD, only by minor, non-substantive 26, 1995. Whitney, Technical Publications Michael K. Dahl, changes. Department, M/S 132–30, 400 Main The FAA has reviewed and approved Acting Manager, Small Airplane Directorate, Street, East Hartford, CT 06108. This Aircraft Certification Service. the technical contents of PW ASB No. information may be examined at the A6153, Revision 1, dated June 8, 1994, [FR Doc. 95–2403 Filed 2–2–95; 8:45 am] FAA, New England Region, Office of the that describes procedures for initial and BILLING CODE 4910±13±U Assistant Chief Counsel, Burlington, repetitive borescope inspections of the MA; or at the Office of the Federal Number 7 fuel nozzle and support Register, 800 North Capitol Street, NW., 14 CFR Part 39 assembly; and PW ASB A6170, Revision suite 700, Washington, DC. 2, dated October 20, 1994, and ASB No. [Docket No. 94±ANE±40; Amendment 39± FOR FURTHER INFORMATION CONTACT: A6169, Revision 2, dated October 26, 9135; AD 95±02±16] Mark A. Rumizen, Aerospace Engineer, 1994, that describe procedures for Engine Certification Office, FAA, Engine replacement of the Number 7 fuel Airworthiness Directives; Pratt & and Propeller Directorate, 12 New nozzle and support assembly with a Whitney JT8D Series Turbofan Engines England Executive Park, Burlington, MA more leak-resistant configuration and AGENCY: Federal Aviation 01803–5299; telephone (617) 238–7137, replacement of the aluminum oil tube Administration, DOT. fax (617) 238–7199. fittings with steel fittings, respectively. ACTION: Final rule; request for SUPPLEMENTARY INFORMATION: On June Since an unsafe condition has been comments. 29, 1994, the Federal Aviation identified that is likely to exist or Administration (FAA) issued develop on other engines of this same SUMMARY: This amendment supersedes airworthiness directive (AD) 94–14–16, type design, this AD supersedes AD 94– an existing airworthiness directive (AD), Amendment 39–8964 (59 FR 35238, July 14–16 to continue to require inspection Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6655 of the Number 7 fuel nozzle and support statement is made: ‘‘Comments to Applicability: Pratt & Whitney (PW) Model assembly for evidence of fuel leakage Docket Number 94–ANE–40.’’ The JT8D–209, –217, –217A, –217C, –219 and burning until replacement of the postcard will be date stamped and turbofan engines; and JT8D–1, –1A, –1B, –7, Number 7 fuel nozzle and support returned to the commenter. –7A, –7B, –9, –9A, –11, –15, –15A, –17, –17A, –17R, and –17AR turbofan engines assembly with an improved sealing The regulations adopted herein will incorporating the original issue or any configuration. This AD also requires not have substantial direct effects on the revision of Pratt & Whitney Service Bulletin replacement of the aluminum oil tube States, on the relationship between the No. 5650; and any PW Model JT8D engine fittings with steel fittings. In addition, national government and the States, or with low emissions fuel nozzles, Part this AD adds a requirement on the distribution of power and Numbers 775485, 809137–01, 802965, and incorporated in PW ASB No. 6170, responsibilities among the various 5004308–02 installed. These engines are Revision 2, dated October 20, 1994, that levels of government. Therefore, in installed on but not limited to Boeing 727 was omitted from AD 94–14–16 to accordance with Executive Order 12612, and 737 series, and McDonnell Douglas DC– replace an additional aluminum oil it is determined that this final rule does 9 and MD–80 series aircraft. Compliance: Required as indicated, scavenge line bolt with a steel bolt, and not have sufficient federalism makes a correction to paragraph unless accomplished previously. implications to warrant the preparation To prevent fuel leakage from the (b)(2)(iv). The actions are required to be of a Federalism Assessment. accomplished in accordance with the Number 7 fuel nozzle and support The FAA has determined that this assembly and melting of the oil pressure alert service bulletins described regulation is an emergency regulation previously. and scavenge tube fittings, which can that must be issued immediately to result in an uncontained engine fire and Since a situation exists that requires correct an unsafe condition in aircraft, the immediate adoption of this damage to the aircraft, accomplish the and is not a ‘‘significant regulatory following: regulation, it is found that notice and action’’ under Executive Order 12866. opportunity for prior public comment (a) Inspect Number 7 fuel nozzle and It has been determined further that support assemblies in accordance with PW hereon are impracticable, and that good this action involves an emergency Alert Service Bulletin (ASB) No. A6153, cause exists for making this amendment regulation under DOT Regulatory Revision 1, dated June 8, 1994, as follows: effective in less than 30 days. Policies and Procedures (44 FR 11034, (1) For Number 7 fuel nozzle and support Comments Invited February 26, 1979). If it is determined assemblies that have accumulated more than that this emergency regulation 2,500 hours time in service (TIS) since last Although this action is in the form of otherwise would be significant under fuel nozzle and support assembly overhaul a final rule that involves requirements on the effective date of this airworthiness DOT Regulatory Policies and affecting flight safety and, thus, was not directive (AD), initially inspect for fuel Procedures, a final regulatory evaluation preceded by notice and an opportunity leakage within 700 hours TIS after the for public comment, comments are will be prepared and placed in the Rules effective date of this AD. invited on this rule. Interested persons Docket. A copy of it, if filed, may be (2) For engines with Number 7 fuel nozzle are invited to comment on this rule by obtained from the Rules Docket at the and support assemblies with 2,500 or less hours TIS since fuel nozzle and support submitting such written data, views, or location provided under the caption ADDRESSES. assembly overhaul on the effective date of arguments as they may desire. this AD, initially inspect prior to Communications should identify the List of Subjects in 14 CFR Part 39 accumulating 3,200 hours TIS since Rules Docket number and be submitted Air transportation, Aircraft, Aviation overhaul. in triplicate to the address specified (3) Thereafter, inspect for fuel leakage in safety, Incorporation by reference, under the caption ADDRESSES. All accordance with PW ASB A6153, Revision 1, Safety. communications received on or before dated June 8, 1994, at intervals not to exceed the closing date for comments will be Adoption of the Amendment 700 hours TIS since last inspection. (4) Remove from service Number 7 fuel considered, and this rule may be Accordingly, pursuant to the amended in light of the comments nozzle and support assemblies that exhibit authority delegated to me by the evidence of fuel leakage as described in PW received. Factual information that Administrator, the Federal Aviation ASB No. A6153, Revision 1, dated June 8, supports the commenter’s ideas and Administration amends part 39 of the 1994, and replace with the improved sealing suggestions is extremely helpful in Federal Aviation Regulations (14 CFR configuration nozzle in accordance with evaluating the effectiveness of the AD part 39) as follows: paragraph (b) of this AD, as follows: action and determining whether (i) Within 25 hours TIS, or 25 cycles in additional rulemaking action would be PART 39ÐAIRWORTHINESS service (CIS), whichever occurs first, after the needed. DIRECTIVES inspection performed in paragraph (a)(1), Comments are specifically invited on (a)(2), or (a)(3) for aircraft with only one the overall regulatory, economic, 1. The authority citation for part 39 engine exhibiting Number 7 fuel nozzle and continues to read as follows: support assembly leakage. environmental, and energy aspects of (ii) Prior to further flight, on aircraft with the rule that might suggest a need to Authority: 49 U.S.C. App. 1354(a), 1421 two engines exhibiting Number 7 fuel nozzle modify the rule. All comments and 1423; 49 U.S.C. 106(g); and 14 CFR and support assembly leakage, remove and submitted will be available, both before 11.89. replace at least one of the leaking Number 7 and after the closing date for comments, fuel nozzle and support assemblies. The in the Rules Docket for examination by § 39.13 [Amended] remaining Number 7 fuel nozzle and support interested persons. A report that 2. Section 39.13 is amended by assembly that exhibits leakage shall be summarizes each FAA-public contact removing Amendment 39–8964, (59 FR removed and replaced in accordance with concerned with the substance of this AD 35238, July 11, 1994), and by adding a paragraph (a)(4)(i) of this AD. (iii) Prior to further flight, on Boeing 727 will be filed in the Rules Docket. new airworthiness directive, Amendment 39–9135, to read as aircraft, with three engines exhibiting Commenters wishing the FAA to Number 7 fuel nozzle and support assembly acknowledge receipt of their comments follows: leakage, remove and replace at least two of submitted in response to this notice 95–02–16 Pratt & Whitney: Amendment 39– the leaking Number 7 fuel nozzle and must submit a self-addressed, stamped 9135. Docket 94–ANE–40. Supersedes support assemblies. The remaining Number 7 postcard on which the following AD 94–14–16, Amendment 39–8964. fuel nozzle and support assembly that 6656 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations exhibits leakage shall be removed and (vi) Number 4 bearing oil pressure tube (5) Description of any other resultant replaced in accordance with paragraph assembly for all other JT8D engines. engine damage. (a)(4)(i) of this AD. (vii) Main bearing pressure manifold (6) Engine serial number. Note: Fuel nozzles and support assemblies assembly for all other JT8D engines. (7) Engine time and cycles since overhaul. that have not undergone overhaul do not (c) Incorporation of the hardware required The reporting requirements of this AD require inspection in accordance with by paragraph (b)(1) of this AD, constitutes terminate after compliance with paragraph paragraph (a) of this AD. terminating action for the inspections (b)(1) of this AD. Information collection (b) At the next accessibility of the diffuser required by paragraph (a) of this AD. requirements contained in this regulation build group after the effective date of this (d) For the purpose of this AD, accessibility have been approved by the Office of AD, but no later than July 31, 1999, of the diffuser build group is defined as Management and Budget (OMB) under the accomplish the following: engine maintenance that entails flange provision of the Paperwork Reduction Act of (1) Replace the Number 7 fuel nozzle and separation of the diffuser case from the 1980 (44 U.S.C. 3501–3520) and have been support assembly with the improved sealing combustion chamber outer case. assigned OMB Control Number 2120–0056. configuration in accordance with Part 1 of (e) For the purpose of this AD, fuel nozzle (g) An alternative method of compliance or PW ASB No. A6169, Revision 2, dated and support assembly overhaul is defined as adjustment of the compliance time that October 26, 1994. disassembly of the fuel nozzle from the provides an acceptable level of safety may be (2) Replace the aluminum pressure and support assembly that entails removal of the used if approved by the Manager, Engine scavenge oil tube fittings with steel fittings in fuel nozzle nut. Certification Office. The request should be accordance with PW ASB No. A6170, (f) For any Number 7 fuel nozzle and forwarded through an appropriate FAA Revision 2, dated October 20, 1994. support assembly that is removed for Principal Maintenance Inspector, who may Note: Replacement of the following oil evidence of leakage in accordance with add comments and then send it to the tubes with corresponding oil tubes that paragraph (a) of this AD, submit the Manager, Engine Certification Office. incorporate steel fittings constitutes following information within 60 days after Note: Information concerning the existence compliance with paragraph (b)(2) of this AD: the removal, to the Manager, Engine of approved alternative methods of (i) Outer internal Number 4 and 5 bearing Certification Office, Engine and Propeller Directorate, Aircraft Certification Service, compliance with this airworthiness directive, pressure tube assembly for PW JT8D–200 if any, may be obtained from the Engine series engines. FAA, 12 New England Executive Park, Certification Office. (ii) Outer internal main bearing pressure Burlington, Massachusetts, 01803–5299; fax tube assembly for PW JT8D–200 series (617) 238–7199: (h) Special flight permits may be issued in engines. (1) Fuel nozzle and support assembly part accordance with §§ 21.197 and 21.199 of the (iii) Main bearing pressure manifold number and serial number. Federal Aviation Regulations (14 CFR 21.197 assembly for PW JT8D–200 series engines. (2) Fuel nozzle and support assembly time and 21.199) to operate the aircraft to a (iv) Front Number 41⁄2 and 6 bearing and cycles since overhaul. location where the requirements of this AD pressure tube assembly for JT8D–200 series (3) Description of fuel nozzle and support can be accomplished. engines. assembly distress. (i) The inspections and modifications shall (v) Number 4 bearing oil scavenge tube (4) Position of distressed fuel nozzle and be done in accordance with the following assembly for all other JT8D engines. support assembly. service documents: Document No. Pages Revision Date PW ASB No. A6153 ...... 1±4 1 ...... June 8, 1994. 5 Original ...... Feb. 4, 1994. 6±8 1 ...... June 8, 1994. 9±12 Original ...... Feb. 4, 1994. Total pages: 12. PW ASB No. A6169 ...... 1 2 ...... Oct. 26, 1994. 2±6 1 ...... June 15, 1993. 7 Original ...... Apr. 29, 1993. 8 2 ...... Oct. 26, 1994. 9±16 Original ...... Apr. 29, 1993. 17 1 ...... June 15, 1994. 18±29 Original ...... Apr. 29, 1993. 30±31 2 ...... Oct. 26, 1994. Total pages: 31. PW ASB No. A6170 ...... 1 2 ...... Oct. 20, 1994. 2±3 1 ...... Sept. 9, 1994. 4±5 2 ...... Oct. 20, 1994. 6±7 1 ...... Sept. 9, 1994. 8 2 ...... Oct. 20, 1994. 9 Original ...... May 13, 1994. 10 2 ...... Oct. 20, 1994. 11±13 Original ...... May 13, 1994. 14 2 ...... Oct. 20, 1994. 15±18 1 ...... Sept. 9, 1994. 19±21 2 ...... Oct. 20, 1994. 22 1 ...... Sept. 9, 1994. Total pages: 22. This incorporation by reference was Department, M/S 132–30, 400 Main Street, at the Office of the Federal Register, 800 approved by the Director of the Federal East Hartford, CT 06108. Copies may be North Capitol Street, NW., suite 700, Register in accordance with 5 U.S.C. 552(a) inspected at the FAA, New England Region, Washington, DC. and 1 CFR part 51. Copies may be obtained Office of the Assistant Chief Counsel, 12 New (j) This amendment becomes effective on from Pratt & Whitney, Technical Publications England Executive Park, Burlington, MA; or February 21, 1995. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6657 Issued in Burlington, Massachusetts, on airspace at Saratoga, Wyoming. The Municipal Airport, WY, Class E airspace January 24, 1995. FAA has determined that this regulation area. Jay J. Pardee, only involves an established body of * * * * * Manager, Engine and Propeller Directorate, technical regulations for which frequent Issued in Seattle, Washington on January Aircraft Certification Service. and routine amendments are necessary 18, 1995. [FR Doc. 95–2405 Filed 2–2–95; 8:45 am] to keep them operationally current. It, Richard E. Prang, BILLING CODE 4910±13±P therefore, (1) is not a ‘‘significant Acting Manager, Air Traffic Division, regulatory action’’ under Executive Northwest Mountain Region. Order 12866; (2) is not a ‘‘significant [FR Doc. 95–2734 Filed 2–2–95; 8:45 am] 14 CFR Part 71 rule’’ under DOT Regulatory Policies BILLING CODE 4910±13±M [Airspace Docket No. 94±ANM±50] and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant Establishment of Class E Airspace; preparation of a regulatory evaluation as DEPARTMENT OF ENERGY Saratoga, WY the anticipated impact is so minimal. Since this is a routine matter that will Federal Energy Regulatory AGENCY: Federal Aviation only affect air traffic procedures and air Commission Administration (FAA), DOT. navigation, it is certified that this rule 18 CFR Part 157 ACTION: Final rule. will not have a significant economic impact on a substantial number of small [Docket No. RM81±19±000] SUMMARY: This action establishes the entities under the criteria of the Project Cost and Annual Limits Saratoga, Wyoming, Class E airspace. Regulatory Flexibility Act. This action is necessary to Issued: January 31, 1995 accommodate a new instrument List of Subjects in 14 CFR Part 71 AGENCY : Federal Energy Regulatory approach procedure at Shively Field Airspace, Incorporation by reference, Commission. Airport, Saratoga, Wyoming. Navigation (air). ACTION : Final rule. EFFECTIVE DATE: 0901 UTC, March 30, Adoption of the Amendment 1995. SUMMARY: Pursuant to the authority FOR FURTHER INFORMATION CONTACT: In consideration of the foregoing, the delegated by 18 CFR 375.307(e)(1), the James Riley, System Management FAA amends 14 CFR part 71 as follows: Director of the Office of Pipeline Branch, ANM–530, Federal Aviation PART 71Ð[AMENDED] Regulation computes and publishes the Administration, Docket No. 94–AMN– project cost and annual limits specified 50, 1601 Lind Avenue SW., Renton, 1. The authority citation for 14 CFR in Table I of § 157.208(d) and Table II Washington 98055–4056; telephone part 71 continues to read as follows: of § 157.215(a) for each calendar year. number: (206) 227–2537. Authority: 49 U.S.C. app. 1348(a), 1354(a), EFFECTIVE DATE: January 1, 1995. SUPPLEMENTARY INFORMATION: 1510; E.O. 10854, 24 FR 9565, 3 CFR, 1959– FOR FURTHER INFORMATION CONTACT: 1963 Comp., p. 389; 49 U.S.C. 106(g); 14 CFR Martin A. Burless, Jr., Chief, Branch I, History 11.69. Division of Pipeline Certificates, OPR On October 28, 1994, the FAA § 71.1 [Amended] (202) 208–0581. proposed to amend part 71 of Federal 2. The incorporation by reference in Aviation Regulations (14 CFR part 71) to SUPPLEMENTARY INFORMATION: 14 CFR 71.1 of the Federal Aviation establish the Saratoga, Wyoming, Class Publication of Project Cost Limits Administration Order 7400.9B, Airspace E airspace area (59 FR 54138). This Under Blanket Certificates Designations and Reporting Points, action is necessary to accommodate a dated July 18, 1994, and effective Order of the Director, OPR new instrument approach procedure at September 16, 1994, is amended as Shively Field Airport, Saratoga, Section 157.208(d) of the follows: Wyoming. The area will be depicted on Commission’s Regulations provides for aeronautical charts for pilot reference. Paragraph 6005 Class E airspace areas project cost limits applicable to Interested parties were invited to extending upward from 700 feet or more construction, acquisition, operation and participate in the rulemaking above the surface of the earth miscellaneous rearrangement of proceeding by submitting written * * * * * facilities (Table I) authorized under the comments on the proposal. No ANM WY E5 Saratoga, WY [New] blanket certificate procedure (Order No. 234, 19 FERC ¶61,216). Section comments were received. The Saratoga, Shively Field, WY coordinates for this airspace docket are (Lat. 41°26′41′′ N, long. 106°49′25′′ W) 157.215(a) specifies the calendar year based on North American Datum 83. Saratoga NDB dollar limit which may be expended on Class E airspace areas extending upward (Lat. 41°26′42′′ N, long. 106°49′56′′ W) underground storage testing and from 700 feet or more above the surface That airspace extending upward from 700 development (Table II) authorized under of the earth are published in Paragraph feet above the surface within a 6.9-mile the blanket certificate. Section 6005 of FAA Order 7400.9B dated July radius of the Shively Field Airport and 157.208(d) requires that the ‘‘limits 18, 1994, and effective September 16, within 3.1 miles each side of the 342° bearing specified in Tables I and II shall be 1994, which is incorporated by from the Saratoga NDB extending from the adjusted each calendar year to reflect reference in 14 CFR 71.1. The Class E 6.9-mile radius to 10 miles northwest of the the ‘GNP implicit price deflator’ airspace designation listed in this NDB; that airspace extending upward from published by the Department of 1,200 feet above the surface bounded by a Commerce for the previous calendar document will be published line beginning at: lat. 41°54′45′′ N, long. subsequently in the Order. 106°47′15′′ W; to lat. 41°17′00′′ N, long. year.’’ ° ′ ′′ ° ′ ′′ Pursuant to § 375.307(e)(1) of the The Rule 106 32 30 W; to lat. 41 10 00 N, long. 107°03′45′′ W; to lat. 41°47′30′′ N, long. Commission’s Regulations, the authority This amendment to part 71 of Federal 107°19′00′′ W; to the point of beginning, for the publication of such cost limits, Aviation Regulations amends Class E excluding that portion within the Rawlins as adjusted for inflation, is delegated to 6658 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations the Director of the Office of Pipeline § 157.215 Underground storage testing SUPPLEMENTARY INFORMATION: Final Regulation. The cost limits for calendar and development. regulations implementing the Family years 1982 through 1995, as published (a) * * * and Medical Leave Act of 1993 (FMLA), in Table I of § 157.208(d) and Table II 29 U.S.C. 2601 et seq., were published of § 157.215(a), are hereby issued. TABLE II in the Federal Register on January 6, Note that these inflation adjustments 1995, with an effective date of February Year Limit are based on the Gross Domestic 6, 1995 (see 60 FR 2180). In response to requests that the Department of Labor Product (GDP) Implicit Price Deflator 1982 ...... $2,700,000 rather than the Gross National Product 1983 ...... 2,900,000 provide additional time to enable (GNP) Implicit Price Deflator, which is 1984 ...... 3,000,000 employers and other members of the not yet available for 1994. The 1985 ...... 3,100,000 public to comply with their new Commerce Department advises that in 1986 ...... 3,200,000 responsibilities and to implement recent years the annual change has been 1987 ...... 3,300,000 revised policies and procedures 1988 ...... 3,400,000 virtually the same for both indices. consistent with the final regulations, the 1989 ...... 3,500,000 Department is deferring, from February Further adjustments will be made, if 1990 ...... 3,600,000 necessary. 1991 ...... 3,800,000 6, 1995, until April 6, 1995, the effective 1992 ...... 3,900,000 date of the final Family and Medical List of Subjects in 18 CFR Part 157 1993 ...... 4,000,000 Leave Act regulations published on Natural gas. 1994 ...... 4,100,000 January 6, 1995. 1995 ...... 4,200,000 Because these rules are scheduled to Robert J. Cupina, become effective very shortly, notice Deputy Director, Office of Pipeline * * * * * and public comment on this change of Regulation. [FR Doc. 95–2707 Filed 2–2–95; 8:45 am] effective date is impracticable, Accordingly, 18 CFR Part 157 is BILLING CODE 6717±01±P unnecessary and contrary to the public amended as follows: interest, and good cause exists for making this deferral effective PART 157Ð[AMENDED] DEPARTMENT OF LABOR immediately. 1. The authority citation for Part 157 Wage and Hour Division List of Subjects in 29 CFR Part 825 continues to read as follows: Employee benefit plans, Health, Authority: 15 U.S.C. 717–717w, 3301– 29 CFR Part 825 Health insurance, Labor management 3432; 42 U.S.C. 7101–7352. RIN 1215±AA85 relations, Maternal and child health, Teachers. § 157.208 [Amended] The Family and Medical Leave Act of Authority: The statutory authority for this 2. Table I in § 157.208(d) is revised to 1993; Deferral of Effective Date of action is as follows: 29 U.S.C. 2654; read as follows: Regulations Secretary’s Order 1–93 (58 FR 21190). § 157.208 Construction, acquisition, AGENCY: Wage and Hour Division, Signed in Washington, DC, this 31st day of operation, and miscellaneous Labor. January, 1995. Maria Echaveste, rearrangement of facilities. ACTION: Deferral of effective date of * * * * * regulations. Administrator, Wage and Hour Division. (d) * * * [FR Doc. 95–2702 Filed 2–2–95; 8:45 am] SUMMARY: This document defers the BILLING CODE 4510±27±M effective date, from February 6, 1995, to TABLE I April 6, 1995, of Labor Department Limit regulations implementing the Family DEPARTMENT OF TRANSPORTATION and Medical Leave Act of 1993, 29 CFR Year Automobile Prior notice Part 825, which were published in the Coast Guard projected cost projected cost Federal Register Friday, January 6, 1995 limit (col. 1) limit (col. 2) (60 FR 2180). This action is taken in 33 CFR Part 117 1982 ...... $4,200,000 $12,000,000 order to provide the public additional [CGD07±93±086] 1983 ...... 4,500,000 12,800,000 time to implement the final regulations, 1984 ...... 4,700,000 13,300,000 including, where appropriate, to revise RIN 2115±AE47 1985 ...... 4,900,000 13,800,000 policies and procedures. Drawbridge Operation Regulations; 1986 ...... 5,100,000 14,300,000 EFFECTIVE DATE: This document is 1987 ...... 5,200,000 14,700,000 effective February 3, 1995. The effective Gulf Intracoastal Waterway, Sarasota, 1988 ...... 5,400,000 15,100,000 date of the final Family and Medical FL 1989 ...... 5,600,000 15,600,000 Leave Act regulations published in the 1990 ...... 5,800,000 16,000,000 AGENCY: Coast Guard, DOT. 1991 ...... 6,000,000 16,700,000 Federal Register on January 6, 1995 (60 ACTION: Final rule. 1992 ...... 6,200,000 17,300,000 FR 2180), is hereby deferred until April 1993 ...... 6,400,000 17,700,000 6, 1995. SUMMARY: At the request of the Sarasota/ 1994 ...... 6,600,000 18,100,000 FOR FURTHER INFORMATION CONTACT: Manatee Metropolitan Planning 1995 ...... 6,700,000 18,400,000 J. Dean Speer, Division of Policy and Organization (MPO) and the Florida Analysis, Wage and Hour Division, Department of Transportation (FDOT), * * * * * Employment Standards Administration, the (bridge owner), the Coast Guard is U.S. Department of Labor, Room S– changing the regulations governing the § 157.215 [Amended] 3506, 200 Constitution Avenue NW., Siesta Key Drawbridge on SR758, Gulf 3. Table II in § 157.215(a) is revised to Washington, DC 20210; telephone (202) Intracoastal Waterway mile 71.6, across read as follows: 219–8412. This is not a toll-free number. Roberts Bay at Sarasota, Sarasota Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6659 County, Florida. This change is cross winds, heavy currents and shallow number of small entities. ‘‘Small intended to relieve highway congestion water adjacent to the channel near the entities’’ include independently owned while still meeting the reasonable needs bridge create holding conditions for and operated small businesses that are of navigation. northbound vessels that could become not dominant in their field and that EFFECTIVE DATE: March 6, 1995. unsafe for navigation if the opening otherwise qualify as ‘‘small business FOR FURTHER INFORMATION CONTACT: schedule is extended to 30 minutes. A concerns’’ under section 3 of the Small Ian L MacCartney, Project Manager, daily 20 minute schedule would help Business Act (15 U.S.C. 632). Because it Bridge Section, at (305) 536–6546. reduce traffic delays without expects the impact of this proposal to be significantly increasing the danger to minimal, the Coast Guard certifies SUPPLEMENTARY INFORMATION: vessels caused by the potentially unsafe under section 605(b) that this proposal, Drafting Information holding conditions. if adopted, will not have a significant impact on a substantial number of small The principal persons involved in Discussion of Comments and Changes entities. drafting this document are Ian L. Two commenters were in favor of the MacCartney, Project Manager, and LT. J. year round 20 minute opening schedule. Collection of Information M. Losego, Project Counsel. One commenter opposed any increase This rule contains no collection of Regulatory History in vessel delays due to unsafe holding information requirements under the conditions near the bridge. He suggested On September 16, 1994, the Coast Paperwork Reduction Act (44 U.S.C. extending the existing 15 minute 3501 et seq.). Guard published a notice of proposed schedule to include peak weekday rulemaking entitled Drawbridge traffic periods and recommended Federalism Operation Regulations; Gulf Intracoastal improving local traffic light The Coast Guard has analyzed this Waterway, Sarasota, FL in the Federal coordination with the bridge openings. proposal under the principles and Register (59 FR 47577). The Coast Guard One commenter recommended openings criteria contained in Executive Order received five letters commenting on the on the hour and half hour similar to the 12612, and has determined that this proposal. A public hearing was not nearby Ringling Causeway Drawbridge. proposal does not have sufficient requested and one was not held. Another commenter recommended federalism implications to warrant the Background and Purpose sailboats be required to operate offshore preparation of a Federalism Assessment. and pay a fee for each bridge opening This drawbridge presently opens on to minimize impacts on highway traffic. Environment signal except that from 11 a.m. to 6 The Coast Guard has carefully The Coast Guard considered the p.m., on weekend and holidays, the considered these comments and has draw need open only on the hour, environmental impact of this proposal concluded the 20 minute schedule will and concluded that, under section quarter hour, half hour, and three reduce bridge openings without creating quarter hour. The MPO and FDOT 2.B.2.g.(5) of Commandant Instruction unsafe holding conditions for waiting M16475.1B, promulgation of operating requested that the bridge open only on vessels. FDOT will be encouraged to the hour and half hour during certain requirements or procedures for install traffic light preemption programs drawbridges is categorically excluded periods of each day to help reduce which should help reduce cross traffic traffic delays, particularly during from further environmental delays and improve vehicular dispersal documentation. A Categorical Exclusion morning and afternoon commuter hours after each bridge opening. and on busy weekends. A comparison of Determination is available for highway traffic volumes between 1985 Regulatory Evaluation inspection or copying at the above address. and 1993 indicated there has been an This rule is not a significant overall increase in traffic volume with regulatory action under section 3(f) of List of Subjects in 33 CFR Part 117 current levels exceeding highway Executive Order 12866 and does not Bridges. capacity on weekday afternoons during require an assessment of potential costs the winter season without any bridge and benefits under section 6(a)(3) of that For the reasons set out in the openings. order. It has been exempted from review preamble, the Coast Guard amends 33 The number of bridge openings by the Office of Management and CFR part 117 as follows: continue to average less than two per Budget under that order. It is not hour with a maximum of 4 openings per PART 117ÐDRAWBRIDGE significant under the regulatory policies OPERATION REGULATIONS hour being experienced periodically and procedures of the Department of during the winter season. Based on Transportation (DOT) (44 FR 11040; 1. The authority citation for part 117 analysis of the highway traffic and February 26, 1979). The Coast Guard continues to read as follows: bridge opening data provided by FDOT expects the economic impact of this on June 28, 1993, the Coast Guard Authority: 33 U.S.C. 499; 49 CFR 1.46; 33 proposal to be so minimal that a full CFR 1.05–1(g). determined that most of the weekday Regulatory Evaluation under paragraph delays were caused by back to back 10e of the regulatory policies and 2. In § 117.287, paragraph (b–1) is bridge openings which did not allow procedures of DOT (44 FR 11040; revised to read as follows: accumulated vehicle traffic to clear February 26, 1979) is unnecessary. We § 117.287 Gulf Intracoastal Waterway. before the next opening. The Coast conclude this because the rule exempts Guard concluded that a 30 minute tugs with tows. * * * * * opening schedule was not warranted, (b–1) The draw of the Siesta Key but as a compromise, tested a 20 minute Small Entities bridge, mile 71.6 at Sarasota, shall open opening schedule which would limit Under the Regulatory Flexibility Act on signal, except that, from 11 a.m. to openings to 3 times per hour daily, year (5 U.S.C. 601 et seq.), the Coast Guard 6 p.m. daily, the draw need open only around. This test was conducted from must consider whether this proposal, if on the hour, 20 minutes past the hour, January 1, 1994, to February 23, 1994. adopted, will have a significant and 40 minutes past the hour. The results demonstrated that strong economic impact on a substantial * * * * * 6660 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations Dated: January 18, 1995. to offer interested parties the read as follows: ‘‘(Approved by the W.P. Leahy, opportunity to comment on proposed Office of Management and Budget under Rear Admiral, U.S. Coast Guard Commander, regulations. However, the publication of control number 1875–0102)’’ Seventh Coast Guard District. OMB control numbers is purely [FR Doc. 95–2659 Filed 2–2–95; 8:45 am] [FR Doc. 95–2650 Filed 2–2–95; 8:45 am] technical and does not establish BILLING CODE 4000±01±P BILLING CODE 4910±14±M substantive policy. Therefore, the Secretary has determined under 5 U.S.C. 553(b)(B), that proposed rulemaking is DEPARTMENT OF VETERANS unnecessary and contrary to the public DEPARTMENT OF EDUCATION AFFAIRS interest and that a delayed effective date 34 CFR Parts 74 and 75 is not required under 5 U.S.C. 553(d)(3). 38 CFR Part 3 Administration of Grants and List of Subjects RIN 2900±AH35 Agreements With Institutions of Higher 34 CFR Part 74 Education, Hospitals, and other Non- Compensation for Certain Profit Organizations; Direct Grant Administrative practice and Undiagnosed Illnesses Programs procedure, Education Department, Grant programs-education, Grant AGENCY: Department of Veterans Affairs. AGENCY: Department of Education. administration, Hospitals, Institutions of ACTION: Final rule. ACTION: Final regulations. higher education, Non-profit organizations, Reporting and SUMMARY: This document amends the SUMMARY: The Secretary amends 34 CFR recordkeeping requirements. Department of Veterans Affairs (VA) parts 74 and 75 to add the Office of adjudication regulations to authorize Management and Budget (OMB) control 34 CFR Part 75 compensation for disabilities resulting numbers to certain sections of the Education Department, Discretionary from the undiagnosed illnesses of regulations. Those sections contain grant programs, Continuation funding, Persian Gulf veterans. This amendment information collection requirements Grant administration, Reporting and provides the necessary regulatory approved by OMB. The Secretary takes recordkeeping requirements, framework to allow the Secretary to pay this action to inform the public that Performance reports, Unobligated funds. compensation under the authority granted by the Persian Gulf War these requirements have been approved. Dated: January 27, 1995. Veterans’ Benefits Act. EFFECTIVE DATE: These regulations are Donald R. Wurtz, EFFECTIVE DATE: November 2, 1994, the effective on February 3, 1995. Chief Financial Officer. FOR FURTHER INFORMATION CONTACT: Greg effective date of Title I of Public Law The Secretary amends Parts 74 and 75 Vick, U. S. Department of Education, 103–446. of Title 34 of the Code of Federal 600 Independence Avenue, S.W., Room FOR FURTHER INFORMATION CONTACT: Regulations as follows: 3636, Regional Office Building 3, Steven Thornberry, Consultant, Washington, D.C. 20202. Telephone PART 74ÐADMINISTRATION OF Regulations Staff, Compensation and (202) 708–8199. Individuals who use a GRANTS AND AGREEMENTS WITH Pension Service, Veterans Benefits telecommunications device for the deaf INSTITUTIONS OF HIGHER Administration, 810 Vermont Avenue, (TDD) may call the Federal Information EDUCATION, HOSPITALS, AND NW, Washington, DC 20420, telephone Relay Service (FIRS) at 1–800–877–8339 OTHER NON-PROFIT ORGANIZATIONS (202) 273–7210. between 8 a.m. and 8 p.m., Eastern time, SUPPLEMENTARY INFORMATION: ‘‘The Monday through Friday. 1. The authority citation for part 74 Persian Gulf War Veterans’ Benefits SUPPLEMENTARY INFORMATION: On June continues to read as follows: Act,’’ Title I of Public Law 103–446, 10, 1994, final regulations for Direct Authority: 20 U.S.C. 1221e–3(a)(1) and authorizes the Secretary of Veterans Grant Programs (part 75) were published 3474; OMB Circular A–110, unless otherwise Affairs to compensate any Persian Gulf in the Federal Register at 59 FR 30258, noted. veteran suffering from a chronic and on July 6, 1994, final regulations for 2. Sections 74.12, 74.21, 74.25, 74.34, disability resulting from an undiagnosed the Administration of Grants and 74.44, 74.45, 74.46, 74.47, 74.51, 74.52, illness or combination of undiagnosed Agreements with Institutions of Higher 74.53, 74.71, and 74.72 are amended by illnesses that became manifest either Education, Hospitals, and other Non- adding the OMB control number at the during active duty in the Southwest Profit Organizations (part 74) were end of these sections to read as follows: Asia theater of operations during the published in the Federal Register at 59 ‘‘(Approved by the Office of Persian Gulf War or to a degree of 10 FR 34722. Compliance with information Management and Budget under control percent or more within a presumptive collection requirements in 34 CFR number 1880–0513)’’ period following such service, as 74.12, 74.21, 74.25, 74.34, 74.44, 74.45, determined by the Secretary. On 74.46, 74.47, 74.51, 74.52, 74.53, 74.71, PART 75ÐDIRECT GRANT December 8, 1994, VA published a 74.72, 75.118 and 75.590 was delayed PROGRAMS proposed rule to implement the statute until those requirements were approved 3. The authority citation for part 75 (59 FR 63283–85). We requested that by OMB under the Paperwork continues to read as follows: comments to the proposed rule be Reduction Act of 1980. OMB approved submitted on or before January 9, 1995. the information collection requirements Authority: 20 US.C. 1221e-3(a)(1) and We received 10 comments. 3474, unless otherwise noted. in the regulations for part 75 on June 3, We had proposed that, for the 1994 and for part 74 on July 12, 1994. § 75.118 [Amended] purposes of § 3.317, a disability resulting from an undiagnosed illness Waiver of Proposed Rulemaking § 75.599 [Amended] would be considered chronic if it had In accordance with the 4. Sections 75.118 and 75.590 are existed for 6 months or more. One Administrative Procedure Act (5 U.S.C. amended by adding the OMB control commenter recommended that VA 553), it is the practice of the Secretary number at the end of these sections to consider disabilities subject to Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6661 intermittent periods of improvement be eligible for compensation under support a diagnosis of CFS. If that and worsening over a 6-month period as § 3.317. The commenter stated that it fatigue does not fall among the chronic. appears that VA would accept even a characteristic signs and symptoms of VA agrees that including this concept single symptom as sufficient to qualify. another disease, it certainly might in the rule will promote clarity and The commenter is correct in assuming indicate the presence of an undiagnosed ensure that the criteria for chronicity are that a single symptom or sign may be illness. consistently applied. Therefore, we have sufficient to establish entitlement under This same commenter stated that VA revised § 3.317(a) as the commenter § 3.317, provided it is determined to be has a working definition of ‘‘Persian suggested. the result of an undiagnosed illness. Gulf Syndrome’’ that lists many of the Another commenter recommended This was intended by our proposed 13 signs and symptoms listed at that the rule specify the point from § 3.317(a)(1): ‘‘* * * objective § 3.317(b) and wondered why this which VA would measure chronicity, indications of chronic disability * ** ‘‘syndrome’’ is not cited in that i.e., forward from the date symptoms manifested by one or more signs and paragraph. were first reported or backward from symptoms * * *’’ (emphasis added). ‘‘Persian Gulf Syndrome’’ is not a date of claim. However, as further clarification, we disease entity currently recognized by The 6-month period of chronicity will have amended the words ‘‘signs and VA or commonly accepted within the be measured from the earliest date the symptoms’’ to read ‘‘signs or medical community. VA has, in fact, symptoms of the disability became symptoms.’’ been unable to establish a single manifest, whether as reported and The proposed regulation, as required ‘‘working definition,’’ and any working documented during the course of a by the statute, contained a list of 13 definition, by its very nature, would not medical examination or as established categories of signs and symptoms which find a firm basis in the current scientific by other, non-medical evidence. In might be manifestations of undiagnosed and medical evidence and, in our order to ensure proper understanding, illnesses. One commenter said that it judgment, should not be used to we have revised § 3.317(a) to clarify this was not clear why VA considered some establish entitlement under the issue. of the 13 signs and symptoms listed at provisions of this rule. The purpose of Another commenter objected to § 3.317(b) undiagnosable. As an this rule making is not to define by defining a chronic disease as one which example, the commenter referred to regulation what the medical community has existed for at least 6 months and fatigue lasting longer than 6 months as has yet to identify or define, but rather suggested that chronicity be determined having a known diagnosis, already to establish criteria for paying on the basis of clinical and laboratory recognized by VA, of chronic fatigue compensation to Persian Gulf veterans findings and application of the criteria syndrome (CFS). for a showing of chronic diseases in 38 The signs and symptoms listed at suffering from chronic disabilities CFR 3.303(b). § 3.317(b) represent possible resulting from undiagnosed illnesses. VA does not agree. The criteria of manifestations of undiagnosed illnesses. One commenter recommended that § 3.303(b) require a combination of However, the commenter’s implication § 3.317(b) specify that other signs and manifestations sufficient to identify the that a medically verifiable sign of an symptoms might qualify as possible disease entity and sufficient observation illness constitutes a diagnosis of a manifestations of undiagnosed illness. to establish chronicity at the time. So specific disease is not correct. A The list at § 3.317(b) is simply a long as we are dealing with a known ‘‘disease’’ is manifested by a guideline presenting the symptoms and disease whose clinical course is characteristic set of symptoms and signs signs which have been encountered in familiar, those criteria are appropriate. (Dorland’s Illustrated Medical over 17,000 completed and analyzed In our judgment, however, they are not Dictionary, 27th ed.). A single sign or examinations of participants in VA’s appropriate for dealing with an symptom may be among the Persian Gulf Health Registry. The undiagnosed illness, which cannot be characteristic signs and symptoms of categories are broad and encompass a associated with a known disease process more than one disease, depending on wide range of conditions and and the clinical course of which cannot any other signs and symptoms with complaints. Section 3.317(b) itself be predicted. In these cases, it is which it appears. Many Persian Gulf clearly indicates that this list is not essential to establish an objective veterans, however, have come forward exclusive, and we do not believe that indicator of chronicity to ensure that the with signs and symptoms which are not revising the language would make the same standard will be applied in every characteristic of any known disease. point any clearer. case. Therefore, we have adopted 6 The commenter’s assertion that Another commenter stated that many months, a period commonly accepted fatigue lasting longer than 6 months by Persian Gulf veterans also complained within the medical community for that itself equates to CFS is also incorrect. of hair loss and memory loss and purpose, as the standard for determining VA has adopted criteria for CFS similar requested that VA clarify whether these chronicity. to those contained in guidelines conditions are encompassed by the 13 One commenter recommended that published by the U.S. Department of listed categories. the regulation include a statement that Health and Human Services (HHS), Hair loss is included within the objective indications of disability mean which require a combination of several category ‘‘signs and symptoms involving both ‘‘signs’’ in the medical sense and major and minor criteria to establish a skin’’ (§ 3.317(b)(2)), and memory loss is non-medical indicators capable of diagnosis of CFS (see the Federal included within the category independent verification, as VA stated Register of November 29, 1994, 59 FR ‘‘neuropsychological signs or in the preamble to the proposed rule. 60901). The major criteria include symptoms’’ (§ 3.317(b)(7)). This is We agree with the commenter’s fatigue so severe as to reduce daily consistent with current VA rating recommendation and have amended activities below 50 percent of the usual, procedures, and we see no need to make § 3.317(a) accordingly. pre-illness level for at least 6 months. the list more specific, since any Another commenter suggested that Fatigue of a lesser severity, which does attempts to expand the list and make it the regulation explicitly state how many not last for 6 months, or which is not exclusive might inadvertently omit ‘‘signs or symptoms’’ of undiagnosed accompanied by the major or minor conditions that could be manifestations illness must be present for a veteran to criteria recognized by VA, would not of undiagnosed illnesses. 6662 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations One commenter recommended that undiagnosed illness was not incurred the criteria to be applied in determining VA alter the wording of proposed during active service in the Persian Gulf whether a condition qualifies as an § 3.317(a)(3) (§ 3.317(a)(4) in the final (§ 3.317(c)(1)), and where affirmative undiagnosed illness. rule), which provides that VA will evidence establishes that an VA does not agree. The concept of evaluate chronic disabilities of undiagnosed illness is the result of a what constitutes a ‘‘known clinical undiagnosed illnesses using the criteria supervening condition or event that diagnosis’’ is not such a matter of of VA’s Rating Schedule for a disease or occurred following the veteran’s most uncertainty within the medical injury in which ‘‘the functions affected, recent departure from the Southwest community as the commenter has anatomical localization, and Asia theater of operations and the onset implied. Examining physicians symptomatology are similar,’’ to read of the illness (§ 3.317(c)(2)). One routinely determine whether or not an ‘‘the functions affected, anatomical commenter stated that § 3.317(c)(1) was illness is part of a disease process that localization, or symptomatology.’’ redundant and unnecessary in light of follows a particular clinical course Since we intend to allow rating § 3.317(c)(2). which can be generally predicted. If the specialists enough flexibility to rate as VA does not agree. The prohibition physician is unable to attribute a accurately and fairly as possible, we contained in § 3.317(c)(2) applies disability to such a known clinical have amended the language as the whether the illness was alleged to have diagnosis, he or she would routinely commenter suggested. occurred during service in the include a statement to that effect on the This same commenter also Southwest Asia theater of operations or examination report. In the event of recommended that VA develop full during the presumptive period conflicting findings, it would be rating criteria specific to the thereafter. However, since Public Law incumbent upon VA to resolve the issue undiagnosed illnesses of Persian Gulf 103–446 did not contemplate eligibility on the basis of all medical evidence of veterans, and covering the full range of by reason of aggravation of a pre- record. physiological and psychological existing undiagnosed illness, the Another commenter believed that the disabilities being reported. provisions of § 3.317(c)(1) are necessary requirement for a finding of Although Persian Gulf veterans have to ensure that entitlement to undiagnosed illness is outside currently reported that they are suffering from a compensation is properly established. accepted standards of medical practice variety of signs and symptoms, the One commenter stated that the and that physicians should not be scientific and medical communities ‘‘affirmative evidence’’ standard for required to make a diagnosis of an have been unable to identify a single determining that an undiagnosed illness ‘‘undefined non-disease.’’ disease process and, in fact, have was the result of a supervening The regulation does not require that suggested that more than one disease condition or event does not equate to physicians make such a diagnosis. category may be involved. Our purpose any standard known in law but is rather Physicians should simply record all in this rule making is to authorize an arbitrary standard established by VA. noted signs and reported symptoms, compensation for the disabilities The commenter suggested substituting document all clinical findings, and resulting from the undiagnosed the recognized legal standard of ‘‘clear provide a diagnosis where possible. If illnesses, and, in our judgment, the and convincing evidence.’’ the signs and symptoms are not criteria in the Rating Schedule are VA does not agree. In fact, the characteristic of a known clinical adequate to evaluate any disabilities standard of ‘‘affirmative evidence’’ is diagnosis, the physician should so which may arise. long established in the statutes and indicate. This conforms with the usual One commenter recommended that regulations governing VA benefits. It is standards of medical practice. VA revise § 3.317 to specify that service used in 38 U.S.C. 1113 to define the The proposed regulation provided connection may be recognized for type of evidence sufficient to rebut a that VA shall pay compensation to a aggravation of a preexisting presumption of service connection. Persian Gulf veteran who exhibits undiagnosed illness during service in Congress again adopted the term at 38 objective indications of chronic the Southwest Asia theater of operations U.S.C. 1116(a)(3), which provides that a disability resulting from an undiagnosed or during the presumptive period. veteran who served in the Republic of illness or combination of illnesses as VA does not agree. In enacting Public Vietnam during the Vietnam era and has manifested by one of the 13 signs and Law 103–446, Congress authorized VA one of the presumptive diseases related symptoms listed at § 3.317(b). One to compensate Persian Gulf veterans to herbicide exposure will be presumed commenter stated that objective who suffer chronic disabilities resulting to have been exposed to herbicides verification of symptoms by an from undiagnosed illnesses that became ‘‘unless there is affirmative evidence’’ to examining physician would be manifest during active service in the the contrary. Under 38 CFR 3.307(d), impossible, since most of the 13 signs Southwest Asia theater of operations or affirmative evidence accepted to rebut a and symptoms are subjective. He within a presumptive period thereafter, presumption of service connection, predicted that many veterans would not as determined by the Secretary. It would although not requiring a conclusive present with objective signs perceptible exceed the Secretary’s statutory showing, must, nonetheless, be to examining physicians and that, authority to compensate for aggravation competent to indicate the time of therefore, examinations would be of disabilities resulting from preexisting existence or inception of a disease and judged inadequate or claims would be undiagnosed illnesses. Furthermore, must support a conclusion that a disease denied for a lack of objective evidence. since the course of an undiagnosed was not incurred in service. We believe Another commenter recommended that illness cannot be predicted, it would be that this standard is both reasonable for VA omit the word ‘‘objective.’’ impossible to determine whether an determining whether a claimed VA does not agree. Some veterans increase in disability was due to the undiagnosed illness is the result of a may present with purely subjective natural progress of the illness or to supervening condition and consistent symptoms, which, nonetheless, aggravation during service. with standards that VA applies to establish the basis for a valid claim The proposed regulation contained presumption for diagnosed conditions. under the provisions of this rule. We provisions prohibiting payment of One commenter recommended that believe, however, that it is not only fair compensation where affirmative the regulation define the term ‘‘known but also in keeping with Congressional evidence establishes that an clinical diagnosis’’ in order to specify intent to require some objective Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6663 indication of the presence of a chronic provide for a 60-day predetermination signs and symptoms of illness shortly disability attributable to an undiagnosed period prior to final rating action in after their return from the Persian Gulf, illness before awarding compensation. order to safeguard a veteran’s due there is as yet little or no medical or In the House of Representatives report process rights. We believe that a scientific evidence definitively linking on H.R. 4386, an earlier version of decision on entitlement under other the illnesses with service in the Gulf, Persian Gulf legislation, the Committee provisions can be made prior to and the credible evidence available on Veterans’ Affairs stated its intention termination or reduction under supports no conclusions regarding ‘‘that there must be some objective § 3.500(y). etiology or definition of these illnesses. indication or showing of the disability While the possibility remains that The National Institutes of Health (NIH)- which is observable by a person other some awards under § 3.317 might be sponsored Technology Assessment than the veteran, or for which medical terminated prior to a final determination Workshop on the Persian Gulf treatment has been sought.’’ (House of entitlement under other provisions, Experience and Health, held in April Report # 103–669, p. 7.) Similarly, at a we have no authority to pay 1994, concluded that it was not possible September 14, 1994, hearing on the compensation in the absence of an to establish a single case definition for Senate Committee on Veterans’ Affairs, actual determination of entitlement. the illnesses of Persian Gulf veterans Senator Rockefeller, then Chairman of However, if payment is terminated but and that, in fact, more than one disease the Committee, stated that in entitlement is subsequently established category might be present, with introducing S. 2330, an earlier Senate on another basis, payments may be overlapping symptoms and causes. version of the legislation, it was his made retroactive to the date More recently, a report of the Medical intention that compensation be paid in compensation under the provisions of Follow-up Agency of the Institute of situations where a veteran ‘‘has § 3.317 was terminated. Medicine (IOM), published in January of symptoms that can be verified by One commenter recommended that this year, endorsed the report of the NIH objective tests that show that the this regulation state that if scientific panel comprized of non-government [veteran] is not well.’’ (S. Hrg. 103–829, research eventually establishes that the experts and stated that ‘‘[t]he Gulf War p. 3.) signs and symptoms of Persian Gulf illness phenomenon may prove to be a Ordinarily, an objective indication is veterans with undiagnosed illnesses mixture of several illnesses, or may established through medical findings, constitute a syndrome which can be prove not to be associated with a i.e., ‘‘signs’’ in the medical sense of attributed to service in the Persian Gulf, specific exposure or disease.’’ The IOM evidence perceptible to an examining the provisions of 38 CFR 3.303(d) will report further concluded that physician. However, we also will provide a basis for establishing service establishment of a case definition was consider non-medical indications which connection for this syndrome. ‘‘handicapped by the lack of any VA does not agree. Section 3.303(d) can be independently observed or generally recognized pathognomonic provides that, notwithstanding statutory verified, such as time lost from work, physical signs or laboratory findings, presumptive periods, service connection evidence that a veteran has sought and by uncertainty about whether a may be granted for a disease first medical treatment for his or her specific syndrome exists and, if it does symptoms, evidence affirming changes diagnosed after discharge from service when all pertinent evidence establishes exist, its prevalence among Gulf War in the veteran’s appearance, physical veterans. The subjectivity of many of the abilities, and mental or emotional that the disease was incurred in service. However, so long as medical and complaints associated with the Gulf War attitude, etc. Lay statements from illness creates serious problems for individuals who establish that they are scientific research has not established those seeking to investigate the validity able from personal experience to make that some or all Persian Gulf veterans and origins of the illness.’’ (Health their observations or statements will be with undiagnosed illnesses are in fact Consequences of Service During the considered as evidence when VA suffering from a recognizable disease Persian Gulf War: Initial Findings and determines whether the veteran is process attributable to service in the Recommendations for Immediate suffering from an undiagnosed illness. Gulf, any regulatory assumption that Two commenters suggested that research will, in fact, eventually support Action, National Academy Press, 1995, where the previously undiagnosed such a finding would be conjectural and p. 26.) Given this uncertainty of illness of a veteran is subsequently premature. available scientific and medical diagnosed, compensation under § 3.317 One commenter remarked that VA, in evidence, we felt that a presumptive should continue until a decision on establishing a presumptive period, period could not be established on this eligibility under other statutory or seems not to have taken into account basis, and we looked to the other 2 regulatory provisions has been reached. either credible scientific and medical factors, historical treatment and Once the illness in a particular case evidence or pertinent circumstances pertinent circumstances, to determine has been diagnosed and a veteran is no regarding the experiences of Persian an appropriate period. longer entitled to compensation under Gulf veterans and, thus, failed to meet For many years Congress has the provisions of § 3.317, the provisions statutory requirements of Public Law authorized a one-year presumptive of § 3.500(y) require termination of 103–446. period for various chronic diseases, compensation as of the last day of the VA does not agree. Public Law 103– many of which present signs and month in which 60 days following the 446 required VA to determine an symptoms similar to those of the final rating decision expires. However, appropriate presumptive period undiagnosed illnesses of Persian Gulf VA will simultaneously begin following a review of the credible veterans (see 38 U.S.C. 1101(3) and consideration of potential entitlement scientific and medical evidence and the 1112(a)). This historical treatment of under other statutory and regulatory historical treatment afforded disabilities chronic diseases might indicate that a provisions and will initiate any required for which manifestation periods have one-year presumptive period would be development for additional evidence. been established, and taking into warranted for the undiagnosed illnesses Although the 60-day period of § 3.500(y) account other pertinent circumstances of Persian Gulf veterans. We felt, is fixed in accordance with the regarding the experiences of veterans of however, that a one-year presumptive requirements of 38 CFR 3.105(d) and (e), the Persian Gulf War. Although many period would not meet the particular those sections of the regulations also veterans began to develop unexplained needs of these veterans, because it was 6664 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations not immediately apparent when most of illnesses. Longer or open-ended The Persian Gulf Registry them left the Southwest Asia theater of presumptive periods for certain examination is not the only acceptable operations that their signs and diseases, such as those associated with means of documenting the presence of symptoms, which some believed exposure to radiation or herbicides, an undiagnosed illness. Other types of resulted from exposure to were established only following many medical evidence may be used, such as environmental hazards, would present years of extensive research. For routine VA medical reports, military the problems of diagnosis and etiology example, to assist in determining what medical records, and reports from that remain unresolved today. We diseases may be associated with private physicians. We believe that believe that two years following service exposure to herbicides used in the where the illness of a veteran in the Gulf provides an adequate period Republic of Vietnam during the Vietnam manifested itself to a compensable of time in which all veterans of the era, VA contracted with the National degree (10 percent or greater), it is very hostilities would have become aware of Academy of Sciences (NAS) to do a likely either that the veteran would have the potential significance of their review of the available scientific and sought medical treatment or that other, symptoms and have had an opportunity medical literature. The NAS non-medical evidence is available to present and document health subsequently reviewed 6,420 abstracts which would document the veteran’s concerns that arose soon after their of scientific or medical studies and signs or symptoms. For example, lay departure from the Gulf. Certainly by approximately 230 epidemiological statements from individuals who the end of the first 2 years following studies prior to submitting establish that they are able from their return, there were great public recommendations. A similar body of personal experience to make their awareness of and concern for Persian medical and scientific evidence observations or statements concerning Gulf veterans with unexplained addressing the undiagnosed illnesses of the appearance of the signs or symptoms illnesses that defied diagnosis but Persian Gulf veterans simply does not of a veteran’s illness may be used to seemed to be in some way linked to exist at this time, and what evidence is establish entitlement. In fact, many service in the Persian Gulf. available supports no conclusions veterans did file claims for An additional reason for establishing regarding etiology or identification. compensation within 2 years of leaving a 2-year presumptive period rather than There is no basis, other than conjecture, the Gulf based on disabilities that they a one-year period is that VA did not for comparing the undiagnosed illnesses felt may have resulted from exposure to begin full-scale operation of its Persian of Persian Gulf veterans to the environmental hazards. VA Gulf Health Registry until November symptoms of slow viruses or to diseases examinations and other medical 1992. Because many Persian Gulf associated with exposure to radiation or evidence reflecting complaints of or veterans first presented their health herbicides. treatment for these disabilities should concerns in connection with VA’s Several commenters believed that a 2- provide adequate documentation for the Persian Gulf Health Registry year presumptive period was either purposes of this regulation. The 2-year examination, veterans of the actual arbitrary, premature, or too restrictive presumptive period is not intended to hostilities, who began to return from the and, citing the current uncertainty of limit the presumption of service Gulf by mid-1991, did not have this medical and scientific evidence, connection under § 3.317 to illnesses resource available to them within their recommended presumptive periods documented within that time frame. first year after leaving the Gulf. Within ranging from 5 years to open-ended. Documentation of the signs and 2 years, however, all veterans of the Although medical and scientific symptoms first made shortly after the hostilities would have had this evidence is accumulating about the presumptive period might establish opportunity to document their illnesses. various signs and symptoms of Persian entitlement if it reasonably supports a Therefore, we established a 2-year Gulf veterans with undiagnosed conclusion that the illness existed presumptive period running from the illnesses, there is little or no evidence during the 2-year period following a date of a veteran’s last service in the definitively linking the illnesses with veteran’s last service in the Persian Gulf Southwest Asia theater of operations. service in the Gulf, and the credible region. Two commenters recommended that evidence available supports no These commenters also stated that in establishing a presumptive period VA conclusions regarding etiology, many who remained on active duty after take into account the bases for the definition of the undiagnosed illnesses, service in the Persian Gulf were hesitant longer presumptive periods established or latency period, which would justify to report their ailments for fear of for certain diseases associated with adopting a longer presumptive period. jeopardizing their military careers. radiation and herbicide exposure. One The commenters offered no other In our judgment, remaining on active of these same commenters specifically reasonable basis to justify a presumptive duty following service in the Persian recommended establishing a period longer than 2 years, and we have Gulf does not necessarily preclude the presumptive period based on the onset not adopted their recommendations. likelihood that alternative of symptoms of ‘‘slow viruses,’’ which Six commenters believe that the 2- documentation acceptable to VA can be may take up to 8 years to become year presumptive period is inadequate obtained. Although many of these manifest. because Persian Gulf veterans were individuals might have been unwilling VA does not agree. Where scientific unaware that they would need to to seek treatment for their illnesses from and medical evidence has concluded document their undiagnosed illnesses. military physicians, documentation of that manifestation of a disease may be They stated that associating the treatment from civilian physicians delayed following exposure to specific presumptive period with establishment might exist for some. In the event that substances, such as herbicides or of the Persian Gulf Health Registry did others chose not to obtain medical radiation, that evidence might justify not give all veterans of the hostilities an treatment of any kind, lay statements, establishment of an appropriate adequate opportunity to document their such as those mentioned earlier, may be presumptive period. However, medical illnesses because availability of the used to establish entitlement. and scientific evidence addressing the Registry examination was not widely These commenters also stated that latency periods of known diseases known until mid-1993, nearly 2 years since many VA and Department of cannot form a basis for determining a after the first U.S. servicemembers Defense (DOD) physicians have been latency period for undiagnosed began returning from the Persian Gulf. unwilling to acknowledge that their Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6665 illnesses could be related to Persian be diagnosed. There is already a well- Authority: 38 U.S.C. 501(a), unless Gulf service, it is possible that established statutory and regulatory otherwise noted. complaints that have been made have framework for compensating disabilities 2. Section 3.317 is added to read as gone unreported to VA regional offices resulting from diagnosed diseases, follows: in connection with claims for which Congress could have revised if it compensation. had chosen to do so. Compensation may § 3.317 Compensation for certain When a veteran files a claim for be awarded when the evidence disabilities due to undiagnosed illnesses. compensation, the regional office of establishes that a disease was incurred (a)(1) Except as provided in paragraph jurisdiction obtains all pertinent VA, directly during active duty or that a (c) of this section, VA shall pay military, and private medical records. preexisting disease was aggravated by compensation in accordance with Whether or not an examining physician active duty, so long as any increase in chapter 11 of title 38, United States agreed with the veteran’s belief that his severity was not due to the natural Code, to a Persian Gulf veteran who or her illness was the result of service progress of the disease. Compensation exhibits objective indications of chronic in the Persian Gulf, it is likely that may also be paid on a presumptive basis disability resulting from an illness or documentation of the complaint exists, for certain chronic diseases that appear combination of illnesses manifested by since the physician would have been within a statutory presumptive period, one or more signs or symptoms such as obligated to record it. If the complaint generally one year. If the undiagnosed those listed in paragraph (b) of this was made within the 2-year illnesses of Persian Gulf veterans are section, provided that such disability: presumptive period, that record will eventually identified and this current (i) became manifest either during serve as documentation to establish legal framework for compensation active military, naval, or air service in potential entitlement to compensation. proves to be inadequate, that will be an the Southwest Asia theater of operations Three commenters recommended that issue for VA and the Congress to during the Persian Gulf War, or to a VA measure the presumptive period consider at that time. degree of 10 percent or more not later from a date other than the date of a VA wishes to thank the commenters than two years after the date on which veteran’s last service in the Southwest for their thoughtful remarks. The rule is the veteran last performed active Asia theater of operations. They hereby adopted as proposed with the military, naval, or air service in the separately recommended that the revisions to § 3.317(a) mentioned in the Southwest Asia theater of operations presumptive period run from the preamble. during the Persian Gulf War; and effective date of Public Law 103–446, The Secretary hereby certifies that (ii) by history, physical examination, the date VA’s Persian Gulf Health this final rule will not have a significant and laboratory tests cannot be attributed registry was established, or the date of economic impact on a substantial to any known clinical diagnosis. (2) For purposes of this section, a veteran’s separation from service. number of small entities as they are VA does not agree. Since the statute ‘‘objective indications of chronic defined in the Regulatory Flexibility presumes that these health concerns are disability’’ include both ‘‘signs,’’ in the Act, 5 U.S.C. 601–612. This final rule related to Persian Gulf service, it is medical sense of objective evidence would not directly affect small entities. reasonable that the presumptive period perceptible to an examining physician, Only VA beneficiaries could be directly be measured from the date service in the and other, non-medical indicators that affected. Therefore, pursuant to 5 U.S.C. Gulf ended, and the statute itself are capable of independent verification. 605(b), this final rule is exempt from the specifically indicates that the (3) For purposes of this section, presumptive period will be so initial and final regulatory flexibility disabilities that have existed for 6 measured. Furthermore, measuring the analysis requirements of §§ 603 and 604. months or more and disabilities that This final rule has been reviewed by presumptive period from the last date of exhibit intermittent episodes of the Office of Management and Budget Gulf service is consistent with other improvement and worsening over a 6- under the provisions of Executive Order presumptive periods, such as those for month period will be considered 12866, Regulatory Planning and Review, diseases related to radiation or herbicide chronic. The 6-month period of dated September 30, 1993. exposure, which are measured from the chronicity will be measured from the last date on which exposure could have (The Catalog of Federal Domestic Assistance earliest date on which the pertinent occurred. Finally, if the presumptive program numbers are 64.109 and 64.110.) evidence establishes that the signs or period were to be measured from the List of Subjects in 38 CFR Part 3 symptoms of the disability first became date a veteran was separated from manifest. service, veterans who remained on Administrative practice and (4) A chronic disability resulting from active duty for several years after they procedure, Claims, Health care, an undiagnosed illness referred to in left the Persian Gulf would be unfairly Individuals with disabilities, Pensions, this section shall be rated using advantaged. Veterans. evaluation criteria from part 4 of this Another commenter felt that, where Approved: January 25, 1995. chapter for a disease or injury in which the undiagnosed illnesses of Persian Jesse Brown, the functions affected, anatomical Gulf veterans are eventually diagnosed, Secretary of Veterans Affairs. localization, or symptomatology are the regulation should also allow a 2-year similar. For the reasons set forth in the presumptive period for the diagnosed (5) A disability referred to in this preamble, 38 CFR Part 3 is amended as conditions. section shall be considered service VA does not agree. The undiagnosed follows: connected for purposes of all laws of the illness provisions of Public Law 103– PART 3ÐADJUDICATION United States. 446, as implemented by § 3.317, were (b) For the purposes of paragraph specifically intended to relieve the Subpart AÐPension, Compensation, (a)(1) of this section, signs or symptoms unique situation in which certain and Dependency and Indemnity which may be manifestations of Persian Gulf War veterans found Compensation undiagnosed illness include, but are not themselves unable to establish limited to: entitlement to VA compensation 1. The authority citation for part 3, (1) fatigue because their illnesses currently cannot subpart A continues to read as follows: (2) signs or symptoms involving skin 6666 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations (3) headache ENVIRONMENTAL PROTECTION Andrew L. Teplitzky (703–308–7275) or (4) muscle pain AGENCY Allen J. Geswein (703–308–7261), Office (5) joint pain of Solid Waste (5306W), U.S. 40 CFR Part 270 (6) neurologic signs or symptoms Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460. (7) neuropsychological signs or [FRL±5149±1] symptoms SUPPLEMENTARY INFORMATION: Determination of Point at Which RCRA (8) signs or symptoms involving the Subtitle C Jurisdiction Begins for Preamble Outline respiratory system (upper or lower) Municipal Waste Combustion Ash at I. Authority (9) sleep disturbances Waste-to-Energy Facilities II. Background (10) gastrointestinal signs or symptoms A. Nature of Ash From Waste-To-Energy (11) cardiovascular signs or symptoms AGENCY: Environmental Protection Facilities Agency (EPA). B. Regulatory History of Waste-to-Energy (12) abnormal weight loss ACTION: Notice of statutory Ash (13) menstrual disorders. interpretation. C. Initial Agency Reaction to the Supreme (c) Compensation shall not be paid Court Decision under this section: SUMMARY: On May 2, 1994, the Supreme III. The Point of Subtitle C Jurisdiction A. EPA’s Interpretation (1) if there is affirmative evidence that Court issued its decision in City of Chicago v. Environmental Defense 1. Legal Analysis an undiagnosed illness was not incurred 2. Illustrative Examples during active military, naval, or air Fund, Inc. 114 S.Ct. 1588 (1994). In so B. Other Interpretations Considered service in the Southwest Asia theater of doing, the Court held that, although 1. Facility Property Boundary operations during the Persian Gulf War; municipal waste-to-energy (WTE) 2. Inside the Combustion Building or facilities that burn household wastes C. Additional Policy Considerations alone, or in combination with IV. Conclusion (2) if there is affirmative evidence that nonhazardous wastes from industrial an undiagnosed illness was caused by a I. Authority and commercial sources, are exempt supervening condition or event that from regulation as a hazardous waste This action interpreting RCRA Section occurred between the veteran’s most treatment, storage, or disposal facility 3001(i) and the hazardous waste recent departure from active duty in the under Subtitle C of the Resource regulations in 40 CFR Parts 260–271 is Southwest Asia theater of operations Conservation and Recovery Act (RCRA), being taken under the authority of during the Persian Gulf War and the the ash that they generate is not exempt. sections 2002 and 3001 of the Solid onset of the illness; or The Court, however, did not specify the Waste Disposal Act of 1970 as amended (3) if there is affirmative evidence that point at which the ash generated by the by the Resource Conservation and the illness is the result of the veteran’s WTE facility becomes subject to Subtitle Recovery Act of 1976, as amended (42 own willful misconduct or the abuse of C of RCRA. EPA is responding to U.S.C. 6912 and 6921). alcohol or drugs. numerous requests for resolution of this II. Background (d) For purposes of this section: issue by announcing today that it (1) the term ‘‘Persian Gulf veteran’’ interprets § 3001(i) of RCRA to first A. Nature of Ash From Waste-to-Energy means a veteran who served on active subject the ash generated by a WTE Facilities military, naval, or air service in the facility to RCRA Subtitle C when it exits Combustion of municipal solid waste, Southwest Asia theater of operations the combustion building following the particularly through WTE facilities, can during the Persian Gulf War. combustion and air pollution control be an important component of a local (2) the Southwest Asia theater of processes. government’s waste management operations includes Iraq, Kuwait, Saudi EFFECTIVE DATE: February 3, 1995. practices. As of 1993, approximately Arabia, the neutral zone between Iraq ADDRESSES: Docket Clerk, OSW (OS– 207 million tons of municipal solid and Saudi Arabia, Bahrain, Qatar, the 305), Docket No. 95–XA2N–FFFFF, U.S. waste were generated annually in the United Arab Emirates, Oman, the Gulf Environmental Protection Agency U.S., 16 percent of which (33 million of Aden, the Gulf of Oman, the Persian Headquarters, 401 M Street, SW., tons) was combusted. There are Gulf, the Arabian Sea, the Red Sea, and Washington, DC 20460. The public approximately 150 municipal waste the airspace above these locations. docket is located in M2616 at EPA combustors in the U.S., 80 percent of (Authority: Title I, Pub. L. 103–446; 38 U.S.C. Headquarters and is available for which are WTE facilities. The remaining 501(a)) viewing from 9:00 a.m. to 4:00 p.m., 20 percent incinerate waste without Monday through Friday, excluding recovering energy. 3. Section 3.500 is amended by Federal holidays. Appointments may be Approximately 25 percent (dry adding paragraph (y) to read as follows: made by calling (202) 260–9327. Copies weight) of the waste that is combusted § 3.500 General. cost $0.15/page. Charges under $25.00 remains as ash, amounting to around are waived. eight million tons of municipal waste * * * * * FOR FURTHER INFORMATION CONTACT: combustor (MWC) ash generated (y) Compensation for certain For general information, contact the annually. While the ash may be disabilities due to undiagnosed illnesses RCRA/Superfund Hotline, Office of collected at a number of locations (§§ 3.105; 3.317). Last day of the month Solid Waste, U.S. Environmental within a WTE facility, it typically is in which the 60-day period following Protection Agency, 401 M Street, SW., characterized as either ‘‘bottom ash’’ or notice to the payee of the final rating Washington, DC, 20460, (800) 424–9346, ‘‘fly ash.’’ Bottom ash collects at the action expires. This applies to both TDD (800) 553–7672 (hearing impaired); bottom of the combustion unit and reduced evaluations and severance of in the Washington, DC metropolitan comprises approximately 75–80% of the service connection. (Authority: Pub. L. area the number is (703) 920–9810, TDD total ash by weight. Fly ash collects in 103–446; 38 U.S.C. 501(a)) (703) 486–3323. the air pollution control devices that [FR Doc. 95–2764 Filed 2–1–95; 9:07 am] For more detailed information on ‘‘clean’’ the gases produced during the BILLING CODE 8320±01±P specific aspects of this Notice, contact combustion of the waste and comprises Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6667 around 20–25% of the total by weight. waste requirements of Subtitle C of interpretation related to the The fly ash from a WTE facility’s RCRA. management of WTE ash that is different air pollution control devices As a result of this decision, persons hazardous (59 Fed. Reg. 29372). First, typically is consolidated and then generating ash from WTE facilities must the notice extended the deadline within combined with the bottom ash via determine whether the ash is hazardous. which owners/operators of facilities that enclosed conveyors at the bottom of the Studies show that ash sometimes is a treat, store, or dispose of hazardous ash MWC where it is cooled and conveyed hazardous waste under RCRA because it must file a hazardous waste permit to a storage area. EPA estimates that exhibits EPA’s toxicity characteristic application. This action gave owners nearly 80% of WTE facilities routinely (TC). Generally, this determination is and operators of facilities that manage combine their ash. made by either testing using the hazardous ash six months to apply for The regulation of WTE ash has been Toxicity Characteristic Leaching ‘‘interim status’’ under the RCRA the subject of controversy and debate Procedure (TCLP) (see 40 CFR § 261.24) hazardous waste regulatory program. ever since the inception of the or by using knowledge of the Without interim status, the facility hazardous waste management program combustion process to determine would be out of compliance with under Subtitle C of RCRA. EPA’s notice whether the ash would exhibit the TC. RCRA’s permit requirements and face of June 7, 1994 (59 Fed. Reg. 29372) Typically, ash that ‘‘fails’’ the TC potentially significant civil and criminal provides a discussion of the regulatory leaches lead or cadmium above levels of penalties. history of ash from WTE facilities. The concern. Existing studies also show that The second issue discussed in this following section summarizes that fly ash contains the highest notice was the Agency’s interpretation discussion. concentrations of inorganic chemical that ash from WTE facilities be constituents. It is more likely to exhibit classified as a ‘‘newly identified waste’’ B. Regulatory History of Waste-to-Energy the TC than either bottom ash or for the purposes of the RCRA land Ash combinations of bottom ash and fly ash. disposal restrictions (LDRs), meaning In 1980, EPA promulgated a rule Ash that is determined to be a that the current land disposal exempting household wastes from all hazardous waste must be handled in restrictions do not apply. When the RCRA requirements for hazardous compliance with EPA regulations for restrictions apply, hazardous ash will wastes (40 CFR 261.4(b)(1)). EPA hazardous waste management. Ash that have to meet specified treatment interpreted this exemption to extend to is determined not to be a hazardous standards prior to land disposal. EPA the residuals from the treatment of waste may be disposed in a non- currently takes the position that if a household wastes, including ash from hazardous waste facility. waste exhibits a hazardous waste the combustion of household wastes. characteristic at its point of generation, C. Initial Agency Reaction to the The exemption, however, did not it must meet LDR standards even if it Supreme Court Decision address ash from the combustion of ceases to exhibit the characteristic prior household wastes combined with While the Supreme Court decision to land disposal. nonhazardous commercial and ended nearly a decade of controversy industrial wastes. over the general regulatory status of ash, III. The Point of Subtitle C Jurisdiction In 1984, Congress added to RCRA a it also raised some new legal and policy A. EPA’s Interpretation new Section 3001(i). This provision issues. To provide some immediate addressed WTE facilities burning interim guidance, the Agency issued 1. Legal Analysis exempt household hazardous wastes several documents shortly after the Neither the Supreme Court’s decision and nonhazardous commercial and Supreme Court decision. on ash nor any of EPA’s previous policy industrial wastes to produce energy. In First, on May 24, 1994, the Agency statements on ash address the point at July 1985, EPA promulgated a rule that released for immediate use a draft which the ash generated by a WTE codified this provision. In the preamble guidance manual for ‘‘Sampling and facility becomes subject to Subtitle C of accompanying this rule, EPA Analysis of Municipal Refuse RCRA—in other words, at which point announced that it interpreted the statute Incinerator Ash.’’ The purpose of the or points in the facility the owner/ to exempt the combustion of waste, but manual was to assist owners and operator must determine whether the not the management of ash, from operators of MWCs in designing a plan ash exhibits the toxicity characteristic of Subtitle C (50 Fed. Reg. 28702, 28725– for testing ash to determine whether it a hazardous waste (and, in the future, 26 (July 15, 1985)). Since 1985, the is hazardous. On June 23, 1994, EPA the point at which LDR restrictions will Agency’s interpretation of § 3001(i) of formally requested public comment on begin to apply). RCRA has been a subject of much the draft guidance (59 Fed. Reg. 32427). Section 3001(i) provides that ‘‘[a] debate. The comment period ended on resource recovery facility recovering In September 1992, EPA September 21, 1994. The Agency energy from the mass burning of Administrator William Reilly signed a intends to issue a final guidance manual municipal solid waste shall not be memorandum announcing that the in the Spring of 1995. deemed to be treating, storing, disposing Agency interpreted Section 3001(i) to Second, on May 27, 1994, EPA issued of, or otherwise managing hazardous exempt from all Subtitle C requirements a memorandum outlining an waste * * *.’’ if certain conditions ash from WTE facilities burning implementation strategy to assist regarding waste receipt are met. In the household wastes and nonhazardous affected parties in achieving compliance City of Chicago case, the Supreme Court wastes. On May 2, 1994, the Supreme with the Court’s decision. The strategy issued a narrowly focused opinion Court issued an opinion interpreting identified the Agency’s priorities for addressing the issue of whether this Section 3001(i) of RCRA, 42 U.S.C. pursuing enforcement actions language created an exemption for ash 6921(i). City of Chicago v. EDF, 114 concerning the management of MWC generated by resource recovery S.Ct. 1588 (1994). The Court held that ash. The Agency intends to issue a facilities. Noting that the provision fails this provision does not exempt ash revised implementation strategy shortly. to mention ash and fails to include generated at WTE facilities burning Third, on June 7, 1994, the Agency ‘‘generation’’ in the list of exempted household wastes and nonhazardous published a notice addressing two activities, the Court found that no commercial wastes from the hazardous issues of statutory and regulatory exemption for ash was intended. 114 S. 6668 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations Ct. at 1591–92. In fact, the Court found the statute allowed regulation of ash the generator’s duties. Further, today’s the statute to be so free from ambiguity inside the building, the facility owner/ interpretation does not create the type of on this issue that there was no need to operator might need to sample and total exemption for ash that the consult legislative history and no analyze ash at multiple points. This Supreme Court rejected in City of occasion to defer, under the principles approach could require owners and Chicago. Operators of MWC facilities of Chevron, U.S.A. v. NRDC, 467 U.S. operators to deal with major logistical still must comply with the generator’s 837 (1984), to the interpretation problems associated with shutting down duty to make a hazardous waste preferred by the Agency. Id. at 1594. individual boilers and retrofitting/ determination. Any ash that exhibits a The Court, however, failed to reach reconfiguring the combustor to characteristic when exiting the the issue of the precise point at which accommodate installation of multiple combustion building must be managed regulation of ash must begin, and handling and storage systems to in compliance with all applicable section 3001(i) does not expressly separately convey the ash streams to Subtitle C requirements. EPA’s address the issue. For the reasons set different load out areas and ash interpretation merely clarifies the out below, EPA believes it is reasonable conditioning systems. Some facilities location at which the determination for to interpret Section 3001(i) to first may not currently have the space to waste characterization purposes must impose hazardous waste regulation at accommodate the additional equipment occur (and the point at which future the point that the ash leaves the required and could be forced to either LDRs requirements will begin to apply). ‘‘resource recovery facility,’’ defined as close or temporarily shut down until 2. Illustrative Examples the combustion building (including additional space could be procured. connected air pollution equipment). Retrofitting a facility in this manner Today’s interpretation is perhaps best Consequently, the point at which an ash could be costly. Some state and industry explained through the use of specific hazardous waste determination should representatives, in fact, have projected examples. For instance, many WTE be made (and, in the future, at which costs in excess of several million dollars facilities automatically convey, via the LDRs will begin to apply) is the per facility. Hence, this interpretation enclosed conveyor, the fly ash collected point at which ash exits the combustion could conflict with Congressional intent at its various locations (including any building following the combustion and by serving as an ‘‘impediment’’ to air pollution control devices such as the air pollution control processes. resource recovery facilities. S. Rep. 98– acid gas scrubbers, baghouse filters, and Section 3001(i) does not define the 284 at 61. In addition, the cost of electrostatic precipitators that may exist term ‘‘resource recovery facility.’’ EPA sampling and analysis alone probably outside the combustion building) to a believes that it is reasonable to conclude would at least double considering quench tank within the combustion that Congress intended to refer to the collection and analysis of at least two building where it is combined with the building that houses the combustion different ash streams—bottom ash and bottom ash. The combined ash is then device. This is the common sense fly ash—instead of a single combined conveyed to a separate, detached storage reading of the term, and it strikes a ash stream. (Although owners and building or to trucks for direct transport better balance between the objectives of operators may legally use knowledge in to an off-site disposal facility. The point section 3001(i) and the rest of Subtitle lieu of testing, due to the variable nature at which RCRA hazardous waste C than either of the alternative readings of ash, virtually all owners and jurisdiction would begin for these described below. Further, EPA believes operators conduct TCLP testing.) These facilities would be the point where the that it is reasonable to conclude that costs would contribute to the total ash exits the combustion building. Congress intended to exempt all burden imposed on the WTE facility. Under this interpretation, the owner/ handling of any hazardous waste within Finally, in selecting an interpretation operator could combine fly ash and the building, including the handling of of section 3001(i), EPA also must bottom ash within the combustion hazardous ash. Subjecting ash within consider Subtitle C’s general goal of building before making any hazardous the building to hazardous waste protecting human health and the waste determination. Any type of device regulation could, for example, require environment from the threats posed by could be used within the building for operators to collect samples of ash for hazardous waste. As explained in ash management activities such as waste determination purposes. It also greater detail in section C below, EPA collection, mixing, and conditioning. could affect the number of hazardous does not believe that this interpretation EPA includes in its interpretation of ash waste streams that would become would have any significant impact on ‘‘resource recovery facility’’ those air subject to LDR treatment standards. the level of environmental protection for pollution control devices that are ‘‘Collection’’ and ‘‘treatment’’ are among ash. integral components of the combustion the activities included in the definition EPA also believes that today’s process. Ash from air pollution control of ‘‘management’’ in section 1004(7) of interpretation is consistent with the devices that is reconveyed back to the RCRA. Section 3001(i) expressly Supreme Court’s 1994 decision combustion building in enclosed ducts exempts treatment, storage, disposal and construing RCRA § 3001(i). In City of has, in EPA’s view, not left the management of hazardous waste at Chicago v. EDF, 114 S. Ct. 1588 (1994), ‘‘resource recovery facility’’ exempted resource recovery facilities. See City of the Court held that Congress intended to under § 3001(i). Moreover, the ducts and Chicago, 114 S. Ct. at 1592. exempt ‘‘resource recovery facilities,’’ air pollution control devices contain the This interpretation is not only a but did not define the term. See, e.g., ash so it does not come into contact reasonable reading of the statutory 114 S. Ct. at 1591–92. While the Court with the environment. language, it also serves Congress’ intent clearly stated that the statute did not A few WTE facilities may exist where to ‘‘encourage commercially viable exempt facility owners from regulation the combustion device is not housed resource recovery facilities and to as hazardous waste generators, id. at within a building. In these instances, remove impediments to their 1592, determining that ash is not subject the combustion device (including air operation.’’ (Emphasis added.) S. Rep. to regulation until it exits the pollution control equipment and 98–284, 98th Cong., 2d Sess. at 61. combustion building does not exempt proximate areas for handling ash) may Regulating ash only at the point it exits the facility owner from regulation as a constructively constitute a combustion the combustion building removes some generator. Rather, it defines the point at building, within the meaning discussed potentially significant impediments. If which the owner must begin to perform above. Thus, if fly ash and bottom ash Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6669 were handled in enclosed systems that within the facility property boundary in with Congress’ goal of ‘‘promoting operate in the same manner as they a landfill that does not meet the resource recovery facilities.’’ S. Rep. 98– would if a building existed and the fly requirements of RCRA Subtitle C. 284, 98th Cong. at 61. ash and bottom ash were mixed in an EPA is rejecting the option of Many of the people advocating this enclosed unit proximate to the designating the point of Subtitle C interpretation maintained that this combustion device, that management jurisdiction at the property boundary. interpretation would require bottom ash activity would be considered to take The most natural reading of the term and fly ash to be sampled separately, place within a combustion building as ‘‘resource recovery facility’’ is the before a facility owner combines them. described above. In this circumstance, combustion device itself. Nothing in the Ash, however, may collect in as many the point at which hazardous waste text of the statute or the legislative as 20 separate locations within an jurisdiction would begin would be the history refers to land holdings or average WTE facility. This point where the combined ash exits the suggests that Congress was familiar with interpretation, if applied literally to the last enclosed ash management unit that them and the types of waste first locations where ash becomes is located proximate to the combustion management conducted on them. identifiable, could lead to a policy device. Rather, the discussion focuses on the requiring that a waste determination be By contrast, where a WTE facility combustion process. EPA believes that made at each of these locations. Such a collects bottom ash within the an exemption for the entire property policy would only increase the combustion building and collects the fly would conflict with the general goals of impediments to viable resource recovery ash outside the combustion building in, Subtitle C because it would provide too facilities. for example, roll-off containers, two many opportunities for potential C. Additional Policy Considerations distinct exit points from the combustion mismanagement of ash at the WTE building exist: (1) the point where the facility without the proper EPA believes that today’s bottom ash ultimately leaves the environmental controls. Such a broad interpretation of § 3001(i) designating combustion building and (2) the point reading of RCRA could allow potential the point of Subtitle C jurisdiction at the where the fly ash leaves the air mismanagement of ash that tested exit of the combustion building pollution control devices (located hazardous within the land boundaries of provides an approach that local outside the combustion building). The the facility in units (e.g., waste piles, governments will find practical and WTE facility operator would thus landfills) that were not appropriately implementable, yet environmentally sample and make a hazardous waste regulated under Subtitle C of RCRA. protective. In accordance with today’s determination at each location. Should EPA believes that this option would not interpretation, ash that is combined the operator determine that either the strike the balance that Congress (and conditioned, for example, with bottom ash or fly ash as is hazardous, intended between section 3001(i)’s goal lime and/or phosphoric acid) at the end management of that ash would have to of promoting resource recovery facilities of the combustion process and within be conducted pursuant to RCRA Subtitle and the general environmental the combustion building, and exhibits C. protection goals of the rest of RCRA no hazardous waste characteristics (i.e., Subtitle C. it passes the TCLP) when it exits that B. Other Interpretations Considered building, may be sent to a nonhazardous Since the Supreme Court decision, the 2. Inside the Combustion Building waste facility for disposal. Agency has received numerous letters Other members of the public argued In comparison, if the Agency had from states, local governments, industry, that the exemption in section 3001(i) selected the option requiring hazardous environmental groups, and others ends at the instant that ash is generated. waste determinations inside the suggesting various approaches to In particular, they objected to any combustion building, the fly ash and determining the point at which the ash temporary exemption for ash that would bottom ash that would have been tested initially becomes subject to RCRA allow facility owners to combine fly ash separately at locations inside the Subtitle C jurisdiction. For example, a and bottom ash before making combustion building and found to number of comments received in hazardous waste determinations. Since exhibit the toxicity characteristic would response to the Agency’s draft sampling combined ash tends to ‘‘pass’’ the TC, not be handled much differently. The and analysis guidance notice of May 24, postponing regulation until combination WTE facility operator could treat (using 1994, addressed this issue. Some has occurred could allow the ash to similar conditioning techniques that are members of the public urged EPA to escape Subtitle C management. These performed inside the combustion adopt the interpretation described commentors argued that such a ‘‘de building under today’s interpretation) above. Other members, however, facto’’ exemption for WTE ash would be the fly ash and bottom ash in on-site suggested two additional options for inconsistent with the spirit of the tanks, containers, or containment interpreting § 3001(i) to establish the Supreme Court’s decision in City of buildings under the provisions of point at which ash becomes subject to Chicago. § 262.34. Such treatment does not Subtitle C regulation. EPA has decided not to read the require a federal hazardous waste statute to require regulation of ash (Subtitle C) permit so long as the ash is 1. Facility Property Boundary within the combustion building. This not retained for more than 90 days. Some members of the public argued interpretation would permit regulation Once the ash ceased to exhibit that the hazardous waste exclusion of the management of hazardous ash hazardous waste toxicity characteristics, under RCRA § 3001(i) applies to all ash within the ‘‘resource recovery facility,’’ it too would be combined and sent for management operations within the in apparent contradiction with the text disposal in a nonhazardous waste property boundary of the WTE facility. of section 3001(i). Further, requiring facility. Similarly, once the LDR This interpretation potentially would sampling, testing, and management of treatment standards for WTE ash allow all ash generated at a WTE facility ash from multiple locations could, as hazardous constituents are promulgated, to be managed on-site, without testing, described below, be unnecessarily the ash would be treated (perhaps using as a non-hazardous waste. It could allow expensive and burdensome in relation some of the same conditioning a WTE facility to dispose of ash that to the environmental benefits received. techniques used today) to meet those would have otherwise failed the TCLP Thus, this interpretation could conflict standards at which point the ash could 6670 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations then be sent for disposal in a health. In fact, the risk of exposure to management guidelines and, if nonhazardous waste facility. fugitive ash emissions could be appropriate, promulgating additional EPA also believes that current heightened if WTE facilities were regulations to address those situations. regulations promulgated under RCRA required to sample or otherwise manage In addition, at individual sites, if the Subtitle D provide protection for the fly ash separately from bottom ash. This disposal of ash presents an imminent disposal of ash as a nonhazardous is because fly ash is generally a fine and substantial endangerment to human waste. In 1991, the Agency promulgated powdery substance that would become health and the environment, EPA may new criteria for municipal solid waste readily airborne were it not for such require responsible persons to landfills, including landfills and normal practices as combining the fly undertake appropriate action under monofills that accept MWC ash (40 CFR ash with the bottom ash in a quench § 7003(a) of RCRA. Part 258). These criteria impose a tank to impede air emissions. Handling comprehensive set of requirements on fly ash before it is combined could IV. Conclusion municipal solid waste landfills increase the risk of release to the In conclusion, today’s interpretation (MSWLFs) including requirements for environment. of RCRA § 3001(i) designates the point location restrictions, facility design and Further, EPA recently published of Subtitle C jurisdiction for WTE ash at operation, ground-water monitoring and proposed regulations under the Clean the exit of the combustion building corrective action, closure and post- Air Act for new and existing municipal following the combustion and air closure care, and financial assurance. waste combustors that address ash. pollution control processes. The Agency The Agency has conducted studies on These regulations would prohibit visible believes that this reading is a reasonable the land disposal of MWC ash from emissions of fugitive fly ash and/or interpretation of the statute that serves WTE facilities and has found no bottom ash from all ash handling the stated goals of § 3001(i). evidence to suggest that disposal in a activities at the facility. They also EPA emphasizes that today’s decision Subtitle D landfill will endanger human address the ash loading areas and ash on the appropriate location to make the health and the environment. Copies of transport vehicles (59 FR 48222, hazardous waste determination for these studies are available in the docket September 20, 1994). MWC ash is unique based on its for this notice. Finally, the Agency understands that interpretation of RCRA § 3001(i). EPA’s For example, EPA has conducted a some groups are concerned about the analysis and conclusions are not study on the effects of MWC ash potential environmental risk posed by relevant to facilities that do not fall leachate on natural and synthetic lining the reuse of ash in projects such as road within the scope of RCRA § 3001(i). materials commonly employed in the base, building blocks, and sidewalks. EPA considers this action to be an construction of municipal solid waste These groups have expressed a desire interpretative rule exempt from the landfill liners. That study indicates that that the Agency either ban ash reuse or requirement for prior notice and carefully selected landfill liner materials place stringent controls on reuse. While opportunity to comment under section can, when exposed to MWC ash reuse of ash currently is not common in 553(b)(3)(A) of the Administrative leachate, be expected to function as an the U.S. (the Agency believes that Procedure Act, 5 U.S.C. 553(b)(3)(A). effective barrier to leachate migration. In significantly less than ten percent of the The notice merely informs the public of addition, EPA is conducting ongoing, in ash generated in the U.S. is reused), the EPA’s view of the definition of situ studies of leachate from monofills Agency does not believe that today’s ‘‘facility’’ in section 3001(i) as derived receiving ash from a WTE facility. These interpretation will stimulate increased from the text of the statute, legislative studies reveal leachate concentrations of interest in ash reuse. It is important to history, and EPA’s view of relevant metals are below their note that, if the WTE facility were Congressional intent. respective TC limits. The States have required to test bottom ash and fly ash Dated: January 27, 1995. indicated that their data also separately and found that either ash corroborates EPA’s findings. failed the TC determination, that facility Carol M. Browner, It is important to note that while could treat the ash on-site to either Administrator. states may allow varying liner designs below TC limits or in accordance with [FR Doc. 95–2627 Filed 2–2–95; 8:45 am] for ash monofills or co-disposal the land disposal restrictions (when BILLING CODE 6560±50±M facilities, these designs must still meet they are set). After this treatment, ash a performance standard intended to would no longer be classified as a protect ground water resources. In hazardous waste and could be used FEDERAL COMMUNICATIONS addition, all landfills regulated under without further hazardous waste COMMISSION RCRA Subtitle D are required to perform regulation (e.g., in construction ground-water monitoring as a way of projects). EPA does not currently 47 CFR Part 73 detecting a release should one occur. In anticipate that future LDR treatment the event of a release to ground water, will differ significantly from some of the Radio Broadcasting Services; Various the owner/operator of the landfill must ash conditioning techniques currently Communities perform corrective action to clean up used at WTE facilities. It also is AGENCY: Federal Communications the ground water. important to note that many states have Commission. The Agency also does not believe that programs addressing the management of ACTION: Final rule. the process of combining and treating ash from WTE facilities. Currently, over ash within the combustion building will one-half of the states address the reuse SUMMARY: The Commission, on its own pose risks to human health. The Agency of ash. motion, editorially amends the Table of understands that many State Should information come to EPA’s FM Allotments to specify the actual environmental programs allow the ash attention suggesting that WTE ash is classes of channels allotted to various to be combined and conditioned prior to being managed or disposed of in a communities. The changes in channel exiting the combustion building for manner that is not protective of human classifications have been authorized in testing. These states have not indicated health and the environment under response to applications filed by to the Agency that these current Subtitle D, the Agency will consider licensees and permittees operating on practices are presenting a risk to human additional actions, including issuing these channels. This action is taken Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6671 pursuant to Revision of Section Channel 276A and adding Channel River; and deleting Channel 249C2 and 73.3573(a)(1) of the Commission’s Rules 276C3 at Plantation Key. adding Channel 249C3 at Rice Lake. Concerning the Lower Classification of 8. Section 73.202(b), the Table of FM 23. Section 73.202(b), the Table of FM an FM Allotment, 4 FCC Rcd 2413 Allotments under Georgia, is amended Allotments under Wyoming, is amended (1989), and the Amendment of the by deleting Channel 258C and adding by deleting Channel 250C and adding Commission’s Rules to Permit FM Channel 258C1 at Douglas. Channel 250C1 at Cheyenne. Channel and Class Modifications 9. Section 73.202(b), the Table of FM Federal Communications Commission. [Upgrades] by Application, 8 FCC Rcd Allotments under Indiana, is amended John A. Karousos, 4735 (1993). by deleting Channel 224A and adding Chief, Allocations Branch, Policy and Rules FOR FURTHER INFORMATION CONTACT: Channel 223A at Kokoma. Division, Mass Media Bureau. 10. Section 73.202(b), the Table of FM Sharon P. McDonald, Mass Media [FR Doc. 95–2682 Filed 2–2–95; 8:45 am] Allotments under Kentucky, is amended Bureau, (202) 418–2180. BILLING CODE 6712±01±F SUPPLEMENTARY INFORMATION: This is a by deleting Channel 250A and adding synopsis of the Commission’s Report Channel 250C3 at Hyden; and deleting Channel 296A and adding Channel and Order, adopted January 18, 1995, DEPARTMENT OF THE INTERIOR and released January 26, 1995. The full 299A at Owingsville. text of this Commission decision is 11. Section 73.202(b), the Table of FM Fish and Wildlife Service available for inspection and copying Allotments under Louisiana, is during normal business hours in the amended by deleting Channel 230C2 50 CFR Part 17 FCC Reference Center (Room 239), 1919 and adding Channel 230C3 at Bastrop. RIN: 1018±AB88 M Street, NW, Washington, D.C. The 12. Section 73.202(b), the Table of FM Allotments under Michigan, is amended complete text of this decision may also Endangered and Threatened Wildlife by deleting Channel 258C1 and adding be purchased from the Commission’s and Plants; Determination of Channel 258C2 Sault Ste. Marie. copy contractors, International Endangered Status for Ten Plants and 13. Section 73.202(b), the Table of FM Transcription Service, Inc., (202) 857– Threatened Status for Two Plants From Allotments under Mississippi, is 3800, 2100 M Street, NW, Suite 140, Serpentine Habitats in the San amended by deleting Channel 243C3 Washington, D.C. 20037. Francisco Bay Region of California and adding Channel 243A Clarksdale. List of Subjects in 47 CFR Part 73 14. Section 73.202(b), the Table of FM AGENCY: Fish and Wildlife Service, Radio broadcasting. Allotments under New Mexico, is Interior. amended by deleting Channel 268C and ACTION: Final rule. Part 73 of Title 47 of the Code of adding Channel 268C1 at Clovis. Federal Regulations is amended as 15. Section 73.202(b), the Table of FM SUMMARY: The U.S. Fish and Wildlife follows: Allotments under New York, is Service (Service) determines PART 73Ð[AMENDED] amended by deleting Channel 263A and endangered status pursuant to the adding Channel 262B1 at Warrensburg. Endangered Species Act of 1973, as 1. The authority citation for Part 73 16. Section 73.202(b), the Table of FM amended (Act) for 10 plants: Castilleja continues to read as follows: Allotments under North Carolina, is affinis ssp. neglecta (Tiburon Authority: 47 U.S.C. 154, 303. amended by deleting Channel 260C and paintbrush), Ceanothus ferrisae (coyote adding Channel 260C1 at Burgaw. ceanothus), Cirsium fontinale var. § 73.202 [Amended] 17. Section 73.202(b), the Table of FM fontinale (fountain thistle), Clarkia 2. Section 73.202(b), the Table of FM Allotments under Oklahoma, is franciscana (Presidio clarkia), Allotments under Alabama, is amended amended by deleting Channel 232A Cordylanthus tenuis ssp. capillaris by deleting Channel 232A and adding adding Channel 232C3 at Elk City. (Pennell’s bird’s-beak), Dudleya Channel 232C3 at Abbeville; and 18. Section 73.202(b), the Table of FM setchellii (Santa Clara Valley dudleya), deleting Channel 293C3 and adding Allotments under Oregon, is amended Eriophyllum latilobum (San Mateo Channel 293C2 at Bay Minette. by deleting Channel 258C and adding woolly sunflower), Pentachaeta 3. Section 73.202(b), the Table of FM Channel 258C1 at Klamath Falls. bellidiflora (white-rayed pentachaeta), Allotments under Alaska, is amended 19. Section 73.202(b), the Table of FM Streptanthus albidus ssp. albidus by deleting Channel 280C3 and adding Allotments under South Dakota, is (Metcalf Canyon jewelflower), and Channel 280A at College. amended by deleting Channel 264C and Streptanthus niger (Tiburon 4. Section 73.202(b), the Table of FM adding Channel 264C1 at Lowry. jewelflower). The Service also Allotments under Arizona, is amended 20. Section 73.202(b), the Table of FM determines threatened status for two by deleting Channel 223C and adding Allotments under Texas, is amended by plants, Calochortus tiburonensis Channel 223C1 at Eagar. deleting Channel 234A and adding (Tiburon mariposa lily) and 5. Section 73.202(b), the Table of FM Channel 234C3 at Corpus Christi; Hesperolinon congestum (Marin dwarf- Allotments under California, is deleting Channel 234C1 and adding flax). These species are restricted to amended by deleting Channel 300C1 Channel 234C at El Paso; and deleting serpentine soil outcrops in the area near and adding Channel 300A at Mount Channel 231C2 and adding Channel San Francisco Bay, California. The 12 Shasta. 231C3 at Point Comfort. plants have been variously affected and 6. Section 73.202(b), the Table of FM 21. Section 73.202(b), the Table of FM are threatened by one or more of the Allotments under Colorado, is amended Allotments under Utah, is amended by following: urbanization, pedestrian, and by deleting Channel 292C2 and adding deleting Channel 238C and adding off-road vehicular traffic, the invasion of Channel 292C3 at Kremmling. Channel 238C1 at Ogden. alien plants, road maintenance, soil 7. Section 73.202(b), the Table of FM 22. Section 73.202(b), the Table of FM erosion and slipping, unauthorized Allotments under Florida, is amended Allotments under Wisconsin, is dumping, livestock grazing, seed by deleting Channel 268C1 and adding amended by deleting Channel 297C2 predation by beetles, and stochastic Channel 268C at Pensacola; and deleting and adding Channel 297C3 at Iron extinction by virtue of the small, 6672 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations isolated nature of the remaining Francisco County; east of the Bay in the of only a few miles or less. The widest populations. This rule implements the Oakland Hills of Alameda County and at ranging species in historic times was Federal protection and recovery Mt. Diablo in Contra Costa County; and Pentachaeta bellidiflora, which provisions afforded by the Act for these north of the Bay on the Tiburon occurred from Marin County to Santa plants. Peninsula in eastern Marin County and Cruz County. It is now restricted to a EFFECTIVE DATE: March 6, 1995. at Mt. Tamalpais, Carson Ridge, and single population as a result of habitat ADDRESSES: The complete file for this near Nicasio Reservoir in western Marin destruction. rule is available for public inspection, County, as well as in Sonoma and Napa The human population of the San by appointment, during normal business Counties. Serpentine soils are variable Francisco Bay region has grown rapidly hours at the U.S. Fish and Wildlife in soil chemistry, texture, and water over the last several decades. Urban Service, 2800 Cottage Way, Room E– availability, both within and between development (including highway 1803, Sacramento, California 95825– sites (McCarten 1987b). This variability construction) has reduced the amount of 1846. and the variety of micro-climates in the serpentine habitat by nearly 20 percent in the past 20 years (McCarten 1987b). FOR FURTHER INFORMATION CONTACT: San Francisco Bay region have a The construction of roads, houses, Elizabeth Warne at 916/978–4866 at the profound effect upon the local flora. recreational facilities, and waste above address. Several serpentine plant communities are found in the San Francisco Bay disposal sites continues. The increasing SUPPLEMENTARY INFORMATION: region (McCarten 1987b). Grassland and numbers of people also place an ever Background annual forb communities (serpentine greater strain on undeveloped bunchgrass grasslands and serpentine wildlands, through activities such as Cordylanthus tenuis ssp. capillaris, wildflower fields) tend to occur on level pedestrian and off-road vehicle traffic, Calochortus tiburonensis, Castilleja ground or on gentle slopes with soils to unauthorized garbage dumping, and affinis ssp. neglecta, Streptanthus niger, 1 meter (m) (3 feet (ft)) or more in depth. changes in the pattern of wildland fires. Clarkia franciscana, Cirsium fontinale Shrub communities (Franciscan Serpentine habitats, because of their var. fontinale, Eriophyllum latilobum, serpentine coastal scrub, mixed often limited vegetative cover, may Hesperolinon congestum, Pentachaeta serpentine chaparral, and Sargent appear to the uninitiated as unoccupied bellidiflora, Ceanothus ferrisae, Dudleya cypress woodlands) tend to occur on space, and so they are especially likely setchellii, and Streptanthus albidus ssp. steep rocky slopes with shallow soils. In to be subject to disturbances. albidus are endemic to serpentine soils some areas, soil development is Recreational activities may directly in the region of the San Francisco Bay minimal and parent rock is extensively impact plants; or may result in in California. Serpentine soils are exposed. These serpentine barrens increased erosion and facilitate the derived from ultramafic rocks such as support a distinctive community invasion of alien species including serpentinite, dunite, and peridotite, composed of only a few species, usually many introduced annual grasses which are found in discontinuous growing at low densities. Another common in California. Competition outcrops in the Sierra Nevada and in the unique habitat on serpentine soils with introduced species is a serious Coast Ranges from Santa Barbara occurs near seasonal springs and seeps, threat to serpentine natives (McCarten County, California to British Columbia. which support species requiring moist 1987b). The destruction of serpentine The chief constituent of the parent rock soil. habitats due to urban development also is some variant of iron-magnesium Most of the 12 species in this rule has increased the fragmentation of rare silicate. Most serpentine soils are occur in the serpentine bunchgrass plant populations, thus, increasing the formed in place over the parent rock, grassland and serpentine wildflower risks of extinction due to chance events and are, therefore, shallow, rocky, and field communities. Cirsium fontinale such as fire, pest or disease outbreaks, highly erodible. Serpentine soils, var. fontinale occurs in serpentine seep reproductive failure, or other natural or because of the parent material, tend to areas. Cordylanthus tenuis ssp. human-caused disaster. have high concentrations of magnesium, capillaris and Ceanothus ferrisae occur The land that supports these 12 taxa chromium, and nickel and low in chaparral, as do a few populations of is owned by local, State, and Federal concentrations of calcium, nitrogen, Hesperolinon congestum. Dudleya agencies, parks, and private parties. potassium, and phosphorus (Kruckeberg setchellii and Streptanthus albidus ssp. Discussion of the Twelve Species 1984). These characteristics make albidus are found on serpentine barrens. serpentine soil inhospitable for the Eriophyllum latilobum grows on North Bay Species growth of most plants. Nevertheless, serpentine-influenced soil in the coast Cordylanthus tenuis ssp. capillaris some plants have adapted to the rigors live oak woodland community. (Pennell’s bird’s-beak) was collected by of life on serpentine soils. In fact, Serpentine endemics may have Herbert Mason about 3.2 kilometers serpentine soils often support a high limited or widespread distributions. (km) (2 miles (mi)) north of Occidental diversity of plants including many rare Some species are restricted to a single in Sonoma County, California, in 1946. species (McCarten 1988). Over 200 taxa outcrop; others occur on serpentine Francis Whittier Pennell described the in California are endemic (restricted) to soils within a particular region; a few plant as Cordylanthus capillaris in serpentine soils (Kruckeberg 1984). species occur throughout almost the 1950, using Mason’s specimen as the Serpentine soils in the San Francisco entire range of serpentine soils in type (Pennell 1950). Pennell was misled Bay region are derived from intrusive California (Kruckeberg 1984). Of the by an erroneous label to think that the igneous rocks associated with fault taxa considered in this rule, plants had been collected in Merced zones in the sedimentary Franciscan (Calochortus tiburonensis) is thought to County (Bacigalupi 1966), which may formation. Outcrops occur south of the always have been restricted to the single have affected his treatment of the taxon Bay in the Coyote Valley of Santa Clara outcrop on which it occurs. Others, (Chuang and Heckard 1986). Artificial County; west of the Bay at Edgewood including Cordylanthus tenuis ssp. hybridization studies of C. brunneus County Park, near Crystal Springs capillaris, Streptanthus niger, and C. capillaris (Chuang and Heckard Reservoir, at Stanford University’s Eriophyllum latilobum, Dudleya 1975) showed a close relationship Jasper Ridge Preserve in San Mateo setchellii, and Streptanthus albidus ssp. between the two plants. The name C. County, and at the Presidio in San albidus, have a known historical range brunneus ssp. capillaris was proposed Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6673 for C. capillaris by Chuang and Heckard tiburonensis from the other two Streptanthus niger (Tiburon (Heckard 1977), but was never formally Calochortus species found on the jewelflower) was described by Edward published. In 1986, Chuang and Tiburon Peninsula, C. umbellatus and C. L. Greene, from a type specimen he had Heckard published a revision of the luteus. collected at St. Hilary’s Church in the genus, in which both C. brunneus and Calochortus tiburonensis is known town of Tiburon in Marin County C. capillaris were treated as subspecies only from its type locality, where it (Greene 1886a). Greene later redefined of C. tenuis (Chuang and Heckard 1986). grows on rocky serpentine slopes among the limits of Euclisia, formerly a Cordylanthus tenuis ssp. capillaris is annual and perennial herbs and grasses. subgenus of Streptanthus, treating it as a branching herbaceous annual of the The population, estimated at 40,000 a genus in its own right (Greene 1904). snapdragon family (Scrophulariaceae). individuals in 1991 (Larry Serpa, The S. niger, as a member of the Euclisia The plant grows 30 to 40 centimeters Nature Conservancy, pers. comm., group, was thus referred to as E. niger. (cm) (12 to 16 inches (in)) tall, with 1992), occurs on land that has been Jepson (1925) returned Euclisia to yellow-green hairless herbage that owned and managed by The Nature subsection status and later authors becomes purplish with age. The leaves Conservancy since 1982. The followed his treatment. Munz treated S. are entire, or those of the primary stem occurrence of this plant in a single niger as a subspecies of S. glandulosus three-parted, and threadlike. The floral population, its proximity to human in A California Flora (1959), and then bracts are three-parted up to two-thirds population centers, and intensive returned it to S. niger in his supplement of their length, with fine marginal hairs development activities renders it (1968), following Kruckeberg (1958). on bracts and calyx. The tubular corolla vulnerable to catastrophic events such Streptanthus niger is an annual herb is 1.5 cm (0.6 in) long and garnet-brown as fire, disease or pest outbreak, severe of the mustard family (Brassicaceae) that laterally, paler dorsally. Each capsule drought, or other natural or human- reaches 30 to 60 cm (1 to 2 ft) in height. contains 10 to 16 seeds. The three-lobed caused disasters. The lower leaves are toothed, the upper outer bracts of Cordylanthus tenuis ssp. The type specimen of Castilleja affinis leaves less toothed or not at all. The capillaris distinguish it from its nearest ssp. neglecta (Tiburon paintbrush) was sepals are a very dark purple; the petals relative (C. tenuis ssp. brunneus) and collected by Katherine Brandegee in the have a purple claw and a white blade from C. pilosus, another Cordylanthus early 1900s. The plant was described by with a purple midvein. The zig-zag found in the area. A further Zeile in 1925 in Willis Jepson’s Manual inflorescence pattern and the lack of distinguishing character is that C. of the Flowering Plants of California. hairs distinguish S. niger from its near pilosus is densely hairy throughout. Castilleja affinis ssp. neglecta is a relative S. glandulosus. Cordylanthus tenuis ssp. capillaris is semi-woody perennial of the Streptanthus niger is found on known only from two locations: the type snapdragon family (Scrophulariaceae), shallow rocky serpentine soils on locality in western Sonoma County and with erect, branched stems 30 to 60 cm southwest-facing slopes on the Tiburon a second occurrence a few miles to the (1 to 2 ft) tall and a sparse covering of Peninsula of Marin County. Two west. A third population may occur on soft, spreading hairs. The lance-shaped populations are known from the property adjacent to the second leaves have one or two pairs of narrow southern end of the peninsula where location, but permission for botanical lobes. The conspicuous floral bracts are they occur within 3 km (2 miles) of one surveys on that property has been yellowish and sometimes red-tipped; another. Populations number from 50 to consistently refused (Betty Guggolz, the flowers are yellow to red and 18 to 2,000 plants (Hunter 1989b, Andrew Milo Baker Chapter, California Native 20 millimeters (mm) (0.7 to 0.8 in) long. Allen, Belvedere-Tiburon Landmarks Plant Society, pers. comm., 1992). The The simple (unbranched) hairs and the Society, in litt., 1991). The plant is total number of plants fluctuates from lack of glands below the inflorescence threatened by residential development, year to year, as is typical of annual distinguish C. affinis spp. neglecta from foot traffic, and road construction. plants. C. tenuis ssp. capillaris is other species of Castilleja on the threatened with potential residential Tiburon Peninsula (C. latifolia var. Central Bay Species development, garbage dumping, and rubra and C. foliosa) (Howell 1970). The type specimen of Clarkia roadside maintenance. Castilleja affinis ssp. neglecta occurs franciscana (Presidio clarkia) was Calochortus tiburonensis (Tiburon in serpentine bunchgrass communities collected by Peter Raven in 1956. C. mariposa lily) was discovered in 1971 on north to west facing slopes. It is franciscana was described by Harlan by Robert West on Ring Mountain on known from four populations in Marin Lewis and Peter Raven (1958). the Tiburon Peninsula in Marin County, County, three of which occur on the Clarkia franciscana is a slender, erect, California. Albert Hill collected the type Tiburon Peninsula, one population in herbaceous annual of the evening- specimen on Ring Mountain the Napa County, and one population in primrose family (Onagraceae), 40 cm (16 following year and published the Santa Clara County. The range of this in) tall with few, very small, and narrow description in 1973 (Hill 1973). plant is approximately 50 km (30 miles) leaves. The lavender-pink petals have a Calochortus tiburonensis is a bulbous from east to west and 112 km (70 miles) lighter basal portion and a reddish- perennial of the lily family (Liliaceae) from north to south. Population sizes purple basal spot. The slender capsule with a single persistent, basal, linear- are small, ranging from 13 plants at a is 2 to 4 cm (1 to 2 in) long. C. oblong leaf 30 to 60 cm (1 to 2 ft) long. location in Santa Clara County (Roxanne franciscana can be distinguished from The flowering stem, about 50 cm (20 in) Bittmann, California Natural Diversity C. rubicunda, a related species that may tall, is usually branched and bears erect Data Base, pers. comm., 1993) to 600 occur in the same area, by its petals that flowers in twos or threes at the ends of plants at Ring Mountain Preserve on the have irregular teeth on the apical the branches. The three petals and three Tiburon Peninsula (Hunter 1989a). A margin. C. rubicunda has petals that are sepals are light yellow-green with total of approximately 1,500 plants rounded at the apex. reddish or purplish-brown markings. exist. The Marin County populations are Clarkia franciscana is restricted to The capsule is triangular in cross- threatened by residential development, serpentine soils in grassland section and about 4 cm (2 in) long. The foot traffic, grazing, and soil slumping; communities in San Francisco and long slender hairs on the upper surface the Napa County population is Alameda Counties. Two populations are and margins of the petals and the lack threatened by gravel mining and known from the Presidio in San of wings on the capsule distinguish C. grazing. Francisco. Three populations are known 6674 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations from the Oakland Hills in Alameda reddish stems 30 to 60 cm (1 to 2 ft) Eriophyllum latilobum is found in County, 27 km (17 mi) east of San high. The basal leaves are 10 to 20 cm shaded moist sites on steep grassy or Francisco, all within 1.0 km (0.6 mi) of (4 to 8 in) long with spine-tipped lobes; sparsely wooded slopes of serpentine- each other. A fourth population in the the leaves on the stems are smaller. The influenced soil. The single remaining Oakland Hills was reported in 1988 flowers are dull white to pinkish, occurrence of E. latilobum consists of a (California Department of Fish and becoming brown with age. The egg- few hundred plants scattered along 4 Game, Natural Diversity Data Base) but shaped, recurved bracts beneath the km (2.5 miles) of Crystal Springs Road could not be relocated during a search flower head distinguish C. fontinale var. in San Mateo County. These conducted in 1991 (David Bigham, East fontinale from the most similar thistle in subpopulations are probably the Bay Chapter, California Native Plant the area, brownie thistle (C. fragments of a once-continuous Society, in litt., 1991). Population sizes quercetorum). The nearest relative of C. population. E. latilobum has also been fluctuate greatly; the upper limit to the fontinale var. fontinale is C. fontinale reported from southern San Mateo total numbers of plants reported in var. obispoense, found further south in County, on Pescadero Road southwest of recent years is approximately 8,000 San Luis Obispo County. La Honda, but this report is most likely plants. The first of the Alameda County Cirsium fontinale var. fontinale is erroneous. At least one of the specimens populations was discovered in 1980 at restricted to perpetually moist clay collected at this site (in 1929) is actually the Redwood Regional Park. Because openings in riparian or serpentine E. confertiflorum (Barry Prigge, this discovery occurred so long after the chaparral. Historically, this plant University of California, Los Angeles original discovery of the plant and occurred in both San Mateo and Santa herbarium, pers. comm., 1992), and because this population was relatively Clara Counties, but it is now found in searches in recent years have found only far from the previously known only three locations in San Mateo E. confertiflorum (Toni Corelli, Santa population at the Presidio, it was County. One population of 1,000 to Clara Valley Chapter, California Native suggested that this population might not 2,800 plants occurs east of Crystal Plant Society, pers. comm., 1992). The be a natural occurrence. This suggestion Springs Reservoir, on both sides of plant is threatened by erosion and soil gained credence because seed collected Interstate 280. A second population of slippage, road maintenance, garbage from the type location in 1964 had been 100 to 200 plants occurs 10 km (6 miles) dumping, and recreational sown in the East Bay Regional Parks to the south in the ‘‘Triangle area,’’ a development. Tilden Botanic Garden and plants had triangular piece of land west of Henry Nicholas Bolander collected grown there for several years (Roof Edgewood County Park that is bounded the type specimen of Hesperolinon 1971). Seed collected from plants at the by Interstate 280 to the east, Edgewood congestum (Marin dwarf-flax) in 1863 in botanic garden had been sown in several Road on the north, and Canada Road on Marin County, while working on the State Geological Survey. Asa Gray sites at the Presidio in 1972 (Roof 1972). the west. A single plant was found in described the new species as Linum It was thought that seed might also have Edgewood County Park in 1987. In congestum, including it in the section been sown at Redwood Regional Park in 1992, only one plant remained in this Hesperolinon that he described in the Alameda County. However, an location (Susan Sommers, Santa Clara same paper (Gray 1865). J.K. Small electrophoretic comparison of the San Valley Chapter, California Native Plant (1907) established Hesperolinon as a Francisco and Alameda populations Society, pers. comm., 1992). The taxon distinct genus in 1907. Jepson (1925) ‘‘strongly suggests that the Oakland is threatened by proposed recreational treated Hesperolinon as a section of the Hills population did not originate by development, competition with alien seed transfer from San Francisco and it genus Linum and treated H. congestum plant species, garbage dumping, and must be regarded as indigenous to its as a subspecies of L. californicum. Helen roadside maintenance. present locality’’ (Gottlieb and Edwards K. Sharsmith (1961) conducted an 1992). C. franciscana is threatened by Eriophyllum latilobum (San Mateo extensive study of Hesperolinon and potential development, roadside woolly sunflower) was first collected by concluded that it definitely warrants maintenance, foot traffic, mowing, Elmer in 1903. The type specimen was distinction as a separate genus. She also competition from alien plants, and collected by A.A. Heller in 1907. The returned H. congestum to the status of shade from native and introduced plant was described by Per Axel a species. shrubs and trees. Rydberg (1915). E. latilobum is believed Hesperolinon congestum is an Cirsium fontinale var. fontinale to have originated as a hybrid between herbaceous annual of the flax family (fountain thistle) was first described as E. confertiflorum and E. lanatum var. (Linaceae) with slender, threadlike Cnicus fontinalis (Greene 1886b). In arachnoideum (Munz 1959, John stems, 10 to 40 cm (4 to 16 in) tall. The 1892, Greene reassigned the plant to the Mooring, Santa Clara University, pers. leaves are linear. The flowers are borne genus Carduus (Greene 1892). Willis comm., 1992). in congested clusters; the pedicels are Jepson, in his Flora of Western Middle Eriophyllum latilobum is a bushy 0.2 to 2 mm (.01 to .08 in) long. The California (1901), put the taxon in the perennial of the aster family sepals are hairy and the five petals are genus Cirsium. In 1938, John Thomas (Asteraceae) with leafy stems 30 to 40 rose to whitish. The anthers are deep Howell described a close relative of the cm (12 to 16 in) high. The upper pink to purple; this character helps fountain thistle, Cirsium fontinale var. surfaces of the deeply three-cleft leaves distinguish H. congestum from H. obispoense (Chorro Creek bog thistle) are a smooth dark green and the lower californicum, found in the same (Howell 1938). According to the rules surfaces are covered with densely geographic area, which has white to rose for botanical nomenclature, when a new interwoven white hairs. The golden anthers, as well as hairless sepals. Two variety is described in a species not flower heads are borne in loose clusters. other species that are found in the same previously divided into infraspecific E. latilobum differs from E. region are H. micranthum and H. taxa, a ‘‘type’’ variety is automatically confertiflorum in having eight ray spergulinum. They differ from H. created. In this case, the type variety is flowers rather than five, larger flower congestum in having hairless sepals and C. fontinale var. fontinale. heads, and a more open inflorescence. a long, open inflorescence, with Cirsium fontinale var. fontinale is an E. lanatum var. arachnoideum differs pedicels 2 to 25 mm (.08 to 1 in) long. herbaceous perennial of the aster family from the other two species in having 13 Hesperolinon congestum is endemic (Asteraceae) with several stout, erect ray flowers and shallowly cleft leaves. to serpentine soils from Marin County Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6675 south to San Mateo County, a range of 1933 by Howard E. McMinn (McMinn cymosa ssp. paniculata and resurrects 80 km (50 miles). Two populations are 1933), professor of botany at Mills Britton and Rose’s D. setchellii for the found in serpentine chaparral; the College and author of An Illustrated Santa Clara Valley dudleya (Bartel others occur in serpentine bunchgrass Manual of California Shrubs. 1993). habitat. Six populations are known from Ceanothus ferrisae is an erect Dudleya setchellii is a low-growing Marin County, one from San Francisco evergreen shrub of the buckthorn family perennial of the stonecrop family County, and seven from San Mateo (Rhamnaceae) that grows 1 to 2 m (3 to (Crassulaceae) with fleshy, glabrous County. Populations fluctuate in size 6 ft) high, with long stiff divergent leaves. The oblong to triangular, slightly from hundreds to thousands of plants branches. Its round leaves are dark glaucous leaves are 3 to 8 cm (1 to 3 in) (Robison and Morey 1992a). The species green and hairless on the upper surface long and 7 to 15 mm (0.3 to 0.6 in) wide. is threatened with residential and and lighter green with minute hairs Two or three flowering stems ascend to recreational development, foot traffic, below. The leaf margins have short teeth heights of 5 to 20 cm (2 to 8 in) in mid and competition with alien species. or sometimes no teeth at all; the leaf to late spring. The pale yellow petals are Pentachaeta bellidiflora (white-rayed base is abruptly tapering or rounded. 8 to 13 mm (0.3 to 0.5 in) long. There pentachaeta) was first collected in The small white flowers are borne in are two related species in the area. D. 1853–54 near Corte Madera by John clusters 1.3 to 2.5 cm (0.5 to 1 in) long. cymosa ssp. cymosa has bright yellow to Milton Bigelow, surgeon and botanist The seed capsules are 7 to 9 mm (.3 to red petals rather than pale yellow and for a railway route exploration (Van .35 in) in width and have three is, therefore, easily distinguished from Horn 1973). The plant was described as conspicuous apical horns. The related D. setchellii with its pale yellow P. bellidiflora (Greene 1885). Keck C. cuneatus has entire leaves with flowers. D. cymosa ssp. paniculata can (1958) transferred the entire genus to wedge-shaped (not rounded) bases and be distinguished from D. setchellii by its Chaetopappa. Van Horn (1973) studied seed capsules only 5 to 6 mm (0.2 in) oblong to oblanceolate leaves (in Chaetopappa and Pentachaeta and wide. contrast to the oblong-triangular leaves concluded that the two genera are not Ceanothus ferrisae grows on dry of D. setchellii), its greater degree of closely related. Based on differences in slopes in serpentine chaparral. It is rebranching of the inflorescence floral and vegetative morphology and known from only three locations, all branches, and its longer pedicels. chromosome number, Van Horn within 6 km (4 miles) of each other, in Dudleya setchellii is restricted to reinstated the genus Pentachaeta. Santa Clara County. Fewer than 6,000 rocky outcrops within serpentine Pentachaeta bellidiflora is a small plants are known to exist. It was thought grasslands in Santa Clara County. It is annual plant of the aster family at one time to occur in both San Mateo found only in the Coyote Valley area, (Asteraceae) with one or a few branches and Santa Cruz Counties as well, but from San Jose south about 30 km (20 that bear narrow, linear leaves. Each these reports have been found to be miles) to San Martin, at elevations of flower head has numerous yellow disk erroneous (Corelli 1991). The existing 100 to 300 m (300 to 900 ft). D. cymosa florets and 5 to 16 white to purplish ray populations are threatened by ssp. paniculata ranges from Contra florets. The fruits are tawny, coarse- residential and recreational Costa County to Fresno and Monterey haired achenes (dry one-seeded fruits). development, unauthorized dumping, Counties; the reports of Moran’s Related species in the San Francisco and lack of natural recruitment. combination D. cymosa ssp. setchellii Bay area (P. exilis ssp. exilis and P. The type specimen of Dudleya from Alameda, Contra Costa, and San alsinoides) differ from P. bellidiflora in setchellii (Santa Clara Valley dudleya) Benito Counties (Munz 1959, Olson and that they have no ray flowers. was collected by Willis L. Jepson in Lake 1991) reflect the distribution of D. Pentachaeta bellidiflora is known 1896 on Tulare Hill in Santa Clara cymosa ssp. paniculata and do not refer only from one location, in a serpentine County. He described it as Cotyledon to D. setchellii, as now recognized. bunchgrass community in San Mateo laxa var. setchellii (Jepson 1901). At the Fourteen sites and a total of County. Historically, P. bellidiflora was same time, he described Cotyledon approximately 33,000 plants are known known from at least nine sites in Marin, caespitosa var. paniculata, which he to exist. The plant is threatened by San Mateo, and Santa Cruz Counties. had collected from Morrison Canyon development, unauthorized dumping, The other populations have been near what is now Fremont. Britton and and off-road vehicles. destroyed by urbanization, off-road Rose (1903) elevated both taxa to full Streptanthus albidus ssp. albidus vehicles, or highway construction over species and transferred them to the (Metcalf Canyon jewelflower) was first the past 50 years (Robison and Morey newly-created genus Dudleya. collected in 1887 by Volney Rattan, a 1992b). As is common among annual Subsequently, Dudleya setchellii was botany teacher and author of an early plants, the size of this population variously treated as Cotyledon setchellii California flora, from hillsides a few fluctuates dramatically from year to (Fedde 1904), Echeveria setchellii miles south of San Jose. Edward Greene year. Numbers have ranged from 10,000 (Nelson and Macbride 1913), and E. described S. albidus ssp. albidus in to just under 100 million in the last 10 laxa var. setchellii (Jepson 1936). Reid 1887 (Greene 1887); later he redefined years, with about 1.5 million plants Moran (1959) combined the material the limits of Euclisia, formerly a growing in each of the last 2 years (Zoe referred to as D. setchellii and D. subgenus of Streptanthus, treating it as Chandik, Santa Clara Valley Chapter, paniculata in D. cymosa ssp. setchellii. a genus in its own right (Greene 1904). California Native Plant Society, pers. Kei Nakai (1987) separated the two S. albidus ssp. albidus, as a member of comm., 1992). The species is threatened entities into D. cymosa ssp. paniculata the Euclisia group, was included in this by recreational development. and D. cymosa ssp. setchellii on the change. Jepson (1925) returned Euclisia basis of leaf shape, inflorescence to subsection status, and later authors South Bay Species branching patterns, and pedicel length. followed his treatment. Jepson (1925) Ceanothus ferrisae (coyote ceanothus) According to Jim Bartel (U.S. Fish and also treated S. albidus ssp. albidus as a was collected in 1917 by LeRoy Abrams, Wildlife Service, pers. comm., 1992), D. subspecies of S. glandulosus. professor of botany at Stanford setchellii should not be placed within D. Kruckeberg published a revision of the University, on Madrone Springs Road cymosa and is, in fact, intermediate to Streptanthus glandulosus complex in above Coyote Creek, in Santa Clara D. cymosa and D. abramsii. His which he recognized the close County. The species was described in treatment of Dudleya retains Nakai’s D. relationships among S. glandulosus, S. 6676 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations albidus, and S. niger (Kruckeberg 1958). and Eriophyllum latilobum as appropriate, but for which substantial In this paper, he notes that the ‘‘sharp threatened taxa. The Service published data on biological vulnerability and genetic discontinuity between S. albidus a notice in the July 1, 1975, Federal threats are not currently known or on and all other populations, coupled with Register (40 FR 27823) of its acceptance file to support proposed rules. On the morphological distinctness and of the report of the Smithsonian November 28, 1983, the Service regional restriction of S. albidus, Institution as a petition within the published in the Federal Register a warrant the restoration of this Greeneian context of section 4(c)(2) (petition supplement to the Notice of Review (48 species.’’ He recognized two subspecies: provisions are now found in section FR 39526). This supplement changed S. albidus ssp. albidus and S. albidus 4(b)(3) of the Act) and its intention Ceanothus ferrisae, Cirsium fontinale ssp. peramoenus (Kruckeberg 1958). thereby to review the status of the plant var. fontinale, Pentachaeta bellidiflora, Streptanthus albidus ssp. albidus is taxa named therein. The above 10 taxa and Streptanthus albidus ssp. albidus an annual herb of the mustard family were included in the July 1, 1975, from category-1 to category-2 (Brassicaceae) that reaches up to 1 m (3 notice. As a result of that review, on candidates. ft) in height. It has bristly hairs at the June 16, 1976, the Service published a The plant notice was again revised on base and pale green, strongly glaucous proposal in the Federal Register (41 FR September 27, 1985 (50 FR 39526). stem and leaves. The flowers are borne 24523) to determine approximately Calochortus tiburonensis, Castilleja in leafless terminal racemes. The upper 1,700 vascular plant species to be neglecta, Clarkia franciscana, three of the white to yellow to whitish- endangered species pursuant to section Eriophyllum latilobum, Hesperolinon green sepals are fused with the lower 4 of the Act. The list of 1,700 plant taxa congestum, and Streptanthus niger were (fourth) sepal free and spreading. The was assembled on the basis of included as category-1 candidates; four petals, 8 to 11 mm (.3 to .4 in) long, comments and data received by the Ceanothus ferrisae, Cirsium fontinale are whitish with light purple veins. The Smithsonian Institution and the Service var. fontinale, Cordylanthus tenuis ssp. erect flattened pods are 3 to 8 cm (1 to in response to House Document No. 94– capillaris, Pentachaeta bellidiflora, and 3 in) long. The only Streptanthus 51 and the July 1, 1975, Federal Streptanthus albidus ssp. albidus were species likely to co-occur with S. Register publication. Calochortus included as category-2 candidates. albidus ssp. albidus is its close relative tiburonensis, Ceanothus ferrisae, Another revision of the plant notice was Streptanthus albidus ssp. peramoenus. Cirsium fontinale var. fontinale, Clarkia published on February 21, 1990 (55 FR S. albidus ssp. peramoenus is franciscana, Cordylanthus tenuis ssp. 6184). In this revision, Castilleja distinguished by its dark purple sepals. capillaris (listed as Cordylanthus neglecta, Ceanothus ferrisae, Cirsium Streptanthus albidus ssp. albidus brunneus ssp. capillaris), Hesperolinon fontinale var. fontinale, Clarkia always has been rare. It is endemic to congestum, Streptanthus albidus ssp. franciscana, Cordylanthus tenuis ssp. serpentine outcrops with little soil albidus, and Streptanthus niger were capillaris, Dudleya setchellii, development. It can be locally abundant included in the June 16, 1976, Federal Eriophyllum latilobum, Hesperolinon but its range is limited, extending less Register document. congestum, Streptanthus albidus ssp. than 30 km (20 miles) from San Jose General comments received in albidus, and Streptanthus niger were south to Anderson Lake, which lies response to the 1976 proposal were included as category-1 candidates; northeast of Morgan Hill. Furthermore, summarized in an April 26, 1978, Calochortus tiburonensis and the serpentine outcrops on which S. Federal Register publication (43 FR Pentachaeta bellidiflora were included albidus ssp. albidus occurs are patchily 17909). The Endangered Species Act as category-2 candidates. Since the distributed and comprise only a small Amendments of 1978 required that all publication of that notice, additional percentage of the area within its range. proposals over 2 years old be information was received on Nine populations and a total of 20,000 withdrawn. A 1-year grace period was Pentachaeta bellidiflora that elevated it to 25,000 plants have been recorded given to those proposals already more to category-1 status. The Service also re- (McCarten 1992b). The plant is than 2 years old. In the December 10, evaluated the information available for threatened by urbanization and off-road 1979, Federal Register (44 FR 70796), Calochortus tiburonensis and elevated it vehicles. the Service published a notice of to category 1-status. The Service, Previous Federal Action withdrawal of the June 16, 1976, therefore, determines that sufficient proposal, along with four other information is now available to support Federal government actions on the 12 proposals that had expired. the listing of these two species. plants began as a result of section 12 of The Service published an updated Section 4(b)(3)(B) of the Act requires the Endangered Species Act of 1973, as notice of review for plants on December the Secretary to make certain findings amended (Act), which directed the 15, 1980 (45 FR 82480). This notice on pending petitions within 12 months Secretary of the Smithsonian Institution included Calochortus tiburonensis, of their receipt. Section 2(b)(1) further to prepare a report on those plants Castilleja neglecta, Ceanothus ferrisae, requires that all petitions pending on considered to be endangered, Cirsium fontinale var. fontinale, Clarkia October 13, 1982, be treated as having threatened, or extinct in the United franciscana, Cordylanthus tenuis ssp. been newly submitted on that date. That States. This report, designated as House capillaris, Hesperolinon congestum, was the case for Calochortus Document No. 94–51, was presented to Pentachaeta bellidiflora, Streptanthus tiburonensis, Ceanothus ferrisae, Congress on January 9, 1975, and albidus ssp. albidus, and Streptanthus Cirsium fontinale var. fontinale, Clarkia included Cordylanthus tenuis ssp. niger as category-1 candidates for franciscana, Cordylanthus tenuis ssp. capillaris (listed as Cordylanthus Federal listing and Eriophyllum capillaris, Hesperolinon congestum, brunneus ssp. capillaris), Calochortus latilobum as a category-2 candidate. Streptanthus albidus ssp. albidus, tiburonensis, Ceanothus ferrisae, Category-1 taxa are those for which the Streptanthus niger, Castilleja neglecta, Cirsium fontinale var. fontinale, Clarkia Service has on file substantial and Eriophyllum latilobum, because the franciscana, Hesperolinon congestum, information on biological vulnerability 1975 Smithsonian report had been Streptanthus albidus ssp. albidus, and and threats to support preparation of accepted as a petition. On October 13, Streptanthus niger as endangered listing proposals. Category-2 taxa are 1982, the Service found that the species and Castilleja neglecta (now those for which data in the Service’s petitioned listing of these species was known as Castilleja affinis ssp. neglecta) possession indicate listing is possibly warranted, but precluded by other Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6677 pending listing actions, in accordance issues and the Service’s response to Service Response: Acts prohibited with section 4(b)(3)(B)(iii) of the Act; each are summarized as follows: under section 9(a)(2)(B) of the Act are notification of this finding was Issue 1. One commenter stated that described in detail in Available published on January 20, 1984 (49 FR the serpentine soils in the Santa Clara Conservation Measures. The Service is 2485). Such a finding requires the Valley between the City of San Jose and concerned over the loss of this species petition to be recycled, pursuant to Anderson Lake have not been during regular road maintenance and section 4(b)(3)(c)(i) of the Act. The adequately surveyed for Dudleya continuing soil slippage that results in finding was reviewed in October of 1984 setchellii; therefore, the current level of plant loss; however, removal from through 1991. There are no pending knowledge does not warrant listing of roadways of debris containing E. petitions for Pentachaeta bellidiflora or this species as endangered. latilobum plants or seeds that has fallen Dudleya setchellii. Service Response: The Santa Clara by natural causes into the roadway is A proposed rule to list Castilleja Valley is the only known habitat for this not a violation of the Act. neglecta, Ceanothus ferrisae, Cirsium edaphically restricted species, first fontinale var. fontinale, Clarkia Summary of Factors Affecting the collected on Tulare Hill in 1896. Many Species franciscana, Cordylanthus tenuis ssp. surveys have been done in this area, After a thorough review and capillaris, Dudleya setchellii, particularly in recent years consideration of all information Eriophyllum latilobum, Pentachaeta (Entomological Consulting Services available, the Service has determined bellidiflora, Streptanthus albidus ssp. 1990; City of San Jose 1991; City of San that Castilleja affinis (Hook and Arn.) albidus, and Streptanthus niger as Jose 1992; CH2M Hill 1992; City of San ssp. neglecta (Zeile) Chuang and Heck. endangered and Calochortus Jose 1993). The Service uses the best (Tiburon paintbrush), Ceanothus tiburonensis and Hesperolinon information available at the time of ferrisae McMinn (coyote ceanothus), congestum as threatened was published listing to make the determination of Cirsium fontinale Jeps. var. fontinale in the Federal Register on December 14, endangered status. Current information 1992 (57 FR 59053). This proposal was (fountain thistle), Clarkia franciscana indicates that the majority of known Lewis and Raven (Presidio clarkia), based primarily on information populations are located on private land supplied by reports from the Natural Cordylanthus tenuis Gray ssp. capillaris and are threatened imminently with Diversity Data Base and observations by (Penn.) Chuang and Heck. (Pennell’s urbanization. Three proposed projects, botanists. bird’s-beak), Dudleya setchellii (Santa which include residential development, Clara Valley dudleya), Eriophyllum Summary of Comments and a school, a church, roads, and a golf latilobum Rydb. (San Mateo woolly Recommendations course, in the Santa Clara Valley are sunflower), Pentachaeta bellidiflora In the December 14, 1992, proposed planned to be built on sites containing Greene (white-rayed pentachaeta), rule and associated notifications, all populations of Dudleya setchellii. Streptanthus albidus Greene ssp. interested parties were requested to Although more populations of this albidus (Metcalf Canyon jewelflower), submit factual reports or information species may be discovered, the amount and Streptanthus niger Greene (Tiburon that might contribute to the of remaining suitable habitat is limited jewelflower) should be classified as development of a final rule. The public and close to rapidly expanding urban endangered species and that comment period ended on February 12, areas. Santa Clara County, which Calochortus tiburonensis Hill (Tiburon 1993. Appropriate State agencies, contains the Santa Clara Valley from mariposa lily) and Hesperolinon county and city governments, Federal San Jose south to Anderson Lake, grew congestum (A. Gray) Small (Marin agencies, scientific organizations, and by 1.5 percent from 1991 to 1992 and is dwarf-flax), should be classified as other interested parties were contacted predicted to grow by 12.0 percent by threatened species. Procedures found at and requested to comment. Newspaper year 2000 (Calif. Dept. of Finance 1992). section 4 of the Endangered Species Act notices were published in The Napa Any newly found sites, therefore, likely (16 U.S.C. 1531 et seq.) and regulations Register on January 5, 1993, The will be subject to the same threats as (50 CFR part 424) promulgated to Oakland Tribune, January 2, 1993, San known populations. In support of the implement the listing provisions of the Jose Mercury News, January 3, 1993, contention that unrecorded populations Act were followed. A species may be San Francisco Chronicle, December 31, of D. setchellii exist in the Valley, the determined to be endangered or 1992, and Santa Rosa Press Democrat, commenter included a list of 11 new threatened due to one or more of the no date recorded, which invited general populations that he had submitted for five factors described in section 4(a)(1). public comment. No public hearing was addition to the CNPS rare plant These factors and their application to requested or held. inventory. Only two of these sites have Calochortus tiburonensis Hill (Tiburon Fifteen written comments were been accepted by CNPS as new mariposa lily), Castilleja affinis (Hook received from 14 individuals. Among populations (R. Bittmann, pers. comm., and Arn.) ssp. neglecta (Zeile) Chuang the 11 commenters supporting the 1993). In addition, the largest of the and Heck. (Tiburon paintbrush), listing were The California Native Plant sites noted by the commenter is an Ceanothus ferrisae McMinn (coyote Society, Sierra Club, and Missouri extension of a previously known ceanothus), Cirsium fontinale Jeps. var. Botanic Garden. Three comments were population and is threatened by the fontinale (fountain thistle), Clarkia neutral. One commenter opposed the proposed Cerro Plata Residential and franciscana Lewis and Raven (Presidio listing of one species. Several Golf Course Project (CNDDB 1993, City clarkia), Cordylanthus tenuis Gray ssp. commenters provided detailed of San Jose 1993). capillaris (Penn.) Chuang and Heck. information on the location and size of Issue 2. The Director of Public Works, (Pennell’s bird’s-beak), Dudleya newly recorded populations and the County of San Mateo, voiced a concern setchellii (Santa Clara Valley dudleya), condition of previously recorded that the responsibility of maintaining Eriophyllum latilobum Rydb. (San populations. This data has been roads for the well being and safety of Mateo woolly sunflower), Hesperolinon incorporated into this rule. The citizens may be in conflict with the Act congestum (A. Gray) Small (Marin opposing comment and other comments when road crews remove soil and debris dwarf-flax), Pentachaeta bellidiflora questioning the rule have been containing plants and seeds of Greene (white-rayed pentachaeta), organized into specific issues. These Eriophyllum latilobum. Streptanthus albidus Greene ssp. 6678 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations albidus (Metcalf Canyon jewelflower), however, no final policy has yet been threatened by sliding of the slope on and Streptanthus niger Greene (Tiburon determined (Betty Guggolz, pers. which they occur. The toe of the slope jewelflower) are as follows: comm., 1993). This donation may afford was removed to accommodate A. The present or threatened protection to part of the second residential development in the 1960s. destruction, modification, or population of C. tenuis ssp. capillaris, Soil material that slides into the street curtailment of its habitat or range. The but since the transfer has not yet taken at the base of the slope is removed by destruction of habitat through place and final plans have not been the City of Corte Madera, and the slope residential or recreational development made concerning protection of the continues to slump. Managers from The is the greatest threat faced by these plant, the population still should be Nature Conservancy estimate that species. All 12 plants are limited to considered threatened by development. approximately one-third of the serpentine soils. Serpentine outcrops in Calochortus tiburonensis is, at population is at risk (Lynn Lozier, The the San Francisco Bay area are limited; present, protected from development Nature Conservancy, pers. comm., 20 percent of those outcrops have and fenced to reduce the incidence of 1992). The Napa County population already been eliminated as plant habitat off-road vehicle use because the land on occurs on private property near a gravel due to development (McCarten 1987b). which it occurs is owned and managed quarry. Although quarry expansion The pressure to build more houses, by The Nature Conservancy (TNC), a plans that would result in the roads, and other facilities for humans is group whose management goals are the destruction of more than 80 percent of great in all the counties under maintenance of biodiversity and the the population are no longer actively consideration. In the 3 counties in protection of rare and endangered being pursued, the potential for which 10 of the species are found species (Larry Serpa, pers. comm., expansion still exists. The Santa Clara (Marin, San Mateo and Santa Clara), 1992). The preserve is still accessible to population consists of 13 plants that estimated percent population growth by bicycles, motorbikes, and pedestrians, may be subject to grazing (R. Bittmann, year 2000 is 2.8, 6.4, and 12.0 percent, however, and it is not patrolled. The pers. comm., 1993). respectively (Calif. Dept. of Finance proximity of the preserve to residential Streptanthus niger is an extremely 1992). Sonoma County, which contains areas renders it vulnerable to overuse narrowly-distributed species; its entire one of the species, is expected to grow and vandalism. Because TNC cannot range amounts to less than one-third of by 21.4 percent by year 2000 (Calif. completely control access to the site or a square mile. Urban development has Dept. of Finance 1992). Serpentine activities on the site, listing is needed. destroyed over 40 percent of potential S. habitats also have been fragmented by Furthermore, this preserve, being on niger habitat (Hunter 1989b). Both of the the construction of roads such as The Nature Conservancy’s list of two known occurrences have multiple Interstate 280. Habitat fragmentation potential divestitures, will transfer landowners. The town of Tiburon owns increases the risks of extinction due to ownership when a suitable organization portions of the occurrence on the chance events such as fire, flood, is found to manage it (Larry Serpa, pers. Middle Ridge of the peninsula, and the landslide, pest or disease outbreaks, comm., 1992). occurrence at St. Hilary’s Church in severe drought, or other natural or Castilleja affinis ssp. neglecta has Tiburon is owned in part by the Tiburon human-caused disaster. never been widespread. Three of the six Cordylanthus tenuis ssp. capillaris populations occur on the Tiburon Landmark Society. The remainder of has never been known from more than Peninsula in Marin County, one occurs each of these two occurrences is the two populations that occur today. in Napa County, and one in Santa Clara privately-owned and proposed for Ownership of the type locality is mixed; County. Two recently discovered development. An area containing 20 part of the population occurs on the populations, one on the Golden Gate plants adjacent to one of the parcels Harrison Grade Preserve, which is National Recreation Area and one east recently was bulldozed for construction owned and managed by the California of Anderson Lake, extend the known of condominiums (Andrew Allen, pers. Department of Fish and Game. Habitat range to western Marin and Santa Clara comm., 1993). Residential development on the preserve is threatened by Counties, respectively. Each of the three is ongoing at several parcels of the unauthorized activities such as off-road occurrences on the Tiburon Peninsula Middle Ridge occurrence (Eva Buxton, vehicle use. Plants on private parcels has multiple landowners. The Nature Belvedere-Tiburon Landmark Society, are threatened with potential Conservancy owns over half of the Ring pers. comm., 1993, Andrew Allen, pers. development. The second population of Mountain occurrence and the town of comm., 1993). Cordylanthus tenuis ssp. capillaris Tiburon owns portions of the Clarkia franciscana was once thought occurs on private property a few miles occurrence in the Middle Ridge area of to be restricted to the Presidio in San to the west of the type locality. Plans for the peninsula. The remainder of each of Francisco County but about 10 years residential development of this site have these occurrences is privately-owned. ago, a population was discovered in been reviewed by the Sonoma County The third occurrence on the peninsula Alameda County in the Oakland Hills. Planning Department (Sigrid is on private property near St. Hilary’s The two populations in San Francisco Swedenborg, Sonoma County Planning Church in Tiburon. Development on the County occur at the Presidio, currently Office, pers. comm., 1993). The owner Tiburon Peninsula is extensive and owned by the National Park Service. of this property has been working with rapid; over 60 percent of C. affinis ssp. These populations are threatened by the California Department of Fish and neglecta habitat has already been habitat degradation. Pedestrian and Game to minimize impacts to C. tenuis destroyed by development (Hunter mountain bicycle traffic on and near ssp. capillaris (Ann Howald, California 1989a). Residential development is casually established ‘‘social trails’’ Department of Fish and Game, pers. ongoing on several parcels of the Middle threatens the habitat. comm., 1992). Plans include the Ridge occurrence and proposed for both The three populations of Clarkia donation of 87 hectares (ha) (212 acres), parcels of the St. Hilary’s occurrence franciscana in Alameda County are all including C. tenuis ssp. capillaris (Andrew Allen, pers. comm., 1993). The threatened by alien species (see Factor habitat, to the county for use as a park habitat at both of these sites also is E). The smallest of the three, consisting (S. Swedenborg, pers. comm., 1993). threatened by pedestrian traffic. The of 30 plants (Olson 1991c), occurs on an The county is considering restricting the plants on Ring Mountain Preserve are undeveloped site adjacent to a proposed park to passive recreation only; protected from development but are 32-unit residential development (Nixon Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6679 Lamb, Oakland Planning Dept., pers. County Park occurs in a drainage ditch One population of Hesperolinon comm., 1993). beside a trail. Clearing of the ditch to congestum is known from San Francisco One occurrence of Cirsium fontinale improve or maintain drainage could County. Footpaths through the var. fontinale has been reported from damage or destroy this plant or any population threaten the plants with Santa Clara County, but the site is seedlings it may produce. trampling (Robison and Morey 1992a). thought to have been destroyed by Eriophyllum latilobum has been In San Mateo County, three urbanization (Niehaus 1977). The three reported from only two locations, one of populations of Hesperolinon congestum remaining populations grow in San which is likely erroneous (specimen are known to occur on private property. Mateo County. The largest population misidentified, according to Barry Prigge, These plants are threatened by proposed occurs to the east of Crystal Springs pers. comm., 1992). The single development and by the consequences Reservoir and north of State Highway remaining population consists of about of recently completed development, 92, along both sides of Interstate 280. It 300 plants that occur along 4 km (2.5 such as trampling, trash dumping, and occurs partly on San Francisco Water miles) of Crystal Springs Road in San changes in hydrology caused by Department land and partly on a Mateo County. Seventy-five percent of irrigation runoff (Robison and Morey California Department of Transportation the plants occur within 9 m (30 ft) of the 1992a). Two populations occur on land right-of-way. Given its proximity to the road, where land ownership is poorly owned by the San Francisco Water roadside, it is likely to be affected by defined (McGuire and Morey 1992). The Department. Their habitat is threatened any highway projects in the area. Major City of Hillsborough, the County of San by the proposed construction of trails in realignments of Highway 92 were Mateo, and the San Francisco Water the watershed. The construction of these planned several years ago but the plans Department have varying jurisdictions trails and the accompanying fences may have been abandoned due to lack of over the land. The steep slopes along damage Hesperolinon congestum funding (Richard Vonarb, California Crystal Springs Road provide a very habitat. Department of Transportation, pers. unstable habitat for E. latilobum. The Pentachaeta bellidiflora historically comm., 1992). They could be revived, slopes are subject to erosion and soil ranged from Marin County to Santa Cruz however, if funding becomes available. slippage. After soil slippage occurs, road County. Three populations in Marin At present, a smaller project to widen maintenance crews remove the slumped County and two in San Mateo County Highway 92 east of the reservoir soil, which may contain mature were destroyed by urbanization. One causeway is under review. Provision for individuals, seedlings, and/or seeds of Marin County occurrence was destroyed the removal of water from the increased E. latilobum. The road cut is then by off-road vehicles. Two sites in Santa road surface may adversely affect some reshaped, which may damage plants Cruz County no longer support P. of the plants. The California Department remaining on the banks. The proposed bellidiflora (Robison and Morey 1992b). of Transportation is aware of the plant construction of the San Mateo Creek The single remaining population of P. locations and vulnerability. The Trail (McGuire and Morey 1992) would bellidiflora was bisected by the proposed construction of multi-use have adverse impacts on the plant if construction of California Interstate 280 recreational trails on San Francisco trail design does not incorporate plant in the late 1960s. The largest portion of Water Department land presents an conservation. The paved trail, which is the population occurs in the Triangle, additional threat. Trail construction 3 m (10 ft) wide, is expected to run on land administered by the San would threaten the plants through direct adjacent to Crystal Springs Road from Francisco Water Department. A small destruction of the habitat or through Skyline Boulevard to the San Mateo City remnant of this population is located to modification of hydrologic regimes. boundary. Construction of the trail the east of Interstate 280, on Edgewood Because C. fontinale var fontinale is could damage or eliminate colonies of E. County Park. The proposed construction dependent upon seeps and springs to latilobum, alter site hydrology, of trails on Water Department land provide abundant soil moisture, any accelerate soil erosion through threaten the P. bellidiflora habitat disruption in the flow of water (such as increased pedestrian and bicycle traffic, (Robison and Morey 1992b). that caused by road, trail, or drain and allow for the introduction of Ceanothus ferrisae is known from construction) would threaten the plants. aggressive alien plant species. three populations in Santa Clara A second and substantially smaller Fourteen populations of Hesperolinon County. The largest population, population of Cirsium fontinale var. congestum exist. One Marin County consisting of approximately 5,000 fontinale occurs in the ‘‘Triangle’’ west population is protected at The Nature plants, occurs near Anderson Dam, of Interstate 280. One to two hundred Conservancy’s Ring Mountain Preserve. partially on Santa Clara County Park plants have been observed on San Two relatively small populations occur property and partially on private Francisco Water Department lands; an on land owned by the Marin Municipal property. The county proposes further outlying colony of about 25 plants Water District. Another small recreational development in the park, occurs on an easement held by the population is found in the Golden Gate which threatens Ceanothus ferrisae California Department of National Recreation Area above Nicasio (Chris Nagano, U.S. Fish and Wildlife Transportation. This colony occupied a Reservoir. A fifth population occurs, in Service, pers. comm., 1992). An smaller territory in 1992 than it had in part, on a small preserve at St. Hilary’s outlying population occurs 3.2 km (2 previous years (Susan Sommers, pers. Church and, in part, on private land miles) west on land leased and managed comm., 1992). The plants on Water which recently has been proposed for by a waste management firm. Waste Department land are threatened by development (Robison and Morey Management, Inc. and The Nature proposed trail construction, as 1992a). The sixth Marin County site is Conservancy jointly funded research on discussed for Hesperolinon congestum. the Middle Ridge area of the Tiburon C. ferrisae; a three-year monitoring In addition, a general management plan Peninsula, on which occur a few program at the Waste Management site for the Water Department lands scattered groups of plants. Some plants has shown no evidence of natural currently is being developed (Ed grow on land designated as open space recruitment. A fire killed 95 percent of Stewart, San Francisco Water by the city of Tiburon. The remainder of the plants in this population in 1992. Department, pers. comm., 1992). the plants occur on private land and are No seed production or seedlings have The single specimen of Cirsium threatened by ongoing or proposed been observed since that time (Kathy fontinale var. fontinale in Edgewood residential development. Freas, CH2M Hill, in litt., 1993). 6680 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations Researchers have found that C. ferrisae restricted as its current distribution. It is Another source suggests, however, that is relatively easy to propagate from seed, found only in the Coyote Valley area of cattle provide little threat to the and both Waste Management and the Santa Clara Valley, primarily on the east American Canyon population because Santa Clara Valley Water District have side of the valley. Of the 13 documented the plants occur on a very steep slope been experimenting with the use of C. sites, 9 are known to still harbor plants. (Jake Ruygt, Napa Valley Chapter, ferrisae for revegetation projects. The Two populations are known to have California Native Plant Society, pers. third population, consisting of been extirpated, one by the construction comm., 1992). Grazing threatens one approximately 500 plants (Corelli 1989) of Anderson Dam, and the other as a population of Streptanthus albidus ssp. occurs on private land scheduled for result of being covered by fill from a albidus in southeast San Jose and three development. housing development. Two occurrences populations in the Metcalf Canyon/ Dudleya setchellii always has been are known from herbarium records only. south Coyote area (McCarten 1992b). restricted to the Coyote Valley area of One of these historical sites was Seed predation by beetle larvae has Santa Clara County. Eleven of the 14 revisited in 1990, but no plants were been reported for Cirsium fontinale var. populations are on private land and are found. Streptanthus albidus ssp. albidus fontinale (Dean Kelch, University of subject to various levels of threat due to was last observed at the other historical California, Davis, pers. comm., 1992), development. The three northernmost site in 1895. One population consisting however, the impact of this seed populations, which occur in of approximately 9,000 plants, predation on C. fontinale var. fontinale southeastern San Jose, and the three approximately 45 percent of all known is unknown. Beetle larvae also have southernmost populations, which occur plants, occurs on the proposed site of been observed in seed heads of in the area around Morgan Hill, the Cerro Plata residential and golf Eriophyllum latilobum, however, the approximately 27 km (17 miles) course project (City of San Jose 1993). extent of predation is unknown southeast of San Jose, are at greatest Although no direct destruction of any (McGuire and Morey 1992). risk. One of the northern populations is plants is planned, construction D. The inadequacy of existing threatened with the proposed Cerro activities, human disturbance, and regulatory mechanisms. Under the Plata Project, consisting of 550 dwelling habitat fragmentation would result in Native Plant Protection Act (Division 2, units and a 67 ha (164 ac) golf course significant impacts to the population. Chapter 10, section 1900 et seq. of the on a 236 ha (575 ac) site. This The proposed construction of the Valley Fish and Game Code) and California population contains approximately Christian School and South Valley Endangered Species Act (Division 3, 20,000 plants, 61 percent of all known Christian Church would destroy 61 Chapter 1.5, section 2050 et seq.), the plants, of which approximately 2,380 percent of the 2,700 plants occurring on California Fish and Game Commission would be directly eliminated by the site (City of San Jose 1992). The has listed three of these species (Cirsium planned construction activities (City of remaining seven populations also are fontinale var. fontinale, Clarkia San Jose 1993). All remaining plants threatened by impending or potential franciscana, and Streptanthus niger) as would be exposed to human activities development. endangered, two species (Calochortus during and after construction that B. Overutilization for commercial, tiburonensis and Castilleja affinis ssp. would result in significant impacts to recreational, scientific, or educational neglecta) as threatened, and one species the population. These impacts include purposes. Overutilization is not (Cordylanthus tenuis ssp. capillaris) as potentially harmful runoff from an currently known to be a factor for any rare. The California Fish and Game upslope golf course, introduction of of the 12 plants, but unrestricted Commission recently voted to list two weedy species during construction, and collecting for scientific or horticultural other species (Eriophyllum latilobum uncontrolled foot traffic. Another of the purposes or excessive visits by and Pentachaeta bellidiflora) as northern sites is threatened by the individuals interested in seeing rare endangered, and one species proposed construction of the Valley plants could result from increased (Hesperolinon congestum) as Christian School and South Valley publicity as a result of this final rule. threatened. Although both statutes Christian Church. This construction Calochortus tiburonensis is a strikingly prohibit the ‘‘take’’ of State-listed plants would eliminate 74 percent of the unusual member of a much-collected (Chapter 1.5 section 2080 and Chapter approximately 1,900 D. setchellii plants genus. Eriophyllum latilobum, with its 10 section 1908), State law appears to found on the site (City of San Jose 1992). showy golden flowers and proximity to exempt the taking of such plants via The other four sites also are developing roads and the proposed San Mateo habitat modification or land use change rapidly and have been proposed for Creek trail, might prove to be especially by the landowner. After the California development at one time or another. tempting to collectors. Dudleya Department of Fish and Game notifies a Two of the central populations also are setchellii also is vulnerable because of landowner that a State-listed plant threatened with imminent development the horticultural appeal of succulents grows on his or her property, State law including residential development and and the slow growth of the plants. The requires only that the landowner notify road construction. One central remaining plants are usually not the agency ‘‘at least ten days in advance population, due to its proximity to an spectacular in flower, but may of changing the land use to allow off-road motorcycle park, may be nonetheless appeal to collectors because salvage of such plant.’’ (Chapter 10 threatened by off-road motorcycle traffic of their rarity. section 1913). and unauthorized dumping. The C. Disease or predation. Both horses The California Environmental Quality remaining two populations that occur and deer have been reported to browse Act (CEQA) requires a full public on private land are on the grounds of on Cordylanthus tenuis ssp. capillaris disclosure of the potential the IBM Bailey Avenue laboratory. The but the number of plants damaged environmental impacts of proposed company apparently plans to preserve generally appears to be minimal (Lynn projects. The public agency with the habitat (McCarten 1992a). Three Lozier, pers. comm., 1992). Cattle primary authority or jurisdiction over populations occur on land owned by grazing has been reported to threaten the project is designated as the lead Santa Clara County. Of these, two the western Marin population of agency and is responsible for populations occur in county parks. Castilleja affinis ssp. neglecta (Martin conducting a review of the project and The known historical distribution of 1991) and a portion of the American consulting with other agencies Streptanthus albidus ssp. albidus is as Canyon occurrence (Hunter 1989a). concerned with resources affected by Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6681 the project. Section 15065 of the CEQA watersheds, which are not protected, number and isolated condition of these Guidelines requires a finding of may result in altered wetland hydrology populations make this species significance if a project has the potential and may adversely affect the plants. In susceptible to stochastic extinction to ‘‘reduce the number or restrict the practice, the Corps’ actions under (Menges 1991). range of a rare or endangered plant or section 404 would not adequately Calochortus tiburonensis is animal.’’ Species that are eligible for protect Cirsium fontinale var. fontinale, threatened, by virtue of its occurrence in listing as rare, threatened, or which occurs in riparian serpentine a single population, with chance events endangered, but are not so listed, are seep areas. such as fire, severe drought, pest or given the same protection as those Most projects within the range of disease outbreak, landslides, or other species that are officially listed with the Cirsium fontinale var. fontinale may natural or human-caused disasters. The State. Once significant effects are require approval from the Corps, as proximity of the plant to a large human identified, the lead agency has the currently described in section 404 of the population increases the likelihood that option to require mitigation for effects Clean Water Act. Federal listing of this human-caused disasters or acts of through changes in the project or to species would ensure greater vandalism could affect the plants or decide that overriding considerations consideration of the effects of permitted their habitat. The preserve is fenced to make mitigation infeasible. In the latter actions during the review process as reduce the incidence of off-road vehicle case, projects may be approved that well as provide the protections of use, but is still accessible to bicycles, cause significant environmental section 7 of the Act. motorbikes, and pedestrians, and it is damage, such as destruction of E. Other natural or manmade factors not patrolled. Pedestrian traffic endangered species or their habitat. The affecting its continued existence. As threatens both of the Streptanthus niger protection of threatened and endangered discussed in the ‘‘Background’’ section, populations. species through CEQA is, therefore, the large and still increasing numbers of The Presidio, which contains one of dependant upon the discretion of the people in the San Francisco Bay area the two populations of C. franciscana, lead agency involved and, in practice, place a great strain on undeveloped represents a significant natural and statements of overriding considerations wildlands, through activities such as cultural resource within San Francisco are commonly prepared. pedestrian and off-road vehicle traffic, city limits, and is expected to be heavily Three of the species occur at hiking and bicycle trails, and used by visitors since its transfer to the Edgewood County Park in San Mateo unauthorized garbage dumping. National Park Service (T. Thomas, pers. County. The park was designated on Disturbance may directly impact plants; comm., 1992). The heavy use will May 5, 1992, as a natural preserve; it can increase erosion and allow the increase the negative impact of traffic on however, this designation was revoked invasion of alien species such as the C. franciscana. The species presently is in August of the same year. The park, many introduced annual grasses threatened by road maintenance subsequently, was considered as a site common in California. Competition (mowing) at the Presidio. Mowing of for construction of a golf course, with introduced species is a serious grasslands before the C. franciscana has although this plan has been rejected and threat to serpentine natives (McCarten set seed also threatens the populations. the park will continue to be managed as 1987b). Edaphic specialists (plants Populations at the Presidio also are public open space (Richard Silver, San restricted to a certain soil type) with threatened by the encroachment of alien Mateo County Board of Supervisors, small populations such as the plant species, including Senecio pers. comm., 1993). serpentine species discussed herein, mikanioides (German ivy), Carpobrotus Section 404 of the Clean Water Act may have low genetic variability sp. (iceplant), Rubus spp. (blackberries), regulates the placement of dredge and (Menges 1991). As a result, populations and by natives planted outside their fill materials into waters of the United that become subdivided by alterations natural range, such as Pinus radiata States (including small acreages above in habitat from road construction and (Monterey pine) (California Department the headwaters of streams). The U.S. urbanization or from natural of Fish and Game 1988). The population Army Corps of Engineers (Corps) is the catastrophes such as disease, fire, or size at the type locality increased agency responsible for administering the drought, may be at high risk of genetic following removal of alien plant species section 404 program. The Service, as changes that decrease the ability of the in the late 1980s. Constant vigilance and part of the section 404 review process, populations to survive (Menges 1991). effort is needed to prevent reinvasion. provides advisory comments on both Cordylanthus tenuis ssp. capillaris At latest report, the largest population pre-discharge notices for nationwide growing along roadsides is threatened of Clarkia franciscana, occurring at permits and public notices for by roadside maintenance such as Redwood Regional Park in Alameda individual permits. mowing and spraying (Lynn Lozier, County, consisted of 4,000 to 5,000 Under section 404, nationwide pers. comm., 1992). Vehicular traffic plants (Gottlieb and Edwards 1992, permits, which undergo minimal public threatens plants in and near the parking Olson 1991a). The East Bay Regional and agency review, can be issued for area at the Harrison Grade Reserve, Park District is aware of the Clarkia projects involving less than 10 acres of which is poorly defined and close to the franciscana population and has been waters of the United States and adjacent plant population (McCarten 1987a). taking it into account in their wetlands, unless a listed species may be Unauthorized dumping of large items management plans (Ray Budzinski, East adversely affected. Individual permits, such as bottles, furniture, appliances, Bay Regional Park District, pers. comm., which are subject to more extensive and cut wood is also a threat. Light 1992). The habitat is threatened by review, are required for projects that disturbance at the Harrison Grade competition with annual grasses (Ray affect greater than 4.1 ha (10 acres). A Reserve, such as infrequent grading of Budzinski, pers. comm., 1992) and other project proponent planning to fill less dirt roads, appears to increase the alien plants, including Cortaderia than 0.4 ha (1 acre) is only required to numbers of C. tenuis ssp. capillaris selloana (pampas grass) and Cytisus notify the Corps of their intent to fill (Lynn Lozier, pers. comm., 1992), but monspessulanus (French broom) (Olson wetlands. Compensatory mitigation higher levels of disturbance may 1991a). The two smaller populations in generally is not required for projects facilitate the invasion of alien species Alameda County, consisting of 200 affecting less than 0.4 ha (1 acre). (McCarten 1987a) and result in a decline plants (Olson 1991b) and 30 plants Additionally, the loss of upland of C. tenuis ssp. capillaris. The limited (Olson 1991c), respectively, also are 6682 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations threatened by alien species Cytisus Works, San Mateo Co., in litt., 1993). E. drought, pest and disease outbreaks, and monspessulanus and Cortaderia latilobum is not a vigorous reproducer; other natural and human-caused jubatum. Low viability caused by low germination rates and low seedling disasters. harmful genetic changes may result survival have been observed under Cordylanthus tenuis ssp. capillaris from inbreeding in small populations greenhouse conditions (John Mooring, occurs in only two sites. One is (Barrett and Kohn 1991). The larger of in litt., 1992; McGuire and Morey 1992). threatened by off road vehicle use; the the two populations occurs on a Because of the existence of only a single second site, although proposed for roadcut. population exhibiting low viability and protection as a county park, is The Crystal Springs Reservoir located in an unstable habitat, this threatened potentially by foot traffic. population of Cirsium fontinale var. species is extremely vulnerable to Five of the six populations of Castilleja fontinale is threatened by several stochastic extinction (Menges). affinis ssp. neglecta are threatened by factors, including roadside Hesperolinon congestum is threatened development, foot traffic, and a nearby maintenance. The California by the encroachment of native shrubs in quarry. The two populations of Department of Transportation is aware San Francisco County. In San Mateo Streptanthus niger are threatened by of the rare plants in this area, and the County, all three populations are residential development and road maintenance division submits spraying threatened by trash dumping as a construction. Clarkia franciscana is plans for internal environmental review consequence of recently completed known from five populations that are before spraying in the area where plants development. In addition, a portion of imperiled by potential development, are known to occur (Richard Vonarb, the H. congestum population located in foot traffic and competition from alien pers. comm., 1992). Alien plants such as Edgewood Park is suffering from foot plants. Proposed trail and road Cortaderia selloana have established traffic and inadequate trail maintenance construction threaten the three themselves near the C. fontinale var. (S. Sommers, in litt., 1993). remaining populations of Cirsium fontinale, and threaten several Pentachaeta bellidiflora potentially is fontinale var. fontinale. The single subpopulations (Zoe Chandik, pers. threatened by competition from alien remaining population of Eriophyllum comm., 1992). Dumping of garden plant species; this competition becomes latilobum occurs on steep slopes subject debris from households on the ridge a problem when the soils are disturbed to erosion that could be accelerated by above the plants covers plants and (Robison and Morey 1992b). If proposed a proposed bike trail. It is extremely renders the habitat unsuitable for plant trail construction occurs on the site, the vulnerable to extinction from random establishment and growth. It has been soil disturbance could result in events. The single remaining population suggested that C. fontinale var. fontinale encroachment and competition from of Pentachaeta bellidiflora, which has may be threatened with hybridization non-native species. been bisected by Highway 280, is with Cirsium quercetorum, but only one Ceanothus ferrisae is threatened by threatened by proposed trail hybrid has been collected in recent unauthorized dumping of litter and construction. It is also extremely years, so this is not thought to be a larger debris at the Anderson Dam site. vulnerable to random events. Ceanothus serious problem (Dean Kelch, pers. Dumping can degrade or threaten a ferrisae occurs in three populations comm., 1992). In addition, seed habitat by directly killing the plants, threatened by proposed residential and predation of this species has been depriving them of light, or disturbing recreational development; 95 percent of observed (Dean Kelch, pers. comm., the soil, thus promoting erosion and the one population was recently destroyed 1992) and may add to the vulnerability invasion of weedy, competitive species. by fire. Eleven of the 14 populations of of the species to elimination by chance Streptanthus albidus ssp. albidus is Dudleya setchellii occur on private land events. threatened by dumping and off-road and are threatened by a proposed golf Eriophyllum latilobum is threatened motorcycle use. Road maintenance or course and by residential, school, by many factors. Dumping of garden construction threaten populations that church and road construction. Proposed debris and downhill seepage of occur on roadcuts. residential and golf course construction, pesticides from homeowners living The Service has carefully assessed the and grazing threaten the nine above the population may have negative best scientific and commercial populations of Streptanthus albidus ssp. impacts on E. latilobum habitat. The information available regarding the past, albidus. plant also is threatened by competition present, and future threats faced by These species are in danger of with alien plants; its habitat is more these species in determining to make extinction throughout all or a part of densely populated with Carduus sp. and this rule final. These 12 plants are their range, and the preferred action is, Bromus sp. than it was 10 years ago endemic to a very specific habitat that therefore, to list Castilleja affinis ssp. (John Mooring, pers. comm., 1992). occurs in scattered outcrops. The rapid neglecta, Ceanothus ferrisae, Cirsium Road maintenance also threatens E. urban development in the San Francisco fontinale var. fontinale, Clarkia latilobum. San Mateo County road Bay region offers the greatest threat to franciscana, Cordylanthus tenuis ssp. maintenance crews were alerted to the these plants. Development has capillaris, Dudleya setchellii, existence of E. latilobum in 1990, and eliminated nearly 20 percent of the Eriophyllum latilobum, Pentachaeta instructed to avoid the plants by the San serpentine habitat in the last 20 years bellidiflora, Streptanthus albidus ssp. Mateo County Planning Department; (McCarten 1987b). The remaining albidus, and Streptanthus niger as however, road maintenance activities habitat is fragmented from road and endangered. Two species are not now in are not monitored to ensure protection urban construction and increasingly immediate danger of extinction (Roman Gankin, San Mateo County will become impacted with predicted throughout all or a significant portion of Planning Division, pers. comm. to Teri growth in population centers. The 12 their range. The single known McGuire, Botanist, California species are threatened further by the population of Calochortus tiburonensis Department of Fish and Game, cited in invasion of alien species, roadside is protected by The Nature Conservancy, McGuire and Morey 1992). San Mateo maintenance, soil erosion and slipping, however, its proximity to human County Department of Public Works has garbage dumping, livestock grazing, population centers and surrounding eliminated the use of weed sprays along seed predation, and small population development make it vulnerable to the section of road where the species sizes that increase their vulnerability to catastrophic events. Proposed occurs (Robert Sans, Director of Public chance events such as fire, flood, residential development and foot traffic Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6683 threaten 10 of the 14 populations of proper agencies have been notified of Castilleja affinis ssp. neglecta occur on Hesperolinon conjestum. If appropriate the locations and importance of the Golden Gate National Recreation management actions are not taken to protecting the habitat of these species. Area. Two populations of Clarkia protect these two species, they are likely Protection of the habitat of these franciscana occur at the Presidio. to become in danger of extinction in the species will be addressed through the The San Francisco Water Department near future. As a result, the preferred recovery process and through the owns 9,300 ha (23,000 acres) of land in action is to list Calochortus tiburonensis section 7 consultation process. San Mateo County. In 1969, a four-party and Hesperolinon congestum as Therefore, the Service finds that agreement among the U.S. Department threatened. designation of critical habitat for these of the Interior, the State of California, Alternatives to this action were plants is not prudent at this time, San Mateo County, and the City and considered but not preferred. Not listing because such designation likely would County of San Francisco established the species or listing Castilleja affinis increase the degree of threat from easements on the watershed lands to ssp. neglecta, Ceanothus ferrisae, vandalism, collecting, or other human ensure that all future land use would be Cirsium fontinale var. fontinale, Clarkia activities. compatible with water quality criteria. franciscana, Cordylanthus tenuis ssp. These easements were granted to the Available Conservation Measures capillaris, Dudleya setchellii, U.S. Department of the Interior and are Eriophyllum latilobum, Pentachaeta Conservation measures provided to jointly administered by the San bellidiflora, Streptanthus albidus ssp. species listed as endangered or Francisco Water Department and the albidus, and Streptanthus niger as threatened under the Act include Golden Gate National Recreation Area. threatened would not provide adequate recognition, recovery actions, Populations of Cirsium fontinale var. protection and would not be in keeping requirements for Federal protection, and fontinale, Eriophyllum latilobum, with the Act. prohibitions against certain activities. Hesperolinon congestum, and Recognition through listing encourages Pentachaeta bellidiflora occur on Water Critical Habitat and results in conservation actions by Department land. Section 4(a)(3) of the Act requires Federal, State, and private agencies, Hesperolinon congestum, Pentachaeta that, to the maximum extent prudent groups, and individuals. The Act bellidiflora, Dudleya setchellii, and and determinable, the Secretary provides for possible land acquisition Streptanthus albidus ssp. albidus co- designate critical habitat concurrently and cooperation with the State and occur with the bay checkerspot butterfly with determining a species to be requires that recovery actions be carried (Euphydryas editha bayensis) in San endangered or threatened. The Service out for all listed species. Such actions Mateo and Santa Clara counties. The finds that designation of critical habitat are initiated by the Service following bay checkerspot is listed as a threatened is not prudent for these species. Because listing. The protection required of species under the Endangered Species the 12 plants face numerous Federal agencies and the prohibitions Act. Permits for incidental take of this anthropogenic threats (see Factors A against certain activities involving listed species granted under section 10(a) of and E in ‘‘Summary of Factors Affecting plants are discussed, in part, below. the Act may affect the plant species the Species’’) and occur predominantly Section 7(a) of the Act requires listed above. Preparation of Habitat on private land, the publication of Federal agencies to evaluate their Conservation Plans for the bay precise maps and descriptions of critical actions with respect to any species that checkerspot butterfly may, therefore, habitat in the Federal Register would is proposed or listed as endangered or require internal section 7 consultation make these plants more vulnerable to threatened and with respect to its with regard to the four species listed incidents of vandalism and, therefore, critical habitat, if any is being above. could contribute to the decline of these designated. Regulations implementing The 12 plants also may be affected by species and increase enforcement this interagency cooperation provision Federal mortgage programs, including problems. The listing of these species as of the Act are codified at 50 CFR Part the Veterans’ Administration and the endangered or threatened also 402. Section 7(a)(4) of the Act requires U.S. Department of Housing and Urban publicizes the rarity of these plants and, Federal agencies to confer with the Development (Federal Home thus, can make them attractive to Service on any action that is likely to Administration loans), or by researchers or collectors of rare plants. jeopardize the continued existence of a construction of roads and highways by Furthermore, critical habitat designation proposed species or result in the Federal Highway Administration. is not prudent due to lack of benefit to destruction or adverse modification of The Service is concerned over the loss the species. All 12 species discussed proposed critical habitat. If a species is of Eriophyllum latilobum during regular herein are restricted to serpentine soils. listed subsequently, section 7(a)(2) road maintenance and continuing soil Several of the species, Eriophyllum requires Federal agencies to ensure that slippage that results in plant loss; latilobum, Calochortus tiburonensis, activities they authorize, fund, or carry however, removal from roadways of Streptanthus niger, and Streptanthus out are not likely to jeopardize the debris containing E. latilobum plants or albidus ssp. albidus likely have always continued existence of such a species or seeds that has fallen by natural causes been confined to their present habitat. to destroy or adversely modify its into the roadway is not a violation of the No areas outside of their present range critical habitat. If a Federal action may Act. are known to have supported these affect a listed species or its critical At least one proposed project that plants in the past; therefore, no habitat, the responsible Federal agency may affect two of the plants also additional sites exist that could be must enter into formal consultation with involves wetlands under the jurisdiction considered essential to the species’ the Service. of the U.S. Army Corps of Engineers. recovery. For these reasons, the Service Federal activities potentially affecting Listing these 12 plants will provide finds that designation of critical habitat 1 or more of the 12 plants will likely for development of a recovery plan (or for the 12 species is not prudent because involve recreation-related projects and plans) for them. Such plan(s) would it would provide no additional benefits perhaps grazing practices on Federal bring together both State and Federal to the species beyond those they would land. Populations of 3 of the 12 plants efforts for conservation of the plants. receive by virtue of their designation as occur on Federal land. Two populations The plan(s) would establish a endangered or threatened species. The of Hesperolinon congestum and one of framework for agencies to coordinate 6684 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations activities and cooperate with each other prohibited activities involving published in the Federal Register on in conservation efforts. The plan(s) endangered or threatened plant species October 25, 1983 (48 FR 49244). would set recovery priorities and under certain circumstances. The References Cited estimate costs of various tasks necessary Service anticipates few trade permits to accomplish them. They also would would ever be sought or issued for the A complete list of all references cited describe site-specific management 12 species because the plants are not herein is available, upon request, from actions necessary to achieve common in cultivation or in the wild. the Field Supervisor, Sacramento Field conservation and survival of the 12 It is the policy of the Service (59 FR Office (see ADDRESSES section). serpentine plant species. 34272) to identify to the maximum Author: The primary author of this final The Act and its implementing extent practicable at the time a species rule is Elizabeth Warne, U.S. Fish and regulations found at 50 CFR 17.61, is listed those activities that would or Wildlife Service, Sacramento Field Office 17.62, and 17.63 for endangered species would not constitute a violation of (see ADDRESSES section). and 17.71 and 17.72 for threatened section 9 of the Act. The intent of this List of Subjects in 50 CFR Part 17 species set forth a series of general policy is to increase public awareness of prohibitions and exceptions that apply the effect of the listing on proposed or Endangered and threatened species, to all endangered or threatened plants. ongoing activities. Activities affected by Exports, Imports, Reporting and With respect to the 12 plants from San the listing were discussed previously in recordkeeping requirements, and Francisco Bay area serpentine habitats, this section. The Service does not at this Transportation. all prohibitions of section 9(a)(2) of the time know of any other activities Regulations Promulgation Act, implemented by 50 CFR 17.61 or affected by this listing. 17.71, would apply. These prohibitions, Questions regarding whether specific Accordingly, Part 17 subchapter B of in part, make it illegal for any person activities will constitute a violation of Chapter I, Title 50 of the Code of subject to the jurisdiction of the United section 9 should be directed to the Field Federal Regulations, is amended as set States to import or export; transport in Supervisor of the Service’s Sacramento forth below: interstate or foreign commerce in the Office (see ADDRESSES section). Requests course of a commercial activity; sell or for copies of the regulations on listed PART 17Ð[AMENDED] offer for sale in interstate or foreign plants and inquiries regarding them may commerce; remove and reduce to 1. The authority citation for Part 17 be addressed to the U.S. Fish and continues to read as follows: possession the species from areas under Wildlife Service, Ecological Services, Federal jurisdiction; maliciously Permits Branch, 911 N.E. 11th Avenue, Authority: 16 U.S.C. 1361–1407; 16 U.S.C. damage or destroy any such species on Portland, Oregon 97232–4181 (503/231– 1531–1544; 16 U.S.C. 4201–4245; Pub. L. 99– any area under Federal jurisdiction; or 6241; FAX 503/231–6243). 625, 100 Stat. 3500, unless otherwise noted. remove, cut, dig up, damage, or destroy 2. Section 17.12(h) is amended by National Environmental Policy Act any such endangered plant species on adding the following species, in any other area in knowing violation of The Fish and Wildlife Service has alphabetical order under the families any State law or regulation or in the determined that an Environmental indicated, and by adding a new family course of any violation of a State Assessment, as defined under the ‘‘Linaceae—Flax Family,’’ in criminal trespass law. Certain authority of the National Environmental alphabetical order, to the List of exceptions apply to agents of the Policy Act of 1969, need not be Endangered and Threatened Plants: Service and State conservation agencies. prepared in connection with regulations The Act and 50 CFR 17.62, 17.63, and adopted pursuant to section 4(a) of the § 17.12 Endangered and threatened plants. 17.72 also provide for the issuance of Act. A notice outlining the Service’s * * * * * permits to carry out otherwise reasons for this determination was (h) * * * Species Historic range Status When listed Critical habitat Special rules Scientific name Common name ******* AsteraceaeÐAster family: ******* Cirsium fontinale var. fontinale Fountain thistle ...... U.S.A. (CA) ...... E 575 NA NA ******* Eriophyllum latilobum ...... San Mateo woolly U.S.A. (CA) ...... E 575 NA NA sunflower. ******* Pentachaeta bellidiflora ...... White-rayed U.S.A. (CA) ...... E 575 NA NA pentachaeta. ******* BrassicaceaeÐMustard family: ******* Streptanthus albidus ssp. Metcalf Canyon U.S.A. (CA) ...... E 575 NA NA albidus. jewelflower. Streptanthus niger ...... Tiburon jewelflower .. U.S.A. (CA) ...... E 575 NA NA Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6685 Species Historic range Status When listed Critical habitat Special rules Scientific name Common name ******* CrassulaceaeÐStonecrop family: ******* Dudleya setchellii ...... Santa Clara Valley U.S.A. (CA) ...... E 575 NA NA dudleya. ******* LiliaceaeÐLily family: ******* Calochortus tiburonensis ...... Tiburon mariposa lily U.S.A. (CA) ...... T 575 NA NA ******* LinaceaeÐFlax family: Hesperolinon congestum ...... Marin dwarf-flax ...... U.S.A. (CA) ...... T 575 NA NA ******* OnagraceaeÐEvening-primrose family: ******* Clarkia franciscana ...... Presidio clarkia ...... U.S.A. (CA) ...... E 575 NA NA ****** RhamnaceaeÐBuckthorn family: ******* Ceanothus ferrisae ...... Coyote ceanothus .... U.S.A. (CA) ...... E 575 NA NA ******* ScrophulariaceaeÐSnapdragon family: **** **** Castilleja affinis ssp. neglecta Tiburon paintbrush ... U.S.A. (CA) ...... E 575 NA NA ******* Cordylanthus tenius ssp. Pennell's bird's beak U.S.A. (CA) ...... E 575 NA NA capillaris. ******* Dated: December 16, 1994. Mollie H. Beattie, Director, U.S. Fish and Wildlife Service. [FR Doc. 95–2689 Filed 2–2–95; 8:45 am] BILLING CODE 4310±55±P 6686 Proposed Rules Federal Register Vol. 60, No. 23 Friday, February 3, 1995 This section of the FEDERAL REGISTER supporting the views and suggestions feet AGL is needed to accommodate this contains notices to the public of the proposed presented are particularly helpful in SIAP and for IFR operations at the issuance of rules and regulations. The developing reasoned regulatory airport. Designations for Class E purpose of these notices is to give interested decisions on the proposal. Comments airspace extending upward from 700 persons an opportunity to participate in the are specifically invited on the overall feet or more above the surface are rule making prior to the adoption of the final rules. regulatory, aeronautical, economic, published in Paragraph 6005 of FAA environmental, and energy-related Order 7400.9B dated July 18, 1994 and aspects of the proposal. effective September 16, 1994 which is DEPARTMENT OF TRANSPORTATION Communications should identify the incorporated by reference in CFR 71.1. airspace docket and be submitted in The Class E airspace designation listed Federal Aviation Administration triplicate to the address listed above. in this document would be published Commenters wishing the FAA to subsequently in the Order. 14 CFR Part 71 acknowledge receipt of their comments The FAA has determined that this [Airspace Docket No. 95±ASO±4] on this notice must submit with those proposed regulation only involves an comments a self-addressed, stamped established body of technical Proposed Amendment to Class E postcard on which the following regulations for which frequent and Airspace; Smithfield, NC statement is made: ‘‘Comments to routine amendments are necessary to Airspace Docket No. 95–ASO–4.’’ The keep them operationally current. It, AGENCY: Federal Aviation postcard will be date/time stamped and Administration (FAA), DOT. therefore, (1) is not a ‘‘significant returned to the commenter. All regulatory action’’ under Executive ACTION: Notice of proposed rulemaking. communications received before the Order 12866; (2) is not a ‘‘significant specified closing date for comments will SUMMARY: This notice proposes to rule’’ under DOT Regulatory Policies amend the Class E airspace area at be considered before taking action on and Procedures (44 FR 11034; February Smithfield, NC, A LOC/DME RWY 3 the proposed rule. The proposal 26, 1979); and (3) does not warrant Standard Instrument Approach contained in this notice may be changed preparation of a regulatory evaluation as Procedure (SIAP) has been developed in the light of comments received. All the anticipated impact is so minimal. for Johnston County Airport. Additional comments submitted will be available Since this is a routine matter that will controlled airspace extending upward for examination in the Office of the only affect air traffic procedures and air from 700 feet above the surface (AGL) is Assistant Chief Counsel for Southern navigation, it is certified that this rule needed to accommodate this SIAP and Region, Room 550, 1701 Columbia when promulgated, will not have a for instrument flight rules (IFR) Avenue, College Park, Georgia 30337, significant economic impact on a operations at the airport. both before and after the closing date for substantial number of small entities comments. A report summarizing each DATES: Comments must be received on under the criteria of the Regulatory substantive public contact with FAA or before March 20, 1995. Flexibility Act. personnel concerned with this ADDRESSES: Send comments on the rulemaking will be filed in the docket. List of Subjects in 14 CFR Part 71 proposal in triplicate to: Federal Aviation Administration, Docket No. Availability of NPRM‘S Airspace, Incorporation by reference, Navigation (Air). 95–ASO–4, Manager, System Any person may obtain a copy of this Management Branch, ASO–530, P.O. Notice of Proposed Rulemaking (NPRM) The Proposed Amendment Box 20636, Atlanta, Georgia 30320. by submitting a request to the Federal In consideration of the foregoing, the The official docket may be examined Aviation Administration, Manager, Federal Aviation Administration in the Office of the Assistant Chief System Management Branch ASO–530, proposes to amend 14 CFR part 71 as Counsel for Southern Region, Room 550, Air Traffic Division, P.O. Box 20636, follows: 1701 Columbia Avenue, College Park, Atlanta, Georgia 30320. Georgia 30337, telephone (404) 305– Communications must identify the PART 71Ð[AMENDED] 5586. notice number of this NPRM. Persons FOR FURTHER INFORMATION CONTACT: interested in being placed on a mailing 1. The authority citation for 14 CFR Michael J. Powderly, System list for future NPRM’s should also part 71 continues to read as follows: Management Branch, Air Traffic request a copy of Advisory Circular No. Division, Federal Aviation Authority: 49 U.S.C. app. 1348(a), 1354(a), 11–2A which describes the application 1510; E.O. 10854, 24 FR 9565, 3 CFR, 1959– Administration, P.O. Box 20636, procedure. 1963 Comp., p. 389; 49 U.S.C. 106(g); 14 CFR Atlanta, Georgia 30320; telephone (404) 11.69. 305–5570. The Proposal § 71.1 [Amended] SUPPLEMENTARY INFORMATION: The FAA is considering an amendment to part 71 of the Federal 2. The incorporation by reference in Comments Invited Aviation Regulations (14 CFR part 71) to 14 CFR 71.1 of the Federal Aviation Interested parties are invited to amend the Class E airspace area at Administration Order 7400.9B, Airspace participate in this proposed rulemaking Smithfield, NC, A LOC/DME RWY 3 Designations and Reporting Points, by submitting such written data, views SIAP has been developed for Johnston dated July 18, 1994 and effective or arguments as they may desire. County Airport. Additional controlled September 16, 1994, is amended as Comments that provide the factual basis airspace extending upward from 700 follows: Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6687 Para. 6005 Class E airspace areas extending DATES: The public comment period is in the Alternate Compliance Program upward from 700 feet above the surface reopened from February 3, 1995 until (ACP), and interested persons are of the earth. April 7, 1995. A public hearing has been invited to submit comments. * * * * * scheduled for Wednesday March 8, DATES: A pilot program will begin ASO NC E5 Smithfield, NC [Revised] 1995, at 1:30 pm. February 3, 1995. Applications for Johnston County Airport, NC ADDRESSES: Written comments on the participation in the pilot program must (Lat. 35°26′28′′ N, long. 78°23′25′′) proposed rule should be addressed to: J. be received not later than May 4, 1995. Jnall NDB Elmer Bortzer, Chief, Regulation Written comments should be submitted (Lat. 35°26′25′′ N, long. 78°21′16′′ W) Development Section (AR–18J), U.S. not later than August 2, 1995. That airspace extending upward from 700 Environmental Protection Agency, ADDRESSES: Applications for feet above the surface within a 7.5-mile Region 5, 77 West Jackson Boulevard, participation in the pilot program must radius of Johnston County Airport and within Chicago, Illinois 60604. be submitted to Commandant (G–MVI– 2.4 miles each side of the 024° bearing from Comments should be strictly limited 1), ATTN: ACP Pilot Program, U.S. the Jnall NDB, extending from the 7.5-mile to the subject matter of the November Coast Guard, 2100 Second Street, S.W., radius to 7 miles northeast of the NDB. 18, 1994, proposed rule. The location of Washington, DC 20593–0001. Written * * * * * the public hearing is the Lake Ontario comments may be mailed to the Issued in College Park, Georgia, on January Room on the twelfth floor of the Ralph Executive Secretary, Marine Safety 24, 1995. H. Metcalfe Federal Building, 77 West Council (G–LRA), U.S. Coast Guard, Michael J. Powderly, Jackson Boulevard, Chicago, Illinois 2100 Second Street S.W., Washington, Acting Manager, Air Traffic Division, 60604. DC 20593–0001, or may be delivered to Southern Region. FOR FURTHER INFORMATION CONTACT: room 3406 at the same address between [FR Doc. 95–2733 Filed 2–2–95; 8:45 am] Steven Rosenthal, Regulation 8 AM and 3 PM, Monday through BILLING CODE 4910±13±M Development Branch, 18th Floor Friday, except Federal holidays. Southwest, 77 West Jackson Boulevard, Comments will become part of this Chicago, Illinois 60604, (312) 886–6052. docket and will be available for inspection or copying at room 3406, ENVIRONMENTAL PROTECTION Dated: January 25, 1995. AGENCY Coast Guard Headquarters, between 8 Michelle D. Jordan, AM and 3 PM, Monday through Friday, 40 CFR Part 52 Acting Regional Administrator. except Federal holidays. Copies of [FR Doc. 95–2628 Filed 2–2–95; 8:45 am] referenced materials are available for [IL12±39±6822, FRL±5149±2] BILLING CODE 6560±50±P inspection and copying in room 1400, U.S. Coast Guard, 2100 Second Street Approval and Promulgation of S.W., Washington, DC 20593–0001, and Implementation Plans; Illinois DEPARTMENT OF TRANSPORTATION may also be obtained from the American AGENCY: Environmental Protection Bureau of Shipping, 16855 Northchase Coast Guard Agency. Drive, Houston, TX 77060, or the International Maritime Organization, ACTION: Proposed rule; notice of public 46 CFR Chapter I hearing; reopening the public comment Publications Section, 4 Albert period. [CGD 95±007] Embankment, London SE1 7SR, United Kingdom, telephone 44 (71) 735 7611, SUMMARY: The United States Alternate Compliance for Inspection facsimile 44 (71) 587 3210, as indicated. Environmental Protection Agency and Certification of Certain U.S. Flag FOR FURTHER INFORMATION CONTACT: (USEPA) promulgated the Chicago Commercial Vessels LCDR David L. Scott, Project Manager, ozone Federal Implementation Plan AGENCY: Coast Guard, DOT. Commandant (G–MV1–1), U.S. Coast Guard, 2100 Second Street, S.W., (FIP) on June 29, 1990 (55 FR 26814). ACTION: Notice; solicitation for Included in USEPA’s FIP was a participants; request for comments. Washington, DC 20593–0001, telephone requirement that staple manufacturing (202) 267–1464. SUMMARY facilities such as Duo-Fast Corporation’s : On January 12, 1995, the U.S. SUPPLEMENTARY INFORMATION: Franklin Park, Illinois facility be subject Coast Guard and the American Bureau to specific emission limits. On of Shipping (ABS) signed a Background November 27, 1990, Duo-Fast filed a Memorandum of Understanding (MOU) Under 46 U.S.C. 3316, the Secretary of petition for reconsideration with USEPA concerning delegation of vessel Transportation may rely upon reports, in which it contended that USEPA inspections and examinations, tonnage documents, and certificates issued by failed to respond to Duo-Fast’s March 2, measurement, and acceptance of plan ABS. The Secretary may also delegate 1990, comments in response to USEPA’s review and approval. Under this MOU, authority to ABS to inspect or examine December 27, 1990, proposed the Coast Guard and the ABS will a vessel of the U.S. The same statute promulgation of the Chicago FIP. On develop a program to provide owners authorizes the Secretary to use ABS for November 18, 1994 (59 FR 59739), and operators of certain ABS classed, reviewing and approving plans required USEPA published a proposed rule on Coast Guard inspected commercial for issuance of a certificate of this reconsideration which offered the vessels with an alternative to inspection. These authorities have been opportunity for a public hearing. A undergoing inspection by the Coast delegated to the Coast Guard. The MOU public hearing was requested on the Guard under existing applicable Federal signed on January 12, 1995, by the Coast November 18, 1994, proposed rule. This regulations. Owners and operators of Guard and the ABS further delegates notice announces that a public hearing certain ABS classed, Coast Guard these authorities to the ABS. on the proposed rule is scheduled for inspected vessels are invited to Currently, the Coast Guard conducts March 8, 1995, and reopens the public participate in a pilot program designed vessel inspections and the ABS comment period from February 3, 1995 to evaluate standards, processes, and conducts vessel surveys. For U.S. flag, until April 7, 1995. procedures under development for use ABS classed, Coast Guard inspected 6688 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules commercial vessels, these inspections unnecessary regulations and duplication ABS reports to issue a Certificate of and surveys are largely duplicative. The of the inspections conducted by the Inspection. The Coast Guard will also U.S. Coast Guard’s ABS Based Alternate Coast Guard with surveys conducted by provide oversight to ensure that vessels Compliance Program (ACP) is a the ABS. The ACP also improves the participating in this program maintain a cooperative effort between the Coast regularity in the processing of requests level of safety equivalent to that Guard and ABS. The goal of the ACP is for equivalency determinations. Owners experienced by vessels inspected under to allow a vessel to be inspected by ABS and operators of vessels which the traditional process. The high level of under the applicable ABS class rules, participate in the ACP may realize safety present on vessels of the U.S. international treaties and agreements to substantial time savings in the vessel merchant marine will not be which the U.S. is a party, and other certification process, as well as compromised. prescribed standards which have been increased flexibility in scheduling Coast Guard user fees are the subject determined by the Coast Guard to required tests and examinations. While of a separate ongoing rulemaking. provide a level of safety equivalent to the ACP is designed to eventually Participants in the pilot program may be compliance with current regulations. include inspection and examination of responsible for payment for both Coast Under current regulations, the Coast newly-constructed vessels, the pilot Guard user fees and costs of ABS Guard may accept a wide range of program is limited to existing vessels. services. Participants in the pilot equivalencies or alternative compliance Although broader application of this program should not expect that any methods on a case-by-case basis. program will be accomplished through applicable user fees will be reduced. The ABS, in cooperation with the rulemaking, the Coast Guard has However, the Coast Guard will collect Coast Guard, has reviewed the current developed a Navigation and Vessel data on the level of Coast Guard regulations in 33 CFR Chapter I and 46 Inspection Circular (NVIC) which resources utilized in the ACP and CFR Chapter I, the ABS Rules for provides an overall description of the evaluate the need for future changes to Building and Classing Steel Vessels, and ACP, identifies the conditions for applicable user fee regulations. applicable international treaties and enrollment, and describes the duties Eligibility agreements such as the International and responsibilities of participating Convention for the Safety of Life at Sea vessel owners and operators, ABS and The Coast Guard invites companies as amended (SOLAS 74/78), the 1973 the Coast Guard. Persons interested in which own or operate U.S. flag, ABS International Convention for the obtaining a copy of this NVIC are classed, Coast Guard inspected Prevention of Pollution from Ships, as invited to contact the Program Manager commercial vessels to apply to modified by the Protocol of 1978 identified above in FOR FURTHER participate in a pilot program beginning (MARPOL 73/78), and the 1969 INFORMATION CONTACT. February 3, 1995. At present, only cargo International Convention on Tonnage Copies of all referenced documents ships and tank ships possessing valid Measurement of Ships. Based on this may be viewed at Room 1400, Coast international certificates are eligible to review, the ABS developed the U.S. Guard Headquarters, 2100 Second enter the pilot program because Supplement to the ABS Rules to address Street, S.W., Washington, DC 20593– currently the U.S. Supplement to the current regulatory requirements that are 0001, between the hours of 8 AM and ABS Rules is only applicable to cargo not satisfied by compliance with the 3 PM Monday through Friday, except ships and tank ships surveyed for other standards. The U.S. Supplement Federal holidays. Copies of the ABS international voyages. In addition, ships also contains amplifying information Rules for Building and Classing Steel offered for the pilot program must necessary to ensure compliance with Vessels and the U.S. Supplement to the currently be classed by the ABS and SOLAR 74/78. The Coast Guard has ABS Rules for Steel Vessels for Vessels have a valid Certificate of Inspection. determined that the U.S. Supplement to on International Voyages may be A company may not participate in the the ABS Rules, when used in obtained from ABS as listed under pilot program if it has a history of conjunction with the ABS Rules for ADDRESSES above. Consolidated editions recurring marine casualties, oil spills, Building and Classing Steel Vessels, and of the SOLAS Convention and MARPOL civil penalties or a record of poor applicable international treaties and 73/78 may be obtained from the maintenance of its vessel or vessels. agreements, provides a degree of safety International Maritime Organization as Due to resource limitations during the consistent with the minimum standards listed under ADDRESSES above. pilot program, the Coast Guard may, on a case by case basis, reject an set forth in the subchapters of Titles 33 Pilot Program and 46 of the Code of Federal application for vessels which will Regulations relating to tankers and cargo The Coast Guard intends to initiate undergo inspection for certification in a vessels. rulemaking on this subject through foreign port. Additionally, due to Under the ACP pilot program, an ABS publication of a notice of proposed limited resources, the Coast Guard will surveyor would examine the vessel to rulemaking. Beginning February 3, also consider scheduling and location of determine compliance with these 1995, it will conduct a limited pilot inspection services as criteria for alternative standards. A Coast Guard program to test and evaluate the participation. Officer in Charge of Marine Inspection standards and procedures that have Selected participants should be (OCMI) may then issue a Certificate of been developed in cooperation with the prepared to provide feedback and Inspection to the vessel based upon a ABS. The Coast Guard will also use the suggestions for improvement of the determination by the Coast Guard that pilot program to check the application program and to participate in other the required international and of these standards and procedures to activities to help the Coast Guard and classification certificates are valid and existing tankers and cargo vessels. the ABS refine the ACP. properly endorsed, other reports from Therefore, during the pilot program, Companies may apply to enroll in the the ABS, and that the vessel is properly ABS surveyors will apply these pilot program by submitting a written manned and maintained by the standards during classification surveys, request to the address listed in operator. damage surveys, drydock examinations ADDRESSES above. Applications must The purpose of the ACP is to increase and other required tests and inspections indicate the name and official number the international competitiveness of the for participating vessels. The cognizant of the vessel or vessels offered for U.S. maritime industry by eliminating Coast Guard OCMI may rely upon the enrollment, the expiration date of each Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6689 Certificate of Inspection, and identify a normal business hours in the FCC distance separation requirements at company representative as the point of Reference Center (Room 239), 1919 M petitioner’s presently authorized site. contact. Street, NW, Washington, D.C. The The coordinates for Channel 266A at The Coast Guard also requests complete text of this decision may also Leavenworth are North Latitude 47–35– comments from interested persons on be purchased from the Commission’s 32 and West Longitude 120–38–35. See the pilot program and the standards and copy contractor, International Supplementary Information, supra. processes developed for use in the ACP. Transcription Services, Inc., (202) 857– DATES: Comments must be filed on or Written comments should be submitted 3800, 2100 M Street, NW, Suite 140, before March 24, 1995 and reply as indicated under ADDRESSES above. Washington, D.C. 20037. comments on or before April 10, 1995. Dated: January 30, 1995. Provisions of the Regulatory ADDRESSES: Federal Communications J.C. Card, Flexibility Act of 1980 do not apply to Commission, Washington, D.C. 20554. this proceeding. Rear Admiral, U.S. Coast Guard Chief, Office In addition to filing comments with the of Marine Safety, Security and Environmental Members of the public should note FCC, interested parties should serve the Protection. that from the time a Notice of Proposed petitioner, or its counsel or consultant, [FR Doc. 95–2648 Filed 2–2–95; 8:45 am] Rule Making is issued until the matter as follows: Melodie A. Virtue, Haley, is no longer subject to Commission BILLING CODE 4910±14±M Bader & Potts, Suite 900, 4350 North consideration or court review, all ex Fairfax Drive, Arlington, Virginia parte contacts are prohibited in 22203–1633 (Counsel for Petitioner). Commission proceedings, such as this FURTHER INFORMATION CONTACT: Sharon FEDERAL COMMUNICATIONS one, which involve channel allotments. COMMISSION P. McDonald, Mass Media Bureau, (202) See 47 CFR 1.1204(b) for rules 634–6530. governing permissible ex parte contacts. 47 CFR Part 73 SUPPLEMENTARY INFORMATION: This is a For information regarding proper synopsis of the Commission’s Notice of [MM Docket No. 95±15, RM±8574] filing procedures for comments, see 47 Proposed Rule Making and Order to CFR 1.415 and 1.420. Radio Broadcasting Services; Pago Show Cause, MM Docket No. 95–14, Pago, American Samoa List of Subjects in 47 CFR Part 73 adopted January 24, 1995, and released January 30, 1995. The full text of this Radio broadcasting. AGENCY: Federal Communications Commission decision is available for Commission. Federal Communications Commission. inspection and copying during normal ACTION: Proposed rule. John A Karousos, business hours in the FCC Reference Chief, Allocations Branch, Policy and Rules Center (Room 239), 1919 M Street, NW, SUMMARY: The Commission requests Division, Mass Media Bureau. Washington, D.C. The complete text of comments on a petition filed by Oceania [FR Doc. 95–2681 Filed 2–2–95; 8:45 am] this decision may also be purchased Broadcasting Network, Inc., seeking the BILLING CODE 6712±01±F from the Commission’s copy contractor, allotment of Channel 226C1 to Pago International Transcription Service, Pago, American Samoa, as the Inc., (202) 857–3800, 2100 M Street, community’s second local FM service. 47 CFR Part 73 NW, Suite 140, Washington, D.C. 20037. Channel 226C1 can be allotted to Pago Additionally, Channel 248C3 can be [MM Docket No. 95±14; RM±8552] Pago in compliance with the allotted at Othello and Channel 249A at Commission’s minimum distance Radio Broadcasting Services; East Wenatchee in compliance with the separation requirements without the Leavenworth, Othello, and East Commission’s minimum distance imposition of a site restriction, at Wenatchee, Washington separation requirements without the coordinates –14–16–41 South Latitude imposition of site restrictions. The and 170–42–09 West Longitude. AGENCY: Federal Communications coordinates for Channel 248C3 at DATES: Comments must be filed on or Commission. Othello are North Latitude 46–45–55 before March 24, 1995, and reply ACTION: Proposed rule. and West Longitude 119–16–49; and the comments on or before April 10, 1995. coordinates for Channel 249A at East SUMMARY: The Commission requests Wenatchee are North Latitude 47–22–52 ADDRESSES: Federal Communications comments on a petition filed by Ronald Commission, Washington, D.C. 20554. and West Longitude 120–17–16. Since A. Murray, d/b/a Murray Broadcasting, Leavenworth, Othello and East In addition to filing comments with the proposing the substitution of Channel FCC, interested parties should serve the Wenatchee are located within 320 266A for Channel 249A at Leavenworth, kilometers (200 miles) of the U.S- petitioner, or its counsel or consultant, Washington, and the modification of as follows: Christopher J. Racine, Canadian border, concurrence of the Station KLVH(FM)’s construction Canadian government has been President, Oceania Broadcasting permit accordingly. In order to Network, Inc., 970 North Kalaheo requested. accommodate the substitution, Provisions of the Regulatory Avenue, Suite C314, Kailua, Hawaii petitioner also requests the downgrade Flexibility Act of 1980 do not apply to 96734 (Petitioner). of Channel 248C1 to Channel 248C3 at this proceeding. FOR FURTHER INFORMATION CONTACT: Othello, Washington, and the Members of the public should note Leslie K. Shapiro, Mass Media Bureau, modification of Station KZLN-FM’s that from the time a Notice of Proposed (202) 418–2180. construction permit accordingly; the Rule Making is issued until the matter SUPPLEMENTARY INFORMATION: This is a substitution of Channel 249A for is no longer subject to Commission synopsis of the Commission’s Notice of Channel 266A at East Wenatchee, consideration or court review, all ex Proposed Rule Making, MM Docket No. Washington, and the modification of parte contacts are prohibited in 95–15, adopted January 24, 1995, and Station KYSN(FM)’s license Commission proceedings, such as this released January 30, 1995. The full text accordingly. Channel 266A can be one, which involve channel allotments. of this Commission decision is available allotted at Leavenworth in compliance See 47 CFR 1.1204(b) for rules for inspection and copying during with the Commission’s minimum governing permissible ex parte contacts. 6690 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules For information regarding proper Federal Communications Commission. filing procedures for comments, see 47 John A. Karousos, CFR 1.415 and 1.420. Chief, Allocations Branch, Policy and Rules Division, Mass Media Bureau. List of Subjects in 47 CFR Part 73 [FR Doc. 95–2680 Filed 2–2–95; 8:45 am] Radio broadcasting. BILLING CODE 6712±01±F 6691 Notices Federal Register Vol. 60, No. 23 Friday, February 3, 1995 This section of the FEDERAL REGISTER Consumer Service, U.S. Department of available appropriation. Thus the contains documents other than rules or Agriculture, 3101 Park Center Drive, Department is required to establish (and proposed rules that are applicable to the Alexandria, Virginia 22302–1594 or if necessary, adjust) rates in such a public. Notices of hearings and investigations, telephone (703) 305–2662. manner as to not exceed the program committee meetings, agency decisions and appropriation. rulings, delegations of authority, filing of SUPPLEMENTARY INFORMATION: Executive petitions and applications and agency Order 12866 Fiscal Year 1994 Adjusted Level of statements of organization and functions are Assistance examples of documents appearing in this This action is exempted from review section. by the Office of Management and The Agriculture, Rural Development, Budget under Executive Order 12866. Food and Drug Administration, and Related Agencies Act of 1993 (Pub. L. Executive Order 12372 DEPARTMENT OF AGRICULTURE 103–111), which appropriated NPE This program is listed in the Catalog funding for Fiscal Year 1994, imposed Food and Consumer Service of Federal Domestic Assistance under different NPE rate management Nos. 10.550 and 10.570 and is subject to requirements for Fiscal Year 1994. Title Nutrition Program for the Elderly; the provisions of Executive Order IV, Domestic Food Programs, of the Act Adjusted Level of Assistance From 12372, which requires provides that ‘‘* * * a maximum rate of October 1, 1993 to September 30, 1994 intergovernmental consultation with reimbursement to States will be and Initial Level of Assistance From State and local officials (7 CFR part established by the Secretary, subject to October 1, 1994 to September 30, 1995 3015, subpart V, and final rule-related reduction if obligations would exceed notices published at 48 FR 29114, June AGENCY: the amount of available funds, with any Food and Consumer Service, 24, 1983 and 49 FR 22676, May 31, USDA. unobligated funds to remain available 1984.) for obligation in the fiscal year ACTION: Notice. Paperwork Reduction Act beginning October 1, 1994.’’ SUMMARY: This notice announces both Based on its projection of the number This notice imposes no new reporting the final level of per-meal assistance for of meals to be claimed during the fiscal or recordkeeping provisions that are the Nutrition Program for the Elderly year, and in light of constitutional and subject to Office of Management and (NPE) for Fiscal Year 1994 and the statutory prohibitions on obligating or Budget review in accordance with the initial level of per-meal assistance for spending funds in excess of the Paperwork Reduction Act of 1980 (44 Fiscal Year 1995. The Fiscal Year 1994 available appropriation, the Department U.S.C. 3507). This action is not a rule initial level of assistance of $.6146 is announced an initial per-meal as defined by the Regulatory Flexibility adjusted to $.6057 for all eligible meals reimbursement rate of $.6146, the Act (5 U.S.C. 601–612) and thus is served during the fiscal year in highest rate which it believed could be exempt from the provisions of that Act. accordance with section 311(c)(2)(A) of sustained throughout the fiscal year. the Older Americans Act of 1965, as Legislative Background This initial level of per-meal assistance amended by section 310 of the Older was announced in the January 3, 1994 Section 310 of Pub. L. 102–375, the Federal Register (57 FR 59). Americans Act Amendments of 1992 Older Americans Act Amendments of and preempted by the Agriculture, Rural The Department’s meal service 1992, amended section 311(a)(4) of the projection for Fiscal Year 1994 assumed Development, Food and Drug Older Americans Act of 1965, 42 U.S.C. a .45 percent meal service increase over Administration, and Related Agencies 3030a(a)(4), to require the Secretary of virtually complete Fiscal Year 1993 Act of 1993. Rates are subject to change Agriculture to maintain an annually meal counts. This growth factor because NPE receives a finite amount of programmed level of assistance equal to represented one-half of the highest rate annual appropriations, but meal service the greater of: (1) The current of growth (.9 percent) the program had is a variable which cannot be accurately appropriation divided by the number of experienced in any one of the four projected. Therefore, if meal service meals served in the preceding fiscal previous fiscal years. However, meal exceeds Department projections, the rate year; or (2) 61 cents per meal adjusted service, which is the basis for rate must be adjusted accordingly. The annually beginning with Fiscal Year setting, cannot always be accurately Fiscal Year 1995 initial level of 1993 to reflect changes in the Consumer projected because it follows no assistance is set at $.60 for each eligible Price Index. Section 311(c)(2) of the Act discernible pattern from year to year. In meal in accordance with section (42 U.S.C. 3030a(c)(2)) was amended to some recent years, for example, meal 311(a)(4) of the Older Americans Act of provide that the final reimbursement service declined when the per-meal 1965, as amended by section 310 of the claims must be adjusted so as to utilize support level remained unchanged or Older Americans Act Amendments of the entire program appropriation for the increased. 1992. fiscal year for per-meal support. Data for the first three quarters of EFFECTIVE DATE: Fiscal Year 1994 Notwithstanding the initial rates Fiscal Year 1994 revealed that the Adjusted Level of Assistance: October 1, established by the Older Americans Act, program had experienced a .31 percent 1993. Fiscal Year 1995 Initial Level of the Department is required to comply meal service increase over the number Assistance: October 1, 1994. with the spending clause of the U.S. of meals served in the first three FOR FURTHER INFORMATION CONTACT: Constitution and 31 U.S.C. 1341(a)(1)(A) quarters in Fiscal Year 1993, well Philip K. Cohen, Chief, Program (known as the Antideficiency Act), within the Department’s projected .45 Administration Branch, Food which prohibit the obligation or percent increase for the year. However, Distribution Division, Food and expenditure of funds in excess of the the program experienced an almost 6692 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices unprecedented increase in meal service hardship that it could cause program Council on Environmental Quality (40 during the fourth quarter, resulting in a operators. In order to guard against the CFR 1508.25). This project-level EIS 1.18 percent increase over the number need for a reduction, the Department will tier to the Kootenai National Forest of meals served in Fiscal Year 1993, the has projected continued significant Land and Resource Management Plan highest annual increase in the program growth in the number of meals that will (Forest Plan) and Final EIS (September since 1989. The Department monitors be served in Fiscal Year 1995. Based on 1987), which provides overall guidance meal service on a monthly basis by such projections, the Department of all land management activities on the comparing data from each month of the announces an initial per-meal support Kootenai National Forest, including current fiscal year to the corresponding level of $.60. road management. month in the previous fiscal year. If this initial rate does not exhaust DATES: Written comments and However, the increase experienced in available funds per the mandate by the suggestions should be received on or the fourth quarter was unpredictable Older Americans Act of 1965, as before March 20, 1995. amended, the rate will be increased to given that, as in past years, there has ADDRESSES: Submit written comments achieve compliance with this been no discernible pattern from month and suggestions on the proposed requirement. However, in the unlikely to month during the fiscal year. management activities or a request to be Final Fiscal Year 1994 meal counts event that the number of meals served placed on the project mailing list to exceeded Departmental projections by exceeds the Department’s projection of Michael L. Balboni, District Ranger, little more than one-half of one percent. significantly expanded participation, it Three Rivers Ranger District, Kootenai However, this marginal unanticipated will be necessary to reduce the rate. In National Forest, 1437 N. Hwy 2, Troy, program growth necessitated a either event, the rate will experience Montana, 59935. retroactive per-meal rate reduction since two adjustments: an intermediate and the program appropriation was final per-meal level of support. The FOR FURTHER INFORMATION CONTACT: consequently insufficient to support all intermediate rate, based on final meal meals served at the initially announced counts and available funds, will be Mark Natale, EIS Team Leader, Three level. Therefore, the Department announced in January 1996. A final rate Rivers Ranger District, Kootenai announces a reduced Fiscal Year 1994 exhausting any unspent funds, which National Forest, Phone (406) 295–4693. per-meal reimbursement rate of $.6057. are anticipated to be minimal, will be SUPPLEMENTARY INFORMATION: A county This final rate applies to all eligible announced in March 1996 after close- easement is proposed on approximately meals served during Fiscal Year 1994 out for the fiscal year has been 1.0 mile of road #398 and 2.0 miles of and claimed in a timely manner. The completed. States will be notified road #8019 to access a subdivision on Department anticipates that a minimal directly of changes in the Fiscal Year private land that has received amount of funds will remain unspent 1995 rate. conditional approval from the county. If approved, the road would then be after close-out for the fiscal year has Dated: January 27, 1995. reconstructed to meet county standards. been completed. In accordance with the George A. Braley, mandate of the Agriculture, Rural The Kootenai Forest Plan provides Acting Administrator. Development, Food and Drug guidance for management activities Administration and Related Agencies [FR Doc. 95–2711 Filed 2–2–95; 8:45 am] within the potentially affected area Act of 1993, these funds will be carried BILLING CODE 3410±30±U through its goals, objectives, standards over into Fiscal Year 1995 and and guidelines, and management area expended in per-meal reimbursement direction. The area of the proposed Forest Service for that year. easement would occur within Management Areas 6 and 11. Road Fiscal Year 1995 Initial Level of Bull Lake Easement; Kootenai National Forest, Lincoln County, Montana reconstruction would occur in these two Assistance management areas. Below is a brief In the absence of overriding AGENCY: Forest Service, USDA. description of the applicable appropriations legislation such as was ACTION: Notice; intent to prepare management direction. enacted for Fiscal Year 1994, the environmental impact statement. Management Area 6—These are Department will for Fiscal Year 1995 be recreational areas (campgrounds, boat operating under the Older Americans SUMMARY: The USDA, Forest Service, ramps, picnic areas, etc.). There is no Act of 1965, as amended. In Fiscal Year will prepare an environmental impact restriction on easements within this 1995, a situation exists similar to that at statement (EIS) to disclose the management area. the beginning of Fiscal Years 1993 and environmental effects of the granting of Management Area 11—These are 1994, i.e., the Fiscal Year 1995 a road easement and of road areas of big game winter range that appropriation will not sustain reconstruction needed to access a allow for easements while including reimbursement at the mandated subdivision in the vicinity of Bull Lake. provisions for scheduling to prevent annually adjusted rate. The area is located in the Kootenai conflicts during periods of wildlife use. It is the Department’s goal to establish National Forest, Three Rivers Ranger The Forest Service has identified two the highest rate that can be sustained District, Lincoln County, Montana. alternatives. These are: (1) The ‘‘no throughout the fiscal year so as to The proposal’s actions to grant an action’’ alternative, in which the maximize the flow of program funds to easement to Lincoln County, Montana easement would not be granted and (2) States. Program operators would prefer for a county easement over portions of to issue the requested easement. to receive their per-meal support roads #398 and #8019, and to The EIS will analyze the direct, steadily throughout the year, rather than reconstruct these roads to county indirect, and cumulative environmental to operate at a lower rate during the year standards, for public access to a effects of the alternatives. Past, present, and receive a compensatory payment in subdivision of land located in Section and projected activities on both private connection with a rate increase after the 29, T29N, R33W, Principle Meridian, and National Forest lands will be year has ended. However, the Montana, are being considered together considered. The EIS will disclose the Department wants also to minimize the because they represent either connected analysis of site-specific mitigation possibility of a rate reduction and the or cumulative actions as defined by the measures and their effectiveness. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6693 Public participation is an important management of this area participate at SUMMARY: The USDA, Forest Service, part of the analysis, commencing with that time. To be most helpful, comments will prepare an environmental impact the initial scoping process (40 CFR on the Draft EIS should be as site- statement (EIS) to disclose the 1501.7), which will occur in the period specific as possible. The Final EIS is environmental effects associated with February/March 1995. In addition, the scheduled to be completed by January fire recovery activities in the areas of public is encouraged to visit with Forest 1996. four 1994 wildfires, including Pulpit, Service officials at any time during the The Forest Service believes, at this Studebaker, Gunsight, and analysis and prior to the decision. The early stage, it is important to give Seventeenmile fires. The project area is Forest Service will be seeking reviewers notice of several court rulings located in the Seventeenmile, O’Brien, information, comments, and assistance related to public participation in the and Lower Yaak Physiographic Areas of from Federal, State, and local agencies environmental review process. First, the Three Rivers Ranger District, and other individuals or organizations reviewers of draft environmental impact Kootenai National Forest, Lincoln who may be interested in or affected by statements must structure their County, Montana. Part of the proposed the proposed action. A public meeting participation in the environmental project’s activities lie within will be held late February or early review of the proposal so that it is Inventoried Roadless Areas (IRA’s). meaningful and alerts an agency to the March 1995 in Troy, Montana. The Forest Service proposes to reviewer’s position and contentions. Comments from the public and other salvage timber, construct and Vermont Yankee Nuclear Power Corp. v. agencies will be used in preparation of reconstruct roads, reduce fuel NRDC, 435 U.S. 519, (1978). Also, the Draft EIS. The scoping process will concentrations, revegetate with trees, environmental objections that could be be used to: native shrubs, and grass, and obliterate raised at the draft environmental impact 1. Identify potential issues. roads. These activities are being statement stage but that are not raised 2. Identify major issues to be analyzed considered together because they until after completion of the final in depth. represent either connected or environmental impact statement may be 3. Eliminate minor issues or those cumulative actions as defined by the waived or dismissed by the courts. City which have been covered by a Council on Environmental Quality (40 of Angoon v. Hodel, 803 F.2d 1016, relevant previous environmental CFR 1508.25). The purposes of the 1022 (9th Cir. 1986) and Wisconsin analysis, such as the Kootenai Forest proposed action’s activities are to Heritages, Inc. v. Harris, 490 F. Supp. Plan EIS. harvest fire killed timber in a timely 1334, 1338 (E.D. Wis. 1980). Because of 4. Identify alternatives to the proposed manner, manage the road systems, these court rulings, it is very important action. reduce future potential for catastrophic that those interested in this proposed 5. Identify potential environmental fire, sustain timber productivity, action participate by the close of the 45- effects of the proposed action and improve wildlife and riparian habitat, day scoping comment period so that alternatives (i.e., direct, indirect, and specifically for threatened, endangered, substantive comments and objections cumulative effects). or sensitive (TES) species, and are made available to the Forest Service 6. Determine potential cooperating accelerate watershed recovery. An at a time when it can meaningfully agencies and task assignments. amendment to the Kootenai Forest Plan consider them and respond to them in Some public comments have already is also part of this proposal. been received. The following developing issues and alternatives. To assist the Forest Service in Overall guidance of land management preliminary issues have been identified activities on the Kootenai National so far: identifying and considering issues on the proposed action, comments should Forest, including timber harvest and 1. How may proposed road be as specific as possible. Reviewers road management, are regulated by the reconstruction and subdivision of the may wish to refer to the Council on Kootenai National Forest Land and private land affect the water quality in Environmental Quality Regulations for Resource Management Plan (Forest Bull Lake? implementing the procedural provisions Plan) (September, 1987). In addition we 2. How will the proposed road considered more recent scientific construction and subdivision affect of the National Environmental Policy Act at 40 CFR 1503.3 in addressing thinking on the functioning of forest threatened, endangered and sensitive ecosystems (Ecosystems Management). species in the area? these points. I have the final authority for issuing Based on this analysis we developed a 3. How may the proposed road a decision regarding this proposal. I proposed action that does not meet construction affect big game winter have delegated the responsibility of Forest Plan standards. Specifically we range use? preparing the EIS to Three Rivers proposed timber harvest in management Other issues commonly associated District Ranger, Michael Balboni. My Area 2, roadless recreation. with such activities include: effects on address is Kootenai National Forest, 506 DATE: Written comments and cultural resources, soils, old growth, U.S. Hwy 2 West, Libby, MT 59923. suggestions should be received on or and scenery values. This list may be before March 6, 1995. verified, expanded, or modified based Dated: January 27, 1995. on public scoping for this proposal. Robert L. Schrenk, ADDRESSES: Submit written comments The Draft EIS is expected to be filed Forest Supervisor. and suggestions on the proposed with the Environmental Protection FR Doc. 95–2633 Filed 2–2–95; 8:45 am] management activities or a request to be Agency (EPA) and available for public BILLING CODE 3410±11±M placed on the project mailing list to review in September of 1995. At that Michael L. Balboni, District Ranger, time, the EPA will publish a Notice of Three Rivers Ranger District, Kootenai Availability of the Draft EIS in the Skyline Ridge EIS, Kootenai National National Forest, 1437 North Hwy 2, Federal Register. The comment period Forest, Lincoln County, Montana Troy, Montana 59935. FOR FURTHER INFORMATION CONTACT: on the Draft EIS will be 45 days from the AGENCY: Forest Service, USDA. date the EPA’s notice of availability Steve Prieve, EIS Team Leader, Three ACTION: Notice; intent to prepare appears in the Federal Register. It is Rivers Ranger District, Kootenai environmental impact statement. very important that those interested in National Forest, Phone (406) 295–4693. 6694 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices SUPPLEMENTARY INFORMATION: The proposed action, along with the number none of the proposed activities would project area consists of approximately of acres proposed for harvest within be implemented. Another alternative 6375 acres of National Forest land. The each MA: will be analyzed which meets Forest Seventeenmile fire was 1773 acres and Management Area 2—These areas are Plan direction. Additional alternatives is located within all or portions of characterized by a natural-appearing will examine varying levels and T33N, R32W, Sections 2, 3, 4, 5, 9, 10, environment offering roadless recreation locations for the proposed activities to 11 and T34N, R32W, Sections 33 and opportunities and are within an achieve the purpose and need, as well 34. The Studebaker fire was 1896 acres unsuitable timber base 680 acres as respond to the issues and concerns and located within all or portions of proposed for salvage harvest. identified by the public. T33N, R33W, Section 36; T33N, R32W, Management Area 2–OG—These MA The interdisciplinary team (IDT) has Sections 30, 31 and 32; and T32N, 2 areas consist of scattered parcels of identified tentative or preliminary R33W, Sections 1, 2 and 3. The Pulpit existing old growth or mature timber issues briefly described as follows: fire was 2085 acres and is located stands which contain component of old (1) The effects of the proposed action within all or portions of T32N, R33W, growth and are within an unsuitable and alternatives on the characteristics of Sections 9, 14, 15, 16, 21, 22, 23 and 27. timber base. 83 acres. the IRA’s and unsuitable management The Gunsight fire was 621 acres and is Management Area 33—These are areas. located within all or portions of T33N, areas with a natural-appearing (2) The effects of the proposed action R33W, Sections 21, 22, 27 and 28. environment and a minimal number of and alternatives on water quality and Timber salvage harvest of dead and adjacent or internal roads offering fisheries. (3) The effects of the proposed action dying timber is proposed on 2556 acres roaded recreation opportunities and are and alternatives on ecosystem health of forested land within the four fires within an unsuitable timber base. They and the risk of catastrophic wildfires using a variety of logging systems. occur mostly in upper elevations from ′ and insert or disease outbreaks. Approximately 20 MMBF is proposed 4,500 and up. 49 acres. Management Area 10—These are (4) The effects of the proposed action for harvest. This includes 750 acres areas that are used by various species of and alternatives on threatened, within the 1773-acres Seventeenmile big game for winter range, usually endangered, or sensitive (TES) species, fire, 429 acres within the 621-acre between December 1 and April 30 and such as the grizzly bear and bull trout. Gunsight fire, 588 acres within the are within an unsuitable timber base. 15 (5) The effects of the proposed action 2085-acre Pulpit fire and 789 acres acres. and alternatives on timber supply. within the 1896-acre Studebaker fire. Management Area 12—These areas The EIS will analyze the direct, Fuel reduction accomplished in are generally located at or above indirect, and cumulative environmental conjunction with the timber harvest elevations of 4000′ and contain effects of the proposed action and each includes grapple piling and prescribed inclusions of moist or wet habitat types. alternative, including no action. These burning. Watershed restoration Most species of big game use this include past, present, and projected activities are proposed within and in the management area during the period activities on both private and National vicinity adjacent to the fires. This from late spring through late fall. This Forest lands along with proposed includes road obliteration management area is characterized by mitigation measures and their (approximately 15 miles) which consists suitable timber producing sites and effectiveness. of scarification, seeding, and pulling moderate to rolling topography. 891 The decision to be made is how culverts from roads, recontouring, and acres. much, if any, fire damaged timber riparian planting and debris placement Management Area 13—These areas should be salvaged in these fire areas, in stream channels (approximately 10 consist of scattered parcels of existing within the context of ecosystem miles). Replanting is proposed on old growth or mature timber stands management and Forest Plan direction. approximately 4412 acres of land— which contain components of old Public participation is an important including both conifer seedlings for growth and are within an unsuitable part of the analysis, commencing with reforestation and native shrubs and timber base. 628 acres. the initial scoping process (40 CFR herbaceous plants for wildlife habitat. Management Area 14—These areas 1501.7), which will occur February 3, The timber harvest operations would are identified Interagency Grizzly 1995 to March 6, 1995. In addition, the require construction of approximately 2 situations 1 and 2 in conjunction with public is encouraged to visit with Forest miles of temporary road and suitable timber land. 105 acres. Service officials at any time during the reconstruction of approximately 22 Management Area 18—This analysis and prior to the decision. The miles of existing roads. This action management area occurs on areas of Forest Service will be seeking would require temporarily opening slopes in excess of 40% where timber information, comments, and assistance approximately 31 miles of roads productivity is moderate to high. It is from Federal, State, and local agencies currently restricted from vehicle traffic. distinguished by the difficulty in and other individuals or organizations Approximately 1131 acres proposed establishing coniferous regeneration and who may be interested in or affected by for harvest lie within one of two is within an unsuitable timber base. 105 the proposed action. A public meeting Inventoried Roadless Areas: Roderick acres. will be scheduled in Troy, Montana on IRK (#684)—710 acres in the For those management areas classified February 28, 1995, and at the Upper Seventeenmile fire, and Saddle IRA an unsuitable for timber production, an Ford Work Center on March 1, 1995. (#168)—421 acres in the Gunsight fire. amendment to the Forest Plan would be Comments from the public and other No road construction would occur required to implement the ecosystem agencies will be used in preparation of within these areas. management based proposal or any the Draft EIS. The scoping process will The areas proposed for salvaging fire alternative which would harvest timber be used to: damaged timber occur in a wide range in unsuitable timber MA’s. These would 1. Identify potential issues. of Management Areas (MA’s) as defined include MA’s 2, 2–OG, 3, and 13. 2. Identify major issues to be analyzed in the Kootenai Forest Plan. The Forest Service will consider a in depth. Below is a brief description of the range of alternatives. One of these will 3. Eliminate minor issues or those affected Management Areas for the be the ‘‘no action’’ alternative, in which which have been covered by a Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6695 relevant previous environmental Act at 40 CFR 1503.3 in addressing FOR FURTHER INFORMATION CONTACT: analysis, such as the Kootenai Forest these points. Mary Furney, Dispersed Recreation Plan. I have the final authority for issuing Assistant, Downieville Ranger District, 4. Identify alternatives to the proposed a decision regarding this proposal. I North Yuba Ranger Station, action. have delegated the responsibility of Camptonville, CA 95922, telephone 916 5. Identify potential environmental preparing the EIS to Three Rivers 288–3231 or 916 478–6253. effects of the proposed action and District Ranger, Michael Balboni. My SUPPLEMENTARY INFORMATION: In alternatives (i.e., direct, indirect, and address is Kootenai National Forest, preparing the environmental impact cumulative effects). Supervisor’s Office, 506 Hwy 2 West, statement, the Forest Service will 6. Determine potential cooperating Libby, MT 59923. identify and analyze a range of agencies and task assignments. Dated: January 27, 1995. opportunities in the plan. The Draft EIS is expected to be filed Robert L. Schrenk, Public participation will be important with the Environmental Protection Forest Supervisor. at several points during the analysis, especially the review of the Draft Agency (EPA) and available for public [FR Doc. 95–2634 Filed 2–2–95; 8:45 am] review in April of 1995. At that time, Environmental Impact Statement. The BILLING CODE 3410±11±M the EPA will publish a Notice of first point is during the scoping process. Availability of the Draft EIS in the The Forest Service will be seeking Federal Register. The comment period Winter Recreation Plan for the Lakes information, comments, and assistance on the Draft EIS will be 45 days from the Basin/Sierra Buttes Area, Tahoe from Federal, State, and local agencies date the EPA’s notice of availability National Forest, Sierra County, CA and other individuals or organizations appears in the Federal Register. It is who may be interested in or affected by very important that those interested in AGENCY: Forest Service, USDA. the proposed action. This input will be management of the analysis area ACTION: Notice of intent to prepare an used in preparation of the draft participate at that time. To be most environmental impact statement. environmental impact statement (DEIS). helpful, comments on the Draft EIS The scoping process includes: should be as site-specific as possible. SUMMARY: The U.S. Department of 1. Identifying potential issues. The Final EIS is scheduled to be Agriculture, Forest Service will prepare 2. Identifying issues to be analyzed in completed by September, 1995. an environmental impact statement depth. The Forest Service believes, at this (EIS) for a Winter Recreation Plan for 3. Eliminating insignificant issues or early stage, it is important to give the Lakes Basin/Sierra Buttes Area on those both which have been covered reviewers notice of several court rulings the Downieville District of the Tahoe by a relevant previous environmental related to public participation in the National Forest. Winter use in the area analysis. environmental review process. First, has been monitored as required by the 4. Exploring additional alternatives. reviewers of draft environmental impact Forest Land and Resource Management 5. Identifying potential environmental statements must structure their Plan, to determine management needs. effects of the proposed action and participation in the environmental The EIS will analyze several proposed alternatives (i.e., direct, indirect, and review of the proposal so that it is snow groomer shed construction sites, cumulative effects and connected meaningful and alerts an agency to the possible opportunities for resorts and actions). reviewer’s position and contentions. organizational camps to broaden 6. Determining potential cooperating Vermont Yankee Nuclear Power Corp. v. services to include winter sports agencies and task assignments. NRDC, 435 U.S. 519, 553 (1978). Also, activities, and further develop both Organizations, and individuals who environmental objections that could be snowmobile trails and nordic ski trails may be interested in, or affected by the raised at the draft environmental impact where snowmobiles may be restricted. decision, will be solicited to identify statement stage but that are not raised The Tahoe National Forest Land and significant issues. Public participation until after completion of the final Resource Management Plan (LRMP), has been previously solicited through environmental impact statement may be completed March, 1990, proposes to mailing letters to private land owners, waived or dismissed by the courts. City prepare a winter recreation management politicians, county supervisors, of Angoon v. Hodel, 803 F.2d 1016, plan ‘‘to assure orderly development continued participation will be 1022 (9th Cir. 1986) and Wisconsin and management of cross country skiing emphasized through public meetings Heritages, Inc. v. Harris, 490 F. Supp. and snowmobiling use within the area.’’ and mailings. 1334, 1338 (E.D. Wis. 1980). Because of The agency invites comments and The draft EIS is expected to be filed these court rulings, it is very important suggestions on the scope of the analysis. with the Environmental Protection that those interested in this proposed In addition, the agency gives notice of Agency (EPA) and to be available for action participate by the close of the 30- the full environmental analysis and public review by May 30, 1995. The day scoping comment period so that decision-making process that will occur comment period on the draft EIS will be substantive comments and objections on the plan so that interested and 45 days from the date the EPA publishes are made available to the Forest Service affected people are aware of how they the notice of availability in the Federal at a time when it can meaningfully may participate and contribute to the Register. consider them and respond to them in final decision. The Forest Service believes, at this developing issues and alternatives. DATES: Comments concerning the early stage, it is important to give To assist the Forest Service in analysis should be received in writing reviewers notice of several court rulings identifying and considering issues on by March 20, 1995. related to public participation in the the proposed action, comments should ADDRESSES: Written comments environmental review process. First, be as specific as possible. Reviewers concerning the project should be reviewers of draft environmental impact may wish to refer to the Council on directed to Jean M. Masquelier, District statements must structure their Environmental Quality Regulations for Ranger, Downieville Ranger District, participation in the environmental implementing the procedural provisions North Yuba Ranger Station, 15924 Hwy review of the proposal so that it is of the National Environmental Policy 49, Camptonville, CA 95922. meaningful and alerts an agency to the 6696 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices reviewer’s position and contentions. Section 13(c) of the Export shall, for a period of three years Vermont Yankee Nuclear Power Corp. v. Administration Act of 1979, as amended beginning on March 1, 1995, be denied NRDC, 435 U.S. 519, 553 (1978). Also, (50 U.S.C.A. app. §§ 2401–2420 (1991, all privileges of participating, directly or environmental objections that could be Supp. 1993, and Pub. L. No. 103–277, indirectly, in any manner or capacity, in raised at the draft EIS stage but that are July 5, 1994)) (the Act),1 and Part 788 of any transaction in the United States or not raised until after completion of the the Export Administration Regulations abroad involving any commodity or final EIS may be waived or dismissed by (currently codified at 15 CFR Parts 768– technical data exported or to be the courts. City of Angoon v. Hodel, 803 799 (1994)) (the Regulations), based on exported from the United States, and F.2d 1016, 1022 (9th Cir. 1986) and allegations that Teledyne Wah Chang subject to the Regulations. Wisconsin Heritages Inc. v. Harris, 490 violated Sections 787.3(b), 787.a(a), A. Without limiting the generality of F. Supp. 1334, 1338 (E.D. Wis. 1980). 787.5(a)(1), and 787.6 of the Regulations the foregoing, participation, either in the Because of the court rulings, it is very in that: United States or abroad, shall include important that those interested in this (1) on or before October 5, 1989, participation, directly or indirectly, in proposed action participate by the close Teledyne Wah Chang engaged in two any manner or capacity: (i) as a party or of the 45 day comment period so that separate conspiracies to export as a representative of a party to any substantive comments and objections zirconium sponge and/or compacts from export license application submitted to are made available to the Forest Service the United States contrary to the terms the Department; (ii) in preparing or at a time when it can meaningfully of validated export licenses issued by filing with the Department any export consider them and respond to them in the Department; license application or request for the final EIS. (2) in carrying out those conspiracies, reexport authorization, or any document To assist the Forest Service in on six separate occasions, Teledyne to be submitted therewith; (iii) in identifying and considering issues and Wah Chang, as a co-conspirator, made obtaining from the Department or using concerns on the proposed action, false or misleading statements of any validated or general export license, comments on the draft EIS should be as material fact to the Department on reexport authorization, or other export specific as possible. It is also helpful if validated export license applications; control document; (iv) in carrying on comments refer to specific pages or (3) in carrying out those conspiracies, negotiations with respect to, or in chapters of the draft EIS or the merits of on four separate occasions, Teledyne receiving, ordering, buying, selling, the alternatives formulated and Wah Chang, as a co-conspirator, delivering, storing, using, or disposing discussed in the statement. Reviewers exported goods from the United States of, in whole or in part, any commodities may wish to refer to the Council on with reason to know that a violation of or technical data exported or to be Environmental Quality Regulations for the Act or any regulation, order, or exported from the United States and implementing the procedural provisions license issued under the Act would subject to the Regulations; and (v) in of the National Environmental Policy occur in connection with each such financing, forwarding, transporting, or Act at 40 CFR 1503.3 in addressing export; and other servicing of such commodities or (4) in carrying out those conspiracies, these points. technical data. The responsible official, who is the on four separate occasions, Teledyne B. After notice and opportunity for Downieville District Ranger, Tahoe Wah Chang, as a co-conspirator, made comment as provided in Section National Forest, will document the false or misleading statements of 788.3(c) of the Regulations, any person, decision and reasons for the decision in material fact on Shipper’s Export firm, corporation, or business the Record of Decision. Declarations that were filed with the organization related to Teledyne Wah U.S. Customs Service; Chang by affiliation, ownership, control, William L. Haire, The Department and Teledyne Wah or position of responsibility in the Public Service Officer. Chang having entered into a Consent conduct of grade or related services may [FR Doc. 95–2691 Filed 2–2–95; 8:45am] Agreement whereby the Department and also be subject to the provisions of this BILLING CODE 3410±11±M Teledyne Wah Chang have agreed to Order. settle this matter in accordance with the C. As provided by Section 787.12(a) of terms and conditions set forth therein the Regulations, without prior DEPARTMENT OF COMMERCE and the terms of the Consent Agreement disclosure of the facts to and specific having been approved by me; authorization of the Office of Exporter Bureau of Export Administration It is therefore ordered, Services, in consultation with the Office First, that a civil penalty of $2,000,000 of Export Enforcement, no person may Action Affecting Export Privileges; is assessed against Teledyne Wah directly or indirectly, in any manner or Teledyne Wah Chang, a Division of Chang, all of which shall be paid to the capacity; (i) apply for, obtain, or use any Teledyne Industries, Inc. Department within 30 days from the license, Shipper’s Export Declaration, date of entry of this Order. Payment bill of lading, or other export control In the matter of: Teledyne Wah Chang, a shall be made in the manner specified division of Teledyne Industries, Inc., 1600 document relating to an export or N.E. Old Salem Road, P.O. Box 460, Albany, in the attached instructions. reexport of commodities or technical Oregon 97321–6990, Respondent. Second, Teledyne Wah Chang, a data by, to , or for another person then division of Teledyne Industries, Inc., subject to an order revoking or denying Order 1600 N.E. Old Salem Road, P.O. Box his export privileges or then excluded The Office of Export Enforcement, 460, Albany, Oregon 97321–6990, and from practice before the Bureau of Bureau of Export Administration, all its successors, assigns, and officers, Export Administration; or (ii) order, United States Department of Commerce representatives, agents, and employees buy, receive, use, sell, deliver, store, (Department), having notified Teledyne when acting on behalf of the company dispose of, forward, transport, finance, Wah Chang, a division of Teledyne or otherwise service or participate: (a) in Industries, Inc. (hereinafter referred to 1 The Act expired on August 20, 1994. Executive any transaction which may involve any Order No. 12924 (59 Fed. Reg. 43437, August 23, as Teledyne Wah Chang), of its 1994) continued the Regulations in effect under the commodity or technical data exported intention to initiate an administrative International Emergency Economic Power Act (50 or to be exported from the United States; proceeding against it pursuant to U.S.C.A. §§ 1701–1706 (1991)). (b) in any reexport thereof; or (c) in any Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6697 other transaction which is subject to the public. Copies of this Order shall be Railway Track Maintenance Equipment Export Administration Regulations, if served on Teledyne Wah Chang and A–433–064 the person denied export privileges may published in the Federal Register. 43 FR 6937 obtain any benefit or have any interest This Order, which constitutes the February 17, 1978 in, directly or indirectly, any of these final agency action in this matter, is Contact: Art DuBois at (202) 482–6312 transactions. effective immediately. Japan D. As authorized by Section 788.17(b) Entered this 26th day of January, 1995. Butt-Weld Pipe Fittings of the Regulations, the denial period John Despres, A–588–602 shall be suspended for a period of two Assistant Secretary for Export Enforcement. 52 FR 4167 years and nine months beginning on [FR Doc. 95–2635 Filed 2–2–95; 8:45 am] February 10, 1987 June 1, 1995, and shall thereafter be BILLING CODE 3510±DT±M Contact: Sheila Forbes at (202) 482– waived, provided that, during the 5253 period of suspension, Teledyne Wah Japan Chang commits no violation of the Act International Trade Administration Melamine or any regulation, order or license A–588–056 issued thereunder. During the period Intent to Revoke Antidumping Duty 42 FR 6366 between June 1, 1995 and March 1, Orders and Findings and to Terminate February 2, 1977 1996, Teledyne Wah Chang’s authority Suspended Investigations Contact: Todd Peterson at (202) 482– to use general license G–NSG is 4195 suspended. Teledyne Wah Chang is AGENCY: Import Administration, The People’s Republic of China eligible to apply for individual validated International Trade Administration, Paint Brushes export licenses for any export that Department of Commerce. A–570–501 would ordinarily be eligible for export ACTION: Notice of Intent to Revoke 51 FR 5880 under general license G–NSG during the Antidumping Duty Orders and Findings February 14, 1986 period that its authority to use general and to Terminate Suspended Contact: Tom Killiam at (202) 482–0665 license G–NSG is suspended. Further, Investigations. for the last two years of the denial If no interested party requests an SUMMARY: The Department of Commerce administrative review in accordance period, Teledyne Wah Chang shall (the Department) is notifying the public report periodically to the Office of with the Department’s notice of of its intent to revoke the antidumping opportunity to request administrative Export Enforcement, Bureau of Export duty orders and findings and to Administration, United States review, and no domestic interested terminate the suspended investigations party objects to the Department’s intent Department of Commerce (OEE), all listed below. Domestic interested parties exports made by Teledyne Wah Chang to revoke or terminate pursuant to this who object to these revocations and notice, we shall conclude that the under the authority of general license terminations must submit their G–NSG during the previous three antidumping duty orders, findings, and comments in writing no later than the suspended investigations are no longer months. The first such report shall be last day of February 1995. provided to OEE on July 1, 1996 and of interest to interested parties and shall EFFECTIVE DATE: shall cover any exports by Teledyne February 3, 1995. proceed with the revocation or Wah Chang under the authority of FOR FURTHER INFORMATION CONTACT: termination. Michael Panfeld or the analyst listed general license G–NSG between March Opportunity to Object 1, 1996 and May 30, 1996. Subsequent under Antidumping Proceeding at: reports shall be made to OEE every three Office of Antidumping Compliance, Domestic interested parties, as months thereafter. Each report shall Import Administration, International defined in § 353.2(k)(3), (4), (5), and (6) include the following information: the Trade Administration, U.S. Department of the Department’s regulations, may date of each general license G–NSG of Commerce, 14th Street & Constitution object to the Department’s intent to shipment made during that quarter; the Avenue, N.W., Washington, D.C. 20230, revoke these antidumping duty orders country of ultimate destination; the telephone (202) 482–4737. and findings or to terminate the suspended investigations by the last day name and address of the ultimate SUPPLEMENTARY INFORMATION: consignee; and a description of the of February 1995. Any submission to the commodities, the quantity, and the Background Department must contain the name and value of the commodities included in The Department may revoke an case number of the proceeding and a each shipment. antidumping duty order or finding or statement that explains how the Third, the timely payment of the civil terminate a suspended investigation if objecting party qualifies as a domestic penalty set forth above is hereby made the Secretary of Commerce concludes interested party under § 353.2(k)(3), (4), a condition to the granting, restoration, that it is no longer of interest to (5), and (6) of the Department’s or continuing validity of any export interested parties. Accordingly, as regulations. license, permission, or privilege required by § 353.25(d)(4) of the Seven copies of such objections granted, or to be granted, to Teledyne Department’s regulations, we are should be submitted to the Assistant Wah Chang. Accordingly, if Teledyne notifying the public of our intent to Secretary for Import Administration, Wah Chang should fail to pay in a revoke the following antidumping duty International Trade Administration, timely manner the civil penalty set forth orders and findings and to terminate the Room B–099, U.S. Department of above, the undersigned will enter an suspended investigations for which the Commerce, Washington, D.C. 20230. Order denying all of Teledyne Wah Department has not received a request You must also include the pertinent Chang’s export privileges for a period of to conduct an administrative review for certification(s) in accordance with one year from the date of entry of this the most recent four consecutive annual § 353.31(g) and § 353.31(i) of the Order. anniversary months: Department’s regulations. Fourth, that the proposed Charging In addition, the Department requests Letter, the Consent Agreement and this Antidumping Proceeding that a copy of the objection be sent to Order shall be made available to the Austria Michael F. Panfeld in Room 4203. This 6698 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices notice is in accordance with 19 CFR other available material. On the basis of 2. Category of Standard. Software 353.25(d)(4)(i). this review, NIST recommended that the Standard, Database. Dated: January 30, 1995. Secretary approve the standard as a 3. Explanation. An SQL environment is an integrated data processing Holly A. Kuga, Federal Information Processing Standard (FIPS), and prepared a environment in which heterogeneous Acting Deputy Assistant Secretary for products, all supporting some aspect of Compliance. detailed justification document for the Secretary’s review in support of that the FIPS SQL standard (FIPS PUB 127), [FR Doc. 95–2719 Filed 2–2–95; 8:45 am] recommendation. are able to communicate with one BILLING CODE 3510±DS±P The detailed justification document another and provide shared access to which was presented to the Secretary, data and data operations and methods under appropriate security, integrity, Minority Business Development and which includes an analysis of the and access control mechanisms. Some Agency written comments received, is part of the public record and is available for components in an SQL environment Native American Business inspection and copying in the will be full-function SQL Development Center Applications: Department’s Central Reference and implementations that conform to an Minnesota Records Inspection Facility, Room 6020, entire level of FIPS SQL and support all Herbert C. Hoover Building, 14th Street of its required clauses of schema AGENCY: Minority Business between Pennsylvania and Constitution definition, data manipulation, Development Agency. Avenues, NW., Washington, DC 20230. transaction management, integrity ACTION: Amendment. This FIPS contains two sections: (1) constraints, access control, and schema An announcement section, which information. Other components in an SUMMARY: This notice amends the SQL environment may be specialized advertisement as it appeared in the provides information concerning the applicability, implementation, and data repositories, lagecy databases, or Wednesday, January 25, 1995 issue, graphical user interfaces and report announcing MBDA’s competitive maintenance of the standard; and (2) a specifications section, which deals with writers, all of which support selected applications for its Native American portions of the SQL standard and Business Development Center. the technical requirements of the standard. Only the announcement thereby provide a degree of integration DATES: The closing date for applications section of the standard is provided in between themselves and other products is March 1, 1995. Applications must be this notice. in the same SQL environment. received on or before March 1, 1995. This FIPS PUB is the beginning of a EFFECTIVE DATE: FOR FURTHER INFORMATION CONTACT: This standard is continuing effort to define appropriate David Vega at (312) 353–0182. effective February 1, 1995. conformance profiles that can be used ADDRESSES: Interested parties may by both vendors and users to specify 11.801 Native American Program purchase copies of this standard, and users to specify exact requirements (Catalog of Federal Domestic Assistance) including the technical specifications for how various products fit into an SQL Dated: January 30, 1995. section, from the National Technical environment. The emphasis in this first Donald L. Powers, Information Service (NTIS). Specific FIPS for SQL Environments is to specify Federal Register Liaison Officer, Minority ordering information from NTIS for this general purpose, SQL external Business Development Agency. standard is set out in the Where to repository interface (SQL/ERL) profiles [FR Doc. 95–2721 Filed 2–2–95; 8:45 am] Obtain Copies Section of the for non-SQL data repositories. These BILLING CODE 3510±21±P announcement section of the standard. profiles specify how a subset of the SQL FOR FURTHER INFORMATION CONTACT: standard can be used to provide limited Mr. Leonard Gallagher, (301) 975–3251, SQL access to legacy databases, or to National Institute of Standards and Computer Systems Laboratory, National support SQL gateways to specialized Technology Institute of Standards and Technology, data managers such as Geographic [Docket No. 940550±4335] Gaithersburg, MD 20899. Information Systems (GIS), full-text document management systems, or RIN 0693±AB28 Dated: January 30, 1995. object database management systems. Samuel Kramer, All of the profiles specified herein are Approval of Federal Information Associate Director. for server-side products, that is, Processing Standards Publication 193, products that control persistent data and SQL Environments Federal Information Processing Standards Publication 193 provide an interface for user access to AGENCY: National Institute of Standards that data. Subsequent versions of this and Technology (NIST), Commerce. (Date) FIPS PUB may specify SQL ACTION: Notice. Announcing the Standard for SQL environment profiles for client-side Environments products, that is, products that access SUMMARY: The purpose of this notice is data and then present that data in to announce that the Secretary of Federal Information Processing graphical or report-writer style to an end Commerce has approved a new Standards Publications (FIPS PUBS) are user, or process the data in some other standard, which will be published as issued by the National Institute of way on behalf of the end user. FIPS Publication 193, SQL Standards and Technology after 4. Approving Authority. Secretary of Environments. On June 22, 1994 (59 FR approval by the Secretary of Commerce Commerce. 32186–32188) notice was published in pursuant to Section 111(d) of the 5. Maintenance Agency. Department the Federal Register that a Federal Federal Property and Administrative of Commerce National Institute of Information Processing Standard for Services Act of 1949 as amended by the Standards and Technology (Computer SQL Environments was being proposed Computer Security Act of 1987, Public Systems Laboratory) for Federal use. Law 100–235. 6. Cross Index. NIST reviewed written comments 1. Name of Standard. SQL —Federal information Resources submitted by interested parties and Environments (FIPS PUB 193). Management Regulations (FIRMR) Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6699 subpart 201.20.303, Standards, and Part 2: Full Text separated data banks under the subpart 201.39.1002, Federal Part 3: Spatial management and control of Standards, April 1992. Part 4: General Purpose Facilities heterogeneous database management —FIPS PUB 127–2, Fedeal Information Other Parts: Reserved for other SQL/ systems. An over-riding requirement is Processing Standards Publication— MM sub-projects with no current that these diverse data managers be able Database Language SQL, adoption of base document (e.g., images, to communicate with one another and ANSI SQL (ANSI X3.135–1992) and photographs, motion pictures, provide shared access to data and data ISO SQL (ISO/IEC 9075:1992) for sound, music, video, etc.) operations and methods under Federal use, U.S. Department of For information on the current status appropriate security, integrity, and Commerce, National Institute of of the above Working Drafts, contact access control mechanisms. FIPS SQL Standards and Technology, June 2, NIST personnel working on SQL provides a powerful database language 1993. Standardization at 301–975–3251. For for data definition, data manipulation, —ANSI/ISO/IEC 9579, International document references to the above and and integrity management to satisfy Standard for Remote Database Access for additional related documents, see many of these requirements. It is (RDA), Part 1: Generic RDA and Part the References section of the SQL/ERI unrealistic to expect that every data 2:SQL Specialization, ISO/IEC 9579– Server Profiles specification (attached). manager involved in electronic 1:1993 and ISO/IEC 9579–2:1993, 8. Objective. The primary objective of commerce will conform to even the published December, 1993. this FIPS PUB for SQL Environments is Entry SQL level of the FIPS SQL —ANSI/ISO/IEC DIS 9075–3, (Draft) to specify SQL profiles that can be used standard; however, it is not unrealistic International Standard for Database by Federal departments and agencies to to require that they support a limited Language SQL, Part 3: Call Level support integration of legacy databases SQL interface, even a read-only Interface (SQL/CLI), JTC1 Draft and other non-SQL data repositories interface, provided by one of the SQL/ International Standard (DIS), into an SQL environment. The intent is ERI Server profiles specified herein. document SC21 N9117, 13 October to provide a high level of control over New procurements to add components 1994. a diverse collection of legacy or to the National Information —ANSI/ISO/IEC CD 9075–4, (Draft) specialized data resources. An SQL Infrastructure, or to upgrade existing International Standard for Database environment allows an organization to components, can define the necessary Language SQL, Part 4; Persistent obtain many of the advantages of SQL SQL schemas and point to appropriate Stored Modules (SQL/PSM), JTC1, without requiring a large, complex, and SQL/ERI Server profiles as procurement Committee Draft (CD), CD Ballot error-prone conversion effort; instead, requirements. document SC21 N8897, August 1994. the organization can evolve, in a This standard may also be applicable, 7. Related Documents. SQL controlled manner to a new integrated on a case-by-case basis, in many of the Environment specifications depend environment. following areas: upon existing standards and stable 9. Applicability. This standard is Legacy databases specifications (see Cross Index above) applicable in any situation where it is Full-Text document databases and upon emerging SQL and SQL desirable to integrate a client-side Geographic Information Systems Multimedia standards. The following productivity tool or a server-side data Bibliographic information retrieval items identify formal ISO/IEC repository into an SQL environment. It Object database interfaces international standards projects for is a non-mandatory standard that may Federal data distribution which preliminary specifications and be invoked on a case-by-case basis Operating system file interface base documents exist, but where the subject to the integration objectives of Open system directory interface development effort has not yet reached the procuring department of agency. It Electronic mail repositories a complete and stable stage (i.e., the is particularly suitable for specifying CASE tool repositories Committee Draft (CD) stage). AS these limited SQL interfaces to legacy XBase repositories specifications mature and move through databases or to specialized data C++ sequence class repositories the standards process, they can be repositories not under the control of a Object Request Broker interface referenced more reliably in procurement full-function SQL database management repository requirements. system. It can be used along with other Real-time database interface (Working Draft) Database Language SQL procurement information to specify SQL Internet file repositories (SQL3) interface requirements for a wide range Further detail on each of these Part 1: Framework of data management procurements. potential application areas can be found Part 2: Foundation—including One special area of application in Section 8, ‘‘Applicability’’, of the Abstract Data Types and Object envisioned for this standard is FIPS specification for SQL SQL Electronic Commerce, a National Environments. Part 3: Call Level Interface— Challenge Application area of the 10. Specifications. See the extensions to ISO/IEC CD 9075–3 National Information Infrastructure. The Specifications for SQL Environments— identified above primary objective of Electronic SQL External Repository Interface (SQL/ Part 4: Persistent Stored Modules— Commerce is to integrate ERI)—Server Profiles (attached). extensions to ISO/IEC CD 9075–4 communications, data management, and 11. Implementation. Implementation identified above security services in a distributed of this standard involves four areas of Part 5: Language Bindings— processing environment, thereby consideration: the effective date, extensions to the binding clauses of allowing business applications within acquisition of conforming ISO/IEC 9075:1992 different organizations to interoperate implementations, interpretation, and Part 6: Encompassing Transactions— and exchange information without validation. to support X/Open XA–interface human intervention. At the data 11.1 Effective date. This publication (Working Draft) SQL Multimedia (SQL/ management level, electronic commerce is effective beginning February 1, 1995. MM) requires a logically integrated database Since it is a non-mandatory Part 1: Framework of diverse data stored in geographically specification, based on the established 6700 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices FIPS SQL standard, and used at the Validation. The agency may select the used as the generic basis for program discretion of individual Federal appropriate validation option and may requirements. procurements, no transitional period or specify appropriate time frames for The public is encouraged to call to delayed effective date is necessary. validation and correction of NIST’s attention documents useful for 11.2 Acquisition. All conforming nonconformities. this purpose. implementations of a specific SQL/ERI Implementations may be evaluated DATES: The workshop will be held profile will support some aspects of the using the NIST SQL Test Suite, a suite Thursday, March 9, 1995, from 10:00 FIPS SQL standard. However, such of automated validation tests for SQL a.m. to 6:00 p.m. Registration will start implementations will not normally be implementations. Although this test at 9:30 am. full function database management suite was designed to test conformance ADDRESSES: The workshop will be held systems and conformance will often be of full-function SQL database in the Green Auditorium at the National dependent upon SQL schema management systems, it can be modified Institute of Standards and Technology, definitions and other requirements to accommodate testing of SQL/ERI Gaithersburg, Maryland. provided as part of each individual Server implementations. The results of FOR FURTHER INFORMATION CONTACT: (1) procurement. In most cases, a validation testing by the SQL Testing For administrative and logistic procurement will not be able to simply Service are published on a quarterly information, contact Ms. Marilyn point to an SQL/ERI profile and demand basis in the Validated Products List, Stream, National Institute of Standards conformance to it. Instead, successful available from the National Technical and Technology, Building 417, Room procurements will normally use an Information Service (NTIS). 107, Gaithersburg, Maryland 20899; appropriate SQL/ERI profile, together Current information about the NIST Phone: (301) 975–4029. Fax: (301) 963– with an application-specific schema SQL Validation Service and the status of 2871. (2) For information concerning the definition, as one aspect of overall validation testing for SQL Environments procurement requirements. In many NVCASE program contact Mr. Robert is available from: National Institute of Gladhill, Program Manager, National cases, vendors of products that provide Standards and Technology, Computer a limited SQL interface will define their Institute of Standards and Technology, Systems Laboratory, Software Standards Building 417, Room 107, Gaithersburg, interfaces in terms of a fixed SQL Validation Group, Building 225, Room schema definition. In those cases, Maryland 20899; Phone: (301) 975– A266, Gaithersburg, Maryland 20899, 4273. Fax: (301) 963–2871. (3) For procurements can point to the vendor- (301) 975–2490. provided schema definition and to an information on how to obtain copies of 12. Where to Obtain Copies. Copies of appropriate SQL/ERI profile as a the documents, contact the American this publication are for sale by the procurement requirement. In some National Standards Institute (ANSI), 11 National Technical Information Service, cases, especially in those situations West 42nd Street, 13th Floor, New York, U.S. Department of Commerce, where schema definitions and New York 10036, USA; Phone: (212) Springfield, VA 22161, telephone 703– requirements are not known in advance, 642–4900. Fax: (212) 398–0023. 487–4650. When ordering, refer to a request for a proposal (RFP) may SUPPLEMENTARY INFORMATION: The require that an SQL schema, and Federal Information Processing National Institute of Standards and adherence to one of the SQL/ERI Server Standards Publication 193 Technology (NIST) offers a voluntary profiles, be presented as part of the (FIPSPUB193), SQL Environments. program on a fee-for-service basis to response proposal. Payment may be made by check, money evaluate the competence of conformity 11.3 Interpretation. NIST provides order, or deposit account assessment activities. for the resolution of questions regarding [FR Doc. 95–2688 Filed 2–2–95; 8:45 am] The National Voluntary Conformity specifications and requirements of the BILLING CODE 3510±CN±M Assessment Systems Evaluation FIPS for SQL Environments, and issues (NVCASE) Program may be applied to official interpretations as needed, activities related to laboratory testing, Procedures for interpretations are Workshop on National Voluntary product certification, and quality system specified in FIPS PUB 29–3. All Conformity Assessment Systems registration. NVCASE evaluates and questions about the interpretation of Evaluation (NVCASE) Program provides official recognition to FIPS SQL Environments should be qualifying bodies in the United States addressed to: Director, Computer AGENCY: National Institute of Standards that effectively demonstrate that they Systems Laboratory, Attn: SQL and Technology, Commerce. satisfy established criteria and Environments, National Institute of ACTION: Meeting notice. applicable regulatory requirements of Standards and Technology, other countries. Gaithersburg, MD 20899, Telephone: SUMMARY: This is to advise the public NVCASE recognition (1) provides (301) 975–2833. that the National Institute of Standards other governments with a basis for 11.4 Validation. Implementations of and Technology (NIST) will conduct a having confidence that qualifying U.S. the FIPS for SQL Environments may be workshop to brief interested parties on conformity assessment bodies are validated in accordance with NIST the NVCASE program and to review competent, and (2) promotes the Computer Systems Laboratory (CSL) documents that will be used as the acceptance of U.S. products in regulated validation procedures for FIPS SQL generic basis for requirements of the foreign markets based on U.S. (FIPS PUB 127). Recommended operational program. The workshop will conformity assessment results. procurement terminology for validation be in two parts: NVCASE offers evaluation services to of FIPS SQL is contained in the U.S. (1) A briefing on the purpose and support U.S. trade in regulated foreign General Services Administration operation of the NVCASE program: the markets, but not for domestic publication Federal ADP & presentation will proceed step-by-step applications. NVCASE does not Telecommunications Standards Index, through the procedures set forth in the unilaterally establish program areas. All Chapter 4 Part 2. This GSA publication April 22, 1994 Federal Register Notice requests to establish evaluation services provides terminology for three (15 CFR part 286); and in a specific product sector are first validation options: Delayed Validation, (2) A review of present and proposed published for public advice and Prior Validation Testing, and Prior international documents that will be comment. If another U.S. Government Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6701 agency has domestic regulatory delisted and lost their traceability to National Oceanic and Atmospheric responsibility for that sector, the NIST. Administration cognizant agency is consulted prior to However, if the accredited groups [I.D. 013095B] any program action by NIST. were not involved in the circumstances A U.S. regulatory agency may, at its that led to the termination of Pacific Fishery Management Council; discretion, defer evaluation and recognition of the accreditation body, Meeting recognition of conformity assessment NVCASE will consider granting a grace activities related to foreign trade to period during which accreditation can AGENCY: National Marine Fisheries NVCASE, or may itself perform required be obtained from another NVCASE- Service (NMFS), National Oceanic and evaluation activities. In the event of recognized accreditation body prior to Atmospheric Administration (NOAA), deferral to NVCASE, the regulatory being delisted. To the extent that one or Commerce. agency fully retains its domestic more accredited bodies were affected by ACTION: Notice of public meeting. authority and responsibility for the the circumstances which lead to the product sector. termination of recognition of the SUMMARY: The Pacific Fishery NVCASE recognition may be obtained accrediting body, all those involved will Management Council’s (Council) for different levels of activity. For be immediately delisted. Salmon Technical Team will hold a example, a body may be recognized to public meeting on February 14–17, Bodies that have had their NVCASE accredit other bodies, (e.g., an accreditor 1995, at the Council office, 2130 SW recognition terminated may regain of laboratories, or of certifiers, or of Fifth Avenue, Suite 224, Portland, OR; recognition if and when they can registrars). If accreditation is not telephone: (503) 326–6352. The meeting demonstrate conformance with all available elsewhere, a body may be will begin on February 14, at 10:00 a.m., requirements. accredited directly by NVCASE to and will continue each day from 8:00 perform some specific function (e.g., to As indicated, the NVCASE Program a.m. until 5:00 p.m. for the remainder of certify specific products, or as a quality intends to rely on and utilize the week. system registrar). international conformity assessment The purpose of this meeting is to draft The NVCASE evaluation process documents such as those developed by the 1995 stock status report, ‘‘Preseason requires that a body provide sufficient the International Organization for I: Stock Abundance Analysis for 1995 information to allow thorough Standardization (ISO) Committee on Ocean Salmon Fisheries.’’ The final evaluation of its management system Conformity Assessment. These report will be distributed to the public and operations. The criteria used are documents adopted jointly by ISO and and reviewed by the Council at its based on internationally accepted the International Electrotechnical March meeting in South San Francisco. requirements. Commission (IEC) are as follows: Prior to obtaining recognition, each FOR FURTHER INFORMATION CONTACT: John ISO/IEC Guide 25, ‘‘General Coon, Fishery Management Coordinator participant must undergo an initial on- Requirements for the Competence site assessment by qualified assessors. (Salmon), Pacific Fishery Management of Calibration and Testing Council, 2130 SW Fifth Avenue, Suite Any elements of non-conformance must Laboratories,’’ Third edition; 1990; be resolved prior to the granting of 224, Portland, OR 97201; telephone: recognition. Once recognition has been ISO/IEC Guide 58, ‘‘Calibration and (503) 326–6352. granted, follow-up assessments are Testing Laboratory Accreditation SUPPLEMENTARY INFORMATION: This conducted on a regular basis, along with Systems—General Requirements for meeting is physically accessible to periodic surveillance visits, both Operation and Recognition,’’ First people with disabilities. Requests for announced and unannounced. NVCASE edition, 1993; sign language interpretation or other recognition is effective until either In addition, under consideration for auxiliary aids should be directed to voluntary or involuntary termination. adoption are: Michelle Perry Sailer at (503) 326–6352, at least 5 days prior to the meeting date. NVCASE listings of all recognized ISO/CASCO 226 (rev. 2), ‘‘General bodies include the name, address, requirements for certification or Dated: January 30, 1995. pertinent contacts, and the scope of registration body assessment and David S. Crestin, recognition. NVCASE also maintains accreditation systems’’; Acting Director, Office of Fisheries listings of qualified bodies that have Conservation and Management, National been accredited or otherwise approved ISO/CASCO 227 (rev. 2), ‘‘General requirements for bodies operating Marine Fisheries Service. by a NVCASE-recognized accreditor (but [FR Doc. 95–2726 Filed 2–2–95; 8:45 am] only within the scope and period of assessment and certification/ BILLING CODE 3510±22±F recognition of the accreditor), indicating registration of quality systems’’; they are traceable to NIST via the ISO/CASCO 228 (rev. 2), ‘‘General NVCASE-recognized body. All listings requirements for bodies operating COMMITTEE FOR PURCHASE FROM are freely disseminated and available to product certification systems’’ (or PEOPLE WHO ARE BLIND OR the public through various media. currently available equivalent). SEVERELY DISABLED In the event that a recognized body is ISO/IEC guides are used as a basis for found not to conform with the many conformity assessment activities Procurement List; Proposed Additions established criteria, NVCASE will at international, regional and national terminate the recognition and delist the levels and have been approved by the AGENCY: Committee for Purchase From body. NIST will no longer assure that American National Standards Institute People Who Are Blind or Severely body’s conformity assessment activities (ANSI), the U.S. member body to ISO. Disabled. are competent. Dated: January 31, 1995. ACTION: Proposed additions to If the body is of a type which procurement list. accredits or otherwise approves other Samuel Kramer, groups (e.g., an accreditation body that Associate Director. SUMMARY: The Committee has received accredits laboratories), these accredited [FR Doc. 95–2718 Filed 2–2–95; 8:45 am] proposals to add to the Procurement List groups (e.g., laboratories) may be BILLING CODE 3510±13±M commodities and services to be 6702 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices furnished by nonprofit agencies NPA: Royal Maid Association for the Blind, 1735 Jefferson Davis Highway, employing persons who are blind or Inc., Hazlehurst, Mississippi Arlington, Virginia 22202–3461. have other severe disabilities. Sweatsuit, USAF (Sweatshirt) FOR FURTHER INFORMATION CONTACT: COMMENTS MUST BE RECEIVED ON OR 8415–00–NIB–0054 (X-Small) Beverly Milkman (703) 603–7740. BEFORE: March 6, 1995. 8415–00–NIB–0055 (Small) SUPPLEMENTARY INFORMATION: On ADDRESSES: Committee for Purchase 8415–00–NIB–0056 (Medium) 8415–00–NIB–0057 (Large) December 9, 1994, the Committee for From People Who Are Blind or Severely Purchase From People Who Are Blind Disabled, Crystal Square 3, Suite 403, 8415–00–NIB–0058 (X-Large) (Sweatpants) or Severely Disabled published notice 1735 Jefferson Davis Highway, 8415–00–NIB–0059 (X-Small) (59 F.R. 63764) of proposed additions to Arlington, Virginia 22202–3461. 8415–00–NIB–0060 (Small) the Procurement List. FOR FURTHER INFORMATION CONTACT: 8415–00–NIB–0061 (Medium) After consideration of the material Beverly Milkman (703) 603–7740. 8415–00–NIB–0062 (Large) 8415–00–NIB–0063 (X-Large) presented to it concerning capability of SUPPLEMENTARY INFORMATION: This NPA: The Arkansas Lighthouse for the Blind, qualified nonprofit agencies to provide notice is published pursuant to 41 Little Rock, Arkansas the services, fair market price, and U.S.C. 47(a) (2) and 41 CFR 51–2.3. Its Georgia Industries for the Blind, impact of the additions on the current purpose is to provide interested persons Bainbridge, Georgia at its facility in or most recent contractors, the an opportunity to submit comments on Atlanta, Georgia Committee has determined that the the possible impact of the proposed Blind Industries & Services of Maryland, services listed below are suitable for actions. Baltimore, Maryland at its facility in procurement by the Federal Government Salisbury, Maryland If the Committee approves the under 41 U.S.C. 46–48c and 41 CFR 51– proposed additions, all entities of the Mississippi Industries for the Blind, Jackson, Mississippi 2.4. I certify that the following action Federal Government (except as Lions Club Industries for the Blind, Inc., will not have a significant impact on a otherwise indicated) will be required to Durham, North Carolina substantial number of small entities. procure the commodities and services Winston-Salem Industries for the Blind, The major factors considered for this listed below from nonprofit agencies Winston-Salem, North Carolina certification were: employing persons who are blind or Winston-Salem Industries for the Blind, 1. The action will not result in any have other severe disabilities. Winston-Salem, North Carolina at its facility in Asheville, North Carolina additional reporting, recordkeeping or I certify that the following action will other compliance requirements for small not have a significant impact on a Lions Volunteer Blind Industries, Inc., Morristown, Tennessee entities other than the small substantial number of small entities. San Antonio Lighthouse, San Antonio, organizations that will furnish the The major factors considered for this Texas services to the Government. certification were: Virginia Industries for the Blind, 2. The action does not appear to have 1. The action will not result in any Richmond, Virginia additional reporting, recordkeeping or BESB Industries, West Hartford, a severe economic impact on current other compliance requirements for small Connecticut contractors for the services. 3. The action will result in entities other than the small Services organizations that will furnish the authorizing small entities to furnish the Janitorial/Custodial, Denver Federal Center, services to the Government. commodities and services to the Buildings 76, 80, 93, and 94, Denver, Government. Colorado, NPA: North Metro Community 4. There are no known regulatory 2. The action does not appear to have Services for Developmentally Disabled, alternatives which would accomplish a severe economic impact on current Westminister, Colorado the objectives of the Javits-Wagner- contractors for the commodities and Janitorial/Custodial, John Weld Peck Federal O’Day Act (41 U.S.C. 46–48c) in services. Building, 550 Main Street, Cincinnati, connection with the services proposed 3. The action will result in Ohio, NPA: Ohio Valley Goodwill for addition to the Procurement List. authorizing small entities to furnish the Rehabilitation Center, Inc. Cincinnati, Ohio Accordingly, the following services are commodities and services to the Beverly L. Milkman, hereby added to the Procurement List: Government. Executive Director. Administrative Services, U.S. Army 4. There are no known regulatory [FR Doc. 95–2715 Filed 2–2–95; 8:45 am] Engineer District, Clock Tower alternatives which would accomplish BILLING CODE 6820±33±P Building, Annex and Adjacent the objectives of the Javits-Wagner- Buildings, Rock Island, Illinois O’Day Act (41 U.S.C. 46–48c) in Janitorial/Custodial, U.S. Army Corps of connection with the commodities and Procurement List; Additions Engineers, Walla Walla District, services proposed for addition to the AGENCY: Committee for Purchase From Headquarters Building, Walla Walla, Procurement List. Comments on this People Who Are Blind or Severely Washington certification are invited. Commenters Disabled. should identify the statement(s) Switchboard Operation, Department of underlying the certification on which ACTION: Additions to the procurement Veterans Affairs Medical Center, 718 they are providing additional list. Smyth Road, Manchester, New Hampshire. information. SUMMARY: This action adds to the The following commodities and Procurement List services to be This action does not affect current services have been proposed for furnished by nonprofit agencies contracts awarded prior to the effective addition to Procurement List for employing persons who are blind or date of this addition or options production by the nonprofit agencies have other severe disabilities. exercised under those contracts. listed: EFFECTIVE DATE: March 6, 1995. Beverly L. Milkman, Commodities ADDRESSES: Committee for Purchase Executive Director. Cup, Disposable, Paper From People Who Are Blind or Severely [FR Doc. 95–2714 Filed 2–2–95; 8:45 am] 7350–01–359–9524 Disabled, Crystal Square 3, Suite 403, BILLING CODE 6820±33±P Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6703 COMMODITY FUTURES TRADING underlying futures contract are under administering the program. COMMISSION review by the Division. Participation of Army contracting office Copies of the terms and conditions of staff and operating contractor staff is Chicago Mercantile Exchange the proposed contract will be available strongly encouraged. This session is Application for Designation as a for inspection at the Office of the open to the public. Contract Market in Mexican Peso Secretariat, Commodity Futures Trading MEETING DATE: March 22–23, 1995. Futures Options Commission, 2033 K Street, NW., PLACE OF MEETING: Blackhawk Hotel, 200 Washington, D.C. 20581. Copies of the AGENCY: Commodity Futures Trading East Third Street, Davenport, IA 52801. Commission. terms and conditions can be obtained through the Office of the Secretariat by TIME OF MEETING: 8:00 a.m.–5:00 p.m. ACTION: Notice of availability of the mail at the above address or by phone FOR FURTHER INFORMATION CONTACT: Mr. terms and conditions of proposed at (202) 254–6314. Richard Auger, ARMS Task Force, HQ commodity futures option contract. Other materials submitted by the CME Army Materiel Command, 5001 SUMMARY: The Chicago Mercantile in support of the application for Eisenhower Avenue, Alexandria, Exchange (CME) has applied for contract market designation may be Virginia 22333; telephone (703) 274– designation as a contract market in available upon request pursuant to the 9838. options on its physical delivery Freedom of Information Act (5 U.S.C. SUPPLEMENTARY INFORMATION: Mexican peso futures contract. The 552) and the Commission’s regulations Reservations should be made directly Director of the Division of Economic thereunder (17 C.F.R. part 145 (1987)), with the Blackhawk Hotel; telephone Analysis (Division) of the Commission, except to the extent they are entitled to (319) 328–6000. Please be sure to acting pursuant to the authority confidential treatment as set forth in 17 mention that you will be attending the delegated by Commission Regulation C.F.R. 145.5 and 145.9. Requests for ARMS workshop meeting to assure 140.96, has determined that publication copies of such materials should be made occupancy in the block of rooms set of the proposal for comment is in the to the FOI, Privacy and Sunshine Act aside for this meeting. You should public interest, will assist the Compliance Staff of the Office of the confirm your reservation prior to 28 Commission in considering the views of Secretariat at the Commission’s February 1995. Request you contact interested persons, and is consistent headquarters in accordance with 17 Debra Yeager in the ARMS Team Office with the purposes of the Commodity C.F.R. 145.7 and 145.8. at Rock Island Arsenal; telephone (309) Exchange Act. Any person interested in submitting 782–4040, if you will be attending the DATE: Comments must be received on or written data, views, or arguments on the meeting so that our roster of attendees before March 6, 1995. terms and conditions, or with respect to is accurate. This number may also be other materials submitted by the CME in ADDRESS: Interested persons should used if other assistance regarding the support of the application, should send submit their views and comments to ARMS meeting is required. such comments to Jean A. Webb, Jean A. Webb, Secretary, Commodity Kenneth L. Denton, Secretary, Commodity Futures Trading Futures Trading Commission, 2033 K Army Federal Register Liaison Officer. Commission, 2033 K Street NW., Street NW., Washington, DC 20581. [FR Doc. 95–2723 Filed 2–2–95; 8:45 am] Washington, DC 20581 by the specified Reference should be made to the CME date. BILLING CODE 3710±08±M option on the physical delivery Mexican peso futures contract. Issued in Washington, DC, on January 30, 1995. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF EDUCATION Steve Sherrod of the Division of Blake Imel, Economic Analysis, Commodity Futures Acting Director. Notice of Proposed Information Trading Commission, 2033 K Street [FR Doc. 95–2660 Filed 2–2–95; 8:45 am] Collection Requests NW., Washington, DC 20581, telephone BILLING CODE 6351±01±M AGENCY: Department of Education. 202–254–7303. ACTION: Notice of proposed information SUPPLEMENTARY INFORMATION: The CME collection requests. physical delivery Mexican peso futures DEPARTMENT OF DEFENSE contract, which would underlie the Department of the Army SUMMARY: The Director, Information proposed option, currently is dormant Resources Group, invites comments on within the meaning of Commission ARMS Initiative Implementation proposed information collection Regulation 5.2.1 Concurrent with its requests as required by the Paperwork application for designation as a contract AGENCY: U.S. Army Materiel Command, Reduction Act of 1980. DOD. market in the subject option, the CME DATES: An expedited review has been ACTION: submitted to the Commission for Meeting notice. requested in accordance with the Act, approval, pursuant to Section 5a(a)(12) SUMMARY: since allowing for the normal review of the Act, a proposal to reactivate Pursuant to Section 10(a)(2) of Public Law 92–463, notice is hereby period would adversely affect the public trading in this dormant futures contract. interest. Approval by the Office of The subject option designation given of the next workshop meeting of the Armament Retooling and Management and Budget (OMB) has application and the proposed been requested by February 13, 1995. reactivation of trading for the Manufacturing Support (ARMS) Public/ Private Task Force (PPTF). The PPTF is ADDRESSES: Written comments should 1 The CME also has applied for designation as a chartered to develop new and be addressed to the Office of contract market in ‘‘hybrid’ Mexican peso futures innovative methods to maintain the Information and Regulatory Affairs, and futures option contracts, which are currently government-owned, contractor-operated Attention: Dan Chenok, Desk Officer, under review by the Division. The hybrid Mexican ammunition industrial base and retain Department of Education, Office of peso futures contract provides for cash settlement, in contrast to the existing dormant Mexican peso critical skills for a national industrial Management and Budget, 725 17th futures contract which provides for physical emergency. Focus of this meeting will Street NW., Room 3208, New Executive delivery of Mexican pesos. be improving the progresses used in Office Building, Washington, DC 20503. 6704 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Requests for copies of the proposed Additional Information: Clearance for proposed information collection information collection request should be this information collection is requests as required by the Paperwork addressed to Patrick J. Sherrill, requested for February 13, 1995. As Reduction Act of 1980. Department of Education, 400 Maryland part of the ‘‘reinventing government’’ Avenue SW., Room 5624, Regional initiative, and in light of comments DATES: An expedited review has been Office Building 3, Washington, DC from the public, the Department is requested in accordance with the Act, 20202–4651. determined to allow the applicants as since allowing for the normal review period would adversely affect the public FOR FURTHER INFORMATION CONTACT: much time as possible to respond. An Patrick J. Sherrill, (202) 708–9915. expedited review is requested in order interest. Approval by the Office of Individuals who use a to implement the program before the Management and Budget (OMB) has telecommunications device for the deaf start of the new year. been requested by February 6, 1995. (TDD) may call the Federal Information Office of Educational Research and EFFECTIVE DATE: Written comments Relay Service (FIRS) at 1–800–877–8339 Improvement should be addressed to the Office of between 8 a.m. and 8 p.m., Eastern time, Information and Regulatory Affairs, Monday through Friday. Type of Review: Expedited Title: Annual Report of Children in Attention: Dan Chenok, Desk Officer, SUPPLEMENTARY INFORMATION: Section Department of Education, Office of 3517 of the Paperwork Reduction Act of Institutions for Neglected or Delinquent Children, Adult Management and Budget, 725 17th 1980 (44 U.S.C. Chapter 3517) requires Street NW., Room 3208, New Executive that the Director of OMB provide Correctional Institutions, and Community Day Programs Office Building, Washington, DC 20503. interested Federal agencies and persons Requests for copies of the proposed an early opportunity to comment on Frequency: Annually Affected Public: State, Local or Tribal information collection request should be information collection requests. OMB Governments addressed to Patrick J. Sherrill, may amend or waive the requirement Reporting Burden: Department of Education, 400 Maryland for public consultation to the extent that Responses: 52 public participation in the approval Avenue SW., Room 5624, Regional Burden Hours: 2,000 process would defeat the purpose of the Office Building 3, Washington, DC Recordkeeping Burden: 20202–4651. information collection, violate State or Recordkeepers: 0 Federal law, or substantially interfere Burden Hours: 0 FOR FURTHER INFORMATION CONTACT: with any agency’s ability to perform its Abstract: An annual survey is Patrick J. Sherrill, (202) 708–9915. statutory obligations. conducted to collect data on (1) the The Director, Information Resources Individuals who use a number of children enrolled in telecommunications device for the deaf Group, publishes this notice with the educational programs of State- attached proposed information (TDD) may call the Federal Information operated institutions for neglected or Relay Service (FIRS) at 1–800–877–8339 collection request prior to submission of delinquent children (N or D), this request to OMB. This notice between 8 a.m. and 8 p.m., Eastern time, community day programs for N or D Monday through Friday. contains the following information: (1) children, and adult correctional Type of review requested, e.g., institutions and (2) the October SUPPLEMENTARY INFORMATION: Section expedited; (2) Title; (3) Abstract; (4) caseload of N or D children in local 3517 of the Paperwork Reduction Act of Additional Information; (5) Frequency institutions. 1980 (44 U.S.C. Chapter 3517) requires of collection; (6) Affected public; and (7) Additional Information: Clearance for that the Director of OMB provide Reporting and/or Recordkeeping this information collection is interested Federal agencies and persons burden. Because an expedited review is requested for February 13, 1995. ED an early opportunity to comment on requested, a description of the must make grant awards to the States information collection requests. OMB information to be collected is also based on these allocations by July 1 included as an attachment to this notice. may amend or waive the requirement because the Cash Management for public consultation to the extent that Dated: January 30, 1995. Information Act makes ED liable for public participation in the approval Gloria Parker, interest incurred by States and process would defeat the purpose of the Director, Information Resources Group. localities for program expenses if information collection, violate State or Federal funds are not made available Federal law, or substantially interfere Office of Educational Research and on that date. In order to meet that Improvement with any agency’s ability to perform its deadline, we must send the revised statutory obligations. Type of Review: Expedited ED Form 4376 to the States by March Title: Application for Grants Under the 1 to collect the data needed to The Director, Information Resources National Diffusion Network determine State grant awards before Group, publishes this notice with the Frequency: Annually July 1. attached proposed information Affected Public: State or local [FR Doc. 95–2647 Filed 2–2–95; 8:45 am] collection request prior to submission of governments; Non-profit institutions BILLING CODE 4001±01±M this request to OMB. This notice Reporting Burden: contains the following information: (1) Responses: 48 Type of review requested, e.g., Burden Hours: 576 Notice of Proposed Information expedited; (2) Title; (3) Abstract; (4) Recordkeeping Burden: Collection Requests Additional Information; (5) Frequency Recordkeepers: 25 of collection; (6) Affected public; and (7) Burden Hours: 300 AGENCY: Department of Education. Abstract: The National Diffusion Reporting and/or Recordkeeping ACTION: Notice of proposed information burden. Because an expedited review is Network supports, under grants, collection requests. dissemination of exemplary programs. requested, a description of the The Department will use the SUMMARY: The Director, Information information to be collected is also information to make grant awards. Resources Group, invites comments on included as an attachment to this notice. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6705 Dated: January 30, 1995. waiver of the requirement that an Department of Education, Room 4621, Gloria Parker, institution use at least 5 percent of the Regional Office Building 3, 7th and D Director, Information Resource Group. total amount of its FWS Federal funds Streets SW., Washington, D.C. Hand- granted for the 1994–95 award year to delivered waiver requests will be Office of Postsecondary Education compensate students employed in accepted between 8:00 a.m. and 4:30 Type of Review: Expedited community service jobs, must mail or p.m. (Eastern time) daily, except Title: William D. Ford Federal Direct hand-deliver its waiver request and any Saturdays, Sundays, and Federal Loan Program Participation supporting information or documents holidays. A waiver request for the 1994– Application on or before March 6, 1995. The 95 award year that is delivered by hand Frequency: Annually Department will not accept a waiver will not be accepted after 4:30 p.m. on Affected Public: Business or other for- request submitted by facsimile the closing date. profit; Not-for-profit institutions transmission. The waiver request must SUPPLEMENTARY INFORMATION: Under Reporting Burden: be submitted to the Campus-Based section 443 (b)(2)(A) of the Higher Responses: 3,000 Programs Financial Management Education Act of 1965, as amended Burden Hours: 600 Division at one of the addresses (HEA), an institution must use at least Recordkeeping Burden: indicated below. 5 percent of the total amount of its FWS Recordkeepers: 0 Federal funds granted for an award year Burden Hours: 0 ADDRESSES: Waiver Request and any Abstract: This form will be the means by Supporting Information or Documents to compensate students employed in which a school applies to participate Delivered by Mail. The waiver request community service, except that the in the William D. Ford Federal Direct and any supporting information or Secretary may waive this requirement if the Secretary determines that enforcing Loan Program. The Department will documents delivered by mail must be it would cause hardship for students at use this information to select schools addressed to Carolyn Short, Financial the institution. The institution must to participate in the Direct Loan Management Specialist, Fund Control provide a written waiver request and Program during the 1996–1997 school Branch, Campus-Based Programs any supporting information or year. Financial Management Division, documents by the established March 6, Additional Information: Clerance for Accounting and Financial Management 1995 closing date. The waiver request this information collection is Service, Student Financial Assistance must be signed by an appropriate requested for February 6, 1995. An Programs, U.S. Department of institutional official and above the expedited review is requested due to Education, Room 4621, Regional Office signature the official must include the the publication of a draft of the form Building 3, 600 Independence Avenue, statement: ‘‘I certify that the information soliciting applications. To comment S.W., Washington, D.C. 20202–5452. An the institution provided in this waiver on this form, please refer to the applicant must show proof of mailing request is true and accurate to the best ‘‘Notice of Solicitation of consisting of one of the following: (1) A of my knowledge. I understand that the Applications’’ In the December 29, legibly dated U.S. Postal Service information is subject to audit and 1994 Federal Register issue, volume postmark; (2) a legible mail receipt with program review by representatives of 59, pages 67579–67582. the date of mailing stamped by the U.S. Postal Service; (3) a dated shipping the Secretary of Education.’’ If the [FR Doc. 95–2646 Filed 2–2–95; 8:45 am] label, invoice, or receipt from a institution submits a waiver request and BILLING CODE 4000±01±M commercial carrier; or (4) any other any supporting information or proof of mailing acceptable to the documents after the closing date, the Secretary of Education. request will not be considered. Office of Postsecondary Education; To receive a waiver, an institution If a waiver request is sent through the Federal Work-Study Programs must demonstrate that the 5 percent U.S. Postal Service, the Secretary does requirement would cause hardship for AGENCY: Department of Education. not accept either of the following as students at the institution. To allow proof of mailing: (1) A private metered ACTION: Notice of the closing date for flexibility to consider factors that may postmark, or (2) a mail receipt that is institutions to submit a request for a be valid reasons for a waiver, the not dated by the U.S. Postal Service. waiver of the requirement that an Secretary is not specifying specific An institution should note that the institution shall use at least 5 percent of circumstances that would support U.S. Postal Service does not uniformly the total amount of its Federal Work- granting a waiver. However, the provide a dated postmark. Before Study (FWS) Federal funds granted for Secretary does not foresee many relying on this method, an institution the 1994–95 award year to compensate instances in which a waiver will be should check with its local post office. students employed in community granted. The fact that it may be difficult An institution is encouraged to use service jobs. for the institution to comply with this certified or at least first class mail. provision of the HEA is not a basis for SUMMARY: The Secretary gives notice to Institutions that submit waiver requests granting a waiver. institutions of higher education of the and any supporting information or deadline for an institution to submit a documents after the closing date will Applicable Regulations written request for a waiver of the not be considered for a waiver. The following regulations apply to the requirement that an institution shall use Waiver Requests and any Supporting Federal Work-Study program: at least 5 percent of its total FWS Information or Documents Delivered by (1) Student Assistance General Federal funds granted for the 1994–95 Hand. A waiver request and any Provisions, 34 CFR part 668. award year (July 1, 1994 through June supporting information or documents (2) Federal Work-Study Programs, 34 30, 1995) to compensate students delivered by hand must be taken to CFR part 675. employed in community service jobs. Carolyn Short, Financial Management (3) Institutional Eligibility Under the DATES: Closing Date for Submitting a Specialist, Fund Control Branch, Higher Education Act of 1965, as Waiver Request and any Supporting Campus-Based Programs Financial amended, 34 CFR part 600. Information or Documents. An Management Division, Student (4) New Restrictions on Lobbying, 34 institution that would like to request a Financial Assistance Programs, U.S. CFR part 82. 6706 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices (5) Governmentwide Debarment and FOR FURTHER INFORMATION CONTACT: A Randolph-Sheppard vending program Suspension (Nonprocurement) and copy of the full text of the arbitration had not been followed. Governmentwide Requirements for panel decision may be obtained from Karla Todd requested and received an Drug-Free Workplace (Grants), 34 CFR George F. Arsnow, U. S. Department of administrative review with respect to part 85. Education, 600 Independence Avenue, the matter. The SLA upheld the election (6) Drug-Free Schools and Campuses, S.W., Room 3230 Switzer Building, of the new candidate. Subsequently, 34 CFR part 86. Washington, D.C. 20202–2738. complainant requested a full evidentiary FOR FURTHER INFORMATION CONTACT: Telephone: (202) 205–9317. Individuals hearing. Carolyn Short, Financial Management who use a telecommunications devise On March 19, 1990, an evidentiary Specialist, Fund Control Branch, for the deaf (TDD) may call the TDD hearing was held in Montgomery, Campus-Based Programs Financial number at (202) 205–8298. Alabama. The hearing officer ruled that Ms. Todd’s objections were without Management Division, Accounting and SUPPLEMENTARY INFORMATION: Pursuant merit. Subsequently, Ms. Todd appealed Financial Management Service, Student to section 107d–2(c) of the Randolph- this ruling to a Federal arbitration panel, Financial Assistance Programs, U.S. Sheppard Act, the Secretary is required which held a hearing on September 27, Department of Education, Room 4621, to publish a synopsis of each arbitration 1991. Regional Office Building 3, 600 panel decision affecting the Independence Avenue, S.W., administration of vending facilities on Arbitration Panel Decision Washington, D.C. 20202–5452, Federal property. Telephone (202) 708–7741. Individuals The issue before the panel was who use a telecommunications device Background whether the process followed by the for the deaf (TDD) may call the Federal SLA on September 20 and October 4, Karla Todd is a blind vendor licensed 1989 was consistent with the State rules Information Relay Service (FIRS) at 1– by the Alabama Division of 800–877–8339 between 8 a.m. and 8 and regulations governing the day-to- Rehabilitative Services, the SLA under day operations of the Business p.m., Eastern time, Monday through the provisions of the Act. On September Friday. Enterprise Program. 20, 1989, Ms. Todd attended a meeting The SLA argued that the issue before (Authority: 42 U.S.C. 2756(b)). of blind vendors from the Mobile area. the arbitration panel was not arbitrable (Catalog of Federal Domestic Assistance At this meeting, the agenda provided for since the policies and procedures of the Number: 84.033 Federal Work-Study the election of a committee Program) Business Enterprises Program only representative for the Committee of allow for review of ‘‘actions arising from Dated: January 31, 1995. Blind Vendors, pursuant to 34 CFR the operation or administration of a David A. Longanecker, 395.14, which states that the SLA shall vending facility.’’ However, it was the Assistant Secretary for Postsecondary provide for the biennial election of a opinion of the majority of the panel that Education. State Committee of Blind Vendors. the complainant’s argument was [FR Doc. 95–2712 Filed 2–2–95; 8:45 am] At the September meeting, persuasive. The Act, in 20 U.S.C. 107b- BILLING CODE 4000±01±P complainant was one of the two 1, states that the Committee of Blind candidates nominated for committee Vendors shall participate with the representative. A vote was held that Vocational Rehabilitation Agency Arbitration Panel Decision Under the resulted in a three to three tie. A second regarding administrative decisions, Randolph-Sheppard Act run-off election was held with the same policies, and program development AGENCY: Department of Education. result. A special meeting of blind decisions affecting the overall ACTION: Notice of arbitration panel vendors to resolve the matter was called administration of the State Vending decision under the Randolph-Sheppard for October 4, 1989. Prior to the meeting Facility Program. Act. the candidate opposing complainant The panel concluded that the actions SUMMARY: Notice is hereby given that on withdrew. of the Committee of Blind Vendors February 3, 1992, an arbitration panel The SLA sent a letter to the vendors indeed had an impact on the operation rendered a decision in the matter of announcing the October 4 meeting, and administration of all vending Karla Todd v. Alabama Division of explaining the problem regarding the facilities, and, therefore, the issue was Rehabilitative Services, (Docket No. R– election on September 20, and stating reviewable by the panel. S/90–4). This panel was convened by that the only purpose of the meeting The panel found that the policies and the U.S. Department of Education would be to elect a member of the State procedures of the Business Enterprise pursuant to 20 U.S.C. 107d–1(a) upon Committee of Blind Vendors. Program, specifically the section on receipt of a complaint filed by Karla Ten vendors attended the October 4, elections, covered the issue before the Todd on June 13, 1990. The Randolph- 1989 meeting, including the panel. The section on elections states, Sheppard Act creates a priority for blind complainant. Ms. Todd was again ‘‘[I]f no candidate receives a majority of individuals to operate vending facilities nominated along with another vendor. the votes, a run-off between the two on Federal property. Under this section The other vendor received the majority highest vote getters will be held.’’ The of the Randolph-Sheppard Act (the Act), of the votes and was elected to the SLA interpreted this to mean that only a blind licensee dissatisfied with the committee. one run-off election had to be held, and State’s operation or administration of Ms. Todd subsequently challenged in the event of a tie in the run-off the vending facility program authorized the candidacy of the vendor elected at election, an entirely new election was under the Act may request a full the October 4, 1989 meeting, stating that appropriate. The panel did not concur evidentiary hearing from the State she should have won the election by with the SLA’s interpretation of this licensing agency (SLA). If the licensee is default when the previous vendor who language. The panel stated that the dissatisfied with the State agency’s had received a tie vote with common sense meaning of the term decision, the licensee may complain to complainant withdrew her candidacy ‘‘run-off’’ is not necessarily a singular the Secretary, who is then required to prior to the October 4th meeting. She act, but implies the act of breaking a tie convene an arbitration panel to resolve asserted that proper procedures under regardless of the number of times the dispute. the rules and regulations of the Alabama necessary to achieve that goal. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6707 Additionally, the panel noted that the Commission’s regulations, 18 CFR Part [Docket No. GP94±19±000] SLA’s policies and procedures are silent 380 (Order No. 486, 52 FR 47910), the regarding holding a new election and Office of Hydropower Licensing (OHL) Oklahoma Corporation Commission also regarding a tie occurring during a reviewed the application for non-project Tight Formation Area Determination run-off election. Therefore, the panel use of project lands for the Pensacola FERC No. JD94±01286T (Oklahoma- found that the language of the policies Hydroelectric Project. The application 57); Preliminary Finding and procedures of the Business proposes to excavate an area January 30, 1995. Enterprise Program regarding elections approximately 174 feet wide, 500 feet On November 26, 1993, the Oklahoma was clear in that once the two highest long, and 10 feet deep and to construct Corporation Commission (Oklahoma) vote getters were determined, those two a breakwater 10 feet wide (to the determined that the Fanshawe vote getters would continue with a run- approximate elevation of 746 feet mean Formation, underlying parts of Latimer off election until one of the vote getters sea level) on Grand Lake O’ The County, Oklahoma, qualifies as a tight ultimately won the election. Cherokees, in Delaware County, formation under Section 107(c)(5) of the On September 26, 1991, a new Oklahoma. The staff prepared an Natural Gas Policy Act of 1978 (NGPA). election was held. The SLA petitioned Environmental Assessment (EA) for the ARCO Oil and Gas Company (ARCO) is the panel to declare the issue moot in action. In the EA, staff concludes that the applicant before Oklahoma. light of the new election. The approval of the non-project use of By letter dated January 10, 1994, staff complainant requested that the panel project lands would not constitute a tolled the Commission’s 45-day review unseat the person elected on October 4, major federal action significantly period and requested additional support 1989, as well as the person elected on affecting the quality of the human for Oklahoma’s conclusion that the September 26. environment. Fanshawe Formation meets the The panel ruled that the election Copies of the EA are available for Commission’s tight formation guidelines process held by the SLA on October 4, review in the Reference and Information in § 271.703(c)(2) of the Commission’s 1989 was a violation of the policies and Center, Room 3308, of the Commission’s regulations.1 Staff requested additional procedures of the Business Enterprise offices at 941 North Capitol Street NE., information because the record did not Program and, further, that Karla Todd Washington, DC 20426. show whether the premeability and won the run-off election that began on Lois D. Cashell, prestimulation stabilized flow rates on September 20, 1989. However, since a which the determination was based Secretary. new and undisputed election was held reflected initial characteristics or on September 26, 1991, the panel [FR Doc. 95–2662 Filed 2–2–95; 8:45 am] characteristics resulting from years of concluded it was without authority to BILLING CODE 6717±01±M sustained production. upset that election, and, therefore, the The Commission has received no issue as to the appropriateness of the response to the January 10, 1994 tolling election held on October 4, 1989 was [Project No. 2114±032 Washington] letter. Without additional information moot and no remedy could be showing that the determination is based fashioned. Public Utility District No. 2 of Grant on initial permeability and Panel member Harris dissented, County; Availability of Environmental prestimulation stabilized flow rates indicating that the rules of the Business Assessment characteristics, we are unable to find Enterprise Program were silent that Oklahoma’s determination is regarding the situation of a run-off January 30, 1995. supported by substantial evidence. election, and, therefore, the SLA did not In accordance with the National Under § 275.202(a) of the regulations, violate its own policy. Environmental Policy Act of 169 and the Commission’s may make a The views and opinions expressed by the Federal Energy Regulatory preliminary finding, before any the panel do not necessarily represent Commission’s regulations, 18 CFR Part determination becomes final, that the the views and opinions of the U.S. 380 (Order No. 486, 52 F.R. 47910), the determination is not supported by Department of Education. Office of Hydropower Licensing (OHL) substantial evidence in the record.2 Dated: January 30, 1995. reviewed the proposal for constructing a Therefore, the Commission hereby Judith E. Heumann, prototype fish surface collector at the makes a preliminary finding that Assistant Secretary, Office of Special Priest Rapids Project in Grant County, Oklahoma’s determination is not Education and Rehabilitative Services. Washington. The Commission prepared supported by substantial evidence in the [FR Doc. 95–2683 Filed 2–2–95; 8:45 am] an environmental assessment (EA) for 1 BILLING CODE 4000±01±P the proposed action. In the EA, the Section 271.703(c)(2) requires a jurisdictional Commission concludes that approval of agency’s tight formation area determination to show that: (1) The estimated average in situ gas construction of the proposed prototype permeability, throughout the pay section, is DEPARTMENT OF ENERGY fish surface collector will not constitute expected to be 0.1 millidarcy or less; (2) the average a major federal action significantly pre-stimulation stabilized natural gas flow rate Federal Energy Regulatory affecting the quality of the human (against atmospheric pressure) of wells completed for production in the formation does not exceed the Commission environment. applicable maximum allowable flow rate; and (3) [Project No. 1494±088 Oklahoma] Copies of the EA are available for wells in the recommended area is expected to produce, without stimulation, more than 5 barrels review in the Reference and Information of crude oil per day. Grand River Dam Authority; Center, Room 3308, of the Commission’s 2 Order No. 567, issued on July 28, 1994, Availability of Environmental offices at 941 North Capitol Street, N.E., rescinded Part 275 of the Commission’s NGPA’s Assessment Washington, D.C. 20426. regulations as of that date (68 FERC ¶ 61,135). The Commission stated, however, that rescission of Part Lois D. Cashell, January 30, 1995. 275 is prospective only and that timely filed Secretary. applications for well determination proceedings In accordance with the National still pending before the Commission will continue Environmental Policy Act of 1969 and [FR Doc. 95–2663 Filed 2–2–95; 8:45 am] to be subject to the requirements of Part 275 as it the Federal Energy Regulatory BILLING CODE 6717±01±M existed before July 28, 1994. 6708 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices record upon which it was made. The Commission reserves the right to offices at 1700 MacCorkle Avenue, SE., Oklahoma or ARCO may, within 30 require a further showing that neither Charleston, West Virginia; 700 days from the date of this preliminary public nor private interests will be Thirteenth Street, NW., Suite 900, finding, submit written comments and adversely affected by continued Washington, DC; and have been mailed request an informal conference with the approval of AIG Trading’s issuances of to all firm customers and affected state Commission, pursuant to § 275.202(f) of securities or assumptions of liability. regulatory commissions. the regulations. A final Commission Notice is hereby given that the Any person desiring to be heard or to order will be issued within 120 days deadline for filing motions to intervene protest said filing should file a motion after the issuance of this preliminary or protests, as set forth above, is to intervene or protest with the Federal finding. February 21, 1995. Energy Regulatory Commission, 825 Copies of the full text of the order are By direction of the Commission. North Capitol Street, NE., Washington, available from the Commission’s Public DC, 20426, in accordance with Rules Lois D. Cashell, Reference Branch, Room 3308, 941 211 or 214 of the Commission’s Rules of Secretary. North Capitol Street, NE., Washington, Practice and Procedures (18 CFR [FR Doc. 95–2708 Filed 2–2–95; 8:45 am] DC 20426. 385.211 or 385.214). All such motions to BILLING CODE 6717±01±M Linwood A. Watson, Jr., intervene or protest should be filed on Acting Secretary. or before February 14, 1995. Protests [FR Doc. 95–2664 Filed 2–2–95; 8:45 am] will be considered by the Commission [Docket No. ER94±1691±000] BILLING CODE 6717±01±M in determining the appropriate action to be taken but will not serve to make AIG Trading Corp.; Notice of Issuance protestants parties to the proceeding. of Order [Docket No. MG95±2±000] Any person wishing to become a party January 27, 1995. Columbia Gas Transmission Corp.; must file a motion to intervene. Copies On September 29, 1994, as completed Filing of this filing are on file with the on November 23, 1994, AIG Trading Commission and are available for public Corporation (AIG Trading) submitted for January 30, 1995. inspection. filing a rate schedule under which AIG Take notice that on January 20, 1995, Lois D. Cashell, Trading will engage in wholesale Columbia Gas Transmission Corporation Secretary. electric power and energy transactions (Columbia), submitted revised standards [FR Doc. 95–2665 Filed 2–2–95; 8:45 am] of conduct under Order Nos. 497 et as a marketer. AIG Trading also BILLING CODE 6717±01±M 1 2 requested waiver of various Commission seq. and Order Nos. 566 et seq. regulations. In particular, AIG Trading Columbia states that it is revising its requested that the Commission grant standards of conduct to incorporate the [Docket No. MG95±3±000] blanket approval under 18 CFR Part 34 changes required by Order Nos. 566 and 566–A. The modifications are also Columbia Gulf Transmission Co.; of all future issuances of securities and Filing assumptions of liability by AIG Trading. necessary to reflect organizational On January 19, 1995, pursuant to changes within Columbia as a result of January 30, 1995. delegated authority, the Director, implementing Order No. 636. Take notice that on January 20, 1995, Columbia states that copies of its Division of Applications, Office of Columbia Gulf Transmission Company filing are available for inspection at its Electric Power Regulation, granted (Columbia Gulf) submitted revised requests for blanket approval under Part 1 Order No. 497, 53 FR 22139 (June 14, 1988), III standards of conduct under Order Nos. 34, subject to the following: FERC Stats. & Regs. ¶ 30,820 (1988); Order No. 497– 497 et seq.1 and Order Nos. 566 et seq.2 Within thirty days of the date of the A, order on rehearing, 54 FR 52781 (December 22, order, any person desiring to be heard 1989), III FERC Stats. & Regs. 30,868 (1989); Order 1 Order No. 497, 53 FR 22139 (June 14, 1988), III No. 497–B, order extending sunset date, 55 FR or to protest the blanket approval of FERC Stats. & Regs. ¶ 30,820 (1988); Order No. 497– 53291 (December 28, 1990), III FERC Stats. & Regs. A, order on rehearing, 54 FR 52781 (December 22, issuances of securities or assumptions of ¶ 30,908 (1990); order No. 497–C, order extending 1989), III FERC Stats. & Regs. 30,868 (1989); Order liability by AIG Trading should file a sunset date, 57 FR 9 (January 2, 1992), III FERC No. 497–B, order extending sunset date, 55 FR Stats. & Regs. ¶ 30,934 (1991), rehearing denied, 57 53291 (December 28, 1990), III FERC Stats. & Regs. motion to intervene or protest with the FR 5815 (February 18, 1992), 58 FERC p 61,139 Federal Energy Regulatory Commission, ¶ 30,908 (1990); Order No. 497–C, order extending (1992); Tenneco Gas. v. FERC (affirmed in part and sunset date, 57 FR 9 (January 2, 1992), III FERC 825 North Capitol Street, NE., remanded in part), 969 F. 2d 1187 (D.C. Cir. 1992); Stats. & Regs. ¶ 30,934 (1991), rehearing denied, 57 Order No. 497–D, order on remand and extending Washington, DC 20426, in accordance FR 5815 (February 18, 1992), 58 FERC ¶ 61,139 sunset date, III FERC Stats. & Regs. ¶ 30,958 (1992); Tenneco Gas v. FERC (affirmed in part and with Rules 211 and 214 of the (December 4, 1992), 57 FR 58978 (December 14, remanded in part), 969 F. 2d 1187 (D.C. Cir. 1992); Commission’s Rules of Practice and 1992); Order No. 497–E, order on rehearing and Order No. 497–D, order on remand and extending extending sunset date, 59 FR 243 (January 4, 1994), Procedure (18 CFR 385.211 and sunset date, III FERC Stats. & Regs. ¶ 30,958 385.214). 65 FERC ¶ 61,381 (December 23, 1993); Order No. 497–F, order denying rehearing and granting (December 4, 1992), 57 FR 58978 (December 14, Absent a request for hearing within clarification, 59 FR 15336 (April 1, 1994), 66 FERC 1992); Order No. 497–E, order on rehearing and this period, AIG Trading is authorized ¶ 61,347 (March 24, 1994); and Order No. 497–G, extending sunset date, 59 FR 243 (January 4, 1994), 65 FERC ¶ 61,381 (December 23, 1993); Order No. to issue securities and assume order extending sunset date, 59 FR 32884 (June 27, 1994), III FERC Stats. & Regs. ¶ 30,996 (June 17, 497–F, order denying rehearing and granting obligations or liabilities as a guarantor, 1994). clarification, 59 FR 15336 (April 1, 1994), 66 FERC indorser, surety, or otherwise in respect 2 Standards of conduct and Reporting ¶ 61,347 (March 24, 1994); and Order No. 497–G, of any security of another person; Requirements for Transportation and Affiliate order extending sunset date, 59 FR 32884 (June 27, 1994), III FERC Stats. & Regs. ¶ 30,996 (June 17, provided that such issuance or Transactions, Order No. 566, 59 FR 32885 (June 27, 1994), III FERC Stats & Regs. ¶ 30,997 (June 17, 1994). assumption is for some lawful object 1994); Order No. 566–A, order on rehearing, 59 FR 2 Standards of Conduct and Reporting within the corporate purposes of the 52896 (October 20, 1994), 69 FERC ¶ 61,044 Requirements for Transportation and Affiliate applicant, and compatible with the (October 14, 1994); Order No. 566–B, order on Transactions, Order No. 566, 59 FR 32885 (June 27, public interest, and is reasonably rehearing, 59 FR 65707 (December 21, 1994); 69 1994), III FERC Stats. & Regs. ¶ 30,997 (June 17, FERC ¶ 61,334 (December 14, 1994); appeal 1994); Order No. 566–A, order on rehearing, 59 FR necessary or appropriate for such docketed sub nom. Conoco, Inc. v. FERC, D.C. Cir. 52896 (October 20, 1994), 69 FERC ¶ 61,044 purposes. No. 94–1745 (December 13, 1994). (October 14, 1994); Order No. 566–B, order on Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6709 Columbia Gulf states that it is revising Within thirty days of the date of the the Commission and open to public its standards of conduct to incorporate order, any person desiring to be heard inspection. the changes required by Order Nos. 566 or to protest the blanket approval of WNG proposes to install the facilities and 566–A. The modifications are also issuances of securities or assumptions of to deliver gas to Manchester to fill its necessary to reflect organizational liability by Destec should file a motion storage facility and to receive gas from changes within Columbia Gulf as a to intervene or protest with the Federal the storage facility. WNG states that the result of implementing Order No. 636. Energy Regulatory Commission, 825 annual volume is estimated to be Columbia Gulf states that copies of its North Capitol Street, NE., Washington, approximately 13,200,000 Dth with a filing are available for inspection at its DC 20426, in accordance with Rules 211 peak day volume of 80,000 Dth. WNG offices at 2603 Augusta, Houston, Texas; and 214 of the Commission’s Rules of states further that the total volume 700 Thirteenth Street, N.W., Suite 900, Practice and Procedure (18 CFR 385.211 would not exceed the total volume Washington, D.C.; and have been mailed and 385.214). currently authorized. The total to all firm customers and affected state Absent a request for hearing within construction cost, it is said, would be regulatory commissions. this period, Destec is authorized to issue reimbursed by Manchester. Any person desiring to be heard or to securities and assume obligations or WNG states further that this change is protest said filing should file a motion liabilities as a guarantor, indorser, not prohibited by an existing tariff and to intervene or protest with the Federal surety, or otherwise in respect of any that WNG has sufficient capacity to Energy Regulatory Commission, 825 security of another person; provided accomplish the deliveries specified North Capitol Street, N.E. Washington, that such issuance or assumption is for without detriment or disadvantage to D.C., 20426, in accordance with Rules some lawful object within the corporate WNG’s other customers. 211 or 214 of the Commission’s Rules of purposes of the applicant, and Any person or the Commission’s staff Practice and Procedure (18 CFR 385.211 compatible with the public interest, and may, within 45 days after issuance of or 385.214). All such motions to is reasonably necessary or appropriate the instant notice by the Commission, intervene or protest should be filed on for such purposes. file pursuant to Rule 214 of the or before February 14, 1995. Protests The Commission reserves the right to Commission’s Procedural Rules (18 CFR will be considered by the Commission require a further showing that neither 385.214) a motion to intervene or notice in determining the appropriate action to public nor private interests will be of intervention and pursuant to be taken but will not serve to make adversely affected by continued § 157.205 of the Regulations under the protestants parties to the proceeding. approval of Destec’s issuances of Natural Gas Act (18 CFR 157.205) a Any person wishing to become a party securities or assumptions of liability. protest to the request. If no protest is must file a motion to intervene. Copies Notice is hereby given that the filed within the time allowed therefor, of this filing are on file with the deadline for filing motions to intervene the proposed activity shall be deemed to Commission and are available for public or protests, as set forth above, is be authorized effective the day after the inspection. February 21, 1995. time allowed for filing a protest. If a protest is filed and not withdrawn Lois D. Cashell, Copies of the full text of the order are within 30 days after the time allowed Secretary. available from the Commission’s Public Reference Branch, Room 3308, 941 for filing a protest, the instant request [FR Doc. 95–2666 Filed 2–2–95; 8:45 am] shall be treated as an application for BILLING CODE 6717±01±M North Capitol Street, NE., Washington, DC 20426. authorization pursuant to Section 7 of the Natural Gas Act. Linwood A. Watson, Jr., Lois D. Cashell, [Docket No. ER94±1612±000] Acting Secretary. Secretary. [FR Doc. 95–2667 Filed 2–2–95; 8:45 am] Destec Power Services, Inc.; Issuance [FR Doc. 95–2668 Filed 2–2–95; 8:45 am] BILLING CODE 6717±01±M of Order BILLING CODE 6717±01±M January 27, 1995. On August 31, 1994, as amended [Docket No. CP95±169±000] Office of Arms Control and November 23, 1994, Destec Power Nonproliferation; Proposed Services, Inc. (Destec) submitted for Williams Natural Gas Co.; Request Subsequent Arrangements filing a rate schedule under which Under Blanket Authorization Pursuant to Section 131 of the Atomic Destec will engage in wholesale electric January 30, 1995. power and energy transactions as a Energy Act of 1954, as amended (42 Take notice that on January 20, 1995, marketer. Destec also requested waiver U.S.C. 2160), notice is hereby given of Williams Natural Gas Company (WNG), of various Commission regulations. In proposed ‘‘subsequent arrangements’’ P.O. Box 3288, Tulsa, Oklahoma 74101, particular, Destec requested that the under the Agreement for Cooperation filed in Docket No. CP95–169–000 a Commission grant blanket approval between the Government of the United request pursuant to Section 157.205 of under 18 CFR Part 34 of all future States of America and the Government the Commission’s Regulations under the issuances of securities and assumptions of Canada concerning Civil Uses of Natural Gas Act (18 CFR 157.205) for of liability by Destec. Atomic Energy, as amended, and the authorization to install bi-directional On January 20, 1995, by direction of Agreement for Cooperation between the measurement facilities for the receipt the Commission, the Secretary of the Government of the United States of and delivery of transportation gas to Commission issued an order granting America and the Government of the Manchester Pipeline Corporation requests for blanket approval under Part Republic of Korea concerning Civil Uses (Manchester), in Grant County, 34, subject to the following: of Atomic Energy, as amended. Oklahoma, under WNG’s blanket The subsequent arrangements to be certificate issued in Docket No. CP82- carried out under the above-mentioned rehearing, 59 FR 65707 (December 21, 1994); 69 FERC ¶ 61,334 (December 14, 1994); appeal 479–000 pursuant to Section 7 of the agreements involves approval of the docketed sub nom. Conoco, Inc. v. FERC, D.C. Cir. Natural Gas Act, all as more fully set following retransfers: RTD/KO(CA)–3, No. 94–1745 (December 13, 1994). forth in the request which is on file with for the transfer from Canada to the 6710 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Republic of Korea of 3,127.4 grams of Final EISs March 20, 1995, Contact: Jo Ellen uranium containing 617.7 grams of the Anderson (619) 532–3912. ERP No. F–USN–E11031–NC, Camp EIS No. 950032, Final EIS, IBR, UT, Narrows isotope uranium–235 (19.75 percent Lejeune Marine Corps Base, Disposal of enrichment) for use as fuel in the KMRR Multi-Purpose Water Development Project, Non-Hazardous Solid Waste Project, Construction and Operation, Funding, research reactor. RTD/KO(CA)–4, for the Implementation, COE Section 404 and Gooseberry Creek, Manti-La Sal National transfer from Canada to the Republic of NPDES Permits, Onslow County, NC. Forest, Sanpete County, UT, Due: March Korea of 51,955.2 grams of uranium Summary: EPA had no objections to 06, 1995, Contact: Ron Willhite (303) 236– containing 10,250.8 grams of the isotope the proposed action. 9336. uranium–235 (19.73 percent EIS No. 950033, Final EIS, FHW, MN, I–35 enrichment) for use as fuel in the KMRR Dated: January 30, 1995. W/Washington Avenue South in research reactor. William D. Dickerson, Minneapolis to I–35E in Burnsville In accordance with Section 131 of the Director, Federal Agency Liaison Division, Improvements, Construction and Atomic Energy Act of 1954, as amended, Office of Federal Activities. Reconstruction, Funding, COE Section 404 [FR Doc. 95–2685 Filed 2–2–95; 8:45 am] and 10 Permits, U.S. CGD Permit, Cities of it has been determined that these Minneapolis and Burnsville, Hennepin and subsequent arrangements will not be BILLING CODE 6560±50±U Dakota Counties, MN, Due: March 06, inimical to the common defense and 1995, Contact: Stephen Bahler (612) 290– security. 3259. These subsequent arrangements will [ER±FRL±4719±8] EIS No. 950034, Draft EIS, AFS, AZ, Carlotta take effect no sooner than fifteen days Open-Pit Copper Mine Project, after the date of publication of this Environmental Impact Statements; Construction and Operation, Plan of notice. Availability Operations and COE Section 404 Permit, Tonto National Forest, Gila and Pinal Issued in Washington, D.C. on January 27, Responsible: Office of Federal Counties, AZ, Due: March 27, 1995, 1995. Activities, General Information (202) Contact: Paul M. Stewart (602) 225–5200. Edward T. Fei, 260–5076 OR (202) 260–5075. Amended Notices Acting Director, International and Regional Weekly receipt of Environmental Security Division, Office of Arms Control and Impact Statements Filed January 23, EIS No. 940525, Draft EIS, DOD, HI, Kauai Nonproliferation. 1995 Through January 27, 1995 Acoustic Thermometry of Ocean Climate [FR Doc. 95–2716 Filed 2–2–95; 8:45 am] Pursuant to 40 CFR 1506.9. (ATOC) Project and Marine Mammal Research Program (MMRP), Funding, BILLING CODE 6450±01±M EIS No. 950025, Draft EIS, AFS, UT, Jacob/ Marine Manual Research Permit and COE Swale Vegetation Management Project, Section 10 Permit Issuance, Kauai, HI, Due: Implementation, Dixie National Forest, March 09, 1995, Contact: Marilyn Cox Escalante Ranger District, Garfield County, ENVIRONMENTAL PROTECTION (619) 534–3860. Published FR 16–95— UT, Due: March 20, 1995, Contact: Kevin Review period extended. AGENCY R. Schulkoski (801) 826–5400. EIS No. 950026, Draft EIS, AFS, MT, Wagner- Dated: January 31, 1995. [ER±FRL±4719±9] Atlanta Vegetation Treatment Project, William D. Dickerson, Implementation, Helena National Forest, Director, Federal Agency Liaison Division, Environmental Impact Statements and Townsend Ranger District, Meagher Office of Federal Activities. County, MT, Due: March 20, 1995, Contact: Regulations; Availability of EPA [FR Doc. 95–2686 Filed 2–2–95; 8:45 am] Comments George Weldon (406) 266–3425. EIS No. 950027, Final EIS, FHW, NC, US 421 BILLING CODE 6560±50±U Availability of EPA comments Highway Improvements, East of Secondary prepared January 2, 1995 through Road 2433 to West of I–77, Funding and January 6, 1995 pursuant to the Possible COE 404 Permit, Wilkes and [FRL±5150±S] Environmental Review Process (ERP), Yadkin Counties, NC, Due: March 06, 1995, Contact: Nicholas L. Graf (919) 856–4346. under Section 309 of the Clean Air Act Interagency Working Group on EIS No. 950028, Final EIS, FHW, OR, New Environmental Justice; Notification of and Section 102(2)(c) of the National Eugene Transfer Station, Site Selection and Environmental Policy Act as amended. Construction, Funding, McDonald Site or Availability of Federal Agency Requests for copies of EPA comments IHOP Site, Lane County, OR, Due: March Environmental Justice Strategies for can be directed to the Office of Federal 06, 1995, Contact: Terry L. Ebersole (206) Comment Activities at (202) 260–5076. 220–7954. An explanation of the ratings assigned EIS No. 950029, Draft SUPPLEMENT, AFS, Executive Order 12898, ‘‘Federal to draft environmental impact WA, East Curlew Creek Analysis Area, Actions to Address Environmental statements (EISs) was published in FR Harvesting Timber and Road Construction, Justice in Minority Populations and Updated Information, Portion of Profanity dated April 10, 1994 (59 FR 16807). Low-income Populations’’ (February 11, Roadless Area, Colville National Forest, 1994) requires Federal agencies to Draft EISs Republic Ranger District, Ferry County, develop Environmental Justice strategies WA, Due: March 20, 1995, Contact: Patricia ERP No. D–AFS–E65047–MS, Rating Egan (509) 775–3305. for carrying out the requirements of the EC1, G. F. Erambert and Black Creek EIS No. 950030, Draft EIS, AFS, OR, Sandy Executive Order. The Order also permits Seed Orchards Pest Management Plan, River Delta Plan, Implementation, Special public input ‘‘relating to the Implementation, Southern Region, Management Area (SMA), Columbia River incorporation of environmental justice National Forests in Mississippi, Forrest Gorge National Scenic Area (NSA), Several principles into Federal agency programs and Perry Counties, MS. Permits for Approval, US Coast Guard or policies.’’ Summary: EPA expressed Bridge Permit and COE Section 404 Permit, As part of its effort to seek public Multnomah County, OR, Due: March 20, environmental concerns regarding the 1995, Contact: Virginia Kelly (503) 386– input, the Interagency Working Group impact of pesticides and recommended 2333. will make available to the public, the that mitigation measures and pest EIS No. 950031, Draft EIS, USN, CA, Long drafts of the Federal agency strategies. damage thresholds be carefully Beach Naval Hospital Disposal and Reuse, The following draft strategies are followed. NPDES Permit, City Long Beach, CA, Due: available for distribution at this time: Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6711 Publication No. and Agency or Washington, DC 20240, (202) 208– Federal Communications Commission. Department 6970 William F. Caton, 200–D–95–900—Agriculture Justice—Cathy Sheafor, Director of Acting Secretary. 200–D–95–901—Defense Environmental Justice, DOJ, Office of [FR Doc. 95–2677 Filed 2–2–95; 8:45 am] the Associate Attorney General, Room 200–D–95–902—Energy BILLING CODE 6712±01±M 200–D–95–001—Environmental 5214, 10th and Constitution, NW., Protection Agency Washington, DC 20530, (202) 307– 200–D–95–903—Health, Human 3904 Public Information Collection Services Nuclear Regulatory Commission—Maria Requirement Submitted to Office of 200–D–95–904—Housing and Urban Lopez-Otin, NRC, Federal Liaison, Management and Budget for Review Development Office of State Programs, Washington, 200–D–95–905—Interior DC 20555, (301) 504–3502 January 26, 1995. 200–D–95–906—Justice Dated: January 31, 1995. The Federal Communications 200–D–95–907—Nuclear Regulatory Jonathan Z. Cannon, Commission has submitted the following information collection Commission Assistant Administrator for Administration These strategies may be obtained, free and Resources Management. requirement to OMB for review and clearance under the Paperwork of charge, by contacting: The National [FR Doc. 95–2845 Filed 2–2–95; 8:45 am] Reduction Act of 1980 (44 U.S.C. 3507). Center for Environmental Publications BILLING CODE 6560±50±M and Information, P.O. Box 42419, Copies of this submission may be Cincinnati, Ohio 45202; Phone: 513/ purchased from the Commission’s copy 489–8190; FAX: 513/489–8695 (Please contractor, International Transcription FEDERAL COMMUNICATIONS Service, Inc., 2100 M Street, NW, Suite include publication number). COMMISSION The following draft strategies should 140, Washington, DC 20037, (202) 857– be available shortly; for information Public Information Collection 3800. For further information on this about their availability please contact: Approved by Office of Management submission contact Judy Boley, Federal Department of Commerce—Paul Taggart and Budget Communications Commission, (202) (202) 482–4115; Department of Labor— 418–0214. Persons wishing to comment Stephen Mallinger (202) 219–7031; January 25, 1995. on this information collection should Department of Transportation—Antonio The Federal Communications (FCC) contact Timothy Fain, Office of Califa (202) 366–4640; and National has received Office of Management and Management and Budget, Room 10214 Aeronautics and Space Budget (OMB) approval for the NEOB, Washington, DC 20503, (202) Administration—Robert Hammond following public information collection 395–3561. (202) 358–0230. pursuant to the Paperwork Reduction OMB Number: 3060–0536. Comments—Send any comments on Act of 1980, Pub. L. 96–511. For further Title: Rules and Requirements for the strategies to the appropriate agency information contact Shoko B. Hair, Telecommunications Relay Services contact listed below by March 1, 1995. Federal Communications Commission, (TRS) Interstate Cost Recovery. (202) 418–1379. Form Number: FCC Form 431. Agency of Department, Contact, and Fax Action: Revision of a currently Agriculture—Velma Charles-Shannon, Federal Communications Commission approved collection. Office of Civil Rights Enforcement, 14 OMB Control No.: 3060–0620. Respondents: Businesses or other for- and Independence Ave., SW., Room Title: Universal Service Fund Data profit. 39A, Washington, DC 20250, (202) Request. Frequency of Response: Annually and 205–2891 Expiration Date: 10/31/95. on occasion reporting requirements Defense—Len Richeson, Environmental Estimated Annual Burden: 125,193 Estimated Annual Burden: 5,000 Security, 3000 Defense Pentagon, total annual hours; 87 hours per responses, 9.266 hours average burden Washington, DC 20301–3000, (703) response. per response, 46,330 hours total annual 604–5396 Description: The Federal burden. Energy—Georgia Johnson, Room 5B110, Communications Commission has Needs and Uses: The Americans with Dept. of Energy, Washington, DC issued a Notice of Inquiry to evaluate Disabilities Act of 1990 (ADA) was 20585, (202) 586–3075 various means of providing financial enacted with the purpose of providing Environmental Protection Agency— assistance to support telephone service a clear and comprehensive national Clarice Gaylord, Office of in areas with high costs of service. The mandate to end discrimination against Environmental Justice, 3103, 401 M Universal Service Fund Data Request individuals with disabilities and to St., SW., Washington, DC, 20460, will give the Commission, State bring persons with disabilities into the (202) 260–0852 regulatory agencies, local exchange economic and social mainstream of Health and Human Services—DHHS carriers (LECs), and interexchange American life; to provide enforceable Environmental Justice Strategic Plan, carriers, and other interested parties, the standards addressing discrimination c/o Office of Minority Health ability to compare the effects of various against individuals with disabilities, Resource Center, P.O. Box 37337, assistance mechanisms on the and to ensure that the Federal Washington, DC 20013–7337, (301) telecommunications industry as a government plays a central role in 589–0884 whole, as well as on an individual LECs. enforcing these standards on behalf of Housing and Urban Development— The importance of the Universal Service individuals with disabilities. On Richard Broun, Dept. of HUD, Room Fund goals and the substantial amount February 19, 1993, the Commission 7240, 451 7th St, SW., Washington, of money involved require thorough adopted an Order on Reconsideration, DC 20410, (202) 708–3363 analysis of those financial effects and Second Report and Order and Further Interior—Robert Faithful, Office of their implications, if any, for Notice of Proposed Rulemaking in this Environmental Policy and reasonably-priced local telephone proceeding (hereinafter referred to as Compliance, Dept. of Interior MS service. The respondents consist of TRS II). In TRS II, the Commission 2340, 1849 C Street, NW., approximately 1439 LECs. adopted a shared-funding mechanism to 6712 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices implement interstate TRS cost recovery Federal Communications Commission. Board of Governors of the Federal Reserve pursuant to Title IV of the ADA, and Rosalind K. Allen, System, January 30, 1995. sought further comments on its Acting Chief, Land Mobile and Microwave Jennifer J. Johnson, proposed rules and requirements Division. Deputy Secretary of the Board. outlining the specifics of the shared- [FR Doc.95–2678 Filed 2–2–95; 8:45 am] [FR Doc. 95–2675 Filed 2–2–95; 8:45 am] funding cost recovery plan. See 47 CFR BILLING CODE 6712±01±F BILLING CODE 6210±01±F 64.604(c)(4) (iii). Pursuant to Section 64.604(c)(4)(iii)(A), every carrier providing interstate telecommunications Regions Financial Corporation; services must contribute to the TRS FEDERAL RESERVE SYSTEM Acquisition of Company Engaged in Fund on the basis of its relative share of Permissible Nonbanking Activities gross interstate revenues. The types of ESB Bancorp, Inc., et al.; Formations interstate services for which of; Acquisitions by; and Mergers of The organization listed in this notice contributions must be made include, but Bank Holding Companies has applied under § 225.23(a)(2) or (f) are not limited to, cellular telephone of the Board’s Regulation Y (12 CFR and paging, mobile radio, operator The companies listed in this notice 225.23(a)(2) or (f)) for the Board’s services, personal communication have applied for the Board’s approval approval under section 4(c)(8) of the service (PCS), interstate access, under section 3 of the Bank Holding Bank Holding Company Act (12 U.S.C. alternative access and special access, Company Act (12 U.S.C. 1842) and § 1843(c)(8)) and § 225.21(a) of Regulation packet-switched, WATS, 800, 900, 225.14 of the Board’s Regulation Y (12 Y (12 CFR 225.21(a)) to acquire or message telephone service, interstate CFR 225.14) to become a bank holding control voting securities or assets of a private line, telex, telegraph, video, company or to acquire a bank or bank company engaged in a nonbanking satellite, international, interstate holding company. The factors that are activity that is listed in § 225.25 of intraLATA and resale services. The FCC considered in acting on the applications Regulation Y as closely related to Form 431 has been revised to include are set forth in section 3(c) of the Act banking and permissible for bank PCS and mobile services. Also, where (12 U.S.C. 1842(c)). holding companies. Unless otherwise noted, such activities will be conducted two carriers have merged during the Each application is available for throughout the United States. year, the successor company should immediate inspection at the Federal report total revenues for the year for The application is available for Reserve Bank indicated. Once the immediate inspection at the Federal both the predecessor and successor application has been accepted for operations. However, the two carriers Reserve Bank indicated. Once the processing, it will also be available for application has been accepted for would continue to report separately if inspection at the offices of the Board of each maintained separate corporate processing, it will also be available for Governors. Interested persons may inspection at the offices of the Board of identities and continued to operate. express their views in writing to the Additionally, the calculation of Governors. Interested persons may Reserve Bank or to the offices of the express their views in writing on the contribution rate changed for the 1995 Board of Governors. Any comment on filing year. question whether consummation of the an application that requests a hearing proposal can ‘‘reasonably be expected to Federal Communications Commission. must include a statement of why a produce benefits to the public, such as William F. Caton, written presentation would not suffice greater convenience, increased Acting Secretary. in lieu of a hearing, identifying competition, or gains in efficiency, that [FR Doc. 95–2679 Filed 2–2–95; 8:45 am] specifically any questions of fact that outweigh possible adverse effects, such are in dispute and summarizing the BILLING CODE 6712±01±F as undue concentration of resources, evidence that would be presented at a decreased or unfair competition, hearing. conflicts of interests, or unsound [Gen Docket No. 88±476; DA 94±1329] Unless otherwise noted, comments banking practices.’’ Any request for a Private Land Mobile Radio Services; regarding each of these applications hearing on this question must be New York Metropolitan Area Public must be received not later than February accompanied by a statement of the Safety Plan Amendment 28, 1995. reasons a written presentation would A. Federal Reserve Bank of not suffice in lieu of a hearing, AGENCY: Federal Communications Richmond (Lloyd W. Bostian, Jr., Senior identifying specifically any questions of Commission. Vice President) 701 East Byrd Street, fact that are in dispute, summarizing the ACTION: Notice. Richmond, Virginia 23261: evidence that would be presented at a hearing, and indicating how the party SUMMARY: The Acting Chief, Land 1. ESB Bancorp, Inc., Enfield, North commenting would be aggrieved by Mobile and Microwave Division and the Carolina; to become a bank holding company by acquiring 100 percent of approval of the proposal. Acting Chief, Spectrum Engineering Comments regarding the application Division released an Order amending the voting shares of Enfield Savings Bank, Inc., SSB, Enfield, North Carolina. must be received at the Reserve Bank the Public Safety Radio Plan for the indicated or the offices of the Board of New York Metropolitan Area (Region 8). B. Federal Reserve Bank of Atlanta Governors not later than February 21, As a result of accepting the amendment (Zane R. Kelley, Vice President) 104 1995. for the Plan for Region 8, the interests Marietta Street, N.W., Atlanta, Georgia A. Federal Reserve Bank of Atlanta of the eligible entities within the region 30303: (Zane R. Kelley, Vice President) 104 will be furthered. 1. Hibernia Corporation, New Marietta Street, N.W., Atlanta, Georgia EFFECTIVE DATE: December 9, 1994. Orleans, Louisiana; to merge with 30303: FOR FURTHER INFORMATION CONTACT: Progressive Bancorporation, Inc., 1. Regions Financial Corporation, Betty Woolford, Private Radio Bureau, Houma, Louisiana, and thereby Birmingham, Alabama; to acquire Policy and Planning Branch, (202) 418- indirectly acquire Progressive Bank & Fidelity Federal Savings Bank, Dalton, 0620. Trust Company, Houma, Louisiana. Georgia, and thereby engage in the Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6713 operation of a federal savings bank, The petition has been placed on availability of a guidance document for pursuant to § 225.25(b)(9) of the Board’s display at the Dockets Management manufacturers of vaginal contraceptive Regulation Y. The proposed activity will Branch (address above). drug products entitled, ‘‘Guidance for be conducted throughout the State of Any petition that meets the Development of Vaginal Contraceptive Georgia. requirements outlined in §§ 170.30 (21 Drugs.’’ This guidance document is Board of Governors of the Federal Reserve CFR 170.30) and 170.35 is filed by the intended to facilitate the development System, January 30, 1995. agency. There is no prefiling review of of data in support of new drug Jennifer J. Johnson, the adequacy of data to support a GRAS applications (NDA’s), which FDA has proposed to require for all over-the- Deputy Secretary of the Board. conclusion. Thus, the filing of a petition for GRAS affirmation should not be counter (OTC) vaginal contraceptives. [FR Doc. 95–2676 Filed 2–2–95; 8:45 am] interpreted as a preliminary indication ADDRESSES: Submit written requests for BILLING CODE 6210±01±F of suitability for GRAS affirmation. single copies of the guidance document The potential environmental impact entitled ‘‘Guidance for Development of of this action is being reviewed. If the Vaginal Contraceptive Drugs’’ to the DEPARTMENT OF HEALTH AND agency finds that an environmental Division of Metabolism and Endocrine HUMAN SERVICES impact statement is not required and Drug Products (HFD–510), Center for this petition results in a regulation, the Food and Drug Administration Drug Evaluation and Research, Food notice of availability of the agency’s and Drug Administration, 5600 Fishers [Docket No. 95G±0009] finding of no significant impact and the Lane, Rockville, MD 20857. Requests evidence supporting that finding will be should be identified with the docket American Dairy Products Institute; published with the regulation in the number found in brackets in the Filing of Petition for Affirmation of Federal Register in accordance with 21 heading of this document. Send two GRAS Status CFR 25.40(c). self-addressed adhesive labels to assist AGENCY: Food and Drug Administration, Interested persons may, on or before that office in processing your requests. HHS. April 4, 1995, review the petition and The guidance document is available for file comments with the Dockets public examination in the Dockets ACTION: Notice. Management Branch (address above). Management Branch (HFA–305), Food Two copies of any comments should be SUMMARY: The Food and Drug and Drug Administration, Rm. 1–23, filed and should be identified with the Administration (FDA) is announcing 12420 Parklawn Dr., Rockville, MD docket number found in brackets in the that the American Dairy Products 20857, between 9 a.m. and 4 p.m., heading of this document. Comments Institute has filed a petition (GRASP Monday through Friday. should include any available 1G0371), proposing to affirm that whey FOR FURTHER INFORMATION CONTACT: Lisa information that would be helpful in protein isolate and dairy product solids Stockbridge, Center for Drug Evaluation determining whether the substance is, are generally recognized as safe (GRAS) and Research (HFD–510), Food and or is not, GRAS for the proposed use. In as direct human food ingredients and to Drug Administration, 5600 Fishers addition, consistent with the regulations broaden the specifications for reduced Lane, Rockville, MD 20857, 301–443– promulgated under the National lactose whey, reduced minerals whey, 3520. Environmental Policy Act (40 CFR and whey protein concentrate. SUPPLEMENTARY INFORMATION: FDA is 1501.4(b)), the agency encourages public announcing the availability of a DATES: Written comments by April 4, participation by review of and comment 1995. guidance document entitled ‘‘Guidance on the environmental assessment for Development of Vaginal ADDRESSES: Submit written comments submitted with the petition that is the Contraceptive Drugs’’ on content of to the Dockets Management Branch subject of this notice. A copy of the NDA’s for manufacturers of vaginal (HFA–305), Food and Drug petition (including the environmental contraceptive drug products. As part of Administration, rm. 1–23, 12420 assessment) and received comments FDA’s ongoing review of OTC drug Parklawn Dr., Rockville, MD 20857. may be seen in the Dockets Management products, the agency is publishing FOR FURTHER INFORMATION CONTACT: Branch between 9 a.m. and 4 p.m., elsewhere in this issue of the Federal Rudolph Harris, Center for Food Safety Monday through Friday. Register a proposed rule that addresses and Applied Nutrition (HFS–207), Food Dated: January 26, 1995. OTC vaginal contraceptive drug and Drug Administration, 200 C St. SW., Alan M. Rulis, products. The preamble to that Washington, DC 20204, 202–418–3090. Acting Director, Office of Premarket proposed rule sets forth FDA’s SUPPLEMENTARY INFORMATION: Under the Approval, Center for Food Safety and Applied determination that the effectiveness of Federal Food, Drug, and Cosmetic Act Nutrition. OTC vaginal contraceptives is highly (secs. 201(s) and 409(b)(5) (21 U.S.C. [FR Doc. 95–2629 Filed 2–2–95; 8:45 am] variable and is dependent on final 321(s) and 348(b)(5)) and the regulations BILLING CODE 4160±01±F formulation. Because in vitro testing for affirmation of GRAS status in does not adequately predict the § 170.35 (21 CFR 170.35), notice is given effectiveness of these products, FDA is that the American Dairy Products [Docket No. 95D±0004] proposing to call for the submission of Institute, 130 North Franklin St., Vaginal Contraceptive Drug Products; product-specific marketing applications Chicago, IL., (c/o Keller and Heckman, Guidance on Content of New Drug for vaginal contraceptives, including Washington, DC) has filed a petition Applications; Availability effectiveness data obtained from clinical (GRASP 1G0371), proposing that whey studies of the products in their final protein isolate and dairy product solids AGENCY: Food and Drug Administration, formulations. be affirmed as GRAS for use as direct HHS. The guidance document is intended human food ingredients, and to broaden ACTION: Notice. to assist manufacturers in the the specifications for reduced lactose preparation of NDA’s for vaginal whey, reduced minerals whey, and SUMMARY: The Food and Drug contraceptive drug products. It whey protein concentrate. Administration (FDA) is announcing the describes the chemistry, pharmacology, 6714 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices biopharmaceutic, and clinical Annual Responses: 108; Total Annual Number of Respondents: 15; Total information required in support of these Hours Requested: 175.5. Annual Hours Requested: 1,800. 2. Type of Information Collection: applications for vaginal contraceptive 2. Type of Information Collection: Reinstatement, without change, of a drug products. New; Type of Review Requested: Like other guidance issued by FDA, previously approved collection; Type of this document states practices or Review Requested: Regular submission; Regular Submission; Title of procedures that may be useful, but are Title of Information Collection: Information Collection: Evaluation of not legal requirements. Such guidance Transmittal and Notice of Approval of the Drug Use Review Demonstrations represents the agency’s position at the State Plan Material; Form No.: HCFA– Projects; Form No.: HCFA–R–171; Use: time of issuance. A person may follow 179; Use: The HCFA–179 is used by The Omnibus Budget Reconciliation Act the guidance or may choose to follow State agencies to transmit State plan of 1990 mandated drug utilization alternate practices or procedures. If a material to HCFA for approval prior to review demonstration projects to test person chooses to use alternate practices amending their State plans; the cost-effectiveness of both on-line or procedures, that person may wish to Respondents: State or local prospective drug utilization review and discuss the matter further with the governments; Obligation to Respond: payment to pharmacists for cognitive agency to prevent an expenditure of Required to obtain or retain benefit; services. The survey will determine the money and effort on activities that may Number of Respondents: 57; Total attitudes, perceptions, and behavior of later be determined to be unacceptable Annual Responses: 22; Total Annual pharmacists relative to the two services to FDA. Hours Requested: 1254. mentioned. The survey is necessary to A guidance such as this does not bind Additional Information or Comments: evaluate complex behavorial FDA, and it does not create or confer Call the Reports Clearance Office on interactions; Respondents: Business or any rights, privileges, or benefits for or (410) 966–5536 for copies of the other for profit; Total Annual on any person. When a guidance states clearance request packages. Written Responses: 670 (owner/manager) and a requirement imposed by statute or comments and recommendations for the 1,710 (pharmacist); Number of regulation, however, the requirement is proposed information collections Respondents: 670 (owner/manager) and law, and its force and effect are not should be sent within 30 days of this 1,710 (pharmacist); Total Annual Hours changed in any way by virtue of notice directly to the OMB Desk Officer inclusion in the guideline. designated at the following address: Requested: 55.61 (owner/manager) and 342.0 (pharmacist). Dated: January 13, 1995. OMB Human Resources and Housing William K. Hubbard, Branch, Attention: Allison Eydt, New 3. Type of Information Collection: Interim Deputy Commissioner for Policy. Executive Office Building, Room 10235, New; Type of Review Requested: Washington, D.C. 20503. Regular Submission; Title of [FR Doc. 95–2630 Filed 2–2–95; 8:45 am] Information Collection: Evaluation of BILLING CODE 4160±01±F Dated: January 26, 1995. Kathleen B. Larson, the Community Supported Living Director, Management Planning and Analysis Arrangements Program (CSLA); Form Health Care Financing Administration Staff, Office of Financial and Human No.: HCFA–R–172; Use: This survey Resources, Health Care Financing will collect data on a sample of 240 Public Information Collection Administration. persons receiving Medicaid CSLA Requirements Submitted to the Office [FR Doc. 95–2636 Filed 2–2–95; 8:45 am] services and about the agencies and of Management and Budget (OMB) for BILLING CODE 4120±03±P individuals providing those services to Clearance them, in order to describe the nature, AGENCY: Health Care Financing adequacy, cost, and quality of CSLA Public Information Collection services, and the extent to which these Administration, HHS. Requirements Submitted to the Office The Health Care Financing contribute to community inclusion, of Management and Budget (OMB) for Administration (HCFA), Department of desired lifestyles, health and safety, self- Clearance Health and Human Services, has determination, and choice; submitted to OMB the following AGENCY: Health Care Financing Respondents: Business or other for proposals for the collection of Administration, HHS. profit; Total Annual Responses: 720; information in compliance with the The Health Care Financing Number of Respondents: 240; Total Paperwork Reduction Act (Public Law Administration (HCFA), Department of Annual Hours Requested: 560. 96–511). Health and Human Services (HHS), has Additional Information or Comments: 1. Type of Information Collection: submitted to OMB the following Call the Reports Clearance Office on Reinstatement, without change, of a proposals for the collection of previously approved collection; Type of information in compliance with the (410) 966–5536 for copies of the Review Requested: Regular submission; Paperwork Reduction Act (Public Law clearance request packages. Written Title of Information Collection: 96–511). comments and recommendations for the Medicaid Eligibility Quality Control 1. Type of Information Collection: proposed information collections (MEQC) Statistical Tables; Form No.: New; Type of Review Requested: should be sent within 30 days of this HCFA–302–309; Use: The MEQC Regular Submission; Title of notice directly to the OMB Desk Officer statistical tables yield information Information Collection: Criteria for designated at the following address: concerning Medicaid eligibility Medicare Coverage of Lung Transplants; OMB Human Resources and Housing payment error rates, which enable the Form No.: HCFA–R–170; Use: Medicare Branch, Attention: Allison Eydt, New HCFA to identify patterns that can lead participating hospitals must file an Executive Office Building, Room 10235, to the misspending of Medicaid dollars; application to be approved for coverage Washington, D.C. 20503 Respondents: State or local and payment of lung transplants governments; Obligation to Respond: performed on Medicare beneficiaries; Required to obtain or retain benefit; Respondents: Business or other for Number of Respondents: 54; Total profit; Total Annual Responses: 15; Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6715 Dated: January 26, 1995. Maternal and Child Health Services; published in the July 19, 1994, issue of Kathleen B. Larson, Federal Set-Aside Program; Research the Federal Register at 59 FR 36703. Director, Management Planning and Analysis and Training Grants The Public Health Service (PHS) is Staff, Office of Financial and Human committed to achieving the health Resources, Health Care Financing AGENCY: Health Resources and Services Administration. Administration (HRSA), PHS. promotion and disease prevention objectives of Healthy People 2000, a [FR Doc. 95–2724 Filed 2–2–95; 8:45 am] ACTION: Notice of availability of funds. PHS-led national activity for setting BILLING CODE 4120±03±P SUMMARY: The Maternal and Child priority areas. The MCH Block Grant Health Bureau (MCHB), HRSA, Federal Set-Aside Program addresses Health Resources and Services announces that fiscal year (FY) 1995 issues related to the Healthy People Administration funds are available for Maternal and 2000 objectives of improving maternal, Child Health (MCH) Special Projects of infant, child and adolescent health and Correction for Program Announcement Regional and National Significance developing service systems for children and Proposed Review Criteria for (SPRANS) research and training grants. with special health care needs. Potential Grants for Geriatric Education Centers Awards will be made under the program applicants may obtain a copy of Healthy for Fiscal Year 1995 authority of section 502(a) of the Social People 2000 (Full Report: Stock No. Security Act, the MCH Federal Set- 017–001–00474–0) or Healthy People The Health Resources and Services Aside Program. MCH research and 2000 (Summary Report: Stock No. 017– Administration (HRSA) announced, in training grants improve the health status 001–00473–1) through the the Federal Register on January 9, 1995 of mothers and children through: Superintendent of Documents, at 60 FR 2396, that applications are development and dissemination of new Government Printing Office being accepted for fiscal year (FY) 1995 knowledge; demonstration of new or Grants for Geriatric Education Centers Washington, DC 20402–9325 improved ways of delivering care or (telephone: 202 783–3238). funded under the authority of section otherwise enhancing Title V program 777(a) of the Public Health Service Act, capacity to provide or assure provision The PHS strongly encourages all grant as amended by the Health Professions of appropriate services; and preparation recipients to provide a smoke-free Education Extension Amendments of of personnel in MCH-relevant workplace and promote the non-use of 1992, Pub. L. 102–408. This specialties. Grants for SPRANS genetic all tobacco products. This is consistent announcement also proposed two services and special MCH improvement with the PHS mission to protect and additional review criteria. Following is projects (MCHIP), which contribute to advance the physical and mental health information regarding where to send the health of mothers, children, and of the American people. public comments on the review criteria. children with special health care needs ADDRESS: Grant applications for MCH This information was inadvertently (CSHCN), are being announced in a omitted from the original notice. research and training grants must be separate notice. No new SPRANS obtained from and submitted to: Chief, Interested persons are invited to hemophilia program grants will be comment on the proposed review Grants Management Branch, Office of funded in FY 1995. Program Support, Maternal and Child criteria. The comment period is 30 days. Of the approximately $7.3 million All comments received on or before Health Bureau, Health Resources and available for SPRANS research and Services Administration, Room 18–12, March 6, 1995 will be considered before $35.6 million for training in FY 1995, the final review criteria are established. Parklawn Building, 5600 Fishers Lane, about $1.0 million will be available to Rockville, Maryland 20857, (301) 443– Written comments should be addressed support approximately 8 new and to: Neil Sampson, Director, Division of 1440. Applicants for research projects competing continuation MCH research will use Form PHS 398, approved by the Associated, Dental, and Public Health projects and about $19.5 million will be Office of Management and Budget Professions, Bureau of Health available for 47 new and competing (OMB) under control number 0925– Professions, Health Resources and training projects. About $6.5 million 0001. Applicants for training projects Services Administration, Parklawn will be used to support continuation of Building, Room 8–101, 5600 Fishers will use Form PHS 6025–1, approved by existing MCH research and $16.3 Lane, Rockville, Maryland 20857 OMB under control number 0915–0060. million will support continuation of All comments received will be Requests should specify the category or existing training. The actual amounts available for public inspection and categories of activities for which an available for awards and their allocation copying at the Division of Associated, application is requested so that the may vary depending on unanticipated Dental, and Public Health Professions, appropriate forms, information and program requirements and the volume Bureau of Health Professions, at the materials may be provided. above address, weekdays (Federal and quality of applications. Awards are holidays excepted) between the hours of made for grant periods which generally DATES: Potential applicants are invited 8:30 a.m. and 5:00 p.m. run from 1 up to 5 years in duration. to request application packages for the Funds for research and training grants particular program category in which Dated: January 27, 1995. under the MCH Federal Set-Aside they are interested, and to submit their Ciro V. Sumaya, Program are appropriated by Public Law applications for funding consideration. Administrator. 103–333. A revised regulation Deadlines for receipt of applications [FR Doc. 95–2626 Filed 2–2–95; 8:45 am] implementing the Federal Set-Aside differ for the several categories of grants. BILLING CODE 4160±15±P Program (42 CFR part 51a) was These deadlines are as follows: 6716 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices MCH FEDERAL SET-ASIDE COMPETITIVE RESEARCH AND TRAINING GRANTS ANTICIPATED DEADLINE, AWARD, FUNDING, AND PROJECT PERIOD INFORMATION, BY CATEGORY; FY 1995 Estimated Category Application deadline number of Estimated amounts Project period awards available Grants in the following areas: 1. Research ...... Cycle 1: 3/1/95* ...... up to 8 ..... $1.0 million ...... up to 5 years. Cycle 2: 8/1/95* ...... 2. Long Term Training: 2.1. Pediatric Pulmonary Centers ...... 4/3/95 ...... up to 9 ..... $1.5 million ...... up to 5 years. 2.2. Neuro developmental Disabilities ...... 4/3/95 ...... up to 30 ... $18 million ...... up to 5 years. 3. Continuing Education ...... 7/3/95 ...... up to 8 ..... $400,000 ...... 1±3 years. * Approximately one-half of the available funds are allocated to each cycle. Applications approved but not funded in one cycle are automati- cally carried forward to the next. Applications will be considered to 3.2. Funding of Approved Applications separately from other SPRANS grants have met the deadline if they are either: 4. Special Projects of Regional and National this year in order to reduce confusion to (1) received on or before the deadline Significance potential applicants from date, or (2) postmarked on or before the 4.1. Research Grants announcement of grants in very large 4.2. Long Term Training Grants deadline date and received in time for 4.2.1. Pediatric Pulmonary Centers numbers of SPRANS categories and orderly processing. Applicants should 4.2.2. MCH Interdisciplinary Leadership subcategories. The research and training request a legibly dated receipt from a Education/Training in grants covered in this notice are commercial carrier or the U.S. Postal Neurodevelopmental and Related intended to improve the health status of Service, or obtain a legibly dated U.S. Disabilities mothers and children. Postal Service postmark. Private 4.3. Continuing Education Research programs focus on the metered postmarks will not be accepted 5. Eligible Applicants development of new knowledge for 6. Public Health System Reporting as proof of timely mailing. Late application in health care promotion applications or those sent to an address Requirements 7. Executive Order 12372 and prevention efforts directed at other than specified in the ADDRESS pregnant women, women of section will be returned to the 1. Program Background and Objectives childbearing age, infants, children, applicant. Under Section 502 of the Social adolescents, and children with special FOR FURTHER INFORMATION CONTACT: Security Act, as amended by the health care needs and their families. Requests for technical or programmatic Omnibus Budget Reconciliation Act Findings are expected to have potential information should be directed to the (OBRA) of 1989, 12.75 percent of for application in health care delivery contact persons identified below for amounts appropriated for the MCH programs for mothers and children. each category covered by this notice. Block Grant in excess of $600 million Training programs focus on Requests for information concerning are set aside by the Secretary of Health development of professionals for business management issues should be and Human Services (HHS) for special leadership roles, in combination with directed to: Dorothy M. Kelley, Acting Community Integrated Service Systems advanced professional preparation. Grants Management Officer (GMO), projects under Section 501(a)(3) of the Training is intended to accomplish the Maternal and Child Health Bureau, at Act. Of the remainder of the total dual objectives of developing high the address specified in the ADDRESS appropriation, 15 percent of the funds levels of clinical competence and section. are to be retained by the Secretary to developing leadership attributes which SUPPLEMENTARY INFORMATION: To support (through grants, contracts, or extend beyond clinical acumen and facilitate the use of this announcement, otherwise) special projects of regional skills. To achieve the latter objective, information in this section has been and national significance, research, and emphasis is placed on those curriculum organized, as outlined in the Table of training with respect to maternal and and practicum areas which relate to: Contents below, into a discussion of: child health and children with special populations as well as individuals; Program Background, Special Concerns, health care needs (including early systems of care as well as specific Overall Review Criteria, SPRANS intervention training and services services; community-based services as Program, and Eligible Applicants. In development); for genetic disease well as institution-based; program addition, for each research and training testing, counseling, and information administration in addition to clinical funding category or subcategory, development and dissemination expertise; public policy in addition to information is presented under the programs; for grants (including funding practice policy; and research in addition following headings: for comprehensive hemophilia to putting new knowledge into practice. • Application Deadline diagnostic treatment centers) relating to In addition, leadership training • Purpose hemophilia without regard to age; and emphasizes cultural and linguistic • Priorities • for the screening of newborns for sickle competence in serving the end user; Special Eligibility Considerations cell anemia, and other genetic disorders trainees, however, are not end users. • Grants/Amounts • Contact and follow-up services. The MCH With an understanding of and SPRANS set-aside was established in appreciation for these broader issues Table of Contents 1981. Support for projects covered by and aspects of health care, professionals 1. Program Background and Objectives this announcement will come from the are more adequately prepared to deliver 2. Special Concerns SPRANS set-aside. Availability of FY care and to provide leadership in 3. Project Review and Funding 1995 funds for MCH research and advancing the field to better serve 3.1. Criteria for Review training grants is being announced mothers and children. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6717 ‘‘Continuing Education’’ (CE) is any 3.1 Criteria for Review identified in this notice. In addition, short-term, non-degree program offered The criteria which follow are used, as special consideration in assigning scores by an institution of higher learning. pertinent, to review and evaluate may be given by reviewers to individual Continuing Education focuses on applications for awards under all applications that address areas increasing leadership skills of MCH SPRANS grants and cooperative identified in this notice as special health professionals; facilitating timely agreement project categories announced concerns. transfer and application of new in this notice. Further guidance in this 4. Special Projects of Regional and information, research findings, and regard is supplied in application National Significance technology related to MCH; and guidance materials, which may specify Three categories of SPRANS grants updating and improving the knowledge variations in these criteria. and skills of health and related are discussed below: Research, Long —The quality of the project plan or professionals in programs serving Term Training, and Continuing methodology. mothers and children, including Education: —The need for the research or training. children with special health care needs —The extent to which the project will 4.1. Research Grants (CSHCN). As a result of the CE, contribute to the advancement of • professionals are more adequately Application Deadlines: March 1 and maternal and child health and/or prepared to deliver comprehensive August 1, 1995. improvement of the health of children • services and to provide leadership in Purpose: To encourage research in with special health care needs; maternal and child health which has the advancing the field to better serve —The extent to which the project is mothers and children. potential for ready transfer of findings to responsive to policy concerns health care delivery programs. Research 2. Special Concerns applicable to MCH grants and to grants may be made only to public or program objectives, requirements, nonprofit institutions of higher learning In its administration of the MCH priorities and/or review criteria for and public or nonprofit private agencies Services Block Grant, the MCHB places specific project categories, as and organizations engaged in research special emphasis on improving service published in program announcements or in maternal and child health or delivery to women and children from or guidance materials. programs for CSHCN. racial and ethnic minority populations —The extent to which the estimated Special consideration will be given to who have had limited access to cost to the Government of the project projects which address the factors and accessible care. This means that is reasonable, considering the processes that lead to disparities in SPRANS projects are expected to serve anticipated results. health status and use of services among and appropriately involve in project —The extent to which the project minority and other disadvantaged activities individuals from the personnel are well qualified by groups as well as health promoting populations to be served, unless there training and/or experience for their behaviors, quality outcome measures, are compelling programmatic or other roles in the project and the applicant and systems integration/reform. justifications for not doing so. The organization has adequate facilities • Grants/Amounts: Approximately MCHB’s intent is to ensure that project and personnel. $1.0 million will be available to support interventions are responsive to the —The extent to which, insofar as up to 8 new or competing renewal cultural and linguistic needs of special practicable, the proposed activities, if research projects at an average of populations, that services are accessible well executed, are capable of attaining $125,000 per award for one year. Project to consumers, and that the broadest project objectives. periods are generally 3 years but may be possible representation of culturally —The strength of the project’s—plans up to 5 years. distinct and historically for evaluation. • Contact: For programmatic or underrepresented groups is supported —The extent to which the project will technical information, contact Gontran through programs and projects be integrated with the administration Lamberty, Dr.P.H., telephone: 301 443– sponsored by the MCHB. of the MCH Block Grant, State 2190. 3. Project Review and Funding primary care plans, public health, and prevention programs, and other 4.2. Long Term Training Grants Within the limit of funds determined related programs in the respective • Application Deadline: April 3, by the Secretary to be available for the State(s). 1995. activities described in this —The extent to which the application is • Purpose: Awards to institutions of announcement, the Secretary will responsive to the special concerns higher learning to support and review applications for funds under the and program priorities specified in strengthen MCH programs through long specific project categories in section 4 this notice. term training of health professionals at below as competing applications and the graduate and postgraduate levels, may award Federal funding for projects 3.2 Funding of Approved Applications with a special focus on family-centered, which will, in her judgment, best Final funding decisions for SPRANS community-based care. The programs promote the purpose of title V of the research and training grants are the are designed to develop leadership Social Security Act, with special responsibility of the Director, MCHB. In personnel to provide for comprehensive emphasis on improving service delivery considering scores for the ranking of health, including health promotion and to women and children from culturally approved applications for funding, disease prevention, and related services distinct populations; best address preferences may be exercised for groups to mothers and children; and to address achievement of Healthy Children 2000 of applications; for example, new special issues, such as HIV; injury; objectives related to maternal, infant, projects may be funded ahead of minority health concerns; and substance child and adolescent health and service competing continuations, or vice versa. abuse. Training is provided to a wide systems for children at risk of chronic Within any category of approved range of health professionals who serve and disabling conditions; and otherwise projects, the score of an individual mothers and children. best promote improvements in maternal project may be favorably adjusted if the Contact: For programmatic and and child health. project addresses specific priorities technical information, contact Elizabeth 6718 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Brannon, M.S., R.D., telephone: 301 which has defined working described above are not being proposed 443–2190. relationships/agreements with academic for public comment this year. In July The following subcategories have (i.e., degree granting) schools or 1993, following publication of the been identified for competition in FY departments providing graduate training Department’s Notice of Proposed 1995 under the MCH long term training in all requisite core disciplines Rulemaking to revise the MCH special program: identified in the program elements and project grant regulations at 42 CFR 51a, 4.2.1. Pediatric Pulmonary Centers requirements for this category. Such the public was invited for a 60-day agreements may be either with period to submit comments regarding all • Application Deadline: April 3, components of the applicant institution aspects of the SPRANS application and 1995. or with one or more other institutions of review process. Public comments • Purpose: To support the higher learning through formal regarding SPRANS priorities received development, enhancement, or affiliation agreements. Although during the comment period were improvement of community-based care multiple institutions and programs may, considered in developing this for children with chronic respiratory and are encouraged to participate, the announcement. In responding to those diseases and their families in a wide application must be submitted by the comments, the Department noted the geographic area by providing university at which the major medical practical limits on Secretarial discretion interdisciplinary training of a range of and other health profession schools/ in establishing SPRANS categories and professional personnel and by working departments are located. All training priorities owing to the extensive with State and local health agencies and components must have their primary prescription in both the statute and providers—public, private, or voluntary. locus in, or proximal to, the applicant annual Congressional directives. The centers are expected to be models institution. Comments on this SPRANS notice of excellence in training, service and • Grants/Amounts: Approximately which members of the public wish to research related to chronic respiratory $18 million will be available to support make are welcome at any time and may diseases in infants and children. up to 30 new or competing renewal be submitted to: Director, Maternal and • Special Qualifications: Applicant projects in this subcategory. Grant Child Health Bureau, at the address qualifications include meeting the award amounts will vary depending listed in the ADDRESS section. special requirements for Training upon budget requirements. Project Suggestions will be considered when Programs in Pediatric Pulmonology of periods are up to 5 years. priorities are developed for the next the Accreditation Council for Graduate • Contact: For programmatic and solicitation. Medical Education (ACGME) Residency technical information, contact Elizabeth Review Committee. Brannon, M.S., R.D., telephone 301 443– 5. Eligible Applicants • Grants/Amounts: About $1.5 2190. million will be available to support up In general, MCH training grants may to 6 new or competing renewal projects 4.3. Continuing Education be made only to public or nonprofit private institutions of higher learning. in this subcategory. Grant awards • Application Deadline: July 3, 1995. Research grants may be made only to average $250,000 for one year. Project • Purpose: To support and strengthen public or nonprofit private institutions periods are up to five years. MCH programs and improve MCH of higher learning and public or • Contact: For programmatic and systems of care through short term, non- nonprofit private agencies and technical information, contact Elizabeth degree related training of health organizations engaged in research in Brannon, M.S., R.D., telephone 301 443– professionals and others providing maternal and child health or programs 2190. health and related services for mothers for CSHCN. As noted above, applicants and children; workshops; seminars; 4.2.2. MCH Interdisciplinary Leadership for certain grant categories or institutes; and other related activities Education/Training in subcategories are expected to have intended to develop or improve Neurodevelopmental and Related additional qualifications. Disabilities standards, practices, curriculum or delivery of health care for the MCH 6. Public Health System Reporting • Application Deadline: April 3, population. Continuing Education Requirements 1995. grants may be made only to public or • This program is subject to the Public Purpose: To support and strengthen nonprofit private institutions of higher Health System Reporting Requirements MCH programs through long term learning. training of a wide range of health • Priorities: Priority for funding in (approved under OMB No. 0937–0195). professionals at the graduate and post- this category will be given to continuing Under these requirements, the graduate levels, with a special focus on education projects in the following community-based nongovernmental family-centered, community-based care. areas: applicant must prepare and submit a Public Health System Impact Statement The programs are designed to develop —Emergency Medical Services for (PHSIS). The PHSIS is intended to leadership personnel to provide for Children. comprehensive health, including health —Violence Prevention in Schools. provide information to State and local promotion and disease prevention, and —Core Public Health. health officials to keep them apprised of related services to children (infants • Grants/Amounts: Approximately proposed health services grant through adolescents) with, or at risk for, $400,000 will be available to support up applications submitted by community- neurodevelopmental delays, to 8 new or competing renewal based nongovernmental organizations developmental disabilities, mental continuing education training projects. within their jurisdictions. retardation, or multiple systems Project periods range from 1 to 3 years. Community-based nongovernmental disabilities, through interdisciplinary • Contact: For programmatic or applicants are required to submit the clinical training, and through provision technical information, contact following information to the head of the of continuing education, technical Stephanie Bryn, M.P.H., telephone: 301 appropriate State and local health assistance and consultation. 443–2190. agencies in the area(s) to be impacted no • Special Qualifications: Universities The categories, priorities, special later than the Federal application with an accredited medical school considerations and preferences receipt due date: Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6719 (a) A copy of the face page of the 5. To facilitate faculty and student Final Funding Preference application (SF 424). research on health issues particularly A funding preference for this program (b) A summary of the project (PHSIS), affecting minority groups. was proposed in the Federal Register on not to exceed one page, which provides: Applicants must address the five November 1, 1994, at 59 FR 54617. One (1) A description of the population to legislative purposes. In addition, grants comment was received during the be served. for eligible HBCUs as described in comment period. The respondent section 799(l)(A) and which have (2) A summary of the services to be recommended that preference be given received a contract under section 788B provided. to previously funded COE programs of the Act (Advanced Financial Distress (3) A description of the coordination which have completed only one grant Assistance) for FY 1987 may also be planned with the appropriate State and cycle. We have proposed that preference used to develop a plan to achieve local health agencies. be given to competing continuation institutional improvements, including applications (renewals) to direct 7.Executive Order 12372 financial independence, to enable the assistance to quality COE programs that The MCH Federal set-aside program school to support programs of have documented sustained or has been determined to be a program excellence in health professions increased accomplishments under this which is not subject to the provisions of education for minority individuals, and program. Therefore, the preference will Executive Order 12372 concerning to provide improved access to the remain as proposed. intergovernmental review of Federal library and informational resources of programs. the school. A funding preference will be given to competing continuation (renewal) The OMB Catalog of Federal Domestic Eligibility applications for Centers of Excellence Assistance number is 93.110. programs whose current project periods Dated: January 31, 1995. Section 739 authorizes the Secretary to make grants to schools of medicine, end in fiscal year 1995. Ciro V. Sumaya, osteopathic medicine, dentistry and Additional Information Administrator. pharmacy for the purpose of assisting [FR Doc. 95–2738 Filed 2–2–95; 8:45 am] the schools in supporting programs of To obtain information regarding the BILLING CODE 4160±15±P excellence in health professions programmatic aspects of this grant education for Black, Hispanic and program, direct inquiries to: A. Roland Native American individuals, as well as Garcia, Ph.D., Chief, Centers of Final Funding Preference for Centers for HBCUs as described in section Excellence Section, Program of Excellence in Minority Health 799(l)(A) and which have received a Coordination Branch, Division of Professions Education for Fiscal Year contract under section 788B of the Act Disadvantaged Assistance, Bureau of 1995 (Advanced Financial Distress Health Professions, HRSA, Parklawn Building, Room 8A–09, 5600 Fishers The Health Resources and Services Assistance) for FY 1987. Lane, Rockville, Maryland 20857, Administration (HRSA) announces the To qualify as a COE, a school is Telephone: (301) 443–4493, FAX: (301) final funding preference for fiscal year required to: 443–5242. (FY) 1995 Grants for Centers of l. Have a significant number of Excellence (COE) in Minority Health minority individuals enrolled in the This program is listed at 93.157 in the Professions Education funded under the school, including individuals accepted Catalog of Federal Domestic Assistance. authority of section 739, title VII of the for enrollment in the school; It is not subject to the provisions of Public Health Service Act (the Act), as 2. Demonstrate that it has been Executive Order 12372, amended by the Health Professions effective in assisting minority students Intergovernmental Review of Federal Education Extension Amendments of of the school to complete the program Programs (as implemented through 45 1992, Pub. L. 102–408, dated October of education and receive the degree CFR part 100). 13, 1992. involved; This program is not subject to the 3. Show that it has been effective in Public Health System Reporting Purposes recruiting minority individuals to attend Requirements. Grants for eligible Historically Black the school, including providing Dated: January 30, 1995. Colleges and Universities (HBCUs), scholarships and other financial Ciro V. Sumaya, Hispanic, Native American and Other assistance to such individuals, and Administrator. Centers of Excellence must be used by encouraging minority students of [FR Doc. 95–2625 Filed 2–2–95; 8:45 am] the schools for the following purposes: secondary educational institutions to l. To establish, strengthen, or expand attend the health professions school; BILLING CODE 4160±15±P programs to enhance the academic and performance of minority students 4. Demonstrate that it has made Health Resources and Services attending the school; significant recruitment efforts to Administration Advisory Council; 2. To establish, strengthen, or expand increase the number of minority Notice of Meeting programs to increase the number and individuals serving in faculty or quality of minority applicants to the administrative positions at the school. In accordance with section 10(a)(2) of school; These entities must be located in any the Federal Advisory Committee Act 3. To improve the capacity of such of the several states, the District of (Public Law 92–463), announcement is school to train, recruit, and retain Columbia, the Commonwealth of Puerto made of the following National minority faculty; Rico, the Commonwealth of the Advisory body scheduled to meet 4. With respect to minority health Northern Mariana Islands, the Virgin during the month of March 1995. issues, to carry out activities to improve Islands, Guam, American Samoa, the Name: Advisory Commission on the information resources and curricula Republic of Palau, the Republic of the Childhood Vaccines (ACCV). of the school and clinical education at Marshall Islands, and the Federated Date and Time: March 1, 1995; 9:00 am– the school; and States of Micronesia. 5:00 pm; March 2, 1995; 9:00 am–12:00 noon. 6720 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Place: Parklawn Building, Conference Agenda Items are subject to change as (Catalog of Federal Domestic Assistance Rooms G & H, 5600 Fishers Lane, Rockville, priorities dictate. Program Nos. 93.306, 93.333, 93.337, 93.393– Maryland 20857. Dated: January 30, 1995. 93.396, 93.837–93.844, 93.846–93.878, The meeting is open to the public. Jackie E. Baum, 93.892, 93.893, National Institutes of Health, Purpose: The Commission: (1) Advises the HHS) Advisory Committee Management Officer, Secretary on the implementation of the Dated: January 27, 1995. Program, (2) on its own initiative or as the HRSA. Susan K. Feldman, result of the filing of a petition, recommends [FR Doc. 95–2624 Filed 2–2–95; 8:45 am] changes in the Vaccine Injury Table, (3) BILLING CODE 4160±15±P Committee Management Officer, NIH. advises the Secretary in implementing the [FR Doc. 95–2632 Filed 2–2–95; 8:45 am] Secretary’s responsibilities under section BILLING CODE 4140±01±M 2127 regarding the need for childhood National Institutes of Health vaccination products that result in fewer or no significant adverse reactions, (4) surveys Division of Research Grants; Notice of Division of Research Grants; Notice of Federal, State, and local programs and Closed Meetings Closed Meeting activities relating to the gathering of information on injuries associated with the Pursuant to Section 10(d) of the Pursuant to Section 10(d) of the administration of childhood vaccines, Federal Advisory Committee Act, as Federal Advisory Committee Act, as including the adverse reaction reporting amended (5 U.S.C. Appendix 2), notice amended (5 U.S.C. Appendix 2), notice requirements of section 2125(b), and advises is hereby given of the following Division the Secretary on means to obtain, compile, is hereby given of the following Division of Research Grants Special Emphasis publish, and use credible data related to the of Research Grants Special Emphasis Panel (SEP) meetings: frequency and severity of adverse reactions Panel (SEP) meeting: associated with childhood vaccines, and (5) Purpose/Agenda: To review individual grant Purpose/Agenda: To review individual recommends to the Director of the National applications Vaccine Program research related to vaccine Name of SEP: Biological and Physiological grant applications. injuries which should be conducted to carry Sciences Name of SEP: Microbiological and out the National Vaccine Injury Date: February 13–14, 1995 Immunological Sciences. Compensation Program. Time: 8:30 a.m. Date: February 3, 1995. Agenda: Agenda items will include, but Place: Holiday Inn, Chevy Chase, MD Time: 9:30 a.m. not be limited to: a vaccine safety update Contact Person: Dr. Sherry Dupere, Scientific Place: NIH, Westwood Building, Room from the Centers for Disease Control and Review Administrator, 5333 Westbard 236A Telephone Conference. Prevention and the Food and Drug Ave., Room 225A, Bethesda, MD 20892, Contact Person: Dr. William Branche, Administration; a report on Children with (301) 594–7097 Scientific Review Admin., 5333 Westbard Special Needs; a report on the National Ave., Room 236A, Bethesda, MD 20892, (301) Name of SEP: Clinical Sciences 594–7297. Vaccine Program; and routine Program Date: February 22, 1995 reports. The meeting will be closed in accordance Time: 8:30 a.m. with the provisions set forth in secs. Public comment will be permitted before Place: River Inn, Washington, DC noon and at the end of the full Commission 552b(c)(4) and 552(c)(6), Title 5, U.S.C. Contact Person: Dr. Mushtag Khan, Scientific Applications and/or proposals and the meeting on March 1; and before the Review Administrator, 5333 Westbard Commission adjourns on the second day on discussions could reveal confidential trade Ave., Room 354B, Bethesda, MD 20892, secrets or commercial property such as March 2. Oral presentations will be limited (301) 594–7168 to 5 minutes per public speaker. patentable material and personal information Name of SEP: Behavioral and Neurosciences Persons interested in providing an oral concerning individuals associated with the Date: March 3, 1995 presentation should submit a written request, applications and/or proposals, the disclosure Time: 8:30 a.m. along with a copy of their presentation to Mr. of which would constitute a clearly Place: Holiday Inn, Bethesda, MD Jerry Anderson, Principal Staff Liaison, unwarranted invasion of personal privacy. Contact Person: Dr. Peggy McCardle, Division of Vaccine Injury Compensation, This notice is being published less than 15 Scientific Review Administrator, 5333 Bureau of Health Professions, Health days prior to the meeting due to the urgent Westbard Ave., Room 305, Bethesda, MD Resources and Services Administration, need to meet timing limitations imposed by 20892, (301) 594–7293 Room 8A–35, 5600 Fishers Lane, Rockville, the grant review cycle. MD 20852; Telephone (301) 443–1533. Name of SEP: Microbiological and (Catalog of Federal Domestic Assistance Requests should contain the name, Immunological Sciences Program Nos. 93.306, 93.333, 93.337, 93.393– address, telephone number, and any business Date: March 8, 1995 93.396, 93.837–93.844, 93.846–93.878, or professional affiliation of the person Time: 2:00 p.m. 93.892, 93.893, National Institutes of Health, desiring to make an oral presentation. Groups Place: NIH, Westwood Building, Room 1A03 HHS) having similar interests are requested to Telephone Conference Dated: January 31, 1995. Contact Person: Dr. Garrett Keefer, Scientific combine their comments and present them Susan K. Feldman, through a single representative. The Review Administrator, 5333 Westbard allocation of time may be adjusted to Ave., Room 1A03, Bethesda, MD 20892, Committee Management Officer, NIH. accommodate the level of expressed interest. (301) 594–7253 [FR Doc. 95–2874 Filed 2–1–95; 8:45 am] The Division of Vaccine Injury Compensation The meetings will be closed in accordance BILLING CODE 4140±01±M will notify each presenter by mail or with the provisions set forth in secs. telephone of their assigned presentation time. 552b(c)(4) and 552b(c)(6), Title 5, U.S.C. Persons who do not file an advance request Applications and/or proposals and the Public Health Service for presentation, but desire to make an oral discussions could reveal confidential trade statement, may sign up in Conference Rooms secrets or commercial property such as Agency Forms Undergoing Paperwork G & H before 10:00 a.m. on March 1 and 2. patentable material and personal information Reduction Act Review These persons will be allocated time as time concerning individuals associated with the permits. applications and/or proposals, the disclosure Each Friday the Public Health Service Anyone requiring information regarding of which would constitute a clearly the Commission should contact Mr. unwarranted invasion of personal privacy. (PHS) publishes a list of information Anderson, Division of Vaccine Injury This notice is being published less than 15 collection requests under review, in Compensation, Bureau of Health Professions, days prior to the meeting due to the urgent compliance with the Paperwork Room 8A–35, 5600 Fishers Lane, Rockville, need to meet timing limitations imposed by Reduction Act (44 U.S.C. Chapter 35). Maryland 20852; Telephone (301) 443–1533. the grant review cycle. To request a copy of these requests, call Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6721 the PHS Reports Clearance Office on Secretary for Health, Room 737–F, including restoration of reputation of 202–690–7100. Humphrey Building, 200 Independence those when allegations are not The following requests have been Ave. SW., Washington, DC 20201. confirmed. This voluntary survey will submitted for review since the list was provide background information to last published on Friday, January 27. Number Average assure institutional compliance with 1. Nominations for ATSDR Number of re- of re- sponses burden regulation and other information. Community Assistance Panels—0923– Title spond- per re- per re- Respondents: Individuals or 0007 (Extension, no change)—This sponse ents spond- (hours) households; Number of Respondents: information collection mechanism ent 112; Number of Responses per allows the Agency for Toxic Substances Respondent: 1; Average Burden per and Disease Registry (ATSDR) to assist Currently ap- proved ...... 72,000 1 .33 Response: .5 hour; Estimated Annual local communities in the nomination of Burden: 56 hours. Send comments to members of the community to become Additional burdenÐ5 Shannah Koss, Human Resources and members of Community Assistance minutes Housing Branch, New Executive Office Panels. The panels provide for a two- more for a Building, Room 10235, Washington, DC way exchange of information between subset of 20503. ATSDR and the concerned public 15,600 do- 7. X-Ray Examination Program/ regarding the public health activities nors ...... 1,295 Federal Mine Safety and Health Act planned for the area. Respondents: 1977 (42 CFR Part 37)—0920–0020 Individuals or households; Number of Estimated total annual burden: 25,295 (Reinstatement)—Information is utilized Respondents: 1350; Number of hours for early identification of incidence and/ Responses per Respondent: 1; Average 4. Survey of Rural Hospitals on or treatment. Identification is followed Burden per Response: 0.16 hour; Telemedicine—New—This survey of by clinical management on miners’ Estimated Annual Burden: 225 hours. rural hospitals will identify all rural health, through appropriate notification Send comments to James Scanlon, telemedicine systems in the United of medical findings and applicable dust Office of the Assistant Secretary for States. The information will be used to transfer rights. Public affected includes Health, Room 737–F, Humphrey design a followup study, which will underground coal miners and operators, Building, 200 Independence Avenue provide baseline data on the systems, a physicians and x-ray facilities. SW., Washington, DC 20201. minimum data set for future studies, Respondents: Individuals or 2. AIDS Education and Training and evaluation methodologies for future households, Business or other for-profit. Centers Program: National Program and evaluations of these systems. Send comments to Shannah Koss, Service Record Reporting Form—0915– Respondents: Business or other for- Human Resources and Housing Branch, 0154 (Revision)—Information will be profit, Not-for-profit institutions; New Executive Office Building, Room obtained from AIDS Education and Number of Respondents: 2,400; Number 10235, Washington, DC 20503. Training Centers to determine of Responses per Respondent: 1; compliance with terms of cooperative Average Burden per Response: .1 hour; Number agreements and specific project Average Estimated Annual Burden: 250 hours. Number of re- burden requirements. The National Program Send comments to Shannah Koss, Title of re- sponses per re- and Service Record Data Reporting spond- per re- Human Resources and Housing Branch, ents spond- sponse Form will be used by ETCs to provide New Executive Office Building, Room ent (hours) standardized reporting of project 10235, Washington, DC 20503. activities for Federal program 5. Survey of NIH Extramural Shared Roentgenog- monitoring. Respondents: Not-for-profit Instrumentation Activities 0925–0318 raphic In- institutions; Number of Respondents: (Extension, no change)—It is generally terpreta- 17; Number of Responses per accepted that the capabilities of tion: 42 Respondent: 4; Average Burden per expensive state-of-the art biomedical CFR Response: 30.15 hours; Estimated instruments can be made available to 37.40(b) ... 20,000 1.05 .02 Annual Burden: 2,050 hours. Send Miner Identi- the largest number of researchers in the fication comments to James Scanlon, Office of most cost-effective manner by awarding Title 42 the Assistant Secretary for Health, Room them on the condition that they be CFR 37.20 10,000 1 .3 737–F, Humphrey Building, 200 shared. This study will examine the Coal Mine Independence Ave. SW., Washington, extent to which such instruments are Operator DC 20201. shared; and how fully they are utilized, Plan 42 3. National Donor Research and by whom, and for what. Respondents: CFR Education Study (REDS) 0925–0383 Not-for profit institutions, Business or 37.4(a) ..... 500 1 .33 (Revision)—This is a mail survey of a other for-profit; Number of Facility Cer- random sample of blood donors from Respondents: 9,870; Number of tification five Blood Centers participating in the 42 CFR Responses Per Respondent: 1; Average 37.42(c) ... 100 20 .17 REDS program. Data will be used to Burden per Response: .286 hour; Interpreting monitor the safety of the U.S. blood Estimated Annual Burden: 2,819 hours. Physical supply and facilitate development, Send comments to James Scanlon, Certifi- evaluation and refinement of donor Office of the Assistant Secretary for cation 42 recruitment and education strategies. Health, Room 737–F, Humphrey CFR Seven additional items will be asked of Building, 200 Independence Avenue, 37.51(c) ... 300 1 .05 a subset of respondents to guide SW., Washington, DC 20201. development of the next major round of 6. Study of Consequences of Being Estimated total annual Burden: 3,940 the survey. Respondents: Individuals or Accused of Scientific Misconduct— hours. households. Send comments to James New—42 CFR Part 50 specifies certain Written comments and Scanlon, Office of the Assistant treatment of accused individuals, recommendations concerning the 6722 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices proposed information collections applicant laboratory must undergo three CORNING MetPath Clinical should be sent within 30 days of this rounds of performance testing plus an Laboratories, 1355 Mittel Blvd., Wood notice directly to the individual on-site inspection. To maintain that Dale, IL 60191, 708–595–3888 designated. certification a laboratory must (formerly: MetPath, Inc.) Dated: January 30, 1995. participate in a quarterly performance CORNING MetPath Clinical James Scanlon, testing program plus periodic, on-site Laboratories, One Malcolm Ave., Teterboro, NJ 07608, 201–393–5000 Director, Division of Data Policy, Office of inspections. Health Planning and Evaluation. Laboratories which claim to be in the (formerly: MetPath, Inc.) applicant stage of certification are not to CORNING National Center for Forensic [FR Doc. 95–2703 Filed 2–2–95; 8:45 am] be considered as meeting the minimum Science, 1901 Sulphur Spring Rd., BILLING CODE 4160±17±M requirements expressed in the HHS Baltimore, MD 21227, 410–536–1485 Guidelines. A laboratory must have its (formerly: Maryland Medical Substance Abuse and Mental Health letter of certification from SAMHSA, Laboratory, Inc., National Center for Services Administration HHS (formerly: HHS/NIDA) which Forensic Science) attests that it has met minimum CORNING Nichols Institute, 7470–A Current List of Laboratories Which standards. Mission Valley Rd., San Diego, CA Meet Minimum Standards To Engage in In accordance with Subpart C of the 92108–4406, 800–446–4728/619–686– Urine Drug Testing for Federal Guidelines, the following laboratories 3200 (formerly: Nichols Institute, Agencies and Laboratories That Have meet the minimum standards set forth Nichols Institute Substance Abuse Withdrawn From the Program in the Guidelines: Testing (NISAT)) ACCU–LAB, Inc., 405 Alderson St., Cox Medical Centers, Department of AGENCY: Substance Abuse and Mental Schofield, WI 54476, 800–627–8200 Toxicology, 1423 North Jefferson Health Services Administration, HHS (formerly: Alpha Medical Laboratory, Ave., Springfield, MO 65802, 800– (Formerly: National Institute on Drug Inc., Employee Health Assurance 876–3652/417–836–3093 Abuse, ADAMHA, HHS). Group, ExpressLab, Inc.) Dept. of the Navy, Navy Drug Screening ACTION: Notice. Aegis Analytical Laboratories, Inc., 624 Laboratory, Great Lakes, IL, Building 38–H, Great Lakes, IL 60088–5223, SUMMARY: The Department of Health and Grassmere Park Rd., Suite 21, Nashville, TN 37211, 615–331–5300 708–688–2045/708–688–4171 Human Services notifies Federal Diagnostic Services Inc., dba DSI, 4048 agencies of the laboratories currently Alabama Reference Laboratories, Inc., Evans Ave., Suite 301, Fort Myers, FL certified to meet standards of Subpart C 543 South Hull St., Montgomery, AL 36103, 800–541–4931/205–263–5745 33901, 813–936–5446/800–735–5416 of Mandatory Guidelines for Federal Doctors Laboratory, Inc., P.O. Box 2658, Workplace Drug Testing Programs (59 American Medical Laboratories, Inc., 14225 Newbrook Dr., Chantilly, VA 2906 Julia Dr., Valdosta, GA 31604, FR 29916, 29925). A similar notice 912–244–4468 listing all currently certified laboratories 22021, 703–802–6900 Associated Pathologists Laboratories, Drug Labs of Texas, 15201 I–10 East, will be published during the first week Inc., 4230 South Burnham Ave., Suite Suite 125, Channelview, TX 77530, of each month, and updated to include 250, Las Vegas, NV 89119–5412, 702– 713–457–3784 laboratories which subsequently apply DrugProof, Division of Laboratory of for and complete the certification 733–7866 Associated Regional and University Pathology of Seattle, Inc., 1229 process. If any listed laboratory’s Pathologists, Inc. (ARUP), 500 Chipeta Madison St., Suite 500, Nordstrom certification is totally suspended or Way, Salt Lake City, UT 84108, 801– Medical Tower, Seattle, WA 98104, revoked, the laboratory will be omitted 583–2787 800–898–0180/206–386–2672, from updated lists until such time as it Baptist Medical Center—Toxicology (formerly: Laboratory of Pathology of is restored to full certification under the Laboratory, 9601 I–630, Exit 7, Little Seattle, Inc.) Guidelines. DrugScan, Inc., P.O. Box 2969 , 1119 If any laboratory has withdrawn from Rock, AR 72205–7299, 501–227–2783 Mearns Rd., Warminster, PA 18974, the National Laboratory Certification (formerly: Forensic Toxicology 215–674–9310 Program during the past month, it will Laboratory Baptist Medical Center) Bayshore Clinical Laboratory, 4555 W. Eagle Forensic Laboratory, Inc., 950 N. be identified as such at the end of the Schroeder Dr., Brown Deer, WI 53223, Federal Highway, Suite 308, Pompano current list of certified laboratories, and 414–355–4444/800–877–7016 Beach, FL 33062, 305–946–4324 will be omitted from the monthly listing Cedars Medical Center, Department of ElSohly Laboratories, Inc., 5 Industrial thereafter. Pathology, 1400 Northwest 12th Ave., Park Dr., Oxford, MS 38655, 601–236– FOR FURTHER INFORMATION CONTACT: Mrs. Miami, FL 33136, 305–325–5810 2609 Giselle Hersh, Division of Workplace Centinela Hospital Airport Toxicology General Medical Laboratories, 36 South Programs, Room 13A–54, 5600 Fishers Laboratory, 9601 S. Sepulveda Blvd., Brooks St., Madison, WI 53715, 608– Lane, Rockville, Maryland 20857; Tel.: Los Angeles, CA 90045, 310–215– 267–6267 (301) 443-6014. 6020 Harrison Laboratories, Inc., 9930 W. SUPPLEMENTARY INFORMATION: Clinical Reference Lab, 11850 West 85th Highway 80, Midland, TX 79706, Mandatory Guidelines for Federal St., Lenexa, KS 66214, 800–445–6917 800–725–3784/915–563–3300, Workplace Drug Testing were developed CORNING Clinical Laboratories, 2320 (formerly: Harrison & Associates in accordance with Executive Order Schuetz Rd., St. Louis, MO 63146, Forensic Laboratories) 12564 and section 503 of Pub. L. 100– 800–288–7293 (formerly: HealthCare/MetPath, 24451 Telegraph 71. Subpart C of the Guidelines, Metropolitan Reference Rd., Southfield, MI 48034, 800–444– ‘‘Certification of Laboratories Engaged Laboratories, Inc.) 0106 ext. 650 (formerly: HealthCare/ in Urine Drug Testing for Federal CORNING Clinical Laboratories, 8300 Preferred Laboratories) Agencies,’’ sets strict standards which Esters Blvd., Suite 900, Irving, TX Holmes Regional Medical Center laboratories must meet in order to 75063, 800–526–0947 (formerly: Toxicology Laboratory, 5200 Babcock conduct urine drug testing for Federal Damon Clinical Laboratories, Damon/ St., N.E., Suite 107, Palm Bay, FL agencies. To become certified an MetPath) 32905, 407–726–9920 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6723 Jewish Hospital of Cincinnati, Inc., 3200 Pathology Associates Medical Atlanta, GA 30340, 404–934–9205 Burnet Ave., Cincinnati, OH 45229, Laboratories, East 11604 Indiana, (formerly: SmithKline Bio-Science 513–569–2051 Spokane, WA 99206, 509–926–2400 Laboratories) LabOne, Inc., 8915 Lenexa Dr., Overland PDLA, Inc. (Princeton), 100 Corporate SmithKline Beecham Clinical Park, Kansas 66214, 913–888–3927 Court, So. Plainfield, NJ 07080, 908– Laboratories, 506 E. State Pkwy., (formerly: Center for Laboratory 769–8500/800–237–7352 Schaumburg, IL 60173, 708–885–2010 Services, a Division of LabOne, Inc.) PharmChem Laboratories, Inc., 1505–A (formerly: International Toxicology Laboratory Specialists, Inc., 113 Jarrell O’Brien Dr., Menlo Park, CA 94025, Laboratories) Dr., Belle Chasse, LA 70037, 504– 415–328–6200/800–446–5177 SmithKline Beecham Clinical 392–7961 PharmChem Laboratories, Inc., Texas Laboratories, 400 Egypt Rd., Marshfield Laboratories, 1000 North Division, 7606 Pebble Dr., Fort Worth, Norristown, PA 19403, 800–523–5447 Oak Ave., Marshfield, WI 54449, 715– TX 76118, 817–595–0294 (formerly: (formerly: SmithKline Bio-Science 389–3734/800–222–5835 Harris Medical Laboratory) Laboratories) Physicians Reference Laboratory, 7800 MedExpress/National Laboratory SmithKline Beecham Clinical West 110th St., Overland Park, KS Center, 4022 Willow Lake Blvd., Laboratories, 8000 Sovereign Row, 66210, 913–338–4070/800–821–3627 Memphis, TN 38175, 901–795–1515 Dallas, TX 75247, 214–638–1301 (formerly: Physicians Reference Medical College Hospitals Toxicology (formerly: SmithKline Bio-Science Laboratory Toxicology Laboratory) Laboratories) Laboratory, Department of Pathology, Poisonlab, Inc., 7272 Clairemont Mesa South Bend Medical Foundation, Inc., 3000 Arlington Ave., Toledo, OH Rd., San Diego, CA 92111, 619–279– 530 N. Lafayette Blvd., South Bend, 43699–0008, 419–381–5213 2600/800–882–7272 Medlab Clinical Testing, Inc., 212 Puckett Laboratory, 4200 Mamie St., IN 46601, 219–234–4176 Cherry Lane, New Castle, DE 19720, Hattiesburg, MS 39402, 601–264– Southwest Laboratories, 2727 W. 302–655–5227 3856/800–844–8378 Baseline Rd., Suite 6, Tempe, AZ MedTox Laboratories, Inc., 402 W. Regional Toxicology Services, 15305 85283, 602–438–8507 County Rd. D, St. Paul, MN 55112, N.E. 40th St., Redmond, WA 98052, St. Anthony Hospital (Toxicology 800–832–3244/612–636–7466 206–882–3400 Laboratory), P.O. Box 205, 1000 N. Methodist Hospital of Indiana, Inc., Roche Biomedical Laboratories, Inc., Lee St., Oklahoma City, OK 73102, Department of Pathology and 1120 Stateline Rd., Southaven, MS 405–272–7052 Laboratory Medicine, 1701 N. Senate 38671, 601–342–1286 Toxicology & Drug Monitoring Blvd., Indianapolis, IN 46202, 317– Roche Biomedical Laboratories, Inc., 69 Laboratory, University of Missouri 929–3587 First Ave., Raritan, NJ 08869, 800– Hospital & Clinics, 301 Business Loop Methodist Medical Center Toxicology 437–4986 70 West, Suite 208, Columbia, MO Laboratory, 221 N.E. Glen Oak Ave., Roche CompuChem Laboratories, Inc., A 65203, 314–882–1273 Peoria, IL 61636, 800–752–1835/309– Member of the Roche Group, 3308 Toxicology Testing Service, Inc., 5426 671–5199 Chapel Hill/Nelson Hwy., Research N.W. 79th Ave., Miami, FL 33166, MetPath Laboratories, 4900 Perry Hwy., Triangle Park, NC 27709, 919–549– 305–593–2260 Pittsburgh, PA 15229, 412–931–7200, 8263/800–833–3984 (Formerly: TOXWORX Laboratories, Inc., 6160 (formerly: Med-Chek Laboratories, CompuChem Laboratories, Inc., A Variel Ave., Woodland Hills, CA Inc., Med-Chek/Damon) Subsidiary of Roche Biomedical 91367, 818–226–4373 (formerly: National Health Laboratories Laboratory) Laboratory Specialists, Inc.; Abused Incorporated, 2540 Empire Dr., Roche CompuChem Laboratories, Inc., Drug Laboratories; MedTox Bio- Winston-Salem, NC 27103–6710, Special Division, A Member of the Analytical, a Division of MedTox Outside NC: 919–760–4620/800–334– Roche Group, 3308 Chapel Hill/ Laboratories, Inc.) 8627 / Inside NC: 800–642–0894 Nelson Hwy., Research Triangle Park, UNILAB, 18408 Oxnard St., Tarzana, National Health Laboratories NC 27709, 919–549–8263 (Formerly: CA 91356, 800–492–0800/818–343– Incorporated, d.b.a. National CompuChem Laboratories, Inc. - 8191 (formerly: MetWest-BPL Reference Laboratory, Substance Special Division) Toxicology Laboratory) Scientific Testing Laboratories, Inc., 463 Abuse Division, 1400 Donelson Pike, Richard Kopanda, Southlake Blvd., Richmond, VA Suite A–15, Nashville, TN 37217, Acting Executive Officer, Substance Abuse 23236, 804–378–9130 615–360–3992/800–800–4522 and Mental Health Services Administration. Scott & White Drug Testing Laboratory, National Health Laboratories 600 S. 25th St., Temple, TX 76504, [FR Doc. 95–2548 Filed 2–2–95; 8:45 am] Incorporated, 13900 Park Center Rd., 800–749–3788 BILLING CODE 4160±20±U Herndon, VA 22071, 703–742–3100 S.E.D. Medical Laboratories, 500 Walter National Psychopharmacology NE, Suite 500, Albuquerque, NM Laboratory, Inc., 9320 Park W. Blvd., 87102, 505–848–8800 DEPARTMENT OF HOUSING AND Knoxville, TN 37923, 800–251–9492 Sierra Nevada Laboratories, Inc., 888 URBAN DEVELOPMENT National Toxicology Laboratories, Inc., Willow St., Reno, NV 89502, 800– 1100 California Ave., Bakersfield, CA 648–5472 Office of the Assistant Secretary for 93304, 805–322–4250 SmithKline Beecham Clinical Community Planning and Northwest Toxicology, Inc., 1141 E. Laboratories, 7600 Tyrone Ave., Van Development 3900 South, Salt Lake City, UT 84124, Nuys, CA 91045, 818–376–2520 [Docket No. N±95±1917; FR±3778±N±22] 800–322–3361 SmithKline Beecham Clinical Occupational Toxicology Laboratories, Laboratories, 801 East Dixie Ave., Federal Property Suitable as Facilities Inc., 2002 20th St., Suite 204A, Leesburg, FL 32748, 904–787–9006 to Assist the Homeless Kenner, LA 70062, 504–465–0751 (formerly: Doctors & Physicians Oregon Medical Laboratories, P.O. Box Laboratory) AGENCY: Office of the Assistant 972, 722 East 11th Ave., Eugene, OR SmithKline Beecham Clinical Secretary for Community Planning and 97440–0972, 503–687–2134 Laboratories, 3175 Presidential Dr., Development, HUD. 6724 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices ACTION: Notice. packet, which will include instructions Buildings (by State) for completing the application. In order Hawaii SUMMARY: This Notice identifies to maximize the opportunity to utilize a Bldg. S900, Naval Station unutilized, underutilized, excess, and suitable property, providers should surplus Federal property reviewed by Pearl Harbor Co: Honolulu HI 96860– submit their written expressions of Landholding Agency: Navy HUD for suitability for possible use to interest as soon as possible. For Property Number: 779510018 assist the homeless. complete details concerning the Status: Unutilized ADDRESSES: For further information, processing of applications, the reader is Comment: 1980 sq. ft. fall out shelter, contact William Molster, room 7256, encouraged to refer to the interim rule possible asbestos and lead base paint, Department of Housing and Urban governing this program, 56 FR 23789 termite damage, off-site use only Development, 451 Seventh Street SW., (May 24, 1991). Bldg. S902, Naval Station Washington, DC 20410; telephone (202) For properties listed as suitable/to be Pearl Harbor Co: Honolulu HI 96860– 708–1226; TDD number for the hearing- excess, that property may, if Landholding Agency: Navy and speech-impaired (202) 708–2565 Property Number: 779510019 subsequently accepted as excess by Status: Unutilized (these telephone numbers are not toll- GSA, be made available for use by the Comment: 1416 sq. ft., most recent use— free), or call the toll-free Title V homeless in accordance with applicable storage, possible asbestos and lead base information line at 1–800–927–7588. law, subject to screening for other paint, termite damage, off-site use only SUPPLEMENTARY INFORMATION: In Federal use. At the appropriate time, Unsuitable Properties accordance with 56 FR 23789 (May 24, HUD will publish the property in a 1991) and section 501 of the Stewart B. Notice showing it as either suitable/ Buildings (by State) McKinney Homeless Assistance Act (42 available or suitable/unavailable. Hawaii U.S.C. 11411), as amended, HUD is For properties listed as suitable/ Bldg. 7 publishing this Notice to identify unavailable, the landholding agency has Naval Magazine Lualualei Federal buildings and other real decided that the property cannot be Waipio Peninsula Co: Oahu HI property that HUD has reviewed for declared excess or made available for Landholding Agency: Navy suitability for use to assist the homeless. use to assist the homeless, and the Property Number: 779510002 The properties were reviewed using property will not be available. Status: Unutilized information provided to HUD by Properties listed as unsuitable will Reason: Extensive deterioration Federal landholding agencies regarding not be made available for any other Bldg. 8 unutilized and underutilized buildings purpose for 20 days from the date of this Naval Magazine Lualualei and real property controlled by such Notice. Homeless assistance providers Waipio Peninsula Co: Oahu HI interested in a review by HUD of the Landholding Agency: Navy agencies or by GSA regarding its Property Number: 779510003 inventory of excess or surplus Federal determination of unsuitability should Status: Unutilized property. This Notice is also published call the toll free information line at 1– Reason: Extensive deterioration in order to comply with the December 800–927–7588 for detailed instructions Bldg. 9 12, 1988 Court Order in National or write a letter to William Molster at Naval Magazine Lualualei Coalition for the Homeless v. Veterans the address listed at the beginning of Waipio Peninsula Co: Oahu HI Administration, No. 88–2503–OG this Notice. Included in the request for Landholding Agency: Navy (D.D.C.). review should be the property address Property Number: 779510004 Properties reviewed are listed in this (including zip code), the date of Status: Unutilized Notice according to the following publication in the Federal Register, the Reason: Extensive deterioration categories: Suitable/available, suitable/ landholding agency, and the property Bldg. 10 unavailable, suitable/to be excess, and number. Naval Magazine Lualualei unsuitable. The properties listed in the For more information regarding Waipio Peninsula Co: Oahu HI three suitable categories have been particular properties identified in this Landholding Agency: Navy Property Number: 779510005 reviewed by the landholding agencies, Notice (i.e., acreage, floor plan, existing sanitary facilities, exact street address), Status: Unutilized and each agency has transmitted to Reason: Extensive deterioration HUD: (1) Its intention to make the providers should contact the appropriate landholding agencies at the Bldg. 11 property available for use to assist the Naval Magazine Lualualei homeless, (2) its intention to declare the following addresses: U.S. Navy: John J. Waipio Peninsula Co: Oahu HI property excess to the agency’s needs, or Kane, Deputy Division Director, Dept. of Landholding Agency: Navy (3) a statement of the reasons that the Navy, Real Estate Operations, Naval Property Number: 779510006 property cannot be declared excess or Facilities Engineering Command, 200 Status: Unutilized made available for use as facilities to Stovall Street, Alexandria, VA 22332– Reason: Extensive deterioration assist the homeless. 2300; (703) 325–0474; Dept. of Bldg. 12 Properties listed as suitable/available Transportation: Ronald D. Keefer, Naval Magazine Lualualei will be available exclusively for Director, Administrative Services & Waipio Peninsula Co: Oahu HI homeless use for a period of 60 days Property Management, DOT, 400 Landholding Agency: Navy from the date of this Notice. Homeless Seventh St. SW., room 10319, Property Number: 779510007 assistance providers interested in any Washington, DC 20590; (202) 366–4246; Status: Unutilized Reason: Extensive deterioration such property should send a written (These are not toll-free numbers). expression of interest to HHS, addressed Bldg. 13 Dated: January 27, 1995. Naval Magazine Lualualei to Judy Breitman, Division of Health Jacquie M. Lawing, Waipio Peninsula Co: Oahu HI Facilities Planning, U.S. Public Health Deputy Assistant Secretary for Economic Landholding Agency: Navy Service, HHS, room 17A–10, 5600 Development. Property Number: 779510008 Fishers Lane, Rockville, MD 20857; Status: Unutilized (301) 443–2265. (This is not a toll-free Title V, Federal Surplus Property Program Reason: Extensive deterioration Federal Register Report for 02/03/95 number.) HHS will mail to the Bldg. 14 interested provider an application Suitable/Available Properties Naval Magazine Lualualei Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6725 Waipio Peninsula Co: Oahu HI Status: Unutilized of the award winners and the amount of Landholding Agency: Navy Reason: Secured Area the awards to be used to further the Property Number: 779510009 Bldg. 118 Department’s commitment to provide Status: Unutilized U.S. Coast Guard Base Reason: Extensive deterioration families living in public and Indian San Juan PR 00902–2029 housing with better access to Bldg. 15 Landholding Agency: DOT employment and training opportunities Naval Magazine Lualualei Property Number: 879510003 Waipio Peninsula Co: Oahu HI Status: Unutilized to achieve self-sufficiency and Landholding Agency: Navy Reason: Secured Area independence, and to rescind scores Property Number: 779510010 Bldg. 119 announced in an amendment published Status: Unutilized U.S. Coast Guard Base July 29, 1994 (59 FR 38617) regarding Reason: Extensive deterioration San Juan PR 00902–2029 the score achievable under the ranking Bldg. 39 Landholding Agency: DOT factor that addressed the evidence of Naval Magazine Lualualei Property Number: 879510004 need for supportive services by eligible Waipio Peninsula Co: Oahu HI Status: Unutilized residents. Landholding Agency: Navy Reason: Secured Area Property Number: 779510011 Bldg. 120 FOR FURTHER INFORMATION CONTACT: Status: Unutilized U.S. Coast Guard Base Marcia Y. Martin, Office of Community Reason: Extensive deterioration San Juan PR 00902–2029 Relations and Involvement (OCRI), or Bldg. 40 Landholding Agency: DOT Dom Nessi, Director, Office of Native Naval Magazine Lualualei Property Number: 879510005 American Programs (ONAP), Waipio Peninsula Co: Oahu HI Status: Unutilized Department of Housing and Urban Landholding Agency: Navy Reason: Secured Area Development, 451 Seventh Street, S.W., Property Number: 779510012 Bldg. 122 Washington, DC 20410; telephone Status: Unutilized U.S. Coast Guard Base Reason: Extensive deterioration numbers: OCRI (202) 708–4214; and San Juan PR 00902–2029 ONAP (202) 755–0032 (these are not Bldg. 43 Landholding Agency: DOT Naval Magazine Lualualei Property Number: 879510006 toll-free numbers). Hearing- or speech- Waipio Peninsula Co: Oahu HI Status: Unutilized impaired persons may use the Landholding Agency: Navy Reason: Secured Area Telecommunications Devises for the Property Number: 779510013 Bldg. 128 Deaf (TDD) by contacting the Federal Status: Unutilized U.S. Coast Guard Base Information Relay Services on 1–800– Reason: Extensive deterioration San Juan PR 00902–2029 877–TDDY (1–800–877–8339) or 202– Bldg. 44 Landholding Agency: DOT 708–9300 (not a toll-free number). Naval Magazine Lualualei Property Number: 879510007 Waipio Peninsula Co: Oahu HI Status: Unutilized SUPPLEMENTARY INFORMATION: Landholding Agency: Navy Reason: Secured Area Section 22 of the United States Property Number: 779510014 Bldg. 129 Housing Act of 1937 (42 U.S.C. 1437t) Status: Unutilized U.S. Coast Guard Base provides for the establishment of Family Reason: Extensive deterioration San Juan PR 00902–2029 Investment Centers. The stated purpose Bldg. 45 Landholding Agency: DOT of Section 22 is to provide families Naval Magazine Lualualei Property Number: 879510008 living in public housing with better Waipio Peninsula Co: Oahu HI Status: Unutilized Landholding Agency: Navy Reason: Secured Area access to educational and employment Property Number: 779510015 opportunities to achieve self-sufficiency Status: Unutilized [FR Doc. 95–2350 Filed 2–2–95; 8:45 am] and independence by: (a) Developing Reason: Extensive deterioration BILLING CODE 4210±29±M facilities in or near public housing for Bldg. 46 training and supportive services; (b) Naval Magazine Lualualei mobilizing public and private resources Waipio Peninsula Co: Oahu HI Office of the Assistant Secretary for to expand and improve the delivery of Landholding Agency: Navy Public and Indian Housing such services; (c) providing funding for Property Number: 779510016 [Docket No. N±95±3714; FR±3397±N±08] such essential training and support Status: Unutilized Reason: Extensive deterioration services that cannot otherwise be Announcement of Funding Awards for funded; and (d) improving the capacity Bldg. 101 the Family Investment Centers Naval Magazine Lualualei of management to access the training Waipio Peninsula Co: Oahu HI ProgramÐFiscal Year 1994 and service needs of families, coordinate the provision of training and Landholding Agency: Navy AGENCY: Office of the Assistant Property Number: 779510017 Secretary for Public and Indian services that meet such needs, and Status: Unutilized Housing, HUD. ensure the long-term provision of such Reason: Extensive deterioration training and services. ACTION: Announcement of funding Puerto Rico awards. Although section 22 is phrased in Bldg. 115 terms of families living in public U.S. Coast Guard Base SUMMARY: In accordance with section housing, the program is also available to San Juan PR 00902–2029 102(a)(4)(C) of the Department of Indian Housing Authorities (IHAs), Landholding Agency: DOT Housing and Urban Development because of section 527 of the National Property Number: 879510001 Reform Act of 1989, this document Affordable Housing Act (104 Stat. 4216: Status: Unutilized Reason: Secured Area notifies the public of funding awards for 42 U.S.C. 1437aa note) (NAHA). Section Fiscal Year 1994 Public and Indian 527 extends the applicability of many Bldg. 117 U.S. Coast Guard Base Housing Authority applicants under the NAHA provisions affecting Title I of the San Juan PR 00902–2029 Family Investment Centers (FIC) 1937 Act (including section 515, which Landholding Agency: DOT Program. The purpose of this document added Section 220 to housing operated Property Number: 879510002 is to announce the names and addresses by an IHA. 6726 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Applicants under FIC receive funding and Indian Family Investment Centers 198 Hanover Street to conduct: Supportive Services (Only), as published on February 28, 1994 (59 Manchester, NH 03104 Renovation/Conversion/New FR 9592), and specifically the (603) 624–2100 Construction (Only), and Combination Contact: Grace Grogan Amendment published on July 29, 1994 Grant Amount: $710,637 Supportive Services/Renovation/ (59 FR 38617), which increased the Conversion/Construction Activities. Providence Housing Authority points achievable in the ranking factor 100 Broad Street On February 28, 1994 (59 FR 9592), that addressed the need for services by Providence, RI 02903–4129 HUD published a Notice of Funding eligible residents. The Department (401) 751–6400 Availability (NOFA) that announced announces that applications were Contact: Stephen O’Rourke $75 million in FIC funds, and stated the reviewed and evaluated in accordance Grant Amount: $997,500 Department’s intention to use $1 million with the ranking factors set forth in the Van Buren Housing Authority of FIC funds to undertake a original NOFA published February 28, 16 Champlain Street Neighborhood Demonstration Program. 1994, and did not include the increased Van Buren, ME 04785–0158 The Notice of Demonstration was number of points specified in the July (207) 868–5441 announced in the Federal Register on 29, 1994 amendment. Applications were Contact: Steve La Pierre Grant Amount: $1,000,000 July 21, 1994 (59 FR 37338). The NOFA selected in accordance with ranking was amended four times as follows: guidance set forth in the July 29, 1994 Municipal Housing Authority of Schenectady • April 19, 1994 (59 FR 18570). 375 Broadway NOFA amendment that allowed that Schenectady, NY 12305–2595 Extended the eligible activities to grants may be awarded out of rank order include new construction and (518) 372–3346 based on project size and geographical Contact: Sharron Jordan acquisition; and extended the diversity. The final ranking list was Grant Amount: $944,995 application submission deadline to compiled from lists that included the Rochester Housing Authority Friday, July 22, 1994. In addition, the four top applications (per funding 140 West Avenue Department announced it’s intention to category) per HUD Region; the top Rochester, NY 14611–2744 use $5 million of FIC funds for a Youth applications in states not represented in (716) 328–6200 Development Initiative to address the the former category; and a mix of small, Contact: Thomas McHugh problems of violence in low-income medium and large housing authorities Grant Amount: $1,000,000 communities. The Demonstration was nationwide. Geneva Housing Authority announced in the Federal Register on In accordance with section P.O. Box 153 May 13, 1994 (59 FR 25262). Geneva, NY 14456–2319 • 102(a)(4)(C) of the Department of (315) 789–8010 June 9, 1994 (59 FR 29816). Revised Housing and Urban Development the NOFA to include language regarding Contact: Andrew Tyman Reform Act of 1989 (Pub. L. 101–235, Grant Amount: $732,626 the Comprehensive Improvement approved December 15, 1989), the Assistance Program (CIAP). In addition, New York City Housing Authority Department is publishing details the Department announced the award of 250 Broadway regarding the recipients of funding New York, NY 10007–2516 $2 million to the Chicago Housing awards. This information is provided in (212) 306–3440 Authority (CHA) on an emergency basis Appendix A to this document. Contact: Jacqueline Barley for FIC eligible purposes. Grant Amount: $950,000 • Dated: January 30, 1995. July 14, 1994 (59 FR 35945). Poughkeepsie Housing Authority Announced new application submission Joseph Shuldiner, P.O. Box 630 requirements for applicants applying to Assistant Secretary for Public and Indian Poughkeepsie, NY 12601–0632 undertake renovation/conversion/new Housing. (914) 485–8862 construction activities (only). This Appendix A Contact: Evelyn Bayon amendment was issued subsequent to Grant Amount: $284,282 Public Housing Authorities the Notice of Demonstration published Atlantic City Housing Authority June 21, 1994. In addition, the Lynn Housing Authority 227 N. Vermont Avenue amendment determined that section 957 174 South Common Street Atlantic City, NJ 08404–7549 Lynn, MA 01905–2513 of the National Affordable Housing Act (609) 344–1107 (617) 598–1225 Contact: Ron Lewis (NAHA) was subject to appropriations Contact: Norm Cole Grant Amount: $392,000 and not applicable at this time. Grant Amount: $985,000 • Morristown Housing Authority Published July 29, 1994 (59 FR Salem Housing Authority 31 Early Street 38617). Announced the change of the 27 Charter Street Morristown, NJ 07960–3883 explanation of the award of funds and Salem, MA 01970 (201) 583–6343 increased the number of points available (508) 744–4432 Contact: Lawrence Jackson in the ranking factor that addresses the Contact: Elayne Hart Grant Amount: $893,440 need for services by eligible residents Grant Amount: $1,000,000 Housing Authority of Baltimore City under the categories for renovation/ Housing Authority City of Hartford 417 E. Fayette Street conversion/supportive services and 475 Flatbush Avenue Baltimore, MD 21202 supportive services (only) from ‘‘10’’ Hartford, CT 06106 (410) 396–3232 points to ‘‘30’’ points. In addition, (203) 275–8487 Contact: Ralph Multhopp Contact: Paul Capra Grant Amount: $1,000,000 maximum points achievable under Grant Amount: $970,000 Renovation/Conversion/Supportive Housing Authority of the City of Clarksburg Portland Housing Authority 916 W. Pike Street Services activities were changed from 14 Baxter Boulevard Clarksburg, WV 26301–2250 ‘‘135’’ to ‘‘155’’. Maximum points Portland, ME 04101–4935 (304) 623–3322 achievable for Supportive Services (207) 773–4753 Contact: Alice Limbers (Only) were changed from ‘‘140’’ to Contact: John Hodge Grant Amount: $450,802 ‘‘160.’’ Grant Amount: $1,000,000 Dover Housing Authority Accordingly, this announcement Manchester Housing & Redevelopment 1266–76 White Oak Road further amends the NOFA for Public Authority Dover, DE 19901–3437 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6727 (302) 678–1965 Northwestern Regional Housing Authority Public Housing Agency of the City of Saint Contact: David Buches P.O. Box 2510 Paul Grant Amount: $1,000,000 Boone, NC 28607 480 Cedar Street Pittsburgh Housing Authority (704) 264–6683 St. Paul, MN 55101–2240 200 Ross Street Contact: E. Fowler (612) 298–5664 Pittsburgh, PA 15219–2068 Grant Amount: $259,700 Contact: Jon Gutzman (412) 456–5000 Housing Authority of the City of McComb Grant Amount: $1,000,000 Contact: Steven Tyson P.O. Box 469 Housing Authority of the City of Santa Fe Grant Amount: $933,517 McComb, MS 39648 P.O. Box 4039 Newport News Redevelopment & Housing (601) 684–7291 Santa Fe, NM 87502–4039 Authority Contact: Dorothy Jones (505) 988–2859 P.O. Box 77 Grant Amount: $638,610 Contact: Michael Varela Grant Amount: $646,500 Newport News, VA 23607–0077 Palatka Housing Authority (804) 247–9701 400 N. 15th Street Housing Authority of El Paso Contact: Judy Coleman Palatka, FL 32077 P.O. Box 9895 Grant Amount: $1,000,000 (904) 329–0132 El Paso, TX 79989–9895 Richmond Redevelopment & Housing Contact: Larry Shoeman (915) 532–5678 Contact: Sharon Busch Authority Grant Amount: $596,242 Grant Amount: $997,648 P.O. Box 26887 Clearwater Housing Authority Housing Authority of Fort Worth Richmond, VA 23261–6887 P.O. Box 960 (804) 644–9881 P.O. Box 430 Clearwater, FL 34617 Contact: Joan Seldon Fort Worth, TX 76101–0430 (813) 441–3643 Grant Amount: $999,860 (817) 336–2419 Contact: Deborah Vincent Contact: Barbara Holston Wise County Redevelopment & Housing Grant Amount: $999,349 Authority Grant Amount: $1,000,000 Housing Authority of Louisville P.O. Box 630 Housing Authority of San Angelo Coeburn, VA 70339–5587 420 South Eighth Street P.O. Box 1751 (703) 395–6104 Louisville, KY 40203 San Angelo, TX 76902–1751 Contact: Charles McConnell (502) 574–3420 (915) 657–4226 Grant Amount: $979,719 Contact: Kevin Fields Contact: Fred Contreras Grant Amount: $1,000,000 Suffolk Redevelopment & Housing Authority Grant Amount: $248,614 P.O. Box 3079 Knoxville Community Development Housing Authority of the City of Galveston Suffolk, VA 23439 Corporation 920 53rd Street (804) 925–6343 P.O. Box 3550 Galveston, TX 77551–1099 Contact: James Armstrong Knoxville, TN 39727 (409) 744–3641 Grant Amount: $426,318 (615) 521–8600 Contact: Walter Norris Contact: Becky Wade D.C. Department of Public and Assisted Grant Amount: $1,000,000 Grant Amount: $1,000,000 Housing Housing Authority of the City of Dumas 1133 North Capitol Street, NE Franklin County Housing Authority Box 115 Washington, DC 20002–7599 P.O. Box 68 Dumas, AR 71639–0115 (202) 535–1500 West Frankfurt, IL 62896–0068 (901) 382–5457 Contact: Joi Yeldell (618) 932–2124 Contact: Margaret Weaver Grant Amount: $1,000,000 Contact: Monica Stewart Grant Amount: $1,000,000 Housing Opportunity Commission, Grant Amount: $999,625 Housing Authority of New Iberia Montgomery County Lucus Metropolitan Housing Authority 325 North Street 10400 Detrick Avenue P.O. Box 477 New Iberia, LA 70560 Kensington, MD 20895 Toledo, OH 43692–0477 (318) 364–5515 (301) 933–9750 (419) 259–9400 Contact: Ernest Wilson Contact: Lillian Durham Contact: Arlene Hinson Grant Amount: $999,887 Grant Amount: $1,000,000 Grant Amount: $1,000,000 Low Rent Housing Agency of Clinton Housing Authority of the City of Macon Inkster Housing Commission 215 6th Aevenue South P.O. Box 4928 4500 Inkster Road Clinton, IA 52732 Macon, GA 31208–4928 Inkster, MI 48141–1871 (319) 243–1280 (912) 752–5070 (313) 561–2600 Contact: Jayne Jochem Contact: John Hiscox Contact: Floyd Simmons Grant Amount: $571,934 Grant Amount: $1,000,000 Grant Amount: $999,990 Southern Iowa Regional Housing Authority Florence Housing Authority Benton Township Housing Commission 219 North Pine Street 303 North Pine Street 1216 Blossom Lane Creston, IA 50801–2413 Florence, AL 35630 Benton Harbor, MI 49022 (515) 782–8585 (205) 764–3030 (616) 927–3541 Contact: Harold Riedel Contact: Shaler Roberts Contact: Sammie Smith Grant Amount: $449,200 Grant Amount: $997,296 Grant Amount: $1,000,000 Eastern Iowa Regional Housing Authority Columbia Housing Authority South Bend Housing Authority P.O. Box 1140 1917 Harden Street P.O. Box 11057 Dubuque, IA 52004–1140 Columbia, SC 29204–1015 South Bend, IN 46634–0057 (319) 556–4166 (803) 254–3886 (219) 235–9346 Contact: Jerelyn O’Connor Contact: George Ray Contact: Barbara Lawson Grant Amount: $353,000 Grant Amount: $638,488 Grant Amount: $1,000,000 North Iowa Regional Housing Authority Housing Authority of the City of Charlotte Indianapolis Housing Authority 217 2nd Street, SW P.O. Box 36795 410 North Meridian Mason City, IA 50401 Charlotte, NC 28236 Indianapolis, IN 46204–1790 (515) 423–0897 (704) 336–5221 (317) 634–2361 Contact: Karen McGreevey Contact: John Hayes Contact: Marcia Pierce Grant Amount: $997,921 Grant Amount: $999,118 Grant Amount: $995,794 Olathe Housing Authority 6728 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices P.O. Box 768 Fresno, CA 93706 P.O. Box 436 Olathe, KS 66061–0768 (209) 443–8493 White Earth, MN 56591 (913) 782–2600 Contact: Donna McBrien (218) 983–3285 Contact: Joyce Keys Grant Amount: $1,000,000 Contact: Mary Heisler Grant Amount: $688,121 Housing Authority of the County of Kings Grant Amount: $1,000,000 Scotts Bluff County Housing Authority 680 North Douty Absentee Shawnee Indian Housing Authority 89A Woodley Park Road Hanford, CA 93230 P.O. Box 425 Gering, NE 69341–1633 (209) 582–2806 Shawnee, OK 74802–0425 (308) 635–3815 Contact: Tracy Insley (405) 273–1050 Contact: Don Neureuther Grant Amount: $177,827 Contact: Sherry Wilson Grant Amount: $408,000 Housing Authority of the City of Las Vegas Grant Amount: $1,000,000 Housing Authority of Saint Louis County 420 North 10th Street Cheyenne River Indian Housing Authority 8865 Natural Bridge Las Vegas, NV 89101 P.O. Box 480 St. Missouri, MO 63121–0580 (702) 386–2727 Eagle Butte, SD 57625 (314) 428–7948 Contact: Paula McDonald (605) 964–4265 Contact: Julia Tibbs Grant Amount: $999,750 Contact: Wayne Ducheneaux Grant Amount: $1,000,000 Alaska Housing Finance Corporation Grant Amount: $430,000 Fort Collins Housing Authority P.O. Box 230329 Menominee Tribal Indian Housing Authority 1715 West Mountain Anchorage, AK 99523–0329 P.O. Box 459 Ft. Collins, CO 80521 (907) 562–2813 Keshena, WI 54135–0459 (303) 221–5484 Contact: James Gurke (715) 799–3236 Contact: Rochelle Stephens Grant Amount: $789,648 Contact: Brian Van Enkenvoort Grant Amount: $830,495 Housing Authority of Portland Grant Amount: $1,000,000 Helena Housing Authority 135 Southwest Ash 812 Abbey Street Portland, OR 97204 [FR Doc. 95–2692 Filed 2–2–95; 8:45 am] Helena, MT 59601 (503) 228–2178 BILLING CODE 4210±33±P (406) 442–7970 Contact: Paul Parker Contact: Joanne Hale Grant Amount: $1,000,000 Grant Amount: $1,000,000 Housing Authority of the City of Salem Sioux Falls Housing & Redevelopment P.O. Box 808 DEPARTMENT OF THE INTERIOR Commission Salem, OR 97308–0808 804 S. Minnesota Avenue (503) 588–6443 Bureau of Land Management Sioux Falls, SD 57104 Contact: Kevin McTeague (605) 331–0704 Grant Amount: $492,757 [OR±015±95±1610±00: G5±063] Contact: Gloria Maher Lincoln County Housing Authority Grant Amount: $342,865 P.O. Box 1470 Proposed Perlite Mining Operation, Housing Authority County of Salt Lake Newport, OR 97365 Lake County, Oregon; Intent to Prepare 1962 South 200 East (503) 265–5326 an Environmental Impact Statement Salt Lake City, UT 84115 Contact: Georgia Stone (801) 487–5453 Grant Amount: $738,032 AGENCY: Bureau of Land Management Contact: Mary Thompson Housing Authority of the City of Tacoma (BLM), DOI. Grant Amount: $1,000,000 1728 East 44th Street ACTION: Notice of Intent to prepare an Housing Authority of Salt Lake City Tacoma, WA 98404–4699 1776 S.W. Temple (206) 479–3694 Environmental Impact Statement (EIS) Salt Lake City, UT 84115 Contact: Patricia Harrington for a proposed mining operation. (801) 487–2161 Grant Amount: $1,000,000 SUMMARY: The Lakeview District is Contact: Terry Feveryear Spokane Housing Authority initiating the EIS process to analyze the Grant Amount: $1,000,000 West 55 Mission Street potential environmental impacts of a Housing Authority of the City of Los Angeles Spokane, WA 99201–2044 proposed perlite mining operation in P.O. Box 17157 (509) 328–2953 Lake County, Oregon. Atlas Perlite, Inc. Los Angeles, CA 90017 Contact: Ruth Robinson (213) 252–2500 Grant Amount: $608,783 is proposing to develop a 15–20 acre Contact: Milton Patterson quarry and associated waste rock dump Grant Amount: $1,000,000 Indian Housing Authorities on Tucker Hill located approximately 35 State of Hawaii Housing Authority Seminole Tribe of Florida northwest of the town of Lakeview, P.O. Box 17907 3101 Northwest 63rd Avenue Oregon. The ore would be hauled from Honolulu, HI 96717 Hollywood, FL 33024 Tucker Hill to Lakeview where it would (808) 848–3230 (305) 983–6727 be crushed and transported via rail to Contact: Bella Belmonte Contact: Peggie Reynolds markets mainly in the northwest. This Grant Amount: $1,000,000 Grant Amount: $999,209 notice has been given so interested or Housing Authority of the City of Oxnard Choctaw Nation Indian Housing Authority affected people may participate and 1470 Colonia Road P.O. Box G contribute to the final decision. Oxnard, CA 93030–3714 Hugo, OK 74743 (805) 385–8089 (405) 326–7521 DATES: This notice constitutes the Contact: M. Bernard Carn Contact: Gary Batton beginning of the 30-day public scoping Grant Amount: $1,000,000 Grant Amount: $1,000,000 process. Interested individuals, Chandler Housing & Redevelopment Division Cherokee Nation Indian Housing Authority organizations, and other agencies are 99 North Delaware Street P.O. Box 1007 encouraged to review the proposal and Chandler, AZ 85225–5577 Tahlequah, OK 74465 provide written comments on or before (602) 786–2600 (918) 456–5482 March 6, 1995 to the address below. Contact: Jennifer Morrison Contact: Joel Thompson Grant Amount: $483,372 Grant Amount: $918,024 ADDRESSES: Scott Florence, Area Housing Authority of the City of Fresno White Earth Reservation Indian Housing Manager, Lakeview Resource Area, 1833 ‘‘E’’ Street Authority BLM, PO Box 151, Lakeview, OR 97630. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6729 FOR FURTHER INFORMATION CONTACT: Ted In exchange for these lands, the Dated: January 24, 1995 Davis, Project Coordinator, at address United States will acquire the following Ken Knowles, above or telephone (503–947–2177). described lands from Dale Klingler: Environmental Protection Specialist. SUPPLEMENTARY INFORMATION: The BLM T. 7 S., R. 26 E., B.M., Blaine County [FR Doc. 95–2638 Filed 2–2–95; 8:45 am] will consider issues and concerns Sec. 16: All. BILLING CODE 4310±66±P identified during the scoping process in The area described contains 640 acres, the preparation of the draft EIS. The more or less. preliminary issues identified include DATES: The publication of this notice in Bureau of Land Management potential impacts to traditional Native the Federal Register will segregate the [ID±014±4210±05; IDI±29418] American uses of the area, public lands described above to the archaeological sites, wildlife, visual extent that they will not be subject to Realty Action; Bureau Motion quality, native plants, noxious weeds, appropriation under the public land Recreation and Public Purposes and socio-economics. Those laws, including the mining laws. As (R&PP) Act Classification; Idaho individuals, organizations, and agencies provided by the regulations of 43 CFR with a known interest in the proposal 2201.1(b), any subsequently tendered AGENCY: Bureau of Land Management, have been sent a scoping letter application, allowance of which is Interior. requesting comments on the proposal. discretionary, shall not be accepted, SUMMARY: The following public lands Persons wishing to be added to the shall not be considered as filed and near the City of Cascade, Valley County, mailing list for this EIS may do so by shall be returned to the applicant. The Idaho have been examined and found contacting Ted Davis. At this time there segregative effect of this notice will suitable for classification for lease to the is no formal scoping meeting planned, terminate upon issuance of patent or in City of Cascade under the provisions of though one could be scheduled if there two years, whichever occurs first. the Recreation and Public Purposes Act, is sufficient interest. ADDRESSES: Detailed information as amended (43 U.S.C. 869 et seq.). The The comment period on the draft EIS concerning the exchange is available for City of Cascade proposes to use the will last 60 days from the date the U.S. review at the Burley District Office, 200 lands for a park in connection with their EPA Notice of Availability appears in South Oakley Highway, Burley, Idaho North Fork Payette River Greenway. the Federal Register and EIS is expected 83318. Boise Meridian, Idaho to be available for review in August SUPPLEMENTARY INFORMATION: The 1995. Because of recent court rulings, it T. 13 N., R. 4 E., purpose of the land exchange is to is very important that those interested Section 6: Lot 2 facilitate more efficient management of in the proposed action participate Containing 8.7 acres more or less. the public lands through consolidation during the scoping and draft EIS review of ownership and to benefit the public The lands are not needed for Federal processes, so that any substantive interest by obtaining important resource purposes. A lease is consistent with comments are provided at a time when values. The public lands to be current BLM land use planning and the BLM can meaningfully consider exchanged are isolated and difficult to would be in the public interest. them. manage parcels with limited resource The lease, when issued, will be Ed Singleton, values. The private lands being offered subject to the following terms, District Manager. would significantly improve the land conditions, and reservations: [FR Doc. 95–2637 Filed 2–2–95; 8:45 am] ownership pattern in the area and 1. Provisions of the Recreation and Public Purposes Act and to all BILLING CODE 4310±33±P provide key access to a large block of public land. The exchange is consistent applicable regulations of the Secretary of the Interior. [ID±020±1430±01; I±29055] with the Bureau of Land Management land use plan for the area which is the 2. All minerals shall be reserved to the United States, together with the Exchange of Public Lands in Blaine Monument Resource Management Plan right to prospect for, mine, and remove County, Idaho; Realty Action (approved February, 1986 and amended January, 1992). The public interest will the minerals. AGENCY: Bureau of Land Management, be served by making this exchange. 3. Lessee shall adhere to the proposed Interior. The value of the lands to be development plan and shall obtain ACTION: Notice of Realty Action; exchanged has been determined through written approval from the Authorized Exchange of Public Lands in Blaine appraisal to be equal. Officer prior to any changes in the County, Idaho. The exchange will be subject to: development plan. 1. All valid existing rights of record, 4. Lessee shall include the Bureau of SUMMARY: The following described including but not limited to, electric Land Management as an interested party public lands have been determined to be power distribution line rights-of-way, I– on any revisions of the North Fork of the suitable for disposal by exchange under 29552 and I–14412. Payette River Greenway Plan. Section 206 of the Federal Land Policy 2. A reservation to the United States 5. Lessee shall have all proper and Management Act of 1976, 43 U.S.C. of a right-of-way for ditches and canals. permits, specifically including but not 1716: For a period of 45 days from the date limited to the permits from the Corps of T. 7 S., R. 26 E., B.M., Blaine County of publication of this notice in the Engineers and/or the Idaho Department Sec. 20: ESE; Federal Register, interested parties may of Water Resources for disturbance of Sec. 21: SW1⁄4; submit comments to the Snake River any wetland/riparian areas, prior to any Sec. 28: NW1⁄4, SW1⁄4SW1⁄4; Area Manager at the above address. construction activities. Sec. 29: E1⁄2NE1⁄4. Objections will be reviewed by the State 6. All merchantable timber shall be T. 8 S., R. 26 E., B.M., Blaine County Director who may sustain, vacate, or reserved to the BLM. The City of Sec. 4: W1⁄2SW1⁄4 modify this realty action. In the absence Cascade will reimburse the BLM for the Sec. 5: SE1⁄4SE1⁄4 of any objections, this realty action will value of the merchantable trees removed The area described contains 640 acres, become the final determination of the or at the Authorized Officer’s discretion more or less. Department of the Interior. the BLM will authorize their removal 6730 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices under a timber sale contract or related SUMMARY: The following described purposes in accordance with the authorization. public land in Henderson, Clark County, transportation plan for Clark County 7. Any signs for the subject park will Nevada has been examined and found and the City of Henderson. include a reference that the land was suitable for sale utilizing modified- The land will be offered for sale at obtained from the Bureau of Land competitive procedures, at not less than public auction beginning at 10:00 am Management. Detailed information the fair market value. Authority for the PST on April 19, 1995, at 4765 West concerning this action is available for sale is Section 203 and Section 209 of Vegas Drive, Las Vegas, Nevada 89108. review at the office of the Bureau of the Federal Land Policy and This sale will be by modified Land Management, Boise District, 3948 Management Act of 1976 (FLPMA). competitive procedures. City of Henderson will be given the Development Avenue, Boise, Idaho. Mount Diablo Meridian, Nevada Upon publication of this notice in the opportunity to meet the highest bid T. 21 S., R. 62 E., Federal Register, the lands will be 1 1 received at public auction. Sale will be Sec. 35: NE ⁄4SW ⁄4. by sealed bid only. All sealed bids must segregated from all forms of Containing 40.00 acres, more or less. appropriation under the public land be submitted to the BLM’s Las Vegas laws, including the general mining laws, Fair Market Value (FMV) $1,020,000.00 District Office at 4765 W. Vegas Drive, except for lease or conveyance under This land is not required for any Las Vegas, Nevada 89108, no later than the Recreation and Public Purposes Act federal purpose. The sale is consistent 4:15 pm PST, April 18, 1995. Bid and leasing under the mineral leasing with current Bureau planning for this envelopes must be marked on the letter laws. For a period of 45 days from the area and would be in the public interest. front corner with the parcel number and date of publication of this notice, In the event of a sale, conveyance, of sale date. Bids must be for not less than interested persons may submit the available mineral interests will the appraised FMV specified in this comments regarding the proposed lease occur simultaneously with the sale of notice. Each sealed bid shall be or classification of the lands to the the land. The mineral interests being accompanied by a certified check, postal District Manager, Boise District Office, offered for conveyance have no known money order, bank draft or cashier’s 3948 Development Avenue, Boise, Idaho mineral value. Acceptance of a sale offer check made payable to the Department 83705. will constitute an application for of the Interior, BLM for not less than 20 CLASSIFICATION COMMENTS: Interested conveyance of those mineral interests. percent of the amount bid. parties may submit comments involving The applicant will be required to pay a Federal law requires that all bidders the suitability of the lands for a park. $50.00 nonreturnable filing fee for must be U.S. citizens 18 years old or Comments on the classification are conveyance of the available mineral older, or in the case of corporations, be restricted to whether the land is interests. subject to the laws of any State of the physically suited for the proposal, The patent, when issued, will contain U.S. Proof of these requirements must whether the use will maximize the the following reservations to the United accompany the bid. Under modified competitive sale future use or uses of the land, whether States: procedures, an apparent high bid will be the use is consistent with local planning 1. A right-of-way thereon for ditches declared at public auction. The apparent and zoning, or if the use is consistent and canals constructed by the authority of the United States, Act of August 30, high bidder and the designated bidder, with State and Federal programs. City of Henderson, will be notified. The APPLICATION COMMENTS: Interested 1890 (43 U.S.C. 945). 2. Oil, gas, sodium, potassium and designated bidder shall have 30 days parties may submit comments regarding from the date of the sale to exercise the the specific use proposed in the saleable minerals and will be subject to: 1. Those rights for airport marker preference consideration given to meet application and plan of development, purposes which have been granted to the high bid. Should the designated whether the BLM followed proper the Federal Aviation Administration by bidder fail to submit a bid that matches administrative procedures in reaching Permit No. N–4245 under the authority the apparent high bid with the specified the decision, or any other factor not of (44LD513). time period, the apparent high bidder, directly related to the suitability of the 2. Those rights for natural gas shall be declared high bidder. The total land for a park. pipeline purposes which have been purchase price for the land shall be paid Any adverse comments will be granted to Southwest Gas Corporation within 180 days of the date of the sale. reviewed by the State Director. In the by Permit No. NEV–015814 under The purchaser will be required to absence of any adverse comments, the section 28 of the Mineral Leasing Act of reimburse the BLM for the costs of classification will become effective 60 1920 (30 U.S.C. 185). publication of this notice. days from the date of publication of this 3. Those rights for water pipeline Upon publication of this notice in the notice. purposes which have been granted to Federal Register, the above described Dated: January 23, 1995. Las Vegas Valley Water District by land will be segregated from all other David Vail, Permit No. NEV–043457 under the Act forms of appropriation under the public Acting District Manager. of October 21, 1976 (43 U.S.C. 1719). land laws, including the general mining [FR Doc. 95–2639 Filed 2–2–95; 8:45 am] 4. Those rights for a public road laws, except for sales and disposals under the mineral disposal laws. This BILLING CODE 4310-gg-p which have been granted to the City of Henderson by Permit No. 31767 under segregation will terminate upon the Act of October 21, 1967 (43 U.S.C. issuance of a patent or 270 days from [NV±930±1430±01; N±59553] 1719). the date of this publication, whichever 5. Those rights for highway (Boulder comes first. Realty Action: Modified-Competitive Highway) purposes which have been For a period of 45 days from the date Sale of Public Lands granted to the Nevada Department of of publication of this notice in the AGENCY: Bureau of Land Management, Transportation by Permit No. CC– Federal Register, interested parties may Interior. 018944 under the Act of November 9, submit comments to the District Manager, Las Vegas District, 4765 West ACTION: Modified-Competitive Sale of 1921 (42 U.S.C. 216). And is also subject to easements for Vegas Drive, Las Vegas, Nevada 89108. Public Lands in Clark County, Nevada. roads, public utilities and flood control Any adverse comments will be reviewed Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6731 by the State Director who may sustain, west boundaries, subdivisional lines, alternative, a 13-mile-long paved road vacate, or modify this realty action. In and the meanders of the left bank of the would be constructed in the shoreline the absence of any adverse comments, Snake River in section 8, the zone of Pictured Rocks National his realty action will become the final subdivision of sections 6, 7, and 8, the Lakeshore. The proposed road would determination of the Department of the survey of the 1994 meanders of the right connect on both ends with Alger County Interior. The Bureau of Land bank of the Snake river in section 6, and Road H–58. Two spur roads would be Management may accept or reject any or a metes-and-bounds survey in sections 6 constructed off the main road to two all offers, or withdraw any land or and 7, T.4 S., R.2 E., Boise Meridian, overlooks. These overlooks would interest in the land from sale, if, in the Idaho, Group No. 881, was accepted provide views of Beaver Basin, Beaver opinion of the authorized officer, January 20, 1995. Lake, Grand Portal Point, the Sevenmile consummation of the sale would not be This survey was executed to meet Creek area, and Lake Superior. Two fully consistent with FLPMA, or other certain administrative needs of the other alternatives are also considered: applicable laws. The lands will not be Bureau of Land Management. the no action alternative, and an offered for sale until at least 60 days All inquiries concerning the survey of alternative under which a new paved after the date of publication of this the above described land must be sent road would be constructed within the notice in the Federal Register. to the Chief, Branch of Cadastral Survey, inland buffer zone of the national Idaho State Office, Bureau of Land Dated: January 19, 1995. lakeshore. Management, 3380 Americana Terrace, Lorraine Buck, The impacts of the proposed action on Boise, Idaho, 83706. the natural resources of the national Acting District Manager. Dated: January 26, 1995. lakeshore are expected to be minor. [FR Doc. 95–2640 Filed 2–2–95; 8:45 am] Gary T. Oviatt, However, significant social impacts BILLING CODE 4310±HC±M Acting Chief Cadastral Surveyor for Idaho. could occur, particularly in the Grand [FR Doc. 95–2642 Filed 2–2–95; 8:45 am] Marais area. The proposed action will [ID±942±04±1420±000] BILLING CODE 4310±66±M also result in changes to visitor experience in the affected portion of the Idaho: Filing of Plats of Survey; Idaho national lakeshore. The plat of the following described National Park Service DATES: Comments on the draft EIS land was officially filed in the Idaho should be received no later than March Beaver Basin Rim Road, Draft 20, 1995. State Office, Bureau of Land Environmental Impact Statement Management, Boise, Idaho, effective The dates, times and locations of 9:00 a.m., January 26, 1995. AGENCY: National Park Service, Interior. public meetings regarding the DEIS are: The plat representing the dependent ACTION: Availability of draft Saturday, February 11, 1995, 3:00–5:00 resurvey of portions of the north environmental impact statement for the pm, Sheraton Oaks Hotel, 27000 boundary and subdivisional lines, the proposed Beaver Basin Rim Road at Sheraton Drive, Novi, Michigan subdivision of section 4, and the survey Pictured Rocks National Lakeshore, Sunday, February 12, 1995, 2:00–4:00 of a portion of the center line of U.S. Alger County, Michigan; announcement pm, Holiday Inn South Convention Highway No. 93 and lots 9, 14, 15, 18, of public meetings for the purpose of Center, 6820 South Cedar Street, and 19 in section 4, and of lot 9 in receiving public comments on the draft Lansing, Michigan section 5, T. 13 N., R. 19 E., Boise environmental impact statement for the Monday, February 13, 1995, 7:00–9:00 Meridian, Idaho, Group No. 869, was Beaver Basin Rim Road. pm, Comfort Inn, 4155 28th Street, accepted January 24, 1995. SE, Grand Rapids, Michigan This survey was executed to meet SUMMARY: Pursuant to section 102(2)(c) Wednesday, February 15, 1995, 7:00– certain administrative needs of the of the National Environmental Policy 9:00 pm, Grand Marais Recreation Bureau of Land Management. Act of 1969, the National Park Service Center, Grand Marais, Michigan All inquiries concerning the survey of (NPS) announces the availability of a Thursday, February 16, 1995, 7:00–9:00 the above described land must be sent draft environmental impact statement pm, Comfort Inn, M–28 East, to the Chief, Branch of Cadastral Survey, (DEIS) for the proposed Beaver Basin Munising, Michigan Rim Road in Pictured Rocks National Idaho State Office, Bureau of Land Friday, February 17, 1995, 7:00–9:00 Lakeshore. The NPS proposes to Management, 3380 Americana Terrace, pm, Ramada Inn, 2750 Ramada Way, construct a paved road in Pictured Boise, Idaho, 83706. Green Bay, Wisconsin Rocks National Lakeshore along the Dated: January 26, 1995. Beaver Basin Rim. The action is being ADDRESSES: Comments on the DEIS Gary T. Oviatt, proposed in response to a mandate by should be submitted to: Superintendent, Acting Chief Cadastral Surveyor for Idaho. Congress in section 6 of the Act of Pictured Rocks National Lakeshore, P.O. [FR Doc. 95–2641 Filed 2–2–95; 8:45 am] October 15, 1966, 16 U.S.C. 460s– Box 40, Munising, MI 49862, 906–387– BILLING CODE 4310±66±M 5(b)(1), establishing Pictured Rocks 2607. National Lakeshore, directing the SUPPLEMENTARY INFORMATION: Public development of a scenic shoreline drive. reading copies of the DEIS will be [ID±942±04±1420±00] The proposed action is also consistent available for review at the Department Idaho: Filing of Plat of Survey; Idaho with and would implement the of Interior Natural Resources Library, management directions of the 1981 1849 C Street, NW., Washington, DC The plat of the following described general management plan for the 20240; Pictured Rocks National land was officially filed in the Idaho national lakeshore. The DEIS was Lakeshore, Sand Point Road, Munising, State Office, Bureau of Land prepared by the NPS. Michigan 49862; Burt Township Office, Management, Boise, Idaho, effective The NPS’s preferred alternative for Grand Marais, Michigan 49839; 9:00 a.m., January 26, 1995. the Beaver Basin Rim Road is identified Munising Public Library, Munising, The plat representing the dependent in the DEIS as Alternative B: Shoreline Michigan 49862; Peter White Public resurvey of portions of the north and Zone Alignment. Under the preferred Library, Marquette, Michigan 49855; 6732 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices and selected public libraries in cities transparency, etc.) and limitations of written statements concerning the where public meetings will be held. foreign commitments agreed upon in matters to be addressed by the FOR FURTHER INFORMATION CONTACT: April 1994. Commission in its report on this Superintendent, Pictured Rocks The Commission will seek to provide investigation. Commercial or financial National Lakeshore at the address or such information in its report. As information that a submitter desires the phone number listed above. requested by the USTR, the Commission to treat as confidential Commission, in its examination of must be submitted on separate sheets of Dated: January 20, 1995. foreign schedules, will focus on sector- paper, each clearly marked Catherine A. Damon, specific commitments pertaining to the ‘‘Confidential Business Information’’ at Acting Regional Director, Midwest Region, following service sectors of the the top. All submissions requesting National Park Service. European Union, Japan, Canada, and confidential treatment must conform [FR Doc. 95–2713 Filed 2–2–95; 8:45 am] Mexico: with the requirements of section § 201.6 BILLING CODE 4310±70±M • Distribution services (defined as of the Commission’s Rules of Practice wholesaling, retailing, and franchising and Procedure (19 CFR 201.6). All services); written submissions, except for INTERNATIONAL TRADE • Education services; confidential business information, will COMMISSION • Communications services (e.g., be made available in the Office of the [Investigation 332±358] enhanced telecommunication services, Secretary of the Commission for courier services, and audiovisual inspection by interested parties. To be General Agreement on Trade in services); assured of consideration by the Services: Examination of Major • Health care services; Commission, written statements relating Trading Partners' Schedules of • Professional services (e.g. to the Commission’s report should be Commitments accounting, engineering, construction, submitted to the Commission at the architectural, and advertising services, earliest practical date and should be AGENCY: International Trade and lawyers); received no later than the close of Commission. • Transportation services (defined as business on June 21, 1995. All ACTION: Institution of investigation and rail and trucking services); and submissions should be addressed to the scheduling of public hearing. • Travel and tourism. Secretary, United States International In addition, as requested by the Trade Commission, 500 E Street SW, EFFECTIVE DATE: January 26, 1995. USTR, the Commission will examine Washington, DC 20436. SUMMARY: Following receipt on January horizontal commitments regarding the Persons with mobility impairments 4, 1995, of a request from the Office of temporary entry and stay of certain who will need special assistance in the United States Trade Representative foreign workers. gaining access to the Commission (USTR), the Commission instituted As requested by the USTR, the should contact the Office of the investigation No. 332–358, General Commission plans to deliver its report Secretary at (202- 205–2000). Agreement on Trade in Services: to the USTR by December 15, 1995. By order of the Commission. Examination of Major Trading Partners’ PUBLIC HEARING: A public hearing in Issued: January 27, 1995 Schedules of Commitments. connection with the investigation will Donna R. Koehnke, FOR FURTHER INFORMATIONCONTACT: be held at the U.S. International Trade Secretary. Information on service industries may Commission Building, 500 E Street SW, [FR Doc. 95–2684 Filed 2–2–95; 8:45 am] be obtained from Mr. Richard Brown, Washington, DC, beginning at 9:30 a.m. Office of Industries (202–205–3438) and on June 7, 1995. All persons shall have BILLING CODE 7020±02±P Ms. Julie Throne, Office of Industries the right to appear, by counsel or in (202–205–3390); economic aspects, from person, to present information and to be Mr. Joseph Flynn, Office of Economics heard. Requests to appear at the public DEPARTMENT OF JUSTICE (202–205–3251); and legal aspects, from hearing should be filed with the Lodging of Consent Decree Pursuant Mr. William Gearhart, Office of the Secretary, United States International to the Clean Water Act General Counsel (202–205–3091). The Trade Commission, 500 E Street SW, media should contact Ms. Margaret Washington, DC 20436, no later than In accordance with Departmental O’Laughlin, Office of Public Affairs 5:15 p.m., May 24, 1995. Any Policy, 28 CFR 50.7, notice is hereby (202–205–1819). Hearing impaired prehearing briefs (original and 14 given that a consent decree in United individuals are advised that information copies) should be filed no later than States of America v. Commonwealth of on this matter can be obtained by 5:15 p.m., May 24, 1995. The deadline Massachusetts, Executive Office for contacting the TDD terminal on (202– for filing posthearing briefs or Administration and Finance, Division of 205–1810). statements is 5:15 p.m., June 21, 1995. Capital Planning and Operations; and BACKGROUND: The USTR in his letter In the event that, as of the close of Dimeo Construction Company, Civ. Act. dated December 28, 1994, requested that business on May 24, 1995, no witnesses No. 93–10280 WD (D. Mass.), was the Commission, pursuant to section are scheduled to appear at the hearing, lodged with the United States District 332(g) of the Tariff Act of 1930, conduct the hearing will be cancelled. Any Court for the District of Massachusetts an investigation to (1) examine the person interested in attending the on January 13, 1995. The proposed content of foreign schedules of hearing as an observer or non- decree concerns alleged violations of the commitments under the General participant may call the Secretary to the Clean Water Act, 33 U.S.C. 1311, as a Agreement on Trade in Services, Commission (202–205–2000) after May result of the discharge of fill materials explaining the commitments in non- 24, 1995 to determine whether the onto approximately 11.6 acres of technical language; and (2) identify the hearing will be held. wetlands by the Commonwealth of potential benefits (e.g., improved market WRITTEN SUBMISSIONS: In lieu of or in Massachusetts (‘‘Commonwealth’’) and access, national treatment, MFN addition to participating in the hearing, its general contractor, Dimeo treatment, greater regulatory interested parties are invited to submit Construction Company (‘‘Dimeo’’), Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6733 during the construction of the Bristol [AAG/A Order No. 97±95] a series of new approvals as required by County House of Corrections on Faunce the CMPPA. The CMPPA provides that Corner Road in Dartmouth, Privacy Act of 1974 as Amended by the based upon approval by agency Data Massachusetts, without a permit issued Computer Matching and Privacy Integrity Boards of a new computer Protection Act of 1988 pursuant to 33 U.S.C. 1344. matching agreement, computer matching activities may be conducted The Consent Decree requires that the This notice is published in the for 18 months and, contingent upon Commonwealth pay a civil penalty of Federal Register in accordance with the requirements of 5 U.S.C. 552a(e)(12). specific conditions, may be similarly $50,000; perform a $1.5 million off-site extended by the Board for an additional compensatory mitigation project; pay The Immigration and Naturalization Service (INS), Department of Justice (the year without the necessity of a new $378,000 in the event the agreement. The most recent one-year Commonwealth sells the undeveloped source agency), is participating in a computer matching program with the extension for this program will expire area around the House of Corrections; March 9, 1995. Therefore, the and provide a $150,000 endowment to Massachusetts Department of Employment and Training (MA–DET) Department’s Data Integrity Board has the Massachusetts Audubon Society approved a new agreement to permit the (‘‘MAS’’) for the management of 264 (the receipt agency). The matching program entitled ‘‘Systematic Alien continuation of the above-named acres of wetlands that will be conveyed Verification for Entitlements (SAVE)’’ computer matching program for another to MAS pursuant to a settlement will permit MA–DET to confirm the 18-month period from the effective date agreement in another Clean Water Act immigration status of alien applicants (described below). Matching activity under the new enforcement matter. Dimeo is required for, or recipients of, Federal benefits agreement will be effective (1) 30 days to offer a comprehensive wetlands assistance (i.e., unemployment after publication of a computer training course to Dimeo’s employees compensation insurance) as required by matching notice in the Federal Register, and to members of the Associated section 121 of the Immigration Reform or (2) 40 days after a report concerning General Contractors of Massachusetts. and Control Act (IRCA) of 1986 (Pub. L. the computer matching program has The Department of Justice will receive 99–603). been transmitted to the Office of Section 121(c) of IRCA amends written comments relating to the Management and Budget and section 1137 of the Social Security Act consent decree for a period of thirty (30) transmitted to Congress along with a and requires agencies which administer days from the date of this notice. copy of the agreement, whichever is the Federal benefit programs designated Comments should be addressed to the later. The agreement (and matching within IRCA to use the INS verification Assistant Attorney General, activity) will continue for 18 months system to determine eligibility. Environment and Natural Resources from the effective date—unless within 3 Accordingly, through the use of user Division, U.S. Department of Justice, months prior to the expiration of the identification codes and passwords, Attention: Daniel W. Pinkston, 10th St. agreement, the Data Integrity Board authorized persons from MA–DET may and Pennsylvania Ave., NW., Room approves a one-year extension pursuant electronically access the data base of an 7303—Main Building, Washington, DC to 5 U.S.C. 552a(o)(2)(D). 20530, and should refer to United States Immigration and Naturalization Service In accordance with 5 U.S.C. 552a(o)(2) v. Commonwealth of Massachusetts and Privacy Act system of records entitled (A) and (r), the required report has been Dimeo Construction Co., DJ Reference ‘‘Alien Status Verification Index, provided to the Office of Management JUSTICE/INS–009.’’ From its automated No. 90–5–1–1–3710. and Budget, and to Congress together records system, MA–DET may enter The proposed consent decree may be with a copy of the agreement. electronically into the INS data base the Inquiries may be addressed to Patricia examined at the Office of the United alien registration number of the E. Neely, Staff Assistant, Systems Policy States Attorney for the District of applicant or recipient. This action will Staff, Justice Management Division, Massachusetts, 1107 John W. initiate a search of the INS data base for Department of Justice, Washington, DC McCormack Federal Bldg., U.S. P.O. & a corresponding alien registration 20530 (Room 850, WCTR Building). Courthouse, Boston, MA 02109, the number. Where such number is located, Region I Office of the United States MA–DET will receive electronically Dated: January 27, 1995. Environmental Protection Agency, from the INS data base the following Michael J. Roper, Office of Regional Counsel, 1 Congress data upon which to determine Acting Assistant Attorney General for Street, 10th Floor, Boston, MA and at eligibility: Alien registration number; Administration. the Consent Decree Library, 1120 G last name; first name; date of birth; [FR Doc. 95–2623 Filed 2–2–95; 8:45 am] Street, NW., 4th Floor, Washington, DC country of birth; Social Security number BILLING CODE 4410±10±M 20005 (202–624–0892). A copy of the (if available); date of entry; immigration proposed consent decree may be status data; and employment eligibility Antitrust Division obtained in person or by mail from the data. In accordance with 5 U.S.C. Consent Decree Library, 1120 G Street, 552a(p), MA–DET will provide the alien United States v. New England Fish NW., 4th Floor, Washington, DC 20005. applicant with 30 days’ notice and an Exchange, et al.; Proposed In requesting a copy, please enclose a opportunity to contest any adverse Termination of Final Decree check in the amount of $9.75 for a copy finding before final action is taken of the consent decree only, or $36.25, against that alien because of ineligible Notice is hereby given that defendant for both the consent decree and exhibits, immigration status as established New England Fish Exchange (‘‘NEFE’’) payable to the Consent Decree Library. through the computer match. has filed with the United States District The original effective date of the Court for the District of Massachusetts a Letitia J. Grishaw, matching program was February 28, motion to terminate the Final Decree Chief, Environmental Defense Section, 1990, for which notice was published in entered in United States v. New England Environment and Natural Resources Division. the Federal Register on January 29, Fish Exchange, et al., No. 810 Equity, [FR Doc. 95–2643 Filed 2–2–95; 8:45 am] 1990 (55 FR 2890). The program has and the Department of Justice BILLING CODE 4410±01±M continued to date under the authority of (‘‘government’’), in a stipulation also 6734 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices filed with the Court, has consented to from the Antitrust Division upon [TA±W±30,317] termination of the Final Decree, but has request and payment of the copying fee reserved the right to withdraw its set by Department of Justice regulations. Exxon Company, U.S.A., A/K/A Exxon consent based on public comments and Corporation; Southeastern Production Interested persons may submit Division, New Orleans, Louisiana for other reasons. comments regarding the proposed The Original Petition in this case was (Formerly Known as Eastern Division filed on June 21, 1917, and charged the termination of the Final Decree to the Production Department, New Orleans, NEFE, and 49 other businesses and government. Such comments must be Louisiana Under TA±W±26,798); A/K/A individuals, with combining and received within the sixty-day period New Orleans Production Organization conspiring to monopolize and restrain established by Court order, and will be New Orleans, Louisiana; Amended interstate trade and commerce in the filed with the Court by the government. Certification Regarding Eligibility To fresh fish industry in New England, in Comments should be addressed to Apply for Worker Adjustment violation of Sections 1 and 2 of the Ralph T. Giordano, Chief, New York Assistance Sherman Act and Section 7 of the Office, Antitrust Division, Department In accordance with Section 223 of the Clayton Act. Specifically, the Petition of Justice, New York, New York 10278 Trade Act of 1974 (19 U.S.C. 2273) the alleged that of the 40 member dealers of (telephone 212–264–0390). Department of Labor issued a the NEFE, 28 were owned by defendant Constance K. Robinson, Certification of Eligibility To Apply for dealer Boston Fish Pier Co. and 8 were Director of Operations. Worker Adjustment Assistance on owned by defendant dealer Boston Fish [FR Doc. 95–2644 Filed 2–2–95; 8:45 am] November 8, 1994, applicable to all Pier Co. and 8 were owned by defendant BILLING CODE 4410±01±M workers of the subject firm engaged in dealer Bay State Fishing Co. Because of employment related to the production of their monopoly power, Boston Fish Pier crude oil and condensate. Co. and Bay State Fishing Co. were able The certification notice was published to impose rules and regulations upon in the Federal Register on December 9, the NEFE that made it impossible for DEPARTMENT OF LABOR 1994 (59 FR 63823). boat captains to get fair prices for their Employment and Training At the request of the State Agency, the fish when it was auctioned off at the Administration Department again reviewed the NEFE. It was also virtually impossible certification for workers of the subject for non-NEFE members to purchase fish firm. New finding show a series of in Boston. [TA±W±30,216] The Final Decree: (i) prohibited the corporate and divisional name changes. NEFE’s practice of restricting its AEG Transportation Systems, On December 31, 1989, the employer membership to only those dealers Incorporated Pittsburgh, PA; account number for unemployment having offices on the Boston Fish Pier; Affirmative Determination Regarding insurance (UI) for the Exxon Company, (ii) ordered Boston Fish Pier Co. to Application for Reconsideration U.S.A., went inactive when a new UI divest and dissolve; (iii) ordered Bay account number bearing the name of the State Fishing Co. to divest; (iv) On November 30, 1994, the company Exxon Corporation becoming the prohibited the defendants from requested administrative successor account. ‘‘splitting trips’’, that is, entering into reconsideration of the Department of Further, the workers of Exxon action pools when lots of fish were Labor’s Notice of Negative Corporation’s Eastern Division being bid on. They were also enjoined Determination Regarding Eligibility to Production Department in New Orleans from ‘‘agreeing among themselves to Apply for Worker Adjustment certified earlier under TA–W–26,798 is raise or depress the price of fish; (v) Assistance for workers at the subject the same group of workers certified limited the NEFE’s annual return on firm. The Department’s Negative under this certification as Exxon capital to 8%; and (iv) prohibited the Determination was issued on October Corporation’s Southeastern Production NEFE from accumulating capital in 17, 1994 and was published in the Division in New Orleans with the name excess of $36,000, plus a safety fund of Federal Register on November 1, 1994 changing to the Exxon Corporation’s an additional $15,000. (59 FR 54631). New Orleans Production Organization The government has filed with the on September 1, 1994. Court a memorandum setting forth the The company submitted additional Other findings show a coverage reasons why the government believes information showing a lost major bid overlap between the Eastern Division that termination of the Final Decree that caused worker separations in 1994. Production Department of Exxon would serve the public interest. Copies Conclusion Corporation in New Orleans, Louisiana of the Petition, Final Decree, the from January 21, 1991 to February 11, Government’s Memorandum, motion After careful review of the 1994 (TA–W–26,798) and the papers and all further papers filed with application, I conclude that the claim is Southeastern Production Division of the Court in connection with this of sufficient weight to justify Exxon Corporation, New Orleans, motion will be available for inspection reconsideration of the Department of Louisiana from August 30, 1993 to at Room 3233, Antitrust Division, Labor’s prior decision. The application November 8, 1994 (TA–W–30,317). Department of Justice, 10th Street and is, therefore, granted. Accordingly, the Department is deleting Pennsylvania Avenue, N.W., the August 30, 1993 impact date for TA– Washington, D.C. 20530 (telephone Signed at Washington, D.C., this 24th day W–30,317 and inserting a new impact of January 1995. 202–633–2481), and at the Office of the date of February 11, 1994. Clerk of the United States District Court Victor J. Trunzo, The amended notice applicable to for the District of Massachusetts, United Program Manager, Policy and Reemployment TA–W–30,317 is hereby issued as States Courthouse, John W. McCormack Services, Office of Trade Adjustment follows: Assistance. Post Office and Courthouse Building, ‘‘All workers of the Southeastern Boston, Massachusetts 02109. Copies of [FR Doc. 95–2696 Filed 2–2–95; 8:45 am] Production Division of Exxon Company, any of these materials may be obtained BILLING CODE 4510±30±M U.S.A., A/K/A Exxon Corporation, New Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6735 Orleans Louisiana and its successor employment on or after January 5, 1992 are this case would serve no purpose, and appropriate subdivision New Orleans eligible to apply for adjustment assistance the investigation has been terminated. Production Organization of Exxon under Section 223 of the Trade Act of 1974.’’ Signed at Washington, D.C. this 18th day Corporation, New Orleans, Louisiana who Signed at Washington, DC, this 23rd day of of January, 1995. became totally or partially separated from January 1995. Victor J. Trunzo, employment on or after February 11, 1994 are Victor J. Trunzo, eligible to apply for adjustment assistance Program Manager, Policy and Reemployment Program Manager, Policy and Reemployment under Section 223 of the Trade Act of 1974.’’ Services, Office of Trade Adjustment Services, Office of Trade Adjustment Assistance. Signed in Washington, D.C., this 23rd day Assistance. of January 1995. [FR Doc. 95–2701 Filed 2–2–95; 8:45 am] [FR Doc. 95–2698 Filed 2–2–95; 8:45 am] Victor J. Trunzo, BILLING CODE 4510±30±M BILLING CODE 4510±30±M Program Manager, Policy and Reemployment Services, Office of Trade Adjustment Assistance. Investigations Regarding Certifications [TA±W±30,508; TA±W±30,509] [FR Doc. 95–2697 Filed 2–2–95; 8:45 am] of Eligibility To Apply for Worker BILLING CODE 4510±30±M Marathon Oil Company, Anchorage, Adjustment Assistance Alaska and Kenai, Alaska; Termination Petitions have been filed with the [TA±W±28,220] of Investigation Secretary of Labor under Section 221(a) of the Trade Act of 1974 (‘‘the Act’’) and M.C.M. Coats Incorporated, Hoboken, Pursuant to Section 221 of the Trade Act of 1974, an investigation was are identified in the Appendix to this New Jersey; Revised Determination on notice. Upon receipt of these petitions, Reopening initiated on November 21, 1994 in response to a worker petition which was the Director of the Office of Trade On January 18, 1995, the Department, filed on behalf of workers and former Adjustment Assistance, Employment on its own motion, reopened its workers at locations of Marathon Oil and Training Administration, has investigation for the former workers of Company, located in Anchorage, Alaska instituted investigations pursuant to the subject firm. The initial (TA–W–30, 508) and Kenai, Alaska, Section 221(a) of the Act. investigation resulted in a negative (TA–W–30, 509). The purpose of each of the determination on February 24, 1993 Workers at the above locations of investigations is to determine whether because the ‘‘contributed importantly’’ Marathon Oil Company are currently the workers are eligible to apply for test of the Group Eligibility covered under an existing certification adjustment assistance under Title II, Requirements of the Trade Act was not (TA–W–30, 455B). Consequently, Chapter 2, of the Act. The investigations met. The denial notice was published in further investigation in this case would will further relate, as appropriate, to the the Federal Register on March 22, 1993 serve no purpose, and the investigation determination of the date on which total (58 FR 15383). has been terminated. or partial separations began or threatened to begin and the subdivision A late response to the Department’s Signed at Washington, D.C. this 20th day customer survey shows that a major of the firm involved. of January 1995. The petitioners or any other persons customer accounting for a substantial James D. Van Erden, portion of the sales decline for M.C.M. showing a substantial interest in the Administrator, Office of Work-Based subject matter of the investigations may Coats’ switched its purchases from the Learning. subject firm to imports. request a public hearing, provided such [FR Doc. 95–2700 Filed 2–2–95; 8:45 am] Other findings show that the plant request is filed in writing with the closed on December 15, 1992 when all BILLING CODE 4510±30±M Director, Office of Trade Adjustment production workers were laid off. Assistance, at the address shown below, U.S. imports of women’s suits and not later than February 13, 1995. [TA±W±30,517] coats increased in 1993 compared to Interested persons are invited to 1992 and in 1992 compared to 1991. submit written comments regarding the Miles Chemical Laboratories, Haledon, subject matter of the investigations to Conclusion NJ; Termination of Investigation the Director, Office of Trade Adjustment After careful consideration of the new Pursuant to Section 221 of the Trade Assistance, at the address shown below, facts obtained on reopening, it is Act of 1974, an investigation was not later than February 13, 1995. concluded that increased imports of initiated on November 28, 1994 in The petitions filed in this case are articles like or directly competitive with response to a worker petition which was available for inspection at the Office of the women’s suits and coats produced filed on behalf of workers at Miles the Director, Office of Trade Adjustment by the subject firm contributed Chemical Laboratories, Haledon, New Assistance, Employment and Training importantly to the decline in production Jersey. Administration, U.S. Department of and to the total or partial separation of All workers were separated from the Labor, 200 Constitution Avenue, N.W., workers at the subject firm. In subject firm more than one year prior to Washington, D.C. 20210. accordance with the provisions of the the date of the petition. Section 223 of Signed at Washington, D.C. this 17th day Trade Act of 1974, I make the following the Act specifies that no certification of January, 1995. revised determination: may apply to any worker whose last Victor J. Trunzo, ‘‘All former workers of M.C.M., separation occurred more than one year Program Manager, Policy & Reemployment Incorporated, Hoboken, New Jersey who before the date of the petition. Services, Office of Trade Adjustment became totally or partially separated from Consequently, further investigation in Assistance. 6736 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices APPENDIX Date re- Date of peti- Petitioner (union/workers/firm) Location ceived tion Petition No. Articles produced Uarco, Inc (Wkrs) ...... Adrian, MI ...... 01/17/95 01/09/95 30,643 Continuous stock computer forms. Energizer Power Systems (Wkrs) ...... El Paso, TX ...... 01/17/95 01/06/95 30,644 Rechargable batteries. Mitchell Energy Corp (Co) ...... Columbus, OH ...... 01/17/95 01/03/95 30,645 Crude oil. Enterra Oilfield Rental Co (Wkrs) ...... Odessa, TX ...... 01/17/95 12/29/94 30,646 Oilfield equipment rental. Amerada Hess Corp (Wkrs) ...... Houston, TX ...... 01/17/95 01/04/95 30,647 Oil and gas. Seagull Mid-South, Inc (Wkrs) ...... Shreveport, LA ...... 01/17/95 01/06/95 30,648 Oil and gas. Dee Exploration, Inc (Co) ...... Whitesboro, TX ...... 01/17/95 01/04/95 30,649 Crude oil exploration and drilling. Lynn Alison Manufacturing Co (Wkrs) Pittston, PA ...... 01/17/95 01/05/95 30,650 Ladies' dresses. Elbit Ft. Worth (Wkrs) ...... Ft. Worth, TX ...... 01/17/95 01/04/95 30,651 Cables and harnesses for F±16 planes. The Coach Factory (LGPN) ...... Carlstadt, NJ ...... 01/17/95 01/03/95 30,652 Leather handbags and accessories. Licensed Clothing (Co) ...... Saddle Brook, NJ ... 01/17/95 01/04/95 30,653 Tee shirts. Guardian Manufacturing Co, Inc Woodstock, IL ...... 01/17/95 01/03/95 30,654 Relays, switches and aerospace grip (Wkrs). assem. LaVelle Powder Co (Wkrs) ...... Butte, MT ...... 01/17/95 03/27/94 30,655 Truck transportation. Becton Dickinson & Co (Wkrs) ...... Franklin Lakes, NJ . 01/17/95 12/26/94 30,656 Ship merchandise to Latin America. JPS Converter and Industrial Corp Laurens, SC ...... 01/17/95 01/06/95 30,657 Griege goods. (Wkrs). [FR Doc. 95–2695 Filed 2–2–95; 8:45 am] (6) New Mexico (TA–W–30,277F); (7) compared to 1992 and in the first six BILLING CODE 4510±30±M Texas (TA–W–30,277G); (8) Utah (TA– months of 1994 compared to the same W–30,277H); (9) Wyoming (TA–W– period in 1993. Corporate-wide 30,277I); and (10) Oklahoma (TA–W– production of natural gas liquids of the [TA±W±30,277; TA±W±30,277A±J] 30,277J). Workers at Union Oil subject firm declined in 1993 compared Union Oil Company of California (d.b.a. Company of California (UNOCAL), to 1992. UNOCAL) Sugar Land, Texas, et al. headquartered in Sugar Land, Texas Employment of workers at Union Oil (TA–W–30,277) and operating in Company of California (UNOCAL) Union Oil Company of California (d.b.a. UNOCAL) Operating at various locations in various locations in the following states declined in 1993 compared to 1992 and the following States: TA–W–30,277A of this entity of the Company (TA–W– in the first six months of 1994 compared Alabama, TA–W–30,277B Illinois, TA–W– 30,277A–J) are engaged in employment to the same period in 1993 (TA–W– 30,277C Louisiana, TA–W–30,277D related to the exploration and 30,277 and TA–W–30,277A–J). Michigan, TA–W–30,277E Montana, TA–W– production of crude oil, natural gas, and Company imports of import purchases 30,277F New Mexico, TA–W–30,277G Texas, natural gas liquids. of crude oil in 1993 compared to 1992. TA–W–30,277H Utah, TA–W–30,277I Workers are not separately Wyoming, TA–W–30,277J Oklahoma; The Department conducted a survey identifiable between crude oil, natural of major customers of Union Oil Certification Regarding Eligibility To Apply gas, and natural gas liquids exploration for Worker Adjustment Assistance. Company of California (UNOCAL). The or production. Crude oil represents an survey revealed that respondents In accordance with Section 223 of the important portion of sales at Union Oil Trade Act of 1974 (19 USC 2273) as increased purchases of imported crude Company of California (UNOCAL). oil in 1993 compared to 1992, and that amended by the Omnibus Trade and Workers at various locations of these respondents continued their Competitiveness Act of 1988 (P.L. 100– UNOCAL Corporation were certified reliance of imported crude oil in the 418), the Department of Labor herein eligible to apply for trade adjustment first nine months of 1994 compared to presents the results of an investigation assistance benefits on September 30, the same period in 1993. regarding certification of eligibility to 1992 (TA–W–27,538; TA–W–27,542– apply for worker adjustment assistance. 27,544; and TA–W–27,544A–D). Conclusion In order to make an affirmative Workers at various other locations of determination and issue a certification UNOCAL Corporation were certified After careful review of the facts of eligibility to apply for adjustment eligible to apply for trade adjustment obtained in the investigation, I conclude assistance each of the group eligibility assistance benefits on November 3, that increases of imports of articles like requirements of Section 222 of the Act 1992. or directly competitive with crude oil must be met. It is determined in this U.S. imports of crude oil and natural and natural gas produced at Union Oil case that all of the requirements have gas increased absolutely and relative to Company of California, d.b.a. UNOCAL been met. domestic shipments and consumption contributed importantly to the decline The investigation was initiated in in the latest twelve month period of in sales or production and to the total response to a petition received on September 1993 through August of 1994 or partial separation of workers of that September 6, 1994 and filed on behalf compared to a year earlier. firm. In accordance with the provisions of workers at Union Oil Company of Corporate-wide sales and production of the Act, I make the following California, d.b.a. UNOCAL, of crude oil at Union Oil Company of certification: headquartered in Sugar Land, Texas California (UNOCAL) declined in 1993 ‘‘All workers of Union Oil Company (TA–W–30,277) and all operations in compared to 1992 and in the first six of California, d.b.a. UNOCAL, the following states: (1) Alabama (TA– months of 1994 compared to the same headquartered in Sugar Land, Texas W–30,277A); (2) Illinois (TA–W– period in 1993. (TA–W–30,277) and at all locations in 30,277B); (3) Louisiana (TA–W– Corporate-wide sales of natural gas the following states listed below (TA– 30,277C); (4) Michigan (TA–W– liquids at Union Oil Company of W–30,277A–J) engaged in employment 30,277D); (5) Montana (TA–W–30,277E); California (UNOCAL) declined in 1993 related to the exploration and Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6737 production of crude oil, natural gas, and of Labor pursuant to the provisions of Administration, Wage and Hour natural gas liquids who became totally the Davis-Bacon Act of March 3, 1931, Division, Division of Wage or partially separated from employment as amended (46 Stat. 1494, as amended, Determination, 200 Constitution Ave., on or after September 6, 1993 through 40 U.S.C. 276a) and of other Federal N.W., Room S–3014, Washington, D.C. two years from the date of certification statutes referred to in 29 CFR part 1, 20210. are eligible to apply for adjustment Appendix, as well as such additional Modification to General Wage assistance under Section 223 of the statutes as may from time to time be Determinations Decisions Trade Act of 1974.’’ enacted containing provisions for the TA–W–30,277A Alabama payment of wages determined to be The number of decisions listed in the TA–W–30,277B Illinois prevailing by the Secretary of Labor in Government Printing Office document TA–W–30,277C Louisiana accordance with the Davis-Bacon Act. entitled ‘‘General Wage Determinations TA–W–30,277D Michigan The prevailing rates and fringe benefits Issued Under the Davis-Bacon and TA–W–30,277E Montana determined in these decisions shall, in Related Acts’’ being modified are listed TA–W–30,277I Wyoming accordance with the provisions of the by Volume and State. Dates of TA–W–30,277J Oklahoma foregoing statutes, constitute the publication in the Federal Register are and minimum wages payable on Federal and in parentheses following the decisions ‘‘All workers of Union Oil Company federally assisted construction projects being modified. of California, d.b.a. UNOCAL, located to laborers and mechanics of the Volume I: New Mexico (TA–W–30,277F); Texas specified classes engaged on contract None (TA–W–30,277G); and Utah (TA–W– work of the character and in the Volume II: 30,277H) engaged in employment localities described therein. None Good cause is hereby found for not related to the exploration and Volume III: utilizing notice and public comment production of crude oil, natural gas, and None procedure thereon prior to the issuance natural gas liquids who became totally Volume IV: of these determinations as prescribed in or partially separated from employment None on or after September 30, 1994 through 5 U.S.C. 553 and not providing for delaying the effective date as prescribed Volume V: two years from the date of certification None are eligible to apply for adjustment in that section, because the necessity to issue current construction industry Volume VI: assistance under Section 223 of the None Trade Act of 1974.’’ wage determinations frequently and in large volume causes procedures to be General Wage Determination TA–W–30,277F New Mexico impractical and contrary to the public TA–W–30,277G Texas Publication interest. TA–W–30,277H Utah General wage determination General wage determinations issued Signed in Washington, D.C. this 9th day of decisions, and modifications and under the Davis-Bacon and related Acts, December 1994. supersedes decisions thereto, contain no including those noted above, may be Victor J. Trunzo, expiration dates and are effective from found in the Government Printing Office Program Manager, Policy and Reemployment their date of notice in the Federal (GPO) document entitled ‘‘General Wage Services, Office of Trade Adjustment Register, or on the date written notice Determinations Issued Under the Davis- Assistance. is received by the agency, whichever is Bacon and Related Acts’’. This [FR Doc. 95–2699 Filed 2–2–95; 8:45 am] earlier. These decisions are to be used publication is available at each of the 50 BILLING CODE 4510±30±M in accordance with the provisions of 29 Regional Government Depository CFR Parts 1 and 5. Accordingly, the Libraries and many of the 1,400 applicable decision, together with any Government Depository Libraries across Employment Standards Administration modifications issued must be made a the country. Subscriptions may be party of every contract for performance purchased from: Wage and Hour Division of the described work within the Superintendent of Documents, U.S. Minimum Wages for Federal and geographic area indicated as required by Government Printing Office, Federally Assisted Construction; an applicable Federal prevailing wage Washington, DC 20402; (202) 783– General Age Determination Decisions law and 29 CFR Part 5. The wage rates 3238. and fringe benefits, notice of which is When ordering subscription(s), be General wage determination decisions published herein, and which are sure to specify the State(s) of interest, of the Secretary of Labor are issued in contained in the Government Printing since subscriptions may be ordered for accordance with applicable law and are Office (GPO) document entitled any or all of the six separate volumes, based on the information obtained by ‘‘General Wage Determinations Issued arranged by State. Subscriptions include the Department of Labor from its study Under the Davis-Bacon and Related an annual edition (issued in January or of local wage conditions and data made Acts,’’ shall be the minimum paid by February) which included all current available from other sources. They contractors and subcontractors to general wage determinations for the specify the basic hourly wage rates and laborers and mechanics. States covered by each volume. fringe benefits which are determined to Any person, organization, or general Throughout the remainder of the year, be prevailing for the described classes of agency having an interest in the rates regular weekly updates will be laborers and mechanics employed on determined as prevailing is encouraged distributed to subscribers. construction projects of a similar to submit wage rate and fringe benefit character and in the localities specified information for consideration by the Signed at Washington, DC, this 27th day of therein. Department. Further information and January 1995. The determinations in these decisions self-explanatory forms for the purpose Alan L. Moss, of prevailing rates and fringe benefits of submitting this data may be obtained Director, Division of Wage Determination. have been made in accordance with 29 by writing to the U.S. Department of [FR Doc. 95–2452 Filed 2–2–95; 8:45 am] CFR part 1, by authority of the Secretary Labor, Employment Standards BILLING CODE 4510±27±M 6738 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices NATIONAL SCIENCE FOUNDATION SW., Washington, DC 20585, U.S. longitudinal surveys of individuals Bureau of Census, Washington, DC included in the system. All users of the Privacy Act of 1974; New System of 20233, and Westat, Inc., 1550 Research data are required to comply by the Records Blvd., Rockville, MD 20850. requirements of the Privacy Act with respect to such records. AGENCY: National Science Foundation. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: ACTION: Notice of new system of records POLICIES AND PRACTICES FOR STORING, and routine uses. The system includes a sample of RETRIEVING, ACCESSING, RETAINING, AND individuals holding bachelor’s and DISPOSING OF RECORDS IN THE SYSTEM: New System of Records master’s degrees from U.S. institutions Pursuant to the Privacy Act of 1974 (5 in science and engineering degree fields. STORAGE: U.S.C. 552a), the National Science CATEGORIES OF RECORDS IN THE SYSTEM: Computer tapes with identifying Foundation is providing notice of a new Educational, professional, and information on individuals and system of records—NSF–58, ‘‘National demographic characteristics of degree questionnaires are kept by the National Survey of Recent College Graduates and holders including name, age, race, Science Foundation, the U.S. Follow-up File.’’ This system is ethnicity, sex, disability, and country of Department of Energy, U.S. Bureau of established and maintained by the birth, social security number, Census, and Westat, Inc. National Science Foundation, the U.S. occupational information, labor force Department of Energy and their present status, professional activities, academic RETRIEVABILITY: and future contractors (present degrees, earlier education, continuing contractors include the U.S. Bureau of Alphabetically by last name of education, marital status, spouse’s individual. Census and Westat, Inc.). The system is employment status, number and ages of used as a source for measuring the new children living at home, parent’s SAFEGUARDS: entrants into the science and educational attainment, citizenship. engineering workforce and for providing Data are kept in secured areas with information on indicators related to the AUTHORITY FOR MAINTENANCE OF THE SYSTEM: access limited to authorized personnel. science and engineering workforce, as National Science Foundation Act of Questionnaires in paper copy are kept required by congressional mandate. The 1950, as amended, 42 U.S.C. 1862(a)(6), in locked cabinets. Published findings system is also used to report on the 1863(j)(1), 1885d. and computer tapes are in formats participation rates of women and which preclude individual PURPOSES: minorities in scientific and technical identification. fields, as required by congressional This system is used as a source of mandate. information on the characteristics of RETENTION AND DISPOSAL: Effective date: Section 552a(e) (4) and individuals with bachelor’s and master’s Computer tapes are kept indefinitely (11) of Title 5 of the U.S. Code provides degrees in science and engineering in by the U.S. Bureau of Census and the public thirty days to comment on the United States. The system is used as Westat, Inc. and the other sponsors in the routine uses of systems of records. a source for measuring the new entrants fulfilling the responsibilities described The new system of records and its into the science and engineering under ‘‘Purposes’’. routine uses will become effective 30 workforce. The system is used to provide information on indicators days after publication of this notice, SYSTEM MANAGER(S) AND ADDRESS unless comments are received on or related to the science and engineering before that date that would result in a workforce, as required by congressional Division Director, Science Resources contrary decision. In this case a notice mandate. The system is also used to Studies, National Science Foundation, will be published to that effect. report on the participation rates of 4201 Wilson Blvd., Arlington, VA Comments: Written comments should women and minorities in scientific and 22230. be addressed to the NSF Privacy Act technical fields, as required by Officer, Office of Information and congressional mandate. It is also used NOTIFICATION PROCEDURE: by researchers interested in policy Resource Management, National Science The NSF Privacy Act Officer should Foundation, Room 485, 4201 Wilson issues related to the scientific and engineering workforce. be contacted in accordance with Blvd., Arlington, VA 22230. procedures found at 45 CFR part 613. Dated: January 30, 1995. ROUTINE USES OF RECORDS MAINTAINED IN THE Herman G. Fleming, SYSTEM, INCLUDING CATEGORIES OF USERS AND RECORD ACCESS PROCEDURES: THE PURPOSES OF SUCH USES: Privacy Act Officer. Disclosure of the records may be See ‘‘Notification procedure’’ above. NSF±58 made to the Federal sponsors listed RECORD SOURCE CATEGORIES: SYSTEM NAME: under ‘‘System location’’ above, their contractors and collaborating Most information was obtained National Survey of recent College researchers and their staff for the voluntarily from individuals. Initial Graduates and Follow-up File. purpose of analyzing data, preparing identifying information was also SECURITY CLASSIFICATIONS: reports, writing articles, and preparing voluntarily obtained from colleges and/ None. public use data tapes in order to or universities and individuals. accomplish the research purpose for SYSTEM LOCATION: which the records are collected. SYSTEM EXEMPTIONS FROM CERTAIN PROVISION Record that make up this system may Disclosure of certain data on records OF THE ACT: be kept in multiple locations: National (including name, address, phone None. Science Foundation, 4201 Wilson Blvd., number, academic institution, degree Arlington, VA 22230: U.S. Department type) are also made to present and [FR Doc. 95–2661 Filed 2–2–95; 8:45 am] of Energy, 1000 Independence Avenue future contractors to conduct BILLING CODE 7555±01±M Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6739 NUCLEAR REGULATORY The proposed amendment would Before issuance of the proposed COMMISSION modify the Technical Specifications license amendment, the Commission (TSs) to eliminate selected response will have made findings required by the All U.S. Pressurized Water Reactors; time testing requirements. The affected Atomic Energy Act of 1954, as amended Issuance of Director's Decision Under TSs are TS 3.3.1.1, ‘‘Reactor Protection (the Act) and the Commission’s 10 CFR 2.206 System (RPS) Instrumentation,’’ TS regulations. The Commission has made a Notice is hereby given that the 3.3.5.1, ‘‘Emergency Core Cooling Director, Office of Nuclear Reactor System (ECCS) Instrumentation,’’ TS proposed determination that the Regulation, has taken action with regard 3.3.6.1, ‘‘Primary Containment and amendment request involves no to a Petition for action under 10 CFR Drywell Isolation Instrumentation,’’ and significant hazards consideration. Under 2.206 received from John Willis of TS 3.5.1, ‘‘ECCS—Operating.’’ the Commission’s regulations in 10 CFR The proposed changes are supported Greenpeace International with respect to 50.92, this means that operation of the by analyses performed by the Boiling all pressurized water reactors (PWRs) in facility in accordance with the proposed Water Reactor Owners Group (BWROG) the United States. The Petitioner amendment would not (1) involve a in their topical report, NEDO–32291, requested that all U.S. PWRs be significant increase in the probability or ‘‘System Analyses for Elimination of examined for cracks in control rod drive consequences of an accident previously Selected Response Time Testing mechanism (CRDM) vessel head evaluated; or (2) create the possibility of Requirements,’’ submitted on January penetrations (VHP) and that any reactors a new or different kind of accident from 14, 1994. NEDO–32291 demonstrated found containing VHP cracking be shut any accident previously evaluated; or that other periodic tests required by down, repaired, and ‘‘relicensed’’ before (3) involve a significant reduction in a TSs, such as channel calibrations, restarting. margin of Safety. As required by 10 CFR The Director of the Office of Nuclear channel checks, channel functional 50.91(a), the licensee has provided its Reactor Regulation has determined to tests, and logic system functional tests, analysis of the issue of no significant deny the Petition. The reasons for this in conjunction with the actions taken in hazards consideration, which is denial are explained in the ‘‘Director’s response to NRC Bulletin 90–01, ‘‘Loss presented below: Decision under 10 CFR 2.296,’’ (DD–95– of Fill-Oil in Transmitters Manufactured by Rosemount,’’ and Supplement 1, are (1) The purpose of the proposed Technical 02) which is available for public Specification (TS) change is to eliminate inspection in the Commission’s Public adequate to ensure that instrument response time testing requirements for Document Room, Gelman Building, response times are within acceptable selected components in the Reactor 2120 L St., N.W., Washington, DC limits. Protection System (RPS), Containment and The staff has reviewed NEDO–32291 20037. A copy of this decision will be Reactor Vessel Isolation Control System and, by letter dated December 28, 1994 (CRVICS) instrumentation, and Emergency filed with the Secretary for the (B. Boger to R. Pinelli), issued its Safety Core Cooling System (ECCS) actuation Commission’s review in accordance Evaluation. Based on a review of the instrumentation. The Boiling Water Reactor with 10 CFR 2.206(c) of the information presented by the BWROG, Owners’ Group (BWROG) has completed an Commission’s regulations. As provided the staff concluded that significant evaluation which demonstrates that response by this regulation, the decision will time testing is redundant to the other TS- degradation of instrument response constitute the final action of the required testing. These other tests, in times, i.e., delays greater than about 5 Commission 25 days after the date of conjunction with actions take in response to seconds, can be detected during the issuance of the decision unless the NRC Bulletin 90–-01, ‘‘Loss of Fill-Oil in performance of other surveillance tests, Commission on its own motion Transmitters Manufactured by Rosemount,’’ principally calibration, if properly and Supplement 1, are sufficient to identify institutes a review of the decision performed. Accordingly, the staff failure modes or degradations in instrument within that time. concluded response time testing can be response time and ensure operation of the Dated at Rockville, Maryland this 26th day eliminated from TSs for the selected associated systems within acceptable of January, 1995. instrumentation identified in the topical limits.There are no known failure modes that For the Nuclear Regulatory Commission. can be detected by response time testing that report and accepted NEO–32291 for cannot also be detected by the other TS- William T. Russell, reference in license amendment required testing. This evaluation was Director, Office on Nuclear Reactor applications for all boiling water documented in NEDO–32291, ‘‘System Regulation. reactors provided that certain Analyses for Elimination of Selected [FR Doc. 95–2728 Filed 2–2–95; 8:45 am] conditions are met. These conditions Response Time Testing Requirements,’’ BILLING CODE 7590±01±M were specified in the staff’s letter to the January 1994. Illinois Power (IP) has BWROG dated December 28, 1994. confirmed the applicability of this evaluation In a letter dated January 27, 1995, the to Clinton Power Station (CPS). In addition, [Docket No. 50±461] licensee submitted an application to IP will complete the actions identified in the amend their technical specifications NRC staff’s safety evaluation of NEDO– Illinois Power Company; Notice of 32291. Consideration of Issuance of based on the BWROG topical report. In Because of the continued application of Amendment to Facility Operating their submittal, the licensee confirmed other existing TS-required tests such as License, Proposed No Significant the applicability of the generic analysis channel calibrations, channel checks, Hazards Consideration Determination, of NEDO–32291 to their plant, and channel functional tests, and logic system and Opportunity for a Hearing provided the supplemental information functional tests, the response time of these demonstrating compliance with the systems will be maintained within the The U.S. Nuclear Regulatory conditions specified in the staff’s Safety acceptance limits assumed in plant safety Commission (the Commission) is Evaluation. In addition, the licensee analyses and required for successful considering issuance of an amendment identified their submittal as a cost mitigation of an initiating event. The proposed changes do not affect the capability to Facility Operating License No. NPF– beneficial licensing action (CBLA) and of the associated systems to perform their 62, issued to the Illinois Power requested prompt approval by the staff intended function within their required Company (the licensee), for operation of so that they could implement the response time, nor do the proposed changes the Clinton Power Station, Unit 1, changes prior to their refueling outage themselves affect the operation of any located in DeWitt County, Illinois. scheduled for March 1995. equipment. As a result, IP has concluded that 6740 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices the proposed changes do not involve a result, for example, in derating or designated Atomic Safety and Licensing significant increase in the probability or the shutdown of the facility, the Board will issue a notice of hearing or consequences of an accident previously Commission may issue the license an appropriate order. evaluated. amendment before the expiration of the (2) The proposed changes only apply to the As required by 10 CFR 2.714, a testing requirements for the components 30-day notice period, provided that its petition for leave to intervene shall set identified above and do not result in any final determination is that the forth with particularity the interest of physical change to these or other components amendment involves no significant the petitioner in the proceeding, and or their operation. As a result, no new failure hazards consideration. The result how that interest may be affected by the modes are introduced. Therefore, the determination will consider all public results of the proceeding. The petition proposed changes do not create the and State comments received. Should should specifically explain the reasons possibility of a new or different kind of the Commission take this action, it will why intervention should be permitted accident from any accident previously publish in the Federal Register a notice evaluated. with particular reference to the (3) The current TS-required response times of issuance and provide for opportunity following factors: (1) the nature of the are based on the maximum allowable values for a hearing after issuance. The petitioner’s right under the Act to be assumed in the plant safety analyses. These Commission expects that the need to made party to the proceeding; (2) the analyses conservatively establish the margin take this action will occur very nature and extent of the petitioner’s of safety. As described above, the proposed infrequently. property, financial, or other interest in changes do not affect the capability of the Written comments may be submitted the proceeding; and (3) the possible associated systems to perform their intended by mail to the Rules Review and function within the allowed response time effect of any order which may be Directives Branch, Division of Freedom entered in the proceeding on the used as the basis for the plant safety analyses. of Information and Publications The potential failure modes for the petitioner’s interest. The petition should components within the scope of this request Services, Office of Administration, U.S. also identify the specific aspect(s) of the were evaluated for impact on instrument Nuclear Regulatory Commission, subject matter of the proceeding as to response time. This evaluation confirmed Washington, DC 20555, and should cite which petitioner wishes to intervene. that, with the exception of loss of fill-oil of the publication date and page number of Any person who has filed a petition for Rosemount transmitters, the remaining TS- this Federal Register notice. Written leave to intervene or who has been required testing is sufficient to identify comments may also be delivered to admitted as a party may amend the failure modes or degradations in instrument Room 6D22, Two White Flint North, response times and ensure operation of the petition without requesting leave of the 11545 Rockville Pike, Rockville, Board up to 15 days prior to the first instrumentation within the scope of this Maryland, from 7:30 a.m. to 4:15 p.m. request is within acceptable limits. The perhearing conference scheduled in the Federal workdays. Copies of written actions taken in response to NRC Bulletin proceeding, but such an amended comments received may be examined at 90–01 and Supplement 1 are adequate to petition must satisfy the specificity the NRC Public Document Room, the identify loss of fill-oil failures of Rosemount requirements described above. transmitters. As a result, it has been Gelman Building, 2120 L Street, NW., concluded that plant and system response to Washington, DC. Not later that 15 days prior to the first an initiating event will remain in compliance The filing of requests for hearing and prehearing conference scheduled in the with the assumptions of the safety analyses. petitions for leave to intervene is proceeding, a petitioner shall file a Further, although not explicitly evaluated, discussed below. supplement to the petition to intervene the proposed changes will provide an By March 6, 1995, the licensee may which must include a list of the improvement to plant safety and operation by file a request for a hearing with respect contentions which are sought to be reducing the time safety systems are to issuance of the amendment to the litigated in the matter. Each contention unavailable, reducing the potential for safety must consist of a specific statement of system actuations, reducing plant shutdown subject facility operating license and risk, limiting radiation exposure to plant any person whose interest may be the issue of law or fact to be raised or personnel, and eliminating the diversion of affected by this proceeding and who controverted. In addition, the petitioner key personnel resources to conduct wishes to participate as a party in the shall provide a brief explanation of the unnecessary testing. Therefore, IP has proceeding must file a written request bases of the contention and a concise concluded that this request will result in an for a hearing and a petition for leave to statement of the alleged facts or expert overall increase in the margin of safety. intervene. Requests for a hearing and a opinion which support the contention The NRC staff has reviewed the petition for leave to intervene shall be and on which the petitioner intends to licensee’s analysis and, based on this filed in accordance with the rely in proving the contention at the review, it appears that the three Commission’s ‘‘Rules of Practice for hearing. The petitioner must also standards of 10 CFR 50.92(c) are Domestic Licensing Proceedings’’ in 10 provide references to those specific satisfied. Therefore, the NRC staff CFR Part 2. Interested persons should sources and documents of which the proposes to determine that the consult a current copy of 10 CFR 2.714 petitioner is aware and on which the amendment request involves no which is available at the Commission’s petitioner intends to rely to establish significant hazards consideration. Public Document Room, the Gelman those facts or expert opinion. Petitioner The Commission is seeking public Building, 2120 L Street, NW., must provide sufficient information to comments on this proposed Washington, DC, and at the local public show that a genuine dispute exists with determination. Any comments received document room located at the Vespasian the applicant or a material issue of law within 30 days after the date of Warner Public Library, 120 West or fact. Contentions shall be limited to publication of this notice will be Johnson Street, Clinton, Illinois 61727. matters within the scope of the considered in making any final If a request for a hearing or petition for amendment under consideration. The determination. leave to intervene is filed by the above contention must be one which, if Normally, the Commission will not date, the Commission or an Atomic proven, would entitle the petitioner to issue the amendment until the Safety and Licensing Board, designed by relief. A petitioner who fails to file such expiration of the 30-day notice period. the Commission or by the Chairman of a supplement which satisfies these However, should circumstances change the Atomic Safety and Licensing Board requirements with respect to at least one during the notice period such that Panel, will rule on the request and/or contention will not be permitted to failure to act in a timely way would petition; and the Secretary of the participate as a party. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6741 Those permitted to intervene become balancing of the factors specified in 10 The presiding officer in this parties to the proceeding, subject to any CFR 2.714(a)(1) (i)–(v) and 2.714(d). proceeding is Administrative Judge limitations in the order granting leave to For further details with respect to this Marshall E. Miller. intervene, and have the opportunity to action, see the application for Following consultation with the Panel participate fully in the conduct of the amendment dated January 27, 1995, Chairman, pursuant to the provisions of hearing, including the opportunity to which is available for public inspection 10 CFR 2.722, the Presiding Officer has present evidence and cross-examine the Commission’s Public Document appointed Dr. Harry Foreman to assist witnesses. Room, the Gelman Building, 2120 L the Presiding Officer in taking evidence If a hearing is requested, the Street, NW., Washington, DC, and at the and in preparing a suitable record for Commission will make a final local public document room located at review. determination on the issue of no the Vespasian Warner Public Library, All correspondence, documents and significant hazards consideration. The 120 West Johnson Street, Clinton, other materials shall be filed with Judge final determination will serve to decide Illinois 61727. Miller and Dr. Foreman in accordance when the hearing is held. with 10 CFR 2.701. Their addresses are; If the final determination is that the Dated at Rockville, Maryland, this 31st day of January, 1995 Administrative Judge Marshall E. Miller, amendment request involves no Presiding Officer, 1920 South Creek For the Nuclear Regulatory Commission. significant hazards consideration, the Boulevard, Spruce Creek Fly-In, Commission may issue the amendment Douglas V. Pickett, Daytona Beach, FL 32124; Dr. Harry and make it immediately effective, Senior Project Manager, Project Directorate Foreman, Special Assistance, 1564 notwithstanding the request for a III–3, Division of Reactor Projects—III/IV, Burton Avenue, St. Paul, MN 55108. hearing. Any hearing held would take Office of Nuclear Reactor Regulations. [FR Doc. 95–2727 Filed 2–2–95; 8:45 am] Issued at Rockville, Maryland, this 27th place after issuance of the amendment. day of January 1995. If the final determination is that the BILLING CODE 7590±01±M B. Paul Cotter, Jr., amendment request involves a significant hazards consideration, any Chief Administrative Judge, Atomic Safety and Licensing Board Panel. hearing held would take place before [Docket No. 30±16055±ML±Ren; ASLBP No. the issuance of any amendment. 95±707±02±ML±Ren [FR Doc. 95–2725 Filed 2–2–95; 8:45 am] A request for a hearing or a petition BILLING CODE 7590±01±M for leave to intervene must be filed with Advanced Medical Systems, Inc.; the Secretary of the Commission, U.S. Cleveland, OH; Designation of Nuclear Regulatory Commission, Presiding Officer SECURITIES AND EXCHANGE COMMISSION Washington, DC 20555, Attention: Pursuant to delegation by the Docketing and Services Branch, or may Commission dated December 29, 1972, [Release No. 34±35293; File No. SR±MSTC± be delivered to the Commission’s Public published in the Federal Register, 37 FR 94±19] Document Room, the Gelman Building, 28710 (1972), and Sections 2.105, 2.700, Self-Regulatory Organizations; 2120 L Street, NW., Washington, DC, by 2.702, 2.714, 2.714a, 2.717 and 2.721 of Midwest Securities Trust Company; the above date. Where petitions are filed the Commission’s Regulations, all as during the last 10 days of the notice Notice of Filing and Order Granting amended, a presiding officer from the period, it is requested that the petitioner Accelerated Approval of Proposed Atomic Safety and Licensing Board promptly so inform the Commission by Rule Change Implementing New Panel is hereby designated to rule on a toll-free telephone call to Western Procedures Regarding the Distribution petitions for leave to intervene and/or Union at 1–(800) 248–5100 (in Missouri of Hardcopy Reorganization Offer requests for hearing and, if necessary, to 1–(800) 342–6700). The Western Union Notices serve as the presiding officer to conduct operator should be given Datagram the hearing in the event that an informal identification Number N1023 and the January 30, 1995. adjudicatory hearing is ordered in the following message addressed to Leif J. Pursuant to Section 19(b)(1) of the following Materials License Renewal Norrholm, Project Director, Project Securities Exchange Act of 1934 proceeding. 1 Directorate III–3, petitioner’s name and (‘‘Act’’), notice is hereby given that on telephone number, date petition was Advanced Medical Systems, Inc., December 8, 1994, the Midwest mailed, plant name, and publication Cleveland, Ohio Securities Trust Company (‘‘MSTC’’) date and page number of this Federal filed with the Securities and Exchange Renewal of Material License No. 34– Register notice. A copy of the petition Commission (‘‘Commission’’) the 19089–01 should also be sent to the Office of the proposed rule change as described in General Counsel, U.S. Nuclear The Presiding Officer is being Items I and II below, which Items have Regulatory Commission, Washington, designated pursuant to 10 CFR 2.1207 of been prepared primarily by MSTC. On DC 20555, and to Leah Manning the Commission’s Regulations, December 15, 1994, MSTC amended the Stetener, Vice President, General ‘‘Informal Hearing Procedures for proposed rule change by requesting that Counsel, and Corporate Secretary, 500 Materials Licensing Adjudications,’’ the Commission consider the proposal 2 South 27th Street, Decatur, Illinois published in Federal Register, 54 F.R. as being filed under Section 19(b)(2) of 3 62525, attorney for the licensee. 8269 (1989). This action is in response the Act instead of Section 19(b)(3)(A) Nontimely filings of petitions for to hearing requests submitted by Earth of the Act.4 The Commission is leave to intervene, amended petitions, Day Coalition, Northeast Ohio Regional publishing this notice and order to supplemental petitions and/or requests Sewer District, and the City of solicit comments from interested for hearing will not be entertained Cleveland, Ohio. The hearing requests absent a determination by the were submitted in response to an 1 15 U.S.C. 78s(b)(1) (1988). 2 Commission, the presiding officer or the application filed with the Commission 15 U.S.C. 78s(b)(2) (1988). 3 15 U.S.C. 78s(b)(3) (1988). presiding Atomic Safety and Licensing by Advanced Medical Systems, Inc. for 4 Letter from David T. Rusoff, Foley & Lardner, to Board that the petition and/or request renewal of its license for possession of Peter R. Geraghty, Division of Market Regulation, should be granted based upon a radioactive materials. Commission (December 15, 1994). 6742 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices persons and to grant accelerated will continue to have available (C) Self-Regulatory Organization’s approval of the proposed rule change. information regarding every Statement on Comments on the reorganization offer, but unless the Proposed Rule Change Received from I. Self-Regulatory Organizations Members, Participants or Others Statement of the Terms and Substance participant has a position in the subject of the Proposed Rule Change security, the information will be MSTC has not solicited or received provided over RPS rather than in any comments. MSTC will notify the In light of the recent implementation hardcopy reorganization notices. Commission of any written comments it of the Reorganization Processing System Consequently, MSTC participants that receives. (‘‘RPS’’),5 MSTC proposes to introduce do not have a position in the affected new procedures regarding distribution security on the date MSTC produces the III. Date of Effectiveness of the of the hardcopy (i.e., paper) reorganization notices will have to use Proposed Rule Change and Timing for reorganization offer notices to MSTC RPS to access the information.7 Commission Action participants. Following this rule change, two Section 17A(b)(3)(F) of the Act II. Self-Regulatory Organization’s hardcopy reports that summarize offer requires that the rules of a clearing Statement of the Purpose of, and information will be provided daily to all agency be designed to promote the Statutory Basis for, the Proposed Rule participants: the ‘‘Offer Information prompt and accurate clearance and 8 Change Report’’ and the ‘‘Active Offers with settlement of securities transactions. The Commission believes that the In its filing with the Commission, Position Report.’’ The Offer Information proposed rule change is consistent with MSTC included statements concerning Report will identify new, updated, and MSTC’s obligations under Section the purpose of and basis for the closed RPS offers, and indicate whether 17A(b)(3)(F) because the rule change proposed rule change and discussed any the participant has a position with should help to reduce the labor and comments it received on the proposed MSTC in the relevant CUSIPs. The expense associated with distributing rule change. The text of these statements Active Offers with Position Report will reorganization notices to all MSTC may be examined at the places specified list all active RPS offers in which the participants and thereby increases the in Item IV below. MSTS has prepared participant has a MCC/MSTC position. efficiency of reorganization processing summaries, set forth in section (A), (B), Sections 3 and 4 of rule 2 of Article and advances the prompt and accurate and (C) below, of the most significant IV set forth MSTC’s responsibility with clearance and settlement of securities aspects of such statements. respect to reorganization information transactions. (A) Self-Regulatory Organization’s disseminated by MSTC. Consistent with MSTC has requested that the Statement of the Purpose of, and MSTC’s current policy, MSTC continues Commission find good cause for Statutory Basis for, the Proposed Rule to disclaim any obligation, approving the proposed rule change Change responsibility, or liability with respect prior to the thirtieth day after the date to these written notices provided to The primary purpose of MSTC’s of publication of notice of the filing. The participants. proposed rule change is to implement Commission finds good cause for so new procedures regarding the MSTC believes that the proposed rule approving the proposed rule change distribution of hardcopy reorganization change is consistent with the because the RPS system has been notices to MSTC members. Rule 4 under requirements of Section 17A of the Act operational for more than six months Article IV of MSTC’s rules describes and the rules and regulations and accelerated approval will allow MSTC’s activities with respect to thereunder applicable to MSTC because MSTC to begin as soon as possible to reorganization information the proposal will further automate the reduce the amount of paper notices that disseminated by MSTC. Pursuant to processing of reorganization offers it must produce. these rules, MSTC provides daily to all through the facilities of MSTC. IV. Solicitation of Comments MSTC participates detailed written (B) Self-Regulatory Organization’s Interested persons are invited to notices, termed ‘‘Goldenrod Notices,’’ of Statement on Burden on Competition submit written data, views, and each newly announced or updated arguments concerning the foregoing. corporate reorganization offer. MSTC MSTC believes that no burden will be Persons making written submissions recently implemented RPS, an on-line placed on competition as a result of the should file six copies thereof with the computer system available to proposed rule change. Secretary, Securities and Exchange participants for accessing reorganization Commission, 450 Fifth Street, NW., information; therefore, MSTC proposes 7 Currently, RPS inquiries can be designed by Washington DC 20549. Copies of the to discontinue providing detailed participants to provide offer information regarding submissions, all subsequent written notices to all participants. any combination of the following: (1) Position only, (2) selected date or date ranges, (3) offer status, (4) amendments, all written statements Under the proposal, MSTC will provide with respect to the proposed rule hardcopy notices only to those specific offer groups or types, (5) CUSIP or CUSIP ranges, and (6) critical date types. Participants change that are filed with the participants with a Midwest Clearing subsequently can create customized reports Commission, and all written Corporation (‘‘MCC’’) or MSTC containing this information. RPS represents offers communications relating to the 6 classified as either nonmandatory, mandatory, or position in the security to which the proposed rule change between the notice relates on the date the RPS notice redemption. These offer classifications will be expanded to include nonexpiring offers. Commission and any person, other than is produced by MSTC. Every participant Nonmandatory offers include tenders, exchanges, those that may be withheld from the puts, rights, and warrants. Mandatory offers include public in accordance with the 5 For a complete description of RPS, refer to mergers, reverse splits, liquidations, bankruptcies, Securities Exchange Act Release No. 34200 (June and name and CUSIP changes. Currently provisions of 5 U.S.C. 552, will be 10, 1994), 59 FR 31283 [File No. SR–MSTC–94–8] redemptions include partial prefundings, and available for inspection and copying at (notice of filing and immediate effectiveness of a convertible partial calls. Full calls, partial calls, and the Commission’s Public Reference proposed rule change relating to reorganization maturities are not yet included in RPS. Notably, Section, 450 Fifth Street, NW., processing). MSTC anticipates that in the future participants 6 A MCC/MSTC position represents securities of will be able to use RPS for processing Washington, DC 20549. Copies of such a particular CUSIP of an individual participant at reorganization offer instructions in a real-time either the MCC or MSTC. environment. 8 15 U.S.C. 78q–1(b)(3)((F) (1988). Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6743 filing will also be available for facilitate uniform short position aggregate should be reported. In this inspection and copying at the principal reporting requirements.4 regard, the Commission notes that like office of MSTC. All submissions should The proposed rule change filed by the accounts should be netted, and then refer to File No. SR–MSTC–94–19 and CBOE was published for comment in multiple accounts should be should be submitted by February 24, Securities Exchange Act Release No. aggregated.7 1995. 35227 (January 13, 1995), 60 FR 4208 The format, time, and method of It is therefore ordered, pursuant to (January 20, 1995). In addition, all of the reporting will be prescribed by each Section 19(b)(2) of the Act, that the other proposed rule changes were SRO receiving short interest data.8 Each proposed rule change (File No. SR– published for comment in Securities such SRO will electronically send the MSTC–94–19) be, and hereby is, Exchange Act Release No. 35147 data to the Securities Industry approved. (December 23, 1994), 60 FR 518 (January Automation Corporation (‘‘SIAC’’).9 4, 1995). No comments were received on With respect to listed securities, SIAC For the Commission, by the Division of Market Regulation, pursuant to delegated the proposal from either notice will in turn consolidate all data in each authority.9 publication. security to generate a number The proposed rule changes emanated representing the national short position Margaret H. McFarland, from an initiative by the SROs, as in each such security. The NASD, Deputy Secretary. Intermarket Surveillance Group however, will be performing this [FR Doc. 95–2694 Filed 2–2–95; 8:45 am] (‘‘ISG’’) 5 members, to ensure uniform function with respect to Nasdaq BILLING CODE 8010±01±M short position reporting in U.S. traded securities. All Nasdaq short interest will securities.6 Although the specific be reported to the NASD by its language of each proposed rule change members. Firms not members of the [Release No. 34±35287; File No. SR±NYSE± differs slightly, the goal of the SROs is NASD will report their short interest 39; SR±Phlx±94±29; SR±PSE±94±34; SR± uniform in proposing the adoption of positions in Nasdaq securities to an BSE±94±15; SR±CHX±94±28; SR±NASD±94± the above referenced rules. Generally, SRO, which will forward it to SIAC, 67; SR±CBOE±94±55] the SROs’ goal is to ensure that a broker- which will then forward Nasdaq data to dealer registered in the United States the NASD. The NASD will compile all Self-Regulatory Organizations; New reports its open short positions to the short interest data in Nasdaq securities York Stock Exchange, Inc., SRO that is the broker-dealer’s and send it, along with a consolidated Philadelphia Stock Exchange, Inc., Designated Examining Authority national short interest position for each Pacific Stock Exchange, Inc., Boston (‘‘DEA’’). If the particular broker- security, to SIAC for dissemination Stock Exchange, Inc., Chicago Stock dealer’s DEA does not have rules purposes. Exchange, Inc., National Association of governing the reporting of short interest Several exceptions to the general Securities Dealers, Inc., and Chicago positions, then the broker-dealer is to requirements outlined above are Board Options Exchange; Order report to another SRO of which it is a clarified in the ISG circular to members Granting Accelerated Approval to member. Non-self-clearing broker- entitled ‘‘Consolidated Reporting of Proposed Rule Change Adopting Rules dealers, however, will be considered to Short Interest Positions.’’ First, members for Short Position Reporting have satisfied their reporting and member organizations for which the January 27, 1995. requirements by making the appropriate CHX is the DEA, and who are self- arrangements with their respective On October 27, 1994, the New York clearing members of the Midwest clearing organizations. Clearing Corporation (‘‘MCC’’), will Stock Exchange, Inc. (‘‘NYSE’’), October Substantively, the new reporting 20, 1994, the Philadelphia Stock have their reporting requirement requirements will continue to include satisfied automatically through the Exchange, Inc. (‘‘Phlx’’), November 23, stocks and warrants, including odd lots, 1994, the Pacific Stock Exchange, Inc. CHX’s ability to capture the required in each such security traded on a United information from the MCC. Further, (‘‘PSE’’), November 28, 1994, the Boston States securities exchange or Stock Exchange, Inc. (‘‘BSE’’), December association. Further, the reports will 7 The aggregation requirement, however, does not 12, 1994, the Chicago Stock Exchange, continue to include both customer and include the netting of short interest against long in Inc. (‘‘CHX’’), December 2, 1994, the proprietary positions, and for those a given security across ‘‘non-like’’ accounts. For National Association of Securities broker-dealers with more then one example, if a broker dealer has three accounts for Dealers, Inc. (‘‘NASD’’),1 and on January different customers, and account 1 has short ‘‘account’’ with a short position in the interest of 100 shares, account 2 has short interest 3, 1995, the Chicago Board Options same stock or warrant, the combined of 225 shares, and account 3 is long 150 shares, the Exchange (‘‘CBOE’’) (collectively, the broker dealer shall report short interest of 325, not ‘‘SROs’’) submitted to the Securities and 4 ‘‘Short’’ positions to be reported are those 175. See CHX proposed Article XI, Rule 9, Exchange Commission (‘‘SEC’’ or resulting from ‘‘short’’ sales as defined in SEC Rule Interpretation and Policy .01. If, however, in the ‘‘Commission’’), pursuant to Section 3b–3, but excludes positions resulting from sales above example account 1 was the firm’s customer specified in clauses (1), (6), (7), (8), (9) and (10) of account, and accounts 2 and 3 were the firm’s 19(b)(1) of the Securities Exchange Act paragraph (e) of SEC Rule 10a–1. Also to be proprietary accounts, then the firm would net of 1934 (‘‘Act’’) 2 and Rule 19b–4 excluded are ‘‘short’’ positions carried for other accounts 2 and 3 to ascertain its proprietary account thereunder,3 proposed rule changes to members and member organizations reporting for position (in this case short 75 shares). The firm themselves. would then report the aggregate of its customer 5 ISG was formed on July 14, 1983 to, among account short interest position of 100 shares and its 9 17 CFR 200.30–3(a)(12) (1994). other things, coordinate more effectively proprietary short interest position of 75 shares—175 1 In addition, the NASD filed Amendment No. 1 surveillance and investigative information sharing shares short in total—for the firm in the particular on January 11, 1995, to clarify who must report to arrangements. See Intermarket Surveillance Group security. the NASD, what the entities must report, and the Agreement, July 14, 1983. 8 Monthly reporting will remain in effect for the mechanics of how to transmit such report. Because 6 Specifically: (1) The BSE is adding § 38 to present but more frequent reporting might be the Amendment does not substantively change the Chapter II of its Rules; (2) the CBOE is adopting initiated in the future. See Circular sent by the ISG proposal, the Commission is not publishing it for interpretation and policy .02 to its Rule 15.1; (3) the to all members and member organizations titled comment. See letter from Joan C. Conley, Secretary, CHX is adopting Article XI, Rule 9, and an ‘‘Consolidated Reporting of Short Interest NASD, to Mark Barracca, Attorney, SEC, dated interpretation thereto; (4) the NASD is amending Positions.’’ January 11, 1995. Article III, Section 41; (5) the NYSE is amending 9 SIAC is a jointly owned subsidiary of the NYSE 2 15 U.S.C. 78s(b)(1) (1988). Rule 421; (6) the PSE is adopting Rule 2.6(f); and and the Amex. Among other things, it handles the 3 17 CFR 240.19b–4 (1991). (7) the Phlx is adopting Rule 786. majority of the automation needs of the ISG. 6744 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices certain CHX members which trade applicable to a national securities For the Commission, by the Division of Nasdaq National Market System exchange, and, in particular, with the Market Regulation, pursuant to delegated securities as specialists may be required requirements of Sections 6(b) and authority.14 by the CHX to report their short interest 15A.12 In particular, the Commission Margaret H. McFarland, positions in those securities directly to believes the proposal is consistent with Deputy Secretary. the NASD. the Section 6(b)(5) and 15A(b)(6) [FR Doc. 95–2653 Filed 2–2–95; 8:45 am] Second, short interest position requirements that the rules of an BILLING CODE 8010±01±M information for member organizations exchange be designed to promote just which act as specialists on the BSE, PSE and equitable principles of trade, to [Rel. No. IC±20867; File No. 812±9320] or Phlx, will be processed by the prevent fraudulent and manipulative clearing corporations utilized by these acts, and, in general, to protect investors G.T. Global Growth Series; Notice of organizations. and the public, in that the proposal Application Third, pursuant to an amendment of should enhance the ability of the SROs, CBOE Rule 15.1, clearing members of both collectively and individually, to January 27, 1995. the CBOE for which the CBOE is the monitor short interest reporting, and to AGENCY: Securities and Exchange DEA, will be required to report any reinforce their regulatory and Commission (‘‘SEC’’). short interest positions to another surveillance capabilities in this area. In ACTION: Notice of Application for exchange or the NASD, even if solely a this regard, the Commission commends Exemption under the Investment member of the CBOE. The CBOE will the ISG in recognizing that consolidated Company Act of 1940 (‘‘the Act’’). designate an exchange or the NASD to short interest figures, that would receive such reports on a case-by-case include the regional exchanges, would APPLICANTS: G.T. Global Growth Series basis.10 serve as an important surveillance tool (‘‘Growth Series’’), G.T. Investment Fourth, the Amex will be sending out to monitor trading activity. Further, the Funds, Inc. (‘‘Investment Funds’’), G.T. a circular to its members informing Commission believes that uniform short Investment Portfolios, Inc. (‘‘Investment them of the new requirements. The interest reporting requirements, and Portfolios’’), G.T. Capital Management, Amex did not submit a new filing subsequent aggregation and reporting by Inc. (the ‘‘Adviser’’), and G.T. Global because it is relying on the general SIAC, will enable the public to make Financial Services, Inc. (‘‘Distributor’’). language in its Rule 30 to encompass the more informed investment decisions in RELEVANT ACT SECTIONS: Order requested proposal at hand.11 the United States market. under section 6(c) of the Act exempting The new reporting requirements being Finally, the Commission finds good applicants from sections 2(a)(32), approved herein will be tested by SIAC cause for approving the proposed rule 2(a)(35), 18(f)(1), 18(g), 18(i), 22(c), and and the ISG members during the months changes prior to the thirtieth day after 22(d) of the Act and rule 22c–1 of March and April, 1995. Testing will the date of publication of notice of filing thereunder. be conducted to ensure the reliability of thereof in the Federal Register. The SUMMARY OF APPLICATION: Applicants the new reporting requirements, but the Commission believes that accelerated request an order that would permit new figures will not be reported to the approval of the proposal is appropriate certain investment companies to issue public. During the test period, broker- in order to allow the SROs to inform multiple classes of shares representing dealers currently subject to a reporting their members about the new short interests in the same portfolios of requirement must report open short interest reporting rules and how the securities and assess, and under certain interest positions under both the new new reporting requirements will be circumstances waive, a contingent reporting requirements and such current tested and implemented. Further, deferred sales charge (‘‘CDSC’’) on reporting requirement. After this test shortly after the approval date hereof, a redemptions of shares. period, the new reporting requirements circular will be sent out by the ISG, as FILING DATES: The application was filed will be the only reporting requirements, indicated above, which will contain on November 4, 1994, and amended on and will be mandatory for all short some additional clarifying information. January 5, 1995. positions. Thus, beginning in May, The Commission notes that the new HEARING OR NOTIFICATION OF HEARING: An 1995, all broker-dealers will be procedures were noticed in the Federal order granting the application will be reporting open short positions to an Register for the full statutory period and issued unless the SEC orders a hearing. SRO under the new requirements. The the Commission did not receive any Interested persons may request a national numbers generated as of that comments on it. Although the CBOE hearing by writing to the SEC’s date will be reported to the public. filing was not published for the full Secretary and serving applicants with a The Commission finds that the period, the Commission notes that the copy of the request, personally or by proposed rule change is consistent with intent of all of the proposals mail. Hearing requests should be the requirements of the Act and the encompassed herein is the same. To received by the SEC by 5:30 p.m. on rules and regulations thereunder facilitate the orderly implementation of February 21, 1995, and should be the changes in short interest reporting accompanied by proof of service on 10 The CBOE and NASD have represented to the requirements, the Commission is applicants, in the form of an affidavit, Commission that currently this exception applies to approving all filings simultaneously. only one firm. That firm will be reporting to the or for lawyers, a certificate of service. NASD pursuant to an agreement between the CBOE It Is Therefore Ordered, pursuant to Hearing requests should state the nature and the NASD. Conversations between Amy Bilbija, Section 19(b)(2) of the Act,13 that the of the writer’s interest, the reason for the Attorney, SEC, and Jim Cangiano, NASD, on proposed rule changes (SR–NYSE–94– request, and the issues contested. January 23, 1995; and Jeff Schroer, CBOE, on 39; SR–Phlx–94–29; SR–PSE–94–34; January 23, 1995. Persons may request notification of a 11 See Amex Rule 30 requiring every member to SR–BSE–94–15; SR–CHX–94–28; SR– hearing by writing to the SEC’s file with the Amex such periodic reports or special NASD–94–67; SR–CBOE–94–55) are Secretary. reports as the Board of Governors may authorize. approved. ADDRESSES: Secretary, SEC, 450 5th The Amex currently requires short interest position Street NW., Washington, DC 20549. reporting of its membership pursuant to this Rule, 12 15 U.S.C. §§ 78f(b), 78o–3 (1988). and will continue to rely on this Rule to require the new reporting. 13 15 U.S.C. § 78s(b)(2) (1988). 14 17 CFR 200.30–3(a)(12) (1991). Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6745 Applicants, 50 California Street, San different sales charge; (3) each class and CDSC imposed on shares of a class Francisco, California 94111. would bear the expense of any will not exceed the maximum sales FOR FURTHER INFORMATION CONTACT: payments made under a rule 12b–1 plan charge provided for in Article III, Bradley W. Paulson, Staff Attorney, at and/or shareholder services plan Section 26(d) of the Rules of Fair (202) 942–0147 or Robert A. Robertson, (collectively, the ‘‘Plans’’), if any, Practice of the National Association of Branch Chief, at (202) 942–0564 entered into with respect to such class; Securities Dealers, Inc. (Division of Investment Management, (4) each class could bear certain other 2. A Portfolio’s CDSC may be imposed Office of Investment Company expenses directly attributable only to at a constant or declining rate over a Regulation). that class described in condition one, specified period of years (‘‘CDSC SUPPLEMENTARY INFORMATION: The below (‘‘Class Expenses’’); (5) only the Period’’). No CDSC would be imposed following is a summary of the holders of a class of shares would be on any redemption of CDSC Shares application. The complete application is entitled to vote on matters pertaining to representing reinvestment of dividends available for a fee from the SEC’s Public a Plan, related agreements, or other or other distributions. As presently Reference Branch. matters relating to such class; and (6) contemplated, no CDSC would be exchange privileges could vary among imposed on any redemption of CDSC Applicants’ Representations the classes. Shares that were purchased more than A. Multi-Class Distribution System 4. With respect to each class, a six years prior to the redemption. Company (on behalf of a Portfolio) 3. The amount of the CDSC would be 1. Growth Series, Investment Funds, could enter into one or more rule 12b– the lesser of the amount representing a and Investment Portfolios are open-end 1 plan agreements and/or shareholder specified percentage of the net asset management investment companies services plan agreements (‘‘Plan value of the CDSC Shares at the time of registered under the Act. Applicants Agreements’’) concerning the provision purchase or the amount representing request relief on behalf of themselves of certain services to shareholders of a such percentage of the net asset value at and any future open-end management particular class by the Adviser, the the time of redemption. As a result, no investment company for which G.T. Distributor, other groups, organizations CDSC would be imposed on amounts Capital (or any person controlling, or institutions. representing an increase in the value of controlled by, or under common control 5. The gross income of each Portfolio the shareholder’s account resulting from with G.T. Capital) serves as investment will be allocated to each class based capital appreciation above the amount adviser or G.T. Global (or any person upon the relative daily net assets of the paid for CDSC Shares purchased in the controlling, controlled by, or under class. Expenses of a company that CDSC Period. In determining the common control with G.T. Global) cannot be attributed directly to any one applicability and rate of any CDSC, it serves as principal underwriter. These Portfolio (‘‘Company Expenses’’) will be would be assumed that a redemption is future companies, together with Growth allocated to each Portfolio based on the made first of shares representing Series, Investment Funds, and relative daily net assets of those reinvestment of dividends and capital Investment Portfolios, are referred to as Portfolios. Expenses attributable to a gain distributions, next of shares held the ‘‘Companies.’’ Existing and future particular Portfolio, but not a particular by the shareholder for a period equal to series of each Company are referred to class of shares (‘‘Portfolio Expenses’’), or greater than the CDSC Period, and as the ‘‘Portfolios.’’ The Adviser is the will be allocated to each class based finally of other shares held by the investment adviser and administrator upon the relative daily net assets of the shareholder for the longest period of for each existing Portfolio, and the class. Class Expenses will be charged time. This would result in a charge, if Distributor serves as principal directly to the net assets of the any, imposed at the lowest possible rate. underwriter for each existing Portfolio. particular class and will be borne on a 4. Applicants request relief to permit 2. The existing Portfolios currently pro rata basis by the outstanding shares each Portfolio to waive or reduce the offer multiple classes of shares in of such class. Accordingly, the net CDSC under certain circumstances. Any accordance with existing exemptive income and net asset value per share of waiver or reduction will comply with orders.1 Under those orders, shares are (and dividends and other distributions the conditions contained in paragraphs offered subject to either a front-end sales payable to) each class may differ from (a) through (d) of rule 22d–1. charge in accordance with the other classes in the same Portfolio. 5. Applicants also request the ability applicable provisions of rule 22d–1 6. The shares of different classes of a to provide a credit for any CDSC paid under the Act and a distribution plan Portfolio will have different exchange in connection with a redemption of adopted in accordance with rule 12b–1 privileges. Applicants anticipate that Shares followed by a reinvestment under the Act or a CDSC and a rule 12b– shares of each class of a Portfolio will effected within a specified period not 1 plan. Applicants request an order be exchangeable for shares of the exceeding 365 days of the redemption. amending and superseding their prior corresponding class of one or more If an investor redeems CDSC Shares and orders to permit them to offer unlimited other Portfolios. Such exchanges will be pays a CDSC, then subsequently classes of shares in accordance with a based on the respective net asset values reinvests all of his redemption proceeds ‘‘Multiple Class System.’’ of the shares being exchanged. All in CDSC Shares of the same or a 3. Under this system, each class of exchange privileges will comply with different Fund within 365 days, the shares of a Portfolio would be identical rule 11a–3 under the Act. investor will be credited for the full in all respects to any other class of amount of the CDSC paid. If the investor B. The CDSC shares of that Portfolio except: (1) Each chooses instead to invest less than the class would have different class 1. Applicants also request an full amount of the redemption proceeds, designations; (2) each class may have a exemption to allow the Portfolios to the investor will be credited a pro rata impose a CDSC on redemptions of amount of the CDSC. The credit will be 1 G.T. Global Growth Series, Investment Company certain classes of shares (‘‘CDSC paid by the principal underwriter. Act Release No. 19022 (Feb. 4, 1994) (notice) and Shares’’) and to waive or reduce the 20101 (Mar. 1, 1994) (order); and G.T. Global Applicants’ Legal Analysis Growth Series, Investment Company Act Release CDSC on redemptions under certain No. 18961 (Sept. 17, 1992) (notice) and 19022 (Oct. circumstances. The sum of any initial 1. Applicants request an exemption 14, 1992) (order). sales charge, asset-based sales charge, under section 6(c) of the Act from 6746 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices sections 18(f)(1), 18(g), and 18(i) of the expenses incurred in connection with the classes of its shares, if there is more Act to the extent that the proposed shareholders meetings as a result of than one class. The board, including a issuance and sale of multiple classes of issues relating to a specific class of majority of the Independent Directors, shares representing interests in a Fund’s shares, (x) organizational expenses shall take such action as is reasonably Portfolios could be deemed: (A) to result related to a specific class of shares and necessary to eliminate any such in a ‘‘senior security’’ within the (xi) any other incremental expenses conflicts that may develop. Each meaning of section 18(g) and to be subsequently identified which should Portfolio’s principal underwriter and prohibited by section 18(f)(1), and (B) to be properly allocated to a specific class investment adviser will be responsible violate the equal voting provisions of of shares and which, as such, are for reporting any potential or existing section 18(i). Applicants believe that the approved by the SEC pursuant to an conflicts to the appropriate board. If proposed allocation of expenses and amended order or by rule or regulation; such a conflict arises, the Portfolio’s voting rights in the manner described (d) the fact that the classes will vote principal underwriter and investment above is equitable and would not separately with respect to matters adviser, at their own expense, will take discriminate against any group of relating to the applicable distribution such actions as are necessary to remedy shareholders. The proposed plan and related agreements, if any, or such conflict, including establishing a arrangement does not involve any other matters appropriately limited new registered management investment borrowings, and does not affect the to such class(es); (e) the different company, if necessary. Funds’ existing assets or reserves. The exchange privileges of the classes of 6. The principal underwriter of each proposed arrangement also will not shares, if any; and (f) the designation of Portfolio implementing a Multiple Class increase the speculative character of the each class of shares of a Portfolio. System will adopt compliance standards shares of a Fund. 2. The board of directors of each with respect to when each class of 2. Applicants also request an Company, including a majority of the shares may be appropriately sold to exemption under section 6(c) from directors who are not interested persons particular investors. Applicants will sections 2(a)(32), 2(a)(35), 22(c), and of the Company (‘‘Independent require all persons selling shares of the 22(d) of the Act and rule 22c–1 Directors’’), will have approved the Portfolios to agree to conform to such thereunder to permit the Funds to Multiple Class System with respect to a standards. assess, and under certain circumstances particular Portfolio of the Company 7. The board of directors of each waive, a CDSC in connection with the prior to the implementation of the Company will receive quarterly and redemption of shares. system by that Portfolio. The minutes of annual statements concerning the the meetings of the board of the amounts expended under the Applicants’ Conditions Company regarding the deliberations of Company’s Plans in compliance with Applicants agree that any order the directors with respect to the paragraph (b)(3)(ii) of rule 12b–1, as it granting the requested relief shall be approvals necessary to implement the may be amended from time to time. In subject to the conditions set forth below. Multiple Class System will reflect in the statements, only expenditures 1. Each class of shares of a Portfolio detail the reasons for the determination properly attributable to the sale or will represent interests in the same by the board that the proposed Multiple servicing of a particular class of shares portfolio of investments, and be Class System is in the best interests of will be used to justify and fee for identical in all respects, except as set each Portfolio and its shareholders. services charged to that class. forth below. The only differences 3. The initial determination of the Expenditures not related to the sale or between the classes of shares of a Class Expenses that will be allocated to servicing of a particular class will not be Portfolio will relate solely to one or a particular class and any subsequent presented to the board to justify any fee more of the following: (a) Expenses changes thereto will be reviewed and attributable to that class. The assessed to a class pursuant to a Plan, approved by a vote of the appropriate statements, including the allocations if any, with respect to such class; (b) board of directors, including a majority upon which they are based, will be sales charges applicable to a class of of the Independent Directors. Any subject to the review and approval of shares, if any (c) the impact of Class person authorized to direct the the Independent Directors in the Expenses, which are limited to any or allocation and disposition of monies exercise of their fiduciary duties. all of the following: (i) Transfer agent paid or payable by a Portfolio to meet 8. Dividends and other distributions fees identified as being attributable to a Class Expense shall provide to the paid by a Portfolio with respect to each specific class of shares, (ii) stationery, applicable board and the directors shall class of its shares, to the extend any printing, postage, and delivery expenses review, at least quarterly, a written dividends and other distributions are related to preparing and distributing report of the amounts so expended and paid, will be declared and paid on the materials such as shareholder reports, the purposes for which such same day and at the same time, and will prospectuses, and proxy statements to expenditures were made. be determined in the same manner and current shareholders of a specific class 4. If any class will be subject to a will be in the same amount, except that of shares, (iii) Blue Sky registration fees shareholder services plan, the plan(s) the amount of the dividends and other incurred by a specific class of shares, will be adopted and operated in distributions declared and paid by a (iv) SEC registration fees incurred by a accordance with the procedures set particular class may be different from specific class of shares, (v) expenses of forth in rule 12b–1 (b) through (f) as if that of another class because payments administrative personnel and services as the expenditures made thereunder were made under a Plan or Plan Agreement required to support the shareholders of subject to rule 12b–1, except that by a class and Class Expenses will be a specific class of shares, (vi) directors’ shareholders need not enjoy the voting borne exclusively by that class. fees or expenses incurred as a result of rights specified in rule 12b–1. 9. The methodology and procedures issues relating to a specific class of 5. On an ongoing basis, the board of for calculating the net asset value and shares, (vii) accounting expenses each Company, pursuant to its fiduciary dividends and other distributions of the relating solely to a specific class of responsibilities under the Act and classes and the proper allocation of shares, (viii) auditors’ fees, litigation otherwise, will monitor each Portfolio, expenses among the classes have been expenses, and legal fees and expenses as applicable, for the existence of any reviewed by an expert (‘‘Expert’’) who relating to a specific class of shares, (ix) material conflicts among the interests of has rendered a report to applicants, Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6747 which has been provided to the staff of appropriate substitute Expert, does not For the Commission, by the Division of the SEC, stating that such methodology so concur in the ongoing reports. Investment Management, pursuant to delegated authority. and procedures are adequate to ensure 11. The prospectuses of each class of that such calculations and allocations shares will contain a statement to the Margaret H. McFarland, will be made in an appropriate manner. effect that a salesperson and any other Deputy Secretary. On an ongoing basis, the Expert, or an person entitled to receive compensation [FR Doc. 95–2656 Filed 2–2–95; 8:45 am] appropriate substitute Expert, will for selling or servicing shares may BILLING CODE 8010±01±M monitor the manner in which the receive different compensation with calculations and allocations are being respect to one particular class of shares made and, based upon such review, will over another in the Portfolios. Issuer Delisting; Notice of Application render at least annually a report to the to Withdraw From Listing and 12. The conditions pursuant to which Registration; (Health-Mor Inc., Portfolios that the calculations and the exemptive order is granted and the allocations are being made properly. Common Stock, $1 Par Value) File No. duties and responsibilities of the board 1±6220 The reports of the Expert will be filed of each Portfolio with respect to the as part of the periodic reports filed with Multiple Class System will be set forth January 30, 1995. the SEC pursuant to sections 30(a) and in guidelines which will be furnished to Health-Mor Inc. (‘‘Company’’) has 30(b)(1) of the Act. The work papers of the directors. filed an application with the Securities the Expert with respect to such reports, 13. Each Portfolio implementing a and Exchange Commission following request by the Portfolios Multiple Class System will disclose the (‘‘Commission’’), pursuant to Section (which the Portfolios agree to provide), respective expenses, performance data, 12(d) of the Securities Exchange Act of will be available for inspection by the distribution arrangements, services, 1934 (‘‘Act’’) and Rule 12d2–2(d) SEC staff upon written request to the fees, sales charges (if any), and exchange promulgated thereunder, to withdraw Portfolios for such work papers by a privileges applicable to each class of its the above specified security (‘‘Security’’) senior member of the Division of shares in every prospectus, regardless of from listing and registration on the Investment Management, limited to the whether all classes of its shares are American Stock Exchange, Inc. Director, an Associate Director, the offered pursuant to each prospectus. (‘‘Amex’’). Chief Accountant, the Chief Financial Each Portfolio will disclose the The reasons alleged in the application Analyst, an Assistant Director, and any respective expenses and performance for withdrawing the Security from Regional Administrators or Associate data applicable to all classes of its listing and registration include the and Assistant Administrators. The shares in every shareholder report. The following: initial report of the Expert is a ‘‘Special shareholder reports will contain, in the According to the Company, its Board Purpose’’ report on ‘‘policies and statement of assets and liabilities and of Directors (‘‘Board’’) unanimously procedures placed in operation’’ in statements of operations, information approved a resolution on October 19, accordance with Statement on Auditing related to the Portfolio as a whole 1994, to withdraw the Security from Standards (‘‘SAS’’) No. 70, ‘‘Reports on generally and not on a per class basis. listing on the Amex and, instead, list the the Processing of Transactions by Each Portfolio’s per share data, Security on the National Association of Service Organizations,’’ of the American however, will be prepared on a per class Securities Dealers Automated Institute of Certified Public Accountants basis with respect to all classes of shares Quotation/National Market System (‘‘AICPA’’). Ongoing reports will he on of such Portfolio. To the extent that any (‘‘NASDAQ/NMS’’). According to the ‘‘policies and procedures placed in advertisement or sales literature Company, the decision of the Board operation and tests of operating describes the expenses or performance followed a lengthy study of the matter effectiveness’’ prepared in accordance data applicable to any class of its shares, and was based upon the belief that with SAS No. 70 of AICPA, as it may be each Portfolio will also disclose the listing of the Security on NASDAQ/ amended from time to time, or similar respective expenses and/or performance NMS will be more beneficial to its auditing standards as may be adopted data applicable to all classes of that stockholders than the present listing on by the AICPA from time to time and any Portfolio’s shares. The information the Amex because: such other then applicable auditing provided by an applicant or other (a) There will be advantage (potential standards as may be adopted by the Portfolio for publication in any for research coverage and other financial AICPA. newspaper or similar listing of a services for example) of the support of Portfolio’s net asset value or public Market Makers (currently there are an 10. Applicants have adequate average of 11 Market Makers on the facilities in place to ensure offering price will present each class of that Portfolio’s shares separately. average NASDAQ company) versus the implementation of the methodology and single specialist; procedures for calculating the net asset 14. Applicants acknowledge that the (b) The nature of the trading activity value and dividends and other grant of the exemptive order requested and pattern of the Amex specialist, in distributions of the classes of shares and by this application will not imply SEC essence being the buyer and seller of the proper allocation of expenses among approval of, authorization of, or last resort, will be eliminated; the classes of shares and this acquiescence in any particular level of (c) There is greater visibility of the representation has been concurred with payments that any Portfolio may make NASDAQ exchange as compared to the by the Expert in the initial report pursuant to a Plan in reliance on the Amex through various media; referred to in the preceding condition exemptive order. (d) The history of NASDAQ being a and will be concurred with by the 15. Applicants will comply with the successful promoter of growth Expert, or an appropriate substitute provisions of proposed rule 6c–10 under companies more appropriately Expert, on an ongoing basis at least the Act, Investment Company Act addresses the Company’s current annually in the ongoing reports referred Release No. 16619 (November 2, 1988), position; to in the preceding condition. as such rule is currently proposed and (e) There is potentially more capital Applicants will take immediate as it may be reproposed, adopted or support for the Company through corrective action if the Expert, or amended. NASDAQ as each Market Maker is 6748 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices responsible to purchase 5,000 shares; result in increased visibility and Commission’s Office of Public and sponsorship for the Security than is Reference. (f) The services offered through the presently the case with the single Interested persons wishing to NASDAQ, which have been reviewed, specialist assigned to the Security on comment or request a hearing on the are more likely to assist the Company in the Amex/ECM; application(s) and/or declaration(s) understanding the market and (2) The NASDAQ SmallCap Market should submit their views in writing by communicating with its shareholders. system will offer the Company’s February 21, 1995, to the Secretary, Any interested person may, on or shareholders more liquidity than Securities and Exchange Commission, before February 21, 1995, submit by presently available on the Amex/ECM Washington, DC 20549, and serve a letter to the Secretary of the Securities and less volatility in quoted price per copy on the relevant applicant(s) and/or and Exchange Commission, 450 Fifth share when trading volume is slight; declarant(s) at the address(es) specified Street, NW., Washington, DC 20549, (3) The NASDAQ SmallCap Market below. Proof of service (by affidavit or, facts bearing upon whether the system will offer the opportunity for the in case of an attorney at law, by application has been made in Company to more effectively certificate) should be filed with the accordance with the rules of the Amex consummate its proposed offering of request. Any request for hearing shall and what terms, if any, should be 1,100,000 Units; and identify specifically the issues of fact or imposed by the Commission for the (4) Firms making a market in the law that are disputed. A person who so protection of investors. The Company’s Security on the NASDAQ requests will be notified of any hearing, Commission, based on the information SmallCap Market system will be if ordered, and will receive a copy of submitted to it will issue an order inclined to issue research reports any notice or order issued in the matter. granting the application after the date concerning the Company, thereby After said date, the application(s) and/ mentioned above, unless the increasing the number of firms or declaration(s), as filed or as amended, Commission determines to order a providing institutional research and may be granted and/or permitted to hearing on the matter. advisory reports. become effective. For the Commission, by the Division of Any interested person may, on or Market Regulation, pursuant to delegated before February 21, 1995, submit by EUA Energy Investment Corporation authority. letter to the Secretary of the Securities (70–8283) Jonathan G. Katz, and Exchange Commission, 450 Fifth EUA Energy Investment Corporation Secretary. Street, NW., Washington, DC 20549, (‘‘EEIC’’), P.O. Box 2333, Boston, [FR Doc. 95–2651 Filed 2–2–95; 8:45 am] facts bearing upon whether the Massachusetts 02107, a wholly owned BILLING CODE 8010±01±M application has been made in subsidiary company of Eastern Utilities accordance with the rules of the Amex Associates, a registered holding and what terms, if any, should be company, has filed a post-effective Issuer Delisting; Notice of Application imposed by the Commission for the amendment under Section 12(b) of the to Withdraw From Listing and protection of investors. The Act and Rule 45 thereunder to its Registration; (NuMed Home Health Commission, based on the information application-declaration filed under Care, Inc., Common Stock, $.001 Par submitted to it, will issue an order Section 6(a), 7, 9(a), 10 and 12(b) of the Value) File No. 1±12992 granting the application after the date Act and Rule 45 thereunder. mentioned above, unless the January 30, 1995. By order dated January 24, 1994 Commission determines to order a (HCAR No. 25976), EEIC was NuMed Home Health Care, Inc. hearing on the matter. (‘‘Company’’) has filed an application authorized, among other things, to with the Securities and Exchange For the Commission, by the Division of provide up to $1 million of capital Commission (‘‘Commission’’), pursuant Market Regulation, pursuant to delegated contributions and up to $2 million of authority. to Section 12(d) of the Securities open account advances and/or loans to Exchange Act of 1934 (‘‘Act’’) and Rule Jonathan G. Katz, TransCapacity L.P. for the research, 12d2–2(d) promulgated thereunder, to Secretary. development and commercialization of withdraw the above specified security [FR Doc. 95–2652 Filed 2–2–95; 8:45 am] an energy-related computer software (‘‘Security’’) from listing and BILLING CODE 8010±01±M and hardware system for the collection, registration on the American Stock compilation and distribution of an information database composed of Exchange, Inc. (‘‘Amex’’). [Release No. 35±26223] The reasons alleged in the application information regarding natural gas for withdrawing the Security from Filings Under the Public Utility Holding pipeline capacity and capacity rights. listing and registration include the Company Act of 1935, as Amended As of December 31, 1994, EEIC has following: (``Act'') provided TransCapacity L.P. with According to the Company, its Board $2.275 million in funding for its of Directors (‘‘Board’’) unanimously January 27, 1995. working capital, leaving EEIC with approved a resolution on January 10, Notice is hereby given that the unexercised authorization to contribute 1995, to withdraw the Security from following filing(s) has/have been made $725,000 to TransCapacity L.P. listing on the Emerging Company with the Commission pursuant to EEIC now proposes to make Marketplace of the Amex (‘‘Amex/ provisions of the Act and rules additional capital contributions to ECM’’) and, instead, list the Security on promulgated thereunder. All interested TransCapacity L.P., through December the National Association of Securities persons are referred to the application(s) 31, 1996 up to an aggregate principal Dealers Automated Quotation Small Cap and/or declaration(s) for complete amount of $2 million. The partners for Market System/National Market System statements of the proposed TransCapacity L.P. project that they will (‘‘NASDAQ/NMS’’). The Company transaction(s) summarized below. The require up to $2 million of additional believes that: application(s) and/or declaration(s) and funding from EEIC for working capital (1) The NASDAQ SmallCap Market any amendments thereto is/are available purposes due to unavoidable delays in system of competing market-makers will for public inspection through the achieving their target date for full Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6749 operation of the Energy Bulletin Board [Rel. No. IC±20866; No. 812±9336] contested. Persons may request system. notification of a hearing by writing to State Mutual Life Assurance Company the Commission’s Secretary. New England Electric Resources, Inc. et of America, et al. al. (70–8513) ADDRESSES: Secretary, SEC, 450 5th January 27, 1995. Street, NW., Washington, DC 20549. New England Electric System AGENCY: Securities and Exchange Applicants, c/o Joseph W. MacDougall, (‘‘NEES’’), a registered holding Commission (‘‘Commission’’ or ‘‘SEC’’). Jr., State Mutual Life Assurance company, and its nonutility subsidiary ACTION: Notice of Application for an Company of America, 440 Lincoln company, New England Electric Order under the Investment Company Street, Worcester, Massachusetts, 01653. Resources, Inc. (‘‘NEERI’’), both located Act of 1940 (the ‘‘1940 Act’’). FOR FURTHER INFORMATION CONTACT: at 25 Research Drive, Westborough, Massachusetts 01582, have filed an APPLICANTS: State Mutual Life Kevin Kirchoff, Senior Attorney, or application-declaration under Sections Assurance Company of America (‘‘State Wendy Friedlander, Deputy Chief, at 6(a), 7, 9(a), 10, and 12(b) of the Act and Mutual’’), Separate Account VA–P of (202) 942–0670, Office of Insurance Rules 40 and 45 thereunder. State Mutual Life Assurance Company Products (Division of Investment Management). By orders dated September 4, 1992, of America (‘‘State Mutual Account’’), April 1, 1994 and May 25, 1994 (HCAR SMA Life Assurance Company (‘‘SMA SUPPLEMENTARY INFORMATION: Following Nos. 25621, 26017 and 26057, Life,’’ together with State Mutual, the is a summary of the application; the respectively), NEES was authorized to ‘‘Insurance Companies’’), Separate complete application is available for a capitalize NEERI in amounts of up to Account VA–P of SMA Life Assurance fee from the Commission’s Public $2.5 million. By the same orders, NEERI Company (‘‘SMA Life Account’’) and Reference Branch. other separate accounts established by was authorized to: (1) Enter into the Applicants’ Representations business of performing consulting the Insurance Companies in the future services on electric utility matters for to support certain deferred variable 1. State Mutual is a mutual life nonaffiliates; (2) provide electrical annuity contracts issued by the insurance company incorporated under related services for nonaffiliates; and (3) Insurance Companies (‘‘Other the laws of Massachusetts. SMA Life, a Accounts,’’ together with the State invest in a start-up company formed to wholly-owned subsidiary of State Mutual Account and the SMA Life develop, manufacture and market a low Mutual, is a stock life insurance Account, the ‘‘Accounts’’). harmonic distortion uninterruptible company organized under the power supply. RELEVANT 1940 ACT SECTIONS: Order provisions of the Delaware Insurance requested under Section 6(c) granting Code. SMA Life is registered as a broker- NEERI now seeks authority, through exemptions from the provisions of dealer under the Securities Exchange 1998, to invest up to $10 million in Sections 26(a)(2)(C) and 27(c)(2). Act of 1934 (‘‘1934 Act’’) and is a research and development activities in SUMMARY OF APPLICATION: Applicants member of the National Association of connection with environmental, new seek an order permitting the deduction Securities Dealers (‘‘NASD’’). State electrical generation and transmission of a mortality and expense risk charge Mutual is authorized to conduct technologies, and electric end-use from the assets of: (a) The Accounts in business as an insurance company in all technologies, NEERI will not acquire connection with the offer and sale of states and in the District of Columbia, any securities in connection with its certain variable annuity contracts Puerto Rico, and the U.S. Virgin Islands. research and development activities (‘‘Annuity Contracts’’); (b) the Accounts without further Commission approval. 2. The Accounts are separate in connection with the issuance of NEES seeks authority for the same investment accounts established by the variable annuity contracts that are period to provide additional financing Insurance Companies for the purpose of substantially similar in all material for NEERI in an amount not to exceed investing purchase payments received respects to the Contracts (‘‘Future $10 million through non-interest under the Contracts. Each of the Contracts,’’ together with Annuity bearing subordinated loans or capital Accounts is a unit investment trust Contracts, the ‘‘Contracts’’); and (c) any contributions. NEES’ request to which has filed a registration statement other separate account established in capitalize NEERI is in addition to its on Form N–4 under the Securities Act the future by the Insurance Companies pending request to provide additional of 1933 to register the offering of the in connection with the issuance of financing to NEERI in amounts of up to Contracts, and the Applicants Contracts. $11.7 million in S.E.C. File No. 70– incorporate such registration statements FILING DATE: 8475. The application was filed into the application by reference. on November 22, 1994. Each Account presently consists of Further, in order to allow NEERI to HEARING OR NOTIFICATION OF HEARING: An seven Subaccounts, each of which will acquire securities in local enterprises order granting the application will be invest solely in the shares of one of the pursuant to Rule 40(a)(5) under the Act, issued unless the Commission orders a portfolios of the Pioneer Variable NEES also seeks authority to provide hearing. Interested persons may request Contracts Trust. Contract owners may additional financing for NEERI in an a hearing by writing to the invest in any one or more of the annual aggregate amount not to exceed Commission’s Secretary and serving the Subaccounts, and may also invest in the $1 million through non-interest bearing Applicants with a copy of the request, fixed account, part of the general subordinated loans or capital personally or by mail. Hearing requests account of the respective Insurance contributions, also through 1998. should be received by the Commission Companies. The Insurance Companies For the Commission, by the Division of by 5:30 p.m. on February 21, 1995, and may, in the future, issue through the Investment Management, pursuant to should be accompanied by proof of Accounts, and through other separate delegated authority. service on Applicants in the form of an accounts that they may establish in the Margaret H. McFarland, affidavit or, for lawyers, a certificate of future, other variable annuity contracts Deputy Secretary. service. Hearing requests should state that are substantially similar in all [FR Doc. 95–2654 Filed 2–2–95; 8:45 am] the nature of the writer’s interest, the material respects to the Annuity BILLING CODE 8010±01±M reason for the request, and the issues Contracts. 6750 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 3. Pioneer Variable Contracts Trust is at each Contract anniversary and at full Years from date of payment to Withdrawal a diversified open-end management surrender during a contract year for its date of withdrawal charge investment company which consists of costs in maintaining each Contract and (percent) various investment series or portfolios the Accounts. The Insurance Companies 0±3 ...... 7 (collectively, ‘‘Portfolios’’) with make a daily charge to the Subaccounts 4 ...... 6 different investment objectives and of the Accounts equal on an annual 5 ...... 5 policies. Shares of the Portfolios are basis to 0.15% of the current value of 6 ...... 4 purchased by the Insurance Companies the Subaccounts (‘‘Administrative 7 ...... 3 for the corresponding Subaccounts at Service Charge’’). The Administrative More than 7 ...... None the net asset value. Shares of the Service Charge is designed to cover Portfolios also are offered to other actual administrative expenses which In no event will the Contingent affiliated or unaffiliated separate exceed the revenue for the Contract Fee. Deferred Sales Charges assessed against accounts of the Insurance Companies or Applicants represent that the a Contract exceed 8% of the gross of other insurance companies offering Administrative Service Charge and the purchase payments. variable annuity or variable life Contract Fee have been set at a level that The Insurance Companies do not insurance contracts. will recover no more that the actual anticipate that the CDSC will generate 4. Allmerica Investments, Inc., an costs associated with administering the sufficient revenues to pay the cost of indirect wholly-owned subsidiary of Contract and the Accounts. The distributing the Contracts. If this charge State Mutual, is registered as a broker- Insurance Companies do not expect to is insufficient to cover the expenses, the dealer under the 1934 Act and is a realize a profit from these charges, and deficiency will be met from the member of the NASD. Allmerica guarantee that the amount of the charges Insurance Companies’ general account Investments, Inc. is the principal will not increase over the life of the assets, which may include amounts underwriter for the Contracts. Contract. derived from the charge for mortality 5. The Contracts are group and 9. The Insurance Companies will and expenses risks, discussed below. 13. A daily charge equal to an individual combination fixed and deduct any premium tax levied by any effective annual rate of 1.25% of the net variable contracts designed for use in governmental entity as a result of the asset value of the Accounts will be retirement plans which qualify for Contracts or the Accounts. Applicants special federal income tax treatment imposed to compensate the Insurance state that, where permitted by state law, under sections 401, 403(b), 408 and 457 Companies for bearing certain mortality the premium taxes will be deducted of the Internal Revenue Code and in and expenses risks in connection with upon annuitization. In all other retirement plans which do not qualify the Contracts. Of this amount, jurisdictions, the taxes will be deducted for special tax treatment under those approximately 0.80% is allocable to upon the death of the annuitant, sections. mortality risks and approximately surrender, or withdrawal, as may be 6. The Contracts provide for 0.45% is allocable to expense risks. The required by the law of the Contract minimum initial purchase payments mortality and expense risk charge is owner’s state of residence. and permit additional minimum guaranteed never to exceed 1.25%. This purchase payments and periodic 10. Prior to the Annuity charge may be a source of profit for the payments, subject to certain limitations. Commencement date, amounts held Insurance Companies which will be The Contracts provide for the under the Contracts may be transferred added to their surplus and may be used accumulation of values on a variable among the Subaccounts and the for, among other things, the payment of basis determined by the investment respective Insurance Company’s general distribution expenses. experience of the Portfolios to which the account. The Insurance Companies 14. The mortality risk arises from the Contract owner allocates payments. currently make no charge for transfers Insurance Companies’ (1) Guarantee that 7. The Contracts also provide for the among the accounts, but reserve the they will make annuity payments, in payment of a death benefit. The death right to assess a charge, guaranteed accordance with annuity rate provisions benefit, payable in a single sum or never to exceed $25. established at the time a Contract is under an optional method of settlement, 11. Applicants represent that the issued for the life of the annuitant or in is provided if the annuitant dies before Insurance Companies will deduct the accordance with the annuity option the maturity, surrender, or termination annual Contract Fee, the annual selected, no matter how long the of a Contract. Upon the death of the Administrative Service Charge, and any annuitant or other payee lives and no annuitant, the death benefit is equal to Transfer Charge in reliance upon and in matter how long all annuitants as a class the greatest of (a) the accumulated value conformity with all of the requirements live, and (2) death benefit guarantees under the Contract next determined of Rule 26a–I under the 1940 Act. under the Contracts. following receipt of due proof of death 12. No sales charges are deducted 15. The expense risk borne by the at the Insurance Companies’ principal from premium payments under the Insurance Companies is the risk that the office, or (b) the total amount of gross Contracts. The Contracts assess a charges for administrative expenses, payments made under the Contracts Contingent Deferred Sales Charge which are guaranteed not to increase for reduced proportionally to reflect the (‘‘CDSC’’) which is applied in the case the life of the Contracts, may be amount of all prior partial withdrawals, of contract surrender, partial insufficient to cover the actual costs of or (c) the death benefit that would have redemptions or annuitization under issuing and administering the Contracts. been payable on the most recent fifth period certain options during the seven interval policy anniversary, increased year period from the date the Insurance Applicants’ Legal Analysis and for subsequent purchase payments and Companies receive and accept each Conditions reduced proportionally to reflect purchase payment. The CDSC is 1. Applicants request an order of the withdrawals after that date. determined by the number of Contract Commission under Section 6(c) for 8. Various fees and expenses are anniversaries that have passed since the exemptions from Sections 26(a)(2)(C) deducted under the Contracts. Prior to purchase payment that is being and 27(c)(2) of the 1940 Act to the a Contract’s maturity, the Insurance withdrawn was made. The CDSC is extent necessary to permit the Companies assess a Contract Fee of $30, computed as follows: deduction of a maximum charge of Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6751 1.25% for the assumption of mortality deposited with a qualified bank and For the Commission, by the Division of and expense risks from the assets of: (a) held under arrangements which prohibit Investment Management, pursuant to The Accounts in connection with the any payment to the depositor or delegated authority. issuance of the Annuity Contracts; (b) principal underwriter except a Margaret H. McFarland, the Accounts in connection with the reasonable fee, as the Commission may Deputy Secretary. issuance of any Future Contracts; and prescribe, for preforming bookkeeping [FR Doc. 95–2655 Filed 2–2–95; 8:45 am] (c) any other separate account and other administrative duties BILLING CODE 8010±01±M established in the future by the normally performed by the bank itself. Insurance Companies in connection 5. Applicants represent that the with the issuance of Future Contracts. DEPARTMENT OF TRANSPORTATION Applicants believe that the requested 1.25% mortality and expense risk exemptions are necessary and charge under the Contracts is within the Office of the Secretary appropriate in the public interest and range of industry practice for consistent with the protection of comparable annuity contracts. This Regional Liaison Outreach and investors and the purposes fairly representation is based upon Services Program (L.O.S.P.); intended by the policy and provisions of Applicants’ analysis of similar industry Announcement of Request for the 1940 Act. products, taking into account such Proposals (RFP) 2. Applicants submit that their factors as current change levels, SUMMARY: The Department of request for exemptive relief for existence of charge level guarantees, and Transportation’s Office of Small and deduction of the 1.25% mortality and guaranteed annuity rates. Applicants Disadvantaged Business Utilization expense risk charge from the assets of represent that the Insurance Companies (O.S.D.B.U.) is responsible for the the Accounts, or any other separate will maintain at their home offices, Department’s implementation and account established by the Insurance available to the Commission, a execution of the functions and duties Companies in the future, in connection memorandum setting forth in detail the under sections eight (8) and fifteen (15) with the issuance of Future Contracts, products analyzed in the course of, and of the Small Business Act (15 U.S.C. would promote competitiveness in the 637) for developing policies and variable annuity contract market by the methodology and results of, their procedures consistent with Federal eliminating the need for the Insurance comparative survey. statutes to provide policy direction for Companies to file redundant exemptive 6. Applicants acknowledge that, if a applications, thereby reducing the profit is realized from the mortality and minority, women-owned, small, and disadvantaged business (S/DBE) Insurance Companies’ administrative expense risk charge under the Contracts, participation in the Department’s expenses and maximizing the efficient all or a portion of such profit may be use of their resources. Applicants procurement and Federal financial available to pay distribution expenses assistance activities. The office is also further submit that the delay and not reimbursed by the CDSC. The expense involved in having repeatedly responsible for implementing and Insurance Companies have concluded monitoring the Department’s goals for to seek exemptive relief would impair that there is a reasonable likelihood that the Insurance Companies’ ability minority, women-owned and small and the proposed distribution financing disadvantaged businesses. The Secretary effectively to take advantage of business arrangements will benefit the Accounts opportunities as they arise. Further, if of Transportation has encouraged DOT and the Contract owners. The basis for the Insurance Companies were required operating administrations to expand that conclusion is set forth in a repeatedly to seek exemptive relief with opportunities for these entrepreneurs to respect to the same issues addressed in memorandum which will be maintained participate fully in all DOT-funded this Application, investors would not by the Insurance Companies at their procurements and assisted programs. receive any benefit or additional administrative offices and will be made On May 10, 1994 OSDBU published a protection thereby. Thus, Applicants available to the Commission. Notice in the Federal Register believe that the requested exemptions 7. Applicants also represent that the requesting proposals from organizations are appropriate in the public interest Accounts will invest only in underlying classified as minority trade associations and consistent with the protection of open-end management investment and/or Minority Chambers of Commerce investors and purposes fairly intended companies which undertake, in the to serve as regional representatives for the LOSP. Based upon the nationwide by the policy and provisions of the 1940 event they should adopt a plan under competition an independent panel Act. Rule 12b–1 to finance distribution recommended and OSDBU selected the 3. Section 6(c) of the 1940 Act expenses, to have a board of directors or authorizes the Commission, by order following as regional representatives: trustees, a majority of whom are not upon application, to conditionally or The National Association of Minority ‘‘interested persons’’ of such company unconditionally grant an exemption Contractors, Washington, D.C. to from any provision, rule or regulation of within the meaning of Section 2(a)(19) represent Region 3 (Delaware, District of the 1940 Act to the extent that the of the 1940 Act, formulate and approve Columbia, Maryland, Pennsylvania, exemption is necessary or appropriate any such plan. Virginia and West Virginia); Latin in the public interest and consistent Conclusion Chamber of Commerce U.S.A., Miami, with the protection of investors and the FL. to represent Region 4 (Alabama, purposes fairly intended by the policy For the reasons set forth above, Florida, Georgia, Kentucky, Mississippi, and provisions of the 1940 Act. Applicants represent that the North Carolina, South Carolina and 4. Sections 26(a)(2)(C) and 27(c)(2) of exemptions requested are necessary and Tennessee); Metropolitan Chamber of the 1940 Act, in relevant part, prohibit appropriate in the public interest and Commerce, Flint, MI. to represent a registered unit investment trust, its consistent with the protection of Region 5 (Illinois, Indiana, Michigan, depositor or principal underwriter, from investors and the purposes fairly Minnesota, Ohio and Wisconsin); selling periodic payment plan intended by the policy and provisions of Hispanic Chamber of Greater Kansas certificates unless the proceeds of all the 1940 Act. City, Kansas City , MO. to represent payments, other than sales loads, are Region 7 (Iowa, Kansas, Missouri and 6752 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Nebraska); Arizona Hispanic Chamber 2.1 Recipient Responsibilities obtain and manage transportation- of Commerce, Phoenix, AZ., and Black 2.2 Work Requirements related contracts, subcontracts and Business Association, Los Angeles, CA. 2.3 Office of Small and Disadvantaged projects. This includes administering to represent Region 9 (Arizona, America Business Utilization Responsibilities the Short Term Lending Program (STLP) 3. Submission of Proposals Samoa, California, Guam, Hawaii and 3.1 Content and Format for Proposals and the Bonding Assistance Program, Nevada). This request solicits 3.2 Address, Number of Copies, Deadline two financial assistance efforts which competitive proposals from for Submission provide assistance in obtaining short- organizations classified as minority 4. Selection Criteria term working capital and bonding for trade associations and/or minority 4.1 General Criteria DBEs. Under the STLP, lines of credit Chambers of Commerce for participation 4.2 Scoring of Applications up to $500,000 are available at prime under the LOSP to represent Regions 1, Appendix A—Application Form for interest rates to finance accounts 2, 6, 8 and 10. The states and territories Proposals receivable for transportation-related comprising these Regions are identified Attachments contracts. The Bonding Assistance in Section 1.4. Eligible applicants must Program enables DBEs to apply for bid, be registered with the Internal Revenue 1. Introduction performance and payment bonds on Service as 501 C(6) tax-exempt 1.1 Background contracts up to $1,000,000. organizations. OSDBU will enter into 1.2 Program Description and Goals Cooperative Agreements with these The United States Department of organizations to provide liaison services Transportation (DOT) established the An area where the OSDBU has between the DOT, its grantees, Office of Small and Disadvantaged focused considerable efforts has been recipients, contractors, subcontractors, Business Utilization (OSDBU) in that of increasing DBE access to DOT and minority, women-owned, and accordance with Public Law 95–507, an financial assistance programs and disadvantaged business enterprises. amendment to the Small Business Act contracting opportunities through the This Request for Proposals contains and the Small Business Investment Act Liaison Outreach and Services Program information concerning: (1) The of 1958. The OSDBU administers the (LOSP). This broad-based initiative principal objectives of the competition, Department’s Small and Disadvantaged utilizes Cooperative Agreements with a eligible applicants, activities and factors Business Enterprise (DBE) Program number of minority Chambers of for award; (2) the application process, which is designed to ensure that small Commerce and minority trade including how to apply and the criteria businesses, including small associations to provide liaison services disadvantaged and minority firms, have used for selection; and (3) a checklist of between DOT, its grantees, recipients, an equitable opportunity to participate application submission requirements. contractors, subcontractors and DBEs. in DOT’s procurement and Federal FOR GENERAL AND SPECIFIC INFORMATION The LOSP includes activities such as financial assistance programs and that information dissemination, outreach CONTACT: Ms. Patricia Martin, Staff they receive a fair share of the resulting Associate, David Benton, LOSP Manager services, conference and seminar contract awards. Because DOT’s policy participation and referrals to technical or Mr. Art Jackson, LOSP Contracting is to encourage and increase DBE Officer Technical Representative, Office assistance agencies (i.e., MBDCs, SBDCs participation in the contracts and and State DOT highway supportive of Small and Disadvantaged Business programs that it funds, during FY 1993, Utilization, U.S. Department of services contractors) which offer DBEs received over $2.6 billion or 14.4 management and technical assistance in Transportation, 400 7th Street, S.W., percent of highway, transit, air and rail financial assistance, marketing and Room 9410, Washington, D.C., 20590, contracts from DOT-assisted State and other business areas. In addition, the Tel. (202) 366–2852 or (800) 532–1169. local transportation agencies. minority organizations include DOT and SEND PROPOSALS TO: Mr. David Benton, OSDBU develops Department-wide other transportation-related information LOSP Manager, Office of Small and policy and administers a number of in their monthly or quarterly Disadvantaged Business Utilization (S– programs and activities to implement newsletters and provide one-on-one 40), U.S. Department of Transportation, the OSDBU’s Congressional mandate of business counseling to DBEs currently 400 7th Street, S.W., Room 9410, increasing the level of participation of doing business or that have the potential Washington, D.C. 20590. DBEs in the Federal financial assistance for doing business with DOT at the DATES: Proposals must be received at the and direct contracting programs of all Federal, state or local levels. above location by March 3, 1995, 4:00 modal administrations of DOT. OSDBU Information dissemination and p.m., Eastern Standard Time. Proposals is responsible for the development and outreach include the distribution of the received after the deadline will be implementation of an effective program following DOT marketing materials: considered non-responsive and not of activities directed at ensuring DBE DOT Bonding Assistance Program reviewed. DOT plans to give notice of participation in the Department’s direct Brochures; DOT Bonding Assistance awards on all applications by March 17, procurement and Federal financial Fact Sheets; DOT Short-Term Lending 1995. assistance activities. This includes the Program Brochures; DOT Short-Term Dated: January 26, 1995 monitoring of all DOT procurement Lending Fact Sheets; Procurement Luz Hopewell, activities that involve the participation Forecasts; DOT Small Business Director, Office of Small and Disadvantaged of DBEs, including the goal settings and Subcontracting Opportunities Directory; Business Utilization. procurement practices of DOT financial Contracting with the United States assistance recipients, namely, State and Department of Transportation Booklets; Table of Contents local transportation agencies. The DOT Bonding Assistance Program 1. Introduction OSDBU also serves an important Applications; and DOT Short-Term 1.1 Background function in assisting firms in their Lending Program Applications. A 1.2 Program Description and Goals marketing of the Department and all of compilation of these materials is 1.3 Description of Competition 1.4 Duration of Agreements its operating administrations. OSDBU available in the DOT’s Marketing 1.5 Authority also is responsible for developing and Information Package, a comprehensive 1.6 Eligibility Requirements administering programs to encourage, document which serves as a resource 2. Program Requirements stimulate, promote and assist DBEs to and reference tool. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6753 Participating LOSP organizations Commerce and minority trade availability of funds in subsequent fiscal make referrals to technical assistance associations to participate in the Liaison years. agencies offering assistance to DBEs in and Outreach Services Program (LOSP). 1.5 Authority the completion and submission of The LOSP shall enable the OSDBU to Short-Term Lending and Bonding establish a regional presence by DOT is authorized under 49 U.S.C. Assistance Program applications. assisting small businesses and DBEs in 322 (P.L. 97–449), to develop by The LOSP was established by the securing information on DOT Cooperative Agreements, support OSDBU in May 1992 in response to the procurement opportunities, Financial mechanisms including liaison and continuing need to outreach to the small Assistance Programs and the short-term assistance programs, that will enable and minority business community and lending and bonding assistance small businesses and DBEs to take increase their participation in DOT programs to increase the number of advantage of transportation-related contracting and financial assistance DBEs that enter into transportation- contracts. programs. To address this need, the related contracts. The LOSP is intended 1.6 Eligibility Requirements LOSP seeks to increase the number of to increase collaboration between small businesses and DBEs that enter OSDBU, minority Chambers of An eligible applicant organization into transportation-related contracts and Commerce and minority trade will be: An established, non-profit, that receive DOT STLP lines of credit associations to strengthen and enhance minority Chamber of Commerce or and bonding assistance. This goal is their ability to provide liaison services minority trade association which has accomplished by the OSDBU working between DOT, its grantees, recipients, the documented experience and closely with minority Chambers of contractors, subcontractors and DBEs. capacity necessary to successfully Commerce and minority trade As the program requirements and operate and administer a coordinated, associations to: selection criteria indicate, the OSDBU regional liaison outreach effort within a (1) Establish a communications link also intends that the LOSP be multi- region of the United States. (network) between DOT, its grantees, dimensional; that is, the selected In addition, to be eligible, a minority recipients, contractors, subcontractors organizations must have the capacity to Chamber of Commerce or minority trade and the small and disadvantaged effectively access and provide association must: business community. supportive services to the broad range of (a) Be an established 501 C(6) tax- (2) Increase awareness of DOT small business and DBE clients within exempt organization (provide contracting opportunities and financial their respective geographical areas and documentation as verification); assistance programs by disseminating must be able to coordinate and establish (b) Have at least one year of DOT marketing materials and relevant effective networks with DOT grant documented and continuous experience information at selected conferences, recipients and local/regional technical prior to the date of application in seminars and marketplace events. assistance agencies to maximize providing advocacy, management and (3) Develop and/or strengthen resources and avoid duplication of marketing assistance services and linkages with State DOTs, local effort. referral to technical assistance agencies transportation agencies, transportation to DBEs within the LOSP regional prime contractors, State highway Cooperative agreement awards will be service area in which proposed services supportive services contractors, up to $95,000. It is DOT’s intent to fund will be provided; and Minority Business Development Centers one agreement in the following regions: (c) Have an office physically located (MBDCs), Small Business Development Region 1, 2, 6, 8, and 10, however, there within the LOSP regional service area. Centers (SBDCs) and other minority may be multiple awards, if warranted to No application will be accepted Chambers of Commerce and minority improve DOT’s diversity of contracting without proof of tax-exempt status. efforts. In addition it is OSDBU’s intent trade associations to encourage DBE 2. Program Requirements participation in DOT programs. to encourage diversity of representation (4) Stimulate referrals of DBEs to in the LOSP by focusing on the selection In conducting the activities to achieve obtain technical assistance from of at least one Native American, Asian the goals of the LOSP, the recipient Federal, State and local agencies such as American and Woman organization. The shall be responsible for implementing MBDCs, SBDCs and State DOT highway geographical distribution of DOT the activities under 2.1 and 2.2 below. supportive services contractors for regions is shown in map form in The OSDBU shall be responsible for management and other business-related Attachment 1. The DOT regions for this conducting activities under 2.3. announcement, with states and territory assistance including completion and 2.1 Recipient Responsibilities submission of DOT Short-Term Lending comprising each, are listed below: Program and Bonding Assistance Region 1: Connecticut, Maine, Massachusetts, 1. Each LOSP participant shall: Program application packages. New Hampshire (a) Collaborate with and coordinate on (5) Increase awareness of DOT Region 2: New Jersey, New York, Puerto Rico programs, activities, services and programs by providing DOT Region 6: Arkansas, Louisiana, New Mexico, technical assistance with other Federal, representation at selected conferences, Oklahoma, Texas State and local organizations and seminars and marketplace events and by Region 8: Colorado, Montana, North Dakota, agencies serving transportation-related providing DOT ads and articles in South Dakota, Utah, Wyoming small businesses and DBEs, particularly organizations’ newsletters. Region 10: Alaska, Idaho, Oregon, State DOTs and DOT grantees. (6) Develop and maintain databases of Washington (b) Initiate, develop and maintain transportation-related DBEs as potential 1.4 Duration of Agreements interagency referral arrangements with participants in DOT procurement and/or agencies offering specialized financial assistance programs. Cooperative agreements will be management and technical assistance awarded for a period of 12 months) with including DOT state supportive services 1.3 Description of Competition a one year renewable option based on contractors, MBDCs, SBDCs and other The purpose of this RFP is to solicit need and program achievement. appropriate programs. proposals from eligible national and Continuation funding will be contingent (c) Establish a transportation advisory regional minority Chambers of upon satisfactory performance and the committee comprised of members who 6754 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices have demonstrated expertise in the familiar with DOT materials and conference report shall be submitted to preparation of financial statements and literature to disseminate appropriate OSDBU no later than 30 days after the bid/proposal development to advise on documents to DBEs at conferences, conference. the development and implementation of seminars, workshops, and to those c. Referrals to Technical Assistance LOSP activities. interested in and have the capacity to Agencies (d) Conduct one (1) regional perform transportation-related projects. conference to address contracting This LOSP ‘‘core service’’ includes Each LOSP participant shall provide opportunities within DOT modal distribution of general information on technical assistance services by referring administrations and from state and local DOT’s overall DBE program, specific DBEs to agencies that offer assistance in transportation agencies within the information on DOT’s short-term the preparation of DOT procurement region. lending and bonding assistance documents and applications for loans (e) Develop structured, consultative programs; and information and and bonds for submission on relationships with key constituent assistance on DOT’s procurement transportation-related projects. In groups within the region to help build opportunities. Materials to be addition, specific referrals shall be made and reinforce collaboration. Such disseminated shall include, but are not to agencies that certify DBEs using DOT relationships will ensure that DOT non- limited to, fact sheets, brochures, short- guidelines. minority and minority prime contractors term lending and bonding assistance d. Database Development as well as minority Chambers of program applications, and reports and Commerce and minority trade advertisements which are directed Each LOSP participant shall develop associations facilitate awareness and toward the DBE communities in each a comprehensive data base of firms utilization of LOSP services. region. within its regional service area that have (f) Implement information The LOSP participant shall publish the capability to perform transportation- dissemination and education activities stories/articles and features in the related contracts. and strategies to maximize outreach recipient’s newsletter which contain regarding DOT procurement 2.3 Office of Small and Disadvantaged information regarding the accessibility Business Utilization (OSDBU) opportunities and the short-term to procurement opportunities within Responsibilities lending and bonding assistance DOT, and the short-term lending and programs. bonding assistance programs. The The OSDBU shall perform the (g) Conduct an on-going evaluation of Director, OSDBU, shall approve all following roles as its contribution to the activities funded through this stories, articles, and special features attainment of LOSP objectives: cooperative agreement. Evaluation will prior to their publication in the 1. Provide consultation and technical quantitatively and qualitatively describe recipient’s monthly or quarterly assistance in planning, implementing LOSP activities, the services and the newsletter. and evaluating activities under this recipients of services. Each applicant announcement. must develop and implement an on- b. Conference and Seminar Participation 2. Provide orientation and training to going evaluation plan. The LOSP participant shall applicants awarded funding for (h) Develop structured, consultative participate in regional, state and local participation in the LOSP. relationships with the private sector procurement conferences on behalf of 3. Systematically monitor the financial community and Federal, State, the OSDBU and disseminate DOT performance of successful applicants’ regional and local agencies which procurement information, short-term activities and program compliance. provide specialized financial technical lending and bonding assistance program 4. Assist successful applicants in assistance services to DBEs. literature and other materials. The collaborating and developing or (i) Establish and maintain an 800 toll conferences/seminars shall be strengthening linkages with State DOTs, free line to be made available to transportation-related and each shall be technical assistance agencies and DOT minority, women-owned, small and approved by the Director, OSDBU, prior grantees within regional geographical disadvantaged businesses interested in to participation. The LOSP participant areas served. transportation-related procurements and shall identify regional, state and local 5. Facilitate the exchange and transfer information on the application process conferences where a significant number of successful LOSP activities and for the DOT Short Term Lending and of DBEs with transportation-related program information among regional Bonding Assistance Programs. Referral capabilities are expected to be in LOSP participants. services shall be provided. attendance. The LOSP participant shall 3. Submission of Proposals (j) Furnish all labor, facilities and maintain the DOT booth at equipment to perform the services transportation-related conferences/ 3.1 Content and Format for Proposals described in this announcement. seminars. A list of proposed DBE Each proposal submitted to DOT must 2.2 Work Requirements conferences and seminars being be in the format and must contain the considered for participation under the Each LOSP participant must perform information set forth in the application Cooperative Agreement shall be work in the following functional areas: form attached as Appendix A to this (a) Information Dissemination and forwarded to OSDBU for review and announcement. Outreach approval. The LOSP participant shall conduct 3.2 Address; Number of Copies; (b) Conference and Seminar Deadline for Submission Participation one (1) regional conference and shall be (c) Referrals to Technical Assistance responsible for all conference planning Any eligible organization (as defined Agencies and logistics which include identifying in Section 1.6 of this RFP) shall submit (d) Database Development and contacting DBEs, mailing only one proposal for consideration by invitational letters, handling details for DOT. Applications should be double a. Information Dissemination and exhibit booths and luncheons, preparing spaced, and printed in a font size not Outreach conference brochures as well as smaller than 12 points. One unbound Each LOSP program director shall tentative and final conference agendas, copy of the proposal with original meet with OSDBU officials to become and securing media coverage. A signatures suitable for reproduction, Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6755 plus four bound copies, should be linking urban and rural DBEs to the in scope and nature to the proposed submitted. All pages should be LOSP should be outlined. The applicant effort must be presented in detail. The numbered at the top of each page. All should describe support and intended Project Director will serve as the documentation, attachments, or other collaboration on LOSP activities from responsible individual for the project a information pertinent to the application DOT grantees, prime contractors, minimum of 50 percent of his/her time. must be included in a single subcontractors, State DOTs, State He/she must be designated in the submission. highway supportive services proposal and his/her resume must Proposals should be submitted to: contractors, SBDCs, MBDCs and reflect appropriate knowledge of the David Benton, LOSP Manager, Office of colleges and universities serving regional area and supervisory Small and Disadvantaged Business minorities including Historically Black experience. Utilization (S–40), U.S. Department of Colleges and Universities (HBCUs), DOT will consider the extent to which Transportation, 400 7th Street, SW., Hispanic Association of Colleges and the applicant’s proposed management room 9414, Washington, DC 20590. Universities’ affiliations (HACUs) and plan (a) clearly delineates staff Proposals must be received by DOT/ Tribal-Affiliated Colleges and responsibilities and accountability for OSDBU no later than March 3, 1995 Universities (TACUs). DOT will also all work required and (b) presents a 4:00 p.m., EST. rate the effectiveness of the applicant’s work plan with a clear and feasible strategy to provide outreach, networking schedule for conducting all project 4. Selection Criteria and liaison activities to the regional area tasks. 4.1 General Criteria to be served. In rating this factor, DOT will consider the extent to which the D. Cost (10 Points) DOT will use the following criteria to applicant demonstrates ability to The budget is the applicant’s estimate rate and rank applications received in effectively access and network of the total cost of establishing and response to this announcement for the supportive services to the broad and administering its participation in the applicant’s region. Applications will be diverse range of DBEs within the LOSP. The applicant’s budget must be evaluated for each region on a point applicant’s regional service area. adequate to support the project and system (maximum number of points = Emphasis will also be placed on the costs must be reasonable in relation to 100). The following five (5) maximum extent to which the applicant identifies project objectives. Applicants are weighted categories will constitute a clear outreach strategy related to encouraged to provide in-kind costs and DOT’s selection criteria: identified needs that can be successfully other innovative cost approaches. —Approach (25 points) carried out within the period of this —Linkages/Networks (25 points) 4.2 Scoring of Applications agreement and a plan for forming and —Organizational Capability (25 points) involving an internal transportation A review panel will score each —Staff Capabilities and Experience (15 application based upon the evaluation points) advisory committee in the execution of that strategy. criteria listed above. Points will be —Cost (10 points) given for each evaluation criteria A. Approach and Linkages (50 Points) B. Organizational Capability (25 Points) category not to exceed the maximum The applicant organization must have number of points allowed for each 1. Approach (25 Points) outreach resources and relevant category. Applications which are not The applicant must describe the experience in carrying out the purposes responsive to the established criteria activities proposed to be implemented of the LOSP. In rating this factor, DOT above will be disqualified. under the cooperative agreement and will consider the extent to which the how the work will be accomplished applicant’s organization has recent, ‘‘Appendix A’’ across the LOSP regional area. Present a relevant and successful experience in Application Form for Submission of well-constructed plan of action. DOT advocating for and addressing the needs Proposals for Department of will consider the extent to which the of minority businesses in general and Transportation, Regional Liaison proposed objectives are specific, transportation-related DBEs in Outreach and Services Program (LOSP) measurable, time-phased, consistent particular. The applicant must also with LOSP goals and the proposed describe technical and administrative Appendix A—Application Form For activities are consistent with the resources it plans to use in achieving Proposals for the Department of applicant organization’s overall mission. proposed objectives (i.e., computer Transportation, Regional Liaison DOT will give priority consideration to facilities, voluntary staff time, space and Outreach and Services Program (LOSP) applicants that demonstrate innovation financial resources). Proposals for the DOT Regional Liaison and creativity of approach in increasing Outreach and Services Program (LOSP) C. Staff Capability and Experience (15 the ability of DBEs to access information should contain all of the following Points) on DOT contracting opportunities and information and should be submitted in the following format. financial assistance programs. DOT will The applicant organization should provide a list of proposed personnel for Applications should be double spaced and also rate the quality of the applicant’s printed in a font size not smaller than 12 plan for conducting program activities the project with salaries, educational points. One unbound copy of the proposal and the likelihood that the proposed levels and previous experience with original signatures suitable for methods will be successful in achieving delineated. The applicant’s project team reproduction, plus four bound copies, should proposed objectives. must be well-qualified and be submitted. Applications, excluding knowledgeable (ensuring diversity) attachments, will be limited to 35 pages. All 2. Linkages (25 Points) which shows evidence of the ability to pages should be numbered at the top of each DOT will consider innovative aspects deal effectively with the broad range of page. All documentation, attachments, or of the applicant’s approach which build DBE clients to be served. Resumes must other information pertinent to the application should be included in a single submission, upon the applicant’s strength(s) and be submitted for all proposed key forwarded directly to the address listed facilitate and encourage linkages to personnel, outside consultants and below. existing resources available within the subcontractors. Experience of key Proposals should be submitted to: David region. The applicant’s structure for personnel in providing services similar Benton, LOSP Manager, Office of Small and 6756 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Disadvantaged Business Utilization (S–40), —Describe the specific services or activities —Describe internal resources available to use U.S. Department of Transportation, 400 7th to be performed and how these services/ in successfully performing/completing the Street, SW., room 9414, Washington, DC activities will be implemented. work. 20590. —Describe innovative and/or creative 7. Staff Capabilities Proposals must be received by DOT/ approaches to be implemented through the OSDBU no later than March 3, 1995, 4:00 LOSP to increase the ability of DBEs to —Describe the qualifications and relevant P.M. EST. access information on DOT contracting experience, in relation to project All applications must contain the opportunities and financial assistance requirements, of the key personnel to be following sections in the following order. programs. used in the project. 1. Table of Contents 5. Linkages 8. Management Plan —Identify all parts, sections and attachments —Describe how personnel are to be organized —Describe outreach activities and linkages to of the application. in the project and how they will be used be implemented to ensure that rural small to accomplish project objectives. Outline 2. Application and minority disadvantaged businesses staff responsibilities, accountability and a participate in LOSP activities. Summary Page schedule for conducting all project tasks. —Provide a one page overview of the —Describe or indicate evidence of linkages or following: collaborations developed or to be 9. Budget Narrative —The applicant’s proposed LOSP, its related developed with State DOTs, DOT grantees, —Outline all proposed budget/cost activities including key elements of the DOT prime contractors, other minority information in detail. plan of action/methodology to achieve Chambers of Commerce as well as minority project objectives. trade associations and technical assistance 10. Assurances —The applicant’s relevant organizational agencies including DOT/FHWA supportive Signature Form experience and capabilities. services contractors, HBCUs, HACUs and —Complete the attached form identified as 3. Understanding of the Work TACUs. Attachment 2. —Provide a narrative which contains specific 6. Organizational Capabilities 11. Certification project information as follows: —Describe recent, relevant and successful Signature Form —The applicant will describe its experience in advocating for and —Complete the attached form identified as understanding of the LOSP, program goals addressing the needs of small and minority and the role of the applicant’s proposed Attachment 3. businesses in general and transportation- LOSP in advancing the applicant’s goals. related DBEs in particular. 12. Standard Form 424 —The applicant will describe specific outreach needs of transportation-related —Describe relevant experience in working or —(Request for Federal Assistance) Complete DBEs in the region served and how the collaborating with minority Chambers of the attached Standard Form 424 identified LOSP will address the identified needs. Commerce and minority trade associations, as Attachment 4. DOT grantees, State DOTs, technical Please be sure that all forms have been 4. Approach/Methodology assistance agencies including DOT/FHWA signed by an authorized official who can —Describe the applicant’s methodology or supportive services contractors, MBDCs, legally represent the organization. plan of action for conducting the project in SBDCs and minority institutions including terms of the tasks to be performed. HBCUs, HACUs and TACUs. BILLING CODE 4910±62±P Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6757 6758 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6759 6760 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6761 6762 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6763 6764 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6765 6766 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices [FR Doc. 95–2494 Filed 2–2–95; 8:45 am] No changes to existing procedural or NOTIFICATION PROCEDURE: BILLING CODE 4910±62±C exemption rules are required for this Inquiries are addressed to the Program proposed new system. Management Staff, TTS–5 (address same The purpose of this report is to as system manager). Federal Transit Administration comply with the Office of Management and Budget Circular, A–130, Appendix RECORD ACCESS PROCEDURES: Privacy Act of 1974 DOT/FTA 196, I, dated June 25, 1993. Same as above. Transit Planning and Research (TTS) Mailing List DOT/FTA 196 CONTESTING RECORD PROCEDURES: Same as above. SYSTEM NAME: The Department of Transportation RECORD SOURCE CATEGORIES: (DOT) proposes to add a new record Office of Technical Assistance & system to its inventory of systems of Safety (TTS) Mailing List. Conference registration lists, Post Office return forms, letter and/or verbal records notices. SYSTEM LOCATION: request to be placed on mailing list and Any person or agency may submit Department of Transportation (DOT), other DOT/FTA mailing lists. written comments on the proposed Federal Transit Administration (FTA), system to the Department of Office of Technical Assistance & Safety, [FR Doc. 95–2497 Filed 2–2–95; 8:45 am] Transportation, Federal Transit Office of Program Management Staff, BILLING CODE 4910±62P±M Administration, Attn: Henry Nejako, TTS–5, 400 7th Street NW., room 6431, TTS–5, 400 Seventh Street, SW., Washington, DC 20590. Washington, DC 20590. Comments to be Federal Highway Administration considered must be received by March CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: 10, 1995. Environmental Impact Statement: Individuals interested in technical Jefferson and Shelby Counties, If no comments are received, the information about transit issues. Alabama proposed system will become effective on the above mentioned date. If CATEGORIES OF RECORDS IN THE SYSTEM: AGENCY: Federal Highway comments are received, the comments Individual’s name, business address, Administration (FHWA), DOT. will be considered and where adopted, telephone number, fax number, areas of ACTION: Notice of intent. the document will be republished with interest, organization type, job type, the change. date of last update. SUMMARY: The FHWA is issuing this notice to advise the public that an Issued in Washington, DC January 20, ROUTEINE USES OF RECORDS MAINTAINED IN THE 1995. Environmental Impact Statement (EIS) SYSTEM, INCLUDING CATEGORIES OF USERS AND and a Major Investment Study (MIS) Melissa J. Allen, THE PURPOSES OF SUCH USES: will be prepared for a proposed highway Deputy Assistant Secretary for For technical information project in Jefferson and Shelby Administration. dissemination. See Prefatory Statement Counties, Birmingham, Alabama. Narrative Statement for the Department of General Routine Uses. FOR FURTHER INFORMATION CONTACT: of Transportation Federal Transit POLICIES AND PRACTICES FOR STORING, Mr. Joe D. Wilkerson, Division Administration RETRIEVING, ACCESSING, RETAINING, AND Administrator, Federal Highway DISPOSING OF RECORDS IN THE SYSTEM: The Federal Transit Administration Administration, 500 Eastern Boulevard, proposes to add the record system, STORAGE: suite 200, Montgomery, Alabama DOT/FTA 196 Office of Technical Records are maintained in a master 36117–2018, telephone (334) 223–7370. Assistance and Safety (TTS) Mailing computer file by a contractor and a SUPPLEMENTARY INFORMATION: The List. The purpose of the system is the working file in FTA. FHWA, in cooperation with the administrative management of a mailing Alabama Department of Transportation, RETRIEVABILITY: list of those individuals and businesses will prepare an EIS/MIS for a proposed interested in technical information Access by computer terminal by any freeway/expressway facility within the available from the Federal Transit item. U.S. 280 corridor extending approximately 16.09 kilometers (10 Administration. SAFEGUARDS: miles) from E.B. Stephens Expressway The authority for the maintenance of Available for use under the control of in Jefferson County to just east of this system is 49 U.S.C. 5312(a). the Mailing List Manager. Alabama State Route 119 in Shelby Authority to conduct research, Computer file is protected by County. Improvements to the corridor development and demonstration password logon and access rights to data are considered necessary to provide for projects implies the duty to disseminate file. the existing and projected traffic results of those projects to interested demand. persons. An automated list is essential RETENTION AND DISPOSAL: Alternatives under consideration to dissemination. Records are retained until notified that individual no longer desires include: (1) Taking no action, (2) Individuals interested in receiving information and then record is conventional six-lane urban freeway technical information from FTA destroyed. with parallels service roads, (3) a four- disclose the subject information to a lane raised toll facility within the right- federal agency; therefore this system SYSTEM MANAGER(S) AND ADDRESS: of-way and along the sides of a six-lane presents no undue threat to privacy Director, Program Management Staff, arterial facility, (4) others build rights of individuals. TTS–5, Federal Transit Administration alternatives which may be developed A description of the steps taken to (FTA), Office of Technical Assistance & through the MIS process, and (5) safeguard these records is given under Safety, Program Management Staff, alternate travel demand strategies such the appropriate heading of the Federal TTS–5, 400 7th Street SW., room 6431, as transit, carpooling, and vanpooling Register system of records notice. Washington, DC 20590. which may also be considered in Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6767 conjunction with proposed copies of this notice or other material October 1 through September 30. This infrastructure improvements. that is referenced herein. would mean that in order to be taken Letters describing the proposed action SUPPLEMENTARY INFORMATION: ‘‘out of service’’ a pipeline must be and soliciting comments will be sent to abandoned in accordance with the appropriate Federal, State, and local I. Background: applicable pipeline safety regulations agencies and officials. A public Section 60301 of Title 49, United found in 49 CFR Parts 192 and 195. information meeting and a public States Code 1 authorizes the assessment B. Procedures for Correcting Previous hearing will be held. Public notice will and collection of pipeline user fees to be given of the time and place of the fund the pipeline safety activities Mileage Reported meeting and hearing. The Draft EIS/MIS conducted under Chapter 601 of that On occasion, operators discover that will be made available for public and title 2. The Research and Special agency review and comment. No formal they have incorrectly reported their Programs Administration (RSPA) actual mileage or storage capacity. The scoping meeting is planned at this time. assesses each operator of regulated To ensure that the full range of issues operators may claim that these errors go interstate and intrastate natural gas back several years. Because the total related to this proposed action are transmission pipelines (as defined in 49 collected is apportioned among all addressed and all significant issues CFR part 192), and hazardous liquid pipeline operators, a change in one identified, comments and suggestions pipelines carrying petroleum, petroleum are invited from all interested parties. products, anhydrous ammonia and operator’s amount could conceivably Comments or questions concerning this carbon dioxide (as defined in 49 CFR affect the amount owed by all other proposed action and the EIS/MIS should part 195), a share of the total Federal pipeline operators. Therefore, RSPA has be directed to FHWA at the address pipeline safety program costs in determined that adjustments of provided above. proportion to the number of miles of assessments will only be allowed for the (Catalog of Federal Domestic Assistant pipeline each operator has in service. current assessment year. Program Number 20.205, Highway, Research, The fee schedule for LNG facilities is Reporting errors must be sent in Planning, and Construction. The regulations based on the number of facilities each writing to the Information Resources implementing Executive Order 12372 operator has in service and total storage regarding inter-governmental consultation of Manager, Research and Special Federal programs and activities apply to this capacity of those facilities. Programs Administration, Office of program). RSPA is authorized to collect an Pipeline Safety, room 2335, 400 Seventh Joe D. Wilkerson, amount equal to or 105% of the annual Street, SW., Washington, DC 20590. Gas Congressional appropriation for Division Administrator, Montgomery, operators should also submit a Alabama. pipeline safety. The fiscal year 1995 supplemental RSPA form 7100.2–1. appropriation is $37.424 million. [FR Doc. 95–2671 Filed 2–2–95; 8:45 am] C. Assessment Procedures BILLING CODE 4910±22±M II. Administrative Clarifications and Proposals Under the regulations implementing RSPA is proposing several program 31 U.S.C. 3717, governing debts owed to Research and Special Programs clarifications and administrative the Federal government, assessments are Administration changes described below. These due 30 days after the date of the Pipeline Safety User Fees proposals will insure that all operators assessment. If payment cannot be made are aware of the effects of certain terms in full within the 30 day time frame, [Docket No. PS±138; Notice 1] and procedures on administering the partial payments, installments, or AGENCY: Research and Special Programs program by the Office of Pipeline Safety extensions may be granted upon written Administration, (RSPA), DOT. (OPS). The public is specifically invited request to the User Fee Manager, room ACTION: Notice of agency action and to comment on these proposals. 2335, 400 Seventh Street, SW., request for comments. A. Definition of ‘‘In Service’’ Washington, DC 20590. Interest, penalties, and administrative charges SUMMARY: This notice announces The annual assessment is for those gas will be assessed on delinquent debts. proposed changes in administering user transmission and hazardous liquid fee assessments for natural gas, liquefied pipelines which are ‘‘in service’’. Over User fees are deposited in the Pipeline natural gas, and hazardous liquid the last year some operators have Safety Fund (the Fund) and since 1987, pipeline facilities beginning with fiscal requested clarification of the term ‘‘in OPS expenditures have been made year 1995 (October 1, 1994) and solicits service’’ as it pertains to calculating using appropriations from the Fund. public comment on these changes. total milage subject to assessment. As Because in prior years OPS DATES: Comments must be submitted on used in the assessment letter, the term appropriations were lower than the or before March 6, 1995: Comments may ‘‘in service’’ applies to each pipeline Fund balance, RSPA was able to collect be mailed to the Dockets Branch, Room that is: transporting a regulated user fees late in each fiscal year (FY). 8421, U.S. Department of commodity, or that has transported a However, the FY 1995 appropriation Transportation, 400 Seventh Street, regulated commodity and has not been exceeds the amount currently in the SW., Washington, DC 20590. All abandoned during the assessment year, Fund (approximately $17 million), and comments and docket material may be future appropriations are likely to also reviewed in the Dockets Branch, room 1 Formerly, section 7005 of the Consolidated exceed the amount in the Fund. 8426, Between the hours of 8:30 a.m. to Omnibus Budget Reconciliation Act of 1985 (Pub.L. Therefore, in order for OPS to have 99–272). The change in citation is the result of the 5:00 p.m. Monday through Friday, enactment, on July 5, 1994, of Pub. L. 103–272, assured funding to operate without a except federal holidays. which recodified various transportation laws. shortfall later in the fiscal year, RSPA FOR FURTHER INFORMATION CONTACT: Lisa 2 Formerly, the Natural Gas Pipeline Safety Act of will need to collect user fees earlier. 1968 and the Hazardous Liquid Pipeline Safety Act RSPA proposes to phase in the earlier C. Kokoszka, (202) 366–4554 regarding of 1979. This change in citation is the result of the the subject matter of this notice, or the enactment, on July 5, 1994, of Pub.L. 103–272, assessment over a period of four years, Dockets Unit, (202) 366–5046, regarding which codified various transportation laws. as follows: 6768 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Fiscal the Department of the Treasury library, Office of Thrift Supervision, Freedom of year Date of assessment Room 5010, 1500 Pennsylvania Avenue, Information Request, 1700 G Street, NW., Washington, DC 20220. NW, Washington, DC 20552 1995 March 1995. 1996 December 1995. FOR FURTHER INFORMATION CONTACT: Dated: January 25, 1995. 1997 November 1996. Alana Johnson, Assistant Director, Alex Rodriguez, 1998 October 1997. Disclosure Services, (202) 622–0930. Deputy Assistant Secretary (Administration). SUPPLEMENTARY INFORMATION: The [FR Doc. 95–2717 Filed 2–2–95; 8:45 am] D. Low Stress Pipelines purpose of the Notice is to bring BILLING CODE 4810±25±M A final rule on hazardous liquid attention to the separate addresses for pipelines operating at 20 percent or less the individual FOIA offices of the Departmental Offices of specified minimum yield strength Treasury Department’s twelve (low stress pipelines), was published in components in accordance with Treasury regulations at 31 CFR part 1, Privacy Act of 1974; System of the Federal Register on July 12, 1994. Records This rule became effective on August stating that FOIA requests should be 11, 1994. Low Stress Pipelines include directed to the office maintaining the AGENCY: Departmental Offices, Treasury. pipelines that carry highly volatile records. The notice identifies the ACTION: Notice of proposed amendment liquids (HVL), pipelines or pipeline individual components within the of a Privacy Act system of records. segments in populated areas, and Treasury Department (ATF, IRS, etc.,) SUMMARY: pipelines or pipeline segments in and the addresses of their own FOIA The Treasury Department navigable waterways. Therefore, offices so that requesters may submit gives notice of a proposed amendment operators must incorporate these low FOIA requests directly to the to a system of records currently entitled stress mileage on the verification notice appropriate component. ‘‘Document Delivery Control System— which were mailed to pipeline operators Treasury/DO .194,’’ which is subject to The Department of the Treasury FOIA the Privacy Act of 1974, as amended by on or about November 30, 1994. Offices the Computer Matching and Privacy Onshore rural gathering pipelines, Protection Act of 1988. pipelines that operate at less than 20% Departmental Offices DATES: of SMYS (non-HVL located outside Disclosure Services—Room 1054–MT, Comments must be received no populated areas and navigable Department of the Treasury, later than March 6, 1995. The amended waterways), and other pipelines Washington, DC 20220 system of records will be effective March 15, 1995, unless comments are excluded from regulation by 49 CFR Bureau of Alcohol, Tobacco and received which result in a contrary 195, should not be included. Firearms, Freedom of Information determination. Issued in Washington, DC on January 30, Request, 650 Massachusetts ADDRESSES: Comments should be sent to 1995. Avenue, NW., Washington, DC 20226 Disclosure Services, 1500 Pennsylvania George W. Tenley, Jr., Avenue, NW., Washington, DC 20220. Associate Administrator for Pipeline Safety. Bureau of Engraving & Printing, Freedom of Information Request, Comments will be made available for [FR Doc. 95–2672 Filed 2–2–95; 8:45 am] inspection and copying upon request at 14th & C Street, SW., Washington, BILLING CODE 4910±60±P the Department of the Treasury library, DC 20228 room 5010, 1500 Pennsylvania Avenue, Comptroller of the Currency, Freedom NW., Washington DC 20220. of Information Request, DEPARTMENT OF THE TREASURY Washington, DC 20219 FOR FURTHER INFORMATION CONTACT: Dale Underwood, Privacy Act Officer, United States Customs Service, Freedom Departmental Offices; Freedom of Department of the Treasury, (202) 622– of Information Request, 1099 14th Information Act 0930. Street, NW, Washington, DC 20229 SUPPLEMENTARY INFORMATION: AGENCY: Departmental Offices, Treasury. Federal Law Enforcement Training This is to give notice of alterations to an existing ACTION: Notice of mailing addresses for Center (FLETC), Freedom of system of records, currently known as Separate Freedom of Information Act Information Request, Department of ‘‘Document Delivery Control System— (FOIA) offices for components (Bureaus) the Treasury, Building 94, Glynco, Treasury/DO .194’’ which is subject to of the Department of the Treasury. GA 31524 the Privacy Act of 1974, as amended, 5 Financial Management Service, U.S.C. 552a. The system notice was last SUMMARY: The Treasury Department Freedom of Information Request, published in its entirety at 57 FR 13923 gives notice of separate mailing 401 14th Street, SW, Washington, addresses for the FOIA offices for the on April 17, 1992. DC 20227 A review of the existing system notice Departmental Offices and for each of the Internal Revenue Service, Freedom of other Treasury components. Although found that the notice no longer Information Request, P.O. Box accurately reflected the operation of the this information may be found 795—Ben Franklin Station, elsewhere, this notice is the first system of records due to a system Washington, DC 20044 upgrade which has changed the system publication of the list of addresses in its United States Mint, Freedom of entirety. configuration. The alterations include Information Request, Judiciary changing the name of the system to EFFECTIVE DATE: Notice will be effective Square Building, 633 3rd Street, ‘‘Circulation System—Treasury/DO February 3, 1995. NW, Washington, DC 20220 .194’’ and the addition of the following ADDRESS FOR COMMENTS: Comments Bureau of the Public Debt, Freedom of routine use to the notice: should be sent to Disclosure Services, Information Request, 999 E Street, These records and information in these Room 1054 MT, 1500 Pennsylvania NW, Washington, DC 20239 records may be used to disclose information Avenue, NW., Washington, DC 20220. United States Secret Service, Freedom to a congressional office in response to an Comments will be made available for of Information Request, 1800 G inquiry made at the request of the individual inspection and copying upon request at Street, NW, Washington, DC 20223 to whom the record pertains. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6769 A change in the software also allows local libraries which are not subject to codes and protocols for calling up the records to be retrieved by the the Privacy Act. data files. Access to the records is employee’s bar code number which is limited to staff of the Readers Services CATEGORIES OF RECORDS IN THE SYSTEM: associated with the individual’s name or Branch who have a need-to-know the the bar code number assigned to the Records of items borrowed from the information for the performance of their book or periodical. Treasury Library collection and patron duties. The altered system of records report, records are maintained on central as required by 5 U.S.C. 552a(r) of the computer. Records are maintained by RETENTION AND DISPOSAL: Privacy Act, has been submitted to the name of borrower, office locator Only current data are maintained Committee on Government Reform and information, and title of publication. online. Records for borrowers are Oversight of the House of AUTHORITY FOR MAINTENANCE OF THE SYSTEM: deleted when employee leaves Treasury. Representatives, the Committee on Governmental Affairs of the Senate, and 5 U.S.C. 301. SYSTEM MANAGER(S) AND ADDRESS: the Office of Management and Budget, PURPOSE(S): Assistant Director, Library and pursuant to Appendix I to OMB Circular Track circulation of library materials Information Services, Department of the A–130, ‘‘Federal Agency and their borrowers. Treasury, Room 5030–MT, 1500 Responsibilities for Maintaining Pennsylvania Ave., NW., Washington, Records About Individuals,’’ dated July ROUTINE USES OF RECORDS MAINTAINED IN THE DC 20220. 15, 1994. SYSTEM, INCLUDING CATEGORIES OF USERS AND The system of records, Circulation THE PURPOSES OF SUCH USES: NOTIFICATION PROCEDURE: System—Treasury/DO .194, is These records and information in Inquiries should be addressed to published in its entirety below. these records may be used to disclose Assistant Director, Disclosure Services, Dated: January 25, 1995. information to a congressional office in Department of the Treasury, room 1054– Alex Rodriguez, response to an inquiry made at the MT, 1500 Pennsylvania Ave., NW., Deputy Assistant Secretary (Administration). request of the individual to whom the Washington, DC 20220. record pertains. Treasury/DO .194 RECORD ACCESS PROCEDURES: POLICIES AND PRACTICES FOR STORING, SYSTEM NAME: CIRCULATION SYSTEMÐ RETRIEVING, ACCESSING, RETAINING, AND See ‘‘Notification procedure’’ above. TREASURY. DISPOSING OF RECORDS IN THE SYSTEM: CONTESTING RECORD PROCEDURES: SYSTEM LOCATION: STORAGE: See ‘‘Notification procedures’’ above. Department of the Treasury, Library Electronic media. and Information Services Division, RECORD SOURCE CATEGORIES: RETRIEVABILITY: Room 5030–MT, 1500 Pennsylvania Patron information records are Avenue, NW, Washington, DC 20220. Data can be retrieved from the system by borrower name or bar code number completed by borrowers and library CATEGORIES OF INDIVIDUALS COVERED BY THE and publication title or its associated staff. SYSTEM: bar code number. EXEMPTIONS CLAIMED FOR THE SYSTEM: Employees who borrow library materials or receive library materials on SAFEGUARDS: None. distribution. The system also contains Access to the system requires [FR Doc. 95–2519 Filed 2–2–95; 8:45 am] records concerning interlibrary loans to knowledge of password identification BILLING CODE 4810±25±M 6770 Sunshine Act Meetings Federal Register Vol. 60, No. 23 Friday, February 3, 1995 This section of the FEDERAL REGISTER COMMODITY FUTURES TRADING COMMISSION Digital Devices. Summary: The contains notices of meetings published under Commission will consider action TIME AND DATE: the ``Government in the Sunshine Act'' (Pub. 10: 30 a.m., Thursday, concerning: (1) the type of equipment L. 94-409) 5 U.S.C. 552b(e)(3). February 23, 1995. authorization required for personal PLACE: 2033 K St., N.W., Washington, computers and peripheral devices; (2) the D.C., 8th Floor Hearing Room. authorization of modular components used to construct personal computers; and (3) COMMODITY FUTURES TRADING COMMISSION STATUS: Closed. the accreditation requirements for TIME AND DATE: 10:00 a.m., Thursday, MATTERS TO BE CONSIDERED: laboratories testing computers. February 23, 1995. Enforcement Matters. 2—Office of Engineering and Technology and PLACE: 2033 K St., NW., Washington, CONTACT PERSON FOR MORE INFORMATION: Wireless Telecommunications—Title: DC, Lower Lobby Hearing Room. Jean A. Webb, 202–254–6314. Allocation of Spectrum Below 5 GHz Transferred from Federal Government Use STATUS: Open. Jean A. Webb, (ET Docket No. 94–32). Summary: The MATTERS TO BE CONSIDERED: Application Secretary of the Commission. Commission will consider action of the Chicago Board of Trade as a [FR Doc. 95–2840 Filed 2–1–95; 2:27 pm] concerning use of 50 megahertz of Contract Market in futures and options BILLING CODE 6351±01±M spectrum being transferred from Federal of Illinois Soybean Yield Insurance, Government to private sector use. Iowa Corn Yield Insurance, Kansas 3—Common Carrier—Title: Computer III Further Remand Proceedings: Bell Winter Wheat Yield Insurance, and U.S. CONSUMER PRODUCT SAFETY COMMISSION Operating Company Provision of Enhanced North Dakota Spring Wheat Yield Services. Summary: The Commission will Insurance. TIME AND DATE: 10:00 a.m., Wednesday, consider action in response to the remand, CONTRACT PERSON FOR MORE February 8, 1995. in part, of the BOC Safeguards Order. INFORMATION: Jean A. Webb, 202–254– LOCATION: Room 420, East West Towers, 4—Common Carrier—Title: Price Cap 6314. 4330 East West Highway, Bethesda, Performance Review for Local Exchange Carriers; Treatment of Video Dialtone Jean A. Webb, Maryland. Services under Price Cap Regulation (CC Secretary of the Commission. STATUS: Open to the Public. Docket No. 94–1). Summary: The [FR Doc. 95–2837 Filed 2–1–95; 8:45 am] MATTER TO BE CONSIDERED: Commission will consider application of BILLING CODE 6351±01±M the price cap rules to video dialtone Toy Labeling/Reporting Requirements services. The staff will brief the Commission on 5—Common Carrier—Title: Applications of COMMODITY FUTURES TRADING COMMISSION final labeling and reporting requirements that NEW ENGLAND TELEPHONE AND TELEGRAPH COMPANY for Authority TIME AND DATE: 11:00 a.m., Tuesday, would implement the Child Safety Protection Act of 1994. Pursuant to Section 214 of the February 14, 1995. Communications Act of 1934, as Amended, PLACE: 2033 K St., NW., Washington, For a recorded message containing the and Section 63.01 of the Commission’s DC, 8th Floor Hearing Room. latest agenda information, call (301) Rules, to Construct, Operate and Maintain STATUS: Closed. 504–0709. Facilities to Provide Video Dialtone CONTACT PERSON FOR ADDITIONAL Service to Communities in Rhode Island MATTERS TO BE CONSIDERED: and Massachusetts (File Nos. W–P–C–6982 INFORMATION: Sadye E. Dunn, Office of Enforcement Matters. and W–P–C–6983).—Summary: The the Secretary, 4330 East West Highway, CONTACT PERSON FOR MORE INFORMATION: Commission will consider action on Bethesda, MD 20207; (301) 504–0800. Jean A. Webb, 202–254–6314. applications to provide commercial video Jean A. Webb, Dated: February 1, 1995. dialtone services. Sadye E. Dunn, 6—Cable Services—Title: Implementation of Secretary of the Commission. Sections of the Cable Television Consumer [FR Doc. 95–2838 Filed 2–1–95; 2:27 pm] Secretary. Protection and Competition Act of 1992: BILLING CODE 6351±01±M [FR Doc. 95–3856 Filed 2–1–95; 2:29 pm] Rate Regulation (MM Docket No. 92–266 BILLING CODE 6355±01±M and MM Docket No. 93–215).—Summary: The Commission will consider providing COMMODITY FUTURES TRADING COMMISSION local franchising authorities and small FEDERAL COMMUNICATIONS COMMISSION TIME AND DATE: 10:00 a.m., Tuesday, systems with additional methods of complying with cable rate regulations. February 28, 1995. FCC To Hold Open Commission Meeting, Tuesday, February 7, 1995 7—Cable Services—Title: Implementation of PLACE: 2033 K St., N.W., Washington, Sections of the Cable Television Consumer D.C., 8th Floor Hearing Room. The Federal Communications Protection and Competition Act 1992: Rate Commission will hold an Open Meeting STATUS: Closed. Regulation (MM Docket No. 92–266).— on the subjects listed below on Tuesday, Summary: The Commission will reconsider MATTERS TO BE CONSIDERED: February 7, 1995, which is scheduled to its actions, which prohibit small operators Enforcement Matters. commence at 9:30 a.m., in Room 856, at and low-price systems that have been CONTACT PERSON FOR MORE INFORMATION: 1919 M Street, N.W., Washington, D.C. provided with transition relief from Jean A. Webb, 202–254–6314. adjusting their transition rates to reflect Item No., Bureau, and Subject Jean A. Webb, increases in inflation. 1—Office of Engineering and Technology— 8—Mass Media—Title: Amendment of Part Secretary of the Commission. Title: Amendment of Parts 2 and 15 of the 74 of the Commission’s Rules With Regard [FR Doc. 95–2839 Filed 2–1–95; 2:27 pm] Commission’s Rules to Deregulate the to the Instructional Television Fixed BILLING CODE 6351±01±M Equipment Authorization Requirements for Service (MM Docket No. 93–24).— Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Sunshine Act Meetings 6771 Summary: The Commission will consider Federal Deposit Insurance Corporation. FOR MORE INFORMATION CONTACT: Becky action concerning methods to enhance the Patti C. Fox, Baker, Secretary of the Board, efficiency of the processing of applications Acting Deputy Executive Secretary. Telephone (703) 518–6304. in the Instructional Television Fixed [FR Doc. 95–2802 Filed 2–1–95; 11:19 am] Becky Baker, Service. BILLING CODE 6714±0±M Secretary of the Board. 9—General Counsel—Title: Amendment of 47 CFR Section 1.1200 et seq. Concerning [FR Doc. 95–2841 Filed 2–1–95; 2:28 pm] BILLING CODE 7535±01±M Ex Parte Presentations in Commission BOARD OF GOVERNORS OF THE FEDERAL Proceedings.—Summary: The Commission RESERVE SYSTEM will consider whether to propose revisions TIME AND DATE: SECURITIES AND EXCHANGE COMMISSION in its ex parte rules. 10:00 a.m., Wednesday, 10—International—Title: Market Entry and February 8, 1995. Notice is hereby given, pursuant to Regulation of Foreign-affiliated Entities.— PLACE: Marriner S. Eccles Federal the provisions of the Government in the Summary: The Commission will consider Reserve Board Building, C Street Sunshine Act, Pub. L. 94–409, that the action concerning market entry and entrance between 20th and 21st Streets, Securities and Exchange Commission regulation of foreign-affiliated entities in N.W., Washington, D.C. 20551. will hold the following meetings during U.S. markets. STATUS: Closed the week of February 6, 1995. An open meeting will be held on Additional information concerning MATTERS TO BE CONSIDERED: Wednesday, February 8, 1995, at 10:00 this meeting may be obtained from 1. Personnel actions (appointments, a.m., in Room 1C30. A closed meeting Audrey Spivack or Maureen Peratino, promotions, assignments, reassignments, and will be held on Friday, February 10, Office of Public Affairs, telephone salary actions) involving individual Federal 1995, at 2:00 p.m. number (202) 418–0500. Reserve System employees. Commissioners, Counsel to the 2. Any items carried forward from a Federal Communications Commission. Commissioners, the Secretary to the previously announced meeting. Commission, and recording secretaries William F. Caton, CONTACT PERSON FOR MORE INFORMATION: will attend the closed meeting. Certain Acting Secretary. Mr. Joseph R. Coyne, Assistant to the staff members who have an interest in [FR Doc. 95–2794 Filed 2–1–95; 11:18 am] Board; (202) 452–3204. You may call the matters may also be present. BILLING CODE 6712±01±M (202) 452–3207, beginning at The General Counsel of the approximately 5 p.m. two business days Commission, or his designee, has certified that, in his opinion, one or FEDERAL DEPOSIT INSURANCE before this meeting, for a recorded more of the exemptions set forth in 5 CORPORATION announcement of bank and bank holding company applications U.S.C. 552b(c)(4), (8), (9)(A) and (10) Pursuant to the provisions of the scheduled for the meeting. and 17 CFR 200.402(a)(4), (8), (9)(i) and ‘‘Government in the Sunshine Act’’ (5 Dated: February 1, 1995. (10), permit consideration of the U.S.C. 552b), notice is hereby given that scheduled matters at a closed meeting. Jennifer J. Johnson, Commissioner Wallman, as duty at 11:32 a.m. on Tuesday, January 31, Deputy Secretary of the Board. 1995, the Board of Directors of the officer, voted to consider the items [FR Doc. 95–2792 Filed 2–1–95; 11:16 am] Federal Deposit Insurance Corporation listed for the closed meeting in a closed met in closed session to consider BILLING CODE 6210±01±P session. matters relating to the Corporation’s The subject matter of the open meeting scheduled for Wednesday, corporate and supervisory activities. NATIONAL CREDIT UNION ADMINISTRATION February 8, 1995, at 10:00 a.m., will be: In calling the meeting, the Board Notice of Previously Held Emergency determined, on motion of Vice The Commission will consider the Meeting adoption of proposed rules 18f–3 and 6c–10 Chairman Andrew C. Hove, Jr., TIME AND DATE: 4:40 p.m. Tuesday, under the Investment Company Act of 1940, seconded by Director Jonathan L. January 31, 1995. and related rule and form amendments. Rule Fiechter (Acting Director, Office of PLACE: Board Room, 7th Floor, Room 18f–3 would allow mutual funds to issue Thrift Supervision), concurred in by 7047, 1775 Duke Street, Alexandria, multiple classes of shares, and form Director Eugene A. Ludwig (Comptroller Virginia 22314–3428. amendments would prescribe prospectus of the Currency), and Chairman Ricki STATUS: Closed. disclosure requirements for multiple class Tigert Helfer, that Corporation business and master-feeder funds. Rule 6c–10 would MATTERS CONSIDERED: required its consideration of the matters allow mutual funds to impose back-end loads, including contingent deferred sales 1. Administrative Action under Sections on less than seven days’ notice to the loads; the form amendment would clarify 206 and 208 of the Federal Credit Union Act. public; that no earlier notice of the that prospectus disclosure requirements for Closed pursuant to exemptions (8), (9)(A)(ii), meeting was practicable; that the public deferred sales loads apply to all types of and (9)(B). interest did not require consideration of back-end loads. 2. Delegation of Authority. Closed pursuant the matters in a meeting open to public The Commission also will consider to exemptions (8), (9)(A)(ii), and (9)(B). observation; and that the matters could proposing for public comment amendments be considered in a closed meeting by The Board voted unanimously that to rule 6c–10 to allow mutual funds to authority of subsections (c)(2), (c)(4), Agency business required that a meeting impose sales loads paid in one or more (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B) of be held with less than the usual seven installments. Related form amendments would prescribe prospectus disclosure the ‘‘Government in the Sunshine Act’’ days advance notice, that it be closed to the public, and that earlier requirements for installment loads. For (5 U.S.C. 552b(c)(2), (c)(4), (c)(6), (c)(8), further information, please contact Karrie (c)(9)(A)(ii), and (c)(9)(B)). announcement of this was not possible. McMillan at (202) 942–0695 (rule 18f–3) or The Board voted unanimously to The meeting was held in the Board Nadya B. Roytblat at (202) 942–0693 (rule close the meeting under the exemptions 6c–10). Room of the FDIC Building located at stated above. General Counsel Robert 550–17th Street, N.W., Washington, D.C. The Commission will consider whether to Fenner certified that the meeting could approve proposed rule changes by the Dated: January 31, 1995. be closed under those exemptions. American Stock Exchange, Inc., Chicago 6772 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Sunshine Act Meetings Board Options Exchange, Incorporated, At times, changes in Commission PLACE: USEC Corporate Headquarters, Chicago Stock Exchange, Incorporated, priorities require alterations in the 6903 Rockledge Drive, Bethesda, Municipal Securities Rulemaking Board, scheduling of meeting items. For further Maryland 20817. National Association of Securities Dealers, information and to ascertain what, if Inc., New York Stock Exchange, Inc., Pacific STATUS: The meeting will be closed to Stock Exchange Incorporated, and any, matters have been added, deleted the public. Philadelphia Stock Exchange, Inc. adopting a or postponed, please contact: The Office continuing education requirement for of the Secretary (202) 942–7070. MATTERS TO BE CONSIDERED: registered persons. For further information, • please contact Francois Mazur at (202) 942– Dated: February 1, 1995. Review of commercial and financial issues 0184. Jonathan G. Katz, of the Corporation • Review of personnel rules and practices The subject matter of the closed Secretary. • Procedural matters meeting scheduled for Friday, February [FR Doc. 95–2810 Filed 2–1–95; 11:38 am] CONTACT PERSON FOR MORE INFORMATION: 10, 1995, at 2:00 p.m., will be: BILLING CODE 8010±01±M Barbara Arnold, 301–564–3354. Institution of injunctive actions. Settlement of injunctive actions. Dated: January 31, 1995. UNITED STATES ENRICHMENT CORPORATION Settlement of administrative proceedings William H. Timbers, Jr., of an enforcement nature. BOARD OF DIRECTORS President and Chief Executive Officer. Institution of administrative proceedings of an enforcement nature. TIME AND DATE: 8:00 a.m. Tuesday, [FR Doc. 95–2793 Filed 2–1–95; 11:17 am] Opinion. February 7, 1995. BILLING CODE 8720±01±M federal register February 3,1995 Friday Proposed Rule Critical ControlPoint(HACCP)Systems; Pathogen Reduction;HazardAnalysisand 9 CFRPart308,etal. Food SafetyandInspectionService Agriculture Department of Part II 6773 6774 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules DEPARTMENT OF AGRICULTURE Clerk, Room 3171 South Building, Food FSIS Food Safety Goal Safety and Inspection Service, U.S. FSIS Food Safety Regulatory Strategy Food Safety and Inspection Service Department of Agriculture, Washington, II. Discussion of Regulatory Proposals Overview DC 20250. Oral comments, as permitted A. Transition to HACCP 9 CFR Parts 308, 310, 318, 320, 325, under the Poultry Products Inspection 326, 327, and 381 Sanitation Standard Operating Procedures Act, should be directed to the Antimicrobial Treatments [Docket No. 93±016P] appropriate person listed under FOR Temperature Controls FURTHER INFORMATION CONTACT. B. Microbial Testing; Interim Targets RIN 0583±AB69 FOR FURTHER INFORMATION CONTACT: (1) Current Testing Program GENERAL: Dr. Judith A. Segal, Director, Proposed Interim Targets and Testing Pathogen Reduction; Hazard Analysis C. Hazard Analysis and Critical Control and Critical Control Point (HACCP) Policy, Evaluation, and Planning Staff, Point Systems Systems (202) 720–7773; (2) SANITATION: Dr. Background Isabel Arrington, Staff Officer, Discussion of HACCP Proposal AGENCY: Food Safety and Inspection Inspection Management Program, Illustrations of HACCP Applications Service, USDA. Inspection Operations, (202) 720–7905; D. Effective Dates ACTION: Proposed rule. (3) ANTIMICROBIAL TREATMENTS: III. Other Issues and Initiatives Dr. William O. James, II, Director, A. Legal Authority B. Improving Food Safety at the Animal SUMMARY: The Food Safety and Slaughter Inspection Standards and Inspection Service (FSIS) is proposing Production Stage Procedures Division, Science and C. Transportation, Distribution, Storage, requirements applicable to all FSIS- Technology, (202) 720–3219; (4) Retail inspected meat and poultry TEMPERATURE CONTROLS: Carl S. D. Health-Based Standards for Pathogenic establishments that are designed to Custer, Staff Officer, Processed Products Microorganisms reduce the occurrence and numbers of Inspection Division, Science and E. FSIS Technology Strategy pathogenic microorganisms in meat and Technology, (202) 501–7321; (5) F. FSIS Inspectional Roles poultry products and to reduce the MICROBIAL TESTING: Dr. Richard A. IV. Economic Impact Analysis and Executive Orders incidence of foodborne illness Carnevale, Assistant Deputy associated with the consumption of V. References Administrator, Scientific Support, VI. Proposed Rules those products. The proposals would (1) Science and Technology, (202) 205– VII. Appendix—Generic HACCP for Raw Beef clarify the responsibility of 0675; (6) HACCP: Dr. Dorothy VIII. Supplement—Preliminary Regulatory establishment management to ensure Stringfellow, Director, HACCP Office, Impact Assessment compliance with sanitation Science and Technology, (202) 690– I. Background requirements; (2) require at least one 2087; (7) TRANSPORTATION AND antimicrobial treatment during the RETAIL: Patrick J. Clerkin, Director, Purpose of This Document slaughter process prior to chilling of the Evaluation and Enforcement Division, The mission of the Food Safety and carcass; (3) establish enforceable Compliance Program, Regulatory Inspection Service (FSIS) is to ensure requirements for prompt chilling of Programs, (202) 254–2537, Food Safety that meat and poultry products are safe, carcasses and parts; (4) establish interim and Inspection Service, U.S. Department wholesome, and accurately labeled. targets for pathogen reduction and of Agriculture, Washington, DC 20250. Current FSIS regulatory requirements mandate daily microbial testing in OBTAINING COPIES OF THIS DOCUMENT: and inspection procedures contribute slaughter establishments to determine Paper or diskette copies of this much to the achievement of these goals, whether targets are being met or document may be ordered from the but there is a critical gap in the FSIS remedial measures are necessary; and National Technical Information Service program. The current program does not (5) require that all meat and poultry (NTIS), U.S. Department of Commerce, directly target pathogenic establishments develop, adopt, and 5285 Port Royal Road, Springfield, VA microorganisms, which frequently implement a system of preventive 22161. Orders must reference NTIS contaminate otherwise wholesome controls designed to improve the safety accession number PB95–166021 for a carcasses. It also does not make meat of their products, known as HACCP paper copy and PB95–502217 for the and poultry establishments legally (Hazard Analysis and Critical Control diskette version. For telephone orders or responsible for taking systematic, Points). FSIS is also announcing its further information on placing an order, preventive measures to reduce or intent to initiate rulemaking jointly with call NTIS at (703) 487–4650 for regular eliminate the presence of pathogenic the Food and Drug Administration service or (800) 533–NTIS for rush microorganisms in meat and poultry (FDA) to establish Federal standards for service. To access this document products. This gap in the FSIS program the safe handling of food during electronically for ordering and has important public health transportation, distribution, and storage downloading via FedWorld, dial (703) implications because a significant of the products prior to delivery to retail 321–8020 with a modem or Telnet portion of the cases of foodborne illness stores, as well as further efforts to fedworld.gov. For technical assistance in the United States is associated with encourage adoption and enforcement by to access FedWorld, call (703) 487– the consumption of meat and poultry States of consistent, science-based 4608. products that are contaminated with standards to ensure food safety at the SUPPLEMENTARY INFORMATION: pathogenic microorganisms. retail level. These proposals and To protect public health and reduce initiatives are part of a comprehensive Table of Contents the risk of foodborne illness, FSIS strategy to improve the safety of meat I. Background proposes to fill the gap in its current and poultry products when they are Purpose of this Document system by requiring new measures that delivered to the consumer. Origins and History of the FSIS Program Foodborne Illness in the United States will target and reduce the presence of DATES: Comments must be received on Consumer Knowledge and Behavior pathogenic microorganisms in meat and or before June 5, 1995. External Studies and Recommendations for poultry products. FSIS is also beginning ADDRESSES: Submit written comments Change a fundamental shift in the paradigm in triplicate to Diane Moore, Docket FSIS Agenda for Change governing its inspection program. FSIS Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6775 will begin to build the principle of establishments described in Upton processing inspection, the inspector prevention into its inspection program Sinclair’s novel The Jungle outraged the focused on the operation of the overall by requiring all meat and poultry U.S. public. Congress responded by production line, not on each production establishments to adopt the Hazard passing the Federal Meat Inspection Act unit (in contrast to slaughter inspection, Analysis and Critical Control Point (FMIA), one of the first Federal where inspectors focused on each (HACCP) approach to producing safe consumer protection measures. It carcass). meat and poultry products. FSIS will established sanitary standards for The FMIA covered all meat and meat also take steps to encourage preventive slaughter and processing products in interstate commerce. It did measures on the farm, require establishments, and mandated not cover poultry. At that time, chickens preventive controls during antemortem inspection of animals and turkeys were produced mainly on transportation, and support State-based (cattle, hogs, sheep, and goats) and small farms for personal consumption or HACCP controls at retail. postmortem inspection of every carcass. sale in the immediate area. They were The purpose of this document is to It also required the continuous inspected only by the purchaser. initiate the rulemaking required to bring presence of Government inspectors in 1946–1975 about these changes in the FSIS all establishments that manufactured program. This document will also meat products for commerce. Because Developments after World War II had explain these changes in the context of the program depended heavily on a major impact on the meat and poultry a broad and long-term strategy to veterinary skills, it was implemented by industry. New establishments opened, improve the safety of meat and poultry USDA’s Bureau of Animal Industry beginning a surge of growth that products. The safety of any food product which, during that first year, oversaw continued through the 1950’s and can be affected—positively or the inspection of nearly 50 million 1960’s. The market for dressed, ready- negatively—at virtually every step in the animals. to-cook poultry expanded rapidly, and process of producing the agricultural The companion Food and Drug Act of both the meat and the poultry industries commodity on the farm, converting the 1906 was implemented by a different began turning out many new kinds of agricultural commodity into a food section of USDA, the Bureau of processed products. An increasing product through slaughter and other Chemistry. It covered the safety of all proportion of the total meat and poultry processing, distributing the product to food products except meat and poultry, supply was being processed into hams, the consumer, and preparing the but it did not require continuous sausages, soups, frankfurters, frozen product for consumption. While this inspection. The Food and Drug dinners, pizza, and so forth. Between document focuses on changes that are Administration (FDA), which now 1946 and 1976, the volume of such needed within FSIS-inspected implements the law, was formed in products almost quadrupled. establishments, these changes are part of USDA in 1930 and transferred to the New technology, new ingredients, and a broader food safety strategy. This Public Health Service in 1940. Meat specialization added complexity to the strategy addresses each step in the inspection, which primarily focused on once-simple processing industry. Small process and takes a long-term approach carcass inspection by veterinarians, establishments, many producing solely to building a comprehensive food safety remained in USDA. for intrastate commerce, began system that works effectively to protect The meat inspection program that producing new products outside the consumers by preventing food safety developed early in this century used slaughterhouse environment. Processing problems. organoleptic methods, based on sight, inspection could no longer be managed To place the regulatory program in touch, and smell. The major public as an extension of slaughter inspection. context, this document will first health concerns of the time were the The growth of the processing sector describe the origins and history of the potential for transmission of diseases presented the inspection program with FSIS program, the problem of foodborne from sick animals to humans and the major challenges. First, the skills illness in the United States, and FSIS’s lack of sanitary conditions for animal needed by the Agency called food safety objectives and proposed slaughter and production of processed increasingly on the disciplines of food strategy for achieving them. products. The purpose of carcass technology and microbiology, along inspection was to keep meat from with those of veterinary medicine. The Origins and History of the FSIS Program diseased animals out of the food supply. Agency began to recruit and develop The following historical account Federal inspectors under the more people with the specialized skills briefly describes the purposes and supervision of veterinarians checked necessary to design processing operation of the inspection program every live animal and every carcass for inspection systems. from its late-nineteenth century signs of disease. They also watched for Second, more inspectors were needed inception through the current efforts to insanitary practices and the use of to meet the industry’s growing improve the program. dangerous preservatives. production and geographic expansion. In addition to requiring carcass-by- A system of ‘‘patrol’’ inspection 1890–1945 carcass inspection in slaughter assignments, with one inspector visiting Federal meat inspection legislation establishments, the 1906 meat several processing establishments daily, dates from 1890, when countries in inspection law provided for continuous was devised to fulfill the statutory Europe raised questions about the safety USDA inspection of processing requirement for continuous inspection of American beef. Congress gave the operations. Processing, which for the in those establishments. U.S. Department of Agriculture (USDA) most part consisted of cutting and Third, new technologies made it responsibility for ensuring that exports boning whole carcasses and the difficult for consumers to check levels would meet European requirements production of sausages, ham, and bacon, of fat, water, and other ingredients used and, in 1891, for conducting ante- and was usually done in or near the as fillers, increasing the risk of postmortem inspection of livestock slaughterhouse. Processing was viewed economic adulteration. As a result, slaughtered for meat intended for as an extension of slaughter and was USDA inspectors were increasingly distribution in the United States. conducted by the same FSIS personnel. called on to protect consumers in this In 1906, the graphic picture of From the inception of the Program, technically complex area. Controlling insanitary conditions in meat-packing however, the Agency recognized that, in the use of certain vegetable proteins as 6776 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules ingredients in meat food products, for to assure uniformity in the regulation of The industry changed in many ways example, became important, because products shipped in interstate, during this period. The poultry industry vegetable proteins can mask the intrastate, and foreign commerce. These became, to a large extent, vertically addition of water to a product. The Acts provide the statutory basis for the integrated, with large companies development of equipment to salvage current meat and poultry inspection controlling each step of the process from formerly discarded high-protein tissue system. Both Acts gave USDA new production of birds to slaughter, from bones and fatty tissue made time- regulatory authority over allied processing, distribution, and marketing temperature requirements necessary to industries, including renderers, food of chicken and turkey products under guard against the growth of spoilage brokers, animal food manufacturers, brand names. The beef and pork organisms. Standards had to be set for freezer storage concerns, transporters, industries grew, but generally did not the use of these ingredients and the retailers, and other entities. Both Acts become vertically integrated. Beef cattle labeling of products containing them. incorporated adulteration and and swine continued to be produced by Meanwhile, better animal husbandry misbranding prohibitions tied to a large number of independent farming practices had improved animal health important provisions of the FFDCA businesses. Consolidation occurred in and reduced the public health risk from relating to food and color additives, slaughter and processing operations, diseased carcasses. The Agency’s animal drugs, and pesticide chemicals. and production increased. Increased extensive, statutorily mandated carcass- Both Acts provided stronger production meant more meat and by-carcass inspection continued, enforcement tools to USDA, including poultry products awaited inspection by however, with the important objective withdrawal or refusal of inspection FSIS inspectors. of eliminating from commerce the services, detention, injunctions, and The Agency strained to keep pace unpalatable signs of disease (such as investigations. Both Acts extended with an industry radically different in tumors and lesions), meat from animals Federal standards to intrastate scale and scope from what it had been with diseases that could pose a human operations, provided for State-Federal in 1906. In September 1976, the Agency health risk (such as salmonellosis or cooperative inspection programs, and hired the management consulting firm cysticercosis), fecal contamination of required that State inspection systems of Booz, Allen and Hamilton, Inc., to meat and poultry carcasses, and visible be ‘‘at least equal to’’ the Federal perform an in-depth study to find less damage (such as bruises). Establishment system. costly ways to inspect meat and poultry sanitation also remained an important Also, under these Acts, meat and that would not reduce the level of object of inspection in both slaughter poultry products from foreign countries consumer protection. The study and processing facilities. that are sold in the United States must recommended, among other things, that The Poultry Products Inspection Act have been inspected under systems that FSIS: (PPIA) of 1957 made inspection are equivalent to that of USDA. • Use quality control mechanisms to mandatory for all poultry products shift responsibilities from inspectors to intended for distribution in interstate 1970s–Present: Increasing Demand for Inspection the establishment, giving inspectors a commerce. It was modeled after the verification responsibility. Federal Meat Inspection Act. By the 1970s, the need to focus on • Establish microbiological criteria The potential for unseen health ‘‘invisible’’ hazards to public health had for finished products. hazards in the food supply also attracted raised the ratio of analytical to • Explore substitution of air chilling increasing regulatory attention. In 1962, organoleptic activities, and the ratio of for water chilling of poultry carcasses. Rachel Carson’s Silent Spring raised out-of-plant to in-plant activities. The • Require chlorination of chiller public awareness of the possible bulk of the Agency’s resources water for poultry. harmful effects of pesticides and other continued to be allocated, however, to • Expand food safety education for chemical contaminants in food. In 1967, in-plant activities addressing the issues consumers and food handlers. the Agency established the National of animal disease and establishment The study elicited a generally Residue Program, the Federal sanitation. During the 1970s, national negative response from consumer Government’s principal regulatory budget constraints reduced the funds groups and some members of FSIS’s mechanism for determining and available for inspection throughout the workforce, who interpreted the controlling the presence and level of United States. As individual States recommended role changes as an those chemicals in meat and poultry exercised their right to request that the abdication of Agency responsibility. that may present a public health Agency take over their inspection Anticipating higher costs and concern. programs, FSIS had either to eliminate concomitant price hikes, industry also Because of the increasing volume and some inspection activities or change the objected to the recommendations. FSIS complexity of food production and the way they were performed, to provide decided to pursue only some of the potential for various forms of the additional coverage. recommendations. adulteration that consumers could not, The driving force behind FSIS’s One that it did pursue in processing by themselves, determine, Congress program changes from the 1970s on was establishments, the voluntary Total enacted new legislation during this the need to keep up with industry’s Quality Control (TQC) program, was period to assure the safety and expansion and its productivity gains, implemented in 1980. The General wholesomeness of all foods, including including the incorporation of Accounting Office (GAO) had meat and poultry products. The 1958 automation in the slaughter process that recommended a TQC-type program in Food Additives Amendment of the increased the rate at which carcasses December 1977, to afford the Agency Federal Food, Drug, and Cosmetic Act could move through the slaughter flexibility to tailor inspection frequency (FFDCA) provided for FDA approval of facility (typically referred to as ‘‘line to individual establishments’ needs. new food additives and their conditions speed’’). Automation has had a This program applied a different kind of and levels of use. particularly great impact on poultry inspection to establishments that FSIS The Wholesome Meat Act of 1967 and operations, where inspectors have had approved for a self-monitored the Wholesome Poultry Products Act of to face faster and faster line speeds, production control program designed to 1968 amended the basic laws governing which today can be as high as 91 birds assure that processed products would mandatory meat and poultry inspection per minute. meet regulatory requirements. In those Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6777 establishments, the inspector, instead of the industry was criticized by consumer billion slaughtered annually) makes personally generating production groups and inspectors, who interpreted antemortem bird-by-bird inspection process information, used establishment the modernization initiative as a pretext impracticable, inspectors or VMO’s production records on the production for deregulation. conduct the antemortem inspection of process, supplemented by in-plant In 1986, Congress granted the Agency poultry on a flock or lot basis. The observations, to verify that product was the authority to vary the frequency and poultry are observed while in coops or in compliance. In many establishments, intensity of inspection in processing grouped for slaughter, before or after TQC reduced the time needed for establishments on the basis of the risk they are removed from trucks. Abnormal inspection, but the statutory provision presented by the particular birds are condemned. for ‘‘continuous’’ inspection meant that, establishment and process. Again, even under TQC, an inspector had to FSIS’s proposal to implement this Antemortem inspection can detect visit the establishment at least daily. authority was interpreted by consumer some diseases (for example, rabies, In 1978, the Agency issued its own groups as an effort to reduce inspection. listeriosis, and heavy metal toxicosis) report, ‘‘A Strengthened Meat and They opposed it, as did some Agency through distinct clinical signs that Poultry Inspection Program.’’ Among employees. Industry members cannot be detected by gross postmortem other things, the report observed that supported the concept but were inspection. Additionally, some types of the poultry postmortem system had skeptical about how it would be microbial diseases that can seriously been designed before both the vertical implemented. For lack of support, the contaminate the slaughter environment, integration of the poultry industry and Agency withdrew its proposal, and the such as abscesses and anthrax, can be the increasing attention to production legislative authority for it expired in detected by antemortem inspection. In control, which had helped producers 1992. those cases, the affected animals are overcome major animal and poultry Each of the foregoing modernization prevented from entering the health problems. With the introduction initiatives aroused the same concerns: slaughterhouse. of high-speed production lines, the Increased line speeds compromised job During the postmortem phase of traditional inspection system had performance; new procedures had not Federal inspection, the viscera and been adequately or objectively tested; become ‘‘severely stressed,’’ with carcasses of all animals and birds and, generally, streamlined slaughter inspectors ‘‘forced to work at speeds slaughtered are examined by an FSIS well over those at which peak inspection policies would not protect inspector on the processing line. (See effectiveness is expected.’’ Scientific consumers. While SIS for poultry Figures 1 and 2 for illustrative evidence indicated that with the survived, the controversy blocked schematics of beef and broiler chicken improvement in animal health, little of FSIS’s attempt to extend SIS to cattle. A the carcass examination performed by special review in 1990 by the National slaughter.) Many of the bacteria inspectors was necessary to protect Academy of Sciences (NAS) pointed out implicated in cases of foodborne illness public health. However, carcass-by- deficiencies in the current system’s live in the intestinal tracts of meat carcass inspection continued to address handling of microbiological hazards but animals and poultry, present no the wholesomeness and quality aspects concluded that a SIS for cattle would be evidence of overt pathologies in the of meat and poultry that consumers at least as effective as traditional animal, and can be shed in the feces. demanded. inspection. However, consumers and For this reason, line inspectors require Between 1980 and 1986, the Agency the Agency’s inspection workforce physical removal of visible fecal and introduced what became known as equated SIS for cattle with ingesta contamination of flesh. streamlined inspection systems (SIS) in deregulation—license for industry to For red meat, inspectors examine the high-speed poultry slaughter operations. increase line speeds at the expense of heads, viscera, and carcass at one or These systems shifted routine tasks that public health. Congress ordered the more postmortem inspection stations. controlled for quality, rather than safety, Agency to stop the pilot tests then in For poultry the viscera, carcasses, and, from inspectors to establishment progress in five cattle operations. for older poultry, heads are examined at employees. Since an increasing amount Today, FSIS inspectors perform a single postmortem inspection station. of the poultry (and meat) supply was hundreds of tasks during slaughter and To detect abnormalities at these being produced under brand names, the processing operations. Slaughter stations, the red meat inspector Agency believed that establishments inspection occurs in two phases: ante- performs a sequence of observations, would be motivated to protect the and postmortem. During antemortem palpations, and incisions of tissues; the reputation of their products by inspection, the inspectors observe all poultry inspector, a sequence of performing systematic quality control red meat animals at rest and in motion, observations and palpations. For both for visible, unpalatable defects. Under segregating any abnormal animals they red meat and poultry, visible streamlined inspection, establishment detect before the animals enter the contaminants (such as feces), damage, employees, working under FSIS slaughter facility. Based on further and other abnormalities are detected supervision, would perform detection examination by a Veterinary Medical and eliminated to ensure only meat and and trimming of carcass defects that Officer (VMO), abnormal animals are poultry that appear fit for human affect the ‘‘quality,’’ but not the ‘‘safety’’ either condemned or allowed to enter consumption ‘‘pass’’ inspection. Only of the product—functions previously the slaughter process under special VMO’s and VMO-supervised inspectors performed by FSIS inspectors. The handling. attempt to streamline carcass inspection Because the large number of chickens make the final determination. by shifting non-public health tasks to and turkeys FSIS inspects (more than 6 BILLING CODE 3410±DM±P 6778 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6779 BILLING CODE 3410±DM±C 6780 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules The prevention of ingesta and fecal contemporary consumers and should be FSIS expects to implement PBIS in contamination of beef and poultry discontinued. FSIS invites public slaughter operations during FY 1996. carcasses in slaughter establishments is comment on this issue. Foodborne Illness in the United States a focal point of the current inspection Of the 129,831,110 meat-animal system, because contamination of the carcasses inspected during Fiscal Year The safety of the meat and poultry flesh with feces and ingesta is a 1993, 384,543 (or .3 percent) were supply has been widely discussed potential cause of contamination of condemned for disease, contamination, during the past few years. Although meat and poultry products with harmful or adulteration during ante- or food safety can be affected by multiple bacterial pathogens, such as Salmonella, postmortem inspection. Of the factors, including animal drug and Campylobacter and E. coli 0157:H7. 7,085,491,852 poultry carcasses pesticide residues and unintentional Contamination can occur as a result of inspected that year, 63,926,693 (or .9 environmental contaminants, the feces entering the slaughter facility on percent) were condemned. Today, more following discussion focuses on the external surface of the animal and than 7,300 FSIS inspectors enforce the pathogenic microorganisms that are contaminating the carcass during the inspection laws in approximately 6,200 associated with foodborne illness, skinning or defeathering process or as a meat and poultry establishments. including the illness and preventable result of ingesta or feces being spilled Inspection activities start prior to deaths associated with meat and poultry from the intestinal tract during slaughter and continue throughout consumption. Pathogenic evisceration or other steps in the processing, handling, and packaging. microorganisms are widely recognized by scientists to be the most significant process. Meat and poultry carcasses FSIS ensures compliance with found to bear fecal contamination must causes of foodborne illness. inspection laws and regulations outside Foodborne illness can strike be condemned or, if possible, reworked inspected establishments through to remove the contamination in an individuals of all ages, sexes, control and condemnation of nationalities, and socioeconomic levels. accepted manner. Removing visible misbranded or adulterated products. fecal contamination is important, but it The most common types of foodborne Specifically, during FY 1993, FSIS illness associated with pathogenic does not assure the absence of harmful detained suspect products 796 times bacteria that cannot be detected microorganisms typically appear as (involving 13,081,409 pounds of acute gastroenteritis with sudden onset visually. product) and monitored product recalls The law requires inspected meat and of vomiting or diarrhea, or both, with 36 times (involving 5,726,378 pounds of poultry products to bear an official accompanying abdominal pain. product). During the same period, inspection legend (21 U.S.C. 601(n)(12), However, the exact combination of 145,526 meat and poultry product labels 453(h)(12)). Specifically, the words symptoms may vary widely, depending were reviewed; 10,154 were not ‘‘inspected and passed’’ must appear on on the type of microorganism and the approved. Other measures FSIS uses to meat products found not to be immune status of the person infected. enforce the regulations include adulterated (21 U.S.C. 606, 607; 9 CFR For example, certain types of bacteria withholding inspection pending 312.2, 312.3); ‘‘inspected for often cause bloody diarrhea, including wholesomeness by U.S. Department of correction of serious problems, E. coli 0157:H7 and, in a smaller Agriculture’’ must appear on poultry controlling product distribution, percentage of cases, Campylobacter products (9 CFR 381.96). The term working with companies to recall jejuni. E. coli 0157:H7 produces a strong ‘‘wholesome’’ has traditionally been violative products, and seeking court- toxin (‘‘shiga-like’’ toxin) which can applied to meat or poultry found upon ordered product seizures when lead to blood clotting abnormalities and visual inspection to be free of disease, necessary. kidney failure (hemolytic uremic not decomposed, and to be otherwise fit The Performance-Based Inspection syndrome) and can cause death, for human consumption. While System (PBIS) is a modernization especially in young children and the ‘‘wholesome’’ as used in this context is initiative implemented in processing elderly. Even if recovery from the acute not intended to be synonymous with establishments during 1989. PBIS is a illness is complete, 15–30 percent of ‘‘safe,’’ consumers could reasonably structured, automated information persons with hemolytic uremic infer a connection between system that helps the Agency document syndrome will have evidence of chronic ‘‘wholesomeness’’ and food safety. findings resulting from inspector tasks; kidney disease. While Salmonella Similarly the words ‘‘inspected and record deficiencies found and actions ordinarily causes transitory and non- passed’’ on meat products could be taken; and discuss deficient findings life-threatening acute gastroenteritis, understood by consumers as a statement and corrective actions with Salmonella can get into the bloodstream about safety, despite the fact that establishment management. PBIS is of some infected patients, particularly organoleptic inspection does not intended to make processing inspection patients who are very young, very old, address invisible hazards, such as more uniform nationwide and provides or immunosuppressed (such as persons pathogenic microorganisms. FSIS with its first easily accessible with AIDS); these bloodstream This problem concerning the meaning database on establishment performance. infections can have serious of the inspection legend arises in part It enables the Agency to capture, store, complications, including death. from the fact that the requirement to and sort the vast quantities of Infections caused by Salmonella may place an inspection legend on every information generated by the 13 million also trigger autoimmune phenomena, product that passes inspection was inspection tasks performed in such as reactive arthritis, which may adopted before the safety concerns processing establishments each year. result in long-term disability. posed by pathogenic microorganisms, These data allow the Agency to examine While there is general consensus that drug residues, and other invisible the long-term operation of a particular foodborne illness is a major cause of hazards came to the fore. Visual establishment or the performance of a morbidity and mortality in this country, inspection does not directly address particular control point nationwide. estimates of the incidence of foodborne these safety issues on a carcass-by- Decisions on inspection intensity are illness vary widely. The Centers for carcass or product-by-product basis. based on these data, although the Disease Control and Prevention (CDC) Thus, some contend that the inspection frequency is never less than one visit maintains a national foodborne disease legends serve only to mislead per day. surveillance system, but the data in this Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6781 system are recognized not to provide an doctor, or the doctor does not collect a with compilations put together by accurate estimate of foodborne disease stool culture, the case does not enter the expert committees of the National incidence. With the exception of a few reporting system. Further, of the major Academy of Sciences and, most pathogens, the data deal only with foodborne pathogens, laboratory-based recently, by the Council for Agricultural outbreaks (two or more cases of illness surveillance is available only for Science and Technology. linked to a common source); are based Salmonella. Recognizing these Taken together, these data suggest that on voluntary reporting by State health deficiencies, a number of groups have foodborne pathogens account for up to departments; and are dependent almost attempted to estimate actual rates of 7 million cases of foodborne illness each entirely on passive surveillance (that is, disease occurrence, drawing both from cases and outbreaks voluntarily reported year, and up to 7,000 deaths. Of these, CDC databases (with their inherent to local health authorities). nearly 5 million cases of illness and A somewhat better picture of disease limitations, discussed above) and more than 4,000 deaths may be incidence can be obtained through extrapolating from population-based associated annually with meat and national laboratory-based reporting studies in specific geographic areas. poultry products contaminated with systems. The model for this is the CDC ‘‘Best estimates’’ of the incidence of pathogenic microorganisms. Even these system for reporting of salmonellosis. specific diseases, and the percentage of estimates may be low; at least one Again, however, data are in most these diseases thought to be foodborne, investigator has suggested that total instances passively collected, and are are provided in Table 1, below (together cases of foodborne illness may reach 33 dependent on physicians submitting with the source of these estimates). million cases a year, with up to 9,000 cultures; if a patient does not see a These estimates are in basic agreement deaths. TABLE 1.ÐSOURCES OF DATA FOR SELECTED FOODBORNE PATHOGENS, 1993 Total deaths Source(s) for case and Percent Pathogen Total cases (#) # foodborne Source ( ) death estimates (%) Bacteria: Campylobacter jejuni or coli 2,500,000 200±730 Tauxe ...... 55±70 Tauxe et al. Clostridium perfringens ...... 10,000 100 Bennett et al ...... 100 Bennett et al. Escherichia coli O157:H7 ... 10,000±20,000 200±500 AGA Conference ...... 80 AGA Conf./CDC comm. Listeria monocytogenes ..... 1,795±1,860 445±510 Roberts and Pinner ...... 85±95 Schuchat. Salmonella ...... 800,000±4,000,000 800±4,000 Helmick et al./Bennett et al 87±96 Bennett et al./Tauxe & Blake. Staphylococcus aureus ...... 8,900,000 7,120 Bennett et al ...... 17 Bennett et al. Parasite: Toxoplasma gondii ...... 4,111 82 Roberts et al ...... 50 Roberts et al. Sources: American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July 11±13, 1994. Bennett, J.V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden of Unnecessary Illness. Oxford University Press, New York. Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious Diarrheas.'' In: Everheart, JE, ed. Digestive Dis- eases in the United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94±1447, pp. 85±123, Wash, DC: USGPO. Roberts, T., K.D. Murrell, and S. Marks. 1944. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419±423. Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, Septem- ber 29, 1994. Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins, ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9±19. Tauxe, R.V. and P.A. Blake, ``Salmonellosis'' rest of reference unknown. Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth. 1988. ``Campylobacter Isolates in the United States, 1982±1986,'' Morbidity and Mortality Weekly Report, vol 31, no. SS±2: page numbers unknown. TABLE 2.ÐMEDICAL COSTS AND PRODUCTIVITY LOSSES ESTIMATED FOR SELECTED HUMAN PATHOGENS, 1993 Foodborne illness Per- Meat/poultry related Total cent costs* Pathogen Foodborne* from meat/ # # costs (bil $) meat/ # # Cases ( ) Deaths ( ) poultry Cases ( ) Deaths ( ) poultry (%) (bil $) Bacteria: Campylobacter jejuni or coli ...... 1,375,000± 110±511 0.6±1.0 75 1,031,250± 83±383 0.5±0.8 1,750,000 1,312,500 Clostridium perfringens** ... 10,000 100 0.1 50 5,000 50 0.1 Escherichia coli 0157:H7 ... 8,000±16,000 160±400 0.2±0.6 75 6,000±12,000 120±300 0.2±0.5 Listeria monocytogenes ..... 1,526±1,767 378±485 0.2±0.3 50 763±884 189±243 0.1±0.2 Salmonella ...... 696,000± 696±3,840 0.6±3.5 50±75 348,000± 348±2,610 0.3±2.6 3,840,000 2,880,000 Staphylococcus aureus** ... 1,513,000 1,210 1.2 50 756,500 605 0.6 Subtotal ...... 3,603,526± 2,654±6,546 2.9±6.7 N/A 2,147,513± 1,395±4,191 1.8±4.8 7,130,767 4,966,884 6782 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules TABLE 2.ÐMEDICAL COSTS AND PRODUCTIVITY LOSSES ESTIMATED FOR SELECTED HUMAN PATHOGENS, 1993Ð Continued Foodborne illness Per- Meat/poultry related Total cent costs* Pathogen Foodborne* from meat/ # # costs (bil $) meat/ # # Cases ( ) Deaths ( ) poultry Cases ( ) Deaths ( ) poultry (%) (bil $) Parasite: Toxoplasma gondii ...... 3,056 41 2.7 100 2,056 41 2.7 Total ...... 3,606,582± 2,695±6,587 5.6±9.4 N/A 2,149,569± 1,436±4,232 4.5±7.5 7,133,823 4,968,940 The costs of the foodborne illnesses (see through cross-contamination in the In 1992, FSIS began a series of Table 2, above) are borne by those who kitchen or other food-handling areas, for Nationwide Microbiological Baseline become ill and their families, example, when raw chicken or beef with Data Collection Programs designed to coworkers, and employers, as well as a Salmonella-contaminated exterior provide a microbiological profile of the food industries, and taxpayers. Costs contaminates a person’s hands, a cutting various classes of inspected product. to stricken individuals include medical board, countertop, or kitchen utensil, The first, on steer and heifer carcasses, bills, time lost from work, pain and which then comes into contact with was reported in January 1994. inconvenience. Food industry costs cooked product or foods consumed raw, Clostridium perfringens was recovered include possible product recalls, such as salad. For some pathogens, such from 2.6 percent of 2,079 carcasses; establishment closings and cleanup, and as Salmonella, it is likely that more Staphylococcus aureus from 4.2 percent higher premiums for product liability cases of illness result from cross- of 2,089 carcasses, Campylobacter insurance. Perhaps most costly in the contamination than from direct jejuni/coli from 4.0 percent of 2,064 long term is loss of product reputation consumption of undercooked product. carcasses; E. coli 0157:H7 from 0.2 and reduced demand when an outbreak Microbiological surveys of meat and percent of 2,081 carcasses; and is traced back and publicized. These poultry products have been conducted Salmonella from 1.0 percent of 2,089 and other ‘‘defensive’’ industry costs of by FSIS over several decades. In cooked, carcasses. foodborne disease run in the millions of ready-to-eat products, the frequency of The ongoing outbreaks of dollars annually and are, for the most pathogenic microorganisms has been salmonellosis, attributed to part, entirely avoidable. Taxpayer costs relatively low. In regulatory testing consumption of contaminated meat, include medical treatment for those who programs of domestically produced, poultry and other food products, and cannot afford it and higher health cooked, ready-to-eat meat and poultry the recent outbreaks of illness caused by insurance premiums. products, for example, Salmonella has E. coli 0157:H7 in undercooked ground Other taxpayer costs include public generally been found to be present in beef, illustrate how serious the public health-sector expenses to operate a only about 0.1 percent of the samples health threat can be, even when the disease surveillance system and to tested and Listeria monocytogenes in incidence of contamination of carcasses investigate and eliminate disease about 1.5–3 percent of samples tested. is relatively low. outbreaks. Approximately $300 million The frequency of pathogenic For example, on January 13, 1993, a is spent on microbial foodborne disease microorganisms in raw, ready-to-cook physician in Washington State reported annually by the Federal public health- products has been greater. For example, to the Washington State Department of sector. Federal costs average about FSIS has conducted surveys on the Health a cluster of children with $200,000 per foodborne illness prevalence of Salmonella in various raw Hemolytic Uremic Syndrome, a serious outbreak. products, including broiler chickens, condition that is the major cause of The Department’s Economic Research beginning as early as 1967. In these acute kidney failure in children. Also Service and CDC estimate the cost of all surveys, Salmonellae were isolated from reported was an increase in emergency foodborne illness in 1993 to have been 28.6 percent of 597 samples in 1967; room visits for bloody diarrhea. This between $5.6 and $9.4 billion. Meat and from 36.9 percent of 601 samples in outbreak was reported to CDC. poultry products were associated with 1979; from 35.2 percent of 1693 samples Cultures taken from symptomatic approximately $4.5–$7.5 billion; the in the 1982–1984 study; and from patients indicated that E. coli 0157:H7 remaining $1.1 to $1.9 billion was approximately 25 percent of the samples was the causative organism. During associated with non-meat and poultry in the 1990–1992 study. FSIS studies on January 16–17 an epidemiological case- sources. Table 2 summarizes data on a fresh pork sausage involved retail-size control study conducted by Washington pathogen-by-pathogen basis. samples. Salmonellae were isolated State and CDC strongly suggested the Foods contaminated with pathogenic from 28.6 percent of 566 samples in consumption of hamburgers at a chain microorganisms can lead to infection 1969, and from 12.4 percent of 603 of fast food restaurants as the source of and illness in two major ways. The first samples in 1979. A benchmark study on the infection. The investigation revealed is by direct consumption of the raw beef was initiated in January 1987 that the hamburger patties were cooked contaminated food under conditions and completed in March 1990. The by the restaurants to a temperature that allow the survival of the pathogen prevalence of Salmonella in 25 gram below the Washington State standard of or its toxin, such as when a meat or portions was found to be 1.6 percent, 155°F, and in some instances below the poultry product is consumed raw or the prevalence of Listeria 140°F then recommended by FDA. undercooked, or products precooked monocytogenes was 7.1 percent and the By February 4, 350 people in during processing are recontaminated prevalence of E. coli 0157:H7 was 0.1 Washington State had contracted and consumed directly. The second is percent. illnesses of the kind associated with E. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6783 coli 157:H7 and, of these cases, 230 of human behavior to change. This regulation requiring safe handling labels were culture-confirmed. In addition, 12 finding is supported by research of on most raw meat and poultry products. people had become ill in Idaho and 30 consumer knowledge and practices, The Agency’s Meat and Poultry Hotline in Nevada. It was also learned that which indicates that a large portion of provides consumers with immediate illness had occurred among 34 persons the U.S. population lacks basic food responses to questions about meat and in San Diego, California, in December safety information and skills and poultry handling and safety. These steps and January. The outbreaks in each of engages in food handling and and other education activities are these States all had in common the preparation practices that important but they are not a substitute consumption of hamburger at the same epidemiological studies have linked for building into the meat and poultry chain of fast food restaurants. The with a significant number of foodborne production and regulatory system greater proportion of these cases were illness outbreaks. Moreover, little measures to reduce to the maximum primary infections, that is, the persons correlation exists between consumers’ extent possible the presence of affected became ill directly from eating food safety knowledge and their food pathogenic microorganisms in meat and contaminated hamburgers. The other handling and preparation practices. poultry products purchased by U.S. cases were secondary infections—the Even people who characterize consumers. affected persons contracted their themselves as ‘‘knowledgeable’’ do not External Studies and Recommendations illnesses through contact with a person necessarily follow good food safety for Change who was infected with the pathogen. procedures. Eventually, four people died and These findings about consumer During the past decade, the National more than 500 other persons became ill behavior related to safe food handling Academy of Sciences (NAS), the during the course of the epidemic. and preparation support the need for a General Accounting Office (GAO), the An important aspect of the comprehensive pathogen reduction National Advisory Committee on Department’s review of this experience effort. Food safety can best be assured Microbiological Criteria for Food was the finding that the winter 1992–93 only if each participant in the food (NACMCF), and consumer groups have outbreak was not caused by a failure in system—from the producer all the way evaluated and called for change in the the operation of the inspection system through to the consumer—understands, current inspection system. as currently designed. Rather, it accepts, and acts on his or her In 1983, FSIS asked NAS to evaluate stemmed in part from an inspection responsibility for food safety. While the scientific basis of its inspection system that does not directly require the FSIS will pursue and support all system and recommend a modernization reduction, minimization, or elimination, possible means of consumer education agenda. The resulting report, Meat and if possible, of pathogenic and outreach, the Agency realizes that Poultry Inspection: The Scientific Basis microorganisms in raw product leaving consumer education alone will not of the Nation’s Program, was issued in inspected establishments. The specific control pathogen-related foodborne 1985. This was the first comprehensive pathogen in this example was highly illness. This is truer today than ever evaluation of the scientific basis for the virulent, meaning that a very low dose before, as more people in our society are Federal meat and poultry inspection was sufficient to cause illness. During assuming responsibility for food system. The report provided a blueprint the beef-grinding process, harmful handling and preparation in the home for change, recommending that FSIS bacteria can easily be spread throughout and elsewhere, without experience in focus on pathogenic organisms and a large volume of product. When such food preparation and knowledge of safe require that all official establishments product becomes widely distributed and food handling and storage methods. operate under a Hazard Analysis and is cooked inadequately to kill any These people include: Critical Control Point (HACCP) system pathogens that might be present, • Food service workers, many of to control pathogens and other safety preventable deaths may result. whom are high-turnover, part-time, or hazards. This report ‘‘encourages FSIS to move as vigorously as possible in the The Relationship Between Foodborne teenaged workers who receive application of the HACCP concept to Illness and Consumer Knowledge and inadequate training; • each and every step in establishment Behavior Men and women in the workplace, who have minimal time for food operations, in all types of enterprises The National Academy of Sciences’ preparation and often little experience involved in the production, processing, Cattle Inspection: Committee on or interest in food preparation; and storage of meat and poultry Evaluation of USDA Streamlined • Children, who are increasingly products.’’ Inspection System for Cattle (SIS–C) expected to shop for and prepare their Two later NAS studies reinforced (1990) reiterated the theme of numerous own meals; these recommendations, urging the other studies, ‘‘* * * the public expects • Immigrants, who might not be able Agency to focus on public health goals: • the government to ensure zero risk of to read food handling instructions, or Poultry Inspection: The Basis for a meat-borne disease through inspection. whose cultural practices include eating Risk Assessment Approach (1987) The [NAS] committee heard little raw or rare meat and poultry products. concluded that a risk-assessment evidence that the public is aware that Vulnerable sectors of the population, approach is needed to evaluate health some bacterial contamination of raw more severely affected by foodborne hazards associated with poultry. Critical meat is inevitable and no mention of the illness, are also increasing in size: control points at which known crucial role of food handling, • Immunocompromised persons (i.e., pathogenic microorganisms may be preparation, and serving methods in persons with diabetes, cancer, chronic introduced into the poultry production limiting foodborne diseases.’’ The intestinal diseases, organ transplants, system should be identified and disturbing but real fact that consumers and AIDS); monitored, preferably as part of a fail to make a connection between their • Persons 65 years and older—a HACCP program. food handling behavior and safe food growing proportion of the population— • The most recent NAS report, Cattle recurs throughout the literature on the who, due to the normal decline in Inspection: Committee on Evaluation of subject. immune response, are at increased risk. USDA Streamlined Inspection System Behavioral research shows that food In 1993, to increase awareness about for Cattle (SIS–C) (1990) stated that habits are the most difficult of all forms pathogens, FSIS promulgated a traditional meat inspection, relying on 6784 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules organoleptic examinations, is not fully Health and Human Services on exclusion of diseased animals from the effective in protecting the public from developing microbiological criteria to food supply, examination of carcasses foodborne health hazards. FSIS was assess food safety and wholesomeness. for other visible defects that can affect urged to move to a risk-based inspection Since 1989, NACMCF has prepared a safety and quality, inspecting for system targeted at significant public series of reports on the development economic adulteration, and monitoring health risks, especially those associated and implementation of HACCP. As one for chemical residues. These activities with pathogenic microorganisms. of its first tasks, the Committee respond to some of the public’s most The GAO has also been advocating developed ‘‘HACCP Principles for Food basic expectations regarding the safety improvements in the present inspection Production’’ in November 1989. In this and quality of the food supply and system in reports and Congressional report the Committee endorsed the reflect the standards and requirements testimony. In numerous reports (see list HACCP system as a rational approach to established by Congress in the laws below), GAO endorses HACCP as a ensure food safety and delineated seven FSIS administers. FSIS is strongly scientific, risk-based system to better HACCP principles to standardize committed to effectively implementing protect the public from foodborne HACCP in the Committee’s own work, these statutory requirements. illness. This sentiment is most clearly as well as in industry, regulatory As the experience of recent years and expressed in the 1994 Food Safety: Risk- applications, and training. In 1992, the the many external studies and reports Based Inspections and Microbial Committee issued an updated guide, indicate, however, there is a need for Monitoring Needed for Meat and ‘‘Hazard Analysis and Critical Control fundamental change in the FSIS Poultry, which states: Point System.’’ program. The most critical reason for To describe the HACCP system more change is the need to ensure that the A HACCP system is generally considered concretely, in 1993 NACMCF published the best approach currently available to FSIS inspection program is fully ensure safe foods because it focuses on The Role of Regulatory Agencies and meeting its paramount obligation to preventing contamination rather than Industry in HACCP. In that report, protect public health. To meet this detecting contamination once it has NACMCF articulated the roles of obligation, there is a pressing need to occurred.* * * To better protect the public regulatory agencies and industry in better address the public health problem from foodborne illnesses, we believe FSIS implementing HACCP, and of foodborne illness associated with the must now move to a scientific, risk-based recommended what the responsibilities consumption of meat and poultry inspection system. Such a system would of FDA, USDA, other agencies and allow FSIS to target its resources towards the products. industry should be during various As documented in the preceding higher risk meat and poultry products and phases of HACCP implementation. sections, many cases of foodborne establishments by increasing inspection of In June 1993, NACMCF developed a such products and establishments, illness are caused annually by model, ‘‘Generic HACCP for Raw Beef,’’ developing methods or tools that would help pathogenic microorganisms that enter which provides a HACCP plan for beef inspectors detect microbial contamination, the food supply during the slaughter slaughter and processing (see increasing product testing, and helping and processing of meat and poultry Appendix). It focuses on the slaughter establishments develop and operate products. With respect to raw meat and microbial testing programs. and processing portions of the total poultry products, the current system of ‘‘farm to consumption’’ scope of a This report further recommends that inspection addresses this problem only Congress ‘‘revise the meat and poultry complete HACCP program. Similar recommendations for program indirectly, by enforcing sanitation acts to provide FSIS with the flexibility change have come from consumer, requirements and inspecting for visible and discretion to target its inspection industry, State, and local government fecal and ingesta contamination and resources to the most serious food safety representatives, as well as other other visible defects that can be risks.’’ pathways for contamination of carcasses These basic recommendations are constituent groups. Consumer representatives at recent public hearings by pathogenic microorganisms. echoed in the five GAO reports The current system must be enhanced describing the current inspection system and the HACCP Round Table held in March 1994 supported implementation to deal more directly with pathogenic and recommending changes to improve microorganisms. In particular, the its effectiveness, listed below: of HACCP throughout the meat and poultry industry. system needs to be changed to make ‘‘Meat Safety: Inspection System’s Ability Industry groups, in clarifying their better use of the science and tools of to Detect Harmful Bacteria Remains Limited’’ support for HACCP to control microbiology to reduce, and where (1994); pathogens, contend that HACCP-based possible eliminate, pathogenic ‘‘Food Safety: A Unified, Risk-Based food production, distribution, and microorganisms. Such change is needed System Needed to Enhance Food Safety’’ to protect public health. (1993); preparation by industry can do more to ‘‘Food Safety: Building a Scientific Risk- protect public health than any Federal Change is also needed to clarify the Based Meat and Poultry Inspection System’’ inspection program. They recommended respective responsibilities of the meat (1993); that HACCP be used to anticipate and poultry industries and the FSIS ‘‘Food Safety: Inspection of Domestic and microbiological hazards in food systems inspection program when it comes to Imported Meat Should be Risk-Based’’ and to identify risks in new and the safety of the food supply. (1993); traditional products. State departments Companies producing meat and poultry ‘‘Food Safety and Quality: Uniform, Risk- of health and agriculture also endorsed products are responsible for ensuring Based Inspection System Needed to Ensure the HACCP approach. that their products are safe and do not Safe Food Supply’’ (1992). violate any of the statutory provisions A third major proponent of HACCP is FSIS Agenda for Change defining adulteration and misbranding. the National Advisory Committee on The meat and poultry inspection FSIS is responsible for inspecting Microbiological Criteria for Foods program currently addresses many products and facilities to verify that (NACMCF), which was established in matters of great importance to the safety these requirements have been met and 1988 by the Secretary of Agriculture to and quality of the food supply, for taking appropriate remedial and advise and provide recommendations to including supervision of industry enforcement actions when the the Secretaries of Agriculture and of compliance with sanitation standards, requirements have not been met. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6785 This line between industry and FSIS To achieve such change, FSIS must hazards are identified and prevented. It responsibility has become blurred. This articulate its food safety goal in broad is based on the public health principle may be due in part to the continuous terms and adopt a food safety strategy that, on a continuing basis, society presence of FSIS inspectors in meat and that will work to achieve both a real should seek out and take preventive poultry establishments and the reduction of pathogens in the near term measures to reduce the risk of illness. It statutorily mandated USDA inspection and, in the long term, the fundamental reflects the Agency’s belief that steps legend, which together may have changes in the inspection program that that can be taken today to reduce the encouraged some establishments to rely are needed to better protect public risk of foodborne illness should be taken on FSIS to ensure the safety of the health. today, but that steps judged adequate today may not be judged adequate establishment’s products rather than FSIS Food Safety Goal take full responsibility themselves for tomorrow. the safety of their products. Because the It is tempting to think of food safety In the case of the major enteric FSIS inspector is obligated to prevent as an absolute. In an ideal world, there pathogens that contaminate meat and adulterated product from leaving the would be no cases of foodborne illness. poultry products during the slaughter establishment, some establishments may The world we live in is, however, far process, FSIS believes that the risk of operate on the assumption that what is from ideal. The production of the food foodborne illness associated with these not specifically prohibited or detected that feeds 250 million Americans every pathogens is largely avoidable and can by the FSIS inspector may continue. day is an enormously complex task. It be minimized by proper implementation This is not acceptable. is undertaken in a natural environment of HACCP. This does not necessarily Likewise, the FSIS inspection where hazards, including pathogenic mean absolute elimination of such program has too often taken on the microorganisms, are common. It pathogens, but it does mean preventing requires a level of technological burden of expending significant and reducing contamination with these intervention—in the form of machinery, inspectional resources to bring pathogenic microorganisms to a degree chemicals, and processing—that itself establishments into compliance—such that very substantially reduces and can introduce hazards. And it is an as in cases of repeat violators of minimizes the risk of foodborne illness. enterprise that depends, in the end, on Achieving this food safety goal sanitation standards—rather than a vast array of human interventions and requires long-term commitment and finding efficient means to hold activities, which means that human action by Government and industry. It establishments accountable for error is a constant factor that can also requires general agreement on a complying with applicable standards. contribute to food safety hazards. regulatory strategy that can achieve the As a result, the inspection resources FSIS believes the public can goal. needed to ensure that all establishments understand that safety is not an have appropriate production controls absolute, and the laws FSIS administers FSIS Food Safety Regulatory Strategy are frequently spent on intensified do not speak in absolute terms. FSIS FSIS believes that to achieve its food inspection of poor performers. For these also believes, however, that public safety goal, and bring about the change reasons, the lines of responsibility for expectations are justifiably high when it described above, a new regulatory food safety must be clarified. comes to measures the food production strategy is needed. The major elements Finally, change is needed to move system should take to reduce risk and of the Agency’s proposed strategy are toward a more preventive approach to ensure the safety of food. Furthermore, outlined in this section, with a brief ensuring the safety of food. The current the laws FSIS administers set high explanation of how the regulatory system relies too heavily on FSIS standards—for example, meat and changes FSIS is proposing in this inspectors to detect and correct poultry products are deemed document will advance the strategy. problems after they have occurred, ‘‘adulterated’’ and thus unlawful if they 1. FSIS must clearly define the whether in establishments or after the are for any reason ‘‘unhealthful’’—and minimum requirements all product has left the establishment. This they empower FSIS to take actions establishments must meet to produce is not the most efficient use of FSIS needed to meet those standards and safe meat and poultry products and resources, and, especially in the case of meet the public’s high expectations make establishments readily pathogenic microorganisms, it is not concerning the safety of the food accountable for meeting them. Good effective in protecting public health. supply. sanitation and basic good manufacturing Many meat and poultry establishments, FSIS believes its food safety goal practices (GMP’s) are generally regarded as well as other segments of the food should be to reduce the risk of as essential prerequisites for the industry, have found that safety can best foodborne illness associated with the production of safe food. The current be ensured by systems designed to consumption of meat and poultry FSIS program includes sanitation prevent food safety problems. To protect products to the maximum extent regulations that set out certain standards public health and make the best use of possible by ensuring that appropriate of cleanliness establishments are its resources, FSIS needs to build the and feasible measures are taken at each required to meet; and the Agency has principle of prevention into its step in the food production process provided guidance, in the form of a inspection system. where hazards can enter and where Sanitation Handbook, on how sanitation The changes FSIS plans in its procedures and technologies exist or requirements can be met. FSIS also has inspection program—targeting can be developed to prevent the hazard promulgated regulations that impose pathogenic microorganisms, setting or reduce the likelihood it will occur. various specific requirements, priorities on the basis of public health There is no single technological or especially regarding processing risk, clarifying roles and procedural solution to the problem of operations, that might be characterized responsibilities, and building in the foodborne illness, and the Agency’s as GMPs. principle of prevention—constitute an food safety goal will not be achieved In the sanitation area, however, FSIS institutional paradigm shift that can overnight. Indeed, inherent in the has not spelled out clearly the significantly enhance the effectiveness nature of the Agency’s goal is the responsibility every establishment has of the FSIS program and reduce the risk concept that food safety requires to install procedures that ensure of foodborne illness. continuous efforts to improve how sanitation requirements are met every 6786 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules day, both before operations commence objective, public health standpoint destruction. As explained in a later and during operation. In the GMP area, whether the measures establishments section of this document, FSIS intends certain important food safety-related have taken to prevent harmful to work with the scientific and public practices that have emerged in recent contamination are adequate or should health communities to develop the years have become recognized by the be deemed acceptable. FSIS has instead scientific basis for setting quantitative majority of the industry as appropriate focused on managing its current system limits for specific pathogens. GMPs, but they have not been made part of visual inspection and encouraging Another approach to pathogen of the basic regulatory requirement all industry efforts to reduce pathogens, but reduction is to set targets for reduction establishments must meet. without an effective tool for requiring or based on what is judged achievable with FSIS believes it is important, evaluating those efforts. available science and technology, and to especially for the near term, to codify FSIS believes that setting public require individual establishments to certain minimum practices all health targets, guidelines, or standards meet such targets on a consistent basis, establishments must observe to produce is the most powerful and effective tool by adoption of appropriate process safe meat and poultry products and to available for bringing about changes in controls. Even with this approach, there improve the Agency’s ability to hold FSIS-inspected establishments, are difficult issues concerning the basis establishments accountable for especially slaughter establishments, that upon which such targets should be set. following those practices. Thus, FSIS is will reduce levels of pathogenic FSIS believes, however, that enough is proposing: (1) to require that all microorganisms and improve the safety known today and can be learned during establishments develop and adopt of meat and poultry products. The the course of this rulemaking to make standard operating procedures for their concept is simply that, by establishing this approach viable and very useful in sanitation programs, (2) to require that targets, guidelines, or standards the near term. all slaughter establishments incorporate establishments are required to meet, Later in this document, FSIS is at least one effective antimicrobial FSIS can stimulate the innovation and proposing to set interim targets for treatment to reduce the levels of change needed to reduce risk from all pathogen reduction, using as the starting microorganisms on carcasses before they sources of foodborne hazards—whether point the current baseline incidence of enter the chilling step, and (3) to codify biological, chemical, or physical—and, Salmonella contamination of finished specific time and temperature at the same time, have a tool for holding carcasses in all raw meat and poultry requirements for cooling of carcasses all establishments accountable for slaughter operations and in raw ground post-slaughter. achieving an acceptable level of food meat or poultry products, and requiring The majority of meat and poultry safety performance. reductions in Salmonella in relation to establishments already observe some or FSIS realizes that this new approach the current baseline. FSIS believes that all of the practices FSIS is proposing to raises some new and difficult scientific significant reductions in the incidence require. They are basic to producing a and policy issues and thus may be of contamination with this human safe product, and FSIS believes all controversial in some quarters. The pathogen are achievable in the relatively establishments should observe them. By most important issues concern the basis near term, and that the process codifying these practices in the upon which the targets, guidelines, or improvements some establishments will Agency’s regulations, FSIS will have an standards (hereafter referred to generally have to make to reach the goal will also effective means to hold all as ‘‘microbial limits’’) will be set and reduce the levels of other pathogens. establishments accountable for meeting the consequences for an establishment Key to the FSIS strategy for using them. Codifying these basic that does not meet them. public health-based microbial limits to requirements is by no means a complete There are many possible approaches reduce pathogens is the recognition that or long-term solution to the food safety for setting and using microbial limits. what is scientifically supportable and problem but rather is part of the One approach is to set specific appropriate will evolve over time. FSIS Agency’s effort to ensure, as more quantitative limits for each significant believes the interim step it is proposing fundamental improvements are being pathogenic microorganism on the basis in this new area to target and reduce the developed, that readily available of a scientific risk assessment, and to incidence of Salmonella is feasible and improvements are incorporated into the use this limit as the basis for excluding can be effective in the near term, but it system in the near term. FSIS invites from commerce any raw product that is just a first step. As knowledge and comment on whether elements of exceeds the limit. This is the approach methodologies improve, additional current GMP’s should be mandated by typically taken in the regulation of food pathogens could be targeted, targets the Agency. additives, chemical contaminants, and could be lowered, and the use of the 2. FSIS must stimulate improvement physical defects, and provides the most targets could expand eventually to in food safety practices by setting public direct and perhaps most effective means include their use in some cases as legal health-oriented targets, guidelines, or of ensuring that standards necessary to standards for products. standards all establishments must meet. protect public health are being met. One FSIS will be working closely in the This is the centerpiece of the FSIS food difficulty with this approach to coming years with the scientific and safety strategy and the most important pathogenic microorganisms is that the public health communities, the departure from the Agency’s current scientific data and understanding industry, and public interest groups to regulatory approach. In its past concerning the link between specific consider how microbial limits can best regulation of the slaughter process and levels of many pathogens and the risk of be used to reduce the risk of foodborne of raw, ready-to-cook meat and poultry foodborne illness that would be needed illness. Later in this document, FSIS products, FSIS has not clearly defined to set such limits based solely on discusses some of the difficult scientific what safety means or set public health considerations of public health are not issues that need to be resolved to make targets, guidelines, or standards for currently available. A second, perhaps the fullest use of microbial limits. reducing the incidence of contamination more significant difficulty is the fact 3. FSIS must make meat and poultry of these products with human that the levels of additives and other establishments responsible for microbial pathogens (pathogens that cause illness chemicals generally remain stable, testing of their products to ensure in humans). Consequently, there has whereas levels of microorganisms can proper process control and verify been no basis for evaluating from an change over time, due to growth and achievement of microbial limits. To Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6787 reduce pathogens and protect public prevent problems from occurring rather numbers at critical points during health, FSIS believes that microbial than relying on end product testing or processing, but also by denying those testing must become an integral part of government inspection to detect and pathogens that are present the the operation of every meat and poultry correct problems after they occur. There opportunity to grow. establishment and that the primary is wide agreement on this among As independent measures, standard responsibility for testing should rest government and industry officials, operating procedures for sanitation, with the establishment, not FSIS. Over consumers and the scientific antimicrobial treatments, and time and the long term, microbial testing will community. FSIS is proposing to build temperature requirements for chilling play a key role in verifying the the principle of prevention into the and cooling finished carcasses and parts successful implementation of an inspection system by requiring that all could have only limited impact on food establishment’s HACCP plan. FSIS also meat and poultry establishments adopt safety. Together, they can make a believes that establishments should be and operate under HACCP systems. significant contribution to reducing responsible for testing their products to 6. FSIS must approach its food safety pathogenic microorganisms and other verify achievement of any microbial mission broadly, and address potential contaminants throughout the limits that FSIS establishes for hazards that arise throughout the food manufacturing process. These measures regulatory purposes. Later in this production and delivery system, are a precursor to HACCP, which document, FSIS is proposing to require including before animals enter FSIS- ensures process control through daily microbial testing to determine inspected establishments and after meat carefully selected critical control points. whether, over time, the proposed and poultry products leave those The above-listed measures, discussed at interim targets for pathogen reduction establishments. There is wide agreement length in II A, have in fact been are being met in all establishments that that ensuring food safety requires taking implemented in many establishments, have slaughter operations or produce steps throughout the chain of including many now operating under raw ground meat or poultry products. production, processing, distribution, HACCP systems. By effecting immediate 4. FSIS must foster scientific and and sale to prevent hazards and reduce pathogen reduction in meat and poultry technological innovation within the the risk of foodborne illness. Although products during the period of transition meat and poultry industries to reduce not the subject of this document, FSIS to HACCP, these interdependent pathogens and the risk of foodborne will work with producers and others to measures would address urgent public illness and must remove any develop and implement ‘‘preharvest’’ health needs. Additionally, unnecessary regulatory obstacles to food safety measures—measures that implementing these measures would innovation. In the past, innovation in can be taken on the farm to reduce the introduce into non-HACCP the meat and poultry industries has risk of harmful contamination of meat establishments the concept and been directed primarily to developing and poultry products. actuality of process control, which is the new products and increasing FSIS is also announcing in this essence of HACCP. Each proposed productivity. This innovation has been document initiatives it plans to measure can be reasonably expected to beneficial because it has responded to undertake in cooperation with the Food constitute a critical control point under consumer demand and need for a and Drug Administration to develop most HACCP plans so, while the diverse, convenient, and economical Federal standards that will help ensure proposed regulatory provisions may no food supply. One of the principle the safe handling of meat and poultry longer need to be mandated upon advantages of holding establishments products during transportation from implementation of HACCP, accountable for meeting public health- FSIS-inspected establishments to the establishments would likely retain them driven microbial limits is to provide an retail level. FSIS and FDA will also as critical elements of process control. incentive for establishments to innovate work together to encourage adoption as they reduce the risk of foodborne The second component of this three- and enforcement by State governments part regulatory package, the illness. of consistent, science-based standards at FSIS believes that scientific and microbiological testing program the retail level. technological innovation in the meat (discussed under II B), would also be FSIS believes that its food safety goal and poultry industry will play a key role implemented during the transition to can be achieved and legitimate public in meeting the Agency’s food safety HACCP. It, too, is integral to the expectations met only by building a goal. FSIS will, therefore, be reviewing regulatory strategy, because microbial chain of responsibility for food safety, its current procedures for evaluating testing will establish a tangible, extending all the way from the farm to and approving new pathogen reduction achievable, measurable target: a the consumer. technologies for use in meat and poultry reduction in the incidence of In the next part of this document, establishments, and is committed to Salmonella in raw product. As with the FSIS proposes a set of regulatory modifying or eliminating any near-term interventions discussed changes that it believes will advance the procedures or requirements that stand above, the microbial testing program Agency’s food safety regulatory strategy. as unnecessary obstacles to the prompt would effect pathogen reduction almost implementation by industry of II. Discussion of Regulatory Proposals immediately upon implementation. As innovations that can reduce the risk of is the case with the near-term foodborne illness. FSIS invites public Overview interventions, microbial testing can be comment on how FSIS can improve its Because the safety of any meat or expected to constitute an element of program to facilitate beneficial poultry product can be positively or process control under HACCP. innovation. adversely affected at virtually every step The third component of this three- 5. FSIS must build the principle of in the manufacturing process, FSIS is part regulatory package is HACCP prevention into the operations of meat proposing the series of regulatory (discussed under III C). As indicated and poultry establishments and into the changes discussed in this section. earlier, the interim measures which, as FSIS inspection program. As discussed Collectively, these changes would proposed, would be implemented earlier in this document, food safety can reduce the incidence of pathogenic during the transition to HACCP would be ensured most effectively and microorganisms on meat and poultry likely continue under HACCP as economically by installing systems that products, not only by reducing their elements of process control, selected on 6788 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules the basis of each establishment’s hazard adhere to written standard operating FSIS recognizes that current analysis. procedures (SOP’s) specifically relating sanitation practices and performances The proposed sanitation SOP’s, to direct contamination or adulteration vary widely among the diverse array of antimicrobial treatment, cooling, and of product; plants FSIS regulates. Well-run meat microbial testing requirements are • A requirement that slaughter and poultry establishments have tight compatible with and establish important establishments use an antimicrobial quality control and sanitation programs, parts of the foundation for treatment on all carcasses; including written sanitation SOP’s, establishments’ subsequent adoption of • A requirement to meet specific time premised in large part on the direct and HACCP procedures. It is expected that requirements for chilling and cooling of substantial link between the existence of HACCP controls will give all finished carcasses and parts; insanitary conditions during production establishments the flexibility to meet • A requirement that certain raw of meat and poultry products and the the objectives reflected in FSIS’s product be tested for Salmonella, a likelihood that bacteria—including existing requirements for meat and representative pathogen, and that pathogenic bacteria—will contaminate poultry products. Once HACCP systems establishments achieve targeted the finished product. Some are integrated fully into all reductions in the incidence of establishments, however, do not have establishments, many existing Salmonella, in relation to the current adequate programs and do not regulations may be redundant. national baseline incidence, in 2 years consistently maintain good sanitation. Anticipating the implementation of (discussed under II B, below); FSIS is nearing completion of its project • HACCP proposed in this document, A requirement that all to conduct unannounced reviews of FSIS has initiated a review of existing establishments adopt HACCP systems 1,000 federally inspected meat and regulations, with the intention of (discussed under II C, below). poultry establishments. The findings, removing those no longer needed, as FSIS intends to proceed to final based on 551 reviews so far, show that well as of ensuring that regulations that rulemaking on the specific changes 60 percent (820) of 1,340 serious remain are sufficiently flexible to be proposed in this document as soon as deficiencies were found in sanitation. HACCP-compatible. FSIS invites possible. After comments are reviewed Poor sanitation is the most frequently comment on which regulations should and analyzed, if it is determined that observed problem in meat and poultry be eliminated or modified. Even now, it some portions of this proposal can be establishments. may be possible to identify means to made into final rules sooner than others FSIS is proposing to require that all achieving prescribed regulatory ends after the close of the comment period, inspected establishments develop that are as effective as the means set they will be separated from the other written sanitation SOP’s to prevent forth in current regulations—that are, in portions so as to not delay regulatory direct contamination or adulteration of other words, ‘‘equivalent’’ to provisions action on this important public health product before and during operations. set forth in regulations. FSIS invites matter. Establishments would be required to comment on specific regulations for These proposals reflect ideas and maintain daily records to document which such performance standards suggestions generated from many people adherence to the SOP’s. The proposed might be appropriate, either and organizations. Recent events have sanitation SOP’s would be compatible immediately or upon implementation of prompted a beneficial, ongoing dialogue with the proposed HACCP requirement. HACCP. between FSIS and consumer Like HACCP, the sanitation SOP’s organizations, trade associations, and reflect a commitment by establishment A. Transition to HACCP other Government agencies, among management to consistently control The following is a discussion of others, as well as among FSIS operations in the interests of public regulations being proposed which, employees and their bargaining health. The SOP’s demonstrate that together, are intended to reduce representatives, on what regulatory establishment owners know their significantly the level and frequency of changes the Agency should undertake. operations and how to keep the facilities consumers’ exposure to foodborne FSIS values and relies greatly on the and equipment clean. FSIS encourages illness associated with pathogenic input from all these sources, and both innovation and self-reliance in the microorganisms and other biological, intends to continue this dialogue achievement of good sanitation in all chemical, and physical hazards in meat throughout this rulemaking and in its inspected establishments. and poultry products. future regulatory activities. Self-reliance is important because The transitional regulations proposed 1. Sanitation Standard Operating identification of sanitation requirements in this document would be made Procedures (SOP’s) has been viewed by some establishment effective 90 days after publication of the owners and personnel as the inspector’s final rule (near-term initiatives). The Need for SOP’s responsibility. Such establishments proposed HACCP requirements would Proper sanitation is an important and often fail to take the initiative to find be implemented in phases during the integral part of every food process and and remedy insanitary conditions, three years following the publication of a fundamental requirement under the relying instead on the inspector to find the final rule. As noted above, the near- law. Insanitary facilities and equipment, deficiencies. term initiatives are designed to reduce and poor food handling and personal Mandatory sanitation SOP’s are the level and frequency of consumers’ hygiene practices among employees intended to clarify that sanitation is exposure to pathogenic microorganisms create an environment in which industry’s responsibility, not the now, pending the more comprehensive pathogens can flourish. The law is quite inspector’s. The sanitation SOP’s reflect controls that will be in place in each clear: product produced or held under the establishment’s commitment to establishment under the proposed insanitary conditions is deemed accomplish those activities consistently, HACCP regulations. adulterated, without any further independent of the inspector. The proposed regulations, roughly in showing required by the Government. Written SOP’s would make it easier order of their sequence in slaughter and FSIS inspectors are expressly charged for FSIS inspectors to perform their processing operations, are as follows: with ensuring that product inspected proper role of verifying that • A requirement that all federally and passed was in fact produced under establishment management is inspected establishments develop and sanitary conditions. conducting its operations in a sanitary Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6789 environment and manner. Failure to corrections when needed. FSIS season’’ carry heavy loads of mud, fecal adhere to the ‘‘core elements’’ of an SOP encourages establishments to material and bacterial contamination on (the proposed regulatory requirements) incorporate additional sanitation the hide. Sanitary removal of the hide would be presumptive evidence of procedures that provide increased under these conditions is very difficult. insanitation and enforcement action, assurance that insanitary conditions One method to control this source of where necessary, would be taken. As is will be prevented. contamination is washing animals prior now the case, inspectors will not permit Each establishment would maintain a to slaughter. Another possibility is an establishment to operate under daily record of the actions prescribed in clipping the hair over the areas where insanitary conditions. Falsification of the SOP, and make such records opening cuts will be made and records designed to document daily available to Program employees for sanitizing the hide prior to cutting. Yet sanitation activities would, in addition inspection audit and verification. another procedure being tested is the to indicating insanitation, be treated as Records would, at a minimum, record complete removal of hair from the hide a criminal act subject to prosecution. deviations from the core elements of the using a chemical hair remover As a more efficient tool for ensuring SOP (the proposed regulatory (depilatory). that establishments are carrying out requirements), along with corrective The Agency has been asked to their sanitation responsibilities, actions taken in conjunction with the consider making mandatory certain sanitation SOP’s can provide the basis monitoring of daily sanitation activities. GMP’s for sanitary slaughter by, among for improved utilization of FSIS Production could not start until the core others, the American Meat Institute. The inspectional resources. Sanitation SOP’s elements of the sanitation SOP’s that are Agency is requesting comments on thus support the transition to HACCP applicable to preoperational sanitation whether GMP’s or other sanitation because, under HACCP, FSIS inspectors have been completed. practices should be made mandatory will be called upon to perform a number The daily monitoring of the sanitation elements of the sanitation SOP. of additional safety-related inspectional program by the establishment The adoption of HACCP systems by tasks to verify that HACCP plans are representative could include establishments would not replace the working properly. If less time can be microbiological tests, routine need for establishments to maintain spent ensuring that basic sanitation organoleptic inspection of areas and sanitation SOP’s. The proposed HACCP requirements are being met, more time equipment, and direct observation of regulations require sanitation SOP’s as a will be available for these new tasks. sanitation procedures while being Some plants already have SOP’s, take prerequisite to a HACCP plan. performed by designated employees. Sanitation activities that directly affect their sanitation responsibilities FSIS will provide guidance materials, the control of a processing hazard seriously, and require a relatively including examples, on development of would be determined according to the modest investment of inspector time to sanitation SOP’s prior to the criteria discussed in the HACCP portion ensure sanitation requirements are met. implementation of this requirement. Other plants do not consistently The following are specific practices of this document, and would, where perform well in the sanitation area and relating to sanitation that might be appropriate, be identified as critical frequently require a substantial included in an SOP: control points in individual HACCP investment of inspector time to ensure • Preoperational microbiological plans. Sanitation activities not basic sanitation compliance before daily testing: Tests for verifying the efficacy of identified as critical control points operations begin. cleaning, sanitizing, and disinfecting under HACCP should remain in the In plants where procedural procedures. Many establishments also sanitation SOP’s. Any SOP requirement requirements are consistently followed currently perform preoperational incorporated into a HACCP plan could and inspectional observations verify microbiological testing for quality be removed from the SOP’s for that good sanitation is being control purposes. The technology for sanitation. consistently achieved, FSIS expects that preoperational sanitation 2. Antimicrobial Treatments sanitation SOP’s will provide the basis microbiological testing is readily for adjusting the manner and frequency available and easy to use. This proposed rulemaking would of FSIS preoperational sanitation • Disinfection of equipment prior to require, for the first time, that inspection. startup: Some data exist to indicate that slaughtering establishments apply FSIS invites comment on the role equipment should be sanitized antimicrobial treatments or sanitation SOP’s should play in immediately prior to the startup of interventions to livestock and poultry allocating responsibility between operations. carcasses. Under the proposal, any one establishment employees and FSIS • Use of an automated hand washer or more of the treatments would have to inspectors for preoperational sanitation, with approved sanitizing solution be applied prior to the chilling or including the role FSIS employees effective for up to six hours. This has cooling operation. Mandating should play in authorizing daily startup been proven to be an important sanitary antimicrobial treatments is a new of operations. practice. approach for FSIS. It reflects the • Handwashing between each carcass judgment that, at least until significant Content of SOP’s in skinning and evisceration operation. progress is made in reducing or Sanitation SOP’s would, at a • Cleaning cattle prior to slaughter: eliminating the presence of pathogenic minimum, detail procedures the Washing and drying, clipping, microorganisms in livestock and poultry establishment will conduct to prevent dehairing, and any other acceptable at the preharvest stage and in sanitary direct contamination or adulteration of method to remove dirt, fecal matter and dressing techniques and practices, some product before and during operations. other potential sources of contamination amount of contamination of beef and Such procedures would constitute the from the exterior of animals before the poultry carcasses with pathogenic required, core elements of an SOP. The edible portions of the carcasses are microorganisms is likely to occur—even SOP’s would also identify establishment exposed. The hides of animals are a in establishments that attempt to follow personnel responsible for evaluating the known source of carcass contamination. the best current practices. To reduce the conduct and effectiveness of the Feedlot cattle in general and most food safety hazard posed by such sanitation SOP’s, and for making bovines during the winter and ‘‘mud pathogens, establishments should be 6790 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules required to take affirmative measures to cannot guarantee the absence of carcasses are subject to the same reduce or eliminate contamination. pathogenic bacteria on raw meat or requirements as are finished livestock One concern regarding the use of poultry product. carcasses, with no visible fecal matter antimicrobial treatments is that such FSIS recognizes that the technologies permitted. Because of confusion on this treatments will be relied on as a now available for reducing bacterial point, FSIS is proposing to remove feces substitute for careful sanitary dressing contamination on raw carcasses are from the FPS for poultry to make clear techniques which provide the best limited. Indeed, the inspection the current policy that there is no opportunity to prevent contamination regulations currently have no listings for tolerance for feces. from occurring in the establishment. antimicrobial agents as such. However, The Agency’s proposal to codify the Other concerns are that some treatments FSIS has over the years permitted a zero tolerance policy for fecal are ineffective at least for certain number of such treatments to be used in contamination was one of a number of organisms, and certain treatments, such inspected establishments on a case-by- recently proposed changes to its poultry as carcass washes or soaks, might make case basis, and is proposing to include inspection regulations, designed matters worse by spreading some of these in the regulations through primarily to address concerns about contamination and can cause economic this rulemaking. Some currently pathogens (July 13, 1994, 59 FR 35639). adulteration. available treatment methods are The proposal drew more than 400 FSIS agrees that antimicrobial described below. comments. Although many critical treatments must not be allowed to New antimicrobial procedures, comments were received, a great substitute for careful sanitary dressing including variations on those listed majority of the comments on point procedures, and that any interventions below, will be approved for use by FSIS supported the use of antimicrobial must be effective and not result in to meet the proposed requirement for an treatments and removal of feces from economic adulteration. FSIS also agrees antimicrobial treatment, provided data the Finished Product Standards. that no one treatment will be effective are submitted demonstrating they are Because these two elements of the July for all pathogens of possible public safe and effective for that purpose. 13 proposal are incorporated in this health concern. FSIS believes that the Current interventions generally provide proposal, comments are again being best way to prevent harmful at least a one order of magnitude (i.e., solicited. This does not, however, contamination of meat and poultry a 90-percent) reduction in the numbers preclude completion of the July products is by adopting multiple of bacteria of concern on treated rulemaking on these two issues and the approaches throughout production, carcasses. issuance of final rules based on that slaughter, and processing that will Antimicrobial treatments are proposal. contribute to preventing or reducing the interventions that decrease One part of the July proposal that was likelihood and degree of microbial microorganisms present on the surfaces criticized in the comments is the contamination, especially by pathogens. of meat and poultry carcasses. requirement that the antimicrobial FSIS believes that mandating at least Antimicrobial treatments are not treatment be limited to application prior one antimicrobial treatment prior to the designed to compensate for sloppy to the chilling or cooling system. Some chilling process is an integral part—but sanitary dressing procedures on the commenters indicated that certain only one part—of the strategy for slaughter floor, and under this proposal, antimicrobial treatments for use in the reducing pathogens on meat and poultry will not be permitted to be used for that chilling or cooling systems are more proposed in this document. Product not purpose. effective than treatments applied before properly treated with at least one Thus, the proposed use of this point. Additionally, some held that antimicrobial treatment would be antimicrobial treatments does not imply certain post-chill treatments, such as retained; the Inspector in Charge would a change in current FSIS policy irradiation, may provide a more determine its disposition. FSIS invites regarding removal of physical effective treatment option. FSIS’s intent public comment on this approach, as contaminants from meat and poultry was, and is, that poultry entering chill well as on the issues raised in the carcasses. Fecal, ingesta, or milk tanks be as clean as possible. However, discussion below concerning what contamination on cattle carcasses must FSIS invites comments on whether treatments are effective and appropriate. be removed by trimming. Wash/trim mandated antimicrobial treatments studies are underway to determine the should be restricted to pre-chill Past and Current Agency Policy best way to remove these visible application, as proposed above. Despite establishment’s best efforts to contaminants. Public comment and Irradiation is another issue related to reduce or eliminate contamination discussion, including peer review, of this proposal on antimicrobial during slaughter and dressing the data from these studies will be treatments. Irradiation is statutorily procedures, livestock and poultry solicited and reviewed as part of the defined as a ‘‘food additive’’ under the carcasses still may harbor pathogenic Agency’s evaluation and Federal Food, Drug, and Cosmetic Act microorganisms. The sources of these decisionmaking process on this issue. (FFDCA) and thus its safety is evaluated organisms, most of which are associated FSIS policy concerning visible by FDA, which must approve its use as with the living livestock and poultry, contaminants on poultry continues to a food additive in a regulation are not fully understood, and fully require carcasses to be free of fecal specifying safe and lawful conditions of effective preharvest preventive contamination before entering the use. FDA has approved irradiation for measures, while under study, are not chillers. The process control program use in controlling foodborne pathogens currently available. Thus, introduction set forth in the current regulations on uncooked poultry (21 CFR 179.26), of pathogenic microorganisms into provides Finished Product Standards and FSIS has promulgated regulations establishments along with the animals (FPS) for poultry where feces are one of under the PPIA specifying inspection cannot be absolutely prevented at this the ‘‘nonconformances’’ that are requirements for establishments using time. The use of the best slaughter and summed with other nonconformances to that process (9 CFR 181.149). FDA sanitary dressing procedures and determine compliance with the standard currently is considering a petition to technologies can reduce the likelihood (9 CFR 381.76). This is only a measure permit use of irradiation to control that product will be contaminated by of the presence of this nonconformance, pathogens on uncooked meat. these invisible pathogens, but they not a tolerance. Finished poultry Irradiation is not being considered an Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6791 antimicrobial treatment for purposes of equipment and utensils also is available water can reduce levels by 99–99.9 this proposal because irradiation from that office. percent. facilities are to date extrinsic, stand- The use of an antimicrobial treatment The effects of hot water washing are alone operations that cannot easily be on raw meat and poultry carcasses dependent on two separate mechanisms. integrated into a slaughter operation— would reduce the levels of bacteria on The first is simply the physical washing the focus of the present effort. the product, but it would not eliminate action of the rinsing. This can account Furthermore, although irradiation has the need for continued careful handling for a significant portion of the overall been shown to be a highly effective of those products before and after the effect, particularly if the bacteria are pathogen control mechanism, it is a antimicrobial treatment. The following only loosely attached to the carcass capital-intensive process largely are available antimicrobial treatments surface. In addition, the thermal effects unavailable to most inspected slaughter that FSIS tentatively concludes could of the elevated temperatures produce establishments. Notwithstanding these satisfy its proposed requirements for a some degree of heat inactivation. As considerations, firms would be able to mandatory antimicrobial treatment. with any thermal processing, the extent use irradiation on raw poultry under FSIS invites comment on each of these. of the inactivation will be directly existing regulations, in addition to the (a) Hot water. Hot potable water or proportional to both the duration and antimicrobial treatments now being steam may be used to reduce temperature of the heating material (i.e., proposed. microbiological counts on meat and water temperature). A hot water rinse can achieve up to a 99.9 percent (3 log) Approved Antimicrobial Treatments poultry. Washing carcasses with hot water has been shown to be effective in decrease in the levels of various A number of methods for reducing the reducing the level of bacteria on carcass pathogenic and non-pathogenic bacteria. number of bacteria that may be on surfaces. It potentially can achieve up to a 99.9 carcasses have been suggested, e.g., The decontamination of carcasses percent reduction in E. coli O157:H7. exposing the carcass to hot water, using hot water has a number of Hot water sprays are most effective chemical sanitizers, such as chlorine or advantages. These include: (1) reliable when applied in a manner that raises trisodium phosphate (TSP), and short reduction of contaminants, (2) removal the water film on the surface of the chain food grade acids, such as lactic, of loose extraneous material, (3) no carcass (surface temperature of the acetic, and citric acids. impairment of meat properties, (4) no carcass) to 82°C (180°F) for 10 seconds. Antimicrobial treatments currently chemical reaction with equipment, such Exposure of beef carcasses to 80°C permitted by FSIS are techniques as the corrosive effects associated with (176°F) water results in a greying of the involving the rinsing of carcasses with acetic acid, (5) no disposal problems, meat surfaces; however, the color a wash or spray, normally using either and (6) readily available and easily returns to its normal appearance after hot water or a solution of water and a accomplished. chilling. When the carcass surface is substance approved by FSIS for that use Disadvantages with hot water sprays exposed to 82°C (180°F) for more than on the basis that it has been found to be include: (1) the need for greater 20 seconds, tissue discoloration effective and its use is consistent with pumping pressures, (2) less recoverable becomes permanent. applicable FDA regulations governing heat energy from the outlet water steam, Researchers have tested the food additives. Some mechanical (3) the likelihood of nozzle blockage if effectiveness of hot water using sprays process modifications currently in use water is recirculated, and (4) the or dips and using decontamination have been shown to enhance the results production of mist which condenses on cabinets, with hot water only and with of rinsing procedures. Countercurrent surfaces in the vicinity of the cabinet if chemical sanitizers. scald tanks with a postscale spray have baffles are not used. One study found that treating beef been shown to be effective in reducing Scientific studies over the course of carcasses with a steam and hot water bacterial levels on poultry carcasses. the past twenty years have investigated spray at 176°F–205°F (80°C–96°C) for 2 Equipment and utensils used in whether the use of hot water (74°–95°C, minutes, sprayed from one foot (25 cm.), preparing or handling meat and poultry 165°–201°F) instead of the commonly lowered bacterial numbers. A volume of products in inspected establishments used lower water temperatures (30°– 18.9 liters of water was sprayed for each are subject to inspection to ensure that 35°C, 85°–95°F) can reduce the general carcass. Some discoloration of the their use will not result in adulteration microflora of aerobic mesophiles carcass surface occurred initially, but or misbranding of the finished product. present on the carcass, including normal color returned after cooling for To promote efficiency and uniformity in members of the family 24 hours. this element of FSIS’s inspection duties, Enterobacteriaceae. This taxonomic Another study found a hot water FSIS reviews newly developed group includes some of the most treatment of beef and mutton samples equipment and utensils intended for use important foodborne pathogens. Hot inoculated with E. coli more effective in in inspected establishments and water rinses have been shown to be reducing bacterial numbers than a publishes a listing of equipment and effective against a number of foodborne naked flame, steam chamber, steam utensils found to be acceptable for that pathogens including Escherichia coli ejection, or washing with water at 37°C use (9 CFR 380.5, 381.53). O157:H7, Salmonella, Yersinia (99°F). When hot water temperatures Establishments and other manufacturers enterocolitica, and Listeria were below 60°C (140°F), no significant of mechanical devices designed for monocytogenes. Quantitative studies color change was noted. Above 85°C antimicrobial treatments, such as assessing the impact of hot water (185°F), the color change was marked scalding tanks and spray cabinets and treatment on the survival of E. coli and permanent. Permanent color devices, must obtain approval of their O157:H7 have suggested that it can changes of the surface tissues caused by equipment from the Facilities, reduce the levels present on the using water at 95°C (203°F) for three Equipment and Sanitation Division, carcasses by 84–99.9 percent, as well as minutes did not extend more than about Science and Technology, Food Safety the number of contaminated carcasses. 0.5 mm below the surface. Temperatures and Inspection Service, U.S. Department Other studies with E. coli biotype 1 (E. of 70°C (158°F) and above gave at least of Agriculture, Washington DC 20250. A coli O157:H7 is one of hundreds of E. a two log (99 percent) reduction of copy of the current list of approved coli serovars) have indicated that hot inoculated E. coli on samples. 6792 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules The hot water spray cabinet used on reduction in bacterial numbers observed FSIS considers the final beef carcass lamb carcasses had water leaving the by spray washing was increased. wash to be an appropriate point at nozzles at 95°C, but the temperature of Another researcher used a deluge which to apply hot water as an the water reaching the carcass could not method instead of conventional antimicrobial treatment. The final be raised above 74°C (165°F). They were pressure spraying. Advantages cited carcass wash occurs at the end of the able to obtain a 99 percent decrease in include: construction simplicity, slaughter and dressing process, after inoculated E. coli at all sites when sheep cheaper running cost, and greater trimming and FSIS postmortem carcasses were immersed in 80°C reduction in bacteria. However, unlike inspection is completed. The final (176°F) water for 10 seconds. Immersion spray decontamination, coverage of the carcass wash is usually the last step in for 30 seconds gave little extra kill of abdominal and thoracic cavities was the dressing process before the carcass inoculated bacteria. In-plant immersion only about 65 percent. He found a enters the cooler for chilling. The final tests on carcasses that had not been significant (<0.05) linear relation carcass wash removes blood, bone dust, inoculated showed a 98 percent between the log reduction in inoculated hair, dirt, and other accidental reduction in bacterial numbers. E. coli and average water film contamination. On November 1, 1994, Researchers have found that pouring temperature which varied with FSIS announced that hot water rinses hot water at 169°F (77°C) on beef (tissue exposure time immediately after will be allowed at the final beef carcass slices) and mutton (carcass) samples for treatment. Longer exposure (20 sec vs 10 wash without prior approval. An 10 seconds destroyed more than 99 sec) produced significantly greater establishment wishing to apply hot reduction at higher temperatures (44.5°, water to beef carcasses at the final wash percent of E. coli and Salmonella ° ° ° inoculated (10 6.5/cm2) onto the samples. 66.0 , 74.2 , 83.5 C). There was no no longer must obtain prior approval by Tissues surfaces were not permanently significant growth of E. coli between 24 FSIS. However, FSIS notes that a hot discolored. When beef slices (2.5 cm and 48 hours, which is consistent with water wash used pre-evisceration might thick) swabbed with bacterial culture the findings of several other researchers. also meet the intent of this regulation ° ° ° After chilling for 48 hours, sides and therefore has the potential were exposed to hot water (60 , 65 , 70 , ° 80°, 90°C) for intervals of 10, 30, 60, and exposed to 83.5 C had a slight and advantage of removing/destroying 120 seconds, it was found that the time apparently permanent bleaching of the bacteria before they have had time to of exposure was not a factor, but a fat and meat tissue in the area of the become tightly attached to carcass progressive decrease in E. coli counts upper thoracic cavity. tissues. FSIS invites comments on In a 1993 study, carcasses were from >101 at 60°C to >104 at 90°C was whether the use of hot water wash to sprayed with 2 liters of hot (95°C) water noted. Coliform and aerobic mesophilic satisfy the proposed requirement of an for 40 seconds with the intent of raising bacteria counts on six naturally antimicrobial treatment should be the meat surface temperature to 82°C for contaminated sheep carcasses were limited to the final carcass wash or 10 seconds before final wash and after reduced from 100 cells/cm2 to below should be permitted at other stages of final wash. The apparatus was designed detectable limits and 8,500 to 310 cells/ the slaughter and dressing process. to raise the temperature within 30 A list of studies on various methods cm2 respectively. seconds and maintain it at 82°C for 10 of applying hot water to meat and A 1979 study applied cold water seconds. Culture samples taken from hot poultry carcasses is on file in the FSIS ° ° 2 (16 C, 60 F)(<14 kg/cm ), hot water water-treated carcasses before final 2 Docket Clerk’s office, and is available 76°C–80°C [168°C–176°F])(14 kg/cm ), 2 wash had a mean log10/cm of 1.1 while from the Director, Slaughter Inspection and steam (95°C) to previously frozen 2 controls had log10/cm of 2.4. Culture Standards and Procedures Division, beef plate strips. Treatment with cold samples taken from hot water-treated FSIS, U.S. Department of Agriculture, water alone reduced the counts by about carcasses after the final wash had a Washington, DC 20250. FSIS welcomes one log. Steam alone only reduced the 2 mean log10/cm of 1.5 while controls additional data on the effectiveness of count by 0.06 log. Initial reduction in 2 had log10/cm of 2.3. It was unclear why hot water as an antimicrobial treatment, counts by hot water alone was 2.0 log. a greater reduction in bacterial numbers ° especially regarding the effectiveness of Samples held at 3.3 C were cultured for occurred when carcasses were sprayed varying temperatures and times of several days after treatment. After an with hot water before the final carcass exposure. initial lag phase of less than a day for rinse. A 15–20 minute elapsed time (b) Lactic, acetic, and citric acid samples treated with cold water or between hot water and final wash may solution sprays. steam, the rates of bacterial growth were have allowed more bacterial attachment Lactic, acetic and citric acids are weak greater on the treated samples than on to take place. The volume of the spray acids that have long been consumed by untreated controls. By the fifth day the and the size of droplets were found to humans in a variety of foods. They aerobic plate counts for steam and cold have a profound effect on the occur naturally (e.g., citric acid in water treated samples exceeded the temperature of the water contacting the limes), have been added in the aerobic plate count on the control carcass surface. processing of a broad variety of foods samples. Presumably this was due to the In view of this research, FSIS is (e.g. acetic acid in mayonnaise), and greater surface moisture from the proposing that hot water treatments develop in the fermentation of foods treatment. The rate of bacterial growth used to meet the intent of this regulation (e.g., lactic acid in cheese). on samples treated with hot water was be applied such that the temperature of FDA lists acetic acid as Generally similar to that on controls, but the the water at the surface of the carcass is Recognized As Safe (GRAS) as a direct initial 2-log difference was maintained ≥ 165°F (≥ 74°C) for ≥ 10 seconds. If food substance in 21 CFR 184.1005 if through 12 days of storage resulting in applied by a spray, this is likely to used at levels not exceeding current nearly 5 additional days for counts to require that the water be heated to a good manufacturing practice (CGMP). reach 108/cm2. somewhat higher temperature. The hot The acetic acid listing specifies that the A 1981 study reported that lamb water would have to contact all carcass CGMP results in a maximum level in carcasses sprayed with hot water at surfaces. Other combinations of time meat of 0.6 percent as served. While the temperatures >169°F (77°C) caused and temperature of hot water also may use of acetic acid on fresh meat was not 2 significant decreases (1.0 log10/cm ) in be effective. FSIS would like comments reviewed by the Select Committee on APC. As temperature was increased the on this point. GRAS Substances in reaching its Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6793 conclusion on the safety of food use of (1) pre- versus post-rigor tissue, (2) pre- and concluded that an acetic acid acetic acid, FDA believes that use of washing prior to treatment, (3) tissue carcass sanitizer could be used as an acetic acid as proposed in this rule will type, (4) method for acid delivery, (5) effective method to control these result in residual levels on product ‘‘as droplet size, (6) flow rate/pressure, (7) bacterial pathogens. Conversely, another served’’ below the most restricted use temperature, (8) pH, (9) contact time, reported that up to 1.5 percent acid levels specified in § 184.1005 for acetic (10) bacterial species, (11) type of acid, treatments did not appreciably reduce E. acid (FDA November 29, 1982), 0.15 (12) buffering capacity, and (13) coli O157:H7, whether at 20° or 55°C percent for ‘‘all other food categories.’’ moisture content. Differences in study and ‘‘was of little value in disinfecting Lactic acid is approved as GRAS at 21 design, especially factors such as beef of E. coli O157.’’ It has been CFR 184.1061 with no limitations other methods used to collect tissue samples reported that there are differences than good manufacturing practice. In and analyze for bacterial species or the among E. coli O157:H7 isolates in addition, lactic acid is listed for use as preadaptation of bacterial cells to an relation to their acid tolerances. These an antimicrobial agent in foods, also at acid environment, affect results. investigators also found that a level not to exceed good Interpretation of research results can inactivation was dependent on acid manufacturing practice. also be confounded by difficulty in concentration (5 percent gave greatest Citric acid is listed for multiple obtaining valid microbiological data reductions), and tissue type (reductions purpose use in 21 CFR 182.1033, when because of large carcass to carcass greater on adipose tissue than lean). used in accordance with good variations, as well as differences in Some investigators have suggested that manufacturing practices. microflora associated with different lactic acid is more effective than acetic In addition, sections 318.7(c)(4) and slaughter facilities, carcasses, and or citric acid against E. coli. It has been 381.147(f)(4) of the regulations (9 CFR sample sites on individual carcasses. suggested that the primary determinants 318.7(c)(4) and 381.147(f)(4)) currently The literature suggests it is important of effectiveness were the pH achieved at allow the use of acetic, lactic, and citric to lower the pH of the meat surface if the surface of the carcass and the acids as acceptable ingredients in bacteria are to be controlled effectively corresponding period of exposure. various meat and poultry products by using an organic acid. Most organic Organic acids apparently are more when used as acidifiers or as esterifiers acids are effective only at low pH values effective when applied as soon after in margarine. Citric acid may also be of pH 5.5. Apparently the anion exerts slaughter as feasible, and when they are used as an anticoagulant, a flavoring some effect on bacteria at pH values of at elevated temperatures (53°–55°C). agent, and a synergist at various levels pH 5.5. The pH affects the extent of The bacteria found on a carcass soon in various meat and poultry food dissociation. Undissociated weak acids after slaughter are believed to be present products. Citric acid is acceptable as a are more effective than the dissociated in a water-film on the surface and, curing accelerator to speed up color form and dissociate to produce therefore, are relatively easy to remove, fixing or preserve color during storage of acidification of the cell interior. contrasted with bacteria that have cured pork and beef cuts and cured Overall, the available scientific data become attached to the carcass surface comminuted meat food products. indicate that washing of carcasses with itself by the time chilling is complete In 1990, FSIS determined that lactic, organic rinses or sprays can achieve a and are therefore more difficult to acetic and citric acids can be safely and 90–99.9 percent reduction in levels of remove. effectively used as antimicrobial spoilage bacteria (e.g., Pseudomonas Overall, organic acid rinses appear to treatments on meat and poultry fluorescens) though in some cases the be a generally effective antimicrobial carcasses and by-products during reductions were not statistically intervention that have several distinct slaughter and dressing procedures. That significant and in others no advantages. Specifically, the advantages determination was based on an improvement was noted. In addition, include: (1) the technique can achieve extensive review of the scientific acid sprays and dips have also been up to a 99.9 percent (3 log) decrease in literature on methods of reduction of shown to decrease the levels of specific the levels of specific pathogenic and bacteria on meat surfaces. pathogens, as well as the incidence of non-pathogenic bacteria; (2) the During the past twenty years the use carcasses that are positive for specific effectiveness of the application can be of organic acid rinses to reduce spoilage pathogens. This includes activity readily monitored; (3) the technology and pathogenic microorganisms on against Salmonella spp., can be implemented through a relatively foods has been studied extensively. Staphylococcus aureus, Campylobacter straightforward modification of existing Numerous researchers have jejeuni, Yersina enterocolitica, and equipment; and (4) this is a process for demonstrated that organic acid rinses Listeria monocytogenes. However, these which there are no apparent ‘‘tradeoffs’’ can produce a significant reduction in techniques do not and cannot be in relation to other risks or negative bacterial levels on the surfaces of meat expected to completely inactivate or attributes (e.g., the presence of residues and poultry. Although most of these eliminate pathogens. or the need to eliminate studies have been conducted under One of the bacterial species that environmentally sensitive byproducts). laboratory conditions, there have been appears to be among the more resistant The primary disadvantage is that the some studies that have specifically to the effects of organic acids is E. coli effectiveness of acetic acid rinses assessed the efficacy of these O157:H7. A number of investigators against E. coli O157:H7 is not as great antimicrobial systems under production have found that O157:H7 has a as against other pathogens, and at least conditions. Also, some of the laboratory relatively high acid tolerance. Again, the some studies indicate that these rinses research has been conducted under extent of inactivation achieved with E. may not achieve the results desired. simulated in-plant conditions. coli O157:H7 has varied among the In 1992, FSIS issued a directive (FSIS The results achieved in the various various studies. For example, one Directive 6340.1, 11/24/92) that research trials have not been researcher found that E. coli O157:H7 provided guidance to FSIS employees unequivocal, in part because the reductions were similar to those on conditions of use, and how to effectiveness of the compounds is observed for Salmonella spp. and evaluate and respond to livestock dependent on their interactions with a Listeria monocytogenes, with up to a establishments’ requests for approval of number of other factors. Some of the 99.9 percent reduction in the levels of pre-evisceration carcass spray systems factors that have been identified include all three bacteria from inoculated tissues using an acid spray to reduce the 6794 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules microbial population and retard further new class of substances to be called FSIS is proposing to permit TSP to be microbial growth on livestock carcasses. ‘‘antimicrobial agents’’ (59 FR 551). TSP applied to poultry carcass surfaces at For beef carcasses, FSIS also recently reduces bacterial levels, including any point prior to entering the chiller as authorized establishments to use acetic, pathogenic bacteria, on raw poultry one means to meet the proposed citric, or lactic acids on inspected and carcasses when applied by spraying or requirement for an antimicrobial passed carcasses before chilling in dipping the raw poultry carcasses for up treatment. FSIS intends to propose in conjunction with the final wash without to 15 seconds post-chill or for up to 30 another rulemaking a regulation to list prior FSIS approval on an seconds pre-chill with an 8–12 percent TSP in part 381.147(f)(4), Table 1, as an establishment-by-establishment basis. solution of TSP in water. TSP may be approved antimicrobial agent. TSP FSIS is proposing that, to satisfy the applied to raw chilled poultry as a would be applied in a solution of 8–12 proposed requirement for at least one solution maintained at 45°F–55°F, and percent concentration in such a fashion antimicrobial treatment, acetic, lactic, or to raw poultry as a solution maintained that all carcass surfaces would be citric acid could be applied to carcass at 65°F–85°F. contacted. surfaces prior to entering the cooler. Industry, university, and Agriculture A list of studies done on the FSIS is preparing to propose in a Research Service studies demonstrate application of TSP to poultry carcasses separate rulemaking that these organic TSP induced reductions in carcass is on file in the FSIS Docket Clerk’s acids be listed, as approved Salmonella levels ranging from 90 to office, and is available from the antimicrobial agents, in 9 CFR 318.7 and >99.9 percent (1.2 to 8.3 log10). The Director, Slaughter Inspection Standards 381.147 for livestock and poultry uses, higher Salmonella reductions were Division, FSIS, U.S. Department of respectively, in a solution of 1.5–2.5 associated with pre-chill TSP Agriculture, Washington, DC 20250. percent concentration and in such a applications. Mean carcass Salmonella (d) Chlorinated water. The washing of fashion that all carcass surfaces would prevalence was reduced from up to 23 carcasses with chlorinated water to be contacted. percent to approximately 1 percent. reduce the amount of spoilage and FSIS invites comments on whether Industry studies demonstrate median pathogenic microorganisms on carcasses the use of these acids to satisfy the reductions in carcass is a longtime practice in the poultry program requirements for an Enterobacteriaceae and E. coli levels of industry. As early as 1951, researchers antimicrobial treatment should be approximately 99.5 percent (2.5 log10). noted the effectiveness of in-plant limited to post-inspection application in In a study conducted by an independent chlorination in lowering bacteria counts conjunction with the final carcass wash laboratory, Campylobacter average on product, increasing shelf life, or should be permitted at earlier stages prevalence was reduced from 100 reducing odors in the establishment, of the slaughter and dressing process, percent to 30 percent with mean and reducing slime on equipment. such as after skinning but before numerical reductions of >99.9 percent Chlorine is now used in most poultry evisceration and completion of (4 log10) following TSP application to establishments, primarily in chill water, postmortem inspection by FSIS raw, unchilled poultry carcasses. TSP to minimize bacterial cross- inspectors, or during chilling. FSIS also application to raw poultry, under the contamination and as an effective invites comment on whether organic above stated time, concentration, and sanitizing agent on facilities and acid sprays should be considered an temperature conditions of use, therefore, acceptable antimicrobial treatment in causes statistically significant equipment, usually at FSIS-sanctioned beef slaughter establishments in light of reductions in these most common gram levels of 20 to 50 parts per million the reported acid-resistance of E. coli negative pathogens associated with raw (ppm) available chlorine. O157:H7, which is a pathogen of poultry. A FSIS study published in 1992 particular public health concern in beef. As part of the poultry chilling showed significant microbial reductions A list of studies on the application of process, poultry carcasses may gain on raw chicken carcasses and giblets organic acids on meat carcasses is on moisture up to the levels permitted in immersed in chlorinated chill water. In file with the FSIS Docket Clerk and may 9 CFR 381.66(d). Poultry establishments this study, the addition of 25 ppm of be obtained from the Director, Slaughter using TSP are not exempted from the chlorine in the chill water resulted in a Inspection Standards and Procedures moisture absorption and retention limits significant decrease in aerobic plate Division, FSIS, U.S. Department of contained in 9 CFR 381.66(d). To counts, Enterobacteriaceae, and E. coli. Agriculture, Washington, DC 20250. preclude the potential for economic Some reduction also occurred without (c) Trisodium phosphate (TSP). The adulteration of poultry carcasses as a chlorine in chill water indicating that application of TSP to raw poultry result of TSP treatments, federally chilling carcasses in this manner carcasses by spraying or dipping with a inspected establishments applying TSP actually reduces the bacterial load on solution of water and food grade TSP to raw poultry carcasses will include the carcasses. The effect on Salmonella was was recently approved by FSIS. TSP application in their washing, a reduction in the amount of cross- Trisodium phosphate (TSP) is listed in chilling, and draining method as contamination. Without chlorine, the the FDA regulations as GRAS for outlined in 9 CFR 381.66(d)(8). percent of carcasses exiting the chiller multiple purpose use, in accordance Commercial use of TSP has only with Salmonella versus the percent with good manufacturing practices. FDA recently begun in some poultry going in increased significantly. With has affirmed that application of TSP to establishments. It is not yet widely the addition of chlorine, the differential raw poultry carcasses is consistent with used. A commercial study investigating was not significant. The conclusion was the GRAS listing for TSP. Additionally, the efficacy of TSP in reducing bacterial that chlorine aids in the control of cross- TSP (sodium phosphate, tribasic) is levels on beef carcasses is in progress. contamination in the chillers. listed in the Food Chemicals Codex III Federally inspected establishments Chlorinated water has long been (1981). using TSP as an antimicrobial agent on recommended for reducing bacteria in FSIS has granted interim approval for raw poultry have consistently met local poultry processing establishments. In use of TSP at pre-chill and post-chill and State effluent phosphate discharge one study 34 ppm chlorine reduced locations, and has begun rulemaking requirements by making minor salmonellae in broiler chill water to procedures to include this compound in modifications to their effluent non-detectable levels, and resulted in 9 CFR 381.147(f)(4), Table 1, under the flocculation methods. significant reductions (10–13 percent) in Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6795 the incidence of Salmonella on the additional lifetime cancer risk in the proposed regulation. Exempted export carcasses. population from consumption of product must be properly identified, A 1968 study demonstrated that by chloroform residues in chicken ranged segregated, and labeled. FSIS invites incorporating chlorine (20 ppm) into from two in one billion (2 × 10¥9) to five comments on this proposed exemption. sheep carcass wash water, bacterial in 100 million (5 × 10¥8) for fat, and 3. Temperature Controls numbers were reduced significantly, but from two in one billion (2 × 10¥9) to usually less than one log. Another study four in 100 million (4 × 10¥8) in skin Temperature is one of the primary showed increased reductions in based on estimates of chicken factors affecting bacterial multiplication; bacterial numbers were obtained as the consumption. These are well below the the lower the temperature, the more chlorine level in water used to wash level of one in one million (1 × 10¥6) slowly the multiplication occurs. lamb carcasses was increased up to 357 additional lifetime cancer risk generally Carcass surfaces become contaminated ppm. Another researcher observed considered negligible by EPA and FDA with bacteria during the slaughter and similar reductions when lamb carcasses in their regulation of pesticides and dressing procedures, while carcass were washed with 150 and 250 ppm other chemicals, such as animal drug interiors remain uncontaminated. Rapid chlorine. A study in 1977 found that up residues. cooling of carcasses prevents the 2 to log100.7/cm reduction could be FSIS believes that these extremely multiplication of pathogenic bacteria on obtained by using water containing 200– small risks are clearly outweighed by the carcass surface, and thus reduces 250 ppm chlorine to spray beef tissue. the public health benefits of chlorine in consumer exposure and risk. An initial mean reduction of 0.31 log reducing microbial contaminants on FSIS has concluded that most raw on beef tissue has been achieved by product. FSIS permits the use of nitrites meat and poultry products must be treating it with a 200–250 ppm chlorine in cured products on a similar basis; the rapidly chilled to 50°F and then wash. FSIS considers the application of antimicrobial safety benefits provided maintained at 40°F or below to chlorine at levels up to 30 ppm on consumers by its use greatly outweigh minimize the risk to public health from poultry, including giblets and salvaged the very small risk posed by possible pathogens on those products. The parts, and in poultry chiller water, to be carcinogenic byproducts. technology needed to achieve the prior sanctioned under the food additive At the request of FSIS, ARS is proposed chilling standards is readily provisions of the Federal Food, Drug, studying the possible risks from any available and for the most part already and Cosmetic Act. The comparable use mutagens that might be formed with the installed in establishments. The change of chlorine in sprays applied to use of chlorinated poultry chiller water. being proposed is that appropriate time- livestock carcasses is also a practice that Early phases of this study indicate only temperature controls for handling raw has long been permitted by FSIS. that very low levels of mutagenic product, already generally adhered to by The vast majority of poultry compounds are associated with many establishments, will become establishments and a growing number of chlorinated poultry chiller water and mandatory for all establishments. meat establishments apply chlorine that they increase as the chlorine levels Accordingly, a new section 318.25 solutions during slaughter and used increase. would be added to the meat inspection processing. To meet the intent of the FSIS will continue to monitor closely regulations requiring that regulation, FSIS would allow the all data on the safety of chlorine when establishments cool livestock carcasses application of 20–50 ppm chlorine in used on carcasses as an antimicrobial and raw meat products so the products ° the final wash for livestock and poultry agent, and will continue to reevaluate reach a temperature of 50 F or below carcasses. the risks and benefits associated with within specified time periods and Some environmental risks have been approved use. maintain cooled carcasses and raw meat associated with the use of chlorine, FSIS invites comments on the risks products at 40°F or below throughout most significantly from the formation of and benefits of chlorine used to reduce handling, holding, and shipping to other byproducts of chlorine reactions with and control microbial levels on meat official establishments, with certain organic compounds in water. The and poultry products. exemptions. One exception is for raw trihalomethane (THM) byproducts are product going directly into processing the current focus of regulation of Product for Export that includes a pathogen-lethal heating drinking water chlorination by the Application of antimicrobial step, and thereby results in a ‘‘ready-to- Environmental Protection Agency under treatments under this proposed eat’’ product. Raw product would be the Safe Drinking Water Act. It has been regulation might interfere with the partially exempt from the time- reported that there is an association export of the products. This may be temperature requirements applying to between long-term exposure to especially true for products from fresh carcasses because when product chlorinated drinking water and a 9–15 carcasses treated with certain chemicals. enters a ready-to-eat process, other time- percent higher incidence of human For example, Canada limits the use of temperature controls applicable to the bladder and rectal cancer. The chlorine on poultry products to a raw ingredients would apply. researchers were of the opinion, maximum of 20 ppm, and chlorine is Additionally, the processing treatment however, that the public health risks not permitted at all in some of the required for ready-to-eat products from microbial contamination in countries of the European Union. stabilizes the product by killing both unchlorinated water ‘‘greatly exceed’’ Therefore, so as not to interfere with pathogens and spoilage bacteria. the risks of possible increased incidence the export of meat and poultry products, Another exception to the proposed of bladder and rectal cancers. and enable companies to meet the cooling requirements is for ‘‘hot-boned’’ Because one of the THMs, chloroform, expectations of their customers, FSIS is product, that is, muscle tissue removed is an animal carcinogen, FSIS proposing to exempt from antimicrobial from the carcass before chilling, which contracted with a private firm to treatment product designated for export would have to be cooled within 5 hours perform a quantitative cancer risk only. This exemption would apply only (meat) or 1.5 hours (poultry) to a surface assessment on chloroform residues to product being prepared for export to temperature of 10°C (50°F). Any edible recovered from the fat and skin of whole a country which will not accept product parts removed from the carcass and not broiler chickens purchased at retail. exposed to the antimicrobial treatment to be heat processed directly, e.g., livers, Based on this assessment, estimates of installed in the establishment under this hearts, and heads with cheek meat, must 6796 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules enter a chiller within 1 hour and chill (2) 40 °F has long been the maximum prior to leaving the establishment. at the same rate as carcasses. temperature recommended, as set forth Requiring a temperature of 40 °F or This proposal also would amend in Agriculture Handbook No. 412; (3) below prior to entering commerce section 381.66 of the poultry regulations the U.S. industry generally uses much provides added assurance that during so they are substantially consistent with lower temperatures (e.g., 30 °F (¥1.1 °C) transportation the product will be the proposed meat inspection to retard spoilage as well); and (4) 40 °F maintained at 40 °F and bacterial regulations regarding temperature and would be the same as the temperature multiplication will be restricted. chilling requirements. Section 381.66 currently required for chilling poultry Carcasses or raw meat products are currently requires that all poultry products (9 CFR 381.66). permitted, however, to enter a ready-to- slaughtered and eviscerated in an Except for hot-boning operations, eat process at the establishment, before official establishment be chilled where muscle tissue is removed from being cooled to an internal temperature immediately after processing so that the the carcass before cooling, FSIS is not of 40 °F. internal temperature is reduced to 40 °F proposing a set time to attain an internal Slaughtering establishments would be or below within a time period temperature of 40 °F. This is because, required to begin cooling raw meat appropriate to the size of the carcass. It when the surface temperature of a products other than carcasses within 1 further requires that eviscerated poultry product reaches 40 °F within the hour of removal of the tissues from the to be shipped from the establishment in proposed 24 hours and is maintained at carcass. Establishments generally packaged form be maintained at 40 °F or that temperature, the laws of remove raw meat products, such as below, with certain exceptions. Section thermodynamics ensure that the interior livers, hearts, heads, and cheek meat, 381.66 would be amended to include will cool to a safe temperature within a before the carcass exits the slaughter new time/temperatures requirements, to reasonable time frame. Since carcass floor. These products have a history of mandate corrective actions when time/ weight and composition affect the poor microbiological quality because the temperature controls fail, and to interior cooling rate, a set time to an products are packed in boxes before eliminate other provisions inconsistent internal temperature would be too strict cooling or are moved to the cooler only with those being proposed for meat. for heavy carcasses and too lenient for after a delay. The requirement that FSIS believes the proposed time- light carcasses. cooling of these products begin within temperature cooling requirements for There are additional reasons to use 1 hour of removal from the carcass meat are equivalent to those in effect surface temperatures. First, any bacterial would reduce the opportunity for and being proposed for poultry in terms pathogens on a fresh carcass are pathogenic bacterial multiplication and of their public health benefits and are concentrated on its surface. The deep improve the microbiological quality of readily attainable under current tissue of carcasses, with few exceptions, these products. The cooling rate commercial conditions. is sterile. Thus, the control point should proposed for these products is the same be where the potential hazard exists. as that for the carcass surface—50 °F Time-Temperature Requirements Second, the surface is the most prudent within 5 hours and 40 °F within 24 FSIS is proposing that establishments place to measure temperatures. Probing hours. cool the surface of meat carcasses to 50 the deep muscle tissue of carcasses The method used to measure the °F or below within 5 hours and to 40 °F before they are fully cooled could cause surface temperature of a carcass or a raw or below within 24 hours from the time a public health problem by injecting any meat product would be at the discretion that carcasses exit the slaughter floor. bacterial pathogens on the surface into of the establishment. Pressing the side This cooling rate is based on the best the sterile warm interior. of a temperature probe against the meat estimate of what is needed to minimize Hot-boned product, however, would surface is the easiest and most multiplication of pathogenic organisms be controlled by internal temperature. inexpensive method. Because air has and what is achievable in a well- Cutting into the carcass increases the low heat capacity relative to meat, this controlled meat establishment. probability of deep tissue contamination method should give a good estimation of Controlling the surface temperature also due to tears in the muscle facia, flexing, the meat surface temperature. Shielding ensures that the interior is cooling at a punctures, and additional handling. the probe from room air should increase reasonable rate. Therefore, the internal temperature is the measurement accuracy. For Carcasses and raw meat products the critical control point. And, since the shielding, one suggestion is to place two would be required to be maintained at integrity of the carcass has been carcasses together and measure the an internal temperature of 40 °F or violated, the internal temperature is the contacting surfaces. Shielding the probe below during handling, holding, and appropriate monitoring point. from room air with a food contact shipping. FSIS considered a higher The proposed cooling rates, holding material having low heat conductance temperature limit because at temperature, and corrective actions and capacitance, such as a dry sponge temperatures below 50 °F, spoilage specified in the proposed rule are based in a plastic bag, after proper sanitizing, bacteria generally multiply faster than primarily on the thermodynamics of would also be effective. pathogens. Thus, meat below 50 °F cooling meat and the effect of The time-temperature profiles being generally will spoil before excessive temperature on bacterial multiplication. proposed might be modified for certain pathogenic bacterial multiplication can Further information on how these were raw products if other factors such as occur. For example, spoilage bacteria, calculated is available in ‘‘The Scientific dryness or acidity are factored in. such as Pseudomonas spp., Pediococcus Basis for Proposed Time-Temperature Therefore, it is possible that an spp., and Lactobacillus spp., not only Requirements,’’ a paper on file in the establishment’s designated processing increase faster than pathogenic bacteria, FSIS Docket Clerk’s office and available authority could develop alternative time below 50 °F, but some also form upon request from Director, Processed and temperature procedures for cooling, inhibitory compounds. However, FSIS Products Inspection Division, FSIS, U.S. shipping, receiving, and, or holding rejected a higher temperature limit and Department of Agriculture, Washington, carcasses and raw meat products that is proposing 40 °F because: (1) The D.C. 20250. would produce microbial profiles lower temperature provides an This proposed rule would also require equivalent to or better than those additional margin of safety against the that carcasses and raw meat products produced under the proposed multiplication of pathogenic bacteria, reach a temperature of 40 °F or below requirements. The Agency is therefore Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6797 proposing to allow use of time and Effect on Commercial Meat This proposal would permit any of temperature limits equivalent to those Manufacturing these cooling procedures as long as the specified in the proposed requirements. Because raw poultry is already subject proposed cooling temperatures and time Any such alternate procedures would, to chilling regulations, it is expected periods are met. (b) Shipping and receiving. Slaughter however, be difficult to monitor for that this proposed regulation primarily establishments may ship meat food regulatory purposes. FSIS welcomes will affect meat establishments. products in several forms, such as comment on this point. Present commercial meat carcasses, cuts, manufacturing meat, or manufacturing and distribution Written Plan for Meeting Time and ground meat. In the past 20 years, the practices are diverse. Some Temperature Requirements geographic concentration of raw meat establishments slaughter animals, processing has made boxed meat the Establishments would be required to prepare raw meats, and process and primary form in which raw meat is develop, implement, and place on file a ship ready-to-eat products. Others may shipped. Boxed meat is often shipped in written plan for meeting the time and only slaughter and dress animals, 60-pound containers of boneless temperature requirements either debone meat, or prepare raw meats as manufacturing meat, cuts, primal cuts, prescribed in this proposed rule or in ingredients for ready-to-eat products. alternative procedures developed by a or subprimal cuts. This proposed rule would cover all However, establishments still ship processing authority. The plan would official establishments that slaughter, include the establishment’s designated carcasses and larger containers of receive, store, transport or otherwise manufacturing meat weighing 500 control points, i.e., the points within an handle carcasses and raw meat establishment’s operation where pounds or more. products. Processing establishments temperatures would be measured; The following is a brief discussion of manufacture raw meat products, ready- monitoring procedures; records to be present commercial meat manufacturing to-eat meat products, or both. Processing kept; standards for the control points, and distribution operations and how establishments that are not also including the cooling rate, holding this proposal would affect those slaughter establishments must receive temperature, and shipping temperature; operations. raw meat products from other corrective actions to be followed if (a) Slaughter establishments. establishments. This proposed rule deviations occur, including a system for Slaughter establishments receive live would affect such processing separating and identifying animals and produce raw meat. The establishments by requiring them to noncomplying product; and, when establishment’s task is to remove the ensure that raw product received is at applicable, the name of the processing animal’s hide and viscera in a manner the required internal temperature of 40 authority. The plan would be required that results in meat with as few bacteria °F or below, and to maintain the raw to be maintained at the establishment as possible. This task is called ‘‘sanitary meat product ingredient at that for as long as the plan is being used by dressing.’’ After dressing, temperature in conformance with the the establishment. The plan and establishments cool carcasses to retard proposed requirements. monitoring records must be made the multiplication of any pathogenic or This proposed rule would require that available to Program employees upon spoilage bacteria. establishments cool the carcasses and request. The primary means of cooling is to raw meat products to an internal Establishments would be required to move the carcass into a cold room temperature of 40 °F or below prior to monitor and record the maximum where the temperature and air shipping such products to help ensure temperature of a representative number movement reduce carcass temperature. that, if the products are shipped to other of carcasses and raw meat products Some establishments use various official establishments, the products periodically during the establishments’ procedures to enhance carcass cooling. arrive at the receiving establishments at operation, as set forth in their written The carcass spray chill method an internal temperature of 40 °F or plan for doing so. The frequency of increases the cooling rate through direct below. monitoring temperatures in a day’s heat absorption and enhanced The shipping establishment would be operation by establishments would vary, evaporative cooling. The sprayed water required to record the date and time of depending on the size and type of an directly absorbs some carcass heat on shipment on the waybill, running slip, establishment’s operations. contact then absorbs even more when it conductor’s card, shipper’s certificate, Establishments would include in this evaporates. Spray chilling is also or any other such papers accompanying written plan the control points and the advantageous to the manufacturer in a shipment. This is necessary to enable frequency of measuring the that it reduces the amount of weight lost the receiving establishment to temperatures in a day’s operation. from the carcass by evaporation. The determine the number of hours the Establishments would be required to use disadvantage is that the increased products have been in shipment. temperature measuring devices readable surface moisture facilitates Compliance with the requirement and accurate to 2 °F (0.9 °C). The multiplication of bacteria. ends when the raw meat product enters monitoring records would be A related practice is hot-boning, a ready-to-eat process at the maintained for up to 6 months after the which involves the removal of the meat establishment or is no longer in the temperature measurement, or until such before the carcass is fully cooled. The possession or under the control of the time that may otherwise be specified by advantage of hot-boning is that the meat establishment. Product in the the Administrator. Program employees is reduced to smaller, more easily possession of or under the control of the would verify the frequency of cooled pieces, and the meat is available establishment remains the responsibility temperature measurement to ensure that for processing sooner than if it were of the establishment. Establishments the establishment’s written plan is being removed only after the carcass is fully must undertake all reasonable followed. Inspection personnel would cooled. However, hot-boning poses a precautions to ensure that such product also measure temperatures at various hazard if exposed warm meat surfaces is maintained as required under the control points and compare these remain at warm temperatures long proposed rule, even when it is in a temperatures with those measured and enough to allow bacterial transport vehicle or otherwise not recorded by the establishment. multiplication. physically at the establishment. 6798 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Although this proposal directly affects raw. The discretionary authority to take —Cooked beef: Listeria monocytogenes, only FSIS-inspected establishments, immediate action in such cases to Salmonella FSIS encourages adherence to the protect public health is an essential part —Sliced ham: Listeria monocytogenes, proposed time/temperature of the Agency’s food safety mandate. Salmonella requirements by all who handle or store Processed products that purport to be —Cooked meat patties: E. coli O157:H7 raw meat and poultry products. At the fully cooked and/or ready-to-eat have —Dry and semi-dry fermented sausages: end of this preamble, the Agency been and will continue to be deemed Staphylococcal enterotoxin discusses plans to consider increasing adulterated if found to contain —Jerky: Listeria monocytogenes, oversight of the commercial handling of pathogenic bacteria or toxic metabolites. Salmonella meat and poultry at locations outside These are products that consumers are —Large diameter cooked sausages (e.g., inspected establishments, including likely to eat without further cooking. bologna, salami): Listeria during transportation, distribution and Consumers should be able to rely on monocytogenes, Salmonella storage to the retail level. FSIS will be processor’s claims, implicit or explicit, —Small diameter cooked sausages (e.g., considering measures to ensure proper that the product is fully cooked and/or hot dogs, kielbasa, bratwurst): Listeria handling and cooking of raw and ready-to-eat. Such product should in monocytogenes, Salmonella poultry products throughout the food fact be ready to eat; further cooking —Meat and poultry salads and spreads: safety continuum. should not be required to protect the Listeria monocytogenes, Salmonella consumer from pathogens. —Cooked poultry products: Listeria B. Microbial Testing; Interim Pathogen FSIS currently operates programs to monocytogenes, Salmonella Reduction Targets test various products for specified Most recently, FSIS determined that As discussed earlier, the centerpiece pathogens. Before establishing microbial raw ground beef found to contain of the FSIS food safety strategy is to testing programs, and if there is Escherichia coli O157:H7 is considered articulate what constitutes an acceptable evidence of a potential public health adulterated. This determination was level of food safety performance by a risk from a pathogen being in or on a made based on several factors. First, meat or poultry establishment and hold particular processed, ready-to-eat only small numbers of the O157:H7 the establishment accountable for product, FSIS performs a risk evaluation strain of E. coli are required to cause achieving that level of performance. In that focuses primarily on the serious illness or death, especially the case of pathogenic microorganisms pathogenicity of the organism and the among children and the elderly. Second, on raw product, this means establishing seriousness of the resulting disease. traditional and accepted cooking targets, guidelines, or standards and If it is determined that there is a practices for raw ground beef (e.g., a requiring establishments to conduct public health threat due to the risk of medium rare or slightly pink regular microbial testing to verify serious illness from consumption of a hamburger) do not kill E. coli O157:H7. current processes and practices are contaminated product, the Agency Third, the illness caused by the bacteria achieving those targets, guidelines, or undertakes three related actions. First, can be transmitted to others (especially standards, or whether further measures product tested and found positive for among highly susceptible small are required. the prohibited organism or toxin is children). FSIS is conducting limited FSIS is proposing interim targets for retained and any implicated product in sampling and testing of raw ground beef pathogen reduction and microbial commerce is recalled voluntarily by the in establishments and in the testing in slaughter establishments. This producing establishment. Second, the marketplace for the presence of E. coli is an initial step toward measurable Agency undertakes a testing program to O157:H7. reductions in the incidence of detect other products similarly The key characteristic of current FSIS contamination of meat and poultry contaminated and acquires data to microbial testing programs is that products with pathogenic decide if further actions are required. sampling and testing is conducted by microorganisms. It also is a first step FSIS works with the manufacturer and FSIS to detect violations and dangerous toward the eventual incorporation of distributors to return all implicated product contamination and to stimulate microbial testing as an integral part of products to the inspected establishment. preventive measures by industry. process control and verification in Appropriate public notices are given. Current programs do not involve facilities operating under the HACCP Recalled product is destroyed or, if microbial testing by establishments as approach proposed later in this appropriate, reprocessed to destroy the part of an effort to verify process control document. contaminant, under FSIS oversight. and evaluate the adequacy of an Before describing the proposal for Third, FSIS works with the establishment’s efforts to control and interim targets and microbial testing, a establishment to determine the cause(s) reduce pathogens. FSIS believes its brief description of the Agency’s current of the contamination and to ensure that current testing programs serve a useful use of microbial testing is provided. appropriate processing or other changes purpose but are not adequate by are made by the establishment to themselves to protect consumers. 1. Current Testing Program prevent a recurrence. Microbial testing by companies to verify FSIS’s current regulatory use of FSIS has made numerous process control and demonstrate microbial testing is generally directed at determinations in the past that progress toward pathogen reduction is detecting product that is contaminated particular pathogens will, if found on a an integral part of FSIS’s food safety with bacteria of particular public health particular processed, fully cooked and/ strategy. concern. or ready-to-eat product, cause that FSIS has made and will continue to product to be considered adulterated 2. Proposed Targets and Testing make, on a case-by-case basis, under the law, and has instituted testing One approach to regulating determinations that a meat or poultry programs accordingly. The following pathogenic microorganisms in meat and product presents an unacceptable public ready-to-eat products are tested for the poultry slaughter operations would be health risk, and is adulterated, due to presence of the microorganisms or their to determine, based on risk assessments, the presence of specific pathogenic toxins, which, if found, will cause the the levels of specific pathogens on raw microorganisms in or on the product. product to be deemed adulterated, as meat and poultry products that do not Affected product may be processed or indicated: pose a significant risk of illness and Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6799 prohibit distribution of products resolution will require a concerted, (3) adoption of, as an interim target exceeding such levels. The acceptable long-term effort. Some of the issues and for pathogen reduction, the requirement level of pathogens would be effectively FSIS’s plans for public meetings to that within two years, or some other zero (<1 per 25 grams) in at least some begin addressing them are described period specified by FSIS through this cases. The establishment of such below in Part III. rulemaking, each establishment achieve standards is the approach generally For the present, FSIS has decided to an incidence of contamination below taken for the regulation of chemical pursue an alternative strategy for the current mean national baseline; additives in food. It provides a very pathogen reduction that is based on the (4) a requirement that each direct means of controlling and avoiding same principle of articulating an establishment conduct daily testing for substances in food that present a public acceptable level of food safety Salmonella to determine whether the health concern. performance and holding establishment’s process controls are, FSIS has not taken this approach in establishments accountable for meeting over a specified period of time, the past with respect to pathogenic it, but that also takes account of what is achieving the interim target; and microorganisms on raw meat and achievable today. Specifically, FSIS is (5) prompt development and poultry. FSIS has been constrained by proposing interim targets for reducing implementation of remedial plans by the lack of a scientific basis for the incidence of contamination of meat establishments not meeting the target determining the levels at which specific and poultry carcasses and ground meat within a specified period. pathogens do or do not present a safety and poultry products with Salmonella, The Agency invites public comment hazard, particularly in regard to the coupled with requirements for all on its proposal to establish interim potential for pathogens to increase or affected establishments to conduct targets for pathogen reduction and decrease during distribution, marketing microbial testing to determine whether require microbial testing. The proposal’s and consumption. FSIS also has relied their targets are being achieved. FSIS major elements are outlined below in part on the fact that proper cooking believes that significant progress can be following a brief discussion of the kills pathogens present on raw product. made in pathogen reduction by taking public health rationale for targeting The closest FSIS has come to this advantage of current technologies and reduction in incidence of a specific approach is its recent decision to treat industry capabilities, even as the pathogen as a step toward reducing the raw ground beef contaminated with any Agency’s HACCP program develops and risk of foodborne illness associated with amount of E. coli O157:H7 as the scientific basis for setting more meat and poultry products. adulterated within the meaning of the definitive targets, guidelines or 3. Public Health Benefit of Interim FMIA, but this was based on the fact standards evolves. Pathogen Reduction that traditional and accepted cooking The proposed Salmonella testing As noted in earlier portions of this methods for raw ground beef (such as in program is an important element of document, Salmonella, Campylobacter, a ‘‘medium rare’’ hamburger) do not kill FSIS’s food safety strategy because it E. coli O157:H7, Listeria this dangerous pathogen. will: FSIS believes that determining the (1) reduce the prevalence of monocytogenes, Staphylococcus aureus, levels of specific pathogens that pose a pathogens of public health concern; and Clostridium perfringens constitute public health risk and using those levels (2) induce process changes by some the major bacterial pathogens associated for regulatory purposes is a desirable establishments that are needed to with foodborne illness. Healthy People goal because it provides a very direct achieve both the target for Salmonella 2000 outlines goals for reducing the means of defining an acceptable level of and a reduction in the frequency and incidence of each of these pathogens. food safety performance by a meat or level of contamination of raw meat and Salmonella, Campylobacter, E. coli poultry establishment and for holding poultry with other pathogens; O157:H7, and Clostridium perfringens the establishment accountable for (3) establish the principle that the appear to be introduced into meat and achieving it. As a general matter, FSIS’s inspection program and poultry primarily at the time of however, this approach currently is not establishment process control programs slaughter. Public health concerns arise available to FSIS to deal with the broad must begin directly targeting and from this initial contamination, in array of pathogens in raw meat and reducing pathogenic microorganisms of combination with other variables poultry. There are large gaps in the public health concern; including subsequent handling by scientific knowledge required to (4) begin building the foundation for industry and the consumer, determine levels of specific pathogens HACCP, which will rely on microbial opportunities for cross-contamination, that do and do not pose a hazard. For targets, guidelines, and standards to cooking practices, and the like. These example, with certain infectious help define the process controls that variables have been described in detail pathogens where the primary mode of will be needed to achieve the desired in the 1987 National Academy of transmission involves cross- level of food safety performance; and Sciences report, Poultry Inspection: The contamination, it is currently not (5) begin building a database on the Basis for a Risk Assessment Approach. possible to correlate pathogen levels prevalence of Salmonella While FSIS cannot quantify the with risk of disease (e.g., Campylobacter contamination, which will be used for reduction in disease incidence which jejuni in raw poultry). national trend analysis and as an will occur with specific interim FSIS intends to continue to work with essential tool for setting future pathogen reductions in bacterial contamination of the scientific and public health reduction goals. raw product, simply reducing the communities and the meat and poultry The Agency’s interim target and percentage of product containing a industry toward determining what microbial testing proposal includes the pathogen should result in a reduction in levels of specific pathogens on specific following major elements: disease incidence, although products pose public health concerns (1) selection of Salmonella as the mishandling may still occur. requiring regulatory action and to target pathogen; Each pathogen has a somewhat reduce pathogens below those levels to (2) identification of a national different epidemiology, and responds to the maximum extent possible. However, baseline occurrence of Salmonella different interventions in different ways; the scientific and public health policy contamination for each major species for example, some interventions may be issues involved are complex and their and for ground meat and poultry; very effective for Salmonella, but have 6800 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules a minimal effect on E. coli O157:H7. For use of Salmonella at this stage as a estimates based on the best data these reasons, it will be important for target organism. Salmonella was currently available to the Agency. FSIS the long term that testing be pathogen- selected for this purpose because: (1) recognizes that the data available for specific: i.e., establishments should look intervention strategies aimed at some species are limited. The Agency for what is known to be important in a reducing Salmonella can be expected to believes, however, that this rulemaking particular product line, and target have comparable effects against most will generate additional data that will interventions and monitoring to that other human enteric foodborne help refine the baselines tentatively particular pathogenic microorganism. pathogens, (2) current methodologies identified here. As a part of implementing HACCP, are available to recover Salmonella from The following is a summary of how processors will need to determine what a variety of products, (3) FSIS baseline the baselines were determined for each pathogens are a major risk for their data suggest that Salmonella colonizes a of the raw products of concern. product, and design interventions and variety of animals and birds often The baseline established for monitoring accordingly. enough for changes to be detected and Salmonella frequency of occurrence on Even under HACCP, it will not be monitored, and (4) Salmonella is the steer and heifer carcasses is based on practical or necessary to test all most common cause of foodborne the FSIS Nationwide Microbiological products for all pathogens. Nonetheless, illness. Baseline Data Collection study there are certain pathogens, such as conducted from 1992 to 1993. In this Salmonella, which are present on 5. The Identification of National program, 2,089 samples were analyzed virtually all raw food products. Baseline Levels as Reference Points for for Salmonella, as well as other Salmonella is the leading cause of Pathogen Reduction microorganisms, and 1 percent of the bacterial foodborne illness in this FSIS proposes that all establishments samples were found to contain country, and causes the greatest that conduct slaughter operations or Salmonella. economic burden. As such, it is likely produce raw ground meat or poultry Raw ground beef from federally- that virtually any HACCP based testing products produce such products such inspected establishments was tested by program for pathogens on raw product that the frequency of occurrence of FSIS. Out of 563 samples taken in this would identify Salmonella during the Salmonella is at or below the current baseline study, 4 percent were positive hazard analysis as an organism of national baseline average. These for Salmonella. primary concern. Based on these proposed baseline levels tentatively FSIS has also conducted several, more considerations, FSIS is proposing identified by FSIS are provided in the limited studies which help provide an reduction in the incidence of product chart below, showing the frequency of estimate of the frequency of occurrence contamination with Salmonella as an occurrence in terms of the percent of of Salmonella in regulated commodities, interim target for pathogen reduction. tests expected to be positive for such as broilers, where baseline studies FSIS recognizes that reductions in Salmonella: are underway or planned. The data for incidence of Salmonella contamination Salmonella on broilers is from a FSIS does not guarantee equal reduction in Frequency nationwide study conducted from 1990 of occur- to 1992. This survey found Salmonella other pathogens. Nonetheless, insofar as Commodity rence of interventions designed to decrease the Salmonella in 25 percent of the 1,874 birds incidence of contamination with (% +) sampled. Salmonella reduce overall levels of fecal A 1979 FSIS study of retail-size, fresh and ingesta contamination, which is the Steers/Heifers ...... 1 pork sausages showed Salmonella in 12 largest single avenue for contamination Broilers ...... 25 percent of the 603 samples tested. The Raw Ground Beef ...... 4 12 percent frequency of occurrence for of meat and poultry by pathogenic Fresh Pork Sausages ...... 12 microorganisms, those interventions Cows/Bulls ...... 1 Salmonella as a baseline in fresh should have a beneficial effect on other Hogs ...... 18 sausages was derived from this study. human pathogens of animal intestinal Turkeys ...... 15 The 1 percent frequency of occurrence origin. The Agency recognizes that there Ground Poultry ...... of Salmonella on cow and bull carcasses are other foodborne human pathogens of is an estimate based on the completed public health concern that can be To the extent possible, FSIS has used baseline study on steers and heifers. The isolated from raw meat and poultry data from its Nationwide baseline study for cows and bulls is in product. The Agency would welcome Microbiological Baseline Data progress. comments on the targeting of other Collection Program as the basis for the As noted above, FSIS has not pathogens in addition to or in lieu of proposed baselines assigned to these completed nationwide surveys for hogs, Salmonella. raw commodities. This program turkeys, or ground poultry, but such The following sections discuss the provides data on the prevalence of studies are in progress or scheduled for major elements of the proposed interim major pathogens and indicator 1995. There have been no studies targets for pathogen reduction and microorganisms associated with meat conducted for Salmonella in ground requirements for microbial testing. and poultry. The data generated from poultry, so revelant data was not these programs provide a available to establish a baseline. Few 4. Use of Salmonella as a Target comprehensive microbiological profile studies have been conducted for Pathogen of the raw commodities studied. The Salmonella on hog carcasses. An FSIS proposes to require that each baseline studies on steers and heifers industry group’s recent review of the establishment that conducts slaughter and ground beef are completed. Studies literature reported several studies of operations or produces raw, ground on cows and bulls, market hogs, and Salmonella on pork carcasses conducted meat or poultry products sample and ground turkey and broilers are in between 1961 and 1973. The studies test representative product daily for the progress, while studies are planned for reported wide ranges in the incidence of presence of Salmonella. ground chicken and turkeys. Salmonella, from 49 percent to 56 Due to logistical problems involved The pathogen reduction baselines for percent, due in large part to the variety with attempting to test for all possible those commodities where FSIS baseline of sampling procedures used. FSIS pathogens, the Agency is proposing the studies have not been completed are believes that in the absence of more Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6801 recent and comprehensive U.S. data on better define the current baseline levels establishments have incidences of hogs, the best available data is that in various products prior to making contamination above the national provided by a Canadian National final decisions on these issues. FSIS baseline, while others are achieving Survey, which FSIS believes to be strongly encourages the industry and all rates of contamination below the adequate to establish a baseline for those who possess relevant data to national baseline. FSIS believes that it is Salmonella applicable to hogs in the submit those data to the Agency in reasonable and feasible to require, as an U.S. In the Canadian survey, response to this proposal and to assist interim pathogen reduction measure, salmonellae were isolated from 17.5 the Agency in adopting appropriate that all establishments control their percent of the pork carcasses sampled. baselines as the reference points for processes so that their Salmonella The Canadian study also reported a pathogen reduction. incidence is no greater than the current Salmonella frequency of 69.1 percent of FSIS is also considering and invites national average. the turkey carcasses sampled. However, comment on alternative approaches to FSIS is also considering a requirement several U.S. surveys had conflicting identifying baselines against which that, for one or more species, the target results. A study conducted in 1979 pathogen reduction would be measured. for pathogen reduction be some showed 6.3 percent of the 79 turkey One alternative would be to require the percentage reduction in Salmonella carcasses sampled were positive for use of pathogens other than Salmonella below the national baseline, such as a Salmonella. Another U.S. survey as the target organism for certain 25 or 50 percent reduction. This option compared Salmonella prevalence in products. For example, it could be is suggested by statements made by three different establishments. The argued that Campylobacter jejuni/coli members of industry that many turkey carcasses positive for Salmonella occurs at a greater frequency in poultry establishments already are achieving a were 13 out of 40 samples (32.5 than Salmonella and as such would be prevalence of contamination well below percent), 6 out of 39 samples (15.4 a more pertinent target pathogen. FSIS’s estimated national baseline percent), and 8 out of 40 samples (12.5 Likewise, according to the available incidence of Salmonella contamination percent). Finally, an industry survey FSIS baseline survey data, beef using currently available methods and conducted from 1987–1988 showed a 15 carcasses have a relatively low technologies. In the case of poultry, for percent frequency of Salmonella on incidence of Salmonella contamination, example, some companies are turkey carcasses from the 25 plants that suggesting the possibility that other reportedly achieving a frequency of were sampled. The Agency believes pathogenic microorganisms, such as occurrence of Salmonella contamination these U.S. industry surveys to be the Campylobacter jejuni/coli, might be as low as 5 percent or less, well below most representative of current preferable target organisms for pathogen the tentatively identified baseline for conditions and is tentatively proposing reduction. FSIS would be prepared to broilers and turkeys. The principle to use the figure obtained from the U.S. adopt such alternatives if the comments underlying FSIS’s effort to establish industry surveys as the proposed received on this proposal demonstrate appropriate interim targets for pathogen baseline for Salmonella on turkey that alternative organisms would reduction is that establishments should carcasses. provide a more effective basis for be moving to adopt process controls and The Agency has no data upon which achieving measurable pathogen production practices that the industry to establish baselines for the other reduction in the near term. itself has demonstrated in actual species of food animals subject to Another alternative, discussed further practice are available and effective for mandatory inspection. As such, it is not below, would be to use the current reducing the incidence of contamination proposing pathogen reduction target performance of a specific establishment with pathogenic microorganisms. If levels for minor livestock species— as that establishment’s baseline for reductions 25 or 50 percent below the sheep, lambs, goats, equines—or for pathogen reduction in lieu of a national national baseline are reasonably minor poultry species—ducks, geese, baseline. and guineas—at this time. The minor FSIS also is interested in receiving achievable in the near term for a livestock species together comprise 4–5 data showing any correlation between particular species, all companies should percent of all livestock slaughtered, and factors other than the species of work to achieve them. At the final rule the minor poultry species comprise only slaughtered animals and the incidence stage, FSIS will adopt specific a fraction of 1 percent of domestic birds of pathogenic bacteria. For example, percentage reductions below the slaughtered. Assuming that the public there are suggestions that old animals national baseline to the extent they are risk of foodborne illness from these (e.g., spent hens and culled cows) are supported by the administrative record animals is comparably small, FSIS has more likely than younger animals of the developed in response to this proposal. decided to focus this rulemaking on the same species to harbor pathogenic FSIS also invites comment on the major food species, and defer bacteria and should be addressed appropriateness of the proposed two rulemaking on these minor species. separately. year time period for reaching the Comment is welcomed on whether FSIS interim target following adoption of the should include these species in its 6. The Interim Targets final rule. Two years allows ample time testing program and, if so, on what basis FSIS is proposing that each for establishments to determine their it should do so. establishment, at a minimum, achieve current performance through the FSIS recognizes that the data process control that will bring their microbial testing FSIS is proposing and currently available to the Agency for incidence of Salmonella contamination implement process controls and determining the current baseline and below the current national baseline interventions that are already available. the appropriate interim target for incidence of Salmonella found on that FSIS may determine on the basis of reduction in Salmonella incidence are product within two years of the effective comments that different time periods, limited. FSIS is also aware that many date of this proposed rule. shorter or longer, may be appropriate for meat and poultry companies have been The baseline levels were chosen as a one or more species, depending on what conducting microbial testing, in some basis for initial targets in part because is feasible for that species and on the cases for many years. The Agency they are by definition averages that degree of pathogen reduction FSIS believes that the industry possesses a reflect a distribution of levels among a adopts as the target. FSIS invites significant body of data that would help broad range of establishments. Some comments on these issues. 6802 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 7. Requirement for Daily Testing is to verify the performance of an Official Analytical Chemists or other Each establishment would be establishment’s system of process recognized scientific body). The method expected to collect a minimum of one controls. As explained below, chosen must be verified by in-house specimen for testing each day from each establishments not meeting the target data within the testing laboratory. An establishment would be allowed slaughter class and/or class of raw within the specified time will be to test the specimens in its own ground product, beginning 90 days required to take remedial measures laboratory or in a commercial/contract following publication of the final rule. under FSIS inspection. laboratory. However, the laboratory that Once-a-day sampling is based on the As proposed, each establishment is selected must demonstrate experience natural daily cycle in production would develop a written protocol, in testing meat and poultry for processes, starting with daily cleanup. available for review by Program Salmonella spp. Either an internal or Contamination builds up as operations employees, outlining specimen collection and handling. It would, at a external laboratory quality assurance/ progress throughout the day. The quality control (QA/QC) program with required sanitation/cleanup returns the minimum, include: • Designation of a responsible check sample analysis would be level of contamination to essentially individual; required. QA/QC records must be zero, thus starting a new cycle. As • The number of specimens to be available to FSIS personnel, with FSIS explained in the next section, FSIS collected from each slaughter class and/ reserving the right to send official considers one sample a day to be or species of ground meat and/or samples to the laboratory to verify statistically adequate to verify process poultry; laboratory capabilities. control. • Description of random sampling The laboratory would record the As alternatives to the one sample per procedure (i.e., how to determine which results and provide the results daily to day being proposed in this document, carcasses are to be sampled to ensure the establishment, which would enter FSIS considered requiring a sampling that specimens are representative of that the results in a chart or table daily to plan based on establishment production day’s production); determine whether the process in volume, or by lot, which would have • Who will conduct the analysis (e.g., question is meeting pathogen reduction meant, for most plants, many more than in-house laboratory, commercial target levels. one sample per species per day. It also laboratory, etc.; and The establishment would provide all considered a sampling plan based on • Moving sum verification procedure the test results at least weekly to less than one sample per species per (chart or table). Program employees for entry into the day, particularly for small plants. FSIS The designated representative of the FSIS’s database. Electronic transmission invites comment on its sampling plan, establishment would collect the of test results would be allowed. including the frequency of sampling. specimen at the end of the production 8. Determining Compliance With Target FSIS recognizes that some process. For meat this would be prior to Levels establishments are currently conducting the carcass leaving the cooler; for broader microbial testing than FSIS is poultry this would be immediately post- In accordance with the FSIS food proposing, and broader microbial testing chiller; for raw ground meat and safety strategy of articulating what will play an important role in an poultry, this would be prior to constitutes an acceptable level of food establishment’s implementation of packaging. Samples would be taken as safety performance by a meat or poultry HACCP. More than once-a-day testing follows: establishment and holding the would have the advantage of providing Poultry: whole bird rinse with the establishment accountable to that more rapid analytical verification of carcass selected after the chiller, at the performance, a moving sum statistical process control. However, the Agency is end of the drip line. procedure is being proposed to evaluate proposing to require only one sample Beef: excised brisket skin tissue, 4 whether establishments are achieving per species per day to achieve the dual inches (10.2 cm)×4 inches (10.2 cm)×1⁄2 the interim targets for pathogen purposes of using a statistically valid inch (1.3 cm) in depth, collected in the reduction. The moving sum procedure method and reducing the cost of testing. cooler, after chilling. is a tool for evaluating whether the The Agency believes that maintaining a Hogs: excised belly skin tissue, 3 process control system is functioning requirement for species-based testing is inches (7.6 cm)×5 inches (12.7 cm)×1⁄2 and is designed to assess the needed to provide analytical verification inch (1.3 cm) in depth, collected in the effectiveness of a system in relation to of process control. cooler, after chilling. a specified target level of performance. As a general matter, single qualitative Raw ground meat and poultry It focuses on a specific number of days tests (positive or negative) provide products: 1⁄2-pound (0.4 kg) sample, (window) within a production process adequate but minimum acceptable collected prior to packaging. and evaluates that process to determine information regarding the level of The analytical sample size and the whether its performance meets or fails process control. These singular results method used would give a result to meet that target level over that period need to be accumulated over time for equivalent to the result that would be of time. process verification. Daily testing (one obtained using the FSIS Procedure for Using this moving sum procedure, test per day) was considered to be the Isolation and Identification of establishments will track the results of minimum sampling required to deliver Salmonella from Food. (Requests for end-product testing to evaluate the acceptable sensitivity for detection of this document should be sent to the effectiveness of their production process deviations within a realistic Director, Microbiological Division, FSIS, systems for controlling pathogens in timeframe. U.S. Department of Agriculture, relation to the interim target FSIS will FSIS is not proposing at this time to Washington, DC 20250.) Samples would be establishing for each specific use these testing results for making be drawn randomly, from all product commodity. This method of evaluation decisions on the disposition of specific produced. Samples would be taken for was chosen because it provides an lots of product. The amount of testing regulatory purposes and, therefore, effective means of utilizing the FSIS is proposing is not adequate to would be required to meet all of the microbiological assessment of end assure a specific lot is free of attributes of an official method products to verify process control, based Salmonella. The purpose of the testing (approved for use by Association of on a single sample per slaughter class Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6803 and/or class of raw, ground product per database. Alternatively, the which results are summed (n) and a day. establishment could transmit the data maximum number of positives that are FSIS believes the specific approach it directly to the headquarters database allowable within that time frame (AL). is proposing for use of the moving sum electronically, under the supervision of These two parameters are based on the procedure will provide an effective a Program employee. In addition to target frequency of occurrence of means of ensuring that establishments being used to verify establishment Salmonella in that particular meet the interim targets for pathogen participation in the program, this commodity and the statistical decision reduction. Any establishment with information will be used, in addition to criteria built into the procedure. positive Salmonella results at a baseline data, for national trend An advantage of a moving sum is once frequency exceeding that allowed for analysis. the criteria are set, all that is required the product will be readily identified as The establishment would be is a count of the positive results over the failing to meet the targets so that responsible for entering the results into most recent window of results. remedial measures can be implemented. a moving sum verification table or chart For example, a chart where the As proposed, the microbiological (see sample of moving sum table below). number of days to be summed is 8 testing laboratory will supply the test The moving sum is a procedure where (n=8), and the maximum permitted results on a daily basis to the results are summed over a number of positives during that time establishment. Results would be passed predetermined period of time. The frame is 3 (AL=3), showing whether the at least weekly to a Program employee moving sum consists of two basic Acceptable Limit is met or exceeded, for transmission to the headquarters elements, a specified length of time over might look like the following: Test Moving Days in- Day No. result sum Comparison to AL cluded 1 ...... 0 0 Meets ...... 1. 2 ...... 0 0 Meets ...... 1, 2. 3 ...... 0 0 Meets ...... 1 to 3. 4 ...... 1 1 Meets ...... 1 to 4. 5 ...... 0 1 Meets ...... 1 to 5. 6 ...... 0 1 Meets ...... 1 to 6. 7 ...... 1 2 Meets ...... 1 to 7. 8 ...... 0 2 Meets ...... 1 to 8. 9 ...... 0 2 Meets ...... 2 to 9. 10 ...... 0 2 Meets ...... 3 to 10. 11 ...... 0 2 Meets ...... 4 to 11. 12 ...... 0 1 Meets ...... 5 to 12. 13 ...... 0 1 Meets ...... 6 to 13. 14 ...... 0 1 Meets ...... 7 to 14. 15 ...... 0 0 Meets ...... 8 to 15. The daily result is recorded as a 1 for (two). It meets the Acceptable Limit, sum gives equal weight to all days in the a Salmonella positive test and a 0 for a AL=3. window, from the most remote to most negative Salmonella test (e.g., the test Several features of moving sum current. for day 4 was positive). The value of the procedures can be noted in the example: FSIS is proposing to specify the moving sum for day 10, for example, is (1) There is a startup period (days 1 to moving sum rules for each product the sum of the daily results for days 3 7) in which there are fewer than n=8 class. The chart below specifies the through 10. This value is merely the results in the sum; (2) a positive affects initial time window values (n) and number of positives in this window the moving sum value for n=8 Acceptable Limit (AL) for each product consecutive days; and (3) the moving class: Moving sum rules Target Commodity (percent Window Accept- positive size (n) able for sal- in days limit monella) (AL) Steers/Heifers ...... 1 82 1 Cows/Bulls ...... 1 82 1 Raw Ground Beef ...... 4 38 2 Fresh Pork Sausages ...... 12 19 3 Turkeys ...... 15 15 3 Hogs ...... 18 17 4 Broilers ...... 25 16 5 These moving sum rules are based on selected from the end of the production positive samples during the window two assumptions: That the production process. They also reflect an effort by period (and thus trigger remedial action) process is running in-control at the FSIS to ensure that an establishment while providing a high likelihood that target level specified for the commodity; operating consistently within the target establishments regularly failing to meet and that specimens are randomly will not exceed the Acceptable Limit for the target will be detected. 6804 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules It is important to recognize that this probability of not exceeding the moving step toward holding establishments approach to verifying process control in sum limit at the target satisfy accountable for meeting acceptable meat and poultry production is consideration (3), but do not satisfy levels of food safety performance, designed to assess the effectiveness of a consideration (4). Establishment because, due to the variability in system over time in relation to a personnel would be very limited in their pathogen levels, establishments specified target level of performance. It ability to detect production processes consistently operating at or just below is not a means of evaluating and not meeting the target. the target are likely to exceed the target approving individual product lots. The There are two ways to improve the from time to time. assumptions of an in-control process ability of the verification procedure to The selection of 80 percent as the and randomly selected specimens allow detect when the production process is criterion for establishing the proposed the performance assessment to be not meeting the target. One is to moving sum rules is intended to provide separated from production volume increase the number of specimens establishments with an incentive to considerations. required to be tested each day, and the design their process controls in a A number of alternative statistical other is to lower the probability of manner that will achieve pathogen criteria were considered as the basis for passing at the target. In view of the reduction significantly below the the proposed moving sum procedures, increase in costs to producers that a designated interim target. As in any ranging from an 80 to a 99 percent higher sampling rate would entail and random sampling scheme, there is a probability of meeting the limit if the the fact that failing the test does not chance of actually having positive process is operating at the target level. condemn product (considerations (1) results, even if the process is meeting The following table shows these and (2)), FSIS selected the procedures the criteria. However, an establishment alternatives with their corresponding based on an 80 percent probability of can decrease its probability of exceeding window sizes and Acceptable Limits for passing at the commodity target. The 80 the AL (by chance alone) by targeting its Salmonella positives. For reasons percent probability was selected process to produce product with a lower discussed below, the 80 percent because it enhanced the chance of frequency of positive samples. For probability was selected. detecting marginal performers and instance, the establishment could gear provides establishments with an its process controls toward a 20 percent Probability of Window Accept- incentive to gear their process controls target as opposed to the 25 percent passing at Target size (in able to achieve frequencies of Salmonella target specified for broilers. This would target days) limit contamination well below the proposed benefit the establishment by providing a 80 ...... 1 82 1 interim targets. FSIS retains the greater assurance of not exceeding the 4 38 2 discretion to not require remedial AL, since its own target is lower than 12 19 3 measures by establishments that the designated one. 15 15 3 demonstrate they were meeting the A document giving a more detailed 18 17 4 interim targets but exceeded the explanation of the moving sum 25 16 5 Acceptable Limits by chance. verification procedure will be made 90 ...... 1 53 1 To further evaluate the moving sum available by FSIS to those wishing more 4 28 2 verification procedures, the Agency information on this aspect of the 12 15 3 simulated their performance at percent proposal. Requests should be sent to 15 12 3 18 14 4 positive levels greater than the interim Assistant Deputy Administrator for 25 15 5 target. As an example, the Agency Science, FSIS, U.S. Department of 95 ...... 1 36 1 looked at the distribution of the number Agriculture, Washington, DC 20250. 4 21 2 of days from startup to the first FSIS welcomes comments on alternative 12 12 3 exceedance of the AL for broilers (target ways by which the Agency and 15 10 3 of 25 percent) assuming a process establishments may ascertain how well 18 12 4 percent positive rate of 30 percent. The process controls are achieving national 25 11 5 first exceedance occurred within 22 target levels. 99 ...... 1 15 1 days in 50 percent of the trials, and it 4 12 2 9. Establishment Action Required for occurred within 70 days in 95 percent 12 8 3 Exceeding Target Limits 15 7 3 of the trials. In other words, a process 18 8 4 running at 30 percent positive rate (5 The establishment will have 90 days 25 9 5 percent above the target of 25 percent) from the effective date of the rule to is very likely to be detected within no establish microbiological testing The alternative procedures differ in more than 70 days. regimes. Six months from promulgation the probability they give for not Under the proposed moving sum of the regulations establishments will be exceeding the moving sum limit when rules, an establishment operating just at required to track these interim target a production process is operating at the the target would have approximately an results using a moving sum verification commodity target. These probabilities 80 percent long-run probability of procedure and report the results to FSIS. range from 80 to 99 percent. satisfying (not exceeding) the moving Two years after promulgation of the There are at least four considerations sum limit. Over the long term, the rules, establishments that are not involved in selecting a verification moving sum value will not exceed the achieving the interim targets for procedure: (1) Sampling and testing AL about 80 percent of the days, pathogen reduction will be required to costs; (2) the nature of the penalties for assuming that the production process take corrective action under FSIS failing the verification procedure; (3) stays on target. The proposed rules also supervision. In such instances, a review having a low probability of exceeding mean that an establishment operating by the establishment of its production verification limits when the producer is just at the target has a 20 percent chance practices and process controls is meeting the target; and (4) having a high of exceeding the Acceptable Limit and required. A written report of the probability of exceeding limits when the triggering remedial action. This is evaluation, including any identified producer is not meeting the target. The consistent with the Agency’s objective process failures and proposed corrective procedures based on a 99 percent in establishing interim targets as a first actions, would be submitted to the Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6805 Inspector in Charge within 14 days from reduction outlined above is that more difficult to administer because it the day the process exceeded the limits. production of raw meat and poultry would require the creation of This report would have to be updated with an incidence of Salmonella at or approximately 2,500 establishment- on a weekly basis until the process is below the national incidence level is specific baselines, and it would not be back within the Acceptable Limit. readily achievable with available based on the principle that there should During the time the results exceed the technology and production methods and be a nationally recognized measure of moving sum limit, sampling should be that all establishments should be food safety performance, regardless of conducted at a higher rate of at least two required in the relative near term to the establishment in which a product is specimens per day. This will provide perform at this level. This would produced. The establishment-specific more accurate and timely data for establish a national standard for food approach would also fail to recognize effective decisionmaking. This safety performance on which future that some establishments are already increased sampling has the advantage pathogen reduction efforts could be operating in accordance with the that, assuming that the problem causing built. One potential disadvantage of this current state of the art and may have the initial deviation from the target limit approach is that it does not take account difficulty achieving significant has been identified and corrected, the of the likelihood that current incidence additional reduction in the near term. extra samples per day will shorten the levels of Salmonella contamination vary The latter concern might be addressed time frame (window) during which the widely. In the case of broilers, for by hybrids of the two basic alternatives establishment would be considered example, FSIS believes that some outlined above. For example, operating above targets. The sampling establishments are already performing establishments currently above the rate would return to normal when the well below the 25 percent baseline national baseline could be required to moving sum value meets the AL. incidence found in the FSIS survey—at reduce the incidence of contamination Additional testing may be conducted by a 5 percent incidence level or lower— to some level at or below the national FSIS, at the Agency’s discretion, as while many establishments are baseline, while the better performing necessary to assist firms in meeting performing well above that level. Some establishments could be required to pathogen reduction targets. of the poorer performing establishments maintain their current level of may not be able to achieve reductions to performance, perhaps within some 10. Relationship to HACCP the targeted prevalence of appropriate range. Once an operation has a history of contamination in the near-term. The FSIS invites public comment on these consistent control and is operating better performing companies—ones and other possible alternatives to its within the established limits, already performing well below the proposed approach. At the final rule improvements in technology and national baseline—may feel economic stage FSIS intends to adopt an approach increased understanding of process pressure to relax their pathogen to setting interim targets for pathogen control can be used to further enhance reduction efforts to compete under a reduction that takes into account its pathogen reduction efforts. The standard that is less strict than they are proposal, the alternatives outlined here, continuous review of the production already achieving. and the comments received during the process with corresponding An alternative approach would be to course of this rulemaking. improvements should set the stage for establish the initial baseline for C. Hazard Analysis and Critical Control implementation of state-of the-art pathogen reduction on an Point (HACCP) Systems process controls, namely HACCP. establishment-specific basis and to FSIS is aware of and continues to require significant interim reductions in 1. Background encourage establishments to implement each establishment from its baseline. Overview of Rationale for Adopting effective HACCP programs as soon as Such baselines would be established on HACCP possible. Establishments that can the basis of either reliable existing data demonstrate that their HACCP process from that establishment or on a brief After having introduced key HACCP controls produce only products that required period of sampling and testing concepts and controls into federally meet or exceed the proposed targets for in each establishment for the target inspected establishments through the pathogen reduction, and have an pathogen. proposed near-term interventions and alternate verification program may, This approach would have some microbial testing program discussed upon approval by the Administrator, advantages. It would take account of the earlier in this document, FSIS would continue their current operating likelihood that current performance in secure its long-term strategy for procedure in lieu of the proposed terms of incidence of Salmonella improving the safety of meat and verification program. contamination varies widely. Requiring, poultry products by requiring that all All establishments that have slaughter for example, a 50 percent reduction such establishments adopt HACCP operations or produce raw, ground beef from the establishment-specific baseline systems. HACCP is a systematic or poultry are required to participate in would ensure that some pathogen approach to the identification and this program unless prior approval is reduction is achieved by all control of hazards associated with food granted by the Administrator, in a establishments and a larger reduction, production that is widely recognized by situation where an establishment has in absolute terms, would be required by scientific authorities, such as the NAS instituted a HACCP system. That system establishments that currently have and the NACMCF and international includes pathogen testing which, in the higher incidences of contamination. organizations, such as the Codex judgment of the Administrator, meets or This approach might achieve a greater Alimentarius Commission, and the exceeds the testing requirements in the overall reduction in incidence of International Commission on proposed regulations. contamination, depending on the Microbiological Specifications for Foods percent reduction required for each (ICMSF), and used in the food industry 11. Alternative Approaches to establishment and the actual current to produce product in compliance with Establishing Pathogen Reduction distribution of incidence rates across all health and safety requirements. HACCP Baselines and Targets establishments. provides assurances and documentation The principle underlying the The establishment-specific baseline that processes used in manufacturing proposed approach to pathogen approach has disadvantages. It would be meat and poultry products are in control 6806 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules and producing safe, wholesome, (4) HACCP has a broad base of can utilize objective measures of how unadulterated products. support. In March 1994, a variety of well the controls have been working. FSIS is proposing these regulations constituent interest groups including (7) Implementation of mandatory because a system of preventive controls consumers, the regulated industry, HACCP systems in inspected with documentation and verification of scientists and other professionals, establishments permits separation and successful operation is the most producers, employee representatives, clarification of the differing roles of effective approach available for and other Federal and State establishment and inspection personnel. producing safe food. Emphasis by the governmental representatives endorsed HACCP is an industry process control regulated industry on improving the the HACCP approach as embodied in system. Holding the industry control of microbiological hazards in the seven principles set forth by the responsible for the development and raw and cooked products in conjunction NACMCF. effective operation of HACCP systems with process control will reduce the risk Meat and poultry industry makes it clear that production of of disease resulting from the presence of representatives have urged the Federal wholesome meat and poultry products pathogenic microorganisms in meat and government to institute the mandatory is industry’s responsibility, not the poultry products. use of a HACCP-based production responsibility of the inspection service. HACCP is a conceptually simple system for their products. In a recent The role of the regulatory agency under system by which meat and poultry letter, the American Meat Institute HACCP is verification that the establishments can identify and (AMI) has petitioned the Agency to establishment is controlling its evaluate the hazards that could affect begin rulemaking to mandate HACCP. processes and consistently producing the safety of their products, institute Members of the International Meat complying products. controls necessary to keep these hazards and Poultry HACCP Alliance strongly Since all raw meat and poultry from occurring, monitor the support implementation of a mandatory products contain microorganisms that performance of these controls, and HACCP program. The Alliance consists may include pathogens, raw food and the products made from it unavoidably maintain records of this monitoring as a of approximately 30 industry matter of routine. The HACCP systems entail some risk of pathogen exposure associations, 10 professional mandated in these proposed regulations and foodborne illness to consumers. associations, 32 university affiliates, 6 will be limited to attributes affecting However, since pathogens are not service groups, 6 Government product safety, as opposed to economic visible to the naked eye, consumers representatives and 5 foreign adulteration and quality parameters. If have no way to determine whether the government representatives. these regulations are adopted, FSIS will food they buy is safe to handle and eat. verify HACCP system operations as part In its 1993 report, Creating a When foodborne illness does occur, of its program of continuous inspection. Government That Works Better and consumers often cannot relate the FSIS is proposing to make HACCP Costs Less, Vice President Gore’s symptoms they experience to a specific mandatory for the meat and poultry National Performance Review food—or any food—because symptoms industry for the following reasons: recommended that: ‘‘[USDA] require all may appear after some time has passed. (1) Adoption of HACCP controls by food processing establishments to Thus, food safety attributes are often not the meat and poultry industry, coupled identify the danger points in their apparent to consumers either before with FSIS inspection activities designed processes on which safety inspections purchase or immediately after to verify the successful operation of the would focus * * * also [to] develop consumption of the food. This HACCP system, will produce a more rigorous, scientifically based systems for information deficit also applies to effective and more efficient system for conducting inspections. * * *’’ wholesalers and retailers who generally ensuring the safety of meat and poultry (5) A federally mandated HACCP use the same sensory tests—sight and products than currently exists. HACCP system of preventive process controls smell—to determine whether a food is appropriately places responsibility on appears to be a prerequisite to safe to sell or serve. meat and poultry establishments to continued access to world markets. For The societal impact of this food safety demonstrate an understanding of example, the United States’ largest information deficit is a lack of hazards and risks associated with their trading partner, Canada, has announced accountability for foodborne illnesses products and an ability to control the its intention to implement HACCP for caused by preventable pathogenic processes they use. meat and poultry processes by 1996. microorganisms. When consumers (2) A federally mandated HACCP Australia and New Zealand are also cannot trace an illness to any particular system will provide the basis for a implementing HACCP-based programs. food or even be certain it was caused by modernized process control system (6) Use of the limited public resources food, food retailers and restaurateurs are capable of dealing with all the hazards available to assure the wholesomeness not held accountable by their customers that might be associated with meat and of the meat and poultry supply can be for selling pathogen-contaminated poultry products currently and in the significantly more effective if all meat products and they, in turn, do not hold future—biological, physical, and and poultry establishments are their wholesale suppliers accountable. chemical. controlling their processes through This lack of marketplace (3) The expertise for applying HACCP HACCP systems. HACCP systems focus accountability for foodborne illness to meat and poultry processes and attention on hazards to product safety means that meat and poultry producers products is in an advanced state of and steps critical for their effective and processors may have little incentive development. Considerable progress in control. HACCP systems generate data to incur costs for more than minimal applying HACCP to meat and poultry that can be used to continuously assess pathogen and other hazard controls. The processes has already been achieved by whether the process is in control, and, Agency believes that today about as FSIS and other USDA agencies (e.g., the when deviations occur, what was done much process control exists as current Extension Service). Work has also been to correct the problem. These two market incentives are likely to generate. done by other Federal agencies, several characteristics of HACCP systems will The existence of significant foodborne States, by academic institutions, by mean that inspector attention can be illness demonstrates the inadequacy of industry trade associations and directed to the safety related elements of the status quo. Thus, if foodborne independent industry members. the process and that inspector review illness is to be reduced, there must be Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6807 an increase in systematic process control cannot keep pace with the Listeria monocytogenes, which is control throughout the industry. FSIS industry’s growth, the industry has frequently a post-processing believes this need is best satisfied by a recognized that it must ensure, and environmental contaminant, and not an mandated HACCP program. document that its products comply with indication of a failure of the heat The Agency invites comment on its applicable residue standards. treatment procedure to produce a rationale for mandating HACCP rather ** * the Congress may wish to consider[:] pathogen-free product. than relying on market incentives to As explained in earlier sections of this —Requiring FSIS to establish scientific, risk- induce voluntary adoption of HACCP. based HACCP systems with the industry document, there is a compelling public FSIS also invites comment on whether for residue prevention, detection and health need to establish systematic market incentives can be increased or control; process controls for raw meat and harnessed to improve food safety as a —Having FSIS shift primary responsibility poultry products, to prevent their supplement or alternative to the for day-to-day residue prevention, contamination by pathogenic measures proposed in this rulemaking. detection and control to the industry; and microorganisms and to reduce FSIS invites comment specifically on —Requiring FSIS to adopt a regulatory contamination when it unavoidably the role label claims about the safety or oversight role designed to ensure the occurs. These proposed rules will, for effectiveness of the industry’s efforts. safety-related processing of meat and the first time, mandate adoption of a poultry products might play in FSIS accepts and agrees with the system of control for all federally encouraging and responding to market direction of these recommendations and inspected meat and poultry demand for safer food products. believes that mandatory HACCP for establishments, build on the foundation slaughter and processing operations of the food safety initiatives proposed The Principal Hazards Addressed by presents the opportunity to make this earlier in this document, provide FSIS HACCP shift so that the industry is more an effective means to verify that Meat and poultry products may completely responsible for the safety of establishments are meeting their food present physical, chemical or biological its products with respect to the safety responsibility with respect to (including microbiological) hazards to chemical hazards presented by residues, pathogenic microorganisms, and consumers. especially animal drugs. provide the basis for the science-based Physical hazards may include Biological hazards associated with inspection system of the future. extraneous materials of various kinds disease conditions in animals are that could be introduced into product presently addressed by specific FSIS Overview of HACCP Principles during slaughtering and processing disease inspection techniques. Hazards The HACCP approach to food safety operations. Usually, these extraneous include such disease conditions as was first developed by the Pillsbury materials (e.g., ‘‘buckshot’’; barbed wire, anthrax, tuberculosis, brucellosis, Company as a means of assuring the glass or metal pieces) are easily leukosis, cysticercosis, and other safety of foods produced for the U.S. prevented from getting into the product septicemic and toxemic conditions. The space program. The National at all and can be detected while the detection and control of these hazards is Aeronautics and Space Administration product is still in the inspected accomplished through ante- and (NASA) wanted a ‘‘zero defects’’ establishment. Other physical hazards postmortem inspection performed by program to guarantee safety in the foods result directly from slaughtering and FSIS employees on livestock and astronauts would be consuming in processing operations (e.g., bone chips poultry. When, upon examination, space. When NASA and Pillsbury and feathers). Random product livestock and poultry display signs or critically evaluated available systems for examinations and finished product symptoms of disease, they are ensuring food safety, they found that, standards are presently used to control condemned or subject to restrictions, even when very large numbers of these hazards. such as ‘‘passed for cooking only.’’ finished product samples were tested, a Chemical hazards might result from Parasitic conditions are also the subject relatively large percentage of potentially residue contamination, improper of inspection procedures. hazardous product could still be formulations, or use of compounds not Several human pathogens of enteric accepted. Pillsbury then introduced and intended for food purposes. The results origin do not normally produce signs or adopted HACCP as a system that could from the past several years of FSIS’s symptoms of disease in animals or birds provide the greatest assurance of safety residue-monitoring program suggest that but will produce foodborne illness in while reducing the dependence on contamination of the meat and poultry humans. These microorganisms are finished product sampling and testing. supply with violative levels of chemical among the most significant contributors HACCP, by virtue of identifying the residues is relatively rare; although FSIS to foodborne illness associated with hazards inherent in the product and test results cannot be extrapolated consumption of meat and poultry process, and devising preventive conclusively to all chemicals in all products, but present inspection measures that could be monitored, products, 0.29 percent of analyses techniques are not effective in detecting would control the process. Pillsbury detected violative residues in 1993. and controlling the presence of recognized that HACCP offered real- Chemical contamination from improper pathogens on raw products. time control of the process as far formulations and inadvertent or Processing procedures used to upstream as possible by utilizing incorrect use of non-food compounds is manufacture ready-to-eat products are operator controls and continuous usually prevented by in-plant control designed to destroy pathogenic monitoring. Through this approach, activities. microorganisms and, if properly Pillsbury dramatically reduced the risk The issue of responsibility for primary conducted, are effective. of microbiological, chemical, and control of hazards presented by Microbiological testing is used to verify physical hazards by anticipation and chemical residues was raised by GAO in these processing procedures. In 1993, prevention rather than inspection. its recent report, ‘‘Food Safety: USDA’s there were 11 voluntary recalls The presentation of the HACCP Role Under the National Residue involving 1.7 million pounds of product system by the Pillsbury Company at the Program Should be Re-evaluated’’ for bacterial contamination in ready-to- 1971 U.S. National Conference on Food (RCED–94–158). GAO reported that eat products. These recalls were Protection led to gradual recognition of while Federal resources for residue principally the result of detecting the value of the HACCP approach. This 6808 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules was reflected in the incorporation of the 1992, publication, ‘‘Hazard Analysis the food will contain pathogens and are HACCP principles into FDA’s and Critical Control Point System.’’ As they likely to increase during the regulations for low-acid canned foods in outlined in a later section, FSIS has normal time and conditions under 1973 to address serious botulism adopted the seven HACCP principles as which the food is stored prior to problems in the canning industry. articulated by the NACMCF, and is consumption? (5) What product safety During the intervening years, the proposing that all HACCP plans include devices are used to enhance consumer concepts and rationale for utilizing the the principles. A discussion of the seven safety (e.g., metal detectors, filters, HACCP approach have slowly gained HACCP principles and associated thermometers, etc.)? (6) Does the acceptance throughout the food industry HACCP plan elements follows: method of packaging affect the and scientific community. Principle No. 1: Conduct a hazard multiplication of pathogenic The USDA and the Department of analysis. Prepare a list of steps in the microorganisms and/or the formation of Health and Human Services (HHS) process where significant hazards occur, toxins? and (7) Is the product established the NACMCF in 1988 at the and describe the preventive measures. epidemiologically linked to a foodborne recommendation of the NAS to advise The first step in establishing a HACCP disease? the two departments on food safety system for a food production process is Principle No. 2: Identify the CCP’s in issues. In 1992, the NACMCF endorsed the identification of the hazards the process. HACCP as an effective and rational associated with the product. NACMCF A critical control point (CCP) is means of assuring food safety from defined a hazard as any biological, defined as a point, step, or procedure at harvest to consumption. chemical, or physical property that may which control can be applied and a food The Committee formulated seven cause a food to be unsafe for safety hazard can be prevented, principles to be employed in the consumption. For inclusion in the list, eliminated, or reduced to an acceptable development of HACCP plans. These the hazard must be of such a nature that level. All significant hazards identified principles include hazard assessment, its prevention, elimination, or reduction during the hazard analysis must be critical control point identification, to acceptable levels is essential to the addressed. establishing critical limits, monitoring production of a safe food. Hazards that procedures, corrective actions, involve low risk and severity and that The information developed during the recordkeeping, and verification are not likely to occur need not be hazard analysis should enable the procedures. Under such a system, if a considered for purposes of HACCP. establishment to identify which steps in deviation occurs indicating that control Examples of several questions to be their processes are CCP’s. To facilitate has been lost, appropriate steps are considered in a hazard analysis include: this process, the NACMCF developed a taken to reestablish control in a timely (1) Does the food contain any sensitive CCP decision tree which can be applied manner to assure that potentially ingredients? (2) Does the food permit to an identified hazard at each step of hazardous product does not reach the survival or multiplication of pathogens the process (see Figure 3, below). The consumer. A complete description of or toxin formation during processing? decision tree asks a series of ‘‘yes’’ or the seven HACCP principles (3) Does the process include a ‘‘no’’ questions to assist in determining recommended by the NACMCF can be controllable processing step that whether a particular step is a CCP. found in the Committee’s March 20, destroys pathogens? (4) Is it likely that BILLING CODE 3410±DM±P Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6809 BILLING CODE 3410±DM±C 6810 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Examples of CCP’s may include, but are set, then the establishment must the establishment employee responsible are not limited to: cooking, chilling, meet those more stringent limits. for monitoring activities. specific sanitation procedures, product Principle No. 4: Establish CCP Principle No. 5: Establish corrective formulation controls, prevention of monitoring requirements. Establish action to be taken when monitoring cross contamination, and certain aspects procedures for using the results of indicates that there is a deviation from of employee and environmental monitoring to adjust the process and an established critical limit. hygiene. All CCP’s must be carefully maintain control. A HACCP system is designed to developed and documented. Monitoring is observations or identify potential health hazards and to Consistent with the principles of the measurements taken to assess whether a establish strategies to prevent their NACMCF, FSIS is proposing to require CCP is under control. Monitoring is occurrence. However, ideal that establishments identify CCP’s for used to determine when a deviation circumstances will not always prevail in food safety hazards in their HACCP occurs at a CCP; therefore, monitoring a processing operation and deviations plans. All three types of hazards procedures must be effective. There are will occur. In such instances, the (physical, chemical and biological, many ways to monitor CCP critical NACMCF points out that corrective including microbiological) must be limits on a continuous or batch basis; action plans must be in place to: (1) addressed and controlled. however, continuous monitoring is determine the disposition of the non- FSIS believes that implementation of always preferred. When continuous compliant product and (2) identify and mandatory HACCP, in conjunction with monitoring is not feasible, frequencies correct the cause of the deviation to related changes described elsewhere in must be sufficient to ensure that the regain control of the CCP. Individuals this document, will result in less risk of CCP is under control. Statistically who have a thorough understanding of foodborne illness being associated with designed data collection or sampling the process, product, and HACCP plan these products. Therefore, identification plans need to be developed in such should be identified and assigned of CCP’s throughout the production instances. responsibility for making decisions. Assignment of the responsibility for When appropriate, scientific experts process for controlling microbial monitoring is an important must be consulted to determine hazards is particularly important. consideration for each CCP. Personnel disposition of the product. Principle No. 3: Establish critical assigned the monitoring activities must FSIS is proposing to require that limits for preventive measures be properly trained to report all results, establishments describe in their HACCP associated with each identified CCP. including any unusual occurrences, so plans the corrective actions that will be A critical limit is defined as a that adjustments can be made and any taken if a critical limit is not met. criterion that must be met for each processes or products that do not meet Corrective actions must be specified in preventive measure associated with a critical limits are identified so that sufficient detail to ensure that no public CCP. Another way of considering immediate corrective actions may be health hazard exists after these actions critical limits is that they serve as taken. have been taken. Although the process boundaries of safety for each CCP. Monitoring activities are necessary to of developing a HACCP plan Critical limits are most often based on assure that the process is in fact under emphasizes organized and preventive process parameters, such as control at each critical control point. thinking about what is occurring as the temperature, time, physical dimensions, Some monitoring procedures could be meat or poultry product is being humidity, moisture level, water activity, accomplished by automatic instruments manufactured, the existence of a HACCP pH, titratable acidity, salt concentration, and devices such as time/temperature plan does not guarantee that problems available chlorine, viscosity, recording devices. Some monitoring will not arise. For this reason, the preservatives, or sensory information, procedures could consist of checks identification of a planned set of such as texture, aroma, or visual performed, with outcomes recorded. activities to address deviations is an appearance in relation to the growth or Other monitoring procedures might important part of a HACCP plan. survival of target pathogens or chemical involve rapid testing technologies that Principle No. 6: Establish effective or physical hazards. Establishment of provide feedback within appropriate recordkeeping procedures that critical limits should be justifiable in time frames, for example, the use of document the HACCP system. relation to knowledge available from quick tests to verify levels of chlorine in The NACMCF points out that an such sources as the meat and poultry poultry chillers. establishment’s HACCP plan and all regulations or guidelines, literature, HACCP requires establishments to associated records must be maintained surveys, experimental studies, or from systematically monitor, control, and, on file at the establishment, and recognized experts in the industry, where necessary, adjust their provides several examples of records academia, or trade associations. production processes to meet a specified that could be maintained, such as those In accordance with the principles set standard. Process monitoring may relating to incoming ingredients, forth by NACMCF, FSIS is proposing necessitate materials or devices to product safety, processing, packaging, that processors identify critical limits in measure, test, or otherwise evaluate the storage, and distribution, deviations and their HACCP plans that must be met at process at critical control points. corrective actions, and employee each CCP to be certain that the hazard Examples would be such items as training. is controlled. Critical limits must reflect thermometers and test kits. A HACCP system will not work relevant FSIS regulations, FDA FSIS is proposing to require that unless records are generated during the tolerances, and action levels where procedures for monitoring each CCP be operation of the plan, and those records appropriate. Processing establishments identified in the HACCP plan. These are maintained and available for review. are encouraged to establish critical monitoring procedures should assure One of the principal benefits of a limits more stringent than those now in that the monitoring systems are capable HACCP process control system to both FSIS regulations or related documents of detecting process deviations, industry and regulatory officials is the to ensure that regulatory requirements including product segregation and availability of objective, relevant data. are routinely met even when deviations holding procedures, effect of deviations Thus, FSIS is proposing to require that occur. If critical limits more stringent on product safety, indicators for the HACCP plan provide for a than regulatory limits or requirements modification of the HACCP plan, and recordkeeping system that will Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6811 document the establishment’s CCP as the regulatory agency, will undertake cooked sausage, and poultry slaughter monitoring, verification activities, and final product testing as one of several in nine volunteer establishments. deviation records. FSIS has also verification activities. Verification tasks The study underscored the concluded that recordkeeping systems provide an opportunity to demonstrate significance of the change in roles and are much more effective when they that a well-functioning HACCP system responsibilities that use of a HACCP include the actual values obtained, as is in fact controlling a process so that system brings both to the regulated opposed to terms such as ‘‘satisfactory’’ safe product is being produced under industry and to the inspection service. or ‘‘unsatisfactory,’’ which reflect a conditions that minimize preventable This finding would later be supported judgment about the values and do not risks. by observations at a Round Table permit trend analysis. The verification principle also links meeting on HACCP in 1994 that Principle No. 7: Establish procedures HACCP with the key element of the successful HACCP implementation will to verify that the HACCP system is FSIS regulatory strategy for pathogenic demand a culture change within the working correctly. microorganisms, which is the inspection service and within the The NACMCF defines verification as establishment of public health-oriented industry. Additionally, the Agency’s the use of methods, procedures, or tests targets, guidelines, or standards earlier experiences with HACCP-based in addition to those used for monitoring, establishments must meet to engage in regulations, such as those for low-acid to determine if the HACCP system is in commerce. Without some objective canned foods, cooked roast beef, and, compliance with the HACCP plan and/ measure of what constitutes an more recently, for cooked, uncured or whether the HACCP plan needs acceptable level of food safety patties had demonstrated the modification and revalidation. Four performance with respect to pathogenic advisability of technical collaboration. processes are identified as steps in the microorganisms, it would be impossible The study experience confirmed these establishment’s verification of its to determine whether an establishment’s earlier conclusions that technical HACCP system. HACCP plan is acceptable and collaboration was essential to successful The first process is the scientific and functioning effectively. FSIS is taking implementation of HACCP. technical process to verify that all the first step toward implementation of (2) HACCP Round Table, 1994. critical limits at CCP’s are adequate and such objective measures with the FSIS was proceeding during 1993 to sufficient to control hazards that are proposed interim targets for pathogen develop a HACCP regulation when a likely to occur in their specific reduction, which focus on Salmonella. group of concerned constituent process(es). This is commonly referred As data become available, these targets organizations requested greater pre- to as ‘‘validating’’ the process. will be refined, and possibly expanded proposal involvement and public The second process is to ensure that in slaughter operations and extended in consultations prior to publication of the HACCP plan functions properly. processing operations, to support the proposed regulations. USDA agreed to Establishments should rely on frequent Agency’s implementation of HACCP. have a public event at which the reviews of their HACCP plan, Verification might well include required application of HACCP in the meat and verification that the HACCP plan is microbial testing for all processes and poultry industry could be discussed. being correctly followed, review of CCP species. Eventually, such testing can be This event became known as the records, and determinations that expected to be an integral part of HACCP Round Table. appropriate management decisions and HACCP verification. On March 30 and March 31, 1994, product dispositions are made when FSIS held a two-day Round Table deviations occur. FSIS Experience With HACCP meeting in Washington, D.C. The third process consists of (1) FSIS HACCP Study, 1990–1992. Participants in the Round Table were documented periodic reviews to ensure In 1990, FSIS initiated a study of primarily selected by a procedure the accuracy of the HACCP plan. Such HACCP that focused on how this system announced in the Federal Register on reviews should include an on-site of process control could be applied January 13, 1994. Participants included review and verification of all flow within the meat and poultry industries public health officials, representatives diagrams, CCPs, critical limits, and what the implications might be for from the meat and poultry industry, monitoring procedures, corrective regulatory inspection activities. This consumer groups, scientists and actions, and records maintained. study was not designed to establish the professional scientific organizations, The fourth and final verification efficacy or benefit of the HACCP producer and farmer groups, USDA and process deals with the regulatory approach as a process control system. other Federal, State, and local agency’s responsibility and actions to Recognition of HACCP as a proven employees. Prior to the Round Table, a ensure that the establishment’s HACCP method for preventing and controlling steering committee of nine of the Round system is functioning satisfactorily. This food safety hazards has been achieved Table participants determined the key verification can be viewed as an overall through practical application of the issues to be addressed during the forum. process validation and can consist of concepts to food production operations For each key issue, a particular question any and all of the verification activities since 1971. was developed to focus the mentioned above, plus final product Recognizing that acceptance of deliberations. Each issue, question, and testing to demonstrate compliance with HACCP within the meat and poultry deliberation is summarized below. regulatory as well as other desired industries would be dependent on a FSIS’s views on those issues addressed performance standards. broad range of constituent support, the by this regulation are covered under FSIS is proposing to require that the FSIS study involved consultations and ‘‘Discussion of HACCP Proposal’’ below. HACCP plan include a set of verification public hearings; technical workshops A report on the HACCP Round Table tasks to be performed by establishment with representatives of industry, has been published and is available personnel. Verification tasks will also be academia, and trade associations to from the FSIS Docket Clerk at the performed by FSIS personnel. However, develop generic HACCP models; and address provided under ADDRESSES. an important benefit of HACCP is for testing and evaluation of in-plant trials HACCP Plan Approval: What is the establishments to take full responsibility through case studies. In-plant testing best way to ensure that HACCP plans for producing a safe product. Thus, it is involved operational application of effectively incorporate the seven envisioned that establishments, as well generic models for refrigerated foods, HACCP principles? 6812 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules There was broad support for Measures of Effectiveness: How can it whistleblower protection for industry incorporating the seven HACCP be determined initially, and on a employees). principles into HACCP plans. Different continuing basis, that HACCP plans are Relationship and Effect of HACCP on perspectives were expressed concerning working effectively? Current Inspection Procedures: To what the means by which this might be Participants discussed the need to extent will the possible changes in the achieved. These perspectives ranged develop measures of effectiveness for regulated industry impact on possible from having plans developed by HACCP plans. These ranged from the changes in the current inspection certified experts, to the use of objective use of baseline data on the process, system? baseline data from industry operations, establishment, and product level; to the and to the use of generic models. Having use of microbial, physical, and chemical Discussion on this issue centered on and applying generic models and guidelines; to the use of in-process, as five points: Modification of inspection guidelines to plant specific situations well as end-product testing; to the procedures to take advantage of HACCP was considered desirable. openness and accessibility of data and plans; advantages and disadvantages of Training/Certification: What should records on selected measures of continuing current regulatory programs be the role of FSIS with regard to effectiveness. There was considerable until HACCP is fully implemented; industry HACCP training? discussion concerning the need for ways to combine HACCP and the This question generated discussion on finished product testing to support current inspection system; the extent to three components: (1) HACCP curricula, verification of a HACCP program. The which changes in industry will affect (2) training approaches, and (3) area of greatest controversy was the changes in inspection; and the potential certification requirements. The need for microbial testing and the effects of HACCP on small centrality of training to successful development of microbial guidelines in establishments. Modification of implementation of HACCP is reflected conjunction with the need for finished inspection procedures to take advantage in the broad range of perspectives product testing. Different perspectives of HACCP plans generally follow offered. Curricula concerns ranged from were offered on these issues, on how NACMCF recommendations that the need for uniform training on such testing could be accomplished, and regulatory verification of HACCP plans principles, to the need for specific on the practical limits of detection, can be accomplished in lieu of, rather training on application of the principles sample collection, and testing. than adding to, existing procedures. within a particular establishment Compliance/Enforcement: What are This would permit reallocation of operation, to the need for joint training the best ways to adequately enforce and inspection resources to food safety between inspectors and industry ensure compliance with HACCP concerns and away from quality employees. Training approaches requirements? attributes and aesthetic concerns. touched on the need for training to be Participants presented views on the HACCP should not invite an arbitrary both available and affordable, and the types of regulatory authority that would reduction in the inspection force and potential for training development and be appropriate in a mandatory HACCP the numbers of inspectors should not be delivery to occur within various private system. Viewpoints ranged from those tied to HACCP implementation. The sector organizations as well as who believed that current enforcement potential effects of HACCP on small academia. Certification requirements authorities are adequate, to those who establishments were noted, along with addressed the alternatives of having stated a need for new authorities (e.g., the view that some accommodation HACCP-trained personnel in civil penalties) and those who believed during implementation should be establishments, having HACCP a review of enforcement authorities afforded to these establishments. consultants available on-call, and should be undertaken to reflect the All issues raised and discussed during having some type of certification changes in roles and responsibilities the HACCP Round Table were taken process for such individuals. between the industry and the inspection into account in formulating this Phase-in: Should the mandatory service. There was significant proposal. HACCP requirement be phased-in and, discussion concerning deviations from if so, how? HACCP requirements and how these FSIS Experience With Process Control There was broad support for the deviations should be handled, including notion of phasing-in HACCP appropriate enforcement responses to (1) Current Application of Hazard requirements, since allowing enough repeated deviations from the HACCP Analysis to Meat and Poultry time for the HACCP program to develop plan. Here, two major points of view Processing. and grow is deemed critical for its were articulated. The first view was that The principle of hazard analysis has success. Proceeding on a deliberate any deviation from a HACCP plan could been utilized to prevent foodborne schedule allows for an orderly transition result in a regulatory remedy (rather illness associated with specific meat within the industry and permits than criminal remedy) and that a and poultry products and to support adjustments of the regulatory deviation from a CCP, while a food regulatory process control for certain infrastructure to suit the HACCP safety concern, should result in a voluntary procedures. The examples structure within inspected regulatory response related to the level discussed below represent FSIS’s early establishments. A variety of approaches of severity (in terms of risk to human efforts using hazard analysis to identify to phase-in and timing were offered. A health) of the deviation. The second CCP’s in a production process and to second point raised was that the phase- view was that any deviation from the establish stringent regulatory in should take advantage of existing HACCP plan constitutes adulteration, requirements for controlling production HACCP knowledge and expertise, hence a violation of law subject to processes. Whereas the earlier advancing first those industry segments enforcement action. This view holds regulations were prescriptive, the whose process control operations are that, since HACCP is intended to current proposal is performance based, more closely aligned with HACCP. A address potentially serious food safety and holds the industry fully responsible third point offered was that the phase- hazards, a deviation is a violation. A for conducting the hazard analysis and in should provide for a transition or trial final point of discussion on this issue identifying the CCP’s and critical limits period as application of HACCP occurs was employee protection from reprisals associated with producing products that within a particular establishment. for reporting food safety hazards (e.g., minimize the risk of foodborne illness. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6813 (a) Low-Acid Canned Foods affected product on a case-by-case basis. tasks to ensure establishments’ The low-acid canned food industry Additionally, whole, intact, cooked compliance with the regulations. The ‘‘Heat Processing Procedures, has had a remarkably good record over roast beef products from several Cooking Instructions, Cooling, Handling the past 50 years, during which more establishments were sampled and found and Storage Requirements for Uncured than 1 trillion cans of commercially positive for salmonellae. As a result of Meat Patties’’ (8/2/93 at 58 FR 41151) canned foods were consumed. the outbreaks, it became apparent that incorporated HACCP concepts (CCPs, Beginning in 1970, however, botulinum salmonellae contamination of cooked beef products needed to be addressed on critical limits, corrective actions, etc.) toxin and C. botulinum were found in an industry-wide basis. associated with the manufacture of commercially canned product produced In 1977, FSIS promulgated a uncooked, partially cooked, char- under the jurisdiction of both FDA and regulation requiring that all cooked beef marked, comminuted products. USDA. From 1970 until 1990, nine products be prepared by ‘‘a cooking (d) Current Process Control Systems incidents of botulinum outbreaks procedure that produces a minimum occurred, resulting in death on six temperature of 145 degrees F in all parts The development and implementation occasions. The products implicated of each roast’’ to destroy any of standardized process control included mushrooms, peppers, salmon, salmonellae that might be present. This procedures, such as Total Quality boned turkey, chicken vegetable soup, regulation was amended in 1978 to Control (TQC) systems and Partial tuna, and bean salad. provide alternate cooking times and Quality Control (PQC) programs have In response to the botulism outbreaks, temperatures to preserve the rare been part of an effort to focus the the canning industry identified CCPs appearance of the product but still responsibility for compliance on the that must be controlled and monitored destroy all salmonellae. (See 9 CFR processing establishment. FSIS first to ensure that canning operations 381.17.) began approving industry operated produce safe canned foods. For products During the summer of 1981, eight quality control programs in the mid under its jurisdiction, FDA in 1973 additional outbreaks of the disease were 1970’s. The QC policy evolved codified the CCPs into a good linked to the consumption of roast beef throughout the late 1970’s until in 1980 manufacturing practice regulation for produced by four separate when it was codified in 9 CFR 318.4 and thermally processed low-acid canned establishments in the northeastern 381.145 providing a regulatory basis for foods packed in hermetically sealed United States. FSIS policies for PQC and TQC. At containers(21 CFR 110). Epidemiologic investigations revealed present, there are over 9,000 approved Since FDA’s promulgation of that that inadequate cooking times and PQC programs in operation in inspected regulation (revised in 1978), the threat temperatures were not the major establishments and 361 approved and of botulism in canned product has been problems. A new regulation was operating TQC systems. greatly reduced. While sporadic implemented in 1983 that addressed the TQC systems are defined by incidents continue, investigations of necessary handling, processing, cooling regulation as plans or systems for such incidents have attributed the times and temperatures, and storage controlling product after antemortem causes to establishments’ failure to requirements to ensure the and postmortem inspection throughout comply with the regulation rather than wholesomeness of cooked roast beef. all stages of preparation adequate to inadequacies in the regulation. In total, the changes that evolved in result in product being in compliance To address problems in the canned the roast beef regulations represented a with the regulations (9 CFR 318.4(c) and meat and poultry industry, in 1986 FSIS HACCP approach in identifying the 381.145(c)). This definition had promulgated HACCP-based low acid CCP’s in roast beef processing that must traditionally been interpreted to mean canned food regulations similar to those be monitored and controlled by an that an establishment’s TQC system of the FDA. CCPs identified in those establishment to ensure production of must include control for all aspects of regulations were incorporated into the unadulterated product. These HACCP- a process. By regulation, PQC programs Agency’s Performance Based Inspection based CCP’s have subsequently been may be approved for controlling the System, so that inspectors’ tasks include incorporated into the FSIS-PBIS system production of individual products, verification of establishments’ for scheduling inspectors’ tasks in individual operations within the compliance with the regulations. establishments that produce cooked establishment, or parts of operations (9 Incidents of foodborne illness involving roast beef. Since 1983, no confirmed CFR 318.4(d) and 381.145(d)). canned meat and poultry products that salmonellae outbreaks have been traced In processing establishments, most occurred following the publication of to commercially prepared roast beef. approved PQC programs are designed to the rules have been attributed to control economic and quality aspects of establishments’ noncompliance with the (c) Uncured Cooked Meat Patties meat and poultry products, such as net regulations. In response to recent outbreaks of weight and label claims. Such PQC foodborne illness caused by E. coli programs are generally voluntary or are (b) Commercially Processed Cooked 0157:H7, FSIS promulgated a rule a condition of label approval. A smaller Roast Beef dealing with the heat-processing, number of procedures operate to control Five outbreaks of salmonellosis cooking, cooling, handling, and storage product wholesomeness factors and are associated with the consumption of requirements for uncured meat patties. mandated in current regulations. These commercially processed cooked beef HACCP principles were used to identify include the production of cooked roast products occurred in the northeastern CCP’s, critical limits, and corrective beef (§ 318.17), mechanically deboned United States from 1975 until 1981. actions; as a result, cooking times and product (§ 319.5), and irradiated poultry These outbreaks resulting from five temperatures, cooling requirements, product (§ 381.145). In addition, some different serotypes of Salmonella, sanitary handling and storage practices, PQC programs are approved as caused up to 200 reported cases of and requirements for the handling of alternative procedures to regulatory illness per incidence. heating or cooling deviations were requirements such as handling thermal FSIS responded to the outbreaks by established. The CCP’s identified in that processing deviations (§§ 318/381.308) supervising the voluntary recall and rule have been incorporated into the and finished product inspections destruction of thousands of pounds of Agency’s PBIS for scheduling inspector (§§ 318/381.309) of shelf stable canned 6814 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules meat and poultry products. In slaughter benchmark for countries to incorporate products of over $40 billion per year. establishments, PQC programs are HACCP principles into their food The United States also imports a designed to control economic, quality, industries. The seven HACCP principles substantial quantity of food products and some product wholesomeness adopted by the Codex Alimentarius each year from many countries around aspects of production. Such programs Commission are identical to those the world. HACCP will improve FSIS’s include finished product standards, proposed in this rule with the exception ability to monitor imports and thus preoperational sanitation and carcass that HACCP principles six (i.e., ensure greater confidence in their safety. presentation. All slaughter PQC recordkeeping) and seven (i.e., Also, HACCP is becoming the world- programs are voluntary. verification) are reversed. wide standard to ensure the safety of Preventive systems of process control In 1993, Agriculture Canada food and will thus serve as the basis for have been formally employed in the implemented a Food Safety harmonizing U.S. food safety slaughter of broilers and Cornish game Enhancement Program, which is regulations with those of other nations. hens since 1983, and in the slaughter of designed to encourage the adoption of The Uruguay Round Negotiations turkeys since 1984. These process HACCP principles across all agri-food under the General Agreement on Tariffs control approaches are integral features processed commodity groups and shell and Trade (GATT) has resulted in of inspection systems known as the New eggs. The food industry will be required further focus on this area. The Line Speed (NELS) inspection system to control and monitor its Agreement on the Application of for broilers and cornish game hens, and manufacturing process and maintain Sanitary and Phytosanitary Measures the New Turkey Inspection System records at CCP’s. FSEP will also provide states the desire of member countries (NTIS) for turkeys (9 CFR 381.76). Forty- a means to help government inspectors including the United States, to further five establishments operate under NELS prioritize their responsibilities and ‘‘* * * the use of harmonized sanitary today, and 27 establishments operate focus their attention on CCP’s in the and phytosanitary measures between under NTIS. process to ensure the production of safe members, on the basis of international Under these slaughter process control food. Full implementation of the FSEP standards, guidelines, and systems, the establishment demonstrates program is scheduled to be completed recommendations developed by the compliance with regulatory by September 1996. relevant international organizations, requirements by identifying the points Recently, the European Union (EU) including the Codex Alimentarius in the slaughter process that are adopted two Directives that made Commission * * *’’. This trend toward important to regulatory compliance. The reference to the HACCP system. One harmonization coupled with the current establishment then sets realistic Directive (93/43/EEC) focuses on the recommendations of the Codex standards for these points, and observes hygiene of foodstuffs and specifies that Alimentarius Commission encouraging them often enough to detect deviation food business operations must identify the international use of HACCP, provide from a standard before non-compliance and control any step in their process further support for FSIS’s proposal for a occurs. The establishment also critical for ensuring food safety using mandatory HACCP program for the identifies action it will take if a standard the HACCP system. The other Directive production of all meat and poultry is not met. The written program and the (92/5/EEC) is one specific to meat products. generated records of observations and products, which also embraces HACCP actions are evidence of the degree of principles. These Directives were FSIS Guidance on Development of process control and regulatory adopted on June 14, 1993 and February HACCP Plans compliance. By reviewing and 10, 1992, respectively. EU members FSIS believes that it can facilitate evaluating establishment records and have up to 30 months from the date of development of HACCP plans in various verifying them with process adoption to implement the provisions of ways without compromising the observations as necessary, FSIS the Directives into national law. principle that these are industry process inspection personnel ensure an Detailed guidelines are now under control plans and, as such, plan establishment is meeting its development for meat products. development is the responsibility of the responsibility to produce safe and New Zealand has also been proactive regulated establishment. Therefore, FSIS wholesome product. in adopting HACCP principles in the has underway a series of planned The principal difference between food industry. Through the publication assistance efforts, which will continue slaughter process control systems in of Guide to the Implementation of and be completed over the next 6–12 place in NELS and NTIS establishments Hazard Analysis and Critical Control months. today, and the proposed HACCP system Point Systems in the Meat Industry, the (a) Generic Models: FSIS has is the focus of the systems. NELS and Ministry of Agriculture and Fisheries published the generic models developed NTIS were designed not only to address provided: (1) a generic model from at Agency workshops and will publish safety hazards associated with raw which an understanding of the HACCP generic models developed by NACMCF poultry carcasses, but quality factors as approach to food safety can be obtained; as they become available. An example, well. The proposed HACCP system (2) a guide to the application of HACCP the ‘‘Generic HACCP for Raw Beef,’’ is focuses on hazards associated with systems, especially in the case of raw provided in the Appendix. safety of product. foods; and (3) specific examples of FSIS has categorized in this proposed application. regulation all processes carried out in International Efforts on HACCP Adopting a HACCP system could the establishments it regulates. Because Between 1990 and 1992, a working potentially enhance international trade FSIS pilot-testing has shown generic group of the Codex Committee on Food opportunities for the United States. plans to be useful to establishments as Hygiene developed a guideline Although enhancing trade has no direct they develop plans specific to their own document that covered the principles effect on public health, participation in processes and products, FSIS will and application of HACCP to all sectors international trade in food products is publish and make widely available a of the food chain from producer to critical to the U.S. economy. The United generic model for each of the nine consumer. The Codex Alimentarius States is by far the world’s major food process categories at least six months in Commission in 1993 adopted the exporter, with exports of raw advance of the due date for each process HACCP document that now serves as a agricultural and processed food category. FSIS believes that use of Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6815 generic plans will assist in assuring the In addition to providing a greater HACCP system. The result of the basic level of uniformity necessary to quantity of information and in effect implementation of the HACCP plan.* have inspection activities based on extending the scope of regulatory Hazard. A biological, chemical, or establishment HACCP plans, and that observations, the presence of functional physical property that may cause a food the provision of generic models will HACCP plans for all products and to be unsafe for consumption.* help to communicate the level of detail processes will also produce more Hazard Analysis. The identification of expected in the elements of the plan. relevant data. This is because the any biological, chemical, or physical FSIS also believes that generic models monitoring and recordkeeping properties in raw materials and can help identify the kinds of hazards requirements of a HACCP plan are processing steps and an assessment of that should be considered at various organized around identified hazards, their likely occurrence and seriousness CCP’s, without interfering with the CCP’s, critical limits, and the actions to cause the food to be unsafe for establishment’s hazard analysis. taken to ensure that defects are consumption. (b) NACMCF Materials: FSIS is corrected before they become a risk. Monitor. To conduct a planned publishing and will make widely Finally, HACCP systems will yield data available guidance materials developed sequence of observations or that are more objective and more measurements to assess whether a CCP by NACMCF describing the optimum scientific. steps to be followed in developing is under control and to produce an HACCP plans. In addition, FSIS is (1) Definitions accurate record for future use in verification.* currently exploring the most effective For the purposes of this discussion and economical approach to developing and within this proposed rule, FSIS has Preventive measures. Physical, a HACCP videotape. adopted some definitions of terms chemical, or other factors that can be (c) Computer Packages: FSIS is aware related to HACCP and HACCP systems used to control an identified health of commercially available software from the NACMCF in the publication hazard.* programs that might assist food titled ‘‘Hazard Analysis and Critical Process. A procedure consisting of processors in developing HACCP plans. Control Point System,’’ dated March 20, any number of separate, distinct, and FSIS has made a commitment to work 1992; these definitions are noted by ‘‘*’’. ordered operations that are directly with companies developing these Other definitions are specific to FSIS under the control of the establishment programs to make them more applicable and its activities. employed in the manufacture of a to meat and poultry processes. Corrective action. Procedures to be specific product, or a group of two or more products wherein all CCP’s are 2. Discussion of HACCP Proposal followed when a deviation occurs.* identical, except that optional Regulatory Considerations Criterion. A requirement on which a judgment or decision can be based.* operations or CCP’s, such as packaging, Process control is neither FSIS’s Critical Control Point (CCP). A point, may be applied to one or more of those responsibility nor a shared step, or procedure at which control can products within the group. responsibility between the Agency and be applied and a food safety hazard can Product. Any carcass, meat, meat industry. Each USDA inspected be prevented, eliminated, or reduced to byproduct, or meat food product, establishment must assume full acceptable levels.* poultry, or poultry food product capable responsibility for making safe and Critical Control Point (CCP) failure. of use as human food. wholesome products. FSIS is Inadequate control at a CCP resulting in Recognized HACCP course. A HACCP responsible for assuring that products in an unacceptable risk of a hazard. course available to meat and poultry marketplace distribution are Critical limit. A criterion that must be industry employees, which satisfies the unadulterated, wholesome, and met for each preventive measure accurately labeled. From a public health following: consists of at least three days, associated with a CCP.* one day devoted to understanding the perspective, the more that industry Deviation. Failure to meet a critical process controls anticipate and prevent seven principles of HACCP, one day limit.* devoted to applying these concepts to problems, the less likely products HACCP. A hazard analysis and this and other regulatory requirements produced under such systems are to critical control point system (HACCP) of FSIS, and one day devoted to become adulterated. that identifies specific hazards and beginning development of a HACCP HACCP is not an inspection system; it preventive measures for their control to plan for a specified process. is an industry process control system ensure the safety of food. that provides opportunities to make HACCP plan. The written document Responsible Establishment Official. inspection more effective. Currently, which is based upon the principles of The management official located on-site FSIS performs inspection by having HACCP and which delineates the at the establishment who is responsible inspectors generate information about procedures to be followed to assure the for the establishment’s compliance with the establishment’s production process control of a specific process or this part. and environment to evaluate the procedure.* Validation. An analysis of verification conditions under which meat and HACCP-trained individual. A person procedures, HACCP plan components, poultry products are being produced. who has successfully completed a and an evaluation of records associated This activity permits oversight of recognized HACCP course in the with the HACCP system to determine its establishment efforts at the time of application of HACCP principles to efficacy for the production of inspection. In contrast to this relatively meat and poultry processing operations, wholesome product for which the small amount of information, HACCP and who is employed by the process was designed. records will enable inspectors to see establishment. A HACCP-trained Verification. The use of methods, how the establishment’s processes have individual must have sufficient procedures, or tests in addition to those operated on a continuing basis over experience and training in the technical used in monitoring to determine if the time. The Program employee will be aspects of food processing and the HACCP system is in compliance with able to determine whether problems principles of HACCP to determine the HACCP plan and/or whether the have occurred and, if so, how they were whether a specific HACCP plan is HACCP plan needs modification and addressed. appropriate to the process in question. revalidation.* 6816 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules (2) HACCP Plans (3) Overview of Plan Content and processing activity conducted in that Format; Consistency With FDA establishment. Establishments coming (a) Basis of Required Elements FSIS is aware that a large number of under inspection after the The question of adherence to the food producing companies are regulated implementation date appropriate for the seven principles of HACCP as defined by both FDA and USDA. Earlier this process(es) to be conducted will be by the NACMCF has been considered by year, FDA proposed to mandate HACCP required to develop their HACCP plans in conjunction with the application for FSIS since it began HACCP activities. for seafood processors (59 FR 4142, the grant of inspection. FSIS FSIS has determined that the January 28, 1994). In formulating the proposal presented in this document, acknowledges that such establishments scientific and conceptual integrity of may need some practical experience FSIS has tried to assure conceptual HACCP as articulated by NACMCF is operating under their HACCP plan to uniformity and consistency with FDA critical to its success and to public finalize their plans. FSIS invites on the practical details to the greatest acceptance of inspection systems based comments on whether new extent possible. However, differing establishments coming under inspection on it. FSIS believes that each principle statutes are administered by the two should be granted a reasonable amount is important to achieving the objectives agencies and each species—livestock, of time, for example, six months, to of HACCP and that the support of the birds and fish and shellfish—differ finalize their HACCP plans under scientific, technical, and industry significantly. commercial conditions. communities for HACCP rests on its In many important respects, the FSIS overall integrity. Furthermore, the and FDA HACCP programs are fully (4) Sanitation as a Prerequisite to external advice from such bodies as consistent. The same underlying HACCP Plan Development NAS and GAO recommending HACCP principles of HACCP form the FSIS believes that there are certain implementation assumed adoption of all foundation of the two programs. Both prerequisites that must be met before seven principles. Therefore, the Agency programs have the goal of improving the successful HACCP plan development has determined that its regulatory microbial profile of regulated food can be accomplished. An important requirements will be founded on products and, thereby, reducing the foundation is the successful control of HACCP principles as articulated by incidence of foodborne illness that the cleanliness and sanitation of the NACMCF. Comments are invited on this might be associated with these foods. facilities and equipment, and adequacy fundamental premise of the FSIS Both programs require that of employee sanitation and hygienic proposed regulation. establishments: develop HACCP plans practices necessary in producing meat that address the health and safety and poultry products. FSIS is proposing (b) Required Elements aspects of their processes; have access to that this be accomplished through at least one HACCP-trained individual; FSIS is proposing to require that Standard Operating Procedures for and recognize and carry out their sanitation. (See ‘‘Near-term inspected establishments develop responsibility to control sanitation as a HACCP plans that include: Interventions’’ section of ‘‘DISCUSSION prerequisite to HACCP. OF REGULATORY PROPOSALS,’’ identification of the processing steps In addition, both regulatory programs that present hazards; identification and above). are similar in that operational success is These proposed regulations reflect the description of the CCP for each the mechanism for acceptance of decision that HACCP plans should identified hazard; specification of the establishment HACCP plans; address food safety factors only. FSIS critical limit, which may not be verification tasks of all types will be invites comment on this approach. exceeded at the CCP and, if appropriate, conducted by regulatory officials; and a target limit; description of the FSIS and FDA will attempt to provide (5) Participation of HACCP-Trained establishment monitoring procedure or assistance to establishments through the Individuals device to be used; description of the development of guidance materials or The Agency believes that corrective action to be taken if the limit generic models from which industry establishments will vary widely in their is exceeded and the individual efforts can begin. familiarity and experience with HACCP. responsible for taking corrective action; FSIS is recommending that the format All establishments will need to have description of the records that will be used in its generic models and those of access to persons who have been trained generated and maintained regarding this the NACMCF be followed by all in HACCP and its application to meat CCP; and description of the establishments; however, Agency and poultry production processes. Some establishment verification activities and personnel will be flexible in this matter establishments have already chosen to the frequency at which they are to be and consider alternative formats that secure HACCP training for their staff or conducted. Critical limits currently a ensure that both establishment and to secure consulting services. Others part of FSIS regulation or other inspection personnel can readily must accomplish this before they begin requirements must be met. FSIS invites identify the hazards, the CCP’s and the the hazard analysis that will initiate comment on permitting approval of specific critical limits, plus actions and their plan development process. FSIS alternative procedures if sound records that should be associated with will consider an individual who has scientific reasons and data are provided. each. The generic models are to provide successfully completed a recognized guidance, not serve as blueprints, and HACCP training course, as defined in FSIS is proposing that the HACCP not substitute for process controls. FSIS §§ 326.1 and 381.601, to be a HACCP- plan be signed by the responsible proposes to publish and make widely trained individual. establishment official as an indication of available both its generic models and A recognized HACCP course would his or her accountability for the plan. the NACMCF models. Comments are consist of at least three days: one day Comment is invited on the merits of invited on this approach. devoted to understanding the seven such a requirement as a method of FSIS is proposing to require that each principles of HACCP; one day devoted ensuring and demonstrating inspected establishment have and to meshing these concepts with this and establishment commitment to, and implement a HACCP plan that is other regulatory requirements of FSIS; formal adoption of, the plan. specific to each kind of meat or poultry and one day devoted to development of Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6817 a HACCP plan for a specified process. that employment of a HACCP trained plan can be ready and validated by the As discussed below, the Agency expects individual could also be accomplished due date. that many organizations will be through acquisition of the services of a In only one circumstance will knowledgeable about such courses and HACCP consultant. The Agency does Program employees be expected to may serve as legitimate sources of such not intend to be overly prescriptive by report on the progress of these training. It is the responsibility of the specifying the conditions of establishment activities with respect to establishment sending its employee(s) to employment between the establishment plan development; that is, if there has a particular training course to ascertain and the HACCP trained individual. It is, been no effort to initiate hazard that the course meets the minimum however, the determination of the analysis, and the subsequent application requirements described above. Agency that the services of a HACCP- of remaining HACCP principles, at least FSIS is aware that, through industry- trained individual able to carry out the one month prior to the due date for the sponsored training courses, several activities described above is essential to HACCP plan. FSIS believes that, in such hundred industry employees have successful operation of a HACCP a circumstance, there is a considerable already received the necessary training. system. Comments are invited on this likelihood that the plan will be It is not expected that such training approach. insufficient and that regulatory action needs to be repeated. Individuals who This proposed requirement for will be necessary. Therefore, Program previously received HACCP training involvement by a HACCP-trained employees will report such a situation should be able to supplement their individual is an alternative to requiring through their supervisory channels. knowledge through guidelines and that there be such an individual in each FSIS invites comment on this particular informational materials made available establishment. FSIS recognizes that, for feature of the proposed implementation by FSIS, NACMCF, professional many establishments, securing HACCP schedule. associations, and trade associations. expertise by training one employee in a FSIS invites comments on this approach (7) Establishment-Specific HACCP Plan recognized HACCP course is the best Acceptance for supplementing knowledge levels of means to meet this requirement. The question of HACCP plan previously trained individuals. In cases Comments are invited on this approach. where a consulting expert serves as the acceptance has been long and HACCP-trained individual for an (6) Hazard Analysis thoroughly considered by the Agency. In reviewing various options, the establishment, it is the responsibility of FSIS believes that success in HACCP Agency has maintained several the establishment to assure that this plan development is founded on a objectives: individual has the requisite training. hazard analysis that is thorough and FSIS is also proposing that the • Any acceptance system should not forces the establishment to critically HACCP-trained individual participate in include a requirement that HACCP think about and analyze its processes. the hazard analysis and subsequent plans be physically forwarded to the Guidance materials prepared by the development of the HACCP plans, and Agency and remain in its possession at NACMCF for carrying out Principle 1 assist in addressing product safety in one or a few central locations. address this issue. Especially for situations where there have been • The acceptance system must deviations from critical limits and establishments without HACCP accommodate varying establishment- judgment is needed to determine the experience, this is a critical and specific HACCP plans for similar adequacy of the response. HACCP- challenging first step. Because FSIS is products, but maintain uniformity on trained individuals must also be concerned that each establishment basic standards. available to establishments to properly begin its application of the • The acceptance system should participate in plan modification and concepts of HACCP, the Agency is involve Agency in-plant Program revalidation. FSIS does not believe it proposing to specify a time frame prior employees to the maximum extent needs to prescribe details about the to the due date for any HACCP plan, possible, after they have been provided hours or days on which the HACCP- during which hazard analysis should be the requisite education and training in trained individual is to be on conducted. HACCP. establishment premises, or what should The proposed time frame is six The Agency gave serious be done in establishments having multi- months; this means that six months consideration to requiring formal plan shift operations, other than to require before any HACCP plan is required to be acceptance prior to full plan operation, that the HACCP-trained individual be completed, establishments should begin either by formal FSIS approval or by an available to the establishment to the hazard analysis process. Activities ‘‘expert’’ computer system. However, accomplish the prescribed role. FSIS is constituting the hazard analysis include: advice from colleagues at FDA proposing that the establishment have accurately and completely describing suggested that any system of acceptance on file the name and a brief resume of product composition, developing a flow prior to operational validation was the HACCP-trained individual on whom diagram, listing of all hazards associated likely to be administratively complex it is relying. with each processing step, and and irrelevant to successful The Agency has determined that a collecting of necessary scientific data to implementation. Therefore, the Agency HACCP-trained individual must be assess and validate the effectiveness and has decided that plan acceptance will employed by each establishment. This variability of process controls. During not be a one-time administrative event individual will be responsible for the six-month hazard analysis period, but a process. Successful process addressing and performing functions there should be regular meetings control, as evidenced by the existence of related to hazard analysis, plan between inspection personnel and the a plan having all the features required development, plan validation, review establishment HACCP team on the by the seven principles plus the and assessment of critical limits, and subject of the hazard analysis. capacity of the plan to result in responses to deviations. The HACCP Once the hazard analysis has been production of complying products, will trained individual will be pivotal in an completed, it is expected that mean that the plan is acceptable. establishment’s ability to successfully identification of CCP’s will begin and Inspection activities will be designed assure process control in an operational the activities related to the remaining to verify that the plan has all the HACCP system. The Agency recognizes principles will be carried out so that the required features, that the plan and the 6818 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules records it generates are a reflection of related activities contain the identity of Extensive copying of records is what has occurred during processing of the product, the product code or anticipated only in cases where there products, that deviations have elicited slaughter production lot, and the date was evidence of non-compliance with appropriate responses, and that the record was made. The purpose of requirements or deviations from critical continually complying products have this proposed requirement is to assure limits that resulted in product safety been produced. Whenever any of these that both the establishment and the problems. In such instances, complete conditions are not met, the plan will be regulator can readily link a record to a access to all pertinent records would be judged to need revision and product and the period during which necessary. FSIS invites comments on revalidation. the product was processed. FSIS is also this issue. In essence, establishment-specific proposing to require that the Training HACCP plans will be developed, information be recorded at the time that reviewed, and validated at the it is observed and that the record be There is significant interest by the establishment level on a continuing signed by the operator or observer. Agency in HACCP training for Agency basis, with activities by both Second, FSIS is proposing to require and industry personnel. FSIS takes full establishment and Program employees. that the HACCP records associated with responsibility for the training of its own This has emerged as the most viable and the product to be shipped be reviewed personnel within time frames that efficient approach for both the Agency by an establishment employee other permit the orderly implementation of and industry. than the one who produced the record, HACCP. The Agency’s interest in before the product is distributed in HACCP training for the regulated Responding to Deviations From Critical industry is based on the need to assure Limits commerce. The purpose of this review is to verify that the HACCP system has that both industry and Agency personnel are receiving training that is FSIS is proposing to require that been in operation during the production founded on a single vision of HACCP deviations from critical limits trigger a of the product, that it has functioned as prescribed set of actions by an and how it is to operate. designed, and that the establishment is Two areas concerning training establishment. taking full responsibility for the product First, under this proposed provision, requirements were considered by the meeting applicable food safety product affected by the deviation from Agency in determining how training for regulatory requirements. If a HACCP- the critical limit must be segregated and HACCP-trained individuals should be trained individual is on-site, that person held until the significance of the evaluated: The availability of training should be this second reviewer. The deviation can be determined. Second, and whether to require acceptance or reviewer should sign the records. FSIS the establishment must make the accreditation for training programs. program personnel will be performing necessary determination of the effect of Upon review the Agency determined similar reviews of HACCP records on a the deviation on product safety. This that there are a number of options for regular basis, but their oversight cannot determination must be made in the industry when selecting the be substituted for the establishment’s consultation with a HACCP-trained appropriate training course for their review. individual and any other subject-matter employee(s). Among these are courses experts needed to deal with the Third, FSIS is proposing that HACCP offered by industry trade associations, deviation in question. In consultation records generated by the establishment such as AMI, the National Food with this person or team, the be retained on site for at least one year Processors’ Association, and others. establishment should also determine and for an additional two years on-site Academia also offers courses in HACCP whether the deviation reveals the need or at another location. HACCP records principles and application. Groups such to modify either the process itself or the will be necessary in the revalidation as the HACCP Alliance, The National HACCP plan. process. Further, FSIS’ experience with Center for Food Safety and Technology, Finally, FSIS is proposing to require other recordkeeping requirements and accredited universities are among that establishments record all steps indicates this is a manageable time the available sources for HACCP taken in response to a deviation from a frame. FSIS invites comments on the training. Private consultants and critical limit and include that appropriateness of these records consulting firms also offer HACCP information as part of the HACCP retention requirements. training. Other available resources record. Documentation of deviations Finally, FSIS is proposing to require include a list of HACCP courses should be brought to the attention of that HACCP plans and records be prepared by USDA’s Extension Service. FSIS personnel. available for review and copying by These training sources are all available program personnel at reasonable times. to the regulated industry although the HACCP Recordkeeping Industry records are reviewed by cost, length, and to some extent, the Maintenance of accurate HACCP Program personnel as part of their content of these courses differ. records is fundamental to a HACCP assigned tasks. Comprehensive records Recognizing that there are differing system and is the cornerstone of its access is necessary to permit needs for technical knowledge and usefulness to regulators. Therefore, FSIS verification of all aspects of a HACCP ability to pay for these courses among is proposing to require that these system. However, FSIS does not intend the regulated industry, FSIS has records contain certain necessary to routinely copy or take possession of determined that each responsible information; that the records be such records. It is the Agency’s intent to establishment official should be systematically reviewed by the generate its own records of its responsible for deciding which provider establishment; that the records be verification tasks and results rather than of training best meets the maintained for a specific period of time; duplicate the records of the establishment’s needs. and that FSIS Program personnel be establishment. Data collection A second concern is whether the given access to these records. instruments for program employee Agency should stipulate that the courses First, FSIS is proposing that the verification tasks are being developed taken by a HACCP-trained individual be records involving measurements during and will become the Agency’s subject to acceptance or accreditation. slaughter and processing, corrective verification record that the HACCP This accreditation could be conducted actions, verification check results, and system is functioning as intended. by the Agency, by an outside body (e.g., Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6819 scientific body or professional urgency because of the food safety prepared by central kitchens, for association) under the auspices of an benefits associated with HACCP. The example cooked sausage, hams, frozen industry-sponsored accreditation time frame for implementation in these fully cooked beef patties, pizzas. system, or a decision to require no proposed regulations attempts to 06 All Other Shelf Stable, Heat accreditation for courses could be balance these competing concerns. The Treated Product: This includes rendered adopted. An outside source for first phase-in of a process begins 12 products, for example lard and oils. accreditation could be created by the months from the publication of the final 07 All Non-Shelf Stable, Heat industry as is the case in thermal rule and ends at 36 months. This Treated, Not Fully Cooked Product: This processing where a nationally balanced phase-in approach will permit category includes ready-to-cook poultry, recognized course is offered by industry. the regulated industry time to cold smoked and products smoked as a A scientific body or a professional accomplish the training of personnel trichinae treatment, partially cooked, association could serve such a function. and adjust their activities to include battered, breaded, char-marked, batter FSIS considered the implications of necessary HACCP activities. set, and low temperature rendered serving as an accrediting body for FSIS proposes to establish a timetable products, for example partially cooked HACCP training courses. This option for phasing in HACCP based on industry patties and nuggets, partially defatted afforded three choices. First, the Agency production process categories. In beef, ready-to-cook barbecued chicken, could provide accreditation review of identifying process categories for phase- mettwurst, etc. all available HACCP courses. This could in of mandatory HACCP, the Agency has 08 Non-Shelf Stable, with Secondary be accomplished by contracting out the taken a number of factors into account. Inhibitors: This includes products that function. Second, the Agency could These include the knowledge of areas are irradiated, fermented, salted, and provide this service to the regulated where controls similar to HACCP brine treated, for example, oriental industry through staff resources. This presently exist; consideration of all sausages, pressed duck, and irradiated would require a significant diversion of activities conducted by regulated poultry. Agency resources from regulatory establishments; consideration of the 09 Slaughter: This includes all red activities to servicing the industry by wide variety of products produced by meat species, all poultry classes, and all approving a large volume of requests for the regulated industry that are difficult voluntarily inspected species and review of HACCP courses. Third, FSIS to sort into separate product categories; classes. could publish a periodic list of and the nature of changing and constant Special considerations for phasing unacceptable HACCP courses based on product development activities HACCP into small establishments are the training received by HACCP-trained conducted by the industry. Also in discussed below. individuals in establishments with keeping with the process control The proposed effective dates for each proven histories of poor performance. principles inherent in HACCP, FSIS has category are expressed in relation to This would serve only to identify those selected process as the basis for phase- publication of a final HACCP regulation; courses the Agency determined through in, rather than product category. The the six month Hazard Analysis period is establishment performance to be Agency has identified process categories to precede the effective date for each inadequate preparation for a HACCP- that appear to encompass all the process category. trained individual. processes of the regulated industry. In determining the phase-in sequence To assure that training is timely, to They are: for these categories, four options were reduce cost requirements for the Agency 01 Raw, Ground: This category considered. and industry, and to assure that a wide includes ground red meat (beef, pork, The first proposed phase-in option range of options is available to the sheep, etc.), ground poultry, all considered is based on the public health industry, the Agency has tentatively mechanically separated species, and and safety risk inherent in the concluded that the adequacy of courses mechanically deboned poultry. production process. Risk considerations for a HACCP-trained individual should 02 Raw, Other: This category dictate that raw ground product be in be evaluated by each responsible includes all red meat species and the initial implementation period, establishment official. FSIS is not poultry classes not fully cooked followed by slaughter since these proposing to establish an accreditation including non-intact muscle products processes result in products that have process to evaluate training courses, (shaped, formed, separated, etc.), all been shown to pose the greatest risk for because the Agency believes that its intact raw muscle products including foodborne illness. The process evaluation of the establishment’s processed (injected, coated, breaded, categories were then ranked according HACCP performance is the most tenderized, etc.) and all cut, or boned to the food safety process controls resource-efficient means to reveal any product both bone-in and boneless. applied during the manufacturing training deficiencies or mistakes in the 03 Thermally Processed/ process. This option would have course selections made by the Commercially Sterile: Included in this phased-in Shelf Stable, Heat Treated establishment. The Agency is soliciting category are retortable pouches and and Thermally Processed/Commercially comment on this approach and will canned meat and poultry products. Sterile processes in the final groups. consider other viable options for 04 All Other Shelf Stable, Not Heat Those processes include areas in which ensuring appropriate training of Treated: This category includes all significant interventions take place industry personnel. products that are shelf stable including during production to assure product dried, controlled by water activity, pH, safety. Implementation Schedule dehydrated, freeze dried, fermented, The second option considered the Since mandatory HACCP was first and products that meet the requirement controls that currently exist in considered by FSIS, the Agency has for a maximum pH of 4.6, for example regulation mandating critical control been considering the significant issues freeze dried soup or meals, shelf stable points and critical limits related to surrounding orderly implementation. salami, jerky, or dried beef. health and safety. This method would Public discussions regarding phase-in 05 Fully Cooked, Not Shelf Stable: have phased-in those processes where have alternated between the need for This includes all keep refrigerated or the greatest process control experience caution in implementing so significant a frozen products including those that are and regulatory standards exist for the change too quickly and a sense of sliced and packaged, and products earliest implementation dates. The 6820 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules burden for the development of a HACCP The proposed phase-in schedule 4 is Defining a small business as one with a plan and hazard analysis would not as follows: maximum of $2.5 million in annual have been as great for these Final rule plus 12 months: Raw sales allows the maximum time for establishments due to past experience. Ground; Thermally Processed/ compliance with the HACCP This option would initially have Commercially Sterile; and all Other requirement for a significant number of phased-in processes such as Thermally Shelf Stable, Heat Treated Products. establishments, with approximately Processed/Commercially Sterile and end Final rule plus 18 months: All Non one-third of all establishments falling with Raw, Ground; Raw, Other, and Shelf Stable, Heat Treated, Not Fully into the ‘‘small’’ category. Further, using Slaughter processes. Phase-in would Cooked; all Other Shelf Stable, Non the amount of $2.5 million the occur in an inverse order from the first Heat Treated. percentage of slaughter establishments option considered. Final rule plus 24 months: Fully considered small is roughly the same as The third phase-in scenario Cooked, Non Shelf Stable; all Non Shelf the percentage of processing considered by the Agency utilized an Stable with Secondary Inhibitors. establishments falling into this category. evaluation of the number of Final rule plus 30 months: All The proposed definition of a small establishments producing products Slaughter; all Raw Other Product. establishment will not significantly covered by a process and the known Final rule plus 36 months: Small affect achievement of the Agency’s food volumes of industry production for each Establishments. safety objectives, because slaughter and of these processes. In this option, Special Consideration for Small processing establishments in this process category Raw, Other would have Establishments category together account for less than been implemented first since this one percent of annual meat and poultry FSIS believes that planned technical comprises a large sector of industry production in the United States. assistance activities offer benefits to production both by volume and the FSIS invites comment on its approach small establishments. Among these are number of producing establishments. to defining small establishments. The second process for phase-in would the provision of generic models from have been slaughter, since again, this which to begin HACCP plan Regulatory Oversight of the HACCP comprises a large portion of the development and the provision of other System regulated industry both in the number guidance material. Additionally, FSIS is The NACMCF has specifically of establishments and the volume of proposing that small establishments, addressed the subject of the roles of product produced. Thermally regardless of the processes performed regulatory agencies with respect to Processed/Commercially Sterile would and products produced, be permitted 36 establishments in which HACCP is the have been the final process phased-in months from the date of publication of system of process control for food safety under this option since this process the final rule in the Federal Register to (‘‘The Role of Regulatory Agencies and constitutes a small segment of the complete plan development. In Industry in HACCP’’). FSIS is in general regulated industry both in the number determining which establishments agreement with that discussion, of producing establishments and the should be eligible for this especially the part that emphasizes that, volume of production. implementation schedule, FSIS with respect to food safety, The fourth option for phase-in, and considered three ways of defining establishments must operate effective the one proposed by the Agency, ‘‘small.’’ The object was to distribute the HACCP systems and the government incorporates considerations from each economic burden equitably among role should focus on verification that of the above-discussed options, various segments of the industry. HACCP plans are working as intended. (1) Defining ‘‘small’’ on the basis of beginning with the processes that If the regulatory agency were to take on units produced (number of head constitute the greatest public health hazard identification, determination of slaughtered, number of birds risks, combining some other processes CCP’s or critical limits, responsibility slaughtered, or pounds of product where the volume of production in the for corrective actions or monitoring regulated industry is lower, using the produced). Because of the difficulty of responsibilities, it would be option for processes where a large body making meaningful economic undermining the need for the of experience and regulatory criteria comparisons among unlike species and establishment to assume full presently exist, and combining these for processes, the Agency decided against responsibility for the processing of safe the existing time frame of total defining small establishments on the product through the HACCP system of implementation over a 1-to-3-year basis of production volume. process control. period from the publication of a final (2) Defining ‘‘small’’ according to the Verification procedures the Agency HACCP regulation. In all options number of establishment employees. might use include: considered, the category encompassing The Agency rejected this approach small establishments will be phased-in because the number of employees is not (1) Review of the HACCP plan; last. FSIS selected the fourth option a good indicator of the ability of the (2) Review of CCP records; because it takes into consideration establishment to undertake additional (3) Review of deviations and responses production, experience with process financial burdens. to deviations; control, and public health risk. FSIS (3) Definitions based on annual sales (4) Visual inspections of operations to invites comments on the proposed in dollars. This simple, across-the board see if CCP’s are under control; phase-in schedule. measure appears both reasonable, (5) Random sample collection and The Agency envisions that, upon the simple, and fair. For this reason, the analysis (including microbial testing); required implementation date for phase- Agency selected this approach, rather (6) Review of critical limits; in, establishments will be completely than either of the others discussed, (7) Review of written records of ready to operate their HACCP system alone or in combination. establishment verification tasks; and that FSIS will conduct inspection For the purposes of HACCP (8) Revalidation of HACCP plans activities according to HACCP implementation scheduling, FSIS is including on-site observations and principles, including verification and proposing that small establishments be complete records review. validation, to ensure that the HACCP defined as those with annual production FSIS intends to review and revise system as operating is acceptable. valued at or below $2.5 million. existing inspection tasks to assure that Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6821 they are focused on the CCP’s for each so, to what extent the records should be be required, and (3) a processing failure of the processes that will be controlled required to be disclosed. results in the production of adulterated by HACCP plans. These revised tasks product. Relationship to Other Process Control will be incorporated into the PBIS and Suspension of all or a part of an Systems become part of regular assignments for establishment’s inspection services will program personnel. To eliminate duplication, be made under rules of practice, redundancy, and confusion, FSIS is proposed in Part 335 of the Federal meat Public Access to Records considering proposing that the inspection regulations and Subpart W of There is a broad policy question about mandatory HACCP plan become the the poultry products inspection public access to establishment records only Agency recognized process control regulations, requiring notice by FSIS to generated under HACCP. Some groups system for health and safety aspects of the establishment of the reasons for the believe that any records used by the processes/products of each suspension. The notice also would regulatory agencies for making a establishment. Those portions of specify the processing operations determination about the safety of meat existing TQC systems or PQC programs affected (if not the entire establishment) and poultry products produced should that address health and safety issues and the corrective action(s) required be made public to the maximum extent would be encompassed within the before inspection service would be possible. Others take the position that mandatory HACCP plan. Those aspects resumed. such broad-scale access compromises of an establishments operations that are While inspection is suspended, the establishments’ rights to protect not health-and-safety related and, facilities identified in the suspension sensitive commercial information from therefore, not covered by the HACCP notice could not be used for the business competitors. plan would be monitored by tasks production of meat or poultry products. FSIS believes that public access to assigned through PBIS at frequencies Furthermore, if product produced prior any records which it generates itself and determined by the demands of HACCP to the suspension were suspected of any establishment records copied by verification activities. Comments are being adulterated, such product would FSIS as part of its verification tasks invited on this approach. be retained at the establishment pending disposition by the Program, and if would be governed by the Freedom of Enforcement already shipped, such product would be Information Act (FOIA) (5 U.S.C. 552) The enforcement provisions would subject to recall as necessary to protect and the implementing regulations of require that establishments have public health. USDA (7 CFR Part 1, Subpart A). FOIA verified HACCP plans for their A suspension would be lifted and exempts particular commercial and processing operations by the dates inspection service restored upon the financial information from mandatory specified for the establishment and designated Program official providing release by government agencies. As a process. As noted, the HACCP written acknowledgement of receipt of a preliminary matter, it appears that at requirements would be phased in by modified plan, coupled with a detailed least some elements of HACCP plans having different effective dates—12 validation of that plan by a HACCP- and monitoring records would be months, 18 months, 24 months, 30 trained individual. The modified plan considered commercial information of months, or 36 months from the date the must have been developed in the kind exempt from disclosure. FSIS final rule is published, depending on consultation with that HACCP-trained is committed to meeting fully the public the establishment and the product(s) individual. In the case of suspension disclosure objectives and requirements being produced. caused by a processing deficiency of the Freedom of Information Act. Establishments that fail to have a resulting in production of adulterated It should be noted that the FOIA verified HACCP plan in place for a product, a written testing plan would presumes that the governmental agency processing operation by the date also be required. The plan must provide has both possession and control of the required for that operation would have for the testing of finished product record. Therefore, when information is its inspection for that process produced under the modified plan for obtained from an establishment and is suspended. Similarly, new chemical or microbial characteristics, as maintained by FSIS, that information establishments and establishments appropriate, to demonstrate that the becomes an agency record subject to applying for inspection of new process under the modified plan would FOIA. As previously discussed, the processing operations would be denied correct the identified problem. Agency is not proposing that HACCP inspection services after those dates Failure to prepare a valid HACCP plans be submitted for approval. HACCP unless and until a HACCP plan is in plan as specified in the notice, by the plans which have been accepted by place for that process. time specified in the notice, will result virtue of successful process controls The enforcement provisions also in service on the establishment of a will be on file in the establishment and provide that, once adopted, HACCP complaint in accordance with the available for review by FSIS program plans would still be subject to Uniform Rules of Practice. Effective personnel. Therefore, the information verification by FSIS. If a HACCP plan is upon service of the complaint, maintained by the establishments, found by FSIS to be invalid, inspection inspection service will be refused or including monitoring records, would would be suspended from existing withdrawn pending resolution of any not be subject to a FOIA request. operations, pending correction of the hearing. However, if during validation of an HACCP plan. Failure to adhere to a modified establishment’s HACCP plan, or during A HACCP plan might be found HACCP plan, and, if applicable, testing an investigation of an alleged violation, invalid for one or more of three reasons: plan, resulting in a repeat of the HACCP records are obtained from an (1) The HACCP plan does not meet the suspension for the same or a related establishment, those records become essential requirements set forth in the deficiency, would in addition to the agency records subject to FOIA. regulation; (2) HACCP records are not requirement for another modified plan, FSIS invites public comment on the being maintained as required by the require a Program review of the issue of whether broader public regulation and/or the plan, preventing establishment’s performance under accessibility to an establishment’s validation of the plan and/or other provisions of the inspection laws records is in the public interest, and, if verification of process controls as may before inspection would be restored. 6822 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Recurring violations of fundamental unsafe product, and difficulty in contaminated clothing in 120°F water or HACCP requirements would be viewed implementing preventive measures. appropriate sanitizer. as indicating an increased likelihood The following are illustrations of the Records resulting from this CCP might that other violations of inspection application of existing generic models include a random post-evisceration requirements exist and that additional and how they can be used by an carcass examination log. Verification enforcement actions may be required by establishment. might consist of supervisory review of FSIS. records and operations, and random Finally, in the event the The HACCP System for Beef Slaughter examination of carcasses after Administrator finds that HACCP records For beef slaughtering establishments, evisceration using a sampling plan have been deliberately falsified, the a generic HACCP plan which reviews sufficient to assure process control. Agency would in addition to any the processing steps of slaughter In a non-HACCP approach, the suspension in effect, issue a complaint operations can provide general guidance establishment may discover for withdrawal of inspection from the for developing an establishment’s contamination from evisceration much establishment and would refer the case specific plan. The goal of HACCP for later in the process, causing delays to the Department of Justice for criminal slaughter operations is to prevent, before the contamination is removed prosecution. eliminate, or reduce both the incidence and making implementation of and levels of microorganisms preventive measures difficult. 3. Illustrations of the Application of Removing the hide from cattle is a HACCP pathogenic to humans. While beef slaughter operations do not include a major source of microbial contamination The HACCP approach to process lethal treatment (e.g., thermal process) during the slaughtering process. Cattle control is systematic and establishment that ensures the elimination of entering the slaughter establishment specific. The generic models prepared pathogenic microorganisms, a number carry with them microbial populations by FSIS and NACMCF to assist federally indicative of what occurred during the of the processing steps can be controlled inspected establishments to develop care and handling of the live animals. to minimize microbiological hazards. HACCP plans would serve as guides for Salmonella and other types of bacteria A beef slaughter establishment the processes described earlier in this can be spread during the skinning document. In order to clarify these performing a hazard analysis of its process through contact with hide, concepts, some examples are included operation may identify several hazards, hands, and various pieces of equipment. to explain the contrast in operations particularly enteric pathogens, such as Therefore, skinning would be a CCP in conducted under the HACCP system Salmonella. CCP’s where Salmonella a beef slaughter HACCP plan. from those conducted under the contamination might occur can be Methods for control of contamination traditional mode of industry operation. identified and then controlled by at skinning might include adequate Since each HACCP system is developed establishing critical limits, monitoring training of the person doing the by an individual establishment to fit those limits at an appropriate frequency, skinning to minimize contamination, with its process(es), the following and taking corrective actions when including pulling the hide down and examples are meant to serve only as deviations occur. Recordkeeping and out from the carcass as opposed to illustrations, and are not intended to verification procedures would also be upward and away; positive serve as prescriptive blueprints for a identified for these CCP’s in the reinforcement through appropriate specific HACCP plan. establishment’s specific HACCP plan. supervision; and proper cleaning and When developing a HACCP plan, all For example, the intestinal tracts of sanitization of equipment and carcass aspects of a food’s production must be animals can harbor large populations of contact surfaces. considered. The development of a enteric pathogens, such as Salmonella, Monitoring at this CCP might include HACCP plan begins with the even though the animals themselves are observation of the effectiveness of the identification of the product, its asymptomatic. As the slaughtered skinning process for each carcass. Ways distribution, and the intended consumer animals are eviscerated (removal of the to ensure this is working would be to set of the product. A hazard analysis is intestinal tract and other organs), there critical limits. Critical limits for conducted, and the plan is developed by is potential for spreading the skinning might include less than or identifying critical control points, Salmonella from the intestinal tract to equal to 20 percent of carcasses with monitoring procedures, critical limits, the carcass, operator, or equipment, if dressing defects. and the remainder of the seven the intestines are accidentally cut. If this critical limit is exceeded, principles discussed earlier in this Therefore, evisceration would be corrective actions would be required. document. considered a CCP in a HACCP plan for These could include: immediate The HACCP system places the beef slaughter. trimming of defects on carcasses, responsibility for production of a safe Critical limits for the evisceration CCP additional establishment employees and unadulterated product with the might be zero percent occurrence of the added to the slaughter line, and/or a industry. The HACCP approach allows following defects for a single carcass: reduction in line speed. the establishment to focus on the fecal material, ingesta, urine or Records resulting from this CCP might process as it is occurring. If abscesses. The establishment include a random post-skinning carcass contamination is occurring, it should be employee(s) working at evisceration examination log. Verification might immediately identified, allowing for would monitor by observing carcasses consist of a supervisory review of prompt corrective action as well as for contamination defects and would records, examination of random providing an opportunity to determine take corrective actions if the critical carcasses after skinning is complete the cause and take action to prevent a limits were exceeded. Corrective actions using a sampling plan sufficient to future recurrence of the problem. In a might include: immediate trimming of assure process control, and reviewing non-HACCP approach, the defects on carcasses, additional control charts to confirm that sampling establishment may not discover establishment employees added to the frequency is sufficient to detect 20 contamination until much later in the slaughter line, a reduction in line speed, percent defect criteria. Additionally, process, if at all, resulting in delays, the sanitization of evisceration tools in baseline data might be established for possibility of producing and distributing 180°F water, and sanitization of expected bacterial numbers. Periodic Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6823 follow-up analyses and trend analysis evisceration equipment, the level of microbiological hazards can be might be performed to verify process antimicrobial treatment in the chiller, controlled. Critical limits must be set by control. and/or the temperature of the chill an establishment to assure that the Other possible CCP’s in beef slaughter water. These would constitute CCP’s product has been sufficiently heat are described in the ‘‘Generic HACCP identified by the establishment. treated to preclude the growth of for Raw Beef’’ (see Appendix). Critical limits would be set based on pathogenic microorganisms. The allowable levels and types of manufacturer of a poultry bologna may The HACCP System for Poultry ° Slaughter antimicrobials used, monitored by set 160 F as the critical limit for the testing at appropriate frequency, and internal temperature and test a set The current systems of postmortem recorded in a log or other record. amount of product, recording the inspection for poultry share elements of Corrective action taken may include internal temperature, time the a HACCP system approach, such as more frequent changes of chill water, temperature was recorded, and the lot critical limits, monitoring, corrective better temperature control to preclude number and size. action plans, recordkeeping, verification the growth of pathogens, or use of an If the product does not meet the tasks, critical limits or tolerance levels, alternate antimicrobial rinse. critical limit set by the establishment, monitoring tasks, corrective actions, and Currently, some establishments rely corrective action can be instituted that recordkeeping. However, these on FSIS personnel to detect could include recooking the lot of components are not arranged in the contamination by visual examination of product or chilling and reworking the highly organized systematic manner that the carcass or by using chiller water lot into subsequent production. is evidenced in a HACCP system. temperatures as an indicator of less than Major differences between a HACCP The cooling process is another satisfactory conditions. This would example of a CCP in the processing of system and the present poultry occur as a result of end product slaughter systems are hazard a cooked sausage product. Improper examination. The HACCP approach chilling after the lethal heat treatment is identification and analysis, and the requires the establishment to implement specific identification of critical control applied can result in the growth of effective preventive measures. microorganisms (particularly vegetative points which are not a part of current Industry would follow a similar poultry slaughter systems. The spores) which may have survived the protocol for all points in the poultry heating process. Improper chilling will progression to a HACCP system in slaughter process where a potential poultry slaughter would cause some permit the growth of these microbes and hazard can be prevented, eliminated, or render the product unsafe. significant changes to emerge. These reduced to an acceptable level. This changes would include more industry The HACCP approach would ensure demonstrates CCP’s in an establishment- that an establishment targets chilling as involvement and responsibility for controlled HACCP system. control of processes executed to a CCP, sets critical limits including time The HACCP System for Cooked Sausage and temperature parameters (e.g., 5 produce an end product that is safe, ° wholesome, and unadulterated. For the development of a HACCP hours to reach and maintain 40 F Under HACCP, the establishment plan, an establishment producing a internally), monitors the temperature at would define processing steps where cooked sausage must evaluate the entire frequent intervals, records the results, control can be exerted to effectively manufacturing process. The focus of a and takes appropriate corrective action prevent, eliminate, or reduce food safety HACCP plan on the prevention of food if the critical limit is exceeded. hazards. Because Salmonella is a safety hazards requires defining where Corrective action might include significant microbial hazard in raw unsafe conditions can occur, setting recooking the lot of product and poultry, establishments would be target limits, and defining corrective recooling. expected to target measures that prevent action. In addition to microbial hazards, contamination and control the growth of Cooked sausage is a broad category physical and chemical hazards must be Salmonella throughout the slaughter which includes frankfurters (hot dogs identified. The use of nitrite in cooked process. and wieners), vienna sausage, bologna, sausages serves two functions—color For example, under a HACCP system, knockwurst, braunschweiger (liver development and some protection the establishment may set criteria for sausage), and similar products. In this against the outgrowth of anaerobic maximum permissible levels of example, assume that the establishment organisms. Under HACCP, an Salmonella in a flock presented for produces bologna. establishment would set a critical limit slaughter. CCP’s for control of this Because HACCP is a hazard for nitrite in the product, monitor the enteric pathogen may include requiring prevention process control system, formulation of each batch of product that flock health records be reviewed, processing hazards must now be produced, record the exact amount of that the level of Salmonella on each identified. The finished product— each ingredient used, and take flock brought for slaughter be bologna—is a fully cooked product that appropriate corrective action if the limit monitored, and that corrective action be can be consumed without further safety were exceeded. Corrective action might taken when appropriate levels are not treatment (i.e., cooking). include the addition of other met. Consequently, raw materials (meat ingredients, such as meat, to offset the At evisceration, critical limits would and other ingredients) must be handled addition of excess nitrite. be set for fecal or other intestinal to reduce the opportunity for Therefore, it becomes the contamination present on the carcass. microbiological growth. CCP’s requiring responsibility of the establishment Monitoring would be conducted at a set limits would include ensuring that under HACCP to identify CCP’s, frequency, the results would be incoming ingredients are adequately monitoring procedures, and corrective recorded after observing the carcasses, packaged to prevent contamination, and action that specifies what would happen and corrective action would be taken if perishable ingredients are kept within to product that is or may be affected and the limits were exceeded. temperature limits that assure their what would happen to prevent the In addition, control of Salmonella safety. violation from recurring. Finally, all may include targeting the chlorine level Cooking is considered a primary kill HACCP plans must identify the in the rinse water required for automatic step in processed products where documentation that would occur to 6824 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules verify that the process is operating packed, or held under insanitary transported to markets and then to appropriately. conditions whereby [they] may have slaughtering establishments. become contaminated with filth, or While FSIS is proposing significant D. Effective Dates whereby [they] may have been rendered enhancement in its regulatory oversight The proposed requirements for injurious to health’’ (21 U.S.C. of FSIS-inspected slaughter and Sanitation SOP’s, antimicrobial §§ 453(g)(4) and 601(m)(4)). The FMIA processing establishments, improving treatments, cooling standards for specifically authorizes the Secretary to food safety at the animal production livestock carcasses, and microbial ‘‘prescribe the rules and regulations of stage would require a different testing would be effective 90 days after sanitation under which establishments approach. Many producers recognize the date of the final rule’s publication in shall be maintained’’ and to refuse to the need to play an active role in the Federal Register. This would afford allow meat or meat food products to be reducing microbiological and chemical those establishments not yet performing labeled, marked, stamped, or tagged as hazards that originate on the farm. FSIS the proposed interventions the time to ‘‘inspected and passed’’ if the sanitary will work with producers and others to make necessary adjustments. Minimal conditions of the establishment are such develop and foster implementation of preparation would be required to begin that the meat or meat food products are food safety measures that can be taken microbial testing. The requirement to rendered adulterated (21 U.S.C. § 608). on the farm and prior to the animals begin tracking test results in accordance Similarly, the PPIA requires all official entering the slaughter facility to reduce with the moving sums process-control establishments to be operated ‘‘in the risk of harmful contamination of procedures and reporting the results to accordance with such sanitary practices, meat and poultry products. Within this FSIS would be effective 6 months after as are required by regulations context, the voluntary application of promulgation of the final rule. FSIS is promulgated by the Secretary’’ and HACCP principles can be useful in proposing to hold establishments authorizes the Secretary ‘‘to refuse to establishing the CCP’s within the farm accountable for meeting the interim render inspection to any establishment management and live animal targets for pathogen reduction beginning whose premises, facilities, or transportation arenas where pathogenic 2 years after promulgation of the final equipment, or the operation thereof, fail organisms can enter the food chain. rule. to meet the requirements of this HACCP principles can be utilized also The 6-month Hazard Analysis period section’’ (21 U.S.C. § 456). to structure voluntary national animal health programs that focus on risk would begin no less than 6 months In addition to this specific authority, reduction and producer incentives to before the HACCP phase-in date, as set the Secretary has broad authority under reduce the prevalence of a given forth for each of nine process categories both Acts to promulgate rules and and for small establishments, as pathogen. Such voluntary programs can regulations necessary to carry out the be built upon similar, successful food provided in the proposed 9 CFR 326.7 Acts (21 U.S.C. § 463, 621). and 381.607. safety efforts presently in use. These Based on these statutory provisions, include industry-sponsored quality FSIS invites comment on these FSIS is proposing that establishments proposed effective dates. assurance programs, such as the Milk take affirmative action, including and Dairy Beef Quality Assurance III. Other Issues and Initiatives adherence to sanitation standard Program, a ten-point grassroots operating procedures, the application of A. Legal Authority education effort by the National Milk antimicrobial treatments and microbial Producers Federation and the American The Poultry Products Inspection Act testing, the adherence to cooling Veterinary Medical Association; pork (PPIA) (21 U.S.C. 451 et seq.) and the requirements for livestock carcasses, and beef quality assurance programs Federal Meat Inspection Act (FMIA) (21 and the development and adherence to developed by the National Pork U.S.C. 601 et seq.) were enacted to HACCP plans, to reduce the occurrence Producers Council and the National protect the health and welfare of and levels of pathogenic bacteria on Cattlemen’s Association; the American consumers by assuring that meat and meat and poultry products and to Veal Association’s quality assurance poultry products distributed in protect the health and welfare of program; the GMP guidelines developed commerce are ‘‘wholesome, not consumers. FSIS is also proposing, by the National Broiler Council and adulterated, and properly marked, based on these statutory provisions, to several quality assurance efforts by the labeled and packaged’’ (21 U.S.C. §§ 451 establish interim targets for quantitative United Egg Producers; the chemical- and 602). The term ‘‘adulterated’’ is reductions in the incidence of residue avoidance program of the defined in the Acts to include any meat contamination of meat and poultry with National Turkey Federation; and the or poultry product that is ‘‘unsound, microbial pathogens. These actions to flock health-certification program of the unhealthful, unwholesome, or otherwise protect public health and improve the American Sheep Industry Association. unfit for human food’’ (21 U.S.C. §§ 453 safety of meat and poultry products are All these programs focus on actions that (g)(3) and 601(m)(3)). Meat and poultry authorized by the various provisions of individual producers can take to products that bear or contain any the Acts referenced above. improve the quality and safety of the poisonous or deleterious added B. Improving Food Safety at the Animal products they market. These programs substance which may render them Production Stage provide a foundation for building future injurious to health, and meat and on-farm food safety initiatives. poultry products that bear or contain There is wide agreement that ensuring There may also be a link between on- inherent substances in sufficient food safety requires taking steps farm control measures and the proposed quantity to ordinarily render them throughout the continuum of mandatory implementation of HACCP injurious to health are also production, slaughter, processing, in FSIS-inspected meat and poultry ‘‘adulterated’’ within the meaning of the distribution, and sale of livestock and establishments. For example, Acts (21 U.S.C. §§ 453(g)(1) and poultry carcasses and meat and poultry establishments may determine that the 601(m)(1)). products to prevent hazards and reduce external cleanliness or degree of The term ‘‘adulterated’’ is also the risk of foodborne illness. The U.S. external contamination of animals with defined to include meat and poultry food safety continuum begins on the pathogenic microorganisms at the time products that have been ‘‘prepared, farm. From there, animals are the animals enter the slaughter Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6825 establishment is a critical control point. service industry are important links in safety of meat and poultry products and This would require that the the chain of responsibility for food other foods during transport; establishment and the producer work safety that extends from the farm to the • Work with the Department of together to ensure that an appropriate consumer. FSIS has historically focused Transportation to implement the critical limit has been met. This possible on the manufacturing of meat and National Food Safety Transportation linkage between in-plant mandatory poultry products, but the Agency’s Act, and investigate whether additional HACCP and the control practices of public health mandate requires that it authority is needed to carry out the producers simply reflects the reality that also work with the animal production, shared food safety mission of FDA and improving the safety of meat and transportation, distribution, and retail FSIS. poultry products will require sectors to implement effective In the area of retail distribution, FSIS cooperative action across the entire food prevention strategies and ensure that the has worked closely with FDA in the system from production on the farm all whole system is working effectively to recent updating of the Food Code, a set the way to the consumer. The expertise prevent food safety problems. of model ordinances that serve as a and commitment of the producer FSIS and FDA share authority and guide for State and local authorities who community will be critical to making responsibility for overseeing the safety have primary responsibility for the real progress. of meat and poultry products after they regulation of retail stores and FSIS invites comment on the role it leave FSIS-inspected facilities. In accord restaurants. FSIS and FDA will continue can best play to improve food safety at with the Administration’s National to work on making the code the animal production stage. Because Performance Review, FSIS and FDA comprehensive, focusing on areas of FSIS resources in this area are limited, have agreed to work together to ensure greatest concern, and using existing the private sector must continue and effective oversight and the adoption of FDA mechanisms such as seminars, perhaps expand its efforts and preventive approaches through the workshops, and evaluations for getting initiatives. One role FSIS expects to chain of transportation, distribution, the word out in a timely manner on play is as a facilitator of research and storage, and retail. important changes and assuring good other activities designed to define FSIS exercises regulatory oversight of understanding of the practices involved. problems and opportunities for meat and poultry products in FSIS and FDA will collaborate in improvement and develop animal transportation, storage, and distribution presenting issues to the Conference for production technologies and practices channels through the activities of about Food Protection and in responding to that can improve food safety. FSIS 130 compliance officers who conduct a the Conference’s recommendations, on intends to work closely with academic nationwide monitoring program to which the States vote. In addition, the researchers, other government agencies, prevent adulterated or misbranded two agencies will work together to producer groups, and consumer product from reaching consumers. FDA facilitate State audits, and to provide organizations to help shape an also conducts regulatory activities in assistance for whatever changes the appropriate research agenda and devise this sector. In addition to monitoring audit results indicate. effective on-farm food safety strategies. retail food safety programs at the State FSIS and FDA will also work together FSIS also intends to work closely and level, FDA provides technical assistance to encourage State adoption of the Food cooperatively with producers and with to States in the form of a uniform code Code as a means to ensure that State health and agricultural officials (the Food Code discussed below) that consistent, science-based food safety when outbreaks of foodborne illness prescribes appropriate food handling standards are being observed at the necessitate investigations to trace a practices in distribution and retail retail level across the country. safety problem to its origins which may channels. in some cases be at the animal FSIS and FDA will review their D. Health-Based Standards for production stage. Such investigations respective programs to determine how Pathogenic Microorganisms are a problemsolving tool intended to they can, considering all of the Overview assist public health authorities in resources being devoted to this sector, controlling an ongoing food safety reconfigure the program or initiate As explained elsewhere in this problem and finding means to prevent activities to increase program document, the FSIS food safety or reduce the likelihood of occurrence effectiveness. Two specific areas of regulatory strategy rests on articulating of the problem in the future. Traceback review will be transportation of product what constitutes an acceptable level of investigations are resource-intensive in commerce and handling and food safety performance by meat and and difficult to conduct. They require preparation of food products by retail poultry establishments and holding cooperation among government agencies stores, restaurants, and institutions. establishments accountable for at all levels and with the animal In the area of transportation, FSIS is achieving that level of performance. The production and processing industries. currently working with FDA on the proposed HACCP regulations will FSIS invites comment on the development of guidelines for provide the framework for adoption by appropriate role of traceback conveyances used to transport food all meat and poultry establishments of investigations and how they can best be products. FSIS and FDA have agreed to: the science-based preventive controls conducted and used to improve food • Ask a group of experts to provide that will be necessary to achieve the safety. systematic information on the hazards food safety objectives established by FSIS. C. Transportation, Distribution, Storage, and controls that currently exist; • Develop practical standards of As an initial step toward articulating Retail performance for establishments and an acceptable level of food safety Just as food safety hazards can arise carriers with respect to the transport of performance and reducing the frequency before animals enter the slaughterhouse food; and degree of contamination of meat so too can they arise after meat and • Develop a list of Good and poultry products with pathogenic poultry products leave FSIS-inspected Manufacturing Practices and options for microorganisms, FSIS is proposing to slaughter and processing encouraging their use; require reductions in the incidence of establishments. The transporter, the • Initiate joint rulemaking to establish one pathogenic microorganism of wholesaler, the retailer, and the food appropriate standards to ensure the significant public health concern, 6826 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Salmonella, based on what is achievable Addressing these public health policy This distribution of the host and in the near term with available science issues is sometimes referred to as risk pathogen characteristics means that the and technology. FSIS may in the future management. potential for infection must be treated as adjust the interim targets for Salmonella FSIS invites public comment on the a probability function. This approach is downward, as experience warrants, and utility of health-based food safety replacing the older concept of minimum may consider adopting similar performance standards and the issues infectious dose, which fails to take into technology-based interim targets for involved in developing them. FSIS also account the distribution of other pathogens. intends to hold one or more public susceptibility within the host As explained earlier in this document, meetings to explore this topic with population. As the number of pathogen FSIS also intends to pursue over the interested persons and experts in the cells to which the host population is long term development of science-based industry, scientific, consumer and exposed increases, there is a food safety performance standards that public health communities. Details on corresponding increase in the are based on what is necessary and the time, place, and agenda for such probability of infection among the appropriate to protect public health. meetings will be published in a future population. This is the approach typically taken in issue of the Federal Register. While the The amount of data on the the regulation of chemical residues in public health policy issues in this area quantitative dose-response relations for food: tolerances are established that are difficult and important, it is human and various foodborne limit the amount of residue that can be necessary first to consider the scientific pathogens is severely limited. However, lawfully present based on an assessment basis for setting health-based food safety available data do allow estimation of of what limit is necessary to ensure the performance standards. The following infection rates for many foodborne safety of the food. For certain cooked, paragraphs describe the current state of pathogens. In many instances this may ready-to-eat products, and more recently knowledge in this area and some of the be sufficient since, barring exceptional in the case of E. coli 0157:H7 in raw scientific issues that need to be pathogenic resistance or host ground beef, FSIS has determined that addressed. susceptibility, the key data for a pathogens at any level pose a safety microbial risk assessment in foods are concern and legally adulterate the Quantitative Risk Assessment for estimates of exposure (i.e., the numbers product, in effect setting a zero Microbial Pathogens of pathogens ingested by consumers) tolerance for such pathogens. Integral to development of public and their correlation with infection Other than E. coli 0157:H7 in raw rates. health-based food safety performance ground beef, a potential hazard that A key limitation on the application of standards is an understanding of the survives traditional cooking practices risk assessment techniques to microbial relationship between bacterial levels followed by many people, FSIS has not food safety issues has been that, unlike taken this approach with pathogenic and the incidence of disease. The most chemical toxins, the levels of microorganisms contaminating raw likelihood that an exposure to a bacteria in food are not constant. They meat and poultry products. FSIS has foodborne pathogen will produce a can change drastically as the result of relied in part on the fact that proper and disease response in an individual is growth or inactivation. The ability to generally accepted cooking practices kill dependent on the pathogenicity of the run risk assessment scenarios to study most pathogens present in most raw microorganism, the level of exposure the potential impact of changing food products. It is also believed that for (i.e., number of microorganisms processing or food preparation protocols some important pathogens, such as ingested), and the susceptibility of the is dependent on acquiring a reasonable Salmonella, Staphylococcus aureus and host. Qualitative and quantitative estimate of the levels of a pathogen Bacillus cereus, some minimum number consideration of these factors is the consumers are ingesting. The ability to of organisms may be required to pose a basis for conducting a microbial risk estimate exposure is, in turn, dependent significant threat of illness, although assessment. on being able to estimate (1) The there is much scientific uncertainty in Pathogenicity describes the overall probability that the pathogen is present this area and susceptibility to illness disease-causing capability of a in the food ingredients, (2) the initial varies among individuals. microorganism. The inherent potential levels of the pathogen that can be The task of establishing science and for a microorganism to cause disease is expected if the microorganism is public-health based food safety associated with one or more genetic present, and (3) how these levels are performance standards for meat and characteristics (i.e., virulence factors). likely to change as a result of operations poultry products, such as by identifying The virulence of a species is reflected in associated with the processing, levels of specific pathogens that pose a the levels of the microorganism that are preparation, and storage of the food. threat to public health and requiring needed to colonize a host and produce While there are still methodological that those levels not be exceeded, raises an infection or toxigenic response, as limitations, recent advances in difficult scientific and public health well as the severity (i.e., medical predictive microbiology and the policy issues. These include consequences) of the disease. However, systematic collection of baseline data on determining the nature of the hazard pathogens must always be considered in the presence of pathogenic bacteria in posed by particular pathogens and the the context of their host, since disease foods have begun to allow the first actual threat to health posed under processes are dependent on host/ quantitative microbial risk assessments. various conditions of exposure to the pathogen interactions. In any In the case of some significant pathogen—an inquiry commonly population, individuals will have a foodborne illness sources, such as referred to as risk assessment. In setting varied response to any specific contamination of raw poultry with such standards, it also must be pathogen. This includes both the levels Salmonella and Campylobacter, the determined how protective the standard of the pathogen needed to elicit an illness is more often caused not by is to be: how strong must the assurance infection or morbidity, and the extent direct consumption of the contaminated of safety be? Is any degree of risk and duration of symptoms. Typically, food but by cross-contamination of other acceptable? How can potential risks be there will be a distribution of foods during handling and preparation. managed by quantitative limits, labeling susceptibilities as a function of the FSIS is not aware of research having or some combination of measures? levels of ingested pathogen. been done to correlate levels of specific Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6827 pathogens in raw meat or poultry with methods and databases for pathogenic technological progress that can improve the risk of cross-contamination and microorganisms. This will likely food safety in such important areas as consequent illness. Whether include laboratory research, in-plant pathogen reduction. At the same time, experimentally derived or acquired studies and community-based representatives of consumer groups through correlation of community epidemiological studies to evaluate have expressed concern that disease rates and pathogen levels in health outcome in meat and poultry technologies claimed to be effective for meat or poultry, FSIS would be inspection. FSIS intends to use the pathogen reduction and other important interested in reviewing any available public meetings mentioned above to food safety purposes be proven effective data. At the same time, recognizing the canvass the current state of knowledge for that purpose and that the scientific key nature of such data, FSIS is in this area and encourage development processes used by FSIS to evaluate committed to working with the CDC and of a coherent research agenda that can technologies be more open to public the research community to obtain the contribute to progress in this important scrutiny and participation. necessary information. area. FSIS believes that the development Finally, quantitative risk assessment and proper use of technology can for pathogenic microorganisms is E. FSIS Technology Strategy contribute significantly to improving the complicated by the wide variability in Overview safety of the food supply, especially susceptibility to particular pathogens with regard to reducing the threat posed among individuals and groups of FSIS has a longstanding interest in the by pathogenic microorganisms; and can, individuals in the population. It is well technologies used in meat and poultry in general, improve the Agency’s ability known, for example, that the young and establishments. The facilities, to carry out its mission. The FSIS food the elderly are at significantly greater equipment, and processes used during safety strategy depends heavily on risk of serious illness or death from slaughter and processing of meat and establishing food safety objectives for consumption of E. coli 0157:H7 than the poultry can significantly affect the the meat and poultry industry, which in general population. Any person with a safety, quality and wholesomeness of turn provide an incentive for industry to weakened or compromised immune the finished product. The safety of the innovate to meet those objectives. To system, whether due to age or illness, is product can be affected adversely by the make this strategy work, FSIS must not generally more vulnerable to foodborne wrong technology, such as equipment be an obstacle to beneficial innovation. illness associated with pathogenic whose food contact surfaces cannot be Therefore, FSIS is reviewing its microorganisms. Thus, in developing adequately cleaned, or by misuse of a current policies and procedures the scientific basis for risk assessment, technology, such as a chemical sanitizer governing review and approval of in- attention must be paid to these or preservative that is used above plant technologies with the intention of subpopulations so that any resulting established safe limits. simplifying them to the maximum health-based standard will be There are also many technologies that extent possible, while ensuring that adequately protective of the population can be used in meat and poultry important safety and efficacy issues are as a whole. establishments to help protect product considered. FSIS invites comment on its from physical, chemical, and biological, technology strategy, including the issues Future Activities especially microbiological, hazards. and activities outlined below. FSIS also FSIS intends to work closely with the These include laboratory and in-plant intends to convene one or more public Centers for Disease Control and methods to test for chemicals, animal meetings to gain further input on how Prevention, the Food and Drug drugs and bacteria; technologies for it can improve its role in fostering and Administration, other public health preventing harmful contamination by overseeing the implementation of new agencies, academic scientists, and the pathogenic microorganisms; chemicals technologies to improve the safety of industry and consumer communities to or physical treatments that can be meat and poultry products. Some of the develop the scientific basis for microbial applied to carcasses to reduce Agency’s current perspectives and risk assessment and the creation of pathogens; and equipment to verify activities in the area of technology health-based performance standards for pathology diagnoses. development and evaluation are pathogenic microorganisms. FSIS FSIS currently regulates virtually all outlined below. recognizes that the scientific issues are substances, processes, and pieces of difficult and that it may not be possible equipment found in meat and poultry Current Perspectives and Activities in the near term to establish health- establishments that might affect the As a general rule, the development of based standards for all pathogens. It is safety, quality, or wholesomeness of the technologies required to produce safe important to begin this effort, however, product, through either prior approval and wholesome products is a because, as progress is made in the near on a plant-by-plant basis or publication responsibility of the meat and poultry term toward pathogen reduction on the of generic approvals or lists of approved industry and allied enterprises, such as basis of available technology, it will be items. The principle objectives FSIS equipment designers and increasingly important to know what pursues with these mechanisms are to manufacturers, pharmaceutical constitutes an acceptable level of food ensure that the technology does what it companies, analytical laboratories, safety performance from a public health is claimed to do (especially if the claim manufacturers of non-food compounds, perspective. Health-based performance is safety related) but does not jeopardize and many others. Innovative standards can provide an incentive for the safety or wholesomeness of the technologies are continually developed further improvement and progress in product, cause or contribute to by these entities to enhance reducing pathogenic microorganisms economic adulteration, interfere with productivity and profitability in the and an indication of the point beyond FSIS inspection, or jeopardize the safety meat and poultry industry. FSIS which further reduction would be of inspectors. believes that industry innovation can unlikely to yield a public health gain. Recently, members of the regulated also be directed to improving food FSIS will seek to stimulate—and to a industry have complained that the safety if the right incentives exist. FSIS limited extent conduct and support— Agency’s control mechanisms, intends as part of its long-term food the scientific research needed to especially its prior approval processes, safety strategy to increase the incentive develop quantitative risk assessment stifle innovation and may retard for such innovation by establishing 6828 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules public health-driven targets, guidelines, In some circumstances, the FSIS programs. The Slaughter Inspection or standards that establishments will be evaluation of a new technology may Standards and Procedures Division has held accountable for meeting. This need to consider the efficacy of the developed and made available protocol should have its greatest impact in technology, that is, its success in guidelines so that companies that want slaughter establishments, where such accomplishing its intended objective. to conduct in-plant demonstrations of targets, guidelines, or standards do not For example, if FSIS has a regulatory antimicrobial treatments will know generally exist today. requirement for the use of an what is necessary to secure Agency FSIS will focus its own limited antibacterial treatment, as is proposed approval. technology development efforts on tools elsewhere in this document, the Agency Providing clear guidance of this kind that can assist the Agency in detecting will take an evaluative interest in assists companies in meeting the and evaluating food safety hazards or whether a specific treatment in fact has Agency’s requirements and will addressing other issues within its the intended and required effect. In continue to be an important part of statutory responsibility, such as addition, if a company intends to make FSIS’s effort to improve its technology economic adulteration. These efforts a marketing claim for a process or review function. As outlined below, have traditionally included, and will technology used in an establishment— however, FSIS intends to take a number continue to include, the development of such as a claim that its product is of additional steps to help foster sensitive and reliable analytical ‘‘pathogen free’’—FSIS will require a development, appropriate review, and methods and diagnostics that can assist demonstration that the claim is valid. prompt implementation of beneficial the Agency in verifying the safety of On the other hand, in circumstances new technologies, especially those that meat and poultry products and where industry interest in the can help improve the safety of meat and detecting product characteristics of technology is not based on required or poultry products. claimed health and safety effects, but on regulatory interest. FSIS will also Future Agency Activities continue its efforts to develop tools that a productivity concern, FSIS interest will be limited to ensuring that relevant As already noted, FSIS is reviewing it can use to advance its food safety all of its existing systems of prior mission but that require long-term safety questions have been addressed. When FSIS makes significant approval or other procedural commitment to develop, such as various decisions about the safety or requirements that are now in place computer models on pathogen behavior. effectiveness of an in-plant technology, regarding the development and In these cases, the Agency has (1) it must ensure that its decisions are implementation of technologies in meat carried out its own technology scientifically sound and open to and poultry establishments. The Agency development efforts, as it did in appropriate public scrutiny and intends to eliminate, streamline, or developing quick tests for antibiotics participation. An example of how this otherwise modify its systems and and species identification; (2) secured can be achieved is the approach taken procedures, as appropriate, to ensure the assistance of the Agricultural in an earlier section of this document to that its legitimate oversight obligations Research Service and Cooperative State inviting public comment on the possible are met without unduly delaying the Research Service, as it has done with antimicrobial treatments that might introduction of beneficial new computer modeling of pathogen growth satisfy the proposed requirement that all technologies or imposing unnecessary under various times and temperatures; meat and poultry establishments adopt burdens on establishments seeking to and (3) occasionally, supported specific at least one antimicrobial treatment. adopt such technologies. work by academic institutions or other FSIS invites comment on this approach One approach FSIS is considering is private entities through use of and other means for ensuring that its a simplified single-stop approval competitive bidding processes, as it did scientific decisions are sound and open mechanism for industry-wide recently by awarding more than to public scrutiny. application of proven pathogen $700,000 in contracts for development During the past several years, staffs in reduction technologies, once necessary of methods to detect pathogenic the Agency have begun efforts that laboratory and in-plant trials have been microorganisms. would permit technological change to completed and the data have been The resources available to FSIS for proceed more readily from the evaluated. The generic approvals FSIS such technology development activities development to the implementation recently granted for use of hot water and are very limited. Moreover, FSIS has stage. The Facilities, Equipment and organic acids in conjunction with the found that there is often considerable Sanitation Division has explained many final carcass wash in beef slaughter interest within the regulated industry in of the principles and criteria that it uses establishments could provide a using technologies that were originally to make decisions in publicly available workable model for expediting the developed by FSIS. FSIS intends to documents so that they can be readily adoption of pathogen-reducing explore mechanisms for stimulating understood and used by companies as technological developments. The private sector investment in analytical they plan changes in their physical Agency’s scientific evaluation would be methods and other technologies that can plants. The Microbiology Division has for the purpose of ensuring that efficacy assist the Agency in its regulatory role provided public notice about the is demonstrated, that conditions of use but that also can assist the industry in circumstances under which it will are specified so the technology can be carrying out its food safety formally evaluate analytical methods widely replicated, and that verification responsibilities. that may be useful in the FSIS program, techniques are available. Once this FSIS believes that its primary role and it has negotiated a Memorandum of scientific evaluation has been with respect to new in-plant Understanding with the AOAC Research completed on a generic basis, approval technologies developed by industry Institute that will permit manufacturers for industry-wide use without further should be to ensure that the of test kits designed for use by the constraints, such as plant-by-plant technologies do not interfere with industry to have their technologies review, could be granted by the inspection, threaten the safety of the evaluated for that purpose. The Administrator or his/her designee. FSIS product, or violate other statutory Processed Products Inspection Division invites comment on this approach, standards, such as those concerning has developed guidelines to be used in including what public process would be economic adulteration. preparing various required QC appropriate in making such decisions. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6829 FSIS is also establishing a single point for this meeting will be published in a represents the Agency’s food inspectors, of contact in the Agency regarding future issue of the Federal Register. as well as organizations representing the technology development and Agency’s veterinarians (National F. FSIS Inspectional Roles implementation. This will be the newly Association of Federal Veterinarians constituted office of technology The current FSIS program, as (NAFV)) and technical and supervisory development in the Science and described in Part I of this document, is personnel (Association of Technical and Technology Program. This office will fundamentally an inspection program. It Supervisory Personnel (ATSP)). The serve as the initial point of contact for is a program designed to ensure through Agency will continue this consultation all inquiries about technology inspection that proper sanitary practices throughout the pathogen reduction and development, and it will help are observed, that organoleptically HACCP rulemaking process. FSIS also coordinate evaluations that involve detectable defects, including diseased intends to work closely with the multiple divisions in the Agency so that and contaminated carcasses, are bargaining unit and the employee responses to inquiries will be timely excluded from the food supply, and that organizations in formulating a plan for and complete. other requirements and standards the optimal utilization of the Agency’s This office will also coordinate related to safety, economic adulteration, inspectional workforce, and FSIS will development of, and make available to and misbranding are met. comply fully with its obligations under interested parties, a single guideline for The long-term FSIS food safety the Basic Agreement with the NJC to experimental protocols to be submitted strategy and the HACCP proposal set bargain on matters that impact to the Agency prior to commencing an forth in this document will bring about inspectors. in-plant study of a new technology. substantial change in industry practice The Agency’s employees and their Some new technologies need to be and in the FSIS program, as the Agency representatives are strongly committed evaluated in in-plant trials to determine clarifies and reinforces the industry’s to ensuring the safety of the food supply their safety and effectiveness before they responsibility for producing safe food, and building the best possible food can be appropriately evaluated by FSIS. prepares to play its oversight role to safety program. They have a critically The Agency does not intend to impede ensure companies are implementing important expertise and perspective that those trials, but it must be assured that HACCP properly, and works to ensure must be brought to bear in developing they produce data that will be adequate that all participants in the food optimal roles and responsibilities for to address the Agency’s concerns. Thus, system—producers, processors, FSIS employees. one important element of the guideline distributors and retailers—are meeting Many of the current roles of FSIS will be a description of the information their food safety responsibilities. inspectors are controlled by the that must be submitted to satisfy the With these changes, inspection of statutory mandates for: (1) Carcass-by- Agency’s basic safety concerns. For products and practices will remain carcass inspection in slaughter those circumstances in which the central to the FSIS program. HACCP establishments; (2) continuous FSIS Agency will be evaluating the efficacy of verification will necessarily expand the inspectional presence in all processing a technology, the guideline will provide roles in-plant inspectors will be called establishments; and (3) inspectional detailed information about the Agency’s upon to play, and HACCP will enhance responsibilities for non-safety expectations for data offered to the contribution in-plant inspection can wholesomeness and economic demonstrate efficacy. This information make to ensuring the safety of food. In adulteration. FSIS is committed to will address such areas as the quality of addition, the need to address food safety carrying out these existing mandates. the experimental design, the necessary across the continuum from the farm to Moreover, changes in FSIS inspectional quantity and quality of data, the plan for the consumer, as discussed in the roles will be constrained by the level of data analysis, and other relevant preceding sections of this document, resources available to support the elements. raises the question of the role FSIS inspection program. Nevertheless, some Finally, FSIS intends to interact inspectional oversight should play of the inspectional issues FSIS expects publicly with the regulated industry and outside of slaughter and processing to be addressing are outlined below. all interested parties to foster the establishments. FSIS recognizes that food safety development of beneficial new food Although the demands that will be begins at the original point of safety technologies and to improve how placed on the FSIS inspection force by production of the food animal—the the Agency plays its role in this critical HACCP and other elements of the farm—and can be affected at every step area. In areas where FSIS is engaged in Agency’s food safety strategy will along the way, including each step of technology development of its own to develop over the next two to four years, animal production and transportation advance its regulatory objectives, the it is important that FSIS begin leading to delivery of the animal to the Agency intends to identify research that considering now the future roles of the slaughterhouse. Many in the agricultural is needed to support its efforts. FSIS is FSIS inspection program and how FSIS producer community have recognized also interested in learning more about can maximize the contribution its the potential for applying quality the opportunities that exist for inspectors make to ensuring the safety assurance principles, including HACCP, improving food safety through the of the food supply. One of the Agency’s on the farm to prevent the introduction adoption by establishments of most important challenges and of potential food safety hazards at their scientifically sound processes and obligations is, by means of training and source. Although the Agency welcomes technologies in both slaughter and a clear definition of roles and this initiative, FSIS does not currently processing operations, and the Agency responsibilities, to prepare its workforce have and does not anticipate on-farm seeks public input on its effort to to meet the demands of the future. inspectional authority. improve its systems for reviewing and In the course of developing the food As discussed in Part I, the first point approving new technologies. As a first safety strategy and regulatory proposals of FSIS inspection is the antemortem step, FSIS intends to hold a public set forth in this document, FSIS has inspection that occurs just before meeting on these topics during the consulted with the National Joint animals enter the slaughter process. It is comment period on the regulations Council (NJC) of Food Inspection Locals appropriate to consider whether FSIS proposed elsewhere in this document. of the American Federation of should broaden its antemortem Details on the time, place and agenda Government Employees, which inspectional oversight of conditions 6830 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules under which animals are held in the At the retail level, FSIS intends to consider how FSIS inspectors could period immediately before slaughter work closely with FDA and State and verify with an acceptable degree of within its current authority. This is a local officials and will continue to rely confidence that functions currently period during which the health of the primarily on State and local authorities performed by a Federal inspector are animal and its external cleanliness and for inspectional coverage of restaurants, being performed consistently, with the degree of external microbial grocery stores and other conventional same rigor and effectiveness, by contamination can be affected in a way retail outlets. FSIS will be exploring establishment employees. If that may adversely affect food safety. how FSIS inspectors and field establishment employees take on such The FSIS in-plant inspectional role compliance officers can better functions currently performed by FSIS will certainly be affected by adoption collaborate with State and local food employees, consideration will have to and implementation of HACCP. As safety inspectors and other officials. be given as to whether ‘‘whistleblower’’ explained above in the portion of this The FSIS inspection program for protection, which would shield them preamble relating to the HACCP imported products relies on review of from retaliation of any kind for proposal, FSIS inspectors will be foreign inspection systems and reporting problems, should be extended playing a verification role to ensure that exporting establishments to ensure that to them. appropriate HACCP plans are in place, their approaches to food safety are equal In general, under its proposed are being implemented properly by the to the U.S. approach, coupled with pathogen reduction and HACCP establishment, and are achieving the limited reinspection of incoming regulatory initiatives, FSIS will be desired food safety results. This role product at the U.S. border by FSIS considering what new inspectional tools will require increased activity by FSIS inspectors. FSIS currently reinspects and techniques FSIS should adopt to inspectors in the areas of records approximately 10 percent of import oversee the safety of meat and poultry review, visual process verification, and shipments, relying largely on products in a regulatory environment product sampling. FSIS inspectors will, organoleptic inspection techniques. where greater responsibility for safety is in some cases, have to develop new Foreign establishments exporting to the being placed on establishments and skills to carry out these activities within United States will be required to adopt their employees. the HACCP framework. FSIS will be the pathogen reduction measures and FSIS invites comment on these issues focusing on the specific additional tasks HACCP requirements FSIS imposes on and on all aspects of how FSIS can best FSIS inspectors should be performing domestic establishments pursuant to make use of its inspectional resources to under HACCP and the training and this rulemaking. As HACCP develops, improve the safety of meat and poultry skills that will be required. FSIS will be considering what effect products, both within currently FSIS is considering, in concert with adoption of HACCP should have on the inspected establishments and FDA, the need for additional standards nature and frequency of import throughout the continuum from the and Federal oversight to ensure that inspection, including whether microbial farm to the consumer. food is handled safely during testing should be incorporated, whether transportation and distribution from the periodic inspections FSIS currently IV. Economic Impact Analysis and processing establishments to the retail conducts of foreign establishments Executive Orders level. In the case of meat and poultry should change, and how FSIS could best A. Executive Order 12866 products, it is critical that products be gain assurance on a continuing basis shipped and stored in sanitary that establishments exporting to the This proposed rule has been conditions and, in many cases, under United States are properly determined to be economically refrigeration. If Federal standards are implementing appropriate HACCP significant and was reviewed by OMB developed in this area, FSIS will have plans. under Executive Order 12866. to consider what the role of Federal Finally, some groups advocate Summary: Preliminary Regulatory inspectors should be in ensuring such amendment of the FMIA and PPIA to Impact Assessment HACCP and Related standards are met. No Federal agency alter or repeal the current requirements Near-Term Initiatives Produce Net would have the inspectional resources for carcass-by-carcass and continuous Benefit to Society to inspect on a regular basis all of the inspection in meat and poultry hundreds of thousands of trucks, trains, establishments. This is necessarily an FSIS has prepared a Preliminary vessels, planes, and storage/distribution issue Congress would have to decide. As Regulatory Impact Assessment (PRIA) facilities in the United States. FSIS will discussed in Part I of this document, that evaluates the costs and benefits of be considering whether there is an carcass-by-carcass and continuous a mandatory HACCP regulatory program appropriate role for a targeted approach inspection play an important role in and related near-term initiatives for all to inspection or random surveillance ensuring sanitation compliance is meat and poultry establishments under inspection, perhaps in collaboration maintained, excluding diseased animals inspection. The PRIA concludes that with State and local food safety from the food supply, and detecting and mandating HACCP systems would result authorities, that would help ensure that removing other defects, such as fecal in net benefits that far exceed industry safe practices are being observed at contamination, which are directly implementation and operation costs. these critical stages of the food safety related to food safety. FSIS believes that, Mandatory HACCP Program continuum. FSIS is interested in under any model of inspection, these implementation at a cost of $2 billion determining whether technologies, such objectives must continue to be met if over 20 years is projected to produce a as recording thermometers or food safety is to be ensured and the direct reduction in foodborne illness temperature indicators on refrigerated legitimate expectations of the public with public health benefits estimated at trucks, could be adopted to enhance the concerning the safety and quality of the $6–24 billion over 20 years. roles of some relatively limited, periodic food supply are to be satisfied. The proposed near-term requirements, inspectional oversight and enable FSIS Some propose that, with or without which would be incorporated into inspectors to work effectively in this any statutory change in the carcass-by- HACCP, would target pathogen area with inspectors from FDA and from carcass and continuous inspection reduction on carcasses and raw product, counterpart agencies at the State and mandates, establishments take more currently the products with the least local levels. initiative in these areas. FSIS must systematically controlled hazards. The Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6831 benefits are calculated for the three most information about meat and poultry The full text of the Preliminary common enteric pathogens of animal product safety and the absence of Regulatory Impact Assessment is origin: Campylobacter jejuni/coli, E. coli adequate incentives for industry to published as a supplement to this 0157:H7, Salmonella and one provide more than minimal levels of document. environmental pathogen Listeria processing safety represents a market B. Executive Order 12778 monocytogenes. The minimization of failure requiring Federal regulatory risk from these pathogens which can intervention. The present combination This proposed rule has been reviewed contaminate meat and poultry during of market regulation and industry self- pursuant to Executive Order 12778, slaughter and processing would produce policing has not resolved increasingly Civil Justice Reform. States and local a 90 percent reduction in the foodborne apparent problems with meat and jurisdictions are preempted under the illness attributed to these pathogenic poultry pathogens. Documented cases of FMIA and PPIA from imposing any microorganisms. Ten percent of foodborne illness each year, some of requirements with respect to federally contamination occurs after the product which have resulted in death, represent inspected premises and facilities, and leaves the manufacturing sector. a public health risk that FSIS has operations of such establishments, that Industry costs to develop, implement, determined to be unacceptable. A are in addition to, or different from, and operate HACCP processing control Federal regulatory program that reaches those imposed under the FMIA or PPIA. systems are estimated to total $2 billion every level of meat and poultry States and local jurisdictions may, over 20 years. The proposed regulation processing for commerce is the only however, exercise concurrent would redistribute costs in a manner means available to society for lowering jurisdiction over meat and poultry more acceptable to societal values foodborne pathogen risks to an products that are outside official which have always given priority to acceptable level. FSIS further concludes establishments for the purpose of eliminating controllable diseases. that a mandatory HACCP regulatory preventing the distribution of meat or Establishments that now have good program is the only means to attain this poultry products that are misbranded or processing controls would have goal. adulterated under the FMIA or PPIA, or, relatively few implementation costs, in the case of imported articles, which while establishments that have little or Alternatives are not at such an establishment, after no process control would need to spend Process Control Regulatory Strategy their entry into the United States. Under more for compliance. the FMIA and PPIA, States that FSIS has determined that effective maintain meat and poultry inspection Market Failure Justifies Regulation of process control is needed throughout programs must impose requirements on Pathogens the meat and poultry industry in order State-inspected products and Since all raw meat and poultry to minimize pathogen contamination of establishments that are at least equal to products contain microorganisms which food products and lower the risk of those required under the FMIA and the may be pathogens, raw food subsequent foodborne illness. PPIA. These States may, however, unavoidably entails some risk to The process control regulatory impose more stringent requirements on consumers of pathogen exposure and strategy was evaluated using five factors such State-inspected products and foodborne illness. The presence and for effectiveness: establishments. level of this risk cannot be determined 1. Controls production safety hazards; by a consumer since pathogens are not 2. Reduces foodborne illness; C. Effect on Small Entities visible to the naked eye. The societal 3. Makes inspection more effective; The Administrator, Food Safety and 4. Increases consumer confidence; impact of this food safety information Inspection Service, has determined that and this proposed rule will have a deficit is a lack of accountability for 5. Provides the opportunity for foodborne illnesses caused by significant economic impact on a increased productivity. substantial number of small entities. For pathogenic microorganisms. Consumers Using these factors, FSIS has purposes of this proposal, a small entity often cannot trace a transitory illness to determined that mandatory HACCP is defined as an establishment with a any particular food or even be certain it provides the greatest effectiveness. sales volume of meat and/or poultry was caused by food. Thus, food retailers FSIS examined six other process products of no more than $2.5 million and restaurateurs are generally not held control approaches before determining per year. Based on this criterion, as of accountable by their customers for that mandatory HACCP was the most November 1994, there are 6,827 small selling pathogen-contaminated products effective means for industry to eliminate slaughter and/or processing and they, in turn, do not hold their pathogens in meat and poultry: establishments that would be affected wholesale suppliers accountable either. 1. Status quo; This lack of marketplace 2. Intensify present inspection; by this proposed rule. This analysis accountability for foodborne illness 3. Voluntary HACCP regulatory assumes that 5 percent of these small means that meat and poultry producers program; establishments or 341 establishments and processors have little incentive to 4. Mandatory HACCP regulation with are currently operating under all the incur extra costs for more than minimal exemption for very small proposed requirements. Therefore, for pathogen controls. The widespread lack establishments; these 341 establishments, this proposed of information about pathogen sources 5. Mandatory HACCP regulation only rule would impose no additional costs. means that businesses at every level for ready-to-eat products; and For the remaining 6,486 small from farm to final sale can market 6. Modified HACCP—negative records establishments, costs would be incurred unsafe products and not suffer legal only. as follows: consequences or a reduced demand for Each of these alternatives was Near-Term Requirements their product. assessed using the five effectiveness The science and technology required factors for process control presented in 1. Sanitation Standard Operating to reduce meat and poultry pathogens is the previous section. None was Procedures well established, readily available, and determined to meet all five criteria; each Establishments would be required to commercially practical. FSIS has was found to be flawed in meeting one develop a written plan addressing the concluded that the lack of consumer or more of the target factors. required operating procedures, monitor 6832 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules the plan, record the results of 4. Microbiological Testing for personnel and increasingly low-cost monitoring, and store any records Salmonella laboratory services for establishments generated under the operating Each establishment that slaughters that choose to contract outside the procedures. Establishments would also livestock or poultry or produces raw, establishment for microbiological be required to train one or more ground meat or poultry products would testing. individuals to carry out the operating be required to collect and test one Another alternative for reducing the procedures. Costs for this activity are specimen of product per day at the end cost burden on small establishments estimated at $50.4 million. of the production process. The would be to require less than daily testing to verify process control. For 2. Use of an Antimicrobial Treatment specimen would be tested for the presence of Salmonella (the target example, every-other-day testing could Establishments would be required to organism). Testing could be conducted reduce costs by half. This would extend use an antimicrobial treatment on all in the establishment’s own laboratory or the time required to detect that any meat and poultry carcasses. Of the 1,923 in a commercial/contract laboratory. establishment is not achieving the target small slaughter establishments, it is Results of the testing would be recorded and to begin corrective measures. estimated that approximately 70 percent daily. Costs for this activity are FSIS invites comment on whether now apply an antimicrobial treatment to estimated at $91.1 million. special consideration should be given to meat and/or poultry carcasses. As a general matter, this approach to small establishments to reduce the cost Therefore, for these establishments, no process control verification testing burden of testing and on the alternatives additional costs should be incurred. For provides a very efficient means of outlined above, as well as any other those establishments that do not now determining whether a slaughter possible alternatives. FSIS is use an antimicrobial treatment, costs are establishment is consistently achieving particularly interested in comment on estimated at $2.7 million. the interim target for pathogen the criteria that should govern eligibility for such special consideration. As 3. Time/Temperature Requirements reduction. Many slaughter establishments currently conduct discussed above, for the purpose of Establishments would be required to voluntarily, for a variety of purposes, allowing small establishments the provide written plans for complying significantly more frequent maximum 3-year period to comply with with the proposed time, temperature, microbiological testing, and for many the proposed HACCP regulation, FSIS is and monitoring requirements for establishments the cost of testing a proposing to define a ‘‘small’’ carcasses and raw meat products, or single sample per species per day will establishment as one with annual sales with alternative procedures which be relatively small (approximately $30– of $2.5 million or below. FSIS invites would be permitted under this proposal. 35 per sample) in relation to the volume comment on whether this would be the The written plan would include the of a day’s production. right criterion for any special relief establishment’s designated control For some small FSIS-inspected regarding testing or whether an points, corrective actions, and, when establishments, however, alternative criterion, such as the number applicable, the name of the processing microbiological testing may be entirely of head or a different dollar volume of authority. Some establishments may new, and the cost of testing will be more sales, should be used. decide to hire a processing authority to significant in relation to the volume of Long-Term Requirement develop such plans, while others may production. For example, some prepare their own plan. If an specialty slaughter plants may slaughter Implementation of HACCP Systems establishment chooses to follow only a few head of livestock per day and Establishments would be required to alternative procedures, the may slaughter multiple species, thus develop and implement HACCP establishment must hire a processing requiring multiple tests, despite a low systems. Costs to develop, implement, authority to develop the alternative volume of production. and monitor HACCP plans for small procedures. FSIS has considered the potential establishments are estimated to be The refrigeration requirements set impact of its proposed microbiological $157.6 million. FSIS has determined forth in this proposed rule may result in testing requirement on small businesses. that it is reasonable to allow small costs associated with purchases of FSIS is considering alternatives to establishments additional time to meet refrigeration facilities. Although all minimize the burden on small the proposed HACCP requirements. establishments must have cooler rooms establishments while still achieving the Therefore, small establishments would and most have refrigerated vehicles for goal of verifying that the establishment’s have 36 months from the publication shipping product, some small process control is achieving the interim date of the regulation to implement their establishments may not have existing target for pathogen reduction. HACCP plan(s). refrigeration facilities that would meet One alternative would be to allow the proposed refrigeration requirements. certain small establishments additional D. Paperwork Requirements The number and size of refrigeration time to prepare for and begin testing. The paperwork requirements in the units that may be required would FSIS is proposing that testing begin 90 current proposal, namely records and depend on cooler room sizes and days after publication of the final rule. plans, represent an alternative to the slaughter volumes of individual By extending this period for small current process of inspection. The establishments. establishments, such establishments industry’s documentation of its Establishments would be required to would have additional time to prepare processes, first in a plan and thereafter monitor the temperatures of carcasses for the testing and to find an efficient in a continuous record of process and raw meat products throughout their means of accomplishing it. In addition, performance, is a more effective food operations to ensure compliance with as the testing gets underway in most safety approach than the sporadic their plan, and maintain ongoing establishments and the demand for generating of information by an monitoring records for the previous 6 efficient testing increases, FSIS expects inspector. It gives inspectors a much months. Costs for time/temperature that the market will respond by broader picture of production than they requirements are estimated at $28.8 producing increasingly economical test can generate on their own and gives million. methods for use by establishment them time to perform higher priority Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6833 tasks. At the same time it gives the required to be maintained on file for 6 of FSIS regulations or other managers a better view of their own months after the temperature requirements must be included. process and more opportunity to adjust measurement, and the records would be Establishments would keep records it to prevent safety defects. made available to Program employees, for measurements during slaughter and To produce this documentation, all upon request. Additionally, the processing, corrective actions, industry managers must learn about the shipping establishment would be verification check results, and related options and methods for making their required to record the date and time of activities that contain the identity of the processes safer, which they do not have shipment of product on the waybill, product, the product code or slaughter to do if the inspector appears to be the running slip, conductor’s card, shipper’s production lot, and the date the record only one responsible for finding defects. certificate, or any other such papers was made. The information would be Therefore, while the proposal contains accompanying the shipment. recorded at the time that it is observed, increased paperwork burden, it is As part of microbiological testing, and the record would be signed by the balanced by a reduction in the number each establishment would develop operator or observer. of face-to-face contacts between written procedures outlining specimen The HACCP records would be management and the inspector that are collection and handling. An reviewed by an establishment employee required to assure the process is being establishment may test the specimens in other than the one who produced the controlled, so that the opportunity for their own laboratory or in a commercial/ record, before the product is distributed better control is accompanied by an contract laboratory. Either an internal or in commerce. If a HACCP-trained increase in productivity for both external QA/QC program with check individual is on-site, that person should inspectors and managers. sample analysis would be required. QA/ be this second reviewer. The reviewer In order not to increase the paperwork QC records must be available to Program would sign the records. Lastly, HACCP burden unnecessarily, the Agency has employees, upon request. records generated by the processor not required that plans be submitted for The laboratory would supply the would be retained on site for at least 1 prior approval. In addition, the Agency results on a daily basis to the year and either on site or in a nearby is considering changing some existing establishment. The establishment would location for an additional two years. prior approval programs, which would be responsible for entering the results The paperwork and recordkeeping further reduce the paperwork burden on daily into a statistical process control requirements contained in this proposed industry. chart. The data and chart would be rule have been submitted to the Office As part of establishments’ sanitation available for review by the Inspector in of Management and Budget for approval requirements, each establishment would Charge upon request. under the Paperwork Reduction Act (44 develop and maintain an SOP that The establishment would notify the U.S.C. 3501 et seq.). Send written would be used by inspection personnel Inspector in Charge if the results of the comments to: Office of Management and in performing verification tasks. The testing exceed the process control Budget, Desk Officer for FSIS, Office of SOP’s would specify the cleaning and limits. In such instances, a complete Information and Regulatory Affairs, sanitizing procedures for all equipment review by the establishment of the Room 3208, New Executive Office and facilities involved in the production production process would be required. Building, Washington, DC 20503, and to of every product. As part of the SOP, A written report of the evaluation, the Clearance Officer, Room 404–W, establishment employees(s) would including the reason for process failure Administration Building, Washington, record results of daily sanitation checks and proposed corrective actions, would DC 20250. on a checklist at the frequencies stated be submitted to the Inspector in Charge in the SOP. The checklist would include within 14 days from the day the process Imports and Exports both preoperational sanitation checks exceeded the limits. This report would The proposed rules will affect and operational sanitation checks. This be updated on a weekly basis until the importers and exporters of meat and checklist would be made available to process is in control. poultry to the U.S. The inspection Program employees, upon request. For the implementation of HACCP, statutes require that imported product As part of the time and temperature the establishment would maintain on be produced under an inspection system requirements, establishments would file the name and a brief resume of the that is equivalent to the U.S. inspection develop, implement, and place on file a HACCP-trained individual(s) who system. The equivalence of a country’s written plan to meet the time and participates in the hazard analysis and system must be established by the temperature requirements. The plan subsequent development of the HACCP United States before product can be would include the establishments plans. Establishments would develop exported to the United States. The designated control points where written HACCP plans that include: notion of equivalence has been clarified temperatures would be measured; Identification of the processing step(s) under the World Trade Organization monitoring procedures; how presents hazard(s); identification and (WTO) Agreement on Sanitary and recordkeeping activities would be description of the CCP for each Phytosanitary measures. Under the performed; standards for control points identified hazard; specification of the WTO all members have an obligation to (e.g., cooling rate, holding temperature, critical limit which may not be apply the principle of equivalence on and shipping temperature); corrective exceeded at the CCP, and, if importing countries. Equivalence actions; and, when applicable, the name appropriate, a target limit; description of determinations are based on scientific of the processing authority. the monitoring procedure or device to evidence and risk assessment Establishment employees would also be used; description of the corrective methodologies. have to maintain records that report the action to be taken if the limit is In light of the WTO emphasis on the maximum temperature of carcasses and exceeded; description of the records use of science to determine equivalence, raw meat and poultry products which would be generated and a number of countries are moving throughout the establishment’s maintained regarding this CCP; and toward implementation of HACCP operations on a daily basis with the description of the establishment systems. frequency of monitoring based on the verification activities and the frequency HACCP and the related near-term establishment’s size and type of at which they are to be conducted. initiatives proposed in this document operation. These records would be Critical limits which are currently a part represent science-based regulation. 6834 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Upon implementation of these 4. NAS, 1990—Committee on Evaluation of 18. Smith, M.G. and Graham, A. 1974. regulations, FSIS will review other USDA Streamlined Inspection System Advanced meat science techniques I: countries’ meat and poultry systems to for Cattle (SIS–C). 1990. Cattle Meat chilling and handling. Brisbane, Inspection. Food and Nutrition Board, CSIRO Div. Food Res. Lab. 5pp. ensure that exporting countries have Institute of Medicine, National Academy 19. Smith, M.G. and Graham. A. 1978. adopted comparable measures, which of Sciences. National Academy Press, Destruction of Escherichia coli and would entitle them to continue Washington, DC. Salmonella on mutton carcasses by exporting product to the United States. 5. Council for Agricultural Science and treatment with hot water. Meat Sci. As other countries improve their Technology publication Food Borne 2:119–128. regulations by adopting provisions Pathogens: Risk and Consequences, Task 20. Davey, K.R. 1990. A model for the hot comparable to those proposed in this Force Report 122, September 1944, water decontamination of sides of beef in Chapter 6, Risk Characterization: a noval cabinet based on laboratory data. document, it is expected that U.S. Economic cost of food borne diseases. Int. J. Food Sci. 25:88–97. exports will similarly be affected. 6. FSIS, January 1994. Nationwide Beef 21. Davey, K.R. 1989. Theoretical analysis of FSIS is soliciting comments from all Microbiological Baseline Data Collection two hot water cabinet systems for interested parties on how the proposed Program—Steers and Heifers—October decontamination of sides of beef. Int. J. rule would affect international trade. 1992 —September 1993. Food Sci. 24:291–304. 22. Kelly, C.A.; J.F. Dempster; and A.J. FSIS believes that these improved 7. NRC 1985. Committee on the Scientific Basis of the Nation’s Meat and Poultry McLoughlin. 1981. The effect of scientific measures will facilitate trade. Inspection Program. Meat and Poultry temperature, pressure and chlorine Comments Inspection: The Scientific Basis of the concentration of spray washing water on Nation’s Program. Food and Nutrition number of bacteria on lamb carcasses. J. Interested persons are invited to Board, Committee on Life Sciences, Appl. Bacteriol. 51:415–424. submit written comments concerning National Research Council, National 23. Graham, A.; I.J. Eustace; and V.H. Powell. Academy Press, Washington, D.C. 1978. Surface decontamination—A new this proposal and the PRIA. Written 8. NRC 1987, Committee on Public Health processing unit for improved hygiene on comments should be sent in triplicate to Risk Assessment of Poultry Inspection carcass meat. Proc. 24th Eur. Meet Meat Diane Moore, Docket Clerk, Food Safety Programs. Poultry Inspection: The Basis Res. Work., Kulmbach 1:B8:3–B8:6. and Inspection Service, U.S. Department for a Risk-Assessment Approach. Food 24. Cain, B.P. and V.H. Powell. 1983. A of Agriculture, Room 3171–S, and Nutrition Board, Commission on prototype cabinet for the Washington, DC 20250. Any person Life Sciences, National Research decontamination of beef sides. Meat desiring an opportunity for an oral Council, Washington, D.C. Research Report 3/83 P. 8. CSIRO 9. General Accounting Office Report, May, Division of Food Research, Meat presentation of views as provided by the 1994, GAO/RCED–94–110. Food Safety: Research Laboratory, Australia. Poultry Products Inspection Act should Risk-Based Inspection and Microbial 25. Anderson, M.E.; R.T. Marshall; and W.C. make such request to the appropriate Monitoring Needed for Meat & Poultry. Stringer. 1982. U.S. Patent 4,337,549 (6 party listed under FOR FURTHER 10. General Accounting Office Report, July). INFORMATION CONTACT so that February 10, 1994, GAO/TCED–94–123. 26. Smith, M.G. 1992. Destruction of bacteria arrangements can be made for such Meat Safety: Inspection System’s Ability on fresh meat by hot water. Epidemol. views to be presented. A record will be to Detect Harmful Bacteria Remains Infect. 109:491–496. Limited. 27. Smith, M.G. and K.R. Davey. 1990. made of all views orally presented. All 11. General Accounting Office Report, Destruction of E. coli on sides of beef by comments submitted in response to this November 4, 1993, GAO/RCED–94–71. a hot water decontamination process. proposal will be available for public Food Safety: A Unified, Risk-Based Food Australia. 42(4):195–198. inspection in the Docket Clerk’s office System Needed to Enhance Food Safety. 28. Smith, G.C. et. al. Fecal-material removal from 8:30 a.m. to 1:00 p.m. and 2:00 12. General Accounting Office Report, March and bacterial-count reduction by p.m. to 4:00 p.m., Monday through 16, 1993, GAO/RCED–93–27. Food trimming and/or spray-washing of beef Friday. Safety: Building a Scientific Risk-Based external-fat surfaces. Submitted for Meat and Poultry Inspection System. publication to Proceedings of 1994 Copies of documents listed under 13. General Accounting Office Report GAO/ American Meat Industry Conference, San ‘‘References,’’ below, are available for T–RCED–93–10, February 18, 1993. Food Francisco, CA. public inspection in the FSIS Docket Safety: Inspection of Domestic and 29. Reagan, J.O. et. al. 1995. Trimming and Room, USDA, 14th and Independence Imported Meat Should be Risk-Based. washing of beef carcasses as a method of Avenue, SW, Room 3175, South 14. General Accounting Office Report GAO/ improving the microbiological quality of RECD–92–152, June 1992. Food Safety meat. J. Food Prot. (Submitted for Agriculture Building, Washington, DC publication.) 20250. and Quality: Uniform Risk-Based Inspection System Needed to Ensure 30. Davey, K.R. and M.G. Smith. 1989. A V. References Safe Food Supply. laboratory evaluation of a noval hot 15. James, W.O.; J.C. Prucha; Brewer R.L.; water cabinet for the decontamination of 1. Booz, Allen, and Hamilton, Inc. Study of W.O. Williams; W.A. Christensen; A.M. sides of beef. Int. J. Food Sci. 24:305– the Federal Meat and Poultry Inspection Thaler; and A.T. Hogue. 1992. Effects of 316. Program, Volume 1—Description of the countercurrent scalding and postscald 31. Barkate, M.L.; G.R. Acuff; L.M. Lucia; and Meat and Poultry Inspection Program, spray on the bacteriologic profile of raw D.S. Hale. 1993. Hot water June 1977, Volume II—Opportunities for chicken carcasses. J.A.V.M.A. 201:705– decontamination of beef carcasses for Change—An Evaluation of Specific 708. reduction of initial bacterial numbers. Alternatives, June 1977, Volume III— 16. Blankenship, L.C.; J.S. Baily; N.A. Cox; Meat Science, 35:397–401. Executive Summary, July 1977. M.T. Musgrove; M.E. Berrand; R.L. 32. Anderson, M.E.; R.T. Marshall; W.C. 2. General Accounting Office Report, Wilson; M.J. Rose; and S.K. Dua. 1993. Stringer; and H.D. Nauman. 1979. December 9, 1977, CED–78–11. A Better Broiler carcass reprocessing, a further Microbial growth on plate beef during Way for the Department of Agriculture to evaluation. J. Food Prot. 56:983–985. extended storage after washing and Inspect Meat and Poultry Processing 17. Patterson, J.T. 1969. Hygiene in meat sanitizing. J. Food Prot. 42:389–392. Plants. processing plants. 4. Hot water washing 33. Kotula, A.W.; W.R. Lusby; J.D. Crouse; 3. FSIS, 1978. A Strengthened Meat and of carcasses. Record of Agr. Res. Ministry and B. de Vries. 1974. Beef carcass Poultry Inspection Program. of Agr. Northern Ireland. 18-pp. 85–87. washing to reduce bacterial contamination. J. Anim. Sci. 39:674–679. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6835 34. Kelly, C.A.; Dempster, J.F. and 49. Woolthuis, C.H.J., D.A.A. Mossel, J.G.V. 63. Anderson, M.E. and R.T. Marshall. 1989. McLoughlin, A.J. 1981. The effect of Logtestijn, J.M. de Kruijf, and F.J.M. Reducing microbial populations on beef temperature, pressure and chlorine Smulders. 1984. Microbial tissues: Concentration and temperature concentration of spray washing water on decontamination of porcine livers with of an acid mixture. J. Food Safety number of bacteria on lamb carcasses. J. lactic acid and hot water. J. Food Prot. 10:181–190. Appl. Bacteriol. 51:415–424. 48:832–837. 64. Acuff, G.R., J.W. Savell, and M.D. Hardin, 35. Smith, M.G. 1985. The generation time, 50. Hamby, P.L., J.W. Savell, G.R. Acuff, C. 1994. Preliminary Results, Comparison lag time, and minimum temperature of Vanderzant, and H.R. Cross, 1987. Spray- of methods for contamination removal growth of coliform organisms on meat, chilling and carcass decontamination from beef carcass surfaces. In response to and the implications for codes of systems using lactic and acetic acid. Federal Register Notice, Beef carcass practice in abattoirs. J. Hyg. Camb. Meat Science 21:1–14. trimming versus washing study, Vol 58. 94:289–300. 51. Van Der Marel, G.M., J.G. VanLogtestijn, No 118, pp. 33925–31. 36. Shaw, M.K.; A.G. Marr; and J.L. D.A.A. Mossell. 1988. Bacteriological 65. Notermans, S. and M. Van Ingraham. 1971. Determination of the quality of broiler carcasses as affected by Schotorst.Dickson,. 1977. Die minimal temperature for growth of in-plant lactic acid decontamination. Int. Geflugelverarbeiiitung: Ein besonderes Escherichia coli., J. Bacteriology. J. Food Microbiology. 31:31–42. Problem der Betriebshygiene. 105:683–684. 52. Prasai, R.K., G.R. Acuff, L.M. Lucia, D.S. Fleischwirtschaft. 57:248–252. 37. Mackey, B.M.; T.A. Roberts; J. Mansfield, Hale, J.W. Savell, and J.B. Morgan. 1991. 66. Brackett, R.E., Y.Y. Hao, and M.P. Doyle. and G. Farkas. 1980. Growth of Microbiological effects of acid 1993. Ineffectiveness of hot acid sprays Salmonella on chilled meat. J. Hyg. decontamination of beef carcasses at to decontaminate Escherichia coli 85:115–124. various locations in processing. J. Food 0157:H7 on Beef. J. Food Prot. 57:198– 38. Barkate, M.L.; G.R. Acuff; L.M. Lucia; and Prot. 54:868–872. 203. D.S. Hale. 1993. Hot water 53. Acuff, G.R., C. Vanderzant, J.W. Savell, 67. Food Safety and Inspection Service decontamination of beef carcasses for D.K. Jones, D.B. Griffin, and J.G. Ehlers. Administrator: 10/13/92 Cross letter; 2/ reduction of initial bacterial numbers. 1987. Effect of acid decontamination of 4/94 Cross letter; 3/29/94 Medley letter. Meat Science, 35:397–401. beef subprimal cuts on the 68. Food Chemical Codes III, 1981, pp. 293– 39. Bulter, J.L.; J.C. Stewart; C. Vanderzant; microbiological and sensory 295. Z.L. Carpenter; and G.C. Smith. 1979. characteristics of steaks. Meat Sci. 69. Tamblyn, K.C., D.E. Conner, S.F. Bilgili, Attachment of microorganisms to pork 19:217–226. and G.S. Hill. 1993. Utilization of the skin and surfaces of beef and lamb 54. Osthold. W.H., K. Shin, J. Dresel, and L. Skin Attachment Model (SAM) to carcasses. J. Food Prot. 42:401–406. Leistner. 1984. Improving the storage life Determine the Antibacterial Activity of 40. Dickson, J.S. 1990. Surface moisture and of carcasses by treating their surfaces Potential Carcass Treatments. Poultry osmotic stress as factors that affect the with an acid spray. Fleischwirtschaft. Sci. 72 supplement (1):298. sanitizing of beef tissue surfaces. J. Food 64:828–830. 70. Dickson, J.A. and A.D. Whittemore. 1993. Prot. 53:674–679. 55. Bell, M.F., R.T. Marshall, and M.E. The effect of dipping processed broiler 41. Greer, G.G. and B.D. Dilts. 1992. Factors Anderson. 1986. Microbiological and carcasses in a trisodium phosphate affecting the susceptibility of meatborne sensory test of beef treated with acetic solution on total aerobes, pathogens and spoilage bacteria to and formic acids. J. Food Prot. 49:207– Enterobacteriaceae, and inoculated organic acid. Food Res. Inter. 25:355– 210. Salmonella. Poultry Sci. 72 supplement 364. 56. Smulders, F.J.M., P. Barendsen, J.G. van (1):S35. 42. Dickson, J.S. and M.E. Anderson. 1992. Logtestijn, D.A.A. Mossel and G.M. van 71. Lillard, H.S. 1994. Effect of trisodium Microbiological decontamination of food der Marel. 1986. Review: Lactic acid: phosphate on Salmonella attached to animal carcasses by washing and considerations in favor of its acceptance chicken skin. J. Food Prot. 57:465–469. sanitizing systems: A review. J. Food as a meat decontaminant. J. Food 72. Rhoˆne-Poulenc pre-chill petition Prot. Vol. 55:133–140. Technol. 21:419–436. (HC015), January 13, 1994. 43. Ingram, M. and T. A. Roberts. 1976. The 57. Anderson, M.E., H.E. Huff, H.D. 73. ABC Research Laboratories, Gainsville, Microbiology of the red meat carcass and Naumann, R.T. Marshall, J. Damare, R. FL. the slaughterhouse. Royal Society of Johnston, and M. Pratt. 1987. Evaluation 74. Gorseline H. 1951. In-plant chlorine does Health Journal. 96:270–276. of Swab and Tissue Excision Methods for a 3-way job. U.S. Egg and Plant 44. Roberts, T.A. and B. Pharm. 1980. Recovering Microorganisms from Magazine. April. Pp. 12, 13, 29–31. Contamination of meat: The effects of Washed and Sanitized Beef Carcasses. J. 75. USDA, FSIS, January 1, 1994. List of slaughter practices on the bacteriology of Food Protection. 50:741–743. Proprietary Substances and Nonfood the red meat carcass. Royal Soc. Health 58. Dickson, J.S. 1991. Control of Salmonella Compounds, Miscellaneous Publication J. 100:3–9. typhimurium, Listeria monocytogenes No. 1419. Page II-vi. 45. Eklund, T. 1983. The antimicrobial effect and Escherichia coli 0157:H7 on beef in 76. James, W.O., R.L. Brewer, J.C. Prucha, of dissociated and undissociated sorbic a model spray chilling system. J. Food W.O. Williams, and D.P. Parham. 1992. acid at different pH levels. J. Appl. Sci. 56:191–193. Effect of chlorination of chill water on Bacteriol 54:383–389. 59. Siragusa, G.R. and J.S. Dickson. 1992. the bacteriologic profile of raw chicken Inhibition of Listeria monocytogenes on carcasses and giblets. J.A.V.M.A. 200:60– 46. Baird-Parker, A.C. 1980. Microbial beef tissue by application of organic acid 63. ecology of foods. Factors affecting life immobilized in calcium alginate gel. J. and death of microorganisms by the 77. Drewniak, E.E., M.A. Howe, Jr., H.E. Food Sci. 57:293–296. International Commission on Goresline and E.R. Baush. 1954. Studies Microbiological Specifications for Foods. 60. Cutter, N.C., and G.R. Siragusa. 1994. on sanitizing methods for use in poultry Chap. 7. In Organic Acids, Vol. 1. Efficancy of organic acids against processing. U.S.D.A. Circular No. 930. Academic Press, New York. Escherichia coli 0157:H7 attached to beef 78. Ranken, M.D., G. Clewlow, D.H. carcass tissue using a pilot scale model Shrimpton, and B.J. H. Stevens. 1965. 47. Hunter, D.R. and I.H. Segel. 1973. Effect carcass washer. J. Food Prot. 57:97–103. Chlorine in poultry processing. Brit. of weak acids on a minoacid transport by Poult. Sci. 6:331– . Penicillium chrysogenum. Evidence for 61. Woolthuis, C.H., and F.J.M. Smulders. proton or change gradient as the driving 1985. Microbial decontamination of calf 79. Patterson, J.T. 1968. Chlorination of water force. J. of Bacteriology, 113:1184–1192. carcasses by lactic acid spray. J. Food used for poultry processing. Brit. Poul. Prot. 48:832–837. Sci 9:129– . 48. Quartey-Papafio, E.A., R.T. Marshall, and 62. Anderson, M.E. and R.T. Marshall. 1990. 80. Lillard, H.A. 1979. Levels of chlorine M.E. Anderson. 1980. Short-chain fatty Reducing microbial populations on beef dioxide of equivalent bactericidal effect acids as sanitizers for beef. J. Food Prot. tissues: Concentration and temperature in poultry processing water. J. Food Sci. 43:168–171. of lactic acid. J. Food Sci. 55:903–905. 44:1594–1597. 6836 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 81. Patterson, J.T. 1968. Hygiene in meat 96. Mattila-Sandholm, T., A. Haikara and E. 112. Lammerding, A.M., M.M. Garcia, E.D. processing plants. 3. Methods of Skytta. 1991. The effect of Pediococcus Mann, Y. Robinson, W.J. Dorward, R.B. reducing carcass contamination. Record damnosus and Pediococcus pentosaceus Truscott, and F. Tittiger. 1988. of Agr. Res. Ministry of Agriculture on the growth of pathogens in minced Prevalence of Salmonella and North Ireland. 17:7. meat. International J. Food Micr. 13:87– thermophilic Campylobacter in fresh 82. Bailey, C. 1971. Spray washing of lamb 94. pork, veal, and poultry in Canada. J. carcasses. pp. 175–181. In Proceeding of 97. Skytta, E., W. Hereijgers and T. Mattila- Food Prot. 51(1):47–52. 17th European Meeting of Meat Research Sandholm. 1991. Broad spectrum 113. Campbell, D.F., S.S. Green, C.S. Custer, Workers. Bristol, England. antibacterial activity of Pediococcus and R.W. Johnston. 1982. Incidence of 83. Stringer, W.C., M.E. Bilskie, and H.D. damnosus and Pediococcus pentosaceus Salmonella in fresh dressed turkeys Naumann. 1969. Microbial proviles of in minced meat. Food Microbiology. raised under Salmonella-controlled and fresh beef. Food Technol. 23:97– . 8:231–237. uncontrolled environments. Poultry Sci. 84. Marshall, R.T., M.E. Anderson, H.D. 98. Vanderzant, C. and C.S. Custer. 1968. 61:1962–1967. Naumann, and W.G. Stringer. 1977. Interactive inhibitory activities among 114. Campbell, D.F., R.W. Johnston, M.W. Experiments in sanitizing beef with certain psychrotrophic bacteria from Wheeler, K.V. Nagaraja, C.D. sodium hypochlorite. J. Food Prot. dairy foods. Journal Milk and Food Szymansaki, and B.S. Pomeroy. 1984. 40:246–249. Technology. 31:302–305. Effects of evisceration and cooling 85. Anderson, M.E., R.T. Marshall, W.C. 99. Agriculture Handbook No. 412. processes on the incidence of Salmonella Stringer, and H.D. Nauman. 1977. 100. Hippe, C.L., R.A. Field, B. Ray and W.C. in fresh dressed turkeys grown under Efficacies of three sanitizers under six Russel. 1991. Effect of spray-chilling on Salmonella-controlled and uncontrolled conditions of application to the surface quality of beef from lean and fatter environments. Poultry Sci. 63:1069– of beef. J. Food Sci. 42:326–329. carcasses. Journal of Animal Science. 1072. 86. Documentation supporting the prior 69:178–183. 115. National Turkey Federation National sanction finding is available for review 101. Retrum, R. 1958. Beef carcass chilling Survey of the Turkey Industry. in the FSIS Docket Clerk’s office. 116. Cox, N.A., J.E. Thomson, and J.S. Bailey. 87. Morris R.D., A.M. Audet, I.F. Angelillo, and holding. Refrigerating Engineering. 1981. Sampling of broiler carcasses for et al. 1992. Chlorination, chloriantion 66:63–64, 74–80. Salmonella with low volume rinse water. by-products, and cancer: a meta-analysis. 102. Gill, C.O. 1979. A review—Intrinsic Poultry Sci. 60:768–770. Am. J. Public Health 82 (7): 955–63. bacterial in meat. J. Appl. Bacteriol. 88. ENVIRON Corporation, Arlington, 47:367–378. 117. ICMFS. 1974. Microorganisms in Foods Virginia. 1994. A risk assessment to 103. Vanderzant, C. and R. Nickelson. 1969. 2: Sampling for Microbiological analyses, evaluate the potential human health A microbiological examination of muscle principles, and specific applications. effects from the presence of chloroform tissue of beef, pork and lamb carcasses. 118. FSIS, HACCP–6 Review of HACCP in chicken fat and skin. Prepared for Journal Milk and Food Technology. Systems Literature (April, 1994). FSIS, USDA. 32:357–361. 119. FSIS, HACCP–7 HACCP Workshops 89. Gill, C.O. and C. McGinnis. 1993. 104. Whiting, R.C. and R.L. Buchanan. 1992. Report Summary (April, 1994). Changes in the microflora on commercial Use of microbial modeling in a HACCP 120. FSIS, HACCP–8 HACCP Workshops beef trimmings during their collection, program, Proceedings of the Second Report—Overview and Summary of the distribution and preparation for retail ASEPT International Conference, Five HACCP Workshops (April, 1994). sale as ground beef. Int. J. Food Predictive Microbiology and HACCP. 121. FSIS, HACCP–9 HACCP Workshops Microbiology. 18:321–332. Laval, France. 125–141. Reports—Overview of the Five 90. Ingham, S.C., R.A. Alford and P. 105. Hanna, M.O., G.C. Smith, F.K. McKeith Workshop Steering Committee Reports McCown. 1990. Comparative growth and C. Vanderzant. 1982. Microbial flora (April, 1994). rates of Salmonella typhimurium and of livers, kidneys and hearts from beef, 122. FSIS, HACCP–10 HACCP Workshops Pseudomonas fragi on cooked crab meat pork and lamb: Effects of refrigeration, Report—Overview of Plant Adaption stored under air and modified freezing and thawing. J. Food Prot. Activities (April, 1994). atmosphere. J. Food Prot. 53:566–567, 45:63–73. 123. National Advisory Committee on 625. 106. Centers for Disease Control and Microbiological Criteria for Foods 91. Lee, C.Y., D.Y.C. Fung and C.L. Kastner. Prevention. 1994. Healthy People 2000. (NACMCF). November 1989—Hazard 1985. Computer-assisted identification Atlanta, GA. Analysis and Critical Control Point on microflora on hot-boned and 107. Nationwide Beef Microbiological System. conventionally processed beef: effect of Baseline Data Collection Program: Steers 124. National Advisory Committee on moderate and slow chilling rate. J. Food and Heifers, 1992–1993. U.S. Department Microbiological Criteria for Foods Sci. 50:553–567. of Agriculture/Food Safety Inspection (NACMCF). March 1992—Hazard 92. Ray, B., C. Johnson and A. Field. 1984. Service. Analysis and Critical Control Point Growth of indicator, pathogenic and 108. Food Safety Inspection Service. System. Int. J. Food Micr. 16:1–23. psychrotrophic bacteria in mechanically Salmonella in Broilers, a National Study: 125. National Advisory Committee on separated beef, lean ground beef and beef 1990–1992. U.S. Department of Microbiological Criteria for Foods bone marrow. J. Food Prot. 47:672–677. Agriculture. (NACMCF). June 1993—Report on 93. Smith, M.G. 1985. The generation time, 109. Food Safety Inspection Service. Generic HACCP for Raw Beef. Food lag time and minimum temperature of Nationwide Retail Ground Beef Micr. 10: 449–488. growth of coliform organisms on meat Microbiological Survey. U.S. Department 126. National Advisory Committee on and the implications for codes of of Agriculture. Microbiological Criteria for Foods practice in abattoirs. J. Hygiene Camb. 110. Johnston, R.W., S.S. Green, J. Chui, M. (NACMCF). June 1993—Report on 94:289–300. Pratt, and J. Rivera. 1982. Incidence of HACCP for Regulatory Agencies and 94. Smith, M.G. 1987. Calculation of the Salmonella in fresh pork sausage in 1979 Industry. Int. J. Food Micr. 21: 187–195. expected increases of coliform compared with 1969. J. Food Sci. 127. March 1994—Comments on the FDA organisms, Escherichia coli and 47(4):1369–1371. Proposed Rule to Establish Procedures Salmonella typhimurium, in raw 111. Estimate based on: Nationwide Beef for the Safe Processing and Importing of blended mutton tissue. Epidemiology Microbiological Baseline Data Collection Fish and Fishery Products. Infection. 99:323–331. Program: Steers and Heifers, 1992–1993. 95. Mattila-Sandholm, T., and E. Skytta. U.S. Department of Agriculture/Food 1991. The effect of spoilage flora on the Safety Inspection Service. growth of food pathogens in minced meat stored at chilled temperature. Lebensm. Wiss. u. Technol. 24:110–120. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6837 128. FSIS—HACCP Round Table, March 30– § 308.3 Establishments; sanitary following treatment methods to reduce 31, 1994—Summary Report (April 1994). conditions; requirements. bacteria, provided that equipment has 129. Office of the U.S. Trade Representation, * * * * * been approved under § 308.5, and that Executive Office of the President. (b) The establishment shall develop operation of the method results in full General Agreement on Tariffs and Trade; and maintain written Sanitation compliance with the Act and this Final Text of Uruguay Round Agreements as signed April 15, 1994 Standard Operating Procedures subchapter. (GPO: Washington, D.C. ISBN 0–16– (Sanitation-SOP’s) which must be (1) Any chlorine compound approved 045022–5): p. 69. available to program employees for by the Administrator and administered verification and monitoring. Sanitation- to raw, uncooled whole livestock VI. Proposed Rules SOP’s shall at a minimum detail daily carcasses or major carcass portions at 20 List of Subjects sanitation procedures to be conducted to 50 parts per million (ppm) in the before and during operations, to prevent intake water at the final wash. The 9 CFR Part 308 direct contamination or adulteration of chlorinated water must contact all Meat inspection, Sanitation. product(s). Sanitation SOP’s must also carcass surfaces. The Administrator will identify plant officials responsible for prepare a list containing compounds 9 CFR Part 310 monitoring daily sanitation activities, approved for use in official Antimicrobial treatment, Microbial evaluating the effectiveness of SOP’s, establishments. A copy of the list may testing, Reporting and Recordkeeping and initiating corrective actions when be obtained from the Compounds and requirements. needed. Packaging Branch, Produce Assessment (1) A ‘‘U.S. Rejected’’ tag will be Division, Regulatory Programs, Food 9 CFR Part 318 attached to the applicable equipment, Safety and Inspection Service, U.S. Meat inspection, Reporting and utensil, room or compartment if a Department of Agriculture, Washington, Recordkeeping requirements, program employee determines that the DC 20250–3700. Reinspection, Processed products, establishment has failed to adhere to the (2) Hot water applied such that the Microbial testing. sanitation SOP’s specifically required by temperature of the water at the carcass FSIS regulations. No equipment, utensil, surface is ≥165 °F (≥74 °C) for ≥10 9 CFR Part 320 room or compartment so tagged shall be seconds. The hot water must contact all Meat inspection, Reporting and used until reinspected and found carcass surfaces. recordkeeping requirements. acceptable by a Program employee. (3) Any antimicrobial compound (2) The establishment owner or listed in the table in § 318.7(c)(4) and 9 CFR Part 325 operator shall be responsible for the permitted for use on livestock products Meat inspection, Reporting and establishment’s adherence to the SOP’s, may be used under the conditions recordkeeping requirements, as well as for all sanitary requirements specified therein. The antimicrobial transportation. specified elsewhere in these regulations. compound must be administered so that Preoperational procedures prescribed in it contacts all carcass surfaces. 9 CFR Part 326 the Sanitation-SOP’s must be completed (4) Any antimicrobial compound Hazard Analysis and Critical Control before the start of operations. previously approved for use in livestock Point (HACCP) systems, Meat (3) The establishment shall develop or livestock products as a food additive inspection, Reporting and and maintain a daily record of or processing aid by the Food and Drug recordkeeping requirements. completion of all sanitation Standard Administration and listed in title 21 of Operating Procedures. Daily records, the Code of Federal Regulations, parts 9 CFR Part 327 including any deviations from 73, 74, 81, 172, 173, 182, or 184 may be Imported products, Hazard Analysis regulatory requirements and corrective used, provided the owner or operator and Critical Control Point (HACCP) actions taken shall be maintained by the has received approval for such use from systems. establishment for a minimum of 6 the Administrator in accordance with months. § 318.7(a) of this subchapter. Any such 9 CFR Part 381 * * * * * antimicrobial compound must be Sanitation, Antimicrobial treatment, administered so that it contacts all Microbial testing, Reinspection, PART 310ÐPOSTMORTEM carcass surfaces. Processed products, Reporting and INSPECTION (c) Exemptions for exported product. recordkeeping, Hazard Analysis and Product designated for export only to a 3. The authority citation for part 310 country which will not accept product Critical Control Point (HACCP) systems, would continue to read as follows: Imports, Transportation. exposed to the antimicrobial treatment Authority: 21 U.S.C. 601–695, 7 CFR 2.17, installed in the establishment will be For the reasons set forth in the 2.55. exempted by the inspection program preamble, 9 CFR chapter III is proposed from the requirement for antimicrobial to be amended as follows: 4. Part 310 would be amended by adding §§ 310.24 and 310.25 to read as treatment if the product is properly PART 308ÐSANITATION follows: identified, segregated, and labeled. § 310.25 Microbial testing. 1. The authority citation for part 308 § 310.24 Treating carcasses to reduce would continue to read as follows: bacteria. (a) General. (1) Incidental sampling. (a) General. Raw livestock carcasses In the event of an outbreak of foodborne Authority: 21 U.S.C. 601–695; 7 CFR 2.17, shall be treated at least once at any disease or other evidence of a threat to 2.55. point during the slaughter and dressing public health attributable to a meat or 2. Section 308.3 would be amended operation, but prior to entering the meat food product, the Administrator by redesignating paragraphs (b) through cooler to reduce levels of bacteria on will conduct a sampling and testing (i) as paragraphs (c) through (j), and carcass surfaces. program as may be required. Carcasses adding a new paragraph (b) to read as (b) Treatment methods. Official at official establishments may be follows: establishments may use any of the included in such a sampling and testing 6838 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules program. Procedures and protocols will The written procedure shall be made Technology, FSIS, Washington, DC vary, depending on the pathogen of available to Program employees for 20250. concern and other circumstances. verification that it is being followed. (ii) Any method for Salmonella (2) Rountine sampling. (i) All (2) The establishment will designate species recognized by the Association of establishments which have slaughter an employee or agent to collect the Official Analytical Chemists or other operations or produce raw, ground meat specimen, as follows: scientific body that may be approved by or raw sausages are required to collect (i) Samples from raw carcasses must the Administrator for this purpose. The a minimum of one sample for testing be taken from chilled product in the analytic method used must be accepted each day from each slaughter class and/ cooler, or if to be used for further by this third party authority as being at or species of ground meat. processing without cooling, prior to least as sensitive as the method used by Establishments shall test the samples for such further processing. Samples will be FSIS for official samples. Salmonella species. The results of the excised brisket skin tissue, 4 inches (10 (d) Reports and recordkeeping. (1) analysis shall be provided to FSIS, as cm) × 4 inches (10 cm) × 1⁄2 inch (1 cm) The designated laboratory or well as to the establishment. The results for beef and belly skin tissue, and 3 establishment employee will record the of the analysis shall be entered by the inches (7 cm) × 5 inches (12 cm) × 1⁄2 results and supply them on a daily basis establishment in a moving sum inch (1 cm) for hogs. to the establishment. The establishment verification chart or table as provided in (ii) Samples from raw, ground or will provide the results, at least weekly, paragraph (d)(2) of this section for comminuted meat products should be to Program employees. The results may review by Program employees. taken prior to packaging. Samples will be electronically transmitted. (ii) Establishment must evaluate and be 1⁄2 pound (0.4 kg). (2) The establishment will be improve their process controls when (c) Analysis. (1) An establishment responsible for entering the results into their performance, as indicated by the may test the specimens in its own a moving sum verification chart or table. number of positive samples over a laboratory or in a commercial/contract The moving sum process verification specified time, exceeds established laboratory. However, the laboratory chart or table will be maintained by the acceptable limits. which is selected must demonstrate establishment for each type of (iii) Establishments which have experience in testing meat and poultry production (slaughter class and/or adopted a Hazard Analysis and Critical for Salmonella spp. Either an internal or species of ground product). This table or Control Point system documenting that external quality assurance/quality chart will consist of a moving sum of product being produced meets or control (QA/QC) program with check results (i.e., a moving count of positives) exceeds the established targets for sample analysis is required. QA/QC that is updated with each new result. pathogen reduction may, upon approval records must be available to FSIS The moving sum procedure is by the Administrator, continue their personnel and FSIS reserves the right to determined by width of window (n) in current operating procedure in lieu of send official check samples to the terms of number of days’ results to the proposed testing verification laboratory to verify laboratory include, and maximum acceptable program set forth in paragraph (a)(2)(i) capabilities. number of positive samples during that of this section. (2) The method used for analyzing a time frame or the Acceptable Limit. (b) Sample collection. (1) Each sample for Salmonella must be one of (i) An example of a moving sum establishment shall prepare written the following: process control chart with the procedures outlining specimen (i) The method published by FSIS in corresponding decision about process collection. Procedures shall address the current edition of the Microbiology acceptability is given below. In the location(s) of sampling, how sampling Laboratory Guidebook. A copy of this example, the window is 8 days (n=8), randomness is achieved, and handling method may be obtained from and the maximum number of positives of the sample to ensure sample integrity. Microbiology Division, Science and permitted in that window is 3 (AL=3). Test Moving Compari- Days in- Day No. result sum son to AL cluded 1 ...... 0 0 Meets ..... 1 2 ...... 0 0 Meets ..... 1, 2 3 ...... 0 0 Meets ..... 1 to 3 4 ...... 1 1 Meets ..... 1 to 4 5 ...... 0 1 Meets ..... 1 to 5 6 ...... 0 1 Meets ..... 1 to 6 7 ...... 1 2 Meets ..... 1 to 7 8 ...... 0 2 Meets ..... 1 to 8 9 ...... 0 2 Meets ..... 2 to 9 10 ...... 0 2 Meets ..... 3 to 10 11 ...... 0 2 Meets ..... 4 to 11 12 ...... 0 1 Meets ..... 5 to 12 13 ...... 0 1 Meets ..... 6 to 13 14 ...... 0 1 Meets ..... 7 to 14 15 ...... 0 0 Meets ..... 8 to 15 Note: Thus, the moving sum value for day 10 is the sum of the results in the 8 day window ending that day; it can be calculated simply by counting the number of 1's in the daily result column on days 3 through 10. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6839 (ii) The chart below specifies the designated by the establishment to paragraph (c)(3) of this section. initial values of width of windows (n) perform certain functions as indicated Establishments shall make the and Acceptable Limit (AL) for each in this section. temperature monitoring records product class. Raw meat product. Any meat, meat available to the Program employees and food product, or meat byproduct that shall retain records up to 6 months after Moving sum rules has not received treatment, such as the temperature measurement or until cooking, to make it ready to eat. such time as may otherwise be specified Target Ready-to-eat-process. Any process, (per- by the Administrator. cent Win- Ac- such as cooking, applied to a raw meat (2) To demonstrate compliance with Commodity cepta- product that effectively inactivates posi- dow ble the time and temperature requirements tive for size (n) limit infective pathogenic hazards that may set forth in this section, establishments Sal- in days be in or on the product. monel- (AL) shall use temperature measuring devices la) Ready-to-eat product. Any food that is readable and accurate to 2°F (0.9°C). safe for human consumption without (3) Establishments shall develop, Steers/Heifers ... 1 82 1 additional treatment. implement, and place on file a written (b) Time and temperature Raw Ground plan for complying with the time and Beef ...... 4 38 2 requirements. (1) All carcasses and raw temperature requirements set forth in Cows/Bulls ...... 1 82 1 meat products from such carcasses shall this section. Establishments shall make Hogs ...... 18 17 4 be cooled to surface temperatures of their plans and records, created under Fresh Pork Sau- 50°F (10°C) or below within 5 hours and the plans, available to Program sages ...... 12 19 3 40°F (4.4°C) or below within 24 hours employees upon request. Each plan from the time the carcasses exit the (e) Corrective action. (1) shall identify the establishment’s slaughter floor, unless such product Establishments failing to meet control points, i.e., points designated in immediately enters a ready-to-eat Acceptable Limits will be presumed to the production process after the chilling process or is part of a hot-boning have process control deficiencies. In procedure where temperatures are operation, as prescribed in paragraph such instances, a complete review by measured; monitoring procedures, (b)(2) of this section. Raw product the establishment of the production including frequency within a day’s removed from the carcass on the process is required. A written report of operation; records; standards for the slaughter floor not entering a ready-to- the evaluation, including the reason for control points, including cooling rate eat process or hot-boning operation, e.g., process failure and proposed corrective and holding temperature; corrective livers, hearts, and heads with cheek actions, will be submitted to the actions, including a system for meat, shall be placed in a chiller within Inspector in Charge within 14 days from separating and identifying 1 hour of removal from the carcass. the day the process exceeded the limits. (2) Establishments that separate raw noncomplying products; and, when This report shall be updated on a meat from the bone before cooling the applicable, the name of the processing weekly basis until the moving sum carcasses (hot-boning) shall cool such authority. procedure indicates the process is in raw meat until it reaches an internal PART 320ÐRECORDS, control. temperature of 50°F (10°C) or below (2) During the time the results fail to REGISTRATION, AND REPORTS within 5 hours of initial separation, and meet the Acceptable Limits, sampling 40°F within 24 hours, except that raw 7. The authority citation for part 320 should be conducted at a rate of two meat from a hot-boning operation may would continue to read as follows: specimens or more per day. The enter a ready-to-eat process at the sampling rate will return to normal Authority: 21 U.S.C. 601–695; 7 CFR 2.17, establishment within 5 hours of initial when the establishment meets 2.55. separation. Acceptable Limits indicating the (3) Carcasses or raw meat products 8. Section 320.1 would be amended process is in control. received at official establishments shall by adding new paragraphs (b) (11), (12), ° (13) and (14) to read as follows: PART 318ÐENTRY INTO OFFICIAL register an internal temperature of 40 F ESTABLISHMENTS; REINSPECTION or below. § 320.1 Records required to be kept. (4) Establishments shall maintain AND PREPARATION OF PRODUCTS carcasses or raw meat products in their * * * * * 5. The authority citation for part 318 possession or under their control at a (b) * * * would continue to read as follows: temperature of 40°F or below. Product (11) Standard operating procedures may not be released into commerce (SOP’s) for sanitation, and daily records, Authority: 7 U.S.C. 138f; 7 U.S.C. 450, as prescribed in § 308.3 of this 1901–1906; 21 U.S.C. 601–695; 7 CFR 2.17, unless chilled to this temperature. 2.55. (5) Establishments may use a subchapter. (12) Temperature control plans and * * * * * processing authority to develop time 6. Part 318 would be amended by and temperature limits records, as required by § 318.25 of this adding a new § 318.25 to read as microbiologically equivalent to those subchapter. follows: provided in paragraphs 318.25 (b)(1) (13) A written protocol for sampling through (b)(4). Any such time and raw product for pathogen testing, as § 318.25 Temperatures and chilling temperature alternatives must be required by § 318.25 of this subchapter. requirements for carcasses and raw meat included in the establishment’s written (14) HACCP plans and records, as products. plan, as provided in § 318.25(c) of this required by part 326 of this subchapter. (a) Definitions: section. 9. Section 320.3 would be amended Processing authority. A person or (c) Temperature monitoring and by adding new paragraphs (c), (d) and organization having expert knowledge written plans. (1) Establishments shall (e) to read as follows: of food processing procedures, having monitor the temperature of raw meat at access to facilities for evaluating the the control points as set forth in the § 320.3 Record retention period. safety of such procedures, and establishment’s written plan required by * * * * * 6840 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules (c) The Sanitation Standard Operation 326.3 HACCP principles. Preventive measures. Physical, Procedures for Sanitation shall be 326.4 Implementation of the HACCP plan. chemical, or other factors that can be retained as required in § 308.3. 326.5 Operation of HACCP system. used to control an identified health (d) Temperature monitoring plan and 326.6 Record review and maintenance. hazard. records shall be retained as required in 326.7 Enforcement. Process. A procedure consisting of § 318.25(e)(1). Authority: 21 U.S.C. 601–695; 7 CFR 2.17, any number of separate, distinct, and (e) Record of HACCP plans and 2.55. ordered operations that are directly systems, shall be retained as required in § 326.1 Definitions. under the control of the establishment § 326.6(d). For purposes of this part, the employed in the manufacture of a 10. Section 320.6 would be amended specific product, or a group of two or following definitions shall apply: by revising paragraph (a) to read as more products wherein all CCPs are Corrective action. Procedures to be follows: identical, except that optional followed when a deviation occurs. operations or CCPs, such as packaging, § 320.6 Information and reports required Criterion. A requirement on which a may be applied to one or more of those from official establishment operators. judgment or decision can be based. products within the group. (a) The operator of each official Critical control point (CCP). A point, Product. Any carcass, meat, meat establishment shall furnish to Program step, or procedure at which control can byproduct, or meat food product employees accurate information as to all be applied and a food safety hazard can capable of use as human food. matters needed by them for making their be prevented, eliminated, or reduced to Recognized HACCP course. A HACCP daily reports of the amount of products acceptable levels. course available to meat and poultry prepared or handled in the departments Critical control point (CCP) failure. industry employees which satisfies the of the establishment to which they are Inadequate control at a CCP resulting in following: consists of at least 3 days, 1 assigned and such reports concerning an unacceptable risk of a hazard. day devoted to understanding the seven sanitation, antimicrobial treatments, Critical limit. A criterion that must be principles of HACCP, 1 day devoted to mandatory microbiological testing, and met for each preventive measure applying these concepts to this and other aspects of the operations of the associated with a CCP. other regulatory requirements of FSIS, establishment and the conduct of Deviation. Failure to meet a critical and 1 day devoted to beginning inspection thereat, as may be required limit. development of a HACCP plan for a by the Administrator in special cases. HACCP. A hazard analysis and specific process. * * * * * critical control point (HACCP) system Responsible establishment official. that identifies specific hazards and The management official located on-site PART 325ÐTRANSPORTATION preventive measures for their control to at the establishment who is responsible ensure the safety of food. for the establishment’s compliance with 11. The authority citation for part 325 HACCP plan. The written document this part. would continue to read as follows: which is based upon the principles of Validation. An analysis of verification Authority: 7 U.S.C. 450, 1901–1906; 21 HACCP and which delineates the procedures, HACCP plan components, U.S.C. 601–695; 7 CFR 2.17, 2.55. procedures to be followed to assure the and an evaluation of records associated 12. Section 325.9 would be added to control of a specific process or with the HACCP system to determine its read as follows: procedure. efficacy for the production of safe and HACCP system. The result of the wholesome product for which the § 325.9 Shipment of carcasses and raw implementation of the HACCP plan. process was designed. meat products. HACCP-trained individual. A person Verification. The use of methods, (a) Carcasses and raw meat products, who has successfully completed a procedures, or tests in addition to those as defined in § 318.25 of this recognized HACCP course in the used in monitoring to determine if the subchapter, shall have an internal application of HACCP principles to HACCP system is in compliance with temperature of 40°F or below when meat processing operations, and who is the HACCP plan and/or whether the loaded on vehicles for shipping. Such employed by the establishment. A HACCP plan needs modification and products that are shipped from an HACCP-trained individual must have revalidation. official establishment to another official sufficient experience and training in the § 326.2 Development of HACCP plan. establishment shall arrive at the technical aspects of food processing and receiving establishment at an internal the principles of HACCP to determine (a) Every official establishment shall temperature of 40°F or below. whether a specific HACCP plan is develop, implement, and operate a (b) The date and time of shipment of appropriate to the process in question. HACCP plan, as set forth in paragraph carcasses and raw meat products from Hazard. A biological, chemical, or (d) of this section, for each process an official establishment to another physical property that may cause a food listed below conducted by the official establishment shall be recorded to be unsafe for consumption. establishment. on the waybill, running slip, Hazard analysis. The identification of Categories of Processes for HACCP: conductor’s card, shipper’s certificate, any biological, chemical, or physical 01 Raw-Ground or any other such papers accompanying properties in raw materials and 02 Raw Other Inclusive a shipment. processing steps and an assessment of 03 Thermally Processed/Commercial Sterile 13. A new part 326 would be added 04 All Other Shelf Stable, Not Heat Treated their likely occurrence and seriousness 05 Fully Cooked—Not Shelf Stable to read as follows: to cause the food to be unsafe for 06 All Other Shelf Stable, Heat Treated consumption. PART 326ÐHAZARD ANALYSIS AND 07 All Non-Shelf Stable, Heat Treated, Not Monitor. To conduct a planned Fully Cooked CRITICAL CONTROL POINT (HACCP) sequence of observations or 08 Non-Shelf Stable, w/Secondary SYSTEM measurements to assess whether a CCP Inhibitors 09 Slaughter, All Meat Species Sec. is under control and to produce an 326.1 Definitions. accurate record for future use in (b) At a minimum, the HACCP plan(s) 326.2 Development of HACCP plan. verification. shall be developed with the assistance Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6841 of a HACCP-trained individual Hazard analysis should take into controlled as demonstrated by process employed by the establishment, whose consideration factors such as: validation performed during the Hazard name and resume is on file at the ingredients; physical characteristics and Analysis and plan development. establishment, and who is composition; processing procedures, (3) All records and documents knowledgeable of each process microbial content of the product or associated with CCP monitoring shall be conducted by the establishment. The products; facility and equipment design; dated and signed or initialed by the person(s) developing the plan shall be packaging; sanitation; conditions of person(s) conducting the monitoring. knowledgeable of HACCP and the storage between packaging and the end associated recordkeeping procedures, user; intended use; and intended (e) Principal No. 5. Establish and shall be capable of: identifying the consumer. All identified hazards corrective action(s) to be taken when hazards of the establishment’s process associated with each step in the process monitoring indicates that there is a and understanding the source of such must be listed and its significant risk deviation from an established critical hazards; establishing relevant CCP’s and severity evaluated. The preventive limit. throughout the process; and developing measures to control the identified (1) The corrective actions shall appropriate critical limits, monitoring hazards must be listed. The steps in describe the step(s) taken to identify and procedures, corrective action application of this principle shall, at a correct the cause of noncompliance to procedures, verification procedures and minimum, include: assure that the CCP is under control, their frequency, and operating (1) A flow chart describing the steps ensure that no safety hazards exist after procedures to implement the HACCP of each process and product flow in the these actions, and define measures to plan. establishment; and prevent recurrence. (c) Prior to the initiation of the Hazard (2) Identification of the intended use (2) Corrective actions shall include a Analysis phase for HACCP plan and consumers of the product based determination of the effect of the development, each establishment shall upon normal use by the general public deviation(s) on product safety; how have on file a copy of its procedures for or a particular segment of the noncompliant product will be handled, maintaining adherence to recommended population. including segregation and holding Standard Operating Procedures for (b) Principle No. 2. Identify the CCP’s procedures; a definition of lot size; sanitation as set forth in § 308.3. in the process using a decision tree and whether the deviation indicates a (d) The development of the HACCP the information derived from § 326.3(a). modification or revision of the HACCP plan shall consist of two stages: a CCP’s shall be identified for purposes of plan is required, and time frames for Hazard Analysis, as provided under product safety only. They must include modification or revision of the HACCP Principle 1 in § 326.3(a); and the physical, chemical, and biological plan. development of the remainder of the (including microbiological and residue) HACCP plan for each specific process, hazards; must encompass the health and (f) Principal No. 6. Establish effective as defined in § 326.2(a), including safety process control points required by recordkeeping and systematic review activities designed to ensure that the FSIS regulations, or their equivalents; procedures that document the HACCP HACCP plan as developed is valid. and must be specified for each system. The required records are These steps shall be completed over a identified hazard. specified in § 326.6. period not to exceed 6 months prior to (c) Principle No. 3. Establish specific (g) Principal No. 7. Establish the phase-in date of the process category critical limits for preventive measures procedures for verification by a HACCP- as prescribed in § 326.7, or upon associated with each identified CCP. trained individual that the HACCP application for the grant of inspection, Critical limits which are a part of other system is functioning effectively to or when a new process is intended for portions of relevant regulations must be ensure product safety and process implementation. included. control. This is the plan validation (1) The HACCP plan should be in a (1) All critical limits shall meet or process and therefore includes methods, format that is similar to the National exceed any requirement set forth in this procedures, or tests in addition to those Advisory Committee on Microbiological subchapter pertaining to a specific used for monitoring. Such validation Criteria for Foods and FSIS generic process and which are currently a part shall ensure: models to ensure that both the of FSIS regulations or other FSIS establishment and program employees requirements. (1) The adequacy of the critical limits can readily identify the requirements in (2) The responsible establishment at each CCP; §§ 326.2(c) and 326.3. official shall ensure that the critical (2) The continuing effectiveness of the (2) Each HACCP principle, as limits are sufficient to control the establishment’s HACCP plan and prescribed in § 326.3, must be included identified hazards through a validation system, including taking into account in the HACCP plan. process consisting of verification and changes in product volumes, monitoring activities. procedures, personnel, and product use; § 326.3 HACCP principles. (d) Principle No. 4. Establish CCP (3) The accuracy of the HACCP plan The following principles and their monitoring requirements. Establish through the completion of all seven associated components shall be specific procedures for using the results principles and their associated actions included in each HACCP plan: of CCP monitoring to adjust and including revalidation whenever (a) Principle No. 1. A hazard analysis maintain process control. shall be conducted to identify biological (1) The responsible establishment significant product, process, deviations, (including microbiological), chemical, official shall ensure that establishment or packaging changes require and/or physical properties of raw employees are assigned to monitor each modification of the plan; and materials and processing steps that may CCP effectively, as determined by (4) The evaluation of product safety in cause a product or products to be unsafe Hazard Analysis. situations where the establishment for consumption. A list of steps in the (2) When monitoring is not possible identifies deviations from critical limits, process where potentially significant on a continuous basis, the monitoring all steps taken in response to a hazards may occur and the preventive interval established shall reliably deviation, and the adequacy of the measures to be taken shall be prepared. indicate that the hazard can be corrective response. 6842 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules § 326.4 Implementation of the HACCP the HACCP plan to ensure Stable, Heat Treated, Not Fully Cooked; plan. completeness, to determine whether all and Shelf Stable, Not Heat Treated. (a) Upon completion of the Hazard critical limits were met and, if (iii) Establishments that conduct the Analysis and development of the appropriate, corrective action(s) were following categories of processes shall HACCP plan, a responsible taken, including proper disposition of comply by [insert date 24 months after establishment official shall review and product. This review shall be publication of final rule]: Fully Cooked, approve the written plan by signing it. conducted, dated, and signed by an Non-Shelf Stable; and Non-Shelf Stable, (b) Upon completion of the Hazard individual who did not produce the with Secondary Inhibitors. Analysis and development of the record(s), preferably by the HACCP- (iv) Establishments that conduct the HACCP plan, the establishment shall trained individual, or the responsible following categories of processes shall conduct activities designed to determine establishment official. meet the requirements of this part by that the HACCP plan is functioning as (b) The following records supporting [insert date 30 months after publication intended, ensuring the adequacy of the the establishment’s HACCP plan shall of final rule]: Raw, other; and Slaughter, CCP’s, critical limits, monitoring and be maintained: all livestock. recordkeeping procedures, and (1) The written HACCP plan (v) Small entities that generate less corrective actions. During this initial including all portions of the Hazard than $2.5 million dollars of product per HACCP plan validation period, the Analysis as prescribed in this part; year shall comply by [insert date 36 establishment shall conduct repeated (2) Records associated with the months after publication of final rule]. verifications and meet frequently with monitoring of CCP’s, which include the (2) Any establishment that obtains Program employees to assure the recording of actual times, temperatures, Federal inspection on or after the HACCP system is functioning as or other quantifiable values, as effective date(s) for the process intended, which shall include a review prescribed in the establishment’s category(ies) to be conducted shall of the records generated by the HACCP HACCP plan; corrective actions, conduct a Hazard Analysis, and shall system. including all actions taken in response develop and validate its HACCP plan(s), (c) When an ingredient change, to a deviation; verification procedures as set forth in § 326.2(d) of this part, product reformulation, manufacturing and results; product code(s), identity, or concurrent with the grant of inspection. process or procedure modification, slaughter production lot; and date the Process analysis, as set forth in equipment change, or any other such record was made; and § 326.4(c), shall commence after change requires modifications to the (3) Records associated with obtaining Federal inspection to assure establishment’s HACCP plan, the supporting documentation for the compliance with the critical limits of responsible establishment official, in Hazard Analysis, development of the the HACCP plan and that the HACCP consultation with a HACCP-trained selected CCP’s, critical limits, frequency system is functioning as intended. individual employed by the of monitoring and verification (3) Any establishment that institutes a establishment, shall ensure that the procedures, and corrective actions new process requiring development of a HACCP plan is modified to reflect such taken. HACCP plan on or after the applicable changes. The development of the (c) All such records shall be made effective date(s) of this regulation shall modified HACCP plan shall be available to any Program employee conduct all activities required for conducted in accordance with §§ 326.2 upon request. A deviation from a critical hazard analysis, development, and and 326.3. limit shall be brought to the attention of validation of its HACCP plan(s) for the the appropriate Program employee process category(ies) as set forth in § 326.5 Operation of HACCP system. promptly. § 326.2(d) of this part, before (a) The establishment’s HACCP (d) All records shall be retained at the commencing production and shall system, as set forth in the establishment at all times, except that conduct process analyses, as set forth in establishment’s HACCP plan, shall be records for monitoring CCP’s, corrective § 326.4(b), to assure compliance with operated with the advice and guidance actions, and verification procedures the critical limits of the HACCP plan of a HACCP-trained individual, as shall be retained at the establishment for and that the HACCP system is defined in § 326.1. no less than 1 year, and for an functioning as intended. (b) The responsible establishment additional 2 years at the establishment (4) Commencing with the applicable official shall be held responsible for the or other location from which the records effective date(s), the Program shall operation of the HACCP system to can be made available to Program refuse new inspection services ensure compliance with the Act and employees. requested for, or, using the procedures regulations thereunder. In all respects, in § 335.33, suspend inspection services however, the Administrator shall § 326.7 Enforcement. from establishments or specific continue to provide the Federal (a) Implementation. (1) The following processes within establishments not inspection necessary to carry out the establishments shall meet the having HACCP plans. provisions of the Act. requirements of this part by the date (b) Verification. The Program shall prescribed: verify that HACCP plan(s) are effective § 326.6 Record review and maintenance. (i) Estabishments that conduct the and validated, and otherwise in (a) Each entry on a record maintained following categories of processes shall compliance with this regulation. Such under the HACCP plan shall be made at comply by [insert date 12 months after verification and process validation may the time the specific event occurs and publication of final rule]: Raw, Ground include: include the time recorded, and the (including mechanically separated (1) Reviewing the HACCP plan, record shall be signed or initialed by the (species)); Thermally Processed/ (2) Reviewing the CCP records, establishment employee making the Commercially Sterile; and All Other, (3) Reviewing and determining the entry. Prior to shipping product Shelf Stable, Heat Treated. adequacy of corrective actions taken produced under each process, the (ii) Establishments that conduct the when a deviation occurs, establishment shall review, on a following categories of processes shall (4) Conducting verification activities defined, systematic basis, all processing comply by (insert date 18 months after to determine whether CCP’s are under and production records associated with publication of final rule): Non-Shelf control, Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6843 (5) Reviewing the critical limits, acknowledgement of any subsequent the applicant or operator of the (6) Reviewing other records pertaining modified plan(s) under paragraph (c)(3) establishment in the manner prescribed to the HACCP plan or system, of this section, also review the in § 1.147(b) of the Uniform Rules of (7) Random sample collection and establishment’s performance under the Practice (7 CFR 1.147(b)). analysis to determine the safety of the inspection regulations generally and (b) If any applicant or operator of an product, and/or make a written recommendation to the establishment so notified fails to take (8) On-site observations and records Administrator whether any additional the necessary action to have a valid review for revalidation of HACCP plans. inspection or enforcement measures HACCP plan within the period specified (c) Suspension, correction of invalid may be required. in the notice, the Administrator may plans. (1) If the Program finds a HACCP issue a complaint in accordance with plan to be invalid, inspection service for PART 327ÐIMPORTED PRODUCTS the Uniform Rules of Practice. Effective the process covered by the HACCP plan upon service of the complaint, will be suspended using the procedures 14. The authority citation for Part 327 would continue to read as follows: inspection service shall be refused or in § 335.33. The processing facilities withdrawn from such establishment identified shall not be used for Authority: 21 U.S.C. 601–695, 7 CFR 2.17, pending final determination in the production of meat or meat food 2.55. proceeding. product pending completion of the 15. Section 327.2 would be amended specified corrective action(s), as by redesignating paragraph (a)(2)(ii)(h) PART 381ÐPOULTRY PRODUCTS prescribed (c)(3) of this section and as (a)(2)(ii)(i) and by adding a new INSPECTION REGULATIONS written acknowledgement thereof by the paragraph a(2)(ii)(h) to read as follows: designated Program official. Products 17. The authority citation for Part 381 produced by the process prior to the § 327.2 Eligibility of foreign countries for would continue to read as follows: suspension suspected of being importation of products into the United Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 States. adulterated shall be retained at the U.S.C. 451–470; 7 CFR 2.17, 2.55. establishment pending disposition by * * * * * Subpart HÐSanitation the Program, and if such product has (a) * * * (2) * * * been shipped, it shall be subject to 18. Section 381.45 would be revised voluntary recall as necessary to protect (ii) * * * (h) Development and maintenance of to read as follows: public health. (2) A HACCP plan may be found a Hazard Analysis and Critical Control § 381.45 Minimum standards for invalid if: Point (HACCP) system pursuant to part sanitation, facilities and operating (i) The HACCP plan does not meet the 326 of this subchapter in each certified procedures in official establishments. requirements of this part, establishment; The provisions of §§ 381.45 through (ii) HACCP records are not being * * * * * 381.61, inclusive, shall apply with maintained as required to validate the 16. Subpart E of part 335 would be respect to all official establishments. plan or verify process control under the redesignated as subpart F, and a new (a) The establishment shall develop plan, or subpart E would be added to read as and maintain written Sanitation (iii) A processing failure results in follows: Standard Operating Procedures production of adulterated product. (Sanitation SOP’s) which must be (3) Invalid HACCP plans must be Subpart EÐRules Applicable to the available to program employees for corrected by: Suspension of Inspection for Failure verification and monitoring. Sanitation (i) Submission to the designated To Have a Validated HACCP Plan SOP’s shall, at a minimum, detail daily Program official of a written, detailed sanitation procedures to be conducted, Authority: 21 U.S.C. 601–695; 7 CFR 2.17, verification by a HACCP-trained 2.55. before and during operations, to prevent individual that a modified HACCP plan direct contamination or adulteration of has been developed in consultation with § 335.33 Refusal or suspension of product(s). Sanitation SOP’s must also that individual and that, as modified, inspection service for failure to comply with identify plant officials responsible for the plan corrects the deficiencies found, HACCP requirements. monitoring daily sanitation activities, and (a) In any situation in which the evaluating the effectiveness of SOP’s, (ii) In the case of a processing Administrator determines that an and initiating corrective actions when deficiency resulting in production of establishment which is applying for needed. adulterated product, submission to the inspection or receiving inspection under (1) A ‘‘US Rejected’’ tag will be designated Program official of and Title I of the Federal Meat Inspection attached to the applicable equipment, adherence to a written plan for finished Act does not have a valid HACCP plan utensil, room or compartment if a product produced under the modified as required by § 326.7, he shall refuse to Program employee determines that the HACCP plan to be tested by an external allow said meat or meat food products establishment has failed to adhere to the laboratory for chemical or microbial to be labeled, marked, stamped, or Sanitation SOP’s specifically required characteristics, at the establishment’s tagged as ‘‘inspected and passed.’’ The by paragraph (a) of this section. No expense, as appropriate to demonstrate Administrator shall notify the applicant equipment, utensil, room, or that the process under the modified or operator of the establishment, orally compartment so tagged shall be used HACCP plan corrects the identified or in writing, as promptly as until reinspected and found acceptable problem. circumstances permit, of such refusal to by a Program employee. The (4) If the establishment fails to adhere inspect and pass the meat or meat food establishment shall maintain daily to the modified HACCP plan and, if products and the reasons therefor, and records for a minimum of 6 months. applicable, the testing plan, resulting in the action which the Administrator (2) The establishment owner or a subsequent suspension of the same deems necessary to have a valid HACCP operator shall be responsible for the process for the same or a related plan. In the event of oral notification, establishment’s adherence to the SOP’s, deficiency, the designated Program written confirmation shall be given, as as well as for all sanitary requirements official will, upon receipt and before promptly as circumstances permit, to specified elsewhere in these regulations. 6844 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Preoperational procedures prescribed in except that raw poultry from a hot- § 381.69 Treating carcasses to reduce the Sanitation SOP’s must be completed boning operation may enter a ready-to- bacteria. before the start of operations. eat process at the establishment within (a) General. Raw poultry carcasses (3) The establishment shall develop 1.5 hours of initial separation. shall be treated at least once at any and maintain a daily record of (iii) Carcasses or raw poultry products point during the slaughter and dressing completion of all sanitation Standard received at official establishments shall operation, but prior to entering the Operating Procedures. Daily records, register an internal temperature of 40°F chiller to reduce levels of bacteria on including any deviations from or below. carcass surfaces. regulatory requirements and corrective (iv) Establishments shall maintain raw (b) Treatment methods. Official actions taken, shall be maintained by poultry carcasses and products in their establishments may use any of the the establishment for a minimum of 6 possession or under their control at a following treatment methods to reduce months. temperature of 40°F or below. Product bacteria, provided that equipment has (b) [Reserved] may not be released into commerce been approved under § 381.53, and that unless chilled to this temperature. operation of the method results in full Subpart IÐOperating Procedures (v) Establishments may use a compliance with the Act and this part. (1) Any chlorine compound approved 19. Section 381.66 would be amended processing authority to develop time by the Administrator and administered by revising paragraph (b) to read as and temperature limits to raw, unchilled whole poultry follows: microbiologically equivalent to those provided in paragraphs 381.66(b)(2)(i) carcasses or major carcass portions at 20 § 381.66 Temperatures and chilling and through (b)(2)(iv). Any such time and to 50 parts per million (ppm) in the freezing procedures. temperature alternatives must be intake water at the final wash. The * * * * * included in the establishment’s written chlorinated water must contact all (b) General chilling requirements—(1) plan, as provided in § 381.66(b)(3) of carcass surfaces. The Administrator will Definitions: this section. prepare a list containing compounds Processing authority. A person or (3) Temperature monitoring and approved for use in official establishments. A copy of the list may organization having expert knowledge written plans. (i) Establishments shall be obtained from the Compounds and of food processing procedures, having monitor the temperature of raw poultry Packaging Branch, Product Assessment access to facilities for evaluating the at the control points as set forth in the Division, Regulatory Programs, Food safety of such procedures, and establishment’s written plan required by Safety and Inspection Service, U.S. designated by the establishment to paragraph (b)(3)(iii) of this section. Department of Agriculture, Washington, perform certain functions as indicated Establishments shall make the DC 20250–3700. in this section. temperature monitoring records Raw poultry product. Any poultry or (2) Hot water applied such that the available to Program employees and temperature of the water at the carcass poultry byproduct that has not received shall retain records up to 6 months after treatment, such as cooking, to make it surface is ≥165°F (≥74°C) for ≥10 the temperature measurement or until seconds. The hot water must contact all ready to eat. such time as may otherwise be specified Ready-to-eat process. Any process, carcass surfaces. by the Administrator. such as cooking, applied to a raw (3) Any antimicrobial compound (ii) To demonstrate compliance with poultry product that effectively listed in the table in § 381.147(f)(4) and the time and temperature requirements inactivates infective pathogenic hazards permitted for use on poultry products set forth in this section, establishments that may be in or on the product. may be used under the conditions shall use temperature measuring devices Ready-to-eat product. Any food that is ° ° specified therein. The antimicrobial safe for human consumption without readable and accurate to 2 F (0.9 C). compound must be administered so that additional treatment. (iii) Establishments shall develop, it contacts all carcass surfaces. (2) Time and temperature implement, and place on file a written (4) Any antimicrobial compound requirements. plan for complying with the time and approved for use in poultry or poultry (i) All poultry and poultry products temperature requirements set forth in products as a food additive or that are slaughtered and eviscerated in this section. Establishments shall make processing aid by the Food and Drug the official establishment shall be their plans and records, created under Administration and listed in title 21 of chilled immediately after processing to the plans, available to Program the Code of Federal Regulations, parts reach surface temperatures of 50 °F employees upon request. Each plan 73, 74, 81, 172, 173, 182, or 184 may be (10°C) or below within 1.5 hours and shall identify the establishment’s used, provided the owner or operator 40°F (4.4°C) or below within 24 hours control points, i.e., points designated in has received approval for such use from from the time that the carcasses exit the the production process after the chilling the Administrator in accordance with slaughter line, unless such product procedure where temperatures are § 381.147(f)(2) of this part. Any such immediately enters a ready-to-eat measured; monitoring procedures, antimicrobial compound must be process or a hot-boning operation, as including frequency within a day’s administered so that it contacts all prescribed in paragraph (b)(2)(ii) of this operation; records; standards for the carcass surfaces. section. Raw product removed from the control points, including cooling rate (5) If the application or use of an carcass on the slaughter line, such as and holding temperature; corrective antimicrobial treatment is determined giblets, shall be placed in a chiller actions, including a system for by the Inspector in Charge to not within 1 hour of removal from the separating and identifying conform to approved parameters, the carcass. noncomplying products; and, when establishment shall make necessary (ii) Establishments that separate raw applicable, the name of the processing adjustments within 15 minutes. If poultry from the bone before cooling the authority. adjustments are not made within 15 carcasses (hot-boning) shall cool such * * * * * minutes, the establishment shall raw poultry until it reaches an internal 20. Subpart I would be amended by suspend the treatment and shall not temperature of 50°F (10°C) or below adding a new § 381.69 to read as process carcasses until appropriate within 1.5 hours of initial separation, follows: adjustments are made. If a second Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6845 antimicrobial treatment is in place and species of ground poultry. The sample available to FSIS employees and FSIS functioning properly, the use of the will be tested for Salmonella species. reserves the right to send official check nonconforming antimicrobial treatment The results of the analysis will be samples to the laboratory to verify may be discontinued and processing of provided to FSIS, as well as to the laboratory capabilities. carcasses may continue. Product not establishment. The results of the (ii) The method used for analyzing a treated in conformance with approved analysis will be entered by the sample for Salmonella must be one of parameters shall be retained for establishment in a moving sum the following: disposition by the Inspector in Charge. verification chart or table for review by (A) The method published by FSIS in (c) Exemptions for exported product. Program employees. Product designated for export only to a (B) FSIS will require producers to the current edition of the Microbiology country which will not accept product evaluate and improve their process Laboratory Guidebook. A copy of this exposed to the antimicrobial treatment controls when their performance, as method may be obtained from the installed in the establishment will be indicated by the number of positive Microbiology Division, Science and exempted by the inspection program samples over a specified time, exceeds Technology, Food Safety and Inspection from the requirement for antimicrobial established Acceptable Limits. Service, Washington, DC 20250. treatment if the product is properly (C) Establishments that have adopted (B) Any method for Salmonella identified, segregated, and labeled. a Hazard Analysis and Critical Control species recognized by the Association of Point system documenting that product Official Analytical Chemists or other Subpart KÐPost Mortem Inspection: being produced meets or exceeds the recognized scientific body that may be Disposition of Carcasses and Parts established targets for pathogen approved by the Administrator for this purpose. The analytic method used 21. In § 381.76, Table 1—Definitions reduction may, upon approval by the must be accepted by this third party of Nonconformances, would be Administrator, continue their current authority as being at least as sensitive as amended in paragraph A–1 by removing operating procedure in lieu of the the method used by FSIS for official the word ‘‘feces’’, by amending proposed testing verification program, samples. paragraph A–2 to remove the end note set forth in paragraph (b)(1)(ii)(C) of this regarding feces, and by removing section. (4) Reports and recordkeeping. (i) The (2) Sample collection. (i) Each paragraph A–8, ‘‘Feces ≥1⁄8’’, and designated laboratory or establishment establishment will prepare written renumbering paragraphs A–9 through employee will record the test results procedures outlining specimen A–20 as A–8 through A–19. and supply them on a daily basis to the 22. Section 381.79 would be amended collection. Procedures will address establishment. The establishment will by revising the heading, redesignating location(s) of sampling, how sampling provide the results, at least weekly, to the existing text as paragraph (a), and randomness is achieved, and handling Program employees. The results may be adding a new paragraph (b) to read as of the sample to ensure sample integrity. electronically transmitted. The written procedure will be made follows: (ii) The establishment will be available to Program employees for responsible for entering the results into § 381.79 Passing of carcasses; microbial verification that it is being followed. a moving sum verification chart or table. testing. (ii) The establishment will designate The verification chart or table will be (a) * * * an employee or agent to collect the maintained by the establishment for (b) Microbial Testing—(1) General. specimen, as follows: (i) Incidental sampling. In the event of (A) Whole birds will be collected at each type of production (slaughter class an outbreak of foodborne disease or the end of the chilling process, after the and/or species of comminuted product). other evidence of a threat to public drip line, and rinsed in an amount of This chart or table will consist of a health attributable to a poultry or buffer appropriate for the type of bird moving sum of results (i.e., a moving poultry food product, the Administrator sampled. count of positives) that is updated with will conduct a sampling and testing (B) Samples from raw ground poultry each new result. The moving sum program as may be required. Poultry at will be taken prior to packaging. procedure is determined by width of official establishments may be included Samples will be 1/2 pound (0.4 kg). window (n) in terms of number of days’ in such a sampling and testing program. (3) Analysis. (i) An establishment may results to include, and maximum Procedures and protocols will vary, test the specimens in its own laboratory acceptable number of positives during depending on the pathogen of concern or in a commercial/contract laboratory. that time frame. and other circumstances. However, the laboratory which is (A) An example of a moving sum (ii) Routine sampling. selected must demonstrate experience process control chart with the (A) All establishments that have in testing poultry for Salmonella spp. corresponding decision about process slaughter operations or produce raw, Either an internal or external quality acceptability is given below. In the ground poultry are required to collect a assurance/quality control (QA/QC) example, the window is 8 days (n=8), minimum of one sample for testing each program with check sample analysis is and the maximum number of positives day from each slaughter class and/or required. QA/QC records must be permitted in that window is 3 (AL=3): Test Moving Days in- Day No. result sum Comparison to AL cluded 1 ...... 0 0 Meets ...... 1. 2 ...... 0 0 Meets ...... 1, 2. 3 ...... 0 0 Meets ...... 1 to 3. 4 ...... 1 1 Meets ...... 1 to 4. 5 ...... 0 1 Meets ...... 1 to 5. 6 ...... 0 1 Meets ...... 1 to 6. 7 ...... 1 2 Meets ...... 1 to 7. 8 ...... 0 2 Meets ...... 1 to 8. 9 ...... 0 2 Meets ...... 2 to 9. 6846 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Test Moving Days in- Day No. result sum Comparison to AL cluded 10 ...... 0 2 Meets ...... 3 to 10. 11 ...... 0 2 Meets ...... 4 to 11. 12 ...... 0 1 Meets ...... 5 to 12. 13 ...... 0 1 Meets ...... 6 to 13. 14 ...... 0 1 Meets ...... 7 to 14. 15 ...... 0 0 Meets ...... 8 to 15. Note: Thus, the moving sum value for day 10 is the sum of the results in the 8 day window ending that day; it can be calculated simply by counting the number of 1's in the daily result column on days 3 through 10. (B) The following chart specifies the (8) Written protocol for sampling raw that are shipped from an official initial values of width of windows (n) product for pathogen testing, as required establishment to another official and Acceptable Limits (AL) for each by § 381.79 of this subpart. establishment shall arrive at the product class: (9) HACCP plans and records, as receiving establishment at an internal required by subpart Z of this part. temperature of 40°F or below. Moving sum rules 24. Section 381.177 would be (b) The date and time of shipment of amended by adding new paragraphs (c), carcasses and raw poultry products from Target Commodity (percent Window Accept- (d) and (e) to read as follows: an official establishment to another able official establishment shall be recorded positive size (n) limit § 381.177 Record retention period. for Sal- in days (AL) on the waybill, running slip, monella) * * * * * conductor’s card, shipper’s certificate, (c) Standard Operating Procedures or any other such papers accompanying Broilers ...... 25 16 5 (SOP) for sanitation shall be retained as a shipment. Turkeys ...... 15 15 3 required in § 381.45 of this subchapter. Raw Ground (d) Temperature monitoring plan and Subpart TÐImported Poultry Products Poultry ...... records shall be retained as required in § 381.66 of this subchapter. 27. Section 381.196 would be (5) Corrective action. (i) (e) Records of HACCP plans and amended by redesignating paragraph Establishments not meeting Acceptable systems, as required by subpart Z of this (a)(2)(ii)(h) as paragraph (a)(2)(ii)(i) and Limits will be presumed to have process part, shall be retained as required in by adding a new paragraph (a)(2)(ii)(h) control deficiencies. In such instances, § 381.606(d). to read as follows: a complete review by the establishment 25. Section 381.180 would be of the production process is required. A § 381.196 Eligibility of foreign countries amended by revising paragraph (a) to for importation of poultry products into the written report of the evaluation, read as follows: United States. including the reason for process failure (a) * * * and proposed corrective actions, will be § 381.180 Information and reports required from official establishment operators. (b) * * * submitted to the Inspector in Charge (ii) * * * within 14 days from the day the process (a) The operator of each official establishment shall furnish to Program (h) Development and maintenance of exceeded the limits. This report shall be a Hazard Analysis and Critical Control updated on a weekly basis until the employees accurate information as to all matters needed by them for making their Point (HACCP) system pursuant to moving sum procedure indicates the subpart Z of this part in each certified process is in control. daily reports of the amount of products prepared or handled in the departments establishment; and (ii) During the time the results fail to * * * * * meet the Acceptable Limits, sampling of the establishment to which they are assigned and such reports concerning should be conducted at a rate of two Subpart WÐRules of Practice sanitation, antimicrobial treatments, specimens or more. The sampling rate Governing Proceedings Under the mandatory microbiological testing, and will return to normal when the Poultry Products Inspection Act establishment meets Acceptable Limits, other aspects of the operations of the indicating the process is in control. establishment, and the conduct of 28. Subpart W would be amended by inspection thereat as may be required by adding a new undesignated center Subpart QÐRecords, Registration, and the Administrator in special cases. heading and a new § 381.237 to read as Reports * * * * * follows: 23. Section 381.175 would be Subpart SÐTransportation; Rules Applicable to the Suspension of amended by adding new paragraphs (b) Exportation; Sale of Poultry or Poultry Inspection for Failure To Have a (6), (7), (8) and (9) to read as follows: Products Validated HACCP Plan § 381.175 Records required to be kept. 26. Subpart S would be amended by § 381.237 Refusal or suspension of adding a new § 381.188 to read as inspection service under the PPIA for * * * * * failure to comply with HACCP requirements. follows: (b) * * * (a) In any situation in which the (6) Written Sanitation Standard § 381.188 Shipment of raw poultry and Administrator determines that an Operating Procedures, and daily poultry products. establishment which is applying for records, as prescribed in § 381.45 of this (a) Poultry carcasses and poultry inspection or receives inspection under part. products, as defined in § 381.66 of this the Poultry Products Inspection Act (7) Temperature control plans and part, shall have an internal temperature does not have a valid HACCP plan as records, as required by § 381.66 of this of 40°F or below when loaded on required by § 381.607, he shall refuse to subpart. vehicles for shipping. Such products render inspection at the establishment. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6847 The Administrator shall notify the control of a specific process or efficacy for the production of safe and applicant or operator of the procedure. wholesome product for which the establishment, orally or in writing, as HACCP-trained individual. A person process was designed. promptly as circumstances permit, of who has successfully completed a Verification. The use of methods, such refusal and the reasons therefor, recognized HACCP course in the procedures, or tests in addition to those and the action which the Administrator application of HACCP principles to used in monitoring to determine if the deems necessary to have valid HACCP poultry processing operations, and who HACCP system is in compliance with plan. In the event of oral notification, is employed by the establishment. A the HACCP plan and/or whether the written confirmation shall be given, as HACCP-trained individual must have HACCP plan needs modification and promptly as circumstances permit, to sufficient experience and training in the revalidation. the applicant or operator of the technical aspects of food processing and § 381.602 Development of HACCP plan. establishment in the manner prescribed the principles of HACCP to determine in § 1.147(b) of the Uniform Rules of whether a specific HACCP plan is (a) Every official establishment shall Practice (7 CFR 1.147(b)). appropriate to the process in question. develop, implement, and operate a (b) If any applicant or operator of an HACCP system. The result of the HACCP plan, as set forth in paragraph establishment so notified fails to take implementation of the HACCP plan. (c) of this section, for each process listed the necessary action to have a valid Hazard. A biological, chemical, or below conducted by the establishment. HACCP plan within the period specified physical property that may cause a food Categories of Processes for HACCP: in the notice, the Administrator may to be unsafe for consumption. 01 Raw-Ground issue a complaint in accordance with Hazard Analysis. The identification of 02 Raw Other—Inclusive the Uniform Rules of Practice. Effective any biological, chemical, or physical 03 Thermally Processed/Commercially upon service of the complaint, properties in raw materials and Sterile inspection service shall be refused or processing steps and an assessment of 04 All Other Shelf Stable, Not Heat Treated withdrawn from such establishment their likely occurrence and seriousness 05 Fully Cooked—Not Shelf Stable 06 All Other Shelf Stable, Heat Treated pending final determination in the to cause the food to be unsafe for consumption. 07 All Non-Shelf Stable, Heat Treated, Not proceeding. Fully Cooked 30. A new subpart Z would be added Monitor. To conduct a planned sequence of observations or 08 Non-Shelf Stable, w/Secondary to read as follows: Inhibitors measurements to assess whether a CCP 09 Slaughter—All Poultry Kind Subpart ZÐHazard Analysis and Critical is under control and to produce an Control Points (HACCP) System accurate record for future use in (b) At a minimum, the HACCP plan(s) Sec. verification. shall be developed with the assistance 381.601 Definitions. Preventive measures. Physical, of a HACCP-trained individual 381.602 Development of HACCP plan. chemical, or other factors that can be employed by the establishment, whose 381.603 HACCP principles. used to control an identified health name and resume is on file at the 381.604 Implementation of the HACCP hazard. establishment, and who is plan. knowledgeable of each process 381.605 Operation of HACCP system. Process. A procedure consisting of 381.606 Record review and maintenance. any number of separate, distinct, and conducted by the establishment. The 381.607 Enforcement. ordered operations that are directly person(s) developing the plan shall be under the control of the establishment knowledgeable of HACCP and the § 381.601 Definitions. employed in the manufacture of a associated recordkeeping procedures, For purposes of this subpart, the specific product, or a group of two or and shall be capable of: identifying the following definitions shall apply: more products wherein all CCP’s are hazards of the establishment’s process Corrective action. Procedures to be identical, except that optional and of understanding the source of such followed when a deviation occurs. operations or CCP’s, such as packaging, hazards; establishing relevant CCP’s Criterion. A requirement on which a may be applied to one or more of those throughout the process; and developing judgment or decision can be based. products within the group. appropriate critical limits, monitoring Critical control point (CCP). A point, Product. Any carcass, poultry, poultry procedures, corrective action step, or procedure at which control can byproduct, or poultry food product procedures, verification procedures and be applied and a food safety hazard can capable of use as human food. their frequency, and operating be prevented, eliminated, or reduced to Recognized HACCP course. A HACCP procedures to implement the HACCP acceptable levels. course available to meat and poultry plan. Critical control point (CCP) failure. industry employees which satisfies the (c) Prior to the initiation of the Hazard Inadequate control at a CCP resulting in following: consists of at least 3 days, 1 Analysis phase of HACCP plan an unacceptable risk of a hazard. day devoted to understanding the seven development, each establishment shall Critical limit. A criterion that must be principles of HACCP, 1 day devoted to have on file a copy of its procedures for met for each preventive measure applying these concepts to this and maintaining adherence to recommended associated with a CCP. other regulatory requirements of FSIS, Standard Operating Procedures for Deviation. Failure to meet a critical and 1 day devoted to development of a sanitation as set forth in § 381.45. limit. HACCP plan for a specified process. (d) The development of the HACCP HACCP. A hazard analysis and Responsible establishment official. plan shall consist of two stages: a critical control point (HACCP) system The management official located on-site Hazard Analysis, as provided under that identifies specific hazards and at the establishment who is responsible Principle 1 in § 381.603(a); and the preventive measures for their control to for the establishment’s compliance with development of the remainder of the ensure the safety of food. this part. HACCP plan for each specific process as HACCP plan. The written document Validation. An analysis of verification defined in § 381.602(a), including which is based upon the principles of procedures, HACCP plan components, activities to ensure that the HACCP HACCP and which delineates the and an evaluation of records associated plan, as developed, is valid. These steps procedures to be followed to assure the with the HACCP system to determine its shall be completed over a period not to 6848 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules exceed 6 months prior to the phase-in must be specified for each identified (g) Principle No. 7. Establish date of the process category, as hazard. procedures for verification by a HACCP- prescribed in § 381.607, or upon (c) Principle No. 3. Establish specific trained individual that the HACCP application for the grant of inspection, critical limits for preventive measures system is functioning effectively to or when a new process is intended for associated with each identified CCP. ensure product safety and process implementation. Critical limits which are a part of other control. This is the plan validation (1) The HACCP plan should be in a portions of relevant regulations must be process and therefore includes methods, format that is similar to the National included. procedures, or tests in addition to those Advisory Committee on Microbiological (1) All critical limits shall meet or used for monitoring. Such validation Criteria for Foods and FSIS generic exceed any requirement set forth in this shall ensure: models to ensure that both the part pertaining to a specific process and (1) The adequacy of the critical limits establishment and program employees which are currently a part of FSIS at each CCP; can readily identify the requirements in regulations or other FSIS requirements. (2) The continuing effectiveness of the §§ 381.602(c) and 381.603. (2) The responsible establishment establishment’s HACCP plan and (2) Each HACCP principle, as official shall ensure that the critical system, including taking into account prescribed in § 381.603 must be limits are sufficient to control the changes in production volumes, included in the HACCP plan. identified hazards through a validation procedures, personnel, and product use; process consisting of verification and (3) The accuracy of the HACCP plan § 381.603 HACCP principles. monitoring activities. through the completion of all seven The following principles and (d) Principle No. 4. Establish CCP principles and their associated actions associated components shall be monitoring requirements. Establish including revalidation whenever included in each HACCP plan: specific procedures for using the results significant product, process, deviations, (a) Principle No. 1. A hazard analysis of CCP monitoring to adjust and or packaging changes require shall be conducted to identify biological maintain process control. modification of the plan; and (including microbiological), chemical, (1) The responsible establishment (4) The evaluation of product safety in and/or physical properties of raw official shall ensure that establishment situations where the establishment materials and processing steps that may employees are assigned to monitor each identifies deviations from critical limits, cause a product or products to be unsafe CCP effectively, as determined by all steps taken in response to a for consumption. A list of steps in the Hazard Analysis. deviation, and the adequacy of the process where potentially significant (2) When monitoring is not possible corrective response. hazards may occur and the preventive on a continuous basis, the monitoring measures to be taken shall be prepared. interval established shall reliably § 381.604 Implementation of the HACCP Hazard analysis should take into indicate that the hazard can be plan. consideration factors such as: controlled as demonstrated by process (a) Upon completion of the Hazard ingredients; physical characteristics and validation performed during the Hazard Analysis and development of the composition; processing procedures; Analysis and plan development. HACCP plan, a responsible microbial content of the product or (3) All records and documents establishment official shall review and products; facility and equipment design; associated with CCP monitoring shall be approve the written plan by signing it. packaging; sanitation; conditions of dated and signed or initialed by the (b) Upon completion of the Hazard storage between packaging and the end person(s) conducting the monitoring. Analysis and development of the user; intended use; and intended (e) Principle No. 5. Establish HACCP plan, the establishment shall consumer. All identified hazards corrective action(s) to be taken when conduct activities designed to determine associated with each step in the process monitoring indicates that there is a that the HACCP plan is functioning as must be listed and its significant risk deviation from an established critical intended, ensuring the adequacy of the and severity evaluated. The preventive limit. CCP’s, critical limits, monitoring and measures to control identified hazards (1) The corrective actions shall recordkeeping procedures, and must be listed. The steps in application describe the step(s) taken to identify and corrective actions. During this initial of this principle shall, at a minimum, correct the cause of noncompliance to HACCP plan validation period, the include: assure that the CCP is under control, establishment shall conduct repeated (1) A flow chart describing the steps ensure that no safety hazards exist after verifications and meet frequently with of each process and product flow in the these actions, and define measures to Program employees to assure the establishment; and prevent recurrence. HACCP system is functioning as (2) Identification of the intended use (2) Corrective actions shall include a intended, which shall include a review and consumers of the product based determination of the effect of the of the records generated by the HACCP upon normal use by the general public deviation(s) on product safety; how system. or a particular segment of the noncompliant product will be handled, (c) When an ingredient change, population. including segregation and holding product reformulation, manufacturing (b) Principle No. 2. Identify the CCP’s procedures; a definition of lot size; process or procedure modification, in the process using a decision tree and whether the deviation indicates a equipment change, or any other such the information derived from modification or revision of the HACCP change requires modifications to the § 381.603(a). CCP’s shall be identified plan is required; and time frames for establishment’s HACCP plan, the for purposes of product safety only. modification or revision of the HACCP responsible establishment official, in They must include physical, chemical, plan. consultation with a HACCP-trained and biological (including (f) Principle No. 6. Establish effective individual employed by the microbiological and residue) hazards; recordkeeping and systematic review establishment, shall ensure that the must encompass the health and safety procedures that document the HACCP HACCP plan is modified to reflect such process control points required by FSIS system. The required records are changes. The development of the regulations, or their equivalents; and specified in § 381.606. modified HACCP plan shall be Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6849 conducted in accordance with upon request. Documents associated conduct all activities required for §§ 381.602 and 381.603. with a deviation from a critical limit hazard analysis, development, and shall be brought to the attention of the validation of its HACCP plan(s) for the § 381.605 Operation of HACCP system. appropriate Program employee process category(ies), as set forth in (a) The establishment’s HACCP promptly. § 381.602(d) of this subpart, before system, as set forth in the (d) All records shall be retained at the commencing production and shall establishment’s HACCP plan, shall be establishment at all times, except that conduct process analyses, as set forth in operated with the advice and guidance records for monitoring CCP’s, corrective § 381.604(b), to assure compliance with of a HACCP-trained individual as actions, and verification procedures the critical limits of the HACCP plan defined in § 381.601(i). shall be retained at the establishment for and that the HACCP system is (b) The responsible establishment no less than 1 year, and for an functioning as intended. official shall be held responsible for the additional 2 years at the establishment (4) Commencing with the applicable operation of the HACCP system to or other location from which the records effective date(s), the Program shall ensure compliance with the Act and can be made available to Program refuse new inspection services regulations thereunder. In all respects, employees. requested for, or, using the procedures however, the Administrator shall in § 381.237, suspend inspection § 381.607 Enforcement. continue to provide the Federal services from establishments or specific inspection necessary to carry out the (a) Implementation. (1) The following processes within establishments not provisions of the Act. establishments shall meet the having HACCP plans. requirements of this subpart by the date § 381.606 Record review and maintenance. (b) Verification. The Program shall prescribed: verify that HACCP plan(s) are effective (a) Each entry on a record maintained (i) Establishments that conduct the under the HACCP plan shall be made at and validated, and otherwise in following categories of processes shall compliance with this regulation. Such the time the specific event occurs and comply by [insert date 12 months after include the time recorded, and the verification and process validation may publication of final rule]: Raw, Ground include: record shall be signed or initialed by the (including mechanically separated (1) Reviewing the HACCP plan, establishment employee making the poultry); Thermally Processed/ (2) Reviewing the CCP records, entry. Prior to shipping product Commercially Sterile; and All Other, (3) Reviewing and determining the produced under each process, the Shelf Stable, Heat Treated. establishment shall review, on a (ii) Establishments that conduct the adequacy of corrective actions taken defined, systematic basis, all processing following categories of processes shall when a deviation occurs, and production records associated with comply by [insert date 18 months after (4) Conducting verification activities the HACCP plan to ensure publication of final rule]: Non-Shelf to determine whether CCP’s are under completeness, to determine whether all Stable, Heat Treated, Not Fully Cooked; control, critical limits were met and, if and Shelf Stable, Not Heat Treated. (5) Reviewing the critical limits, appropriate, corrective action(s) were (iii) Establishments that conduct the (6) Reviewing other records pertaining taken, including proper disposition of following categories of processes shall to the HACCP plan or system, product. This review shall be comply by [insert date 24 months after (7) Random sample collection and conducted, dated, and signed by an publication of final rule]: Fully Cooked, analysis to determine the safety of the individual who did not produce the Non-Shelf Stable; and Non-Shelf Stable product, and/or record(s), preferably by the HACCP- with Secondary Inhibitors. (8) On-site observations and records trained individual, or the responsible (iv) Establishments that have the review for revalidation of HACCP plans. establishment official. following categories of processes shall (c) Suspension, correction of invalid (b) The following records supporting meet the requirements of this part by plans. (1) If the Program finds a HACCP the establishment’s HACCP plan shall [insert date 30 months after publication plan to be invalid, inspection service for be maintained: of final rule]: Raw, Other; and Slaughter, the process covered by the HACCP plan (1) The written HACCP plan All Poultry Kind. will be suspended using the procedures including all portions of the Hazard (v) Small entities that generate less in § 381.237. The processing facilities Analysis as prescribed in this subpart; than $2.5 million dollars of product per identified shall not be used for (2) Records associated with the year shall comply by [insert date 36 production of poultry product pending monitoring of CCP’s, which include the months after publication of final rule]. completion of the specified corrective recording of actual times, temperatures, (2) Any establishment that obtains action(s), as prescribed in paragraph or other quantifiable values, as Federal inspection on or after the (c)(3) of this section, and written prescribed in the establishment’s effective date(s) for the process acknowledgement thereof by the HACCP plan; corrective actions, category(ies) to be conducted shall designated Program official. Product including all actions taken in response conduct a Hazard Analysis, and shall produced by that process prior to the to a deviation; verification procedures develop and validate its HACCP plan(s), suspension suspected of being and results; product code(s) identity, or as set forth in § 381.602(d) of this adulterated shall be retained at the slaughter production lot; and date the subpart, concurrent with the grant of establishment pending disposition by record was made; and inspection. Process analysis, as set forth the Program, and if such product has (3) Records associated with in § 381.604(c), shall commence after been shipped, it shall be subject to supporting documentation for the obtaining Federal inspection to assure voluntary recall as necessary to protect Hazard Analysis, development of the compliance with the critical limits of public health. selected CCP’s, critical limits, frequency the HACCP plan and that the HACCP (2) A HACCP plan may be found of monitoring and verification system is functioning as intended. invalid if: procedures, and corrective actions (3) Any establishment that institutes a (i) The HACCP plan does not meet the taken. new process requiring development of a requirements of this subpart, (c) All such records shall be made HACCP plan on or after the applicable (ii) HACCP records are not being available to any Program employee effective date(s) of this regulation shall maintained as required to validate the 6850 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules plan or verify process control under the IV. Hazard Analysis to minimize microbiological hazards. plan, or V. Generic HACCP The overall objective of the HACCP (iii) A processing failure results in A. Farm Management Practices program is to ensure that processing is production of adulterated product. B. Slaughter Operations conducted in a manner that enhances (3) Invalid HACCP plans must be C. Distribution, Retailing, and Preparation VI. Role of Regulators and Industry in the microbiological safety of the corrected by: HACCP-based Beef Processing product. This is achieved through the (i) Submission to the designated VII. New Technologies and Procedures effective management of key operations program official of a written, detailed VIII. Research Needs that can be used to realistically prevent verification by a HACCP-trained IX. Attachments or control the introduction or growth of individual that a modified HACCP plan A. General Sanitation Guidelines for Raw pathogens. has been developed in consultation with Beef Slaughter and Fabrication Integral to HACCP systems is that individual and that as modified the Operations. adherence to the general practices plan corrects the deficiencies found, B. General Guidelines for the Handling of common to all well controlled food Raw Beef Products in Retail Food Stores and and Food Service Establishments. production facilities such as adequate (ii) In the case of a processing C. General Guidelines for the Handling of sanitation, good manufacturing deficiency resulting in production of Raw Beef Products by Consumers. practices (GMPs), effective equipment/ adulterated product, submission to the D. Control Points and Critical Control facility design, and maintenance designated Program official of and Points for Beef Slaughter and Fabrication (ICMSF, 1988; Druce, 1988). A adherence to a written plan for finished Operations. knowledgeable, well trained workforce product produced under the modified I. Introduction is essential in carrying out these HACCP plan to be tested by an external practices. Important GMPs related to laboratory for chemical or microbial The following generic Hazard beef slaughter operations are outlined in characteristics, at the establishment’s Analysis Critical Control Point (HACCP) ATTACHMENT A. expense, as appropriate to demonstrate plan for beef slaughter and processing Several new technologies for beef that the process under the modified focuses on the slaughter and processing slaughtering are in various stages of HACCP plan corrects the identified portions of the total ‘‘farm to development, testing, and problem. consumption’’ scope of a complete implementation. New technologies that (4) If the establishment fails to adhere HACCP program. The Committee are likely to become operational in the to the modified HACCP plan and, if realizes that animal production near future are included in the generic applicable, the testing plan, resulting in practices can play a significant role in HACCP plan. A summary that discusses a subsequent suspension of the same controlling microorganisms of food each of the new technologies and the process for the same or a related safety concern. An overview of key anticipated benefits of implementation deficiency, the designated Program attributes of live animal management is included (Section VII). Areas where official will, upon receipt and before that significantly impact introduction or additional research is required are also acknowledgement of any subsequent control of foodborne pathogens in discussed (Section VIII). Academic, modified plan(s) under paragraph (c)(3) relation to the ultimate microbiological government, and industry researchers of this section, also review the safety of raw beef products is included should be encouraged to address these establishment’s performance under the in Section V.A. Likewise, specific and related areas that provide new inspection regulations generally and practices and procedures are required to knowledge and technologies for make a written recommendation to the ensure the microbiological integrity of enhancing the microbiological safety of Administrator as to whether any beef products while they are in beef products. additional inspection or enforcement distribution networks and during The generic plan provides general measures may be required. retailing. Improper handling of products guidance for developing plant-specific (5) If the Administrator finds during processing, distribution, in food plans. Such individualized HACCP deliberate falsification of HACCP service establishments or in the home, plans for specific products and facilities records, the Administrator will issue a can result in the introduction, survival, should be developed and implemented complaint for withdrawal of inspection or growth of pathogenic by manufacturers as the optimal means services from the establishment and will microorganisms. A lack of adequate for food safety management (NACMCF, refer the case to the Department of controls throughout the complex food 1992). HACCP is also recommended for Justice for criminal prosecution. chain will increase the risk of foodborne use as a tool for inspection operations. disease. This portion of the total HACCP The food processor has the Done at Washington, DC, on January 25, program is introduced in Section V.C, responsibility for developing and 1995. and will be additionally discussed in a implementing well-defined HACCP Michael R. Taylor, more general document that will be plans. The role of the regulatory agency Acting Under Secretary for Food Safety. developed to identify critical factors is to verify that the processor’s HACCP Note: The following Appendix will not that must be controlled to ensure the plans are effective and being followed. appear in the Code of Federal Regulations. safe distribution and marketing of meat The USDA inspector should use the and poultry products. HACCP plan for monitoring and Appendix—Generic HACCP for Raw The generic HACCP plan reviews the conducting verification as necessary. A Beef processing steps of slaughter operations. discussion of the role of regulatory National Advisory Committee on The goal of HACCP for slaughter agencies and industry is included in Microbiological Criteria for Foods operations is to prevent, eliminate, or Section VI. reduce both the incidence and levels of In addition, a generic document Adopted June 17, 1993 microorganisms pathogenic for humans. which outlines the specific roles of the Table of Contents While beef slaughter operations do not regulatory agencies and industry in I. Introduction include a lethal treatment (e.g., thermal HACCP has been prepared by a separate II. Epidemiology of Foodborne Illness process) that ensures elimination of Working Group of the Committee. Associated with Raw Beef pathogenic microorganisms, a number The Committee recommends the III. Microbiological Profile of Raw Beef of the processing steps can be controlled adoption of HACCP principles to reduce Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6851 the risk of contamination by pathogenic and Derrick, 1979; Smeltzer, 1984; implicated (Bean and Griffin, 1990). microorganisms. In accordance with the Chandran, et al., 1986; Grau, 1987; Similar results were reported for Canada NACMCF focus on safety (NACMCF, Dixon, et al. 1991). Foods of animal (Todd, 1989). Raw beef has been 1992), the current plan specifically origin may also be contaminated by reported to serve as a vehicle for a addresses microbiological safety. microorganisms persisting in the variety of disease causing organisms However, it is worth noting that the processing environment, or as a result of (i.e., viruses, protozoa, parasites, etc.); increased process/product control contact with food handling personnel or however, bacterial pathogens accounted achieved through the adoption of equipment during processing, for 92% (159 of 172) of beef-associated HACCP is also likely to enhance the distribution, retailing, and use (Empey outbreaks in which an etiologic agent microbiological quality of raw beef and Scott, 1939; Ingram, 1949; DeWit was identified (Bean and Griffin, 1990). products. Full implementation is critical and Kampelmacher, 1981, 1982; The primary bacterial etiologic agents for HACCP plans to be successful. Smeltzer, 1984; Smulders and for beef-related outbreaks were Management’s commitment to the Woolthuis, 1983; Druce, 1988; Salmonella spp. (48%), Clostridium HACCP concept is imperative for Ligugnana and Fung, 1990; Restaino and perfringens (32%), and Staphylococcus successful implementation. The Wind, 1990). The extent of this aureuas (14%). Recently, Escherichia Committee recommends that HACCP contamination will depend, to a large coli 0157:H7 has played an increasingly plans include consideration of specific degree, on the sanitary control exerted important role as a cause of raw beef mechanisms for facilitating during slaughtering and dressing (Ayers, associated foodborne illness. communication among all levels of 1955; Empey and Scott, 1949; Ingram, Contamination of the raw beef plant operations and management. 1949; Smulders and Woolthuis, 1983; combined with improper food handling Chandran, et al., 1986; Dixon, et al., practices is an important factor in a References 1991). This section focuses on the substantial portion of the Salmonella 1. Druce, E. 1988. Ensuring the compliance microorganisms that are the primary cases (Silliker, 1982; Bryan, 1979). of food manufacture with the design of cause of morbidity and mortality Clostridium perfringens outbreaks are the food. Food Sci. Technol. Today associated with raw beef products. generally associated with cooked 2(1):58–59. products that are held at inadequate 2. ICMSF (International Commission on B. Sources and Limitations of Data Microbiological Specification for Foods). holding temperatures in institutional 1988 ‘‘Microorganisms in Foods 4. In the United States, foodborne and food service settings (Bryan, 1980). Application of the Hazard Analysis disease data are derived from outbreak Spices and other dry ingredients can Critical Control Point (HACCP) System investigations, prospective studies, and also be a source of C. perfringens, to Ensure Microbiological Safety and outbreak and sporadic disease enterotoxigenic Bacillus cereus, S. Quality.’’ Blackwell Scientific Pub. surveillance conducted and reported by aureus, and Salmonella (NRC, 1985). London. public health organizations such as the Food handling personnel are the 3. NACMCF (National Advisory Committee U.S. Centers for Disease Control and primary source of S. aureus, and on Microbiological Criteria for Foods). Prevention (CDC). The majority of the outbreaks are generally associated with 1992. Hazard analysis and critical data is acquired through passive temperature abuse after contamination control point system. Int. J. Food outbreak surveillance programs. It is Microbiol. 16:1–23. of the cooked products (Bryan, 1980). assumed that the incidence data II. Epidemiology of Foodborne Illness represent only a fraction of the total D. Sporadic Cases Associated With Raw Beef number of cases due to significant under Foodborne diseases that are reporting (Bean and Griffin, 1990; predominately associated with sporadic A. Introduction Buchanan and DeRoever, 1993). Such cases are under-represented by outbreak Foodborne disease is an important programs do not effectively record the data. A pertinent recent example cause of morbidity in the United States incidence of sporadic disease. Assessing associated with beef is E. coli 0157:H7, and throughout the world (Archer and the impact of raw beef products on a major agent of hemorrhagic colitis Kvenberg, 1985; Cliver, 1987). foodborne disease is complicated by the (Belongia, et al., 1991; Doyle, 1991; Surveillance of foodborne diseases and potential for such foods to serve as an Griffin, et al., 1988; Riley, 1987; Wells, prospective studies have identified indirect source of pathogens. Further, et al., 1991). A prospective study of foods of animal origin as important most available outbreak data are for diarrheal disease in the State of vehicles for microorganisms causing cooked beef products. Identification of Washington identified this organism as human illness (Todd, 1983, 1989; Bean any relationship between an outbreak the third most frequently isolated cause and Griffin, 1990). The live animal is and the presence of pathogenic of bacterial diarrheal disease exposed to a variety of potential sources microorganisms in raw beef must be (MacDonald, et al., 1988). Of particular of microorganisms (e.g., soil, water, determined through adequate concern is this organism’s association feeds, air, other animals, etc.), and often investigations that pinpoint food with hemolytic uremic syndrome acquires pathogenic microorganisms handling, processing, and preparation (HUS), a sequela of hemorrhagic colitis. initially as a result of exposure ‘‘on the errors. Typically, microbial foodborne This life-threatening, chronic kidney farm’’ or during transport (Galton, et al., disease outbreaks involve errors disease occurs in 2–7% of patients with 1954; Ayers, 1955; Linton, et al., 1974; associated with mishandling or shiga-like toxin E. coli-associated Martin and Smith, 1984; Clegg, et al., inadequate processing of the raw beef, disease (Griffin and Tauxe, 1991). HUS 1986; Grau, 1987; Linton and Hinton, failure to control time and temperature has a 6% rate of mortality, with children 1987). In healthy animals, after cooking, or post-processing being the most susceptible. microorganisms are confined primarily contamination. Listeria monocytogenes is another to the gastrointestinal tract and exterior pathogen where a substantial portion of surfaces (hooves, hide, hair). During C. Outbreak Data the cases caused by this microorganism slaughtering and dressing, the surface of In the United States between 1973 are sporadic. While foodborne the carcass and subsequent cuts of meat and 1987, beef products accounted for transmission appears to account for may become contaminated with these 9% of reported outbreaks and 10% of most human listeriosis cases, no microorganisms (Ayers, 1955; Mackey the cases in which a food vehicle was epidemiological link to beef products 6852 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules has been established (Schuchat, et al., characterized by a large number of small 12. DeWit, J.C. and E.H. Kampelmacher. 1991, 1992; Farber and Peterkin, 1991; operators. A recent survey of the beef 1982. Microbiological Aspects of Ryser and Marth, 1991). slaughter industry indicated that the Washing Hands in Slaughterhouse. Zbl. overall microbiological quality of raw Bakt. Hyg. I Abt. Orig. B 176:553–561. E. Mechanisms of Transmission and beef was inversely correlated to 13. Dixon, Z.R., G.R. Acuff, L.M. Lucia, C. Risk Factors Vanderzant, J.B. Morgan, S.G. Mayand, slaughter volume; however, no such Since beef products may be eaten after and J.W. Sevell. 1991. Effect of degree of association was observed for Salmonella sanitation from slaughter through cooking procedures that are insufficient contamination (Hogue, et al., 1993). fabrication on microbiological and to assure elimination of bacterial Salmonella contamination was more sensory characteristics. J. Food pathogens, intrinsic contamination of closely related to the health of animals Protection 54:200–207. the raw product represents a potential brought to slaughter. It is important to 14. Doyle, M.P. 1991. Escherichia coli risk. This is particularly true for ground note that surveys of this type only 0157:H7 and its significance in foods. beef where contamination that would provide broad statistical trends. Further Int. J. Food Microbiol. 12:289–302. normally be limited to the exterior of work is needed to determine the 15. Empey, W.A. and W.J. Scott. 1939. meat is spread throughout the product operational differences both within and Investigations on chilled beef. Part I. during grinding (ICMSF, 1980). This between large and small volume Microbial contamination acquired in the problem has also occurred when roast meatworks. Aust. Coun. Sci. Ind. Res. operations that could account for the Bull. No. 126. beef that was internally contaminated observed trends. by restructuring or injection was 16. Farber, J.M. and Peterkin, P.I. 1991. inadequately cooked (Bryan and References Listeria monocytogenes, a food-borne pathogen. Microbiol. Rev. 55:476–511. McKinley, 1979). 1. Archer, D.L. and Kvenberg, J.E. 1985. Food handling errors often contribute Incidence and cost of foodborne 17. Galton, M.M., W.V.Smith, H.B. McElrath diarrheal disease in the United States. J. and A.B. Hardy. 1954. Salmonella in to foodborne disease outbreaks (Todd, swine, cattle and the environment of 1983, 1989). These include such factors Food Protection 48:887–894. 2. Ayers, J.C. 1955. Microbiological abattoirs. J. Infect. Dis. 95:236–245. as improper holding temperatures, 18. Grau, F.H. 1987. Prevention of microbial inadequate cooking, contaminated implications in the handling, slaughtering, and dressing of meat contamination in the export beef equipment, and food handler hygiene. animals. Adv. Food Res. 6:109–161. abattoir. In: F.J.M. Smulders (ed.), Inadequate cooking and improper 3. Bean, N.H. and Griffin, P.M. 1990. ‘‘Elimination of pathogenic organisms holding temperatures are particularly Foodborne disease outbreaks in the from meat and poultry, Proceedings of pertinent for beef products. A number of United States, 1973–1987: Pathogens, the international symposium: Prevention these factors have been addressed vehicles, and trends. J. Food Protection of contamination, and decontamination successfully. For example, 53:804–817. in the meat industry.’’ Zeist, The undercooking in commercial plants has 4. Belongia, E.A., MacDonald, K.L., Parham, Netherlands. June 2–4, 1986. Elsevier, New York, pp.221–233. been addressed through the G.L., White, K.E., Korlath, J.A., Lobato, M.N., Strand, S.M., Casale, K.A., and 19. Griffin, P.M., Ostroff, S.M., Tauxe, R.V., standardization of thermal processing Greene, K.D., Wells, J.G., Lewis, J.H., and requirements, such as the guidelines for Osterholm, M.T. 1991. An outbreak of Escherichia coli 0157:H7 colitis Blake, P.A. 1988. Illnesses associated roast beef (USDA, 1983 NACMCF, associated with consumption of with Escherichia coli 0157:H7 infections. 1989). However, similar levels of control precooked meat patties. J. Infec. Dis. Ann. Intern. Med. 109:705–712. have not been achieved in the home or 164:338–343. 20. Griffin, P.M. and Tauxe R.V. 1991. The in all food service establishments. 5. Bryan, F.L. 1979. Prevention of foodborne epidemiology of infections caused by Other factors that appear to influence diseases in food service establishments. Escherichia coli 0157:H7, other the incidence of foodborne disease are J. Environ. Health 41:198–206. Bryan, enterohemorrhagic E. coli, and the the source, primary purpose, and health F.L. 1980. Foodborne diseases in the associated hemolytic uremic syndrome. of the animals. At least for E. coli United States associated with meat and Epidemiol. Rev. 13:60–98. 0157:H7, there is a strong correlation poultry. J. Food Protection 43:140–150. 21. Hogue, A.T., D.W. Dreesen, S.S. Green, with meat from dairy cattle, but not 6. Bryan, F.L. and T.W. McKinley. 1979. R.D. Ragland, W.O. James, E.A. Bergeron, Hazard analysis and control of roast beef L.V. Cook, M.D. Pratt, and D.R. Martin. ‘‘fed’’ cattle (Wells, et al., 1991; Doyle, preparation in foodservice 1993. Bacteria on beef briskets and 1991; Griffin and Tauxe, 1991). The establishments. J. Food Protection 42:4– ground beef: Correlation with slaughter incidence was highest in young animals. 18. volume and antemortem condemnation. Higher incidences of Salmonella 7. Buchanan, R.L. and DeRoever, C.M. 1993. J. Food Protection 56:110–113. contamination of raw beef products also Limits in assessing microbiological food 22. ICMSF (International Commission of appears to be correlated with calf safety. J. Food Protection (In Press). Microbiological Specifications for slaughter operations (Hogue, et al., 8. Chandran, S.K., J.W. Savell, D.B. Griffin, Foods). 1980. ‘‘Microbial Ecology of 1993). and C. Vanderzant. 1986. Effect of Foods, Vol 2, Food Commodities.’’ The beef industry is made up of two slaughter, dressing, fabrication, and Academic Press, New York. pp.367–372. storage conditions on the microbiological 23. Ingram, M. 1949. Benjamin Ward major segments. Animals for the fed- and sensory characteristics of vacuum cattle market come through feedlots to Richardson lecture— Science in packaged beef steaks. J. Food Sci. 51:37– imported meat industry. Part III. Hygiene the slaughter plants. These are largely 39. and storage. J. Roy. Sanit. Inst. 69:39–47. animals raised for higher quality meat, 9. Clegg, F.G., Wray, C. Duncan, A.L., and 24. Ligugnana, R. and Y.C. Fung. 1990. and are processed into wholesale cuts Appleyard, W.T. 1986. Salmonellosis in Training of food and dairy staff for for boxed beef. The trimmings go into two dairy herds associated with a sewage microbiological air and surface hygiene. manufacturing ground beef or sausage. farm and water reclamation plant. J. Hyg. Dairy Food Environ. Sanit. 10(3):130– The majority of fed-cattle are Camb. 97:237–246. 135. slaughtered by a small number of large 10. Cliver, D.O. 1987. Foodborne disease in the United States, 1946–1986. Int. J. operators. Cow meat is produced from Food Microbiol. 4:269–277. culled dairy cattle or beef cows 11. DeWit, J.C. and E.H. Kampelmacher. advanced in age. The primary use of 1981. Some aspects of washing hands in cow meat is ground beef and processed slaughter houses. Zbl. Bakt. Hyg. I Abt. meats. This segment of the industry is Orig. B 172:390–406. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6853 25. Linton, A.H. and M.H. Hinton. 1987. 38. Smeltzer, T.I. 1984. Salmonella 2. Moisture Content Prevention of microbial contamination of contamination of beef in the abattoir Fresh meat has a water activity (aw) of red meat in the ante mortem phase: environment. In Snoyenbos, G.H. (ed), ≥ epidemiological aspects. In: F.J.M. ‘‘Proceedings of the International 0.99 which supports the growth of a Smulders (ed.), ‘‘Elimination of Symposium on Salmonella.’’ Amer. wide variety of bacteria, yeast, and pathogenic organisms from meat and Assoc. Avian Pathologists. University of molds. At high aw values (aw >0.97), the poultry, Proceedings of the international Pennsylvania. pp.262–274. rapid growth rates characteristic of symposium: Prevention of 39. Smulders, F.J.M. and C.H.J. Woolthuis. bacteria allow them to predominate. contamination, and decontamination in 1983. Influence of two levels of hygiene However, as meat surfaces dry, the the meat industry.’’ Zeist, The on the microbiological condition of veal differential in growth rates becomes less Netherlands. June 2–4, 1986. Elsevier, as a product of slaughtering/processing important. Below aw values of 0.94, New York, pp.221–233. sequences. J. Food Protection 46:1032– 26. Linton, A.H., K. Howe, S. Pethiyagoda, 1035. fungal species play an increasingly and A.D. Osborne. 1974. Epidemiology 40. Todd, E.C.D. 1983. Foodborne Disease in important role as the dominant type of of Salmonella infection in calves (1): its Canada—A 5-year summary. J. Food microorganism. relation to their husbandry and Protection 46:650–657. 3. pH management. Vet. Rec. 94:581–585. 41. Todd, E.C.D. 1989. Food and waterborne 27. Mackey, B.M. and C.M. Derrick. 1979. disease in Canada— 1983 annual The pH of fresh beef is dependent on Contamination of deep tissues by summary. J. Food Protection 52:436–442. a number of factors including feeding bacteria present on the slaughter 42. USDA. 1983. USDA Regulation and handling practices at the time of instruments or in the cut. J. Appl. 9CFR318.17: Requirements for the slaughter, and range from 5.3–6.5. Bacteriol. 46:355–366. production of cooked beef, roast beef, Under normal conditions, the pH of beef 28. MacDonald, K.L., O’Leary, M.J., Cohen, and cooked corned beef. First Issued on after slaughter and chilling is ≤5.8. Both M.L., et al. 1988. Escherichia coli June 1, 1983. the rate of microbial growth and the 0157:H7, an emerging gastrointestinal 43. Wells, J.G., Shipman, L.D., Greene, K.D., diversity of the microflora will be pathogen. J. Amer. Med. Assoc. Sowers, E.G., Green, J.H., Cameron, D.N., 259:3567–3570. Downes, F.P., Martin, M.L., Griffin, P.M., restricted at the lower end of the pH 29. Martin, P.A.J. and Smith B.P. 1984. Ostroff, S.M., Potter, M.E., Tauxe, R.V., range (Grau, 1981). Control of salmonellosis in dairy calves. and Wachsmuth, I.K. 1991. Isolation of 4. Oxygen Availability In Snoyenbos, G.H. (ed), ‘‘Proceedings of Escherichia coli Serotype 0157:H7 and the International Symposium on other shiga-like-toxin-producing E. coli Unpackaged fresh beef actually Salmonella.’’ Amer. Assoc. Avian from dairy cattle. J. Clin. Microbiol. represents two microbiological Pathologists. University of Pennsylvania. 29:985–989. environments in relation to oxygen pp.194–199. availability. The surface is aerobic; an III. Microbiological Profile of Raw Beef 30. NACMCF. 1989. National Advisory environment that permits the rapid Committee on Microbiological Criteria A. General Microbiological Parameters growth of aerobic psychrotrophs such as for Foods Recommendation on the Food Safety Inspection Service Docket Associated with Beef Pseudomonas. However, the poising Number 86–041P, Processing Procedures capacity of meat tissue is high, and an and Cooking Instructions for Cooked, Beef muscle is a nutrient-rich anaerobic environment predominates Uncured Meat Patties. January 26, 1989. substrate that can support the growth of within 2 mm of the surface. This selects 31. NRC (National Research Council). 1985. a wide range of microorganisms. It is for anaerobes, microaerophiles, and ‘‘An Evaluation of the Role of generally assumed that the interior of facultative anaerobes. Restricting Microbiological Criteria for Foods and intact muscle is free of microorganisms. oxygen availability through the use of Food Ingredients.’’ National Academy However, localized presence of bacteria physical barriers can substantially alter Press. Washington, D.C. can occur in lymph nodes or the area microbial growth at the surface of meats. 32. Restaino, L. and Wind, C.E. 1990. adjacent to bone joints, particularly if Fresh beef is an actively respiring Antimicrobial effectiveness of hand system and even a partial restriction of washing for food establishments. Dairy they are inflamed. Microorganisms are Food Environ. Sanit. 10(3):136–141. introduced into the interior of meats as oxygen permeability across a plastic 33. Riley, L.W. 1987. The epidemiologic, a result of the translocation of bacteria wrap results in a depletion of oxygen clinical, and microbiologic features of from the surface of the carcass. The and an accompanying increase in hemorrhagic colitis. Ann. Rev. initial microflora is diverse at the time carbon dioxide. This produces a shift Microbiol. 41:383–407. of slaughter; however, subsequent from aerobic species (e.g., 34. Ryser, E.T. and Marth, E.H. 1991. refrigerated storage selects for a limited pseudomonads) to microaerophiles and ‘‘Listeria, Listeriosis, and Food Safety.’’ group of aerobic psychrotrophic species, facultative anaerobes such as Marcel Dekker, Inc. New York. particularly those of the Pseudomonas- Lactobacillus, Pediococcus, 35. Schuchat, A. Swaminathan, B. and Leuconostoc, Streptococcus, Broome, C.V. 1991. Epidemiology of Moraxella-Acinetobacter group (Johnston and Tompkin, 1992). The Carnobacterium, and Brochothrix. human listeriosis. Clin. Microbiol. Rev. Grinding raw beef increases the surface 4:169–183. specific genera encountered is area exposed to oxygen, at the same 36. Schuchat, A. Deaver, K.A., Wenger, J.D., dependent on the storage temperature, time distributing any contamination Plikaytis, B.D., Mascola, L., Pinner, R.W., oxygen availability, pH, and moisture present on the surface throughout the et al. 1992. Role of foods in sporadic content (von Holy and Holzapfel, 1988). listeriosis. I. Case-control study of meat. However, the increased surface dietary risk factors. J. Amer. Med. Assoc. 1. Temperature area also increases the amount of 267:2041–2045. actively respiring muscle tissue, leading 37. Silliker, J.H. 1982. The Salmonella Microbial growth in beef is strongly to rapid oxygen depletion within problem: Current status and future dependent on environmental packaging material that restricts oxygen direction. J. Food Protection 45:661–666. temperature. As storage temperatures availability. are lowered toward freezing there is a There has been speculation that significant decrease in the rate of vacuum packaging or modified microbial growth as well as a reduction atmosphere packaging (VP/MAP) could in the diversity of the microflora. lead to a situation where if a product 6854 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules was temperature abused, the normal surface or the interior if the meat is held Kaya and Schmidt, 1991) or the physical aerobic spoilage microflora could be above 8–10°C (Mackey, et al., 1980; form (cuts versus ground) (Buchanan suppressed, but pathogenic facultative Grau, 1981; Gibson and Roberts, 1986; and Klawitter, 1991) of the meat. The anaerobes would grow unabated Smith, 1987). The microflora of raw beef effects of individual microorganisms of (Genigeorgis, 1985; Hintlian and may contain members that meat microflora on the growth of L. Hotchkiss, 1986; Gill and DeLacy, 1991). competitively inhibit the growth of monocytogenes include none, At present, there is little enteric pathogens such as Salmonella inhibitory, and even stimulatory, epidemiological or other data available under certain conditions (Gilliland and depending on the specific species or indicating that there are any problems Speck, 1977; Gill and Newton, 1980). strain (Ingram, et al., 1990; Tran, et al., with VP/MAP of raw beef. However, the However, a number of studies have 1990; Mattila-Sandholm and Skytta, potential must be considered when concluded that the microflora of raw 1991). A number of raw meat isolates of evaluating the hazards associated with beef cannot be relied on to prevent the beef. growth of mesophilic pathogens in lactic acid bacteria, particularly temperature-abused beef (Mackey, et al., Carnobacterium and Lactobacillus B. Potential for Foodborne Pathogens 1980; Smith, 1985, 1987; Mackey and species, have been reported to produce Low levels of pathogenic bacteria can Kerridge, 1988). Further, vacuum and bacteriocins against L. monocytogenes be isolated from a varying percentage of modified atmosphere packaged raw beef (Schillinger and Lucke, 1989; Ahn and raw beef products. A number of studies that is temperature abused at ≥12°C and Stiles, 1990a, b; Mortvedt and Nes, have examined raw beef products for L. ≥15°C may support significant growth of 1990; Lewus, et al., 1991; Buchanan and monocytogenes worldwide, with Salmonella before overt spoilage is Klawitter, 1992a, b). While there are reported incidence rates ranging from 0 detected (Gill and DeLacy, 1991). Initial potential applications for controlling to >50% (Ryser and Marth, 1991). The studies on the growth characteristics of foodborne pathogens through the use of incidence rates for Salmonella on raw E. coli 0157:H7 (Buchanan and a competitive microflora (Buchanan and beef are generally low (<5%); however, Klawitter, 1992c; Glass, et al., 1992) Klawitter, 1992b), the current state of higher rates have been reported indicate that it is likely to behave in a knowledge does not allow this to be (Felsenfeld, et al., 1950; Weissman and manner similar to other serotypes of E. relied on as a primary means of control. Carpenter, 1969; Goo, et al., 1973; Nazer coli and Salmonella (Smith, 1985, 1987; The primary means for controlling and Osborne, 1976; Stolle, 1981). The Hughes and McDermott, 1989). psychrotrophic pathogen growth incidence of E. coli 0157:H7 in raw beef Psychrotrophic pathogenic species, remains the maintenance of storage appears to be low, and associated with including L. monocytogenes, Yersinia temperatures as low as possible (≤2°C) dairy cattle (Doyle and Schoeni, 1987; enterocolitica, Aeromonas hydrophila, and a normal low pH (<5.8). Belongia, et al., 1991; Wells, et al., and some strains of Bacillus cereus, 1991). represent a special concern because they References The sources of pathogenic are capable of growth at refrigeration 1. Ahn, C. and Stiles, M.E. 1990a. Plasmid- microorganisms vary. For example, S. temperatures. While both Y. associated bacteriocin production by a aureus is generally associated with food enterocolitica and B. cereus have been strain of Carnobacterium piscicola from handlers or mastitic cows. Salmonella, epidemiologically linked to products of meat. Appl. Environ. Microbiol. E. coli, and other enteric pathogens are animal origin, typically they are not 56:2503–2510. typically associated with fecal material associated with raw beef products. 2. Ahn, C. and Stiles, M.E. 1990b. and can be commonly isolated from the Aeromonas hydrophila can be Antibacterial activity of lactic acid hooves and hides of cattle (Stolle, 1981). frequently isolated from refrigerated raw bacteria isolated from vacuum-packaged There appear to be several means by beef; however, the role of this organism meats. J. Appl. Bacteriol. 69:302–310. which enteric pathogens become in disease outbreaks involving non- 3. Belongia, E.A., MacDonald, K.L., Parham, attached to raw beef, though there does immunocompromised individuals is G.L., White, K.E., Korlath, J.A., Lobato, M.N., Strand, S.M., Casale, K.A., and appear to be a preferential binding to still poorly understood (Palumbo, et al., connective tissue (Benedict, et al., Osterholm, M.T. 1991. An outbreak of 1991). Escherichia coli 0157:H7 colitis 1991). Recent research has indicated While there have been no outbreaks of associated with consumption of that the preferential binding of listeriosis attributed to raw beef precooked meat patties. J. Infec. Dis. Salmonella to connective tissue products, L. monocytogenes’ growth 164:338–343. involves a genetically encoded cell characteristics, increased thermal 4. Benedict, R.C., Schultz, F.J., and Jones, surface binding site (Sanderson, et al., resistance compared to enteric S.B. 1991. Attachment and removal of 1991). L. monocytogenes can be pathogens, and incidence in raw and Salmonella spp. on meat and poultry endemic in cattle; however, recent cooked meat products (Ryser and Marth, tissues. J. Food Safety 11:135–148. European studies (Ryser and Marth, 1991) has prompted investigations of its 5. Buchanan, R.L., Stahl, H.G., and Archer, 1991) suggest that the food processing behavior in raw beef. Listeria D.L. 1987. Improved plating media for environment can be an important source monocytogenes is capable of growth in simplified, quantitative detection of of this pathogen. The presence of low temperature-abused raw beef (Buchanan Listeria monocytogenes in foods. Food Microbiol. 4:269–275. levels of pathogenic bacteria on beef and Klawitter, 1992a); however, there 6. Buchanan, R.L. and Klawitter, L.A. 1991. may be unavoidable; however, care are conflicting reports concerning the Effect of temperature history on the must be exercised to ensure that this ability of the organism to grow in raw growth of Listeria monocytogenes Scott level is minimal. Further, beef products beef at ≥5°C (Kahn, et al., 1972; 1973: A at refrigeration temperatures. Int. J. should be handled in a manner that Johnson, et al., 1988a, b; Grau and Food Microbiol. 12:235–246. assures that pathogens of significance Vanderlinde, 1988; Buchanan, et al., 7. Buchanan, R.L. and Klawitter, L.A. 1992a. have little or no opportunity to 1989; Gill and Reichel, 1989; Glass and Characterization of a lactic acid proliferate (Gill and DeLacy, 1991). Doyle, 1989; Shelef, 1989; Dickson, bacterium, Carnobacterium piscicola A variety of mesophilic foodborne 1990; Buchanan and Klawitter, 1991; LK5, with activity against Listeria pathogens are potentially capable of Kaya and Schmidt, 1989, 1991). The monocytogenes at refrigeration growing in the microbiological observed differences may be attributable temperatures. J. Food Safety 12:199–217. environment associated with both the to either the pH (Gill and Reichel, 1989; Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6855 8. Buchanan, R.L. and Klawitter, L.A. 1992b. 22. Hughes, A.H. and McDermott, J.C. 1989. 36. Nazer, A.H.K. and Osborne, A.D. 1976. Effectiveness of Carnobacterium The effect of phosphate, sodium Salmonella infection and contamination piscicola LK5 for controlling the growth chloride, sodium nitrite, storage of veal calves: a slaughterhouse survey. of Listeria monocytogenes Scott A in temperature and pH on the growth of Brit. Vet. J. 132:192–201. refrigerated foods. J. Food Safety 12:219– enteropathogenic Escherichia coli in a 37. Palumbo, S.A., Bencivengo, M.M., Del 236. laboratory medium. Int. J. Food Corral, F., Williams, A.C. and Buchanan, 9. Buchanan, R.L. and Klawitter, L.K. 1992c. Microbiol. 9:215–223. ′ R.L. 1989. Characterization of the The effect of incubation temperature, 23. Ingram, S. C., Escude, J. M., and McCown, Aeromonas hydrophila group isolated initial pH, and sodium chloride on the P. 1990. Comparative growth rates of from retail foods of animal origin. J. Clin. growth kinetics of Escherichia coli Listeria monocytogenes and Microbiol. 27:854–859. 0157:H7. Food Microbiol. 9:185–196. Pseudomonas fragi on cooked chicken 38. Ryser, E.T. and Marth, E.H. 1991. 10. Dickson, J.S. 1990. Survival and growth loaf stored under air and two modified ‘‘Listeria, Listeriosis, and Food Safety.’’ of Listeria monocytogenes on beef tissue atmospheres. J. Food Protection 53:289– Marcel Dekker, Inc. New York. pp.405– surfaces as affected by simulated 291. 462. processing conditions. J. Food Safety 24. Johnson, J.L., Doyle, M.P., Cassens, R.G. 39. Sanderson, K., Thomas, C.J. and 10:165–174. Doyle, M.P. and Schoeni, and Schoeni, J.L. 1988a. Fate of Listeria McMeekin, T.A. 1991. Molecular basis of J.L. 1987. Isolation of Escherichia coli monocytogenes in tissues of the adhesion of Salmonella serotypes to 0157:H7 from retail fresh meats and experimentally infected cattle and in chicken muscle fascia. Biofouling 5:89– poultry. Appl. Environ. Microbiol. hard salami. Appl. Environ. Microbiol. 101. 53:2394–2396. 54:497–501. 40. Schillinger, U. and Lucke, F.K. 1989. 11. Felsenfeld, O., Young, V.M. and 25. Johnson, J.L., Doyle, M.P. and Cassens, Antibacterial activity of Lactobacillus Yoshimura, T. 1950. A survey of R.G. 1988b. Survival of Listeria sake isolated from meat. Appl. Environ. Salmonella organisms in market meat, monocytogenes in ground beef. Int. J. Microbiol. 55:1901–1906. eggs, and milk. J. Amer. Vet. Med. Assoc. Food Microbiol. 6:243–247. 41. Shelef, L.A. 1989. Survival of Listeria 116:17–21. monocytogenes in ground beef or liver 26. Johnston, R.W. and R.B. Tompkin. 1992. ° 12. Genigeorgis, C.A. 1985. Microbial and Meat and poultry products. In: during storage at 4 and 25 C. J. Food safety implications of the use of ‘‘Compendium of Methods for the Protection 52:379–383. modified atmospheres to extend the Microbiological Examination of Foods. 42. Smith, M.G. 1985. The generation time, storage life of fresh meat and fish. Int. J. 3rd Ed. C. Vanderzant and D.F. lag time, and minimum temperature of Food Microbiol. 1:237–251. Splittstoesser, eds. Washington, D.C., growth of coliform organisms on meat, 13. Gill, C.O. and Delacy, K.M. 1991. Growth American Public Health Association. and the implications for codes of practice in abattoirs. J. Hyg., Camb. of Escherichia coli and Salmonella 27. Kaya, M. and Schmidt, U. 1989. 94:289–300. typhimurium on high-pH beef packaged Verhlaten von Listeria monocytogenes 43. Smith, M.G. 1987. Calculation of the under vacuum or carbon dioxide. Int. J. im Hackfleisch bei Kuhl- und expected increases of coliform Food Microbiol. 13:21–30. Gefrierlagerung. Fleischwirtschaft organisms, Escherichia coli and 14. Gill, C.O. and Reichel, M.P. 1989. Growth 69:617–620. Salmonella typhimurium, in raw of the cold-tolerant pathogens Yersinia 28. Kaya, M. and Schmidt, U. 1991. Behavior blended mutton tissue. Epidem. Inf. enterocolitica, Aeromonas hydrophila, of Listeria monocytogenes on vacuum- 99:323–331. and Listeria monocytogenes on high-pH packed beef. Fleischwirtschaft 71:424– 44. Stolle, A. 1981. Spreading of salmonellas beef packaged under vacuum or carbon 426. dioxide. Food Microbiol. 6:223–230. during cattle slaughtering. J. Appl. 29. Khan, M.A., Palmas, C.V., Seaman, A. Bacteriol. 50:239–245. 15. Gilliland, S.E. and Speck, M.L. 1977. and Woodbine, M. 1972. Survival versus 45. Tran, T.T., Stephenson, P. and Hitchins, Antagonistic action of Lactobacillus growth of a facultative psychrotroph. A.D. 1990. The effect of aerobic acidophilus toward intestinal and Acta Microbiol. Acad. Sci. Hung. microfloral levels on the isolation of foodborne pathogens in associative 19:357–362. inoculated Listeria monocytogenes strain cultures. J. Food Protection 40:820–823. 30. Khan, M.A., Palmas, C.V., Seaman, A. LM82 from selected foods. J. Food Safety 16. Glass, K.A. and Doyle. M.P. 1989. Fate of and Woodbine, M. 1973. Survival versus 10:267–275. Listeria monocytogenes in processed growth of a facultative psychrotroph: 46. Von Holy, A. and Holzapfel, W.H. 1988. meat products during refrigerated Meat and products of meat. Zbl. The influence of extrinsic factors on the storage. Appl. Environ. Microbiol. Bakteriol. Hyg. Abt. Orig. B. 157:277– microbiological spoilage pattern of 55:1565–1569. 282. ground beef. Int. J. Food Microbiol. 17. Glass, K.A., Loeffelholz, J.M., Ford, J.P., 31. Lewus, C.B., Kaiser, A. and Montville, 6:269–280. Wells, J.G., Shipman, L.D., and Doyle, M.P. 1992. Fate of T.J. 1991. Inhibition of food-borne Greene, K.D., Sowers, E.G., Green, Escherichia coli 0157:H7 as affected by bacterial pathogens by bacteriocins from 47. J.H., Cameron, D.N., Downes, F.P., pH or sodium chloride and in fermented, lactic acid bacteria isolated from meat. Martin, M.L., Griffin, P.M., Ostroff, S.M., dry sausage. Appl. Environ. Microbiol. Appl. Environ. Microbiol. 57:1683–1688. Potter, M.E., Tauxe, R.V. and 58:2513–2516. 32. Mackey, B.M., Roberts, T.A., Mansfield, Wachsmuth, I.K. 1991. Isolation of 18. Goo, V.Y.L., Ching, G.Q.L. and Gooch, J. and Farkas, G. 1980. Growth of Escherichia coli serotype 0157:H7 and J.M. 1973. Comparison of brilliant green Salmonella on chilled meat. J. Hyg., other shiga-like-toxin-producing E. coli agar and Hektoen enteric agar media in Camb. 85:115–124. from dairy cattle. J. Clin. Microbiol. the isolation of salmonellae from food 33. Mackey, B.M. and Kerridge, A.L. 1988. 29:985–989. products. Appl. Microbiol. 26:288–292. The effect of incubation temperature and 48. Weissmann, M.A. and Carpenter, J.A. 19. Grau, F.H. 1981. Role of pH, lactate and inoculum size on growth of salmonellae 1969. Incidence of salmonellae in meat anaerobiosis in controlling the growth of in minced beef. Int. J. Food Microbiol. and meat products. Appl. Microbiol. some fermentative Gram-negative 6:57–65. 7:899–902. bacteria on beef. Appl. Environ. 34. Mattila-Sandholm, T. and Skytta, E. 1991. Microbiol. 42:1043–1050. The effect of spoilage flora on the growth IV. Hazard Analysis 20. Grau, F.H. and Vanderlinde, P.B. 1990. of food pathogens in minced meat stored Epidemiological data (section II. A–E) Growth of Listeria monocytogenes on at chilled temperature. Lebensm. Wiss. indicate that three microorganisms have vacuum-packaged beef. J. Food U.-Technol. 24:116–120. Protection 53:739–741, 746. accounted for 94% of the outbreaks in 35. Mortvedt, C.I. and Nes, I.F. 1990. which beef has been implicated. Raw 21. Hintlian, C.B. and Hotchkiss, J.H. 1986. Plasmid-associated bacteriocin The safety of modified atmosphere beef has been a major source for production by a Lactobacillus sake salmonellae in the outbreaks. Raw beef packaging: a review. Food Technol. strain. J. Gen. Microbiol. 136:1601–1607. 40(12):70–76. has been one of many potential sources 6856 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules for C. perfringens. Raw beef can be a two years of age. Mature beef comes 3. Animal Husbandry source of S. aureus. This is a concern in from dairy or beef animals that have Numerous management practices are the manufacture of fermented and dried been marketed after being used for milk influenced by environmental meats. Raw beef is a source for sporadic or calf production. Fed beef serves as conditions. For example, excessive cases and, occasionally, outbreaks of the major source of whole beef products moisture conditions generally result in illness due to E. coli 0157:H7. and some ground beef products. Mature higher levels of hide contamination The hazard analysis leads to the dairy and beef animals are a primary with mud, feces, and other extraneous conclusion that raw beef can be an source of ground meat and patties to matter. Management systems that important vehicle in the transmission of consumers, including food service minimize the impact of adverse two important foodborne pathogens: establishments. environmental conditions would be salmonellae and E. coli 0157:H7. These The husbandry practices under which expected to decrease microbial pathogens are similar in a number of fed beef cattle and mature dairy and contamination. This may involve basic respects, such as: beef cattle are managed are quite changes in animal husbandry (Smith a. Sensitivity to heat and cold, different. However, potential for and House, 1992). Controlling exposure b. Sensitivity to chemicals, and contamination is especially c. The ability to multiply microbial contamination of the final product exists in both and they share important immediately prior to asymptomatically in the bovine shipment to slaughter. intestinal tract, and many of the same risks. There are major d. Potential for low infectious doses. aspects in the production phase that can 4. Role of Stress influence incidence, control, and E. coli 0157:H7 and certain Stressed animals have lowered Salmonella serovars may cause prevention of potential human pathogens in cattle. disease resistance, making them more secondary infections and chronic susceptible to pathogens and at sequelae. Also, both pathogens may 1. Transportation increased risk of shedding potential cause death, particularly with E. coli human pathogens (Breazile, 1988). For The production cycle, especially of 0157:H7. example, animals which are exposed to The primary microbiological hazards fed beef, typically involves time spent salmonellae can become intermittent encountered during the beef on two or more premises prior to shedders of this organism. Various slaughtering process are salmonellae movement to processing facilities. forms of stress can result in increased and E. coli 0157:H7. The following Transportation is often necessary but shedding and clinical disease, causing generic HACCP plan will be directed contributes to an increased incidence of increased exposure to pennates, primarily at control of these pathogens. contamination due to both the stress increasing the risk also to humans Efforts to improve slaughter hygiene placed upon animals and the increased through contaminated meat. will reduce the presence of other risk of exposure of cattle to potential Management systems addressing pathogens (C. perfringens, S. aureus, L. human pathogens (Cole, et al., 1988; increased animal welfare and better monocytogenes) on carcass meat. Hutcheson and Cole, 1986). Dairy husbandry decrease levels of stress, and animals handled in a similar manner V. Generic HACCP would be expected to decrease the would experience similar risk. incidence of pathogens. For example, The factors that impact the Transport time should be such that improvements in cattle handling microbiological safety of raw beef the animals reach other production systems reduce stress-related immune products during its ‘‘farm to consumer’’ facilities and processing establishments suppression associated with animal lifetime can be subdivided into four in an expedient manner, with stress processing procedures (Grandin, 1984, segments: (1) live animal practices, (2) kept to a minimum. Transport vehicles 1987). A number of other factors, such slaughter and processing operations, (3) should be free of injurious structural as animal density, frequency of feedlot distribution and retailing operations, defects. Vehicles should be clean at the pen use, and commingling of sick and (4) consumer food handling time animals are loaded, and cleaned animals, can affect stress levels and thus practices. Key factors associated with and sanitized following unloading at the risk of human pathogen exposure. live animal practices are introduced and slaughter facility. Salmonella is capable of surviving discussed in Section V.A. The variable, prolonged periods of time in individual steps involved in slaughter 2. Marketing animal facilities (Rings, 1985). and processing operations are detailed as a generic HACCP plan in Section V.B. Marketing is accomplished through a 5. Feed and Water Contamination number of outlets that introduce varying The primary thrust of the first two Feed and water are potential sources degrees of risk. Cattle frequently are sections is the control of enteric of microbial contamination to cattle sold or moved through either auction bacteria, the class of pathogenic (Robinson, et al., 1991). Feedstuffs markets, direct selling from producer to microorganisms associated with and should be documented free of backgrounder or feedlot, video auctions, amenable to control during these phases Salmonella and other enteric pathogens or collection points. Animals from of raw beef production and processing. (Mitchel and McChesney, 1991). This is multiple sources are commonly The factors associated with distribution, especially critical for feeds containing commingled at one or more points retailing, and consumer practices that rendered byproducts. Water must be during production, resulting in transfer impact the safety of raw beef products from clean, non-fecally contaminated of potential pathogens between animals. are introduced in Section V.C. sources. Inspectors at slaughter plants must A. Farm Management Practices maintain high standards regarding 6. Antimicrobial Use Raw beef originates from several diseased and otherwise inferior animals, Therapeutic and subtherapeutic use of sources of cattle. These can be classified including continued close antimicrobials has long been a practice into two major categories, fed beef and communication with cattle producers to in the cattle industry. Recent emphasis mature beef. Fed beef typically comes provide information to improve quality on regulations and resulting industry from animals that have been raised to and safety standards in slaughter response, such as quality assurance desired market weight, usually less than animals. programs, has resulted in more Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6857 responsible use of antibiotics in cattle. detailed examination of each of the cleaned and sanitized. The operator Therapeutic use of antibiotics is used to steps is provided in ATTACHMENT D. performing the skinning process must reduce effects of clinical diseases in A CCP within a Hazard Analysis and be trained to minimize contamination. cattle, including potential human Critical Control Point (HACCP) program Management must reinforce the proper pathogens such as salmonellae. is defined as any point, step, or techniques through adequate Additional information is needed procedure at which control can be supervision. regarding advisability of some currently applied and a food safety hazard can be The effectiveness of the CCPs outlined accepted practices, especially when prevented, eliminated, or reduced to in this document are based on the considering human health risks (Rings, acceptable levels (NACMCF, 1992). concept of additive impact. Wash and 1985; Kennedy and Hibbs, 1993). Seven specific CCP process steps have bactericidal rinse steps will significantly been designated in the processing of raw reduce the level of microbial 7. Animal Identification beef (Figure 1 and Table 1). These contamination resulting from the The beef and dairy industries, along include (1) skinning, (2) post-skinning skinning or evisceration steps; however, with state and federal agencies, must wash/bactericidal rinse, (3) evisceration, the efficacy of these processes are continue to develop adequate means to (4) final wash/bactericidal rinse, (5) dependent on control of skinning and identify animals from the initial chill, (6) refrigerated storage, and (7) evisceration. The procedures and production unit through the slaughter labeling. corrective actions outlined for CCP 1 process. Permanent animal For each of these CCP steps critical and CCP 3 minimize the level of identification is essential so producers limits are defined for proper control. contaminating material that must be can assume further responsibility for the These CCPs must be monitored at a removed by the wash and rinse steps. beef they market by being able to track frequency sufficient to ensure process If critical limits for CCP 1 are animals through the entire production, control. Corrective actions to be taken exceeded, corrective actions must be slaughter, wholesale, and retail when CCPs do not meet critical limits taken prior to the carcasses being processes. Currently, mature animals are should be specified clearly in the subjected to the post-skinning wash and identified by backtags as part of the HACCP plan. This should include the bactericidal rinse. Corrections of CCP 1 Brucellosis eradication program. priorities of actions to be taken and the deviations can be achieved by adding Retention of this portion of the program individuals to be notified of the additional operators to the skinning is suggested until better means of deviation. The HACCP system should be procedure, reducing the chain speed in identification are implemented. verified according to HACCP principle the skinning area, and/or conducting Permanent identification is a critical #7 (NACMCF, 1992). carcass trimming prior to the post- issue for improving the safety of raw The seven CCPs with procedures skinning wash and bactericidal rinse. beef at the producer level. associated with the processing step are CCP 2: Post-Skinning Wash and Projected Needs: Current and future shown in the following outline. strategies that may be useful in Bactericidal Rinse decreasing the risk of microbial Implementation and Management of During the skinning process, newly contamination at production levels HACCP Critical Control Points exposed carcass surfaces can become contaminated with dressing defects, i.e., include assessments of the prevalence of CCP 1: Skinning human pathogens in cattle, permanent fecal material, hide and/or dirt, that may identification of animals using The hide is the first major source of introduce bacterial pathogens. A post- advanced technology (USAHA, 1992; microbial contamination on fresh beef skinning wash and bactericidal rinse is Maher 1991; Nelson, 1991), use of new carcasses. Cattle leaving the farm, feed an effective means of reducing this and improved vaccines, use of improved lot, or sales barn for delivery to the contamination. Any pathologic management methods in reducing slaughter plant, carry with them conditions, i.e., abscesses, septic microbial contamination risk, and microbial populations indicative of bruises, etc., should be removed prior to incorporation of biotechnological what occurred during the care and CCP 2. advances in cattle production as they handling of the live animal. Salmonella Maximum benefit of post-skinning are proven to be beneficial in and other types of bacteria can be wash and bactericidal rinse can be minimizing or preventing microbial spread during the skinning process achieved if the amount of contaminating contamination. through contact with hide, hands and material is minimized, emphasizing the Producers should be encouraged to various pieces of equipment (Empey importance of CCP 1 (skinning). Proper carefully review production methods and Scott, 1939; Newton, et al., 1978; skinning procedures must be achieved and HACCP guidelines to decrease risks Stolle, 1981; Grau, 1987). Current for effective post-skinning wash and associated with pathogenic microbial skinning technology does not provide a bactericidal rinse. contamination (Smith and House, 1992). means for destroying enteric pathogens Post-skinning wash and bactericidal Utilization of quality management that reside on the hide of animals rinse should occur as soon after principals is recommended since these coming to slaughter. There also is no skinning as possible to limit irreversible concepts will result in improved quality available means to remove all soil from attachment of pathogens to the carcass. assurance and pre-harvest food safety the hide of animals prior to slaughter; An in-line, post-skinning, potable water programs (Schmitz, 1993; FAPMC, 1992; however, preslaughter washing does wash at 90–100°F and a pressure of AVMA, 1992). Implementation of have a positive effect (Empey and Scott, 345–2070 kPa (50–300 psi) removes production practices suggested by these 1939; Dixon, et al., 1991). Skinning, much of the visible surface programs are critical at all phases of therefore, should be done in a manner contamination (hair, specks) and cattle production regardless of unit size that will minimize cross-contamination reduces microbial contamination to or type. from the hide to the carcass. This some extent (DeZuniga, et al., 1991). contamination can be minimized by The water wash should be followed B. Slaughter Operations pulling the hide down and out from the immediately by a bactericidal rinse to Unit operations associated with the carcass as opposed to upward and away. provide an effective reduction of surface slaughter and dressing of beef are In addition, equipment and carcass bacteria. The bactericidal rinse should summarized in Figure 1. A more contact surfaces must be properly be an approved antimicrobial agent such 6858 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules as chlorine (50 mg/L) or an organic acid accidentally cut and contamination and Anderson 1992; Siragusa and (1–2% acetic, lactic, or citric acids) at a occurs, immediate sanitizing of Dickson, 1992; Dickson, 1992). temperature of 120–140°F and a equipment and knives should be CCP 5: Chill pressure of 70–275 kPa (10–40 psi) performed with 180°F water, and (Prasai, et al., 1991). Monitoring of this involved personnel should utilize hand The bacterial flora including any CCP should be conducted by continuous washing and sanitizing facilities to enteric pathogens found on the sides of confirmation of concentration, avoid contamination of subsequent fresh beef could multiply if the meat is temperature, pressure, and chain speed. carcasses. The most effective means of not properly chilled. Cooling rates must Validation of CCP 2 should be control lies in adequate training of the be sufficient to limit the growth of accomplished by microbiological testing operator in the correct procedures, enteric pathogens. Temperature of carcasses before and after CCP 2. A including providing the rationale on the guidelines would include a deep muscle reasonable level of testing should be importance of maintaining the viscera (6 in.) temperature of ≤ 45°F within 36 performed at the initiation of a HACCP intact, coupled with positive hours, with a temperature of ≤ 50°F program to establish baselines for total reinforcement through appropriate reached within the first 24 hours aerobic, mesophilic bacteria and/or supervision. Accordingly, monitoring (Reuter, 1990). Overnight rapid chilling Enterobacteriaceae. These this CCP entails periodic observation of of properly spaced beef sides is a proven microbiological indices are useful the evisceration operations including system to control the multiplication of indicators of process control and overall visual inspection of eviscerated enteric pathogens (Grau, 1987; Mackey, sanitation, but are not effective as carcasses. This can correlate to potential et al., 1980). The CCP can be monitored indicators of enteric pathogens. All carcass contamination. through the continuous confirmation of testing should be performed using physical factors affecting cooling rates standard methods (Vanderzant and CCP 4: Carcass Final Wash such as environmental temperatures and Splittstoesser, 1992). After Additional microbial contamination air circulation rates. Verification can be establishment of the baseline, of the carcass surface is likely to occur achieved through the periodic recording verification of CCP 2 can be achieved by as a result of evisceration, viscera of deep muscle cooling rates for selected periodic sampling of carcasses for the handling, and carcass splitting. An in- carcasses, using appropriately calibrated two microbiological indicators, using line, potable water wash at 90–100°F temperature recording devices (e.g. the same methods employed in and a pressure of 345–2070 kPa (50–300 thermocouple). psi) will help reduce microbial levels, establishing the baseline. These data CCP 6: Refrigerated Storage should be reviewed using trend analysis including enteric pathogens (DeZuniga, and statistically significant increases et al., 1991). This final water wash After chilling, the carcasses and should prompt a review of CCP 2 should be followed by a bactericidal resulting raw products must be operations. Literature indicates a rinse containing an approved maintained under adequate refrigeration functioning wash and bactericidal rinse antimicrobial agent such as chlorine (50 during all subsequent handling and step in conjunction with acceptable mg/L) or an organic acid (e.g., 1–2% processing until the final product is adherence to CCP 1 should deliver an acetic, lactic, or citric acids) at a ultimately consumed. This highly approximate 90% reduction in temperature of 120–140°F and a diffuse CCP requires that manufacturers, microbial levels. Specific bactericidal pressure of 70–275 kPa (10–40 psi) distributors, retailers, food service agent concentrations, temperatures, and (Prasai, et al., 1991). operators, and consumers each take pressures to be used should be based on This combination of a final wash and responsibility for assuring that raw beef appropriate available literature and in- bactericidal rinse will help minimize products are kept under adequate plant testing to obtain optimal bacterial carriage of pathogens through the refrigeration. Maintaining products in a reductions (Patterson, 1968, 1969; remaining beef fabrication and refrigerated state (product temperature Kotula, et al., 1974; Emswiler, et al., packaging processes. Monitoring of this ≤45°F), along with appropriate cleaning 1976; Quartey-Papafio, et al., 1980; CCP should be through continuous and sanitizing of equipment and food Osthold, et al., 1984; Woolthuis and confirmation of antimicrobial contact surfaces, will control the Smulders, 1985; Acuff, et al., 1987; concentration, temperature, pressure, multiplication or accumulation of non- Prasai, et al., 1991; and Dickson and and chain speed. Verification can be psychrotrophic pathogens. Further, Anderson 1992). achieved by conducting microbiological maintaining storage temperatures as testing as described in CCP 2 to confirm close to freezing as practical will CCP 3: Evisceration that CCP 4 is providing the anticipated enhance control of psychrotrophic The intestinal tract is the second level of control of microbial levels. pathogens. major source of enteric pathogens Maximum effectiveness of CCP 4 can during the slaughtering process. only be realized if the critical limits for CCP 7: Labeling Although the animals may be CCP 1–3 are maintained. Any deviations Adequate product identification (e.g., asymptomatic, they can still harbor associated with the earlier CCPs must be code dates, lot identification) is large populations of enteric pathogens corrected before the product is subjected necessary for product control in the in their intestinal tract. The bunging and to the final wash. Specific bactericidal event that product must be traced or evisceration operators must be properly agent concentrations, temperatures, and retrieved. To facilitate the trained in removing the intestinal tract pressures to be used should be based on responsibilities of distributors, retailers, intact to successfully adhere to the appropriate available literature and in- food service operators and consumers, control parameters of CCP 3. It is plant testing to obtain optimal bacterial all raw and partially cooked beef essential that the viscera not be reductions (Patterson, 1968, 1969; products should be labeled to indicate accidentally cut and the contents Kotula, et al., 1974; Emswiler, et al., that the product must be refrigerated, contaminate the carcass, the operator, or 1976; Quartey-Papafio, et al., 1980; handled, and cooked properly to ensure equipment (Empey and Scott, 1939; Osthold, et al., 1984; Snijders, et al., safety. Methods of cooking and sanitary Mackey and Derrick, 1979; Eustace, 1985; Woolthuis and Smulders, 1985; handling should reflect the needs of the 1981; Smeltzer and Thomas, 1981; Grau, Smulders, et al., 1986; Acuff, et al., specific product. Labels should be 1987). When the intestines are 1987; Prasai, et al., 1991; and Dickson appropriate for either retail and Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6859 institutional consumers. A universal 2. Assuring the destruction of enteric objective and subjective observations logo should be designed to identify raw and other non-spore forming pathogens that should be maintained must be beef products for consumers. The logo through proper cooking procedures; specified in the HACCP plan and should include space for instructional 3. Preventing the reintroduction of maintained at the processing location. information specific for the product. An pathogens to the cooked product and All records should be reviewed and example of a potential logo is depicted cross-contamination of other foods; and integrated on a specified, routine basis. in Figure 2. 4. Controlling the growth of spore This should include subjecting the data The seven CCPs are summarized in forming pathogens (e.g., C. perfringens) to trend analysis to identify and correct Table 1. by use of proper time/temperature problems before they result in CCPs relations for storage, holding, and exceeding critical limits. It is C. Distribution, Retailing, and serving. recommended strongly that this review Preparation An effective HACCP system in food be integrated, and the results distribution and preparation depends on communicated to both employees and An effective HACCP plan for the a general understanding of and production, slaughtering, and initial supervisory personnel. The mechanism adherence to the principles of and duration of records maintenance is processing of raw beef will greatly sanitation, good manufacturing and food increase control of pathogenic the responsibility of plant management, preparation practices as well as proper and should be specified in the HACCP microorganisms; however, even under facility layout and equipment design the best operating conditions low plan. However, any system established and maintenance (See Attachment A). must take into account the primary role numbers of pathogens may remain on The education and training of all the carcass. Further, care must be that records review plays in personnel is critical to the process and verifications by regulatory agencies. exercised to prevent re-introduction of effectiveness of any HACCP program. pathogens, such as Salmonella and S. HACCP plans for handling and Establishing procedures for aureus, that are epidemiologically processing raw beef should be verification that the HACCP system is linked to beef products. developed and implemented by food working correctly is an integral element After slaughter, dressing and retailers and food service establishments in developing an effective HACCP plan processing, raw beef goes through a as the optimal system for food safety and system. The verification procedures complex system of distribution and assurance. In institutional feeding should: marketing (including wholesalers, operations such as hospitals, nursing 1. Verify that the critical limits for distributors, retail stores and food homes, day care centers, and prisons CCPs are satisfactory, service establishments) before where the populations may be more 2. Ensure that the facility’s HACCP ultimately reaching the end users who vulnerable to foodborne disease, special plan is functioning effectively, consume the products. Throughout care must be taken in the preparation of 3. Consist of documented distribution and preparation of raw all foods, including raw beef products . revalidations, audits, or other meats, there is a significant potential for The Committee recommends that verification procedures to ensure the product mishandling leading to the HACCP systems be implemented accuracy of the HACCP plan, and introduction of additional pathogenic immediately by food service 4. Provide regulatory verification that microorganisms, or the spread of any establishments and institutions the HACCP system is functioning pathogens remaining on raw beef to preparing foods for these special groups satisfactorily. other foods. Improper handling and with increased susceptibility. General References storage practices, including improper guidelines for the safe handling of raw holding temperatures, inadequate beef in retail food stores and food 1. Acuff, G.R., Vanderzant, C., Savell, J.W., cooking, contaminated equipment and service establishments are provided in Jones, D.K., Griffin, D.B., and Ehlers, J.G. 1987. Effect of acid decontamination of food worker hygiene, have all Attachment B. beef subprimal cuts on the contributed to beef associated foodborne Several national surveys (Weimer and microbiological and sensory outbreaks (Bryan, 1988). The Jones, 1977; Williamson, et al., 1992) characteristics of steaks. Meat Sci. microbiological hazards associated with have shown that the public has a 19:217–226. raw beef can be controlled by extending limited understanding of the basic 2. AVMA. 1992. Recommendations from the HACCP principles to product handling principles of food microbiology and safe AVMA workshop on the safety of foods activities in retail stores, food service home food handling and preparation of animal origin. J. Amer. Vet. Med. establishments, institutional feeding practices. In households, the successful Assoc. 201:263–266. facilities, and homes. use of HACCP principles is dependent 3. Breazile, J.E. 1988. The Physiology of on the interest, knowledge and skills of Stress and Its Relationship to The goal of the HACCP system in food Mechanisms of Disease and distribution and preparation is to the food preparer. General guidelines for Therapeutics. ‘‘The Veterinary Clinics of minimize microbial contamination, the safe handling of raw beef by North America: Food Animal Practice.’’ reduce the opportunities for pathogens consumers are provided in Attachment W. B. Saunders Co., Philadelphia. Vol. 4, that may be present to multiply, assure C. No. 3:441–480. the destruction of pathogenic 4. Cole, N.A., T.H. Camp, L. D. Rowe Jr., D. D. HACCP Records and Verification G. Stevens, and D. P. Hutcheson. 1988. microorganisms through proper cooking The acquisition and maintenance of Effect of Transport on Feeder Calves. procedures, and prevent the cross- records are an integral and critical Amer. J. Vet. Res. 49:178–183. contamination of pathogens from raw to principle of HACCP (NACMCF, 1992). 5. DeZuniga, A.G., M.E. Anderson, R.T. cooked foods. Records of CCP performance along with Marshall and E.L. Iannotti, 1991. A HACCP properly applied to all documentation of related verification model system for studying the penetration of microorganisms into meat. segments of distribution and activities and process deviations are the preparation has the potential for: J. Food Protection 54: 256–258. primary tool by which a HACCP 6. Dickson, J.S. 1992. Acetic acid action on 1. Reducing the opportunities for operation is managed and decisions are beef tissue surfaces contaminated with pathogen growth, thereby reducing the reached concerning the efficacy of Salmonella typhimurium. J. Food Sci. risk of foodborne disease; process. The records of designated 57:297–301. 6860 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 7. Dickson, J.S. and Anderson, M.E. 1992. 21. Maher, K. D. 1991. Implantable electronic 32. Rings, D. M. 1985. Salmonellosis in Microbiological decontamination of food identification, an update of global field calves. ‘‘The Veterinary Clinics of North animal carcasses by washing and trials and its application in animal America: Food Animal Practice.’’ W. B. sanitizing systems: A review. J. Food disease control and eradication Saunders Co., Philadelphia. Vol. 1, No. Protection 55:133–140. programs. ‘‘Proceedings of the 95th 3:529–539. 8. Empey, W.A. and Scott, W.J. 1939. Annual Meeting of the U. S. Animal 33. Robinson, R. A., K. E. Ferris, D. A. Miller, Investigations on chilled beef Part I. Health Association.’’ San Diego, CA. pp. and S. Srinand. 1992. Descriptive Microbial contamination acquired in the 283–286. Epidemiology of Salmonella Serotypes meatworks. Council for Sci. and Indus. 22. Mitchell, G. A. and McChesney, D. G. from Cattle in the USA (1982–1991). Res. Bull. No. 126, Melbourne, Australia. 1991. A plan for Salmonella control in ‘‘XVII World Buiatrics Congress. Amer. 9. Emswiler, B.S., Kotula, A.W. and Rough, animal feeds. ‘‘Proceedings of Assoc. of Bovine Practitioners D.K. 1976. Bactericidal effectiveness of Symposium on the Diagnosis and Conference,’’ St. Paul, MN. pp.15–19. three chlorine sources used in beef Control of Salmonella.’’ San Diego, CA. 34. Schmitz, J.A. 1993. Preharvest food carcass washing. J. Animal Sci. 42:1445– U.S. Anim. Health Assoc. pp. 28–31. safety, an international concern. J. Amer. 1450. 23. NACMCF (National Advisory Committee Vet. Med. Assoc. 202:718–729. 10. Eustace, I.J. 1981. Control of bacterial on Microbiological Criteria for Foods). 35. Siragusa, G.R. and Dickson, J.S. 1992. contamination of meat during 1992. Hazard analysis and critical Inhibition of Listeria monocytogenes on processing. Food Technol. Aust. 33:28– control point system. Int. J. Food beef tissue by application of organic 32. Microbiol. 16:1–23. acids immobilized in a calcium alginate 11. FAPMC. 1992. Implementing food animal 24. Nelson, R. E. 1991. Progress toward gel. J. Food Sci. 57:293–296. pre-harvest food safety internationally. implementation of electronic 36. Smeltzer, T. and Thomas, R. 1981. ‘‘Proceedings: Providing Safe Food for identification in the dairy industry. Transfer of Salmonellae to meat and offal the Consumer.’’ Food Animal Production ‘‘Proceedings of the 95th Annual by knives. Austral. Vet. J. 57:433. Medicine Consortium. Washington, D.C. Meeting of the U. S. Animal Health 37. Smith, B. P. and House, J. 1992. Prospects 12. Grandin, T. 1984. Reduce stress of Association.’’ San Diego, CA. pp. 289– of Salmonella Control in Cattle. handling to improve productivity of 293. ‘‘Proceedings, XVII World Buiatrics livestock. Vet. Med. 79:827–831. 25. Newton, K.G. and Harrison, J.C.L. and Congress. Amer. Assoc. Bovine Practitioners Conf.’’ St. Paul, MN. Vol 1, 13. Grandin, T. 1987. Using cattle psychology Wauters, A.M. 1978. Sources of pp.67–73. to aid handling. AgricPractice 8(5):32– psychrotrophic bacteria on meat at the 38. Smulders, F.J.M., Barendsen, P., van 36. abattoir. J. Appl. Bacteriol. 45:75–82. 26. Osthold, W., Shin, H.-K., Dresel, J. and Logtestijn, J.G., Mossel, A.A. and van der 14. Grau, F.H. 1987. Prevention of microbial Marel, G.M. 1986. Review: Lactic acid: contamination in the export beef Leistner, L. 1984. Improving the storage life of carcasses by treating their surfaces considerations in favour of its abattoir. pp. 221–233. In F.J.M. Smulders acceptance as a meat decontaminant. J. (ed). Elimination of Pathogenic with an acid spray. Fleischwirtsch 64:828–830. Food Technol. 21:419–436. Organisms from Meat and Poultry, 39. Snijders, J.M.A., van Logtestijn, J.G., 27. Patterson, J.T. 1968. Hygiene in meat Elsevier Science Publishing Co., Mossel, D.A.A. and Smulders, F.J.M. processing plants—3. Methods of Amsterdam. 1985. Lactic acid as a decontaminant in reducing carcass contamination. Rec. 15. Hutcheson, D. P. and N. A. Cole. 1986. slaughter and processing procedures. Agric. Res., Ministry of Agriculture, N. Management of transit-stress syndrome Vet. Q. 7:277–282. Ireland 17:7–12. in cattle: Nutritional and environmental 40. Stolle, A. 1981. Spreading of Salmonellas effects. J. Anim. Sci. 62:555–560. 28. Patterson, J.T. 1969. Hygiene in meat during cattle slaughtering. J. Appl. 16. Kennedy, G. A. and C. M. Hibbs. 1993. processing plants—4. Hot water washing Bacteriol. 50:239–245. Salmonellosis. ‘‘Current Veterinary of carcasses. Rec. Agric. Res., Ministry of 41. USAHA. 1992. Report of the Committee Therapy 3: Food Animal Practice.’’ W.B. Agriculture, N. Ireland 18:85–87. on Livestock Identification. ‘‘Proceedings Saunders Co., Philadelphia. pp. 562–565. 29. Prasai, R.K., Acuff, G.R., Lucia, L.M., of the 96th Annual Meeting of the U.S. 17. Kotula, A.W., Lusby, W.R., Crouse, J.D. Hale, D.S., Savell, J.W. and Morgan, J.B. Animal Health Assoc.’’ pp.111–113. and de Vries, B. 1974. Beef carcass 1991. Microbiological effects of acid 42. Vanderzant, C. and Splittstoesser, D. G., washing to reduce bacterial decontamination of beef carcasses at eds. 1992. ‘‘Compendium of Methods for contamination. J. Animal Sci. 39:674– various locations in processing. J. Food the Microbiological Examination of 679. Protection 54:868–872. Foods. 3rd ed. American Public Health 18. Mackey, B.M. and Derrick, C.M. 1979. 30. Quartey-Papafio, E.A., Marshall, R.T. and Association. Washington, D.C. Contamination of the deep tissues of Anderson, M.E. 1980. Short-chain fatty 43. Weimer, J. and Jones, J. 1977. Food safety: carcasses by bacteria present on the acids as sanitizer for beef. J. Food Homemakers attitudes and practices. slaughter instruments or in the gut. J. Protection 43:168–171. U.S.D.A. Report No. 360. pp.155. Appl. Bacteriol. 46:355–366. 31. Reuter, G. 1990. ‘‘Hygiene and 44. Williamson D. M., Gravani, R. B., and 19. Mackey, B.M., Roberts, T.A., Mansfield, Technology in Red Meat Production.’’ In: Lawless, H. T. 1992. Correlating food J. and Farkas, G. 1980. The Scientific Basis for Harmonizing safety knowledge with home food 20. Growth of Salmonella on chilled meat. J. Trade in Read Meat (J. Hannan and J.D. preparation practices. Food Technol Hyg., Camb. 85:115–124. Collins, Eds.), Proceedings of Roundtable 46(5):94–100. Conference of the World Association of 45. Woolthuis, C.H.J. and Smulders, F.J.M. Veterinary Food Hygienists, University 1985. Microbial decontamination of calf College Dublin. pp. 19–36. carcasses by lactic acid sprays. J. Food Protection 48:832–837. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6861 TABLE 1.ÐGENERIC HACCP PLAN CRITICAL CONTROL POINTS FOR BEEF SLAUGHTER AND FABRICATION Monitoring pro- Process/step CCP Critical limits cedure/frequency Corrective action Records Verification Skinning ...... CCP(1) ... ≤20% of car- Operator ob- Add operators ... Random post- Examination of random carcasses casses with serves effec- Reduce chain skinning car- after skinning is complete using dressing de- tiveness of speed. cass examina- sampling plan sufficient to as- fects. skinning proc- Conduct carcass tion log. sure process control. ess for each trimming. Supervisory review of records. carcass. Vis- ual analysis should be con- ducted under adequate light- ing per USDA requirements. Initially, conduct microbiological analyses for aerobic mesophiles and/or Enterobacteriaceae to establish baseline data on expected bac- terial numbers. Periodic follow- up analyses and trend analysis to verify process control. Review control charts to confirm that sampling frequency is suffi- cient to detect 20% defect cri- teria. Post-skinning CCP(2) ... Washing: Continuous mon- Washing: adjust Post-skinning Supervisory review of records. Spray Wash 1. 90±100°F. itoring of tem- temperature or wash spray Periodic microbiological analyses and Bacteri- 2. 345±2070 kPa perature, pres- pressure. and bacteri- for aerobic mesophiles and/or cidal Spray. (50±300 psi). sure and bac- Bactericidal cidal spray log. Enterobacteriaceae coupled Bactericidal tericidal rinse spray: adjust Log of preventa- with trend analysis to confirm Spray: concentration.. temperature, tive mainte- adequacy of process in com- 1. Organic acid: pressure or nance. parison to data collected at 1±2%. 115± concentration CCP(1). 130°F. Examine and re- Periodic testing of equipment to 2. Chlorine: 50 pair equipment ensure it is operating according ppm. Ambient as needed. to design specifications. temperature. 3. 70±275 kPa (10±40 psi) 4. Other applica- tions per USDA±FSIS guidelines. Evisceration ...... CCP(3) ... 0% occurrence Employee ob- 1. Trained em- Random post- Supervisory review of records and of the follow- serves con- ployee imme- evisceration operations. ing defects for tamination and diately trims carcass exam- Random examination of car- a single car- routes con- defect area on ination log. casses after evisceration using cass: Fecal taminated car- carcass. a sampling plan sufficient to as- material, cass for imme- 2. Add sure process control. ingesta, urine diate trimming. operators. or abscesses. 3. Reduce chain speed. 4.4. Sanitize soiled evis- ceration tools with 180°F water. 5. Sanitize soiled clothing 120°F water or ap- propriate sani- tizer. 6862 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules TABLE 1.ÐGENERIC HACCP PLAN CRITICAL CONTROL POINTS FOR BEEF SLAUGHTER AND FABRICATIONÐContinued Monitoring pro- Process/step CCP Critical limits cedure/frequency Corrective action Records Verification Final Wash CCP(4) ... Washing: 1. 90± Continuous mon- Washing: adjust Final wash spray Supervisory review of records. Spray and 100°F. itoring of tem- temperature or and bacteri- Periodic microbiological assays Bactericidal 2. 345±2070 kPa perature, pres- pressure. cidal spray log. for aerobic mesophiles and/or Spray. (50±300 psi). sure and bac- Bactericidal Log of preventa- Enterobacteriaceae to confirm Bactericidal tericidal rinse spray: adjust tive mainte- an adequate reduction in bac- Spray: concentration. temperature, nance. terial numbers compared to 1. Organic acid: pressure or baseline data collected at 1±2%. 115± concentration. CCP(1) and CCP(3). An effec- 130°F. Examine and re- tive organic acid decontamina- 2. Chlorine: 50 pair equipment tion system is indicated by a ppm. Ambient as needed. ≤90% reduction in bacterial temperature. numbers from CCP(1) to 3. 70±275 kPa CCP(4). (10±40 psi). Periodic testing of equipment to 4. Other applica- ensure operation in accordance tions per to design specifications. USDA±FSIS guidelines. Chill ...... CCP(5) ... Deep muscle (6 Continual con- Adjust carcass Chill log ...... Supervisory review of records. in.) tempera- firmation of spacing. Review thermometer calibration ture of ≤45°F environmental Adjust chill cool- log and spacing control charts. within 36 conditions er tempera- Periodic monitoring of cooling hours, reach- (e.g., room ture, air veloci- rates of deep muscle tissue ing ≤50°F after temperature, ties, etc. through the use of temperature the first 24 air velocity, Alert mainte- recording devices. hours. humidity, etc.) nance if cooler Carcasses that influence unit is not spaced a mini- cooling rates. functioning mum of 1±2 Monitor carcass properly. inches apart. spacing upon Continue chilling arrival to chill carcass until coolers. internal tem- Conduct random perature temperature reaches monitoring of ≤45°F. carcasses after appro- priate chill time. Refrigerated CCP(6) ... Product tem- Check product Adjust tempera- Temperature Supervisor record review. Storage. perature of temperature. ture of storage records. ≤45°F). Continuous mon- facility. itoring of tem- Place product on peratures of hold (i.e., re- storage facility. tain), inves- tigate, and take appro- priate action. Labeling ...... CCP(7) ... Instructional la- Visual checks of Assure correct Labeling records Supervisory review of records. bels and logo. each lot. label and Product date Inspection of relabel if incor- product to en- rect. sure use of correct instruc- tional label and/or logo. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6863 6864 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6865 BILLING CODE 3410±DM±C plan, CCPs, critical limits, monitoring, HACCP plan will be made in response VI. Role of Regulators and Industry in deviations, product disposition, and to the regulatory inspection. HACCP-based Beef Processing corrective actions. The HACCP plan and It is recommended that the beef associated processor records must be processors and associated regulatory The processor has primary agency(s) adopt the principles for responsibility for development and considered proprietary information that implementation of HACCP as outlined implementation of HACCP plans for must not be made available outside the by the HACCP Subcommittee on the beef slaughter, fabrication, packaging regulatory agency(s). Role of Regulatory Agencies in HACCP. and distribution. These plans, however, Specific verification procedures may must consider the entire food system include: Establishing verification These recommendations include from production to consumption. The inspection schedules based on risk; uniformity in adopting HACCP major role of the regulatory agency(s) is review of the HACCP plan; review of principles, the characteristics of a to verify that the processor’s HACCP CCP records; review of deviations and HACCP-based inspection program, and system is effective and working as corrective actions; visual inspection of procedures to facilitate the adoption and intended. In general, this includes operations, random sampling of final implementation of HACCP. assurance that following the HACCP products; review of critical limits; Reference plan fulfills the intended purpose of review of the processors verification 1. NACMCF (National Advisory Committee providing a product that is safe when records; review of revalidation of the on Microbiological Criteria for Foods). properly handled and prepared for HACCP plan; and review of HACCP 1992. Hazard analysis and critical consumption. plan modifications. The regulatory control point system. Int. J. Food The role of regulatory agency(s) in agency(s) should establish the manner Microbiol. 16:1–23. inspection of beef processing operations and frequency of verification, format for VII. New Technologies and Procedures should be based on the verification reports, and other activities recommendations of the HACCP based on the HACCP Subcommittee New technologies and procedures for Subcommittee on ‘‘The Role of recommendations (NACMCF, 1992). improved microbial control during the Regulatory Agencies and Industry in slaughtering process fall into two HACCP’’. The regulatory agency(s) in Industry’s responsibility is to develop, activities: preventing contamination and cooperation with industry and other implement and maintain an effective decontamination. Both will be experts in HACCP shall be actively HACCP system. The system should be considered. In addition to microbial involved in promoting the HACCP based on the NACMCF control, improvements in carcass principles and their application to recommendations on HACCP principles identification and product coding can assure uniformity and common and application (NACMCF, 1992). Each be beneficial for determining the source understanding. Regulations and facility should develop an HACCP team of microbial pathogens. guidelines that are promulgated by the and provide for proper training in A. Reducing the Potential for regulatory agency(s) should be HACCP principles. It is the processor’s Contamination consistent with these principles. responsibility to provide HACCP The focus of the regulatory agency(s) records to the regulatory agency(s). The This section includes those new should be on those activities associated processor must assure that the records technologies or improvements in with verification of critical control are complete, accurate and up to date. existing procedures which can be used points. The processor must make Records for review must include during slaughtering to reduce HACCP records available to the pertinent information for verification contamination from current levels to regulatory agency(s). These records and revalidation of the HACCP plan. lower levels. Operators of slaughter would include the processor’s HACCP When necessary, amendments to the facilities should be encouraged to 6866 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules develop procedures which reduce or more steps during slaughtering and/or C. Carcass Identification, Product control the spread of pathogens from chilling. The Committee encourages the Coding manure, internal organs, hair, water, etc. development and implementation of Procedures should be developed so to the carcass or the processing such bactericidal systems to reduce the that carcasses can be identified as to environment. Such systems might number and incidence of enteric source and can be traced back to the include improved methods for hide pathogens on carcasses and fresh meat. farm. In addition, minimum removal; dehairing before removing the As systems are developed and requirements for the coding of raw beef hide; washing and/or sanitizing saws, approved, FSIS should consider products should be developed so that knives or other equipment during requiring the use of systems that have information can be obtained relative to slaughtering operations; or other new been proven to actively reduce enteric processing establishment(s), sources of techniques. pathogens. The minimum efficacy raw materials and time of production. The trim rail, for example, should be required for such systems should be a moved to an area as far forward in the specified reduction of References slaughter process as possible, preferably Enterobacteriaceae (e.g. a 10-fold 1. Cross, H.R. 1992. Irradiation of poultry before the pre-evisceration wash. Such a reduction) using standardized protocols products. 9 CFR Part 381. Federal move would facilitate preventing recognized by the regulatory agency Register 57:43588–43600. 2. ICGFI. 1992. Ninth Meeting of the carcass contamination. This trim area with input from other interested parties should also be used to trim bruises, International Consultative Group on (e.g., academia, industry, USDA–ARS, Food Irradiation. Inventory of product lesions, and grubs before spraying the NACMCF, and professional clearances. International Consultative carcass with water or other approved organizations). The conditions (e.g., Group on Food Irradiation, Joint FAO/ solutions. time, temperature, pH, acid IAEA Division, International Atomic The method of cutting around and concentration, etc.) for effective Energy Agency, Vienna. handling the bung (e.g. tying off, operation of the decontamination VIII. Research Needs covering, etc.) is another example. The system should be specified in the preferred method has been debated for HACCP plan of the slaughter 1. Recent research has indicated that a number of years. There is general establishment. the attachment of enteric pathogens agreement, although there is little or no involves a specific, genetically- published data, that this step can be a In addition to its use as an in-line controlled interaction between the significant source of contamination to system for decontamination, this bacterial cell surface and connective the carcass. It is recommended that this technology can be applied to unique tissue. Further research is needed to step be reviewed and one or more situations. For example, under current confirm these observations and methods be specified which will inspection procedures for cattle, the elucidate the underlying biochemistry minimize carcass contamination. following occurs in the event that of attachment. Potentially, this during evisceration a break in viscera information could be used to develop B. Decontamination contaminates the body cavity: enhanced methods for preventing There are two basic approaches to Carcass siderailed; contamination and/or enhancing the decontamination. The first approach removal of enteric pathogens from raw usually consists of spraying carcasses Carcass trimmed by peeling out fascia in beef. during slaughtering and/or chilling. body cavity; 2. One of the long standing questions These procedures can reduce but will Exposed bone is trimmed; and with raw meat and poultry products has not destroy all the enteric pathogens. Visual reinspection. been the epidemiological significance of The second approach consists of low numbers of infectious bacteria such irradiating packaged meat. Irradiation An alternate approach to the above as Salmonella, Listeria, and E. coli doses currently approved for use with may be the following: O157:H7. Recent biotechnological poultry (Cross, 1992) would be Carcass siderailed. advances allow for the first time the sufficient to destroy the levels of enteric active tracing of such foodborne pathogens that would normally be Decontamination of the body cavity pathogens from the farm, through the present on freshly packaged meat. by: processing operations, and to ultimate Both approaches require that the Extensive body cavity and carcass wash isolation in a clinical setting. An active slaughtering process be controlled to with potable water. surveillance study should be minimize contamination. The number of undertaken to establish unequivocally enteric pathogens on the carcasses Decontamination of the body cavity by the role of raw meat and poultry in should be as low as possible before an approved procedure (e.g., organic transmission of human enteric diseases. either method of decontamination is acid, alkaline solution, hot water, This research should be designed and applied. In addition, the method of steam, etc.) conducted to identify the major points decontamination and the organoleptic 2. Irradiation of introduction and/or dissemination of quality of the decontaminated meat Salmonella and E. coli O157:H7. This must still be acceptable to consumers. Irradiation is an effective technology information is needed to perform for destroying enteric pathogens in fresh accurate hazard analyses and risk 1. Organic Acid Sprays, etc. meats. The irradiation of poultry for assessments to develop preventive Research and commercial experience pathogen control has been approved in measures on the basis of sound has demonstrated that microbial the United States and ten other information. contaminants on the surface of carcasses countries (e.g., France, United Kingdom, The study should be conducted in a can be reduced through the use of and The Netherlands) (ICGFI, 1992). manner that permits acquisition of organic acid sprays, hot water, steam Irradiation of raw beef should, likewise, quantitative information of the levels of and various combinations of these and be approved. Used appropriately, pathogens related to overt disease. other approved bactericidal materials. irradiation can be an effective method While the establishment of an absolute There may be more than one for assuring the safety of raw meats, Minimum Infectious Dose for combination of treatments at one or particularly raw ground beef. individuals is not a reasonable Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6867 objective, there is a need to know on a 6. Establish how refrigerated raw beef clean and sanitary manner. Disposable population basis the incidence of active should be stored to maximize personal items should be changed as infections that are likely to occur as a microbiological safety, with particular required to assure cleanliness. function of levels enteric pathogens reference to control of psychrotrophic Hot water sanitizing stations should ingested. This information is needed to pathogens. be kept at 180°F with frequent changes make realistic, cost-effective decisions 7. Identify microbiological inhibitors of water. After knives are dipped they concerning microbiological criteria. For that could be used in raw meat and should be sanitized by approved example, if the infection rate at 10,000 poultry, particularly ground beef. sanitizers for an appropriate time cfu/g is 90% whereas at 100 cfu/g it is 8. Evaluate decontamination interval before reuse. This may require 0.01%, one could estimate risk factors procedures to determine if they could be multiple knives to allow adequate time versus the cost of achieving a significant employed as an alternate means to in the sanitizer to assure proper improvement in public health. Using trimming for effectively eliminating microbial kill. the cited example, it is unlikely that fecal contamination from carcasses. Knives and all personal equipment there would be much practical 9. The continued development of should be cleaned, sanitized, and dried significance in mandating a minimum improved methods for the identification prior to storage. Special attention level of less than 1 cfu/g if there was not of foodborne pathogens in meat and should be given to boots and footwear. further reduction in infection rate. poultry products should be encouraged. Storage lockers should be kept clean 3. Determine how techniques in This includes rapid methods that can be and free of dirty clothes, rags, etc. microbial risk assessment can be used both to identify animals that Shrouds, aprons, gloves, and cotton applied to the transmission of bacterial harbor enteric pathogens prior to items should be placed in a marked pathogens via raw beef products. This slaughter and to periodically verify the plastic container after use. These items includes quantifying the relative effectiveness of HACCP operations. should be given a proper wash with a importance of both the different Studies of improved means for sampling chlorine rinse and dried thoroughly potential sources of pathogenic bacteria to decrease lower limits of detection, before being returned to the processing and the critical control points that enhance accuracy, and decrease number plant. control the microbiological hazards of samples required for statistical associated with beef slaughter validity should also be encouraged. B. Equipment operations. 10. It is often assumed that enteric Acquisition of USDA approved 4. Establish baseline data for the types pathogens are limited to the surface of equipment should include and extent (level) of microbial beef carcasses. However, evidence consideration of ease of cleaning, contamination that can be expected on indicates that lymph nodes can harbor sanitation, and maintenance. raw beef products produced under good enteric pathogens (e.g., salmonellae). All equipment should be cleaned and manufacturing conditions. These data This suggests that the processing sanitized daily. Pre-operative will serve as the basis for assessing the procedures described in this document inspections should be conducted prior efficacy of alternate intervention would be less effective than anticipated. to start-up. The relative significance of beef carcass approaches. This should include an All equipment must be maintained in lymph nodes as a potential source of examination of large and small volume good repair. As materials age, Salmonella and E. coli O157:H7 is slaughter operations for fed-cattle and deterioration occurs and care must be unknown. Studies should be undertaken dairy cattle to determine factors that taken to monitor the equipment. to determine the incidence of these effect incidence of foodborne pathogens Preventive maintenance helps ensure pathogens in bovine lymph nodes. in these segments of the beef industry. equipment works properly and These surveys should be accompanied Attachment A—General Sanitation facilitates proper cleaning and with an evaluation of the relationship Controls for Beef Slaughter and sanitizing. between the results of traditional Fabrication Operations Plastic or metal pallets are preferable, organoleptic inspections and Successful implementation of HACCP however, if unavailable, wooden pallets assessments of both the incidence and within a beef slaughter or fabrication may be used provided they are kept dry extent of contamination with specific facility requires the following basic and clean. human pathogens. Particular emphasis plant support programs. Good All plastic belts and other food should be directed to assessing the manufacturing practices (GMPs) must be conveyance surface should be inspected relationship between animal health at stressed throughout the facility. These frequently, and replaced or resurfaced the time of slaughter and the overall practices include programs that cover as soon as there is evidence of cracking, degree of contamination of the meat. employee personal hygiene, effective pitting, or other defects that would 5. Surveys of the adequacy of sanitation, pest management, equipment hamper effective cleaning and refrigeration in distribution channels, selection and maintenance, plant sanitizing. retail markets, food service environmental management, potable A major equipment concern is establishments, and the home have water sources, operational practices, controlling material buildup, i.e., bone indicated that there is a significant and proper storage of packaging dust and meat particle accumulation in potential that raw beef products will be materials and supplies. Effective areas that increase in temperature temperature abused before adherence to GMPs requires orientation during processing. Such problems can consumption. There is a need to and follow-up training for all be minimized by regular cleaning and establish quantitative data on the impact employees. appropriate documentation of all of transitory or marginal temperature actions. abuse on the growth of pathogens on A. Hygiene Practices C. Movement of Personnel and raw beef products. Data on time/ All personnel should be trained in the Equipment temperature relationships would importance of personal hygiene. provide a scientific basis for courses of Hair nets, beard covers, knives, steels, Movement of personnel and action that should be followed when lockers, aprons, smocks, boots, etc., equipment between areas, particularly there is a loss of temperature control. should be handled and maintained in a between slaughter and fabrication or 6868 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules processing zones can be a source of should be used before newly received paper bag to help prevent excessive cross contamination. foods. warming during transport. Fork lifts can be a continuing source Raw products should be stored Take purchases home immediately of cross-contamination. Movement must separately from cooked, ready-to-eat and place items to be kept refrigerated be excluded from areas where product products to prevent cross- or frozen in proper storage as soon as is exposed. contamination. possible. Movement of personnel between The cooler should be regularly B. Kitchen Appliances and Utensils zones should be controlled and inspected for good sanitary conditions minimized. Sinks, boot washes, and and maintained at the proper Use a thermometer to assure ° clean outer garment exchange should be temperature (<40°F) and humidity. refrigerator temperature is 40 F or below used at zone entrances, particularly if and that freezer temperature is below Products should be stored to assure ° individuals are moving from a ‘‘dirty’’ sufficient air circulation. 0 F. zone to a ‘‘clean’’ area (e.g., movement Keep refrigerator and freezer shelves from abattoir to fabrication room). C. Food Preparation clean and sanitize periodically. Delicatessen employees and food Separate raw from cooked foods in the D. Packaging service workers should be aware of and refrigerator or freezer. Raw foods should A basis for selection of approved food practice good personal hygiene at all never be stacked on top of cooked foods. Use an oven thermometer to verify packaging material should be times, especially when preparing and that the oven temperature is effectiveness for protecting the product handling foods. approximately the same as the and preventing contamination. Employees should not work when ill temperature dial selector. Most oven Packaging integrity must be maintained and should wash hands frequently, owner’s manuals will have instructions to avoid recontamination, i.e., proper especially after handling raw foods and for adjusting the temperature selector seals, clips, covers, vacuum levels, etc. after using the restroom. All packaging materials and supplies for accuracy. Clean clothing and appropriate hair Counter tops, sinks, and cutting should be received and stored in cover should be worn by all personnel manner that ensures their integrity. surfaces should be cleaned and involved in food preparation. sanitized after contacting any raw food. E. Pest Control Raw foods should be kept separate Clean surfaces with hot soapy water and from cooked, ready-to-eat foods. An active program for control of rinse thoroughly. Sanitize the surface Equipment and utensils used in the with a chlorine solution (one cap of insects, rodents, wild birds, and other preparation of raw beef products should pests should be maintained, including bleach in one gallon of cold water; a be properly cleaned and thoroughly new solution prepared weekly). periodic examination of facilities for sanitized before use with other foods. evidence of infestations. If washing utensils by hand, knives Intact cuts of beef (roasts, chops, etc.) and cutting boards used with raw meats F. Plant Environment Management should be cooked to a minimum should be washed with hot, soapy internal temperature of 140°F. The The processing environment should water, followed by a hot water rinse and temperature should be checked with a be maintained to meet GMP sanitation with a chlorine solution after good quality thermometer in the requirements. This includes daily each use. Washing in a dishwasher thickest part of the meat. operative checks to ensure compliance. having a hot water rinse will sufficiently Hamburgers and other ground or sanitize utensils (the temperature of the G. Water restructured beef products should be rinse should be at least 120°F). Water for processing should be cooked to a minimum internal ° C. Food Preparation obtained from a potable source or where temperature of 155 F. At this permitted, recycled according to temperature, the meat is well done and Cross-contamination occurs when approved guidelines. Periodic analysis has no pink color. utensils, plates, or hands used in of the water should be conducted to Beef products that are cooked and preparing raw foods are not thoroughly ensure that the source meets the held for hot display should be kept at washed and sanitized before using with ° recognized microbiological criteria for a temperature of at least 140 F. cooked foods or foods that will not be potable water. Leftover meat products should be cooked (e.g., salads). Never use the same refrigerated immediately in shallow plate to transport raw and cooked beef General Guidelines for the Handling of containers so quick cooling can be unless thoroughly washed and sanitized Raw Beef Products in Retail Food achieved and microbial growth can be between uses. Stores and Food Service Establishments prevented. Frozen products should be thawed in the refrigerator or under cold running A. Food Receiving and Storage Reheat leftover meats and other precooked beef products to a minimum water. Raw beef products should be received internal temperature of 165°F. Cook intact beef cuts (roasts, chops, in good condition and at a temperature etc.) to a minimum internal temperature of 40°F or less. A visual inspection General Guidelines for the Handling of of 140°F. Always check temperatures should be conducted to assure the Raw Beef Products by Consumers with a meat thermometer at the thickest condition of raw beef products. A. Food Purchasing part of the meat. Hamburgers and other ground or B. Refrigerated Storage Buy perishable foods last, after all restructured beef products should be Storage temperatures of less than 40°F other grocery items have been selected. cooked until the meat is well-done (no will minimize microbial growth of Insist that grocery baggers place all raw pink color, juices run clear). The Salmonella. Proper stock rotation food of animal origin (red meat, poultry, temperature at the coolest portion of the should be practiced and: seafood, eggs, etc.) in a separate plastic meat should reach 155°F. A first-in, first-out stock rotation bag for transport. Never allow raw meat Cold beef should be stored and served system should be utilized. All foods to contact a package of food that will not at 40°F or less. should be kept covered, wrapped, dated, be cooked before consumption. Cold Leftovers should be refrigerated labelled and rotated. Older products foods should be placed together in a immediately in shallow containers to Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6869 prevent bacterial growth. Allowing a temperature before refrigerating may Reheat leftovers and other precooked cooked food to ‘‘cool down’’ at room allow bacterial growth. beef products to an internal temperature of 165°F. ATTACHMENT D: CONTROL POINTS AND CRITICAL CONTROL POINTS FOR BEEF SLAUGHTER AND FABRICATION Æ Potential site of minor contamination. • Potential site of major contamination. • Criteria or critical Monitoring pro- Corrective/pre- Process/step Æ, , CCP limits cedure/frequency ventive action Records Verification Cattle receiving: Pens ...... Æ ...... Pens dry and Visual check Reclean. Re- Receiving/hold- Supervisory review of records. clean. each shift. move standing ing log. water. Cattle hold- Æ ...... Holding <24 h ... Check holding Coordinate hold- Receiving/hold- Supervisory review of records. ing. records each ing and ing log. shift. slaughter speed. Stunning: Bleeding ...... Sanitize knife Visual checks Correct proce- None ...... Supervisory review. (180 °F water) and water dures and between sticks. temperature temperature. checks each shift. Head/shank re- moval: Skinning ..... CCP(1) • ≤20% of car- Operator ob- Add operators. Random post- Examination of random carcasses casses with serves effec- Reduce chain skinning car- after skinning is complete using dressing de- tiveness of speed. cass examina- sampling plan sufficient to as- fects. skinning proc- Conduct carcass tion log. sure process control. ess for each trimming. Supervisory review of records. carcass. Vis- Initially, conduct microbiological ual analysis analyses for aerobic should be con- mesophiles and/or ducted under Enterobacteriaceae to establish adequate light- baseline data on expected bac- ing per USDA terial numbers. Periodic follow- requirements.. up analyses and trend analysis to verify process control. Review control charts to confirm that sampling frequency is suffi- cient to detect 20% defect cri- teria. Post-skin- CCP(2) ... Washing: Continuous mon- Washing: adjust Post-skinning Supervisory review of records. ning spray 1. 90±100 °F. itoring of tem- temperature or wash spray Periodic microbiological analyses wash and 2. 345±2070 kPa perature, pres- pressure. and bacteri- for aerobic mesophiles and/or bacteri- (50±300 psi). sure and bac- Bactericidal cidal spray log. Enterobacteriaceae coupled cidal Bactericidal tericidal rinse spray: adjust Log of preventa- with trend analysis to confirm spray. Spray: concentration. temperature, tive mainte- adequacy of process in com- 1. Organic acid: . pressure or nance. parison to data collected at 1±2% concentration. CCP(1). 115±130°F. Examine and re- Periodic testing of equipment to 2. Chlorine: pair equipment ensure it is operating according x 50 ppm...... as needed to design specifications. Ambient tem- perature ...... 3. 70±275 kPa (10±40 psi) .... 4. Other applica- tions per USDA±FSIS guidelines. 6870 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules ATTACHMENT D: CONTROL POINTS AND CRITICAL CONTROL POINTS FOR BEEF SLAUGHTER AND FABRICATIONÐContinued Æ Potential site of minor contamination. • Potential site of major contamination. • Criteria or critical Monitoring pro- Corrective/pre- Process/step Æ, , CCP limits cedure/frequency ventive action Records Verification Evisceration CCP(3) • 0% occurrence Employee ob- 1. Trained em- Random post- Supervisory review of records and of the follow- serves con- ployee imme- evisceration operations. ing defects for tamination and diately trims carcass exam- Random examination of car- a single car- routes con- defect area on ination log. casses after evisceration using cass: Fecal taminated car- carcass. a sampling plan sufficient to as- material, cass for imme- 2. Add operators sure process control. ingesta, urine diate trimming. 3. Reduce chain or abscesses. speed. 4. Sanitize soiled evisceration tools with 180°F water. 5. Sanitize soiled clothing with 120°F water or appropriate sanitizer Viscera han- • ...... No viscera con- Visual checks .... Correct defects .. None ...... Supervisory review of operations. dling. tamination of carcasses. Splitting ...... Æ ...... Clean saw and Visual checks .... Reclean saw ..... None ...... Supervisory review of operations. sanitize in 180 °F water. Final wash CCP(4) ... Washing: Continuous mon- Washing: adjust Final wash spray Supervisory review of records. spray and 1. 90±100 °F. itoring of tem- temperature or and bacteri- Periodic microbiological assays bacteri- 2. 345±2070 kPa perature, pres- pressure. cidal spray log. for aerobic mesophiles and/or cidal (50±300 psi). sure and bac- Bactericidal Log of preventa- Enterobacteriaceae to confirm spray. Bactericidal tericidal rinse spray: adjust tive mainte- an adequate reduction in bac- Spray: concentration. temperature, nance. terial numbers compared to 1. Organic acid: . pressure or baseline data collected at 1±2%. concentration. CCP(1) and CCP(3). An effec- 115±130°F. Examine and re- tive organic acid decontamina- 2. Chlorine: pair equipment tion system is indicated by a 50 ppm. as needed. >90% reduction in bacterial Ambient tem- numbers from CCP(1) to perature CCP(4). 3. 70±275 kPa Periodic testing of equipment to (10±40 psi). ensure operation in accordance 4. Other applica- to design specifications. tions per USDA±FSIS guidelines. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6871 ATTACHMENT D: CONTROL POINTS AND CRITICAL CONTROL POINTS FOR BEEF SLAUGHTER AND FABRICATIONÐContinued Æ Potential site of minor contamination. • Potential site of major contamination. • Criteria or critical Monitoring pro- Corrective/pre- Process/step Æ, , CCP limits cedure/frequency ventive action Records Verification Chill ...... CCP(5) ... 1. Deep muscle Continual con- Adjust carcass Chill log ...... Supervisory review of records. (6 in.) tem- firmation of spacing. Review thermometer calibration perature of environmental Adjust chill cool- log and spacing control charts. ≤45 °F within conditions er tempera- Periodic monitoring of cooling 36 hours, (e.g., room ture, air veloci- rates of deep muscle tissue reaching ≤50 temperature, ties, etc. through the use of temperature °F after the air velocity, Alert mainte- recording devices. first 24 hours. humidity, etc.) nance if cooler 2. Carcasses that influence unit is not spaced a mini- cooling rates. functioning mum of 1±2 Monitor carcass properly. inches apart. spacing upon Continue chilling arrival to chill carcass until coolers. internal tem- Conduct random perature temperature reaches ≤45 monitoring of °F. Product carcasses should not be after appro- moved to the priate chill next step in time sufficient processing to maintain until tempera- process con- ture is trol. reached. Fabrication Æ ...... 1. Product tem- Checks of prod- Adjust room tem- Temperature and Supervisory review of records. (cut up). perature of uct tempera- perature. product speed ≤45°F. ture. Adjust speed of records. 2. Product trans- Continuous mon- incoming prod- ported through itoring of room uct to accom- fabrication pro- temperatures. modate 1 hour cedures and Check speed of fabrication into storage product move- room limit. within 1 hour.. ment through fabrication. Note: The following Supplement will not II. Market Failure Justifies Regulation of B. Costs of Foodborne Illness appear in the Code of Federal Regulations. Pathogens To Protect Public Health C. The Relationship Between Foodborne III. Alternatives Illness and Consumer Knowledge and Supplement—Preliminary Regulatory A. Process Control Regulatory Strategy Behavior Impact Assessment for Docket No. 93– B. Factors Considered in Evaluating a V. Costs Associated with HACCP Process Control Strategy 016P, ‘‘Pathogen Reduction; Hazard A. Cost Analysis Procedures Analysis and Critical Control Point C. Evaluation of Mandatory HACCP to Provide Process Control B. Costs of the Near-term Initiatives (HACCP) Systems’’ D. Evaluation of Other Alternatives C. Costs of the Long-term HACCP Table of Contents IV. HACCP Benefits—Foodborne Illness Intervention A. Incidence of Foodborne Illness in the D. Estimated Costs Per Plant I. HACCP Produces Net Benefit to Society United States 6872 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules I. HACCP Produces Net Benefit to aspects of products and production Safety and Inspection Service, U.S. Society efficiency. However, the benefits Department of Agriculture, Washington, Food Safety and Inspection Service assessed here are based only upon DC 20250.) (FSIS) is proposing, in docket no. 93– pathogen reduction and control for Because there are no scientific data 016P, above, to require all federally safety. that can be used to relate intermediate inspected meat and poultry plants to FSIS has selected mandatory HACCP pathogen reductions to reductions in adopt a Hazard Analysis and Critical as the centerpiece for this new foodborne illness, benefits have been Control Points (HACCP) processing regulatory program because scientists based on the Agency’s intention to control system for each of its processes and industry leaders agree that it minimize the risk of foodborne illness within 3 years of publication of the final provides the most effective food in the manufacturing sector. Risk rule. The proposed regulations also processing controls available to reduce minimization means the elimination of mandate some near-term pathogen and control meat and poultry pathogens almost all the foodborne illness caused reduction interventions prior to HACCP and accomplish other food safety by the contamination of meat and plan implementation. In the same objectives such as chemical residue poultry products with the four document, FSIS provides advance control. pathogens listed above in inspected notice of plans to establish interim The function of this regulatory impact plants. The amount of reduction in targets, guidelines, and standards to assessment is to evaluate the costs and pathogens needed to do this is unknown establish public health goals for benefits of a mandatory HACCP-based and would vary for individual pathogens. regulatory program for all meat and pathogens and products. The testing The objective of these regulations is to poultry establishments under requirement will enable the Agency to initially reduce and eventually inspection. The HACCP ‘‘program’’ learn more about what pathogen minimize the risk of foodborne illness includes all the interventions in this reduction standards would be from four human pathogens in meat and proposal. Because contamination can appropriate to minimize risk. poultry in the manufacturing sector occur any place in the production The conclusion of the cost-benefit under current production technologies. process, no one intervention can analysis is that mandating HACCP- These pathogens are: minimize the risk; indeed, the value of based processing control systems will 1. Campylobacter jejuni/coli; the HACCP system is that it provides a result in net benefits that far exceed 2. Escherichia coli 0157:H7; framework for systematically using implementation and operation costs. 3. Listeria monocytogenes; and interventions to minimize risk. For this Table 1 provides a summary of these 4. Salmonella. reason benefits have been estimated costs and benefits. The proposed These regulations also require only for the entire HACCP program. regulation will redistribute costs in a appropriate controls to minimize or Costs are provided for each individual fashion more acceptable to societal prevent other biological, chemical and intervention. (A Supplement on Costs is values which have always given priority physical safety hazards. To a certain available from Diane Moore, Docket to minimizing the occurrence of extent HACCP can improve quality Clerk, Room 3171, South Building, Food controllable diseases. TABLE 1.ÐCOST-BENEFIT COMPARISON HACCP/PATHOGEN REDUCTION PROPOSAL (Millions of $Ðdiscounted 20 years) * Costs Benefits ** Total ...... $2,298.9 Total ...... $6,422±23,935 Near-Term: Foodborne illness avoided:. Micro testing ...... 131.9 Campylobacter jejuni/coli ...... 2,919±4,670 Sanitation SOP ...... 86.6 E. coli 0157:H7 ...... 1,168±2,419 Time/Temperature Requirements ...... 45.5 Listeria monocytogenes ...... 584±1,168 Antimicrobial Treatments ...... 51.7 Salmonella ...... 1,751±15,178 Subtotal ...... 315.7 HACCP Implementation: Plan development ...... 35.7 Micro testing ...... 1,262.5 Record keeping ...... 456.4 HACCP Training ...... 24.2 Aseptic Training ...... 1.9 Fed. TQC Overtime ...... 20.9 Agency Training ...... 0.4 SOP under HACCP ...... 181.2 Subtotal ...... 1,983.2 Source: Economic Research Service, Centers for Disease Control and Prevention, and Food Safety and Inspection Service. * These costs have been discounted using the OMB suggested rate of 7%. ** Benefits from elimination of Salmonella, E. coli 0157:H7, Campylobacter jejuni/coli and Listeria monocytogenes are estimated at 90% of the total meat- and poultry-related medical costs and productivity losses associated with each pathogen as depicted in Table 4. Total benefits start 5 years after publication of final rule. It is not known exactly what distribution and preparation. It is clear contamination during further percentage of contamination takes place that most contamination takes place processing. Agency microbiologists have in the manufacturing sector in contrast during manufacturing since it derives estimated that about 90 percent of to that which occurs afterwards during from processing animals and cross pathogen contamination occurs within Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6873 the manufacturing sector, and Sensitivity Analysis for Table 1 5 through 20, an analysis was performed accordingly, only 90 percent of the The calculation of benefits in table 1 to examine the sensitivity of the cost- benefits from the reduction of foodborne assumes benefits are zero for years 1 to benefit analysis to changes in the illness costs have been included as 4 and the maximum possible (i.e., 100 estimated stream of benefits. The results benefits in the analysis. percent of the 90 percent attributable to of this analysis are presented in table 1A, and a discussion of the assumptions FSIS expects it to take about five years contamination in the inspected plants) used in this analysis follows. from the publication of the final rule for for years 5 to 20. Given achievement of First, the assumption of zero benefits the proposed interventions and HACCP the estimated benefits in years 5 through until year 5 is replaced by the to reach the risk minimization goal. By 20, actual benefits to society would assumption that benefits grow linearly that time, all establishments will have likely exceed these benefit estimates for starting from zero and reach the implemented effective pathogen several reasons. These reasons include the conservative valuation of a human undiscounted maximum of $0.99–$3.7 reduction interventions and will have life, no consideration of consumers’ billion in year 5. Thus, the low and high been systematically controlling their willingness to pay for avoidance of end estimates of undiscounted benefits processes for from 2 to 4 years. illness, and the assumption of zero in the first year are $0.198–$0.74 billion. Although there is reason to believe that benefits from near-term interventions Benefits increase in year 2 to $0.396– during the first five years, significant and early implementation of HACCP. $1.48 billion and increase at the same benefits will be generated by the The achievement of maximum benefits rate until year 5. The discounted value interventions and controls in place, is also subject to uncertainty. of benefits for years 1 to 4 is $1.733 to there are no data to estimate these In order to account for the possibility $6.478 billion. The discounted value of benefits. of positive benefits in years 1 through 4 benefits over 20 years becomes $8.155– and the uncertainty of benefits in years $30.413 billion. SENSITIVITY ANALYSIS OF ALTERNATIVE BENEFIT LEVELS Added benefits, years 1± Baseline benefits 2 Reduced benefits, years 4 1 5±20 3 Low High Low High Low High Year Billion dollars, discounted at 7 percent 1 ...... 0.20 0.74 0 0 0 0 2 ...... 0.37 1.38 0 0 0 0 3 ...... 0.52 1.94 0 0 0 0 4 ...... 0.65 2.41 0 0 0 0 5 ...... 0.76 2.82 0 0 0 0 Sum of benefits, years 1±4 ...... 1.73 6.48 0 0 0 0 Sum of benefits, years 5±20 ...... 6.42 23.94 6.42 23.94 5.78 21.54 Total benefits, years 1±20 ...... 8.16 30.41 6.42 23.94 5.78 21.54 Benefit-cost ratio 4 ...... 3.5 13.2 2.8 10.4 2.5 9.4 1 Assumes benefits start at 0 and increase linearly to base level benefits in year 5. 2 Base level of benefits are those presented in table 1. 3 Assumes 90 percent of base level of benefits. 4 Assumes costs presented in table 1. Alternative assumptions regarding the set of assumptions. The benefit-cost $6.4 to $23.9 billion as 20 years of size of benefits are possible. The linear ratio ranges from 2.5:1 to 13.2:1. foodborne illness and attendant costs to assumption is arbitrary; the purpose is Costs society are avoided. (The wide range of to demonstrate that any benefits in years benefits is attributable to uncertainties 1 to 4 will increase the 20-year total Costs to meat and poultry processors in the data used to estimate the discounted value of benefits. across the Nation will vary according to incidence of foodborne illness.) how much improvement in process Second, the assumption of zero The predictability of foodborne illness benefits until year 5 is retained but the control each plant needs. Plants that now have good processing controls will reductions from a reduction of realized benefit in year 5 and later is have relatively few implementation pathogens in meat and poultry is made reduced by 10 percent, making the costs, while plants that have little or no difficult by the fact that little annual undiscounted benefits $0.89– process control will need to spend more quantitative data on the relationship $3.32 billion. The discounted value of for implementation. A detailed analysis between these two variables exists benefits over 20 years becomes $5.780– of industry’s costs to develop, because many of the risk assessments $21.542 billion. The uncertainty implement, and operate HACCP systems necessary to establish this relationship involved in estimating the annual cost appears in Section V. have not been undertaken. Therefore, it of foodborne illness is already Costs to the Government would be for is not known how much pathogens need accounted for in the range reported in training FSIS employees. Existing to be reduced to minimize the risk of table 4. The 10 percent reduction is an resources would be used. No additional foodborne disease from meat and arbitrary assumption to demonstrate the funding is anticipated. poultry. One component of the proposal sensitivity of the cost-benefit analysis. is the testing of product to generate data In neither case are costs affected. All Program Goals on pathogen incidence which will help estimates of discounted benefits are far The quantifiable benefits to society to elucidate the relationship between larger than the discounted costs for each from the proposed regulation range from pathogen contamination and foodborne 6874 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules disease, and the Agency also intends to indications such as unpleasant odor or In the U.S. food industry, nationally undertake additional risk assessments to discoloration caused by spoilage recognized brand names have generate dose/response curves for microorganisms, consumers cannot historically provided significant specific pathogens. The Agency will use assume products are safe in the absence motivation for manufacturers to ensure the new information from this research of spoilage. They simply have no clear- safe products. In recent years, more and to adjust targets, if necessary, to meet its cut way to determine whether the food more meat and poultry have come to be goal of risk minimization. they buy is safe to handle and eat. marketed under brand names. The Agency believes that it is When foodborne illness does occur, Yet in the case of meat and poultry reasonable to set a goal of risk consumers often cannot correlate the contaminated with pathogenic minimization assuming the symptoms they experience with a microorganisms, even brand name implementation of the requirements in specific food because some pathogens protection has not provided enough this proposal. Current technologies can do not cause illness until several days motivation for processors to produce the and frequently do produce product of after exposure. Thus, food safety safest product they can make. minimal risk. Contamination occurs attributes are often not apparent to The failure of meat and poultry from poor practices (errors) and lack of consumers either before purchase or industry manufacturers to produce systematic preventive controls immediately after consumption of the products with the lowest risk of throughout the production process. For food. This information deficit also pathogens and other hazards cannot be the first time, in this proposal the applies to wholesalers and retailers who attributed to a lack of knowledge or Agency is focusing on reducing generally use the same sensory tests— appropriate technologies. The science pathogens. It is mandating interventions sight and smell—to determine whether and technology required to significantly that a large part of the industry already a food is safe to sell or serve. reduce meat and poultry pathogens and uses to correct errors that cause The societal impact of this food safety other hazards is well established, pathogen contamination, and it is information deficit is a lack of readily available and commercially proposing the use of a system of accountability for foodborne illnesses practical. controls that prevents pathogens which caused by preventable pathogenic There are three main explanations for is the most effective way of reducing microorganisms. Consumers often why a large portion of the meat and them. Empirical evidence of how cannot trace a transitory illness to any poultry industry has not taken full effective these interventions and particular food or even be certain it was advantage of available science and HACCP process controls are where they caused by food. Thus, food retailers and technology to effectively control are currently used and the Agency’s restaurateurs are generally not held manufacturing processes. knowledge that many establishments do accountable by their customers for 1. Meat and poultry processing not currently use them leads the Agency selling pathogen-contaminated products businesses are relatively easy to enter; to believe that the risk of pathogens in and they, in turn, do not hold their there are no training or certification the manufacturing sector can be wholesale suppliers accountable. requirements for plant operators. minimized by the implementation and This lack of marketplace Consequently, the level of scientific and enforcement of these requirements for accountability for foodborne illness technical knowledge of management in all inspected establishments. means that meat and poultry producers many plants is minimal. Further, the Agency is mandating and processors have little incentive to 2. The industry is very competitive product testing for pathogens which incur extra costs for more than minimal and largely composed of small and will enable it to set targets that can pathogen and other hazard controls. The medium-sized firms that have limited establish a standard of pathogen control widespread lack of information about capital and small profits. throughout the industry that will pathogen sources means that businesses 3. Management in many of these minimize the risk of foodborne illness. at every level from farm to final sale can plants has little incentive to make market unsafe products and not suffer capital improvements for product safety II. Market Failure Justifies Regulation legal consequences or a reduced of Pathogens to Protect Public Health because they are not distinguishable by demand for their product. An additional customers and therefore yield no Consumers make choices about the complication is that raw product is income. food they purchase based upon factors often fungible at early stages of the In spite of these barriers, many such as price, appearance, convenience, marketing chain. For example, beef from industry establishments do produce texture, smell, and perceived quality. In several slaughterhouses may be meat or poultry products using process an ideal world, people would be able to combined in a batch of hamburger controls that assure the lowest practical make these decisions with full delivered to a fast food chain. risk of pathogens and other hazards. But information about product attributes Painstaking investigation by public a significant part, particularly those and choose those foods which maximize health officials in cases of widespread producing raw products for consumers their satisfaction. In the real world, disease often fails to identify foodborne for further processing, do not. however, information deficits about illness causes; in half the outbreaks the FSIS has concluded that the lack of food safety complicate consumer buying etiology is unknown. consumer information about meat and decisions. Most markets in industrialized poultry product safety and the absence Since all raw meat and poultry economies operate without close of adequate incentives for industry to products contain microorganisms that regulation of production processes in provide more than minimal levels of may include pathogens, raw food spite of consumers having limited processing safety represents a market unavoidably entails some risk of technical or scientific knowledge about failure requiring Federal regulatory pathogen exposure and foodborne goods in commerce. Branded products intervention to protect public health. illness to consumers. However, the and producer reputations often presence and level of this risk cannot be substitute for technical or scientific Regulating Pathogens determined by a consumer, since information and result in repeat The present combination of market pathogens are not visible to the naked purchases. Thus brand names and regulation and industry self-policing has eye. Although they may detect product reputations become valuable not resolved increasingly apparent unwholesomeness from obvious capital for producers. problems with meat and poultry Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6875 pathogens. Documented cases of and without causing significant Even with demonstrated net benefits foodborne illness each year, some of economic or social distortions, FSIS as to society, it is important to keep the which have resulted in death, represent a public health agency can support no HACCP costs to industry down as much a public health risk that FSIS judges to alternative to HACCP. as possible to avoid unintended be unacceptable. A Federal regulatory The economic argument supporting economic effects of HACCP program that reaches every level of meat HACCP is that its benefits to society implementation such as higher food and poultry production, processing, outweigh the costs imposed by this prices or putting firms out of business. distribution and marketing is the only proposal. Table 1 shows that in terms of The use of systematic process control as the costs and benefits that can be means available to society for lowering reflected in the HACCP system would quantified, HACCP implementation foodborne pathogen risks to an not require any establishment to change would generate considerable net acceptable level. FSIS further concludes benefits to society. its production process, and the costs of that a mandatory HACCP program is the In addition, HACCP is supported by monitoring a HACCP system are only means of achieving this goal. redistribution arguments that are based relatively small. Alternatives cannot achieve the on widely accepted social values. Public Thus, costs should have a minimal reduction in pathogens necessary to health legislation itself clearly implies effect on the industry as a whole. Table assure the maximum reduction in food society’s preference for having costs 2 shows the increased cost per pound of illness. To the extent that reductions in manifest themselves as regulatory or product based on the estimated HACCP pathogen levels in meat and poultry can production costs rather than as costs costs. be achieved with current technology associated with illness. TABLE 2.ÐEFFECTS ON THE COST PER POUND OF MEAT AND POULTRY Near-term Four-year and HACCP 1993 estimated implementa- Cost per Inspection program poundage* poundage tion total pound (billion) (billion) costs (million) Total State and Federal ...... 77.7 310.9 $733.5 $0.00236 *Poundage data is slaughter carcass weight for Federal and State establishments with 26 of 27 states reporting slaughter data. A reduction in the incidence of recognize the benefits of good process human health—are now present in foodborne illness is the principal control. significant percentages of raw meat and performance goal for both USDA and Process control is a proactive strategy poultry products; and industry. Mandatory HACCP that all segments of industry can 3. These pathogens and resulting risks implementation is projected to produce undertake to anticipate manufacturing of foodborne illness can be largely a direct reduction in foodborne illness problems in advance and prevent unsafe avoided by uniform meat and poultry with public health benefits estimated at foods from ever being produced. In industry efforts to attain and maintain $6.4–24.0 billion for 20 years (see Table practice, process control is a systematic more effective methods of control 1). The Agency believes that these means to: during the manufacturing process. benefits clearly outweigh industry • identify and control production The focus of this strategy is explicitly discounted costs of $2.3 billion hazards; on prevention; it is designed to prevent associated with implementing and • determine control points in the the production of defective product as maintaining HACCP controls for 20 processing system; opposed to more costly and less years. • establish standard measures for effective detect-and-condemn methods. each control point; Process control is not a substitute for III. Alternatives • set procedures for plant workers to inspection any more than inspection A. Process Control Regulatory Strategy monitor requirements; could be a substitute for process control. • provide clear instructions for This distinction is important because FSIS has determined that effective appropriate corrective actions when a Federal inspection was never intended process control is needed throughout control point goes out of control; to be—and cannot be—the front-line the meat and poultry industry in order • establish record-keeping to control for food safety in meat and to minimize pathogen contamination document control point measurements; poultry processing plants. Safety and control other hazards in food and controls must be built into the products and lower the risk of • provide procedures for product manufacturing process and be subsequent foodborne illness. verification tests to ensure system administered continuously by industry. Accordingly, a regulatory strategy has continues to operate as planned. The objective of inspection in a process been formulated to mandate process The process control strategy control environment is to assure that control improvements to achieve summarized in this paper is founded on those controls are present, adequate and immediate reductions and an eventual three principles: are being used properly. minimization of the risk of meat and 1. USDA regulatory policy should be The primary benefits of a process poultry pathogens in the Nation’s food focused on providing a solution to meat control regulatory strategy are that it supply. Chemical and physical hazards and poultry biological, chemical and will: (1) Provide industry the tools and will also be prevented. This strategy is physical hazards that present the incentive to reduce meat and poultry supported by consumers, scientists, and highest public health risks; pathogens as a means to improve food the majority of meat and poultry 2. Pathogenic microorganisms—which safety and (2) help reorient Federal industry processors who already present the greatest foodborne risk to inspection to better address product, 6876 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules process and plant risks. A regulatory residues, pesticides, extraneous additional efforts to reduce pathogens program that imposes better materials, or other physical during manufacturing will reduce these manufacturing process control methods contaminants is not known. Foodborne risks as well. This, coupled with the as a means to reduce pathogen illness is nevertheless recognized by improved retail regulatory controls from contamination and control other scientists around the world as a state adoption and enforcement of the hazards emphasizes the fact that significant public health problem and Food and Drug Administration’s Food industry is primarily responsible for there is wide agreement that pathogenic Code should reduce this cause of product safety while the Government’s microorganisms are the major cause of illness. role is oversight. food-related disease. The cost of A significant portion of the meat and foodborne illness related to meat and poultry industry does not take B. Factors Considered in Evaluating A poultry products alone is between $4.5– advantage of readily available methods Process Control Strategy 7.5 billion annually. to control its manufacturing processes. The process control regulatory This is due in large part to the fact that Makes Inspection More Effective strategy was evaluated using five factors meat and poultry processing industries for effectiveness. A processing control Currently, FSIS inspectors in meat are relatively easy to enter and are program is effective if it: and poultry plants perform random composed largely of small and medium- 1. Controls production safety hazards; inspection tasks that generate sized firms. Managers in these firms are 2. Reduces foodborne illness; independent data about a plant’s frequently not as knowledgeable about 3. Makes inspection more effective; production processes and environment. safe production practices as they should 4. Increases consumer confidence; and This activity produces ‘‘snapshots’’ of be. 5. Provides the opportunity for plant operations at that moment. In The Department has concluded that increased productivity. contrast, process control generates further regulation will bring industry The following sections discuss these records of plant performance over time. standards up to what can practically be five effectiveness factors that have been These records and periodic verification achieved in the manufacture of meat applied to evaluate process control inspections will enable FSIS inspectors and poultry products through current alternatives. to see how a plant operates at all times, scientific knowledge and available i.e., whether and where processing process control techniques. Raising the Controls Production Safety Hazards problems have occurred, and if so, how safety floor through regulations that Process control is a system for they were addressed. mandate better process controls will identifying food hazards and reducing The availability of more and better demonstrate to the public that USDA or eliminating the risks they present. In processing data will establish trends and industry are making a concerted operation, control points are established that set benchmarks from which effort to reduce the risk of foodborne in a food production line where deviations can be more quickly and illness from meat and poultry. potential health hazards exist; accurately assessed. USDA inspectors The economic benefits of increased management of these points has proven will be trained to spot these deviations consumer confidence can be to be effective in reducing the and take action when needed to ensure conceptually realized in the amount probability that unsafe product will be plants bring a faulty process back into consumers would be willing to pay for produced. Ongoing records of each control. This type of Federal oversight is safer food. This overall ‘willingness to process control will enable plant substantially more effective than a pay’ is made up of several components. managers and quality control personnel regulatory program that merely detects It reflects consumer desires to avoid to spot trends that could lead to and condemns faulty end products. In foodborne illness and the expected problems and devise a strategy that the words of the National Advisory medical and other costs associated with prevents them before they occur. Committee on Microbiological Criteria pathogens. In theory the total benefit Detection by end product testing is for Foods, ‘‘Controlling, monitoring, and associated with processing control not a viable alternative to process verifying processing systems are more regulations could be decomposed into control because it only sorts good effective than relying upon end-product two parts: first, the reduction in medical product from bad and does not address testing to assure a safe product.’’ and other costs associated with pathogen-related illnesses (as discussed the root cause of unacceptable foods. Increases Consumer Confidence Additionally, keeping ‘‘bad’’ foods out in a previous section), and the of commerce through sorting end The number of foodborne illness additional benefits which accrue to product is possible only when tests and outbreaks and incidents attributable to consumers not made ill but who may standards for sampling are well pathogens in meat or poultry raise place a value on reduced risk of established and it is practical only questions about whether federal exposure to pathogens. At this time, the where the ‘‘test’’ is not expensive inspection is as effective as it should be. data are not available to make because sorting requires a huge number Highly visible public controversies quantitative estimates of the consumer’s of samples for reliability. about meat and poultry inspection willingness to pay. indicate an erosion of public confidence Reduces Foodborne Illness in the safety of meat and poultry Provides the Opportunity for Increased As industry improves its control over products. There are growing demands Productivity the safety aspects of meat and poultry that USDA improve its regulation of Better process control is a sound and production, foodborne illness will begin pathogens. The process control rational investment in the future of our to decline. This is the principal non- regulatory strategy described in this nation’s meat and poultry industry. negotiable goal for both USDA and paper is USDA’s response to those USDA’s process control strategy will industry. demands. educate industry management about the The precise occurrence of human Many outbreaks of foodborne illness need and methodology for development health problems attributed to have been determined to be caused by of a consistent, preventive, problem- pathogenic microorganisms or other mishandling of meat and poultry solving approach to safety hazards, potential foodborne hazards, such as products after federally-inspected which can be expanded to other chemical contaminants, animal drug processing. USDA believes that business objectives such as product Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6877 quality and production efficiency. There risks due to meat and poultry assess food safety and wholesomeness. is much evidence of how process consumption. Since 1989 NACMCF has prepared a control has improved worldwide HACCP is widely recognized by series of reports on the development industrial productivity in the past 40 scientific authorities such as the and implementation of HACCP. As one years. This proposal will extend process National Academy of Sciences and of its first tasks, the Committee control principles to parts of the meat international organizations such as the developed ‘‘HACCP Principles for Food and poultry industry that have not Codex Alimentarius. It is used today by Production’’ in November 1989. In this formerly used them. a number of plants in the food industry report, the Committee endorsed HACCP Some important non-safety benefits to produce consistently safe products. as a rational approach to ensure food that will accrue from industry use of This approach has been supported for safety and set forth principles to better process control methods are: years by numerous groups that have standardize the technique. In 1992, the • First, better production controls studied USDA meat and poultry Committee issued an updated guide, will result in more efficient processing regulatory activities. ‘‘Hazard Analysis and Critical Control operations overall with fewer product In 1983 FSIS asked the National Point System.’’ defects. Fewer defects mean less Academy of Sciences to evaluate the In 1993 NACMCF defined the roles of reworking, waste and give-away, scientific basis of its inspection system regulatory agencies and industry in resulting in increased yields and more and recommend a modernization implementing HACCP. ‘‘The Role of profit opportunities. agenda. The resulting report, issued in Regulatory Agencies and Industry in • Second, better controls will 1985, was the first comprehensive HACCP’’ proposed responsibilities for evaluation of a scientific basis for significantly reduce the risk to FDA, USDA, and other agencies and inspection. The 1985 NAS report processors that product with food safety industry during various phases of provided a blueprint for change: it defects will slip into commerce. HACCP implementation. Similar recommended that FSIS focus on Expensive and embarrassing product suggestions for program change have pathogenic microorganisms and require recalls can be entirely avoided with been voiced by consumers, industry, that all official establishments operate proper process controls. state and local government under a HACCP system to control • Third, better control of pathogens representatives, as well as other pathogens and other safety hazards. constituent groups. For example, will impact all microorganisms, After urging the intensification of consumers at recent public hearings and including those responsible for ‘‘current efforts to control and eliminate the HACCP Round Table supported decomposition, resulting in quality contamination with micro-organisms implementation of mandatory HACCP improvements and longer shelf life for that cause disease in humans,’’ NAS throughout the meat and poultry products. encouraged USDA to ‘‘move as • industry. Fourth, better production controls vigorously as possible in the application The meat and poultry industry has improve plant employee productivity of the HACCP concept to each and every itself provided broad support for which improves profit opportunities. step in plant operations of all types of HACCP as a means to control pathogens, enterprises involved in the production, C. Evaluation of Mandatory HACCP to emphasizing that HACCP-based food Provide Process Control processing, and storage of meat and poultry products.’’ production, distribution, and Considering the five effectiveness The General Accounting Office (GAO) preparation can do more to protect factors of process control, the most has also identified needed public health than any Federal effective means for ensuring that all improvements in USDA’s present inspection program. They have industry uses adequate process control inspection system. In its reports and recommended that HACCP be used to systems is a mandatory HACCP congressional testimony, and in anticipate microbiological hazards in regulatory program. This alternative numerous publications, GAO has food systems and to identify risks in clearly meets all five criteria described endorsed HACCP as the most scientific new and traditional products. State above. In fact, a mandatory HACCP system available to protect consumers departments of health and agriculture program was judged to be the only from foodborne illness. This sentiment have also endorsed the HACCP option that will effect adequate is most clearly expressed in a May 1994 approach. processing improvements in all report, ‘‘Food Safety: Risk-Based D. Evaluation of Other Alternatives establishments throughout the industry. Inspections and Microbial Monitoring Only through mandatory HACCP can Needed for Meat and Poultry,’’ in which FSIS examined six other approaches pathogen risks be minimized to the GAO recommended development of a before determining that mandatory fullest extent possible; thereby reducing mandatory HACCP program that HACCP was the most effective means foodborne illness to the maximum, includes microbial testing guidelines. for industry to eliminate pathogens in improving effectiveness of inspection, GAO urged USDA to assist meat and meat and poultry: increasing consumer confidence, and poultry plants in the development of 1. Status quo; ensuring a more viable industry. No their microbial testing programs by, 2. Intensify present inspection; other alternative accomplishes as much among other things, disseminating 3. Voluntary HACCP regulatory in these five areas as mandatory information on the programs already in program; HACCP. operation. 4. Mandatory HACCP regulation with In summary, FSIS has determined A third major proponent of HACCP is exemption for very small that: the National Advisory Committee on establishments; • HACCP is a processing control Microbiological Criteria for Foods 5. Mandatory HACCP regulation only strategy that has been scientifically (NACMCF), which was established in for ready-to-eat products; and proven effective in food manufacturing 1988 by the Secretary of Agriculture to 6. Modified HACCP—recording plants; and, therefore advise and provide recommendations to deviations and responses only. • Mandating HACCP systems in all the Secretaries of Agriculture and of These alternatives were assessed plants under USDA jurisdiction will Health and Human Services on using the five effectiveness factors protect the public from unreasonable developing microbiological criteria to presented in the previous section. Since 6878 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules FSIS’s goal is to achieve the maximum knowledgeable about process control or of low performing plants that FSIS must pathogen reduction possible, and none to implement process control systems. reach to attain its public health goal. is judged to be as effective as mandatory Agency experience with mandating Nothing short of a mandatory HACCP HACCP, the costs of these alternatives specific requirements has sometimes regulatory program will be effective in are not relevant. The following six succeeded, where HACCP-like bringing processing improvements to sections summarize the appraisal of regulations have been successful in these marginal performers. each alternative. correcting food safety problems in The Agency’s regulation permitting certain ready-to-eat products. However, the use of voluntary Total Quality Status Quo these controls largely consisted of lethal Control (TQC) Systems provides a This option would essentially heat treatments applied during final useful analogy to how effective a continue plant processing controls and product processing. This approach is voluntary HACCP program would be. Federal inspection as they are now. obviously inappropriate for product that TQC focuses on establishment Good plants with adequate methods for is marketed raw which is most responsibility for meeting or exceeding managing process lines would probably frequently associated with meat and the standards set by FSIS for all remain under control. The Agency, poultry foodborne illness. operations that are conducted in a plant, under its present authority, cannot shift Thus, intensified regular inspection including incoming raw materials, resources out of good plants so the fails to meet the primary criterion for processing procedures, critical limits for situation of poor performing plants is process control, i.e., control production product standards, and action limits for unlikely to change. This situation raises safety hazards at all stages of meat and establishment quality control personnel. immediate questions about the first poultry slaughter and processing. These systems operate under Agency factor—controls production safety Related to this failing, inspection would oversight with an emphasis on timely hazards—being met. Experience has be ineffective without all plants and accurate record-keeping and the proven that Federal inspection cannot maintaining process control systems necessity for appropriate action to be substitute for management in (factor three.) This option would require taken by an establishment when a limit establishments which have difficulty significant resource increases and set forth in an approved system is met producing safe product consistently. results in more of the same type of or exceeded. However, over the last 10 Also, inspection cannot be as effective Federal oversight which would be more years the number of plants with active in the current plant environment as in costly to taxpayers without the payback TQC Systems has declined from a high a process control plant environment. of significant reductions in foodborne of around 500 (approximately 8% of all Status quo does not target industry illness (factor two). With the burden of plants) to the present 351 participating and inspection resources at preventing control and monitoring on USDA’s plants (approximately 5% of all plants). hazards in areas of highest risk which inspection force rather than plant USDA experience has shown that a leads to the greatest reduction in managers, industry performance would voluntary approach to HACCP would foodborne illness (factor two). In be unlikely to improve. Industry growth provide little assurance that a major addition, food safety experts, would be less certain which is counter portion of meat and poultry products consumers, and other observers have to meeting factor five. had been produced under controls told USDA they are not satisfied with designed to minimize food safety Voluntary HACCP Regulatory Program pathogen control by organoleptic hazards. methods as practiced in the present A voluntary HACCP program would plant program. Doing nothing new not provide reduction of pathogens Mandatory HACCP Regulation With would perpetuate consumer doubts uniformly across the processing Exemption for Small Establishments about the ability of Federal inspection to spectrum (i.e., many in industry would Under this alternative, FSIS would regulate pathogens which is counter to choose not to participate) and therefore mandate HACCP; but, provide an factor four. Consequently, the would not be sufficient to attain the exemption for small establishments as Department has concluded that business necessary reduction in foodborne illness was done with nutrition labeling. as usual is not an acceptable response (factor two). However, since major goals in to proven problems with pathogens Voluntary HACCP would be implementing HACCP are to improve associated with meat and poultry implemented most frequently in plants processing controls and plant products. Agency public health with good processing controls already, performance across all of industry responsibilities alone require that more while plants with unsophisticated (factor one) as a means to achieve positive actions be taken. controls would be less likely to foodborne illness reductions (factor participate. The explanation for this two), this option is inherently flawed by Intensify Present Inspection flaw is to be found in simple economics exemption of plants that perform the As one alternative to the proposed and, to a large degree, the attitudes of least process control. USDA inspection mandatory HACCP regulation, FSIS plant management. Plants with good experience shows that some of the small could intensify its present inspection processing controls now are most likely establishments which would be system i.e., focus new resources on to adopt HACCP voluntarily because exempted under this option have suspected areas of risk in each plant. their management understands the particular difficulties maintaining This approach would assign to FSIS linkage between how a product is control over their processing system. responsibility for designing, testing and handled during preparation and its While it is true that small mandating by specific regulation, finished quality and safety. establishments produce a minimal process control systems for all meat and Conversely, plants without good amount of the total meat and poultry poultry products with potential safety processing controls today are much less supply, they do produce a full range of hazards. A major flaw with this likely to participate in a voluntary products, including those most approach is the burden of ensuring a HACCP program. These plants are more frequently associated with foodborne safe product would be placed largely on often operated by management that illness from the meat and poultry FSIS instead of plant managers where it lacks the knowledge or motivation to supply. belongs. Plant management would have institute better processing controls. This option also fails on factor three— little motivation to become Nevertheless, it is precisely this group provide more effective inspection. Two Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6879 different inspection systems would be system which can be reviewed in its affected by secondary person-to-person needed: one risk-based system to entirety, so that a comprehensive spread of infectious agents from cases inspect HACCP plants with good picture of the process is available, not caused by consumption of pathogen- processing controls; the other to provide just the truncated version which grows contaminated food. resource intensive coverage for plants out of recording deviations. Foods contaminated with pathogenic that largely do not. If the number of microorganisms can lead to infection small plants continues to increase, more IV. HACCP Benefits—Foodborne Illness and illness in two major ways. The first inspection resources would be required. A. Incidence of Foodborne Illness in the is by direct consumption of the United States contaminated food under conditions Mandatory HACCP Regulation Only for that allow the survival of the pathogen The safety of the meat and poultry Ready-to-Eat Products or its toxin, such as when a meat or supply has been widely discussed This option would mandate HACCP poultry product is consumed raw or during the past few years. Precise data only for establishments that prepare undercooked. The second way on the incidence of illness associated ready-to-eat meat and poultry products, contaminated product can lead to with meat and poultry or other food but not for plants that produce raw illness is through cross-contamination products. However, this decision would products are lacking. There is no in the processing plant (e.g. cooked leave the public without adequate mandatory reporting system for such product), kitchen or other food-handling protection from pathogenic illnesses and there is no complete area, such as when the Salmonella- microorganisms clearly associated with national database on the occurrence of contaminated exterior of raw chicken product marketed in raw form. Very human health problems that might be contaminates a cutting board, little reduction in the most frequent attributed to pathogenic microorganisms countertop, or kitchen utensil, which causes of foodborne illness (factor two) or potential foodborne hazards, such as then comes into contact with cooked could be anticipated from this approach. chemical contaminants, animal drug product or foods consumed raw, such as Government inspection costs would residues, pesticides, extraneous salad. For some pathogens, such as continue to increase to provide materials, or other physical Salmonella, more cases of illness result traditional resource-intensive inspection contaminants. Foodborne illness is from cross-contamination than from for slaughtering and allied processing nevertheless recognized by scientists as direct consumption of undercooked plants that would not be subject to a significant public health problem in product. Poor hygiene by infected food mandatory HACCP. Since most of the the United States, and there is wide handlers, plant employees, etc, can also unsolved problems with pathogenic agreement among scientists that introduce pathogens which later cause microorganisms are associated with raw pathogenic microorganisms are the illness. products, not on those which would be primary cause of foodborne illness. The Foodborne illness appears to have the subject of this HACCP option, this following discussion focuses on remained steady or increased slightly is an especially inappropriate regulatory pathogenic microorganisms. during the last decade. Possible approach. Foodborne illness can strike increases in foodborne illness are individuals of all ages, sexes, variously attributed to changes in Modified HACCP—Only Recording nationalities and socioeconomic levels. animal production procedures, Deviations and Responses People have been getting sick from automated processing, increased A final alternative considered would foods throughout the ages; the reasons reliance on fast foods, greater use of be to mandate HACCP, modified to change but the problem persists. The prepackaged foods and microwave eliminate the recordkeeping burden to most common types of foodborne illness ovens, extended shelf-lives, more the inspected industry, especially small typically appear as acute gastroenteritis complex distribution systems, establishments. Specifically, this option with sudden onset of vomiting or urbanization, public naivete about food would modify the HACCP record- diarrhea, or both, with accompanying manufacturing methods, and lack of keeping principle so that instead of abdominal pain. Some episodes include knowledge about the hygienic demanding continuous records at fever, prostration, shock, or neurological precautions required at all stages of food critical control points, companies would symptoms. The incubation period, i.e., handling, including preparation and need to record only deviations from the time between eating and onset of serving. Other factors contributing to critical limits and the response to them. first symptom, as well as the type and reported increases may include better This would mean that HACCP- duration of symptoms can vary from a surveillance, improved reporting, more controlled operations would not few hours to several days, depending on sensitive diagnostic tests, emerging generate continuous monitoring data to the etiological agent, the infected pathogens, and improved methods of reflect the operation at critical control individual’s genetic predisposition and detecting pathogens and chemical points, but would only record data physical condition. In a percentage of residues. when deviations occurred. This the population—especially among Data for evaluating trends and the arrangement eliminates the continuous children, the elderly, and immuno- most common causes of foodborne picture of plant operations which is the compromised individuals—foodborne illness are compiled by the Centers for underpinning of factor three—make illness can be life-threatening. Disease Control and Prevention (CDC), inspection more effective. Researchers estimate that between 6 based on reported ‘‘outbreaks’’ of Such an approach would substantially and 33 million people, (between 3 and illness, discussed below. reduce the paperwork burdens 14 percent of the population) become ill Estimates of the current foodborne associated with mandatory HACCP as each year from pathogenic disease burden in the United States are recommended by NACMCF and microorganisms in their food. An based on estimates of the annual recognized by CODEX. However, it estimated 6,000 to 9,000 of these incidence of disease. Incidence would also seriously compromise the illnesses annually result in death. Other estimates are the annual estimates of the usefulness of HACCP as a means to data show at least 18 million cases of new cases of foodborne disease which make inspection more effective and diarrheal disease of foodborne origin occur each year. CDC compiles reports avoid program cost increases. occur in the United States annually; from State and local health authorities Regulatory officials need to have a another several million persons may be of foodborne illness outbreaks where 6880 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules two or more persons have become ill • While some foodborne pathogens States have no surveillance staff from a common source. These reported cause illness within a few hours of food assigned to monitor foodborne diseases. cases are only a fraction of the actual consumption (Staphylococcus aureus For the 4 foodborne pathogens of annual incidence of foodborne disease and Salmonella), many common greatest concern, the case and severity cases for many reasons: pathogens cause illness after a lag of estimates presented here are the ‘‘best • Symptoms typical of several forms several days (E. coli O157:H7 and estimates’’ of the actual incidence of of foodborne illness include diarrhea, Campylobacter) or weeks (Listeria foodborne disease associated with vomiting, abdominal pain, and physical monocytogenes). The longer the lag specific pathogens, rather than the between consumption and illness, the weakness. These symptoms are also fraction of cases actually reported to less likely the connection to food will be common to a wide variety of bacterial CDC. Many of the ‘‘best estimates’’ were and viral infections not generally made. • Individual cases of foodborne developed by the landmark CDC study associated with food consumption. illness are excluded from the CDC by Bennett, Holmberg, Rogers, and Consequently, many treated cases of reporting system, except for botulism, Solomon, published in 1987, which foodborne illness are generically toxic fish, mushrooms, and certain used CDC surveillance and outbreak diagnosed as non-specific gastroenteritis chemical poisonings where one case data, published reports, and expert or ‘‘the flu’’ and not identified as being constitutes an outbreak. opinion to estimate the overall caused by a specific foodborne • Around half of CDC’s reported incidence and case-fatality ratio for all pathogen. outbreaks and cases are never identified infectious and parasitic diseases, and • Most foodborne illness is transitory with a causative pathogen. identified 17 as foodborne pathogens. and self-limiting. People often become • CDC primarily relies upon All the estimates of bacterial foodborne sick within a few hours after voluntary reporting from State and local disease cases in Table 3 are based on consumption of contaminated food, health agencies which, in turn, rely on CDC data to estimate actual cases of suffer acute symptoms, and recover hospitals, clinics, and individual health foodborne disease caused by each spontaneously. These people are care professionals for information. All pathogen. (The estimated cases for the unlikely to seek medical attention, and these institutions have resource parasitic disease, congenital will not become part of the reporting limitations and different disease toxoplasmosis, are based on various database. reporting requirements. For example, 12 reports in the medical literature.) TABLE 3.ÐREFERENCE SOURCES OF DATA FOR SELECTED HUMAN PATHOGENS, 1993 Foodborne illness cases Source(s) for case Pathogen (#) estimates Bacteria: Campylobacter jejuni or coli ...... 1,375,000±1,750,000 Tauxe; Tauxe et al. Clostridium perfringens ...... 10,000 Bennett et al. Escherichia coli O157:H7 ...... 8,000±16,000 AGA Conference. Listeria monocytogenes ...... 1,616±1,674 Roberts and Pinner; Schuchat. Salmonella ...... 732,000±3,660,000 Helmick et al.; Bennett et al.; Tauxe & Blake. Staphylococcus aureus ...... 1,513,000 Bennett et al. Parasite: Toxoplasma gondii ...... 2056 Roberts, Murrell, and Marks. Sources: American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July 11±13, 1994. Bennett, J.V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden of Unnecessary Illness. Oxford University Press, New York. Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious Diarrheas.'' In: Everheart, JE, ed. Digestive Dis- eases in the United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94±1447, pp. 85±123, Wash, DC: USGPO. Roberts, T., K.D. Murrell, and S. Marks. 1944. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419±423. Roberts, T. and R. Pinner. ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J. Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137±149. Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, Septem- ber 29, 1994. Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins, ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9±19. Tauxe, R.V. and P.A. Blake, Salmonellosis. Chap. 12. In: Public Health & Preventive Medicine. 13th ed. (Eds: Last JM; Wallace RB; Barrett- Conner E) Appleton & Lange, Norwalk, Connecticut, 266±268. Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth, 1988, ``Campylobacter Isolates in the United States, 1982±1986,'' Morbidity and Mortality Weekly Report, vol. 31, no. 88±2. Data collected by CDC also show food foodborne illness. Among foodborne 75% of total reported outbreaks caused source for foodborne illness. Food illness outbreaks reported to CDC, the by a bacterial agent. products of all types, including beef, majority of those which can be B. Costs of Foodborne Illness pork, turkey, chicken, bakery products, identified are traced to pathogenic dairy products, eggs, finfish, shellfish, bacteria. The six target pathogens Table 4 shows the estimated cost of ice cream, mushrooms, fruits and account for nearly all meat and poultry all foodborne illness to be vegetables, are associated with foodborne illness outbreaks and about approximately $5.6–9.4 billion in 1993. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6881 Meat and poultry products are billion is associated with non-meat and associated with approximately $4.5–7.5 poultry sources. billion and the remaining $1.1–1.9 TABLE 4.ÐFoodborne Illness Costs and HACCP Benefits, 1993 Foodborne illness Food source Costs bil- Benefits lions) (billions) All Foods ...... $5.6±9.4 Non-meat and Poultry ...... $1.1±1.9 Meat and Poultry Only ...... $4.5±7.5 Meat and Poultry Parasitic Pathogens ...... $2.7 Meat and Poultry Bacterial Pathogens ...... $1.8±4.8 USDA Target Bacterial Pathogens ...... $1.1±4.1 Campylobacter jejuni/coliÐ.5±.8 E. coli 0157:H7Ð.2±.5 Listeria monocytogenesÐ.1±.2 SalmonellaÐ.3±2.6 Reduction of USDA target pathogens attributed to HACCP (90%) ...... 99±3.7 Source: Economic Research Service and Centers for Disease Control and Prevention. The proposed HACCP system is microbial pathogens. The remaining labels should significantly impact designed to control all of the public 10% are due to causes not affected by practices in the home. health hazards identified in each meat the proposed regulations because The costs described in this section for and poultry establishment. FSIS contamination also occurs after product foodborne illness costs are borne not regulation currently and under HACCP leaves the inspected plant. (The only by those who become ill, but by will address all public health hazards. estimated reduction is based on the their families, and employers; the food Table 5 shows the bacterial pathogens expert judgement of FSIS industries; and taxpayers. Costs to largely responsible for meat and poultry microbiologists.) This would result in a stricken individuals include medical illnesses. $.99–3.69 billion saving annually, as bills, time lost from work, pain, and The proposed near-term requirements shown in Table 4. inconvenience. Food industry costs and significant parts of HACCP will include product recalls, loss of plant target pathogen reduction on carcasses Two other pathogens—Clostridium production due to closings for cleanup, and raw product, currently the least perfringens and Staphylococcus and higher premiums for product systematically controlled hazard. This is aureus—primarily enter meat and liability insurance. Perhaps most costly the most effective overall approach for poultry foods in restaurants, other to industry in the long-term is loss of reducing pathogen contamination. The commercial kitchens and in homes. product reputation and reduced demand benefits are calculated for the three most Consequently, the proposed regulatory when an outbreak is traced back and common enteric pathogens of animal program, which focuses on federally publicized. These and other ‘‘defensive’’ origin: Campylobacter jejuni/coli, E. coli inspected processing, will not industry costs of foodborne disease run 0157:H7, Salmonella and one significantly affect the incidence of in the millions of dollars annually and environmental pathogen Listeria disease caused by these organisms. It is are, for the most part, entirely avoidable. monocytogenes. The reduction of these expected, however, that the FDA’s Food Taxpayer costs include medical pathogens to as near to zero as possible Code will dramatically reduce the cause treatment for those who cannot afford it, in meat and poultry during slaughter of illness attributable to retail practices including higher health insurance and processing would produce an upon its adoption and implementation. premiums and costs of public assistance estimated 90% reduction in the Our continued consumer education to disabled individuals and their foodborne illness attributed to these activities coupled with safe handling dependents. Table 5.ÐMEDICAL COSTS AND PRODUCTIVITY LOSSES ESTIMATED FOR SELECTED HUMAN PATHOGENS, 1993 Foodborne illness cases Foodborne* Percent Total costs* Pathogen # from meat/ meat/poultry ( ) costs (bil. $) poultry (%) (bil. $) Bacteria: Campylobacter jejuni or coli ...... 1,375,000±1,750,000 0.6±1.0 75 0.5±0.8 Clostridium perfringens** ...... 10,000 0.1 50 0.1 Escherichia coli O157:H7 ...... 8,000±16,000 0.2±0.6 75 0.2±0.5 Listeria monocytogenes ...... 1,616±1,674 0.2±0.3 50 0.1±0.2 Salmonella ...... 732,000±3,660,000 0.6±3.5 50±75 0.3±2.6 Staphylococcus aureus** ...... 1,513,000 1.2 50 0.6 Subtotal ...... 3,639,616±6,950,674 2.9±6.7 N/A 1.8±4.8 Parasite: Toxoplasma gondii ...... 2,056 2.7 100 2.7 6882 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Table 5.ÐMEDICAL COSTS AND PRODUCTIVITY LOSSES ESTIMATED FOR SELECTED HUMAN PATHOGENS, 1993Ð Continued Foodborne illness cases Foodborne* Percent Total costs* Pathogen # from meat/ meat/poultry ( ) costs (bil. $) poultry (%) (bil. $) Total ...... 3,641,672±6,952,730 5.6±9.4 N/A 4.5±7.5 Source: Economic Research Service and Centers for Disease Control and Prevention, 1993. *Column rounded to one decimal place. **Roberts' rough approximation of costs in ``Human Illness Costs of Foodborne Bacteria'', Amer. J. of Agricultural Economics, vol. 71, no. 2 (May 1989) pp. 468±474 were updated to 1993 dollars using the Consumer Price Index (all items, annual average). Cost estimates for other pathogens are more detailed, see the following for a discussion of the methodology: listeriosisÐRoberts, Tanya and Robert Pinner, ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J. Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137±149, E. coli O157:H7ÐRoberts, T. and Marks, S., ``E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease,'' FoodReview, USDA/ERS, Sept-Dec 1993, pp. 51±59, salmonellosisÐRoberts, Tanya, ``Salmonellosis Control: Estimated Economic Costs,'' Poultry Science. Vol. 67 (June 1988) pp. 936±943, campylobacteriosisÐMorrison, Rosanna Mentzer, Tanya Rob- erts, and Lawrence Witucki, ``Irradiation of U.S. PoultryÐBenefits, Costs, and Export Potential, FoodReview, Vol. 15, No. 3, October-December 1992, pp. 16±21, congenital toxoplasmosisÐRoberts, T., K.D. Murrell, and S. Marks. 1944. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419±423; and Roberts, Tanya and J.K. Frenkel, ``Estimating Income Losses and Other Prevent- able Costs Caused by Congenital Toxoplasmosis in People in the United States,'' J. of the Amer. Veterinary Medical Assoc., vol. 196, no. 2 (Jan- uary 15, 1990) pages 249±256. N/A indicates item is not-applicable. Other taxpayer costs include public estimated fringe benefits. For illness in food handling behavior and safe food health sector expenses to operate a subsequent years, a present value of the recurs throughout the literature on the disease surveillance system and to reduced stream of earnings is subject. investigate and eliminate disease calculated. For deaths, Landefeld and Behavioral research shows that food outbreaks. Approximately $300 million Seskin’s human capital/willingness to habits are the most difficult of all forms is spent for this annually by the Federal pay method was used. It combines of human behavior to change. This public health sector. Government costs elements of both methods to generate finding is supported by research of in the United States, Canada, and other the present value of expected lifetime consumer knowledge and practices, countries, average about $200,000 per after-tax income and housekeeping which indicate that a large portion of foodborne illness outbreak. services at a 3-percent real rate of the U.S. population lacks basic food return, adjusted for an annual 1-percent Cost Computation Methodology safety information and skills and increase in labor productivity and a engages in food handling and The costs of foodborne disease risk-aversion premium that increases preparation practices that associated with meat and poultry the estimates by 60 percent. epidemiological studies have linked pathogens were estimated using a These cost estimates are based on the with a significant number of foodborne traditional ‘‘cost of illness’’ method annual incidence of disease, rather than illness outbreaks. Moreover, little which includes medical costs, the prevalence, to help us estimate correlation exists between consumers’ productivity losses, and special preventable illness. Incidence estimates food safety knowledge and their food educational or residential care are the annual increase in cases and handling and preparation practices. associated with some chronic associated disease costs. Interventions Even people who characterize conditions. Disease frequencies reflect today which prevent future costs will themselves as ‘‘knowledgeable’’ do not CDC’s ‘‘best estimate’’ of the actual eliminate all the medical, productivity, necessarily follow good food safety number of foodborne illness cases each and special care costs of prevented procedures. The CDC estimates that 20– year. cases, and so represents one component 30 percent of foodborne illness is due in The present value of lifetime medical of the overall economic benefit of part to consumer mishandling of food. costs for those becoming ill in 1993 was disease prevention. estimated using nationwide databases, Available evidence concerning such as published Medicare C. The Relationship Between Foodborne consumer behavior related to safe food reimbursement rates and per-capita Illness and Consumer Knowledge and handling and preparation supports the expenditures on physicians’ services Behavior need for a comprehensive pathogen from the Health Care Financing The National Academy of Science’s reduction effort. Food safety can best be Administration, the National Center for Cattle Inspection: Committee on assured by establishing a ‘‘chain of Health Statistics’ National Hospital Evaluation of USDA Streamlined responsibility,’’ with each participant in Discharge Survey, the American Inspection System for Cattle (SIS-C) the food system, from the producer all Hospital Association’s Hospital (1990) repeated the theme of numerous the way through to the consumer— Statistics, or Blue Cross/Blue Shield other studies, stating ‘‘. . . the public understanding, accepting, and acting on charges. The average cost to community expects the government to ensure zero its responsibility for food safety. While hospital per patient was used to risk of meat-borne disease through FSIS will pursue and support all compute hospitalization costs. inspection. The [NAS] committee heard possible means of consumer education Productivity losses occur because little evidence that the public is aware and outreach, the Agency realizes that workers are ill and miss work. These that some bacterial contamination of consumer education alone will not have been approximated by the Average raw meat is inevitable and no mention control pathogen-related foodborne Weekly Earnings for non supervisory of the crucial role of food handling, illness. This is even more true today production workers in private preparation, and serving methods in than ever before, as more people in our nonagricultural jobs, published by the limiting foodborne diseases.’’ The society are assuming responsibility for Bureau of Labor Statistics (BLS) of the disturbing but real fact that consumers food handling and preparation in the U.S. Department of Labor, plus fail to make a connection between their home and elsewhere, without Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6883 experience in food preparation and • The longer-term Hazard Analysis than $2.5 million in annual sales. (This knowledge of safe food handling and and Critical Control Point (HACCP) definition does not coincide with the storage methods. These people include: systems developed by establishments Small Business Association definition • Food service workers, many of would be phased in over an for a small business.) Using the FSIS whom receive inadequate training, are approximate three-year period after the criterion, 42.2 percent of processing part-time and teenagers, who experience final rule is promulgated. plants (Federal and State) and 16.8 high-turnover; Total cost of the near-term initiatives percent of slaughter plants would be • Men and women in the workplace, and the three-year HACCP considered small establishments. A who have minimal time for food implementation is estimated at $733.5 medium establishment is defined as one preparation and often little experience million. This includes $552.8 million with annual sales of more than $2.5 or interest in food preparation; for federally inspected establishments million and less than $50 million. A • Children, who are increasingly and $180.7 million for State large establishment is one whose sales expected to shop and prepare their own establishments. The costs for small are greater than $50 million per year. meals; establishments, which make up about a State establishments are all • Immigrants, who might not be able third of the total establishments, are considered to be small establishments. to read food handling instructions, or estimated at $330.6 million, or just Since figures on these plants’ sales whose cultural practices include eating under 45 percent of the total. The volumes were not available, the size raw or very rare meat and poultry Agency recognizes the problem these determination was based on amount of products. Other vulnerable sectors of costs could present to small firms and production, which was below the the population, more severely affected has requested in the proposal public average for Federal establishments with by foodborne illness, are also increasing comments that will help it make sales less than $2.5 million. FSIS invites in size; appropriate adjustments to modify this comments on the State classifications. • Immunocompromised persons (i.e., burden. 3. Process Categories persons with diabetes, cancer, chronic A. Cost Analysis Procedures In keeping with the process control intestinal diseases, organ transplants, In estimating the costs of the principles inherent in HACCP, FSIS and AIDS); proposed rule, FSIS used data generated identified 14 process categories (see • Persons 65 years and older—a by various Agency operational and Table 6 at the end of this section.) There growing proportion of the population— research components such as Total is a separate category for each of the who, due to the normal decline in Quality Control (TQC), Partial Quality nine actual slaughter and processing immune response, are at increased risk. Control (PQC), and the various Baseline processes and for each of the five In 1993, to increase awareness about Microbiological Surveys. An especially species slaughtered. FSIS believes the pathogens, FSIS promulgated a important source was the cost 14 categories encompass all the regulation requiring safe handling labels information from the HACCP Pilot products of the regulated industry. on most raw meat and poultry products. Program conducted from 1991 to 1993. Every plant must develop a HACCP plan The Agency’s Meat and Poultry Hotline The cost analysis also relied heavily on for each applicable category. The provides consumers with immediate four of the Agency’s main databases. estimated costs for plan development responses to questions about food New databases were created by are based on the total number of handling and safety. These steps are merging selected variables from the four processes in all plants. important but they are not a substitute FSIS databases and enhancing them 4. Implementation Schedule for building into the food production with additional economic and financial and regulatory system measures to data. The Enhanced Economic Analysis FSIS plans that the final rule will reduce to the maximum extent possible Database contains information on each become effective. The near-term the presence of microbial pathogens in of the slaughter and processing initiatives would go into effect three meat and poultry products purchased by establishments active as of August 1994. months after it is published in the U.S. consumers. Described below as a prelude to the Federal Register and remain in effect in V. Costs Associated With HACCP sections containing the estimated near- each plant until that plant’s HACCP term and long-term costs are the program begins (except for the This section details the costs to the assumptions, criteria, and other factors sanitation SOP’s, which will continue meat and poultry industry of the underlying or used in this cost analysis. with HACCP). HACCP implementation proposed measures to control Details of cost methodology and would be phased in by process over pathogenic microorganisms and other estimations are available in an three years, from date of final rule biological, physical and chemical appendix. promulgation, with each process hazards. Unless otherwise stated, the category assigned a slot in that time figures used are three-year 1. Number of Establishments frame when its HACCP plan would be undiscounted costs. They have been There are 6,186 Federal slaughter, implemented. Small plants would have estimated for: processing, and combination the option of implementing the plans for • Four near-term initiatives that (performing both slaughter and all their processes three years from could be implemented shortly after processing operations) establishments. promulgation instead of implementing promulgation of a final rule. These An additional 2,893 establishments fall plans for individual processes according include the creation of Standard under State inspection. For some cost to the time frame for medium and large Operating Procedures (SOPs) for analysis purposes, combination plants. sanitation and three pathogen reduction establishments (performing both 5. Compliance and control interventions: antimicrobial slaughter and processing) were counted treatment of carcasses, microbiological as two separate plants. Some establishments may find that testing, and time and temperature their present process(es) cannot requirements for all raw product 2. Establishment Size consistently produce product that meets received, held, and shipped by For its cost analysis, FSIS defines a the specified interim target. This target, inspected establishments. small establishment as one with less although a new ‘‘measure’’ of safety, is 6884 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules based on levels currently achieved by $172.9 million. The four initiatives and establishments would use the most cost- many industry plants and is considered their estimated costs are described effective treatment. For meat by the Agency to represent the current below. establishments the cost analysis is based acceptable level of safety. An on the hot water system, at a cost of $.08 1. Sanitation Standard Operating establishment whose product does not per carcass. For poultry establishments Procedures meet the target under the proposed it is based on a hypochlorination system requirements must, as it must do under Federal plants—$81.1 million at $.0125 per carcass. current regulations, take action to adjust State plants—21.0 million 3. Time and Temperature Requirements its process to produce product that Total—$102.1 million meets this standard. The cost of taking Small establishments—$50.4 million Federal plants—$26.5 million this action is not considered a cost of The SOPs would not add new State plants—22.9 million the proposed requirement. sanitation standards but would require Total—$49.4 million 6. Equipment and Materials documentation of cleaning and Small establishments—$28.8 million sanitizing procedures for all equipment These requirements are already in The proposed rule does not make any and facilities involved in the production existing equipment obsolete. (Some effect for poultry plants, so would affect of every product. This would serve as a only the meat industry. An modification may be necessary, basis for the plant’s monitoring and the however, such as increasing cooling establishment would be required to inspector’s verification. An maintain the cooled carcass and raw capacity for complying with the time- establishment’s owner or manager and-temperature requirements.) The meat at the specified temperature would be required to detail in a written throughout handling, holding, and proposal does require establishments to plan how the basic sanitation systematically monitor their processes. shipping to other official requirements would be met. establishments. Costs are reduced by the Costs of the necessary materials, such as Establishment employees would record thermometers and test kits, are number of meat establishments already results of the daily sanitation checks on meeting these requirements. First-year estimated at $10 to $20 per a checklist, which would be made establishment. costs for Federal establishments are available to the inspector. estimated at $13.7 million, which covers 7. Wages The amount of time to develop the developing a plan, training employees, plan would vary by establishment size, The hourly wage rates used in upgrading cooling equipment, and equipment, production capacity, and keeping records. For State estimating costs are based on data from the process being performed. Plan the Bureau of Labor Statistics and Meat establishments the estimate is $18.9 development costs are one-time costs million. and Poultry Magazine. They are $25.60 which would be incurred in the six for a quality control manager, $18.13 for months before the effective date of the 4. Microbiological Testing a quality control technician, and $12.87 regulation. They are estimated at $1.99 Federal plants—$100.3 million for a laborer. They include a 33 percent million for Federal establishments and State plants—47.8 million overhead rate. $0.522 million for State establishments. Total—$148.1 million 8. Cost Offsets Establishments now following a written Small establishments—$91.1 million Because many establishments are sanitation program are not considered in FSIS would mandate testing and currently operating or capable of the one-time or the recurring cost reporting procedures to determine the operating quality control systems and estimates. pathogen incidence rate for each process programs, total costs are reduced to the Training establishment employees in at each establishment that slaughters extent that establishments already have the requirements of the SOP livestock or poultry or produces raw, the required plan development, intervention program would represent ground meat or poultry products. One- monitoring, record keeping, and another one-time cost incurred in the time costs for plan development and training. six months before the regulation takes effect. The training cost for Federal employee training are estimated at $6.7 9. TQC Overtime Costs establishments is estimated at $1.1 million. With the publication of the rule, TQC million and for State establishments Specimens would be collected once a plants could lose their authority to $0.251 million. day at the end of the production process produce and ship product after their Recurring SOP costs would involve and tested for the presence of the target normal shift production time. As a recordkeeping. Annual record keeping organism (Salmonella) in the result, 287 active TQC establishments costs are estimated at $19.5 million for establishment’s own laboratory or in a could begin to incur annual overtime Federal establishments and $5.1 for commercial/contract laboratory. The charges. State establishments. sample collection and analysis cost in the first year after promulgation of the 2. Antimicrobial Treatments B. Costs of the Near-term Initiatives rule is estimated at $67.5 million. This Costs associated with the four near- Federal plants—$58.7 million includes $46.4 for Federal term initiatives can be thought of as pre- State plants—0.6 million establishments and $21.1 million for implementation HACCP costs. Since Total—$59.4 million State establishments. The cost for small these interventions or similar controls Small establishments—$2.7 million establishments represents 59 percent of will for the most part be incorporated Slaughter establishments would be the total, or $39.8 million. into HACCP systems, their cost will required for the first time to provide First-year costs for record keeping are reduce the overall cost of HACCP. Total antimicrobial treatments before the estimated at $2.4 million. Large cost of these initiatives is estimated at carcasses enter the chiller or cooler. establishments account for only about $358.9 million, including $266.7 for Costs are reduced by the number of 10 percent of this total, since most of Federal establishments and $92.3 establishments already meeting these them are already performing quality million for State establishments. The requirements. In estimating the resulting control functions which require estimated cost to small establishments is costs, it is assumed that the continuous records. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6885 C. Costs of the Long-term HACCP million for Federal plants and $.6 estimate, on the basis of FSIS estimates Intervention million for State plants. The total for of cost, how much a particular Federal plants—$279.7 million small establishments is $1.5 million. establishment could expect to spend on State plants—88.5 million (This cost is related to product testing. one-time and recurring costs during the Total—$368.2 million See item 4 below.) implementation period: Small establishments—$157.6 million 4. Product Testing 1. Determine the establishment’s size The near-term initiatives are a prelude (small, medium, or large) according to to the types of activities that are The pre-HACCP product testing in its annual sales volume, using the required under a HACCP process slaughter plants and plants producing following criteria: raw, ground product would continue control system. The HACCP costs above, Small=less than $2.5 million sales which represent the full 36-month under HACCP as described above under short-term initiatives. In addition, the Medium=$2.5–$50 million sales implementation period, include Large=over $50 million sales continuing components of the previous Agency intends to require product initiatives and the new costs listed testing in the processing plants not 2. Using the table for that size plant, below: covered by the short-term requirement. find the column that describes its Although the precise nature of this function (meat slaughter, poultry 1. Industry HACCP Training testing is not yet known, the Agency slaughter, or processing). Note that each FSIS would require that each expects that in every establishment, at type of operation is subdivided into two establishment have at least one person least one sample a day would have to groups: those with and those without complete a course of at least three days be taken for each process. This would their own quality control laboratory. in the application of HACCP principles. amount to nearly six million samples a Plants with a laboratory will not have to The total estimated cost of $27.9 million year, at an estimated annual cost of spend as much in some cost categories. was calculated by multiplying a per- $149.8 million. Although this testing On the table for small plants, it is course cost of $2,514 (for tuition, travel requirement is not included in the assumed that none have their own expenses, and labor replacement) by the proposed rule, it is discussed in the laboratory. On the table for large plants, number of Federal and State preamble and is included in the it is assumed that all processing but not establishments now lacking someone proposed costs in order to give a all slaughter plants have their own with the necessary training (assumed to realistic estimate of the ultimate costs of laboratory. be 95 percent of establishments). the effort that is being initiated by this 3. In meat slaughter plants, the proposal. HACCP costs for plan development and 2. Plan Development record keeping are per process, with 5. Recordkeeping FSIS would require each inspected each species counted as a separate establishment to have and implement a A fundamental HACCP principle calls process. For meat plants slaughtering HACCP plan that is specific to each for recording and reviewing more than one species, both costs must kind of meat or poultry process observations at critical points in the be multiplied by the number of species. performed in the establishment. The manufacturing process on an ongoing In poultry slaughter plants, only the Agency is aware that the requirement basis. The cost of recording this HACCP cost for record keeping should may be especially burdensome to small information is expected to total $47.9 be multiplied by the number of species establishments producing small million annually: $41.7 million for slaughtered (chicken, turkey, and/or amounts of a variety of products. Federal establishments and $6.3 million duck). In estimating the cost of the plans, for State establishments. The recording 4. In processing plants, the HACCP FSIS considered the difficulty of writing costs for small establishments are costs for plan development and record a plan for each of the 14 HACCP estimated at $11.9 million. keeping vary from process to process processes that encompass all meat and The cost of reviewing the records according to whether the process—and poultry products. The cost for generated is expected to total $28.0 thus its HACCP plan—is easy, moderate, developing a plan ranges from $2,000 to million annually: $24.5 million for or difficult. To calculate a plant’s total $15,000 according to the degree of Federal establishments; $3.5 for State HACCP plan development and record difficulty and its order of development. establishments. The annual reviewing keeping costs, perform these steps: The overhead costs of developing the cost for small establishments is • For each process, use Table 6 to plant’s first plan do not appear again for estimated at $6.7 million. determine its degree of difficulty, and its subsequent plans. The annual cost of maintaining then, again using the relevant plant-size Total plan development costs are (storing) HACCP records as required chart, find the plan development cost estimated at $42.9 million: $30.7 would be $671,813: $575,852 for and the record keeping cost for that million for Federal establishments and Federal establishments; $95,961 for process. Write them down. $12.2 million for State establishments. State establishments. • (In the absence of production Add all the plan development costs. 6. FSIS HACCP Training • information for State establishments, it Add all the record keeping costs. was assumed that each will have 1.5 FSIS would provide employees with Use the two sums instead of the plans.) The total for small awareness training and HACCP table’s per-process costs when the establishments is $21.6 million. inspection activity training. The plant’s total HACCP costs are estimated cost is $416,880. calculated. 3. Aseptic Training 5. Under near-term interventions, note Plants not covered by the near-term D. Estimated Costs Per Plant that modifying a cooler to comply with microbiological testing requirement and The following charts show the time-and-temperature requirements that do not have their own quality estimated costs for the near-term would cost an estimated $6,000. Any control laboratory would have to train initiatives and for HACCP that would be plant needing such modification should an employee to collect specimens for incurred by various types of plants. The add $6,000 to the near-term analysis. Estimated costs are $1.5 following steps can be followed to interventions subtotal. 6886 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules TABLE 6.ÐDEGREE OF DIFFICULTY FOR DEVELOPING A HACCP PLAN Degree of dif- Plan No. HACCP process ficulty 1 Raw: Ground ...... Easy. 2 Raw Other: Inclusive ...... Easy. 3 Thermally processed ...... Difficult. 4 All other shelf stable: not heat treated ...... Difficult. 5 Fully cooked: not shelf stable ...... Moderate. 6 Shelf stable: heat treated, other ...... Moderate. 7 Non-shelf stable: heat treated, not fully cooked ...... Moderate. 8 Non-shelf stable: with secondary inhibitors ...... Moderate. 9±14 Slaughter ...... Easy. BILLING CODE 3410±DM±P Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6887 6888 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6889 [FR Doc. 95–2366 Filed 1–31–95; 8:45 am] BILLING CODE 3410±DM±C federal register February 3,1995 Friday Rule Over-the-Counter HumanUse;Proposed Vaginal ContraceptiveDrugProductsfor 21 CFRPart310 Food andDrugAdministration Services Health andHuman Department of Part III 6891 6892 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules DEPARTMENT OF HEALTH AND products. This proposal is part of the comments received are on public HUMAN SERVICES ongoing review of OTC drug products display in the Dockets Management conducted by FDA. While this Branch. Food and Drug Administration document does not address the use of The advance notice of proposed vaginal contraceptive drug products for rulemaking, which was published in the 21 CFR Part 310 prophylaxis against human Federal Register on December 12, 1980, [Docket No. 80N±0280] immunodeficiency virus (HIV) and was designated as a ‘‘proposed rule’’ in other sexually transmitted diseases order to conform to terminology used in RIN 0905±AA06 (STD’s), FDA is aware of literature the OTC drug review regulations reports and other data relative to such § 330.10. Similarly, the present Vaginal Contraceptive Drug Products use. FDA strongly encourages document is designated in the OTC drug for Over-the-Counter Human Use manufacturers to evaluate these review regulations as a tentative final rule. Its legal status, however, is that of AGENCY: Food and Drug Administration, products for use in the prevention of a proposed rule. To establish new HHS. infectious diseases. DATES: Written comments, objections, or § 310.535 by this notice of proposed ACTION: Notice of proposed rulemaking. requests for oral hearing on the rulemaking, FDA responds to public comment and states, for the first time, SUMMARY: The Food and Drug proposed regulation before the Administration (FDA) is issuing a notice Commissioner of Food and Drugs by its position on OTC vaginal contraceptive drug products. Final of proposed rulemaking that would June 5, 1995. New data by February 5, agency action on this matter will occur require manufacturers of over-the- 1996. Comments on the new data by with the publication, at a future date, of counter (OTC) vaginal contraceptive April 3, 1996. Written comments on the a final rule relating to OTC vaginal drug products to obtain approved agency’s economic impact determination by June 5, 1995. contraceptive drug products. applications for marketing of their This proposal constitutes FDA’s ADDRESSES: Written comments, products. The agency is taking this tentative adoption of the Panel’s objections, new data, or requests for oral action because the effectiveness of these conclusions and recommendations on hearing to the Dockets Management products is dependent upon the final OTC vaginal contraceptive drug Branch (HFA–305), Food and Drug formulation. Therefore, each product products as modified on the basis of the Administration, rm. 1–23, 12420 must be tested in appropriate clinical comments received, the agency’s trials under actual conditions of use. Parklawn Dr., Rockville, MD 20857. independent evaluation of the Panel’s This action will ensure the maximum FOR FURTHER INFORMATION CONTACT: report, and evolving new information on effectiveness of OTC vaginal William E. Gilbertson, Center for Drug these products. Modifications have been contraceptive drug products for Evaluation and Research (HFD–810), made for clarity and regulatory accuracy consumers. This proposed rulemaking Food and Drug Administration, 5600 and to reflect new information. Such does not affect the current marketing Fishers Lane, Rockville, MD 20857, new information has been placed on file status of OTC vaginal contraceptives. 301–594–5000. in the Dockets Management Branch Thus, persons who are using or wish to SUPPLEMENTARY INFORMATION: In the (address above). These modifications are use these drug products may do so. Federal Register of December 12, 1980 reflected in the following summary of However, on the effective date of a final (45 FR 82014), FDA published, under the comments and FDA’s responses to regulation, an OTC vaginal § 330.10(a)(6) (21 CFR 330.10(a)(6)), an them. contraceptive drug product that is not advance notice of proposed rulemaking The OTC drug procedural regulations the subject of an approved application to establish a monograph for OTC (§ 330.10) provide that any testing would be regarded as a new drug and vaginal contraceptive drug products, necessary to resolve the safety or subject to regulatory action. together with the recommendations of effectiveness issues that formerly Manufacturers will have adequate time the Advisory Review Panel on OTC resulted in a Category III classification, to conduct studies and submit Contraceptives and Other Vaginal Drug and submission to FDA of the results of applications before the effective date of Products (the Panel), which was the that testing or any other data, must be the final rule. Under existing advisory review panel responsible for done during the OTC drug rulemaking procedures, there is a minimum of 26 evaluating data on the active ingredients process before the establishment of a months from today before a final rule in OTC vaginal contraceptive drug final monograph. Accordingly, FDA is could become effective. Despite this products. Interested persons were no longer using the terms ‘‘Category I’’ timeframe, manufacturers are urged to invited to submit comments by March (generally recognized as safe and contact the agency regarding submission 12, 1981. Reply comments in response effective and not misbranded), of their application as soon as possible. to comments filed in the initial ‘‘Category II’’ (not generally recognized OTC contraceptives that are marketed comment period could be submitted by as safe and effective or misbranded), for use with or as part of a device, e.g., April 13, 1981. and ‘‘Category III’’ (available data are diaphragm, condom, or contraceptive In accordance with § 330.10(a)(10), insufficient to classify as safe and cervical cap will not be addressed in the data and information considered by effective, and further testing is required) this document but will be addressed in the Panel were put on public display in at the final monograph stage. In place of a separate publication. FDA is issuing the Dockets Management Branch Category I, the term ‘‘monograph this notice of proposed rulemaking after (address above), after deletion of a small conditions’’ is used; in place of Category considering the report and amount of trade secret information. II or III, the term ‘‘nonmonograph recommendations of the Advisory In response to the advance notice of conditions’’ is used. Review Panel on OTC Contraceptives proposed rulemaking, six drug Based on all information available to and Other Vaginal Drug Products, manufacturers, two governmental date, the agency has tentatively public comments on an advance notice agencies, two reproductive health concluded that any OTC vaginal of proposed rulemaking that was based groups, one trade association, one contraceptive drug product should be on those recommendations, and chemical company, and one consumer regarded as a new drug and be subject evolving new information about these submitted comments. Copies of the to regulatory action unless it is the Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6893 subject of an approved application or OTC vaginal contraceptive products possible concerning the content of these abbreviated application (hereinafter that are marketed for use with or as part applications. Inquiries should be called application). of a condom, diaphragm, or a directed to the Division of Metabolism The agency has concluded that contraceptive cervical cap will not be and Endocrine Drug Products (HFD– although nonoxynol 9 and octoxynol 9 subject to the final rule. When labeled 510), Center for Drug Evaluation and kill sperm in vitro and in vivo, the for use only with a device such as a Research, Food and Drug spermicidal activity and resulting condom (see 21 CFR 884.5310), Administration, 5600 Fishers Lane, effectiveness of these contraceptive diaphragm (see 21 CFR 884.5350), or Rockville, MD 20857, 301–443–3490. active ingredients cannot be considered cervical cap (a premarket approval The Department of Health and Human separately from a product’s vehicle. application has been approved for a Services has published the ‘‘13th Studies show that these active cervical cap for use as a barrier method Edition of Approved Drug Products with ingredients lose some of their of contraception, when used with a Therapeutic Equivalence Evaluations,’’ effectiveness in humans when the spermicidal cream or jelly), a commonly called ‘‘the Orange Book,’’ spermicide in final formulation is spermicide is considered an accessory which identifies currently marketed diluted by varied amounts of genital to a device. The regulation of products approved by FDA on the basis secretions during coitus. Thus, clinical spermicides for use only with a device of safety and effectiveness data. The studies are necessary to establish the will be addressed at a future date by the main criterion for the inclusion of any effectiveness of the spermicide’s final agency. In the interim, manufacturers of product in the Orange Book is that the formulation when used in humans. (See such products should direct inquiries to product is the subject of an approved discussion in section I.A., comment 3 of the Obstetrics/Gynecology Branch application that has not been withdrawn this document.) Such clinical studies (HFZ–471), Office of Device Evaluation, for safety or effectiveness reasons. For would determine the influence of the Center for Devices and Radiological vaginal contraceptive drug products for potential interactions among the genital Health, Food and Drug Administration, which there is a previously approved secretions, microorganisms, and 1390 Piccard Dr., Rockville, MD 20850, listed drug product in the Orange Book, contraceptive product vehicle. 301–594–1180. an abbreviated application may be The agency recognizes a need for The agency has determined that submitted. The abbreviated application consumers to continue to have access to nonoxynol 9 and octoxynol 9 would be must contain information to show OTC vaginal contraceptive drug appropriate ingredients for an approved bioequivalence to the listed drug products and to avoid disruption in the application. This determination is based product. Further, the abbreviated marketplace. The majority of OTC on: (1) The findings of the Panel application may contain labeling only vaginal contraceptive drug products (nonoxynol 9 and octoxynol 9 were for the claims approved for the product, currently marketed contain nonoxynol recommended as Category I active i.e. a contraceptive. None of the 9. At the present time, two approved ingredients), and (2) the history of use products containing nonoxynol 9 that applications exist for OTC vaginal of drug products with approved NDA’s are listed in the Orange Book has a contraceptives: Delfen Contraceptive containing nonoxynol 9. claim for the prevention of infectious Foam (new drug application (NDA) 14– Applications for products containing disease. Manufacturers should consult 349) and Today Sponge (NDA 18– these ingredients will not need to with the Office of Generic Drugs (HFD– 683). The NDA for Delfen Contraceptive include preclinical data, but, instead, 600), Center for Drug Evaluation and Foam was approved a number of years may refer to the Panel’s report as a Research, Food and Drug ago, and the product as currently general basis for the safety of these Administration, 5600 Fishers Lane, marketed uses a different formulation ingredients. The applications will need Rockville, MD 20857, 301–594–0340, to from the one approved in the NDA. The to include the results of clinical studies determine the procedures for obtaining manufacturer of this product will be that establish the effectiveness of the approval of abbreviated applications. required to provide additional contraceptive ingredient in the For vaginal contraceptive drug products information. The manufacturer of the product’s final formulation. These for which there is no previously Today Sponge recently announced studies to establish the effectiveness of approved listed drug product in the that it plans to discontinue production the product’s final formulation need to Orange Book, an abbreviated application of this product. However, the firm has comply with the requirements of 21 CFR may not be submitted. For these not indicated to FDA that it plans to part 314. The clinical studies should products, an application that includes withdraw its application. contain evidence of the effectiveness of adequate and well-controlled clinical Only a few vaginal contraceptive drug the spermicide in final formulation in studies of the effectiveness of the products contain octoxynol 9, and none normal volunteers or patients that is specific formulation of the vaginal have approved applications. Because consistent with correct use of the contraceptive must be submitted. the final rule for this class of OTC drug product. In addition, the agency is Manufacturers of such products should products will be effective 12 months aware that the use of either of the direct inquiries to the Division of after the date of its publication in the contraceptive ingredients addressed in Metabolism and Endocrine Drug Federal Register, FDA strongly this proposed rulemaking may be Products, as noted above. recommends that manufacturers of associated with varying degrees of Both types of applications, i.e., full or products not having an approved vaginal irritation under certain abbreviated, would also have to include application consult with the agency as conditions of use and it is unclear information on the drug product’s soon as possible concerning the content whether this may play a role in the formulation, manufacture, and quality of these applications. Elsewhere in this transmission of STD’s (Refs. 1 through control procedures to ensure that the issue of the Federal Register, the agency 5). Therefore, as part of the application applicant has the ability to manufacture is announcing the availability of a for approval of these products for a safe and effective OTC vaginal guidance document that is intended to contraceptive use, information regarding contraceptive drug product. (Also, see help manufacturers of vaginal the rate of occurrence and degree of section I.C., comment 15 of this contraceptive drug products develop vaginal irritation should be presented. document.) data in support of new drug FDA encourages manufacturers to The agency is aware of literature applications. consult with the agency as soon as reports and other data concerning the 6894 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules use of certain contraceptive active the proposed rule at the earliest possible 13. Feldblum, P. J. and J. A. Fortney, ingredients to prevent sexual date. ‘‘Condoms, Spermicides and the transmission of infectious diseases All ‘‘OTC Volumes’’ cited throughout Transmission of Human Immunodeficiency this document refer to the submissions Virus: A Review of the Literature,’’ American (Refs. 1 through 17). However, none of Journal of Public Health, 78(1):52–54, 1988. these products currently has an made by interested persons pursuant to 14. Hermonat, P. L. et al., ‘‘The Spermicide approved indication for this use. the call-for-data notice published in the Nonoxynol-9 Does Not Inactivate Although this document is not intended Federal Register of May 16, 1973 (38 FR Papillomavirus,’’ Sexually Transmitted to address the use of vaginal 12840) or to additional information that Diseases, 19(4):203–205, July-August 1992. contraceptive drug products in has come the agency’s attention since 15. Hicks, D. R. et al., ‘‘Inactivation of publication of the advance notice of HTLV/LAV-Infected Cultures in Normal preventing the transmission of STD’s, Human Lymphocytes by Nonoxynol 9 In the identification of safe and effective proposed rulemaking. The volumes are on public display in the Dockets Vitro,’’ Lancet, (2)8469–8470, 1422–1423, products to prevent the transmission of December 21/28, 1985. HIV and other STD’s is a high priority Management Branch (address above). 16. Singh, B. et al., ‘‘Studies in the public health concern. Therefore, FDA References Development of a Vaginal Preparation strongly encourages evaluation of OTC Providing Both Prophylaxis Against Venereal 1. Louv, W. C. et al., ‘‘A Clinical Trial of contraceptive products for this use. Disease and Other Genital Infections and Nonoxynol 9 for Preventing Gonococcal and Contraception,’’ British Journal of Venereal Manufacturers who wish to submit Chlamydial Infections,’’ Journal of Infectious Disease, 48:57–62, 1972. applications for such use should be Diseases, 158:518–523, 1988. 17. Trap, R. et al., ‘‘Evaluation of the aware that the study designs for 2. Bird, K. D., ‘‘The Use of Spermicides Amount of Nonoxynol-9 Available in effectiveness as a contraceptive and for Containing Nonoxynol 9 in the Prevention of Condoms for the Inhibition of HIV Using a prevention of infectious disease may be HIV Infection,’’ AIDS, 5(7):791–796, 1991. Method Based on HPLC, International 3. Kreiss, J. et al., ‘‘Efficacy of Nonoxynol different. Therefore, manufacturers Journal of Sexually Transmitted Diseases and 9 Contraceptive Sponge Use in Preventing AIDS, 1(5):436–438, September 1990. should consult with the agency Heterosexual Acquisition of HIV in Nairobi concerning the content of contraceptive Prostitutes,’’ Journal of the American Medical I. The Agency’s Tentative Conclusions applications that also include an Association, 268(4):477–482, July 29, 1992. on the Comments indication for prevention of infectious 4. Miller, C. J. et al., ‘‘The Effect of disease. Inquiries regarding use for Contraceptives Containing Nonoxynol-9 on A. General Comments on OTC Vaginal Contraceptive Drug Products prevention of infectious disease for the Genital Transmission of Simiam antiviral prophylaxis should be directed Immunodeficiency Virus in Rhesus 1. One comment contended that OTC Macaques,’’ Fertility and Sterility, drug monographs are interpretive, as to the Supervisory Consumer Safety 57(5):1126–1128, May 1993. Officer, Division of Antiviral Drug 5. Niruthisard, S. et al. ‘‘The Effects of opposed to substantive, regulations. The Products (HFD–530), Center for Drug Frequent Nonoxynol-9 Use on the Vaginal comment referred to statements on this Evaluation and Research, Food and and Cervical Mucosa, Sexually Transmitted issue submitted earlier to other OTC Drug Administration, 5600 Fishers Diseases, 18(3):176–179, 1991. drug rulemaking proceedings. Lane, Rockville, MD 20857, 301–443– 6. Cates, W., Jr. et al.,‘‘Commentary,’’ The agency addressed this issue in 9550, and inquiries regarding bacterial American Journal of Public Health, 82:1479– paragraphs 85 through 91 of the 82, 1992. preamble to the procedures for and other nonviral pathogens should be 7. Cates, W., Jr. and K. M. Stone, ‘‘Family directed to the Division of Anti-Infective classification of OTC drug products, Planning, Sexually Transmitted Diseases, and published in the Federal Register of Drug Products (HFD–520), Center for Contraceptive Choice: A Literature Update,’’ Drug Evaluation and Research, Food Family Planning Perspectives, 24:75–84, May 11, 1972 (37 FR 9464 at 9471 and Drug Administration, 5600 Fishers 122–128, 1992. through 9472), and in paragraph 3 of the Lane, Rockville, MD 20857, 301–443– 8. Rosenberg, M. J. et al., ‘‘Barrier preamble to the tentative final 4310. Contraceptives and Sexually Transmitted monograph for OTC antacid drug Diseases in Women: A Comparison of products, published in the Federal If this proposal is adopted as a final Female-dependent Methods and Condoms,’’ Register of November 12, 1973 (38 FR rule, the agency advises that the American Journal of Public Health, 82:669– 31260). FDA reaffirms the conclusions conditions under which the drug 674, 1992. stated in those documents. Court 9. World Health Organization, ‘‘Meeting on products that are subject to this rule are decisions have confirmed the agency’s not generally recognized as safe and the Development of Vaginal Microbicides for the Prevention of Heterosexual Transmission authority to issue substantive effective and are misbranded of HIV,’’ press release, Geneva, Switzerland, regulations by rulemaking. (See, e.g., (nonmonograph conditions) will be 1993. National Nutritional Foods Association effective 12 months after the date of 10. Chantler, E., ‘‘New and Existing v. Weinberger, 512 F.2d 688, 696 to 698 publication of the final rule in the Spermicides with Virucidal Properties,’’ in (2d Cir. 1975) and National Association Federal Register. On or after that date, ‘‘Heterosexual Transmission of AIDS; of Pharmaceutical Manufacturers v. no OTC drug product that is subject to Proceedings of the Second Contraceptive FDA, 487 F. Supp. 412 (S.D.N.Y. 1980), Research and Development (CONRAD) the rule may be initially introduced or aff’d, 637 F.2d 887 (2d Cir. 1981).) initially delivered for introduction into Program International Workshop,’’ edited by Alexander, N. J., H. L. Gabelnick, and J. M. 2. Referring to the Panel’s interstate commerce unless it is the Spieler, February 1989, New York, Wiley- recommendation on the advertising of subject of an approved application. Liss, pp. 303–310, 1990. OTC vaginal contraceptive drug Further, any OTC drug product subject 11. Curran, J. W., ‘‘Prevention of Sexually products (45 FR 82014 at 82025), one to the final rule that is repackaged or Transmitted Diseases,’’ in ‘‘Sexually comment agreed that labeling should be relabeled after the effective date of the Transmitted Diseases,’’ edited by Himes, K. truthful and nondeceptive but disagreed final rule must be in compliance with K. et al., McGraw-Hill Book Co., pp. 973–991, that only those words adopted by the the final rule regardless of the date the 1984. Panel be allowed in OTC drug 12. Edwards, S., ‘‘Contraceptive Sponge product was initially introduced or Fails to Prevent Heterosexual Transmission advertising. The comment pointed out initially delivered for introduction into of HIV Among the Prostitutes in Kenya,’’ that on February 11, 1981, the Federal interstate commerce. Manufacturers are International Family Planning Perspectives, Trade Commission (FTC) declined to encouraged to comply voluntarily with 18(4):152–153, 1992. propose a rule which would require that Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6895 only FDA-approved words be used in limited usefulness because anatomic insertion in 96 women. The authors advertisements for OTC drugs, and some and physiologic changes in the vagina found that vaginal conditions associated of the Commissioners expressed doubt during sexual arousal, which can affect with alkaline pH, multiparity, and that approved OTC drug labeling would the distribution of the contraceptive, are vaginal dryness have an important role be appropriate for OTC drug advertising. not considered. The comment proposed in the rupture of the capsules. The study FTC has the primary responsibility for using a particular in vivo testing points out the importance of the regulating OTC drug advertising. procedure prior to full clinical testing. contraceptive vehicle as well as other However, FDA does have the authority One comment suggested that the conditions of the vaginal environment to regulate OTC drug advertising that agency require an in vitro test other than in determining the effectiveness of constitutes labeling under the Federal that recommended by the Panel, vaginal contraceptive drug products. Food, Drug, and Cosmetic Act (the act). claiming that the Panel’s test is Stone and Cardinale (Ref. 16) Under the act, a manufacturer can be ‘‘inadequately sensitive in that it only conducted a study using a series of in prohibited from advertising a drug to provides pass or fail end-point vitro and in vivo tests to evaluate the treat a condition for which there are not information, and does not quantitate the effectiveness of a suppository product adequate directions for use on the label. spermicidal potency of the compared to a cream or foam product See, e.g., United States v. Article of Drug contraceptive formulation.’’ Another having the same active ingredient, * * * B–Complex Cholinos Capsules, 362 comment opposed requiring clinical nonoxynol 9. The authors found some F.2d 923 (3d Cir. 1966); V. E. Irons, Inc. testing, but stated that if such testing is evidence indicating that the solubility of v. United States, 244 F.2d 34 (10th Cir.), to be required, a recognized postcoital the suppository may vary from subject cert. denied, 354 U.S. 923 (1957). In test would be sufficient. to subject depending on, for example, addition, if advertising for an OTC The agency has reviewed the available the volume of vaginal secretions. In the vaginal contraceptive drug product data and information regarding in vitro in vitro study, instant immobilization of testing procedures for vaginal offers the product for conditions not all sperm was obtained when foam, contraceptive drug products and included in FDA approved labeling, the cream, or effervescent vaginal tentatively concludes that in vitro drug product could be subject to suppository foam was mixed with 2 testing is not sufficient to assure regulatory action by FDA. (See also milliliters of semen. In the in vivo effectiveness of the product when used section I.C., comment 11 of this study, a good volume of foam covering in humans. Although in vitro testing document for discussion of FDA’s the external os of the cervix was will provide a measure of a product’s labeling policy.) observed in only 11 of the 20 patients 3. A number of comments disagreed potential effectiveness, reports in the in whom the suppository was inserted. with the agency’s position that clinical literature (Refs. 1 through 14) indicate However, very little if any foam was testing of all final formulations, that such in vitro tests will not conducted under the provisions of a adequately describe the effectiveness of observed in the other nine women, and new drug application, may be the only the final formulation when it is used in the suppository was removed almost means of assuring effectiveness of OTC humans. In these reports, certain OTC intact after the 15-minute observation vaginal contraceptive drug products. vaginal contraceptives found to be period. The authors commented that in Several of these comments argued that effective when tested in vitro were vitro and laboratory evaluations of the Panel’s recommended in vitro shown to be ineffective when tested in chemical contraceptives do not correlate testing procedures are sufficient to vivo. well to their effectiveness in clinical demonstrate effectiveness. One Formulations differ in the speed of trials in different populations. In comment stated that requiring distribution in the vagina and the degree addition, they noted that formulations manufacturers to submit an application of surface coverage and these and other containing a highly effective contradicts the agency’s stated purpose factors have a significant impact on spermicidal agent but that do not diffuse of the monograph process. Another effectiveness (Refs. 3, 15, and 16). well are less effective. comment was concerned that requiring Homm et al. (Ref. 3) compared seven Postcoital tests in humans have been clinical testing might mean that new marketed vaginal contraceptives (foams, considered as an alternative to clinical clinical trials would be needed each suppository, cream, jelly) in in vitro and trials. However, the agency does not time a manufacturer made changes in a in vivo (rabbit) studies and concluded believe that the currently available product’s inactive ingredients. The that the dosage form of a vaginal postcoital tests can be relied upon. The comment maintained that this would be contraceptive product is of considerable Sims-Huhner test (SHT) is an in vivo costly, would not benefit consumers, importance in its contraceptive potency. postcoital test that is used to diagnose and would stifle a manufacturer’s Homm et al. found that foam products certain types of infertility and assess the incentive to improve products. were more available than suppository presence, quality, and motility of sperm Two comments advocated requiring products, which were more potent than in the cervical mucus. References in the clinical testing of OTC vaginal jelly products. However, the authors medical literature indicate that the SHT contraceptives. One comment asserted stated that these comparative ratings has poor predictive value because a that such testing would provide needed could only be regarded as negative SHT does not confirm the quantitative effectiveness data and ‘‘user generalizations because the in vivo absence of sperm (Refs. 17, 18, and 19). information.’’ This comment also contraceptive potencies found in the Kably et al. (Ref. 17) stated that they had questioned how appropriate directions rabbits were difficult to relate to human found the results of the SHT to for use could be determined based only contraceptive effectiveness. At present, ‘‘paradoxical’’ relative to conception. on in vitro testing. The other comment there is no in vitro test available that Therefore, the authors examined claimed that research has shown that can be considered a reliable reflection of whether sperm were present or absent certain OTC drug products judged to be in vivo conditions. There is also no in the peritoneal fluid of five subjects effective by standard in vitro testing reliable in vivo animal model that can with good SHT’s and five subjects with were in fact largely ineffective when simulate the human condition. Bassol poor or negative SHT’s. In three of five evaluated by standard in vivo testing (Ref. 15) compared the rupture time of subjects with a positive SHT and in four procedures. The comment also two types of soft jelly capsules of five subjects with a poor SHT, sperm contended that in vitro testing is of containing nonoxynol 9 after vaginal were found in the aspirate. 6896 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules Asch (Ref. 18) also reported that References Correlation With The Sims-Huhner Test,’’ Ginecologia y Obstetricia de Mexico, 57:82– pregnancy frequently occurs in women 1. MacLeod, J. et al., ‘‘In Vitro Assessment with a negative or poor SHT. Asch 84, 1989. of Commercial Contraceptive Jellies and 18. Asch, R. H., ‘‘Laparoscopic Recovery of reported the recovery of mature, Creams: Positive Correlation Between Sperm from Peritoneal Fluid In Patients With morphologically normal sperm from the Laboratory Tests and Clinical Use Awaits Negative or Poor Sims-Huhner Test,’’ Fertility peritoneal fluid of six of the eight Further Investigation,’’ Journal of the and Sterility, 27:1111–1114, 1976. women who had a negative SHT. In American Medical Association, 176:427–431, 19. Griffith, Carolyn S. and D. A. Grimes, three other women who had a poor 1961. ‘‘The Validity of the Postcoital Test,’’ 2. Bernstein, G. S., ‘‘Physiological Aspects American Journal of Obstetrics and SHT, sperm were also recovered in the of Vaginal Contraception: A Review,’’ aspirate. Griffith and Grimes (Ref. 19) Gynecology, 162:615–620, 1990. Contraception, 9:333–345, 1974. 4. One comment stated that FDA does reviewed the literature and evaluated 3. Homm, R. E. et al., ‘‘A Comparison of not have the authority to enforce the validity of the postcoital test for the In Vivo Contraceptive Potencies of a § 351.30(f) of the Panel’s recommended predicting infertility. The authors Variety of Marketed Vaginal Contraceptive monograph, which would require concluded that the SHT has poor Dosage Forms,’’ Current Therapy and Research, 22:588–596, 1977. manufacturers to retain the in vitro validity, its reproducibility is unknown, effectiveness testing data and permit and its suffers from a lack of 4. ‘‘Population Reports,’’ Series H, No. 3, January 1975, Population Information FDA to inspect these data. The comment standardized methodology and a Program, The Johns Hopkins University, requested that § 351.30(f) be deleted. uniform definition of normal. Because Baltimore. As discussed in section I.A., comment the absence of sperm in the SHT 5. Johnson, V. E. and W. H. Masters, 3 of this document, the agency is frequently has been associated with ‘‘Intravaginal Contraceptive Study, Phase II, proposing that each OTC vaginal subsequent pregnancy, the agency Physiology (A Direct Test for Protective contraceptive drug product should be Potential),’’ Western Journal of Surgery, concludes that this in vivo postcoital the subject of an approved application test is not reliable for evaluating the Obstetrics and Gynecology, 71:144–153, 1963. prior to marketing. Therefore, there will efficacy of a vaginal contraceptive. 6. Johnson, V. E. et al., ‘‘Factors in be no monograph and the comment’s Because of the difficulties that arise in Failure—The Physiology of Intravaginal request is moot. trying to simulate the human condition Contraceptive Failure,’’ in ‘‘Manual of Family 5. Two comments objected to the in an in vitro test and determine the Planning and Contraceptive Practice,’’ 2d ed., Panel’s statement questioning the safety influence of the potential interactions Williams & Wilkins Co., Baltimore, p. 232, and effectiveness of quaternary 1970. ammonium compounds for use as among the sperm, cervical mucus, 7. ‘‘Population Reports,’’ Series H, No. 5, microorganisms, and contraceptive preservatives in OTC vaginal September 1979, Population Information contraceptive drug products (45 FR vehicle on the effectiveness of the Program, The Johns Hopkins University, contraceptive, the results of in vitro Baltimore. 82014 at 82042). The comments stated testing cannot be relied upon to reach 8. Masters, W. H. et al., ‘‘In Vivo that the Panel’s concern stems solely conclusions about effectiveness in Evaluation of an Effervescent Intravaginal from a review of eight reports (45 FR humans. For example, due to the varied Contraceptive Insert by Simulated Coital 82042) suggesting that the use of Activity,’’ Fertility and Sterility, 32:161–165, amounts of cervical mucus and semen quaternary ammonium compounds may 1979. be associated with outbreaks of that may be present in humans during 9. Bernstein, G. S., ‘‘Conventional Methods Pseudomonas infections because they sexual arousal, the concentration of the of Contraception: Condom, Diaphragm, and do not inhibit the growth of contraceptive in the vagina is not Vaginal Foam,’’ Clinical Obstetrics and Pseudomonas. The comments argued always equivalent to the concentration Gynecology, 17(1):21–33,1974. that the Panel failed to state that these used in in vitro testing. Furthermore, in 10. Sobrero, A. J., ‘‘Spermicidal Agents: reports resulted from the contamination vitro testing cannot determine the Effectiveness, Use, and Testing,’’ in ‘‘Vaginal of solutions that were employed in following important information: How Contraception: New Developments,’’ Harper & Row, Hagerstown, MD, p. 62, 1979. laboratory and hospital settings to long before intercourse the 11. Zaneveld, L. J. D. et al., ‘‘Primate Model sterilize medical devices used in urinary contraceptive should be inserted; if the for Evaluation of Vaginal Contraceptives,’’ and cardiac catheterization or intravaginal distribution of the American Journal of Obstetrics and cystoscopic or related invasive contraceptive is sufficient to assure Gynecology, 129(4):368–373, 1977. procedures. Such procedures are effectiveness; or how long the 12. Connell, E. B., ‘‘Vaginal Contraception,’’ in ‘‘Advances in Fertility usually conducted on patients whose contraceptive remains effective in the normal body defenses have been vaginal environment. Therefore, the Research,’’ Raven Press, New York, pp. 19– 37, 1982. compromised. Because Pseudomonas agency has determined that clinical 13. Jackson, M., G. S. Berger, and L. G. infections occur primarily in debilitated studies in humans are necessary to Keith, ‘‘Vaginal Contraception,’’ G. K. Hall patients and Pseudomonas does not establish the effectiveness of final Medical Publishers, Boston, pp. 245–255, cause vulvovaginitis, the comments formulations of OTC vaginal 1981. stated that it is scientifically contraceptive drug products. 14. Sobrero, A. J., ‘‘Vaginal Chemical inappropriate to cite these reports and Products,’’ in ‘‘Manual of Family Planning The results of such testing should be and Contraceptive Practice,’’ 2d ed., Williams through extrapolation conclude that the submitted in the form of an application & Wilkins Co., Baltimore, pp. 275–282, 1970. use of quaternary ammonium that complies with all of the 15. Bassol, S. et al., ‘‘Comparative Trial compounds in vaginal contraceptive requirements that are necessary to Between Two Soft Jelly Capsules Containing drug products presents a health hazard establish the safety and effectiveness of Nonoxynol As Spermicidal Contraceptives,’’ to normal individuals. The comments the product’s final formulation, as Contraception, 39:110–118, 1989. cited several references to support the discussed above. Reference to the 16. Stone, C. S. and F. Cardinale, argument that the Panel’s concern, with Panel’s report and this document, as ‘‘Evaluation of a New Vaginal respect to vaginal contamination by Contraceptive,’’ American Journal of appropriate, may be used to satisfy the Obstetrics and Gynecology, 133:635–638, Pseudomonas in the presence of requirements of portions of the 1979. quaternary ammonium compounds, is application related to the safety of the 17. Kably, et al., ‘‘Laparoscopic Recovery of not supported by the weight of scientific active ingredient. Spermatozoa in the Peritoneal Fluid, Its and medical opinion (Refs. 1 through 4). Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6897 The comments concluded that the list of inactive ingredients would be have a right to an informed choice when agency should affirm the safety of meaningless to all but a few consumers buying such products. quaternary ammonium compounds and and that such a list might As discussed in section I.A., comment reclassify these ingredients in Category overemphasize the importance of the 6 of this document, listing of active I for use as preservatives in OTC vaginal inactive ingredients; obscure more ingredients is required for all drug drug products. meaningful information such as products under section 502(e)(1) of the Although the comments requested warnings, directions for use, and the act (21 U.S.C. 352(e)(1)). that the agency affirm the safety of name and quantity of the active B. Comments on OTC Vaginal quaternary ammonium compounds for ingredients; and be more confusing than Contraceptive Active Ingredients use as preservatives and reclassify them helpful. The comments also stated that as Category I, the agency points out that if the quantity of the inactive 8. Three comments supported the the OTC drug review is primarily a ingredients had to be listed there would Panel’s Category I classification of review of active ingredients, not be an additional problem and expense menfegol and disagreed with the inactive ingredients. However, because of changing the labels whenever the agency’s conclusion that menfegol is a the purpose of the OTC drug review quantity of an inactive ingredient is new drug because it is a new molecular process is to determine the safety and changed. entity, never before marketed as a drug effectiveness of OTC drugs, the OTC The act does not require the in the United States. The comments advisory review panels occasionally identification of all inactive ingredients stated that a lack of United States’ made recommendations with respect to in the labeling of OTC drug products. marketing experience does not preclude inactive ingredients. These Section 502(e) of the act (21 U.S.C. a drug from being considered generally recommendations were made to call 352(e)) does require disclosure of active recognized as safe and effective nor attention to those inactive ingredients ingredients and of certain ingredients, require a drug to be considered a new that could potentially interfere with the whether included as active or inactive drug. One comment argued that data on safety and effectiveness of the product. components in a product. Although the the marketing of vaginal contraceptive In the case of the quaternary act does not require the disclosure of all drug products in foreign countries can ammonium compounds, the agency inactive ingredients in the labeling of be equated to marketing in this country agrees with the comments’ reasoning OTC drug products, the agency agrees because the mode of action of these that the reports cited by the Panel with the Panel that listing of inactive products is based on the spermicidal cannot be used to conclude that the use ingredients in OTC drug product activity of an ingredient in the vagina of these compounds as preservatives in labeling would be useful information for and not on the medical problems, diets, OTC vaginal contraceptive drug some consumers. Consumers with customs, and environments of other products may present a health hazard to known allergies or intolerances to countries. The comment urged FDA to normal individuals. certain ingredients would then be able reconsider its decision to refuse to As discussed in section I.A., comment to identify substances that they may recognize data on the marketing of a 3 of this document, the agency is wish to avoid. product outside the United States proposing that each OTC vaginal The Nonprescription Drug regardless of the ingredient, type of contraceptive drug product should be Manufacturers Association (formerly product, or its mode of action. Another the subject of an approved application known as The Proprietary Association), comment added that the act defines a prior to marketing. Information the trade association that represents new drug as any drug not generally regarding the appropriateness of approximately 85 OTC drug recognized as safe and effective among ingredients used in the product as manufacturers who reportedly market experts, whereas menfegol was so preservatives should be included in the between 90 and 95 percent of the recognized by a panel of experts. The Panel’s Category I classification application. volume of all OTC drug products sold of menfegol was based on its review of in the United States, has established References safety and effectiveness data. The guidelines (Ref. 1) for its member Panel’s recommendation did not 1. Forkner, Jr., C. E., ‘‘Pseudomonas companies to list voluntarily inactive Aeruginosa Infections,’’ in ‘‘Modern Medical address the issue whether menfegol ingredients in the labeling of OTC drug meets the statutory requirement Monographs,’’ vol. 22, edited by I. S. Wright products. Under another voluntary and R. H. Orr, Gruen and Stratton, New York, concerning use of a drug. Menfegol was p. 71, 1960. program begun in 1974, the member determined to be a new drug within the 2. Gardner, H. L. and R. H. Kaufman, companies of the Association have been meaning of section 201(p)(2) of the act ‘‘Nonvenereal Bacterial Vulvovaginitides,’’ in including the quantities of active (21 U.S.C. 321(p)(2)), which defines a ‘‘Benign Diseases of the Vulva and Vagina,’’ ingredients on OTC drug labels. The new drug as: * * * ‘‘any drug * * * that 2d ed., G. K. Hall Medical Publishers, Boston, agency is not at this time proposing to p. 306, 1981. * * * has become so recognized, but require the listing of inactive which has not * * * been used to a 3. Ridley, C. M., ‘‘The Vulva,’’ in ‘‘Major ingredients in OTC drug product Problems in Dermatology,’’ vol. 5, edited by material extent or for a material time A. Rook, W. B. Saunders Co., Philadelphia, labeling. However, the agency under such conditions.’’ The agency’s p. 99, 1975. commends these voluntary efforts and longstanding interpretation of section 4. Mead, P. B. and D. W. Gump, urges all other OTC drug manufacturers 201(p)(2) of the act has been that ‘‘Antibiotic Therapy in Obstetrics and to similarly label their products. marketing outside the United States Gynecology,’’ in ‘‘Clinical Obstetrics and Gynecology,’’ vol. 19, No. 1, edited by H. J. Reference cannot fulfill this independent statutory requirement of use to a ‘‘material Osofsky and G. Schaefer, Harper and Row, 1. ‘‘Guidelines for Disclosure of Inactive Hagerstown, MD, p. 114, 1976. Ingredients in OTC Medicines,’’ The extent’’ and for a ‘‘material time.’’ 6. Several comments disagreed with Proprietary Association, Washington, July 12, Currently, based on several petitions to the Panel’s recommendations that 1984, in OTC Vol. 11ATFM. another OTC drug review rulemaking inactive ingredients and the quantity of 7. One comment urged that the label (Refs. 1, 2, and 3), the agency is the ingredient be listed in the labeling of OTC vaginal contraceptive drug reevaluating this interpretation of the of OTC vaginal contraceptive drug products contain a list of all active act. (See section II.C., comment 34 of products. The comments argued that a ingredients, arguing that consumers this document, in the tentative final 6898 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules monograph for OTC sunscreen drug this document) data and information The comments further stated that, products published in the Federal specifying the levels of 1,4-dioxane and although the Panel acknowledged that Register of May 12, 1993, 58 FR 28194 ethylene oxide that are contained in the alkylmercury compounds and inorganic at 28210). The agency will discuss its finished product. mercury salts have greater toxicity than decision on this matter in a future issue The concern over possible arylmercury compounds, it should be of the Federal Register. Thus, the teratogenicity of OTC vaginal recognized that differences also occur agency is reconsidering its policy on contraceptives was also raised at the between mercury compounds within the foreign marketing data, as the comment congressional hearing. The agency aryl series. Therefore, the comments requested. However, in view of the explained at the hearing that animal argued, conclusions should be limited agency’s tentative conclusion that all teratogenicity data and recent to the compound specifically vaginal contraceptive drug products will epidemiological data indicate that considered, phenylmercuric acetate, need an approved application for nonoxynol 9 is not teratogenic. when used specifically for its marketing, this issue, as it relates to However, FDA stated that it was spermicidal action and should not menfegol, is moot. considering a special warning condemn phenylmercuric nitrate by References concerning the use of any spermicide by association. women who suspect that they may be The agency acknowledges the 1. Citizen Petition, submitted by BASF AG, pregnant. Data and information on the March 16, 1990, coded CP2, Docket No. 78N– comments’ concern regarding the possible teratogenicity of vaginal varying toxicities of the different 0038, Dockets Management Branch. spermicides were subsequently 2. Citizen Petition, submitted by Haarmann mercury compounds, but concurs with and Reimer Corp., July 27, 1990, coded CP3, presented to the agency’s Fertility and the Panel that mercury-containing Docket No. 78N–0038, Dockets Management Maternal Health Drugs Advisory compounds, when used as active Branch. Committee to determine if any of the ingredients in vaginal contraceptive 3. Citizen Petition, submitted by Givaudan studies contains sufficient evidence to drug products, are unsafe. The Panel Corp., October 31, 1990, coded CP4, Docket warrant a special warning in the recommended that all vaginal No. 78N–0038, Dockets Management Branch. labeling concerning the use of vaginal 9. Two comments submitted data and contraceptives containing mercury spermicides during pregnancy. At its compounds as active ingredients be information on the safety of nonoxynol December 15, 1983 meeting (Ref. 5), the 9 (Ref. 1). These data were submitted placed in Category II because such committee decided that such a warning compounds are potentially hazardous to after publication of the Panel’s report in was not warranted. The agency concurs response to concerns regarding the the fetus and the breast-fed infant (45 with the advisory committee’s FR 82014 at 82038). Because data in potential teratogenicity or conclusion. carcinogenicity of this ingredient (Refs. animals and humans indicate that 2, 3, and 4). References phenylmercuric acetate is absorbed from Although nonoxynol 9 was classified the vagina into the system and partially 1. ‘‘Nonoxynol 9 Safety Information,’’ metabolized to inorganic mercury in the by the Panel as a Category I ingredient Advanced Care Products, Division of Ortho for use as an OTC vaginal contraceptive, Pharmaceutical Corp., coded RPT and blood and various tissues where it may concern over the possible RPT002, Docket No. 80N–0280, Dockets accumulate (Refs. 1 through 4), the carcinogenicity of nonoxynol 9 surfaced Management Branch. Panel concluded that mercury- in relation to the agency’s approval of 2. Jick, H. et al., ‘‘Vaginal Spermicides and containing compounds related to an application for a vaginal Congenital Disorders,’’ Journal of the phenylmercuric acetate, such as contraceptive sponge product American Medical Association, 245:1329– phenylmercuric nitrate, may be 1332, 1981. expected to behave in a similar manner. containing this ingredient. In reviewing 3. Rothman, K. J., ‘‘Spermicide Use and the data in support of the application, Down’s Syndrome,’’ American Journal of Other than the comments’ contention, the agency learned that nonoxynol 9 Public Health, 72:399–401, 1982. no data or information was submitted to may contain low levels of the suspected 4. Citizen Petition, submitted by A. Lione, demonstrate that phenylmercuric nitrate carcinogens 1,4-dioxane and ethylene Associated Pharmacologists and and related mercury-containing oxide as residuals from the Toxicologists, June 20, 1983, coded CP2, compounds react by a different manufacturing process. The concern Docket No. 83P–0187, Dockets Management mechanism or are not absorbed from the that the agency had approved an Branch. vagina. Although no overt symptoms of 5. Minutes of the Meeting of the Fertility application for a product containing and Maternal Health Drugs Advisory mercury poisoning from the use of suspected carcinogens was one of the Committee, National Center for Drugs and vaginal preparations containing mercury bases of a congressional hearing held by Biologics, FDA, pp. 1–3, December 15, 1983, compounds have been detected in the Subcommittee on Intergovernmental copy included in OTC Vol. 11ATFM. infants and children, there are sufficient Relations and Human Resources on July 10. Two comments disagreed with the animal data to suggest that inorganic 13, 1983. At that hearing, FDA Panel’s intention that data submitted on mercury from mercury-containing presented testimony and evidence that the safety of phenylmercuric acetate be compounds can be transferred to the the levels of 1,4-dioxane and ethylene regarded as equally relevant for all fetus and to breast-fed offspring. (See 45 oxide contained in the sponge product related mercury compounds, such as FR 82014 at 82033 and 82035.) In are within the residue limits that are phenylmercuric nitrate (45 FR 82014 at addition, the Panel cited animal considered acceptable by the agency. 82031). One comment stated that the teratology studies that showed a higher However, because the presence of 1,4- greatest part of the Panel’s discussion on percentage of fetal abnormalities when dioxane and ethylene oxide is not phenylmercuric acetate and related phenylmercuric acetate was unique to the sponge product and it is compounds is devoted to a discussion of administered either vaginally or possible that other products could the reported toxicity of orally ingested intravenously (45 FR 82034). The Panel contain different levels of these alkylmercury compounds and that this also cited cases of congenital mercury contaminants, the agency believes that discussion unjustifiably imputes poisoning in humans following manufacturers should submit as part of toxicity to arylmercury compounds ingestion of mercury compounds by the the application required for these when used in topically applied mother (45 FR 82032). These studies are products (see section I.A., comment 3 of preparations under ordinary conditions. at least suggestive, regardless of the Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6899 method of administration, of the terms from which indications for use for held by the Panel on April 28 and 29, potential hazard of mercury to offspring OTC drug products must be drawn and 1978, was that quantitative effectiveness when the drug is systemically absorbed to prohibit labeling terminology which claims should not be required. by the mother. Therefore, because of the is truthful, accurate, not misleading, and A number of comments indicated that possibility that mercury-containing intelligible to the consumer. A second quantitative effectiveness claims should compounds which can be metabolized comment stated that it would be not be required, but that manufacturers to inorganic mercury may pose a risk to inappropriate to restrict manufacturers should be permitted to use these claims fetuses and nursing infants, the agency to the specific wording recommended at their own discretion. Several of these concurs with the Panel that such by the Panel for package insert comments also objected to the Panel’s compounds are unsafe for use in vaginal statements. recommendation that such claims be contraceptive drug products. In the Federal Register of May 1, 1986 permitted in labeling only after prior (51 FR 16258), the agency published a approval by FDA through the new drug References final rule changing its labeling policy procedures. 1. Al-Jobori, I. M., ‘‘Mercury Levels in for stating the indications for use of Two comments questioned whether Females Exposed to Phenylmercuric OTC drug products. Under 21 CFR the quantitative effectiveness claims Acetate,’’ Master Thesis, University of 330.1(c)(2), the label and labeling of could be written in a manner that would Baghdad, pp. 10–110, 1975, in OTC Vol. OTC drug products are required to be understood by consumers. Providing 110058. contain in a prominent and conspicuous consumers with actual numbers relevant 2. Fukuchi, H. et al., ‘‘The Absorption of to method effectiveness, use Organomercurial Compounds from the location, either: (1) The specific Vaginal Route of the Rabbits. I. Comparative wording on indications for use effectiveness, and extended-use Study on the Effect of Suppository Vehicles established under an OTC drug effectiveness was specifically cited as a on the Absorption of Omega– monograph, which may appear within a potential source of confusion. Ethylmercurithio-n-undecanoic Acid, boxed area designated ‘‘APPROVED One comment pointed out that the Phenylmercuric Acetate and Ethylmercuric USES’’; (2) other wording describing patient labeling of oral contraceptives is Chloride after Single Dose Administration,’’ such indications for use that meets the required to contain a discussion Chemical and Pharmaceutical Bulletin, statutory prohibitions against false or comparing the effectiveness of different 12:540–548, 1964. contraceptive methods and, therefore, it 3. Fukuchi, H. et al., ‘‘The Absorption of misleading labeling, which shall neither Organomercurial Compounds from the appear within a boxed area nor be would be inconsistent for FDA to Vaginal Route of the Rabbits. II. Distribution designated ‘‘APPROVED USES’’; or (3) conclude that there are insufficient data and Excretion of Omega-Ethylmercurithio-n- the approved monograph language on available to support the validity of undecanoic Acid and Phenylmercuric indications, which may appear within a comparative effectiveness claims in the Acetate,’’ Chemical and Pharmaceutical boxed area designated ‘‘APPROVED labeling of OTC vaginal contraceptive Bulletin, 12:548–557, 1964. USES,’’ plus alternative language drug products. 4. Murkami, U., Y. Kameyama, and T. Kato, describing indications for use that is not The agency believes that consumers ‘‘Effects of a Vaginally Applied Contraceptive false or misleading, which shall appear should be provided with the most with Phenylmercuric Acetate Upon informative labeling available when Developing Embryos and Their Mother elsewhere in the labeling. All other OTC Animals,’’ Annual Report of the Research drug labeling required by a monograph choosing a contraceptive drug product. Institute of Environmental Medicine, Nagoya or other regulation (e.g., statement of After reviewing the complete University, pp. 88–99, 1955. identity, warnings, and directions) must administrative record for this appear in the specific wording rulemaking, including the record of the C. Comments on Labeling of OTC Panel’s symposium on vaginal Vaginal Contraceptive Drug Products established under the OTC drug monograph or other regulation where contraception and the comments Although the proposed rule included exact language has been established and submitted to the Panel’s report on this in this document does not include identified by quotation marks, e.g., 21 issue, the agency concludes that the monograph conditions, the responses to CFR 201.63 or 330.1(g). There will be no most informative labeling for users of the following comments should be monograph for OTC vaginal vaginal contraceptive drug products is considered as FDA’s tentative position contraceptive drug products, and all information on the relative effectiveness on the labeling of OTC vaginal labeling for these products will be of the various methods of contraception. contraceptive drug products. FDA has approved via applications. Therefore, The agency is currently working to considered the Panel’s labeling the comments are moot with respect to create a consistent and understandable recommendations and the following this current rulemaking. presentation of this important comments in developing the agency’s 12. Several comments agreed with the information to include in the labeling of position on labeling for OTC vaginal Panel that quantitative claims of all marketed contraceptive products, contraceptive drug products. This effectiveness should not be required in drugs, and devices. document will serve as the basis for the the labeling of OTC vaginal 13. Two comments objected to the development of guidelines for the contraceptive drug products because of Panel’s labeling recommendations for content and format of the labeling of the difficulty in conducting the studies the outer and primary containers of OTC OTC vaginal contraceptive drug that would be necessary to substantiate vaginal contraceptive drug products (45 products similar to those currently such claims. The size of the sample that FR 82014 at 82031). The comments available for oral contraceptive drug would be needed, the variations in questioned the propriety of the Panel in products. (See 54 FR 22585 and 22624, subject motivation, varying methods of specifying the order of appearance and May 25, 1989.) The agency intends to product use, and the lack of an adequate location of the various required complete these guidelines for OTC representative population of American statements. The comments also objected vaginal contraceptive drug products women were specifically cited in the to the number of required labeling after the comments to this proposal are comments as factors that would make statements. One comment stated that evaluated. such studies difficult to conduct. The listing of all the recommended labeling 11. One comment noted its continuing comments also pointed out that the statements would require the use of position that FDA lacks statutory consensus of the participants in the small illegible typeface. The second authority to prescribe exclusive lists of symposium on vaginal contraception, comment noted that if space were 6900 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules limited, listing of all items in the CFR 211.137 require an expiration date the comment suggested revising the recommended order would preempt for the product, except for OTC drug statement to read ‘‘Extra protection for those labeling statements required by products for human use whose labeling women who forget to take one or two law. The second comment also does not bear dosage limitations and contraceptive pills.’’ requested that the general warning which are stable for at least 3 years as The comment added that the statements, ‘‘Keep this and all drugs out supported by appropriate stability data. indication in recommended of the reach of children’’ and ‘‘In case In addition, the expiration date is also § 351.56(b)(8), which reads, ‘‘Effective of accidental ingestion call a Poison required to relate to any storage contraceptive alone or in the event the Control Center, emergency medical conditions stated on the labeling. As contraceptive pill is forgotten,’’ is more facility, or a doctor,’’ not be included in discussed in section I.A., comment 3 of acceptable than the one in the Panel’s priority system of labeling. this document, the agency is proposing § 351.56(b)(5), but it appears to imply The comment pointed out that warnings that each OTC vaginal contraceptive that vaginal and oral contraceptives similar to these are already required by drug product should be the subject of an provide equivalent protection. The 21 CFR 330.1(g), which only requires approved application prior to comment recommended that both that these warnings appear somewhere marketing. Information relating to statements either be modified or in the labeling. The comment stated that dosage limitations, stability conditions, deleted. there is no basis for special treatment of and storage conditions should be The agency believes that information these warnings for OTC vaginal included in the application. regarding what to do when a contraceptive drug products. 16. Three comments agreed with the contraceptive pill is forgotten is more Existing regulations (21 CFR 201.15 Panel that the labeling of OTC vaginal appropriate for inclusion in the labeling and 21 CFR part 201, subpart C— contraceptive drug products should of oral contraceptives. Such information Labeling Requirements for Over–the– contain precise directions that can be is required to be included in the patient Counter Drugs) adequately address the easily understood by the average labeling of oral contraceptives. placement and prominence of labeling consumer. One of these comments Therefore, the agency does not believe statements. While there may be certain added that diagrams on proper use of that this type of information is selected situations where it is necessary the contraceptive might also be useful. necessary for inclusion in the labeling to alter these general requirements, the The agency agrees that vaginal for OTC vaginal contraceptive drug agency is unaware of any data contraceptives should contain precise products. demonstrating that it is necessary in the directions that are understandable to 19. Two comments urged deletion of case of OTC vaginal contraceptive drug consumers, including diagrammed the statement recommended by the products. In addition, the labeling instructions, as appropriate, to show the Panel in § 351.56(a)(5), which reads, ‘‘If statements required by § 330.1(g) are proper method of application. douching is desired, always wait at least similar to those recommended by the 17. One comment suggested that the 6 hours after intercourse before Panel and the agency considers the Panel’s recommended directions douching.’’ The comments claimed that labeling requirements in § 330.1(g) to be statement in § 351.56(a)(3), which reads, there are no data or information in the appropriate for OTC vaginal ‘‘If this product is used together with scientific literature or from common contraceptive drug products. another contraceptive method, there usage demonstrating the need for such 14. One comment suggested that the will probably be better protection labeling. One of these comments accidental ingestion warning against pregnancy,’’ be modified to specifically argued that the only recommended by the Panel be changed include examples of various supporting reference cited by the Panel from ‘‘In case of accidental ingestion, contraceptive methods, such as a (Ref. 1) discusses the persistence of call a Poison Control Center, emergency diaphragm, condom, or intrauterine sperm in the cervix and vagina medical facility, or a doctor device. following intercourse but does not immediately’’ to ‘‘In case of accidental As discussed in section I. C., express any concern about douching ingestion of large amounts by children, comment 12 of this document, the following the use of a vaginal call a Poison Control Center or agency believes that the labeling of OTC spermicide. The comment added that emergency medical facility, or call a vaginal contraceptive drug products this reference actually indicates that doctor.’’ The comment contended that should contain a summary of the douching was ‘‘associated with because of the well-established safety of effectiveness of the various methods of reductions in proportions of smears OTC vaginal contraceptive drug contraception. In light of this, the containing spermatozoa.’’ Both products the Panel’s recommended agency considers the modification comments also specifically noted that warning is unnecessarily alarming to recommended by the comment to be the Panel admitted that there are no data adult users. unnecessary. establishing the optimum time interval The agency does not believe that the 18. One comment stated that if the between use of a spermicide and Panel or the comment have presented indication recommended by the Panel douching. sufficient data or information to warrant in § 351.56(b)(5), which reads, ‘‘Extra Although the comments are correct a change from the accidental ingestion protection for women who forget to take that no data are available concerning the warning required by § 330.1(g) or one or more contraceptive pills,’’ is optimum time interval between § 369.9 for all OTC drug products. adopted, the labeling of the product intercourse and douching when using a 15. One comment agreed with the should also refer the user to the vaginal spermicide product, it is Panel that the labeling of an OTC directions for use of the oral generally accepted that douching too contraceptive drug product should contraceptive. The comment reasoned soon after intercourse could likely contain an expiration date and that a woman who has missed more interfere with a spermicide by diluting information on the product’s than two consecutive pills should it or removing it from the vagina. appropriate storage condition. discontinue taking them, whereas the Therefore, the agency believes that a To assure that a drug product meets use of the word ‘‘extra’’ implies that the statement regarding the time interval applicable standards of identity, pills should be continued. As an between intercourse and douching strength, quality, and purity at the time alternative to referring the user to the would provide useful information to the of use, existing FDA regulations at 21 oral contraceptive’s directions for use, consumer. The Panel stated that it is Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6901 generally accepted opinion that when considerations, FDA has not set such testing is not required under FDA’s vaginal contraceptives are used as the standards for all labeling found in OTC OTC combination policy. primary method of birth control, drug products. Accordingly, OTC drug As discussed in section I. D., douching should be delayed for at least monographs address only those labeling comment 25 of this document, testing 6 hours after coitus (45 FR 82014 at items that are related in a significant guidelines for conditions that industry 82030). The agency concurs. way to the safe and effective use of wishes to upgrade to monograph status covered products by lay persons. These will not be included. However, criteria Reference labeling items are the product statement for establishing combinations of OTC 1. Silverman, E. M. and A. G. Silverman, of identity; names of active ingredients; drugs as generally recognized as safe ‘‘Persistence of Spermatozoa in the Lower indications for use; directions for use; and effective are provided in 21 CFR Genital Tracts of Women,’’ Journal of the warnings against unsafe use, side 330.10(a)(4)(iv). Guidance on OTC American Medical Association, 240:1875– effects, and adverse reactions; and combination drug products has also 1877, 1978. claims concerning mechanism of drug been provided in the agency’s General 20. One comment suggested that the action. Guidelines for OTC Drug Combination labeling of OTC vaginal contraceptive Based on the discussion above, the Products (Ref. 1). Thus, two or more safe drug products include a warning agency tentatively concludes that the and effective OTC vaginal contraceptive specifying possible adverse allergic Panel’s entire list of Category II labeling active ingredients may be combined reactions such as itching and burning in claims as well as certain descriptive provided the final formulation of the the vaginal area and in the penile area. terms included in the Panel’s product meets the combination policy The comment also recommended that recommended list of other allowable in all respects. The Panel did not the warning advise consumers to statements (recommended § 351.56(c)), include any contraceptive combinations discontinue use if these symptoms i.e., safe, effective, powerful, highly) in its monograph because the data were occur. would be outside the scope of a insufficient for any of the combinations The agency agrees with the comment monograph, if one were being that were reviewed to be generally that consumers should be warned about established. Because all OTC vaginal recognized as safe and effective. The possible allergic reactions such as contraceptive drug products will require agency concurs with the Panel’s burning and itching that may occur an approved application for marketing, decision. Furthermore, as noted in when using vaginal contraceptive drug such claims can be evaluated, during section I. A., comment 3 of this products. The agency also agrees that the approval process, on a product-by- document, the agency is proposing to the warning should advise consumers to product basis for compliance with require that all combination or single- discontinue use if these symptoms section 502 of the act (21 U.S.C. 352) ingredient OTC vaginal contraceptive should occur. Furthermore, if the relating to labeling that is false or drug products be subject to approved irritation persists after use has been misleading. applications prior to marketing. discontinued, it could indicate a 22. After reviewing the Panel’s problem other than an allergic reaction recommended labeling, the agency has Reference to the product, so that a physician tentatively determined that the 1. Food and Drug Administration, ‘‘General should be contacted. The agency following additional changes in the Guidelines for OTC Drug Combination believes the following warning is Panel’s recommendations are warranted. Products, September 1978,’’ Docket No. 78D– appropriate for inclusion in the labeling Although the Panel recommended 0322, Dockets Management Branch. of OTC vaginal contraceptive drug ‘‘spermicide’’ as an indication, the 24. One comment stated that the data products: ‘‘If you or your partner agency believes that it would be more on which the Panel based its Category develops irritation, such as burning or appropriate as an optional statement of II classification of the combinations: (1) itching in the genital area, stop using identity. In addition, although the Panel Phenylmercuric acetate and boric acid; this product. If irritation continues, recommended a number of indications (2) phenylmercuric acetate, boric acid, contact your physician.’’ statements, the agency believes that the and nonoxynol 9; and (3) 21. One comment stated that the indication ‘‘For the prevention of phenylmercuric acetate, octoxynol 9, Category II labeling claims pregnancy’’ is sufficient to convey to and sodium borate show that these recommended by the Panel (45 FR consumers the intended use of the combinations were so classified because 82014 at 82040) are not proper subject product. The agency has also tentatively of ‘‘hazards’’ associated with the use of matter for the OTC drug review and determined that the statement ‘‘If your phenylmercuric acetate rather than with should not be classified. The comment physician has told you that you should the use of boric acid or sodium borate argued that these claims are not not become pregnant, ask your (Refs. 1 through 6). The comment added indications for use, but rather are physician if you can use this product for that it appears that the use of borates in statements of fact which are unrelated to contraception,’’ should be a warning vaginal contraceptives is for ‘‘pH the safety or effectiveness of a vaginal instead of a direction statement. control.’’ The comment also noted that contraceptive drug. The comment added boron compounds were listed as that the claims cannot legally be D. Comments on Combinations inactive ingredients in the Panel’s report prohibited if truthful and should not be 23. One comment objected to the (45 FR 82014 at 82042) and were not placed in Category II without a finding Panel’s statement at 45 FR 82014 at placed in Category II, as were mercury- that they are inherently false or 82026 that if two or more Category I containing compounds. misleading. vaginal contraceptive active ingredients The agency agrees that boron The OTC drug review program are combined, the specific ingredients compounds should not have been establishes conditions under which as well as the combination product must included as active ingredients in the OTC drugs are generally recognized as be subjected to laboratory and clinical listing of Category II combinations. The safe and effective and not misbranded. testing according to the recommended submissions of data on OTC vaginal One aspect of the program is to develop testing guidelines. The comment argued contraceptive drug products containing standards for certain parts of the that no useful purpose is served or boron compounds (Refs. 1 through 6) labeling of OTC drug products. Because information gained by clinical testing of indicate that the boron compounds are of time, resources, and other single Category I ingredients and that included in these products as 6902 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules pharmaceutical necessities or determined that clinical studies in drug products, a period of 120 days preservatives and not as active humans are necessary to establish the from the date of publication of this ingredients. effectiveness of final formulations of proposed rulemaking in the Federal vaginal contraceptive drug products Register will be provided for comments References and, therefore, any drug product that is on this subject to be developed and 1. OTC Vol. 110004. labeled, represented, or promoted for submitted. The agency will evaluate any 2. OTC Vol. 110005. use as a vaginal contraceptive is comments and supporting data that are 3. OTC Vol. 110006. regarded as a new drug within the received and will reassess the economic 4. OTC Vol. 110017. meaning of section 201(p) of the act (21 impact of this rulemaking in the 5. OTC Vol. 110018. U.S.C. 321(p)), for which an approved preamble to the final rule. 6. OTC Vol. 110021. application under section 505 of the act The agency has determined under 21 E. Comments on Testing Guidelines (21 U.S.C. 355) and 21 CFR part 314 of CFR 25.24(c)(6) that this action is of a type that does not individually or 25. Numerous comments criticized the regulations is required for cumulatively have a significant effect on the safety and effectiveness testing marketing. In the absence of an the human environment. Therefore, guidelines recommended by the Panel approved application, such a product also would be misbranded under section neither an environmental assessment to upgrade a vaginal contraceptive 502 of the act (21 U.S.C. 352). nor an environmental impact statement ingredient from Category III to Category FDA has examined the impacts of the is required. I (45 FR 82014 at 82020 and 82043). proposed rule under Executive Order In the Federal Register of December Generally, the comments stated that the 12866 and the Regulatory Flexibility Act 12, 1980 (45 FR 82014 at 82047), the guidelines are unclear, needlessly (Pub. L. 96–354). Executive Order 12866 agency proposed that the monograph for specific, unnecessary, or based on directs agencies to assess all costs and OTC vaginal contraceptive drug unsound logic. Some of the comments benefits of available regulatory products be included in subpart A of subsequently proposed using alternative alternatives and, when regulation is new part 351 of Title 21 of the Code of testing methods, while others urged necessary, to select regulatory Federal Regulations. In the Federal elimination of certain methods. approaches that maximize net benefits Register of October 13, 1983 (48 FR The agency has not addressed specific (including potential economic, 46694 at 46727), the agency proposed testing guidelines in this document. In environmental, public health and safety, that a monograph for OTC vaginal drug revising the OTC drug review and other advantages; distributive products be included in subpart B of procedures relating to Category III, impacts; and equity). The agency part 351. The current proposal published in the Federal Register of believes that this proposed rule is supersedes subpart A of part 351 and, if September 29, 1981 (46 FR 47730), the consistent with the regulatory finalized as proposed, Part 310—New agency advised that tentative final and philosophy and principles identified in Drugs would be amended to include final monographs will not include the Executive Order. In addition, the OTC vaginal contraceptive drug recommended testing guidelines for proposed rule is not a significant products. conditions that industry wishes to regulatory action as defined by the Interested persons may, on or before upgrade to monograph status. Instead, Executive Order, and thus, is not subject June 5, 1995 submit to the Dockets the agency will meet with industry to review under the Executive Order. Management Branch written comments, representatives at their request to The Regulatory Flexibility Act objections, or requests for oral hearing discuss testing protocols. However, in requires agencies to analyze regulatory before the Commissioner on the view of the agency’s determination that options that would minimize any proposed regulation. A request for an all OTC vaginal contraceptive drug significant impact of a rule on small oral hearing must specify points to be products should be the subject of entities. There are a limited number of covered and time requested. Written approved applications prior to OTC vaginal contraceptive products that comments on the agency’s economic marketing, interested parties can use are not marketed for use with a condom, impact determination may be submitted that forum to meet with the agency to diaphragm, or contraceptive cervical on or before June 5, 1995. Three copies discuss appropriate testing procedures, cap. Accordingly, the agency certifies of all comments, objections, and and the comments do not need to be that the proposed rule will not have a requests are to be submitted, except that addressed in this document. Also, significant economic impact on a individuals may submit one copy. elsewhere in this issue of the Federal substantial number of small entities. Comments, objections, and requests are Register, the agency is announcing the Therefore, under the Regulatory to be identified with the docket number availability of a guidance document that Flexibility Act, no further analysis is found in brackets in the heading of this is intended to help manufacturers of required. document and may be accompanied by vaginal contraceptive drug products The agency invites public comment a supporting memorandum or brief. develop data in support of new drug regarding any substantial or significant Comments, objections, and requests may applications. economic impact that this rulemaking be seen in the office above between 9 would have on OTC vaginal a.m. and 4 p.m., Monday through II. The Agency’s Tentative Conclusions contraceptive drug products. Types of Friday. Any scheduled oral hearing will on OTC Vaginal Contraceptive Drug impact may include, but are not limited be announced in the Federal Register. Products to, costs associated with product testing, Interested persons, on or before Dodecaethyleneglycol monolaurate, relabeling, repackaging, or February 5, 1996, may also submit in laureth 10S, reformulating. Comments regarding the writing new data demonstrating the methoxypolyoxyethyleneglycol 550 impact of this rulemaking on OTC safety and effectiveness of those laurate, nonoxynol 9, octoxynol 9, vaginal contraceptive drug products conditions not classified in Category I. phenylmercuric acetate, and should be accompanied by appropriate Written comments on the new data may phenylmercuric nitrate have been documentation. Because the agency has be submitted on or before April 3, 1996. present as ingredients in OTC vaginal not previously invited specific comment These dates are consistent with the time contraceptive drug products. Based on on the economic impact of the OTC periods specified in the agency’s final the available evidence, the agency has drug review on vaginal contraceptive rule revising the procedural regulations Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6903 for reviewing and classifying OTC of Food and Drugs, it is proposed that (b) Any drug product that is labeled, drugs, published in the Federal Register 21 CFR part 310 be amended as follows: represented, or promoted for OTC use as of September 29, 1981 (46 FR 47730). a vaginal contraceptive is regarded as a Three copies of all data and comments PART 310ÐNEW DRUGS new drug within the meaning of section on the data are to be submitted, except 1. The authority citation for 21 CFR 201(p) of the Federal Food, Drug, and that individuals may submit one copy, part 310 continues to read as follows: Cosmetic Act (the act), for which an and all data and comments are to be Authority: Secs. 201, 301, 501, 502, 503, approved application or abbreviated identified with the docket number 505, 506, 507, 512–516, 520, 601(a), 701, 704, application under section 505 of the act found in brackets in the heading of this 705, 721 of the Federal Food, Drug, and and part 314 of this chapter is required document. Data and comments should Cosmetic Act (21 U.S.C. 321, 331, 351, 352, for marketing. In the absence of an be addressed to the Dockets 353, 355, 356, 357, 360b–360f, 360j, 361(a), approved new drug application or Management Branch (address above). 371, 374, 375, 379e); secs. 215, 301, 302(a), abbreviated new drug application, such 351, 354–360F of the Public Health Service Received data and comments may also Act (42 U.S.C. 216, 241, 242(a), 262, 263b– product is also misbranded under be seen in the office above between 9 263n). section 502 of the act. a.m. and 4 p.m., Monday through 2. Section 310.535 is added to subpart (c) Clinical investigations designed to Friday. E to read as follows: obtain evidence that any drug product In establishing a final rule for OTC labeled, represented, or promoted for vaginal contraceptive drug products, the § 310.535 Drug products containing active ingredients offered over-the-counter (OTC) OTC use as a vaginal contraceptive is agency will ordinarily consider only safe and effective for the purpose data submitted prior to the closing of for human use as a vaginal contraceptive. (a) Dodecaethyleneglycol intended must comply with the the administrative record on April 3, requirements and procedures governing 1996. Data submitted after the closing of monolaurate, laureth 10S, methoxypolyoxyethyleneglycol 550 the use of investigational new drugs set the administrative record will be forth in part 312 of this chapter. reviewed by the agency only after a final laurate, nonoxynol 9, octoxynol 9, rule for OTC vaginal contraceptive drug phenylmercuric acetate, and (d) After (date 12 months after date of products is published in the Federal phenylmercuric nitrate have been publication in the Federal Register of Register, unless the Commissioner finds present as ingredients in OTC vaginal the final rule), any such OTC drug that good cause has been shown that contraceptive drug products. The product initially introduced or initially warrants earlier consideration. evidence currently available shows that delivered for introduction into interstate clinical studies in humans are necessary commerce that is not in compliance List of Subjects in 21 CFR Part 310 to establish the effectiveness of with this section is subject to regulatory Administrative practice and nonoxynol 9 and octoxynol 9 in final action. procedure, Drugs, Labeling, Medical formulation for use in OTC vaginal Dated: January 10, 1995. devices, Reporting and recordkeeping contraceptive drug products. There are William K. Hubbard, requirements. inadequate data to establish the safety Therefore, under the Federal Food, and effectiveness of any other Interim Deputy Commissioner for Policy. Drug, and Cosmetic Act and under ingredients offered for use as OTC [FR Doc. 95–2631 Filed 2–2–95; 8:45 am] authority delegated to the Commissioner vaginal contraceptive drug products. BILLING CODE 4160±01±F federal register February 3,1995 Friday Notice andFinalRule Proceedings ConcerningAirportFees; Charges; andRulesofPracticefor Policy RegardingAirportRatesand 14 CFRPart302 Federal AviationAdministration Office oftheSecretary Transportation Department of Part IV 6905 6906 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices DEPARTMENT OF TRANSPORTATION Transportation (OST) and the FAA to aeronautical users must be fair and issued two related notices on the subject reasonable, with more detailed guidance Office of the Secretary of Federal policy on airport rates and on the practices and restrictions that Federal Aviation Administration charges. A notice of proposed policy define ‘‘fair and reasonable.’’ The entitled ‘‘Proposed Policy Regarding guidance for this principle incorporates [Docket No. 27782] Airport Rates and Charges’’ listed and flexibility to deviate from the proposed explained the principles that the policy guidance based on agreement Policy Regarding Airport Rates and Department believes define Federal with aeronautical users; recognition that Charges policy on the rates and fees that an both compensatory and residual pricing AGENCY: Office of the Secretary and airport proprietor can charge to approaches are legitimate; standards for Federal Aviation Administration (FAA), aeronautical users of the airport. Docket the valuation of airport property in Department of Transportation (DOT). No. 27782 (59 FR 29874, June 9, 1994). establishing rates; prescription of the Notice 94–18, a notice of proposed kinds of costs that can be reflected in ACTION: Policy statement; request for comments. rulemaking entitled ‘‘Rules of Practice the rate base for aeronautical users; and for Federally Assisted Airports,’’ guidance on subsidization of other SUMMARY: This document announces proposed detailed procedures for the airports. The policy makes certain DOT and FAA policy on the fees filing, investigation, and adjudication of distinctions in the reasonable charged by Federally-assisted airports to complaints against airports for alleged accommodation of air carriers versus air carriers and other aeronautical users. violation of Federal requirements other aeronautical users, and does not The statement of policy was required by involving rates and charges and other establish fee standards for rates and the Federal Aviation Administration airport-related requirements (59 FR charges for nonaeronautical users or Authorization Act of 1994, Public Law 29880, June 9, 1994). limit the amount of revenues generated 103–305 (August 23, 1994). While the The FAA Authorization Act of 1994, by nonaeronautical rates and charges. policy stated in this document is Public Law 103–305 (1994 The third principle restates the legal effective immediately, the Department is Authorization Act) was signed into law prohibition on unjustly discriminatory requesting further comment on the on August 23, 1994. In response to rates and charges. policy adopted because of substantial provisions in the 1994 Authorization The fourth principle restates the legal industry interest in the proposed policy Act that specifically address airport obligation of the airport sponsor to and because the final policy adopted rates and charges, the Department maintain a fee and rental structure that differs in several respects from the issued a supplemental notice of makes the airport as self-sustaining as proposal, in response to comments proposed policy with revisions to reflect possible. Supplemental guidance received on the proposal. relevant provisions of the Act. (59 FR encourages the sponsor of an airport DATES: Comments must be received by 51835, October 12, 1994). The relevant that is not currently self-sustaining to May 4, 1995. provisions of the 1994 Authorization establish long-term goals and targets to Act were summarized in the October 12 make the airport financially self- ADDRESSES: Comments should be notice. sustaining. While the requirement that mailed, in quadruplicate, to: Federal The 1994 Authorization Act also an airport be as self-sustaining as Aviation Administration, Office of Chief required that the Secretary issue two possible under the circumstances Counsel, Attention: Rules Docket (AGC– other documents relating to airport fees existing at the airport is required by 10), Docket No. 27782, 800 and finances: first, procedural rules for statute to be included in each sponsor’s Independence Avenue, SW., the resolution of disputes between air grant assurances, and is subject to Washington, DC 20591. All comments carriers and airport owners and enforcement by the FAA in accordance must be marked: ‘‘Docket No. 27782.’’ operators regarding airport fees; and with its grant compliance procedures, it Commenters wishing the FAA to second, policies and procedures for the is not the intent of the Department that acknowledge receipt of their comments enforcement of Federal restrictions on this requirement alone be the grounds must include a preaddressed, stamped the use of airport revenue. The for a complaint as to the reasonableness postcard on which the following procedural rules are being published in of an airport fee. statement is made: ‘‘Comments to the Federal Register on the same date as The fifth principle restates the basic Docket No. 27782.’’ The postcard will be this Policy Regarding Airport Rates and legal requirements for the application date stamped and mailed to the Charges; the policies and procedures on and use of airport revenues. commenter. revenue use and revenue diversion will Supplemental guidance on the use of Comments on this Notice may be be published within the next several airport revenue has been deleted from examined in room 915G on weekdays, weeks. the statement of policy on airport fees, except on Federal holidays, between and instead will be incorporated in a 8:30 a.m. and 5 p.m. Summary of Policy Statement separate statement of policy on the FOR FURTHER INFORMATION CONTACT: John The policy statement being adopted enforcement of the revenue use Rodgers, Director, Office of Aviation retains the structure of the proposed provisions of the Airport and Airway Policy, Plans and Management Analysis, policy, and is organized into five Improvement Act of 1982 and the 1994 Federal Aviation Administration, 800 general principles with supporting FAA Authorization Act. Independence Ave. SW., Washington, guidance for each. In brief, the first DC 20591, telephone (202) 267–3274; principle establishes the continued Comments on the Notices of Proposed Barry Molar, Manager, Airports Law reliance on direct local negotiation Policy Branch, Office of the Chief Counsel, between airports and aeronautical users. The Department received more than Federal Aviation Administration, 800 The Department is available to resolve 150 comments on the Notice and Independence Avenue, SW., the issues raised in a dispute when the Supplemental Notice of Proposed Washington, DC 20591, telephone (202) airport and aeronautical users are Policy. Comments were received from 267–3473. unable to resolve disputes directly. all segments of the airport community, SUPPLEMENTARY INFORMATION: On June 9, The second principle restates the legal including airport operators and 1994, the Office of the Secretary of requirement that rates, fees and charges representative organizations; Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6907 associations representing air carriers businesses and airports. In particular, The policy statement adopted applies and commuter airlines; representatives more access to evidentiary hearing to all fees charged to air carriers for of other aeronautical businesses at procedures should be available to non- aeronautical uses, although the policy airports; general aviation carrier complainants than proposed by itself makes clear that carriers and representatives; representatives of the Department. airport operators have wide latitude to airport concessionaires; aviation In the policy adopted, the Department agree on alternate arrangements. The consultants and law firms; and the staff has continued to apply the policy to rules for implementation of the dispute of the Bureau of Economics of the rates and charges assessed against all resolution procedure provided in § 113 Federal Trade Commission. Many of the aeronautical users. Existing grant of the 1994 Authorization Act clarify comments from airport operators and assurances obligate airport proprietors that expedited ALJ procedures will be representatives were similar, and all of to give access on fair and reasonable not be applicable to rates and charges the comments tended to focus on certain terms to all types, kinds, and classes of excluded by § 113. However, The issues. Accordingly, the following aeronautical uses. However, where Department will consider claims that a discussion of comments is organized by differences exist as a practical matter fee is not covered by the exclusion issue rather than by commenter. Issues between air carriers and other kinds of because it was not in fact ‘‘imposed are grouped by their applicability aeronautical users, those differences pursuant to a written agreement,’’ even generally or to one of the five principles have either been reflected in the if a written agreement is in effect. Also, stated in the policy. Airport proprietors guidance stated in the policy, or the claims that are not subject to the § 113 and representatives who took the same policy will be applied with sufficient dispute resolution procedure position on an issue are collectively flexibility to reflect those differences. technically may still be brought under referred to as ‘‘airports;’’ the Air Some commenters noted that § 113 of 14 CFR Part 13, which applies to Transport Association (ATA) and other the 1994 Authorization Act applies only complaints that an airport proprietor air carrier commenters are referred to as to air carriers and argued that the policy has violated the grant assurance that ‘‘air carriers.’’ The summary of statement should be similarly limited. rates and charges for aeronautical users comments is intended to represent the However, § 113 relates only to the will be fair and reasonable. general divergence or correspondence in procedures for special handling of C. Should the policy and procedures industry views on various issues, and is airport-airline fee disputes; it does not apply differently to different uses of the not intended to be an exhaustive define limits on the applicability of airport facilities by air carriers? restatement of the comments received. policy. All comments received were considered Several airports commented that The policy adopted applies to foreign elements of the policy may be by The Department even if not air carrier rates as well as those imposed specifically identified in this summary. appropriate when applied to the airfield on domestic air carriers. The principles and terminal, but would not be Discussion of Comments Received and guidance contained in the policy appropriate if applied to other facilities statement are consistent with the The final policy statement includes an leased or used by carriers on the airport. provisions of bilateral air service expanded introduction that reflects the The Department agrees, and the policy agreements, and the application of the discussion below. adopted makes distinctions, where same policy on fair and reasonable applicable, between various kinds of 1. General: Scope of Policy and airport fees to both foreign and U.S. air facilities on the airport. Procedures carriers is appropriate. D. What airport users/tenants are A. Should the policy apply to all B. Should the policy and procedures apply to rates excluded by section 113? included within the term ‘‘aeronautical aeronautical users or just air carriers? users’’? Airports commented that policy and Airports commented that the policy related procedures should apply only to and implementing regulations should Airport commenters in particular rates and charges imposed on air clearly exclude rates and charges stated that the term aeronautical user carriers. The policy is mandated by specifically excluded by the statute, e.g., was not clearly defined, and that it was § 113 of the 1994 FAA Authorization rates established by agreement; Congress not clear whether the policy applied to Act; based on the terms of § 113, the directed that the policies and certain businesses commonly found on policy should be limited to air carriers. procedures not apply to such excluded an airport but which arguably are not If new policy guidance is needed for rates; in addition, the policy should ‘‘aeronautical’’ in nature. Also, fees assessed on other aeronautical reflect § 47129(f), which states that that representatives of concessionaires who users, the issue should be addressed section shall not adversely affect the commented on the proposal conceded separately. The American Association of rights of any party under any existing that concessions such as car rentals Airport Executives (AAAE) and some written agreement between an airport were not aeronautical activity, but individual airports specifically objected and air carrier or the ability of an airport argued that the rates and charges policy to the inclusion of foreign air carriers. operator to meet its debt obligations. and dispute resolution procedures Commenters suggested that automatic Air carriers commented that the should apply to concessions. inclusion of foreign air carriers would policy should recognize that it is The final policy statement does not provide them with valuable rights common for airports to increase fees by substantially differ from the proposal. ordinarily secured through negotiation asserting that the increase is a routine The Department believes that in most of intergovernmental agreements. adjustment to a preexisting agreement, cases it is immediately clear whether a General aviation commenters stated even if the agreement does not allow for particular airport business is an that the Department should provide the such an increase; therefore; the policy aeronautical activity or not within the same rights and protections for all should make clear that a dispute as to definition given in the policy. Where an aeronautical tenants, not just air whether a fee increase is within the ambiguous situation exists, an airport carriers. However, the policy should terms of a contract or not should be operator or airport user may contact the reflect differences in the relationships covered by the policy to the same extent FAA Office of Airport Safety and between air carriers and airports and as a fee increase imposed in the absence Standards, AAS–300, for a those between other aeronautical of any agreement. determination. 6908 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 2. General: Proprietary Powers of disputes, ATA argued, and airports a brief list of the information that the Airport Operators should not be permitted to adopt new Department believes would provide Airports commented that the policy fees unilaterally after failing to reach a carriers the justification for a particular adopted must preserve the airport’s consensus; such a policy would give fee and sufficient information to assess right, as landlord, to set fees and charges airports carte blanche to impose an the reasonableness of the fee. The when consensus is not possible. If the unreasonable fee. information, in summary, is historic General aviation representatives policy establishes narrow federal financial information for the two years commented that at hundreds of general standards, it would eliminate incentives prior to the change in the fee at issue; aviation airports operated by local to set fees and resolve disputes at the economic, financial and/or legal governments, unreasonable economic local level. Policies should not be so justification for the change; aeronautical requirements can be imposed without cost information; numbers of passengers rigid as to stifle innovation that may effective challenge. and aircraft operations for the two lead to more efficient financing and In light of the enactment of § 113, the preceding years; and certain planning management of airport facilities. Department believes that it is not at all and forecasting information. The list is Airports argued that the Department clear that the presumption of validity especially should not allow carriers to general, for adaptability to different normally associated with governmental airport and local government accounting invoke the policy to challenge the actions applies to the imposition of and recordkeeping, and is not intended wisdom of particular infrastructure airport fees on air carriers. Even before to include every category of information enhancement or airport expenditures. enactment of § 113, some judicial that may be relevant to each fee dispute. Such an outcome would be perceived in decisions recognized that the traditional The procedural rules adopted for the the capital market as shifting presumption may not apply in cases of resolution of airport-air carrier fee management prerogatives away from the airport rate-setting. See, for example, disputes address the exchange of airport and would result in higher Raleigh-Durham Airport Authority v. information. Following a complaint financing costs. The policy, airports Delta Air Lines, 429 F. Supp. 1069, 1083 under 49 U.S.C. § 47129, if the airport argued, should make clear that a fee to (D.N.C., 1976); New England Legal proprietor has not previously made that cover debt service for a completed Foundation v. Massachusetts Port information available to carriers, the project cannot be challenged as Authority, 883 F.2d 157, 169 (1st Cir. rules provide for discovery. The unreasonable after the project comes on 1989) (Massport II). In Kent County, the Department has not acted to require line and the debt service costs are added Supreme Court applied the relatively disclosure of information on a fee to the rate base. deferential standard of the Evansville increase by regulation, but the agency Airports are operated by state or local decision in part because the parties will reconsider that decision if governmental entities to meet invited its use, and the Court noted that experience indicates that airports are community and national needs. Prior the Secretary had discretion to ‘‘apply not providing sufficient information to Department statements, including the some other formula (including one that carriers during consultation on fee Government’s amicus curiae brief to the entails more rigorous scrutiny).’’ Kent increases. Supreme Court in Northwest Airlines v. County, at lll, n. 14. The policy In the statement on the timing of County of Kent, Michigan (510 U.S. adopted does not expressly affirm or consultations, the Department has lll ; 114 S.Ct. 855; 127 L. Ed. 2d 183 displace the presumption of validity inserted ‘‘if practical’’ in the language (1994) ‘‘Kent County’’) and Secretary that may apply to local government suggesting consultation well in advance Pen˜ a’s December 1993 letter, recognize actions. In response to comments of a fee change. Finally, in response to that airport proprietors have latitude to relating to challenge of project the recommendation by several set fees to meet immediate and longer- decisions, the Department considers the commenters for arbitration or mediation term needs of airports. Actions of state dispute resolution process to apply to clauses in leases, the Department has and local government are presumed at significant disputes actually related to added language encouraging the use of law to be reasonable and lawful. This fees, and do not intend to make the alternate dispute resolution in lease and same presumption, the airport process available to challenge particular use agreements. commenters argued, should apply to the capital construction projects after the 4. Fair and Reasonable Rates: establishment of rates and charges, even fact under the guise of challenging the when imposed unilaterally by a Compensatory and Residual Costs reasonableness of associated rates and Methodology proprietor through ordinance or charges. regulation. The Supreme Court, in the Airport commenters generally Kent County litigation, recently 3. Local Negotiation and Consultation supported the policy approach that reaffirmed the standard of Air carriers requested that the final recognizes the discretion of an airport reasonableness first enunciated in the policy include a more specific proprietor to establish compensatory or Evansville decision; this standard description of the information that residual methodology, or a combination afforded substantial deference to the airports are expected to provide to of the two. Airports also generally airport proprietor. Airport commenters carriers in connection with a fee accepted the policy that airports could further argued that in keeping with the increase, and one carrier suggested that not unilaterally impose a residual presumption of validity, air carriers consultations and information exchange system absent carrier agreement, filing complaints under § 113 of the be required rather than just encouraged. although two commenters suggested FAA Authorization Act should bear the Airports commented that the that § 113 gives an airport proprietor a burden of proving unreasonableness. statement that consultations should be right to impose a residual costing ATA stated that airports possess conducted well in advance of changes to methodology even absent agreement. monopoly power, which in recent years fees did not acknowledge that local Air carriers stated that the policy has not been kept in check. Section 113 governments must sometimes act must deal realistically with the fact that of the 1994 FAA Authorization Act was quickly, to avoid revenue shortfalls or excessive revenues can and will be enacted to respond to this potential for other reasons. generated by an airport’s shifting of all monopoly power by providing for active The Department has included, in an costs to airlines and all profits to itself; DOT involvement in airport-carrier appendix to the final policy statement, the policy should not exclude from Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6909 consideration revenues derived from base if the facility at issue supports the appropriate because other airports may activities such as concessions and aeronautical activity being charged, and have different credit ratings and, parking, which are also the product of the allocation to aeronautical users is in therefore, different capital costs. aviation activities. Failure to consider proportion to the aeronautical purpose ATA argued that routine inclusion of such revenues to be ‘‘aviation related,’’ and use of the facility. ‘‘implied capital costs’’ is inconsistent carriers argued, is inconsistent with the For example, the costs of roadways on with the concept of dedicated aviation requirement in § 110 to take all airport the airport that provide public access to resources; an airport should not be revenue into consideration in setting the passenger terminal could not be allowed to collect interest for use of its aeronautical fees. charged entirely to any class of own reserves; allowance of implied The Department has retained the aeronautical users. However, a portion capital costs is a device to generate more policy as proposed. The approach of roadway costs could be included in revenue than is needed for airport requested by ATA was specifically the rate base for the terminal building, purposes in violation of the rejected by the Supreme Court in the for example, so long as the portion of congressional direction that airports Kent County decision, and § 113 the shared costs allocated to terminal should not seek to accumulate excessive expressly preserves an airport users does not exceed an amount that reserves. proprietor’s right to use a compensatory reflects the respective aeronautical and The final policy adopted by the methodology, which does not require nonaeronautical use of the same facility. Department continues to permit the carrier agreement or the cross-crediting The Department does not expect the use charge of imputed interest on the of concession revenues. Moreover, § 110 of any particular formula for the expenditure of airport funds generated recognizes that airports may depend on determination of aeronautical portion of from non-aeronautical sources, but not revenue generated from non- shared costs, because the circumstances on those generated from aeronautical aeronautical uses for airport capital may vary. For example, an airfield uses. While ATA is correct that all improvements and other airport system crash-fire-rescue facility may exist reserves must generally be used for purposes. Accordingly, the policy primarily to support Part 121 air carrier airport purposes, Federal law does not adopted does not define concessions operations, but may actually be used require that the funds be used for and parking as aeronautical revenue or primarily for landside public emergency aeronautical activities. Therefore, an require the cross-crediting of concession calls. An airport proprietor must be able airport decision to fund an aeronautical revenue to carriers. However, as to justify the reason for the allocation activity is an investment choice that discussed below, terminal costs and used. benefits aeronautical users, and the other shared costs must be allocated reasonable costs of that investment, 6. Fair and Reasonable Rates: Imputed fairly among aeronautical and including imputed interest, are Interest and Rate of Return nonaeronautical users. appropriately recoverable in the Airports argued that the final policy aeronautical rate base. The policy 5. Fair and Reasonable Rates: Allowable should expressly provide that while the provides that the borrowing rate, rather Capital Costs rates charged to aeronautical users than interest obtainable, is the Airports commented that capital costs cannot exceed costs of providing appropriate measure of reasonable allowed in the rate base should services, those costs should be imputed interest for a public entity. specifically include such ‘‘indirect’’ considered to include a reasonable rate The Department does not agree with costs as debt coverage, cash and capital of return on investment; the return the comment that imputed interest reserves, and allocation of some airport should apply to all internally generated should be allowed for the use of funds capital expenditures, e.g., roadways, in funds, regardless of source; a reasonable generated by aeronautical uses. First, a the carrier rate base. rate of return would permit an airport rate of return or imputed interest on the ATA did not comment specifically on proprietor to accumulate cash reserves, use of aeronautical revenues is not what capital expenditures should be which may be necessary as a condition necessary for bond coverage and other allocated to aeronautical users, but of financing agreements and to reserves, because the policy adopted expressed concerns that airport compensate a proprietor for the risk of expressly allows the establishment of proprietors are seeking unconstrained undertaking a particular investment; such reserves as a direct cost. Second, rights to generate ‘‘excessive surpluses’’ and allowance of rate of return will the use of any reserves generated from based on airport proprietors’ assertions assure that the Department’s policy is aeronautical revenues does not carry that adequate reserves are necessary. consistent with Article 10 of the United with it any implicit cost to the airport The final policy clarifies that the States-United Kingdom Air Services for the use of capital, since the reserve reserves and coverage required in bond Agreement (‘‘Bermuda 2’’), which was generated by direct charge to users; indentures and other debt instruments, permits a competent charging authority the Department sees no justification for as well as reserves to cover normal to recover a reasonable return. Airport an additional charge for the use of these income fluctuations and unforeseen commenters further argued that airport funds for the purposes for which they contingencies, may be included in the proprietors should be permitted to were collected. rate base. The final policy statement recover the implicit cost of capital for To the extent that airports would also clarifies policy regarding what internally generated funds without justify a particular rate of return policy some commenters referred to as regard to source, aeronautical or on the basis of bilateral agreements such ‘‘indirect’’ capital expenditures, which nonaeronautical; in addition, the rate as Bermuda 2, that reliance is the Department understands to refer to allowed should be the highest of either misplaced; Bermuda 2 does not obligate airport facilities that support the rates of return available on the the United States to permit its airports aeronautical use of the airport but proprietor’s investment at the time of to earn a rate of return; rather the which also receive nonaeronautical use, the capital expenditure (lost investment provision requires that each country such as airport roads and fire-rescue opportunity rates) or the cost of recognize the other’s authority to permit facilities. The policy provides that costs borrowed funds available to the airport its airports to earn a rate of return on allocable to both aeronautical and proprietor at the time of the assets, after depreciation, to the extent nonaeronautical uses, or shared costs, expenditure; rates prevailing on bonds provided by the domestic law of each may be included in a particular rate at similarly-sized airports is not country. 6910 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 7. Fair and Reasonable Rates: Allowable 8. Fair and Reasonable Rates: Facilities that reflect historical cost asset Environmental Costs Currently in Use valuation. For many assets that are fully Airport commenters stated that the Airports asserted that the only proposed limitation of allowable costs depreciated, including terminals, the restriction in current law is that costs use of historic cost valuation would to reasonable environmental costs must relate to the development or should be stricken; the costs of result in a subsidy to carriers in the improvement of an existing airport; the form of rental rates that did not reflect compliance with all Federal, state, and restriction to the costs of facilities in use local environmental mandates, the value of the facilities. In addition, a is overly restrictive and not supported strict historic cost requirement could including clean air and clean water by law. Airports argued that land and requirements, mitigation required to expose airports to claims of unjust construction costs should be recoverable discrimination if carriers using newer obtain approvals for development before a facility is in use; the proposed projects, and all expenditures for noise facilities are charged more than carriers policy does not even clearly permit using older facilities that are fully mitigation should be includable in the recovery of costs for borrowing to rate base; the policy should clarify that depreciated. At a minimum, some finance improvements until project airports urge that the policy make clear mitigation (such as wetlands completion, which could lower bond replacement) may occur on or off that blending of asset values is ratings and postpone land acquisition, permitted to avoid this problem. airports. Also, airports argued, because thereby increasing project costs. the airport proprietor is liable for noise Further, airports claimed that the use Comair praised the currently-in-use damages, the sponsor’s judgment in of historic cost valuation may distort the limitation on the grounds that it would developing a noise mitigation program perception of the relative value of impose needed discipline on airport should be given deference. Airport existing and new facilities. A new expansion policies that show little commenters also argued that the facility may fail the test of economic regard for airline profitability. limitation to current expenditures for feasibility based on the disparity environmental costs should be removed; The Department continues to believe between fees based on historic costs of airports should have discretion to that the traditional approach of limiting the original facility and those based on include in the rate base reserves to fund recovery of costs to facilities in use is current costs of a new facility. any future liability for cleanup of clear, easy to administer, widely Moreover, in the case of gates and other environmental contamination likely to accepted, and supported by judicial terminal facilities and other facilities result from current operations. decisions. Accordingly, the final policy such as hangars or flight kitchens, air The carrier view is that airport statement continues to provide that only carriers themselves recognize the value proprietors should not be permitted to the costs of facilities currently in use of the facilities by subleasing at rates prefund future environmental liability may be included in the rate base; higher than historic value. A policy for environmental remediation, other financing costs incurred for requiring airports to value their facilities than through documented self-insurance construction, including debt service and at historic value would allow airlines to requirements, subject to standard reserves, may be recovered at the time enjoy a windfall in the form of a industry conventions and practices. a facility comes on line. Users may, of differential between the market rates The final policy statement adopted by course, agree to incur present costs for they can obtain for subleases and rates the Department adds language clarifying a future facility. The policy continues to paid to the airport based on historic that the following environmental costs, provide that current costs of planning cost. The public interest would be better to the extent actually incurred by the for future facilities may be recovered as served, airports argued, if the airport airport proprietor, will be presumed to they are incurred. proprietor were able to capture this appreciation through market-based rates be reasonable costs: 9. Fair and Reasonable Rates: Asset • and to apply the proceeds for the Costs of complying with Federal, Valuation state, and local environmental laws and development of airport infrastructure. regulations, provided that, in the case of Airport comments: Airports It was also argued that historic cost local requirements, such requirements commented that the proposed limitation valuation could limit the effectiveness are applied to other similarly situated on valuation of airport property to of peak period pricing. If an airport is enterprises (to avoid possible historic cost is unduly restrictive; is not unable to reflect the opportunity costs of impermissible use of airport revenues). required by existing legal its scarce assets in its rate base, the • Mitigation requirements on or off interpretations; is inconsistent with maximum peak price that can be airport associated with airport existing airport practice and Department charged may not be enough to cause development (for aeronautical use). policies; is inconsistent with the traffic to shift away from the peak • Noise mitigation pursuant to an objective of promoting efficient use of period. approved Part 150 program or other resources; and could interfere with the The proposed historic cost publicly-disclosed airport noise successful implementation of peak requirement, in the airports’ view, is not compatibility program; period pricing. Commenters stated that supported in law or FAA policy. • Costs of insurance or self-insurance airports typically use various asset Decisional law is clear that results, not for correction or cleanup of valuation methods for their assets, methodology, are significant in environmental damage. The Department including current cost, fair market determining reasonableness. In agrees with carrier comments that value, or the use of inflation indices addition, under the Evansville standard, considerations of forward financing of (although few individual airport a rate is considered reasonable if based environmental cleanup costs do require proprietors claimed to be using other on some fair approximation of use and some limitation on the charge to current than historical valuation). In addition, not excessive in comparison with the users, and the policy limits self- rates and charges for many aeronautical government benefit conferred. A rate insurance costs to costs incurred assets are based on percentage of gross based on the standard of ‘‘benefit pursuant to a formal self-insurance revenue. The use of indices and gross conferred’’ will in most cases be program that meets applicable insurance revenue formulas is not generally different from rate based on a facility’s industry standards. expected to result in rates and charges historic cost. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6911 Airports also pointed to FAA policy services that reflects the age of facilities, objectives and direction of the AAIA statements that apparently support rather than true economic costs. and Public Law 103-305, in addition to alternative valuation methods. FAA’s FTC staff recognized that airport being the most widely accepted Order 5190.6A recommends that long services are not generally produced in methodology under applicable term leases include automatic escalation competitive markets. Therefore, airport standards for both public finance provisions based on recognized proprietors might possess monopoly accounting and ratemaking. The economic indicators. In addition, the market power in pricing their services. financial and accounting standards Order identifies a fee for use of landing However, FTC staff maintained that issued by the Financial Accounting areas based on a specified percentage of there are effective means for the Standards Board and the Government ticket sales to enplaning passengers as Department to regulate the pricing of Accounting Board, which form the basis acceptable. Neither of these airport services other than cost of of Generally Accepted Accounting methodologies would produce rates service pricing based on historic costs. Principles (GAAP), prescribe historic based on historic costs. While cost-of-service regulation based cost valuation as the accepted Finally, airports stated that the DOT on historic costs has typically been used accounting convention for valuing the Office of the Inspector General (DOT/ in the United States, FTC staff assets of local government enterprise OIG) has criticized the failure of airports commented that this approach has a functions such as airports. The to obtain fair market value for number of defects. Failure to use a valuation of assets for purposes of an aeronautical rentals. The DOT/OIG pricing system that reflects opportunity accurate financial statement is position indicates that use of costs could lead to greater levels of somewhat different from the objective of methodologies other than historic cost is airport capacity than is warranted by establishing lease rates, but does at least permitted, if not mandated by economic efficiency, as excess demand indicate the longstanding general assurances relating to maintaining a fee leads to congestion and delays which in acceptance of historic cost valuation as and rental structure that will make the turn lead to calls for new capacity. the standard. airport as self-sustaining as possible. Even if a cost basis other than historic Air carrier comments: Air carriers costs is used, FTC staff believed that As recognized by commenters on both considered the concept of using historic cost-of-service regulation can be a sides of the cost valuation issue, historic costs for asset valuation to be sound and source of economic inefficiency. One cost has also been the standard for use consistent with Federal law. While regulatory alternative that addresses in the establishment of rates in parties might mutually agree to another some of these shortcomings is price-cap regulated industries. However, as valuation method, the policy must regulation. Under price-cap regulation, several commenters noted, the rates provide that only historic cost valuation the regulator sets a price ceiling, but the charged by airport proprietors are not may be unilaterally used, to protect firm is free to charge any price below perfectly analogous to public utility against rampant overcharging and this ceiling. The price ceiling is adjusted rates, and the Department has not accumulation of excess surpluses by periodically by a factor that is strictly applied the principles of public airports. Airports have access to capital independent of the firm. Price cap utility ratemaking law in developing the for replacement of assets without regulation has been used in the policy. Nevertheless, many of the generating excess revenue from other privatization of nationalized industries reasons for the use of historic cost apply valuation methodologies. The use of in the United Kingdom, including to both public and private enterprise historical cost valuation is quickly and airports, and in the telecommunications activities. Historic cost is the simplest, easily verifiable and eliminates industry in the United States. most direct, and easiest-to-verify instability in the rate base. Final policy statement: The final measure of cost. Moreover, in a FTC comments: The staff of the policy retains the historic valuation regulatory system in which the Bureau of Economics of the Federal principle proposed; for property other proprietor’s revenue is limited to the Trade Commission (FTC) submitted than airfield and land, however, the costs of providing services, historic cost comments on the proposed policy, with policy permits airport operators to use valuation provides for full the caveat that the comments do not other valuation methods if the reimbursement of actual costs incurred necessarily represent the views of the methodology does not result in total by the proprietor. The airport fee policy Commission or of individual aeronautical revenues exceeding total adopted by the Department does limit commissioners. FTC staff took the aeronautical costs and if the the revenue that can be generated from position that the requirement to use methodology is applied consistently for aeronautical uses to the costs of historic costs will not promote the similar facilities. If an airport proprietor providing services, and historical cost efficient use of resources. Historic cost uses valuation other than historic costs valuation is, therefore, both sufficient valuation will likely result in prices that for establishing any aeronautical charge, and appropriate for determining the are below the value of airport facilities. the airport operator will be responsible amount of revenue (and the limit on When prices are below the value of for demonstrating that the methodology reasonable fees) that can be collected for facilities, excess demand results. If a is justified, upon complaint by an air aeronautical uses. The use of an community is served by two airports carrier or other aeronautical user. Where alternative methodology such as built at different times and fees are similar facilities have a different historic replacement cost valuation, for example, based on historic costs, airlines will be cost basis, the cost may be averaged would generate funds in excess of past attracted to the older, lower-cost airport across all similar facilities to produce a and current costs, and could result in and avoid the newer, more expensive common rate. the accumulation of excess funds that one. Demand at the older airport would The Department recognizes, as many could be used for the replacement of the have to be rationed by nonprice means. of the airports and FTC staff facilities being used or for any other Carriers compete by offering commented, that valuation based on airport purpose. The accumulation of connecting service over various hubs. other than historic cost may be surplus aeronautical revenues for Because fees charged by hub airports are justifiable in certain situations. replacement of facilities is not permitted a determinant of air fares, it is important Nonetheless, we continue to believe that by the policy adopted, which limits that competition between carriers not be the use of historic cost asset valuation charges to recovery of costs for facilities distorted by a pricing system for airport methodology is consistent with the in use. Nor are the surplus funds that 6912 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices would be generated by replacement cost historic cost is used to determine some deviation from this policy with pricing needed for other purposes, since rates. First, aeronautical revenues in the justification. aeronautical users can be charged aggregate cannot exceed the cost of FTC staff acknowledged that the directly for the amounts needed to aeronautical facilities (valued at historic monopoly power of airport operators maintain debt service and coverage cost) and services provided, and the use requires some pricing regulation. With reserves, working reserves for normal of a valuation higher than historic cost respect to the use of price-cap regulation operations, and contingency funds. would not increase the total limit on suggested by FTC staff, such an Also, surplus funds for any airport aeronautical revenues since the total approach does not appear to be feasible. purpose can be accumulated from cost of aeronautical facilities would The examples cited by FTC staff revenues generated by nonaeronautical continue to be calculated using historic represented monopoly or near uses, which are not covered by the cost. Therefore, charging a market rate monopoly regimes where a cap was policy. In summary, historical cost not based on historic costs for one being set for one, or at most a handful valuation is the most widely used and category of leased aeronautical facility of firms. In contrast, there are more than accepted valuation methodology; it may require charging less than a full 400 commercial service airports and reimburses the airport proprietor fully compensatory rate for other facilities thousands of obligated airports that may for costs incurred; and it is consistent used by the same aeronautical users. be subject to the airport fee policy. The with the policy’s provision that fees Second, only historic cost valuation will Department cannot effectively establish charged to aeronautical users are limited be considered reasonable for airfield a separate price cap regime for each to the costs of services provided. facilities and land. Any potential effects regulated entity, and it is not clear that The Department believes that many of of inefficiency or subsidy would apply the benefits of a price cap regime would the impacts of historic costs noted by particularly to terminal and other be available if the Department were to airport commenters would not be as landside facilities, which may be develop a single industry standard problematic as the commenters suggest. exclusively leased. Accordingly, the formula. In the U.K. airport context, the First, historic costs would result in rents Department will consider the possibility British determined different price-cap substantially below market only where that a fee based on valuation other than values for each of the airports covered a facility has not been renovated, historic cost could be reasonable, but by the price cap regulation. Finally, the reconstructed, or replaced for many only with respect to facilities other than U.S. Government’s own experience with years. While there are such cases, it the airfield, and only to improvements, price cap regulation of airports in the would be the exception for airport not land. Finally, because historic cost United Kingdom demonstrates that in facilities. Second, increased use of valuation remains the standard in both order to be effective in preventing shorter airport leases reduces the public finance accounting and in excessive returns, price cap regulation instance of potential windfall situations, ratemaking methodology, historic cost must be implemented with care. Among in which a lessee who pays the airport asset valuation methodology will be other things, it is important to assure proprietor a historic cost-based rate is presumed to be reasonable for facilities that the base prices relied on do not able to sublease at market rates, because other than airfield facilities and land. themselves reflect excessive profits, the airport proprietor can reallocate the Subject to the general limit on total which in turn makes it necessary to property to the actual user after a aeronautical revenue, for facilities other undertake a cost-of-service evaluation of shorter time. Third, the policy adopted than airfield facilities and land an each firm’s costs and revenues. expressly permits airport proprietors to airport proprietor may demonstrate that 10. Fair and Reasonable Rates: Multiple average the historic cost basis of all an alternate valuation methodology is Airport Systems in the Rate Base property, new and old, in the same justified in the circumstances existing at general category (e.g., terminal gates). Airports generally commented that it the airport. Accordingly, lessees of similar facilities is unduly restrictive to require can be charged identical rates regardless The Department believes the policy quantification of the benefits of the of the age and original cost of each adopted represents the most reasonable secondary airport for inclusion of facility. Finally, the policy should not approach to valuation of airport assets, subsidy costs in the first airport’s rate result in any significant disruption of in consideration of the comments base; benefits will be difficult to existing practice. Historic cost is already received and the policy direction in quantify, and should be presumed if the the most widely accepted basis for asset recent legislation. The policy applies a airport has been designated as a reliever valuation; also, existing airport-air strict historical valuation standard to in the FAA’s National Plan of Integrated carrier agreements and air carrier fees core aeronautical use facilities, i.e., the Airport Systems (NPIAS); also, the that were not in dispute as of August 23, airfield and land. For terminal and blending of rates of multiple airports is 1994, are not subject to challenge under exclusively leased areas of the airport an accepted current practice and should the special expedited procedures in any the policy permits flexibility in rate continue to be considered reasonable. event. methodology and avoids disruption of The Airports Council International- That said, as airport commenters and existing arrangements, while at the same North America (ACI–NA) requested that the FTC staff noted, rates based on time discouraging accumulation of common ownership not be a historic cost can potentially result in excess revenues. prerequisite of inter-airport cost sharing. inefficiencies and unintended subsidies. The policy adopted is intended to ACI–NA notes that FAA permits the Accordingly, the Department believes cover the fees for use of aeronautical transfer of AIP entitlement funds that it is reasonable that airport facilities, and is not intended for strict between airports under different proprietors, where justification exists, application to a transfer of assets. The sponsorship; there is no reason to have some flexibility to use an asset policy applies the general rule that impose stricter standards on the valuation other than historic cost for the subsequent airport proprietors will airport’s own funds, as the benefits of a purpose of ratesetting. However, for acquire the cost basis of assets used in reliever airport are the same regardless overall aeronautical fees to be consistent the rate base at the original airport of ownership. AAAE and individual with the provisions of the policy, proprietor’s historic cost. However, operators of airport systems, including several limitations will necessarily requests for approval of the transfer of Kansas City and the Metropolitan apply when asset valuation other than airport assets may include requests for Washington Airports Authority, agree Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6913 with the Department proposal that charges, the Department should not 12. Unjust Discrimination: Charging common ownership be required, but further complicate matters by bringing Differential Based on Status as urge that the system proprietor be given in extraneous matters in this policy Nonsignatory Carrier wide latitude to blend rates. statement. The Regional Airline Airports argue that existing practices Air carriers supported the proposed Association (RAA) commented that and policy recognize an airport policy, arguing that while cross- peak pricing provides a cloak for unjust proprietor’s authority to establish subsidization has at times been discrimination against smaller aircraft reasonable classifications of carriers, for troubling, airlines have generally been operators, since smaller aircraft are less example signatory and non-signatory able to resolve issues at the local level. able to absorb the price differential on Carriers stated that the requirement of carriers, and to charge differential rates a per-seat basis; commuter carriers are accordingly. This practice should not be common ownership should not be especially affected because they cannot eliminated; and commented that it is overturned, even if the premiums practically use reliever airports and assessed result in a rate that exceeds ironic that airports are interested in must schedule during peak times to subsidizing other airports and at the allocated costs. meet connecting banks of jet operators; same time claim insufficient funding to The Department acknowledges the peak hour pricing will not expand meet their own needs. existing practice, and the final policy The Department has retained the capacity, and airport operators favor statement clarifies that reasonable policy as proposed, but have added the peak pricing because expanding distinctions, such as between signatory clarification that an airport designated capacity involves facing difficult and non-signatory carriers (i.e., carriers by the FAA as a reliever will be political and environmental issues. that respectively have and have not presumed to confer a reasonable benefit The National Air Transport entered into a use agreement with the on users of the primary airport. The Association (NATA) expressed concern airport proprietor), are permitted. Department continues to believe that the that peak-hour pricing language will be However, the limit on recovery of total best means to assure that benefits of used by airports to justify excessive fees costs would continue to apply. cross-subsidy are commensurate with to block or severely limit access by 13. Financially Self-sustaining: costs is where cross-subsidy is the result general aviation and on-demand charter Requirement That General Aviation of agreement. In the absence of such an operators. Airports be Self-sustaining agreement or designation by the FAA as The Aircraft Owners and Pilots a reliever in the NPIAS, the Department General aviation commenters Association (AOPA) objected to peak is reluctant to presume that benefit is expressed concern that the proposed pricing, which would only serve to limit commensurate, and believe it is policy did not recognize that and ration capacity. Airline scheduling reasonable to require that the subsidy commercial circumstances at many reflect a showing of actual benefits. practices would remain unchanged, airports would not support a rate The requirement for common with peak prices being absorbed by the structure that would both make the ownership is retained. The basis for a airlines system-wide. Noncommercial airport self-sustaining and permit reasonable fee is the compensation of general aviation operations could be commercial operators at the airport to the airport proprietor for the costs of priced out, even though general aviation earn a profit; the policy should not facilities and services it provides; the does not contribute to congestion at require proprietors of such airports to proprietor is not providing facilities most airports; general aviation adopt unreasonably high fees. owned by another sponsor. represents 5 to 10% of total flight The Department agrees that the The analogy to the transfer of operations at large hub airports and in requested change is consistent with the entitlement funds argued by airport many instances is able to use shorter intent of the proposed policy. The final commenters is not persuasive. parallel runways without affecting the policy statement includes language to Entitlement funds are Federal funds long runways used by airlines. clarify that Federal law does not require provided directly to the airport under The National Business Aircraft each obligated airport to be self- special criteria for grants, and are not Association (NBAA) also opposed peak sustaining, and that the Department subject to the same standard of pricing, which it argued should not be recognizes that some airports may not reasonableness that applies by statute to used as a substitute for capacity be able to achieve a self-sustaining any cross-subsidy charged to enhancement, and should not be condition. aeronautical users. imposed with discriminatory impact on 14. Financially Self-sustaining: 11. Unjust Discrimination: Peak Pricing small aircraft operators. Generation of Surpluses Airports supported the recognition in The Department has adopted the In general, airport comments the proposed policy that peak pricing is policy statement essentially as supported the approach of the policy not per se impermissible; peak pricing proposed, although the term statement and endorsed the treatment of can be an effective means of improving ‘‘maximize’’ efficient utilization of the § 110 of the FAA Authorization Act as efficient use of existing infrastructure. airport has been changed to ‘‘enhance’’ a matter under revenue generation, FTC staff also argued that peak pricing efficient utilization, a more realistic rather than as a matter relating to the would promote economic efficiency and standard. The peak pricing concept reasonableness of fees. Airports note avoid overbuilding of airport assets, and stated in the policy is adopted from the that some other provisions of the policy, urged that rates during peak periods be Department’s decision in the Massport for example the proposed historic cost permitted to reflect opportunity costs of PACE decision (Order and Opinion, requirement and limitation on rate of using scarce resources during peak December 22, 1988), and represents no return, could hinder an airport in times. change in existing Department policy. becoming as financially self-sustaining ATA and the International Air Peak pricing is specifically included in as possible. ACI–NA urged that the Transport Association (IATA) urged that the policy statement to clarify that the policy be modified to recognize that all references to peak pricing be new policy language on unjust some airports may never be able to eliminated; in light of the already discrimination does not affect the achieve self-sustaining status and that complex issues surrounding rates and existing policy on peak pricing. some aeronautical activities may be 6914 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices beneficial to the public even though the AAIA and would penalize airports provision’’ of § 511(a)(12) of the AAIA. they do not produce enough revenue to for preserving a sound financial The statement also indicates that FAA’s pay fair market value. AAAE stated that position. policy will continue to be to consider the requirement to make the airport as The City of Los Angeles Department accumulation of surplus funds as one self-sustaining as possible should be of Airports commented that paragraph factor militating against award of treated as the paramount principle in 5.6 should be clarified to permit airport discretionary grants. the review of airport fees; the remaining revenue to be used to directly or principles and guidance would follow indirectly influence use of the airport 16. Use of Airport Revenues: Policy on from that statutory directive. system, e.g., for promotional activity. Accumulation of Surpluses Air carriers found the statement of the AAAE commented that the detailed Airports commented that the self-sustaining principle in the proposed discussion of permissible and provision that accumulation of reserves policy to be consistent with existing impermissible uses of airport revenues may warrant FAA inquiry should be law, but urged that the requirement to should be deleted from the policy deleted, as should the provision be self-sustaining be defined in a statement on rates and charges, on the encouraging conversion of airport manner that prohibited airports from grounds that Congress mandated a surplus into airport improvements, accumulating massive surpluses. separate policy statement; existing because accumulated surpluses provide Several general aviation commenters paragraphs should be replaced with a tangible benefits to airports. As noted, stated that the requirement to be self- simple statement referring to applicable AAAE requested deletion of the entire sustaining should be clarified so that law and a separate FAA policy discussion of the use of airport revenue. airport proprietors are not compelled to statement on revenue use. AAAE further Air carriers argued that an admonition adopt unrealistic fee schedules that requested that the policies and that accumulation of surplus may preclude aviation businesses from procedures on revenue diversion should warrant an inquiry is not strong enough; operating profitably. be issued through notice and comment the provision should be modified to The Department has retained the rulemaking, in keeping with the severity state that accumulation of surplus shall policy as proposed, but have modified of potential penalties. trigger an investigation; encouragement the statement to clarify that an airport Air carriers generally supported the of the use of accumulated surpluses to must only be as financially self- proposal. IATA commented that fund non-AIP eligible projects will sustaining as possible; that this paragraph 5.6 should be modified to exacerbate the tendency of airport requirement does not permit an airport state that listed practices are to be proprietors to seek excessive revenues proprietor to establish fees that exceed regarded as a minimum, and that more for questionable purposes. costs associated with aeronautical users; practices may be added. The policy adopted includes the and that an airport proprietor’s decision The Department agrees with the language in the proposal, which reflects to charge commercially feasible rates AAAE recommendation to state agency existing FAA practice and represents a below what might be required to break policy on use of revenue in a separate reasonable balance between the airport’s even does not in itself violate the document dedicated to revenue interest in maintaining appropriate requirement to be as self-sustaining as diversion policy, and not in the reserves and the Government’s interest possible. Language from § 110 of the statement on airport fees. Accordingly, in preventing unnecessary accumulation 1994 FAA Authorization Act regarding much of the language in the proposal of surplus funds. the policy on accumulation of surplus, has been deleted from the final policy which was included under the use of statement. The policy does retain a basic Policy Statement Regarding Airport revenue section of the proposal, has statement of the revenue use Fees been moved under the self-sustaining requirement and a reference to the For the reasons discussed above, the principle in the final policy statement. statute, and also the statement that the Department adopts the following The Department does not agree with FAA may inquire into a progressive statement of policy for airport fees the AAAE comment that the accumulation of surplus. As noted charged to aeronautical users: requirement for an airport to be as self- previously, language from § 110 of the sustaining as possible should be the 1994 FAA Authorization Act regarding Policy Regarding the Establishment of primary principle for determination of policy on accumulation of surplus, Airport Rates and Charges airport fees, and the policy retains the which was included under the use of Introduction general structure and emphasis of the revenue section of the proposal, has It is the fundamental position of the proposed policy. been moved under the self-sustaining principle in the final policy statement. Department that the issue of rates and 15. Use of Airport Revenues: General FAA is issuing a separate policy charges is best addressed at the local Approach. statement on policies and procedures level by agreement between users and Airports commented that discussion for enforcement against illegal revenue airports. By providing guidance on of the use of airport revenue should diversion, as required by § 112 of the standards applicable to airport fees expressly refer to the grandfather 1994 FAA Authorization Act. That imposed for aeronautical use of the provision of 49 U.S.C. 47107(b)(2); also, statement includes the practices that the airport, the Department intends to proposed paragraph 5.6 should be Department considers to be diversion of facilitate direct negotiation between the modified so that actions listed there are revenue, including the four practices proprietor and aeronautical users and to not considered to be revenue diversion listed in § 112. The Department minimize the need to seek direct per se, but only to warrant FAA inquiry interprets § 112 as requiring the agency Federal intervention to resolve about whether diversion is taking place. to define the listed practices as differences over airport fees. Airports further requested that the diversion, if not otherwise Applicability of the Policy policy alluded to in the preamble—that grandfathered, and not merely as a basis FAA will consider accumulation of for inquiry as suggested by airport A. Scope of Policy surpluses in awarding discretionary commenters. The revenue diversion Under the terms of grant agreements grants—should not be implemented; policy statement includes a separate administered by the FAA for airport that policy is not required by § 507(3) of discussion of the ‘‘grandfather improvement, all aeronautical users are Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6915 entitled to airport access on fair and policy statements, or guidelines airport as financially self-sustaining as reasonable terms without unjust establishing procedures for deciding possible. discrimination. Therefore, the cases under § 47129 and the standards 5. In accordance with relevant Federal Department considers that the to be used by the Secretary in statutory provisions governing the use principles and guidance set forth in this determining whether a fee is reasonable. of airport revenue, airport proprietors policy statement apply to all Section 47129(e) excludes from the may expend revenue generated by the aeronautical uses of the airport. The applicability of § 47129 a fee imposed airport only for statutorily allowable Department recognizes, however, that pursuant to a written agreement with air purposes. airport proprietors may use different carriers, a fee imposed pursuant to a Local Negotiation and Resolution mechanisms and methodologies to financing agreement or covenant establish fees for different facilities, e.g., entered into before the date of 1. In general, the Department relies for the airfield and terminal area, and enactment of the statute (August 23, upon airport proprietors, aeronautical for different aeronautical users, e.g., air 1994), and an existing fee not in dispute users, and the market and institutional carriers and fixed-base operators. The on August 23, 1994. Section 47129(f) arrangements within which they Department will take these differences further provides that § 47129 shall not operate, to ensure compliance with into account if we are called upon to adversely affect the rights of any party applicable legal requirements. Direct resolve a dispute over aeronautical fees. under existing air carrier/airport Federal intervention will be available, agreements or the ability of an airport to however, where needed. B. Aeronautical Use and Users 1.1 The Department encourages meet its obligations under a financing direct resolution of differences at the The Department considers the agreement or covenant that is in effect local level between aeronautical users aeronautical use of an airport to be any on August 23, 1994. and the airport proprietor. Such activity that involves, makes possible, is The Department does not interpret resolution is best achieved through required for the safety of the operations § 47129 to repeal or narrow the scope of adequate and timely consultation of, or is otherwise directly related to, the the basic requirement that fees imposed operation of aircraft. Aeronautical use between the airport proprietor and the on aeronautical users be reasonable and includes services provided by air aeronautical users. Airport proprietors not unjustly discriminatory. Sections carriers related directly and should engage in adequate and timely 47219(e) and (f) specifically apply the substantially to the movement of consultation with aeronautical users expedited hearing procedures mandated passengers, baggage, mail and cargo on about airport fees. by § 47129(b) and (c) to air carriers, but the airport. Persons, whether 1.1.1 Airport proprietors should do not preclude the adoption of policy individuals or businesses, engaged in consult with aeronautical users well in guidance applicable to fees imposed on aeronautical uses involving the advance, if practical, of introducing aeronautical users other than air operation of aircraft, or providing flight significant changes in charging systems carriers. support directly related to the operation and procedures or in the level of of aircraft, are considered to be Therefore, the Department will apply charges. The proprietor should provide aeronautical users. the policy guidance in the case of a adequate information to permit In addition, the Department considers dispute over any aeronautical fee, aeronautical users to evaluate the that the operation by air carriers or including those described in § 47129(e) airport proprietor’s justification for the foreign air carriers of facilities such as and (f). change and to assess the reasonableness a reservations center, headquarters In addition, as the statute provides, a of the proposal. For consultations to be office, or flight kitchen on an airport dispute over matters described by effective, airport proprietors should give does not constitute an aeronautical § 47129(e) and (f) will not be processed due regard to the views of aeronautical activity subject to the principles and under the procedures mandated by users and to the effect upon them of guidance contained in this policy § 47129. Rather those disputes will be changes in fees. Likewise, aeronautical statement with respect to processed under procedures applicable users should give due regard to the reasonableness and unjust to airport compliance matters in general. views of the airport proprietor and the discrimination. Such facilities need not Principles Applicable to Airport Rates financial needs of the airport. be located on an airport. A carrier’s and Charges 1.1.2 To further the goal of effective decision to locate such facilities is based consultation, Appendix 1 of this policy on the negotiation of a lease or sale of 1. In general, the Department relies statement contains a description of property. Accordingly, the Department upon airport proprietors, aeronautical information that the Department relies on the normal forces of users, and the market and institutional considers would be useful to the carriers competition for commercial or arrangements within which they and other aeronautical users to permit industrial property to assure that fees operate, to ensure compliance with meaningful consultation and evaluation for such property are not excessive. applicable legal requirements. Direct of a proposal to modify fees. Federal intervention will be available, 1.1.3 Airport proprietors should C. Applicability of § 113 of the FAA however, where needed. consider the public interest in Authorization Act of 1994 2. Rates, fees, rentals, landing fees, establishing airport fees, and Section 113 of the Federal Aviation and other service charges (‘‘fees’’) aeronautical users should consider the Authorization Act of 1994 imposed on aeronautical users for public interest in consulting with (‘‘Authorization Act’’), 49 U.S.C. 47129, aeronautical use of airport facilities airports on setting such fees. directs the Secretary of Transportation (‘‘aeronautical fees’’) must be fair and 1.1.4 Airport proprietors and to issue a determination on the reasonable. aeronautical users should consult and reasonableness of certain fees imposed 3. Aeronautical fees may not unjustly make a good-faith effort to reach on air carriers in response to carrier discriminate against aeronautical users agreement. Absent agreement, airport complaints or a request for or user groups. proprietors are free to act in accordance determination by an airport proprietor. 4. Airport proprietors must maintain with their proposals, subject to review Section 47129 further directs the a fee and rental structure that in the by the Secretary or the Administrator on Secretary to publish final regulations, circumstances of the airport makes the complaint by the user or, in the case of 6916 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices fees subject to 49 U.S.C. § 47129, upon complaint procedure described in 1.2.1.; generally referred to as the request by the airport operator, or, in however, the 60-day period for filing a compensatory approach. unusual circumstances, on the complaint under § 47129 is not 2.1.3 Airports frequently adopt Department’s initiative. extended or tolled by such a request. charging systems that employ elements 1.1.5 To facilitate local resolution 1.2.3 In the case of fees imposed on of both approaches. and reduce the need for direct Federal other aeronautical users, where 2.1.4 Federal law does not require a intervention to resolve differences over negotiations between the parties are single approach to airport financing. aeronautical fees, the Department unsuccessful and a complaint is filed Rates may be set according to a residual encourages airport proprietors and alleging that airport fees violate an or compensatory rate-setting aeronautical users to include alternative airport proprietor’s federal grant methodology, or any combination of the dispute resolution procedures in their obligations, the Department will, where two, or according to a new rate-setting lease and use agreements. warranted, exercise the agency’s broad methodology, as long as the 1.1.6 Any newly established fee or statutory authority to review the legality methodology used is applied fee increase that is the subject of a of those fees and to issue such consistently to similarly situated complaint under 49 U.S.C. § 47129 that determinations and take such actions as aeronautical users and as otherwise is not dismissed by the Secretary must are appropriate based on that review. required by this policy. Airport be paid to the airport proprietor under 1.3 Airport proprietors must retain proprietors may set rates for protest by the complainant. Unless the the ability to respond to local conditions aeronautical use of airport facilities by airport proprietor and complainant with flexibility and innovation. An ordinance, statute or resolution, agree otherwise, the airport proprietor airport proprietor is encouraged to regulation, or by agreement. will obtain a letter of credit, or surety achieve consensus and agreement with 2.2 The ‘‘rate base’’ is the total of all bond, or other suitable credit instrument its airline tenants before implementing aeronautical costs that may be recovered in accordance with the provisions of 49 a practice that would represent a major from aeronautical users through U.S.C. 47129(d). Pending issuance of a departure from this guidance. However, aeronautical fees. Airport proprietors final order determining reasonableness, the requirements of any law, including must employ a reasonable, consistent, an airport proprietor may not deny a the requirements for the use of airport and ‘‘transparent’’ (i.e., clear and fully complainant currently providing air revenue, may not be waived, even by justified) method of establishing the rate service at the airport reasonable access agreement with the aeronautical users. base and adjusting the rate base on a to airport facilities or services, or Fair and Reasonable Fees timely and predictable schedule. otherwise interfere with that complainant’s prices, routes, or services, 2. Rates, fees, rentals, landing fees, 2.3 In the absence of an agreement as a means of enforcing the fee, if the and other service charges (‘‘fees’’) with aeronautical users, costs that may complainant has complied with the imposed on aeronautical users for the be included in the rate base (allowable requirements for payment under protest. aeronautical use of the airport costs) are limited to all operating and 1.2 Where airport proprietors and (‘‘aeronautical fees’’) must be fair and maintenance expenses directly and aeronautical users have been unable, reasonable. indirectly associated with the provision despite all reasonable efforts, to resolve 2.1 Revenues from aeronautical fees of aeronautical facilities and services disputes between them, the Department (aeronautical revenues) may not exceed (including environmental costs, as set will act to resolve the issues raised in the costs to the airport proprietor of forth below); all capital costs associated the dispute. providing airport services and facilities with the provision of aeronautical 1.2.1 In the case of a fee imposed on currently in aeronautical use facilities and services currently in use, one or more air carriers or foreign air (aeronautical costs) unless otherwise as set forth below; and current costs of carriers, the Department will issue a agreed to by the affected aeronautical planning future aeronautical facilities determination on the reasonableness of users. and services. the fee upon the filing of a written 2.1.1 Aeronautical users may receive 2.3.1 Where airport proprietors have request for a determination by the a cross-credit of nonaeronautical expended funds from nonaeronautical airport proprietor or, if the Department revenues only if the airport proprietor sources to finance capital investments determines that a significant dispute agrees. Agreements providing for such for aeronautical use, the implicit capital exists, upon the filing of a complaint by cross-crediting are commonly referred to cost of these funds may be included in one or more air carriers or foreign air as ‘‘residual agreements’’ and generally the aeronautical rate base in addition to carriers, in accordance with 49 U.S.C. provide a sharing of nonaeronautical the cost of the asset. The Department 47129 and implementing regulations. revenues with aeronautical users. The considers it reasonable to use, as a Pursuant to the provisions of 49 U.S.C. aeronautical users may in turn agree to measure of the implicit capital cost, the 47129, the Department may only assume part or all of the liability for rate of interest prevailing on bonds determine whether a fee is reasonable or non-aeronautical costs, or an airport issued for a comparable purpose at the unreasonable, and may not set the level proprietor may cross-credit time of the expenditure at that airport or of the fee. nonaeronautical revenues to at another airport with similar bond 1.2.2 In the case of fees imposed on aeronautical users even in the absence rating. other aeronautical users, the Department of such an agreement, but an airport 2.3.2 Airport proprietors may will first offer its good offices to proprietor may not require aeronautical include reasonable environmental costs facilitate parties reaching a successful users to cover losses generated by in the rate base to the extent that the outcome in a timely manner. Prompt nonaeronautical facilities except by airport proprietor incurs a resolution of these disputes is always agreement. corresponding actual expense. All desirable since extensive delay can lead 2.1.2 In other situations, an airport revenues received based on the to uncertainty for the public and a proprietor assumes all liability for inclusion of these costs in the rate base hardening of the parties’ positions. Air airport costs and retains all airport are subject to Federal requirements on carriers and foreign air carriers may profits for its own use in accordance the use of airport revenue. Reasonable request the assistance of the Department with Federal requirements. This environmental costs include, but are not in advance of or in lieu of the formal approach to airport financing is necessarily limited to, the following: Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6917 (a) The costs of investigating and uses (shared costs) may be included in are reasonably related to the aviation remediating environmental a particular aeronautical rate base if the benefits that the second airport provides contamination caused by aeronautical facility in question supports the or is expected to provide to the operations at the airport at least to the aeronautical activity reflected in that aeronautical users of the first airport. extent that such investigation or rate base. The portion of shared costs (a) Element no. 3 above will be remediation is required by or consistent allocated to aeronautical users should presumed to be satisfied if the second with local, state or federal not exceed an amount that reflects the airport is designated as a reliever airport environmental law, and to the extent aeronautical purpose and proportionate for the first airport in the FAA’s such requirements are applied to other aeronautical use of the facility in National Plan of Integrated Airport similarly situated enterprises. relation to nonaeronautical use of the Systems (NPIAS). (b) The cost of mitigating the facility, unless the affected aeronautical 2.5 At all times, airport proprietors environmental impact of an airport users agree to the allocation. must comply with the following development project (if the Aeronautical users may not be allocated practices: development project is one for which all costs of facilities that are used by 2.5.1 Indirect costs may not be costs may be included in the users’ rate both aeronautical and nonaeronautical included in the rate base unless they are base), at least to the extent that these users unless they agree to that based on a reasonable, transparent cost costs are incurred in order to secure allocation. allocation formula calculated necessary approvals for such projects, 2.4 Airport proprietors must comply consistently for other units or cost including but not limited to approvals with the following practices in centers of government. under the National Environmental establishing the rate base, provided, 2.5.2 The costs of airport Policy Act and similar state statutes; however, that one or more aeronautical development or planning projects paid (c) The costs of aircraft noise users may agree to a rate base that for with government grants and abatement and mitigation measures, deviates from these practices in the contributions and passenger facility both on and off the airport, including establishment of those users’ fees. charges (PFCs) may not be included in but not limited to land acquisition and 2.4.1 Airport assets included in the the rate base. acoustical insulation expenses, to the rate base must be valued according to 2.5.2(a) In the case of a PFC-funded extent that such measures are their historic cost to the original airport project for terminal development, for undertaken as part of a comprehensive proprietor. Subsequent airport gates and related areas, or for a facility and publicly-disclosed airport noise proprietors generally shall acquire the that is occupied by one or more carriers compatibility program; and cost basis of an asset at the original on an exclusive or preferential use basis, (d) The costs of insuring against airport proprietor’s historic cost. the fees paid to use those facilities shall future liability for environmental (a) For facilities other than airfield be no less than the fees charged for contamination caused by current facilities and land, an airport proprietor similar facilities that were not financed aeronautical activities. Under this may use valuation methodologies other with PFC revenue. provision, the costs of self-insurance than historic cost valuation as set forth Prohibition on Unjust Discrimination may be included in the rate-base only to above, so long as total aeronautical the extent that they are incurred revenues do not exceed the total costs 3. Aeronautical fees may not pursuant to a self-insurance program (based on historic costs) included in the unjustly discriminate against that conforms to applicable insurance aeronautical rate base, and so long as aeronautical users or user groups. industry standards for self-insurance the valuation method is justified and 3.1 Unless aeronautical users agree, practices. applied on a consistent basis to aeronautical fees imposed on any 2.3.3 Airport proprietors are comparable facilities. aeronautical user or group of encouraged to establish fees with due (b) Where comparable assets, e.g., two aeronautical users may not exceed the regard for economy and efficiency. runways or two terminals, were built at costs allocated to that user or user group 2.3.4 The airport proprietor may different times and have different under a cost allocation methodology include in the rate base amounts needed historic costs, the airport proprietor may adopted by the airport proprietor that is to fund debt service and other reserves combine the cost basis of the consistent with this guidance. and to meet cash flow requirements as comparable assets to develop a single 3.1.1 The prohibition on unjust specified in financing agreements or cost basis applicable to all such discrimination does not prevent an covenants (for facilities in use); to fund facilities. airport proprietor from making cash reserves to protect against the risks 2.4.2 The costs of facilities not yet reasonable distinctions among of cash-flow fluctuations associated built and operating may not be included aeronautical users (such as signatory with normal airport operations; and to in the rate base. However, the debt- and non-signatory carriers) and fund reasonable cash reserves to protect service and other carrying costs assessing higher fees on certain against other contingencies. incurred by the airport proprietor categories of aeronautical users based on 2.3.5 The airport proprietor may during construction may be capitalized those distinctions (such as higher fees include in the rate base capital costs in and amortized once the facility is put in for non-signatory carriers, as compared accordance with the following guidance, service. The airport proprietor may to signatory carriers). which is based on the principle of cost include in the rate base the costs of land 3.2 A properly structured peak causation: that facilitates the current operations of pricing system that allocates limited (a) Costs of facilities directly used by the airport. resources using price during periods of the aeronautical users may be fully 2.4.3 The rate base of an airport may congestion will not be considered to be included in the rate base, in a manner include costs associated with another unjustly discriminatory. An airport consistent with this policy. For airport currently in use only if: (1) The proprietor may, consistent with the example, the capital cost of a runway proprietor of the first airport is also the policies expressed in this policy may be included in the rate base used proprietor of the second airport; (2) the statement, establish fees that enhance to establish landing fees. second airport is currently in use; and the efficient utilization of the airport. (b) Costs of airport facilities used for (3) the costs of the second airport to be 3.3 Relevant provisions of the both aeronautical and non-aeronautical included in the first airport’s rate base Convention on International Civil 6918 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices Aviation (Chicago Convention) and make the airport as self-sustaining as Issued in Washington, DC, on January 30, many bilateral aviation agreements possible does not permit the airport 1995. specify, inter alia, that charges imposed proprietor to establish aeronautical fees Federico Pen˜ a, on foreign airlines must not be unjustly that exceed the airport proprietor’s Secretary of Transportation. discriminatory, must not be higher than aeronautical costs. David R. Hinson, those imposed on domestic airlines 4.1.2 At some airports, market engaged in similar international air conditions may not permit an airport Administrator, Federal Aviation Administration. services and must be equitably proprietor to establish fees that are apportioned among categories of users. sufficiently high to recover aeronautical Appendix 1—Information for Aeronautical Charges to foreign air carriers for costs and sufficiently low to allow User Charges Consultations aeronautical use that are inconsistent commercial aeronautical services to The Department of Transportation with these principles will be considered operate at a profit. In such ordinarily expects the following information unjustly discriminatory or unfair and circumstances, an airport proprietor’s to be available to aeronautical users in unreasonable. decision to charge rates that are below connection with consultations over changes 3.4 Allowable costs—costs properly those needed to achieve self- in airport rates and charges: included in the rate base—must be sustainability in order to assure that 1. Historic Financial Information covering allocated to aeronautical users by a services are provided to the public is two fiscal years prior to the current year transparent, reasonable, and not not inherently inconsistent with the including, at minimum, a profit and loss unjustly discriminatory rate-setting obligation to make the airport as self- statement, balance sheet and cash flow methodology. The methodology must be sustaining as possible in the statement for the airport implementing the applied consistently and cost circumstances. charges. differences must be determined 4.2 In establishing new fees, and 2. Justification. Economic, financial and/or quantitatively, when practical. generating revenues from all sources, legal justification for changes in the charging 3.4.1 Common costs (costs not airport owners and operators should not methodology or in the level of aeronautical directly attributable to a specific user seek to create revenue surpluses that rates and charges at the airport. Airports group or cost center) must be allocated exceed the amounts to be used for should provide information on the according to a reasonable, transparent airport system purposes and for other aeronautical costs they are including in the and not unjustly discriminatory cost purposes for which airport revenues rate base. allocation formula that is applied may be spent under 49 U.S.C. 3. Traffic Information. Annual numbers of consistently, and does not require any 47107(b)(1), including reasonable terminal passengers and aircraft movements for each of the two preceding years. air carrier, foreign air carrier or other reserves and other funds to facilitate 4. Planning and Forecasting Information. aeronautical user group to pay costs financing and to cover contingencies. (a) To the extent applicable to current or properly allocable to other users. While fees charged to nonaeronautical proposed fees, the long-term airport strategy users may exceed the costs of service to Requirement To Be Financially Self- setting out long-term financial and traffic those users, the surplus funds Sustaining forecasts, major capital projects and capital accumulated from those fees must be expenditure, and particular areas requiring 4. Airport proprietors must maintain used in accordance with § 47107(b). strategic action. This material should include a fee and rental structure that in the any material provided for public or circumstances of the airport makes the Requirements Governing Revenue Application and Use government reviews of major airport airport as financially self-sustaining as developments, including analyses of demand possible. 5. In accordance with relevant and capacity and expenditure estimates. 4.1 If market conditions or demand Federal statutory provisions governing (b) Accurate, complete information specific for air service do not permit the airport the use of airport revenue, airport to the airport for the current and the forecast to be financially self-sustaining, the proprietors may expend revenue year, including the current and proposed airport proprietor should establish long- generated by the airport only for budgets, forecasts of airport charges revenue, term goals and targets to make the statutorily allowable purposes. the projected number of landings and airport as financially self-sustaining as 5.1 Additional information on the passengers, expected operating and capital possible. statutorily allowed uses of airport expenditures, debt service payments, 4.1.1 Airport proprietors are revenue is contained in separate contributions to restricted funds, or other encouraged, when entering into new or guidance published by the FAA required accounts or reserves. revised agreements or otherwise pursuant to § 112 of the FAA (c) To the extent the airport uses a residual establishing rates, charges, and fees, to Authorization Act of 1994, which is or hybrid charging methodology, a undertake reasonable efforts to make codified at 49 U.S.C 47107(l). description of key factors expected to affect their particular airports as self 5.2 The progressive accumulation of commercial or other nonaeronautical sustaining as possible in the substantial amounts of airport revenues revenues and operating costs in the current circumstances existing at such airports. may warrant an FAA inquiry into the and following years. (a) Absent agreement with airport proprietor’s application of [FR Doc. 95–2673 Filed 1–31–95; 3:15 pm] aeronautical users, the obligation to revenues to the local airport system. BILLING CODE 4910±13±P Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6919 DEPARTMENT OF TRANSPORTATION violation of Federal requirements under provisions, the comments generally the Airport and Airway Improvement expressed support for the overall Office of the Secretary Act of 1982, as amended, and the Anti- concept of the proposed rule. The Head Tax Act provisions of the Federal proposed regulatory approach, i.e., 14 CFR Part 302 Aviation Act (59 FR 29880); subpart J of consolidating all complaints as soon as [Docket No. 49830] the proposed rule provided special the first carrier files a complaint under procedures for the expedited review of the new subpart, received several RIN 2105±AC18 complaints by airlines involving the fees supporting comments and no Rules of Practice for Proceedings charged by an airport proprietor. opposition. Accordingly, the final rule Subsequently, Congress passed the Concerning Airport Fees follows this approach with only minor FAA Authorization Act of 1994, which modifications. We turn now to a AGENCY: Office of the Secretary, DOT. was signed into law on August 23, 1994. discussion of the issues most widely ACTION: Final rule. Section 113 of the FAA Authorization addressed in the comments. Other Act included specific provisions for the comments are addressed in the section- SUMMARY: This final rule establishes resolution of airport-air carrier disputes by-section analysis. specific procedural rules under which concerning airport fees. The procedures the Department of Transportation will contemplated by the FAA Authorization Party Status handle complaints by air carriers and Act were substantially different from A number of commenters addressed foreign air carriers for a determination those proposed by the FAA. issues involving who should be able to of the reasonableness of a fee increase Accordingly, the FAA withdrew its make use of the expedited procedures or newly established fee imposed upon NPRM on September 16, 1994, insofar contained in the new subpart. JAL the carrier by the owner or operator of as it applied to the resolution of the expressed specific support for our an airport. It also establishes rules that reasonableness of airport fees charged to proposal to allow foreign air carriers to would apply to requests by the owner or air carriers. (59 FR 47568). However, the use the expedited procedures along with operator of an airport for such a remaining procedures proposed in the U.S. air carriers. AAAE stated that it determination. The final rule responds FAA NPRM, which would apply to the considers this proposal acceptable, and to the mandate in the recently enacted various other kinds of complaints filed ACI–NA also indicated that it did not Federal Aviation Administration against airports relating to Federal object, although ACI–NA added that ‘‘a Authorization Act of 1994 requiring the requirements, are not affected by the foreign air carrier, like any other carrier, Department to issue regulations FAA Authorization Act, and the which initiates or joins a case should establishing procedures for acting upon comment period on the remaining not be allowed to pursue remedies in such complaints by air carriers and proposals closed on December 1, 1994. other forums, in order to avoid In lieu of the procedures proposed by requests by airport owners and duplicative proceedings which could the FAA for handling air carrier operators. lead to inconsistent or conflicting complaints about airport rates and EFFECTIVE DATE: This rule is effective on results.’’ Only the Los Angeles charges, the Office of the Secretary February 3, 1995. Department of Airports opposed issued a new NPRM on October 24, FOR FURTHER INFORMATION CONTACT: including foreign air carriers. It claims 1994. As contemplated by the FAA Robert Klothe, Office of Regulation and that ‘‘Congress intentionally provided Authorization Act, the October 24 Enforcement, Office of the General the expedited procedures only to U.S. NPRM stated that the procedures Counsel, United States Department of carriers,’’ and suggests that making this contained in 14 CFR Part 302 would Transportation, 400 Seventh Street, SW, forum available to foreign carriers generally govern air carrier complaints Washington, DC 20590, telephone (202) forfeits a bargaining position for the as well as requests by airport owners or 366–9307. United States and contravenes the operators for a determination of the principle of international reciprocity. SUPPLEMENTARY INFORMATION: reasonableness of airports fees and charges. The final rule adopts the proposal to Background allow foreign air carriers to file This rulemaking had its origins in two Discussion of Comments complaints under subpart F. As we related notices on the subject of Federal The Department received twelve noted in the NPRM, we anticipate that policy on airport rates and charges comments on the NPRM. They were both domestic and foreign carriers will issued by the Office of the Secretary of submitted by the Air Transport dispute airport fees they believe to be Transportation (OST) and the Federal Association (ATA), the Aircraft Owners unreasonable. Since the economic and Aviation Administration on June 9, and Pilots Association (AOPA), the other issues involved in determining the 1994. A jointly-issued notice entitled Airports Council International—North reasonableness of a fee are essentially ‘‘Proposed Policy Regarding Airport America (ACI–NA), the American the same whether the complainant Rates and Charges’’ (Proposed Policy) Association of Airport Executives carrier is U.S. or foreign, it will be listed and explained the proposed (AAAE), the General Aviation simpler for the carriers, the airport and Federal policy on the rates and charges Manufacturers Association (GAMA), the the Department to make that that an airport proprietor can charge to International Air Transport Association determination in a single proceeding. aeronautical users of the airport. (59 FR (IATA), Japan Airlines Company (JAL), Therefore, while the FAA Authorization 29874); a supplemental notice the Los Angeles Department of Airports, Act was only directed at complaints by concerning the proposed policy was the Maryland Aviation Administration, U.S. carriers, we will include foreign issued on October 12, 1994 (59 FR the Massachusetts Port Authority carriers on our own initiative. 51836). The FAA also issued a notice of (Massport), the Metropolitan With respect to the comment that proposed rulemaking entitled ‘‘Rules of Washington Airports Authority, and the foreign carriers filing claims under Practice for Federally Assisted Airports’’ National Business Aircraft Association, subpart F should be barred from seeking setting forth procedures for the filing, Inc. (NBAA). remedies in other forums, we note that investigation, and adjudication of Although there were numerous the various bilateral agreements on air complaints against airports for alleged requests for changes to particular service between the United States and 6920 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations other countries govern the rights of complaints should contain all The Los Angeles Department of Airports foreign air carriers in this regard. supporting evidence and testimony, and agreed, and also suggested the GAMA, AOPA, and NBAA all argue that answers should similarly be recommended 21-day period should not that we should further expand the complete with all evidence and start until the last day that complaints applicability of this subpart to cover testimony on which the party intends to could be filed (i.e., on the 60th day after complaints by general aviation rely. notice of the fee or the seventh day after operators. In their view, the arguments IATA commented that a carrier might the first complaint is filed). This would for including foreign air carriers apply not have access to much of the give parties a total of up to 28 days to with equal force to general aviation information necessary to its complaint file answers. Massport asked for a 14 users. While we recognize that there unless the airport had agreed to furnish calendar-day answer period, and the may be cases in which an airport it. IATA requested that the final rule Metropolitan Washington Airports imposes essentially similar fees on both make clear that information within the Authority recommended 14 days for the general aviation and air carrier custody of the airport could be used by initial complaint and seven days for any operations, we cannot grant the request the carrier if it was able to obtain the additional complaints. The Maryland to expand the expedited procedures to information only after the complaint Aviation Administration requested general aviation operators. The FAA was filed. ATA raised the same issue, seven business days instead of seven Authorization Act requires the Secretary but suggested that we provide for a calendar days. to determine the reasonableness of a formal discovery process within the 30- We will retain the requirement that challenged fee within 120 days after a day period following the complaint. answers contain all testimony and complaint is filed and indicates a The Department’s Policy Regarding exhibits on which the answering party preference for oral evidentiary Airport Rates and Charges, published in intends to rely. The carriers pointed out procedures, to the extent that such today’s Federal Register, states that that airport owners and operators procedures are consistent with the 120- airports should consult with carriers in possess much of the information that day timeframe. Our procedures must advance of changing fees, and should they might need to introduce in carry out the Congressional intent. If provide adequate information to permit challenging a fee. However, there is no general aviation operators are permitted carriers to evaluate the justification for fee information in the hands of the to make use of this subpart, however, the change and the reasonableness of carriers that an airport would need to the scope of the hearing would be the new or increased fee. We expect that support the reasonableness of the fee. In dramatically expanded. It is possible airports will comply with this policy. view of the extremely short decisional that there would be dozens, conceivably The Department finds the IATA and deadlines imposed by the FAA even hundreds, of additional parties, ATA concerns valid. However, we Authorization Act, it is important that possibly with divergent interests. If this believe that the conduct of discovery in we have the most information possible happened, it would so overwhelm the the 30-day period following the at the beginning of a proceeding. While Department’s resources that it could complaint would be a burden to the it is true, as commenters noted, that become impossible for the Department airport owner or operator and to the complaining carriers have up to 60 days to meet the statutory deadline. government. Moreover, any discovery to file complaints, we do not agree that The Metropolitan Washington conducted would be unnecessary, and this gives complainants an unfair Airports Authority argues that there is therefore excessive, if the complaint is advantage. We expect airports to have an integral relationship between the fees subsequently dismissed because the all the economic evidence they need in paid by ‘‘signatory’’ and ‘‘non- Secretary determines that there is no support of a new or increased fee before signatory’’ carriers. (Signatory carriers significant dispute. Accordingly, the the fee is increased rather than after a are airlines that have entered into a use Department will provide, where complaint is filed. While an answer or operating agreement with the airport necessary, special procedures for the must, of course, respond to the specific operator.) Therefore, ‘‘it is important for exchange or disclosure of information matters raised in a complaint, an airport the procedures to specify that the by the parties. should not have to generate significant airport can join as indispensable parties Airport parties had equivalent new data. the signatory airlines when the airports objections with respect to the proposed On the other hand, we believe that it rates and charges are challenged by a requirements for the timing and is reasonable to allow some additional non signatory airline.’’ The final rule completeness of answers. ACI–NA, time to prepare and submit answers. In does not incorporate this suggestion. If AAAE, the Los Angeles Department of the case of complaints, it will be easier a carrier (signatory or otherwise) would Airports, and Massport all argued that for both the answering party and the be affected by the outcome of a airports should not have to submit their Department if answers are consolidated complaint filed by another carrier at the entire response with the answer. They to address both the initial complaint same airport, it may well choose to believe that answering parties should and any follow-on complaints. participate in the proceeding, such as by only have to submit a brief in response Accordingly, the final rule provides that filing an answer to the complaint. The to a complaint, and should be able to answers will be due 14 calendar days NPRM’s proposal to require service of supplement their submission with after the initial complaint is filed. Thus, any complaint on other carriers exhibits and testimony at a later point if there are follow-on complaints, the (discussed more fully below) was made in the proceeding. answering parties will still have a partly to facilitate such participation. In addition, they claim that it is unfair minimum of seven days to address But there is no reason to require the that complainants will have up to 60 them. We will also allow 14 days for participation of carriers with no days to gather evidence and prepare answers to requests for determination. complaint of their own and no interest exhibits and testimony, while, under the Determination of ‘‘Significant Dispute’’ in the fee being challenged. proposal, respondents would be required to submit their complete Within 30 days after a carrier files a Evidence To Be Submitted With response seven calendar days after the complaint, the FAA Authorization Act Complaints, Requests and Answers complaint is filed. AAAE and ACI–NA requires the Department to determine A number of commenters addressed suggested that we allow answers to be whether there is a ‘‘significant dispute;’’ the proposal in the NPRM that carrier filed 21 days after the initial complaint. if not, the statute requires the Secretary Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6921 to dismiss the complaint. Accordingly, judgment under Federal Rule of Civil Act makes no provision for dismissal on a number of commenters addressed Procedure 56. Under this approach, as that basis (in contrast with its specific issues associated with the Secretary’s ATA states, ‘‘a ’significant dispute’ requirement to dismiss carrier determination. would exist whenever there was a complaints that do not present a IATA pointed out that the language in genuine issue of material fact or law.’’ significant dispute). IATA, on the other proposed § 302.611 stated that the Accepting either of ATA’s hand, claimed that our failure to Secretary would issue an order within recommendations would mean that the provide for dismissal of an airport 30 days determining whether a carrier Department would set for hearing owner or operator’s request ‘‘is clearly complaint presented a significant virtually all complaints brought, no arbitrary and capricious.’’ As IATA’s dispute, but there was no corresponding matter how trivial. We believe that this comments note, however, the statutory language on requests for determination is inconsistent with the statutory intent. language on dismissals, in § 47129(c)(2), submitted by an airport owner or If Congress had meant for the ‘‘on its face appears to be applicable operator. As the preamble in the NPRM Department to hear every complaint in only to complaints and air carriers.’’ indicated, it has been our intention to which a claim is made, it surely would (Emphasis in original.) While IATA issue such orders within 30 days. not have mandated in § 47129(c)(2) that suggests that this ‘‘may be the result of However, as provided in § 302.619(c), ‘‘the Secretary shall dismiss any legislative oversight,’’ we believe this when both a complaint and a request for complaint if no significant dispute language is plain, and we will adopt the determination have been filed with exists.’’ (Emphasis added.) Congress NPRM’s proposal to proceed to a final respect to the same airport fee, the established the extraordinary dispute order on the merits when an airport statutorily-imposed 120-day schedule resolution program in § 47129 to ensure properly submits a request for for resolving complaints controls the that carriers and airports can obtain a determination. course of the proceeding. That is, as prompt decision when there is an required by the FAA Authorization Act, important fee dispute. It plainly Service of Documents the Secretary will determine whether understood that the Department has In order to ensure compliance with there is a significant dispute within 30 limited resources; if the expedited the extremely short time frames days of the date the first complaint is procedures are employed any time a provided by the FAA Authorization Act filed. In such cases, the determination complainant can state a claim or for action on fee disputes, the NPRM may come more than 30 days after the establish that there is a fact in dispute, proposed special service requirements. date of the airport request. In light of the Department could be unable to The proposal contained three main IATA’s comment, we have revised the respond adequately when there are truly elements: (1) Complaints and requests language of § 302.613 to clarify this significant fee disputes. Moreover, for determination would have to be point. while we are sympathetic to IATA’s served on all carriers providing service The comments of both IATA and ATA request for clear guidelines and to the airport; (2) For most filings, ask that any order dismissing a standards for review, we believe that the service would have to be made by hand, complaint for lack of a significant circumstances at each airport and the by electronic transmission, or by dispute should be clearly stated to be facts behind each fee dispute vary too overnight express delivery; and (3) final and appealable. IATA goes on to widely for us to be able to set out Parties would actually have to receive argue the proposed rule would leave an specific standards in the final rule. As the documents no later than the day airport owner or operator in a better we proposed, however, § 302.611 states they are filed. position following dismissal of a request that we will set forth our reasoning in The NPRM stated that the Department for determination than a carrier would any order dismissing a complaint on the realized that these service requirements be following dismissal of a complaint. grounds that the alleged dispute is not could pose a burden in some situations, We disagree, and we find that no change significant. but it also expressed our belief that they is necessary in the final rule. If the AAAE objected to the statement in the are necessary to permit a consolidated Secretary dismisses a complaint after preamble that one piece of evidence that hearing for all complaints. Nevertheless, finding that there is no significant a dispute is significant would be that we specifically invited comment on the dispute within the meaning of the FAA the complaining carrier had attempted service proposals, and particularly on Authorization Act, the order of to resolve the dispute with the airport an additional proposal to substitute dismissal is subject to the same judicial but had been unsuccessful. AAAE service of complaints or requests for review as any other order of the points out, ‘‘Airports and their tenant determination on members of any Secretary. (If the Secretary instead finds air carriers can have legitimate, and airline negotiating committee at the that the complaint fails to meet the even vehement disagreements about airport rather than on all carriers serving procedural requirements of this subpart, issues that are, objectively, minor.’’ We the airport. A number of commenters the order will set forth the conditions agree with AAAE that the intensity of responded to this invitation. under which a revised complaint may the discussions between airports and To begin with, AAAE and ACI–NA be filed.) carriers does not by itself mean that supported the proposal to allow service IATA asks that § 302.611 ‘‘provide there is a significant dispute within the of documents on airline committee some reasonably accurate guidelines meaning of § 47129. Nevertheless, as the members at those airports having such and standards of review’’ under which preamble to the NPRM stated, the committees. The Metropolitan the Secretary will review complaints to failure of direct negotiations ‘‘would be Washington Airports Authority claimed determine whether they present a some indication, although not that it should be adequate to serve the significant dispute. ATA suggests that necessarily proof, that there is a committee itself, without serving the we employ the standards of Federal significant dispute.’’ individual carrier members. ATA, Rule of Civil Procedure 12(b)(6), ACI–NA and IATA disagree sharply however, strongly argued that service on accepting any complaint as constituting on our authority to dismiss airport the airline committee members would a significant dispute as long as it ‘‘states requests for determination when there is not provide adequate notice to other a claim for relief under Section 47129.’’ no significant dispute. ACI–NA stated carriers serving the airport; it advocated In the alternative, it suggests we employ that the Department was correct in requiring service on all carriers serving the standards for grant of summary determining that the FAA Authorization the airport, preferably at their 6922 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations headquarters’ offices. Complaints by The ACAIS list is routinely made transmission. There are few if any carriers drive the schedule for available to airport operators. However, places in the world where facsimile determining the reasonableness of since carriers do not file PFC service and/or electronic mail are airport fees. It is essential that carriers applications, we recognize that they unavailable. Indeed, it is hard to have adequate notice when a document have not previously used the ACAIS list imagine in today’s market that a carrier is filed, particularly an initiating to identify carriers for the purposes of could conduct international operations complaint, which starts the seven-day service. The Department’s Office of without having some capacity to receive period for follow-on complaints. In light Aviation Analysis will provide the electronic communications. Moreover, of ATA’s comments, therefore, the final names of the carriers on the most many carriers, even foreign air carriers, rule does not provide for serving the recently published ACAIS list at the will not need to be served with members of the airport’s carrier request of a carrier considering filing a complaints or requests for committee.1 Nevertheless, we continue complaint about a newly established or determination in their home country. to be concerned about the potential newly increased airport fee. Not all Unless a carrier indicates that a different burden of a literal application of a information from ACAIS will be person should receive service for the requirement to serve ‘‘all carriers.’’ As available on request. Much of the data purposes of this subpart, the final rule the comments of the Metropolitan is potentially sensitive, and we believe authorizes service on the person Washington Airports Authority pointed most carriers would not want it made responsible for communicating with the out, ‘‘the requirement to serve ’all’ available to competitors. Therefore, only airport on behalf of the air carrier or carriers could become an unnecessary carrier identities will be released foreign air carrier about airport fees. procedural hurdle that prevents the through this process. This person will be familiar with fee expeditious resolution of a fee dispute,’’ The Los Angeles Department of disputes involving the airport, and is a because it could be read to require Airports objected to the requirement to logical contact point for routing the service on even the most infrequent certify that the parties served have document quickly to other key carrier users of the airport. The Metropolitan actually received the documents, personnel. Washington Airports Authority arguing that it cannot know when a In addition to the foregoing, one recommended that service be limited to document will be received. It argued additional point warrants mention with carriers that operated at the airport that parties should only have to certify regard to the service of documents. All within the 30 days prior to the filing, that the documents were sent. We exhibits and briefs prepared on while AAAE and ACI–NA suggested disagree. The short response time electronic spreadsheet or word using the Air Carrier Activity required by these procedures makes it processing programs should be Information System (ACAIS) as the basis essential that the receiving party accompanied by standard-format for determining which carriers should receives the maximum notice possible computer diskettes containing those be served. As these parties note, airports that a complaint, request, or responsive submissions. Word processing and already use the list of carriers on the document has been filed. Moreover, spreadsheets files must be readable by ACAIS in determining which carriers to while we recognize that this constitutes current versions of one or more of the serve with respect to Passenger Facility an additional burden on the filer, that following programs, or in such other Charges under 14 CFR Part 158. burden is not insurmountable. All three format as may be specified by notice in Accordingly, we believe that the ACAIS of the specified service methods allow the Federal Register: Microsoft Word, list can similarly serve as the basis for the sender to ascertain quickly that the Word Perfect, Ami Pro, Microsoft Excel, an acceptable means of compliance with receiving party has received the filing. Lotus, Quattro Pro, or ASCII tab- the service requirements of subpart F as In the case of hand delivery, receipt is delineated files. Parties should submit well. obvious. For electronic transmission, one copy of each diskette to the docket While the ACAIS list provides an both facsimile machines and many section, one copy to the office of the objective and convenient starting point electronic mail systems provide for Chief Administrative Law Judge (M–50), for parties needing to serve all carriers, receipts from the recipients. And the and one copy to the Chief, Economic it must be recognized that the list is availability of immediate proof of and Financial Analysis Division (X–55), based on carriers that served the airport delivery is a widely-advertised service of the Office of Aviation Analysis. of major overnight express delivery during the preceding year, and thus may Submissions in electronic form will companies. not include new entrants. In addition, assist the Department and the The Los Angeles Department of carriers operating under 14 CFR Part Airports also argues that hand delivery administrative law judge in quickly 135 are not required to submit data for and overnight express may not be analyzing the record and in preparing ACAIS, although many do so available to serve foreign air carriers, decisions under these expedited voluntarily. Therefore, as ACI–NA and it suggests that we permit procedures. The paper copy will be the proposed, any party intending to make utilization of ‘‘the next most- official record copy, but filers shall use of the ACAIS list for service must expeditious, commercially available certify that files on the diskette are true also serve any other carrier known to be manner for sending documents to the copies of the data file used to prepare operating at the airport but not on the country in which the foreign air carrier the printed versions of the exhibits or list. This is the same practice that is must be served.’’ Since in many cases briefs. Filers should ensure that files on followed with respect to PFC this would make it difficult or the diskettes are locked. applications. impossible to achieve service in time to Section-by-Section Analysis allow meaningful responsive pleadings, 1 For the same reason, we will not adopt ATA’s Section 302.601 Applicability contingent suggestion to allow carriers to serve only we cannot agree. Overnight express a written notice that a complaint had been filed, delivery is increasingly available Section 302.601 describes the kinds of along with instructions on how to obtain complete commercially throughout the world, proceedings for which the Department copies. We believe interested persons must have although it is true that the service is not will employ the expedited procedures immediate, full information about the filing. (In any event, ATA stated that its suggestion assumed available everywhere. However, that is contained in subpart F. ATA additional time would be allowed for follow-on one reason why the NPRM also complained that we should not be complaints). proposed to permit service by electronic issuing a procedural rule separate from Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6923 the policy statement that will govern statement. Specifically, it suggests address.) ATA’s comments stated that consideration of airport fee disputes. adding the words ‘‘for aeronautical use’’ the proposed rule failed ‘‘to specify the (As noted above, the FAA’s to describe the kinds of fees imposed by type and form of briefs to be presented Supplemental Notice of Proposed Policy airports on carriers that may be upon the filing of complaints.’’ ATA is was published in the Federal Register challenged under this subpart. The thus incorrect. on October 12, 1994 (59 FR 51836). The Department agrees that the language of As noted above, no commenter comment period closed on the proposed the procedural rule should be parallel to objected in principle to the basic policy on October 26, 1994, and a final that in the policy statement, and the procedure proposed in the NPRM for policy statement is published elsewhere suggested change has been adopted. consolidating all complaints and any in today’s Federal Register.) ATA urges Paragraph (b) of § 302.601 sets out the request for determination once any us to consolidate these proceedings and three limitations on applicability carrier has filed a complaint under this allow additional comment on a contained in the Authorization Act. The subpart. The final rule adopts the consolidated proposal. We disagree. Secretary would not entertain language of the NPRM. Following the Because of the extremely short deadline complaints about a fee imposed first complaint, other air carriers or for issuing rules governing these pursuant to a written agreement with foreign air carriers wishing to file their proceedings, the Department decided carriers using the facilities of an airport; own complaints would have seven days that the best course was to proceed in a fee imposed pursuant to a financing to do so. An airport owner or operator’s this two-stage fashion. Relatively few agreement or covenant entered into request for determination would also changes were needed in the proposed prior to August 23, 1994, or any other have to be submitted no later than seven policy statement after the adoption of existing fee not in dispute as of August days after a carrier complaint. The the FAA Authorization Act, while the 23, 1994. August 23, 1994 is the date the Authorization Act specifies that all FAA’s previously proposed procedures Authorization Act was enacted. complaints would have to be submitted had to be completely rewritten. If we Some commenters suggested within 60 days of the written notice, had waited until the new proposed additional provisions. ACI–NA, for even if this is less than seven days after procedures were ready so that we could example, recommends that ‘‘Airlines the initial complaint. The law does not issue a consolidated document, the should not be allowed to challenge a fee provide for entertaining later highly-abbreviated public comment increase that is the result of the complaints. No potential complainant, period that was necessary in this recalculation of airline fees due to the having had 54 or more days to prepare, proceeding would have had to apply to airport’s loss of one or more air carriers, will be disadvantaged by the both the proposed procedures and the or the substantial diminution of service immutability of the 60-day filing limit. proposed policy statement. by one or more air carriers.’’ We do not As indicated above, JAL’s request to As discussed above, the final rule agree that this should be added to the extend the statutory deadline for foreign adopts the proposal to include final rule. If a fee is increased as a result carriers is denied. While there is no complaints by foreign air carriers, but of a proper recalculation of charges, the statutory limitation on submitting complaints by other airport users would increase will be found reasonable. airport requests for determination, no not be heard under this subpart. Subpart However, that is no basis for denying a commenter objected to our proposal to F also contains the procedural rules for carrier’s right to file a complaint under impose a similar 60-day limit on such reviewing an airport owner or operator’s this subpart. ATA would have us limit requests, and that proposal is also made request for a determination of the the exclusions on using subpart F to final here. As noted in the NPRM, reasonableness of an airport fee. challenge fees imposed pursuant to airport fee increases become By statute, a fee is subject to review agreements with carriers or pursuant to incontestable under this subpart 60 days under this subpart only after it has been a financing agreement. These exclusions after the airport provides written notice ‘‘imposed’’ on air carriers. As was should apply, ATA believes, only if the to carriers of the imposition of a new or proposed, § 302.601(a) states that a fee agreements contain a basis for increased fee. The early determination is considered to be imposed as soon as determining how fees are to be set. of the reasonableness of a fee, which is the airport owner or operator has taken ‘‘[S]ome airports require air carriers to the purpose of the Act, would be all steps necessary under its procedures sign operating agreements that provide undermined by allowing more time. to establish the fee. Under the FAA ** * that the carrier is required to pay There is no point in expending Authorization Act in new 49 U.S.C. whatever fees are established by the Departmental resources on airport 47129(a)(1)(B), one essential element to airport operator.’’ We will not adopt requests brought after that date. those procedures is providing written ATA’s comment; the statutory language notice to carriers of any new or is clear that these rules may not be used Section 302.605 Contents of Complaint increased fee. Also as proposed, the 60- to challenge fees based on agreements. or Request for Determination day filing period for complaints begins Most of the issues pertaining to this to run as soon as the requirements for Section 302.603 Complaint by an Air section have been fully discussed above. imposing a fee are met, whether or not Carrier or Foreign Air Carrier; Request The following is only a brief summary the fee is being paid by the carriers. for Determination by an Airport Owner of the requirements in the final rule. ACI–NA points out that this ‘‘may help or Operator Carriers filing complaints and airports resolve fee disputes before the airport is This section describes the filing requests for determination will actually counting on receiving the requirements for carrier complaints and generally be expected to submit amounts in dispute, and would thus be airport requests for determination. In documentation that contains the filing less disruptive of airport planning and keeping with the proposal, paragraph (a) party’s entire position and supporting financing.’’ To the extent that it states that both complaints and requests evidence. We recognize, however, that encourages airports to avoid raising fees would be submitted in accordance with an airport may control information or on short notice, it should be less the usual technical requirements of documents that a complaining carrier disruptive of carrier planning as well. proceedings under 14 CFR Part 302. (14 would need. If that is the case, and the AAAE commented that the language CFR § 302.3 specifies such matters as carrier has unsuccessfully attempted to in § 302.601 should be made consistent the number of copies to be filed, the size obtain the necessary information, with the final language in the policy of pages that may be used, and the filing § 302.605 now provides that the carrier 6924 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations must state that fact in the complaint. As new arguments in opposition to the fee a case, the replying party would thus discussed above, the Department should do so in a follow-on complaint have at least three calendar days to anticipates that airports will promptly under § 302.603. prepare and submit its reply, although disclose any necessary information. Both the airport owner or operator we recognize that two of those days are The carrier filing the complaint or the and any carrier serving the airport may on the weekend. airport owner or operator filing the file an answer to a complaint under this In accordance with our proposal, only request must serve the complaint or subpart. In the case of an airport request the carrier originating a complaint or the request and accompanying documents for determination, any carrier serving airport originating a request for on all carriers serving the airport using the airport would be authorized to file determination would be authorized to the expedited procedures proposed in an answer. While only carriers subject file a reply. Except as provided in the NPRM. If a complaint has already to a new or increased fee at the airport subpart A of 14 CFR Part 302, replies by been filed with respect to a particular may submit a follow-on complaint any other party would not be accepted, airport’s fees, additional complaints are under § 302.603, any carrier at the nor would further responsive pleadings. due seven days after the initial airport may submit an answer. For that reason, the NPRM did not complaint. All complaints must be filed As stated above, answering parties propose to require that replies be served within 60 days after the carrier has would generally be expected to set out under the expedited procedures received written notice of a new or all of their responsive arguments, required for complaints, requests for increased fees. testimony and exhibits in their answer. determination, and answers. The NPRM The final rule retains the language The answering party will serve the specifically invited commenters to that the filing carrier or airport would complaining carrier or carriers or the address whether expedited procedures have to certify that it had previously airport owner or operator requesting the were necessary for replies, but no party attempted to resolve any fee dispute determination by hand, by electronic did so. We conclude that ordinary directly. In addition, as noted above, the transmission, or by overnight express service as provided by 14 CFR § 302.8 filing party must certify that any delivery. The answering party must (including service by mail) will suffice submission on computer diskette is a certify that the answer and for replies. As with complaints, requests true copy of the data file used to prepare accompanying documents will be for determination, and answers, the brief or exhibit. received no later than the day the however, the replying party must certify answer is due, and that any submission that any submission on computer Section 302.607 Answers to a on computer diskette is a true copy of Complaint or Request for Determination diskette is a true copy of the data file the data file used to prepare the brief or used to prepare the brief or exhibit. As discussed above, the most exhibit. Answers need only be served on significant change in this section the party to which the answer is Section 302.611 Review of Complaints involves the time for filing answers to directed. As was proposed, paragraph (a) of complaints or requests for § 302.611 provides that the Secretary Section 302.609 Replies determination. Answers will be due 14 will determine within 30 days after a days after the first complaint is filed ACI–NA argued that we should complaint is filed whether a significant rather than seven days after each eliminate the opportunity to file replies, dispute exists and whether the complaint. Answers are to respond to claiming that they are unnecessary, and complaint meets the procedural both the initiating complaint and any that the requirement that they be filed requirements of subpart F. If the follow-on complaints, which will two calendar days after the answer Secretary determines that there is no continue to be due seven days after the makes the opportunity to reply illusory. significant dispute, he or she will issue initial complaint. This will respond to We see no need to eliminate the an order dismissing the complaint, as requests that we make it possible for opportunity to file replies, although we required by the FAA Authorization Act. parties to submit a consolidated answer emphasize that replies are voluntary The Secretary’s order will include an to all complaints, while still allowing submissions. explanation of the reasons for the the Department sufficient time to review While no other party suggested determination. If the Secretary complaints or requests and the answers eliminating replies altogether, Massport, determines that the complaint does not submitted. the Maryland Aviation Administration, meet the procedural requirements of Under the final rule, therefore, upon and AAAE all recommended that we this subpart (for example, the complaint receiving a copy of a complaint filed by allow two business days rather than two was not properly served on the airport another carrier, an air carrier or foreign calendar days. In part, it appears that owner or operator), the Secretary will air carrier could file its own complaint this recommendation may stem from a dismiss the complaint without within seven days or an answer to the misunderstanding of our procedures. prejudice. In this case, the order would first complaint within 14 days. As noted AAAE, for example, states that ‘‘The explain any conditions necessary for the in the preamble to the NPRM, it is rules as proposed would require that a complaint to be re-filed. technically permissible for a party to party replying to an answer filed on a When one or more properly filed submit both its own complaint and an Friday file its reply on Sunday evening, complaints have been submitted, the answer to the initiating complaint. when the agency is not even open for Secretary will issue an instituting order However, because of the limited time business.’’ This is simply wrong. As consolidating all complaints that raise available for the Department to review provided in our rules of practice (14 significant issues and any request for complaints and answers, parties are CFR § 302.16), any filing that would be determination. The instituting order strongly urged to avoid duplicative due on a Saturday, Sunday, or will assign the consolidated case to an filings. Naturally, answers, including government holiday is automatically administrative law judge and describe answers in support of a complainant’s due instead on the next business day. the issues to be considered and the position, do not give the answering Accordingly, when an answer is due on parties that will participate. party status as an additional a Thursday or Friday, any reply to the In addition, § 302.611 now provides complainant, nor may answers raise answer would be due by close of that the instituting order may contain new objections to a fee or fees in business on the following Monday (or special provisions for exchange or dispute. A carrier that wants to raise any the first business day thereafter). In such disclosure of information by the parties. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6925 As discussed above, the Department would ordinarily not require any subpart or a direction in the instituting presumes that airports will provide all additional procedures, the Secretary order. As the FAA Authorization Act information necessary for carriers to would retain discretion to require expressly states, following assignment understand the basis and justification whatever additional procedures are of the proceeding to an administrative for any new or increased airport fee. necessary in a particular case. law judge, ‘‘the matter shall be handled However, we have included this ACI–NA notes that paragraph (b) in accordance with part 302 of title 14, provision to clarify the Department’s differs from paragraph (c) in that the Code of Federal Regulations, or as ability to ensure that adequate latter specifies that the Secretary’s modified by the Secretary to ensure an information is made available. determination with respect to orderly disposition of the matter within Finally, the Secretary’s order will reasonableness will be issued within the 120-day period and any specifically state when the administrative law judge 120 days after the airport request is applicable provisions of this section.’’ must issue a recommended decision (60 filed. ACI–NA asks that we insert the (49 U.S.C. 47129(c)(2)). Similarly, days after the instituting order, unless 120-day language in paragraph (b) as subpart A of part 302 states as follows: the order specifies a shorter period). well. While ACI–NA is correct that the Subpart A of this part sets forth general two provisions should be parallel, Section 302.613 Review of Requests for rules applicable to all types of proceedings. § 302.619(b) contains the completion Determination Each of the other subparts of this part sets time applicable to all requests for forth special rules applicable to the type of An airport owner or operator’s request determination. Therefore, to avoid proceedings described in the title of the for determination of the reasonableness confusion, the final rule deletes the last subpart. Therefore, for information as to of an airport fee will generally be sentence of proposed paragraph (c). applicable rules, reference should be made to handled in the same manner as a carrier subpart A and to the rules in the subpart complaint. As discussed above, we have Section 302.615 Decision by relating to the particular type of proceeding revised the language of § 302.613 to Administrative Law Judge 14 CFR 302.1(b). clarify the timing for action on an As provided by the FAA ACI–NA argued that a prehearing airport’s request. Authorization Act, § 302.615 requires conference should be mandatory for all When only an airport request has the administrative law judge to issue a parties in any proceeding brought under been filed, and not a carrier complaint, recommended decision within 60 days this subpart in which an oral hearing is the Secretary will determine within 30 after the case is assigned by the scheduled. Although ACI–NA points days whether there is a significant Secretary for hearing, unless the out that this is common practice in the dispute and whether the procedural instituting order specifies a shorter federal courts and many state courts, we requirements of the subpart have been period. do not believe that it is desirable to met. Properly submitted requests raising ATA asked that we set out in this include this requirement in the rule. a significant dispute will be assigned to subpart specific requirements for Once the case is assigned for hearing, an administrative law judge in the same hearings on airport fee disputes. It we anticipate that the administrative manner as carrier complaints, with recommended that ‘‘the Rule provide law judge will frequently choose to appropriate guidelines on the scope of clear definition as to the nature of these order a prehearing conference. There the issues and the parties to participate. hearings and a standardized approach to might even be situations in which it If there is a procedural deficiency, the the resolution of the complicated factual would be appropriate for the Secretary request will be dismissed without and legal issues raised by airport fee to require a prehearing conference, in prejudice, and the order of dismissal disputes. As presently crafted, the which case the instituting order will will set forth the terms and conditions NPRM would apparently rely upon the direct one be held. However, there is no under which a revised request could be Secretary’s order to draft a different reason for the final rule to make a filed. approach in each and every case. Aside prehearing conference mandatory in all However, when both an airport from the logical impracticality of such cases. request and one or more carrier an unpredictable approach, we believe complaints have been filed, the it to be so lacking in procedural Section 302.617 Petitions for Secretary will proceed under the guidance as to be fundamentally Discretionary Review statutorily prescribed schedule for inconsistent with the requirements of The Los Angeles Department of resolving the complaint. As required by Section 47129. As an alternative, we Airports objected to our proposal to the FAA Authorization Act, the propose that the Secretary incorporate provide for the filing of petitions for Secretary will determine whether any the procedures governing hearings set discretionary review of the complaint presents a significant dispute forth in 14 CFR part 302, subpart A, as administrative law judge’s within 30 days after the first complaint modified in order to meet the time recommended decision. Instead, it is submitted. If the first complaint is constraints imposed by Section 47129.’’ argues that the FAA Authorization Act filed after the airport owner or ATA appears to be suggesting that the mandates Secretarial review of the operator’s request, the request will be Department lacks authority to impose recommended decision. It advocated reviewed in conjunction with the specific requirements on the conduct of allowing seven days for parties to complaints, and the consolidated individual proceedings. This is simply provide exceptions to the recommended instituting order may be issued more incorrect, and indeed one important decision, and an additional seven days than 30 days following the request. purpose of an instituting order is to in which to file cross-exceptions. As discussed above, the Secretary will tailor the general rules to the needs of As we stated in the preamble to the not dismiss an airport owner or a particular case. However, with respect NPRM, we anticipate that the Secretary operator’s request for determination on to ATA’s alternative suggestion that we will issue all final orders in proceedings the basis that it does not raise a rely generally on subpart A procedures, under subpart F. Nevertheless, we do significant issue. In such cases, the no change from the NPRM language is not agree that the Authorization Act Secretary would usually proceed necessary. We have made it clear makes this mandatory. In fact, the directly to issue a final order throughout this rulemaking that subpart statute specifically anticipates that the determining whether the fee is A procedures will apply in the absence Secretary might not issue a final order: reasonable. While this determination of a specific applicable provision in this It provides that the administrative law 6926 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations judge’s recommended decision is to be the timetable for resolving carrier ACI–NA asks that the rule clarify that considered the Secretary’s final order if complaints would control the schedule ‘‘any finding of unreasonableness the Secretary does not act within 120 for action by the Department. Thus, if a resulting from a complaint filed by a days after a complaint is filed. carrier complaint is filed before the non-signatory carrier does not affect the Accordingly, we will adopt the airport request, the Department would underlying rates for signatory carriers, proposed structure of providing for issue a final order in the consolidated since the signatory fees may not be discretionary review of the proceeding in less than 120 days after challenged.’’ No rule change is needed recommended decision. the airport’s request for determination. here. However, it is obvious that no fee As we proposed, a party to the If one or more carriers file a complaint will be found to be unreasonable under proceeding will be able to file a petition after the airport request, the 120-day subpart F unless it is the subject of a for discretionary review of the period would begin on the day the first complaint or a request for administrative law judge’s decision carrier complaint is filed. determination. within five days after the recommended As stated above, the Department decision is served. The petitioner will Section 302.621 Final Order expects the Secretary to issue all final serve all parties by hand, electronic Following review of the orders. However, if the Secretary fails to transmission or overnight express recommended decision, the Secretary issue an order within 120 days after a delivery, and will certify that all parties will issue a final determination with complaint is filed, the FAA had received the petition or would respect to the reasonableness of an Authorization Act requires that the receive it by the date of filing. Any other airport fee that is the subject of a administrative law judge’s decision be party could then submit an answer, complaint or a request under this deemed the final order of the Secretary. which would be due four days after the subpart. The Secretary’s order will set Section 302.621(c) restates this petition is filed. AAAE and ACI–NA forth the reasoning underlying the requirement. There is no corresponding stated that answers should be subject to determination, and, if a fee is legislative requirement with respect to the same expedited service determined to be unreasonable, the airport requests for determination. requirements as petitions, but they did order will provide for a refund or credit Therefore Section 302.621 does not not explain why this would be of the unreasonable charge. As noted in contain any provision for automatic necessary. The Department does not the NPRM, the exact terms under which adoption of the administrative law anticipate permitting further pleadings the refund or credit would be ordered judge’s decision. The Department at this stage of the proceeding, and we would vary with the particular nevertheless intends to resolve airport do not believe that the burden of circumstances of each case, but the requests for determination within 120 expedited service is justified. Department intends to ensure prompt days after they are filed. Section 302.619 Completion of action. Justification for Immediate Proceeding The FAA Authorization Act, in new Effectiveness This section sets out the completion 49 U.S.C. Section 47129 (a) (3), limits Section 553 of the Administrative dates for proceedings conducted under the Secretary’s order to determining Procedure Act provides that the this subpart. No comments were reasonableness, and the order would not effective date of a new rule should be at submitted on it, and it is unchanged set the level of the fee. The Maryland least 30 days after it is published, unless from the NPRM. Aviation Administration expressed the agency finds good cause for a shorter Paragraph (a) states that the Secretary concern in its comments that disputes period. will issue a final order determining may not really be resolved within the In enacting the FAA Authorization whether the disputed fee is reasonable 120-day limit unless the Department Act, the Congress made it clear that it within 120 days after the filing of a states what a reasonable fee would be. intends for fee disputes between carriers complaint by an air carrier or foreign air In the absence of such a statement, a and airports to be resolved promptly. carrier, unless the complaint is revised fee would still be subject to Congress required that the Department dismissed as provided in proposed challenge. Because the limitation on the issue this rule within 90 days of § 302.611. This is the time limit for Secretary’s authority is a matter of enactment of the Authorization Act, and resolving air carrier complaints set forth statute, there is nothing we can do in mandated that all proceedings brought in the FAA Authorization Act. this rulemaking to change it. However, under the new procedures lead to a final Paragraphs (b) and (c) address the Secretary’s order will attempt to set order within 120 days. The Department proceedings involving requests for out the analysis underlying the decision will be unable to process any carrier determination by airport owners and as clearly as possible. If a fee is found complaints under this subpart until the operators. Although the FAA unreasonable, we hope and expect that procedures are effective. Accordingly, Authorization Act does not impose a parties will be able to establish a the Department finds that good cause time limit on such requests, § 302.619 reasonable fee after reviewing the exists to make this rule effective on provides a 120-day limit on these decision and analysis. publication in the Federal Register. proceedings as well. When an airport The Maryland Aviation has filed a request for determination but Administration also states that ‘‘the Regulatory Evaluation Summary there are no carrier complaints with Department, or as may be required, the This final rule contains new respect to the same fee, paragraph (b) framers of the underlying statutory procedures for the filing and states that the Secretary would issue a scheme, should consider whether the adjudication of complaints by air final order within 120 days of the Department should award costs to carriers and foreign air carriers alleging request. However, as noted in § 302.613, airports’’ when a disputed fee is found that an airport has imposed an the Department will consolidate reasonable. As the commenter appears unreasonable fee or charge on the proceedings concerning the same airport to appreciate, the Department does not complaining carrier. It also sets forth fee or fees that are the subject of both have authority to award costs to the corresponding procedures under which a carrier complaint and an airport prevailing party in a fee dispute under an airport owner or operator may request for determination. In this subpart F. Accordingly, the comment is request and receive a determination of situation, paragraph (c) provides that beyond the scope of this rulemaking. the reasonableness of a fee or charge it Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6927 has imposed on one or more air carriers Conclusion newly established fee for aeronautical or foreign air carriers. The new Although the Department has uses that is imposed upon the air carrier procedures replace existing procedures concluded that the economic effects of or foreign air carrier by the owner or under 14 CFR part 13, and impose no this rulemaking are minimal, this rule is operator of an airport. This subpart also new substantive requirements on either considered significant under Executive applies to requests by the owner or carriers or airports. The only commenter Order 12866 because of the public operator of an airport for such a to question the tentative conclusion in interest in this rulemaking. The determination. An airport owner or the NPRM that the economic effect of Department certifies that this rule will operator has imposed a fee on an air the proposed rule would be minimal not have a significant economic impact, carrier or foreign air carrier when it has was the Maryland Aviation positive or negative, on a substantial taken all steps necessary under its Administration, which argues that number of small entities under the procedures to establish the fee, whether ‘‘[t]he cost to provide expert witnesses criteria of the Regulatory Flexibility Act. or not the fee is being collected or and legal counsel if it is determined that This rule is considered significant under carriers are currently required to pay it. there is a ‘significant dispute’ may well DOT Regulatory Policies and Procedures (b) This subpart does not apply to— prove to be material.’’ The Maryland (44 FR 11034; February 26, 1978). (1) A fee imposed pursuant to a Aviation Administration did not written agreement with air carriers or attempt to quantify the costs it believed List of Subjects in 14 CFR Part 302 foreign air carriers using the facilities of involved. More importantly, it did not Administrative practice and an airport; establish that the costs are actually the procedure, Air carriers, Airports, Postal (2) A fee imposed pursuant to a result of the procedural rules at issue Service. financing agreement or covenant here rather than the general cost of the entered into prior to August 23, 1994; or litigation authorized by 49 U.S.C. 47129. The Amendments (3) Any other existing fee not in Accordingly, the Department concludes Accordingly, the Department of dispute as of August 23, 1994. that the economic impact of the final Transportation amends 14 CFR part 302 as follows: § 302.603 Complaint by an air carrier or rule is minimal and that further foreign air carrier; request for determination calculation of the economic effects is by an airport owner or operator. not warranted. PART 302ÐRULES OF PRACTICE IN PROCEEDINGS (a) Any air carrier or foreign air carrier Regulatory Flexibility Determination may file a complaint with the Secretary 1. The authority citation for 14 CFR for a determination as to the The Regulatory Flexibility Act of 1980 Part 302 is revised to read: reasonableness of any fee imposed on (RFA) was enacted by Congress to Authority: 5 U.S.C. 551 et seq.; 39 U.S.C. the carrier by the owner or operator of ensure that small entities are not 5402; 42 U.S.C. 4321; 49 U.S.C. 40101, an airport. Any airport owner or unnecessarily or disproportionately 40102, 40113, 40114, Chapters 411–415, operator may also request such a burdened by government regulations. 41702, 41705, 41706, 41901, 41907, 41909, determination with respect to a fee it The RFA requires a Regulatory 41910, 42111, 46301, 46302, 46303, 46105, has imposed on one or more air carriers. Flexibility Analysis if a rule would have 47129. The complaint or request for a significant economic impact, either 2. A new subpart F is added to 14 CFR determination shall conform to the detrimental or beneficial, on a Part 302 to read as follows: requirements of this subpart and § 302.3 substantial number of small entities. Subpart FÐRules Applicable to concerning the form and filing of This rule contains procedural Proceedings Concerning Airport Fees documents. requirements for processing carrier (b) If an air carrier or foreign air complaints and airport requests. The Sec. 302.601 Applicability of this subpart. carrier has previously filed a complaint Department concludes that the rule will 302.603 Complaint by an air carrier or with respect to the same airport fee or not have a significant economic impact foreign air carrier; request for fees, any complaint by another carrier on a substantial number of small determination by an airport owner or and any airport request for entities. operator. determination shall be filed no later 302.605 Contents of complaint or request Federalism Implications for determination. than 7 calendar days following the 302.607 Answers to a complaint or request initial complaint. In addition, all The final rule will not have complaints or requests for substantial direct effects on the States, for determination. 302.609 Replies. determination must be filed on or before on the relationship between the national 302.611 Review of complaints. the 60th day after the carrier receives government and the States, or on the 302.613 Review of requests for written notice of the imposition of the distribution of power and determination. new fee or the imposition of the responsibilities among the various 302.615 Decision by administrative law increase in the fee. levels of government. Therefore, in judge. 302.617 Petitions for discretionary review. (c) To ensure an orderly disposition of accordance with Executive Order 12612, the matter, all complaints and any it is determined that this rule does not 302.619 Completion of proceedings. 302.621 Final order. request for determination filed with have sufficient federalism implications respect to the same airport fee or fees to warrant the preparation of a Subpart FÐRules Applicable to will be considered in a consolidated Federalism Assessment. Proceedings Concerning Airport Fees proceeding, as provided in §§ 302.611 and 302.613. Paperwork Reduction Act § 302.601 Applicability of this subpart. This rule contains no information (a) This subpart contains the specific § 302.605 Contents of complaint or collection requirements that require rules that apply to a complaint filed by request for determination. approval of the Office of Management one or more air carriers or foreign air (a) The complaint or request for and Budget pursuant to the Paperwork carriers, pursuant to 49 U.S.C. 47129 (a), determination shall set forth the entire Reduction Act of 1980 (44 U.S.C. 3507 for a determination of the grounds for requesting a determination et seq.). reasonableness of a fee increase or a of the reasonableness of the airport fee. 6928 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations The complaint or request shall include (5) Any submission on computer (c) Answers to a complaint shall be a copy of the airport owner or operator’s diskette is a true copy of the data file filed no later than fourteen calendar written notice to the carrier of the used to prepare the printed versions of days after the filing date of the first imposition of the fee, a statement of the exhibits or briefs. complaint with respect to the fee or fees position with a brief, and all supporting (d) When an airport owner or operator in dispute at a particular airport. testimony and exhibits available to the files a request for determination, it must Answers to a request for determination carrier on which the filing party intends also submit the following certifications: shall be filed no later than fourteen to rely. In lieu of submitting duplicative (1) The airport owner or operator has calendar days after the filing date of the exhibits or testimony, the filing party served the request, brief, and all request. may incorporate by reference testimony supporting testimony and exhibits on all (d) All exhibits and briefs prepared on and exhibits already filed in the same air carriers and foreign air carriers electronic spreadsheet or word proceeding. serving the airport by hand, by processing programs should be (b) All exhibits and briefs prepared on electronic transmission, or by overnight accompanied by standard-format electronic spreadsheet or word express delivery. (Unless the air carrier computer diskettes containing those processing programs should be or foreign air carrier has informed the submissions. Word processing and accompanied by standard-format airport owner or operator that a different spreadsheets files must be readable by computer diskettes containing those person should be served, service may be current versions of one or more of the submissions. Word processing and made on the person responsible for following programs, or in such other spreadsheets files must be readable by communicating with the airport on format as may be specified by notice in current versions of one or more of the behalf of the carrier about airport fees.); the Federal Register: Microsoft Word, following programs, or in such other (2) The carriers served have received Word Perfect, Ami Pro, Microsoft Excel, format as may be specified by notice in the request, brief, and all supporting Lotus, Quattro Pro, or ASCII tab- the Federal Register: Microsoft Word, testimony and exhibits or will receive delineated files. Parties should submit Word Perfect, Ami Pro, Microsoft Excel, them no later than the date the request one copy of each diskette to the docket Lotus, Quattro Pro, or ASCII tab- is filed; section, one copy to the office of the delineated files. Parties should submit (3) The airport owner or operator has Chief Administrative Law Judge (M–50), one copy of each diskette to the docket previously attempted to resolve the and one copy to the Chief, Economic section, one copy to the office of the dispute directly with the carriers; and and Financial Analysis Division (X–55), Chief Administrative Law Judge (M–50), (4) Any submission on computer of the Office of Aviation Analysis. Filers and one copy to the Chief, Economic diskette is a true copy of the data file should ensure that files on the diskettes and Financial Analysis Division (X–55), used to prepare the printed versions of are unalterably locked. of the Office of Aviation Analysis. Filers the exhibits or briefs. (e) The answering party must also should ensure that files on the diskettes submit the following certifications: are unalterably locked. § 302.607 Answers to a complaint or (c) When a carrier files a complaint, request for determination. (1) The answering party has served it must also submit the following (a)(1) When an air carrier or foreign the answer, brief, and all supporting certifications: air carrier files a complaint under this testimony and exhibits by hand, by (1) The carrier has served the subpart, the owner or operator of an electronic transmission, or by overnight complaint, brief, and all supporting airport and any other air carrier or express delivery on the carrier filing the testimony and exhibits on the airport foreign air carrier serving the airport complaint or the airport owner or owner or operator and all other air may file an answer to the complaint as operator requesting the determination; carriers and foreign air carriers serving provided in paragraphs (b) and (c) of (2) The parties served have received the airport by hand, by electronic this section. the answer and exhibits or will receive transmission, or by overnight express (2) When the owner or operator of an them no later than the filing date of the delivery. (Unless an air carrier or foreign airport files a request for determination answer; and air carrier has informed the complaining of the reasonableness of a fee it has (3) Any submission on computer carrier that a different person should be imposed, any air carrier or foreign air diskette is a true copy of the data file served, service may be made on the carrier serving the airport may file an used to prepare the printed versions of person responsible for communicating answer to the request. the exhibits or briefs. (b) The answer to a complaint or with the airport on behalf of the carrier § 302.609 Replies. about airport fees.); request for determination shall set forth (2) The parties served have received the answering party’s entire response. (a) The carrier submitting a complaint the complaint, brief, and all supporting When one or more additional may file a reply to any or all of the testimony and exhibits or will receive complaints or a request for answers to the complaint. The airport them no later than the date the determination has been filed pursuant owner or operator submitting a request complaint is filed; to § 302.603(b) with respect to the same for determination may file a reply to any (3) The carrier has previously airport’s fee or fees, the answer shall set or all of the answers to the request for attempted to resolve the dispute directly forth the answering party’s entire determination. with the airport owner or operator; response to all complaints and any such (b) The reply shall be limited to new (4) When there is information on request for determination. The answer matters raised in the answers. It shall which the carrier intends to rely that is shall include a statement of position constitute the replying party’s entire not included with the brief, exhibits, or with a brief and any supporting response to the answers. It shall be in testimony, the information has been testimony and exhibits on which the the form of a reply brief and may omitted because the airport owner or answering party intends to rely. In lieu include supporting testimony and operator has not made that information of submitting duplicative exhibits or exhibits responsive to new matters available to the carrier. The certification testimony, the answering party may raised in the answers. In lieu of shall specify the date and form of the incorporate by reference testimony and submitting duplicative exhibits or carrier’s request for information from exhibits already filed in the same testimony, the replying party may the airport owner or operator; and proceeding. incorporate by reference testimony and Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations 6929 exhibits already filed in the same concise explanation of the reasons for date of the instituting order, unless a proceeding. the determination that the dispute is not shorter period is specified by the (c) The reply shall be filed no later significant. Secretary. than two calendar days after answers are (d) If the Secretary determines that the filed. complaint does not meet the procedural § 302.617 Petitions for discretionary review. (d) All exhibits and briefs prepared on requirements of this subpart, the electronic spreadsheet or word complaint will be dismissed without (a) Within 5 calendar days after processing programs should be prejudice to filing a new complaint. The service of a decision by an accompanied by standard-format order of the Secretary will set forth the administrative law judge, any party may computer diskettes containing those terms and conditions under which a file with the Secretary a petition for submissions. Word processing and revised complaint may be filed. discretionary review of the spreadsheets files must be readable by administrative law judge’s decision. current versions of one or more of the § 302.613 Review of requests for (b) Petitions for discretionary review following programs, or in such other determination. shall comply with § 302.28(a). The format as may be specified by notice in (a) Except as provided in paragraph petitioner must also submit the the Federal Register: Microsoft Word, (e) of this section, within 30 days after following certifications: Word Perfect, Ami Pro, Microsoft Excel, an airport owner or operator files a (1) The petitioner has served the Lotus, Quattro Pro, or ASCII tab- request for determination of the petition by hand, by electronic delineated files. Parties should submit reasonableness of a fee under this transmission, or by overnight express one copy of each diskette to the docket subpart, the Secretary will determine delivery on all parties to the proceeding; section, one copy to the office of the whether the request meets the and Chief Administrative Law Judge (M–50), procedural requirements of this subpart (2) The parties served have received and one copy to the Chief, Economic and whether a significant dispute exists. the petition or will receive it no later and Financial Analysis Division, (X–55) (b) If the Secretary determines that a than the date the petition is filed. of the Office of Aviation Analysis. Filers significant dispute exists, he or she will (c) Any party may file an answer in should ensure that files on the diskettes issue an instituting order assigning the support of or in opposition to any are unalterably locked. request for hearing before an petition for discretionary review. The (e) The carrier or airport owner or administrative law judge. The answer shall be filed within 4 calendar operator submitting the reply must instituting order will establish the scope days after service of the petition for certify that it has served the reply and of the issues to be considered and the discretionary review. The answer shall all supporting testimony and exhibits on procedures to be employed and will comply with the page limits specified in the party or parties submitting the indicate the parties to participate in the § 302.28(b). hearing. The instituting order will answer to which the reply is directed § 302.619 Completion of proceedings. and that any submission on computer consolidate into a single proceeding all diskette is a true copy of the data file complaints and any request for (a) When a complaint with respect to used to prepare the printed versions of determination with respect to the fee or an airport fee or fees has been filed the exhibits or briefs. fees in dispute. under this subpart and has not been (c) If the Secretary finds that the dismissed, the Secretary will issue a § 302.611 Review of complaints. request for determination presents no determination as to whether the fee is (a) Within 30 days after a complaint significant dispute, the Secretary will reasonable within 120 days after the is filed under this subpart, the Secretary either issue a final order as provided in complaint is filed. will determine whether the complaint § 302.621 or set forth the schedule for (b) When a request for determination meets the procedural requirements of any additional procedures required to has been filed under this subpart and this subpart and whether a significant complete the proceeding. has not been dismissed, the Secretary dispute exists, and take appropriate (d) If the Secretary determines that the will issue a determination as to whether action pursuant to paragraph (b), (c), or request does not meet the procedural the fee is reasonable within 120 days (d) of this section. requirements of this subpart, the request after the date the request for (b) If the Secretary determines that a for determination will be dismissed determination is filed. significant dispute exists, he or she will without prejudice to filing a new (c) When both a complaint and a issue an instituting order assigning the request. The order of the Secretary will request for determination have been complaint for hearing before an set forth the terms and conditions under filed with respect to the same airport fee administrative law judge. The which a revised request may be filed. or fees and have not been dismissed, the instituting order will— (e) When both a complaint and a Secretary will issue a determination as (1) Establish the scope of the issues to request for determination have been to whether the fee is reasonable within be considered and the procedures to be filed with respect to the same airport fee 120 days after the complaint is filed. employed; or fees, the Secretary will issue a § 302.621 Final order. (2) Indicate the parties to participate determination as to whether the in the hearing; complaint, the request, or both meet the (a) When a complaint or request for (3) Consolidate into a single procedural requirements of this subpart determination stands submitted to the proceeding all complaints and any and whether a significant dispute exists Secretary for final decision on the request for determination with respect within 30 days after the complaint is merits, he or she may dispose of the to the fee or fees in dispute; and filed. issues presented by entering an (4) Include any special provisions for appropriate order, which will include a exchange or disclosure of information § 302.615 Decision by administrative law statement of the reasons for his or her by the parties. judge. findings and conclusions. Such an order (c) The Secretary will dismiss any The administrative law judge shall shall be deemed a final order of the complaint if he or she finds that no issue a decision recommending a Secretary. significant dispute exists. The order disposition of a complaint or request for (b) The final order of the Secretary dismissing the complaint will contain a determination within 60 days after the shall include, where necessary, 6930 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Rules and Regulations directions regarding an appropriate filing of a complaint by an air carrier or Issued in Washington, DC, on January 30, refund or credit of the fee increase or foreign air carrier, the decision of the 1995. newly established fee which is the administrative law judge shall be Federico Pen˜ a, subject of the complaint or request for deemed to be the final order of the Secretary. determination. Secretary. [FR Doc. 95–2674 Filed 1–31–95; 3:15 pm] (c) If the Secretary has not issued a BILLING CODE 4910±62±P final order within 120 days after the federal register February 3,1995 Friday Safety ActNationalMasterList;Notice Changes totheHotelandMotelFire Management Agency Federal Emergency Part V 6931 6932 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices FEDERAL EMERGENCY SUPPLEMENTARY INFORMATION: Acting updates, the three categories mean and MANAGEMENT AGENCY under the Hotel and Motel Fire Safety include the following: Act of 1990, 15 U.S.C. 2201 note, the ‘‘Additions’’ are either names of Changes to the Hotel and Motel Fire United States Fire Administration has properties submitted by a State but Safety Act National Master List worked with each State to compile a inadvertently omitted from the initial AGENCY: United States Fire national master list of all of the places master list or names of properties Administration, FEMA. of public accommodation affecting submitted by a State after publication of commerce located in each State that ACTION: Notice. the initial master list; meet the requirements of the guidelines SUMMARY: The Federal Emergency under the Act. FEMA published the ‘‘Corrections/changes’’ are corrections Management Agency (FEMA or Agency) national master list in the Federal to property names, addresses or gives notice of additions and Register on Tuesday, November 29, telephone numbers previously corrections/changes to, and deletions 1993, 58 FR 62718, and published published or changes to previously from, the national master list of places changes approximately monthly since published information directed by the of public accommodations which meet then. State, such as changes of address or the fire prevention and control Parties wishing to be added to the telephone numbers, or spelling guidelines under the Hotel and Motel National Master List, or to make any corrections; and Fire Safety Act. other change, should contact the State ‘‘Deletions’’ are entries previously EFFECTIVE DATE: March 6, 1995. office or official responsible for submitted by a State and published in ADDRESSES: Comments on the master compiling listings of properties which the national master list or an update to list are invited and may be addressed to comply with the Hotel and Motel Fire the national master list, but the Rules Docket Clerk, Federal Safety Act. A list of State contacts was subsequently removed from the list at Emergency Management Agency, 500 C published in 58 FR 17020 on March 31, the direction of the State. Copies of the Street, SW., room 840, Washington, D.C. 1993. If the published list is unavailable national master list and its updates may 20472, (fax) (202) 646–4536. To be to you, the State Fire Marshal’s office be obtained by writing to the added to the National Master List, or to can direct you to the appropriate office. Government Printing Office, make any other change to the list, please Periodically FEMA will update and Superintendent of Documents, see SUPPLEMENTARY INFORMATION below. redistribute the national master list to Washington, DC 20402–9325. When FOR FURTHER INFORMATION CONTACT: John incorporate additions and corrections/ requesting copies please refer to stock Ottoson, Fire Management Programs changes to the list, and deletions from number 069–001–00049–1. Branch, United States Fire the list, that are received from the State The update to the national master list Administration, Federal Emergency offices. follows below. Management Agency, National Each update contains or may contain Emergency Training Center, 16825 three categories: ‘‘Additions;’’ Dated: January 30, 1995. South Seton Avenue, Emmitsburg, MD ‘‘Corrections/changes;’’ and John P. Carey, 21727, (301) 447–1272. ‘‘Deletions.’’ For the purposes of the General Counsel. HOTEL AND MOTEL FIRE SAFETY ACT NATIONAL MASTER LIST JANUARY 20, 1995 UPDATE Index and Property name PO Box/Rt No. Street address City, State/ZIP Telephone ADDITIONS Alaska AK0042 Alaska Ocean View Bed and Breakfast ...... 1101 Edgecumbe Dr . Sitka, AK 99835 ...... (907) 747±8310 California CA1441 Mandarin Oriental, San Francisco ...... 222 Sansome St ...... San Francisco, CA (415) 885±0999 94109. Kansas KS0153 Hampton Inn, Topeka ...... 1401 Ashworth Place Topeka, KS 66604 .... (913) 273±0003 Maine ME0056 Holiday Inn ...... 404 Odlin Rd ...... Bangor, ME 04401 ... (207) 947±0101 Minnesota MN0288 Park Inn International ...... 250 Canal Park Drive Duluth, MN 55802 .... (218) 727±8821 MN0292 Hanpton Inn, Eagan ...... 3000 Eagandale Eagan, MN 55121 .... (612) 688±3343 Place. MN0290 The Old Railroad Inn ...... 219 Moore Street ...... Jackson, MN 56143 .. (507) 847±5348 MN0291 Motel 6 ...... 11274 210th Street .... Lakeville, MN 55044 . (612) 469±1900 MN0289 Motel 6 ...... 2107 West Frontage Rochester, MN 55901 (507) 282±6625 Road. New York NY0606 Howard Johnson Lodge ...... 551 Rt. 211 East ...... Middletown, NY (914) 342±5822 10954. NY0605 Ramada Inn, Airport ...... 1273 Chili Ave ...... Rochester, NY 14624 (716) 464±8800 Oklahoma OK0098 Century Center Hotel ...... 1 North Broadway ...... Oklahoma City, OK (405) 235±2780 73102. Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6933 HOTEL AND MOTEL FIRE SAFETY ACT NATIONAL MASTER LIST JANUARY 20, 1995 UPDATEÐContinued Index and Property name PO Box/Rt No. Street address City, State/ZIP Telephone Oregon OR0182 Portland/Beaverton Shilo Inn ...... 9900 SW Canyon Rd Beaverton, OR 97225 (503) 297±2551 OR0172 Bend Alpine Hotel ...... 19 SW Century Drive Bend, OR 97702 ...... (503) 389±3813 OR184 Motel 6 ...... 997 Oregon Ave ...... Burns, OR 97720 ...... (503) 573±3013 OR0171 Wilderness Inn Motel ...... 301 W. North St ...... Enterprise, OR 97828 (503) 426±4535 OR0183 Mt. Hood Inn ...... 87450 E. Government Government Camp, (503) 272±3205 Camp Loop. OR 97028. OR0181 Grants Pass Shilo Inn ...... 1880 NW 6th St ...... Grants Pass, OR (503) 479±8391 975261038. OR0186 Motel 6 ...... 5136 S. 6th Street ..... Klamath Falls, OR (503) 884±2110 97601. OR0180 Lakeview Lodge Motel ...... 301 North 9 Street ..... Lakeview, OR 97630 (503) 947±2225 OR0187 Motel 6 ...... US 5 Rt 62 ...... 2400 Biddle Road ...... Medford, OR 97504 .. (503) 779±0550 OR0173 The Vikings Cottages and Condominiums ...... 729 NW Coast St ...... Newport, OR 97365 .. (503) 265±2477 OR0185 Motel 6 ...... 275 NE 12 St ...... Ontario, OR 97914 ... (503) 889±6617 OR0178 Motel 6 ...... 17959 SW McEwan Portland, OR 97224 .. (503) 684±0760 Rd. OR0179 Motel 6 ...... 3104±06 SE Powelll Portland, OR 97202 .. (503) 238±0600 Blvd. OR174 Oxford Suites ...... 12226 N. Jantzen Portland, OR 97217 .. (503) 283±3030 Ave.. OR0175 Best Western Mill Creek Inn ...... 3125 Ryan Dr. NE ..... Salem, OR 97301 ..... (503) 585±3332 OR0177 Motel 6 ...... 1401 Hawthorne Ave. Salem, OR 97301 ..... (503) 371±8024 NE. OR0188 Kah Nee Ta Resort ...... PO Box K ...... 100 Main St ...... Warm Sprints, OR (503) 553±1112 97761. South Carolina SC0216 Jameson Inn ...... 128 Interstate Blvd .... Anderson, SC 29621 (803) 375±9800 SC0215 Knights Inn, Airport Boulevard ...... 1987 Airport Blvd ...... Cayce, SC 29033 ..... (803) 794±0222 SC0217 Hawthorne Suites Hotel ...... 181 Church St ...... Charleston, SC (803) 577±2644 29401. Texas TX0626 Hawthorn Suites Hotel-Austin South ...... 4020 I±35 South ...... Austin, TX ...... (512) 440±7722 TX0625 Hawthorn Suites Hotel ...... 250 Municipal Dr ...... Richardson, TX ...... (214) 669±1000 TX0627 Hawthorn Suites Hotel-San Antonio ...... 4041 Bluemel Dr ...... San Antonio Rd, TX . (210) 561±9660 Utah UT0087 Salt Lake City Shilo Inn ...... 206 S. West Temple .. Salt Lake City, UT (801) 521±9500 841011994. Wyoming WY0089 Hitching Post Inn ...... 1700 W. Lincolnway .. Cheyenne, WY (307) 638±3301 82001. CORRECTIONS/CHANGES Arizona AZ0128 Mesa Pavilion Hilton ...... 1011 W. Homes Ave . Mesa, AZ 85210 ...... (602) 833±5555 Kansas KS0045 Holiday Inn ...... 1118 N. 6th St ...... Levenworth, KS (913) 651±5800 66048. KS0053 Holiday Inn ...... 530 Richards Dr ...... Manhattan, KS 66502 (913) 539±5311 Minnesota MN0112 Econo Lodge Airport ...... 4197 Haines Rd ...... Duluth, MN 55811 .... (218) 722±5522 MN0216 Holiday Inn, Minneapolis Airport ...... 2700 Pilot Knob Rd ... Eagan, MN 55121 .... (612) 454±3434 MN0254 Econolodge of Mille Lacs ...... 40993 U.S. Hwy. 169 Onamia, MN 56359 .. (612) 532±3838 Oregon OR0119 Peppertree Motel ...... 10720 SW Allen ...... Beverton, OR 97005 . (503) 641±7477 OR0158 Motel 6 #1244 ...... 1445 Bayshore Dr ..... Coos Bay, OR 97420 (503) 267±7171 OR0159 Motel 6 #418 ...... 3752 International Ct . Eugene, OR 97477 ... (503) 741±1105 OR0128 Mt Hood Inn ...... PO Box 400 ...... 87450 E. Govt Camp Government Camp, (503) 272±3307 Loop. OR 97028. OR0154 Holiday Inn Express, Grants Pass ...... 105 NE Agness Ave .. Grants Pass, OR (503) 471±6144 97526. OR0038 Pony Soldier Motor Inn ...... 1060 E Cleveland Ave Gresham, OR 97030 (503) 665±1591 OR0165 Best Western Klamath Inn ...... 4061 S. 6th St ...... Klamath Falls, OR (503) 882±1200 97603. OR0153 Best Western Rama Inn ...... 4430 SE Hwy. 101 .... Lincoln City, OR (503) 994±6060 97367. 6934 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices HOTEL AND MOTEL FIRE SAFETY ACT NATIONAL MASTER LIST JANUARY 20, 1995 UPDATEÐContinued Index and Property name PO Box/Rt No. Street address City, State/ZIP Telephone OR0168 Best Western Vineyard Inn ...... 2035 S. Hwy. 99 W ... McMinnville, OR (503) 472±4900 97128. OR0162 Motel 6 #89 ...... 950 Alba Dr ...... Medford, OR 97504 .. (503) 773±4290 OR0160 Motel #349 ...... 325 SE Nye Ave ...... Pendleton, OR 97801 (503) 276±3160 OR0170 Best Western New Kings Inn ...... 3658 Market St. NE ... Salem, OR 97301 ..... (503) 582±1559 OR0169 Best Western Pacific Hwy Inn ...... 4646 Portland Rd. NE Salem, OR 97305 ..... (503) 390±3200 OR0134 Shilo Inn Seaside East ...... 900 S. Holladay ...... Seaside, OR 97138 .. (503) 641±6565 OR0133 Shilo Inn Seaside Oceanfront ...... 30 N. Prom ...... Seaside, OR 97138 .. (503) 641±6565 OR0149 Rodeway Inn ...... 3480 Hutton St ...... Springfield, OR (503) 746±8471 97477. OR0099 Springfield Shilo Inn ...... 3350 Gateway ...... Springfield, OR (503) 641±6565 974771094. OR0131 Shilo Inn Tillamook ...... 2525 N. Main ...... Tillamook, OR 97141 (503) 641±6565 OR0129 Shilo Inn ...... 1609 East Harbor Dr . Warrenton, OR (503) 641±6565 97146. OR0163 B/W Willamette Inn ...... 30800 SW Pkwy ...... Wilsonville, OR (503) 682±2288 97070. Washington WA0187 Hawthorn Suites ...... 6329 S. 212th St ...... Seattle/Kent, WA (206) 395±3800 98032. DELETIONS Oregon OR0127 Val-U Inn (Newport) ...... 531 SW Fall Street .... Newport, OR 97365 .. (503) 265±6623 OR0138 Silo Inn Eugene ...... 3350 Gateway ...... Springfield, OR (503) 641±6565 97477. Virginia VA0209 Holiday Inn, Hampton Coliseum ...... 1815 West Mercury Hampton, VA (804) 838±0200 Blvd.. 236660000. [FR Doc. 95–2709 Filed 2–2–95; 8:45 am] BILLING CODE 6718±26±U federal register February 3,1995 Friday Safety ActNationalMasterList;Notice Changes totheHotelandMotelFire Management Agency Federal Emergency Part VI 6935 6936 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices FEDERAL EMERGENCY SUPPLEMENTARY INFORMATION: Acting updates, the three categories mean and MANAGEMENT AGENCY under the Hotel and Motel Fire Safety include the following: Act of 1990, 15 U.S.C. 2201 note, the ‘‘Additions’’ are either names of Changes to the Hotel and Motel Fire United States Fire Administration has properties submitted by a State but Safety Act National Master List worked with each State to compile a inadvertently omitted from the initial AGENCY: United States Fire national master list of all of the places master list or names of properties Administration, FEMA. of public accommodation affecting submitted by a State after publication of commerce located in each State that ACTION: Notice. the initial master list; meet the requirements of the guidelines ‘‘Corrections/changes’’ are corrections SUMMARY: The Federal Emergency under the Act. FEMA published the to property names, addresses or Management Agency (FEMA or Agency) national master list in the Federal telephone numbers previously gives notice of additions and Register on Tuesday, November 29, published or changes to previously corrections/changes to, and deletions 1993, 58 FR 62718, and published from, the national master list of places changes approximately monthly since published information directed by the of public accommodations which meet then. State, such as changes of address or telephone numbers, or spelling the fire prevention and control Parties wishing to be added to the corrections; and guidelines under the Hotel and Motel National Master List, or to make any Fire Safety Act. other change, should contact the State ‘‘Deletions’’ are entries previously EFFECTIVE DATE: March 6, 1995. office or official responsible for submitted by a State and published in ADDRESSES: Comments on the master compiling listings of properties which the national master list or an update to list are invited and may be addressed to comply with the Hotel and Motel Fire the national master list, but the Rules Docket Clerk, Federal Safety Act. A list of State contacts was subsequently removed from the list at Emergency Management Agency, 500 C published in 58 FR 17020 on March 31, the direction of the State. Street, SW., room 840, Washington, D.C. 1993. If the published list is unavailable Copies of the national master list and 20472, (fax) (202) 646–4536. To be to you, the State Fire Marshal’s office its updates may be obtained by writing added to the National Master List, or to can direct you to the appropriate office. to the Government Printing Office, make any other change to the list, please Periodically FEMA will update and Superintendent of Documents, see Supplementary Information below. redistribute the national master list to Washington, DC 20402–9325. When FOR FURTHER INFORMATION CONTACT: John incorporate additions and corrections/ requesting copies please refer to stock Ottoson, Fire Management Programs changes to the list, and deletions from number 069–001–00049–1. Branch, United States Fire the list, that are received from the State The update to the national master list Administration, Federal Emergency offices. follows below. Management Agency, National Each update contains or may contain Emergency Training Center, 16825 three categories: ‘‘Additions;’’ Dated: January 30, 1995. South Seton Avenue, Emmitsburg, MD ‘‘Corrections/changes;’’ and John P. Carey, 21727, (301) 447–1272. ‘‘Deletions.’’ For the purposes of the General Counsel. HOTEL AND MOTEL FIRE SAFETY ACT NATIONAL MASTER LIST 12/16/94 UPDATE PO BOX/RT NO AND STREET AD- INDEX/PROPERTY NAME DRESS CITY STATE/ZIP TELEPHONE ADDITIONS AR: AR0074 BUDGETEL INN ...... 1300 SOUTH 48TH STREET ...... SPRINGDALE ...... AR 72764 ...... (501) 751±2626 AR0075 SHONEY'S INN ...... 5210 NORTH STATE LINE ...... TEXARKANA ...... AR 75502 ...... (501) 772±0070 CA: CA1438 BEST WESTERN VINEYARD INN ...... 877 E. D ST ...... LEMOORE ...... CA 93245 ...... (209) 924±1261 CA1439 LIGHTHOUSE LODGE AND SUITES ...... 1249 LIGHTHOUSE AVE ...... PACIFIC GROVE ...... CA 93950 ...... (408) 655±2111 CA1440 YORK HOTEL ...... 940 SUTTER ST ...... SAN FRANCISCO ...... CA 94109 ...... (415) 885±6800 GA: GA0340 MOTEL 6 ALBANY ...... 201 S. THORNTON DR ...... ALBANY ...... GA 31705 ...... (912) 439±0078 GA0337 MOTEL 6 ATLANTA ...... 3585 CHAMBLEE-TUCKER RD ...... ATLANTA ...... GA 30341 ...... (404) 455±8000 GA0344 MOTEL 6 AUGUSTA ...... 2650 CENTER WEST PKWY ...... AUGUSTA ...... GA 30909 ...... (706) 736±1934 GA0332 BEST WESTERN BURNSWICK ...... I±95 & U.S. 341 ...... BRUNSWICK ...... GA 31520 ...... (912) 264±0144 GA0331 DAYS INN BRUNSWICK ...... 2307 GLOUCESTER ST ...... BRUNSWICK ...... GA 31520 ...... (912) 265±8830 GA0334 HOLIDAY INN JESUP ...... 5252 NEW JESUP HWY ...... BRUNSWICK ...... GA 31525 ...... (912) 264±4033 GA0339 MOTEL 6 COLUMBUS ...... 3050 VICTORY DR ...... COLUMBUS ...... GA 31903 ...... (706) 687±7214 GA0335 MOTEL 6 DALTON ...... 2200 CHATTANOOGA RD ...... DALTON ...... GA 30720 ...... (706) 278±5522 GA0336 MOTEL 6 DECATUR ...... 2565 WESLEY CHAPEL RD ...... DECATUR ...... GA 30035 ...... (404) 288±6911 GA0341 MOTEL 6 MACON ...... 4991 HARRISON RD ...... MACON ...... GA 31206 ...... (912) 474±2870 GA0333 CLUBHOUSE INN NORCROSS ...... 5945 OAKBROOK PKWY ...... NORCROSS ...... GA 30093 ...... (404) 368±9400 GA0338 MOTEL 6 NORCROSS ...... 6015 OAKBROOK PKWY ...... NORCROSS ...... GA 30093 ...... (404) 446±2311 GA0343 MOTEL 6 RICHMOND HILL ...... I±95 & U.S. HWY. 17 ...... RICHMOND HILL ...... GA 31324 ...... (912) 756±3543 GA0342 MOTEL 6 VALDOSTA ...... 2003 WEST HILL AVE ...... VALDOSTA ...... GA 31601 ...... (912) 333±0047 IA: IA0141 MOTEL 6 ...... 810 1ST AVENUE ...... CORALVILLE ...... IA 52241 ...... (319) 354±0030 IA0147 MOTEL 6 ...... 3032 S. EXPRESSWAY ...... COUNCIL BLUFFS ...... IA 51501 ...... (712) 366±2405 IA0144 MOTEL 6 ...... 6111 N BRADY ...... DAVENPORT ...... IA 52806 ...... (319) 391±8997 IA0142 MOTEL 6 ...... PO BOX 3002, 4940 NE 14TH DES MOINES ...... IA 50316 ...... (515) 266±5456 STREET. IA0145 MOTEL 6 ...... 4817 FLEUR DR ...... DES MOINES ...... IA 50321 ...... (515) 287±6364 IA0146 MOTEL 6 ...... 2670 DODGE ST ...... DUBUQUE ...... IA 52003 ...... (319) 556±0880 IA0143 MOTEL 6 ...... GEN. DEL., 6166 HARBOR DR ...... SERGEANT BLUFF ...... IA 51054 ...... (712) 277±3131 IL: IL0540 HAWTHORN SUITES ...... 10 WESTMINSTER WAY ...... LINCOLNSHIRE ...... IL 60069 ...... (708) 945±9300 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Notices 6937 HOTEL AND MOTEL FIRE SAFETY ACT NATIONAL MASTER LIST 12/16/94 UPDATEÐContinued PO BOX/RT NO AND STREET AD- INDEX/PROPERTY NAME DRESS CITY STATE/ZIP TELEPHONE IN: IN0413 MOTEL 6 ...... 5810 SCATTERFIELD RD ...... ANDERSON ...... IN 46013 ...... (317) 642±9023 IN0415 MOTEL 6 ...... 4201 WHY 41 N & YOKEL RD ...... EVANSVILLE ...... IN 47711 ...... (812) 424±6431 IN0414 MOTEL 6 ...... 3003 COLISEUM BLVD WEST ...... FORT WAYNE ...... IN 46808 ...... (219) 482±3972 IN0416 MOTEL 6 ...... 3840 179TH ST ...... HAMMOND ...... IN 46324 ...... (219) 845±8330 IN0417 MOTEL 6 ...... 2016 OLD HIGHWAY 31 EAST ...... JEFFERSONVILLE ...... IN 47129 ...... (812) 283±7703 KY: KY0413 COMFORT INN ...... 3749 NASHVILLE RD ...... FRANKLIN ...... KY 42134 ...... (502) 586±6100 KY0411 FRIENDSHIP INN ...... 2923 FT. CAMPBELL BLVD ...... HOPKINSVILLE ...... KY 42240 ...... (502) 885±1126 KY0412 COMFORT SUITES ...... 3820 SCOTSVILLE ROAD ...... LONDON ...... KY 40741 ...... (606) 877±7848 LA: LA0122 HOLIDAY INN MACARTHUR DRIVE ...... 2716 N. MACARTHUR DR ...... ALEXANDRIA ...... LA 71303 ...... (318) 487±4261 NY: NY0603 MOTEL 6 ...... 155 BUELL ROAD ...... GATES ...... NY 14624 ...... (716) 436±2170 NY0634 TRAVELODGE INTERNATIONAL HOTEL BLDG. #144, VAN WYCK EXPWAY JAMAICA ...... NY 11430 ...... (718) 995±9000 TX: TX0624 RAMADA EMILY MORGAN HOTEL ...... 705 E. HOUSTON ST ...... SAN ANTONIO ...... TX 78205 ...... (210) 225±8486 VA: VA0599 BEST WESTERN HANOVER HOUSE ..... I±95 EXIT 86, ATLEE-ELMONT ...... ASHLAND ...... VA 23005 ...... (804) 550±2805 WV: WV0202 BRIAR MOTEL ...... 3206 CUMBERLAND RD ...... BLUEFIELD ...... WV 24701 ...... (304) 325±9111 CORRECTIONS/CHANGES GA: GA0324 COMFORT INN ASHBURN ...... 820 SHOENYS DR ...... ASHBURN ...... GA 31214 ...... (912) 567±0080 GA0250 BUDGETEL INN LENOX ...... 2535 CHANTILLY DR ...... ATLANTA ...... GA 30324 ...... (404) 321±0999 GA0270 DAYS INN ATLANTA ...... 300 SPRING ST ...... ATLANTA ...... GA 30308 ...... (404) 523±1144 GA0327 ECONO LODGE AUGUSTA ...... 2852 WASHINGTON RD ...... AUGUSTA ...... GA 30909 ...... (706) 736±0707 GA0266 WELCOME INN MACON ...... 4709 CHAMBERS RD ...... MACON ...... GA 31206 ...... (912) 781±6680 GA0277 DAVIS INN ...... STATE PARK RD ...... PINE MOUNTAIN ...... GA 31822 ...... (706) 663±2522 GA0316 ISLAND INN ...... 301 MAIN ST ...... SAINT SIMON'S ISLA .... GA 31522 ...... (912) 638±7805 GA0313 CLOISTER HOTEL ...... 100 FIRST ST ...... SEA ISLAND ...... GA 31561 ...... (912) 638±3611 GA0309 MOTEL 6 STOCKBRIDGE ...... 7233 DAVIDSON PKWY ...... STOCKBRIDGE ...... GA 30281 ...... (404) 389±1142 GA0169 CLUBHOUSE INN VALDOSTA ...... 1800 CLUBHOUSE DR ...... VALDOSTA ...... GA 31601 ...... (912) 247±7755 HI: HI0168 ASTON AT THE WAIKIKI BANYAN ...... 201 OHUA ST ...... HONOLULU, OAHU ...... HI 96815 ...... (808) 922±0555 HI0159 HILTON WAIKOLOA VILLAGE ...... 69±425 WAIKOLOA DR ...... KAMUELA ...... HI 967439791 ..... (808) 885±1234 HI0030 SHERATON LUXURY PRINCEVILLE PO BOX 3069, 5520 KA HAKU RD . PRINCEVILLE, KAUAI .... HI 967223069 ..... (808) 826±9644 HOTEL. IL: IL0516 FAIRFIELD INN CHAMPAIGN ...... 187 MORELAND BLVD ...... CHAMPAIGN ...... IL 61820 ...... (217) 355±0604 KY: KY1062 COMFORT INN ...... 2381 BUENA VISTA DR ...... LEXINGTON ...... KY 40505 ...... (606) 299±0302 DELETIONS HI: HI0127 BREAKERS HOTEL ...... 250 BEACHWALK ...... HONOLULU, OAHU ...... HI 96815 ...... (808) 923±3181 HI0050 HAWAIIAN REGENT HOTEL KUHIO ...... 2552 KALAKAUA AVE ...... HONOLULU, OAHU ...... HI 96815 ...... (808) 922±6611 HI0131 HAWAIIANA HOTEL ...... 260 BEACH WALK ...... HONOLULU, OAHU ...... HI 96815 ...... (808) 923±3811 HI0073 MOANA HOTEL DIAMOND ...... 2365 KALAKAUA AVE ...... HONOLULU, OAHU ...... HI 96815 ...... (808) 923±3111 HI0113 WAIKIKI BEACHSIDE HOTEL ...... 2452 KALAKAUA AVE ...... HONOLULU, OAHU ...... HI 96815 ...... (808) 931±2180 HI0144 PLANTATION HALE ...... 484 KUHIO HWY ...... KAPAA, KAUAI ...... HI 96746 ...... (808) 822±4941 HI0151 SHERATON MAUI HOTEL ...... 2605 KAANAPALI PKWY ...... LAHAINA, MAUI ...... HI 967611991 ..... (808) 661±0031 HI0013 MANELE BAY HOTEL ...... MANELE HWY ...... LANAI CITY, LANAI ...... HI 96763 ...... (808) 565±7700 HI0155 ASTON KAUAI BEACH VILLAS ...... 4330 KAUAI BEACH DR ...... LIHUE, KAUAI ...... HI 96766 ...... (808) 245±7711 HI0026 THE WESTIN KAUAI ...... 3610 RICE ST ...... LIHUE, KAUAI ...... HI 96766 ...... (808) 245±5050 [FR Doc. 95–2710 Filed 2–2–95; 8:45 am] federal register February 3,1995 Friday Proposed Rule Student AssistanceGeneralProvisions; 34 CFRPart668 Education Department of Part VII 6939 6940 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules DEPARTMENT OF EDUCATION changes in these regulations are number of issues that could be necessary to implement changes to the addressed in regulations or in non- 34 CFR Part 668 HEA made by the Equity in Athletics binding guidance and requests Disclosure Act (EADA), which was comments on the following questions: RIN 1840±AC14 included in the Improving America’s • Which, if any, of these issues Student Assistance General Provisions Schools Act of 1994 (IASA), Pub. L. should be addressed in the final 103–382, enacted on October 20, 1994. regulations and how should they be AGENCY: Department of Education. The EADA requires that certain addressed? ACTION: Notice of proposed rulemaking. institutions of higher education • Which issues instead should be disclose—to students, potential addressed in non-binding guidance SUMMARY: The Secretary proposes to students, and the public—financial, provided by the Department and how amend the Student Assistance General participation, and other information should they be addressed? Provisions regulations. These concerning the institutions’ women’s • Which issues should not be amendments are necessary to and men’s intercollegiate athletic addressed by the Department because implement a new requirement in the programs. The EADA is a ‘‘sunshine’’ the statutory language is clear or for Higher Education Act of 1965, as law designed to make ‘‘prospective other reasons? amended (HEA), recently added by the students and prospective student • Which other issues should be Improving America’s Schools Act of athletes . . . aware of the commitments addressed in the final regulations or in 1994 (IASA). The IASA provision, titled of an institution to providing equitable non-binding guidance from the the ‘‘Equity in Athletics Disclosure Act athletic opportunities for its men and Department and how should they be (EADA),’’ requires certain coeducational women students.’’ (IASA, section addressed? institutions of higher education to 360B(b)(7)) In enacting the EADA, 1. Institutions of higher education prepare—and make available to Congress expected that ‘‘knowledge of that are subject to the EADA. students, potential students, and the an institution’s expenditures for The EADA applies to any public—a report on participation rates, women’s and men’s athletic programs coeducational institution of higher financial support, and other information would help prospective students and education (IHE) that participates in a on men’s and women’s intercollegiate prospective student athletes make Title IV, HEA program and has an athletic programs. These proposed informed judgments about the intercollegiate athletic program. This regulations would implement this new commitments of a given institution of statutory provision is set forth in statutory requirement. The statute higher education to providing equitable proposed § 668.48(a). requires that the Secretary issue final athletic benefits to its men and women The Secretary interprets regulations implementing the EADA not students.’’ (IASA, section 360B(b)(8)) ‘‘intercollegiate athletic program’’ to later than 180 days following The EADA does not require that this refer to varsity teams. The term enactment. Thus, the statute requires information be submitted to the Federal ‘‘varsity’’ is also used in the EADA. that final regulations be issued by April Government. Institutions of higher These are the teams that compete at a 18, 1995. education that are subject to the EADA certain level of play (against other IHEs’ DATES: Comments must be received on must make the information available to varsity-level teams). The EADA does not or before April 4, 1995. students, potential students, and the apply to intramural teams or to club public. teams even if such a team plays a ADDRESSES: All comments concerning limited number of intercollegiate games these proposed regulations should be Summary of the Proposed Regulations against varsity teams. The Secretary addressed to: Ms. Paula M. Husselmann, The following is a summary of the requests comments on whether the type U.S. Department of Education, 600 regulations that the Secretary proposes or level of financial support by the IHE Independence Avenue, S.W., ROB3, to implement the EADA. The Secretary should also be a determinant of whether Room 4318, Washington, D.C. 20202– is interested both in ensuring that a team should be considered a varsity 5346, or to the following internet students and the public receive team under the EADA. address: Athletic—[email protected]. consistent, useful information from The Secretary interprets the term A copy of any comments that concern institutions of higher education about ‘‘coeducational’’ to refer to the information collection requirements their intercollegiate athletic programs, composition of an IHE’s undergraduate should also be sent to the Office of and in keeping regulatory burden on student body. Thus, if an IHE has Management and Budget at the address those institutions to the minimum undergraduate students of only one listed in the Paperwork Reduction Act necessary to carry out congressional gender, the EADA would not apply to section of this preamble. intent. The Secretary is also committed the IHE’s intercollegiate athletic FOR FURTHER INFORMATION CONTACT: Ms. to working with organizations that are program. Paula Husselmann, U.S. Department of interested in women’s and men’s sports 2. Annual report. Education, 600 Independence Avenue, in implementing the EADA, including The EADA requires that an institution S.W., ROB3, Room 4318, Washington, development of proposed and final subject to this law shall annually, for D.C. 20202–5346. Telephone: (202) 708– regulations and any optional reporting the immediately preceding academic 7888. Individuals who use a formats. The Secretary began consulting year, prepare a report that contains telecommunications device for the deaf with a number of these organizations certain information regarding (TDD) may call the Federal Information soon after the law was enacted, and will intercollegiate athletics. The EADA Relay Service (FIRS) at 1–800–877–8339 continue to do so in the future. specifies the information that must be between 8 a.m. and 8 p.m., Eastern time, The proposed regulations include included in the report. The statutory Monday through Friday. only the statutory requirements reporting requirement is in proposed SUPPLEMENTARY INFORMATION: The contained in the EADA, as described § 668.48(b). Student Assistance General Provisions below. The proposed regulations do not 3. Full-time male and female regulations (34 CFR part 668) apply to include any requirements except those undergraduates. all institutions that participate in the imposed by the statute. In this The report must include the number Title IV, HEA programs. The proposed summary, the Secretary describes a of male and female full-time Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6941 undergraduates that attended the Secretary also believes that ‘‘total and that having a single definition institution for the immediately operating expenses’’ should include the would promote clarity and consistency preceding academic year. (Proposed expenses incurred by a team during an in the administration of these statutes. § 668.48(b)(1)) entire year, not just those incurred Thus, the Secretary proposes that the The terms ‘‘academic year’’ and ‘‘full- during the sports season of a team. The definition in subsection (e)(8) be made time student’’ are defined in the Student Secretary interprets the statute to applicable to the EADA. The Secretary Assistance General Provisions (34 CFR exclude any categories of expenses that requests comments on whether 668.2(b)). For the definition of ‘‘full- are not specifically listed in the law. ‘‘athletically related student aid’’ should time student,’’ see 59 FR 22419, The Secretary is interested in comments also include scholarships to students published on April 29, 1994. For the on which expenses should or should not who are on medical waivers (who definition of ‘‘academic year,’’ see 59 FR be included under each of the statutory therefore are not currently participating 61178, published on November 29, categories (lodging and meals, on the team) or who continue to receive 1994. The Secretary could apply these transportation, officials, uniforms, and athletically related aid after they cease definitions to the EADA regulations and equipment). to participate on a team for which they requests comments on whether to use 6. Head coaches and assistant had been awarded that aid. (1) these definitions, (2) other coaches. 8. Ratio of aid to male and female definitions, or (3) no definitions. In The institution must indicate in its athletes. particular, should the definition of report—for the immediately preceding The report must give—for the ‘‘academic year,’’ which does not refer academic year—whether the head coach immediately preceding academic year— to a 12-month period, apply? The for each varsity team was male or female the ratio of athletically related student Secretary believes that the categories of and whether the head coach was aid awarded male athletes to athletically information required to be reported by assigned to that team on a full-time or related student aid awarded female the EADA should be with respect to a part-time basis. The EADA requires that athletes. (Proposed § 668.48(b)(4)) 12-month period, but requests the institution consider graduate The Secretary interprets this comments on this issue. assistants and volunteers who served as provision to require an IHE to calculate The Secretary also requests comments head coaches to be head coaches for the a ratio of the total of athletically related on whether the term ‘‘undergraduate’’ purposes of this requirement. The student aid awarded male athletes to the should be defined, and, if so, how. institution must also indicate, for each total of athletically related student aid 4. Participants on varsity teams. team, the number of assistant coaches awarded female athletes. The report must include—for the who were male and the number of 9. Expenditures on recruiting. immediately preceding academic year— assistant coaches who were female and The report must include—for the a listing of the varsity teams that whether a particular coach was assigned immediately preceding academic year— competed in intercollegiate athletic to that team on a full-time or part-time the total amount of expenditures on competition and—for each team—the basis. As with head coaches, the EADA recruiting, separately for men’s and total number of participants, by team, as requires the institution to consider women’s teams overall. (Proposed of the day of the first scheduled contest graduate assistants and volunteers who § 668.48(b)(5)) for the team. (Proposed § 668.48(b)(2)(i)) served as assistant coaches to be The Secretary interprets this The Secretary requests comments on assistant coaches for the purposes of provision of the statute to require that who should be included and who this requirement. (Proposed the IHE report two totals—one total for should be excluded as team § 668.48(b)(2)(iii) and (iv)) men’s teams and one total for women’s ‘‘participants’’ under the EADA. For 7. Total amount of athletically related teams. example, since ‘‘red-shirted’’ players student aid. The Secretary requests comments on typically practice with a team and The report must include—for the whether a definition of ‘‘expenditures receive athletically-related financial aid, immediately preceding academic year— on recruiting’’ is necessary, and, if so, should they be included as the total amount of money spent on which expenditures should or should ‘‘participants?’’ athletically related student aid, not be included in the report as 5. Operating expenses. including the value of waivers of ‘‘expenditures on recruiting.’’ The report must include—for the educational expenses, separately for 10. Total annual revenues. immediately preceding academic year— men’s and women’s teams overall. The report must include—for the the total operating expenses attributable (Proposed § 668.48(b)(3)) immediately preceding academic year— to each varsity team. The EADA defines The Secretary interprets this the total annual revenues generated ‘‘operating expenses’’ to mean provision of the statute to require that across all men’s teams and across all expenditures on lodging and meals, the IHE report two totals—one total for women’s teams. In addition, an transportation, officials, uniforms, and men’s teams and one total for women’s institution may report those revenues by equipment. In addition to reporting total teams. individual team. (Proposed operating expenses for each team, an The term ‘‘athletically related student § 668.48(b)(6)) institution may also report those aid’’ is defined in section 485(e)(8) of The Secretary interprets this expenses on a per capita basis for each the HEA to mean any scholarship, grant, provision of the statute to require that team. An institution may report or other form of financial assistance, the the IHE report two totals—one total for combined expenditures attributable to terms of which require the recipient to men’s teams and one total for women’s closely related teams—such as track and participate in a program of teams. The Secretary interprets the term field or swimming and diving. Any such intercollegiate athletics at an IHE in ‘‘total annual revenues’’ to mean gross combinations must be reported order to receive that assistance. This income, since there is no indication in separately for men’s and women’s definition does not apply automatically the EADA that Congress intended teams. (Proposed § 668.48(b)(2)(ii)) to the EADA, which is in subsection (g) anything less than that amount. The Secretary interprets the EADA to of section 485. However, the Secretary Under section 487(a)(18) of the HEA, include expenses for both home and believes that the definition in IHEs are currently required to make an away games and training sessions, subsection (e)(8) would provide useful annual compilation of revenues and including lodging and meals. The guidance for the purposes of the EADA expenses attributable to ‘‘football, men’s 6942 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules basketball, women’s basketball, all other example, should ‘‘salary’’ include the information required by the EADA? men’s sports combined, and all other bonuses or other monetary benefits? What guidance should the Secretary women’s sports combined [with respect The Secretary also requests comments offer to assist schools in making the to the institution’s] intercollegiate on the determination of an average prorations in a consistent manner that athletics activities.’’ The revenues and annual institutional salary if unpaid allows for comparisons among schools? expenses to be calculated for this volunteers serve as head coaches or What burdens would be imposed on purpose are set forth in section assistant coaches. Consistent with the IHEs in prorating expenses, revenues, or 487(a)(18)(B) (i) and (ii) (20 U.S.C. provisions in the EADA that volunteers salaries? 1094(a)(18)(B) (i) and (ii)). The serving as part-time or full-time coaches In calculating and reporting expenses, Department’s regulations implementing or assistant coaches should be counted revenues, and salaries, the Secretary these statutory requirements are in 34 as such, the Secretary believes that their interprets the EADA to require IHEs to CFR 668.14 (d) and (e) (59 FR 22427– salaries (or lack thereof) should be use actual amounts expended or earned 22428, published April 29, 1994). The reflected in the average annual during the immediately preceding specific definition of ‘‘operating institutional salaries calculated by the academic year, not budgeted or expenses’’ in the EADA precludes using IHE. The Secretary believes that unpaid estimated amounts. The Secretary the definition of ‘‘expenses’’ in section volunteer coaches and assistant coaches requests comments on any burdens that 487 and the Department’s regulations. could be included in these would be imposed on schools in However, the Secretary will consider computations with a designated salary meeting an October 1 deadline and in the extent to which the definition of of zero dollars. However, the Secretary using actual data. ‘‘revenue’’ in these provisions should be requests comments as to whether the The EADA requires that the used in deciding what should be report should instead simply include information in the annual report be for included in ‘‘total annual revenues’’ the number of unpaid volunteers who the immediately preceding academic under the EADA. served as coaches and assistant coaches year. How can this requirement be made The Secretary requests comments on without including them in the to work for an IHE whose fiscal year is whether the EADA regulations should computation of average annual not the same as its academic year? As noted above, certain definitions in adopt a definition of ‘‘total annual institutional salaries. 34 CFR Part 668, the Student Assistance revenues’’ that is different from the Because the EADA states that an IHE ‘‘should’’ allocate a coach’s salary if he General Provisions (SAGP), could apply definition of ‘‘revenue’’ in § 668.14, and, or she coaches more than one team, the to these regulations. The SAGP also if so, what specific sources of income Secretary believes that the statute contains other regulations that are should or should not be included in requires that an IHE shall do the pertinent to the EADA, including ‘‘total annual revenues.’’ allocation, and the proposed regulations recordkeeping requirements in § 668.23 11. Coaches’ and assistant coaches’ so provide. and the enforcement and appeal salaries. 12. General issues. provisions in Subparts G and H of Part The report must include—for the The Secretary believes that 668. Under section 443 of the General immediately preceding academic year— coeducational teams should be reflected Education Provisions Act (20 U.S.C. the average annual institutional salary in the IHE’s report, and requests 1232f), as amended by the IASA, of the head coaches of men’s teams, comments on how this could be done records under the EADA generally will across all offered sports, and the average most accurately and with minimal have to be maintained by an IHE for annual institutional salary of the head burden, particularly under the EADA three years. coaches of women’s teams, across all provisions that ask for information Under the Student Right-to-Know Act offered sports. If a head coach had separately for ‘‘men’s and women’s (20 U.S.C. 1092(a)(5)), the Secretary is responsibilities for more than one team teams.’’ For example, the salary for a required to permit an IHE that is a and the institution does not allocate that head coach of a coeducational team member of an athletic association or coach’s salary by team, the EADA states could be prorated according to how athletic conference that has voluntarily that the institution should divide the many members of the team are male and published data, or has agreed to publish salary by the number of teams for which how many are female. data, that the Secretary considers the coach had responsibility and Some expenses, revenues, and salaries substantially comparable to the allocate the salary among the teams on may be attributable to more than one information required under the Act, to a basis consistent with the coach’s activity. In general, the Secretary use that data to satisfy the requirements responsibilities for the different teams. believes that an IHE should prorate of the Act. The Secretary requests The report must also include the these figures in a reasonable manner comment on whether a similar average annual institutional salary of and to indicate in the report how the provision should be included in the the assistant coaches of men’s teams, figures were calculated, so that students, EADA regulations. across all offered sports, and the average potential students, and the public will 13. Format for the report. annual institutional salary of the understand the basis for the The Secretary believes that the assistant coaches of women’s teams, calculations. If a faculty or staff member information in IHEs’ reports under the across all offered sports. (Proposed also coaches, the IHE should make a EADA should be as consistent as § 668.48(b) (7) and (8)) reasonable determination of how much possible to assist students, potential The Secretary interprets ‘‘across all of the professor’s salary is attributable to students, and the public understand and offered sports’’ to mean a single average his or her coaching duties. If a women’s use that information. The Secretary is for all men’s sports in the aggregate and team and a men’s team share also aware that differences exist among a single average for all women’s sports transportation to competitions held at intercollegiate athletic programs. Given in the aggregate. the same site, the transportation these factors, the Department is The Secretary requests comments on expense should be prorated according to considering development of an optional what types of compensation should be the relative number of female and male model format that IHEs could use for the included in a coach’s or assistant athletes who share the transportation. annual report required by the EADA. coach’s ‘‘salary’’ to provide an accurate Are there other situations where Such a format would be based on and picture of relative compensation. For proration would be necessary to develop developed in consultation with athletic Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules 6943 conferences, schools, and groups and explained elsewhere in this have a significant economic impact on interested in women’s and men’s sports. preamble under the heading Paperwork these small entities because the Should such a form be developed and Reduction Act of 1980. regulations would not impose excessive made available? Can one format be used To assist the Department in regulatory burdens or require by all of the types of IHEs that will be complying with the specific unnecessary Federal supervision. The subject to the law, or will a small requirements of Executive Order 12866, proposed regulations would not impose number of different formats be the Secretary invites comment on how any requirements except the statutory necessary? If the latter, on what basis the final regulations should be written requirements in the EADA. should institutions be differentiated? to minimize potential costs or to Paperwork Reduction Act of 1980 Do any of the categories of increase potential benefits resulting information required by the EADA from these proposed regulations Section 668.48 contains information simply not apply to some IHEs? If so, consistent with the purposes of the collection requirements. As required by how should regulations, non-regulatory EADA. the Paperwork Reduction Act of 1980, guidance, or a model format address this 2. Clarity of the Regulations the Department of Education will situation? submit a copy of these sections to the 14. Disclosure to students and the Executive Order 12866 requires each Office of Management and Budget public. agency to write regulations that are easy (OMB) for its review. (44 U.S.C. 3504(h)) The EADA requires that an institution to understand. Educational institutions that are of higher education subject to the Act The Secretary invites comments on public or nonprofit institutions or shall make available to students and how to make these regulations easier to businesses or other for-profit potential students, upon request, and to understand, including answers to institutions may participate in the Title the public, the information contained in questions such as the following: (1) Are IV, HEA programs. IHEs will need and the report. The institution shall inform the requirements in the regulations use the information required by these all students of their right to request that clearly stated? (2) Do the regulations regulations to meet the disclosure information. The Act requires that each contain technical terms or other requirements of the EADA. institution make available its first report wording that interferes with their Annual public reporting and not later than October 1, 1996. These clarity? (3) Does the format of the recordkeeping burden contained in the statutory provisions are set forth in regulations (grouping and order of collection of information proposed in proposed § 668.41(e). sections, use of headings, paragraphing, these regulations is estimated to be Each IHE must make its first report etc.) aid or reduce their clarity? Would 18,000 hours, including the time for available by October 1, 1996. The the regulations be easier to understand searching existing data sources and Secretary believes that October 1 also if they were divided into more (but gathering and maintaining the data should be the deadline for subsequent shorter) sections? (A ‘‘section’’ is needed. annual reports, and would best meet the preceded by the symbol ‘‘§ ’’ and a Organizations and individuals needs of IHEs, students, and potential numbered heading; for example, desiring to submit comments on the students. § 668.48 Report on athletic program information collection requirements The Secretary believes it is participation rates and financial should direct them to the Office of particularly important that students, support data.) (4) Is the description of Information and Regulatory Affairs, potential students, and parents have the proposed regulations in the OMB, Room 3002, New Executive Office easy and timely access to the ‘‘Supplementary Information’’ section of Building, Washington, D.C. 20503; information in this report. How should this preamble helpful in understanding Attention: Daniel J. Chenok. the proposed regulations? How could an IHE give notice to each of these Invitation To Comment groups that the report is available? How this description be more helpful in should the IHE make the information making the proposed regulations easier Interested persons are invited to accessible to students, potential to understand? (5) What else could the submit comments and recommendations students, and the public? The Secretary Department do to make the regulations regarding these proposed regulations. does not believe that students or easier to understand? All comments submitted in response potential students should be charged for A copy of any comments that concern to these proposed regulations will be copies of the report but is sensitive to how the Department could make these available for public inspection, during the possible financial burden on IHEs proposed regulations easier to and after the comment period, in Room and requests comments on this matter. understand should be sent to Stanley M. 4318, Regional Office Building 3, 7th Also, should an IHE be allowed to Cohen, Regulations Quality Officer, U.S. and D Streets, S.W., Washington, D.C., charge the public for copies of the Department of Education, 600 between the hours of 8:30 a.m. and 4:00 report? Independence Avenue, S.W. (Room p.m., Monday through Friday of each 5121, FB–10), Washington, D.C. 20202– week except Federal holidays. Executive Order 12866 2241. Assessment of Educational Impact 1. Assessment of Costs and Benefits Regulatory Flexibility Act Certification The Secretary particularly requests These proposed regulations have been The Secretary certifies that these comments on whether the proposed reviewed in accordance with Executive proposed regulations would not have a regulations in this document would Order 12866. Under the terms of the significant economic impact on a require transmission of information that order the Secretary has assessed the substantial number of small entities. is being gathered by or is available from potential costs and benefits of the The small entities that would be any other agency or authority of the regulatory action. The potential costs affected by these regulations are small United States. associated with the proposed coeducational institutions of higher regulations are those resulting from education that participate in Title IV, List of Subjects in 34 CFR Part 668 statutory requirements. Burdens HEA programs and that have Administrative practice and specifically associated with information intercollegiate athletic programs. procedure, Colleges and universities, collection requirements are identified However, the regulations would not Consumer protection, Education, Grant 6944 Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Proposed Rules programs—education, Loan programs— (Authority: 20 U.S.C. 1092(g)(3), (5)) of assistant coaches who were female for education, Reporting and recordkeeping 3. Section 668.48 is added to subpart each team and whether a particular requirements, Student aid. D to read as follows: coach was assigned to that team on a Dated: January 26, 1995. full-time or part-time basis. § 668.48 Report on athletic program (B) The institution shall consider Richard W. Riley, participation rates and financial support Secretary of Education. data. graduate assistants and volunteers who served as assistant coaches to be (a) Applicability. This section applies (Catalog of Federal Domestic Assistance assistant coaches for the purposes of to each coeducational institution of Numbers: 84.007 Federal Supplemental this report. Educational Opportunity Grant Program; higher education that— 84.032 Federal Stafford Loan Program; 84.032 (1) Participates in any Title IV, HEA (3) The total amount of money spent Federal PLUS Program; 84.032 Federal program; and on athletically related student aid, Supplemental Loans for Students Program; (2) Has an intercollegiate athletic including the value of waivers of 84.033 Federal Work-Study Program; 84.038 program. educational expenses, separately for Federal Perkins Loan Program; 84.063 (b) Report. An institution subject to men’s and women’s teams overall. Federal Pell Grant Program; 84.069 State this section shall annually, for the Student Incentive Grant Program; 84.268 (4) The ratio of— Federal Direct Student Loan Program; and immediately preceding academic year, (i) Athletically related student aid 84.272 National Early Intervention prepare a report that contains the awarded male athletes; to following information regarding Scholarship and Partnership Program. (ii) Athletically related student aid intercollegiate athletics: Catalog of Federal Domestic Assistance awarded female athletes. Number for the Presidential Access (1) The number of male and female Scholarship Program has not been assigned.) full-time undergraduates that attended (5) The total amount of expenditures on recruiting, separately for men’s and The Secretary proposes to amend Part the institution. women’s teams overall. 668 of Title 34 of the Code of Federal (2) A listing of the varsity teams that Regulations as follows: competed in intercollegiate athletic (6) The total annual revenues competition and for each team the generated across all men’s teams and PART 668ÐSTUDENT ASSISTANCE following data: across all women’s teams. An institution GENERAL PROVISIONS (i) The total number of participants, may also report those revenues by by team, as of the day of the first individual team. 1. The authority citation for Part 668 scheduled contest for the team. is revised to read as follows: (7)(i) The average annual institutional (ii) Total operating expenses salary of the head coaches of men’s Authority: 20 U.S.C. 1085, 1088, 1091, attributable to those teams. For the teams, across all offered sports, and the 1092, 1094, 1099c, and 1141, unless purposes of this section, the term average annual institutional salary of otherwise noted. ‘‘operating expenses’’ means the head coaches of women’s teams, 2. Section 668.41 is amended by expenditures on lodging and meals, across all offered sports. revising the heading, removing and transportation, officials, uniforms and equipment. An institution— (ii) If a head coach had reserving paragraphs (a) and (b), responsibilities for more than one team reserving paragraphs (c) and (d), and (A) Also may report those expenses on a per capita basis for each team; and and the institution does not allocate that adding a new paragraph (e), to read as coach’s salary by team, the institution follows: (B) May report combined expenditures attributable to closely shall divide the salary by the number of § 668.41 Reporting and disclosure of related teams—such as track and field or teams for which the coach had information. swimming and diving. Those responsibility and allocate the salary (a)–(d) [Reserved] combinations must be reported among the teams on a basis consistent (e)(1)(i) An institution of higher separately for men’s and women’s with the coach’s responsibilities for the education subject to § 668.48 shall make teams. different teams. available to students and potential (iii) (A) Whether the head coach was (8) The average annual institutional students, upon request, and to the male or female and whether the head salary of the assistant coaches of men’s public, the information contained in the coach was assigned to that team on a teams, across all offered sports, and the report described in § 668.48(b). full-time or part-time basis. average annual institutional salary of (ii) The institution shall inform all (B) The institution shall consider the assistant coaches of women’s teams, students of their right to request that graduate assistants and volunteers who across all offered sports. served as head coaches to be head information. (Authority: 20 U.S.C. 1092(g)(1), (2), (4)) (2) Each institution shall make coaches for the purposes of this report. available its first report under § 668.48 (iv)(A) The number of assistant [FR Doc. 95–2777 Filed 2–2–95; 8:45 am] not later than October 1, 1996. coaches who were male and the number BILLING CODE 4000±01±P i Reader Aids Federal Register Vol. 60, No. 23 Friday, February 3, 1995 CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING FEBRUARY Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202±523±5227 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Public inspection announcement line 523±5215 the revision date of each title. 1139...... 6606 Laws 3 CFR 1485...... 6352 Public Laws Update (numbers, dates, etc.) 523±6641 Executive Order: Proposed Rules: 12898 (Amended by Presidential Documents 29...... 6452, 6453 EO 12948)...... 6381 Executive orders and proclamations 523±5227 12948...... 6381 8 CFR The United States Government Manual 5 CFR 103...... 6647 523±5227 292...... 6647 211...... 6595 299...... 6647 Other Services 214...... 6383 310...... 6647 Electronic and on-line services (voice) 523±4534 317...... 6383 312...... 6647 Privacy Act Compilation 523±3187 319...... 6383 313...... 6647 TDD for the hearing impaired 523±5229 353...... 6595 315...... 6647 359...... 6383 316...... 6647 430...... 6595 316a...... 6647 ELECTRONIC BULLETIN BOARD 534...... 6383 319...... 6647 Free Electronic Bulletin Board service for Public Law numbers, 2635...... 6390 322...... 6647 Federal Register finding aids, and list of documents on public Proposed Rules: 324...... 6647 inspection. 202±275±0920 532...... 6041 325...... 6647 327...... 6647 7 CFR FAX-ON-DEMAND 328...... 6647 You may access our Fax-On-Demand service. You only need a fax 70...... 6638 329...... 6647 machine and there is no charge for the service except for long 319...... 5997 330...... 6647 distance telephone charges the user may incur. The list of 322...... 5997 331...... 6647 documents on public inspection and the daily Federal Register’s 372...... 6000 332...... 6647 table of contents are available using this service. The document 985...... 6392 332a...... 6647 numbers are 7050-Public Inspection list and 7051-Table of 997...... 6394 332b...... 6647 Contents list. The public inspection list will be updated 1001...... 6606 332c ...... 6647 immediately for documents filed on an emergency basis. 1002...... 6606 332d...... 6647 1004...... 6606 333...... 6647 NOTE: YOU WILL ONLY GET A LISTING OF DOCUMENTS ON 1005...... 6606 334...... 6647 FILE AND NOT THE ACTUAL DOCUMENT. Documents on 1006...... 6606 334a...... 6647 public inspection may be viewed and copied in our office located 1007...... 6606 335...... 6647 at 800 North Capitol Street, N.W., Suite 700. The Fax-On-Demand 1011...... 6396, 6606 335a...... 6647 telephone number is: 301±713±6905 1012...... 6606 335c ...... 6647 1013...... 6606 336...... 6647 FEDERAL REGISTER PAGES AND DATES, FEBRUARY 1030...... 6606 337...... 6647 1032...... 6005, 6606 5997±6382...... 1 338...... 6647 1033...... 6606 6383±6646...... 2 339...... 6647 1036...... 6606 340...... 6647 6647±6944...... 3 1040...... 6606 343b...... 6647 1044...... 6606 344...... 6647 1046...... 6606 499...... 6647 1049...... 6606 1050...... 6606 9 CFR 1064...... 6606 Proposed Rules: 1065...... 6606 94...... 6454 1068...... 6606 308...... 6774 1075...... 6606 310...... 6774 1076...... 6606 318...... 6774 1079...... 6606 320...... 6774 1093...... 6606 325...... 6774 1094...... 6606 326...... 6774 1096...... 6606 327...... 6774 1106...... 6606 381...... 6774 1108...... 6606 1124...... 6606 12 CFR 1126...... 6606 Proposed Rules: 1131...... 6606 208...... 6042 1134...... 6606 225...... 6042 1135...... 6606 1137...... 6606 14 CFR 1138...... 6606 25...... 6616 ii Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 / Reader Aids 39 ...... 6397, 6652, 6654 24 CFR 38 CFR 572...... 6482 71...... 6657 907...... 6399 3...... 6660 97...... 6398 47 CFR 121...... 6616 29 CFR 39 CFR 135...... 6616 825...... 6658 Proposed Rules: 73...... 6670 302...... 6919 111...... 6047 Proposed Rules: Proposed Rules: 30 CFR Ch. 1 ...... 6482 Ch. I ...... 6045 914...... 6400 40 CFR 73 ...... 6068, 6483, 6490, 6689 25...... 6456, 6632 926...... 6006 52 ...... 6022, 6027, 6401 39...... 6045, 6459 80...... 6030 48 CFR 71 ...... 6461, 6462, 6686 31 CFR 180...... 6032 121...... 6632 575...... 6376 270...... 6666 Proposed Rules: 125...... 6632 Proposed Rules: 28...... 6602 32 CFR 135...... 6632 52 ...... 6049, 6051, 6052, 6467, 32...... 6602 199...... 6013 6687 52...... 6602 16 CFR 180...... 6052 Proposed Rules: 33 CFR 261...... 6054 49 CFR Ch. 1 ...... 6463 117...... 6658 44 CFR 571...... 6411 34 CFR 18 CFR 64...... 6034, 6035 157...... 6657 74...... 6660 65...... 6403, 6404 50 CFR 75...... 6660 67...... 6407 19 CFR 17...... 6671 Proposed Rules: Proposed Rules: Proposed Rules: 668...... 6940 67...... 6470 229...... 6036 134...... 6464 651...... 6446 36 CFR 46 CFR 663...... 6039 21 CFR 7...... 6021 Proposed Rules: 676...... 6448 Proposed Rules: Proposed Rules: Ch. I ...... 6687 Proposed Rules: 310...... 6892 242...... 6466 381...... 6067 100...... 6466