Pages 13063±13310 Vol. 64 3±17±99 eDt 3MR9 71 a 6 99Jt134 O000Fm001Ft41 ft41 :F\M1MW.X fm2PsN:17MRWS pfrm02 E:\FR\FM\17MRWS.XXX Sfmt4710 Fmt4710 Frm00001 PO00000 Jkt183247 17:14Mar16, 1999 VerDate 03-MAR-99 No. 51 federal register March 17,1999 Wednesday announcement ontheinsidecoverofthisissue. For informationonbriefingsinWashington,DC,see Briefings onhowtousetheFederalRegister 1 II Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999

The FEDERAL REGISTER is published daily, Monday through SUBSCRIPTIONS AND COPIES Friday, except official holidays, by the Office of the Federal Register, National Archives and Records Administration, PUBLIC Washington, DC 20408, under the Federal Register Act (44 U.S.C. Subscriptions: Ch. 15) and the regulations of the Administrative Committee of Paper or fiche 202–512–1800 the Federal Register (1 CFR Ch. I). The Superintendent of Assistance with public subscriptions 512–1806 Documents, U.S. Government Printing Office, Washington, DC 20402 is the exclusive distributor of the official edition. General online information 202–512–1530; 1–888–293–6498 Single copies/back copies: The Federal Register provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 512–1800 Federal agencies. 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How To Cite This Publication: Use the volume number and the page number. Example: 64 FR 12345.

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Contents Federal Register Vol. 64, No. 51

Wednesday, March 17, 1999

Agricultural Marketing Service NOTICES PROPOSED RULES Meetings; Sunshine Act, 13174 Avocados grown in— Settlement agreements: South Florida, 13123–13125 Nordstrom, Inc., 13174–13176 Milk marketing orders: Nebraska-Western Iowa, 13125–13126 Cooperative State Research, Education, and Extension NOTICES Service Agency information collection activities: NOTICES Proposed collection; comment request, 13147–13148 Grants and cooperative agreements; availability, etc.: Food and Agricultural Sciences National Needs Graduate Agriculture Department Fellowship Program (FY 1999), 13305–13310 See Agricultural Marketing Service See Animal and Plant Health Inspection Service Customs Service See Cooperative State Research, Education, and Extension PROPOSED RULES Service Financial and accounting procedures: Duties, taxes, interest and fees; expanded methods of Animal and Plant Health Inspection Service payment, 13141–13142 RULES Foreign trade zones; weekly entry procedure; withdrawal, Livestock and poultry disease and control: 13142–13143 Pseudorabies in swine; payment of indemnity Technical amendment, 13064–13065 Defense Department See Defense Logistics Agency Centers for Disease Control and Prevention NOTICES Defense Logistics Agency Agency information collection activities: NOTICES Proposed collection; comment request, 13206–13208 Grants and cooperative agreements; availability, etc.: Submission for OMB review; comment request, 13208– Procurement technical assistance centers, 13176 13209 Grants and cooperative agreements; availability, etc.: Education Department Water Intervention Studies; fraction determination of NOTICES gastrointestinal illness attributable to drinking water, Agency information collection activities: 13209–13210 Proposed collection; comment request, 13176–13178 Meetings: Human immunodeficiency virus; U.S. Public Health Energy Department Service recommendations for counseling and See Federal Energy Regulatory Commission voluntary testing for pregnant women, 13210 NOTICES Injury Prevention and Control Advisory Committee, Atomic energy agreements; subsequent arrangements, 13179 13224 Defense Nuclear Facilities Safety Board recommendations: Children and Families Administration Pantex plant; Secretary’s response, 13179 NOTICES Environmental statements; availability, etc.: Agency information collection activities: Oak Ridge Y-12 Plant, TN, 13179–13183 Submission for OMB review; comment request, 13211– Meetings: 13212 Environmental Management Site-Specific Advisory Grants and cooperative agreements; availability, etc.: Board— Developmental disabilities— Rocky Flats, 13183 Projects of National Significance Program; family International Energy Agency Industry Advisory Board, support model demonstration projects, 13212– 13183–13184 13222 Applications, hearings, determinations, etc.: Cogen Energy Technology L.P., et al., 13178 Commerce Department See International Trade Administration Environmental Protection Agency See National Oceanic and Atmospheric Administration RULES Air programs; approval and promulgation; State plans for Consumer Product Safety Commission designated facilities and pollutants: PROPOSED RULES Pennsylvania, 13075–13078 Flammable Fabrics Act: Air quality implementation plans; approval and Carpets and rugs; surface flammability standard, 13132– promulgation; various States; air quality planning 13137 purposes; designation of areas: Children’s sleepwear (Sizes 0-6X and 7-14); flammability Ohio, 13070–13075 standards, 13126–13132 Pesticides; tolerances in food, animal feeds, and raw Matresses and matress pads; flammability standards, agricultural commodities: 13137–13141 Azoxystrobin, 13106–13112

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Dicloran, 13094–13096 Federal Reserve System Maneb (manganous ethylenebisdithiocarbamate), 13097– NOTICES 13103 Agency information collection activities: Pendimethalin, 13086–13088 Reporting and recordkeeping requirements, 13200–13203 Potato leaf roll virus resistance gene (orf1/orf2 gene), Submission for OMB review; comment request, 13204– 13078–13080 13205 Propiconazole, 13080–13086, 13103–13105 Tebufenozide, 13088–13094 Federal Trade Commission Superfund program: NOTICES Radionuclide releases; administrative reporting Prohibited trade practices: exemptions, 13113–13115 R.J. Reynolds Tobacco Co., 13205–13206 PROPOSED RULES Air quality implementation plans; approval and Fish and Wildlife Service promulgation; various States: RULES designation of areas: Endangered and threatened species: California, 13143–13145 Catesbaea melanocarpa, 13116–13120 Ohio, 13146 NOTICES NOTICES Endangered and threatened species: Agency information collection activities: Incidental take permits— Submission for OMB review; comment request, 13185– Lamar County, MS; Gopher tortoise, 13227–13228 13187 Environmental statements; availability, etc.: Meetings: Incidental take permits— Innovative approaches to environmental protection; Riverside County, CA; coastal California gnatcatcher, formation of a task force, 13187–13189 etc., 13228–13229 Oxygenate Use in Gasoline Panel, 13189 Science Advisory Board, 13189–13191 Food and Drug Administration Pesticide, food, and feed additive petitions: RULES ICI Surfactants, 13192–13195 Animal drugs, feeds, and related products: Rhodia Inc., 13195–13198 Bacitracin methylene disalicylate powder, 13068 Pesticide registration, cancellation, etc.: Lasalocid, 13068–13069 Oxythioquinox, 13191 Monensin and Virginiamycin, 13069 Reports and guidance documents; availability, etc.: Human drugs: Clean Air Act; estimation carbon monoxide exposures Labeling of drug products (OTC)— and carboxyhemoglobin level in Denver residents Analgesic and antipyretic active ingredients for internal using pNEM/CO, 13198–13199 use; required alcohol warning, 13066–13067 Superfund; response and remedial actions, proposed Standardized format, 13253–13303 settlements etc.: NOTICES ILCO Superfund Site, 13199 Meetings: Anti-Infective Drugs Advisory Committee, 13222 Equal Employment Opportunity Commission Human Tissue Seminar, 13222 NOTICES Agency information collection activities: Government Ethics Office Submission for OMB review; comment request, 13199– RULES 13200 Ethical conduct standards for executive branch employees, 13063–13064 Federal Aviation Administration NOTICES Health and Human Services Department Meetings: See Centers for Disease Control and Prevention RTCA, Inc., 13244 See Children and Families Administration Satellite-based navigation user forum, 13244 See Food and Drug Administration See National Institutes of Health Federal Deposit Insurance Corporation NOTICES NOTICES Meetings: Agency information collection activities: Blood Safety and Availability Advisory Committee, 13206 Submission for OMB review; comment request, 13200 Privacy Act: Systems of records, 13206 Federal Emergency Management Agency RULES Housing and Urban Development Department Flood insurance program: NOTICES Insurance coverage and rates, 13115–13116 Agency information collection activities: Reporting and recordkeeping requirements, 13224–13225 Federal Energy Regulatory Commission Submission for OMB review; comment request, 13225 NOTICES Hydroelectric applications, 13185 Immigration and Naturalization Service Applications, hearings, determinations, etc.: NOTICES Florida Gas Transmission Co., 13184 Agency information collection activities: Williston Basin Interstate Pipeline Co., 13185 Proposed collection; comment request, 13237–13238

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Indian Affairs Bureau National Oceanic and Atmospheric Administration NOTICES RULES Grants and cooperative agreements; availability, etc.: Fishery conservation and management: Housing Improvement Program, 13229–13230 Alaska; fisheries of Exclusive Economic Zone— Pacific cod, 13122 Interior Department Sablefish, 13121 See Fish and Wildlife Service Caribbean, Gulf, and South Atlantic fisheries— See Indian Affairs Bureau Gulf of Mexico and South Atlantic coastal migratory See Land Management Bureau pelagic resources, 13120–13121 See Minerals Management Service See National Park Service National Park Service See Reclamation Bureau NOTICES See Surface Mining Reclamation and Enforcement Office Agency information collection activities: NOTICES Proposed collection; comment request, 13232 Privacy Act: Boundary establishment, descriptions, etc.: Systems of records, 13226–13227 Cabrillo National Monument, CA, 13232–13233 Environmental statements; notice of intent: Internal Revenue Service Big Cypress National Preserve, FL, 13233 NOTICES Oil and gas plans of operations; availability, etc.: Agency information collection activities: Padre Island National Seashore, TX, 13233–13234 Proposed collection; comment request, 13249–13252 Nuclear Regulatory Commission NOTICES International Trade Administration Agency information collection activities: NOTICES Proposed collection; comment request, 13238 Antidumping: Submission for OMB review; comment request, 13238– Gray portland cement and clinker from— 13239 Mexico, 13148–13169 Meetings; Sunshine Act, 13241 Oil country tubular goods from— Applications, hearings, determinations, etc.: Korea, 13169–13174 Pathfinder Mines Corp., 13239–13241 Justice Department Public Health Service See Immigration and Naturalization Service See Centers for Disease Control and Prevention See Food and Drug Administration Land Management Bureau See National Institutes of Health NOTICES Committees; establishment, renewal, termination, etc.: Railroad Retirement Board Southeast Oregon Resource Advisory Council, 13230 NOTICES Realty actions; sales, leases, etc.: Agency information collection activities: New Mexico; correction, 13231 Proposed collection; comment request, 13241–13242 Oregon, 13231 Recreation management restrictions, etc.: Reclamation Bureau Upper Missouri National Wild and Scenic River, MT; NOTICES seasonal boating restrictions, 13231 Privacy Act: Systems of records, 13226–13227 Minerals Management Service NOTICES Securities and Exchange Commission Agency information collection activities: RULES Submission for OMB review; comment request, 13231– Securities: 13232 Exchanges and alternative trading systems Correction, 13065–13066 National Highway Traffic Safety Administration NOTICES Self-regulatory organizations; proposed rule changes: NOTICES Government Securities Clearing Corp., 13242–13243 Motor vehicle safety standards; exemption petitions, etc.: Nonconforming vehicles— Small Business Administration Importation eligibility; determinations, 13244–13249 NOTICES Applications, hearings, determinations, etc.: National Institutes of Health EOS Partners SBIC II, L.P., 13243 NOTICES Meetings: Social Security Administration National Cancer Institute, 13222–13223 NOTICES National Institute of Neurological Disorders and Stroke, Foreign insurance or pension systems: 13223 Hungary, 13243–13244 National Institute of Nursing Research, 13223 National Institute on Deafness and Other Communication Surface Mining Reclamation and Enforcement Office Disorders, 13223–13224 NOTICES National Library of Medicine, 13224 Agency information collection activities: Scientific Review Center, 13210–13211 Proposed collection; comment request, 13236–13237

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Transportation Department Separate Parts In This Issue See Federal Aviation Administration See National Highway Traffic Safety Administration Part II Department of Health and Human Services, Food and Drug Administration, 13253–13303 Treasury Department See Customs Service Part III See Internal Revenue Service Department of Agriculture, Cooperative State Research, Education, and Extension Service, 13305–13310 United States Information Agency NOTICES Reader Aids Art objects; importation for exhibition: Consult the Reader Aids section at the end of this issue for Nainsukh: Painter from the Punjab Hills, 13252 phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.

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CFR PARTS AFFECTED IN THIS ISSUE

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

5 CFR 2635...... 13063 7 CFR Proposed Rules: 915...... 13123 1065...... 13125 9 CFR 52...... 13064 16 CFR Proposed Rules: 1615...... 13126 1616...... 13126 1630...... 13132 1631...... 13132 1632...... 13137 17 CFR 202...... 13065 240...... 13065 242...... 13065 249...... 13065 19 CFR Proposed Rules: 24...... 13141 146...... 13142 21 CFR 201 (2 documents) ...... 13066, 13254 330...... 13254 331...... 13254 341...... 13254 346...... 13254 355...... 13254 358...... 13254 369...... 13254 520...... 13068 556...... 13068 558 (2 documents) ...... 13068, 13069 701...... 13254 40 CFR 52...... 13070 62...... 13075 81...... 13146 180 (8 documents) ...... 13078, 13086, 13088, 13094, 13097, 13103, 13106 302...... 13113 355...... 13113 Proposed Rules: 52 (2 documents) ...... 13143, 13146 44 CFR 61...... 13115 50 CFR 17...... 13116 622...... 13120 679 (2 documents) ...... 13121, 13122

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Rules and Regulations Federal Register Vol. 64, No. 51

Wednesday, March 17, 1999

This section of the FEDERAL REGISTER herewith publishing the proposed the process by which provisions on contains regulatory documents having general amendments to subpart F as a final rule, prospective employment in the criminal applicability and legal effect, most of which with no changes, effective April 16, statute and Executive order were are keyed to and codified in the Code of 1999. A summary of those amendments implemented jointly. As questions from Federal Regulations, which is published under follows. 50 titles pursuant to 44 U.S.C. 1510. ethics officials have arisen concerning Subpart F these apparent discrepancies, OGE has The Code of Federal Regulations is sold by advised that the requirements of 18 the Superintendent of Documents. Prices of Subpart F of the standards of ethical U.S.C. 208 control. In order to more new books are listed in the first FEDERAL conduct regulation, as promulgated for clearly align the provisions of subpart F REGISTER issue of each week. codification at 5 CFR part 2635 in 1992, with that advice and the criminal implemented certain provisions of a statute, OGE is amending § 2635.601 criminal statute and an Executive order, and § 2635.602 accordingly, by this OFFICE OF GOVERNMENT ETHICS specifically: (1) 18 U.S.C. 208, current rulemaking. restricting employees’ official 5 CFR Part 2635 participation in matters wherein a Additionally, amendments in this RIN 3209±AA04 person or organization with whom they current rulemaking to § 2635.601, are negotiating for or have an § 2635.602, § 2635.604, § 2635.605, and Standards of Ethical Conduct for arrangement concerning prospective § 2635.606 clarify initially in each Employees of the Executive Branch employment has a financial interest, section that the restrictions apply only AGENCY: Office of Government Ethics and (2) sections 101(h) and 101(j) of when the employee would be (OGE). Executive Order 12674, directing ‘‘participating personally and employees to act impartially in official ACTION: Final rule; amendments. substantially’’ in a particular matter. matters and not to engage in seeking or These modifications will further ensure SUMMARY: The Office of Government negotiating for outside employment that that subpart F is consistent with 18 Ethics is amending portions of the conflicts with official duties and U.S.C. 208 and in conformance with regulation governing standards of responsibilities. Because these OGE advice. ethical conduct for executive branch provisions of the criminal statute and employees on seeking other Executive order are so closely related, Matters of Regulatory Procedure they were combined for implementation employment, to conform with Executive Order 12866 interpretive advice and to improve at subpart F, with a requirement clarity. generally for disqualification from In promulgating these final rule EFFECTIVE DATE: April 16, 1999. participation in certain matters when an amendments, the Office of Government FOR FURTHER INFORMATION CONTACT: G. employee is ‘‘seeking other Ethics has adhered to the regulatory Sid Smith, Senior Associate General employment,’’ a term that encompasses philosophy and the applicable Counsel, Office of Government Ethics; both negotiating and other specified principles of regulation set forth in telephone: 202–208–8000; TDD: 202– lesser contacts. section 1 of Executive Order 12866, 208–8025; FAX: 202–208–8037. The existing language of § 2635.601 Regulatory Planning and Review. These SUPPLEMENTARY INFORMATION: On August and § 2635.602 in that subpart suggests amendments have also been reviewed that coverage may be limited to 26, 1998, the Office of Government by the Office of Management and situations where the employee’s Ethics (OGE) published proposed minor Budget under that Executive order. amendments to the standards of ethical ‘‘performance or nonperformance of conduct for executive branch employees official duties will affect’’ the financial Regulatory Flexibility Act (5 CFR part 2635), to codify interpretive interests of a prospective employer. A As Director of the Office of advice and clarify intended meaning in somewhat more accurate test, for subpart F (Seeking Other Employment) purposes of 18 U.S.C. 208, is contained Government Ethics, I certify under the and in the definition of ‘‘receive’’ at in the existing § 2635.604(a), Regulatory Flexibility Act (5 U.S.C. § 2635.807 of subpart H (Outside § 2635.605(a), and § 2635.606(a), which chapter 6) that this rulemaking will not Activities). See 63 FR 45415–45417. We is that coverage extends to participation have a significant economic impact on received only one comment, which in ‘‘a particular matter that has a direct a substantial number of small entities, related exclusively to the proposed and predictable effect’’ on those because it primarily affects Federal amendment to § 2635.807. Upon further financial interests. The criminal statute executive branch agencies and their consideration, and in view of separate does not limit its application to employees. concerns about other provisions of situations where one’s performance of Paperwork Reduction Act § 2635.807, we have decided not to official duties will affect a financial make the proposed definitional revision interest, but instead focuses on whether The Paperwork Reduction Act (44 a matter in which the employee in § 2635.807 at this time. If, in the U.S.C. chapter 35) does not apply, participates will affect the financial future, OGE decides to revive that because this rulemaking does not interest. Further, the statute is triggered proposal, we will issue a new proposed contain any information collection rule revision, with opportunity for only if the effect on the financial requirements that require the approval comments. interest will be direct and predictable. No comments were received This variation among sections of the of the Office of Management and concerning subpart F, so OGE is regulation was an unintended result of Budget.

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List of Subjects in 5 CFR Part 2635 substantial have the respective days as warranted or necessary. In this Conflict of interests, Executive branch meanings set forth in § 2635.402(b)(1), amendment we are clarifying that standards of ethical conduct, (3), and (4). intent. DATES: Government employees. § 2635.604 [Amended] This amendment is effective March 11, 1999. We invite you to Approved: December 7, 1998. 5. Section 2635.604 is amended by comment on Docket No. 98–123–2 as Stephen D. Potts, adding the words ‘‘personally and amended by this docket. We will Director, Office of Government Ethics. substantially’’ after the word consider all comments that we receive For the reasons set forth in the ‘‘participate’’ in the first sentence of by April 16, 1999. preamble, the Office of Government paragraph (a). ADDRESSES: Please send your comment Ethics is amending part 2635 of § 2635.605 [Amended] and three copies to: Docket No. 98–123– subchapter B of chapter XVI of title 5 of 6. Section 2635.605 is amended by 2, Regulatory Analysis and the Code of Federal Regulations, as Development, PPD, APHIS, Suite 3C03, follows: adding the words ‘‘personally and substantially’’ after the word 4700 River Road, Unit 118, Riverdale, PART 2635Ð[AMENDED] ‘‘participate’’ in the first sentence of MD 20737–1238. paragraph (a), and by adding the words Please state that your comment refers 1. The authority citation for part 2635 ‘‘personally and substantially’’ after the to Docket No. 98–123–2. continues to read as follows: word ‘‘participate’’ in the first sentence You may read any comments that we Authority: 5 U.S.C. 7301, 7351, 7353; 5 of paragraph (b). receive on these dockets in our reading U.S.C. App. (Ethics in Government Act of room. The reading room is located in 1978); E.O. 12674, 54 FR 15159, 3 CFR, 1989 § 2635.606 [Amended] room 1141 of the USDA South Building, Comp., p. 215, as modified by E.O. 12731, 55 7. Section 2635.606 is amended by 14th Street and Independence Avenue, FR 42547, 3 CFR, 1990 Comp., p. 306. removing the words ‘‘taking official SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., § 2635.601 [Amended] action’’ from the first sentence of paragraph (a) and adding the words Monday through Friday, except 2. Section 2635.601 is amended by holidays. To be sure someone is there to removing the words ‘‘who otherwise ‘‘participating personally and substantially’’ in their place. help you, please call (202) 690–2817 would be affected by the performance or before coming. nonperformance of the employees’ [FR Doc. 99–6492 Filed 3–16–99; 8:45 am] APHIS documents published in the official duties.’’ from the end of the first BILLING CODE 6345±01±U Federal Register, and related sentence and adding the words ‘‘whose information, including the names of financial interests would be directly and organizations and individuals who have predictably affected by particular DEPARTMENT OF AGRICULTURE commented on APHIS rules, are matters in which the employees available on the Internet at http:// participate personally and Animal and Plant Health Inspection www.aphis.usda.gov/ppd/rad/ substantially.’’ in their place, and by Service webrepor.html. adding the new sentence ‘‘See FOR FURTHER INFORMATION CONTACT: 9 CFR Part 52 Dr. § 2635.402 and § 2640.103 of this Keith Hand, Senior Staff Veterinarian, chapter.’’ between the second and third [Docket No. 98±123±3] VS, APHIS, 4700 River Road Unit 41, sentences. Riverdale, MD 20737–1231; (301) 734– RIN 0579±AB10 § 2535.602 [Amended] 8073. 3. Section 2635.602 is amended by Pseudorabies in Swine, Payment of SUPPLEMENTARY INFORMATION: removing the words ‘‘the employee’s Indemnity; Technical Amendment Background official duties would affect’’ from the In an interim rule published in the first sentence of the undesignated AGENCY: Animal and Plant Health Federal Register on January 15, 1999, introductory text and adding the words Inspection Service, USDA. and effective as of January 12, 1999 (64 ‘‘particular matters in which the ACTION: Interim rule; technical FR 2545–2550, Docket No. 98–123–2), employee will be participating amendment and notice of extension of we established animal health personally and substantially would comment period. regulations to provide for the payment directly and predictably affect’’ in their of indemnity by the United States place, and by removing the words SUMMARY: In an interim rule published Department of Agriculture for the ‘‘affected by the performance or in the Federal Register on January 15, voluntary depopulation of herds of nonperformance of his official duties’’ 1999, and effective as of January 12, swine known to be infected with from the first sentence of the note 1999, we established animal health pseudorabies. Although we provided in following the undesignated introductory regulations to provide for the payment our interim rule that a premises that has text and adding the words ‘‘affected of indemnity by the United States been depopulated of swine may not be directly and predictably by particular Department of Agriculture for the restocked for at least 30 days following matters in which he participates voluntary depopulation of herds of cleaning and disinfection of the personally and substantially’’ in their swine known to be infected with premises, it was our intent to allow an place. pseudorabies. Although we provided in official pseudorabies epidemiologist to 4. Section 2635.603 is amended by our interim rule that a premises that has allow restocking in less than 30 days or revising paragraph (d) to read as been depopulated of swine may not be to require a waiting period longer than follows: restocked for at least 30 days following 30 days before restocking. cleaning and disinfection, it was our We included the 30-day waiting § 2635.603 Definitions. intent to also allow an official period in the interim rule in order to * * * * * pseudorabies epidemiologist to allow ensure that the vacated premises was (d) Direct and predictable effect, restocking in less than 30 days or to completely free of the pseudorabies particular matter, and personal and require a waiting period longer than 30 virus before being repopulated with

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Background for the elimination of any pseudorabies All premises, including barns, virus that might remain on the premises stockyards and pens, and all cars and The final regulations that are the after cleaning and disinfection. other conveyances, and the materials on subject of these corrections relate to the However, a premises that has been any premises or conveyances used to regulation of exchanges and alternative adequately cleaned and disinfected house or transport swine for which trading systems. indemnity is paid under this part must may, in some cases, not need a 30-day Need for Correction waiting period to ensure that the virus be cleaned and disinfected under the has been eliminated. Conversely, it is supervision of an APHIS employee after As published, the final regulations possible that it might not be entirely removal of the swine from the known contain a rule designation which was safe to restock a premises until more infected herd. Premises may be previously designated by another final than 30 days have elapsed following restocked with swine 30 days following rule. In the final rules for OTC cleaning and disinfection. an approved cleaning and disinfection, derivatives dealers, published on Tuesday, November 3, 1998, new Rule It was our intent to allow an official unless an official pseudorabies 17a–4(b)(10) was adopted and became pseudorabies epidemiologist familiar epidemiologist determines that a shorter effective on January 4, 1999. The final with the individual premises and the or longer period of time is adequate or rules for the regulation of exchanges and cleaning and disinfection done on that necessary to protect new animals alternative trading systems erroneously premises to determine whether any against infection. The owner to whom also designated a new Rule 17a– reduction or addition to the 30-day the indemnity is paid will be 4(b)(10). This correction redesignates waiting period was warranted or responsible for expenses incurred in the Rule 17a–4(b)(10) contained in the advisable for that premises. Therefore, connection with the cleaning and regulation of exchanges and alternative we are adding language to § 52.4 to disinfection, except for cleaning and trading systems release as Rule 17a– clarify that intent. disinfection of the conveyances used to transport the swine to the location of 4(b)(11) and makes the necessary This technical amendment is disposal. changes throughout the release text and consistent with procedures outlined in final rules. our ‘‘State-Federal-Industry Program Done in Washington, DC, this 11th day of March 1999. Under section 553(b), notice of Standards for Pseudorabies proposed rulemaking is not required Craig A. Reed, Eradication.’’ (A copy of the standards when the agency for good cause finds can be obtained by contacting the Administrator, Animal and Plant Health that notice and public procedure Inspection Service. person listed above under FOR FURTHER thereon are ‘‘impracticable, INFORMATION CONTACT.) At the onset of [FR Doc. 99–6491 Filed 3–16–99; 8:45 am] unnecessary, or contrary to the public our accelerated pseudorabies BILLING CODE 3410±34±P interest.’’ Because the amendments eradication program, we advised States adopted today are technical corrections participating in the eradication program to clarify the rule designations, the that we would proceed in accordance SECURITIES AND EXCHANGE Commission finds that publishing the with our existing program standards. COMMISSION amendments for comment would be The language we are adding to the 17 CFR Parts 202, 240, 242 and 249 unnecessary. The rule being amended regulations is consistent with the was adopted after notice and the existing standards. [Release No. 34±40760A; File No. S7±12± opportunity for public comment. Comments sent to us on our January 98] Under section 553(d), publication of a 15, 1999, interim rule (Docket No. 98– RIN 3235±AH41 substantive rule not less than 30 days 123–2) were required to be received on before its effective date is required or before March 16, 1999. To allow the Regulation of Exchanges and except as otherwise provided by the public enough time to comment on this Alternative Trading Systems; agency for good cause. For the same technical amendment as it relates to the Correction reasons as described above with respect interim rule, we are extending the to notice and opportunity for comment, AGENCY: period during which we will accept Securities and Exchange the Commission finds that there is good comments on Docket No. 98–123–2. Commission. cause for having the rule become ACTION: Correction to final regulations. effective on April 21, 1999. List of Subjects in 9 CFR Part 52 SUMMARY: This document contains The Paperwork Reduction Act of 1 Animal diseases, Pseudorabies, corrections to the final regulations 1995 does not apply to this rulemaking Swine, Indemnity payments, which were published Tuesday, since these correcting amendments do Transportation. December 22, 1998, (63 FR 70844). The not require any ‘‘collection of Accordingly, we are amending 9 CFR information.’’ regulations related to regulation of 2 part 52 as follows: exchanges and alternative trading Section 23(a)(2) of the Exchange Act systems. requires the Commission to consider the PART 52ÐSWINE DESTROYED anti-competitive effects of any rules it EFFECTIVE DATE: April 21, 1999, except adopts thereunder, and to balance them BECAUSE OF PSEUDORABIES §§ 242.301(b)(5)(i)(D) and (E) and against the benefits that further the §§ 242.301(b)(6)(i)(D) and (E), which 1. The authority citation for part 52 purposes of the Act. Furthermore, shall become effective on April 1, 2000. continues to read as follows: section 2 of the Securities Act 3 and FOR FURTHER INFORMATION CONTACT: section 3 of the Exchange Act,4 as Authority: 21 U.S.C. 111–113, 114, 114a, Kevin Ehrlich, Attorney, at (202) 942– 114a-1, 120, 121, 125, and 134b; 7 CFR 2.22, 2.80, and 371.2(d). 0778, Division of Market Regulation, 1 44 U.S.C. 3501 et seq. Securities and Exchange Commission, 2 15 U.S.C. 78w(a)(2). 2. Section § 52.4 is revised to read as 450 Fifth Street, N.W., Washington, DC 3 15 U.S.C. 77b. follows: 20549–1001. 4 15 U.S.C. 78c.

VerDate 03-MAR-99 15:02 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.XXX pfrm04 PsN: 17MRR1 13066 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations amended by the recently enacted DEPARTMENT OF HEALTH AND In the Federal Register of October 23, National Securities Markets HUMAN SERVICES 1998 (63 FR 56789), FDA issued a final Improvements Act of 1996,5 provide rule amending part 201 and establishing that whenever the Commission is Food and Drug Administration in § 201.322 a required alcohol warning engaged in rulemaking and is required for OTC drug products containing 21 CFR Part 201 to consider or determine whether an internal analgesic/antipyretic active action is necessary or appropriate in the [Docket No. 77N±094W] ingredients. The final rule requires public interest, the Commission shall manufacturers to add certain new also promote efficiency, competition, Over-the-Counter Drug Products warnings for any OTC drug product, and capital formation. Because the Containing Analgesic/Antipyretic labeled for adult use, containing any amendments here do not effect any Active Ingredients for Internal Use; internal analgesic/antipyretic active substantive change in the rules they do Required Alcohol Warning; Final Rule; ingredients (including, but not limited to, acetaminophen, aspirin, carbaspirin not have any anti-competitive effects. Compliance Date calcium, choline salicylate, ibuprofen, Because they correct mistakes or clarify AGENCY: Food and Drug Administration, ketoprofen, magnesium salicylate, ambiguity present in the Commission’s HHS. naproxen sodium, and sodium rules, they serve to promote efficiency, ACTION: Final rule; compliance date. salicylate) alone or in combination and competition, and capital formation, and marketed with or without an approved are therefore in the public interest. SUMMARY: The Food and Drug application. The wording of the Correction of Publication Administration (FDA) is establishing a warnings in the final rule was different compliance date of October 22, 1999, for than the wording in the proposal. The Accordingly, the publication on the regulation that published in the final rule specified an effective date of December 22, 1998 of the final Federal Register of October 23, 1998 (63 April 23, 1999, for any OTC drug regulations which were the subject of FR 56789). The regulation established product subject to this section. warning statements that advise FR Doc. 98–33299 beginning on page II. Summary of Comments Received 70844 is corrected as follows: consumers with a history of heavy alcohol use to consult a physician for In response to the final rule, the 1. On page 70845 in the first column advice about the use of OTC internal agency received several comments (Ref. under XII. in the table of contents, ‘‘D. analgesic/antipyretic drug products. The 1) and a citizen petition (Ref. 2) Rule 17a–4(b)(10)’’ is corrected to read compliance date applies to all affected requesting more time to implement the ‘‘D. Rule 17a–4(b)(11)’’. OTC drug products, whether marketed new required alcohol warnings and a 2. On page 70909 in the second with or without an approved mechanism by which manufacturers column, line 11 of the last paragraph, application. FDA is taking this action in may petition the agency for a variance ‘‘17a–4(b)(10)’’ is corrected to read response to correspondence and a or extension of time to comply with the ‘‘17a–4(b)(11)’’. citizen petition requesting more time to regulation’s 6-month implementation relabel these products. date. The comments were submitted by 3. On page 70911 in the third column, several large manufacturers of brand 9th line from the bottom in the last DATES: 21 CFR 201.322, published on October 23, 1998 (63 FR 56789), is name OTC internal analgesic/antipyretic paragraph, ‘‘Rule 17a–4(b)(10)’’ is drug products and a manufacturer of a effective April 23, 1999; but compliance corrected to read ‘‘Rule 17a–4(b)(11)’’. large number of private label OTC is not required until October 22, 1999. 4. On page 70913 in the second internal analgesic/antipyretic drug column, heading ‘‘D. Rule 17a–4(b)(10)’’ FOR FURTHER INFORMATION CONTACT: products. The comments stated that is corrected to read ‘‘D. Rule 17a– Gerald M. Rachanow, Center for Drug relabeling procedures generally take Evaluation and Research (HFD–560), 4(b)(11)’’ and lines 5 and 11 of the last longer than the 6 months provided for Food and Drug Administration, 5600 paragraph, ‘‘Rule 17a–4(b)(10)’’ is in the final rule and that the companies Fishers Lane, Rockville, MD 20857, corrected to read ‘‘Rule 17a–4(b)(11)’’. simply lack the needed manpower and 301–827–2307. equipment to comply by April 23, 1999. 5. On page 70913 in the third column SUPPLEMENTARY INFORMATION: The comments added that the in the first line, ‘‘Rule 17a–4(b)(10)’’ is implementation period for the new rule I. Background corrected to read ‘‘Rule 17a–4(b)(11)’’. must ensure that label integrity is not 6. On page 70919 in the third column, In the Federal Register of November compromised or done haphazardly. The the last line of instruction 11, 14, 1997 (62 FR 61041), FDA published comments stated that 6 months is an ‘‘paragraph (b)(10)’’ is corrected to read a proposed amendment of part 201 (21 insufficient period of time for a number ‘‘paragraph (b)(11)’’. CFR part 201) to establish alcohol of companies to accomplish the warnings for all OTC drug products 7. On page 70920 in the first column relabeling, and the short timeframe does labeled for adult use containing internal at the first line, the designation ‘‘(10)’’ not promote emphasis on labeling analgesic/antipyretic active ingredients. is corrected to read ‘‘(11)’’. integrity and good manufacturing The agency stated that it may change the practice compliance. All of the 8. On page 70920 in the first column wording of the proposed warnings or comments expressed concern that in the first paragraph, lines 11 and 16, not require them as a result of numerous products could become ‘‘(b)(10)’’ is corrected to read ‘‘(b)(11)’’. comments filed in response to the unavailable and estimated significant Dated: March 11, 1999. proposal. Because it wished to loss of inventory if required to encourage the voluntary use of the Jonathan G. Katz, implement the labeling change by April proposed warning statements, the 23, 1999. Secretary. agency advised that manufacturers One comment requested permission [FR Doc. 99–6411 Filed 3–16–99; 8:45 am] would be given ample time after to use up all existing supplies of BILLING CODE 8010±01±P publication of a final rule to use up any labeling that contain the precise alcohol labeling printed in conformance with warning contained in an agency letter 5 Pub. L. 104–290, 106, 110 Stat. 3416 (1996). the proposal (62 FR 61041 at 61052). dated March 14, 1996 (Ref. 3). Another

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.018 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13067 comment, submitted by a manufacturer, Further, because of the importance of V. Paperwork Reduction Act of 1995 stated that it would implement the new the alcohol warnings, the agency alcohol warnings by the effective date continues to encourage all affected FDA concludes that the labeling and that other affected companies manufacturers to bring their labeling requirements in this document are not should also be required to meet that into compliance with the final rule as subject to review by the Office of date (Ref. 4). promptly as possible. Management and Budget because they The agency held a public meeting on do not constitute a ‘‘collection of January 20, 1999 (Ref. 5), to hear the Because this document merely information’’ under the Paperwork views of interested parties regarding the establishes a compliance date, FDA Reduction Act of 1995 (44 U.S.C. 3501 implementation date of the rule. At this finds that notice and comment et seq.). Rather, the labeling statements meeting, one large private label procedures are unnecessary and not in are a ‘‘public disclosure of information manufacturer of internal analgesic/ the public interest (5 U.S.C. 553(b) and originally supplied by the Federal antipyretic drug products stated that it (d)). Moreover, because of the need for government to the recipient for the would not be able to meet the April 23, the agency to publish this document purpose of disclosure to the public’’ (5 1999, implementation date, and that if before the original April 23, 1999, CFR 1320.3(c)(2)). effective date, notice and comment the deadline were not extended a real VI. Environmental Impact possibility existed that there would be rulemaking would be impracticable for a national shortage of certain products this document. The agency has determined under 21 that it manufactures. Another IV. Analysis of Impacts CFR 25.31(c) that this action is of a type manufacturer at the meeting stated that that does not individually or it would be able to comply by the The economic impact of the final cumulatively have a significant effect on implementation date. regulation was discussed in the final the human environment. Therefore, III. The Agency’s Response rule (63 FR 56789 at 56798 to 56799). neither an environmental assessment This document will provide additional nor an environmental impact statement As stated in the final rule, the agency time for companies to relabel affected is required. considers the lack of sufficient alcohol products and will reduce label warnings to be a significant public VII. References obsolescence, as there will be additional health issue. However, additional information (Refs. 6 through 11) that the time to use up more existing labeling. The following references are on agency has obtained since publication of Thus, setting a compliance date of display in the Dockets Management the final rule suggests that the agency October 22, 1999, should reduce the Branch (HFA–305), Food and Drug may have underestimated the number of economic impact on industry Administration, 5630 Fishers Lane, rm. individual label changes that some significantly. 1061, Rockville, MD 20852, and may be manufacturers will have to make. This FDA has examined the impacts of this seen by interested parties between 9 information also indicates that there final rule (establishment of the a.m. and 4 p.m., Monday through may be a significantly greater disparity compliance date) under Executive Order Friday. in the effect of the required labeling 12866 and the Regulatory Flexibility Act 1. Comment Nos. C20, C21, and C22, Docket No. 77N–094W, Dockets Management upon manufacturers than originally (5 U.S.C. 601–612). Executive Order anticipated. For these reasons, FDA now Branch. 12866 directs agencies to assess all costs 2. Comment No. CP1, Docket No. 77N– believes that the original 6-month and benefits of available regulatory 094W, Dockets Management Branch. implementation period would not alternatives and, when regulation is 3. Letter from D. Bowen, FDA, to R. Soller, provide adequate time for many necessary, to select regulatory Nonprescription Drug Manufacturers manufacturers of affected products to approaches that maximize net benefits Association, Coded LET2, Docket No. 77N– relabel a significant number of their (including potential economic, 094W, Dockets Management Branch. products and that strict adherence to the environmental, public health and safety, 4. Comment No. C19, Docket No. 77N– 094W, Dockets Management Branch. April 23, 1999, effective date might and other advantages; distributive 5. Comment No. MM, Docket No. 77N– result in short-term shortages of some of impacts; and equity). The agency these important OTC drug products, 094W, Dockets Management Branch. believes that this final rule is consistent 6. Letter from K. Rothschild, FDA, to D. which are widely used by many with the regulatory philosophy and consumers. Consequently, the agency Jespersen, Perrigo, coded LET3, Docket No. principles set out in the Executive 77N–094W, Dockets Management Branch. believes that establishing a compliance Order. The final rule is not a significant 7. Letter from K. Rothschild, FDA, to H. date for the regulation, until October 22, regulatory action as defined by the McCain, Whitehall-Robins, coded LET4, 1999, will provide sufficient time for Executive Order and so is not subject to Docket No. 77N–094W, Dockets Management industry to implement the labeling review under the Executive Order. Branch. revisions required for these OTC 8. Comment No. C23, Docket No. 77N– internal analgesic/antipyretic drug The Regulatory Flexibility Act 094W, Dockets Management Branch. products. requires agencies to analyze regulatory 9. Comment No. C24, Docket No. 77N– The agency does not believe that there options that would minimize any 094W, Dockets Management Branch. should be an open-ended period, as one significant impact of a rule on small 10. Letter from K. Rothschild, FDA, to H. comment requested, to use up existing entities. This final rule sets a McCain, Whitehall-Robins, coded LET5, supplies of labeling that contain an compliance date, which will provide Docket No. 77N–094W, Dockets Management manufacturers additional time to use up Branch. alcohol warning that was implemented 11. Comment No. C25, Docket No. 77N– voluntarily in response to an agency existing product labeling. Accordingly, 094W, Dockets Management Branch. letter dated March 14, 1996 (Ref. 3). the agency certifies that the final rule Rather, FDA believes that there should will not have a significant economic Dated: March 11, 1999. be a date certain after which all impact on a substantial number of small William K. Hubbard, products initially introduced or initially entities. Therefore, under the Regulatory Acting Deputy Commissioner for Policy. delivered for introduction into interstate Flexibility Act, no further analysis is [FR Doc. 99–6447 Filed 3–12–99; 12:40 pm] commerce contain the new warnings. required. BILLING CODE 4160±01±F

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DEPARTMENT OF HEALTH AND (HFA–305), Food and Drug medicated article to make a Type C HUMAN SERVICES Administration, 5630 Fishers Lane, rm. rabbit feed used for prevention of 1061, Rockville, MD 20852, between 9 coccidiosis and to provide for a Food and Drug Administration a.m. and 4 p.m., Monday through tolerance for drug residues in rabbits. Friday. EFFECTIVE DATE: March 17, 1999. 21 CFR Part 520 The agency has determined under 21 FOR FURTHER INFORMATION CONTACT: CFR 25.33(a)(1) that this action is of a Oral Dosage Form New Animal Drugs; type that does not individually or Estella Z. Jones, Center for Veterinary Bacitracin Methylene Disalicylate cumulatively have a significant effect on Medicine (HFV–135), Food and Drug Soluble the human environment. Therefore, Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7575. AGENCY: Food and Drug Administration, neither an environmental assessment HHS. nor an environmental impact statement SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., ACTION: Final rule. is required. Parsippany, NJ 07054–1298, filed List of Subjects in 21 CFR Part 520 SUMMARY: The Food and Drug supplemental NADA 96–298 that Administration (FDA) is amending the Animal drugs. provides for use of Bovatec (15 percent animal drug regulations to reflect Therefore, under the Federal Food, lasalocid) in addition to previously approval of a supplemental new animal Drug, and Cosmetic Act and under approved use of Avatec (20 percent drug application (NADA) filed by authority delegated to the Commissioner lasalocid) Type A medicated articles to Alpharma Inc. The supplemental NADA of Food and Drugs and redelegated to make 113 grams per ton lasalocid Type provides for using soluble bacitracin the Center for Veterinary Medicine, 21 C rabbit feeds used for prevention of methylene disalicylate (BMD) powder to CFR part 520 is amended as follows: coccidiosis caused by Eimeria stiedae. make a medicated drinking water for The supplemental NADA is approved as replacement chickens as an aid in the PART 520ÐORAL DOSAGE FORM of February 5, 1999, and the regulations prevention and control of necrotic NEW ANIMAL DRUGS are amended in 21 CFR 558.311(b)(4) to enteritis. 1. The authority citation for 21 CFR reflect the approval. The basis of EFFECTIVE DATE: March 17, 1999. part 520 continues to read as follows: approval is discussed in the freedom of information summary. FOR FURTHER INFORMATION CONTACT: Authority: 21 U.S.C. 360b. William T. Flynn, Center for Veterinary At this time, the human food safety Medicine (HFV–133), Food and Drug § 520.154a [Amended] data originally submitted in public Administration, 7500 Standish Pl., 2. Section 520.154a Soluble bacitracin master file 5042 for use of lasalocid in Rockville, MD 20855, 301–827–7570. methylene disalicylate is amended in rabbits was reevaluated and a tolerance for drug residues in edible rabbit tissues SUPPLEMENTARY INFORMATION: paragraph (a) by removing the phrase Alpharma is established in 21 CFR 556.347. Also, Inc., One Executive Dr., Fort Lee, NJ ‘‘paragraphs (d)(3) and (d)(4)’’ and by adding in its place the phrase that section is revised to reflect current 07024, filed supplemental NADA 65– format. 470 that provides for use of BMD ‘‘paragraph (d)’’, and in paragraph (d)(2) In accordance with the freedom of Soluble (BMD soluble powder) to make by removing the heading ‘‘Broiler information provisions of 21 CFR part a medicated drinking water for chickens’’ and by adding in its place 20 and 514.11(e)(2)(ii), a summary of replacement chickens. Medicated ‘‘Broiler and replacement chickens’’. safety and effectiveness data and drinking water containing the Dated: February 26, 1999. information submitted to support equivalent of 100 milligrams (mg) of Margaret Ann Miller, approval of this supplemental bacitracin per gallon is used as an aid Acting Director, Office of New Animal Drug application may be seen in the Dockets in the prevention of necrotic enteritis Evaluation, Center for Veterinary Medicine. Management Branch (HFA–305), Food caused by Clostridium perfringens [FR Doc. 99–6458 Filed 3–16–99; 8:45 am] and Drug Administration, 5630 Fishers susceptible to BMD. Medicated drinking BILLING CODE 4160±01±F Lane, rm. 1061, Rockville, MD 20852, water containing the equivalent of 200 between 9 a.m. and 4 p.m., Monday to 400 mg of bacitracin per gallon is through Friday. used as an aid in the control of necrotic DEPARTMENT OF HEALTH AND The agency has determined under 21 enteritis caused by C. perfringens HUMAN SERVICES CFR 25.33(a)(1) that this action is of a susceptible to BMD. The supplemental type that does not individually or NADA is approved as of February 2, Food and Drug Administration cumulatively have a significant effect on 1999, and the regulations in § 520.154a the human environment. Therefore, (21 CFR 520.154a) are amended to 21 CFR Parts 556 and 558 neither an environmental assessment reflect the approval. The basis for New Animal Drugs For Use In Animal nor an environmental impact statement approval is discussed in the freedom of Feeds; Lasalocid is required. information summary. In addition, the specifications AGENCY: Food and Drug Administration, List of Subjects paragraph is revised to reflect that the HHS. 21 CFR Part 556 200 grams per pound concentration has ACTION: Final rule. been previously approved for use in all Animal drugs, Foods. species as in § 520.154a(d). SUMMARY: The Food and Drug 21 CFR Part 558 In accordance with the freedom of Administration (FDA) is amending the information provisions of 21 CFR part animal drug regulations to reflect Animal drugs, Animal feeds. 20 and 514.11(e)(2)(ii), a summary of approval of a supplemental new animal Therefore, under the Federal Food, safety and effectiveness data and drug application (NADA) filed by Roche Drug, and Cosmetic Act and under information submitted to support Vitamins, Inc. The supplemental NADA authority delegated to the Commissioner approval of this application may be seen provides for use of a lower of Food and Drugs and redelegated to in the Dockets Management Branch concentration lasalocid Type A the Center for Veterinary Medicine, 21

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CFR parts 556 and 558 are amended as DEPARTMENT OF HEALTH AND FDA has determined under 21 CFR follows: HUMAN SERVICES 25.33(a)(2) that this action is of a type that does not individually or PART 556ÐTOLERANCES FOR Food and Drug Administration cumulatively have a significant effect on RESIDUES OF NEW ANIMAL DRUGS the human environment. Therefore, 21 CFR Part 558 IN FOOD neither an environmental assessment New Animal Drugs For Use In Animal nor an environmental impact statement 1. The authority citation for 21 CFR Feeds; Monensin and Virginiamycin is required. part 556 continues to read as follows: List of Subjects in 21 CFR Part 558 Authority: 21 U.S.C. 342, 360b, 371. AGENCY: Food and Drug Administration, HHS. 2. Section 556.347 is revised to read Animal drugs, Animal feeds. ACTION: Final rule. as follows: Therefore, under the Federal Food, Drug, and Cosmetic Act and under § 556.347 Lasalocid. SUMMARY: The Food and Drug Administration (FDA) is amending the authority delegated to the Commissioner (a) [Reserved] animal drug regulations to reflect of Food and Drugs and redelegated to (b) Tolerances—(1) Chickens. A approval of a new animal drug the Center for Veterinary Medicine, 21 tolerance is established for lasalocid application (NADA) filed by Elanco CFR part 558 is amended as follows: Animal Health, a Division of Eli Lilly residues of 0.3 part per million (ppm) PART 558ÐNEW ANIMAL DRUGS FOR parent lasalocid (marker residue) in skin and Co. The NADA provides for combining approved monensin and USE IN ANIMAL FEEDS with adhering fat (target tissue). virginiamycin Type A medicated (2) Cattle. A tolerance is established articles to make combination drug Type 1. The authority citation for 21 CFR for lasalocid residues of 0.7 ppm parent C medicated growing turkey feeds used part 558 continues to read as follows: lasalocid (marker residue) in liver for prevention of certain forms of Authority: 21 U.S.C. 360b, 371. (target tissue). coccidiosis and for increased rate of 2. Section 558.355 is amended by (3) Sheep. A tolerance for residues of weight gain and improved feed efficiency. adding paragraph (f)(2)(iv) to read as lasalocid is not needed. follows: EFFECTIVE DATE: March 17, 1999. (4) Rabbits. A tolerance is established for lasalocid residues of 0.7 ppm parent FOR FURTHER INFORMATION CONTACT: § 558.355 Monensin. Charles J. Andres, Center for Veterinary lasalocid (marker residue) in liver * * * * * (target tissue). Medicine (HFV–128), Food and Drug Administration, 7500 Standish Pl., (f) * * * PART 558ÐNEW ANIMAL DRUGS FOR Rockville, MD 20855, 301–827–1600. (2) * * * SUPPLEMENTARY INFORMATION: Elanco USE IN ANIMAL FEEDS (iv) Amount per ton. Monensin, 54 to Animal Health, a Division of Eli Lilly 90 grams, with virginiamycin, 10 to 20 3. The authority citation for 21 CFR and Co., Lilly Corporate Center, grams. part 558 continues to read as follows: Indianapolis, IN 46285, filed NADA 141–110 that provides for combining (a) Indications for use. For the Authority: 21 U.S.C. 360b, 371. approved monensin and virginiamycin prevention of coccidiosis caused by 4. Section 558.311 is amended by Type A medicated articles to make Eimeria adenoeides, E. meleagrimitis, revising paragraph (b)(4) to read as combination drug Type C medicated and E. gallopavonis, and for increased follows: growing turkey feeds containing 54 to rate of weight gain and improved feed 90 grams per ton (g/t) monensin and 10 efficiency in growing turkeys. § 558.311 Lasalocid. to 20 g/t virginiamycin. The Type C (b) Limitations. For growing turkeys * * * * * medicated growing turkey feed is used only. Feed continuously as sole ration. for the prevention of coccidiosis caused (b) * * * Do not allow horses, other equines, by Eimeria meleagrimitis, E. mature turkeys, or guinea fowl access to (4) 15 percent activity to No. 063238 adenoeides, and E. gallopavonis, and for feed containing monensin. Ingestion of for use in Type C rabbit feeds as in increased rate of weight gain and monensin by horses, mature turkeys, paragraph (e)(1)(xvi) of this section and improved feed efficiency. The NADA is for use in ruminant free-choice Type C approved as of January 29, 1999, and the and guinea fowl has been fatal. Some feeds as in paragraphs (e)(2) and (e)(3) regulations are amended in 21 CFR strains of turkey coccidia may be of this section. 558.355 to reflect the approval. monensin tolerant or resistant. Monensin may interfere with * * * * * In accordance with the freedom of information provisions of 21 CFR part development of immunity to turkey Dated: February 23, 1999. 20 and 514.11(e)(2)(ii), a summary of coccidiosis. Virginiamycin as provided Andrew J. Beaulieu, safety and effectiveness data and by No. 000069 in § 510.600(c) of this Acting Director, Office of New Animal Drug information submitted to support chapter. Evaluation, Center for Veterinary Medicine. approval of this application may be seen * * * * * [FR Doc. 99–6461 Filed 3–16–99; 8:45 am] in the Dockets Management Branch Dated: February 26, 1999. BILLING CODE 4160±01±F (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. Stephen F. Sundlof, 1061, Rockville, MD 20852, between 9 Director, Center for Veterinary Medicine. a.m. and 4 p.m., Monday through [FR Doc. 99–6460 Filed 3–16–99; 8:45 am] Friday. BILLING CODE 4160±01±F

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ENVIRONMENTAL PROTECTION Boulevard, Chicago, Illinois 60604. (It is reconsider its position regarding the AGENCY recommended that you telephone need for Ohio to adopt State rules to Phuong Nguyen at (312) 886–6708 replace Federal rules, prior to 40 CFR Parts 52 and 81 before visiting the Region 5 office.) redesignating several areas in Ohio to [OH121±1a; FRL±6239±3] FOR FURTHER INFORMATION CONTACT: attainment for sulfur dioxide. In a Phuong Nguyen at (312) 886–6701. September 25, 1996 letter to the State, Approval and Promulgation of SUPPLEMENTARY INFORMATION: EPA reaffirmed its position. On August Implementations; Ohio; Designation of 20, 1998, Ohio submitted material Areas for Air Quality Planning I. Background requested by EPA, including State Purposes; Ohio The NAAQS for SO2 consists of three adopted limits, to support the State’s standards: Two primary standards for requests to redesignate Lake and AGENCY: Environmental Protection the protection of public health and a Jefferson Counties to attainment with Agency (EPA). secondary standard for protection of respect to SO2. ACTION: Direct final rule. public welfare. The primary SO2 The criteria for redesignation to standards address 24-hour average and SUMMARY: EPA is approving two attainment are given in section 107 annual average ambient SO2 (d)(3)(E) of the Clean Air Act (Act). Of redesignation requests submitted by the concentrations. The secondary standard State of Ohio. This action, which was particular note is section 107 addresses 3-hr average ambient SO2 requested on October 26, 1995, (d)(3)(E)(ii), requiring that EPA has fully concentrations (See 40 CFR 50.2–50.5). approved the applicable plan. These redesignates Lake and Jefferson EPA promulgated the FIP regulations Counties to attainment of National criteria will be discussed in more detail in 1976. These regulations required below. Ambient Air Quality Standard (NAAQS) significant emission reductions at for sulfur dioxide (SO2). EPA is also specific facilities throughout the State in The sulfur dioxide nonattainment approving the maintenance plans for order to attain and maintain the NAAQS area in Lake County is described as the Lake and Jefferson Counties, to ensure cities of Eastlake, Lakeline, Mentor for SO2. On October 5, 1978, Lake and maintenance of the NAAQS, which Jefferson Counties (among others) were (north of US 20 and west of SR 306), were submitted with the redesignation designated nonattainment for the Timberlake and Willoughby (north of requests. In conjunction with these primary standards. The State adopted its US 20). The only major sulfur dioxide actions, EPA is also approving State- own regulations in 1979, generally source located within this area is the adopted emission limits for the Eastlake imposing limits similar to those Eastlake Plant. The State adopted Plant (currently operated by First promulgated in the FIP. The State emission limits for sources at this Energy, formerly operated by Cleveland submitted these regulations for EPA facility are equivalent to those found in Electric Illuminating), and the Ohio approval in 1980, including regulations the FIP. Compliance with these limits Rubber Company Plant, replacing for Jefferson and Lake Counties. The was determined by examining equivalent limits in the Federal State withdrew its submittal with information submitted in the facility’s Implementation Plan (FIP) for Lake respect to specified Lake County Title V permit application. The Ohio County. In the proposed rules section of sources, namely the Eastlake Plant Rubber Company plant and Painesville this Federal Register, EPA is proposing (formerly operated by Cleveland Electric Municipal Plant are located in the sulfur approval of, and soliciting comments Illuminating company), the Ohio Rubber dioxide attainment portion of Lake on, this approval. If adverse written Company Plant, and the Painesville county, and emissions of these sources comments are received on this action, Municipal Plant boiler number 5. EPA are not expected to have a significant EPA will withdraw this final rule and approved these regulations on January impact on air quality in the address the comments received in 27, 1981 (for Jefferson County, 46 FR nonattainment portion of the county. response to this action in a final rule 8481) and on April 20, 1982 (for Lake The sulfur dioxide nonattainment based on the related proposed rule. A County, 47 FR 16784). Revised area in Jefferson county is described as second public comment period will not regulations for Jefferson County were the cities of Steubenville and Mingo be held. Parties interested in approved on December 9, 1996 (61 FR Junction, and the townships of commenting on this action should do so 52882). However, the federally Steubenville, Island Creek, Cross Creek, at this time. promulgated FIP regulations have Knox and Wells. The largest sulfur DATES: This ‘‘direct final’’ rule is remained in effect for the above sources dioxide sources located within this area effective on May 17, 1999, unless EPA in Lake County. are the American Electric Power, receives adverse written comments by On October 26, 1995, Governor Cardinal Power Plant and Tidd Plant, April 16, 1999. If an adverse written Voinovich requested that EPA move both in Brilliant; The First Energy, W.H. comment is received, EPA will publish forward with redesignation to Sammis Plant in Stratton; The First a timely withdrawal of the rule in the attainment for all remaining SO2 Energy, Toronto Plant, in Toronto; The Federal Register and inform the public nonattainment areas within the State of Wheeling-Pittsburgh Steel, Steubenville that rule will not take effect. Ohio including Lake and Jefferson South Plant, in Mingo Junction; and the ADDRESSES: Written comments should Counties. On May 28, 1996, EPA Wheeling-Pittsburgh Steel, Steubenville be sent to: J. Elmer Bortzer, Chief, Administrator Browner sent a letter to North Plant, in Steubenville. The state Regulation Development Section. Air Governor Voinovich informing him that emission limits for sources at these Program Branch (AR–18J), the redesignation request depended on facilities were approved by EPA as part Environmental Protection Agency, 77 approval of State adopted rules in place of the State Implementation Plan (SIP), West Jackson Boulevard, Chicago, of FIP rules. On July 30, 1996, the effective January 27, 1981. Revised Illinois 60604. Copies of the revision Director of the Ohio Environmental limits for these sources were approved request are available for inspection at Protection Agency replied by objecting on December 9, 1996. Compliance with the following address: Environmental to EPA’s position that such further these limits was determined by Protection Agency, Region 5, Air and materials are a prerequisite for these examining information submitted in the Radiation Division, 77 West Jackson redesignations and requesting that EPA sources’ title V permit applications.

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II. SIP Approval nonattainment counties; therefore, this SIP, and no indication of an existing air On August 20, 1998, Ohio submitted maintenance plan can also be applied quality deficiency exists. Modeling was material including State adopted limits for these counties. These reductions in performed in 1976 to show that, under for sources in Lake County. The State minor source emissions, in combination all allowed operating scenarios, the requested approval of SIP limits for the with the limits on major source emission limit in these two counties’ First Energy Eastlake Plant and the Ohio emissions, are expected to provide for SO2 SIPs would lead to attainment and Rubber Plant in place of federally continued attainment in Jefferson and maintenance of the SO2 standards. These approvals were based on promulgated FIP limits. Lake Counties. Therefore, EPA approves modeling showing that compliance with Guidance relevant to the request at the maintenance plan for these two the submitted limits would assure issue is provided in a September 28, counties. attainment of the standards. Therefore, 1994 memorandum from the Director, IV. Redesignation Evaluation Criteria an important part of Ohio’s August 20, Air Quality Management Division, Section 107(d)(3)(E) of the Act, as 1998 submittal was evidence that Office of Air Quality Planning and amended in 1990, establishes sources are complying with applicable Standards, EPA, to the Director, Air and requirements to be met before an area limits. This evidence is in the form of Radiation Division, Region 5, entitled, may be redesignated from certifications of compliance by the ‘‘Response to Request for Guidance on nonattainment to attainment. The affected sources, pursuant to Issues with Ohio Sulfur Dioxide Federal criteria used to review redesignation certification requirements of Title V. Implementation Plan’’. This memo set requests are derived from the Act. An Based on this evidence, EPA concludes forth three criteria to be met for the area can be redesignated to attainment that emissions are sufficiently low as to approval of State limits that are if the following conditions are met: (A) assure attainment throughout the areas equivalent to existing FIP limits without The area has attained the applicable currently designated nonattainment. new modeling. Under the first two NAAQS; (B) The area has a fully criteria, there must be no known approved SIP under section 110(k) of B. Fully Approved SIP inadequacy in the original attainment the Act; (C) The EPA has determined The SIP for the area at issue must be demonstration. Under the third criteria, that the improvement in air quality in fully approved under section 110(k) of the State limits must reflect no the area is due to permanent and the Act and must satisfy all relaxation of existing emission limits. enforceable emission reductions; (D) requirements that apply to the area. All three of these criteria are met by the EPA has determined that the EPA’s guidance for implementing State promulgated SIP limits. Therefore, maintenance plan for the area has met section 110 of the Act is discussed in the revised limits can be considered to all of the requirements of the section the General Preamble to Title I (44 FR be adequate to assure attainment 175A of the Act; and, (E) The state has 20372, April 14, 1979, and 57 FR 13498, without further modeling. met all requirements applicable to the April 16, 1992). The SO2 SIP for Consequently, EPA approves adopted area under section 110 and part D of the Jefferson County and for most of Lake revisions to rule OAC 3745–18–49(G) Act. County met the requirements of section (the emission limitations for the First 110 of the Act and were approved by Energy, Eastlake plant) and rule OAC A. Demonstrated Attainment of the EPA on January 27, 1981 (46 FR 8481) 3745–18–49(H) (the emission NAAQS and on April 20, 1982 (47 FR 16784), limitations for the Ohio Rubber As explained in an April 21, 1983, respectively. Also on December 9, 1996, Company plant). These emission limits memorandum ‘‘Section 107 Designation EPA approved a SIP revision submitted are equivalent to the FIP limits for Lake Policy Summary’’ from the Director of by State of Ohio which amends the SO2 County. the Office of Air Quality Planning and regulations applying to First Energy’s As a result of the limits just Standards, eight consecutive quarters of Sammis and Toronto Plants in Jefferson discussed, attainment in Lake County is data showing SO2 NAAQS attainment County. This revision involves reverting assured on the basis of State-adopted, are required for redesignation. A to an emission limit option presented in EPA-approved limits. Consequently, violation of NAAQS occurs when more the FIP for Jefferson County. State limits there is no further need for a federally than one exceedance of the SO2 NAAQS for the remainder of Lake County promulgated limit, and the is recorded in any year (40 CFR 50.4). (except for the Painesville Municipal corresponding FIP limits for these Ohio’s August 3, 1998, submittal Plant) are being approved in this sources in Lake County can be provided ambient monitoring data rulemaking. The SIP supplemented a set rescinded. showing that Lake and Jefferson of general Statewide SO2 limitations Counties have met the NAAQS for the III. Maintenance Plan Approval with a set of individual emission limits years 1992–1998, the most recent for specific sources in the respective Ohio’s attainment plan for sulfur consecutive years with quality-assured counties. dioxide provides for attainment even monitoring data. There has not been a with major sources emitting their monitored violation of the NAAQS for C. Permanent and Enforceable maximum allowable emissions. sulfur dioxide within the state for over Reductions in Emissions Therefore, maintenance is provided by 15 years. Lake and Jefferson Counties’ assuring that minor source impacts do Dispersion modeling is commonly attainment of the SO2 standards can be not increase significantly. The principal used to demonstrate attainment of the attributed to the implementation of the minor sources are distant point sources SO2 NAAQS. A September 4, 1992 EPA SO2 SIP controls and other permanent and diesel vehicles. Title IV reductions policy memorandum on ‘‘procedures for emission reductions. On January 27, and the required national conversion to processing requests to redesignate areas 1981 and also on April 20, 1982, EPA low sulfur diesel fuel were the to attainment’’ explains that additional approved the control strategies and identified maintenance provisions dispersion modeling is not required in emissions limits in Ohio’s SO2 SIP for contained in the approved redesignation support of an SO2 redesignation request Jefferson and for Lake (except for for Washington and Morgan counties in if an adequate modeled attainment Eastlake plant, Ohio Rubber Company 1994 (59 FR 48403). These reductions demonstration is submitted and plant, and Painesville Municipal plant will also be realized in the other approved as part of the implemented boiler number 5) Counties respectively,

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The regulations are nonattainment to attainment for SO2. and Coordination With Indian Tribal permanent, and any future revisions to EPA is publishing this action without Governments the rules must be submitted to and prior proposal because EPA views this Under E.O. 13084, EPA may not issue approved by EPA. as a noncontroversial revision and a regulation that is not required by The major emissions of SO2 in statute, that significantly or uniquely Jefferson County are due to power anticipates no adverse comments. affects the communities of Indian tribal plants and steelmaking operations and However, in a separate document in this governments, and that imposes the major emissions of SO2 in Lake Federal Register publication, EPA is substantial direct compliance costs on County are due to power plant and proposing to approve the State Plan these communities, unless the Federal combustion sources. The reductions in should adverse written comments be government provides the funds SO2 emissions are due primarily to the filed. This action will be effective necessary to pay the direct compliance conversion of some fuel-burning sources without further notice unless EPA to lower sulfur content fuels, and to the receives relevant adverse written costs incurred by the tribal shutdown of various types of sources. comment by April 16, 1999. Should governments. If the mandate is unfunded, EPA must provide to the The use of lower-sulfur ‘‘cleaner’’ fuels EPA receive such comments, it will OMB in a separately identified section is reflected in the facilities’’ air permits publish a final rule informing the public of the preamble to the rule, a and federally enforceable SIP that this action will not take effect. Any regulations. description of the extent of EPA’s prior parties interested in commenting on this consultation with representatives of D. Fully Approved Maintenance Plan action should do so at this time. If no affected tribal governments, a summary such comments are received, the public As discussed above, EPA has of the nature of their concerns, and a is advised that this action will be concluded that the combination of statement supporting the need to issue effective on May 17, 1999. limitations on maximum allowable the regulation. In addition, E.O. 13084 emissions from major point sources and VI. Administration Requirements requires EPA to develop an effective implementation of programs that will process permitting elected and other yield reductions in minor source A. Executive Order 12866 representatives of Indian tribal governments ‘‘to provide meaningful emissions will assure maintenance of The office of Management and Budget the standards. and timely input in the development of (OMB) has exempted this regulatory regulatory policies on matters that E. Part D and Other Section 110 action from Executive Order (E.O.) significantly or uniquely affect their Requirements 12866, entitled ‘‘Regulatory Planing and communities.’’ Today’s rule does not EPA approved the SO2 SIPs for Review.’’ significantly or uniquely affect the Jefferson County on January 27, 1981, B. Executive Order 12875: Enhancing communities of Indian tribal and later on December 9, 1996, and for Intergovernmental Partnerships governments. Accordingly, the Lake County on April 20, 1982. Several requirements of section 3(b) of E.O. of the section 110 requirements were Under E.O. 12875, EPA may not issue 13084 do not apply to this rule. revised in the 1990 amendments to the a regulation that is not required by D. Executive Order 13045 Act. These existing SIPs conform with statute and that creates a mandate upon the new provisions of the Act. The plans a state, local or tribal government, Protection of Children from Environmental Health Risks and Safety provide for the implementation of unless the Federal government provides Risks (62 FR 19885, April 23, 1997), reasonably available control measures the funds necessary to pay the direct applies to any rule that: (1) is for SO2 under Ohio’s SIP rule. As compliance cost incurred by those required by part D of the Act, Ohio has determined to be ‘‘economically governments. If the mandate is significant’’ as defined under E.O. a fully approved and implemented New unfunded , EPA must provide to the Source Review Plan. The existing 12866, and (2) concerns an OMB a description of the extent of Prevention of Significant Deterioration environmental health or safety risk that EPA’s prior consultation with program, which was federally delegated EPA has reason to believe may have a representatives of affected State, local for all attainment areas, will apply in all disproportionate effect on children. If of Lake and Jefferson Counties and tribal governments, the nature of the regulatory action meets both criteria, subsequent to redesignation. their concerns, copies of any written the Agency must evaluate the communications from the governments, environmental health or safety effects of V. Final Rulemaking Action and a statement supporting the need to the planned rule on children, and EPA has completed an analysis of the issue the regulation. In addition, E.O. explain why the planned regulation is SIP revision request based on a review 12875 requires EPA to develop an preferable to other potentially effective of material presented, and has effective process permitting elective and reasonably feasible alternative determined that the revisions for the official and other representatives of considered by the Agency. EPA First Energy Eastlake plant and Ohio State, local and tribal governments ‘‘to interprets E.O. 13045 as applying only Rubber Company Plant are approvable. provide meaningful and timely input in to those regulatory actions that are In addition, EPA is also approving the the development of regulatory proposals based on health or safety risks, such that SO2 maintenance plan for Lake and containing significant unfunded the analysis required under section 5– Jefferson Counties, which were mandates.’’ Today’s rule does not create 501 of the Order has the potential to submitted with the redesignation a mandate on State, local or tribal influence the regulation. This action is request, as adequately ensuring that governments. The rule does not imposes not subject to E.O. 13045 because it attainment will be maintained. Finally, any enforceable duties on these entities. approves a state rule implementing a EPA is approving redesignation requests Accordingly, the requirements of previously promulgated health or safety- from the State of Ohio which were based Federal standard, and preserves section 1(a) of E.O. 12875 do not apply submitted on October 26, 1995 and is the existing level of pollution control for to this rule. redesignating those portions of Lake and the affected areas.

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E. Regulatory Flexibility Act G. Submission to Congress and the § 52.1870 Identification of plan. Comptroller General * * * * * The Regulatory Flexibility Act (RFA) (c) * * * generally requires an agency to conduct The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small (118) On October 26, 1995, and a regulatory flexibility analysis of any August 20, 1998, Ohio submitted rule subject to notice and comment Business Regulatory Enforcement Fairness Act of 1996, generally provides material including State adopted limits rulemaking requirements unless the for Lake County, and requested approval agency certifies that the rule will not that before a rule may take effect, the agency promulgating the rule must of limits for the Ohio First Energy have a significant economic impact on Eastlake Plant and the Ohio Rubber a substantial number of small entities. submit a rule report, which includes a copy of the rule, to each house of the Company Plant. Small entities include small businesses, (i) Incorporation by reference small not-for-profit enterprises, and Congress and to the Comptroller General (A) Rule 3745–18–49 (G) and (H) of small governmental jurisdictions. This of the United States. EPA will submit a the Ohio Administrative Code, effective final rule will not have a significant report containing this rule and other May 11, 1987. impact on a substantial number of small required information to the U.S. Senate, 3. Section 52.1881 is amended by entities because plan approvals under the U.S. House of Representatives, and revising paragraphs (a)(4) and (a)(8) and section 110 do not create any new the Comptroller General of the United adding paragraph (a)(13) to read as requirements but simply approve States prior to the publication of the follows: requirements that the State is already rule in the Federal Register. A major rule cannot take effect until 60 days § 52.1881 Control strategy; Sulfur oxide imposing. Therefore, because the federal (sulfur dioxide). approval does not create any new after it is published in the Federal requirements, I certify that this action Register. This rule is not a ‘‘major rule’’ (a) * * * (4) Approval-EPA approves the sulfur will not have a significant economic as defined by 5 U.S.C. 804(2). dioxide emission limits for the impact on a substantial number of small H. Petitions for Judicial Review following counties: Adams County entities. Moreover, due to the nature of Under section 307(b)(1) of the CAA, (except Dayton Power & Light-Stuart), the Federal-state relationship under the petitions for judicial review of this Allen County (except Cairo Chemical), CAA preparation of a flexibility analysis action must be filed in the United States Ashland County, Ashtabula County, would constitute Federal inquiry into Court of Appeals for the appropriate Athens County, Auglaize County, the economic reasonableness of state circuit by May 17, 1999. Filing a Belmont County, Brown County, Carroll action. The CAA forbids EPA to base its petition for reconsideration by the County, Champaign County, Clark actions on such grounds. Union Electric administrator of this final rule does not County, Clermont County, (except Co., v. U.S. EPA, 427 U.S. 246, 255–66 affect the finality of this rule for the Cincinnati Gas & Electric-Beckjord), (1976); 42 U.S.C. 7410(a)(2). purposes of judicial review nor does it Clinton County, Columbiana County, F. Unfunded Mandates extend the time within which a petition Coshocton County, (except Columbus & for judicial review may be filed, and Southern Ohio Electric-Conesville), Under section 202 of the Unfunded shall not postpone the effectiveness of Crawford County, Darke County, Mandates Reform Act of 1995 such rule or action. This action may not Defiance County, Delaware County, Erie (‘‘Unfunded Mandates Act’’), signed be challenged later in proceedings to County, Fairfield County, Fayette into law on March 22, 1995, EPA must enforce its requirements. (See section County, Fulton County, Gallia County prepare a budgetary impact statement to 307(b)(2).) (except Ohio Valley Electric Company- accompany any proposed or final rule Kyger Creek and Ohio Power-Gavin), List of Subjects that includes a Federal mandate that Geauga County, Greene County, may result in estimated annual cost to 40 CFR Part 52 Guernsey County, Hamilton County, State, local, or tribal governments in the Environmental protection, Air Hancock County, Hardin County, aggregate; or to private sector, of $100 Harrison County, Henry County, million or more. Under Section 205, pollution control, Incorporation by reference, Intergovernmental relations, Highland County, Hocking County, EPA must select the most cost-effective Holmes County, Huron County, Jackson and least burdensome alternative that Reporting and recordkeeping requirements, Sulfur dioxide. County, Jefferson County, Knox County, achieves the objectives of the rule and Lake County (except Painesville is consistent with statutory 40 CFR Part 81 Municipal Plant boiler number 5) , requirements. Section 203 requires EPA Air pollution control, National parks, Lawrence County (except Allied to establish a plan for informing and Wilderness areas. Chemical-South Point), Licking County, advising any small governments that Logan County, Lorain County (except Dated: February 26, 1999. may be significantly or uniquely Ohio Edison-Edgewater, Cleveland impacted by the rule. Jo Lynn Traub, Electric Illuminating-Avon Lake, U.S. The EPA has determined that the Acting Regional Administrator, Region 5. Steel-Lorain, and B.F. Goodrich), Lucas approval action promulgated does not For the reasons stated in the County (except Gulf Oil Company, include a Federal mandate that may preamble, chapter I, title 40 of the Code Coulton Chemical Company, Phillips result in estimated annual cost of $100 of Federal Regulations is amended as Chemical Company and Sun Oil million or more to either State, local, or follows: Company), Madison County, Marion tribal governments in the aggregate, or County, Medina County, Meigs County, to the private sector. This Federal action PART 52Ð[AMENDED] Mercer County, Miami County, Monroe approves pre-existing requirements 1. The authority citation for part 52 County, Morgan County, Montgomery under State or local law, and imposes continues to read as follows: County (except Bergstrom Paper, Miami no new requirements. Accordingly, no Paper, Bergstrom Paper, Morrow additional costs to State, local, or tribal Authority: 42 U.S.C. 7401 et seq. County, Muskingum County, Noble governments, or to the private sector, 2. Section 52.1870 is amended by County, Ottawa County, Paulding result from this action. adding (c)(118) to read as follows: County, Perry County, Pickaway

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County, Pike County (except Light-Stuart), Allen County (Cairo Company), and Wood County (Libbey- Portsmouth Gaseous Diffusion Plant), Chemical), Butler County, Clermont Owens-Ford Plants Nos. 4 and 8 and No. Portage County, Preble County, Putnam County (Cincinnati Gas & Electric- 6). County, Richland County, Ross County Beckjord), Coshocton County (Columbus * * * * * (except Mead Corporation), Sandusky & Southern Ohio Electric-Conesville), (13) In a letter dated October 26, 1995, County (except Martin Marietta Cuyahoga County, Franklin County, Ohio submitted a maintenance plan for Chemicals), Scioto County, Seneca Gallia County (Ohio Valley Electric sulfur dioxide in Lake and Jefferson Company-Kyger Creek, and Ohio Power- County, Shelby County, Trumbull Counties. Gavin), Lake County (Painesville County, Tuscarawas County, Union * * * * * County, Van Wert County, Vinton Municipal Plant boiler number 5), County, Warren County, Washington Lawrence County (Allied Chemical- PART 81Ð[AMENDED] County (except Shell Chemical), Wayne South Point), Lorain County (Ohio County, Williams County, Wood County Edison-Edgewater Plant, Cleveland 1. The authority citation for part 81 (except Libbey-Owens-Ford Plants Nos. Electric Illuminating Avon Lake, U.S. continues to read as follows: Steel-Lorain, and B.F. Goodrich), Lucas 4 and 8 and No. 6), and Wyandot Authority: 42 U.S.C. 7401 et seq. County. County (Gulf Oil Company, Coulton Chemical Company, Phillips Chemical Subpart K KÐOhio * * * * * Company and Sun Oil Company), (8) No Action-EPA is neither Mahoning County, Montgomery County 2. In § 81.336 the table entitled ‘‘Ohio approving nor disapproving the (Bergstrom Paper and Miami Paper), SO2’’ is revised to read as follows: emission limitations for the following Pike County (Portsmouth Gaseous counties on sources pending further Diffusion Plant), Stark County, § 81.336 Ohio. review: Adams County (Dayton Power & Washington County (Shell Chemical * * * * *

OHIOÐSO2

Does not Does not meet meet Cannot be Better than Designated area primary secondary classified national standards standards standards

Athens County ...... X Clermont County ...... X Columbiana County ...... X Coshocton County: Franklin Township ...... X1 The remainder of Coshocton County ...... X1 Cuyahoga County: The Cities of Bay Village, Westlake, North Olmsted, Olmsted Falls, Rock River, Fairview Park, Berea, Middleburg Hts., Strongsville, North Royalton, Broadview Hts., Brecksville and the Townships of Olmsted and Riveredge ...... X The remainder of Cuyahoga County ...... X Gallia County: Addison Township ...... X1 The remainder of Gallia County ...... X1 Greene County ...... X Hamilton County: The City of Cincinnati bounded on the west by 175 and U.S. Route 127, and on the south by the Ohio and Little Miami Rivers; the Cities of Norwood, Fairfax, Silverton, Golf Manor, Amberly, Deer Park, Arlington Heights, Elwood Place, and St. Bernard ...... X1 The remainder of Hamilton County ...... X1 Jefferson County: Cities of Steubenville & Mingo Junction, Townships of Steubenville, Island Creek, Cross Creek, Knox and Wells ...... X The remainder of Jefferson County ...... X1 Lake County: The Cities of Eastlake, Timberlake, Lakeline, Willoughby (north of U.S. 20), and Mentor (north of U.S. 20 west of S.R. 306) ...... X The remainder of Lake County ...... X Lorain County: Area bounded on the north by the Norfolk and Western Railroad Tracks, on the east by State Route 301 (Abbe Road), on the south by State Route 254, and on the west by Oberlin Road ...... X The remainder of Lorain County ...... X Lucas County: The area east of Rte. 23 & west of eastern boundary of Oregon Township ...... X1 The remainder of Lucas County ...... X1 Mahoning County ...... X Montgomery County ...... X Morgan County ...... X Center Township ...... X1 The remainder of Morgan County ...... X1 Summit County:

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OHIOÐSO2ÐContinued

Does not Does not meet meet Cannot be Better than Designated area primary secondary classified national standards standards standards

Area bounded by the following linesÐNorthÐInterstate 76, EastÐRoute 93, SouthÐVanderhoof Road, WestÐSummit County Line ...... X Area bounded by the following linesÐNorthÐBath Road (48 east to Route 8, Route 8 north to Barlow Road, Barlow Road east to county line, EastÐSum- mit/Portage County line, South Interstate 76 to Route 93, Route 93 south to Route 619, Route 619 east to County line, West-Summit/Medina County line ... 2 2 2 2 Entire area northwest of the following line Route 80 east to Route 91, Route 91 north to the County line ...... X3 The remainder of Summit County ...... X4 Trumbull County ...... X Washington County ...... X Waterford Township ...... X The remainder of Washington County ...... X All other counties in the State of Ohio ...... X1 1 EPA designation replaces State designation. 2 This area remains undesignated at this time as a result of a court remand in PPG Industries, Inc. vs. Costle, 630 F.2d 462 (6th Cir. 1980). 3 This area was affected by the Sixth Circuit Court remand but has since been designated. 4 The area was not affected by the court remand in PPG Industries, Inc. vs. Costle, 630 F.2d 462 (6th Cir. 1980).

[FR Doc. 99–6256 Filed 3–16–99; 8:45 am] Agency, Region III, 1650 Arch Street, rule, and as a result, it became effective BILLING CODE 6560±50±P Philadelphia, Pennsylvania 19103; and on August 17, 1998. Allegheny County Health Department, II. Response to Public Comments Bureau of Environmental Quality, ENVIRONMENTAL PROTECTION Division of Air Quality, 301 39th Street, During the public comment period AGENCY Pittsburgh, Pennsylvania 15201. offered on the approval of the Allegheny County MSW landfill 111(d) plan, EPA FOR FURTHER INFORMATION CONTACT: 40 CFR Part 62 received an adverse comment from James B. Topsale, P.E., at (215) 814– Browing-Ferris Industries, Inc. opposing [PA±107±4066c; FRL±6311±3] 2190, or by e-mail at approval of the Allegheny County [email protected]. Approval and Promulgation of State portion of the Commonwealth of Air Quality Plans for Designated SUPPLEMENTARY INFORMATION: Pennsylvania’s plan. The following Facilities and Pollutants; Allegheny I. Background paragraphs present the commenter’s County, Pennsylvania; Control of remarks and EPA’s responses. Landfill Gas Emissions from Existing On April 10, 1998 (63 FR 17683), EPA Comment: On May 12, 1998, the Municipal Solid Waste Landfills published a direct final rule for commenter noted that the effective date approval of the MSW landfill 111(d) specified in ‘‘Section G. Compliance AGENCY: Environmental Protection plan submitted by the PADEP on behalf Schedule’’ of the direct final rule can be Agency (EPA). of ACHD. EPA concurrently published a no sooner than the date of Federal ACTION: Final rule. proposed rule on April 10, 1998 (63 FR Register publication, April 10, 1998. 17793) to allow interested parties to The direct final rule states: ‘‘The final SUMMARY: EPA is approving a municipal submit comments. During the public compliance date and enforceable solid waste landfill (MSW) 111(d) plan comment period, EPA received one increments of progress under the 111(d) submitted by the Commonwealth of adverse comment from Browning-Ferrris plans are tied to the effective date of the Pennsylvania Department of Industries, Inc. As a result, EPA County’s MSW landfill regulation Environmental Protection (PADEP) on withdrew the direct final rule granting (Article XXI, section 2105.73).’’ The behalf of the Allegheny County Health approval of the MSW landfill 111(d) table ‘‘Reporting and Required Department (ACHD) for the purpose of plan for Allegheny County on June 18, Increments of Progress,’’ which appears controlling MSW landfill gas emissions 1998 (63 FR 33250). in Section G, indicates that the first from existing facilities. The plan was On June 16, 1998, EPA published in compliance/reporting deadline pursuant submitted to fulfill requirements of the the Federal Register (63 FR 32743) a to the emission guidelines (EG) is Clean Air Act (CAA). The Allegheny direct final action which amends, ‘‘Within 90 days of the effective date of County plan establishes landfill gas corrects errors, and clarifies the Article XXI Regulation*.’’ The footnote emissions limits for existing MSW regulatory text of the ‘‘Standards of (*) states that ‘‘The regulation became landfills, and provides for the Performance for New Stationary Sources effective on August 15, 1997.’’ implementation and enforcement of and Guidelines for Control of Existing According to the commenter, use of the those limits. Sources: Municipal Solid Waste state/county effective date to trigger EFFECTIVE DATE: This final rule is Landfills,’’ which was promulgated on subsequent requirements is inconsistent effective on April 16, 1999. March 12, 1996. The Background with previous EPA approvals under 40 ADDRESSES: Copies of the documents section of the amended rule (63 FR CFR Part 60, Subpart Cc, and with relevant to this action are available for 32744) states, ‘‘These changes do not proposed revisions to the landfill new public inspection during normal significantly modify the requirements of source performance standards/emission business hours at the Air Protection the regulation.’’ No adverse comments guidelines (NSPS/EG). Also, the Division, U.S. Environmental Protection were received on the amended landfill Pennsylvania Air Pollution Control Act

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(Section 4004.2(b)) prohibits the state submittal of the Allegheny County MSW III. Final Action from establishing more stringent landfill 111(d) plan to EPA. Based upon the rationale discussed in requirements than the federal Although the 111(d) plan increments the proposed and related direct final government. The commenter identified of progress are tied to the effective date rulemaking (63 FR 17793 and 17683, four EPA 111(d) plan approvals, of the County’s MSW landfill regulation, April 10, 1998), EPA is approving the excluding Allegheny County, to support the controlling date that triggers and Allegheny County portion of the his argument that the EG ‘‘effective defines the required increments of Pennsylvania MSW landfill 111(d) plan. date’’ is not established by the effective As provided by 40 CFR 60.28(c), any date of the state/local regulation. progress dates, from the time of submittal of the design plan to final revisions to the Allegheny County Furthermore, the commenter noted that portion of the plan or associated a Title V application should not be due source compliance, is the date when the NMOC emissions rate is first calculated regulations will not be considered part until one year plus 90 days from April of the applicable plan until submitted 10, 1998, and that installation/operation to exceed 50 Mg/yr. This is clearly noted in ‘‘Section G. Compliance by PADEP in accordance with 40 CFR of an EG compliant gas collection/ 60.28(a) or (b), as applicable, and until control system should not be required Schedule’’ of the direct final rule. approved by EPA . until three years plus ninety days from Nevertheless, the design capacity and April 10, 1998. To support his position, initial NMOC emission rate reports were IV. Administrative Requirements due within 90 days of the effective date the commenter referenced the pending A. Executive Orders 12866 amended EG provision, 40 CFR (i.e., August 15, 1997) of the Article XXI 60.32c(c), relating to Title V permits, Regulation. The Office of Management and Budget (OMB) has exempted this regulatory that was negotiated under the lawsuit EPA has been involved in litigation settlement over the MSW Landfill action from review under Executive over the requirements of the MSW Order (E.O.) 12866, entitled ‘‘Regulatory NSPS/EG [National Solid Waste landfill EG and NSPS since the summer Management Association v. Browner Planning and Review.’’ of 1996. On November 13, 1997, EPA No. 96–1152 (D.C. Cir)]. B. Executive Order 12875 EPA’s Response: It appears the issued a notice of proposed settlement commenter has misinterpreted the in National Solid Wastes Management Under E.O. 12875, EPA may not issue requirements of the EG, as amended, Association v. Browner No. 96–1152 a regulation that is not required by and EPA’s approval with respect to (D.C. Cir), in accordance with Section statute and that creates a mandate upon compliance schedule requirements for 113(g) of the Act. (See 62 FR 60898.) It a state, local, or tribal government, Allegheny County’s 111(d) plan is important to note that the proposed unless the Federal government provides landfills. Any ambiguity in the text of settlement did not vacate or void the the funds necessary to pay the direct the direct final rule published on April March 12, 1996 MSW landfill EG or compliance costs incurred by those 10, 1998 that may have caused NSPS. Pursuant to the proposed governments. If EPA complies by confusion should now be clarified with settlement agreement, EPA published a consulting, E.O. 12875 requires EPA to the discussion below. direct final rulemaking on June 16, provide to the Office of Management A state’s 111(d) plan must include a 1998, in which EPA amends 40 CFR and Budget a description of the extent compliance schedule that landfill Part 60, Subparts Cc and WWW, to add of EPA’s prior consultation with owners/operators must meet. Most clarifying language, make editorial representatives of affected state, local, states have proposed that the initial amendments, and to correct and tribal governments, the nature of design capacity and NMOC emissions typographical errors. One particular their concerns, copies of written rate report must be submitted 90 days clarification addresses the commenters communications from the governments, after EPA approval of their 111(d) plans. concern regarding the date when Title V and a statement supporting the need to The promulgated landfill EG require the applications are due. Specifically, issue the regulation. In addition, E.O. same reporting and record keeping as 60.32c(c), as amended, makes it clear 12875 requires EPA to develop an the related NSPS. However, the EG do that EG sources will not become subject effective process permitting elected not stipulate when the initial NMOC to the requirement to apply for a Title officials and other representatives of emissions and design capacity reports V permit until 90 days after the effective state, local, and tribal governments ‘‘to are due for existing landfills. Even if a date of EPA’s approval of a state’s provide meaningful and timely input in date were clearly specified in the EG, 111(d) plan. (See 63 FR 32743–32753, the development of regulatory proposals states can exercise their own judgement containing significant unfunded 32783–32784.) EPA regulations at 40 as to when the initial reporting mandates.’’ Today’s rule does not create CFR 60.23(a)(2) provide that a state has requirement must be met, providing the a mandate on state, local or tribal nine months to adopt and submit any requirement is no less stringent than governments. The rule does not impose necessary state plan revisions after that in the EG. EPA has no any enforceable duties on these entities. publication of a final revised emission documentation that the Allegheny Accordingly, the requirements of County landfill regulation violates any guideline document. Thus, states are not Section 1(a) of E.O. 12875 do not apply of the requirements of the Pennsylvania yet required to submit state plan to this rule. Air Pollution Control Act (Section revisions to address the June 16, 1998 4004.2(b)). Based on our review of the direct final amendments in the EG. In C. Executive Order 13045 public participation documents addition, as stated in the June 16, 1998 E.O. 13045, entitled ‘‘Protection of submitted with Allegheny County’s rule’s preamble, the changes to 40 CFR Children from Environmental Health 111(d) plan, the issues now raised by Part 60, Subparts Cc and WWW, do not Risks and Safety Risks’’ (62 FR 19885, the commenter in his May 12, 1998 significantly modify the requirements of April 23, 1997), applies to any rule that comments to EPA were not raised by those subparts. (See 63 FR 32744.) the EPA determines (1) is ‘‘economically that commenter, or anyone else, during Accordingly, the MSW landfill EG significant,’’ as defined under E.O. the 111(d) plan public comment period. published on March 12, 1996, was used 12866, and (2) the environmental health Furthermore, none of these comments or as a basis by EPA for review of state or safety risk addressed by the rule has concerns were identified in the PADEP 111(d) plan submittals. a disproportionate effect on children. If

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.039 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13077 the regulatory action meets both criteria, substantial number of small entities. this action to approve the Allegheny the Agency must evaluate the This Federal action approves pre- County portion of the Pennsylvania environmental health or safety effects of existing requirements under Federal, MSW landfill 111(d) plan must be filed the planned rule on children and State, or Local law and imposes no new in the United States Court of Appeals explain why the planned regulation is requirements on any entity affected by for the appropriate circuit by May 17, preferable to other potentially effective this rule, including small entities. 1999. Filing a petition for and reasonably feasible alternatives Therefore, these amendments will not reconsideration by the Administrator of considered by the Agency. This final have a significant impact on a this final rule does not affect the finality rule is not subject to E.O. 13045 because substantial number of small entities. of this rule for the purposes of judicial it is not an economically significant F. Unfunded Mandates review nor does it extend the time regulatory action as defined by E.O. within which a petition for judicial 12866, and it does not address an Under Section 202 of the Unfunded review may be filed, and shall not environmental health or safety risk that Mandates Reform Act of 1995 postpone the effectiveness of such rule would have a disproportionate effect on (‘‘Unfunded Mandates Act’’), signed or action. This action may not be children. into law on March 22, 1995, EPA must challenged later in proceedings to prepare a budgetary impact statement to D. Executive Order 13084 enforce its requirements. (See section accompany any proposed or final rule 307(b)(2).) Under E.O. 13084, EPA may not issue that includes a Federal mandate that a regulation that is not required by may result in estimated annual costs to List of Subjects in 40 CFR Part 62 statute, that significantly affects or State, local, or tribal governments in the Environmental protection, uniquely affects the communities of aggregate; or to a private sector, of $100 Administrative practice and procedure, Indian tribal governments, and that million or more. Under Section 205, Air pollution control, Intergovernmental imposes substantial direct compliance EPA must select the most cost-effective relations, Non-methane organic costs on those communities, unless the and least burdensome alternative that compounds, Methane, Municipal solid Federal government provides the funds achieves the objectives of the rule and waste landfills, Hydrocarbons, necessary to pay the direct compliance is consistent with statutory Reporting and record keeping costs incurred by the tribal requirements. Section 203 requires EPA requirement. governments. If EPA complies by to establish a plan for informing and consulting, E.O. 13084 requires EPA to advising any small governments that Dated: March 9, 1999. provide to the Office of Management may be significantly or uniquely Thomas Voltaggio, and Budget, in a separately identified impacted by the rule. EPA has Acting, Regional Administratopr, Region III. section of the preamble to the rule, a determined that the approval action description of the extent of EPA’s prior promulgated does not include a Federal 40 CFR Part 62, Subpart NN, is consultation with representatives of mandate that may result in estimated amended as follows: affected tribal governments, a summary annual costs of $100 million or more to PART 62Ð[AMENDED] of the nature of their concerns, and a either State, local, or tribal governments statement supporting the need to issue in the aggregate, or to the private sector. 1. The authority citation for Part 62 the regulation. In addition, E.O. 13084 This Federal action approves pre- continues to read as follows: requires EPA to develop an effective existing requirements under State or Authority: 42 U.S.C. 7401–7671q. process permitting elected and other local law, and imposes no new representatives of Indian tribal requirements. Accordingly, no Subpart NNÐPennsylvania governments ‘‘to provide meaningful additional costs to State, local, or tribal and timely input in the development of governments, or to the private sector, 2. Subpart NN is amended by adding regulatory policies on matters that result from this action. a new center heading and §§ 62.9630, significantly or uniquely affect their 62.9631, and 62.9632 to read as follows: communities.’’ Today’s rule does not G. Submission to Congress and the significantly or uniquely affect the Comptroller General Landfill Gas Emissions From Existing communities of Indian tribal The Congressional Review Act, 5 Municipal Solid Waste Landfills governments. This action does not U.S.C. 801 et seq., as added by the Small (Section 111(d) Plan) involve or impose any requirements that Business Regulatory Enforcement § 62.9630 Identification of plan. affect Indian Tribes. Accordingly, the Fairness Act of 1996, generally provides requirements of section 3(b) of E.O. that before a rule may take effect, the Section 111(d) plan for municipal 13084 do not apply to this rule. agency promulgating the rule must solid waste landfills and the associated submit a rule report, which includes a Allegheny County Health Department E. Regulatory Flexibility Act copy of the rule, to each House of the Regulation in Article XXI, § 2105.73, as The Regulatory Flexibility Act (RFA) Congress and to the Comptroller General submitted on October 23, 1997, by the generally requires an agency to conduct of the United States. EPA will submit a Commonwealth of Pennsylvania. a regulatory flexibility analysis of any report containing this rule and other § 62.9631 Identification of sources. rule subject to notice and comment required information to the U.S. Senate, rulemaking requirements unless the the U.S. House of Representatives, and The plan applies to all Allegheny agency certifies that the rule will not the Comptroller General of the United County, Pennsylvania, existing have a significant economic impact on States prior to publication of the rule in municipal solid waste landfills for a substantial number of small entities. the Federal Register. This rule is not a which construction, reconstruction, or Small entities include small businesses, ‘‘major rule’’ as defined by 5 U.S.C. modification was commenced before small not-for-profit enterprises, and 804(2). May 30, 1991 and that has accepted small governmental jurisdictions. waste at any time since November 8, Pursuant to section 605 (b) of the RFA H. Petitions for Judicial Review 1987 or that has additional capacity I certify that this rule will not have a Under section 307(b)(1) of the Clean available for future waste deposition, as significant economic impact on a Air Act, petitions for judicial review of described in 40 CFR part 60, subpart Cc.

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§ 62.9632 Effective date. must be submitted to: Hearing Clerk 346a(e) announcing the filing of a The effective date of the plan for (1900), Environmental Protection pesticide tolerance petition by municipal solid waste landfills is April Agency, Rm. M3708, 401 M St., SW., Monsanto Company, St. Louis, 16, 1999. Washington, DC 20460. Fees Missouri. This notice included a [FR Doc. 99–6500 Filed 3–16–99; 8:45 am] accompanying objections and hearing summary of the petition prepared by the requests shall be labeled ‘‘Tolerance petitioner and this summary contained BILLING CODE 6560±50±U Petition Fees’’ and forwarded to: EPA conclusions and arguments to support Headquarters Accounting Operations its conclusion that the petition ENVIRONMENTAL PROTECTION Branch, OPP (Tolerance Fees) and complied with the Food Quality AGENCY forwarded to: EPA Headquarters Protection Act (FQPA) of 1996. The Accounting Operations Branch, OPP petition requested that 40 CFR part 180 40 CFR Part 180 (Tolerance Fees), P.O. Box 360277M, be amended by establishing an Pittsburgh, PA 15251. A copy of any exemption from the requirement of a [OPP±300530A; FRL±6052±3] objections and hearing requests filed tolerance for residues of the biological RIN 2070±AB78 with the Hearing Clerk identified by the pest control agent Replicase Protein of docket control number, [OPP–00530A], Potato Leaf Roll Virus and the genetic Potato Leaf Roll Virus Resistance must also be submitted to: Public material necessary for it’s production in Gene (also known as orf1/orf2 gene); Information and Records Integrity or on all food commodities. EPA Exemption from the Requirement of a Branch, Information Resources and published a final rule establishing a Tolerance Services Division (7502C), Office of tolerance exemption in the Federal AGENCY: Environmental Protection Pesticide Programs, Environmental Register on August 15, 1997 (62 FR Agency (EPA). Protection Agency, 401 M St., SW., 43650) (FRL–5738–3) amending 40 CFR Washington, DC 20460. In person, bring ACTION: Final rule; Technical 180.1183. An amendment to this a copy of objections and hearing amendment. petition and thus the final rule requests to Rm. 119, Crystal Mall #2, establishing a tolerance exemption, was SUMMARY: EPA is issuing a technical 1921 Jefferson Davis Hwy., Arlington, requested by Monsanto Company to amendment to a tolerance exemption it VA. change the name of the active ingredient published in the Federal Register on A copy of objections and hearing from the above to Potato Leaf Roll Virus August 15, 1997 (62 FR 43650). This requests filed with the Hearing Clerk Resistance Gene (also known as orf1/ technical amendment changes the name may be submitted electronically by orf2 gene) and the genetic material of the active ingredient from ‘‘Replicase sending electronic mail (e-mail) to: opp- necessary for it’s production. This Protein of Potato Leaf Roll Virus and the [email protected]. Copies of request came at the suggestion of the genetic material necessary for it’s electronic objections and hearing Agency as a result of the review of data production’’ to ‘‘Potato Leaf Roll Virus requests must be submitted as an ASCII which indicated that the former active Resistance Gene (also known as orf1/ file avoiding the use of special ingredient, ‘‘Replicase Protein of Potato orf2 gene) and the genetic material characters and any form of encryption. leaf Roll Virus and the genetic material necessary for it’s production.’’ This Copies of electronic objections and necessary for it’s production,’’ was not action is requested by Monsanto hearing requests will also be accepted solely responsible for providing the Company, who originally filed the on disks in WordPerfect 5.1/6.1 file plant with it’s pesticidal properties (i.e., pesticide petition requesting an format or ASCII file format. All copies resistance to infection by the Potato Leaf exemption from the requirement of a of electronic objections and hearing Roll Virus). A change in the name of the tolerance for residues of the biological requests must be identified by the active ingredient will in no way amend pest control agent under the name docket number [OPP–300530A]. No the text of the original petition or EPA’s ‘‘Replicase Protein of Potato Leaf Roll Confidential Business Information (CBI) findings, conclusions or determinations Virus and the genetic material necessary should be submitted through e-mail. as described in the August 15, 1997 for it’s production.’’ The change was Copies of electronic objections and Final Rule (62 FR 43650). Additionally, suggested by the Agency as a result of hearing requests on this rule may be a change in the name of the active the review of data which indicated that filed online at many Federal Depository ingredient does not affect and/or the former active ingredient, Replicase Libraries. compromise the Agency’s original Protein of Potato Leaf Roll Virus and the FOR FURTHER INFORMATION CONTACT: By dietary risk exposure assessment which genetic material necessary for it’s mail: Linda Hollis, Product Manager concluded that the active ingredient production, was not solely responsible (PM) 90, Biopesticides and Pollution posed no dietary risk of concern under for providing the plant product with its’ Prevention Division (7511C), normal conditions. Therefore, this pesticidal properties (i.e., resistance to Environmental Protection Agency, 401 technical amendment only changes in infection by the Potato Leaf Roll Virus). M St., SW., Washington, DC 20460. the name of the active ingredient. All Changing the active ingredient name in Office location, telephone number and other text remains the same as in the no way changes the findings, e-mail address: 9th fl., Crystal Mall #2 final rule of August 15, 1997 (62 FR determinations, or effects of the 1921 Jefferson Davis Hwy., Arlington, 43650) which amended 40 CFR originally issued final rule published in VA 22202, (703)308-8733. e-mail: 180.1183. For the reasons set forth the Federal Register of August 15, 1997 [email protected]. above, EPA believes that it is approprate (62 FR 43650). SUPPLEMENTARY INFORMATION: to issue this rule as a technical DATES: This regulation is effective amendment. Because this amendment March 17, 1999. Objections and requests I. Background makes a minor corrective change to an for hearings must be received by EPA on In the Federal Register of June 25, existing regulation and has no or before May 17, 1999. 1997 (62 FR 34283-34286) (FRL–5728– substantive impact, EPA has determined ADDRESSES: Written objections and 4), EPA issued a notice pursuant to that good cause exists to dispense with hearing requests, identified by the section 408 of the Federal Food, Drug, the notice and comment provisions of docket control number [OPP–300530A], and Cosmetic Act (FFDCA), 21 U.S.C. the Administrative Procedure Act (APA)

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.043 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13079 pursuant to 5 U.S.C. 553(b)(B). Section would, if established resolve one or Federal Regulations (CFR). As such, this 408 of the FFDCA provides that the more of such issues in favor of the action does not require review by the Administrator, before issuing a requestor, taking into account Office of Management and Budget comment unless the Administrator for uncontested claims or facts to the (OMB) under Executive order 12866, good cause finds that it would be in the contrary; and resolution of the factual entitled Regulatory Planning and public interest to provide a shorter issues(s) in the manner sought by the Review (58 FR 51735, October 4, 1993), period. EPA has determined that there requestor would be adequate to justify the Paperwork Reduction Act (PRA), 44 is good cause for making today’s rule the action requested (40 CFR 178.32). U.S.C. 3501., or Executive Order 13045, final without prior proposal and Information submitted in connection entitled Protection of Children from opportunity for comment because EPA with an objection or hearing request Environmental Health Risks and Safety is merely correcting the name of a may be claimed confidential by marking Risks (62 FR 19885, April 23, 1991). chemical for which a tolerance any part or all of that information as This action does not impose any exemption has already been issued. CBI. Information so marked will not be enforceable duty, contain any unfunded Thus, notice and public procedure are disclosed except in accordance with mandate, or impose any significant or unnecessary. The Agency finds that this procedures set forth in 40 CFR part 2. unique impact on small governments as constitutes good cause under section A copy of the information that does not described in the Unfunded Mandates 408(e)(2). Under section 408(g)(1) of the contain CBI must be submitted for Reform Act of 1995 (UMRA) (Pub. L. FFDCA, today’s rule is effective upon inclusion in the public record. 104–4). Nor does it require prior publication. Information not marked confidential consultation with State, local, and tribal may be disclosed publicly by EPA government officials as specified by II. Objections and Hearing Requests without prior notice. Executive Order 12875, entitled The new FFDCA section 408(g) Enhancing the Intergovernmental III. Public Record and Electronic provides essentially the same process Partnership (58 FR 58093, October 28, Submissions for persons to ‘‘object’’ to a regulation 1993) and Executive Order 13084, for an exemption from the requirement EPA has established a record for this entitled Consultation and Coordination of a tolerance issued by EPA under new rulemaking under docket control with Indian Tribal Governments (63 FR section 408(d)and as was provided in number [OPP-300530A]. A public 27655, May 19, 1998), or special the old section 408 and in section 409. version of this record, including consideration of environmental justice However, the period for filing objections printed, paper versions of electronic related issues under Executive Order is 60 days, rather than 30 days. EPA comments, which does not include any 12898, entitled Federal Actions to currently has procedural regulations information claimed as CBI, is available Address Environmental Justice in which governs the submission of for inspection from 8:30 a.m. to 4 p.m., Minority Populations and Low-Income objections and hearing requests. These Monday through Friday, excluding legal Populations (59 FR 7629, February 16, regulations will require some holidays. The public record is located in 1994). This action does not involve any modification to reflect the new law. Room 119 of the Public Information and technical standards that would require However, until those modifications can Records Integrity Branch, Information Agency consideration of voluntary be made, EPA will continue to use those Resources and Services Division consensus standards pursuant to section procedural regulations with appropriate (7502C), Office of Pesticide Programs, 12(d) of the National Technology adjustments to reflect the new law. Environmental Protection Agency, Transfer and Advancement Act of 1995 Any person may, by May 17, 1999, Crystal Mall #2, 1921 Jefferson Davis (NTTAA), Pub. L. 104-113, section 12(d) file written objections to any aspect of Hwy., Arlington, VA 22202. (15 U.S.C. 272 note). In addition, since this regulation and may also request a Electronic comments can be sent this action is not subject to notice-and- hearing on those objections. Objections directly to EPA at: comment requirements under the and hearing requests must be filed with [email protected] Administrative Procedure Act (APA) or the Hearing Clerk, at the address given any other statute, it is not subject to the under the ‘‘ADDRESSES’’ section (40 Electronic comments must be regulatory flexibility provisions of the CFR 178.20). A copy of the objections submitted as an ASCII file avoiding the Regulatory Flexibility Act (RFA) (5 and/or hearing requests filed with the use of special characters and any form U.S.C. 601 et seq.) hearing clerk should be submitted to the of encryption. OPP docket for this rulemaking. The The official record for this V. Submission to Congress and the objections submitted must specify the rulemaking, as well as the public Comptroller General provisions of the regulation deemed version, as described above, is kept in The Congressional Review Act, 5 objectionable and the grounds for the paper form. Accordingly, in the event U.S.C. 801 et seq., as added by the Small objections (40 CFR 178.25). Each there are objections and hearing request, Business Regulatory Enforcement objection must be accompanied by the EPA will transfer any copies of Fairness Act of 1996, generally provides fee prescribed by 40 CFR 180.33(i). If a objections and hearing requests received that before a rule may take effect, the hearing is requested, the objections electronically into printed, paper form agency promulgating the rule must must include a statement of the factual as they are received and will place the submit a rule report, which includes a issues(s) on which a hearing is paper copies in the official rulemaking copy of the rule, to each House of the requested, the requestor’s contentions record. The official rulemaking record is Congress and to the Comptroller General on such issues, and a summary of any the paper record maintained at the of the United States. Section 808 allows evidence relied upon by the objector (40 Virginia address in ‘‘ADDRESSES’’ at the issuing agency to make a good cause CFR 178.27). A request for a hearing the beginning of this document. finding that notice and public will be granted if the Administrator determinations must be supported by a determines that the material submitted IV. Regulatory Assessment brief statement 5 U.S.C. 808(2). EPA has shows the following: There is a genuine Requirements made such a good cause finding for this and substantial issue of fact; there is a This final rule does not impose any final rule, and established an effective reasonable possibility that available new requirements. It only implements a date of March 17, 1999. Pursuant to 5 evidence identified by the requestor technical correction to the Code of U.S.C 808(2), this determination is

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.011 pfrm07 PsN: 17MRR1 13080 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations supported by the brief statement in Unit metabolites determined as 2,4- Crystal Mall #2, 1921 Jefferson Davis I. of this preamble. EPA will submit a dichlorobenzoic acid and expressed as Hwy., Arlington, VA, (703) 308–9354, report containing this rule and other parent compound in or on corn, peanuts [email protected]. required information to the U.S. Senate, and pineapples. Novartis Crop SUPPLEMENTARY INFORMATION: In the the U.S. House of Representatives and Protection, Inc. requested these Federal Register of November 20, 1998 the Comptroller General of the United tolerances under the Federal Food, (63 FR 64498) (FRL–6042–1), EPA States prior to publication of the rule in Drug, and Cosmetic Act, as amended by issued a notice pursuant to section 408 the Federal Register. This is not a the Food Quality Protection Act of 1996. of the Federal Food, Drug, and Cosmetic ‘‘major rule’’ as defined by 5 U.S.C. The tolerances will expire on December Act (FFDCA), 21 U.S.C. 346a, as 804(2). 31, 2000. amended by the Food Quality Protection DATES: This regulation is effective Act of 1996 (FQPA) (Pub. L. 104–170) List of Subjects in 40 CFR Part 180 March 17, 1999. Objections and requests announcing the filing of pesticide Environmental protection, for hearings must be received by EPA on petitions (PP) for tolerances by Novartis Administrative practice and procedure, or before May 17, 1999. Crop Protection, Inc., P.O. Box 18300, Agricultural commodities, pesticides ADDRESSES: Written objections and Greensboro, NC 27419. This notice and pests, Reporting and recordkeeping hearing requests, identified by the included a summary of the petitions requirements. docket control number [OPP–300810], prepared by Novartis Crop Protection, must be submitted to: Hearing Clerk Inc., the registrant. There were no Dated: March 2, 1999. (1900), Environmental Protection comments received in response to the Janet L. Andersen, Agency, Rm. M3708, 401 M St., SW., notice of filing. Director, Biopesticides and Pollution Washington, DC 20460. Fees The petitions requested that 40 CFR Prevention Division, Office of Pesticide accompanying objections and hearing 180.434 be amended by establishing Programs. requests shall be labeled ‘‘Tolerance time-limited tolerances for combined Therefore, 40 CFR chapter I is Petition Fees’’ and forwarded to: EPA residues of the fungicide propiconazole, amended as follows: Headquarters Accounting Operations 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3- Branch, OPP (Tolerance Fees), P.O. Box dioxolan-2-yl]methyl]-1H-1,2,4-triazole PART 180Ð [AMENDED] 360277M, Pittsburgh, PA 15251. A copy and its metabolites determined as 2,4- of any objections and hearing requests dichlorobenzoic acid and expressed as 1. The authority citation for part 180 filed with the Hearing Clerk identified parent compound on corn, fodder at 12 continues to read as follows: by the docket control number, [OPP– parts per million (ppm); corn, forage at Authority: 21 U.S.C. 321(q), 346a and 371. 300810, must also be submitted to: 12 ppm; corn, grain at 0.1 ppm; corn, 2. Section 180.1183 is revised to read Public Information and Records sweet (kernels plus cobs with husks as follows: Integrity Branch, Information Resources removed) at 0.1 ppm; peanuts at 0.2 and Services Division (7502C), Office of ppm; peanuts, hay at 20 ppm; pineapple § 180.1183 Potato Leaf Roll Virus Pesticide Programs, Environmental at 0.1 ppm and pineapple, fodder at 0.1 Resistance Gene (also known as orf1/orf2 Protection Agency, 401 M St., SW., ppm. These proposed tolerances will gene) and the genetic material necessary for it's production; Exemption from the Washington, DC 20460. In person, bring expire on December 31, 2000 and will requirement of a tolerance. a copy of objections and hearing replace previously established requests to Rm. 119, Crystal Mall #2, tolerances which expired on December An exemption from the requirement 1921 Jefferson Davis Hwy., Arlington, 31, 1998. of a tolerance is established for residues VA. of the biological plant pesticide Potato A copy of objections and hearing I. Background and Statutory Findings Leaf Roll Virus Resistance Gene (also requests filed with the Hearing Clerk Section 408(b)(2)(A)(i) of the FFDCA known as orf1/orf2 gene) and the may also be submitted electronically by allows EPA to establish a tolerance (the genetic material necessary for its sending electronic mail (e-mail) to: opp- legal limit for a pesticide chemical production. [email protected]. Copies of electronic residue in or on a food) only if EPA [FR Doc. 99–6176 Filed 3–16–99; 8:45 am] objections and hearing requests must be determines that the tolerance is ‘‘safe.’’ BILLING CODE 6560±50±F submitted as an ASCII file avoiding the Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to use of special characters and any form mean that ‘‘there is a reasonable of encryption. Copies of objections and certainty that no harm will result from ENVIRONMENTAL PROTECTION hearing requests will also be accepted aggregate exposure to the pesticide AGENCY on disks in WordPerfect 5.1/6.1 or chemical residue, including all ASCII file format. All copies of anticipated dietary exposures and all 40 CFR Part 180 electronic objections and hearing other exposures for which there is [OPP±300810; FRL±6068±4] requests must be identified by the reliable information.’’ This includes docket control number [OPP–300810]. exposure through drinking water and in RIN 2070±AB78 No Confidential Business Information residential settings, but does not include (CBI) should be submitted through e- occupational exposure. Section Propiconazole; Establishment of Time- mail. Copies of electronic objections and 408(b)(2)(C) requires EPA to give special Limited Pesticide Tolerances hearing requests on this rule may be consideration to exposure of infants and AGENCY: Environmental Protection filed online at many Federal Depository children to the pesticide chemical Agency (EPA). Libraries. residue in establishing a tolerance and ACTION: Final rule. FOR FURTHER INFORMATION CONTACT: By to ‘‘ensure that there is a reasonable mail: Mary L. Waller, Registration certainty that no harm will result to SUMMARY: This regulation establishes Division (7505C), Office of Pesticide infants and children from aggregate time-limited tolerances for combined Programs, Environmental Protection exposure to the pesticide chemical residues of propiconazole, 1-[[2-(2,4- Agency, 401 M St., SW., Washington, residue. . . .’’ dichlorophenyl)-4-propyl-1,3-dioxolan- DC 20460. Office location, telephone EPA performs a number of analyses to 2-yl]methyl]-1H-1,2,4-triazole, and its number, and e-mail address: Rm. 249, determine the risks from aggregate

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.011 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13081 exposure to pesticide residues. For unossified sternebrae, and nominally in males. There was a statistically further discussion of the regulatory increased rudimentary ribs, and significant increase in combined requirements of section 408 and a shortened or absent renal papillae. The adenomas and carcinomas of the liver in complete description of the risk maternal NOAEL was 30 mg/kg/day and male mice at the 2,500 ppm level assessment process, see the final rule on the maternal LOAEL was 90 mg/kg/day (equivalent to 375 mg/kg/day). Bifenthrin Pesticide Tolerances (62 FR based on reduced body weight gain and 9. A battery of mutagenicity studies to 62961, November 26, 1997) (FRL–5754– occurrence of rales in 1/24 females. determine the potential of 7). 3. A developmental toxicity study propiconazole to induce gene mutation, with rabbits which were gavaged with chromosomal aberrations, and other II. Aggregate Risk Assessment and doses of 0, 30, 90, or 180 mg/kg/day genotoxic effects were all negative. Determination of Safety with no evidence of maternal or Consistent with section 408(b)(2)(D), developmental toxicity observed under B. Toxicological Endpoints EPA has reviewed the available the conditions of the study. 1. Acute toxicity. The acute reference scientific data and other relevant 4. A developmental toxicity study dose (RfD) is 0.3 mg/kg/day based on information in support of this action. with rabbits which were gavaged with the NOAEL of 30 mg/kg/day from a EPA has sufficient data to assess the doses of 0, 100, 250, or 400 mg/kg/day developmental toxicity study in rats and hazards of propiconazole and to make a on gestation days 7 through 19 with no using an uncertainty factor (UF) of 100. determination on aggregate exposure, developmental toxicity observed under 2. Short- and intermediate-term consistent with section 408(b)(2), for the conditions of the study. The toxicity. For short- and intermediate- time-limited tolerances for combined maternal NOAEL was 100 mg/kg/day term dermal margin of exposure (MOE) residues of propiconazole, 1-[[2-(2,4- and the maternal LOAEL was 250 mg/ calculations, the developmental NOAEL dichlorophenyl)-4-propyl-1,3-dioxolan- kg/day based on decreased food of 30 mg/kg/day from a developmental 2-yl]methyl]-1H-1,2,4-triazole and its consumption, weight gain, and an toxicity study in rats was selected. For metabolites determined as 2,4- increase in the number of resorptions at short- and intermediate-term inhalation dichlorobenzoic acid and expressed as the higher dose levels. The MOE calculations the NOAEL of 92.8 parent compound on corn, fodder at 12 developmental NOAEL was 400 mg/kg/ mg/kg/day (0.5 mg/L), the highest dose parts per million (ppm); corn, forage at day. tested, from a 5–day inhalation toxicity 12 ppm; corn, grain at 0.1 ppm; corn, 5. A 2-generation reproduction study study was selected. sweet (kernels plus cobs with husks with rats fed diets containing 0, 1, 100, 3. Chronic toxicity. EPA has removed) at 0.1 ppm; peanuts at 0.2 500 or 2,500 ppm showed no established the RfD for propiconazole at ppm; peanuts, hay at 20 ppm; pineapple reproductive effects under the 0.013 milligrams/kilogram/day (mg/kg/ at 0.1 ppm and pineapple, fodder at 0.1 conditions of the study. The day). This RfD is based on a 1–year ppm. EPA’s assessment of the dietary developmental NOAEL was 500 ppm feeding study in dogs with a NOAEL of exposures and risks associated with (equivalent to 25 mg/kg/day), and the 1.25 mg/kg/day and an uncertainty establishing the tolerances follows. developmental LOAEL was 2,500 ppm factor of 100. The LOAEL of 6.25 mg/ (equivalent to 125 mg/kg/day) based on kg/day was based on mild irritation of A. Toxicological Profile decreased offspring survival, body the gastric mucosa. EPA has evaluated the available weight depression, and increased 4. Carcinogenicity. Propiconazole has toxicity data and considered its validity, incidence of hepatic lesions in rats. The been classified as a Group C, ‘‘possible completeness, and reliability as well as parental NOAEL was 100 ppm human carcinogen’’, chemical. The the relationship of the results of the (equivalent to 5 mg/kg/day) and the Cancer Peer Review Committee studies to human risk. EPA has also parental LOAEL was 500 ppm recommended using the RfD approach considered available information (equivalent to 25 mg/kg/day) based on for quantification of human risk. concerning the variability of the increased incidence of hepatic cell C. Exposures and Risks sensitivities of major identifiable change. subgroups of consumers, including 6. A 1–year feeding study with dogs 1. From food and feed uses. infants and children. The nature of the fed diets containing 0, 5, 50, or 250 ppm Tolerances have been established (40 toxic effects caused by propiconazole with a NOAEL of 50 ppm (equivalent to CFR 180.434) for the combined residues are discussed in this unit. 1.25 mg/kg/day). The LOAEL was 250 of propiconazole, 1-[[2-(2,4- 1. Acute toxicity data were as follows: ppm (equivalent to 6.25 mg/kg/day dichlorophenyl)-4-propyl-1,3-dioxolan- acute oral LD50 = 1,517 m/kg (toxicity based on mild irritation of stomach 2-yl]methyl]-1H-1,2,4-triazole and its category III); acute dermal LD50 > 4,000 mucosa. metabolites determined as 2,4- mg/kg (toxicity category III); acute 7. A 2–year chronic feeding/ dichlorobenzoic acid and expressed as inhalation LC50 = 1.26 mg/L; primary carcinogenicity study with rats fed diets parent compound, in or on a variety of eye irritation - clear by 72 hours containing 0, 100, 500, or 2,500 ppm raw agricultural commodities. Among (toxicity category III); primary skin with a systemic NOAEL of 100 ppm these tolerances are stone fruits, various irritation - slight irritation (toxicity (equivalent to 5 mg/kg/day) based on grain crops, grass, bananas, celery, category IV); and dermal sensitization - hepatocyte changes in males at the 500 mushrooms and pecans. Tolerances negative. ppm level and in both sexes at the 2,500 have also been established for meat, 2. A developmental toxicity study ppm level. There were no carcinogenic milk, poultry and eggs. Risk assessments with rats which were gavaged with effects observed under the conditions of were conducted by EPA to assess doses of 0, 30, 90 or 360/300 mg/kg/day. the study. dietary exposure from propiconazole as The developmental no observed adverse 8. A 2–year chronic feeding/ follows: effect level (NOAEL) was 30 mg/kg/day. carcinogenicity study with mice fed Section 408(b)(2)(E) authorizes EPA to Evidence of developmental toxicity diets containing 0, 100, 500, or 2,500 use available data and information on observed at the 90 mg/kg/day level ppm with a systemic NOAEL of 100 the anticipated residue levels of lowest observed adverse effect level ppm (equivalent to 15 mg/kg/day) based pesticide residues in food and the actual (LOAEL) included statistically on decreased body weight, and levels of pesticide chemicals that have significant increased incidence of increased liver lesions and liver weight been measured in food. If EPA relies on

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.012 pfrm07 PsN: 17MRR1 13082 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations such information, EPA must require that propiconazole may be applied in a dietary risk (food only) does not exceed data be provided 5 years after the particular area. the Agency’s level of concern. tolerance is established, modified, or The Agency used percent of crop 2. From drinking water. In the absence left in effect, demonstrating that the treated (PCT) information as follows: of reliable, available monitoring data, levels in food are not above the levels The percent crop treated data used in EPA uses models to estimate anticipated. Following the initial data the risk estimates for propiconazole for concentrations of pesticides in ground submission, EPA is authorized to the crops for which tolerances are being and surface water. For propiconazole, require similar data on a time frame it established are: corn, 6%; pineapples, modeling data were used to estimate deems appropriate. As required by 100%; and peanuts, 1%. Percent crop surface water concentrations because section 408(b)(2)(E), EPA will issue a treated data was used in determinations very limited surface water monitoring data call-in for information relating to for several crops for which tolerances data were available. EPA does not use anticipated residues to be submitted no are already established (pecans, these model estimates to quantify risk. later than 5 years from the date of peaches, rice, rye and wheat). Currently, EPA uses drinking water issuance of this tolerance. i. Acute exposure and risk. Acute levels of comparison (DWLOCs) to Section 408(b)(2)(F) states that the dietary risk assessments are performed estimate risk associated with exposure Agency may use data on the actual for a food-use pesticide if a toxicological to pesticides in drinking water. A percent of food treated for assessing study has indicated the possibility of an DWLOC is the concentration of a chronic dietary risk only if the Agency effect of concern occurring as a result of pesticide in drinking water that would can make the following findings: That a 1–day or single exposure. The acute be acceptable as an upper limit in light the data used are reliable and provide a dietary (food only) risk assessment used of total aggregate exposure to that valid basis to show what percentage of the theoretical maximum residue pesticide from food, water, and the food derived from such crop is contribution (TMRC), individual food residential uses. A DWLOC will vary likely to contain such pesticide residue; consumption data as reported in the depending on the residue level in foods, that the exposure estimate does not USDA Nationwide Food Consumption the toxicity endpoint and with drinking underestimate exposure for any Survey (NFCS) which accumulates water consumption patterns and body significant population subgroup; and if exposure to propiconazole from each weights for specific population data are available on pesticide use and commodity, and the assumption that subgroups. EPA believes model food consumption in a particular area, 100% of the crops were treated with estimates to be overestimations of the exposure estimate does not propiconazole. This risk assessment concentrations of propiconazole understate exposure for the population used high-end exposure estimates and expected in drinking water. in such area. In addition, the Agency should be viewed as a conservative risk Propiconazole is moderately persistent must provide for periodic evaluation of assessment which overestimates the and moderately mobile to immobile in any estimates used. To provide for the risk. The acute dietary exposure for the soil and aqueous environments. It has periodic evaluation of the estimate of only population subgroup of concern, the potential to be transported with percent of crop treated as required by females 13 years and older, used 3.3% water, particularly in coarse-textured the section 408(b)(2)(F), EPA may of the acute RfD of 0.3 mg/kg/day. The soils low in organic matter. require registrants to submit data on acute dietary risk (food only) does not Propiconazole’s persistence indicates percent of crop treated. exceed the Agency’s level of concern. the potential to reach surface water with Percent of crop treated estimates are ii. Chronic exposure and risk. The run-off or adsorb to soil particles. There derived from Federal and private market chronic dietary risk assessment used the is no established Maximum survey data, which are reliable and have RfD of 0.013 mg/kg/day. EPA used data Contaminant Level for residues of a valid basis. Typically, a range of from the USDA NFCS, and made partial propiconazole in drinking water. No estimates are supplied and the upper refinements to the exposure health advisory levels for propiconazole end of this range is assumed for assumptions. Tolerance level residues in drinking water have been established. exposure assessment. By using this were used for corn, pineapples and i. Acute exposure and risk. The acute upper end estimate of percent of crop peanuts. Percent of crop treated DWLOC is 8,700 µg/L for the only treated, the Agency is reasonably certain estimates were made for corn (6%), population subgroup of concern, that the percentage of the food treated pineapple (100%) and peanuts (1%). females 13 years old or older. The is not likely to be an underestimated. For some of the other crops included in estimated environmental concentration Regional consumption information and the analysis, anticipated residue levels (EEC) in surface water (0.11 µg/L, peak consumption information for significant and percent crop treated estimates were value) is much lower than EPA’s population subgroups is taken into used. The existing propiconazole DWLOC of 8,700 µg/L for the population account through EPA’s computer-based tolerances (published and pending, subgroup, females 13 years old or older. model for evaluating the exposure of including tolerances for emergency Therefore, EPA concludes with significant population subgroups exemptions) resulted in exposure reasonable certainty that exposure to including several regional groups. Use estimates that are equivalent to the propiconazole in drinking water will of this consumption information in following percentages of the RfD: U.S. result in no harm. EPA’s risk assessment process ensures population (48 states), 7%; non-nursing ii. Chronic exposure and risk. The that EPA’s exposure estimate does not infants less than 1 year old, 20%; chronic DWLOC is 100 µg/L for the understate exposure for any significant children 1-6 years old, 13%; children 7- population subgroup with the lowest subpopulation group and allows the 12 years old, 9%; all other subgroups, 6- chronic DWLOC (non-nursing infants < Agency to be reasonably certain that no 9%. EPA generally has no concern for 1 year old). The lowest chronic DWLOC regional population is exposed to exposures below 100% of the chronic is substantially higher than the Generic residue levels higher than those RfD (when the FQPA factor has been Expected Environmental Concentration estimated by the Agency. Other than the removed) because this RfD represents (GENEEC) 56-day EEC of 0.09 µg/L. data available through national food the level at or below which daily Therefore, EPA concludes with consumption surveys, EPA does not aggregate dietary exposure over a reasonable certainty that exposure of have available information on the lifetime will not pose appreciable risks propiconazole in drinking water is less regional consumption of food to which to human health. Therefore, the chronic than EPA’s level of concern.

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3. From non-dietary exposure. 8,700 µg/L which is substantially higher addressed by the aggregate chronic Propiconazole is currently registered for that the peak EEC of 0.11 µg/L. exposure analysis using the chronic use on the following residential non- Therefore, the risk from acute aggregate RfD. Therefore, EPA concludes that food sites: wood preservative. Under exposure to propiconazole does not there is reasonable certainty that no current Agency guidelines, this use does exceed the Agency’s level of concern. harm will result from aggregate not present an acute or chronic 2. Chronic risk. Using the exposure exposure to propiconazole residue. exposure scenario, but may constitute a assumptions described in this unit, EPA 5. Determination of safety. Based on short- and/or intermediate-term dermal has concluded that aggregate exposure these risk assessments, EPA concludes and inhalation exposure scenario for to propiconazole from food will utilize that there is a reasonable certainty that applicators. The Agency calculated 7% of the RfD for the U.S. population. no harm will result from aggregate short- and intermediate-term dermal The major identifiable subgroup with exposure to residues of propiconazole. the highest aggregate exposure is and inhalation margins of exposure E. Aggregate Risks and Determination of discussed below. EPA generally has no (MOEs) of 200 and 200,000 respectively Safety for Infants and Children for the wood preservative use of concern for exposures below 100% of propiconazole. MOEs above 100 do not the RfD because the RfD represents the 1. Safety factor for infants and exceed the Agency’s level of concern. level at or below which daily aggregate children—i. In general. In assessing the For post application exposure, the dietary exposure over a lifetime will not potential for additional sensitivity of Agency determined that propiconazole pose appreciable risks to human health. infants and children to residues of is volatile and not readily aerosolized. Despite the potential for exposure to propiconazole, EPA considered data Therefore, post-application exposure propiconazole in drinking water and from developmental toxicity studies in from contact with treated wood is from non-dietary, non-occupational the rat and rabbit and a 2-generation expected to be minimal and the Agency exposure, EPA does not expect the reproduction study in the rat. The determined that a risk assessment for aggregate exposure to exceed 100% of developmental toxicity studies are post-application exposure is not needed. the RfD. EPA concludes that there is a designed to evaluate adverse effects on 4. Cumulative exposure to substances reasonable certainty that no harm will the developing organism resulting from with common mechanism of toxicity. result from aggregate exposure to maternal pesticide exposure gestation. Section 408(b)(2)(D)(v) requires that, propiconazole residues. Reproduction studies provide when considering whether to establish, 3. Short- and intermediate-term risk. information relating to effects from modify, or revoke a tolerance, the Short- and intermediate-term aggregate exposure to the pesticide on the Agency consider ‘‘available exposure takes into account chronic reproductive capability of mating information’’ concerning the cumulative dietary food and water (considered to be animals and data on systemic toxicity. effects of a particular pesticide’s a background exposure level) plus short- FFDCA section 408 provides that EPA residues and ‘‘other substances that and intermediate-term dermal and shall apply an additional tenfold margin have a common mechanism of toxicity.’’ inhalation exposure from residential of safety for infants and children in the EPA does not have, at this time, uses. The dermal and inhalation case of threshold effects to account for available data to determine whether endpoints used for estimating short- and pre-and post-natal toxicity and the propiconazole has a common intermediate-term exposure via the two completeness of the database unless mechanism of toxicity with other routes of exposure measured different EPA determines that a different margin substances or how to include this toxic effects. Therefore, the dermal of safety will be safe for infants and pesticide in a cumulative risk margin of exposure (MOE) and the children. Margins of safety are assessment. Unlike other pesticides for inhalation MOE should not be incorporated into EPA risk assessments which EPA has followed a cumulative aggregated. For residential uses, dermal either directly through use of a margin risk approach based on a common exposure of applicators was considered of exposure (MOE) analysis or through mechanism of toxicity, propiconazole to be the driving factor in the short- and using uncertainty (safety) factors in does not appear to produce a toxic intermediate-term risk assessment, and calculating a dose level that poses no metabolite produced by other the contribution of inhalation exposure appreciable risk to humans. EPA substances. For the purposes of this to the short- and intermediate-term risk believes that reliable data support using tolerance action, therefore, EPA has not assessment was negligible (inhalation the standard uncertainty factor (usually assumed that propiconazole has a MOE = 200,000). Therefore, the 100 for combined inter- and intra- common mechanism of toxicity with inhalation exposure was not calculated species variability) and not the other substances. For information in the aggregate short-and intermediate- additional tenfold MOE/uncertainty regarding EPA’s efforts to determine term risk assessment. The aggregate factor when EPA has a complete data which chemicals have a common short- and intermediate-term risk base under existing guidelines and mechanism of toxicity and to evaluate assessment estimated the dietary MOE when the severity of the effect in infants the cumulative effects of such to be 33,000, the dermal MOE to be 200 or children or the potency or unusual chemicals, see the final rule for and the DWLOC to be 4,500 µg/L which toxic properties of a compound do not Bifenthrin Pesticide Tolerances (62 FR is higher than the EEC of 0.09 µg/L. raise concerns regarding the adequacy of 62961, November 26, 1997). Therefore, the short- and intermediate- the standard MOE/safety factor. term aggregate risk does not exceed the ii. Pre- and post-natal sensitivity. The D. Aggregate Risks and Determination of Agency’s level of concern. pre- and post-natal toxicology data base Safety for U.S. Population 4. Aggregate cancer risk for U.S. for propiconazole is complete with 1. Acute risk. The acute dietary (food population. EPA classified respect to current FQPA-relevant only) risk does not exceed the Agency’s propiconazole as a Group C, possible toxicological data requirements. level of concern. Using the TMRC, the human carcinogen and determined that Propiconazole is not developmentally population subgroup of concern, the RfD approach be used to estimate toxic in the rabbit. There is evidence females 13 years old and older, utilizes the carcinogenic risk to humans. Risk that propiconazole is developmentally 3.3% of the dietary (food only) acute concerns for carcinogenicity due to toxic in the rat at doses that are toxic to RfD . For drinking water, the acute long-term consumption of the parents. In the developmental DWLOC for this population subgroup is propiconazole residues are adequately toxicity study in rats, the toxicity noted

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.012 pfrm07 PsN: 17MRR1 13084 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations at the maternal LOAEL of 90 mg/kg/day 4. Determination of safety. Based on tolerances will expire on December 31, consisted of rales and decreased weight these risk assessments, EPA concludes 2000 and will replace previously gain on gestation days 6–8 whereas the that there is a reasonable certainty that established tolerances which expired on toxicity noted at the developmental no harm will result to infants and December 31, 1998. These tolerances are LOAEL of 90 mg/kg/day consisted of children from aggregate exposure to time-limited because the Agency has not statistically significant increased propiconazole residues. completed the review of a modified carcinogenicity study in mice which incidences of unossified sternebrae, and III. Other Considerations nominally increased incidences of required testing at a mid-dose level. rudimentary ribs and shortened or A. Metabolism In Plants and Animals This study was requested to confirm or absent renal papillae. Where fetotoxic The nature of the residues in plants supplement findings in an Agency effects occur at the maternally toxic and animals is adequately understood. reviewed carcinogenicity study in mice dose levels, they generally are of less The residues of concern are in which testing was conducted at low concern than those occurring at non- propiconazole and its metabolites and high dose levels. maternally toxic dose levels because of determined as 2,4-dichlorobenzoic acid V. Objections and Hearing Requests the influence of toxicity in the mothers and expressed as parent compound. on the fetal toxicity expressed. The new FFDCA section 408(g) However, where the fetal effects are B. Analytical Enforcement Methodology provides essentially the same process judged to be qualitatively more severe Adequate enforcement methodology for persons to ‘‘object’’ to a tolerance than the effects in the maternal animals, (GC/ECD) is available to enforce the regulation issued by EPA as was there may be greater sensitivity in the tolerance expression. The method may provided in the old section 408 and in fetus and thus of greater concern. Here, be requested from: Calvin Furlow, section 409. However, the period for the effects in the fetus (delayed PRRIB, IRSD (7502C), Office of Pesticide filing objections is 60 days, rather than development) were not judged to be Programs, Environmental Protection 30 days. EPA currently has procedural more sever than the effects in the Agency, 401 M St., SW., Washington, regulations which govern the maternal animals (decreased weight DC 20460. Office location and telephone submission of objections and hearing gain). number: Rm 101FF, Crystal Mall #2, requests. These regulations will require some modification to reflect the new iii. Conclusion. There is a complete 1921 Jefferson Davis Hwy., Arlington, law. However, until those modifications toxicity database for propiconazole and VA, (703) 305–5229. can be made, EPA will continue to use exposure data is complete or is C. Magnitude of Residues those procedural regulations with estimated based on data that reasonably appropriate adjustments to reflect the accounts for potential exposures. Based The currently established time- limited tolerances for corn, peanuts, and new law. on the completeness of the data base Any person may, by May 17, 1999, and the lack of any data indicating pineapple commodities are appropriate for these crops. file written objections to any aspect of increased pre- or post-natal sensitivity, this regulation and may also request a EPA concludes that an additional safety D. International Residue Limits hearing on those objections. Objections factor is not necessary to protect the There are no CODEX, Canadian, or and hearing requests must be filed with safety of infants and children. Mexican Maximum Residue Limits the Hearing Clerk, at the address given 2. Acute risk. The available studies (MRL) for propiconazole on corn, under ‘‘ADDRESSES’’ section (40 CFR suggest the only acute risk infants and peanuts, or pineapple. Thus, 178.20). A copy of the objections and/ children face from propiconazole is harmonization of tolerances is not an or hearing requests filed with the through exposure to the developing issue for the extension of these Hearing Clerk should be submitted to fetus as a result of exposure to the tolerances. the OPP docket for this rulemaking. The mother. As shown in Unit II. D.1. of this objections submitted must specify the preamble, the acute risk to the E. Rotational Crop Restrictions provisions of the regulation deemed developing fetus from this exposure is Soybeans may be planted as a double objectionable and the grounds for the not above the Agency’s level of concern. crop following a cereal crop which has objections (40 CFR 178.25). Each 3. Chronic risk. Using the been treated with propiconazole. Crops objection must be accompanied by the conservative exposure assumptions intended for food, grazing, or any fee prescribed by 40 CFR 180.33(i) or a described in this unit, EPA has component of animal feed or bedding request for a fee waiver. EPA is concluded that aggregate exposure to may not be rotated within 105 days of authorized to waive any fee requirement propiconazole from food will utilize propiconazole application unless the ‘‘when in the judgement of the 50% of the RfD for infants and children. crop appears on the product label. Administrator such a waiver or refund EPA generally has no concern for is equitable and not contrary to the exposures below 100% of the RfD IV. Conclusion purpose of this subsection.’’ For because the RfD represents the level at Therefore, the time-limited tolerances additional information regarding or below which daily aggregate dietary are extended for combined residues of tolerance objection fee waivers, contact exposure over a lifetime will not pose propiconazole, 1-[[2-(2,4- James Tompkins, Registration Division appreciable risks to human health. dichlorophenyl)-4-propyl-1,3-dioxolan- (7505C), Office of Pesticide Programs, Despite the potential for exposure to 2- yl]methyl]-1H-1,2,4-triazole and its Environmental Protection Agency, 401 propiconazole in drinking water and metabolites determined as 2,4- M St., SW., Washington, DC 20460. from non-dietary, non-occupational dichlorobenzoic acid and expressed as Office location, telephone number, and exposure, EPA does not expect the parent compound on corn, fodder at 12 e-mail address: Rm. 239, Crystal Mall aggregate exposure to exceed 100% of ppm; corn, forage at 12 ppm; corn, grain #2, 1921 Jefferson Davis Hwy., the RfD. EPA concludes that there is a at 0.1 ppm; corn, sweet (kernels, plus Arlington, VA, (703) 305–5697, reasonable certainty that no harm will cobs with husks removed) at 0.1 ppm; [email protected]. Requests for result to infants and children from peanuts at 0.2 ppm; peanuts, hay at 20 waiver of tolerance objection fees aggregate exposure to propiconazole ppm; pineapple at 0.1 ppm and should be sent to James Hollins, residues. pineapple, fodder at 0.1 ppm. These Information Resources and Services

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Division (7502C), Office of Pesticide paper form. Accordingly, EPA will to the Chief Counsel for Advocacy of the Programs, Environmental Protection transfer any copies of objections and Small Business Administration. Agency, 401 M St., SW., Washington, hearing requests received electronically B. Executive Order 12875 DC 20460. into printed, paper form as they are If a hearing is requested, the received and will place the paper copies Under Executive Order 12875, objections must include a statement of in the official record which will also entitled Enhancing the the factual issues on which a hearing is include all comments submitted directly Intergovernmental Partnership (58 FR requested, the requestor’s contentions in writing. The official record is the 58093, October 28, 1993), EPA may not on such issues, and a summary of any paper record maintained at the Virginia issue a regulation that is not required by evidence relied upon by the requestor address in ‘‘ADDRESSES’’ at the statute and that creates a mandate upon (40 CFR 178.27). A request for a hearing beginning of this document. a State, local or tribal government, will be granted if the Administrator unless the Federal government provides determines that the material submitted VII. Regulatory Assessment the funds necessary to pay the direct shows the following: There is genuine Requirements compliance costs incurred by those governments. If the mandate is and substantial issue of fact; there is a A. Certain Acts and Executive Orders reasonable possibility that available unfunded, EPA must provide to OMB a evidence identified by the requestor This final rule establishes time- description of the extent of EPA’s prior would, if established, resolve one or limited tolerances under section 408(d) consultation with representatives of more of such issues in favor of the of the FFDCA in response to a petition affected State, local, and tribal requestor, taking into account submitted to the Agency. The Office of governments, the nature of their uncontested claims or facts to the Management and Budget (OMB) has concerns, copies of any written contrary; and resolution of the factual exempted these types of actions from communications from the governments, issues in the manner sought by the review under Executive Order 12866, and a statement supporting the need to requestor would be adequate to justify entitled Regulatory Planning and issue the regulation. In addition, the action requested (40 CFR 178.32). Review (58 FR 51735, October 4, 1993). Executive Order 12875 requires EPA to Information submitted in connection This final rule does not contain any develop an effective process permitting with an objection or hearing request information collections subject to OMB elected officials and other may be claimed confidential by marking approval under the Paperwork representatives of State, local, and tribal any part or all of that information as Reduction Act (PRA), 44 U.S.C. 3501 et governments ‘‘to provide meaningful CBI. Information so marked will not be seq., or impose any enforceable duty or and timely input in the development of disclosed except in accordance with contain any unfunded mandate as regulatory proposals containing procedures set forth in 40 CFR part 2. described under Title II of the Unfunded significant unfunded mandates.’’ A copy of the information that does not Mandates Reform Act of 1995 (UMRA) Today’s rule does not create an unfunded Federal mandate on State, contain CBI must be submitted for (Pub. L. 104–4). Nor does it require any local, or tribal governments. The rule inclusion in the public record. prior consultation as specified by does not impose any enforceable duties Information not marked confidential Executive Order 12875, entitled on these entities. Accordingly, the may be disclosed publicly by EPA Enhancing the Intergovernmental requirements of section 1(a) of without prior notice. Partnership (58 FR 58093, October 28, Executive Order 12875 do not apply to 1993), or special considerations as VI. Public Record and Electronic this rule. Submissions required by Executive Order 12898, entitled Federal Actions to Address C. Executive Order 13084 EPA has established a record for this Environmental Justice in Minority regulation under docket control number Under Executive Order 13084, Populations and Low-Income [OPP–300810] (including any comments entitled Consultation and Coordination and data submitted electronically). A Populations (59 FR 7629, February 16, with Indian Tribal Governments (63 FR public version of this record, including 1994), or require OMB review in 27655, May 19, 1998), EPA may not printed, paper versions of electronic accordance with Executive Order 13045, issue a regulation that is not required by comments, which does not include any entitled Protection of Children from statute, that significantly or uniquely information claimed as CBI, is available Environmental Health Risks and Safety affects the communities of Indian tribal for inspection from 8:30 a.m. to 4 p.m., Risks (62 FR 19885, April 23, 1997). governments, and that imposes Monday through Friday, excluding legal In addition, since tolerances and substantial direct compliance costs on holidays. The public record is located in exemptions that are established on the those communities, unless the Federal Room 119 of the Public Information and basis of a petition under FFDCA section government provides the funds Records Integrity Branch, Information 408(d), such as the tolerances in this necessary to pay the direct compliance Resources and Services Division final rule, do not require the issuance of costs incurred by the tribal (7502C), Office of Pesticide Programs, a proposed rule, the requirements of the governments. If the mandate is Environmental Protection Agency, Regulatory Flexibility Act (RFA) (5 unfunded, EPA must provide OMB, in Crystal Mall #2, 1921 Jefferson Davis U.S.C. 601 et seq.) do not apply. a separately identified section of the Hwy., Arlington, VA. Nevertheless, the Agency previously preamble to the rule, a description of Objections and hearing requests may assessed whether establishing the extent of EPA’s prior consultation be sent by e-mail directly to EPA at: tolerances, exemptions from tolerances, with representatives of affected tribal [email protected]. raising tolerance levels or expanding governments, a summary of the nature E-mailed objections and hearing exemptions might adversely impact of their concerns, and a statement requests must be submitted as an ASCII small entities and concluded, as a supporting the need to issue the file avoiding the use of special generic matter, that there is no adverse regulation. In addition, Executive Order characters and any form of encryption. economic impact. The factual basis for 13084 requires EPA to develop an The official record for this regulation, the Agency’s generic certification for effective process permitting elected as well as the public version, as tolerance actions published on May 4, officials and other representatives of described in this unit will be kept in 1981 (46 FR 24950), and was provided Indian tribal governments ‘‘to provide

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.012 pfrm07 PsN: 17MRR1 13086 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations meaningful and timely input in the ENVIRONMENTAL PROTECTION A copy of objections and hearing development of regulatory policies on AGENCY requests filed with the Hearing Clerk matters that significantly or uniquely may also be submitted electronically by affect their communities.’’ 40 CFR Part 180 sending electronic mail (e-mail) to: opp- Today’s rule does not significantly or [OPP±300804; FRL±6063±9] [email protected]. Copies of electronic objections and hearing requests must be uniquely affect the communities of RIN 2070±AB78 submitted as an ASCII file avoiding the Indian tribal governments. This action use of special characters and any form does not involve or impose any Pendimethalin; Extension of of encryption. Copies of objections and Tolerances for Emergency Exemptions requirements that affect Indian tribes. hearing requests will also be accepted Accordingly, the requirements of AGENCY: Environmental Protection on disks in WordPerfect 5.1/6.1 or section 3(b) of Executive Order 13084 ASCII file format. All copies of do not apply to this rule. Agency (EPA). ACTION: Final rule. electronic objections and hearing VIII. Submission to Congress and the requests must be identified by the Comptroller General SUMMARY: This regulation extends time- docket control number [OPP–300804]. limited tolerances for the combined No Confidential Business Information The Congressional Review Act, 5 residues of the herbicide pendimethalin (CBI) should be submitted through e- U.S.C. 801 et seq., as added by the Small and its metabolites in or on fresh mint mail. Copies of electronic objections and Business Regulatory Enforcement hay and mint oil at 0.1 and 5.0 parts per hearing requests on this rule may be Fairness Act of 1996, generally provides million (ppm), respectively, for an filed online at many Federal Depository that before a rule may take effect, the additional 1-year period. These Libraries. Agency promulgating the rule must tolerances will expire and are revoked FOR FURTHER INFORMATION CONTACT: By submit a rule report, which includes a on May 31, 2000. This action is in mail: Stephen Schaible, Registration copy of the rule, to each House of the response to EPA’s granting of emergency Division (7505C), Office of Pesticide Congress and the Comptroller General of exemptions under section 18 of the Programs, Environmental Protection the United States. EPA will submit a Federal Insecticide, Fungicide, and Agency, 401 M St., SW., Washington, report containing this rule and other Rodenticide Act (FIFRA) authorizing DC 20460. Office location, telephone required information to the U.S. Senate, use of the pesticide on mint. Section number, and e-mail address: Rm. 271, the U.S. House of Representatives and 408(l)(6) of the Federal Food, Drug, and Crystal Mall #2, 1921 Jefferson Davis the Comptroller General of the United Cosmetic Act requires EPA to establish Hwy., Arlington, VA, 703–308–9362, States prior to publication of the rule in a time-limited tolerance or exemption [email protected]. from the requirement for a tolerance for the Federal Register. This rule is not a SUPPLEMENTARY INFORMATION: EPA pesticide chemical residues in food that ‘‘major rule’’ as defined by 5 U.S.C. issued a final rule, published in the will result from the use of a pesticide 804(2). Federal Register of May 23, 1997 (62 FR under an emergency exemption granted 28355) (FRL–5718–5), which announced List of Subjects in 40 CFR Part 180 by EPA under FIFRA section 18. that on its own initiative under section DATES: This regulation becomes 408 of the Federal Food, Drug, and Environmental protection, effective March 17, 1999. Objections Cosmetic Act (FFDCA), 21 U.S.C. 346a Administrative practice and procedure, and requests for hearings must be and (l)(6), as amended by the Food Agricultural commodities, Pesticides received by EPA, on or before May 17, Quality Protection Act of 1996 (FQPA) and pests, Reporting and recordkeeping 1999. (Pub. L. 104–170) it established time- requirements. ADDRESSES: Written objections and limited tolerances for the combined Dated: March 4, 1999. hearing requests, identified by the residues of pendimethalin and its docket control number [OPP–300804], metabolites in or on fresh mint hay and James Jones, must be submitted to: Hearing Clerk mint oil at 0.1 ppm and 5.0 ppm, (1900), Environmental Protection Director, Registration Division, Office of respectively, with an expiration date of Pesticide Programs. Agency, Rm. M3708, 401 M St., SW., May 31, 1998. EPA extended the Washington, DC 20460. Fees expiration date of these tolerances to Therefore, 40 CFR chapter I is accompanying objections and hearing May 31, 1999 in a Federal Register amended as follows: requests shall be labeled ‘‘Tolerance notice published March 4, 1998 (63 FR Petition Fees’’ and forwarded to: EPA 10545–10547) (FRL–5772–9). EPA PART 180Ð[AMENDED] Headquarters Accounting Operations established the tolerances because Branch, OPP (Tolerance Fees), P.O. Box section 408(l)(6) of the FFDCA requires 1. The authority citation for part 180 360277M, Pittsburgh, PA 15251. A copy EPA to establish a time-limited continues to read as follows: of any objections and hearing requests tolerance or exemption from the Authority: 21 U.S.C. 321(q), 346a and 371. filed with the Hearing Clerk identified requirement for a tolerance for pesticide by the docket control number, [OPP– chemical residues in food that will § 180.434 [Amended] 300804], must also be submitted to: result from the use of a pesticide under 2. In § 180.434, in the table to Public Information and Records an emergency exemption granted by paragraph (a), by changing the Integrity Branch, Information Resources EPA under FIFRA section 18. Such expiration dates for corn, fodder; corn, and Services Division (7502C), Office of tolerances can be established without forage; corn, grain; corn, sweet (kernels Pesticide Programs, Environmental providing notice or period for public plus cobs with husks removed); Protection Agency, 401 M St., SW., comment. peanuts; peanuts, hay; pineapple; and Washington, DC 20460. In person, bring EPA received a request to extend the pineapple, fodder, to read ‘‘12/31/00’’. a copy of objections and hearing use of pendimethalin on mint for this requests to Rm. 119, Crystal Mall #2, year growing season due to the [FR Doc. 99–6388 Filed 3–16–99; 8:45 am] 1921 Jefferson Davis Hwy., Arlington, continued emergency situation for BILLING CODE 6560±50±F VA. Idaho, Oregon and Washington mint

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.012 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13087 growers. Due to the potential spread of However, until those modifications can CBI. Information so marked will not be Verticillium wilt by tillage equipment, be made, EPA will continue to use those disclosed except in accordance with mechanical control of kochia and procedural regulations with appropriate procedures set forth in 40 CFR part 2. redroot pigweed is no longer considered adjustments to reflect the new law. A copy of the information that does not a viable option. The continuous use of Any person may, by May 17, 1999, contain CBI must be submitted for terbacil in past years has resulted in file written objections to any aspect of inclusion in the public record. development of resistance to this this regulation and may also request a Information not marked confidential chemical in kochia and pigweed, hearing on those objections. Objections may be disclosed publicly by EPA resulting in inadequate control of this and hearing requests must be filed with without prior notice. pest by registered alternatives. After the Hearing Clerk, at the address given having reviewed the submissions, EPA under the ‘‘ADDRESSES’’ section (40 II. Public Record and Electronic concurs that emergency conditions CFR 178.20). A copy of the objections Submissions exist. EPA has authorized under FIFRA and/or hearing requests filed with the EPA has established a record for this section 18 the use of pendimethalin on Hearing Clerk should be submitted to regulation under docket control number mint for control of kochia and redroot the OPP docket for this rulemaking. The [OPP–300804] (including any comments pigweed in mint. objections submitted must specify the and data submitted electronically). A EPA assessed the potential risks provisions of the regulation deemed public version of this record, including presented by residues of pendimethalin objectionable and the grounds for the printed, paper versions of electronic in or on fresh mint hay and mint oil. In objections (40 CFR 178.25). Each comments, which does not include any doing so, EPA considered the safety objection must be accompanied by the information claimed as CBI, is available standard in FFDCA section 408(b)(2), fee prescribed by 40 CFR 180.33(i). EPA for inspection from 8:30 a.m. to 4 p.m., and decided that the necessary is authorized to waive any fee Monday through Friday, excluding legal tolerances under FFDCA section requirement ‘‘when in the judgement of holidays. The public record is located in 408(l)(6) would be consistent with the the Administrator such a waiver or Room 119 of the Public Information and safety standard and with FIFRA section refund is equitable and not contrary to Records Integrity Branch, Information 18. The data and other relevant material the purpose of this subsection.’’ For Resources and Services Division have been evaluated and discussed in additional information regarding (7502C), Office of Pesticide Programs, the final rule of May 23, 1997. Based on tolerance objection fee waivers, contact Environmental Protection Agency, that data and information considered, James Tompkins, Registration Division Crystal Mall #2, 1921 Jefferson Davis the Agency reaffirms that extension of (7505C), Office of Pesticide Programs, Hwy., Arlington, VA. the time-limited tolerances will Environmental Protection Agency, 401 Objections and hearing requests may continue to meet the requirements of M St., SW., Washington, DC 20460. be sent by e-mail directly to EPA at: section 408(l)(6). Therefore, the time- Office location, telephone number, and [email protected]. limited tolerances are extended for an e-mail address: Rm. 239, Crystal Mall E-mailed objections and hearing additional 1-year period. EPA will #2, 1921 Jefferson Davis Hwy., requests must be submitted as an ASCII publish a document in the Federal Arlington, VA, (703) 305–5697, file avoiding the use of special Register to remove the revoked [email protected]. Requests for characters and any form of encryption. tolerances from the Code of Federal waiver of tolerance objection fees The official record for this regulation, Regulations (CFR). Although these should be sent to James Hollins, as well as the public version, as tolerances will expire and are revoked Information Resources and Services described in this unit will be kept in on May 31, 2000, under FFDCA section Division (7502C), Office of Pesticide paper form. Accordingly, EPA will 408(l)(5), residues of the pesticide not in Programs, Environmental Protection transfer any copies of objections and excess of the amounts specified in the Agency, 401 M St., SW., Washington, hearing requests received electronically tolerances remaining in or on fresh mint DC 20460. into printed, paper form as they are hay and mint oil after that date will not If a hearing is requested, the received and will place the paper copies be unlawful, provided the pesticide is objections must include a statement of in the official record which will also applied in a manner that was lawful the factual issues on which a hearing is include all comments submitted directly under FIFRA and the application requested, the requestor’s contentions in writing. The official record is the on such issues, and a summary of any occurred prior to the revocation of the paper record maintained at the Virginia evidence relied upon by the requestor tolerances. EPA will take action to address in ‘‘ADDRESSES’’ at the (40 CFR 178.27). A request for a hearing revoke these tolerances earlier if any beginning of this document. experience with, scientific data on, or will be granted if the Administrator other relevant information on this determines that the material submitted III. Regulatory Assessment pesticide indicate that the residues are shows the following: There is genuine Requirements and substantial issue of fact; there is a not safe. A. Certain Acts and Executive Orders reasonable possibility that available I. Objections and Hearing Requests evidence identified by the requestor This final rule establishes a tolerance The new FFDCA section 408(g) would, if established, resolve one or under section 408 of the FFDCA. The provides essentially the same process more of such issues in favor of the Office of Management and Budget for persons to ‘‘object’’ to a tolerance requestor, taking into account (OMB) has exempted these types of regulation as was provided in the old uncontested claims or facts to the actions from review under Executive section 408 and in section 409. contrary; and resolution of the factual Order 12866, entitled Regulatory However, the period for filing objections issues in the manner sought by the Planning and Review (58 FR 51735, is 60 days, rather than 30 days. EPA requestor would be adequate to justify October 4, 1993). This final rule does currently has procedural regulations the action requested (40 CFR 178.32). not contain any information collections which govern the submission of Information submitted in connection subject to OMB approval under the objections and hearing requests. These with an objection or hearing request Paperwork Reduction Act (PRA), 44 regulations will require some may be claimed confidential by marking U.S.C. 3501 et seq., or impose any modification to reflect the new law. any part or all of that information as enforceable duty or contain any

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.013 pfrm07 PsN: 17MRR1 13088 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations unfunded mandate as described under Today’s rule does not create an ‘‘major rule’’ as defined by 5 U.S.C. Title II of the Unfunded Mandates unfunded Federal mandate on State, 804(2). Reform Act of 1995 (UMRA) (Pub. L. local, or tribal governments. The rule List of Subjects in 40 CFR Part 180 104–4). Nor does it require any prior does not impose any enforceable duties consultation as specficed by Executive on these entities. Accordingly, the Environmental protection, Order 12875, entitled Enhancing the requirements of section 1(a) of Administrative practice and procedure, Intergovernmental Partnership (58 FR Executive Order 12875 do not apply to Agricultural commodities, Pesticides 58093, October 28, 1993), or special this rule. and pests, Reporting and recordkeeping considerations as required by Executive requirements. C. Executive Order 13084 Order 12898, entitled Federal Actions to Dated: March 3, 1999. Address Environmental Justice in Under Executive Order 13084, Peter Caulkins, Minority Populations and Low-Income entitled Consultation and Coordination Populations (59 FR 7629, February 16, with Indian Tribal Governments (63 FR Acting Director, Registration Division, Office 1994), or require OMB review in 27655, May 19, 1998), EPA may not of Pesticide Programs. accordance with Executive Order 13045, issue a regulation that is not required by Therefore, 40 CFR chapter I is entitled Protection of Children from statute, that significantly or uniquely amended as follows: Environmental Health Risks and Safety affects the communities of Indian tribal Risks (62 FR 19885, April 23, 1997). governments, and that imposes PART 180±[AMENDED] In addition, since tolerances and substantial direct compliance costs on exemptions that are established under 1. The authority citation for part 180 those communities, unless the Federal continues to read as follows: section 408(l)(6) of FFDCA, such as the government provides the funds tolerance/exemption in this final rule, necessary to pay the direct compliance Authority: 21 U.S.C. 321(q), 346a and 371. do not require the issuance of a costs incurred by the tribal proposed rule, the requirements of the governments. If the mandate is § 180.361 [Amended] Regulatory Flexibility Act (RFA) (5 unfunded, EPA must provide OMB, in 2. In § 180.361, by amending U.S.C. 601 et seq.) do not apply. a separately identified section of the paragraph (b) in the table, for the Nevertheless, the Agency previously preamble to the rule, a description of commodities ‘‘Mint hay, fresh’’ and assessed whether establishing the extent of EPA’s prior consultation ‘‘Mint oil’’ by changing the date ‘‘5/31/ tolerances, exemptions from tolerances, with representatives of affected tribal 99’’ to read ‘‘5/31/00’’. raising tolerance levels or expanding governments, a summary of the nature exemptions might adversely impact [FR Doc. 99–6386 Filed 3–16–99; 8:45 am] of their concerns, and a statement BILLING CODE 6560±50±F small entities and concluded, as a supporting the need to issue the generic matter, that there is no adverse regulation. In addition, Executive Order economic impact. The factual basis for 13084 requires EPA to develop an ENVIRONMENTAL PROTECTION the Agency’s generic certification for effective process permitting elected tolerance actions published on May 4, AGENCY officials and other representatives of 1981 (46 FR 24950), and was provided Indian tribal governments ‘‘to provide 40 CFR Part 180 to the Chief Counsel for Advocacy of the meaningful and timely input in the Small Business Administration. development of regulatory policies on [OPP±300799; FRL±6065±2] B. Executive Order 12875 matters that significantly or uniquely RIN 2070±AB78 Under Executive Order 12875, affect their communities.’’ entitled Enhancing the Today’s rule does not significantly or Tebufenozide; Pesticide Tolerances for Intergovernmental Partnership (58 FR uniquely affect the communities of Emergency Exemptions 58093, October 28, 1993), EPA may not Indian tribal governments. This action issue a regulation that is not required by does not involve or impose any AGENCY: Environmental Protection statute and that creates a mandate upon requirements that affect Indian tribes. Agency (EPA). a State, local or tribal government, Accordingly, the requirements of ACTION: Final rule. unless the Federal government provides section 3(b) of Executive Order 13084 the funds necessary to pay the direct do not apply to this rule. SUMMARY: This regulation establishes time-limited tolerances for residues of compliance costs incurred by those IV. Submission to Congress and the tebufenozide in or on lychee and governments. If the mandate is Comptroller General unfunded, EPA must provide to OMB a longan. This action is in response to description of the extent of EPA’s prior The Congressional Review Act, 5 EPA’s granting of an emergency consultation with representatives of U.S.C. 801 et seq., as added by the Small exemption under section 18 of the affected State, local, and tribal Business Regulatory Enforcement Federal Insecticide, Fungicide, and governments, the nature of their Fairness Act of 1996, generally provides Rodenticide Act authorizing use of the concerns, copies of any written that before a rule may take effect, the pesticide tebufenozide on lychee and communications from the governments, Agency promulgating the rule must longan. This regulation establishes a and a statement supporting the need to submit a rule report, which includes a maximum permissible level for residues issue the regulation. In addition, copy of the rule, to each House of the of benzoic acid, 3,5-dimethyl-1–(1,1- Executive Order 12875 requires EPA to Congress and the Comptroller General of dimethylethyl)-2–(4- develop an effective process permitting the United States. EPA will submit a ethylbenzoyl)hydrazide in these food elected officials and other report containing this rule and other commodities pursuant to section representatives of State, local, and tribal required information to the U.S. Senate, 408(l)(6) of the Federal Food, Drug, and governments ‘‘to provide meaningful the U.S. House of Representatives and Cosmetic Act, as amended by the Food and timely input in the development of the Comptroller General of the United Quality Protection Act of 1996. The regulatory proposals containing States prior to publication of the rule in tolerances will expire and are revoked significant unfunded mandates.’’ the Federal Register. This rule is not a on December 31, 2001.

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DATES: This regulation is effective tebufenozide, in or on lychee and requirement for a tolerance for pesticide March 17, 1999. Objections and requests longan at 1.0 part per million (ppm). chemical residues in food that will for hearings must be received by EPA on These tolerances will expire and are result from the use of a pesticide under or before May 17, 1999. revoked on December 31, 2001. EPA an emergency exemption granted by ADDRESSES: Written objections and will publish a document in the Federal EPA under section 18 of FIFRA. Such hearing requests, identified by the Register to remove the revoked tolerances can be established without docket control number [OPP–300799], tolerance from the Code of Federal providing notice or period for public must be submitted to: Hearing Clerk Regulations. comment. (1900), Environmental Protection Because decisions on section 18- I. Background and Statutory Findings Agency, Rm. M3708, 401 M St., SW., related tolerances must proceed before Washington, DC 20460. Fees The Food Quality Protection Act of EPA reaches closure on several policy accompanying objections and hearing 1996 (FQPA) (Pub. L. 104–170) was issues relating to interpretation and requests shall be labeled ‘‘Tolerance signed into law August 3, 1996. FQPA implementation of the FQPA, EPA does Petition Fees’’ and forwarded to: EPA amends both the Federal Food, Drug, not intend for its actions on such Headquarters Accounting Operations and Cosmetic Act (FFDCA), 21 U.S.C. tolerances to set binding precedents for Branch, OPP (Tolerance Fees), P.O. Box 301 et seq., and the Federal Insecticide, the application of section 408 and the 360277M, Pittsburgh, PA 15251. A copy Fungicide, and Rodenticide Act new safety standard to other tolerances of any objections and hearing requests (FIFRA), 7 U.S.C. 136 et seq. The FQPA and exemptions. amendments went into effect filed with the Hearing Clerk identified II. Emergency Exemption for by the docket control number, [OPP– immediately. Among other things, FQPA amends FFDCA to bring all EPA Tebufenozide on Lychee and Longan 300799], must also be submitted to: and FFDCA Tolerances Public Information and Records pesticide tolerance-setting activities Integrity Branch, Information Resources under a new section 408 with a new There are approximately 611 and 410 and Services Division (7502C), Office of safety standard and new procedures. acres of commercial lychee and longan Pesticide Programs, Environmental These activities are described in this grown in Florida, respectively. Lychee Protection Agency, 401 M St., SW., preamble and discussed in greater detail and longan have been relatively pest- free in Florida up until 1998. However, Washington, DC 20460. In person, bring in the final rule establishing the time- during the mid-1990’s lychee webworm a copy of objections and hearing limited tolerance associated with the was introduced into Florida. During the requests to Rm. 119, Crystal Mall 2 (CM emergency exemption for use of 1998 growing season up to 80–90% of #2), 1921 Jefferson Davis Hwy., propiconazole on sorghum (61 FR the lychee trees and 50–60% of the Arlington, VA. 58135, November 13, 1996) (FRL–5572– longan trees beared little to no A copy of objections and hearing 9). New section 408(b)(2)(A)(i) of the marketable fruit due to lychee webworm requests filed with the Hearing Clerk FFDCA allows EPA to establish a infestation. There are very few may also be submitted electronically by tolerance (the legal limit for a pesticide pesticides registered for use on lychee sending electronic mail (e-mail) to: opp- chemical residue in or on a food) only and longan and none have proven [email protected]. Copies of electronic if EPA determines that the tolerance is effective in controlling the lychee objections and hearing requests must be ‘‘safe.’’ Section 408(b)(2)(A)(ii) defines webworm. Therefore, growers are left submitted as an ASCII file avoiding the ‘‘safe’’ to mean that ‘‘there is a with no viable measures to control the use of special characters and any form reasonable certainty that no harm will lychee webworm. EPA has authorized of encryption. Copies of objections and result from aggregate exposure to the under FIFRA section 18 the use of hearing requests will also be accepted pesticide chemical residue, including tebufenozide on lychee and longan for on disks in WordPerfect 5.1/6.1 or all anticipated dietary exposures and all control of lychee webworms in Florida. ASCII file format. All copies of other exposures for which there is After having reviewed the submission, electronic objections and hearing reliable information.’’ This includes EPA concurs that emergency conditions requests must be identified by the exposure through drinking water and in exist for this state. docket control number [OPP–300799]. residential settings, but does not include As part of its assessment of this No Confidential Business Information occupational exposure. Section emergency exemption, EPA assessed the (CBI) should be submitted through e- 408(b)(2)(C) requires EPA to give special potential risks presented by residues of mail. Copies of electronic objections and consideration to exposure of infants and tebufenozide in or on lychee and hearing requests on this rule may be children to the pesticide chemical longan. In doing so, EPA considered the filed online at many Federal Depository residue in establishing a tolerance and safety standard in FFDCA section Libraries. to ‘‘ensure that there is a reasonable 408(b)(2), and EPA decided that the FOR FURTHER INFORMATION CONTACT: By certainty that no harm will result to necessary tolerance under FFDCA mail: Barbara Madden, Registration infants and children from aggregate section 408(l)(6) would be consistent Division (7505C), Office of Pesticide exposure to the pesticide chemical with the safety standard and with Programs, Environmental Protection residue. . . .’’ FIFRA section 18. Consistent with the Agency, 401 M St., SW., Washington, Section 18 of FIFRA authorizes EPA need to move quickly on the emergency DC 20460. Office location, telephone to exempt any Federal or State agency exemption in order to address an urgent number, and e-mail address: Rm. 284, from any provision of FIFRA, if EPA non-routine situation and to ensure that CM #2, 1921 Jefferson Davis Hwy., determines that ‘‘emergency conditions the resulting food is safe and lawful, Arlington, VA, (703) 305–6463, exist which require such exemption.’’ EPA is issuing this tolerance without [email protected]. This provision was not amended by notice and opportunity for public SUPPLEMENTARY INFORMATION: EPA, on FQPA. EPA has established regulations comment under section 408(e), as its own initiative, pursuant to sections governing such emergency exemptions provided in section 408(l)(6). Although 408 and (l)(6) of the Federal Food, Drug, in 40 CFR part 166. this tolerance will expire and is revoked and Cosmetic Act (FFDCA), 21 U.S.C. Section 408(l)(6) of the FFDCA on December 31, 2001, under FFDCA 346a and (l)(6), is establishing requires EPA to establish a time-limited section 408(l)(5), residues of the tolerances for residues of the insecticide tolerance or exemption from the pesticide not in excess of the amounts

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.014 pfrm07 PsN: 17MRR1 13090 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations specified in the tolerance remaining in studies to human risk. EPA has also 4. Carcinogenicity. Tebufenozide is or on lychee and longan after that date considered available information classified as Group E (no evidence of will not be unlawful, provided the concerning the variability of the carcinogenicity in humans). pesticide is applied in a manner that sensitivities of major identifiable C. Exposures and Risks was lawful under FIFRA, and the subgroups of consumers, including residues do not exceed a level that was infants and children. The nature of the 1. From food and feed uses. authorized by this tolerance at the time toxic effects caused by tebufenozide are Tolerances have been established (40 of that application. EPA will take action discussed in this unit. CFR 180.482) for the residues of to revoke this tolerance earlier if any tebufenozide, in or on a variety of raw experience with, scientific data on, or B. Toxicological Endpoint agricultural commodities. Tolerances, in other relevant information on this 1. Acute toxicity. No toxicological support of registrations, currently exist pesticide indicate that the residues are endpoint has been identified for acute for residues of tebufenozide on apples not safe. toxicity. Toxicity observed in oral and walnuts. Additionally, time-limited Because this tolerance is being toxicity studies were not attributable to tolerances associated with emergency approved under emergency conditions a single dose (exposure). No exemptions have been established for EPA has not made any decisions about neurological or systemic toxicity was cotton, eggs, leafy vegetables, milk, whether tebufenozide meets EPA’s observed in rats given a single oral pears, peanuts, pecans, peppers, rice, registration requirements for use on administration of tebufenozide at 0, 500, sugar beet, sugarcane, sweet potatoes, lychee and longan or whether a 1,000 or 2,000 milligrams/kilogram/day turnip tops and livestock commodities permanent tolerance for this use would (mg/kg/day). No maternal or of cattle, goats, hogs, horses, poultry and be appropriate. Under these developmental toxicity was observed sheep. Risk assessments were conducted circumstances, EPA does not believe following oral administration of by EPA to assess dietary exposures and that this tolerance serves as a basis for tebufenozide at 1,000 mg/kg/day (limit- risks from tebufenozide as follows: i. Acute exposure and risk. Acute registration of tebufenozide by a State dose) during gestation to pregnant rats dietary risk assessments are performed for special local needs under FIFRA or rabbits. for a food-use pesticide if a toxicological section 24(c). Nor does this tolerance 2. Short - and intermediate - term serve as the basis for any State other study has indicated the possibility of an toxicity. No toxicological endpoints effect of concern occurring as a result of than Florida to use this pesticide on this have been identified for short- and crop under section 18 of FIFRA without a 1-day or single exposure. Toxicity intermediate-term toxicity. No dermal or observed in oral toxicity studies were following all provisions of EPA’s systemic toxicity was seen in rats regulations implementing section 18 as not attributable to a single dose or one administered 15 dermal applications at day exposure. Therefore, no identified in 40 CFR part 166. For 1,000 mg/kg/day (limit dose) over 21 additional information regarding the toxicological endpoint was identified days with either technical tebufenozide for acute toxicity and no acute dietary emergency exemption for tebufenozide, or 23% active ingredient formulation. contact the Agency’s Registration risk assessment is needed. Despite hematological effects seen in the ii. Chronic exposure and risk. The Division at the address provided under dog study, similar effects were not seen the ‘‘ADDRESSES’’ section. Agency conducted a chronic dietary in these rats receiving the compound via exposure analysis and risk assessment. III. Aggregate Risk Assessment and the dermal route indicating poor dermal The chronic analysis for tebufenozide Determination of Safety absorption. Also, no developmental used a RfD of 0.018 mg/kg/day. The EPA performs a number of analyses to endpoints of concern were evident due analysis evaluated individual food determine the risks from aggregate to the lack of developmental toxicity in consumption as reported by exposure to pesticide residues. For either rat or rabbit studies. respondents in the USDA 1989-92 further discussion of the regulatory 3. Chronic toxicity. EPA has Continuing Surveys of Food Intake by requirements of section 408 and a established the RfD for tebufenozide at Individuals and accumulates exposure complete description of the risk 0.018 mg/kg/day. This RfD is based on to the chemical for each commodity. assessment process, see the final rule on the no observable adverse effect level Tolerance level residues and some Bifenthrin Pesticide Tolerances (62 FR (NOAEL) of 1.8 mg/kg/day based on percent crop treated (%CT) assumptions 62961, November 26, 1997) (FRL–5754– growth retardation, alterations in were made for the proposed 7) . hematology parameters, changes in commodities to estimate the Anticipated Consistent with section 408(b)(2)(D), organ weights, and histopathological Residue Concentration (ARC) for the EPA has reviewed the available lesions in the bone, spleen and liver at general population and subgroups of scientific data and other relevant the lowest observable adverse effect interest. Since the FQPA safety factor information in support of this action. level (LOAEL) of 8.7 mg/kg/day. An has been removed for all population EPA has sufficient data to assess the uncertainty factor of 100 (10X for inter- subgroups, the percent RfD that would hazards of tebufenozide and to make a species extrapolation and 10X for intra- exceed the Agency level of concern determination on aggregate exposure, species variability) was applied to the would be 100%. The existing consistent with section 408(b)(2), for a NOAEL of 1.8 mg/kg/day to calculate tebufenozide tolerances (published, time-limited tolerance for residues of the RfD of 0.018 mg/kg/day. EPA has pending, and including the necessary tebufenozide on lychee and longan at determined that the 10X factor to Section 18 tolerance(s)) result in a ARC 1.0 ppm. EPA’s assessment of the account for enhanced susceptibility of that is equivalent to percentages of the dietary exposures and risks associated infants and children (as required by RfD below 100% for all subgroups i.e., with establishing the tolerance follows. FQPA) can be removed. This U.S. population, 12% and non-nursing determination is based on the results of infants (<1 year old), the most highly A. Toxicological Profile reproductive and developmental exposed subgroup, 25%. EPA has evaluated the available toxicity studies. No evidence of Section 408(b)(2)(F) states that the toxicity data and considered its validity, additional sensitivity to young rats or Agency may use data on the actual completeness, and reliability as well as rabbits was observed following pre- or percent of food treated (PCT) for the relationship of the results of the postnatal exposure to tebufenozide. assessing chronic dietary risk only if the

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Agency can make the following Because the Agency does not have information’’ concerning the cumulative findings: That the data used are reliable comprehensive and reliable monitoring effects of a particular pesticide’s and provide a valid basis to show what data, drinking water concentration residues and ‘‘other substances that percentage of the food derived from estimates must be made by reliance on have a common mechanism of toxicity.’’ such crop is likely to contain such some sort of simulation or modeling. To EPA does not have, at this time, pesticide residue; that the exposure date, there are no validated modeling available data to determine whether estimate does not underestimate approaches for reliably predicting tebufenozide has a common mechanism exposure for any significant pesticide levels in drinking water. The of toxicity with other substances or how subpopulation group; and if data are Agency is currently relying on GENEEC to include this pesticide in a cumulative available on pesticide use and food and PRZM/EXAMS for surface water, risk assessment. Unlike other pesticides consumption in a particular area, the which are used to produce estimates of for which EPA has followed a exposure estimate does not understate pesticide concentrations in a farm pond cumulative risk approach based on a exposure for the population in such and SCI-GROW, which predicts common mechanism of toxicity, area. In addition, the Agency must pesticide concentrations in tebufenozide does not appear to provide for periodic evaluation of any groundwater. None of these models produce a toxic metabolite produced by estimates used. To provide for the include consideration of the impact other substances. For the purposes of periodic evaluation of the estimate of processing of raw water for distribution this tolerance action, therefore, EPA has percent crop treated as required by the as drinking water would likely have on not assumed that tebufenozide has a section 408(b)(2)(F), EPA may require the removal of pesticides from the common mechanism of toxicity with registrants to submit data on PCT. source water. The primary use of these other substances. For more information The Agency used PCT information as models by the Agency at this stage is to regarding EPA’s efforts to determine follows: almonds, <1%; apples, 2%; dry provide a coarse screen for sorting out which chemicals have a common beans and peas, 1%; fresh cabbage, 3%; pesticides for which it is highly unlikely mechanism of toxicity and to evaluate cole crops, 2%; cotton, 4%; pears, <5; that drinking water concentrations the cumulative effects of such fresh spinach, 3%; processed spinach, would ever exceed human health levels chemicals, see the final rule for 29%; sugarcane, 5%; and walnuts, 16%. of concern. For the proposed uses, based Bifenthrin Pesticide Tolerances (62 FR The Agency believes that the three on the GENEEC and SCI-GROW models 62961, November 26, 1997). conditions, discussed in section 408 the chronic drinking water (b)(2)(F) in this unit concerning the concentration value are estimated to be D. Aggregate Risks and Determination of Agency’s responsibilities in assessing 29 parts per billion (ppb) for surface Safety for U.S. Population chronic dietary risk findings, have been water and 1 pbb for ground water. 1. Acute risk. As discussed above, no met. The PCT estimates are derived In the absence of monitoring data for toxicological endpoint was identified from Federal and private market survey pesticides, drinking water levels of for acute toxicity. Therefore, no acute data, which are reliable and have a valid comparison (DWLOCs) are calculated aggregate risk assessment is needed. basis. Typically, a range of estimates are and used as a point of comparison 2. Chronic risk. Using the ARC supplied and the upper end of this against the model estimates of a range is assumed for the exposure pesticide’s concentration in water. exposure assumptions described above, assessment. By using this upper end DWLOCs are theoretical upper limits on EPA has concluded that aggregate estimate of the PCT, the Agency is a pesticide’s concentration in drinking exposure to tebufenozide from food will reasonably certain that the percentage of water in light of total aggregate exposure utilize 12% of the RfD for the U.S. the food treated is not likely to be to a pesticide in food, drinking water, population. The major identifiable underestimated. The regional and residential uses. A DWLOC will subgroup with the highest aggregate consumption information and vary depending on the toxic endpoint, exposure, non-nursing infants (<1 year consumption information for significant with drinking water consumption, and old) (discussed below) will utilize 25% subpopulations is taken into account body weights. Different populations will of the RfD. EPA generally has no through EPA’s computer-based model have different DWLOCs. DWLOCs are concern for exposures below 100% of for evaluating the exposure of used in the risk assessment process as the RfD because the RfD represents the significant subpopulations including a surrogate measure of potential level at or below which daily aggregate several regional groups. Use of this exposure associated with pesticide dietary exposure over a lifetime will not consumption information in EPA’s risk exposure through drinking water. pose appreciable risks to human health. assessment process ensures that EPA’s DWLOC values are not regulatory Despite the potential for exposure to exposure estimate does not understate standards for drinking water. Since tebufenozide in drinking water, after exposure for any significant DWLOCs address total aggregate calculating DWLOCs (560 ppb) and subpopulation group and allows the exposure to tebufenozide they are comparing them to conservative model Agency to be reasonably certain that no further discussed in the aggregate risk estimates of concentrations of regional population is exposed to sections below. tebufenozide in surface and ground residue levels higher than those 3. From non-dietary exposure. water (29 ppb and 1 ppb, respectively), estimated by the Agency. Other than the Tebufenozide is not registered on any EPA does not expect the aggregate data available through national food use sites which would result in non- exposure to exceed 100% of the RfD. consumption surveys, EPA does not dietary, non-occupational exposure. 3. Short- and intermediate-term risk. have available information on the Therefore, EPA expects only dietary and Short- and intermediate-term aggregate regional consumption of food to which occupational exposure from the use of exposure takes into account chronic tebufenozide may be applied in a tebufenozide. dietary food and water (considered to be particular area. 4. Cumulative exposure to substances a background exposure level) plus 2. From drinking water. The Agency with common mechanism of toxicity. indoor and outdoor residential lacks sufficient water-related exposure Section 408(b)(2)(D)(v) requires that, exposure. Tebufenozide is not registered data to complete a comprehensive when considering whether to establish, on any use sites which would result in drinking water exposure analysis and modify, or revoke a tolerance, the non-dietary, non-occupational exposure. risk assessment for tebufenozide. Agency consider ‘‘available Therefore no short- and intermediate-

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.014 pfrm07 PsN: 17MRR1 13092 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations term aggregate risk assessments are higher doses than in the maternal/ IV. Other Considerations needed. parental animals. A. Metabolism In Plants and Animals 4. Aggregate cancer risk for U.S. iv. Pre- and post-natal sensitivity. The Residue of concern in plants is population. Tebufenozide is classified data provided no indication of increased as Group E (no evidence of adequately understood and is sensitivity of rats or rabbits to in utero carcinogenicity in humans). tebufenozide per se. Residues of 5. Determination of safety. Based on and/or postnatal exposure to concern in animals are not adequately these risk assessments, EPA concludes tebufenozide. No maternal or understood. Studies to address residues that there is a reasonable certainty that developmental findings were observed of concern for animals are currently no harm will result from aggregate in the prenatal developmental toxicity under Agency review. For the purpose exposure to tebufenozide residues. studies at doses up to 1,000 mg/kg/day of these section 18 actions only, the in rats and rabbits. In the 2-generation Agency has assumed the residue of E. Aggregate Risks and Determination of reproduction studies in rats, effects concern is tebufenozide per se. Safety for Infants and Children occurred at the same or lower treatment 1. Safety factor for infants and levels in the adults as in the offspring. B. Analytical Enforcement Methodology children i. In general. In assessing the v. Conclusion. There is a complete Adequate enforcement methodology potential for additional sensitivity of toxicity database for tebufenozide and (example - gas chromatography) is infants and children to residues of exposure data is complete or is available to enforce the tolerance tebufenozide, EPA considered data from estimated based on data that reasonably expression. The method may be developmental toxicity studies in the rat accounts for potential exposures. Data requested from: Calvin Furlow, PRRIB, and rabbit and a 2-generation provided no indication of increased IRSD (7502C), Office of Pesticide reproduction study in the rat. The sensitivity of rats or rabbits to in utero Programs, Environmental Protection developmental toxicity studies are and/or postnatal exposure to Agency, 401 M St., SW., Washington, designed to evaluate adverse effects on tebufenozide. Based on this, EPA DC 20460. Office location and telephone the developing organism resulting from concludes that reliable data support the number: Rm 101FF, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, maternal pesticide exposure during use of the standard 100-fold uncertainty (703) 305–5229. gestation. Reproduction studies provide factor, and that an additional information relating to effects from uncertainty factor is not needed to C. Magnitude of Residues exposure to the pesticide on the protect the safety of infants and reproductive capability of mating Residues of tebufenozide per se are children. animals and data on systemic toxicity. not expected to exceed 1.0 ppm on FFDCA section 408 provides that EPA 2. Acute risk. No toxicological lychee and longan as a result of these shall apply an additional tenfold margin endpoint was identified for acute section 18 uses. of safety for infants and children in the toxicity. Therefore, no acute aggregate D. International Residue Limits case of threshold effects to account for risk assessment is needed. There are currently no Canadian, or pre-and post-natal toxicity and the 3. Chronic risk. Using the exposure completeness of the database unless Mexican listings for tebufenozide assumptions described above, EPA has residues. Codex maximum residue EPA determines that a different margin concluded that aggregate exposure to of safety will be safe for infants and levels (MRLs) have been set for tebufenozide from food will utilize 25% tebufenozide at 0.1 ppm for rice children. Margins of safety are of the RfD for infants and 19% of the incorporated into EPA risk assessments (husked), 0.05 ppm for walnuts, and 1 RfD for children. EPA generally has no ppm for pome fruits. either directly through use of a margin concern for exposures below 100% of of exposure (MOE) analysis or through the RfD because the RfD represents the E. Rotational Crop Restrictions using uncertainty (safety) factors in level at or below which daily aggregate Rotational crop restrictions do not calculating a dose level that poses no dietary exposure over a lifetime will not apply to lychee and longan since they appreciable risk to humans. EPA pose appreciable risks to human health. are tree crops. believes that reliable data support using Despite the potential for exposure to the standard MOE and uncertainty tebufenozide in drinking water, after V. Conclusion factor (usually 100 for combined inter- calculating DWLOCs (140 ppb) and Therefore, the tolerance is established and intra-species variability) and not the comparing them to conservative model for residues of tebufenozide in lychee additional tenfold MOE/uncertainty estimates of concentrations of and longan at 1.0 ppm. factor when EPA has a complete data tebufenozide in surface and ground VI. Objections and Hearing Requests base under existing guidelines and water (29 ppb and 1 ppb, respectively), when the severity of the effect in infants EPA does not expect the aggregate The new FFDCA section 408(g) or children or the potency or unusual exposure to exceed 100% of the RfD. provides essentially the same process toxic properties of a compound do not for persons to ‘‘object’’ to a tolerance 4. Short- or intermediate-term risk. raise concerns regarding the adequacy of regulation as was provided in the old Tebufenozide is not registered on any the standard MOE/safety factor. section 408 and in section 409. ii. Developmental toxicity studies. In use sites which would result in non- However, the period for filing objections prenatal developmental toxicity studies dietary, non-occupational exposure. is 60 days, rather than 30 days. EPA in rats and rabbits, there was no Therefore no short- and intermediate- currently has procedural regulations evidence of maternal or developmental term aggregate risk assessments are which govern the submission of toxicity; the maternal and needed. objections and hearing requests. These developmental NOAELS were 1,000 mg/ 5. Determination of safety. Based on regulations will require some kg/day (highest dose tested). these risk assessments, EPA concludes modification to reflect the new law. iii. Reproductive toxicity study. In 2- that there is a reasonable certainty that However, until those modifications can generation reproduction studies in rats, no harm will result to infants and be made, EPA will continue to use those toxicity to the fetuses/offspring, when children from aggregate exposure to procedural regulations with appropriate observed, occurred at equivalent or tebufenozide residues. adjustments to reflect the new law.

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Any person may, by May 17, 1999, contain CBI must be submitted for considerations as required by Executive file written objections to any aspect of inclusion in the public record. Order 12898, entitled Federal Actions to this regulation and may also request a Information not marked confidential Address Environmental Justice in hearing on those objections. Objections may be disclosed publicly by EPA Minority Populations and Low-Income and hearing requests must be filed with without prior notice. Populations (59 FR 7629, February 16, the Hearing Clerk, at the address given 1994), or require OMB review in VII. Public Record and Electronic under the ‘‘ADDRESSES’’ section (40 accordance with Executive Order 13045, Submissions CFR 178.20). A copy of the objections entitled Protection of Children from and/or hearing requests filed with the EPA has established a record for this Environmental Health Risks and Safety Hearing Clerk should be submitted to regulation under docket control number Risks (62 FR 19885, April 23, 1997). the OPP docket for this rulemaking. The [OPP–300799] (including any comments In addition, since tolerances and objections submitted must specify the and data submitted electronically). A exemptions that are established on the provisions of the regulation deemed public version of this record, including basis of a petition under FFDCA section objectionable and the grounds for the printed, paper versions of electronic 408(l)(6), such as the tolerance in this objections (40 CFR 178.25). Each comments, which does not include any final rule, do not require the issuance of objection must be accompanied by the information claimed as CBI, is available a proposed rule, the requirements of the fee prescribed by 40 CFR 180.33(i). EPA for inspection from 8:30 a.m. to 4 p.m., Regulatory Flexibility Act (RFA) (5 is authorized to waive any fee Monday through Friday, excluding legal U.S.C. 601 et seq.) do not apply. requirement ‘‘when in the judgement of holidays. The public record is located in Nevertheless, the Agency previously the Administrator such a waiver or Rm. 119 of the Public Information and assessed whether establishing refund is equitable and not contrary to Records Integrity Branch, Information tolerances, exemptions from tolerances, the purpose of this subsection.’’ For Resources and Services Division raising tolerance levels or expanding additional information regarding (7502C), Office of Pesticide Programs, exemptions might adversely impact tolerance objection fee waivers, contact Environmental Protection Agency, CM small entities and concluded, as a James Tompkins, Registration Division #2, 1921 Jefferson Davis Hwy., generic matter, that there is no adverse (7505C), Office of Pesticide Programs, Arlington, VA. economic impact. The factual basis for Environmental Protection Agency, 401 Objections and hearing requests may the Agency’s generic certification for M St., SW., Washington, DC 20460. be sent by e-mail directly to EPA at: tolerance actions published on May 4, Office location, telephone number, and [email protected]. 1981 (46 FR 24950), and was provided e-mail address: Rm. 239, CM #2, 1921 E-mailed objections and hearing to the Chief Counsel for Advocacy of the Jefferson Davis Hwy., Arlington, VA, requests must be submitted as an ASCII Small Business Administration. (703) 305-5697, [email protected]. file avoiding the use of special B. Executive Order 12875 characters and any form of encryption. Requests for waiver of tolerance Under Executive Order 12875, objection fees should be sent to James The official record for this regulation, as well as the public version, as entitled Enhancing the Hollins, Information Resources and Intergovernmental Partnership (58 FR Services Division (7502C), Office of described in this unit will be kept in paper form. Accordingly, EPA will 58093, October 28, 1993), EPA may not Pesticide Programs, Environmental issue a regulation that is not required by transfer any copies of objections and Protection Agency, 401 M St., SW., statute and that creates a mandate upon hearing requests received electronically Washington, DC 20460. a State, local or tribal government, into printed, paper form as they are If a hearing is requested, the unless the Federal government provides received and will place the paper copies objections must include a statement of the funds necessary to pay the direct in the official record which will also the factual issues on which a hearing is compliance costs incurred by those include all comments submitted directly requested, the requestor’s contentions governments. If the mandate is in writing. The official record is the on such issues, and a summary of any unfunded, EPA must provide to OMB a paper record maintained at the Virginia evidence relied upon by the requestor description of the extent of EPA’s prior address in ‘‘ADDRESSES’’ at the (40 CFR 178.27). A request for a hearing consultation with representatives of will be granted if the Administrator beginning of this document. affected State, local, and tribal determines that the material submitted VIII. Regulatory Assessment governments, the nature of their shows the following: There is genuine Requirements concerns, copies of any written and substantial issue of fact; there is a communications from the governments, reasonable possibility that available A. Certain Acts and Executive Orders and a statement supporting the need to evidence identified by the requestor This final rule establishes a tolerance issue the regulation. In addition, would, if established, resolve one or under section 408 of the FFDCA. The Executive Order 12875 requires EPA to more of such issues in favor of the Office of Management and Budget develop an effective process permitting requestor, taking into account (OMB) has exempted these types of elected officials and other uncontested claims or facts to the actions from review under Executive representatives of State, local, and tribal contrary; and resolution of the factual Order 12866, entitled Regulatory governments ‘‘to provide meaningful issues in the manner sought by the Planning and Review (58 FR 51735, and timely input in the development of requestor would be adequate to justify October 4, 1993). This final rule does regulatory proposals containing the action requested (40 CFR 178.32). not contain any information collections significant unfunded mandates.’’ Information submitted in connection subject to OMB approval under the Today’s rule does not create an with an objection or hearing request Paperwork Reduction Act (PRA), 44 unfunded Federal mandate on State, may be claimed confidential by marking U.S.C. 3501 et seq., or impose any local, or tribal governments. The rule any part or all of that information as enforceable duty or contain any does not impose any enforceable duties CBI. Information so marked will not be unfunded mandate as described under on these entities. Accordingly, the disclosed except in accordance with Title II of the Unfunded Mandates requirements of section 1(a) of procedures set forth in 40 CFR part 2. Reform Act of 1995 (UMRA) (Pub. L. Executive Order 12875 do not apply to A copy of the information that does not 104–4). Nor does it require any special this rule.

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C. Executive Order 13084 Dated: March 3, 1999. EPA to establish a time-limited tolerance or exemption from the Under Executive Order 13084, Peter Caulkins, entitled Consultation and Coordination requirement for a tolerance for pesticide Acting Director, Registration Division, Office chemical residues in food that will with Indian Tribal Governments (63 FR of Pesticide Programs. 27655, May 19, 1998), EPA may not result from the use of a pesticide under issue a regulation that is not required by Therefore, 40 CFR chapter I is an emergency exemption granted by statute, that significantly or uniquely amended as follows: EPA under FIFRA section 18. affects the communities of Indian tribal DATES: This regulation becomes PART 180Ð[AMENDED] governments, and that imposes effective March 17, 1999. Objections substantial direct compliance costs on 1. The authority citation for part 180 and requests for hearings must be those communities, unless the Federal continues to read as follows: received by EPA, on or before May 17, 1999. government provides the funds Authority: 21 U.S.C. 321(q), 346a and 371. necessary to pay the direct compliance ADDRESSES: Written objections and costs incurred by the tribal 2. In § 180.482, add the following hearing requests, identified by the governments. If the mandate is commodities to the table in paragraph docket control number [OPP–300806], unfunded, EPA must provide OMB, in (b) to read as follows: must be submitted to: Hearing Clerk a separately identified section of the § 180.482 Tebufenozide; tolerances for (1900), Environmental Protection preamble to the rule, a description of residues. Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees the extent of EPA’s prior consultation ***** with representatives of affected tribal (b) * * * accompanying objections and hearing governments, a summary of the nature requests shall be labeled ‘‘Tolerance of their concerns, and a statement Petition Fees’’ and forwarded to: EPA supporting the need to issue the Headquarters Accounting Operations regulation. In addition, Executive Order Expira- Branch, OPP (Tolerance Fees), P.O. Box 13084 requires EPA to develop an Commodity Parts per tion/rev- 360277M, Pittsburgh, PA 15251. A copy effective process permitting elected million ocation of any objections and hearing requests date officials and other representatives of filed with the Hearing Clerk identified Indian tribal governments ‘‘to provide by the docket control number, [OPP– meaningful and timely input in the ******* 300806], must also be submitted to: development of regulatory policies on Longan ...... 1.0 12/31/01 Public Information and Records matters that significantly or uniquely Lychee ...... 1.0 12/31/01 Integrity Branch, Information Resources affect their communities.’’ and Services Division (7502C), Office of Today’s rule does not significantly or ******* Pesticide Programs, Environmental uniquely affect the communities of Protection Agency, 401 M St., SW., Indian tribal governments. This action ***** Washington, DC 20460. In person, bring does not involve or impose any [FR Doc. 99–6385 Filed 3–16–99; 8:45 am] a copy of objections and hearing requirements that affect Indian tribes. BILLING CODE 6560±50±F requests to Rm. 119, Crystal Mall #2, Accordingly, the requirements of 1921 Jefferson Davis Hwy., Arlington, section 3(b) of Executive Order 13084 VA. do not apply to this rule. ENVIRONMENTAL PROTECTION A copy of objections and hearing AGENCY requests filed with the Hearing Clerk IX. Submission to Congress and the may also be submitted electronically by Comptroller General 40 CFR Part 180 sending electronic mail (e-mail) to: opp- The Congressional Review Act, 5 [OPP±300806; FRL 6065±6] [email protected]. Copies of electronic U.S.C. 801 et seq., as added by the Small objections and hearing requests must be Business Regulatory Enforcement RIN 2070±AB78 submitted as an ASCII file avoiding the Fairness Act of 1996, generally provides use of special characters and any form Dicloran; Extension of Tolerance for that before a rule may take effect, the of encryption. Copies of objections and Emergency Exemptions Agency promulgating the rule must hearing requests will also be accepted submit a rule report, which includes a AGENCY: Environmental Protection on disks in WordPerfect 5.1/6.1 or copy of the rule, to each House of the Agency (EPA). ASCII file format. All copies of Congress and the Comptroller General of electronic objections and hearing ACTION: Final rule. the United States. EPA will submit a requests must be identified by the report containing this rule and other SUMMARY: This regulation extends time- docket control number [OPP–300806]. required information to the U.S. Senate, limited tolerances for residues of the No Confidential Business Information the U.S. House of Representatives and fungicide 2,6-dichloro-4-nitroaniline (CBI) should be submitted through e- the Comptroller General of the United (dicloran) in or on peanuts at 3.0 parts mail. Copies of electronic objections and States prior to publication of the rule in per million (ppm) and peanut oil at 6.0 hearing requests on this rule may be the Federal Register. This rule is not a ppm for an additional 2–year period. filed online at many Federal Depository ‘‘major rule’’ as defined by 5 U.S.C. This tolerance will expire and is Libraries. 804(2). revoked on October 31, 2001. This FOR FURTHER INFORMATION CONTACT: By action is in response to EPA’s granting mail: Barbara Madden, Registration List of Subjects in 40 CFR Part 180 of an emergency exemption under Division (7505C), Office of Pesticide Environmental protection, section 18 of the Federal Insecticide, Programs, Environmental Protection Administrative practice and procedure, Fungicide, and Rodenticide Act (FIFRA) Agency, 401 M St., SW., Washington, Agricultural commodities, Pesticides authorizing use of the pesticide on DC 20460. Office location, telephone and pests, Reporting and recordkeeping peanuts. Section 408(l)(6) of the Federal number, and e-mail address: Rm. 284, requirements. Food, Drug, and Cosmetic Act requires Crystal Mall #2, 1921 Jefferson Davis

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Hwy., Arlington, VA, (703) 305–6463; e- Federal Regulations (CFR). Although should be sent to James Hollins, mail: [email protected]. this tolerance will expire and is revoked Information Resources and Services SUPPLEMENTARY INFORMATION: EPA on October 31, 2001, under FFDCA Division (7502C), Office of Pesticide issued a final rule, published in the section 408(l)(5), residues of the Programs, Environmental Protection Federal Register of January 5, 1998 (63 pesticide not in excess of the amounts Agency, 401 M St., SW., Washington, FR 162) (FRL–5762–4), which specified in the tolerance remaining in DC 20460. announced that on its own initiative or on peanuts and peanut oil after that If a hearing is requested, the under section 408 of the Federal Food, date will not be unlawful, provided the objections must include a statement of Drug, and Cosmetic Act (FFDCA), 21 pesticide is applied in a manner that the factual issues on which a hearing is U.S.C. 346a and (l)(6), as amended by was lawful under FIFRA and the requested, the requestor’s contentions the Food Quality Protection Act of 1996 application occurred prior to the on such issues, and a summary of any (FQPA) (Pub. L. 104–170) it established revocation of the tolerance. EPA will evidence relied upon by the requestor time-limited tolerances for the residues take action to revoke this tolerance (40 CFR 178.27). A request for a hearing of dicloran in or on peanuts at 3.0 ppm earlier if any experience with, scientific will be granted if the Administrator and peanut oil at 6.0 with an expiration data on, or other relevant information determines that the material submitted date of October 31, 1999. EPA on this pesticide indicate that the shows the following: There is genuine established the tolerances because residues are not safe. and substantial issue of fact; there is a section 408(l)(6) of the FFDCA requires I. Objections and Hearing Requests reasonable possibility that available evidence identified by the requestor EPA to establish time-limited tolerances The new FFDCA section 408(g) or exemption from the requirement for would, if established, resolve one or provides essentially the same process more of such issues in favor of the a tolerance for pesticide chemical for persons to ‘‘object’’ to a tolerance residues in food that will result from the requestor, taking into account regulation as was provided in the old uncontested claims or facts to the use of a pesticide under an emergency section 408 and in section 409. contrary; and resolution of the factual exemption granted by EPA under FIFRA However, the period for filing objections issues in the manner sought by the section 18. Such tolerances can be is 60 days, rather than 30 days. EPA requestor would be adequate to justify established without providing notice or currently has procedural regulations the action requested (40 CFR 178.32). period for public comment. which govern the submission of Information submitted in connection EPA received a request to extend the objections and hearing requests. These with an objection or hearing request use of dicloran on peanuts for the 1999 regulations will require some may be claimed confidential by marking growing season since environmental modification to reflect the new law. any part or all of that information as conditions conducive for disease However, until those modifications can CBI. Information so marked will not be outbreaks of Sclerotinia blight have be made, EPA will continue to use those developed every year and are likely to procedural regulations with appropriate disclosed except in accordance with develop this growing season. The adjustments to reflect the new law. procedures set forth in 40 CFR part 2. disease is favored by high humidity and Any person may, by May 17, 1999, A copy of the information that does not cool to warm temperatures. The disease file written objections to any aspect of contain CBI must be submitted for is expected to be most severe in the late this regulation and may also request a inclusion in the public record. summer when the prevailing hearing on those objections. Objections Information not marked confidential temperatures are cooler and the peanut and hearing requests must be filed with may be disclosed publicly by EPA plant canopy shades the soil and cools the Hearing Clerk, at the address given without prior notice. soil temperatures. After having under the ‘‘ADDRESSES’’ section (40 II. Public Record and Electronic reviewed the submission, EPA concurs CFR 178.20). A copy of the objections Submissions that emergency conditions exist. EPA and/or hearing requests filed with the has authorized under FIFRA section 18 Hearing Clerk should be submitted to EPA has established a record for this the use of dicloran on peanuts for the OPP docket for this rulemaking. The regulation under docket control number control of Sclerotinia blight in peanuts. objections submitted must specify the [OPP–300806] (including any comments EPA assessed the potential risks provisions of the regulation deemed and data submitted electronically). A presented by residues of dicloran in or objectionable and the grounds for the public version of this record, including on peanuts and peanut oil. In doing so, objections (40 CFR 178.25). Each printed, paper versions of electronic EPA considered the safety standard in objection must be accompanied by the comments, which does not include any FFDCA section 408(b)(2), and decided fee prescribed by 40 CFR 180.33(i). EPA information claimed as CBI, is available that the necessary tolerance under is authorized to waive any fee for inspection from 8:30 a.m. to 4 p.m., FFDCA section 408(l)(6) would be requirement ‘‘when in the judgement of Monday through Friday, excluding legal consistent with the safety standard and the Administrator such a waiver or holidays. The public record is located in with FIFRA section 18. The data and refund is equitable and not contrary to Room 119 of the Public Information and other relevant material have been the purpose of this subsection.’’ For Records Integrity Branch, Information evaluated and discussed in the final rule additional information regarding Resources and Services Division of January 5, 1998 (63 FR 162) (FRL– tolerance objection fee waivers, contact (7502C), Office of Pesticide Programs, 5762–4). Based on that data and James Tompkins, Registration Division Environmental Protection Agency, information considered, the Agency (7505C), Office of Pesticide Programs, Crystal Mall #2, 1921 Jefferson Davis reaffirms that extension of the time- Environmental Protection Agency, 401 Hwy., Arlington, VA. limited tolerances will continue to meet M St., SW., Washington, DC 20460. Objections and hearing requests may the requirements of section 408(l)(6). Office location, telephone number, and be sent by e-mail directly to EPA at: Therefore, the time-limited tolerances e-mail address: Rm. 239, Crystal Mall [email protected]. are extended for an additional 2–year #2, 1921 Jefferson Davis Hwy., E-mailed objections and hearing period. EPA will publish a document in Arlington, VA, (703) 305–5697, requests must be submitted as an ASCII the Federal Register to remove the [email protected]. Requests for file avoiding the use of special revoked tolerance from the Code of waiver of tolerance objection fees characters and any form of encryption.

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The official record for this regulation, Chief Counsel for Advocacy of the Small meaningful and timely input in the as well as the public version, as Business Administration. development of regulatory policies on described in this unit will be kept in B. Executive Order 12875 matters that significantly or uniquely paper form. Accordingly, EPA will affect their communities.’’ Under Executive Order 12875, transfer any copies of objections and Today’s rule does not significantly or hearing requests received electronically entitled Enhancing the uniquely affect the communities of into printed, paper form as they are Intergovernmental Partnership (58 FR Indian tribal governments. This action received and will place the paper copies 58093, October 28, 1993), EPA may not in the official record which will also issue a regulation that is not required by does not involve or impose any include all comments submitted directly statute and that creates a mandate upon requirements that affect Indian tribes. in writing. The official record is the a State, local or tribal government, Accordingly, the requirements of paper record maintained at the Virginia unless the Federal government provides section 3(b) of Executive Order 13084 address in ‘‘ADDRESSES’’ at the the funds necessary to pay the direct do not apply to this rule. beginning of this document. compliance costs incurred by those governments. If the mandate is IV. Submission to Congress and the III. Regulatory Assessment unfunded, EPA must provide to OMB a Comptroller General Requirements description of the extent of EPA’s prior The Congressional Review Act, 5 A. Certain Acts and Executive Orders consultation with representatives of U.S.C. 801 et seq., as added by the Small affected State, local, and tribal Business Regulatory Enforcement This final rule establishes a tolerance governments, the nature of their under section 408 of the FFDCA. The concerns, copies of any written Fairness Act of 1996, generally provides Office of Management and Budget communications from the governments, that before a rule may take effect, the (OMB) has exempted these types of and a statement supporting the need to Agency promulgating the rule must actions from review under Executive issue the regulation. In addition, submit a rule report, which includes a Order 12866, entitled Regulatory Executive Order 12875 requires EPA to copy of the rule, to each House of the Planning and Review (58 FR 51735, develop an effective process permitting Congress and the Comptroller General of October 4, 1993). This final rule does elected officials and other the United States. EPA will submit a not contain any information collections representatives of State, local, and tribal report containing this rule and other subject to OMB approval under the governments ‘‘to provide meaningful required information to the U.S. Senate, Paperwork Reduction Act (PRA), 44 and timely input in the development of the U.S. House of Representatives and U.S.C. 3501 et seq., or impose any regulatory proposals containing the Comptroller General of the United enforceable duty or contain any significant unfunded mandates.’’ States prior to publication of the rule in unfunded mandate as described under Today’s rule does not create an the Federal Register. This rule is not a Title II of the Unfunded Mandates unfunded Federal mandate on State, ‘‘major rule’’ as defined by 5 U.S.C. Reform Act of 1995 (UMRA) (Pub. L. local, or tribal governments. The rule 804(2). 104–4). Nor does it require any prior does not impose any enforceable duties consultation as specficed by Executive on these entities. Accordingly, the List of Subjects in 40 CFR Part 180 Order 12875, entitled Enhancing the requirements of section 1(a) of Intergovernmental Partnership (58 FR Executive Order 12875 do not apply to Environmental protection, 58093, October 28, 1993), or special this rule. Administrative practice and procedure, considerations as required by Executive Agricultural commodities, Pesticides Order 12898, entitled Federal Actions to C. Executive Order 13084 and pests, Reporting and recordkeeping Address Environmental Justice in Under Executive Order 13084, requirements. Minority Populations and Low-Income entitled Consultation and Coordination Dated: March 5, 1999. Populations (59 FR 7629, February 16, with Indian Tribal Governments (63 FR 1994), or require OMB review in 27655, May 19, 1998), EPA may not James Jones, accordance with Executive Order 13045, issue a regulation that is not required by Director, Registration Division, Office of entitled Protection of Children from statute, that significantly or uniquely Pesticide Programs. affects the communities of Indian tribal Environmental Health Risks and Safety Therefore, 40 CFR chapter I is Risks (62 FR 19885, April 23, 1997). governments, and that imposes amended as follows: In addition, since tolerances and substantial direct compliance costs on exemptions that are established under those communities, unless the Federal PART 180 Ð [AMENDED] section 408(l)(6) of FFDCA, such as the government provides the funds tolerance in this final rule, do not necessary to pay the direct compliance 1. The authority citation for part 180 require the issuance of a proposed rule, costs incurred by the tribal continues to read as follows: the requirements of the Regulatory governments. If the mandate is Flexibility Act (RFA) (5 U.S.C. 601 et unfunded, EPA must provide OMB, in Authority: 21 U.S.C. 346a and 371. seq.) do not apply. Nevertheless, the a separately identified section of the Agency previously assessed whether preamble to the rule, a description of establishing tolerances, exemptions the extent of EPA’s prior consultation §180.200 [Amended] from tolerances, raising tolerance levels with representatives of affected tribal 2. In §180.200, by amending the table or expanding exemptions might governments, a summary of the nature in paragraph (b) for the following adversely impact small entities and of their concerns, and a statement commodities ‘‘Peanut, oil ’’ and ‘‘ concluded, as a generic matter, that supporting the need to issue the Peanuts’’ by changing the date ‘‘10/31/ there is no adverse economic impact. regulation. In addition, Executive Order 99’’ to read ‘‘10/31/01.’’ The factual basis for the Agency’s 13084 requires EPA to develop an generic certification for tolerance effective process permitting elected [FR Doc. 99–6384 Filed 3–16–99; 8:45 am] actions published on May 4, 1981 (46 officials and other representatives of BILLING CODE 6560±50±F FR 24950), and was provided to the Indian tribal governments ‘‘to provide

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ENVIRONMENTAL PROTECTION A copy of objections and hearing the emergency exemption for use of AGENCY requests filed with the Hearing Clerk propiconazole on sorghum (61 FR may also be submitted electronically by 58135, November 13, 1996) (FRL–5572– 40 CFR Part 180 sending electronic mail (e-mail) to: opp- 9). [email protected]. Copies of electronic New section 408(b)(2)(A)(i) of the [OPP±300809; FRL±6067±9] objections and hearing requests must be FFDCA allows EPA to establish a RIN 2070±AB78 submitted as an ASCII file avoiding the tolerance (the legal limit for a pesticide use of special characters and any form chemical residue in or on a food) only Maneb (manganous of encryption. Copies of objections and if EPA determines that the tolerance is ethylenebisdithiocarbamate); Pesticide hearing requests will also be accepted ‘‘safe.’’ Section 408(b)(2)(A)(ii) defines Tolerances for Emergency Exemptions on disks in WordPerfect 5.1/6.1 or ‘‘safe’’ to mean that ‘‘there is a ASCII file format. All copies of reasonable certainty that no harm will AGENCY: Environmental Protection electronic objections and hearing result from aggregate exposure to the Agency (EPA). requests must be identified by the pesticide chemical residue, including ACTION: Final rule. docket control number [OPP–300809]. all anticipated dietary exposures and all No Confidential Business Information other exposures for which there is SUMMARY: This regulation establishes a (CBI) should be submitted through e- reliable information.’’ This includes time-limited tolerance for residues of mail. Copies of electronic objections and exposure through drinking water and in maneb (manganous hearing requests on this rule may be residential settings, but does not include ethylenebisdithiocarbamate), calculated filed online at many Federal Depository occupational exposure. Section as zinc ethylenebisdithiocarbamate and Libraries. 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and its metabolite ethylenethiourea in or on FOR FURTHER INFORMATION CONTACT: By children to the pesticide chemical walnuts . This action is in response to mail: Meredith Laws, Registration residue in establishing a tolerance and EPA’s granting of an emergency Division (7505C), Office of Pesticide to ‘‘ensure that there is a reasonable exemption under section 18 of the Programs, Environmental Protection certainty that no harm will result to Federal Insecticide, Fungicide, and Agency, 401 M St., SW., Washington, infants and children from aggregate Rodenticide Act authorizing use of the DC 20460. Office location, telephone exposure to the pesticide chemical pesticide on walnuts.This regulation number, and e-mail address: Rm. 282, residue. . . .’’ establishes a maximum permissible CM #2, 1921 Jefferson Davis Hwy., level for residues of maneb (manganous Section 18 of FIFRA authorizes EPA Arlington, VA, (703) 308–9366, to exempt any Federal or State agency ethylenebisdithiocarbamate) in this food [email protected]. commodity pursuant to section 408(l)(6) from any provision of FIFRA, if EPA SUPPLEMENTARY INFORMATION: EPA, on of the Federal Food, Drug, and Cosmetic determines that ‘‘emergency conditions its own initiative, pursuant to sections Act, as amended by the Food Quality exist which require such exemption.’’ 408 and (l)(6) of the Federal Food, Drug, Protection Act of 1996. The tolerance This provision was not amended by and Cosmetic Act (FFDCA), 21 U.S.C. will expire and is revoked on December FQPA. EPA has established regulations 346a and (l)(6), is establishing a 31, 2000. governing such emergency exemptions tolerance for residues of the fungicide in 40 CFR part 166. DATES: This regulation is effective maneb (manganous Section 408(l)(6) of the FFDCA March 17, 1999. Objections and requests ethylenebisdithiocarbamate), calculated requires EPA to establish a time-limited for hearings must be received by EPA on as zinc ethylenebisdithiocarbamate and tolerance or exemption from the or before May 17, 1999. its metabolite ethylenethiourea, in or on requirement for a tolerance for pesticide ADDRESSES: Written objections and walnuts at 0.05 part per million (ppm). chemical residues in food that will hearing requests, identified by the This tolerance will expire and is result from the use of a pesticide under docket control number [OPP–300809], revoked on December 31, 2000. EPA an emergency exemption granted by must be submitted to: Hearing Clerk will publish a document in the Federal EPA under section 18 of FIFRA. Such (1900), Environmental Protection Register to remove the revoked tolerances can be established without Agency, Rm. M3708, 401 M St., SW., tolerance from the Code of Federal providing notice or period for public Washington, DC 20460. Fees Regulations. comment. accompanying objections and hearing I. Background and Statutory Findings Because decisions on section 18- requests shall be labeled ‘‘Tolerance related tolerances must proceed before Petition Fees’’ and forwarded to: EPA The Food Quality Protection Act of EPA reaches closure on several policy Headquarters Accounting Operations 1996 (FQPA) (Pub. L. 104–170) was issues relating to interpretation and Branch, OPP (Tolerance Fees), P.O. Box signed into law August 3, 1996. FQPA implementation of the FQPA, EPA does 360277M, Pittsburgh, PA 15251. A copy amends both the Federal Food, Drug, not intend for its actions on such of any objections and hearing requests and Cosmetic Act (FFDCA), 21 U.S.C. tolerances to set binding precedents for filed with the Hearing Clerk identified 301 et seq., and the Federal Insecticide, the application of section 408 and the by the docket control number, [OPP– Fungicide, and Rodenticide Act new safety standard to other tolerances 300809], must also be submitted to: (FIFRA), 7 U.S.C. 136 et seq. The FQPA and exemptions. Public Information and Records amendments went into effect Integrity Branch, Information Resources immediately. Among other things, II. Emergency Exemption for Maneb and Services Division (7502C), Office of FQPA amends FFDCA to bring all EPA (manganous Pesticide Programs, Environmental pesticide tolerance-setting activities ethylenebisdithiocarbamate) on Protection Agency, 401 M St., SW., under a new section 408 with a new Walnuts and FFDCA Tolerances Washington, DC 20460. In person, bring safety standard and new procedures. The California Department of a copy of objections and hearing These activities are described in this Pesticide Regulation has requested an requests to Rm. 119, Crystal Mall 2 (CM preeamble and discussed in greater emergency exemption under FIFRA #2), 1921 Jefferson Davis Hwy., detail in the final rule establishing the section 18 to use maneb on walnuts to Arlington, VA. time-limited tolerance associated with control bacterial blight. Currently,

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.016 pfrm07 PsN: 17MRR1 13098 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations copper based bactericides are the only section 24(c). Nor does this tolerance milligrams/kilogram/day (mg/kg/day)) registered products for control of this serve as the basis for any State other than the NOAEL for acute dietary risk disease. The increase of walnut blight than to use this pesticide on this crop for maneb (20 mg/kg/day). Therefore, an since 1992 is attributed to the under section 18 of FIFRA without acceptable margin of exposure (MOE) development of a tolerance to copper following all provisions of EPA’s for ETU will also be protective of based bactericides. The state has regulations implementing section 18 as exposure to maneb. The oral demonstrated that copper resistant identified in 40 CFR part 166. For developmental NOAEL in rats for ETU bacteria have become economically additional information regarding the is 5 mg/kg/day, based on a threshold important, with a potential 55,000 acres emergency exemption for maneb finding of delayed ossification in the affected. EPA has authorized under (manganous fetal skeletal structures at the NOAEL. FIFRA section 18 the use of maneb ethylenebisdithiocarbamate), contact the The NOAEL is more correctly identified (manganous Agency’s Registration Division at the as a slightly lower dose level which is ethylenebisdithiocarbamate) on walnuts address provided under the close to a threshold NOAEL in the for control of bacterial blight in ‘‘ADDRESSES’’ section. developmental study. The EBDC PD-4 California. After having reviewed the stated that MOEs could be calculated III. Aggregate Risk Assessment and submission, EPA concurs that from the 5 mg/kg/day NOAEL, which Determination of Safety emergency conditions exist for this was close to the NOAEL, and was the state. EPA performs a number of analyses to lowest dose tested. As part of its assessment of this determine the risks from aggregate 2. Short - and intermediate - term emergency exemption, EPA assessed the exposure to pesticide residues. For toxicity. EPA recommends use of the potential risks presented by residues of further discussion of the regulatory systemic NOAEL of 100 mg/kg/day from maneb (manganous requirements of section 408 and a the 3-week dermal toxicity study in ethylenebisdithiocarbamate) in or on complete description of the risk rabbits. At the lowest observed adverse walnuts. In doing so, EPA considered assessment process, see the final rule on effect level (LOAEL) of 300 mg/kg/day, the safety standard in FFDCA section Bifenthrin Pesticide Tolerances (62 FR there were slightly increased thyroid 408(b)(2), and EPA decided that the 62961, November 26, 1997) (FRL–5754– weights and follicular cell hypertrophy necessary tolerance under FFDCA 7) . of the thyroid. section 408(l)(6) would be consistent Consistent with section 408(b)(2)(D), 3. Chronic toxicity. EPA has with the safety standard and with EPA has reviewed the available established the Reference Dose (RfD) for FIFRA section 18. Consistent with the scientific data and other relevant ETU at 0.00008 mg/kg/day. This RfD is need to move quickly on the emergency information in support of this action. based on the LOAEL of 0.25 mg/kg/day exemption in order to address an urgent EPA has sufficient data to assess the due to thyroid hyperplasia in a 2-year non-routine situation and to ensure that hazards of maneb (manganous rat feeding study, with an uncertainty the resulting food is safe and lawful, ethylenebisdithiocarbamate) and to factor of 3,000. The uncertainty factor of EPA is issuing this tolerance without make a determination on aggregate 3,000 was based on a factor of 3 for notice and opportunity for public exposure, consistent with section absence of a NOAEL for ETU, a factor comment under section 408(e), as 408(b)(2), for a time-limited tolerance of 10 for data gaps for ETU, and a factor provided in section 408(l)(6). Although for residues of maneb (manganous of 100 to take into account inter- and this tolerance will expire and is revoked ethylenebisdithiocarbamate), calculated intra-species variability. on December 31, 2000, under FFDCA as zinc ethylenebisdithiocarbamate and 4. Carcinogenicity. Maneb has been section 408(l)(5), residues of the its metabolite ethylenethiourea on classified as a Group B2, probable pesticide not in excess of the amounts walnuts at 0.05 ppm. EPA’s assessment human carcinogen, based on evidence of specified in the tolerance remaining in of the dietary exposures and risks thyroid tumors in rats and liver tumors. or on walnuts after that date will not be associated with establishing the The Q1* for quantitation of human oral unlawful, provided the pesticide is tolerance follows. risk is 0.0601 (mg/kg/day)±1 for the applied in a manner that was lawful carcinogenic metabolite, ETU. under FIFRA, and the residues do not A. Toxicological Profile C. Exposures and Risks exceed a level that was authorized by EPA has evaluated the available this tolerance at the time of that toxicity data and considered its validity, 1. From food and feed uses. application. EPA will take action to completeness, and reliability as well as Tolerances have been established (40 revoke this tolerance earlier if any the relationship of the results of the CFR 180.110) for the residues of maneb experience with, scientific data on, or studies to human risk. EPA has also (manganous other relevant information on this considered available information ethylenebisdithiocarbamate), calculated pesticide indicate that the residues are concerning the variability of the as zinc ethylenebisdithiocarbamate and not safe. sensitivities of major identifiable its metabolite ethylenethiourea, in or on Because this tolerance is being subgroups of consumers, including a variety of raw agricultural approved under emergency conditions infants and children. The nature of the commodities including almonds at 0.1 EPA has not made any decisions about toxic effects caused by maneb (based on ppm. Risk assessments were conducted whether maneb (manganous calculations on its metabolite, by EPA to assess dietary exposures and ethylenebisdithiocarbamate) meets ethylenethiourea) are discussed in this risks from maneb (manganous EPA’s registration requirements for use unit. ethylenebisdithiocarbamate) as follows: on walnuts or whether a permanent i. Acute exposure and risk. Acute tolerance for this use would be B. Toxicological Endpoint dietary risk assessments are performed appropriate. Under these circumstances, 1. Acute toxicity. The acute dietary for a food-use pesticide if a toxicological EPA does not believe that this tolerance risk assessment is being conducted for study has indicated the possibility of an serves as abasis for registration of maneb ethylenethiourea (ETU) rather than effect of concern occurring as a result of (manganous maneb, since the no observed adverse a 1-day or single exposure. The high end ethylenebisdithiocarbamate) by a State effect level (NOAEL) for acute dietary dietary exposure for the population for special local needs under FIFRA risk for ETU is 4 times lower (5 subgroup of concern, females 13+ years

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The Agency’s responsibilities in assessing toxicological endpoints (RfD’s or acute chronic exposure estimate for the chronic dietary risk findings, have been dietary no observed adverse effect levels general population is 0.000020 mg/kg/ met. The PCT estimates are derived (NOAEL’s)) and assumptions about day and the anticipated residue from Federal and private market survey body weight and consumption, to contribution (ARC) as percentage of the data, which are reliable and have a valid calculate, for each pesticide, the RfD is 24.4%. basis. Typically, a range of estimates are increment of aggregate risk contributed Section 408(b)(2)(E) authorizes EPA to supplied and the upper end of this by consumption of contaminated water. use available data and information on range is assumed for the exposure While EPA has not yet pinpointed the the anticipated residue levels of assessment. By using this upper end appropriate bounding figure for pesticide residues in food and the actual estimate of the PCT, the Agency is exposure from contaminated water, the levels of pesticide chemicals that have reasonably certain that that the ranges the Agency is continuing to been measured in food. If EPA relies on percentage of the food treated is not examine are all below the level that such information, EPA must require that likely to be underestimated. The would cause maneb (manganous data be provided 5 years after the regional consumption information and ethylenebisdithiocarbamate) to exceed tolerance is established, modified, or consumption information for significant the RfD if the tolerance being left in effect, demonstrating that the subpopulations is taken into account considered in this document were levels in food are not above the levels through EPA’s computer-based model granted. The Agency has therefore anticipated. Following the initial data for evaluating the exposure of concluded that the potential exposures submission, EPA is authorized to significant subpopulations including associated with maneb (manganous require similar data on a time frame it several regional groups. Use of this ethylenebisdithiocarbamate) in water, deems appropriate. As required by consumption information in EPA’s risk even at the higher levels the Agency is section 408(b)(2)(E), EPA will issue a assessment process ensures that EPA’s considering as a conservative upper data call-in for information relating to exposure estimate does not understate bound, would not prevent the Agency anticipated residues to be submitted no exposure for any significant from determining that there is a later than 5 years from the date of subpopulation group and allows the reasonable certainty of no harm if the issuance of this tolerance. Agency to be reasonably certain that no tolerance is granted. Section 408(b)(2)(F) states that the regional population is exposed to 3. From non-dietary exposure. Maneb Agency may use data on the actual residue levels higher than those (manganous percent of food treated (PCT) for estimated by the Agency. Other than the ethylenebisdithiocarbamate) is currently assessing chronic dietary risk only if the data available through national food registered for use on the following Agency can make the following consumption surveys, EPA does not residential non-food sites: turf, lawn, findings: That the data used are reliable have available information on the trees, and shrubs. Maneb is not and provide a valid basis to show what regional consumption of food to which registered for indoor uses. While EPA percentage of the food derived from maneb may be applied in a particular such crop is likely to contain such area. does not consider that these types of pesticide residue; that the exposure 2. From drinking water. Submitted outdoor residential uses constitute a estimate does not underestimate environmental fate studies suggest that chronic residential exposure scenario, exposure for any significant maneb has moderate potential to leach EPA acknowledges that there may be subpopulation group; and if data are into ground water; thus maneb could short- and intermediate-term non- available on pesticide use and food potentially leach to ground water and occupational exposure scenarios. The consumption in a particular area, the runoff to surface water under certain Agency has identified toxicity exposure estimate does not understate environmental conditions. There are no endpoints for short- and intermediate- exposure for the population in such established Maximum Contaminant term residential risk assessments. For area. In addition, the Agency must Levels (MCLs) for residues of maneb in this action, the risk to public health provide for periodic evaluation of any drinking water. No Health Advisories from the use of maneb is calculated estimates used. To provide for the (HA) for maneb in drinking water have based on it’s metabolite/degradate ETU. periodic evaluation of the estimate of been established. However, EPA has However, no acceptable reliable percent crop treated as required by the considered the carcinogenic risk exposure data to assess these potential section 408(b)(2)(F), EPA may require resulting from a maximum theoretical risks are available at this time. Given the registrants to submit data on PCT. drinking water residue of 1.0 parts per time-limited nature of this request, the The Agency used PCT information as billion (ppb) for ETU. ETU, which is need to make emergency exemption follows: highly soluble in water, is assumed to decisions quickly, the significant In the Dietary Risk Evaluation Model be persistent and highly mobile. scientific uncertainty at this time about (DEEM), it was assumed that 100% of Chronic exposure and risk. Because how to aggregate non-occupational the walnut crop would be treated under the Agency lacks sufficient water- exposure with dietary exposure, the this emergency exemption. Refined related exposure data to complete a Agency will make it’s safety percent crop treated values were used comprehensive drinking water risk determination for these tolerances based for some commodities such as 10% for assessment for many pesticides, EPA on those factors which it can reasonably cranberries, 50% for apples, 15% for has commenced and nearly completed a integrate into a risk assessment. pears, and 10% for almonds. The DEEM process to identify a reasonable yet i. Chronic exposure and risk. The run did not use refined percent crop conservative bounding figure for the Agency has concluded that a chronic treated values for all registered uses, potential contribution of water-related residential exposure scenario does not however, 100% crop treated was used exposure to the aggregate risk posed by exist for non-occupational uses of for a number of commodities such as a pesticide. In developing the bounding maneb.

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ii. Short- and intermediate-term expect the aggregate exposure to exceed or more subsequent to the March exposure and risk. The amortized ETU 100% of the RfD. sampling event. ETU was not detected cancer risk for the U.S. population for 3. Short- and intermediate-term risk. in any of these ground-water samples at short- and intermediate-term exposure Short- and intermediate-term aggregate that later date. to the turf use of maneb has been exposure takes into account chronic There were two ETU detections in the calculated to be 2.2 x 10±7. dietary food and water (considered to be ground water in the U.S. EPA’s 4. Cumulative exposure to substances a background exposure level) plus statistically designed National Pesticide with common mechanism of toxicity. indoor and outdoor residential Survey (NPS). The NPS analyzed a Section 408(b)(2)(D)(v) requires that, exposure. statistically representative sample of when considering whether to establish, Although surface and ground water wells to provide a national assessment modify, or revoke a tolerance, the monitoring data are limited, maneb does of the presence of pesticides in drinking Agency consider ‘‘available have the potential to leach into water wells. On the basis of this study, information’’ concerning the cumulative groundwater and run off to surface EPA estimated that nationally, 8,470 effects of a particular pesticide’s water. California monitoring programs rural domestic wells could contain ETU residues and ‘‘other substances that have picked up one detect of .725 ppb, over the NPS reporting limit of 4.5 ppb. have a common mechanism of toxicity.’’ in three years of sampling (1986–89). The 95% confidence interval ranged Subsequent sampling 4 - 5 months later EPA does not have, at this time, from 1 to 111,000 wells. One quantified showed no residues. California has not available data to determine whether ETU detection of 16.0 ppb was obtained found ETU when surveying high EBDC maneb (manganous from a rural well in Warren County, use areas. There were two detections in ethylenebisdithiocarbamate) has a Illinois. A second detection, described the U.S. EPA’s National Pesticide common mechanism of toxicity with as a ‘‘trace’’ detection, was reported in Survey. The MOE for the U.S. other substances or how to include this Iowa. For this compound in the NPS, population exceeds the desired MOE, pesticide in a cumulative risk samples containing ETU at therefore, EPA has no short- or concentrations greater than 9.0 ppb assessment. Unlike other pesticides for intermediate-term aggregate risk were quantified; samples containing which EPA has followed a cumulative concerns. concentrations between 4.5 and 9.0 ppb risk approach based on a common 4. Aggregate cancer risk for U.S. were reported as ‘‘trace’’; and no mechanism of toxicity, maneb population. The aggregate dietary cancer detections were reported if (manganous risk for maneb is based on ETU. The concentrations were below 4.5 ppb. The ethylenebisdithiocarbamate) does not dietary cancer risk is calculated using source of the ETU was not determined; appear to produce a toxic metabolite the Q* for ETU, 0.601 mg/kg/day±1. EPA however, both agricultural and produced by other substances, other calculated that the dietary cancer risk industrial practices may contribute to than ETU, a metabolite common to the for the EBDC pesticides, including this ETU contamination of the ground water. EBDC pesticides. For more information use on walnuts is 1.2 x 10-6. This risk These limited sampling results regarding EPA’s efforts to determine assessment is partially refined; indicate some potential for ETU to be which chemicals have a common incorporation of percent crop treated found in ground water. However, there mechanism of toxicity and to evaluate information for all commodities would are significant uncertainties associated the cumulative effects of such result in a lower dietary exposure with using these data in quantitative chemicals, see the final rule for estimate. The cancer risk from the carcinogenic risk assessment for Bifenthrin Pesticide Tolerances (62 FR residential uses of EBDC pesticides is purposes of national tolerance-setting. 62961, November 26, 1997). approximately 10-7. The aggregate EPA is uncertain as to whether a D. Aggregate Risks and Determination of cancer risk estimate would not exceed significant subpopulation would be Safety for U.S. Population EPA’s acceptable level unless the exposed to high enough concentrations drinking water concentration exceeds 1 of ETU (greater than 1 ppb) for a long 1. Acute risk. The MOE for females ppb. The availability of surface-water enough period of time to pose a 13+ years was calculated to be 5,000. and ground-water monitoring data for significant carcinogenic risk. For Therefore, aggregate acute risk estimates maneb and ETU is limited. EPA is not example, in the ground-water sampling do not exceed the Agency’s level of aware of any surface-water monitoring conducted in San Joaquin County concern. data for either maneb or ETU, and it between 1986–1989, the single 2. Chronic risk. Using the ARC does not have any ground-water contaminated well (out of 65 tested) exposure assumptions described in this monitoring data for maneb. However, subsequently was found 4 months later unit, EPA has concluded that aggregate EPA has ground-water monitoring data to have no detectable levels of ETU. exposure to maneb (manganous which indicates that ETU has leached Additionally, although the NPS results ethylenebisdithiocarbamate) from food into the ground water; some of which show two detections of ETU in ground will utilize 24.4% of the RfD for the U.S. are direct drinking water sources. water, it is not clear whether population. The major identifiable In California from 1986 to 1989, 65 agricultural or industrial practices were subgroup with the highest aggregate wells were monitored for ETU. One well the source of the ETU. If the source of exposure is non-nursing infants (<1 year in San Joaquin County during March the ETU was industrial and not old) discussed below. EPA generally has 1988 had an ETU concentration of 0.725 agricultural use, it is likely that no concern for exposures below 100% ppb. The remainder of the samples had contamination of ground water with of the RfD because the RfD represents no ETU detections (limit of detection ETU would be less widespread than is the level at or below which daily (LOD) of 0.5 ppb). The California suggested by the statistical analysis of aggregate dietary exposure over a Department of Food and Agriculture the NPS results. EPA does not believe lifetime will not pose appreciable risks concluded that this ETU concentration that the available data demonstrate that to human health. Despite the potential in the ground water did not represent a a significant subpopulation would be for exposure to maneb (manganous legal agriculture use based upon another exposed to residues of ETU in drinking ethylenebisdithiocarbamate) in drinking sampling event where this well and five water greater than 1 ppb; therefore, EPA water and from non-dietary, non- nearby wells in a predominantly walnut does not believe that the aggregate occupational exposure, EPA does not orchard use area were sampled 125 days cancer risk associated with the granting

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.016 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13101 of this tolerance would exceed day. The developmental (pup) NOAEL 5. Determination of safety. Based on acceptable levels. was 6.0 mg/kg/day, based on increased these risk assessments, EPA concludes 5. Determination of safety. Based on startle response at the LOAEL of 25 mg/ that there is a reasonable certainty that these risk assessments, EPA concludes kg/day. no harm will result to infants and that there is a reasonable certainty that iv. Pre- and post-natal sensitivity. The children from aggregate exposure to no harm will result from aggregate rat developmental study with ETU maneb (manganous exposure to maneb (manganous demonstrated a special prenatal ethylenebisdithiocarbamate) residues. ethylenebisdithiocarbamate) residues. sensitivity for infants and children. The IV. Other Considerations E. Aggregate Risks and Determination of results of the rat reproduction study Safety for Infants and Children with maneb do not demonstrate any A. Metabolism In Plants and Animals additional special post-natal sensitivity The nature of the residue in plants is 1. Safety factor for infants and for infants and children, since the children —i. In general. In assessing the adequately understood. The residues of NOAEL and LOAEL for parental toxicity concern are the fungicide maneb, potential for additional sensitivity of and pup toxicity occur at the same infants and children to residues of calculated as zinc doses and the pup effects are not of ethylenebisdithiocarbamate, and its maneb (manganous unusual concern. ethylenebisdithiocarbamate), EPA metabolite ethylenthiourea. Secondary v. Conclusion. In the absence of a considered data from developmental residues are not expected in animal complete data base for ETU, EPA is toxicity studies in the rat and a 2- commodities as no feed items are assuming an additional tenfold safety generation reproduction study in the rat. associated with this use. factor to account for the possibility of The developmental toxicity studies are special prenatal sensitivity for infants B. Analytical Enforcement Methodology designed to evaluate adverse effects on and children. Adequate enforcement methodology the developing organism resulting from is available for maneb in the Pesticide maternal pesticide exposure during 2. Acute risk. The acute dietary risk Analytical Manual (PAM) II Method III. gestation. Reproduction studies provide assessment for ETU residues information relating to effects from demonstrated an MOE of 5,000 based on C. Magnitude of Residues the NOAEL of 5 mg/kg/day in the rat exposure to the pesticide on the Residues of maneb (manganous reproductive capability of mating developmental study. Therefore, this calculated MOE for ETU for females 13+ ethylenebisdithiocarbamate) calculated animals and data on systemic toxicity. as zinc ethylenebisdithiocarbamate and FFDCA section 408 provides that EPA years of age shows that the MOEs for this population subgroup are far in its metabolite ethylenethiourea are not shall apply an additional tenfold margin expected to exceed 0.05 ppm in or on of safety for infants and children in the excess of the required dietary MOE of 1,000 due to ETU data gaps. Therefore, walnuts as a result of this proposed use. case of threshold effects to account for Secondary residues are not expected in pre-and post-natal toxicity and the the acute dietary risks for ETU to females 13+ years of age are below animal commodities as no feed items completeness of the database unless are associated with this use. EPA determines that a different margin EPA’s level of concern. The RfD for ETU of safety will be safe for infants and incorporates an uncertainty factor of D. International Residue Limits 3,000. The uncertainty factor was based children. Margins of safety are No Codex, Canadian, or Mexican on a factor of 3 for absence of a NOAEL incorporated into EPA risk assessments maximum residue levels have been for ETU, a factor of 10 for data gaps either directly through use of a margin established for residues of maneb in/on needed to assess extra sensitivity to of exposure (MOE) analysis or through walnuts. using uncertainty (safety) factors in infants and children for ETU, and the calculating a dose level that poses no normal factor of 100 for converting V. Conclusion appreciable risk to humans. EPA between and within species (EBDC PD/ Therefore, the tolerance is established believes that reliable data support using 4, 3/2/92). for residues of maneb (manganous the standard MOE and uncertainty 3. Chronic risk. Using the exposure ethylenebisdithiocarbamate), calculated factor (usually 100 for combined inter- assumptions described in this unit, EPA as zinc ethylenebisdithiocarbamate and and intra-species variability) and not the has concluded that aggregate exposure its metabolite ethylenethiourea in additional tenfold MOE/uncertainty to maneb (manganous walnuts at 0.05 ppm. factor when EPA has a complete data ethylenebisdithiocarbamate) from food VI. Objections and Hearing Requests base under existing guidelines and will utilize 78.4% of the RfD for when the severity of the effect in infants nonnursing infants (<1 year old). EPA The new FFDCA section 408(g) or children or the potency or unusual generally has no concern for exposures provides essentially the same process toxic properties of a compound do not below 100% of the RfD because the RfD for persons to ‘‘object’’ to a tolerance raise concerns regarding the adequacy of represents the level at or below which regulation issued by EPA under new the standard MOE/safety factor. daily aggregate dietary exposure over a section 408 and (l)(6) as was provided ii. Developmental toxicity studies. lifetime will not pose appreciable risks in the old section 408 and in section From the rat developmental study for to human health. Despite the potential 409. However, the period for filing ETU, the oral developmental NOAEL is for exposure to maneb (manganous objections is 60 days, rather than 30 5 mg/kg/day, based on a threshold ethylenebisdithiocarbamate) in drinking days. EPA currently has procedural finding of delayed ossification in the water and from non-dietary, non- regulations which govern the fetal skeletal structures at the NOAEL. occupational exposure, EPA does not submission of objections and hearing iii. Reproductive toxicity study. There expect the aggregate exposure to exceed requests. These regulations will require is no reproduction study with ETU 100% of the RfD. some modification to reflect the new available. In the rat reproduction study 4. Short- or intermediate-term risk. law. However, until those modifications for maneb, the parental (systemic) The MOEs for infants and children can be made, EPA will continue to use NOAEL was 6.0 mg/kg/day, based on exceed the desired MOE, therefore, EPA those procedural regulations with decreased body weight and food has no short- and intermediate-term appropriate adjustments to reflect the consumption at the LOAEL of 25 mg/kg/ aggregate risk concerns. new law.

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Any person may, by May 17, 1999, contain CBI must be submitted for 104–4). Nor does it require any special file written objections to any aspect of inclusion in the public record. considerations as required by Executive this regulation and may also request a Information not marked confidential Order 12898, entitled Federal Actions to hearing on those objections. Objections may be disclosed publicly by EPA Address Environmental Justice in and hearing requests must be filed with without prior notice. Minority Populations and Low-Income the Hearing Clerk, at the address given Populations (59 FR 7629, February 16, VII. Public Record and Electronic under the ‘‘ADDRESSES’’ section (40 1994), or require OMB review in Submissions CFR 178.20). A copy of the objections accordance with Executive Order 13045, and/or hearing requests filed with the EPA has established a record for this entitled Protection of Children from Hearing Clerk should be submitted to regulation under docket control number Environmental Health Risks and Safety the OPP docket for this rulemaking. The [OPP–300809] (including any comments Risks (62 FR 19885, April 23, 1997). objections submitted must specify the and data submitted electronically). A In addition, since tolerances and provisions of the regulation deemed public version of this record, including exemptions that are established on the objectionable and the grounds for the printed, paper versions of electronic basis of a petition under FFDCA section objections (40 CFR 178.25). Each comments, which does not include any 408(l)(6), such as the tolerance in this objection must be accompanied by the information claimed as CBI, is available final rule, do not require the issuance of fee prescribed by 40 CFR 180.33(i). EPA for inspection from 8:30 a.m. to 4 p.m., a proposed rule, the requirements of the is authorized to waive any fee Monday through Friday, excluding legal Regulatory Flexibility Act (RFA) (5 requirement ‘‘when in the judgement of holidays. The public record is located in U.S.C. 601 et seq.) do not apply. the Administrator such a waiver or Rm. 119 of the Public Information and Nevertheless, the Agency previously refund is equitable and not contrary to Records Integrity Branch, Information assessed whether establishing the purpose of this subsection.’’ For Resources and Services Division tolerances, exemptions from tolerances, additional information regarding (7502C), Office of Pesticide Programs, raising tolerance levels or expanding tolerance objection fee waivers, contact Environmental Protection Agency, CM exemptions might adversely impact James Tompkins, Registration Division #2, 1921 Jefferson Davis Hwy., small entities and concluded, as a (7505C), Office of Pesticide Programs, Arlington, VA. generic matter, that there is no adverse Environmental Protection Agency, 401 Objections and hearing requests may economic impact. The factual basis for M St., SW., Washington, DC 20460. be sent by e-mail directly to EPA at: the Agency’s generic certification for Office location, telephone number, and [email protected]. tolerance actions published on May 4, e-mail address: Rm. 239, CM #2, 1921 1981 (46 FR 24950), and was provided Jefferson Davis Hwy., Arlington, VA, E-mailed objections and hearing to the Chief Counsel for Advocacy of the (703) 305–5697, [email protected]. requests must be submitted as an ASCII Small Business Administration. Requests for waiver of tolerance file avoiding the use of special objection fees should be sent to James characters and any form of encryption. B. Executive Order 12875 Hollins, Information Resources and The official record for this regulation, Under Executive Order 12875, Services Division (7502C), Office of as well as the public version, as entitled Enhancing the Pesticide Programs, Environmental described in this unit will be kept in Intergovernmental Partnership (58 FR Protection Agency, 401 M St., SW., paper form. Accordingly, EPA will 58093, October 28, 1993), EPA may not Washington, DC 20460. transfer any copies of objections and issue a regulation that is not required by If a hearing is requested, the hearing requests received electronically statute and that creates a mandate upon objections must include a statement of into printed, paper form as they are a State, local or tribal government, the factual issues on which a hearing is received and will place the paper copies unless the Federal government provides requested, the requestor’s contentions in the official record which will also the funds necessary to pay the direct on such issues, and a summary of any include all comments submitted directly compliance costs incurred by those evidence relied upon by the requestor in writing. The official record is the governments. If the mandate is (40 CFR 178.27). A request for a hearing paper record maintained at the Virginia unfunded, EPA must provide to OMB a will be granted if the Administrator address in ‘‘ADDRESSES’’ at the description of the extent of EPA’s prior determines that the material submitted beginning of this document. consultation with representatives of shows the following: There is genuine VIII. Regulatory Assessment affected State, local, and tribal and substantial issue of fact; there is a Requirements governments, the nature of their reasonable possibility that available concerns, copies of any written evidence identified by the requestor A. Certain Acts and Executive Orders communications from the governments, would, if established, resolve one or This final rule establishes a tolerance and a statement supporting the need to more of such issues in favor of the under section 408 of the FFDCA. The issue the regulation. In addition, requestor, taking into account Office of Management and Budget Executive Order 12875 requires EPA to uncontested claims or facts to the (OMB) has exempted these types of develop an effective process permitting contrary; and resolution of the factual actions from review under Executive elected officials and other issues in the manner sought by the Order 12866, entitled Regulatory representatives of State, local, and tribal requestor would be adequate to justify Planning and Review (58 FR 51735, governments ‘‘to provide meaningful the action requested (40 CFR 178.32). October 4, 1993). This final rule does and timely input in the development of Information submitted in connection not contain any information collections regulatory proposals containing with an objection or hearing request subject to OMB approval under the significant unfunded mandates.’’ may be claimed confidential by marking Paperwork Reduction Act (PRA), 44 Today’s rule does not create an any part or all of that information as U.S.C. 3501 et seq., or impose any unfunded Federal mandate on State, CBI. Information so marked will not be enforceable duty or contain any local, or tribal governments. The rule disclosed except in accordance with unfunded mandate as described under does not impose any enforceable duties procedures set forth in 40 CFR part 2. Title II of the Unfunded Mandates on these entities. Accordingly, the A copy of the information that does not Reform Act of 1995 (UMRA) (Pub. L. requirements of section 1(a) of

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Executive Order 12875 do not apply to and pests, Reporting and recordkeeping for an additional 1–year period. These this rule. requirements. tolerances will expire and are revoked on July 31, 2000. This action is in C. Executive Order 13084 Dated: March 5, 1999. response to EPA’s granting of an Under Executive Order 13084, James Jones, emergency exemption under section 18 entitled Consultation and Coordination of the Federal Insecticide, Fungicide, with Indian Tribal Governments (63 FR Director, Registration Division, Office of Pesticide Programs. and Rodenticide Act (FIFRA) 27655, May 19, 1998), EPA may not authorizing use of the pesticide on issue a regulation that is not required by Therefore, 40 CFR chapter I is almonds. Section 408(l)(6) of the statute, that significantly or uniquely amended as follows: Federal Food, Drug, and Cosmetic Act affects the communities of Indian tribal requires EPA to establish a time-limited PART 180Ð[AMENDED] governments, and that imposes tolerance or exemption from the substantial direct compliance costs on 1. The authority citation for part 180 requirement for a tolerance for pesticide those communities, unless the Federal continues to read as follows: chemical residues in food that will government provides the funds Authority: 21 U.S.C. 321(q), 346a and 371. result from the use of a pesticide under necessary to pay the direct compliance an emergency exemption granted by costs incurred by the tribal EPA under FIFRA section 18. governments. If the mandate is 2. In § 180.110, by revising paragraph DATES: This regulation becomes unfunded, EPA must provide OMB, in (b) to read as follows: effective March 17, 1999. Objections a separately identified section of the and requests for hearings must be preamble to the rule, a description of § 180.110 Maneb; tolerances for residues. received by EPA, on or before May 17, the extent of EPA’s prior consultation * * * * * 1999. with representatives of affected tribal (b) Section 18 emergency exemptions. governments, a summary of the nature A time-limited tolerance is established ADDRESSES: Written objections and of their concerns, and a statement for residues of the fungicide maneb hearing requests, identified by the supporting the need to issue the (manganous docket control number [OPP–300797], regulation. In addition, Executive Order ethylenebisdithiocarbamate), calculated must be submitted to: Hearing Clerk 13084 requires EPA to develop an as zinc ethylenebisdithiocarbamate, and (1900), Environmental Protection effective process permitting elected its metabolite ethylenethiourea in Agency, Rm. M3708, 401 M St., SW., officials and other representatives of connection with use of the pesticide Washington, DC 20460. Fees Indian tribal governments ‘‘to provide under a section 18 emergency accompanying objections and hearing meaningful and timely input in the exemption granted by EPA. The requests shall be labeled ‘‘Tolerance development of regulatory policies on tolerance will expire and is revoked on Petition Fees’’ and forwarded to: EPA matters that significantly or uniquely the date specified in the following table: Headquarters Accounting Operations affect their communities.’’ Branch, OPP (Tolerance Fees), P.O. Box Today’s rule does not significantly or 360277M, Pittsburgh, PA 15251. A copy uniquely affect the communities of of any objections and hearing requests Indian tribal governments. This action Expira- filed with the Hearing Clerk identified does not involve or impose any Parts per tion/rev- by the docket control number, [OPP– Commodity million ocation requirements that affect Indian tribes. date 300797], must also be submitted to: Accordingly, the requirements of Public Information and Records section 3(b) of Executive Order 13084 Walnuts ...... 0.05 12/31/00 Integrity Branch, Information Resources do not apply to this rule. and Services Division (7502C), Office of * * * * * Pesticide Programs, Environmental IX. Submission to Congress and the Protection Agency, 401 M St., SW., [FR Doc. 99–6383 Filed 3–16–99; 8:45 am] Comptroller General Washington, DC 20460. In person, bring The Congressional Review Act, 5 BILLING CODE 6560±50±F a copy of objections and hearing U.S.C. 801 et seq., as added by the Small requests to Rm. 119, Crystal Mall 2 (CM Business Regulatory Enforcement #2), 1921 Jefferson Davis Hwy., Fairness Act of 1996, generally provides ENVIRONMENTAL PROTECTION AGENCY Arlington, VA. that before a rule may take effect, the A copy of objections and hearing Agency promulgating the rule must 40 CFR Part 180 requests filed with the Hearing Clerk submit a rule report, which includes a may also be submitted electronically by copy of the rule, to each House of the [OPP±300797; FRL±6064±2] sending electronic mail (e-mail) to: opp- Congress and the Comptroller General of RIN 2070±AB78 [email protected]. Copies of electronic the United States. EPA will submit a objections and hearing requests must be report containing this rule and other Propiconazole; Extension of submitted as an ASCII file avoiding the required information to the U.S. Senate, Tolerances for Emergency Exemptions use of special characters and any form the U.S. House of Representatives and of encryption. Copies of objections and the Comptroller General of the United AGENCY: Environmental Protection hearing requests will also be accepted States prior to publication of the rule in Agency (EPA). on disks in WordPerfect 5.1/6.1 or the Federal Register. This rule is not a ACTION: Final rule. ASCII file format. All copies of ‘‘major rule’’ as defined by 5 U.S.C. electronic objections and hearing 804(2). SUMMARY: This regulation extends time- requests must be identified by the limited tolerances for combined docket control number [OPP–300797]. List of Subjects in 40 CFR Part 180 residues of the fungicide propiconazole No Confidential Business Information Environmental protection, and its metabolites in or on almond (CBI) should be submitted through e- Administrative practice and procedure, nutmeats at 0.1 parts per million (ppm), mail. Copies of electronic objections and Agricultural commodities, Pesticides and in or on almond hulls at 2.5 ppm, hearing requests on this rule may be

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.016 pfrm07 PsN: 17MRR1 13104 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations filed online at many Federal Depository reaffirms that extension of the time- (7505C), Office of Pesticide Programs, Libraries. limited tolerances will continue to meet Environmental Protection Agency, 401 FOR FURTHER INFORMATION CONTACT: By the requirements of section 408(l)(6). M St., SW., Washington, DC 20460. mail: Stephen Schaible, Registration Therefore, the time-limited tolerances Office location, telephone number, and Division (7505C), Office of Pesticide are extended for an additional 1–year e-mail address: Rm. 239, CM #2, 1921 Programs, Environmental Protection period. EPA will publish a document in Jefferson Davis Hwy., Arlington, VA, Agency, 401 M St., SW., Washington, the Federal Register to remove the (703) 305–5697, [email protected]. DC 20460. Office location, telephone revoked tolerances from the Code of Requests for waiver of tolerance number, and e-mail address: Rm. 271, Federal Regulations (CFR). Although objection fees should be sent to James Crystal Mall 2 (CM #2), 1921 Jefferson these tolerances will expire and are Hollins, Information Resources and Davis Hwy., Arlington, VA, 703 308– revoked on July 31, 2000, under FFDCA Services Division (7502C), Office of 9362, [email protected]. section 408(l)(5), residues of the Pesticide Programs, Environmental pesticide not in excess of the amounts Protection Agency, 401 M St., SW., SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the specified in the tolerances remaining in Washington, DC 20460. If a hearing is requested, the Federal Register of April 11, 1997 (62 or on almond nutmeats and almond hulls after that date will not be objections must include a statement of FR 17710) (FRL–5600–5), which unlawful, provided the pesticide is the factual issues on which a hearing is announced that on its own initiative applied in a manner that was lawful requested, the requestor’s contentions under section 408 of the Federal Food, under FIFRA and the application on such issues, and a summary of any Drug, and Cosmetic Act (FFDCA), 21 occurred prior to the revocation of the evidence relied upon by the requestor U.S.C. 346a and (l)(6), as amended by tolerances. EPA will take action to (40 CFR 178.27). A request for a hearing the Food Quality Protection Act of 1996 revoke these tolerances earlier if any will be granted if the Administrator (FQPA) (Pub. L. 104–170) it established experience with, scientific data on, or determines that the material submitted time-limited tolerances for the other relevant information on this shows the following: There is genuine combined residues of propiconazole and pesticide indicate that the residues are and substantial issue of fact; there is a its metabolites in or on almond nutmeat not safe. reasonable possibility that available and almond hulls at 0.1 ppm and 2.5 evidence identified by the requestor ppm, respectively, with an expiration I. Objections and Hearing Requests would, if established, resolve one or date of July 31, 1998. EPA extended the The new FFDCA section 408(g) more of such issues in favor of the expiration date of these tolerances to provides essentially the same process requestor, taking into account July 31, 1999 in a Federal Register for persons to ‘‘object’’ to a tolerance uncontested claims or facts to the notice published April 3, 1998 (63 FR regulation as was provided in the old contrary; and resolution of the factual 16437) (FRL–5781–7). EPA established section 408 and in section 409. issues in the manner sought by the the tolerances because section 408(l)(6) However, the period for filing objections requestor would be adequate to justify of the FFDCA requires EPA to establish is 60 days, rather than 30 days. EPA the action requested (40 CFR 178.32). a time-limited tolerance or exemption currently has procedural regulations Information submitted in connection from the requirement for a tolerance for which govern the submission of with an objection or hearing request pesticide chemical residues in food that objections and hearing requests. These may be claimed confidential by marking will result from the use of a pesticide regulations will require some any part or all of that information as under an emergency exemption granted modification to reflect the new law. CBI. Information so marked will not be by EPA under FIFRA section 18. Such However, until those modifications can disclosed except in accordance with tolerances can be established without be made, EPA will continue to use those procedures set forth in 40 CFR part 2. providing notice or period for public procedural regulations with appropriate A copy of the information that does not comment. adjustments to reflect the new law. contain CBI must be submitted for EPA received a request to extend the Any person may, by May 17, 1999, inclusion in the public record. use of propiconazole on almonds for file written objections to any aspect of Information not marked confidential this year growing season due to the lack this regulation and may also request a may be disclosed publicly by EPA of available effective alternative hearing on those objections. Objections without prior notice. fungicides, and wetter-than-normal and hearing requests must be filed with conditions. After having reviewed the the Hearing Clerk, at the address given II. Public Record and Electronic submission, EPA concurs that under the ‘‘ADDRESSES’’ section (40 Submissions emergency conditions exist. EPA has CFR 178.20). A copy of the objections EPA has established a record for this authorized under FIFRA section 18 the and/or hearing requests filed with the regulation under docket control number use of propiconazole on almonds for Hearing Clerk should be submitted to [OPP–300797] (including any comments control of anthracnose in almonds. the OPP docket for this rulemaking. The and data submitted electronically). A EPA assessed the potential risks objections submitted must specify the public version of this record, including presented by residues of propiconazole provisions of the regulation deemed printed, paper versions of electronic in or on almonds. In doing so, EPA objectionable and the grounds for the comments, which does not include any considered the safety standard in objections (40 CFR 178.25). Each information claimed as CBI, is available FFDCA section 408(b)(2), and decided objection must be accompanied by the for inspection from 8:30 a.m. to 4 p.m., that the necessary tolerance under fee prescribed by 40 CFR 180.33(i). EPA Monday through Friday, excluding legal FFDCA section 408(l)(6) would be is authorized to waive any fee holidays. The public record is located in consistent with the safety standard and requirement ‘‘when in the judgement of Rm. 119 of the Public Information and with FIFRA section 18. The data and the Administrator such a waiver or Records Integrity Branch, Information other relevant material have been refund is equitable and not contrary to Resources and Services Division evaluated and discussed in the final rule the purpose of this subsection.’’ For (7502C), Office of Pesticide Programs, of April 11, 1997 (62 FR 17710) (FRL– additional information regarding Environmental Protection Agency, CM 5600–5). Based on that data and tolerance objection fee waivers, contact #2, 1921 Jefferson Davis Hwy., information considered, the Agency James Tompkins, Registration Division Arlington, VA.

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Objections and hearing requests may economic impact. The factual basis for 13084 requires EPA to develop an be sent by e-mail directly to EPA at: the Agency’s generic certification for effective process permitting elected [email protected]. tolerance actions published on May 4, officials and other representatives of 1981 (46 FR 24950), and was provided Indian tribal governments ‘‘to provide E-mailed objections and hearing to the Chief Counsel for Advocacy of the meaningful and timely input in the requests must be submitted as an ASCII Small Business Administration. development of regulatory policies on file avoiding the use of special B. Executive Order 12875 matters that significantly or uniquely characters and any form of encryption. affect their communities.’’ The official record for this regulation, Under Executive Order 12875, Today’s rule does not significantly or as well as the public version, as entitled Enhancing the uniquely affect the communities of described in this unit will be kept in Intergovernmental Partnership (58 FR Indian tribal governments. This action paper form. Accordingly, EPA will 58093, October 28, 1993), EPA may not does not involve or impose any transfer any copies of objections and issue a regulation that is not required by requirements that affect Indian tribes. hearing requests received electronically statute and that creates a mandate upon Accordingly, the requirements of a State, local or tribal government, into printed, paper form as they are section 3(b) of Executive Order 13084 unless the Federal government provides received and will place the paper copies do not apply to this rule. in the official record which will also the funds necessary to pay the direct include all comments submitted directly compliance costs incurred by those IV. Submission to Congress and the in writing. The official record is the governments. If the mandate is Comptroller General paper record maintained at the Virginia unfunded, EPA must provide to OMB a description of the extent of EPA’s prior The Congressional Review Act, 5 address in ‘‘ADDRESSES’’ at the U.S.C. 801 et seq., as added by the Small beginning of this document. consultation with representatives of affected State, local, and tribal Business Regulatory Enforcement III. Regulatory Assessment governments, the nature of their Fairness Act of 1996, generally provides Requirements concerns, copies of any written that before a rule may take effect, the Agency promulgating the rule must A. Certain Acts and Executive Orders communications from the governments, and a statement supporting the need to submit a rule report, which includes a This final rule establishes a tolerance issue the regulation. In addition, copy of the rule, to each House of the under section 408 of the FFDCA. The Executive Order 12875 requires EPA to Congress and the Comptroller General of Office of Management and Budget develop an effective process permitting the United States. EPA will submit a (OMB) has exempted these types of elected officials and other report containing this rule and other actions from review under Executive representatives of State, local, and tribal required information to the U.S. Senate, Order 12866, entitled Regulatory governments ‘‘to provide meaningful the U.S. House of Representatives and Planning and Review (58 FR 51735, and timely input in the development of the Comptroller General of the United October 4, 1993). This final rule does regulatory proposals containing States prior to publication of the rule in not contain any information collections significant unfunded mandates.’’ the Federal Register. This rule is not a subject to OMB approval under the Today’s rule does not create an ‘‘major rule’’ as defined by 5 U.S.C. Paperwork Reduction Act (PRA), 44 unfunded Federal mandate on State, 804(2). U.S.C. 3501 et seq., or impose any local, or tribal governments. The rule enforceable duty or contain any does not impose any enforceable duties List of Subjects in 40 CFR Part 180 unfunded mandate as described under on these entities. Accordingly, the Environmental protection, Title II of the Unfunded Mandates requirements of section 1(a) of Administrative practice and procedure, Reform Act of 1995 (UMRA) (Pub. L. Executive Order 12875 do not apply to Agricultural commodities, Pesticides 104–4). Nor does it require any special this rule. and pests, Reporting and recordkeeping considerations as required by Executive requirements. Order 12898, entitled Federal Actions to C. Executive Order 13084 Address Environmental Justice in Under Executive Order 13084, Dated: March 3, 1999. Minority Populations and Low-Income entitled Consultation and Coordination Populations (59 FR 7629, February 16, with Indian Tribal Governments (63 FR Peter Caulkins, 1994), or require OMB review in 27655, May 19, 1998), EPA may not Acting Director, Registration Division, Office accordance with Executive Order 13045, issue a regulation that is not required by of Pesticide Programs. entitled Protection of Children from statute, that significantly or uniquely Therefore, 40 CFR chapter I is Environmental Health Risks and Safety affects the communities of Indian tribal amended as follows: Risks (62 FR 19885, April 23, 1997). governments, and that imposes In addition, since tolerances and substantial direct compliance costs on PART 180Ð[AMENDED] exemptions that are established under those communities, unless the Federal section 408(l)(6) of FFDCA, such as the government provides the funds 1. The authority citation for part 180 tolerance/exemption in this final rule, necessary to pay the direct compliance continues to read as follows: do not require the issuance of a costs incurred by the tribal Authority: 21 U.S.C. 321(q), 346a and 371. proposed rule, the requirements of the governments. If the mandate is Regulatory Flexibility Act (RFA) (5 unfunded, EPA must provide OMB, in § 180.434 Amended U.S.C. 601 et seq.) do not apply. a separately identified section of the 2. In § 180.434, by amending Nevertheless, the Agency previously preamble to the rule, a description of paragraph (b) by changing the date for assessed whether establishing the extent of EPA’s prior consultation the commodities ‘‘almond hull’’ and tolerances, exemptions from tolerances, with representatives of affected tribal ‘‘almond nutmeat’’ from ‘‘7/31/99’’ to raising tolerance levels or expanding governments, a summary of the nature ‘‘7/31/00’’. exemptions might adversely impact of their concerns, and a statement small entities and concluded, as a supporting the need to issue the [FR Doc. 99–6382 Filed 3–16–99; 8:45 am] generic matter, that there is no adverse regulation. In addition, Executive Order BILLING CODE 6560±50±F

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ENVIRONMENTAL PROTECTION sending electronic mail (e-mail) to: opp- azoxystrobin (only) in eggs at 0.4 ppm; AGENCY [email protected]. Copies of objections fat of cattle, goats, hogs, horses, poultry, and hearing requests must be submitted and sheep at 0.01 ppm; kidney of cattle 40 CFR Part 180 as an ASCII file avoiding the use of at 0.06 ppm; liver of cattle, goats, [OPP±300801; FRL±6064±6] special characters and any form of horses, and sheep at 0.3 ppm; liver of encryption. Copies of objections and hogs at 0.2 ppm; liver of poultry at 0.4 RIN 2070±AB78 hearing requests will also be accepted ppm; meat of cattle, goats, hogs, horses, on disks in WordPerfect 5.1/6.1 file poultry, and sheep at 0.01 ppm; and Azoxystrobin; Pesticide Tolerance format or ASCII file format. All copies milk at 0.006 ppm. AGENCY: Environmental Protection of objections and hearing requests in I. Background and Statutory Findings electronic form must be identified by Agency (EPA). Section 408(b)(2)(A)(i) of the FFDCA ACTION: Final rule. the docket control number [OPP– 300801]. No Confidential Business allows EPA to establish a tolerance (the SUMMARY: This regulation establishes Information (CBI) should be submitted legal upper limit for a pesticide tolerances for combined residues of through e-mail. Electronic copies of chemical residue in or on a food) only azoxystrobin (methyl(E)-2-(2-(6-(2- objections and hearing requests on this if EPA determines that the tolerance is cyanophenoxy)pyrimidin-4- rule may be filed online at many Federal ‘‘safe.’’ Section 408(b)(2)(A)(ii) defines yloxy)phenyl)-3-methoxyacrylate and its Depository Libraries. ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will Z isomer (methyl(Z)-2-(2-(6-(2- FOR FURTHER INFORMATION CONTACT: By result from aggregate exposure to the cyanophenoxy)pyrimidin-4- mail: Cynthia Giles-Parker, Registration pesticide chemical residue, including yloxy)phenyl)-3-methoxyacrylate) in or Division (7505C), Office of Pesticide all anticipated dietary exposures and all on almond hulls, aspirated grain Programs, Environmental Protection other exposures for which there is fractions, bananas (postharvest), canola, Agency, 401 M St., SW., Washington, reliable information.’’ This includes cucurbits, peanut hay, pistachios, DC 20460. Office location, telephone exposure through drinking water and in potatoes, rice, stone fruits, and wheat; number, and e-mail address: Rm. 249, residential settings, but does not include and residues of azoxystrobin (only) on Crystal Mall #2, 1921 Jefferson Davis occupational exposure. Section fat of cattle, goats, hogs, horses, and Hwy., Arlington, VA, 703–305–7740, 408(b)(2)(C) requires EPA to give special sheep; meat of cattle, goats, hogs, [email protected]. consideration to exposure of infants and horses, and sheep; meat byproducts of SUPPLEMENTARY INFORMATION: In the children to the pesticide chemical cattle, goats, hogs, horses, and sheep; Federal Register of October 8, 1997 (62 residue in establishing a tolerance and and milk. Zeneca Ag Products requested FR 52544)(FRL–5746–9) and December to ‘‘ensure that there is a reasonable these tolerances under the Federal Food, 11, 1998 (63 FR 68458)(FRL–6043–3), certainty that no harm will result to Drug, and Cosmetic Act, as amended by EPA issued notices pursuant to section infants and children from aggregate the Food Quality Protection Act of 1996. 408 of the Federal Food, Drug, and exposure to the pesticide chemical DATES: This regulation is effective Cosmetic Act (FFDCA), 21 U.S.C. 346a residue....’’ March 17, 1999. Objections and requests as amended by the Food Quality EPA performs a number of analyses to for hearings must be received by EPA on Protection Act of 1996 (FQPA) (Pub. L. determine the risks from aggregate or before May 17, 1999. 104–170) announcing the filing of two exposure to pesticide residues. For ADDRESSES: Written objections and pesticide petitions (PP) 8F4995 and further discussion of the regulatory hearing requests, identified by the 7F4864, for tolerances by Zeneca Ag requirements of section 408 and a docket control number, [OPP–300801], Products, 1800 Concord Pike, P.O. Box complete description of the risk must be submitted to: Hearing Clerk 15458, Wilmington, DE 19850–5458. assessment process, see the final rule on (1900), Environmental Protection This notice included a summary of the Bifenthrin Pesticide Tolerances (62 FR Agency, Rm. M3708, 401 M St., SW., petition prepared by Zeneca Ag 62961, November 26, 1997) (FRL–5754– Washington, DC 20460. Fees Products, the registrant. There were no 7). accompanying objections and hearing comments received in response to the requests shall be labeled ‘‘Tolerance notices of filing. II. Aggregate Risk Assessment and Petition Fees’’ and forwarded to: EPA The petitions requested that 40 CFR Determination of Safety Headquarters Accounting Operations part 180 be amended by establishing Consistent with section 408(b)(2)(D) Branch, OPP (Tolerance Fees), P.O. Box tolerances for combined residues of the of the FFDCA, EPA has reviewed the 360277M, Pittsburgh, PA 15251. A copy fungicide azoxystrobin (methyl(E)-2-(2- available scientific data and other of any objections and hearing requests (6-(2-cyanophenoxy)pyrimidin-4- relevant information in support of this filed with the Hearing Clerk identified yloxy)phenyl)-3-methoxyacrylate) and action. EPA has sufficient data to assess by the docket control number, [OPP– its Z isomer (methyl(Z)-2-(2-(6-(2- the hazards of azoxystrobin and to make 300801], must also be submitted to: cyanophenoxy)pyrimidin-4- a determination on aggregate exposure, Public Information and Records yloxy)phenyl)-3-methoxyacrylate) in or consistent with section 408(b)(2), for Integrity Branch, Information Resources on almond hulls at 4.0 parts per million establishment of permanent tolerances and Services Division (7502C), Office of (ppm), bananas (postharvest) at 2.0 for combined residues of azoxystrobin Pesticide Programs, Environmental ppm, canola at 1.0 ppm, cucurbits at 0.3 (methyl(E)-2-(2-(6-(2- Protection Agency, 401 M St., SW., ppm, peanut hay at 1.5 ppm, pistachios cyanophenoxy)pyrimidin-4- Washington, DC 20460. In person, bring at 0.01 ppm, potatoes at 0.03 ppm, rice yloxy)phenyl)-3-methoxyacrylate) and a copy of objections and hearing grain at 4.0 ppm, rice straw at 11 ppm, its Z isomer (methyl(E)-2-(2-(6-(2- requests to Rm. 119, Crystal Mall #2, rice hulls at 20 ppm, stone fruits at 1.5 cyanophenoxy)pyrimidin-4- 1921 Jefferson Davis Hwy., Arlington, ppm, tree nuts at 0.01 ppm; wheat grain yloxy)phenyl)-3-methoxyacrylate) in or VA. at 0.04 ppm, wheat bran at 0.12 ppm, on almond hulls at 4.0 ppm, aspirated A copy of objections and hearing wheat hay at 13.0 ppm, wheat straw at grain fractions at 10 ppm, bananas (pre- requests filed with the Hearing Clerk 4.0 ppm; wheat aspirated grain fractions harvest and postharvest) at 2.0 ppm (of may be submitted electronically by at 15.0 ppm, and for the residues of which not more than 0.1 ppm is

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.044 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13107 contained in the pulp), canola at 1.0 acute inhalation study of technical ii. In a subchronic toxicity study in ppm, cucurbits at 0.3 ppm, peanut hay azoxystrobin in rats resulted in an LC50 which azoxystrobin was administered to at 2.0 ppm, pistachios at 0.01 ppm, of 0.962 mg/liter (mg/L) in males and dogs by capsule for 92 or 93 days, the potatoes at 0.03 ppm, rice grain at 5.0 0.698 mg/L in females. In an acute oral NOAEL for both males and females was ppm, rice straw at 12 ppm, rice hulls at neurotoxicity study in rats dosed once 50 mg/kg/day. The LOAEL was 250 mg/ 20 ppm, stone fruits at 1.5 ppm, tree by gavage with 0, 200, 600, or 2,000 mg/ kg/day, based on treatment-related nuts at 0.010 ppm, wheat grain at 0.10 kg azoxystrobin, the systemic toxicity clinical observations and clinical ppm, wheat bran at 0.20 ppm, wheat no observable adverse effect level chemistry alterations at this dose. hay at 15 ppm, wheat straw at 4.0 ppm, (NOAEL) was < 200 mg/kg and the iii. In a 21–day repeated-dose dermal and for the residues of azoxystrobin systemic toxicity lowest observed rat study using azoxystrobin, the (only) in fat of cattle, goats, hogs, horses, adverse effect level (LOAEL) was 200 NOAEL for both males and females was and sheep at 0.010 ppm; meat of cattle, mg/kg, based on the occurrence of greater than or equal to 1,000 mg/kg/day goats, hogs, horses, and sheep at 0.01 transient diarrhea in both sexes. There (the highest dosing regimen); a LOAEL ppm; meat byproducts of cattle, goats, was no indication of neurotoxicity at the was therefore not determined. hogs, horses, and sheep at 0.010 ppm; doses tested. 5. Chronic feeding toxicity and and milk at 0.006 ppm. A permanent 2. Mutagenicity. Azoxystrobin was carcinogenicity. i. In a 2–year feeding domestic tolerance of 0.5 ppm already negative for mutagenicity in the study in rats fed diets containing 0, 60, exists for bananas and will be amended salmonella/mammalian activation gene 300, and 750/1,500 ppm (males/ by this rule. Temporary tolerances mutation assay, the mouse females), the systemic toxicity NOAEL already exist for fat of cattle, goats, hogs, micronucleus test, and the unscheduled was 18.2 mg/kg/day for males and 22.3 horses, and sheep at 0.01 ppm; kidney DNA synthesis in rat hepatocytes/ mg/kg/day for females. The systemic of cattle, goats, hogs, and sheep at 0.06 mammalian cells (in vivo/in vitro toxicity LOAEL for males was 34 mg/kg/ ppm; liver of cattle, goats, horses, and procedure study). In the forward day, based on reduced body weights, sheep at 0.3 ppm; liver of hogs at 0.2 mutation study using L5178 mouse food consumption, and food efficiency; and bile duct lesions. The systemic ppm; meat of cattle, goats, hogs, horses, lymphoma cells in culture, azoxystrobin toxicity LOAEL for females was 117.1 and sheep at 0.01 ppm; cucurbits at 1.0 tested positive for forward gene mg/kg/day, based on reduced body ppm; milk at 0.006 ppm; potatoes at mutation at the TK locus. In the in vitro weights. There was no evidence of 0.03 ppm; rice grain at 4 ppm; rice hulls human lymphocytes cytogenetics assay carcinogenic activity in this study. at 20 ppm; and rice straw at 10 ppm. A of azoxystrobin, there was evidence of a tolerance of 0.8 ppm already exists for ii. In a 1–year feeding study in dogs concentration related induction of to which azoxystrobin was fed by peaches; this will be superseded by the chromosomal aberrations over stone fruits tolerance of 1.5 ppm that is capsule at doses of 0, 3, 25, or 200 mg/ background in the presence of moderate kg/day, the NOAEL for both males and being established in this rule. Several of to severe cytotoxicity. the tolerances that are being established females was 25 mg/kg/day and the 3. Rat metabolism. In this study, by this rule are different from (often LOAEL was 200 mg/kg/day for both azoxystrobin--unlabeled or with a higher than) those proposed by Zeneca sexes, based on clinical observations, pyrimidinyl, phenylacrylate, or Ag Products. EPA review of the data clinical chemistry changes, and liver cyanophenyl label--was administered to submitted by the company lead to an weight increases that were observed in rats by gavage as a single dose or as 14– Agency decision to modify the proposed both sexes. day repeated doses. Less than 0.5% of tolerances. During these reviews it was iii. In a 2–year carcinogenicity feeding the administered dose was detected in also determined that azoxystrobin uses study in mice using dosing the tissues and carcass up to 7 days that have been registered so far do not concentrations of 0, 50, 300, or 2,000 lead to a need to establish tolerances for post-dosing and most of it was in ppm, the systemic toxicity NOAEL was poultry commodities (including eggs). excretion-related organs. There was no 37.5 mg/kg/day for both males and EPA’s assessment of the exposures and evidence of potential for females. The systemic toxicity LOAEL risks associated with establishment of bioaccumulation. The primary route of was 272.4 mg/kg/day for both sexes, the above tolerances follows. excretion was via the feces, though 9- to based on reduced body weights in both 18% was detected in the urine of the sexes at this dose. There was no A. Toxicological Profile various dose groups. Absorbed evidence of carcinogenicity at the dose EPA has evaluated the available azoxystrobin appeared to be extensively levels tested. toxicity data and considered its validity, metabolized. A metabolic pathway was According to the new proposed completeness, and reliability as well as proposed showing hydrolysis and guidelines for Carcinogen Risk the relationship of the results of the subsequent glucuronide conjugation as Assessment (April, 1996), the studies to human risk. EPA has also the major biotransformation process. appropriate descriptor for human considered available information This study was classified as carcinogenic potential of azoxystrobin is concerning the variability of the supplementary but upgradeable; the ‘‘Not Likely.’’ The appropriate sensitivities of major identifiable company has submitted data intended subdescriptor is ‘‘has been evaluated in subgroups of consumers, including to upgrade the study to acceptable and at least two well conducted studies in infants and children. The nature of the these data have been scheduled for two appropriate species without toxic effects caused by azoxystrobin is review. demonstrating carcinogenic effects.’’ discussed in this unit. 4. Sub-chronic toxicity. i. In a 90–day 6. Developmental and reproductive 1. Acute toxicity. The acute oral rat feeding study the NOAEL was 20.4 toxicity. i. In a prenatal development toxicity study in rats of technical mg/kg/day for males and females. The study in rats gavaged with azoxystrobin azoxystrobin resulted in an LD50 of > LOAEL was 211.0 mg/kg/day based on at dose levels of 0, 25, 100, or 300 mg/ 5,000 milligrams/kilogram (mg/kg) decreased weight gain in both sexes, kg/day during days 7 through 16 of (limit test) for both males and females. clinical observations of distended gestation, lethality at the highest dose The acute dermal toxicity study in rats abdomens and reduced body size, and caused the discontinuation of dosing at of technical azoxystrobin resulted in an clinical pathology findings attributable that level. The developmental NOAEL LD50 of > 2,000 mg/kg (limit dose). The to reduced nutritional status. was greater than or equal to 100 mg/kg/

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.044 pfrm07 PsN: 17MRR1 13108 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations day and the developmental LOAEL was children to azoxystrobin. Therefore, no old), 3% and non-Hispanic (other than > 100 mg/kg/day because no significant additional uncertainty factor to protect black or white), 4%. The subgroups adverse developmental effects were infants and children is needed at this listed are infants/children and other observed. In this same study, the time. subgroups for which the percentage of maternal NOAEL was not established; 4. Carcinogenicity. The Agency the RfD occupied is greater than the the maternal LOAEL was 25 mg/kg/day, determined that azoxystrobin should be group U.S. population (48 states). based on increased salivation. classified as ‘‘Not Likely’’ to be a human 2. From drinking water. In the absence ii. In a prenatal developmental study carcinogen according to the proposed of reliable, available monitoring data, in rabbits gavaged with 0, 50, 150, or revised Cancer Guidelines. This EPA uses models to estimate 500 mg/kg/day during days 8 through 20 classification is based on the lack of concentrations of pesticides in ground of gestation, the developmental NOAEL evidence of carcinogenicity in long-term and surface water. For azoxystrobin, was 500 mg/kg/day and the rat and mouse feeding studies. modeling was used to estimate surface developmental LOAEL was > 500 mg/ water concentrations because of very C. Exposures and Risks kg/day because no treatment-related limited surface water monitoring data. adverse effects on development were 1. From food and feed uses. However, EPA does not use these model seen. The maternal NOAEL was 150 mg/ Permanent tolerances have been estimates to quantify risk. Currently, kg/day and the maternal LOAEL was established (40 CFR 180. 507(a)) for the EPA uses drinking water levels of 500 mg/kg/day, based on decreased combined residues of azoxystrobin comparison (DWLOC’s) as a surrogate to body weight gain. (methyl(E)-2(2-(6-(2- capture risk associated with exposure to iii. In a two-generation reproduction cyanophenoxy)pyrimidin-4- pesticides in drinking water. A DWLOC study, rats were fed 0, 60, 300, or 1,500 yloxy)phenyl)-3-methoxyacrylate) and is the concentration of a pesticide in ppm of azoxystrobin. The reproductive its Z isomer (methyl (Z)-2-(2-(6-(2- drinking water that would be acceptable NOAEL was 32.2 mg/kg/day. The cyanophenoxy)pyrimidin-4- as an upper limit in light of total reproductive LOAEL was 165.4 mg/kg/ yloxy)phenyl)-3-methoxyacrylate)), in or aggregate exposure to that pesticide day; reproductive toxicity was on the following raw agricultural from food, water, and residential uses. demonstrated as treatment-related commodities: pecans at 0.01 ppm, A DWLOC will vary depending on the reductions in adjusted pup body peanuts at 0.01 ppm, peanut oil at 0.03 residue level in foods, the toxicity weights as observed in the F1a and F2a ppm, grapes at 1.0 ppm, bananas at 0.5 endpoint and with drinking water pups dosed at 1,500 ppm (165.4 mg/kg/ ppm, peaches at 0.80 ppm, tomatoes at consumption patterns and body weight day). 0.2 ppm, and tomato paste at 0.6 ppm. for specific subpopulations. EPA In addition, time-limited tolerances B. Toxicological Endpoints believes model estimates to be have been established for crops, overestimations of concentrations of 1. Acute toxicity. The Agency processed foods and animal azoxystrobin expected in drinking evaluated the existing toxicology commodities (40 CFR 180.507(b)) at water. Azoxystrobin is moderately database for azoxystrobin and did not levels ranging from 0.006 ppm in milk persistent in soil in the absence of light identify any acute dietary endpoint to 20 ppm in rice hulls and including and one of its metabolites is potentially because there were no effects of concern cucurbits at 1.0 ppm, rice grain at 4 moderately mobile in coarse textured attributable to a single dose (exposure) ppm, rice hulls at 20 ppm, rice straw at soils. The potential mobility and in oral toxicology studies including 10 ppm, and potatoes at 0.03 ppm. Risk persistence of some degradates based on developmental toxicity studies in the rat assessments were conducted by EPA to batch equilibrium studies, aerobic soil and rabbit and acute neurotoxicity study assess dietary exposures from metabolism and some field dissipation in the rat. Therefore, this risk azoxystrobin as follows: studies are similar to pesticides with a assessment is not required. i. Acute exposure and risk. The potential to leach into ground water 2. Short- and intermediate-term Agency did not conduct an acute risk under some conditions. There is no toxicity. The Agency evaluated the assessment because no toxicological established Maximum Contaminant existing toxicology database for short- endpoint of concern was identified Level for residues of azoxystrobin in term and intermediate-term dermal and during review of available data. drinking water. No health advisory inhalation exposure and determined ii. Chronic exposure and risk. The levels for azoxystrobin in drinking water that this risk assessment is not required Dietary Exposure Evaluation Model have been established. because no dermal or systemic effects (DEEM), a chronic exposure analysis, i. Acute exposure and risk. An were seen in the repeated dose dermal was used in conducting this chronic assessment was not conducted because study at the limit dose. The only dietary risk assessment. EPA has made no toxicological end-point of concern registered residential use for very conservative assumptions -- 100% was identified. azoxystrobin is residential turf. of all commodities having azoxystrobin ii. Chronic exposure and risk. Based 3. Chronic toxicity. EPA has residues at the level of the tolerance on the chronic dietary (food) exposure established the Reference Dose (RfD) for with the exception of raisins and grape estimates, chronic DWLOC’s for azoxystrobin at 0.18 mg/kg/day. This juice which are expected to result in an azoxystrobin were calculated and are RfD is based on a NOAEL of 18.2 mg/ over estimation of human dietary summarized as follows: U. S. Population kg/day from the rat chronic toxicity/ exposure. Thus, in making a safety (48 states) 6,200 µg/L; females (13+) carcinogenicity feeding study. Effects determination for this tolerance, the (using the highest TMRC for the 5 observed at the LOAEL’s (34 mg/kg/day Agency is taking into account these subgroups of females), 5,200 µg/L; for males, 117.1 mg/kg/day for females) conservative exposure assessments. The infants/children (using the highest included reduced body weights, food following percentages of the RfD from TMRC for the 5 subgroups of infants/ consumption and efficiency. Males also dietary exposure were calculated: U.S. children) 1,600 µg/L and non-Hispanic had bile duct lesions. An uncertainty population (48 states, all seasons), 2%; (other than black or white), 6,100 µg/L. factor of 100 was used to allow for all infants (< 1 year old), 7%; nursing The highest EEC for azoxystrobin in interspecies sensitivity and intraspecies infants (< 1 year old), 2%; non-nursing surface water is from the application of variability. There was no evidence of infants (< 1 year old), 9%; children (1– azoxystrobin on grapes (39 µg/L) and is increased susceptibility of infants or 6 years old), 5%; children (7–12 years substantially lower than the DWLOCs

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.044 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13109 calculated. Therefore, chronic exposure Based on the chronic (food only) of safety will be safe for infants and to azoxystrobin residues in drinking exposure, chronic DWLOC’s were children. Margins of safety are water does not exceed EPA’s level of calculated. The lowest DWLOC of 1,600 incorporated into EPA risk assessments concern. µg/L was for infants/children (using the either directly through use of a margin 3. From non-dietary exposure. The highest TMRC for the five subgroups of of exposure (MOE) analysis or through only registered indoor/outdoor infants/children listed in the DEEM using uncertainty (safety) factors in residential use for azoxystrobin is analysis). The highest Estimated calculating a dose level that poses no residential turf. The Agency evaluated Environmental Concentration (EEC) in appreciable risk to humans. EPA the existing toxicology database and surface water is from application to believes that reliable data support using determined that there are no grapes (39 µg/L) and is substantially the standard MOE and uncertainty toxicological end points of concern. lower than the calculated DWLOC. The factor (usually 100 for combined inter- 4. Cumulative exposure to substances EEC’s as a result of application to the and intra species variability) and not the with common mechanism of toxicity. proposed uses are no higher than those additional tenfold MOE/uncertainty Section 408(b)(2)(D)(v) requires that, calculated for grapes. Therefore chronic factor when EPA has a complete data when considering whether to establish, exposure in drinking water does not base under existing guidelines and modify, or revoke a tolerance, the exceed the Agency’s level of concern. when the severity of the effect in infants Agency consider ‘‘available 3. Short- and intermediate-term risk. or children or the potency or unusual information’’ concerning the cumulative Short- and intermediate-term risk. No toxic properties of a compound do not effects of a particular pesticide’s dermal or systemic effects were seen in raise concerns regarding the adequacy of residues and ‘‘other substances that the repeated dose dermal study at the the standard MOE/safety factor. have a common mechanism of toxicity.’’ limit dose. The only indoor or outdoor ii. Developmental toxicity studies— a. EPA does not have, at this time, residential use currently registered for Rabbit. In the developmental toxicity available data to determine whether azoxystrobin is residential turf. EPA study in rabbits, developmental NOAEL azoxystrobin has a common mechanism concluded that azoxystrobin does not was 500 mg/kg/day, at the highest dose of toxicity with other substances or how pose a short- or intermediate-term risk. tested (HDT). Because there were no to include this pesticide in a cumulative 4. Aggregate cancer risk for U.S. treatment-related effects, the risk assessment. Unlike other pesticides population. The Agency determined developmental LOAEL was greater than for which EPA has followed a that azoxystrobin should be classified as 500 mg/kg/day. The maternal NOAEL cumulative risk approach based on a ‘‘Not Likely’’ to be a human carcinogen was 150 mg/kg/day. The maternal common mechanism of toxicity, according to the proposed revised LOAEL of 500 mg/kg/day was based on azoxystrobin does not appear to produce Cancer Guidelines because there was no decreased body weight gain during a toxic metabolite produced by other evidence of carcinogenicity in valid dosing. substances. For the purposes of this chronic toxicity studies using two b. Rat. In the developmental toxicity tolerance action, therefore, EPA has not species of mammals. The Agency has study in rats, the maternal (systemic) assumed that azoxystrobin has a therefore concluded that azoxystrobin NOAEL was not established. The common mechanism of toxicity with does not pose a cancer risk. maternal LOAEL of 25 mg/kg/day at the other substances. For information 5. Determination of safety. Based on lowest dose tested (LDT) was based on regarding EPA’s efforts to determine these risk assessments, EPA concludes increased salivation. The developmental which chemicals have a common that there is a reasonable certainty that (fetal) NOAEL was 100 mg/kg/day mechanism of toxicity and to evaluate no harm will result from aggregate (HDT). the cumulative effects of such exposure to azoxystrobin residues as a iii. Reproductive toxicity study. Rat. chemicals, see the final rule for result of current use patterns. In the 2-generation reproductive toxicity Bifenthrin Pesticide Tolerances (62 FR study in rats, the parental (systemic) E. Aggregate Risks and Determination of 62961, November 26, 1997). NOAEL was 32.3 mg/kg/day. The Safety for Infants and Children parental LOAEL of 165.4 mg/kg/day was D. Aggregate Risks and Determination of 1. Safety factor for infants and based on decreased body weights in Safety for U.S. Population children—i. In general. In assessing the males and females, decreased food 1. Acute risk. There were no effects of potential for additional sensitivity of consumption and increased adjusted concern attributable to a single dose infants and children to residues of liver weights in females, and (exposure) in oral toxicological studies azoxystrobin, EPA considered data from cholangitis. The reproductive NOAEL including developmental toxicity developmental toxicity studies in the rat was 32.3 mg/kg/day. The reproductive studies in rat and rabbit and an acute and rabbit and a 2-generation LOAEL of 165.4 mg/kg/day was based neurotoxicity study in rats. Accordingly, reproduction study in the rat. The on increased weanling liver weights and EPA concludes that azoxystrobin does developmental toxicity studies are decreased body weights for pups of both not pose an acute risk. designed to evaluate adverse effects on generations. 2. Chronic risk. Using the exposure the developing organism resulting from iv. Pre- and post-natal sensitivity. The assumptions described in this unit, EPA maternal pesticide exposure during pre- and post-natal toxicology data base has concluded that aggregate exposure gestation. Reproduction studies provide for azoxystrobin is complete with to azoxystrobin from food will utilize information relating to effects from respect to current toxicological data from 2% to 9% of the RfD for the U.S. exposure to the pesticide on the requirements. The results of these population. The major identifiable reproductive capability of mating studies indicate that infants and subgroup with the highest aggregate animals and data on systemic toxicity. children are no more sensitive to exposure is non-nursing infants (<1 year FFDCA section 408 provides that EPA exposure than adults, based on the old). EPA generally has no concern for shall apply an additional tenfold margin results of the rat and rabbit exposures below 100% of the RfD of safety for infants and children in the developmental toxicity studies and the because the RfD represents the level at case of threshold effects to account for 2-generation reproductive toxicity study or below which daily aggregate dietary pre- and post-natal toxicity and the in rats. There are no developmental exposure over a lifetime will not pose completeness of the database unless effects in the rat and rabbit appreciable risks to human health. EPA determines that a different margin developmental studies and the effects

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.044 pfrm07 PsN: 17MRR1 13110 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations observed in the offspring in the azoxystrobin only. This determination B. Magnitude of Residues reproduction study occur at the same was based on the results of metabolism Azoxystrobin has been subjected to dose levels in which toxicity was studies performed on goats and poultry. FDA’s multiresidue protocols. It could observed in the parents. The effects in The goat metabolism study was not be recovered through application of the young are not more severe than reviewed in conjunction with PP any protocol. Residues of azoxystrobin those observed with the parents 5F4541. The poultry metabolism study and its Z isomer are not expected to (decreased body weights in both parents was reviewed in conjunction with PP exceed the proposed tolerance levels and pups). 6F4762. Azoxystrobin and one and the submitted data support v. Conclusion. There is a complete metabolite (compound 28) were tolerance levels for combined residues toxicity database for azoxystrobin and identified in egg yolk and compound 28 of azoxystrobin (methyl(E)-2-(2-(6-(2- exposure data are complete or are alone was found in liver. Residues in cyanophenoxy)pyrimidin-4- estimated based on data that reasonably extracts of egg whites, muscle, and skin yloxy)phenyl)-3-methoxyacrylate) and account for potential exposures. with underlying peritoneal fat were less its Z isomer (methyl(Z)-2-(2-(6-(2- Accordingly, EPA has determined that than 0.01 ppm. Residues of azoxystrobin cyanophenoxy)pyrimidin-4- the standard margin of safety of infants were less than 0.01 ppm at a feeding yloxy)phenyl)-3-methoxyacrylate) in or and children and the additional tenfold level of 1.4x in the radiolabeled study on almond hulls at 4.0 ppm, aspirated safety factor can be removed. and also less than 0.01 ppm in a feeding grain fractions at 10 ppm, bananas (pre- 2. Chronic risk. Using the exposure study at 60 ppm (about 7x). As a result, harvest and postharvest) at 2.0 ppm (of assumptions described in this unit, EPA there is no reasonable expectation of which not more than 0.1 ppm is has concluded that aggregate exposure finite residues of azoxystrobin in contained in the pulp), canola at 1.0 to azoxystrobin from food will utilize poultry commodities. ppm, cucurbits at 0.3 ppm, peanut hay from 2% to 9% of the RfD for infants The registrant submitted three at 2.0 ppm, pistachios at 0.01 ppm, and children. EPA generally has no analytical methods for the analysis of potatoes at 0.03 ppm, rice grain at 5.0 concern for exposures below 100% of the subject commodities. ppm, rice straw at 12 ppm, rice hulls at the RfD because the RfD represents the 20 ppm, stone fruits at 1.5 ppm, tree level at or below which daily aggregate 1. The first method, RAM 243, is a gas chromatography with nitrogen- nuts at 0.010 ppm, wheat grain at 0.10 dietary exposure over a lifetime will not ppm, wheat bran at 0.20 ppm, wheat pose appreciable risks to human health. phosphorus detection (GC/NPD) method which can be used for the analysis of hay at 15 ppm, wheat straw at 4.0 ppm, Despite the potential for exposure to and for the residues of azoxystrobin azoxystrobin in drinking water and from cereals, processed cereals, dried beans, peas, leafy crops, bananas, soft fruits, (only) in fat of cattle, goats, hogs, horses, non-dietary, non-occupational exposure, and sheep at 0.010 ppm; meat of cattle, processed soft fruits, citrus, fruiting EPA does not expect the aggregate goats, hogs, horses, and sheep at 0.01 vegetables, root crops, stone fruits, exposure to exceed 100% of the RfD. ppm; meat byproducts of cattle, goats, wine, and citrus juice. This method has 3. Determination of safety. Based on hogs, horses, and sheep at 0.010 ppm; been reviewed and validated by the these risk assessments, EPA concludes and milk at 0.006 ppm. The submitted Agency, and will be submitted to the that there is a reasonable certainty that residue data support a tolerance level of Food and Drug Administration (FDA) no harm will result to infants and 2.0 ppm for residues of azoxystrobin in for inclusion in PAM II. children from aggregate exposure to or on whole bananas and a tolerance azoxystrobin residues. 2. The second method, RAM 260, is level of 0.1 ppm in or on banana pulp. a GC/NPD method for the analysis of III. Other Considerations The tolerance for bananas must be listed azoxystrobin and its Z isomer in crops as 2.0 ppm for the combined residues of A. Metabolism In Plants and Animals of high lipid content. The registrant has azoxystrobin and its Z isomer in/on used it for analysis of peanut kernel and The qualitative nature of the residue bananas (whole fruit) and residues in hull, processed peanut, pecan kernel, in plants is adequately understood. A banana pulp must not exceed 0.1 ppm. coffee bean, citrus skin, and canola oil. grape metabolism study was evaluated This method has been validated by the C. International Residue Limits by the Agency in December, 1995 and Agency and will be submitted to the There are no Codex, Canadian or it was determined that the residues of FDA for inclusion in PAM II. Mexican Maximum Residue Limits concern in grapes were the parent and (MRL) established for azoxystrobin for its Z isomer. In peanut and wheat 3. The third method, RAM 255, uses gas chromatography with thermionic bananas, curcurbits, potatoes, or stone metabolism studies the major residues fruits. were also azoxystrobin and its Z isomer. detection, nitrogen mode, for analysis of Azoxystrobin does not accumulate in animal commodities. It has been D. Rotational Crop Restrictions validated by the Agency for analysis of crop seeds or fruits. Metabolism of Rotational crop data were previously milk and animal tissues. The laboratory azoxystrobin in plants is complex, with submitted. Based on this information, a will issue a written report shortly and more than 15 metabolites identified. 45–day plantback interval is appropriate the method will be submitted to FDA for However, these metabolites are present for all crops other than those having inclusion in PAM II. at low levels, typically much less than tolerances for azoxystrobin and its Z 5% of the total radioactive residue level. Therefore, adequate analytical isomer. Based on parent being the predominant methodology is available to enforce the residue in the grape, wheat and peanut tolerance expression. The method may IV. Conclusion metabolism studies, the Agency be requested from: Calvin Furlow, Therefore, tolerances are established concludes that the residues of concern PIRIB, IRSD (7502C), Office of Pesticide for combined residues of azoxystrobin in all directly treated crops are the Programs, Environmental Protection (methyl(E)-2-(2-(6-(2- parent and its Z isomer. Agency, 401 M St., SW., Washington, cyanophenoxy)pyrimidin-4- The nature of the residue in animals DC 20460. Office and telephone yloxy)phenyl)-3-methoxyacrylate) and is adequately understood. The Agency number: Rm. 101FF, Crystal Mall #2, its Z isomer (methyl(Z)-2-(2-(6-(2- has determined that the residue of 1921 Jefferson Davis Hwy., Arlington, cyanophenoxy)pyrimidin-4- concern in livestock is parent VA, (703) 305–5229. yloxy)phenyl)-3-methoxyacrylate) in or

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.044 pfrm07 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13111 on almond hulls at 4.0 ppm, aspirated Arlington, VA, (703) 305-5697, file avoiding the use of special grain fractions at 10 ppm, bananas (pre- [email protected]. Requests for characters and any form of encryption. harvest and postharvest) at 2.0 ppm (of waiver of tolerance objection fees The official record for this regulation, which not more than 0.1 ppm is should be sent to James Hollins, as well as the public version, as contained in the pulp), canola at 1.0 Information Resources and Services described in this unit will be kept in ppm, cucurbits at 0.3 ppm, peanut hay Division (7502C), Office of Pesticide paper form. Accordingly, EPA will at 2.0 ppm, pistachios at 0.01 ppm, Programs, Environmental Protection transfer any copies of objections and potatoes at 0.03 ppm, rice grain at 5.0 Agency, 401 M St., SW., Washington, hearing requests received electronically ppm, rice straw at 12 ppm, rice hulls at DC 20460. into printed, paper form as they are 20 ppm, stone fruits at 1.5 ppm, tree If a hearing is requested, the received and will place the paper copies nuts at 0.010 ppm, wheat grain at 0.10 objections must include a statement of in the official record which will also ppm, wheat bran at 0.20 ppm, wheat the factual issues on which a hearing is include all comments submitted directly hay at 15 ppm, wheat straw at 4.0 ppm, requested, the requestor’s contentions in writing. The official record is the and for the residues of azoxystrobin on such issues, and a summary of any paper record maintained at the Virginia (only) in fat of cattle, goats, hogs, horses, evidence relied upon by the requestor address in ‘‘ADDRESSES’’ at the and sheep at 0.010 ppm; meat of cattle, (40 CFR 178.27). A request for a hearing beginning of this document. goats, hogs, horses, and sheep at 0.01 will be granted if the Administrator ppm; meat byproducts of cattle, goats, determines that the material submitted VII. Regulatory Assessment hogs, horses, and sheep at 0.010 ppm; shows the following: There is genuine Requirements and milk at 0.006 ppm. and substantial issue of fact; there is a A. Certain Acts and Executive Orders reasonable possibility that available This final rule establishes a tolerance V. Objections and Hearing Requests evidence identified by the requestor under section 408(d) of the FFDCA in The new FFDCA section 408(g) would, if established, resolve one or provides essentially the same process more of such issues in favor of the response to a petition submitted to the for persons to ‘‘object’’ to a tolerance requestor, taking into account Agency. The Office of Management and regulation as was provided in the old uncontested claims or facts to the Budget (OMB) has exempted these types section 408 and in section 409. contrary; and resolution of the factual of actions from review under Executive However, the period for filing objections issues in the manner sought by the Order 12866, entitled Regulatory is 60 days, rather than 30 days. EPA requestor would be adequate to justify Planning and Review (58 FR 51735, currently has procedural regulations the action requested (40 CFR 178.32). October 4, 1993). This final rule does which govern the submission of Information submitted in connection not contain any information collections objections and hearing requests. These with an objection or hearing request subject to OMB approval under the regulations will require some may be claimed confidential by marking Paperwork Reduction Act (PRA), 44 modification to reflect the new law. any part or all of that information as U.S.C. 3501 et seq., or impose any However, until those modifications can CBI. Information so marked will not be enforceable duty or contain any be made, EPA will continue to use those disclosed except in accordance with unfunded mandate as described under procedural regulations with appropriate procedures set forth in 40 CFR part 2. Title II of the Unfunded Mandates adjustments to reflect the new law. A copy of the information that does not Reform Act of 1995 (UMRA) (Pub. L. Any person may, by May 17, 1999, contain CBI must be submitted for 104–4). Nor does it require any prior file written objections to any aspect of inclusion in the public record. consultation as specified by Executive this regulation and may also request a Information not marked confidential Order 12875, entitled Enhancing the hearing on those objections. Objections may be disclosed publicly by EPA Intergovernmental Partnership (58 FR and hearing requests must be filed with without prior notice. 58093, October 28, 1993), or special the Hearing Clerk, at the address given considerations as required by Executive under the ‘‘ADDRESSES’’ section (40 VI. Public Record and Electronic Order 12898, entitled Federal Actions to CFR 178.20). A copy of the objections Submissions Address Environmental Justice in and/or hearing requests filed with the EPA has established a record for this Minority Populations and Low-Income Hearing Clerk should be submitted to regulation under docket control number Populations (59 FR 7629, February 16, the OPP docket for this regulation. The [OPP–300801] (including any comments 1994), or require OMB review in objections submitted must specify the and data submitted electronically). A accordance with Executive Order 13045, provisions of the regulation deemed public version of this record, including entitled Protection of Children from objectionable and the grounds for the printed, paper versions of electronic Environmental Health Risks and Safety objections (40 CFR 178.25). Each comments, which does not include any Risks (62 FR 19885, April 23, 1997). objection must be accompanied by the information claimed as CBI, is available In addition, since tolerances and fee prescribed by 40 CFR 180.33(i). EPA for inspection from 8:30 a.m. to 4 p.m., exemptions that are established on the is authorized to waive any fee Monday through Friday, excluding legal basis of a petition under FFDCA section requirement ‘‘when in the judgement of holidays. The public record is located in 408(d), such as the tolerances in this the Administrator such a waiver or Room 119 of the Public Information and final rule, do not require the issuance of refund is equitable and not contrary to Records Integrity Branch, Information a proposed rule, the requirements of the the purpose of this subsection.’’ For Resources and Services Division Regulatory Flexibility Act (RFA) (5 additional information regarding (7502C), Office of Pesticide Programs, U.S.C. 601 et seq.) do not apply. tolerance objection fee waivers, contact Environmental Protection Agency, Nevertheless, the Agency previously James Tompkins, Registration Division Crystal Mall #2, 1921 Jefferson Davis assessed whether establishing (7505C), Office of Pesticide Programs, Hwy., Arlington, VA. tolerances, exemptions from tolerances, Environmental Protection Agency, 401 Objections and hearing requests may raising tolerance levels or expanding M St., SW., Washington, DC 20460. be sent by e-mail directly to EPA at: exemptions might adversely impact Office location, telephone number, and [email protected]. small entities and concluded, as a e-mail address: Rm. 239, Crystal Mall E-mailed objections and hearing generic matter, that there is no adverse #2, 1921 Jefferson Davis Hwy., requests must be submitted as an ASCII economic impact. The factual basis for

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.044 pfrm07 PsN: 17MRR1 13112 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations the Agency’s generic certification for effective process permitting elected (a)(1), by redesignating paragraph (a)(2) tolerance actions published on May 4, officials and other representatives of as paragraph (a)(3), and by adding a new 1981 (46 FR 24950), and was provided Indian tribal governments ‘‘to provide paragraph (a)(2) to read as follows: to the Chief Counsel for Advocacy of the meaningful and timely input in the Small Business Administration. development of regulatory policies on § 180.507 Azoxystrobin; tolerances for residues General. B. Executive Order 12875 matters that significantly or uniquely affect their communities.’’ (a) General. (1) * * * Under Executive Order 12875, Today’s rule does not significantly or entitled Enhancing the uniquely affect the communities of Commodity Parts per million Intergovernmental Partnership (58 FR Indian tribal governments. This action 58093, October 28, 1993), EPA may not does not involve or impose any Almond hulls ...... 4.0 issue a regulation that is not required by requirements that affect Indian tribes. Aspirated grain frac- 10 statute and that creates a mandate upon Accordingly, the requirements of tions. a State, local or tribal government, section 3(b) of Executive Order 13084 Bananas (pre-harvest 2.0 (of which not unless the Federal government provides do not apply to this rule. and post harvest). more than 0.1 is the funds necessary to pay the direct contained in the compliance costs incurred by those VIII. Submission to Congress and the pulp) governments. If the mandate is Comptroller General Canola ...... 1.0 unfunded, EPA must provide to OMB a The Congressional Review Act, 5 Cucurbits ...... 0.3 description of the extent of EPA’s prior U.S.C. 801 et seq., as added by the Small consultation with representatives of Business Regulatory Enforcement ***** affected State, local, and tribal Fairness Act of 1996, generally provides Peanut hay ...... 2.0 governments, the nature of their that before a rule may take effect, the Pistachios ...... 0.010 concerns, copies of any written Agency promulgating the rule must Potatoes ...... 0.03 Rice grain ...... 5.0 communications from the governments, submit a rule report, which includes a Rice hulls ...... 20 and a statement supporting the need to copy of the rule, to each House of the Rice straw ...... 12 issue the regulation. In addition, Congress and the Comptroller General of Stone fruits ...... 1.5 Executive Order 12875 requires EPA to the United States. EPA will submit a develop an effective process permitting report containing this rule and other elected officials and other ***** required information to the U.S. Senate, Tree nuts ...... 0.010 representatives of State, local, and tribal the U.S. House of Representatives and governments ‘‘to provide meaningful Wheat bran ...... 0.20 the Comptroller General of the United Wheat grain ...... 0.10 and timely input in the development of States prior to publication of the rule in regulatory proposals containing Wheat hay ...... 15 the Federal Register. This rule is not a Wheat straw ...... 4.0 significant unfunded mandates.’’ ‘‘major rule’’ as defined by 5 U.S.C. Today’s rule does not create an 804(2). unfunded Federal mandate on State, (2) Tolerances are established for local, or tribal governments. The rule List of Subjects in 40 CFR Part 180 residues of the fungicide, azoxystrobin does not impose any enforceable duties Environmental protection, [methyl(E)-2-(2-(6-(2- on these entities. Accordingly, the Administrative practice and procedure, cyanophenoxy)pyrimidin-4- requirements of section 1(a) of Agricultural commodities, Pesticides yloxy)phenyl)-3-methoxyacrylate] in or Executive Order 12875 do not apply to and pests, Reporting and recordkeeping on the following food commodities. this rule. requirements. C. Executive Order 13084 Parts per Dated: March 5, 1999. Commodity million Under Executive Order 13084, James Jones, entitled Consultation and Coordination Cattle, fat ...... 0.010 with Indian Tribal Governments (63 FR Director, Registration Division, Office of Cattle, meat ...... 0.01 27655, May 19, 1998), EPA may not Pesticide Programs. Cattle, meat byproducts ...... 0.010 issue a regulation that is not required by Therefore, 40 CFR chapter I is Goats, fat ...... 0.010 statute, that significantly or uniquely amended as follows: Goats, meat ...... 0.01 affects the communities of Indian tribal Goats, meat byproducts ...... 0.010 governments, and that imposes PART 180Ð[AMENDED] Hogs, fat ...... 0.010 substantial direct compliance costs on 1. The authority citation for part 180 Hogs, meat ...... 0.01 Hogs, meat byproducts ...... 0.010 those communities, unless the Federal continues to read as follows: government provides the funds Horses, fat ...... 0.010 Authority: 21 U.S.C. 321(q), 346a and 371. necessary to pay the direct compliance Horses, meat ...... 0.01 Horses, meat byproducts ...... 0.010 costs incurred by the tribal § 180.507 [Amended] governments. If the mandate is Milk...... 0.006 unfunded, EPA must provide OMB, in 2. In § 180.507, paragraph (a)(1), by Sheep, fat ...... 0.010 a separately identified section of the removing from the table the Sheep, meat ...... 0.01 preamble to the rule, a description of commodities ‘‘Bananas’’, and Sheep, meat byproducts ...... 0.010 the extent of EPA’s prior consultation ‘‘Peaches’’. with representatives of affected tribal 3. Section 180.507 is further amended * * * * * governments, a summary of the nature in paragraph (a)(1) by changing the [FR Doc. 99–6387 Filed 3–16–99; 8:45 am] of their concerns, and a statement words ‘‘raw agricultural commodities’’ BILLING CODE 6560±50±F supporting the need to issue the to read ‘‘food commodities’’, by regulation. In addition, Executive Order alphabetically adding the following 13084 requires EPA to develop an commodities to the table in paragraph

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ENVIRONMENTAL PROTECTION clarification is intended to remove Washington, DC metropolitan area, AGENCY misunderstanding as to which contact 703/412–9810). The radionuclide releases are subject to the Telecommunications Device for the Deaf 40 CFR Parts 302 and 355 final reporting exemptions. (TDD) Hotline number is 800/553–7672 EFFECTIVE DATE: (in the Washington, DC metropolitan [FRL±6309±3a] March 17, 1999. ADDRESSES: area, contact 703/486–3323); or the Administrative Reporting Exemptions Release Notification: The toll-free Office of Emergency and Remedial for Certain Radionuclide Releases telephone number of the National Response (5202G), U.S. Environmental Response Center is 800/424–8802; in the Protection Agency, 401 M Street, SW, AGENCY: Environmental Protection Washington, DC metropolitan area, the Washington, DC 20460 (contact Agency (EPA). number is 202/267–2675. The facsimile Elizabeth Zeller 703/603–8744). ACTION: Technical amendment of final number for the National Response SUPPLEMENTARY INFORMATION: rule. Center is 202/267–2165 and the telex number is 892427. Potentially Affected Entities SUMMARY: The Environmental Protection Docket: Copies of materials relevant to Agency today is issuing amended the March 19, 1998, rulemaking are Entities that may be affected by this language to a final rule published on contained in the U.S. EPA CERCLA technical amendment include: (1) March 19, 1998, (63 FR 13460) that Docket Office, Crystal Gateway #1, 1st persons in charge of vessels or facilities granted exemptions from certain Floor, 1235 Jefferson Davis Highway, that may have naturally occurring reporting requirements under the Arlington, VA 22202 [Docket Number radionuclide releases into the Comprehensive Environmental 102RQ3–RN–2]. The docket is available environment that are among those Response, Compensation, and Liability for inspection, by appointment only, granted an administrative reporting Act and the Emergency Planning and between the hours of 9:00 a.m. and 4:00 exemption by the March 19, 1998, final Community Right-to-Know Act. p.m., Monday through Friday, excluding rule; and (2) entities that plan for or Among other reporting exemptions, Federal holidays. Appointments to respond to such releases. the March 19, 1998, final rule exempted review the docket can be made by The table below lists potentially from certain reporting requirements calling 703/603–9232. The public may affected entities. This table is not releases of naturally occurring copy a maximum of 266 pages from any intended to be exhaustive, but rather radionuclides associated with land regulatory docket at no cost. If the provides a guide for readers regarding disturbance incidental to extraction number of pages copied exceeds 266, entities likely to be affected by this activities, except that which occurs at however, an administrative fee of $25 action. Other entities not listed in the uranium, phosphate, tin, zircon, and a charge of $0.15 per page for each table could also be affected. To hafnium, vanadium, and rare earth page after page 266 will be incurred. determine whether your organization is mines. Today’s technical amendment The Docket Office will mail copies of affected by this action, carefully will clarify that land disturbance materials to requestors who are outside examine the changes to 40 CFR parts incidental to extraction includes the Washington, DC metropolitan area. 302 and 355. If you have questions replacing in mined-out areas coal ash, The docket for the March 19, 1998, regarding the applicability of this action earthen materials from farming and rulemaking will be kept in paper form. to a particular entity, consult the contact construction, or overburden or other FOR FURTHER INFORMATION CONTACT: The names and phone numbers listed in the raw materials generated from the RCRA/UST, Superfund, and EPCRA preceding FOR FURTHER INFORMATION exempted mining activities. The Hotline at 800/424–9346 (in the CONTACT section of this preamble.

POTENTIALLY AFFECTED ENTITIES

Type of entity Examples of affected entities

Industry ...... Mines and entities that backfill mined-out areas. State, Local, or Tribal Governments ...... State Emergency Response Commissions, Local Emergency Planning Committees. Federal Government ...... National Response Center, and any Federal agency that may have radionuclide releases granted a reporting exemption.

Reasons for Today’s Amendment exemptions to eliminate needless areas so long as such materials have not reporting burdens on persons been beneficiated or processed and do The March 19, 1998, final rule responsible for certain mine sites and not contain elevated radionuclide broadened exemptions from the coal and coal ash piles. The reporting concentrations (defined as greater than CERCLA section 103 and EPCRA section exemptions also allow the government 7.6 picocuries per gram or pCi/g of 304 release reporting requirements to to better focus its resources on the most Uranium-238, 6.8 pCi/g of Thorium-232, include releases of naturally occurring serious releases, resulting in more or 8.4 pCi/g of Radium-226, which equal radionuclides from land disturbance effective protection of public health and two times the upper end of the incidental to extraction activities at all welfare and the environment. concentration range reported in the mines except certain categories of mines Sections 302.6(c)(2) and literature for typical surface soil). One that are likely to handle raw materials 355.40(a)(2)(vi)(B) of the final rule person involved with a mining with elevated radionuclide stated that land disturbance incidental operation has since commented that this concentrations. The final rule also to extraction includes: land clearing; language can be read to suggest that broadened the reporting exemptions to overburden removal and stockpiling; mines subject to the reporting include releases of naturally occurring excavating, handling, transporting, and exemption would have to test their raw radionuclides to and from coal and coal storing ores and other raw materials; materials or any other materials they use ash piles at all sites. EPA granted these and replacing materials in mined-out to backfill mined-out areas to determine

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.045 pfrm07 PsN: 17MRR1 13114 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations whether they are below the stated not a ‘‘significant regulatory action’’ and House of Representatives, and the concentration thresholds. If so, such a is therefore not subject to review by the Comptroller General of the United requirement would in fact impose a new Office of Management and Budget. In States prior to publication of the rule in burden on those categories of mines that addition, this action does not impose the Federal Register. This rule is not a were supposed to be granted regulatory any enforceable duty, contain any ‘‘major rule’’ as defined by 5 U.S.C. relief. unfunded mandate, or impose any 804(2). EPA did not intend for the reporting significant or unique impact on small exemptions to be contingent on new governments as described in the List of Subjects in 40 CFR Parts 302 and measurements of radionuclide Unfunded Mandates Reform Act of 1995 355 concentrations in materials handled at (Pub. L. 104–4). This rule also does not Environmental protection, Air mines. Instead, the final rule itself require prior consultation with State, pollution control, Chemicals, Hazardous distinguished between the exempt local, and tribal government officials as materials, Hazardous wastes, Reporting mines and those mines handling ores specified by Executive Order 12875 (58 and recordkeeping requirements, likely to have elevated radionuclide FR 58093, October 28, 1993) or Superfund, Water pollution control, concentrations. The final rule granted Executive Order 13084 (63 FR 27655 Water supply. the exemption for radionuclide releases (May 10, 1998), or involve special Dated: February 19, 1999. from land disturbance incidental to consideration of environmental justice Timothy Fields, Jr., extraction based on the Agency’s review related issues as required by Executive Acting Assistant Administrator. of available data showing that Order 12898 (59 FR 7629, February 16, overburden and raw (not beneficiated or 1994). Because this action is not subject For the reasons set out above, title 40, processed) ore generated at most types to notice-and-comment requirements chapter I of the Code of Federal of mines have radionuclide under the Administrative Procedure Act Regulations is amended as follows: concentrations that are at or near or any other statute, it is not subject to PART 302ÐDESIGNATION, background. EPA intended to exempt all the regulatory flexibility provisions of land disturbance in the exempt mines, the Regulatory Flexibility Act (5 U.S.C. REPORTABLE QUANTITIES, AND including replacement, so long as the 601 et seq.). This rule also is not subject NOTIFICATION replacement materials originated from to Executive Order 13045 (62 F.R. 1. The authority citation for part 302 an exempt activity. Therefore, mines 19885, April 23, 1997) because EPA continues to read as follows: subject to the exemption do not need to interprets E.O. 13045 as applying only test their raw materials when backfilling Authority: 42 U.S.C. 9602, 9603, and 9604; to those regulatory actions that are 33 U.S.C. 1321 and 1361. mined-out areas. based on health or safety risks, such that In summary, mines subject to the the analysis required under section 5– 2. Section 302.6 is amended by exemption do not need to report 501 of the Order has the potential to revising paragraph (c)(2) to read as releases associated with the placement influence the regulation. This rule is not follows: of raw materials that they generate into subject to E.O. 13045 because it does not § 302.6 Notification requirements. mined-out areas. Moreover, mines establish an environmental standard subject to the exemption do not need to intended to mitigate health or safety * * * * * report radionuclide releases associated risks. EPA’s compliance with these (c) * * * (2) Releases of naturally occurring with the placement of coal ash or statutes and Executive Orders for the radionuclides from land disturbance earthen materials from farming or underlying rule is discussed in the activities, including farming, construction into mined-out areas, March 19, 1998 Federal Register notice. because these materials have also been construction, and land disturbance found to have radionuclide Submission to Congress and the incidental to extraction during mining concentrations that are at or near General Accounting Office activities, except that which occurs at background. Today’s technical The Congressional Review Act, 5 uranium, phosphate, tin, zircon, amendment to the final regulatory U.S.C. 801 et seq., as added by the Small hafnium, vanadium, monazite, and rare language clarifies these points and Business Regulatory Enforcement earth mines. Land disturbance removes confusing language from the Fairness Act of 1996, generally provides incidental to extraction includes: land regulation. that before a rule may take effect, the clearing; overburden removal and Today’s notice does not create any agency promulgating the rule must stockpiling; excavating, handling, new or any different regulatory submit a rule report, which includes a transporting, and storing ores and other requirement; rather, it clarifies which copy of the rule, to each House of raw (not beneficiated or processed) activities are covered by the Congress and to the Comptroller General materials; and replacing in mined-out administrative exemptions promulgated of the United States. Section 808 allows areas coal ash, earthen materials from on March 19, 1998. For this reason, EPA the issuing agency to make a rule farming or construction, or overburden finds that this rule falls under the good effective sooner than otherwise or other raw materials generated from cause exemption in section 553(b) of the provided by the CRA if the agency the exempted mining activities. Administrative Procedure Act (APA), makes a good cause finding that notice * * * * * allowing the Agency to forego prior and public procedure is impracticable, notice and opportunity for public unnecessary or contrary to the public PART 355ÐEMERGENCY PLANNING comment before issuing this final rule. interest. This determination must be AND NOTIFICATION For the same reason, EPA finds that supported by a brief statement. 5. U.S.C. 3. The authority citation for part 355 good cause exists to provide for an § 808(2). As stated previously, EPA has continues to read as follows: immediate effective date under section made such a good cause finding, 553(d) of the APA. including the reasons therefor, and Authority: 42 U.S.C. 11002, 11004, and established an effective date of March 11048. Administrative Requirements 17, 1999. EPA will submit a report 4. Section 355.40 is amended by Under Executive Order 12866 (58 FR containing this rule and other required revising paragraph (a)(2)(vi)(B) to read 51735, October 4, 1993), this action is information to the U.S. Senate, the U.S. as follows:

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§ 355.40 Emergency release notification. [email protected]. 202–646– agency’s repetitive for dealing with (a) * * * 4536, or (email) [email protected]. properties with multiple flood losses. (2) * * * SUPPLEMENTARY INFORMATION: We The Amite River Basin Drainage and (vi) * * * proposed a rule at 64 FR 3909, January Water Conservation District agreed with (B) Naturally from land disturbance 26, 1999, that would increase the our overall objective of minimizing activities, including farming, premium rates that we charge under the losses, but disagreed with the rule as construction, and land disturbance National Flood Insurance Program for proposed saying that ‘‘we do not agree incidental to extraction during mining pre-FIRM, V-zone properties. We on the proposed rules to increase the activities, except that which occurs at received comments from: the subsidized rates for pre-FIRM properties uranium, phosphate, tin, zircon, Association of State Floodplain in A and V zones.’’ The District went on hafnium, vanadium, monazite, and rare Managers, Inc., the Amite River Basin to say that any ‘‘increase in subsidized earth mines. Land disturbance Drainage and Water Conservation insurance rates should be considered in incidental to extraction includes: land District, and the Coast Alliance. the context of an overall strategy and clearing; overburden removal and The Association of State Floodplain program to reduce flood losses at this stockpiling; excavating, handling, Managers, Inc. raised three issues. The time, which FEMA has not done. The transporting, and storing ores and other first issue deals with the subsidy. The overall strategy and program should raw (not beneficiated or processed) Association said that ‘‘we believe that include a very critical and important materials; and replacing in mined-out any rate increase, however justified, ‘phase-out’ program that will lead us from a ‘high loss’ status to a ‘low loss’ areas coal ash, earthen materials from needs to be made in the context status. This will require time (years) and farming or construction, or overburden established by Congress—that owners of funding at the federal, state, and local or other raw materials generated from buildings constructed before the the exempted mining activities. level.’’ communities joined the NFIP are There are several misunderstandings * * * * * intended to be subsidized.’’ This rule by the District. First, the rule does not [FR Doc. 99–6512 Filed 3–16–99; 8:45 am] does not eliminate the subsidy for pre- affect pre-FIRM, A-zone properties. The FIRM, V-zone structures. It only reduces BILLING CODE 6560±50±P rule affects only the rates for pre-FIRM, the subsidy. The change in rates for the V-zone properties. The affected pre-FIRM, V-zone policyholders, properties currently constitute a little currently paying an average annual more than one percent of the National FEDERAL EMERGENCY premium of $440, will result in an MANAGEMENT AGENCY Flood Insurance Program’s policies in average increase of about seven percent. force. Second, our action complements The rule remains consistent with the 44 CFR Part 61 rather than stands apart from other National Flood Insurance Program’s initiatives that FEMA has undertaken or RIN 3067±AC96 enabling legislation and the is currently developing, particularly discretionary authority granted to FEMA with regard to structures with multiple National Flood Insurance Program to administer the program. flood losses. The agency is currently (NFIP); Insurance Coverage and Rates The second issue the Association looking at permanent solutions, raised is that the National Flood including funding, technical assistance, AGENCY: Federal Emergency Insurance Reform Act of 1994 requires Management Agency (FEMA). and insurance approaches, to the FEMA to conduct a study ‘‘of the impact recurring problems of multiple-flood- ACTION: Final rule. of reducing the subsidy of pre-FIRM loss structures. Taking this action now policies.’’ The Association pointed out in no way diminishes any of those other SUMMARY: We (the Federal Insurance correctly that FEMA has not yet finished Administration) are increasing the initiatives. Third, we have phased in that study. However, the Association’s rate increases for pre-FIRM properties amount of premium you (the flood comment incorrectly characterizes the insurance policyholder) pay for flood over time. The last time we increased nature of the study, which involves subsidized premium rates was in 1996. insurance coverage for ‘‘pre-FIRM’’ examining economic impacts of buildings in coastal areas subject to high So we believe we are consistent with the eliminating the subsidy by charging full District’s recommendation for a phased- velocity waters, such as storm surges, actuarial premiums to pre-FIRM and wind-driven waves (‘‘V’’ zones). in approach. structures. Our current regulatory action The Coast Alliance agreed with the (‘‘Pre-FIRM’’ buildings are those whose calls for a modest rate increase for pre- proposed rule saying, ‘‘We support the construction was started before January FIRM, V-zone properties and does not Federal Emergency Management 1, 1975, or the effective date of a need to await completion of the study. Agency’s proposed rule to increase the community’s Flood Insurance Rate Map The Association’s third issue is that amount of premium paid by the (FIRM), whichever is later. Pre-FIRM ‘‘any rate increase must be part of an policyholder for flood insurance for buildings and their contents are eligible overall effort to evaluate all measures to ‘pre-FRM’ buildings in coastal areas for subsidized rates.) We are increasing reduce flood losses, and such measures subject to high velocity waters and rates for pre-FIRM, V-zone properties to must not be based solely on increasing wind-driven waves (‘V’ zones).’’ The recognize the inherently greater flood income by increasing the cost of Coast Alliance, however, expressed risk of these properties. insurance, but needs to focus on concern about any availability of EFFECTIVE DATE: This rule is effective on mitigation measures to reduce claims subsidized or non-actuarial premium May 1, 1999. against the NFIP.’’ We have not forsaken rates in coastal areas and recommended FOR FURTHER INFORMATION CONTACT: nor do we intend to forsake mitigation that ‘‘FEMA must take the next logical Charles M. Plaxico, Jr., Federal efforts in favor of merely raising step to deny new flood policies in high Emergency Management Agency, premiums for a small group of risk areas.’’ We believe that this Federal Insurance Administration, 500 policyholders. Experience shows us that recommendation should be dealt with C Street, SW., room 840, Washington, we can make small improvements to the legislatively, as were the two precedents DC 20472, 202–646–3422, (facsimile) program without jeopardizing or for denying flood insurance coverage in 202–646–4327, or (email) delaying larger initiatives such as the certain geographical areas at 42 U.S.C.

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4028–4029. As required by the National human environment as a result of the Executive Order 12778, Civil Justice Flood Insurance Reform Act of 1994, we issuance of this final rule, and no Reform are evaluating the impact of erosion Environmental Impact Statement will be hazards on the NFIP. Part of that study prepared. Copies of the environmental This rule meets the applicable will explore the economic impact of assessment are on file for inspection standards of § 2(b)(2) of E.O. 12778. denying insurance in areas subject to through the Rules Docket Clerk, Federal List of Subjects in 44 CFR Part 61 coastal erosion. It is premature for us to Emergency Management Agency, room comment on the Alliance’s 840, 500 C Street SW., Washington, DC Flood insurance. recommendation before we complete 20472. Accordingly, we amend 44 CFR Part that study and report to Congress. Executive Order 12866, Regulatory 61 as follows: In summary, we believe that targeting Planning and Review a particularly risky class of properties PART 61ÐINSURANCE COVERAGE This rule is not a significant with higher premium rates supports AND RATES regulatory action within the meaning of FEMA’s overall program of loss § 2(f) of E.O. 12866 of September 30, 1. The authority citation for Part 61 reduction. It more accurately reflects the 1993, 58 FR 51735, but attempts to continues to read as follows: loss exposure of pre-FIRM, V-zone adhere to the regulatory principles set properties, which are at a greater Authority: 42 U.S.C. 4001 et seq.; forth in E.O. 12866. The rule has not exposure to flood loss than pre-FIRM, Reorganization Plan No. 3 of 1978, 43 FR been reviewed by the Office of A-zone properties. Also, it helps make 41943, 3 CFR, 1978 Comp., p. 329; E.O. Management and Budget under E.O. 12127 of Mar. 31, 1979, 44 FR 19367, 3 CFR, policyholders aware of the danger of 12866. 1979 Comp., p. 376. their V-zone properties. Paperwork Reduction Act 2. We are revising Section 61.9 to read National Environmental Policy Act This rule does not contain a collection as follows: Under section 102(2)(C) of the of information and therefore is not § 61.9 Establishment of chargeable rates. National Environmental Policy Act of subject to the provisions of the 1969, 42 U.S.C. 4371 et seq., and the Paperwork Reduction Act of 1995. (a) Under section 1308 of the Act, we implementing regulations of the Council are establishing annual chargeable rates on Environmental Quality, 40 CFR parts Executive Order 12612, Federalism for each $100 of flood insurance 1500–1508, we conducted an This rule involves no policies that coverage as follows for pre-FIRM, A environmental assessment of this rule. have federalism implications under E.O. zone properties, pre-FIRM, V zone The assessment concludes that there 12612, Federalism, dated October 26, properties, and emergency program will be no significant impact on the 1987. properties.

A zone rates1 per year per V zone rates 2 per year per Type of structure $100 coverage on: $100 coverage on: Structure Contents Structure Contents

1. Residential: No Basement or Enclosure ...... 68 .79 .82 .95 With Basement or Enclosure ...... 73 .79 .88 .95 2. All other including hotels and motels with normal occupancy of less than 6 months duration: No Basement or Enclosure ...... 79 1.58 .95 1.90 With Basement or Enclosure ...... 84 1.58 1.01 1.90 1 A zones are zones A1±A30, AE, AO, AH, and unnumbered A zones. 2 V zones are zones V1±V30, VE, and unnumbered V zones.

(b) We will charge rates for contents DEPARTMENT OF THE INTERIOR amended (Act). Catesbaea melanocarpa in pre-FIRM buildings according to the is known from Puerto Rico, St. Croix in use of the building. Fish and Wildlife Service the U.S. Virgin Islands, Barbuda, Antigua, and Guadeloupe. In Puerto (c) A-zone rates for buildings without 50 CFR Part 17 basements or enclosures apply Rico, it is currently known from only one location in Cabo Rojo; in the U.S. uniformly to all buildings throughout RIN 1018±AE48 Virgin Islands, it is known from one emergency program communities. Endangered and Threatened Wildlife location near Christiansted, St. Croix. (Catalog of Federal Domestic Assistance No. and Plants; Determination of Both populations are located on 83.100, ‘‘Flood Insurance’’; No. 83.516, Endangered Status for Catesbaea privately-owned land subject to intense ‘‘Disaster Assistance’’) Melanocarpa pressure for development for Dated: March 11, 1999. residential, tourist, and industrial AGENCY: Fish and Wildlife Service, Jo Ann Howard purposes. This final rule implements Interior. the Federal protection and recovery Administrator, ACTION: Final rule. provisions afforded by the Act for C. Federal Insurance Administration. melanocarpa. [FR Doc. 99–6466 Filed 3–16–99; 8:45 am] SUMMARY: We, the U.S. Fish and Wildlife Service, determine Catesbaea EFFECTIVE DATE: April 16, 1999. BILLING CODE 6718±03±P melanocarpa (no common name) to be ADDRESSES: The complete file for this an endangered species under the rule is available for inspection, by Endangered Species Act of 1973, as appointment, during normal business

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Box Plant Conservation (1992) recommend priority (Tier 1) to processing 491, Boquero´n, Puerto Rico 00622. its protection due to the extremely small emergency rules to add species to the FOR FURTHER INFORMATION CONTACT: Ms. number of individuals currently known, Lists of Endangered and Threatened Susan Silander, Botanist, at the above the intense pressure for development in Wildlife and Plants (Lists); second address (telephone 787/851–7297; these areas, and the potential for an priority (Tier 2) to processing final facsimile 787/851–7440). appreciable loss of the species’ genetic determinations on proposals to add diversity. species to the Lists, processing new SUPPLEMENTARY INFORMATION: Catesbaea melanocarpa is a proposals to add species to the Lists, Background branching shrub that may reach processing administrative findings on The German collector Hienrich approximately 3 meters (9.8 feet) in petitions (to add species to the Lists, Rudolph Wullschlaegel first discovered height. Spines, 1 to 2 centimeters (.39 to delist species, or reclassify listed Catesbaea melanocarpa (no common .78 in) long, occur on the stems between species), and processing a limited name) in the mid-nineteenth century on the leaves. Leaves are small, from 5 to number of proposed or final rules to 25 mm (.19 to 1.0 in) long and 2 to 15 the British island of Antigua. In about delist or reclassify species; and third mm (.07 to .58 in) wide, often in 1881, the Danish collector Baron H. F. priority (Tier 3) to processing proposed clusters, and the small stipules A. von Eggers found C. melanocarpa in or final rules designating critical habitat. (appendages at the base of the leaf stalk) St. Croix, U.S. Virgin Islands, and in Processing of this final rule is a Tier 2 are deciduous (shed seasonally). The 1886, the German collector Paul action. flowers are white, solitary or paired, and Sintenis found it in Gua´nica, Puerto almost sessile (attached directly at the Summary of Comments and Rico. Although other herbariums base) in the axils. The corolla (petals) is Recommendations maintain duplicate specimens, bombing funnelform and from 8 to 10 mm (.31 to In the December 16, 1997, proposed during World War II destroyed the .39 in) long. The fruit is globe-shaped, rule and associated reports of original collections in the herbarium at 5 to 6 mm (.19 to .23 in) in diameter, information that might contribute to the Berlin-Dahlem, Germany. and black with a brittle fruit wall. The development of a final rule. We Howard (1989) and Proctor (1991) 2-celled fruit contains five to seven contacted appropriate agencies of the reported the species from Barbuda and seeds in each cell (Proctor 1991). Commonwealth of Puerto Rico and the Guadeloupe, islands of the Lesser Territory of the Virgin Islands, Federal Antilles. Little is known about its status Previous Federal Action agencies, scientific organizations and on these islands; the Center for Plant We had identified Catesbaea other interested parties and requested Conservation (1992) describes C. melanocarpa as a Category 2 species in their comments. We published a melanocarpa as rare on Antigua. It was notices of review published in the newspaper notice inviting public not rediscovered in St. Croix until 1988 Federal Register on February 21, 1990 comment in El Nuevo Dia on January 27, and, to date, it has not been relocated (55 FR 6184), and September 30, 1993 1998, and in The Daily News of the in the Gu´ nica, Puerto Rico, area. The St. (58 FR 51144). Prior to 1996, a Category Virgin Islands on January 31, 1998. We Croix population, located near 2 species was one that we were also solicited the expert opinions of four Christiansted, consists of about 24 considering for possible addition to the appropriate and independent specialists individual plants (Breckon and Federal List of Endangered and regarding the pertinent scientific or Kolterman 1993). In 1995, a single plant Threatened Plants, but for which commercial data and assumptions was located in Cabo Rojo, Puerto Rico conclusive data on biological relating to taxonomy, population (Puerto Rico Planning Board 1995). One vulnerability and threat were not models, and biological and ecological specimen, collected in 1974, located in available to support a proposed rule. We information for this species. We did not the herbarium in San Juan, apparently discontinued designation of Category 2 receive any comments from these originated from the Susu´ a species in the February 28, 1996, Notice experts. We received two letters of Commonwealth Forest. However, this of Review (61 FR 7596). We approved comment, neither of which opposed the specimen is sterile and poorly Catesbaea melanocarpa as a candidate listing. The Puerto Rican Planning developed; therefore, its identification species on September 6, 1995, and Board did not have comments on the cannot be confirmed. identified as such in the 1996 Notice of listing, but stated that they would use Catesbaea melanocarpa, of the family Review. A candidate species is now the information in the evaluation of Rubiaceae, belongs to a genus that defined as a species for which we have projects that might affect the species. consists of ten or more species of spiny on file sufficient information to propose The U.S. Department of Housing and shrubs. Most are confined to the it for protection under the Act. This Urban Development did not have Antilles, but some may extend into the small shrub is considered a ‘‘critical’’ comments concerning the listing. A Bahamas and the Florida Keys. In plant species by the Natural Heritage public hearing was neither requested Puerto Rico, two species are known—C. Program of the Puerto Rico Department nor held. melanocarpa and C. parviflora. These of Natural and Environmental two species are differentiated by the size Resources. The Center for Plant Summary of Factors Affecting the and color of the fruits; black and larger, Conservation (1992) has assigned the Species 5 to 6 millimeters (mm) (.19 to .23 species a Priority Status of A (a species After a thorough review and inches (in)) in diameter, in the former, which could possibly go extinct in the consideration of all information and white and smaller, 2 to 4 mm (.07 wild in the next 5 years). On December available, we have determined that to .15 in) in diameter in the latter 16, 1997, we published a proposed rule Catesbaea melanocarpa should be (Breckon and Kolterman 1993, Britton to list Catesbaea melanocarpa (62 FR classified as an endangered species. We and Wilson 1925). Some authors note 65783). followed procedures found at Section that C. melanocarpa may be a synonym On May 8, 1998, we published Listing 4(a)(1) of the Act and regulations or variant of C. parviflora (Howard Priority Guidance for Fiscal Years 1998 implementing the listing provisions of 1989, Proctor 1991) and recommend and 1999 (63 FR 25502). The guidance the Act (50 CFR part 424). We may further review. However, Breckon and clarifies the order in which we will determine a species to be endangered or

VerDate 03-MAR-99 08:08 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\A17MR0.003 pfrm07 PsN: 17MRR1 13118 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations threatened due to one or more of the ‘‘Available Conservation Measures’’ for (50 CFR 424.12) require that, to the five factors described in section 4(a)(1). discussion of prohibitions). As with the maximum extent prudent and These factors and their application to Commonwealth, the existence of a determinable, we designate critical Catesbaea melanocarpa Krug and Urban section 6 cooperative agreement with habitat at the time the species is are as follows: the Service will increase possibilities for determined to be endangered or funding needed research with this plant. threatened. Our regulations (50 CFR A. The Present or Threatened 424.12(a)(1)) state that the designation E. Other Natural or Manmade Factors Destruction, Modification, or of critical habitat is not prudent when Affecting Its Continued Existence Curtailment of Its Habitat or Range one or both of the following situations Catesbaea melanocarpa is known One of the most important factors exist—(1) the species is threatened by only from Puerto Rico, St. Croix, affecting the continued survival of this taking or other human activity, and Barbuda, Antigua, and Guadeloupe. species is its limited distribution. identification of critical habitat can be Available information indicates that it is Because so few individuals are known expected to increase the degree of threat rare on Antigua (Center for Plant to occur in limited areas, the risk of to the species, or (2) such designation of Conservation 1992). In Puerto Rico, only extinction is extremely high. critical habitat would not be beneficial a single plant is known to exist. This Catastrophic natural events, such as to the species. We find that designation plant is located on privately owned hurricanes, may dramatically affect of critical habitat for Catesbaea land, in Cabo Rojo, currently proposed forest species composition and melanocarpa is not prudent because for a residential/tourist development, structure, felling large trees and creating such designation would not be consisting of a hotel, condo-hotel, numerous canopy gaps. Breckon and beneficial to the species and may residential villas and lots, a golf course, Kolterman (1993) documented the loss increase the threats to the species. and other associated facilities. In St. of individuals in St. Croix following the Critical habitat designation, by Croix, only one population consisting of passing of hurricane Hugo in 1989. In definition, directly affects only Federal about 24 plants is known to exist. This addition, the limited gene pool may agency actions through consultation population is located on privately- depress reproductive vigor. under section 7(a)(2) of the Act. Section owned land near Christiansted and is We have carefully assessed the best 7(a)(2) requires Federal agencies to subject to pressure for development. scientific and commercial information ensure that activities they authorize, available regarding the past, present, fund, or carry out are not likely to B. Overutilization for Commercial, and future threats faced by this species jeopardize the continued existence of a Recreational, Scientific, or Educational in determining to make this rule final. listed species or destroy or adversely Purposes Based on this evaluation, the preferred modify its critical habitat. Neither of the We have not received information action is to list Catesbaea melanocarpa two known populations of Catesbaea documenting that the use of the species as endangered. Within the United melanocarpa occur on Federal land. for such purposes is a factor in its States, the species occurs in only one However, Federal involvement with this decline. Although overcollection has locality in Puerto Rico and one in St. species may occur through the use of not been documented, the extremely Croix, U.S. Virgin Islands. Deforestation Federal funding for rural housing and small population size and limited range for residential and tourist development development on non-Federal lands. The make this species vulnerable to are imminent threats to the survival of use of such funding for projects overcollection (see ‘‘CRITICAL the species. Because this species is in affecting occupied habitat for this HABITAT’’ below). danger of extinction throughout all or species would be subject to review significant portion of its range, it meets under section 7(a)(2), whether or not C. Disease or Predation the definition of endangered under the critical habitat was designated. The Disease and predation have not been Act. We discuss the reasons for not precarious status of C. melanocarpa is documented as factors in the decline of designating critical habitat for this such that any adverse modification or this species. species in the ‘‘Critical Habitat’’ section destruction of its occupied habitat D. The Inadequacy of Existing below. would also jeopardize its continued existence. This would also hold true as Regulatory Mechanisms Critical Habitat the species recovers and its numbers The Commonwealth of Puerto Rico’s Critical habitat is defined in section 3 increase. In addition, we believe that regulations recognize and provide of the Act as: (i) the specific areas notification of Federal agencies of the protection for certain Commonwealth within the geographical area occupied areas where these plants occur can be listed species. However, Catesbaea by a species, at the time it is listed in accomplished without the designation melanocarpa is not yet on the accordance with the Act, on which are of critical habitat. All involved parties Commonwealth list and therefore found those physical or biological and landowners have been notified of receives no special protection. Federal features (I) essential to the conservation the location and importance of listing will provide immediate of the species and (II) that may require protecting this species’ habitat. For protection under the Act and, by virtue special management considerations or these reasons, we believe that of an existing section 6 cooperative protection; and (ii) specific areas designation of currently occupied agreement with the Commonwealth, it outside the geographic area occupied by habitat of this species as critical habitat will also ensure the addition of this a species at the time it is listed, upon would not result in any additional species to the Commonwealth list and a determination that such areas are benefit to the species and that such enhance possibilities for funding essential for the conservation of the designation is not prudent. needed research. The Territory of the species. ‘‘Conservation’’ means the use Potential introduction sites within U.S. Virgin Islands has amended an of all methods and procedures needed unoccupied lands occur on lands under existing regulation to provide for to bring the species to the point at Federal management (Cabo Rojo, Laguna protection of endangered and threatened which listing under the Act is no longer Cartagena, and Sandy Point National wildlife and plants. The U.S. Virgin necessary. Wildlife Refuges) and Commonwealth Islands consider Catesbaea Section 4(a)(3) of the Act, as management (Gua´nica Commonwealth melanocarpa to be endangered (see amended, and implementing regulations Forest). As managers of these

VerDate 03-MAR-99 15:02 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.XXX pfrm04 PsN: 17MRR1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13119 subtropical dry forest lands, the Service and results in conservation actions by The Act and 50 CFR 17.62 and 17.63 and the Puerto Rico Department of Federal, Commonwealth, Territory, and also provide for the issuance of permits Natural and Environmental Resources private agencies, groups and to carry out otherwise prohibited are actively involved in conservation individuals. The Act provides for activities involving endangered species activities. Both agencies are committed possible land acquisition and under certain circumstances. Such to the protection of these forested areas cooperation with the Commonwealth permits are available for scientific and would minimize or avoid any and/or Territory, and requires that purposes and to enhance the impacts to such habitat. Any recovery actions be carried out for all propagation and survival of the species. introduction would be closely listed species. We initiate such actions We anticipate that few trade permits for coordinated with the area managers. following listing. We discuss the this species will ever be sought or Introduction of this species onto protection required of Federal agencies issued, since the species is neither unoccupied private lands likely would and the prohibitions against certain common in cultivation nor common in not be pursued because suitable habitat activities involving listed plants, in part, the wild. under private ownership occurs only in below. very small patches which are Section 7(a) of the Act, as amended, It is our policy, published in the interspersed among developed areas and requires Federal agencies to evaluate Federal Register on July 1, 1994 (59 FR are too small for development of viable their actions with respect to any species 34272), to identify to the maximum populations. For these reasons, we that is proposed or listed as endangered extent practicable those activities that believe that designation of currently or threatened and with respect to its would or would not constitute a unoccupied habitat of this species as critical habitat, if any is being violation of section 9 of the Act at the critical habitat would not result in any designated. Regulations implementing time of listing. The intent of this policy additional benefit to the species and, this interagency cooperation provision is to increase public awareness of the therefore, such designation is not of the Act are codified at 50 CFR part effect of listing on proposed or ongoing prudent. 402. Section 7(a)(2) requires Federal activities. The only known populations To publish precise maps and agencies to ensure that activities they of Catesbaea melanocarpa are located descriptions of critical habitat in the authorize, fund, or carry out are not on privately-owned land. Since there is Federal Register, as required in a likely to jeopardize the continued no Federal ownership, and the species proposal for critical habitat, would existence of the species or to destroy or is not currently in trade, the only make this plant vulnerable to incidents adversely modify its critical habitat. If a potential section 9 involvement would of collection and vandalism and, Federal action may affect a listed relate to removing or damaging the plant therefore, could contribute to the species or its critical habitat, the in knowing violation of Commonwealth decline of the species. The Center for responsible Federal agency must enter Plant Conservation (1992) described into formal consultation with us. We are or Territorial law, or in knowing Catesbaea melanocarpa as a ‘‘handsome not designating critical habitat for this violation of Commonwealth or little shrub’’ with good horticulture species, as discussed above. Federal Territorial criminal trespass law. potential. The listing of this species as involvement may occur through the use Section 15.01(b) of the Commonwealth endangered publicizes its rarity and, of Federal funding for rural housing and ‘‘Regulation to Govern the Management thus, may make this plant more development (for example, the Rural of Threatened and Endangered Species attractive to researchers, collectors, and Development or Housing and Urban in the Commonwealth of Puerto Rico’’ those wishing to see rare plants. Development). states: ‘‘It is illegal to take, cut, mutilate, Additionally, designating critical habitat The Act and its implementing uproot, burn or excavate any would not only provide specific regulations set forth a series of general endangered plant species or part thereof location information to potential trade prohibitions and exceptions that within the jurisdiction of the vandals, but the effects of a critical apply to all endangered plants. All Commonwealth of Puerto Rico.’’ The habitat designation on private property prohibitions of section 9(a)(2) of the Act, U.S. Virgin Islands’ regulation states are often misunderstood. This implemented by 50 CFR 17.61, apply. that ‘‘no person may harass, injure or misunderstanding can create a negative These prohibitions, in part, make it kill, or attempt to do the same, or sell perception of the species’ listing and illegal for any person subject to the or offer for sale any specimen, or parts could contribute to the threat of jurisdiction of the United States to or produce of such specimen, of an vandalism or intentional habitat import or export any endangered plant, endangered or threatened species.’’ We destruction. Because of its few transport it in interstate or foreign are not aware of any otherwise lawful populations, Catesbaea melanocarpa is commerce in the course of commercial activities being conducted or proposed especially susceptible to adverse activity, sell or offer it for sale in by the public that will be affected by consequences resulting from the loss of interstate or foreign commerce, or this listing and result in a violation of individuals or habitat damage due to remove and reduce to possession the section 9. vandalism. We find that the increased species from areas under Federal degree of threat from vandalism jurisdiction. In addition, for plants You should direct questions regarding outweighs any benefits that might listed as endangered, the Act prohibits whether specific activities will derive from the designation of critical the malicious damage or destruction on constitute a violation of section 9 to the habitat. areas under Federal jurisdiction and the Field Supervisor of the Service’s removal, cutting, digging up, or Boquero´n Field Office (see ADDRESSES Available Conservation Measures damaging or destroying of endangered section). You may request copies of the Conservation measures provided to plants in knowing violation of any regulations on listed species from and species listed as endangered or Commonwealth or Territorial law or address inquiries regarding prohibitions threatened under the Act include regulation, including Commonwealth or and permits to the U.S. Fish and recognition, recovery actions, Territorial criminal trespass law. Certain Wildlife Service, Ecological Services, requirements for Federal protection, and exceptions can apply to agents of the 1875 Century Boulevard, Atlanta, prohibitions against certain practices. Service and Commonwealth and Georgia 30345–3301 (telephone 404/ Recognition through listing encourages Territorial conservation agencies. 679–7313).

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National Environmental Policy Act References Cited Puerto Rico Planning Board. 1995. Draft Environmental Impact Statement for We have determined that an Breckon, G. and D. Kolterman. 1993. Monte Carlo Resort and Boqueron Bay Environmental Assessment and Catesbaea melanocarpa Krug & Urban Site. San Juan, Puerto Rico. 88 pp. Environmental Impact Statement, as [Rubiaceae]. Final Report under Cooperative Agreement No. 14–16– Author defined under the authority of the 0004–92–970 between the U.S. Fish and The primary author of this final rule National Environmental Policy Act of Wildlife Service and the University of is Ms. Susan Silander (see ADDRESSES 1969, need not be prepared in Puerto Rico, Mayaguez Campus. section). connection with regulations adopted Britton, N.L. and P. Wilson. 1925. Scientific pursuant to section 4(a) of the survey of Porto Rico and the Virgin List of Subjects in 50 CFR Part 17 Islands. Volume VI—Part 2. Botany of Endangered Species Act of 1973, as Endangered and threatened species, amended. We published a notice Porto Rico and the Virgin Islands. Descriptive flora—Spermatophyta Exports, Imports, Reporting and outlining our reasons for this (continued). New York Academy of recordkeeping requirements, determination in the Federal Register Sciences, New York. 158 pp. Transportation. on October 25, 1983 (48 FR 49244). Center for Plant Conservation. 1992. Report Regulation Promulgation on the Rare Plants of Puerto Rico. Required Determinations Missouri Botanical Garden, St. Louis, Accordingly, we amend part 17, This rule does not contain any new Missouri. subchapter B of chapter I, title 50 of the collections of information other than Howard, R.A. 1989. Flora of the Lesser Code of Federal Regulations as follows: Antilles. Leeward and Windward those already approved under the Islands. Volume 6. Dicotyledoneae—Part PART 17Ð[AMENDED] Paperwork Reduction Act, 44 U.S.C. 3. Arnold Arboretum, Harvard 3501 et seq., and assigned Office of University, Jamaica Plain, 1. The authority citation for Part 17 Management and Budget clearance Massachusetts. 658 pp. continues to read as follows: number 1018–0094. For additional Liogier, H.L. and L.F. Martorell. 1982. Flora Authority: 16 U.S.C. 1361–1407; 16 U.S.C. information concerning permit and of Puerto Rico and Adjacent Islands: a 1531–1544; 16 U.S.C. 4201–4245; Pub. L. 99– associated requirements for endangered systematic synopsis. Editorial de la 625, 100 Stat. 3500, unless otherwise noted. ´ plants, see 50 CFR 17.62 and 17.63. Universidad de Puerto Rico, Rıo Piedras, Puerto Rico. 342 pp. 2. Amend Section 17.12(h) by adding Proctor, G. R. 1991. Puerto Rican plant the following, in alphabetical order species of special concern. Status and under FLOWERING PLANTS, to the List recommendations. Publicacio´n Cientı´fica of Endangered and Threatened Plants: Miscela´nea No. 2. Departamento de Recursos Naturales de Puerto Rico. San 17.12 Endangered and threatened plants. Juan, Puerto Rico. 197 pp. * * * * * (h) * * *

Species Historic Family Status When Critical Special Scientific name Common name range listed habitat rules

FLOWERING PLANTS

******* Catesbaea U.S.A.(PR, VI), Anti- Rubiaceae ...... E ...... 657 NA NA melanocarpa None. gua, Barbuda, Guadeloupe.

*******

Dated: March 1, 1999. DEPARTMENT OF COMMERCE SUMMARY: NMFS closes the commercial Jamie Rappaport Clark, fishery for king mackerel in the Director, Fish and Wildlife Service. National Oceanic and Atmospheric exclusive economic zone (EEZ) in the Administration [FR Doc. 99–6444 Filed 3–16–99; 8:45 am] Florida east coast subzone. This closure is necessary to protect the overfished BILLING CODE 4310±55±P 50 CFR Part 622 Gulf king mackerel resource. [Docket No. 961204340±7087±02; I.D. DATES: Effective 12:01 a.m., local time, 031299A] March 13, 1999, through March 31, 1999. Fisheries of the Caribbean, Gulf of FOR FURTHER INFORMATION CONTACT: Mexico, and South Atlantic; Coastal Mark Godcharles, 727–570–5305. Migratory Pelagic Resources of the SUPPLEMENTARY INFORMATION: The Gulf of Mexico and South Atlantic; fishery for coastal migratory pelagic fish Closure (king mackerel, Spanish mackerel, cero, AGENCY: National Marine Fisheries cobia, little tunny, dolphin, and, in the Service (NMFS), National Oceanic and Gulf of Mexico only, bluefish) is Atmospheric Administration (NOAA), managed under the Fishery Commerce. Management Plan for the Coastal Migratory Pelagic Resources of the Gulf ACTION: Closure. of Mexico and South Atlantic (FMP).

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The FMP was prepared by the Gulf of fee or when there are more than three SUPPLEMENTARY INFORMATION: Since Mexico and by the South Atlantic persons aboard, including operator and 1995, NMFS has managed fishing for Fishery Management Councils crew. Pacific halibut (Hippoglossus (Councils) and is implemented under During the closure, king mackerel stenolepis) and sablefish (Anoplopoma the authority of the Magnuson-Stevens from the closed zones or subzones taken fimbria) with fixed gear in the IFQ Fishery Conservation and Management in the EEZ, including those harvested regulatory areas defined in § 679.2 Act by regulations at 50 CFR part 622. under the bag and possession limits, under the IFQ Program. The IFQ Based on the Councils’ recommended may not be purchased or sold. This Program is a regulatory regime designed total allowable catch and the allocation prohibition does not apply to trade in to promote the conservation and ratios in the FMP, NMFS implemented king mackerel from the closed zones management of these fisheries and to a commercial quota for the Gulf of that were harvested, landed ashore, sold further the objectives of the Magnuson- Mexico migratory group of king prior to the closure, and held in cold Stevens Fishery Conservation and mackerel in the Florida east coast storage by a dealer or processor. Management Act and the Northern subzone of 1.17 million lb (0.53 million Classification Pacific Halibut Act. Persons holding kg) (50 CFR 622.42(c)(1)(i)(A)(1). The quota share receive an annual allocation This action is taken under 50 CFR Florida east coast subzone extends from of IFQ. Persons receiving an annual 25°20.4’ N. lat. (due east of the Dade/ 622.43(a)(3) and is exempt from review ° under E.O. 12866. allocation of IFQ are authorized to Monroe County, FL, boundary) to 29 25’ harvest IFQ species within specified N. lat. (due east of the Flagler/Volusia Authority: 16 U.S.C. 1801 et seq. limitations. Further information on the County, FL, boundary) through March Dated: March 12, 1999. implementation of the IFQ Program, and 31, 1999. Bruce C. Morehead, the rationale supporting it, are Under 50 CFR 622.43(a)(3), NMFS is contained in the preamble to the final required to close any segment of the Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. rule implementing the IFQ Program king mackerel commercial fishery when [FR Doc. 99–6494 Filed 3–12–99; 3:28 pm] published in the Federal Register, its quota has been reached, or is projected to be reached, by filing a BILLING CODE 3510±22±F November 9, 1993 (58 FR 59375) and notification at the Office of the Federal subsequent amendments. This announcement is consistent with Register. NMFS has determined that the DEPARTMENT OF COMMERCE commercial quota of 1.17 million lb § 679.23(g)(1), which requires that the (0.53 million kg) for Gulf group king National Oceanic and Atmospheric directed fishing season for sablefish mackerel for vessels fishing in the Administration managed under the IFQ program be Florida east coast subzone was reached specified by the Administrator, Alaska on March 12, 1999. Accordingly, the 50 CFR Part 679 Region, and announced by publication commercial fishery for king mackerel for in the Federal Register. This method of [I.D. 030999C] such vessels in the Florida east coast season announcement was selected to subzone is closed effective 12:01 a.m., Fisheries of the Exclusive Economic facilitate coordination between the local time, March 13, 1999, through Zone Off Alaska; Sablefish Managed sablefish season, chosen by the March 31, 1999. The closure remains in Under the Individual Fishing Quota Administrator, Alaska Region, and the effect until April 1, 1999, when the Program halibut season, chosen by the IPHC. The boundary separating the Gulf from the directed fishing season for sablefish Atlantic migratory group of king AGENCY: National Marine Fisheries with fixed gear managed under the IFQ mackerel shifts from the east coast to the Service (NMFS), National Oceanic and program will open at 1200 hrs, A.l.t., west coast of Florida. Atmospheric Administration (NOAA), March 15, 1999, and will close 1200 hrs, Except for a person aboard a charter Commerce. A.l.t., November 15, 1999. This period vessel or headboat, during the closure, ACTION: Fishing season dates. runs concurrently with the IFQ season no person aboard a vessel for which a for Pacific halibut announced by the SUMMARY: NMFS is opening directed commercial permit for king mackerel IPHC. The IFQ halibut season is fishing for sablefish with fixed gear has been issued may fish for Gulf group announced by publication in the managed under the Individual Fishing king mackerel in the EEZ in the closed Federal Register. zones or retain Gulf group king Quota (IFQ) program. The season will mackerel in or from the EEZ of the open on 1200 hrs, Alaska local time Classification closed zones. A person aboard a vessel (A.l.t.), March 15, 1999, and will close that has a valid charter vessel/headboat 1200 hrs, A.l.t., November 15, 1999. This action is taken under permit for coastal migratory pelagic fish This period is the same as the IFQ § 679.23(g)(1) and is exempt from may continue to retain king mackerel in season for Pacific halibut announced by review under E.O. 12866. or from the closed zones under the bag the International Pacific Halibut Authority: 16 U.S.C. 773 et seq. and 1801 and possession limits set forth in 50 Commission (IPHC). The IFQ halibut et seq. CFR 622.39(c)(1)(ii) and (c)(2), provided season is announced by publication in Dated: March 11, 1999. the vessel is operating as a charter the Federal Register. vessel or headboat. A charter vessel or DATES: Effective March 15, 1999, 1200 Gary C. Matlock, headboat that also has a commercial hrs, A.l.t., until 1200 hrs, A.l.t., Director, Office of Sustainable Fisheries, king mackerel permit is considered to be November 15, 1999. National Marine Fisheries Service. operating as a charter vessel or headboat FOR FURTHER INFORMATION CONTACT: [FR Doc. 99–6483 Filed 3–12–99; 3:28 pm] when it carries a passenger who pays a James Hale, 907–586-7228. BILLING CODE 3510±22±F

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DEPARTMENT OF COMMERCE SUPPLEMENTARY INFORMATION: NMFS vessels catching Pacific cod for manages the groundfish fishery in the processing by the inshore component in National Oceanic and Atmospheric GOA exclusive economic zone the Central Regulatory Area of the GOA. Administration according to the Fishery Management Maximum retainable bycatch amounts Plan for Groundfish of the Gulf of 50 CFR Part 679 may be found in the regulations at Alaska (FMP) prepared by the North § 679.20(e) and (f). Pacific Fishery Management Council [Docket No. 981222314±8321±02; I.D. under authority of the Magnuson- Classification 031199A] Stevens Fishery Conservation and This action responds to the final TAC Management Act. Regulations governing limitations and other restrictions on the Fisheries of the Exclusive Economic fishing by U.S. vessels in accordance fisheries established in the final 1999 Zone Off Alaska; Pacific Cod by with the FMP appear at subpart H of 50 harvest specifications for groundfish in Vessels Catching Pacific Cod for CFR part 600 and 50 CFR part 679. Processing by the Inshore Component The Final 1999 Harvest Specifications the GOA. It must be implemented in the Central Regulatory Area of the of Groundfish for the GOA (64 FR immediately to prevent overharvesting Gulf of Alaska 12094, March 11, 1999) established the the amount of the final 1999 Pacific cod Pacific cod TAC apportioned to the TAC apportioned to vessels catching AGENCY: National Marine Fisheries inshore component in the Central Pacific cod for processing by the inshore Service (NMFS), National Oceanic and Regulatory Area as 30,913 metric tons component in the Central Regulatory Atmospheric Administration (NOAA), (mt) in accordance with Area of the GOA. A delay in the Commerce. § 679.20(c)(3)(ii). effective date is impracticable and ACTION: Closure. In accordance with § 679.20(d)(1)(i), contrary to the public interest, and the Administrator, Alaska Region, further delay would only result in SUMMARY: NMFS is prohibiting directed NMFS (Regional Administrator), has overharvest. NMFS finds for good cause fishing for Pacific cod by vessels determined that the amount of the that the implementation of this action catching Pacific cod for processing by interim 1999 harvest specification of should not be delayed for 30 days. the inshore component in the Central Pacific cod for processing by the inshore Accordingly, under 5 U.S.C. 553(d), a Regulatory Area of the Gulf of Alaska component of the Central Regulatory delay in the effective date is hereby (GOA). This action is necessary to Area of the GOA will be reached. waived. prevent exceeding the amount of the Therefore, the Regional Administrator is This action is required by § 679.20 Pacific cod total allowable catch (TAC) establishing a directed fishing and is exempt from review under E.O. apportioned to vessels catching Pacific allowance of 30,613 mt, and is setting 12866. cod for processing by the inshore aside the remaining 300 mt as bycatch Authority: 16 U.S.C. 1801 et seq. component of the Central Regulatory to support other anticipated groundfish Area of the GOA. fisheries. In accordance with Dated: March 11, 1999. DATES: Effective 1200 hrs, Alaska local § 679.20(d)(1)(iii), the Regional Bruce C. Morehead, time (A.l.t.), March 14, 1999, until 2400 Administrator finds that this directed Acting Director, Office of Sustainable hrs, A.l.t., December 31, 1999. fishing allowance will soon be reached. Fisheries, National Marine Fisheries Service. FOR FURTHER INFORMATION CONTACT: Consequently, NMFS is prohibiting [FR Doc. 99–6482 Filed 3–12–99; 3:28 pm] Mary Furuness, 907–586–7228. directed fishing for Pacific cod by BILLING CODE 3510±22±F

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Proposed Rules Federal Register Vol. 64, No. 51

Wednesday, March 17, 1999

This section of the FEDERAL REGISTER Winter Haven, FL 33883–2276; the order, any provision of the order, or contains notices to the public of the proposed telephone: (941) 299–4770, Fax: (941) any obligation imposed in connection issuance of rules and regulations. The 299–5169; or George Kelhart, Technical with the order is not in accordance with purpose of these notices is to give interested Advisor, Marketing Order law and request a modification of the persons an opportunity to participate in the Administration Branch, Fruit and order or to be exempted therefrom. Such rule making prior to the adoption of the final rules. Vegetable Programs, AMS, USDA, room handler is afforded the opportunity for 2525–S, P.O. Box 96456, Washington, a hearing on the petition. After the DC 20090–6456; telephone: (202) 720– hearing the Secretary would rule on the DEPARTMENT OF AGRICULTURE 2491, Fax: (202) 720–5698. Small petition. The Act provides that the businesses may request information on district court of the United States in any Agricultural Marketing Service complying with this regulation, or district in which the handler is an obtain a guide on complying with fruit, inhabitant, or has his or her principal 7 CFR Part 915 vegetable, and specialty crop marketing place of business, has jurisdiction to [Docket No. FV99±915±1 PR] agreements and orders by contacting Jay review the Secretary’s ruling on the Guerber, Marketing Order petition, provided an action is filed not Avocados Grown in South Florida; Administration Branch, Fruit and later than 20 days after the date of the Increased Assessment Rate Vegetable Programs, AMS, USDA, P.O. entry of the ruling. Box 96456, room 2525–S, Washington, This rule would increase the AGENCY: Agricultural Marketing Service, DC 20090–6456; telephone (202) 720– assessment rate established for the USDA. 2491, Fax: (202) 720–5698, or E-mail: Committee for the 1999–2000 and ACTION: Proposed rule. [email protected]. You may subsequent fiscal years from $0.08 per view the marketing agreement and order 55-pound bushel container or SUMMARY: This proposed rule would small business compliance guide at the equivalent to $0.16 per 55-pound bushel increase the assessment rate from $0.08 following web site: container or equivalent of South Florida to $0.16 per 55-pound bushel container avocados handled. or equivalent of avocados established http://www.ams.usda.gov/fv/ The Florida avocado marketing order for the Avocado Administrative moab.html. provides authority for the Committee, Committee (Committee) under SUPPLEMENTARY INFORMATION: This rule with the approval of the Department, to Marketing Order No. 915 for the 1999– is issued under Marketing Agreement formulate an annual budget of expenses 2000 and subsequent fiscal years. The No. 121 and Order No. 915, both as and collect assessments from handlers Committee is responsible for local amended (7 CFR part 915), regulating to administer the program. The administration of the marketing order the handling of avocados grown in members of the Committee are which regulates the handling of South Florida, hereinafter referred to as producers and handlers of South Florida avocados grown in South Florida. the ‘‘order.’’ The marketing agreement avocados. They are familiar with the Authorization to assess avocado and order are effective under the Committee’s needs and with the costs handlers enables the Committee to incur Agricultural Marketing Agreement Act for goods and services in their local area expenses that are reasonable and of 1937, as amended (7 U.S.C. 601–674), and are thus in a position to formulate necessary to administer the program. hereinafter referred to as the ‘‘Act.’’ an appropriate budget and assessment The fiscal year begins April 1 and ends The Department of Agriculture rate. The assessment rate is formulated March 31. The assessment rate would (Department) is issuing this rule in and discussed in a public meeting. remain in effect indefinitely unless conformance with Executive Order Thus, all directly affected persons have modified, suspended, or terminated. 12866. This rule has been reviewed under an opportunity to participate and DATES: Comments must be received by Executive Order 12988, Civil Justice provide input. April 16, 1999. Reform. Under the marketing order now For the 1998–99 and subsequent fiscal ADDRESSES: Interested persons are in effect, Florida avocado handlers are years, the Committee recommended, invited to submit written comments subject to assessments. Funds to and the Department approved, an concerning this rule. Comments must be administer the order are derived from assessment rate that would continue in sent to the Docket Clerk, Fruit and such assessments. It is intended that the effect from fiscal year to fiscal year Vegetable Programs, AMS, USDA, room assessment rate as issued herein will be unless modified, suspended, or 2525–S, P.O. Box 96456, Washington, applicable to all assessable avocados terminated by the Secretary upon DC 20090–6456; Fax: (202) 720–5698; or beginning on April 1, 1999, and recommendation and information l E-mail: moabdocket [email protected]. continue until amended, suspended, or submitted by the Committee or other Comments should reference the docket terminated. This rule will not preempt information available to the Secretary. number and the date and page number any State or local laws, regulations, or The Committee met on January 13, of this issue of the Federal Register and policies, unless they present an 1999, and unanimously recommended will be available for public inspection in irreconcilable conflict with this rule. 1999–2000 expenditures of $167,335 the Office of the Docket Clerk during The Act provides that administrative and an assessment rate of $0.16 per 55- regular business hours. proceedings must be exhausted before pound bushel container or equivalent of FOR FURTHER INFORMATION CONTACT: parties may file suit in court. Under avocados handled. In comparison, last Doris Jamieson, Southeast Marketing section 608c(15)(A) of the Act, any year’s budgeted expenditures were Field Office, Fruit and Vegetable handler subject to an order may file $174,344. The assessment rate of $0.16 Programs, AMS, USDA, P.O. Box 2276; with the Secretary a petition stating that is $0.08 higher than the rate currently in

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 13124 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules effect. For the 1998–99 fiscal period, the assessment rate is needed. Further of $167,335 and an assessment rate of Committee voted to lower its assessment rulemaking would be undertaken as $0.16 per 55-pound bushel container or rate from $0.16 to $0.08 to reduce the necessary. The Committee’s 1999–2000 equivalent handled. The proposed funds in its operating reserve. It wanted budget and those for subsequent fiscal assessment rate of $0.16 is $0.08 higher to bring its reserve closer to one year’s years would be reviewed and, as than the 1998–99 rate. The quantity of operating expenses. With this appropriate, approved by the assessable avocados for the 1999–2000 accomplished, the Committee voted to Department. season is estimated at 900,000 return the assessment rate to the Pursuant to requirements set forth in containers. Thus, the $0.16 rate should previous level of $0.16 to cover 1999– the Regulatory Flexibility Act (RFA), the provide $144,000 in assessment income. 2000 expenses. As discussed later, the Agricultural Marketing Service (AMS) Assessment income, along with interest Committee expects to use interest has considered the economic impact of income and funds from the Committee’s income and reserve funds to cover its this rule on small entities. Accordingly, authorized reserve, would be adequate anticipated expenses during 1999–2000 AMS has prepared this initial regulatory to cover budgeted expenses. because the $0.16 per 55-pound bushel flexibility analysis. The major expenditures container or equivalent assessment rate The purpose of the RFA is to fit recommended by the Committee for the is expected to generate $144,000, which regulatory actions to the scale of 1999–2000 year include $46,000 for is $23,335 less than the Committee’s business subject to such actions in order salaries, $39,500 for production budgeted expenses. that small businesses will not be unduly research, $27,000 for local and national The major expenditures or disproportionately burdened. enforcement, $10,040 for employee recommended by the Committee for the Marketing orders issued pursuant to the benefits, $8,955 for insurance and 1999–2000 year include $46,000 for Act, and the rules issued thereunder, are bonds, and $5,500 for travel. Budgeted salaries, $39,500 for production unique in that they are brought about expenses for these items in 1998–99 research, $27,000 for local and national through group action of essentially were $46,000, $41,500, $32,000, $9,778, enforcement, $10,040 for employee small entities acting on their own $8,516, and $7,000, respectively. benefits, $8,955 for insurance and behalf. Thus, both statutes have small During the 1998–99 season, the bonds, and $5,500 for travel. Budgeted entity orientation and compatibility. Committee voted to decrease the expenses for these items in 1998–99 There are approximately 149 assessment rate to bring its operating were $46,000, $41,500, $32,000, $9,778, producers of avocados in the production reserve closer to one year’s operating $8,516, and $7,000, respectively. area and approximately 48 handlers expenses. For the 1999–2000 fiscal The assessment rate recommended by subject to regulation under the period, the Committee voted to return to the Committee was derived by dividing marketing order. Small agricultural the previous rate of $0.16 to cover anticipated expenses by expected producers have been defined by the authorized expenses. The Committee shipments of Florida avocados. Avocado Small Business Administration (13 CFR expects to use interest income and shipments for the year are estimated at 121.601) as those having annual receipts funds from its operating reserve to cover 900,000 55-pound bushel containers less than $500,000, and small 1999–2000 expenses. This would be which should provide $144,000 in agricultural service firms are defined as necessary because assessment income is assessment income. Income derived those whose annual receipts are less expected to total $144,000, and the from handler assessments, along with than $5,000,000. Committee’s budget totals $167,335. interest income and funds from the The average price for fresh avocados The Committee’s 1999–2000 budgeted Committee’s authorized reserve, would during the 1996–97 season was $13.20 expenditures of $167,335 include be adequate to cover budgeted expenses. per 55-pound bushel box equivalent for increases in employee benefits and Funds in the reserve (currently all domestic shipments and the total office equipment. Prior to arriving at $187,615) would be kept within the shipments were 917,861 bushels. this budget, the Committee considered maximum of 3 fiscal years’ operational Approximately 10 percent of all information from various sources, such expenses permitted by the order handlers handled 90 percent of the as the Committee’s Budget (§§ 915.42 and 915.142). South Florida avocado shipments Subcommittee. Alternative expenditure The proposed assessment rate would during that season. Many handlers ship levels were discussed, based upon the continue in effect indefinitely unless other tropical fruit and vegetable relative value of various research modified, suspended, or terminated by products which are not included in the projects to the South Florida avocado the Secretary upon recommendation Committee data but would contribute industry. and information submitted by the further to handler receipts. Using the The assessment rate of $0.16 per 55- Committee or other available average price per 55-pound container or pound bushel container or equivalent of information. equivalent, about 90 percent of the assessable avocados was then Although this assessment rate would avocado handlers could be considered determined by dividing the total be in effect for an indefinite period, the small businesses under SBA’s definition recommended budget by the quantity of Committee would continue to meet and about 10 percent of the handlers assessable avocados, estimated at prior to or during each fiscal period to could be considered large businesses. 900,000 55-pound bushel containers or recommend a budget of expenses and The majority of handlers and producers equivalents for the 1999–2000 fiscal consider recommendations for of Florida avocados may be classified as period. This rate is expected to provide modification of the assessment rate. The small entities. $144,000 in assessment income, which dates and times of Committee meetings This rule would increase the is $23,335 below budgeted expenses. are available from the Committee or the assessment rate established for the The Committee found this acceptable Department. Committee meetings are Committee and collected from handlers because interest income and funds from open to the public and interested for the 1999–2000 and subsequent fiscal the Committee’s operating reserve persons may express their views at these years from $0.08 per 55-pound bushel would be available to make up the meetings. The Department would container or equivalent to $0.16 per 55- deficit. evaluate Committee recommendations pound bushel container or equivalent of A review of historical information and other available information to avocados. The Committee unanimously indicates that the grower price for the determine whether modification of the recommended 1999–2000 expenditures 1999–2000 season could range between

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$13.20 and $14.90 per 55-pound bushel PART 915ÐAVOCADOS GROWN IN FOR FURTHER INFORMATION CONTACT: container or equivalent of avocados. SOUTH FLORIDA Constance M. Brenner, Marketing Therefore, the estimated assessment Specialist, USDA/AMS/Dairy Programs, revenue for the 1999–2000 fiscal year as 1. The authority citation for 7 CFR Order Formulation Branch, Room 2971, a percentage of total grower revenue part 915 continues to read as follows: South Building, P.O. Box 96456, could range between 1 and 1.2 percent. Authority: 7 U.S.C. 601–674. Washington, DC 20090–6456, (202) 720– This action would increase the 2. Section 915.233 is revised to read 2357, e-mail address: assessment obligation imposed on [email protected]. handlers. While assessments impose as follows: SUPPLEMENTARY INFORMATION: The some additional costs on handlers, the § 915.233 Assessment rate. Department is issuing this proposed rule costs are minimal and uniform on all On and after April 1, 1999, an in conformance with Executive Order handlers. Some of the additional costs assessment rate of $0.16 per 55-pound 12866. may be passed on to producers. bushel container or equivalent is This proposed rule has been reviewed However, these costs would be offset by established for avocados grown in South under Executive Order 12988, Civil the benefits derived by the operation of Florida. the marketing order. In addition, the Justice Reform. This rule is not intended Committee’s meeting was widely Dated: March 11, 1999. to have a retroactive effect. If adopted, publicized throughout the Florida Robert C. Keeney, this proposed rule will not preempt any avocado industry and all interested Deputy Administrator, Fruit and Vegetable state or local laws, regulations, or persons were invited to attend the Programs. policies, unless they present an meeting and participate in Committee [FR Doc. 99–6490 Filed 3–16–99; 8:45 am] irreconcilable conflict with the rule. The Agricultural Marketing deliberations on all issues. Like all BILLING CODE 3410±02±P Committee meetings, the January 13, Agreement Act of 1937, as amended (7 1999, meeting was a public meeting and U.S.C. 601–674), provides that all entities, both large and small, were DEPARTMENT OF AGRICULTURE administrative proceedings must be able to express views on this issue. exhausted before parties may file suit in Finally, interested persons are invited to Agricultural Marketing Service court. Under section 608c(15)(A) of the submit information on the regulatory Act, any handler subject to an order may 7 CFR Part 1065 and informational impacts of this action request modification or exemption from on small businesses. such order by filing with the Secretary This proposed rule would impose no [DA±99±01] a petition stating that the order, any additional reporting or recordkeeping provision of the order, or any obligation requirements on either small or large Milk in the Nebraska-Western Iowa imposed in connection with the order is Florida avocado handlers. As with all Marketing Area; Proposed Suspension not in accordance with law. A handler Federal marketing order programs, of Supply Plant Shipping is afforded the opportunity for a hearing reports and forms are periodically Requirements on the petition. After a hearing, the Secretary would rule on the petition. reviewed to reduce information AGENCY: Agricultural Marketing Service, The Act provides that the district court requirements and duplication by USDA. industry and public sector agencies. of the United States in any district in ACTION: Proposed suspension of rule. The Department has not identified which the handler is an inhabitant, or has its principal place of business, has any relevant Federal rules that SUMMARY: This document invites written jurisdiction in equity to review the duplicate, overlap, or conflict with this comments on a proposal to suspend Secretary’s ruling on the petition, rule. portions of the supply plant shipping provided a bill in equity is filed not A 30-day comment period is provided requirements for the Nebraska-Western later than 20 days after the date of the to allow interested persons to respond Iowa order for the months of March entry of the ruling. to this proposed rule. Thirty days is through September 1999. This action deemed appropriate because: (1) The was requested by North Central Small Business Consideration 1999–2000 fiscal year begins on April 1, Associated Milk Producers, Inc. (AMPI), In accordance with the Regulatory 1999, and the marketing order requires a cooperative association that supplies that the rate of assessment for each Flexibility Act (5 U.S.C. 601 et seq.), the milk for the market’s fluid needs. Agricultural Marketing Service has fiscal year apply to all assessable Suspension would enable AMPI avocados handled during such fiscal considered the economic impact of this producers historically associated with action on small entities and has certified year; (2) the Committee needs to have the order to share in the Nebraska- sufficient funds to pay its expenses that this proposed rule will not have a Western Iowa Federal order pool for significant economic impact on a which are incurred on a continuous March through August 1999. basis; and (3) handlers are aware of this substantial number of small entities. For DATES: Comments must be submitted on action which was unanimously the purpose of the Regulatory Flexibility or before March 24, 1999. recommended by the Committee at a Act, a dairy farm is considered a ‘‘small public meeting and is similar to other ADDRESSES: Comments (two copies) business’’ if it has an annual gross assessment rate actions issued in past should be filed with the USDA/AMS/ revenue of less than $500,000, and a years. Dairy Programs, Order Formulation dairy products manufacturer is a ‘‘small Branch, Room 2971, South Building, business’’ if it has fewer than 500 List of Subjects in 7 CFR Part 915 P.O. Box 96456, Washington, DC 20090– employees. For the purpose of Avocados, Marketing agreements, 6456. Advance, unofficial copies of such determining which dairy farms are Reporting and recordkeeping comments may be faxed to (202) 690– ‘‘small businesses,’’ the $500,000 per requirements. 0552 or e-mailed to year criterion was used to establish a For the reasons set forth in the [email protected]. production guideline of 326,000 pounds preamble, 7 CFR part 915 is proposed to Reference should be given to the title of per month. Although this guideline does be amended as follows: action and docket number. not factor in additional monies that may

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These laundering size, if the plant is part of a larger All written submissions made procedures help assure that any company operating multiple plants that pursuant to this notice will be made chemical flame retardants are not collectively exceed the 500-employee available for public inspection in the removed or degraded with repeated limit, the plant will be considered a Dairy Programs during regular business washing and drying, thereby creating a large business even if the local plant has hours (7 CFR 1.27(b)). flammability hazard. The Commission is fewer than 500 employees. Statement of Consideration proposing these amendments because For the month of January 1999, 1,248 the detergent specified by the existing dairy farmers were producers under The proposed suspension was laundering procedure is no longer Order 65. Of these producers, 1,176 requested by AMPI, a cooperative available and the operating producers (i.e., 94 percent) were association that supplies milk for the characteristics of the washing and considered small businesses having market’s fluid needs. AMPI requests that drying machines required by that monthly milk production under 326,000 language be suspended from the procedure are no longer representative pounds. A further breakdown of the Nebraska-Western Iowa order’s pool of machines now used for home monthly milk production of the supply plant definition for the purpose laundering. producers on the order during January of allowing producers who have DATES: Written comments concerning 1999 is as follows: 753 produced less historically supplied the fluid needs of the proposed amendments must be than 100,000 pounds of milk; 322 Nebraska-Western Iowa distributing received by the Office of the Secretary produced between 100,000 and 200,000; plants to maintain their pool status. not later than June 1, 1999. 101 produced between 200,000 and AMPI contends that because a fluid ADDRESSES: Written comments should 326,000; and 72 produced over 326,000 milk plant operator reduced its be captioned ‘‘Children’s Sleepwear, pounds. During the same month, 5 purchase of fluid milk from AMPI by Laundering Procedures’’ and mailed to handlers were pooled under the order. more than 50 percent, AMPI will not be the Office of the Secretary, Consumer None are considered small businesses. able to pool milk historically associated Product Safety Commission, This rule would lessen the regulatory with the Nebraska-Western Iowa order Washington, D.C. 20207, or delivered to impact of the order on certain milk for March 1999, and thus will not that office, room 502, 4330 East-West handlers and would tend to ensure that qualify for the automatic qualification Highway, Bethesda, Maryland. dairy farmers would continue to have months of April through August. their milk priced under the order and AMPI maintains that through Comments may also be filed by thereby receive the benefits that accrue discussions with other handlers in the telefacsimile to (301) 504–0127 or by from such pricing. order, it is certain that no additional email to [email protected]. Interested parties are invited to milk is needed at this time. FOR FURTHER INFORMATION CONTACT: submit comments on the probable Accordingly, it may be appropriate to Margaret Neily, Project Manager, regulatory and informational impact of suspend the aforesaid regulatory Directorate for Engineering Sciences, this proposed rule on small entities. language for the months of March Consumer Product Safety Commission, Also, parties may suggest modifications through September 1999. Washington, D.C. 20207; telephone of this proposal for the purpose of (301) 504–0508, extension 1293. List of Subjects in 7 CFR Part 1065 tailoring their applicability to small SUPPLEMENTARY INFORMATION: businesses. Milk marketing orders. A. Background The authority citation for 7 CFR Part Preliminary Statement 1065 continues to read as follows: The Flammable Fabrics Act (‘‘FFA’’) Notice is hereby given that, pursuant (15 U.S.C. 1191 et seq.) authorizes Authority: 7 U.S.C. 601–674. to the provisions of the Agricultural issuance and amendment of Dated: March 11, 1999. Marketing Agreement Act, suspension flammability standards and regulations for the months of March through Richard M. McKee, to protect the public from unreasonable September 1999 of the following Deputy Administrator, Dairy Programs. risks of death, injury, and property language from the pool plant provisions [FR Doc. 99–6488 Filed 3–16–99; 8:45 am] damage from fire associated with of the order regulating the handling of BILLING CODE 3410±02±P products of wearing apparel made from milk in the Nebraska-Western Iowa fabric and related materials. marketing area is being considered: In 1971, the Secretary of Commerce In the first sentence of § 1065.7(b)(4), CONSUMER PRODUCT SAFETY issued a flammability standard for suspending the following language: COMMISSION children’s sleepwear in sizes 0 through ‘‘each of the months of,’’ ‘‘through 6X to protect young children from death March,’’ and ‘‘for the following months 16 CFR Parts 1615 and 1616 and serious burn injuries which had of April.’’ been associated with ignition of All persons who want to submit Standard for the Flammability of sleepwear garments such as nightgowns written data, views or arguments about Children's Sleepwear: Sizes 0 Through and pajamas, by small open-flame the proposed suspension should send 6X; Standard for the Flammability of sources. That standard became effective two copies of their views to the USDA/ Children's Sleepwear: Sizes 7 Through in 1972, and is codified at 16 CFR Part AMS/Dairy Programs, Order 14 1615. Formulation Branch, Room 2971, South AGENCY: Consumer Product Safety In 1973, authority to issue Building, P.O. Box 96456, Washington, Commission. flammability standards under the FFA DC 20090–6456, by the 7th day after ACTION: Proposed amendments. was transferred from the Department of publication of this notice in the Federal Commerce to the Consumer Product Register. The period for filing comments SUMMARY: The Commission proposes to Safety Commission by section 30(b) of is limited to 7 days because a longer amend the flammability standards for the Consumer Product Safety Act (15

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U.S.C. 2079(b)). In 1974, the the current procedures are out of date in rinse, and drying temperatures, and Commission issued a flammability several respects, and the Commission is detergent used for home laundering in standard for children’s sleepwear in therefore proposing to change them. the 1960s. For example, AATCC sizes 7 through 14. That standard Standard Detergent 124 is a high- 1. Current Laundering Procedures became effective in 1975 and is codified phosphate powder with optical at 16 CFR Part 1616. Each of the children’s sleepwear brightener, similar to the phosphate- Both standards prescribe a test which standards describes the apparatus and based detergents sold to consumers requires that specimens of fabrics, procedure used to test items for between 1950 and 1970. (3) seams, and trim of children’s sleepwear compliance with the standard. See 16 CFR 1615.4 and 1616.5. The standards Since 1970, environmental concerns garments must self-extinguish after about water pollution have resulted in exposure to a small open flame. The address the possibility that a flame- retardant treatment used in children’s the elimination of phosphate-based standards do not require or prohibit the detergents for home laundering. Today, use of any particular type of fabric as sleepwear might progressively deteriorate by washing or drying. all laundry detergents sold to consumers long as the manufacturer successfully are nonphosphate-based. Additionally, completes the prescribed prototype and Section 1615.4(g)(4) of the standard for sizes 0 through 6X and section energy-efficient washing machines and production testing. dryers currently sold for consumer use Each standard defines the term 1616.5(c)(4) of the standard for sizes 7 have operating characteristics and ‘‘children’s sleepwear’’ to mean ‘‘any through 14 require that testing shall be temperature settings which differ from product of wearing apparel’’ in the sizes performed on finished items, as those specified by AATCC Test Method covered by the standard ‘‘such as produced (or after one washing and 124–69. (3) nightgowns, pajamas, or similar or drying in the case of garments labeled related items, such as robes, intended to with instructions to wash before 2. Revised Laundering Test Method be worn primarily for sleeping or wearing) and after they have been activities related to sleeping.’’ The washed and dried 50 times in In 1996, AATCC revised AATCC Test standard for sizes 0 through 6X excludes accordance with a specified laundering Method 124, ‘‘Appearance of Fabrics infant garments sized for children nine procedure. That laundering procedure is After Repeated Home Laundering.’’ (2) months of age or younger. Both AATCC Test Method 124–69, published The 1996 AATCC test method more standards exclude diapers, underwear, by the American Association of Textile closely resembles the equipment and and certain tight-fitting garments. See 16 Chemists and Colorists (‘‘AATCC’’). (1) 1 practices currently used for household CFR 1615.1(a) and 1616.2(a), as Each standard incorporates specific laundering of fabrics. The revised test amended September 9, 1996 (61 FR aspects of that laundering procedure by method differs from AATCC Test 47634). reference. Method 124–69 by specifying the use of The AATCC Test Method was a nonphosphate-based detergent. The B. Amending the Flammability developed in 1967 and revised in 1969. 1996 test method also specifies use of a Standards AATCC Test Method 124–69 specifies washing machine with different As discussed below, laundering operating characteristics of the washing operating characteristics than those procedures are prescribed by the machine and dryer to be used, wash specified by AATCC Test Method 124– standards to help assure than any flame water and rinse water temperatures, 69, and rinse water temperatures which retardant treatment used in the exhaust temperature of the dryer, and a differ from those in the older test production of children’s sleepwear does particular detergent, AATCC Standard method. (3) Table 1, below, provides a not deteriorate over time and thereby Detergent 124. These specifications are summary comparison of the two test create a flammability hazard. However, representative of the equipment, wash, methods.

TABLE 1.ÐAATCC TEST METHOD 124

WASH/DRY CONDITIONS VERSION 1969 VERSION 1996

Washing Machine: Cycle ...... Normal ...... Normal/Cotton Sturdy. Wash Water Temp ...... 60 ± 3°C ...... 60 ± 3°C. Rinse Water Temp ...... 41 ± 3°C ...... Less Than 29°C. Water Level ...... Full ...... 18 ± 1 gal. Agitator Speed ...... 70 ± 5 spm ...... 179± 2 spm. Wash Time ...... 12 minutes ...... 12 minutes. Spin Speed ...... 500±510 rpm ...... 630±660 rpm. Final Spin Cycle ...... 4 minutes ...... 6 minutes.

Dryer: Cycle ...... Normal ...... Cotton Sturdy Durable Press. Exhaust Temp ...... 140±160°F ...... 140±160°F ... 140±160°F. Cool Down Cycle ...... 5 minutes ...... 5 minutes ..... 10 minutes. spm = strokes (or cycles) per minute. rpm = revolutions per minute.

1 Numbers in parentheses identify reference end of this notice. Requests for inspection of any of the Secretary, 4330 East-West Highway, room documents in the List of Relevant Documents at the of these documents should be made at the Office 502, or by calling that office at (301) 504–0800.

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In 1996, AATCC also announced that phosphorous-based Pyrovatex CP-new section further requires findings that a when that organization’s supply of did not perform well in flammability flammability standard issued under the Standard Detergent 124 is depleted, that testing after laundering with the new FFA is ‘‘reasonable, technologically detergent will no longer be available. AATCC detergent. The Pyrovatex- practicable, and appropriate.’’ AATCC is the only source for Standard treated sleepwear also did not perform The proposed changes to the Detergent 124. Additionally, washing well in flammability testing after standards are needed to make the machines now offered for sale do not laundering with common powder specified laundering procedures have the settings and operating detergents. Liquid detergents did not represent those currently used by characteristics of the washing machine seem to adversely affect flammability consumers. The proposed amendments specified by AATCC Test Method 124– performance. Fabrics treated with the are also needed to assure that the 69. (3). antimony-based FR showed some standards will continue to be random failures that, according to 3. Review of Existing Standards ‘‘technologically practicable,’’ for both laboratory chemical analyses, the Commission’s laboratory and those In addition to reviewing AATCC Test apparently were unrelated to the manufacturers of children’s sleepwear Method 124–1996, the Commission staff detergent and laundering conditions. required to use the laundering reviewed and analyzed twelve other The new AATCC detergent did not procedures and perform the testing international and technical association affect the flammability of the untreated required by the standards. standards or test methods to determine polyester fabrics. However, one Section 4(g) of the FFA (15 U.S.C. if any were appropriate for polyester fabric did show reduced flame 1193(g)) states that a proceeding ‘‘for the consideration in this proceeding. resistance when a liquid fabric softener promulgation of a regulation under this Standards and test methods from was used. Labels on both liquid and section’’ shall be initiated by AATCC, ASTM, the International sheet fabric softener packages state that publication of an advance notice of Standards Organization, the United they should not be used on garments proposed rulemaking (‘‘ANPR’’), and Kingdom, Australia, Canada, China and labeled as flame resistant. sets forth requirements for the contents the Soap and Detergent Association After conducting these studies CPSC of the ANPR. However, these proposed were identified. All of these methods informed the manufacturer of Pyrovatex amendments are necessary because could be used for sleepwear fabrics and of the results. The manufacturer technical advances and the passage of mattress pads. conducted additional studies to evaluate All of the identified standards for time have rendered the existing test its product’s performance on children’s method obsolete. The amendments fabric laundering have significant sleepwear as it is used and laundered by preserve the original intent and effect of deficiencies. They are either based on consumers. The manufacturer the existing test method, modifying that earlier versions of AATCC Test Method determined that such factors as the method only as necessary to reflect the 124 (with obsolete detergent and fabric, the application process, storage existence of modern equipment and equipment), require equipment not conditions, and consumer care practices detergent. Moreover, the existing available in the U.S., use only water in can affect the flame resistance of the regulations permit the Commission to the laundering procedure, or specify light weight fabrics used for children’s employ a laundering test method significantly lower wash and rinse water sleepwear. Because the manufacturer different from AATCC Test Method 124 temperatures than those still available has little control over these factors, the if it concludes that the test method is for consumers. company decided, with one exception, substantively as protective. Because the to withdraw Pyrovatex from sale to the 4. Comparability of Test Results existing regulations allow the sleepwear industry. In order to compare the results of With the withdrawal of Pyrovatex for Commission to achieve without any laundering using AATCC Test Method treating children’s sleepwear, the amendment the substance of what it 124–69 with those of the new AATCC change in detergent and laundering now proposes to achieve by Test Method 124–96 the Commission equipment from AATCC 124–69 to amendment, and because the proposed performed some tests of fabrics using AATCC 124–96 will not have any effect amendments preserve the regulatory each method. The staff conducted on the flammability performance of status quo, save for the reflection of laundering comparisons using children’s sleepwear on the market. modern equipment and detergent, the sleepwear made of cotton fabrics with Commission has determined that it is the two known FR treatments being 5. Proposed Amendment of Standards not legally required to commence this used to treat children’s sleepwear at the The Commission proposes to revise proceeding with an ANPR, nor is it time of the testing (organic phosphorous the laundering procedures specified in necessary for the Commission to make compound and antimony trioxide) and the children’s sleepwear standards at 16 the findings that FFA sections 1193(g) two untreated flame resistant polyester CFR 1615.4(g)(4) and 1616.5(c)(4) to and (h) would otherwise require. fabrics. All fabrics met the requirements those of AATCC Test Method 124–1996. The amendments proposed below of the children’s flammability test in The children’s sleepwear standards would require specimens to be tested as their original state (as marketed or after were issued under section 4 of the FFA produced (or after one washing and one laundering, as appropriate) and (15 U.S.C. 1193), which authorizes the drying) and after washing and drying 50 after 50 launderings with the old issuance or amendment of flammability times using the procedure specified in AATCC detergent and equipment standards to protect the public against AATCC Test Method 124–1996. The specified in AATCC 124–69. unreasonable risks of fire leading to proposed amendments would The laundering tests indicated that death, personal injury, or significant incorporate that test method into the changes in washing machine and dryer property damage. As required by section sleepwear standard by reference. operating conditions between the old 4(b) of the FFA, both standards are The amendments proposed below also and new versions of AATCC Test based on findings that they are needed include minor changes to the Method 124 did not make a difference to adequately protect the public against enforcement regulations at 16 CFR in the flammability performance of the the unreasonable risk of the occurrence 1615.32 and 1616.32 prescribing the fabrics tested. However, the cotton of fire leading to death, personal injury, procedure for seeking approval from the sleepwear that was treated with the or significant property damage. That Commission for use of alternate

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules 13129 laundering procedures. The proposed standards will also benefit from a nor an environmental impact statement amendments of those sections: relatively short effective date. is required. (i) update the laundering procedure The Commission invites comments on 3. Executive Orders prescribed by the sleepwear standards the proposed effective date and factual to AATCC Test Method 124–1996; and information relating to that issue. Executive Order 12988 (February 5, (ii) substitute the words ‘‘Assistant 1996), requires agencies to state in clear Executive Director for Compliance’’ for C. Other Issues language the preemptive effect, if any, to ‘‘Associate Executive Director for 1. Impact on Small Businesses be given to a new regulation. The Compliance and Enforcement’’ to reflect amendments proposed below, if issued the current title for that position. In accordance with section 605(b) of on a final basis, would modify two The proposed amendments of the the Regulatory Flexibility Act (5 U.S.C. flammability standards issued under the enforcement rules implementing the 605(b)), the Commission hereby certifies FFA. With certain exceptions which are standard for sizes 7 through 14 also that the amendments to the children’s not applicable in this instance, no state include a revision of section 1616.32(g), sleepwear standards and enforcement or political subdivision of a state may Commission testing for compliance. The rules proposed below will not have a enact or continue in effect ‘‘a proposed amendment corrects an significant economic impact on a flammability standard or other erroneous citation in the regulations to substantial number of small entities, regulation’’ applicable to the same fabric the laundering provisions of the including small businesses, if issued on or product covered by an FFA standard standard. The correct citation in the a final basis. As noted above, the if the state or local flammability proposed amendment is to section requirements for washing and drying standard or other regulations is 1616.5(c)(4)(ii) of the standard rather specimens 50 times before testing were ‘‘designed to protect against the same than 1616.5(c)(4)(iii) in the existing text. included in the standards to assure that risk of the occurrence fire’’ unless the No similar error exists in the any flame retardant treatment used in state or local flammability standard or enforcement rules implementing the children’s sleepwear would not be regulation ‘‘is identical’’ to the FFA standard for sizes 0 through 6X. removed by repeated laundering. standard. See section 16 of the FFA (15 When the standards were issued in U.S.C. 1203). Consequently, if issued on 6. Effective Date 1971 and 1974, some fabrics used in the a final basis, the amendments proposed Section 4(b) of the FFA (15 U.S.C. production of children’s sleepwear were below will preempt nonidentical state 1193(b)) provides that an amendment of treated with flame retardants. However, or local flammability standards or a flammability standard shall become at this time, nearly all fabrics used for regulations that are intended to address effective one year from the date it is children’s sleepwear are made without the unreasonable risk of fire associated promulgated, unless the Commission flame retardant treatments. The ability with ignition of children’s sleepwear in finds for good cause that an earlier or of these fabrics to pass the flammability sizes 0 through 14. later effective date is in the public tests in the standards is not affected by In accordance with Executive Order interest, and publishes that finding. washing or drying. (3) Moreover, the 12612 (October 26, 1987), the Section 4(b) also requires that an proposed changes are intended to bring Commission certifies that the proposed amendment of a flammability standard the standards promulgated in the 1970s amendments do not have sufficient shall exempt products ‘‘in inventory or into conformance with current implications for federalism to warrant a with the trade’’ on the date the practices. Independent testing Federalism Assessment. amendment becomes effective, unless laboratories report that they currently List of Subjects in 16 CFR Parts 1615 the Commission limits or withdraws use the requirements of the revised test and 1616 method (AATCC Test Method 124–96) that exemption because those products Clothing, Consumer protection, that the Commission is proposing. are so highly flammable that they are Flammable materials, Infants and Because the proposed amendment dangerous for use by consumers. children, Labeling, Records, Sleepwear, would codify existing industry testing One reason for proposing these Textiles, Warranties amendments of the children’s sleepwear practices (and reflect current consumer standards is that the standard detergent practices), the proposal is not expected Conclusion specified by the existing laundering to have an effect on small entities. Therefore, pursuant to the authority of method in the standards is no longer 2. Environmental Considerations section 30(b) of the Consumer Product available. The Commission has reason Safety Act (15 U.S.C. 2079(b)) and to believe that an effective date 30 days The amendments proposed below fall sections 4 and 5 of the Flammable after publication of final amendments within the categories of Commission Fabrics Act (15 U.S.C. 1193, 1194), the will be in the public interest. The actions described at 16 CFR 1021.5(c) Commission hereby proposes to amend Commission does not propose to that have little or no potential for title 16 of the Code of Federal withdraw or limit the exemption for affecting the human environment. The Regulations, Chapter II, Subchapter D, products in inventory or with the trade amendments are not expected to have a Parts 1615 and 1616 to read as follows: as provided by section 4(b) of the FFA. significant effect on production The Commission believes that an processes or on the types or amounts of PART 1615ÐSTANDARD FOR THE effective date of thirty days would materials used for construction or FLAMMABILITY OF CHILDREN'S provide adequate notice to all interested packaging of children’s sleepwear. The SLEEPWEAR: SIZES 0 THROUGH 6X persons of the change in laundering amendments will not render existing 1. The authority for subpart A of part procedure, and at the same time would inventories unsalable, or require 1615 continues to read as follows: assure that the Commission will be able destruction of existing goods. The to test for compliance with the Commission has no information Authority: Sec. 4, 67 Stat. 112, as standards without interruption. Those indicating any special circumstances in amended, 81 Stat. 569–570; 15 U.S.C. 1193. manufacturers who perform premarket which these amendments may affect the 2. Section 1615.4 is amended by testing in accordance with the human environment. Accordingly, revising paragraph (g)(4)(i) and (ii) to laundering procedures specified in the neither an environmental assessment read as follows:

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§ 1615.4 Test procedure. § 1615.32 Method for establishment and (3) Records of revalidation testing use of alternate laundering procedures (g) Testing * ** need not be submitted to the Assistant under section 4(g)(4)(ii) of the standard. Executive Director for Compliance. (4) Laundering. (i) The procedures (a) Scope. (1) Section 1615.4(g)(4)(ii) *** described in paragraphs (b) through (g) of the Standard for the Flammability of (e) Revalidation testing failures. (1) If of this section shall be carried out on Children’s Sleepwear in sizes 0–6X (16 revalidation testing for any fabric or finished items (as produced or after one CFR 1615.4(g)(4)(ii)) requires that all garment does not meet the criteria of washing and drying) and after they have fabrics and certain garments subject to paragraph (f) of this section, the been washed and dried 50 times in the standard be tested for flammability applicant must immediately discontinue accordance with sections 8.2.2, 8.2.3, as produced (or after one washing and use of the alternate laundering and 8.3.1(A) of AATCC Test Method drying) and after the items have been procedure for the fabric or garment and 124–1996 ‘‘Appearance of Fabrics After washed and dried 50 times in machines, must immediately notify the Assistant Repeated Home Laundering,’’ Technical using the procedure specified in AATCC Executive Director for Compliance in Manual of the American Association of 5 Test Method 124–1996. This section writing of the failure to meet the Textile Chemists and Colorists, vol. 73, also provides that items may be criteria. * * * 1997, which is incorporated by laundered a different number of times (2) When use of an alternate reference. Copies of this document are under another washing and drying available from the American laundering procedure for a particular procedure if the Commission finds that fabric or garment has been discontinued Association of Textile Chemists and such an alternate laundering procedure Colorists, P.O. Box 12215, Research because of a failure to meet the criteria is equivalent to the procedure specified of paragraph (f) of this section, the Triangle Park, North Carolina 27709. in the standard. This document is also available for alternate laundering procedure shall not * * * * * inspection at the Office of the Federal be used again unless a new application (b) Application procedure. (1) Register, 800 North Capitol Street, NW., for approval is submitted to the Applicants seeking approval for use of Suite 700, Washington, DC. This Assistant Executive Director for an alternate laundering procedure under incorporation by reference was Compliance and that officer approves section 1615.4(g)(4)(iii) of the standard approved by the Director of the Federal the application in writing. * ** must submit the following information Register in accordance with 5 U.S.C. (f) Commission criteria for evaluating to the Assistant Executive Director for 552(a) and 1 CFR part 51. These applications. (1) The Assistant Compliance, Consumer Product Safety materials are incorporated as they exist Executive Director for Compliance will Commission, Washington, DC 20207: in the edition which has been approved approve the alternate laundering by the Director of the Federal Register * * * * * procedure as equivalent to the and which has been filed with the (2) Applications shall be certified by laundering procedure specified in Office of the Federal Register. Items the chief executive officer of the section 1615.4(g)(4)(ii) of the standard if which do not withstand 50 launderings applicant or the official to whom the testing from 20 specimens laundered by shall be tested at the end of their useful duty to certify has been delegated in the proposed alternate procedure yields service life. writing. The Commission’s Assistant as many or more char lengths in excess Executive Director for Compliance must of five inches as does testing from the (ii) Washing shall be performed in be notified in writing of any such twenty specimens laundered by the 50- accordance with sections 8.2.2 and 8.2.3 delegation. laundering cycle method prescribed in of AATCC Test Method 124–1996, using (c) Use of alternate laundering the standard. wash temperature V (60°±3°C, 140°±5°F) procedure. (1) The applicant may begin (2) If the alternate laundering specified in Table II of that method, and to use the alternate laundering the water level, agitator speed, washing procedure yields fewer char lengths in procedure 30 days after the application excess of five inches than does the 50- time, spin speed and final spin cycle is received by the Assistant Executive specified for ‘‘Normal/Cotton Sturdy’’ in wash and dry cycle, then the Assistant Director for Compliance unless notified Executive Director for Compliance will Table III. A maximum washer load shall to the contrary. The Assistant Executive be 3.64 Kg (8 pounds) and may consist not consider the alternate procedure to Director for Compliance will normally be equivalent with the following of any combination of test samples and furnish an applicant with written notice dummy pieces. Drying shall be exception: If the number of five-inch of approval within 30 days. The chars from the alternate procedure is performed in accordance with section applicant may be notified that a longer 8.3.1(A) of that test method, Tumble within one of the number of five-inch time is needed for evaluation of the chars obtained from the 50-cycle Dry, using the exhaust temperature application, and in the discretion of the (66°±5°C, 150°±10°F) and cool down procedure, the applicant may repeat the Assistant Executive Director for original test with new specimens and if time of 10 minutes specified in the Compliance, may be authorized to use ‘‘Durable Press’’ conditions of Table IV. the combined results of both tests show the alternate laundering procedure the count of chars exceeding five inches * * * * * * pending the final decision. * ** from the alternate is equal to, or greater 3. The authority for subpart B of part (2) As provided in detail in than, the count from the 50-wash cycle 1615 continues to read as follows: 1615.32(e), applicants must procedure, the Assistant Executive Authority: Sec. 5, 67 Stat. 112–113, as immediately discontinue use of an Director for Compliance will approve amended, 81 Stat. 570; 15 U.S.C. 1194. alternate procedure, and must the alternate laundering procedure. immediately notify the Assistant * * * * * 4. Section 1615.32 is amended by Executive Director for Compliance if revising paragraphs (a)(1), (b)(1), there are test failures during PART 1616ÐSTANDARD FOR THE introductory text and (b)(2), the first 3 revalidation testing. FLAMMABILITY OF CHILDREN'S sentences of (c)(1), (c)(2), the first (d) Revalidation testing. * ** SLEEPWEAR: SIZES 7 THROUGH 14 sentence of (d)(3), the first sentence of (e)(1), the first sentence of (e)(2), and (f) 5 American Association of Textile Chemists and 1. The authority for subpart A of part to read as follows: Colorists, Technical Manual. Vol 73, 1997. 1616 continues to read as follows:

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Authority: Sec. 4, 67 Stat. 112, as Authority: Sec. 5, 67 Stat. 112–113, as the alternate laundering procedure amended, 81 Stat. 569–570; 15 U.S.C. 1193. amended, 81 Stat. 570; 15 U.S.C. 1194. pending the final decision. * ** 2. Section 1616.5 is amended by 4. Section 1616.32 is amended by (2) As provided in detail in paragraph revising paragraphs (c)(4)(i) and (ii) to revising paragraphs (a)(1), (b)(1) (e) of this section, applicants must read as follows: introductory text and (b)(2), the first 3 immediately discontinue use of an sentences of (c)(1), (c)(2), the first alternate procedure, and must § 1616.5 Test procedure. sentence of (d)(3), the first sentence of immediately notify the Assistant (c) Testing * ** (e)(1), the first sentence of (e)(2), (b) and Executive Director for Compliance if (4) Laundering. (i) The procedures (g)(1) to read as follows: there are test failures during described under § 1616.4 Sampling and revalidation testing. acceptance procedures, paragraph (b) of § 1616.32 Method for establishment and (d) Revalidation testing. * ** this section, Mounting and conditioning use of alternate laundering procedures (3) Records of revalidation testing of specimens, and paragraph (c) of this under section 5(c)(4)(ii) of the standard. need not be submitted to the Assistant section Testing shall be carried out on (a) Scope. (1) Section 1616.5(c)(4)(ii) Executive Director for Compliance. finished items (as produced or after one of the Standard for the Flammability of *** washing and drying) and after they have Children’s Sleepwear in sizes 7–14 (16 (e) Revalidation testing failures. (1) If been washed and dried 50 times in CFR 1616.5(c)(4)(ii)) requires that all revalidation testing for any fabric or garment does not meet the criteria of accordance with sections 8.2.2, 8.2.3, fabrics and certain garments subject to paragraph (f) of this section, the and 8.3.1(A) of AATCC Test Method the standard be tested for flammability applicant must immediately discontinue 124–1996 ‘‘Appearance of Fabrics After as produced (or after one washing and use of the alternate laundering Repeated Home Laundering,’’ Technical drying) and after the items have been procedure for the fabric or garment and Manual of the American Association of washed and dried 50 times in machines, must immediately notify the Assistant Textile Chemists and Colorists, vol. 73, using the procedure specified in AATCC Executive Director for Compliance in 1997, which is incorporated by Test Method 124–1996.3 This section writing of the failure to meet the reference. Copies of this document are also provides that items may be laundered a different number of times criteria. * * * available from the American (2) When use of an alternate under another washing and drying Association of Textile Chemists and laundering procedure for a particular procedure if the Commission finds that Colorists, P.O. Box 12215, Research fabric or garment has been discontinued such an alternate laundering procedure Triangle Park, North Carolina 27709. because of a failure to meet the criteria is equivalent to the procedure specified This document is also available for of paragraph (f) of this section, the in the standard. inspection at the Office of the Federal alternate laundering procedure shall not Register, 800 North Capitol Street, NW., * * * * * be used again unless a new application Suite 700, Washington, DC. This (b) Application procedure. (1) for approval is submitted to the incorporation by reference was Applicants seeking approval for use of Assistant Executive Director for approved by the Director of the Federal an alternate laundering procedure under Compliance and that officer approves Register in accordance with 5 U.S.C. section 1616.5(c)(4)(ii) of the standard the application in writing. * ** 552(a) and 1 CFR part 51. These must submit the following information (f) Commission criteria for evaluating materials are incorporated as they exist to the Assistant Executive Director for applications. (1) The Assistant in the edition which has been approved Compliance, Consumer Product Safety Executive Director for Compliance will by the Director of the Federal Register Commission, Washington, DC 20207: approve the alternate laundering and which has been filed with the *** procedure as equivalent to the Office of the Federal Register. Items * * * * * laundering procedure specified in which do not withstand 50 launderings (2) Applications shall be certified by section 1616.5(c)(4)(ii) of the standard if shall be tested at the end of their useful the chief executive officer of the testing from 20 specimens laundered by service life with prior approval of the applicant or the official to whom the the proposed alternate procedure yields Consumer Product Safety Commission. duty to certify has been delegated in as many or more char lengths in excess (ii) Washing shall be performed in writing. The Commission’s Assistant of five inches as does testing from the accordance with sections 8.2.2 and 8.2.3 Executive Director for Compliance must twenty specimens laundered by the 50- of AATCC Test Method 124–1996, using be notified in writing of any such laundering cycle method prescribed in °± °± wash temperature V (60 3–C, 140 5– delegation. the standard. F) specified in Table II of that method, (c) Use of alternate laundering (2) If the alternate laundering and the water level, agitator speed, procedure. (1) The applicant may begin procedure yields fewer char lengths in washing time, spin speed and final spin to use the alternate laundering excess of five inches than does the 50- cycle specified for ‘‘Normal/Cotton procedure 30 days after the application wash and dry cycle, then the Assistant Sturdy’’ in Table III. A maximum is received by the Assistant Executive Executive Director for Compliance will washer load shall be 3.64 Kg (8 pounds) Director for Compliance unless notified not consider the alternate procedure to and may consist of any combination of to the contrary. The Assistant Executive be equivalent with the following test samples and dummy pieces. Drying Director for Compliance will normally exception: If the number of five-inch shall be performed in accordance with furnish an applicant with written notice chars from the alternate procedure is section 8.3.1(A) of that test method, of approval within 30 days. The within one of the number of five-inch Tumble Dry, using the exhaust applicant may be notified that a longer chars obtained from the 50-cycle °± °± temperature (66 5–C, 150 10–F) and time is needed for evaluation of the procedure, the applicant may repeat the cool down time of 10 minutes specified application, and in the discretion of the original test with new specimens and if in the ‘‘Durable Press’’ conditions of Assistant Executive Director for the combined results of both tests show Table IV. Compliance, may be authorized to use the count of chars exceeding five inches * * * * * from the alternate is equal to, or greater 3. The authority for subpart B of part 3 American Association of Textile Chemists and than, the count from the 50-wash cycle 1616 continues to read as follows: Colorists, Technical Manual. Vol 73, 1997. procedure, the Assistant Executive

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Director for Compliance will approve Executive Director, including SDA Directorate for Engineering Sciences, the alternate laundering procedure. Recommended Wash Conditions for CFR Consumer Product Safety Commission, (g) Commission testing for 1615.4, September 15, 1998. Washington, DC 20207; telephone (301) compliance. (1) For the purpose of 12. Letter from Jenan Al-Atrash, Director, 504–0508, extension 1293. Human Health & Safety, The Soap and determining compliance with the Detergent Association, to Margaret Neily, SUPPLEMENTARY INFORMATION: standard, the Commission will rely on Technical Program Coordinator, Office of the A. Background testing employing the laundering Executive Director, follow-up comments to procedure now prescribed by section September 15, 1998, letter, November 12, The Flammable Fabrics Act (‘‘FFA’’) 1616.5(c)(4)(ii) of the standard. (15 1998. (15 U.S.C. 1191 et seq.) authorizes U.S.C. 1193, 1194; 15 U.S.C. 2079(b)) 13. Memorandum from Margaret L. Neily, issuance and amendment of * * * * * Project Manager, Directorate for Engineering flammability standards and regulations Dated: March 8, 1999. Sciences, to the Commission, ‘‘Laundering/ to protect the public from unreasonable Detergent Updates—FR notice supplements,’’ Sadye E. Dunn, risks of death, injury, and property February 19, 1999. damage from fire associated with Secretary, Consumer Product Safety Commission. [FR Doc. 99–6075 Filed 3–16–99; 8:45 am] products of interior furnishing made BILLING CODE 6355±01±P from fabric and related materials. List of Relevant Documents In 1970, the Secretary of Commerce 1. American Association of Textile issued two flammability standards for Chemists and Colorists, ‘‘Appearance of CONSUMER PRODUCT SAFETY carpets and rugs to protect the public Durable Press Fabrics After Repeated Home COMMISSION from risks of deaths, injuries, and Launderings,’’ AATCC Test Method 124– economic losses associated with 1969. AATCC Technical Manual, Vol. 46, 16 CFR Parts 1630 and 1631 ignition of carpets and rugs by small 1970. ignition sources. The Standard for the 2. American Association of Textile Standard for the Surface Flammability Surface Flammability of Carpets and Chemists and Colorists, ‘‘Appearance of of Carpets and Rugs; Standard for the Rugs, now codified at 16 CFR Part 1630, Fabrics After Repeated Home Laundering,’’ Surface Flammability of Small Carpets AATCC Test Method 124–1996. AATCC is applicable to carpets and rugs with a Technical Manual, Vol. 73, 1997. and Rugs surface area greater than 24 square feet 3. Briefing memorandum from Margaret AGENCY: Consumer Product Safety and one dimension longer than six feet. Neily, Project Manager, Directorate for Commission. The Standard for the Surface Engineering Sciences, to the Commission, Flammability of Small Carpets and ACTION: Proposed amendments. ‘‘Proposed Amendments to Flammable Rugs, now codified at 16 CFR Part 1631, Fabrics Act Standards to Replace Obsolete SUMMARY: The Commission proposes to is applicable to carpets and rugs which Standard Detergent and Update Laundering have an area of 24 square feet or less, Procedures Required for Tests,’’ l, 1998. amend the flammability standards for 4. Memorandum from Gail Stafford, carpets and rugs and for small carpets and no dimension longer than six feet. Directorate for Laboratory Sciences, to and rugs by revising the laundering Both standards prescribe a test which Margaret Neily, Project Manager, ‘‘Amending procedure specified in those standards. involves exposing specimens from a the Laundering Provisions of the CPSC The laundering procedures help assure carpet or rug to a standard ignition Flammability Regulations,’’ August 18, 1998. that any fire retardant treatment used on source. Eight specimens, each 5. Memorandum from Gail Stafford, carpets or on fibers used in the measuring nine inches by nine inches, Directorate for Laboratory Sciences, to manufacture of carpets will not be are taken from the product to be tested. Margaret Neily, Project Manager, ‘‘Textile A specimen passes the test in the Laundering Standards,’’ August 18, 1998. removed or degraded by cleaning, thereby creating a flammability hazard. standards if charring does not extend 6. Memorandum from Gail Stafford and more than three inches in any direction Shing-Bong Chen, Directorate for Laboratory The Commission is proposing these Sciences, to Margaret Neily, Project Manager, amendments because the detergent from the ignition source. The ‘‘Detergent Comparison Tests,’’ August 19, specified by the existing laundering flammability standard for large carpets 1998. procedure is no longer available and the and rugs requires that seven of the eight 7. Log of Meeting on January 21, 1998 operating characteristics of the washing specimens taken from a carpet or rug concerning Flammability Test of Pyrovatex- and drying machines required by that must pass the test. See 16 CFR 1630.3. treated Flame Resistant Fabrics. procedure are no longer representative The standard for small carpets and 8. Memorandum from Terrance R. Karels, rugs requires that seven of eight Directorate for Economic Analysis, to of machines now used for home laundering. specimens taken from a carpet or rug Margaret Neily, Project Manager, must pass the test, or that the product ‘‘Amendments to FFA Standards,’’ August DATES: Written comments concerning must be permanently labeled indicating 10, 1998. the proposed amendments must be 9. Memorandum from Margaret Neily, received by the Office of the Secretary that it fails the flammability standard. Project Manager, Directorate for Engineering not later than June 1, 1999. See 16 CFR 1631.3, 1631.5(a) and Sciences, to the Commission, ‘‘Briefing 1631.34. ADDRESSES: Written comments should Package Supplement: Laundering/Detergent In 1973, authority to issue and amend Update for Flammable Fabrics Act be captioned ‘‘Carpet and Rug flammability standards under the FFA Standards—The Soap and Detergent Standards, Laundering Procedures’’ and was transferred from the Department of Association (SDA) Laundering Procedures,’’ mailed to the Office of the Secretary, Commerce to the Consumer Product January 11, 1999. Consumer Product Safety Commission, Safety Commission by section 30(b) of 10. Memorandum from Gail Stafford, Washington, D.C. 20207, or delivered to the Consumer Product Safety Act (15 Directorate for Laboratory Sciences, to that office, room 502, 4330 East-West U.S.C. 2079(b)). Margaret Neily, Project Manager, ‘‘Soap and Highway, Bethesda, Maryland. Detergent Association Proposed Laundering Comments may also be filed by B. Amending the Flammability Procedure,’’ December 23, 1998. telefacsimile to (301) 504–0127 or by Standards 11. Letter from Jenan Al-Atrash, Director, Human Health & Safety, The Soap and email to [email protected]. As discussed below, laundering Detergent Association, to Margaret Neily, FOR FURTHER INFORMATION CONTACT: procedures are required by the Technical Program Coordinator, Office of the Margaret Neily, Project Manager, standards to help assure that any fire-

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules 13133 retardant chemicals used in the found to be equivalent by the Consumer optical brightener, similar to the production of carpets or rugs will not be Product Safety Commission.’’ phosphate-based detergents sold to removed or degraded by repeated The laundering procedure specified consumers between 1950 and 1970. (3) cleaning and create a flammability by the standards is AATCC Test Method Since 1970, environmental concerns hazard. However, the current 124–67, published by the American about water pollution have resulted in procedures are out of date in several Association of Textile Chemists and the elimination of phosphate-based respects, and the Commission therefore Colorists (‘‘AATCC’’). (1)1 This detergents for home laundering. Today, proposes to change them. procedure involves washing and drying all laundry detergents sold to consumers the specimens in a household washing are nonphosphate-based. Additionally, 1. Current Procedures machine and dryer. The AATCC test energy-efficient washing machines and The carpet flammability standards method is similar to the method that dryers currently sold for consumer use describe the apparatus and procedure to might be used by consumers to clean have operating characteristics and be used to test carpets and rugs for small carpets and rugs such as bath mats temperature settings which differ from compliance with the standards. See 16 and small area rugs. those specified by AATCC Test Method CFR 1630.4 and 1631.4. Although the AATCC laundering 124–67. (3) At the time the carpet standards were procedure does not resemble the issued, some carpets and rugs were method that consumers could be 2. Revised Laundering Test Method treated with fire retardants or made expected to use for cleaning wall-to-wall In 1996, AATCC revised AATCC Test from fibers that were treated with fire carpeting and large carpets or rugs, the Method 124, ‘‘Appearance of Fabrics retardants. The standards address the Commission has not made a finding that After Repeated Home Laundering.’’ (2) possibility that any fire-retardant any other washing and drying procedure The 1996 AATCC test method more treatment used on carpets or rugs or on is equivalent to AATCC Test Method closely resembles the equipment and fibers used in the production of carpets 124–67. practices used for household laundering or rugs might be progressively reduced AATCC Test Method 124–67 specifies of fabrics at this time. The revised test by cleaning. Section 1630.4(b)(1)(ii) of operating characteristics of the washing method differs from AATCC Test the standard for large carpets and rugs machine and dryer to be used, wash Method 124–67 by specifying the use of and section 1631.4(b)(1)(ii) of the water and rinse water temperatures, 1993 AATCC detergent, a standard for small carpets and rugs exhaust temperature of the dryer, and a nonphosphate-based detergent. The require that specimens of a carpet or rug particular detergent, AATCC Standard 1996 test method also specifies use of a that has a fire-retardant treatment or that Detergent 124. AATCC Test Method washing machine with different is made from fibers which have had a 124–67 was developed in 1967. These operating characteristics than those fire-retardant treatment shall be tested specifications are representative of the specified by AATCC Test Method 124– after they have been washed and dried equipment, wash, rinse, and drying 67, and rinse water temperatures which 10 times in accordance with a specified temperatures, and detergent used for differ from those in the older test laundering procedure, or ‘‘such number home laundering in the 1960s. For method. (3) Table 1, below, provides a of times under such other washing and example, AATCC Standard Detergent summary comparison of the two test drying procedures as shall have been 124 is a high-phosphate powder with methods.

TABLE 1.ÐAATCC TEST METHOD 124

Wash/dry conditions Version 1967 Version 1996

Washing Machine: Cycle ...... Normal ...... Normal/Cotton Sturdy. Wash Water Temp ...... 60 ± 3°C ...... 60 ± 3°C. Rinse Water Temp ...... 41 ± 3°C ...... Less Than 29°C. Water Level ...... Full ...... 18 ± 1 gal. Agitator Speed ...... 70 ± 5 spm ...... 179 ± 2 spm. Wash Time ...... 12 minutes ...... 12 minutes. Spin Speed ...... 500±510 rpm ...... 630±660 rpm. Final Spin Cycle ...... 4 minutes ...... 6 minutes.

Dryer: Cycle ...... Normal ...... Cotton Sturdy Durable Press. Exhaust Temp ...... 140±160°F ...... 140±160°F ... 140±160°F. Cool Down Cycle ...... 5 minutes ...... 5 minutes ..... 10 minutes. spm = strokes (or cycles) per minute. rpm = revolutions per minute.

In 1996, AATCC also announced that machines offered for sale at this time do The laundering procedures specified when that organization’s supply of not have the settings and operating in the carpet flammability standards Standard Detergent 124 is depleted, that characteristics of the washing machine must be followed by the Commission detergent will no longer be available. specified by AATCC Test Method 124– when testing carpets manufactured with AATCC is the only source for Standard 67. (3) a fire-retardant treatment to determine Detergent 124. Additionally, washing their compliance. Information available

1 Numbers in parentheses identify reference end of this notice. Requests for inspection of any of the Secretary, 4330 East-West Highway, room documents in the List of Relevant Documents at the of these documents should be made at the Office 502, or by calling that office at (301) 504–0800.

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 13134 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules to the Commission indicates that at this Rugs. Further, the AATCC 138 was proceeding with an ANPR, nor is it time, no carpets or rugs treated with a judged to be too harsh for the hand necessary for the Commission to make fire retardant or made from fibers which washable flokati rugs because of the the findings that FFA sections 1193(g) have been treated with a fire retardant brushing specified by the method. and (h) would otherwise require. are offered for sale. However, it is The amendments proposed below 4. Proposed Amendment possible that carpets treated with fire would require specimens of carpet retardants may be marketed in the The carpet flammability standards manufactured with a fire-retardant future. were issued under section 4 of the FFA treatment to be tested after washing and Section 8 of the FFA (15 U.S.C. 1197) (15 U.S.C. 1193), which authorizes the drying 10 times using the procedure provides that no person shall be subject issuance or amendment of flammability specified in AATCC Test Method 124– to criminal prosecution under section 7 standards to protect the public against 1996. The proposed amendments would of the FFA (15 U.S.C. 1196) if that unreasonable risks of fire leading to incorporate that test method into the person holds in good faith a written death, personal injury, or significant carpet flammability standards by guaranty to the effect that ‘‘reasonable property damage. As required by section reference. and representative tests conducted in 4(b) of the FFA, both standards are Existing sections 1630.4(b)(1)(ii) and accordance with the applicable based on findings that they are needed 1631.4(b)(1)(ii) contain the following standard’’ show that a product subject to to adequately protect the public against language: the unreasonable risk of the occurrence a flammability standard issued under Alternatively, the selected sample or the FFA complies with that standard. of fire leading to death, personal injury, oversized specimens thereof may be washed, Enforcement regulations codified at 16 or significant property damage. That dry-cleaned, or shampooed 10 times prior to CFR 1630.31 and 1631.31 establish section further requires findings that a cutting of test specimens, in such manner as minimum requirements for reasonable flammability standard issued under the the manufacturer or other interested party and representative tests to support FFA is ‘‘reasonable, technologically shall previously have established to the guaranties of compliance with the practicable, and appropriate.’’ satisfaction of the Consumer Product Safety carpet flammability standards. The proposed change to the standards Commission is normally used for that type of Although issuance of a guaranty is not is needed to make the specified carpet or rug in service. [Emphasis added.] mandatory, manufacturers who elect to laundering procedures represent those Alternative laundering procedures issue guaranties must perform the currently used by consumers. The have been approved in accordance with testing required by the standard, proposed amendments are also needed provisions of sections 1630.4(b)(1)(ii) including the laundering procedure to assure that the carpet flammability and 1631.4(b)(1)(ii) for hide carpets and specified by the standard for those standards will continue to be rugs and wool flokati carpets and rugs. carpets and rugs manufactured with a ‘‘technologically practicable’’ for both See 16 CFR 1630.61, 1630.62 and fire-retardant treatment unless the Commission’s laboratory and those 1630.63; 16 CFR 1631.61 and 1631.62. exempted from the use of that procedure manufacturers of carpets and rugs The amendments proposed below by other provisions of the standards. required to use the laundering would change the references in Subpart procedures when testing for guaranty C of sections 1630 and 1631 to the 3. Review of Other Existing Standards purposes. revised AATCC Test Method 124–1996 In addition to reviewing AATCC Test Section 4(g) of the FFA (15 U.S.C. so that they are consistent with the Method 124–1996, the Commission staff 1193(g)) states that a proceeding ‘‘for the other proposed changes. reviewed and analyzed fourteen other promulgation of a regulation under this international and technical association section’’ shall be initiated by 5. Effective Date standards or test methods to determine publication of an advance notice of Section 4(b) of the FFA (15 U.S.C. if any were appropriate for proposed rulemaking (‘‘ANPR’’), and 1193(b)) provides that an amendment of consideration in this proceeding. sets forth requirements for the contents a flammability standard shall become Standards and test methods from of the ANPR. However, these proposed effective one year from the date it is AATCC, ASTM, the International amendments are necessary because promulgated, unless the Commission Standards Organization, the United technical advances and the passage of finds for good cause that an earlier or Kingdom, Australia, Canada, China and time have rendered the existing test later effective date is in the public the Soap and Detergent Association method obsolete. The amendments interest, and publishes that finding. were identified. preserve the original intent and effect of Section 4(b) also requires that an All of the standards designed for the existing test method, modifying that amendment of a flammability standard fabric laundering have significant method only as necessary to reflect the shall exempt products ‘‘in inventory or deficiencies. They are either based on existence of modern equipment and with the trade’’ on the date the earlier versions of AATCC Test Method detergent. Moreover, the existing amendment becomes effective, unless 124 (with obsolete detergent and regulations permit the Commission to the Commission limits or withdraws equipment), require equipment not employ a laundering test method that exemption because those products available in the U.S., use only water in different from AATCC Test Method 124 are so highly flammable that they are the laundering procedure, or specify if it concludes that the test method is dangerous for use by consumers. significantly lower wash and rinse water substantively as protective. Because the One reason for proposing these temperatures than those still available existing regulations allow the amendments of the carpet flammability for consumers. Commission to achieve without any standards is that the standard detergent Two of these methods (AATCC 138 amendment the substance of what it specified by the existing laundering and a Canadian standard CAN/CGSB– now proposes to achieve by method in the standard is no longer 4.2 No. 30.2–M90) were specifically amendment, and because the proposed available. The Commission has reason developed for carpets. However, they amendments preserve the regulatory to believe that an effective date 30 days use different liquid detergents, and status quo, save for the reflection of after publication of final amendments neither of these methods approximates modern equipment and detergent, the will be in the public interest. The the typical home laundering used in the Commission has determined that it is Commission does not propose to Flammability Standard for Carpets and not legally required to commence this withdraw or limit the exemption for

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules 13135 products in inventory or with the trade environment. For that reason, neither an footnote 3, redesignating footnotes 4 and as provided by section 4(b) of the FFA. environmental assessment nor an 5 as footnotes 3 and 4 respectively, and The Commission believes that an environmental impact statement is adding new paragraph (b)(1)(iii) to read effective date of thirty days would give required. as follows: adequate notice to all interested persons 3. Executive Orders § 1630.4 Test procedure. of the change in laundering procedure, and at the same time would assure that Executive Order 12988 (February 5, * * * * * the Commission will be able to test for 1996), requires agencies to state in clear (b) Sampling—(1)(i) * * * compliance with the standards without language the preemptive effect, if any, to (ii) If the carpet or rug has had a fire- interruption. Those manufacturers who be given to any new regulation. The retardant treatment, or is made of fibers perform testing in accordance with the amendments proposed below, if issued which have had a fire-retardant laundering procedure specified in the on a final basis, would modify two treatment, the selected sample or over- standard will also benefit from a flammability standards issued under the sized specimens thereof shall be washed, prior to cutting of test relatively short effective date. FFA. With certain exceptions which are The Commission invites comments on not applicable here, no state or political specimens after they have been washed and dried either 10 times in accordance the proposed effective date and factual subdivision of a state may enact or with sections 8.2.2, 8.2.3, and 8.3.1(A) information relating to that issue. continue in effect ‘‘a flammability standard or other regulation’’ applicable of AATCC Test Method 124–1996 C. Other Issues to the same fabric or product as an FFA ‘‘Appearance of Fabrics After Repeated Home Laundering,’’ using wash 1. Impact on Small Businesses standard if the state or local ° ±3° ° ± ° flammability standard or regulation is temperature V (60 C, 140 5 F) In accordance with section 605(b) of ‘‘designed to protect against the same specified in Table II of that method, and the Regulatory Flexibility Act (5 U.S.C. risk of the occurrence of fire’’ unless the the water level, agitator speed, washing 605(b)), the Commission hereby certifies state or local flammability standard or time, spin speed and final spin cycle that the amendments to the carpet regulation ‘‘is identical’’ to the FFA specified for ‘‘Normal/Cotton Sturdy’’ in flammability standards proposed below standard. See section 16 of the FFA (15 Table III, and drying shall be performed will not have a significant economic U.S.C. 1203). Consequently, if issued on in accordance with section 8.3.1(A) of impact on a substantial number of small a final basis, the amendments proposed that test method, Tumble Dry, entities, including small businesses, if below will preempt nonidentical state maximum load 3.64 Kg (8 pounds), issued on a final basis. ° ±5° or local flammability standards or using the exhaust temperature (66 As noted above, the Commission has C,150° ±10° F) and cool down time of 10 regulations that are intended to address not been able to find any carpets or rugs minutes specified in the ‘‘Durable the unreasonable risk of the occurrence currently offered for sale which have Press’’ conditions of Table IV; or such of fire associated with ignition of been treated with a fire-retardant number of times by another washing carpets and rugs. treatment or made from fibers treated In accordance with Executive Order and drying procedure which the with a fire-retardant. In the event that 12612 (October 26, 1987), the Consumer Product Safety Commission some carpets treated with a fire- Commission certifies that the proposed has determined to be equivalent of retardant or made from fibers treated amendments do not have sufficient AATCC Test Method 124–1996. with a fire-retardant treatment come implications for federalism to warrant a Alternatively, the selected sample or onto the market in the future, Federalism Assessment. oversized specimens thereof may be manufacturers will be able to apply for washed, drycleaned, or shampooed 10 approval of any alternate laundering List of Subjects in 16 CFR Parts 1630 times, prior to cutting of test specimens, procedure which is normally used for and 1631 in such manner as the manufacturer or cleaning those products if the procedure Carpets and rugs, Consumer other interested party shall previously specified by the amendments is not protection, Flammable materials, Floor have established to the satisfaction of appropriate. coverings, Labeling, Records, Rugs, the Consumer Product Safety Consequently, the Commission Textiles, Warranties. Commission is normally used for that estimates that the amendments type of carpet or rug in service. proposed below will have no economic Conclusion (iii) AATCC Test Method 124–1996 consequences to any manufacturers, Therefore, pursuant to the authority of ‘‘Appearance of Fabrics After Repeated large or small, of carpets and rugs. section 30(b) of the Consumer Product Home Laundering,’’ is found in Safety Act (15 U.S.C. 2079(b)) and Technical Manual of the American 2. Environmental Considerations sections 4 and 5 of the Flammable Association of Textile Chemists and The amendments proposed below fall Fabrics Act (15 U.S.C. 1193, 1194), the Colorists, vol. 73, 1997, is incorporated within the categories of Commission Commission hereby proposes to amend by reference. Copies of this document actions described at 16 CFR 1021.5(c) title 16 of the Code of Federal are available from the American that have little or no potential for Regulations, Chapter II, Subchapter D, Association of Textile Chemists and affecting the human environment. The Parts 1630 and 1631 to read as follows: Colorists, P.O. Box 12215, Research amendments are not expected to have a Triangle Park, North Carolina 27709. significant effect on production PART 1630ÐSTANDARD FOR THE This document is also available for processes or on the types or amounts of SURFACE FLAMMABILITY OF inspection at the Office of the Federal materials used for the manufacture of CARPETS AND RUGS Register, 800 North Capitol Street, NW., carpets and rugs. The amendments will Suite 700, Washington, DC. This 1. The authority for subpart A of part not render existing inventories incorporation by reference was 1630 continues to read as follows: unsalable, or require destruction of approved by the Director of the Federal existing goods. The Commission has no Authority: Sec. 4, 67 Stat. 112, as Register in accordance with 5 U.S.C. information indicating any special amended, 81 Stat. 569–570; 15 U.S.C. 1193. 552(a) and 1 CFR part 51. These circumstances in which these 2. Section 1630.4 is amended by materials are incorporated as they exist amendments may affect the human revising paragraph (b)(1)(ii), removing in the edition which has been approved

VerDate 23-NOV-98 16:21 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm08 PsN: 17MRP1 13136 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules by the Director of the Federal Register Detergent as specified in AATCC that test method, Tumble Dry, and which has been filed with the Method 124–1996 (or equivalent) per maximum load 3.64 Kg (8 pounds), Office of the Federal Register. liter of water preheated to 105 °F. * * * using the exhaust temperature (66° ±5 * * * * * * * * * * °C, 150° ±10 °F) and cool down time of 3. The authority for subpart C of part 6. Section 1630.63 is amended by 10 minutes specified in the ‘‘Durable 1630 continues to read as follows: revising the first sentence in paragraph Press’’ conditions of Table IV; or such number of times by another washing Authority: Secs. 4, 5, 67 Stat. 112, as (a)(1) to read as follows: and drying procedure which the amended, 81 Stat. 569–570; 15 U.S.C. 1193, § 1630.63 Suspension of washing 1194. Consumer Product Safety Commission requirements for carpets and rugs with has determined to be equivalent of alumina trihydrate in the backing. 4. Section 1630.61 is amended by AATCC Test Method 124–1996. revising the first sentence of paragraph (a)(1) The Standard for the Surface Alternatively, the selected sample or (a) to read as follows: Flammability of Carpets and Rugs (FF oversized specimens thereof may be 1–70) at § 1630.4(b)(1)(ii) provides that washed, drycleaned, or shampooed 10 § 1630.61 Hide carpets and rugsÐ if a carpet or rug has had a fire-retardant alternative washing procedure. times, prior to cutting of test specimens, treatment, or is made of fibers which (a) The Standard for the Surface in such manner as the manufacturer or have had a fire-retardant treatment, the other interested party shall previously Flammability of Carpets and Rugs (FF sample or oversized specimens thereof 1–70) at § 1630.4(b)(1)(ii) provides that have established to the satisfaction of selected for testing under the standard the Consumer Product Safety if a carpet or rug has had a fire-retardant shall be washed prior to the cutting of treatment, or is made of fibers which Commission is normally used for that test specimens either 10 times under the type of carpet or rug in service. have had a fire-retardant treatment, the washing and drying procedure sample or oversized specimens thereof (iii) AATCC Test Method 124–1996 prescribed in Method 124–1996 of the ‘‘Appearance of Fabrics After Repeated selected for testing under the standard American Association of Textile shall be washed prior to the cutting of Home Laundering,’’ is found in Chemists and Colorists or such number Technical Manual of the American test specimens either 10 times under the of times under such other washing and washing and drying procedure Association of Textile Chemists and drying procedure as shall previously Colorists, vol. 73, 1997, is incorporated prescribed in Method 124–1996 of the have been found to be equivalent by the American Association of Textile by reference. Copies of this document Consumer Product Safety Commission. are available from the American Chemists and Colorists or such number *** of times under such other washing and Association of Textile Chemists and * * * * * drying procedure as shall previously Colorists, P.O. Box 12215, Research have been found to be equivalent by the Triangle Park, North Carolina 27709. PART 1631ÐSTANDARD FOR THE This document is also available for Consumer Product Safety Commission. SURFACE FLAMMABILITY OF SMALL *** inspection at the Office of the Federal CARPETS AND RUGS Register, 800 North Capitol Street, NW., * * * * * Suite 700, Washington, DC. This 5. Section 1630.62 is amended by 1. The authority for subpart A of part incorporation by reference was revising the first sentences in 1631 continues to read as follows: approved by the Director of the Federal paragraphs (a) and (d)(3) as follows: Authority: Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569–570; 15 U.S.C. 1193. Register in accordance with 5 U.S.C. § 1630.62 Wool flokati carpets and rugsÐ 552(a) and 1 CFR part 51. These alternative washing procedure. 2. Section 1631.4 is amended by materials are incorporated as they exist revising paragraph (b)(1)(ii), removing (a) The Standard for the Surface in the edition which has been approved footnote 3, redesignating footnotes 4 and Flammability of Carpets and Rugs (FF by the Director of the Federal Register 5 as footnotes 3 and 4 respectively, and 1–70) at § 1630.4(b)(1)(ii) provides that and which has been filed with the adding new paragraph (b)(1)(iii) to read if a carpet or rug has had a fire-retardant Office of the Federal Register. as follows: treatment, or is made of fibers which * * * * * have had a fire-retardant treatment, the 1631.4 Test procedure. 3. The authority for subpart C of part sample or oversized specimens thereof * * * * * 1631 continues to read as follows: selected for testing under the standard (b) Sampling—(1) * ** Authority: Secs. 4, 5, 67 Stat. 112, as shall be washed prior to the cutting of (ii) If the carpet or rug has had a fire- amended, 81 Stat. 569–70; 15 U.S.C. 1193, test specimens either 10 times under the retardant treatment, or is made of fibers 1194. washing and drying procedure which have had a fire-retardant 4. Section 1631.61 is amended by prescribed in Method 124–1996 of the treatment, the selected sample or over- revising the first sentence of paragraph American Association of Textile sized specimens thereof shall be (a) as follows: Chemists and Colorists or such number washed, prior to cutting of test of times under such other washing and specimens after they have been washed § 1631.61 Hide carpets and rugsÐ drying procedure as shall previously and dried either 10 times in accordance alternative washing procedure. have been found to be equivalent by the with sections 8.2.2, 8.2.3, and 8.3.1(A) (a) The Standard for the Surface Consumer Product Safety Commission. of AATCC Test Method 124–1996 Flammability of Carpets and Rugs (FF *** ‘‘Appearance of Fabrics After Repeated 1–70) at § 1630.4(b)(1)(ii) provides that * * * * * Home Laundering,’’ using wash if a carpet or rug has had a fire-retardant (d) * * * temperature V (60° ±3 °C, 140° ±5 °F) treatment, or is made of fibers which (3) Place individual specimen face specified in Table II of that method, and have had a fire-retardant treatment, the down in a shallow pan which has been the water level, agitator speed, washing sample or oversized specimens thereof filled to a depth of 2′′ with a wash time, spin speed and final spin cycle selected for testing under the standard solution of 1.1 grams of AATCC specified for ‘‘Normal/Cotton Sturdy’’ in shall be washed prior to the cutting of (American Association of Textile Table III, and drying shall be performed test specimens either 10 times under the Chemists and Colorists) Standard in accordance with section 8.3.1(A) of washing and drying procedure

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules 13137 prescribed in Method 124–1996 of the Procedures Required for Tests,’’ llll, the laundering procedure specified in American Association of Textile 1998. that standard for mattress pads which Chemists and Colorists or such number 4. Memorandum from Gail Stafford, contain a chemical fire retardant. These of times under such other washing and Directorate for Laboratory Sciences, to laundering procedures help assure that Margaret Neily, Project Manager, ‘‘Amending drying procedure as shall previously the Laundering Provisions of the CPSC any chemical flame retardant is not have been found to be equivalent by the Flammability Regulations,’’ August 18, 1998. removed or degraded by repeated Consumer Product Safety Commission. 5. Memorandum from Gail Stafford, washing and drying, thereby creating a *** Directorate for Laboratory Sciences, to flammability hazard. The Commission is * * * * * Margaret Neily, Project Manager, ‘‘Textile proposing these amendments because 5. Section 1631.62 is amended by Laundering Standards,’’ August 18, 1998. the detergent specified by the existing 6. Memorandum from Gail Stafford and revising the first sentences in laundering procedure is no longer Shing-Bong Chen, Directorate for Laboratory available and the operating paragraphs (a) and (d)(3) to read as Sciences, to Margaret Neily, Project Manager, follows: ‘‘Detergent Comparison Tests,’’ August 19, characteristics of the washing and 1998. drying machines required by that § 1631.62 Wool flokati carpets and rugsÐ 7. Log of Meeting on January 21, 1998 procedure are no longer representative alternative washing procedure. concerning Flammability Test of Pyrovatex- of machines now used for home (a) The Standard for the Surface treated Flame Resistant Fabrics. laundering. Flammability of Carpets and Rugs (FF 8. Memorandum from Terrance R. Karels, DATES: Written comments concerning 1–70) at § 1630.4(b)(1)(ii) provides that Directorate for Economic Analysis, to Margaret Neily, Project Manager, the proposed amendments must be if a carpet or rug has had a fire-retardant received by the Office of the Secretary treatment, or is made of fibers which ‘‘Amendments to FFA Standards,’’ August 10, 1998. not later than June 1, 1999. have had a fire-retardant treatment, the 9. Memorandum from Margaret Neily, sample or oversized specimens thereof ADDRESSES: Written comments should Project Manager, Directorate for Engineering be captioned ‘‘Mattress Pads, selected for testing under the standard Sciences, to the Commission, ‘‘Briefing shall be washed prior to the cutting of Package Supplement: Laundering/Detergent Laundering Procedures’’ and mailed to test specimens either 10 times under the Update for Flammable Fabrics Act the Office of the Secretary, Consumer washing and drying procedure Standards—The Soap and Detergent Product Safety Commission, prescribed in Method 124–1996 of the Association (SDA) Laundering Procedures,’’ Washington, D.C. 20207, or delivered to American Association of Textile January 11, 1999. that office, room 502, 4330 East-West Chemists and Colorists or such number 10. Memorandum from Gail Stafford, Highway, Bethesda, Maryland. Directorate for Laboratory Sciences, to of times under such other washing and Comments may also be filed by Margaret Neily, Project Manager, ‘‘Soap and telefacsimile to (301) 504–0127 or by drying procedure as shall previously Detergent Association Proposed Laundering have been found to be equivalent by the Procedure,’’ December 23, 1998. email to [email protected]. Consumer Product Safety Commission. 11. Letter from Jenan Al-Atrash, Director, FOR FURTHER INFORMATION CONTACT: *** Human Health & Safety, The Soap and Margaret Neily, Project Manager, * * * * * Detergent Association, to Margaret Neily, Directorate for Engineering Sciences, Technical Program Coordinator, Office of the (d) * * * Consumer Product Safety Commission, Executive Director, including SDA Washington, D.C. 20207; telephone (3) Place individual specimen face Recommended Wash Conditions for CFR down in a shallow pan which has been 1615.4, September 15, 1998. (301) 504–0508, extension 1293. filled to a depth of 2′′ with a wash 12. Letter from Jenan Al-Atrash, Director, SUPPLEMENTARY INFORMATION: solution of 1.1 grams of AATCC Human Health & Safety, The Soap and (American Association of Textile Detergent Association, to Margaret Neily, A. Background Chemists and Colorists) Standard Technical Program Coordinator, Office of the The Flammable Fabrics Act (‘‘FFA’’) Detergent as specified in AATCC Executive Director, follow-up comments to (15 U.S.C. 1191 et seq.) authorizes September 15, 1998, letter, November 12, Method 124–1996 (or equivalent) per issuance and amendment of ° 1998. liter of water preheated to 105 F. * * * 13. Memorandum from Margaret L. Neily, flammability standards and regulations * * * * * Project Manager, Directorate for Engineering to protect the public from unreasonable Dated: March 8, 1999. Sciences, to the Commission, ‘‘Laundering/ risks of death, injury, and property Sadye E. Dunn, Detergent Updates—FR notice supplements,’’ damage from fire associated with Secretary, Consumer Product Safety February 19, 1999. products of interior furnishing made Commission. [FR Doc. 99–6074 Filed 3–16–99; 8:45 am] from fabric and related materials. In 1972, the Secretary of Commerce List of Relevant Documents BILLING CODE 6355±01±P issued a flammability standard for 1. American Association of Textile mattresses and mattress pads to protect Chemists and Colorists, ‘‘Appearance of the public from death and serious burn Durable Press Fabrics After Repeated Home CONSUMER PRODUCT SAFETY Launderings,’’ AATCC Test Method 124– COMMISSION injuries associated with ignition of 1969. AATCC Technical Manual, Vol. 46, mattresses and mattress pads by 1970. 16 CFR Part 1632 smoldering cigarettes. That standard 2. American Association of Textile became effective in 1973, and is Chemists and Colorists, ‘‘Appearance of Standard for the Flammability of codified at 16 CFR Part 1632. Fabrics After Repeated Home Laundering,’’ Mattresses and Mattress Pads The standard prescribes a test for AATCC Test Method 124–1996. AATCC AGENCY: Consumer Product Safety mattresses and mattress pads which Technical Manual, Vol. 73, 1997. requires placement of lighted cigarettes 3. Briefing memorandum from Margaret Commission. Neily, Project Manager, Directorate for ACTION: Proposed amendments. at specified locations on the surface of Engineering Sciences, to the Commission, the mattress or mattress pad. An ‘‘Proposed Amendments to Flammable SUMMARY: The Commission proposes to individual mattress or mattress pad Fabrics Act Standards to Replace Obsolete amend the flammability standard for prototype passes the test in the standard Standard Detergent and Update Laundering mattresses and mattress pads by revising if no cigarette test location produces a

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 13138 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules char length more than two inches in any flammability hazard. However, the phosphate-based detergents sold to direction. current procedures are out of date in consumers between 1950 and 1970.(3) In 1973, authority to issue several respects and the Commission Since 1970, environmental concerns flammability standards under the FFA therefore proposes to change them. about water pollution have resulted in was transferred from the Department of the elimination of phosphate-based Commerce to the Consumer Product 1. Current Procedures detergents for home laundering. Today, Safety Commission by section 30(b) of The mattress flammability standard all laundry detergents sold to consumers the Consumer Product Safety Act (15 describes the apparatus and procedure are nonphosphate-based. Additionally, U.S.C. 2079(b)). used to test mattress pads for energy-efficient washing machines and On June 8, 1973, the Commission compliance with the standard. See 16 dryers currently sold for consumer use amended the standard by adding CFR 1632.4 and 1632.5(a). The standard have operating characteristics and requirements for premarket testing of addresses the possibility that a fire- temperature settings which differ from mattresses and mattress pads by retardant chemical used in the those specified by AATCC Test Method manufacturers. As amended in 1973, the production of mattress pads might be 124–82.(3) standard required manufacturers to progressively reduced or degraded by 2. Revised Laundering Test Method perform prototype testing on each washing and drying. Sections 1632.5(a) In 1996, AATCC revised AATCC Test combination of materials and and (b) of the standard require that any Method 124, ‘‘Appearance of Fabrics construction methods used in the mattress pad manufactured with a fire After Repeated Home Laundering’’. (2) production of mattresses or mattress retardant chemical shall be tested in the pads. After successful completion of The 1996 AATCC test method more condition in which it is intended to be prototype testing, the standard required closely resembles the equipment and sold, and after it has been washed and manufacturers to obtain samples at practices currently used for household dried ten times in accordance with a specified intervals during production laundering of fabrics. The revised test specified laundering procedure. That and test those samples for compliance method differs from AATCC Test laundering procedure is AATCC Test with the standard. See 38 FR 15095 Method 124–82 by specifying the use of Method 124–82, published by the (June 8, 1973). 1993 AATCC detergent, a American Association of Textile In 1984, the Commission amended the nonphosphate-based detergent. The Chemists and Colorists (‘‘AATCC’’).(1) 1 standard to eliminate the requirements 1996 test method also specifies use of a The mattress standard incorporates that for production sampling and testing. washing machine with different The amended standard requires that laundering procedure by reference. See operating characteristics than those manufacturers perform prototype testing 16 CFR 1632.5(b)(2)(iv). specified by AATCC Test Method 124– with acceptable results before AATCC Test Method 124–82 specifies 82, and rinse water temperatures which introducing products subject to the operating characteristics of the washing differ from those in the older test standard into commerce, but does not machine and dryer to be used, wash method. (3) Table 1, below, provides a require manufacturers to perform water and rinse water temperatures, summary comparison of the two test production sampling and testing. See 49 exhaust temperature of the dryer, and a methods. FR 39780 (October 10, 1984). particular detergent, AATCC Standard In 1996, AATCC also announced that Detergent 124. AATCC Test Method when that organization’s supply of B. Amending the Flammability 124–82 was originally developed in Standard Detergent 124 is depleted, that Standard 1967 and subsequently revised. These detergent will no longer be available. As discussed below, laundering specifications are representative of the AATCC is the only source for Standard procedures are prescribed by the equipment, wash, rinse, and drying Detergent 124. Additionally, washing standard to help assure that any fire- temperatures, and the detergent used for machines now offered for sale do not retardant chemicals used in the home laundering in the 1960s. For have the settings and operating production of mattress pads will not be example, AATCC Standard Detergent characteristics of the washing machine removed or degraded by repeated 124 is a high-phosphate powder with specified by AATCC Test Method 124– washing and drying and create a optical brightener, similar to the 82.(3)

TABLE 1.ÐAATCC TEST METHOD 124

Wash/Dry conditions Version 1982 Version 1996

Washing Machine: Cycle ...... Normal ...... Normal/Cotton Sturdy. Wash Water Temp ...... 60 ± 3°C ...... 60 ± 3°C. Rinse Water Temp ...... 41 ± 3°C ...... Less Than 29°C. Water Level ...... Full ...... 18 ± 1 gal. Agitator Speed ...... 70 ± 5 spm ...... 179 ± 2 spm. Wash Time ...... 12 minutes ...... 12 minutes. Spin Speed ...... 500±510 rpm ...... 630±660 rpm. Final Spin Cycle ...... 4 minutes ...... 6 minutes

Dryer: Cycle ...... Normal ...... Cotton Sturdy Durable Press. Exhaust Temp ...... 140±160°F ...... 140±160°F ... 140±160°F.

1 Numbers in parentheses identify reference of these documents should be made at the Office 502, Bethesda, Md., or by calling that office at (301) documents in the List of Relevant Documents at the of the Secretary, 4330 East-West Highway, room 504–0800. end of this notice. Requests for inspection of any

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Cool Down Cycle ...... 5 minutes ...... 5 minutes ..... 10 minutes. spm = strokes (or cycles) per minute. rpm = revolutions per minute.

3. Review of Other Existing Standards authorizes the issuance or amendment The amendments proposed below In addition to reviewing AATCC Test of flammability standards to protect the would require a mattress pad containing Method 124–1996, the Commission staff public against unreasonable risks of fire a fire retardant chemical to be tested in reviewed and analyzed twelve other leading to death, personal injury, or the condition in which it is intended to international and technical association significant property damage. As be sold and after washing and drying 10 standards or test methods to determine required by section 4(b) of the FFA, the times using the procedure specified in if any were appropriate for standard is based on findings that it is AATCC Test Method 124–1996. The consideration in this proceeding. needed to adequately protect the public proposed amendments would Standards and test methods from against the unreasonable risk of the incorporate that test method into the AATCC, ASTM, the International occurrence of fire leading to death, mattress standard by reference. Standards Organization, the United personal injury, or significant property The mattress flammability standard Kingdom, Australia, Canada, China and damage. That section further requires and enforcement rules exempt any the Soap and Detergent Association findings that a flammability standard ‘‘one-of-a-kind’’ mattress or mattress were identified. All of these methods issued under the FFA is ‘‘reasonable, pad manufactured to a physician’s could be used for sleepwear fabrics and technologically practicable, and written prescription from all mattress pads. appropriate.’’ requirements of the standard. See All of the identified standards for The proposed change to the standard sections 1632.2(b)(4) and 1632.31(f). fabric laundering have significant is needed to make the specified Those sections are not affected by the deficiencies. They are either based on laundering procedures represent those amendments proposed below. Additionally, existing section earlier versions of AATCC Test Method currently used by consumers. The 1632.5(b)(1)(i) exempts from the 124 (with obsolete detergent and proposed amendments are also needed laundering requirements of the standard equipment), require equipment not to assure that the standard will continue any mattress pad intended for ‘‘one time available in the U.S., use only water in to be ‘‘technologically practicable’’ for use’’ and any mattress pad which is not the laundering procedure, or specify both the Commission’s laboratory and intended to be laundered. Existing significantly lower wash and rinse water those manufacturers of mattress pads section 1632.5(b)(1)(ii) states that temperatures than those still available required to use the laundering for consumers. mattress pads that cannot be laundered procedures before prototype testing. and are labeled ‘‘dryclean only’’ shall be 4. Comparability of Test Results Section 4(g) of the FFA (15 U.S.C. drycleaned by a procedure which has 1193(g)) states that a proceeding ‘‘for the The Commission intended to perform been found to be acceptable by the promulgation of a regulation under this some testing of mattress pads Commission before testing. Existing section’’ shall be initiated by manufactured with chemical fire section 1632.5(b)(2)(v) allows publication of an advance notice of retardants after washing and drying 10 manufacturers of mattress pads proposed rulemaking (‘‘ANPR’’), and times in accordance with AATCC Test manufactured with a chemical fire sets forth requirements for the contents Method 124–82 and after washing and retardant to test specimens after of the ANPR. However, these proposed drying 10 times using AATCC Test laundering ‘‘a different number of wash amendments are necessary because Method 124–1996 to compare the two and dry cycles using another procedure test methods. However, the staff has technical advances and the passage of .. . if that procedure has previously been unable to locate any flame time have rendered the existing test been found to be equivalent by the retardant-treated mattress pads for this method obsolete. The amendments Consumer Product Safety Commission.’’ comparison. The mattress pads located preserve the original intent and effect of These sections are not affected by the by the staff are made of fabric and filling the existing test method, modifying that amendments proposed below. method only as necessary to reflect the materials that do not need to be treated 6. Effective Date to pass the flammability test of the existence of modern equipment and mattress standard. However, since there detergent. Moreover, the existing Section 4(b) of the FFA (15 U.S.C. is a demand for natural fibers such as regulations permit the Commission to 1193(b)) provides that an amendment of cotton (which may need to be FR treated employ a laundering test method a flammability standard shall become to pass the flammability standard) in different from AATCC Test Method 124 effective one year from the date it is other products, the Commission if it concludes that the test method is promulgated, unless the Commission believes it is appropriate to propose substantively as protective. Because the finds for good cause that an earlier or revising the laundering method so that existing regulations allow the later effective date is in the public it is consistent with actual consumer Commission to achieve without any interest, and publishes that finding. and industry laundering practices amendment the substance of what it Section 4(b) also requires that an should cotton mattress pads return to now proposes to achieve by amendment of a flammability standard the market in the future. amendment, and because the proposed shall exempt products ‘‘in inventory or amendments preserve the regulatory with the trade’’ on the date the 5. Proposed Amendment status quo, save for the reflection of amendment becomes effective, unless The Commission proposes to revise modern equipment and detergent, the the Commission limits or withdraws the laundering procedures specified in Commission has determined that it is that exemption because those products 16 CFR 1632.5(b) to those of AATCC not legally required to commence this are so highly flammable that they are Test Method 124–1996. proceeding with an ANPR, nor is it dangerous for use by consumers. The mattress flammability standard necessary for the Commission to make One reason for proposing these was issued and amended under section the findings that FFA sections 1193(g) amendments of the mattress 4 of the FFA (15 U.S.C. 1193), which and (h) would otherwise require. flammability standard is that the

VerDate 03-MAR-99 15:00 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\17MRP1.XXX pfrm07 PsN: 17MRP1 13140 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Proposed Rules standard detergent specified by the destruction of existing goods. The 2. Section 1632.5 is amended by existing laundering method in the Commission has no information revising paragraphs (b)(2)(i) through (iv) standard is no longer available. The indicating any special circumstances in and by removing the undesignated Commission has reason to believe that which these amendments may affect the paragraph following (b)(2)(iv) to read as an effective date 30 days after human environment. Accordingly, follows: publication of final amendments will be neither an environmental assessment in the public interest. The Commission nor an environmental impact statement § 1615.5 Mattress pad test procedure. does not propose to withdraw or limit is required. * * * * * the exemption for products in inventory (b) * * * 3. Executive Orders or with the trade as provided by section (2) Laundering procedure. (i) Washing 4(b) of the FFA. Executive Order 12988 (February 5, shall be performed in accordance with The Commission believes that an 1996), requires agencies to state in clear sections 8.2.2 and 8.2.3 of AATCC Test effective date of thirty days would give language the preemptive effect, if any, to Method 124–1996, using wash adequate notice to all interested persons be given to a new regulation. The temperature V (60° ± 3°C, 140° ± 5°F) of the change in laundering procedure, amendments proposed below, if issued specified in Table II of that method, and and at the same time would assure that on a final basis, would modify a the water level, agitator speed, washing the Commission will be able to test for flammability standard issued under the time, spin speed and final spin cycle compliance with the standards without FFA. With certain exceptions which are specified for ‘‘Normal/Cotton Sturdy’’ in interruption. Those manufacturers who not applicable here, no state or political Table III. perform prototype testing in accordance subdivision of a state may enact or (ii) Drying shall be performed in with the laundering procedure specified continue in effect ‘‘a flammability accordance with section 8.3.1(A) of in the standard will also benefit from a standard or other regulation’’ applicable AATCC Test Method 124–1996 relatively short effective date. to the same fabric or product covered by ‘‘Appearance of Fabrics After Repeated The Commission invites comments on an FFA standard if the state or local Home Laundering,’’ Tumble Dry, using the proposed effective date and factual flammability standard or regulation is the exhaust temperature (66° ± 5°C, 150° information relating to that issue. ‘‘designed to protect against the same ± 10°F) and cool down time of 10 risk of the occurrence of fire’’ unless the minutes specified in the ‘‘Durable C. Other Issues state or local standard or regulation is Press’’ conditions of Table IV. 1. Impact on Small Businesses ‘‘identical’’ to the FFA standard. See (iii) Maximum washer load shall be section 16 of the FFA (15 U.S.C. 1203). 3.64 Kg (8 pounds) and may consist of In accordance with section 605(b) of Consequently, if issued on a final basis, any combination of test samples and the Regulatory Flexibility Act (5 U.S.C. the amendments proposed below will dummy pieces. 605(b)), the Commission hereby certifies preempt nonidentical state or local that the amendments to the mattress (iv) AATCC Test Method 124–1996 flammability standards or regulations flammability standard proposed below ‘‘Appearance of Fabrics After Repeated that are intended to address the will not have a significant economic Home Laundering,’’ is found in unreasonable risk of fire from ignition of impact on a substantial number of small Technical Manual of the American mattress pads. entities, including small businesses, if Association of Textile Chemists and In accordance with Executive Order issued on a final basis. The Colorists, vol. 73, 1997, which is 12612 (October 26, 1987), the requirements for washing and drying incorporated by reference. Copies of this Commission certifies that the proposed mattress pads manufactured with a fire document are available from the amendments do not have sufficient retardant chemical were included in the American Association of Textile implications for federalism to warrant a standards to assure that any flame Chemists and Colorists, P.O. Box 12215, Federalism Assessment. retardant treatment used in mattress Research Triangle Park, North Carolina 27709. This document is also available pads would not be removed or degraded List of Subjects in 16 CFR Part 1632 by repeated laundering. for inspection at the Office of the Consumer protection, Flammable Federal Register, 800 North Capitol At this time, all mattress pads subject materials, Labeling, Mattresses and to the standard are made without flame Street, NW., Suite 700, Washington, DC. mattress pads, Records, Textiles, This incorporation by reference was retardant treatments. Accordingly, most Warranties. manufacturers of mattress pads are not approved by the Director of the Federal required to launder mattress pads before Conclusion Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. These testing, and the Commission does not Therefore, pursuant to the authority of expect that the proposed amendments materials are incorporated as they exist section 30(b) of the Consumer Product in the edition which has been approved will have a significant effect on any Safety Act (15 U.S.C. 2079(b)) and businesses, large or small. by the Director of the Federal Register sections 4 and 5 of the Flammable and which has been filed with the 2. Environmental Considerations Fabrics Act (15 U.S.C. 1193, 1194), the Office of the Federal Register. Commission hereby proposes to amend The amendments proposed below fall * * * * * title 16 of the Code of Federal Dated: March 8, 1999. within the categories of Commission Regulations, Chapter II, Subchapter D, Sadye E. Dunn, actions described at 16 CFR 1021.5(c) Part 1632 to read as follows: that have little or no potential for Secretary, Consumer Product Safety affecting the human environment. The PART 1632ÐSTANDARD FOR THE Commission. amendments are not expected to have a FLAMMABILITY OF MATTRESSES List of Relevant Documents significant effect on production AND MATTRESS PADS 1. American Association of Textile processes or on the types or amounts of 1. The authority for part 1632 Chemists and Colorists, ‘‘Appearance of materials used for construction or Durable Press Fabrics After Repeated Home packaging of mattress pads. The continues to read as follows: Launderings,’’ AATCC Test Method 124– amendments will not render existing Authority: 15 U.S.C. 1193, 1194; 15 U.S.C. 1969. AATCC Technical Manual, Vol. 46, inventories unsalable, or require 2079(b). 1970.

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2. American Association of Textile DEPARTMENT OF THE TREASURY use of credit cards (either debit cards or Chemists and Colorists, ‘‘Appearance of credit cards) authorized by the Fabrics After Repeated Home Laundering,’’ 19 CFR Part 24 Commissioner of Customs. These AATCC Test Method 124–1996. AATCC RIN 1515±AC40 changes will assist Customs in Technical Manual, Vol. 73, 1997. improving customer service and 3. Briefing memorandum from Margaret Expanded Methods of Payment of financial management. The proposal Neily, Project Manager, Directorate for Duties, Taxes, Interest and Fees affords Customs customers the broadest Engineering Sciences, to the Commission, range of payment options. ‘‘Proposed Amendments to Flammable AGENCY: Customs Service, Department Also, Customs proposes to revise the Fabrics Act Standards to Replace Obsolete of the Treasury. heading and text of both introductory Standard Detergent and Update Laundering ACTION: Notice of proposed rulemaking. paragraph (a) and paragraph (a)(1) to Procedures Required for Tests,’’ ————, include the terms ‘‘fees’’ and ‘‘interest’’ SUMMARY: This document proposes to 1998. to reflect that the proposed payment 4. Memorandum from Gail Stafford, amend the Customs Regulations to methods may be used to pay fees Directorate for Laboratory Sciences, to expand the number of ways that assessed pursuant to 19 U.S.C. 58a Margaret Neily, Project Manager, ‘‘Amending Customs will accept payment of duties, through 58c and to pay fees and interest the Laundering Provisions of the CPSC taxes, fees, interest and other charges. pursuant to 19 U.S.C. 1505, as amended Flammability Regulations,’’ August 18, 1998. Currently, the regulations allow by section 642 of the North American 5. Memorandum from Gail Stafford, payment by credit or charge cards that Free Trade Agreement Implementation Directorate for Laboratory Sciences, to have been authorized by the Act. Margaret Neily, Project Manager, ‘‘Textile Commissioner of Customs only at Laundering Standards,’’ August 18, 1998. designated locations, and then only by Comments 6. Memorandum from Gail Stafford and non-commercial entities. In this Before adopting this proposal, Shing-Bong Chen, Directorate for Laboratory document, Customs is proposing to consideration will be given to any Sciences, to Margaret Neily, Project Manager, allow payment by any electronic written comments timely submitted to ‘‘Detergent Comparison Tests,’’ August 19, technology or charge cards (debit cards Customs. Comments submitted will be 1998. or credit cards) that are authorized by available for public inspection in 7. Log of Meeting on January 21, 1998 the Commissioner of Customs and to accordance with the Freedom of concerning Flammability Test of Pyrovatex- remove the limitation that these Information Act (5 U.S.C. 552), § 1.4, treated Flame Resistant Fabrics. methods of payment may only be used Treasury Department Regulations (31 8. Memorandum from Terrance R. Karels, by non-commercial entities. These CFR 1.4), and § 103.11(b), Customs Directorate for Economic Analysis, to changes, if adopted, will assist Customs Regulations (19 CFR 103.11(b)), on Margaret Neily, Project Manager, in improving customer service and regular business days between the hours ‘‘Amendments to FFA Standards,’’ August financial management. 10, 1998. of 9:00 a.m. and 4:30 p.m. at the DATE: 9. Memorandum from Margaret Neily, Comments must be received on or Regulations Branch, Office of Project Manager, Directorate for Engineering before May 17, 1999. Regulations and Rulings, U.S. Customs Sciences, to the Commission, ‘‘Briefing ADDRESS: Written comments may be Service, 1300 Pennsylvania Avenue Package Supplement: Laundering/Detergent submitted to and comments submitted NW., Third Floor, Washington, DC Update for Flammable Fabrics Act may be inspected at the Regulations 20229. Standards—The Soap and Detergent Branch, Office of Regulations and Regulatory Flexibility Act Association (SDA) Laundering Procedures,’’ Rulings, U.S. Customs Service, 1300 January 11, 1999. Pennsylvania Avenue NW., Third Floor, Because this proposal expands the 10. Memorandum from Gail Stafford, Washington, DC 20229. options available for payments due to Directorate for Laboratory Sciences, to FOR FURTHER INFORMATION CONTACT: Customs and facilitates the public Margaret Neily, Project Manager, ‘‘Soap and Elizabeth Dichysyn, Accounting payment process, it is certified that the Detergent Association Proposed Laundering Services Division, U.S. Customs Service, amendment will not have a significant Procedure,’’ December 23, 1998. 317–298–1200, extension 1339. economic impact on a substantial 11. Letter from Jenan Al-Atrash, Director, SUPPLEMENTARY INFORMATION: number of small entities. Accordingly, Human Health & Safety, The Soap and the proposed amendment is not subject Detergent Association, to Margaret Neily, Background to the regulatory analysis or other Technical Program Coordinator, Office of the Section 24.1(a)(7) of the current requirements of 5 U.S.C. 603 or 604. Executive Director, including SDA Customs Regulations (19 CFR 24.1(a)(7)) Executive Order 12866 Recommended Wash Conditions for CFR provides for the use of credit or charge 1615.4, September 15, 1998. cards that have been authorized by the This document does not meet the 12. Letter from Jenan Al-Atrash, Director, Commissioner of Customs for the criteria for a significant regulatory Human Health & Safety, The Soap and payment of duties, taxes and/or other action under Executive Order (E.O.) Detergent Association, to Margaret Neily, charges at Customs service locations for 12866. Technical Program Coordinator, Office of the non-commercial entries, subject to Executive Director, follow-up comments to Drafting Information ultimate collection from the credit card September 15, 1998, letter, November 12, company. Payment by this manner is The principal author of this document 1998. currently limited to non-commercial was Janet L. Johnson, Regulations 13. Memorandum from Margaret L. Neily, entries. Persons paying by charge or Branch. However, personnel from other Project Manager, Directorate for Engineering offices participated in its development. Sciences, to the Commission, ‘‘Laundering/ credit card remain liable for all such charges until paid. Detergent Updates—FR notice supplements,’’ List of Subjects in 19 CFR Part 24 February 19, 1999. This proposed regulation would extend this privilege to commercial Accounting, Claims, Fees, Financial [FR Doc. 99–6073 Filed 3–16–99; 8:45 am] entries and allow payment through the and accounting procedures, Imports, BILLING CODE 6355±01±P use of electronic technology or by the Taxes.

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Proposed Amendments to the DEPARTMENT OF THE TREASURY zone, as would otherwise be the case, Regulations Customs accepts one entry from a zone Customs Service user covering all its anticipated It is proposed to amend part 24, removals fro an entire weekly period. Customs Regulations (19 CFR part 24), 19 CFR Part 146 The use of this procedure, however, has as set forth below. RIN 1515±AC05 been limited exclusively to merchandise that is manufactured or changed into its PART 24ÐCUSTOMS FINANCIAL AND Weekly Entry Procedure for Foreign final form just shortly (within 24 hours) ACCOUNTING PROCEDURE Trade Zones before physical transfer from the zone. The weekly entry procedure is 1. The general authority citation for AGENCY: Customs Service, Department believed to be especially necessary for part 24 and the relevant specific of the Treasury. assembly-line type manufacturing authority for § 24.1 would continue to ACTION: Proposed rule; withdrawal. operations because, in these read as follows: SUMMARY: This document withdraws the circumstances, there would otherwise Authority: 5 U.S.C. 301; 19 U.S.C. 58a–58c, proposed amendments to the Customs be little time for examination of the 66, 1202 (General Note 20, Harmonized Tariff Regulations that would have expanded merchandise and furnishing of entry Schedule of the United States), 1450, 1624; the weekly entry procedure for foreign documentation after the merchandise 31 U.S.C. 9701. § 24.1 also issued under 19 trade zones to include merchandise was in its final form but before its U.S.C. 197, 198, 1648; involved in activities other than physical removal from the zone. Thus, under the weekly entry process, the exclusively assembly-line type * * * * * assembly-line operation would not have production operations. Customs has 2. It is proposed to amend § 24.1 by to be delayed pending acceptance of an determined that the proposed expanded entry and Customs examination of the revising the heading, paragraph (a), weekly entry procedure would merchandise. introductory text, and paragraph (a)(7) significantly reduce the collection of the to read as follows: On March 14, 1997, Customs merchandise processing fee (MPF) that published in the Federal Register (62 § 24.1 Collection of Customs duties, taxes, Customs needs to offset its FR 12129) a notice of proposed fees, interest and other charges. administrative costs incurred in rulemaking that would have expanded processing imported merchandise that is the use of weekly entry by adding a (a) Except as provided in paragraph formally entered or released. (b) of this section, the following weekly entry procedure to cover DATE: The withdrawal is effective on merchandise involved in activities other procedure applies to the collection of March 17, 1999. Customs duties, taxes, fees, interest and than manufacturing operations. It was FOR FURTHER INFORMATION CONTACT: expected that the expanded weekly other charges (see §§ 111.29(b) and Linda Walfish, Office of Field entry procedure would be available to 141.1(b) of this chapter): Operations, (202–927–0042). zones (including subzones) having large * * * * * SUPPLEMENTARY INFORMATION: quantities of different types of (7) Wherever authorized by the Background merchandise. Commissioner of Customs, transfer of The principal purpose of the The Foreign Trade Zones Act of 1934, funds through electronic technology or proposed expanded weekly entry as amended (19 U.S.C. 81a–u) (the use of charge cards (either debit cards or procedure, which would have required ‘‘FTZA’’) provides for the establishment credit cards) authorized by the electronic entry filing, was to reduce the and regulation of foreign trade zones. number of paper entries from zones and Commissioner of Customs may be used Foreign trade zones are secured areas to for payment of duties, taxes, fees, further facilitate the processing of zone which foreign and domestic entries, with resulting reductions in interest and/or other charges to merchandise, except that prohibited by paperwork and associated industry Customs. Persons using these methods law, may be exempted from the Customs costs. to make payment to Customs remain laws of the United States for the In order to test the expanded weekly liable for the amounts transferred or purposes enumerated in the FTZA. entry procedure, a pilot program had charged until Customs receives Foreign trade zones, by virtue of their been authorized in September 1994 for payment. Payment by these methods is potential to allow exemption from the a selected number of zones/subzones. subject to ultimate collection from the Customs laws, are intended to attract financial institution or charge card and promote legitimate international Effect on Merchandise Processing Fee company. Information about authorized trade and commerce. Based upon further evaluation of the methods of payment at specific Customs Part 146, Customs Regulations (19 pilot program, and comments made by locations may be obtained from Customs CFR part 146), sets forth the zone operators and others on the officers. documentation and recordkeeping proposed rule, it is clear that the requirements governing, among other expanded procedure would significantly * * * * * things, the admission of merchandise impact Customs collection of the Raymond W. Kelly, into a zone, its manipulation, merchandise processing fee (MPF). This Commissioner of Customs. manufacture, storage, destruction or poses a serious funding concern for the Approved: February 16, 1999. exhibition while in the zone, and its Government. Under 19 U.S.C. 58c(a)(9)(A) and Dennis M. O’Connell, entry and removal from the zone. To this latter end, Customs has in (B)(i), the MPF is the fee that Customs Acting Deputy Assistant Secretary of the place a weekly entry procedure for assesses on importers in order to offset Treasury. foreign trade zones, as prescribed in its administrative costs (salaries and [FR Doc. 99–6468 Filed 3–16–99; 8:45 am] § 146.63(c)(1), Customs Regulations (19 expenses) incurred in connection with BILLING CODE 4820±02±P CFR 146.63(c)(1)). Under the procedure, the processing of imported merchandise instead of requiring a separate entry for that is formally entered or released. The each removal of merchandise from a fees collected are deposited in the

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Applicability provided, merchandise that is formally The rule being proposed for approval entered is subject to an ad valorem MPF Approval and Promulgation of Implementation Plans; California State into the California SIP is Bay Area Air of .21 percent (19 CFR 24.23(b)(1)(i)(A)); Quality Management District, however, on any one such entry of Implementation Plan Revision, Bay Area Air Quality Management District BAAQMD, Rule 8–51, Adhesive and merchandise, the fee may not exceed Sealant Products. This rule was $485, subject to certain provisions not AGENCY: Environmental Protection submitted by the California Air here relevant (19 CFR 24.23(b)(1)(i)(B)). Agency (EPA). Resources Board to EPA on June 23, As a result, in those cases where a ACTION: Proposed rule. 1998. company must now make a separate SUMMARY: II. Background entry for each of its removals of EPA is proposing a limited merchandise from a zone, and its total approval and limited disapproval of a revision to the California State On March 3, 1978, EPA promulgated payment of the MPF for all entries so Implementation Plan (SIP) which a list of ozone nonattainment areas made during a week greatly exceeds concerns the control of volatile organic under the provisions of the 1977 Clean $485, the company would be able to compound (VOC) emissions from Air Act (1977 CAA or pre-amended lower this payment substantially if it adhesive and sealant products. Act), that included the San Francisco could instead make one entry covering The intended effect of proposing a Bay Area. 43 FR 8964. The San all its removals from the zone for the limited approval and limited Francisco Bay Area did not attain the week, with the MPF thereby capped at disapproval of this rule is to regulate ozone standard by the approved $485. emissions of VOCs in accordance with attainment date. On May 26, 1988, EPA Clearly, Customs collection of the the requirements of the Clean Air Act, notified the Governor of California, MPF would be significantly reduced as amended in 1990 (CAA or the Act). pursuant to section 110(a)(2)(H) of the under an expanded weekly entry EPA’s final action on this proposed rule pre-amended Act, that the Bay Area Air program. Indeed, some parties will incorporate this rule into the Quality Management District’s portion expressing interest in the proposed rule federally approved SIP. EPA has of the SIP was inadequate to attain and even asserted that they would apply for evaluated the rule and is proposing a maintain the ozone standard and foreign trade zone status just to gain the simultaneous limited approval and requested that deficiencies in the benefit of the reduced MPF through the limited disapproval under provisions of existing SIP be corrected (EPA’s SIP- use of a weekly entry. the CAA regarding EPA action on SIP Call). On November 15, 1990, submittals and general rulemaking amendments to the 1977 CAA were Moreover, other industries, such as authority because this revision, while enacted. Pub. L. 101–549, 104 Stat. bonded warehouse associations, stated strengthening the SIP, does not fully 2399, codified at 42 U.S.C. 7401–7671q. that similar entry procedures should as meet the CAA provisions regarding plan In amended section 182(a)(2)(A) of the well be available to them, which also submissions and requirements for CAA, Congress statutorily adopted the raised a fairness concern. nonattainment areas. requirement that nonattainment areas Withdrawal of Proposal DATES: Comments must be received on fix their deficient reasonably available or before April 16, 1999. control technology (RACT) rules for ozone and established a deadline of May In view of the foregoing, and ADDRESSES: Comments may be mailed following further consideration of the to: Andrew Steckel, Rulemaking Office 15, 1991 for states to submit corrections matter, Customs has determined to [AIR–4], Air Division, U.S. of those deficiencies. withdraw the notice of proposed Environmental Protection Agency, Section 182(a)(2)(A) applies to areas rulemaking that was published in the Region IX, 75 Hawthorne Street, San designated as nonattainment prior to Federal Register (62 FR 12129) on Francisco, CA 94105–3901. enactment of the amendments and March 14, 1997. Customs, however, will Copies of the rule and EPA’s classified as marginal or above as of the continue to cooperate with the trade in evaluation report of the rule are date of enactment. It requires such areas seeking mutually satisfactory ways in available for public inspection at EPA’s to adopt and correct RACT rules which to further facilitate entry Region IX office during normal business pursuant to pre-amended section 172(b) processing or imported merchandise, so hours. Copies of the submitted rule are as interpreted in pre-amendment as to reduce associated paperwork and also available for inspection at the guidance.1 EPA’s SIP-Call used that costs to industry, while at the same time following locations: guidance to indicate the necessary reasonably preserving the integrity of Bay Area Air Quality Management corrections for specific nonattainment the MPF which is necessary to offset District, 939 Ellis Street, San areas. The San Francisco Bay Area is merchandise processing costs incurred Francisco, CA 94109. designated as nonattainment without by the Government in this regard. California Air Resources Board, 1 Raymond W. Kelly, Stationary Source Division, Rule Among other things, the pre-amendment Evaluation Section, 2020 ‘‘L’’ Street, guidance consists of those portions of the proposed Commissioner of Customs. Post-1987 ozone and carbon monoxide policy that Sacramento, CA 95812. Approved: February 9, 1999. concern RACT, 52 FR 45044 (November 24, 1987) FOR FURTHER INFORMATION CONTACT: and the document ‘‘Issues Relating to VOC John P. Simpson, Yvonne Fong, Rulemaking Office, [AIR– Regulation Cutpoints, Deficiencies, and Deviations, Deputy Assistant Secretary of the Treasury. Clarification to Appendix D of November 24, 1987 4], Air Division, U.S. Environmental Federal Register Notice’’ (Blue Book) (notice of [FR Doc. 99–6467 Filed 3–16–99; 8:45 am] Protection Agency, Region IX, 75 availability was published in the Federal Register BILLING CODE 4820±02±M Hawthorne Street, San Francisco, CA on May 25, 1988).

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In 8–51 (February 1999), which is available 1998, including the rule being acted on general, these guidance documents have from the U.S. EPA, Region IX office. in this document. This document been set forth to ensure that VOC rules Because of these deficiencies, the rule is addresses EPA’s proposed action for are fully enforceable and strengthen or not approvable pursuant to section BAAQMD Rule 8–51, Adhesives and maintain the SIP. 182(a)(2)(A) of the CAA because it is not Sealant Products. The BAAQMD There is currently no version of consistent with the interpretation of adopted this rule on January 7, 1998. BAAQMD Rule 8–51, Adhesive and section 172 of the 1977 CAA as found This submitted rule was found to be Sealant Products in the SIP. The in the Blue Book and may lead to rule complete on August 25, 1998, pursuant submitted rule includes provisions enforceability problems. to EPA’s completeness criteria that are which: Because of the above deficiencies, set forth in 40 CFR Part 51, Appendix • Specify VOC content limits for EPA cannot grant full approval of this V; 3 and is being proposed for limited adhesives, aerosol adhesives, and rule under section 110(k)(3) and Part D. approval and limited disapproval. sealants (Sections 301, 302, 303, and Also, because the submitted rule is not BAAQMD Rule 8–51 limits the 304); composed of separable parts which meet volatile organic compound (VOC) • Allow sources to comply using all the applicable requirements of the emissions resulting from the application emission control systems with an CAA, EPA cannot grant partial approval of adhesive and sealant products. VOCs overall abatement efficiency of at least of the rule under section 110(k)(3). contribute to the production of ground 85 percent (Section 305); However, EPA may grant a limited level ozone and smog. Rule 8–51 is a • Prohibit the specification and sale approval of the submitted rule under new rule which has been adopted to of any adhesives, aerosol adhesives, or section 110(k)(3) in light of EPA’s meet the EPA’s SIP-Call and the section sealants that would result in a violation authority pursuant to section 301(a) to 182(a)(2)(A) CAA requirement. The of the provisions of Rule 8–51 (Section adopt regulations necessary to further following is EPA’s evaluation and 306 and 307); air quality by strengthening the SIP. The proposed action for BAAQMD Rule 8– • Require any person using organic approval is limited because EPA’s 51. solvents for surface preparation and action also contains a simultaneous limited disapproval. In order to III. EPA Evaluation and Proposed clean-up to use closed containers and to strengthen the SIP, EPA is proposing a Action minimize evaporation of organic compounds to the atmosphere (Section limited approval of BAAQMD’s In determining the approvability of a 320); submitted Rule 8–51 under sections VOC rule, EPA must evaluate the rule • Require facilities within the District 110(k)(3) and 301(a) of the CAA. for consistency with the requirements of that use more than 20 gallons of At the same time, EPA is also the CAA and EPA regulations, as found adhesive and/or sealant products per proposing a limited disapproval of this in section 110 and Part D of the CAA year to keep monthly records (Section rule because it contains deficiencies that and 40 CFR Part 51 (Requirements for 501); have not been corrected as required by Preparation, Adoption, and Submittal of • Mandate that persons using an section 182(a)(2)(A) of the CAA, and, as Implementation Plans). The EPA emission control system keep daily such, the rule does not fully meet the interpretation of these requirements, records of key system operating requirements of Part D of the Act. Under which forms the basis for today’s action, parameters and amounts of adhesive or section 179(a)(2), if the Administrator appears in the various EPA policy sealant product used (Section 502); and disapproves a submission under section guidance documents listed in footnote • Provide test methods for 110(k) for an area designated 1. Among those provisions is the determining the amount of VOC in nonattainment, based on the requirement that a VOC rule must, at a adhesives and sealants, aerosol submission’s failure to meet one or more minimum, provide for the adhesives, and low solids adhesives, of the elements required by the Act, the implementation of RACT for stationary sealant products and primers and for Administrator must apply one of the sources of VOC emissions. This determining control and collection sanctions set forth in section 179(b) requirement was carried forth from the efficiency (Sections 601 and 602). unless the deficiency has been corrected pre-amended Act. Although these provisions will within 18 months of such disapproval. strengthen the SIP, this rule also Section 179(b) provides two sanctions 2 The San Francisco Bay Area, originally contains deficiencies which are required available to the Administrator: highway designated as an ozone nonattainment area on March 3, 1978, retained its designation and was to be corrected pursuant to the section funding and offsets. The 18 month classified by operation of law pursuant to sections 182(a)(2)(A) requirement of Part D of the period referred to in section 179(a) will 107(d) and 181(a) upon the date of enactment of the CAA. Rule 8–51 contains the following begin on the effective date of EPA’s final CAA. See 56 FR 56694 (November 6, 1991). On May deficiencies: limited disapproval. Moreover, the final 22, 1995 EPA approved BAAQMD’s request for • redesignation and the San Francisco Bay Area was The rule does not require users of disapproval triggers the Federal reclassified as an attainment area. See 60 FR 27028. adhesive and sealant products to record implementation plan (FIP) requirement Based on a number of violations of the National their daily use of non-compliant under section 110(c). It should be noted Ambient Air Quality Standards, EPA redesignated that the rule covered by this proposed the San Francisco Bay Area back to nonattainment coatings; for ozone on July 10, 1998 without assigning it a • The rule allows for director’s rulemaking has been adopted by the specific classification of marginal, moderate, discretion in the approval of alternate BAAQMD and is currently in effect in serious, severe, or extreme. See 63 FR 37258. recordkeeping plans; and the BAAQMD. EPA’s final limited 3 EPA adopted completeness criteria on February • The rule contains a number of disapproval action will not prevent the 16, 1990 (55 FR 5830) and, pursuant to section 110(k)(1)(A) of the CAA, revised the criteria on deviations from RACT level controls BAAQMD or EPA from enforcing this August 26, 1991 (56 FR 42216). which have not been substantiated by rule.

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Nothing in this action should be the Agency must evaluate the imposing. Therefore, because the construed as permitting or allowing or environmental health or safety effects of Federal SIP approval does not create establishing a precedent for any future the planned rule on children, and any new requirements, I certify that this request for revision to any state explain why the planned regulation is action will not have a significant implementation plan. Each request for preferable to other potentially effective economic impact on a substantial revision to the state implementation and reasonably feasible alternatives number of small entities. Moreover, due plan shall be considered separately in considered by the Agency. to the nature of the Federal-State light of specific technical, economic, This rule is not subject to E.O. 13045 relationship under the Clean Air Act, and environmental factors and in because it does not involve decisions preparation of a flexibility analysis relation to relevant statutory and intended to mitigate environmental would constitute Federal inquiry into regulatory requirements. health or safety risks. the economic reasonableness of state IV. Administrative Requirements D. Executive Order 13084 action. The Clean Air Act forbids EPA to base its actions concerning SIPs on A. Executive Order 12866 Under E.O. 13084, Consultation and such grounds. Union Electric Co., v. Coordination with Indian Tribal U.S. EPA, 427 U.S. 246, 255–66 (1976); The Office of Management and Budget Governments, EPA may not issue a 42 U.S.C. 7410(a)(2). (OMB) has exempted this regulatory regulation that is not required by action from Executive Order (E.O.) statute, that significantly or uniquely F. Unfunded Mandates 12866, Regulatory Planning and Review. affects the communities of Indian tribal Under Section 202 of the Unfunded B. Executive Order 12875 governments, and that imposes substantial direct compliance costs on Mandates Reform Act of 1995 Under E.O. 12875, Enhancing the those communities, unless the Federal (‘‘Unfunded Mandates Act’’), signed Intergovernmental Partnership, EPA government provides the funds into law on March 22, 1995, EPA must may not issue a regulation that is not necessary to pay the direct compliance prepare a budgetary impact statement to required by statute and that creates a costs incurred by the tribal accompany any proposed or final rule mandate upon a state, local, or tribal governments, or EPA consults with that includes a Federal mandate that government, unless the Federal those governments. If EPA complies by may result in estimated annual costs to government provides the funds consulting, E.O. 13084 requires EPA to State, local, or tribal governments in the necessary to pay the direct compliance provide to the OMB, in a separately aggregate; or to the private sector, of costs incurred by those governments, or identified section of the preamble to the $100 million or more. Under Section EPA consults with those governments. If rule, a description of the extent of EPA’s 205, EPA must select the most cost- EPA complies by consulting, E.O. 12875 prior consultation with representatives effective and least burdensome requires EPA to provide to the OMB a of affected tribal governments, a alternative that achieves the objectives description of the extent of EPA’s prior summary of the nature of their concerns, of the rule and is consistent with consultation with representatives of and a statement supporting the need to statutory requirements. Section 203 affected state, local, and tribal issue the regulation. In addition, E.O. requires EPA to establish a plan for governments, the nature of their 13084 requires EPA to develop an informing and advising any small concerns, copies of any written effective process permitting elected and governments that may be significantly communications from the governments, other representatives of Indian tribal or uniquely impacted by the rule. and a statement supporting the need to governments ‘‘to provide meaningful EPA has determined that the approval issue the regulation. In addition, E.O. and timely input in the development of action promulgated does not include a 12875 requires EPA to develop an regulatory policies on matters that Federal mandate that may result in effective process permitting elected significantly or uniquely affect their estimated annual costs of $100 million officials and other representatives of communities.’’ or more to either State, local, or tribal state, local, and tribal governments ‘‘to Today’s rule does not significantly or governments in the aggregate, or to the provide meaningful and timely input in uniquely affect the communities of private sector. This Federal action the development of regulatory proposals Indian tribal governments. Accordingly, approves pre-existing requirements containing significant unfunded the requirements of section 3(b) of E.O. under State or local law, and imposes mandates.’’ 13084 do not apply to this rule. no new requirements. Accordingly, no Today’s rule does not create a E. Regulatory Flexibility Act additional costs to State, local, or tribal mandate on state, local or tribal governments, or to the private sector, The Regulatory Flexibility Act (RFA) governments. The rule does not impose result from this action. any enforceable duties on these entities. generally requires an agency to conduct Accordingly, the requirements of a regulatory flexibility analysis of any List of Subjects in 40 CFR Part 52 section 1(a) of E.O. 12875 do not apply rule subject to notice and comment to this rule. rulemaking requirements unless the Environmental protection, Air agency certifies that the rule will not pollution control, Hydrocarbons, C. Executive Order 13045 have a significant economic impact on Incorporation by reference, Protection of Children from a substantial number of small entities. Intergovernmental relations, Ozone, Environmental Health Risks and Safety Small entities include small businesses, Reporting and recordkeeping Risks (62 FR 19885, April 23, 1997), small not-for-profit enterprises, and requirements, Volatile organic applies to any rule that: (1) is small governmental jurisdictions. This compounds. determined to be ‘‘economically final rule will not have a significant Authority: 42 U.S.C. 7401 et seq. significant’’ as defined under E.O. impact on a substantial number of small Dated: March 4, 1999. 12866, and (2) concerns an entities because SIP approvals under environmental health or safety risk that section 110 and subchapter I, Part D of Laura Yoshii, EPA has reason to believe may have a the Clean Air Act do not create any new Deputy Regional Administrator, Region IX. disproportionate effect on children. If requirements but simply approve [FR Doc. 99–6506 Filed 3–16–99; 8:45 am] the regulatory action meets both criteria, requirements that the State is already BILLING CODE 6560±50±P

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ENVIRONMENTAL PROTECTION source emissions, will provide for does not plan to institute a second AGENCY continued attainment in Lake and comment period on this action. Any Jefferson Counties. Finally, USEPA is parties interested in commenting on this 40 CFR Parts 52 and 81 approving two redesignation requests action should do so at this time. from the State of Ohio. This action, [OH 121±1b; FRL±6239±4] DATES: Written comments must be which was requested on October 26, received on or before April 16, 1999. Approval and Promulgation of 1995, and also on August 20, 1998, redesignates Lake and Jefferson ADDRESSES: Written comments may be Implementations; Ohio Designation of mailed to J. Elmer Bortzer, Chief, Areas for Air Quality Planning Counties to attainment of National Ambient Air Quality Standard (NAAQS) Regulation Development Section, Air Purposes; Ohio Programs Branch (AR–18J), Region 5 at for SO2. AGENCY: Environmental Protection In the final rules section of this the address listed below. Agency (EPA). Federal Register, the EPA is approving Copies of the materials submitted by the Ohio Environmental Protection ACTION: Proposed rule. the State’s request as a direct final rule without prior proposal because EPA Agency may be examined during normal SUMMARY: EPA is approving the SIP views this action as noncontroversial business hours at the following location: revision request submitted by the State and anticipates no adverse comments. A Regulation Development Section, Air of Ohio on August 20, 1998, which detailed rationale for approving the Programs Branch (AR–18J), U.S. replaces the federally promulgated State’s request is set forth in the direct Environmental Protection Agency, 77 limits by state promulgated limits for final rule. The direct final rule will West Jackson Boulevard, Chicago, the relevant portion of Lake County. The become effective without further notice Illinois, 60604. revision affects rule OAC 3745–18– unless EPA receives relevant adverse FOR FURTHER INFORMATION CONTACT: 49(G) (containing emission limits written comment. Should EPA receive Phuong Nguyen at (312) 886–6701. applicable to the First Energy, EastLake such comment, it will publish a timely SUPPLEMENTARY INFORMATION: For plant) and rule OAC 3745–18–49 (H) withdrawal informing the public that additional information see the direct (containing the emission limitations the direct final rule will not take effect final rule published in the rules section applicable to the Ohio Rubber Company and such public comment received will of this Federal Register. plant in Lake County). In addition, EPA be addressed in a subsequent final rule Dated: February 26, 1999. also approves the sulfur dioxide (SO2) based on the proposed rule. If no maintenance plan for Lake and Jefferson adverse written comments are received, Jo Lynn Traub, Counties. This plan ensures that the the direct final rule will take effect on Acting Regional Administrator, Region 5. reductions in minor source emissions, the date stated in that document, and no [FR Doc. 99–6257 Filed 3–16–99; 8:45 am] in combination with the limits on major further action will be taken. USEPA BILLING CODE 6560±50±P

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Notices Federal Register Vol. 64, No. 51

Wednesday, March 17, 1999

This section of the FEDERAL REGISTER product and adequate returns to The information collected is used contains documents other than rules or producers. Under the Agricultural only by authorized representatives of proposed rules that are applicable to the Marketing Agreement Act of 1937 the USDA, including AMS, Fruit and public. Notices of hearings and investigations, (AMAA), as amended (7 U.S.C. 601– Vegetable Programs’ regional and committee meetings, agency decisions and 674), marketing order programs are rulings, delegations of authority, filing of headquarter’s staff, and authorized petitions and applications and agency established if favored in referendum employees of the Board. Authorized statements of organization and functions are among producers. The handling of the Board employees and the industry are examples of documents appearing in this commodity is regulated. The Secretary the primary users of the information and section. of Agriculture is authorized to oversee AMS is the secondary user. the order’s operations and issue regulations recommended by a Estimate of Burden: Public reporting DEPARTMENT OF AGRICULTURE committee of representatives from each burden for this collection of information commodity industry. The Almond is estimated to average 0.40 hours per Agricultural Marketing Service Board of California (Board) is response. [Docket No. FV99±981±2 NC] responsible for locally administering the Respondents: California almond program. growers, handlers and accepted users of Notice of Request for Extension and The information collection inedible almonds. Revision of a Currently Approved requirements in this request are Estimated Number of Respondents: Information Collection essential to carry out the intent of the 7,658. AMAA, to provide the respondents the AGENCY: Agricultural Marketing Service, type of service they request, and to Estimated Number of Responses per USDA. administer the California almond Respondent: .86. ACTION: Notice and request for marketing order program, which has Estimated Total Annual Burden on comments. been operating since 1950. Respondents: 2,638 hours. The California almond marketing SUMMARY: In accordance with the order authorizes the issuance of quality Comments are invited on: (1) Whether Paperwork Reduction Act of 1995 (44 and volume control regulations, as well the proposed collection of information U.S.C. Chapter 35), this notice as inspection requirements. Regulatory is necessary for the proper performance announces the Agricultural Marketing provisions apply to almonds shipped of the functions of the agency, including Service’s (AMS) intention to request an within and outside of the production whether the information will have extension for and revision to a currently area, except those specifically exempt. practical utility; (2) the accuracy of the approved information collection for The order also has authority for agency’s estimate of the burden of the Almonds Grown in California, production and marketing research and proposed collection of information, Marketing Order 981. development projects, including paid including the validity of the DATES: Comments on this notice must be advertising. Handlers who advertise methodology and assumptions used; (3) received by May 17, 1999. may receive credit for their advertising ways to enhance the quality, utility, and FOR FURTHER INFORMATION CONTACT: expenses according to specific clarity of the information to be Contact Tershirra T. Yeager, Program guidelines. collected; and (4) ways to minimize the Assistant, Marketing Order The order, and rules and regulations burden of the collection of information Administration Branch, Fruit and issued thereunder, require handlers and on those who are to respond, including Vegetable Programs, AMS, USDA, room growers to submit certain information. through the use of appropriate 2525-S., P.O. Box 96456, Washington, Much of this information is compiled by automated, electronic, mechanical, or DC 20090–6456; Tel: (202) 720–2491, the Board in aggregate and provided to other technological collection Fax: (202) 720–5698, or E-mail: the industry to assist in marketing techniques or other forms of information [email protected]. decisions. technology. SUPPLEMENTARY INFORMATION: The Board has developed forms as a Title: Almonds Grown in California, means for persons to file required Comments should reference OMB No. Marketing Order 981. information with the Board relating to 0581–0071 and the California Almond OMB Number: 0581–0071. almond supplies, shipments, Marketing Order No. 981, and be mailed Expiration Date of Approval: August dispositions, and other information to Docket Clerk, Fruit and Vegetable 31, 1999. needed to effectively carry out the Programs, AMS, USDA, P.O. Box 96456, Type of Request: Extension and purpose of the AMAA and order. As Room 2525-S, Washington, DC, 20090– revision of a currently approved shipments of California almonds are 6456; Fax: (202) 720-5698; or E-mail: information collection. normally year-round, these forms are [email protected]. All Abstract: Marketing order programs utilized accordingly. A USDA form is comments received will be available for provide an opportunity for producers of used to allow growers to vote on public inspection during regular fresh fruits, vegetables and specialty amendments or continuance of the business hours at the same address. crops, in a specified production area, to marketing order. In addition, almond All responses to this notice will be work together to solve marketing growers and handlers who are summarized and included in the request problems that cannot be solved nominated by their peers to serve as for OMB approval. All comments will individually. Order regulations help representatives on the Board must file also become a matter of public record. ensure adequate supplies of high quality nomination forms with the Secretary.

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Dated: March 11, 1999. made to the Tariff Act of 1930 (the Act) original documentation containing Robert C. Keeney, by the Uruguay Round Agreements Act relevant information. Our verification Deputy Administrator, Fruit and Vegetable (URAA). In addition, unless otherwise results are outlined in public versions of Programs. indicated, all citations to the the verification reports, dated August [FR Doc. 99–6489 Filed 3–16–99; 8:45 am] Department of Commerce’s (the 21, 1998, and located in the public file BILLING CODE 3410±22±P Department’s) regulations are to the in Room B–099 of the Department’s regulations at 19 CFR part 351 (1998). main building. Background Final Results of Review DEPARTMENT OF COMMERCE On September 10, 1998, the We determine that the following International Trade Administration Department published in the Federal weighted-average margin exists for the Register the preliminary results of its period August 1, 1996, through July 31, [A±201±802] administrative review of the 1997: antidumping duty order on gray Gray Portland Cement and Clinker portland cement and clinker from Company Margin From Mexico; Final Results of Mexico. Preliminary Results of Antidumping Duty Administrative Antidumping Duty Administrative CEMEX/CDC ...... 49.58% Review Review: Gray Portland Cement and The Department shall determine, and AGENCY: Import Administration, Clinker From Mexico, 63 FR 48471 (1998) (preliminary results). The the Customs Service shall assess, International Trade Administration, antidumping duties on all appropriate Department of Commerce. Southern Tier Cement Committee (the petitioner) submitted its case brief on entries. The Department shall issue ACTION: Notice of final results of October 13, 1998; CEMEX and CDC appraisement instructions directly to antidumping duty administrative submitted case briefs on October 30, the Customs Service. For assessment review. 1998. CDC re-submitted its case brief on purposes, we have calculated an importer-specific duty assessment rate SUMMARY: On September 10, 1998, the December 2, 1998. The petitioner, Department of Commerce published the CEMEX, and CDC submitted their for the merchandise based on the ratio preliminary results of its administrative rebuttal briefs on November 3, 1998. of the total amount of antidumping review of the antidumping duty order The Department held a public hearing duties calculated for the examined sales on gray portland cement and clinker on November 20, 1998. All issues raised to the total entered value of sales from Mexico. The review covers one in the case and rebuttal briefs by parties examined. Furthermore, the following deposit manufacturer/exporter, CEMEX, S.A. de to this administrative review are requirements shall be effective upon C.V. (CEMEX), and an affiliated party, addressed in the ‘‘Issues Appendix,’’ publication of this notice of final results Cementos de Chihuahua, S.A. de C.V. which is appended to this notice of final of review for all shipments of gray (CDC), and the period August 1, 1996, results. The Department has now portland cement and clinker from through July 31, 1997. We gave completed this review in accordance Mexico, entered, or withdrawn from interested parties an opportunity to with section 751(a) of the Act. warehouse, for consumption on or after comment on the preliminary results. Scope of the Review the publication date, as provided for by Based on our analysis of the comments section 751(a)(1) of the Act: (1) The cash received, we have made changes, The products covered by this review deposit rate for CEMEX/CDC will be including corrections of certain include gray portland cement and 49.58 percent; (2) for previously inadvertent programming and clerical clinker. Gray portland cement is a investigated or reviewed companies not errors, in the margin calculation. These hydraulic cement and the primary listed above, the cash deposit rate will corrections and adjustments to margin component of concrete. Clinker, an continue to be the company-specific rate calculation program are described in the intermediate material product produced published for the most recent period; (3) sections entitled ‘‘6. Difference-in- when manufacturing cement, has no use if the exporter is not a firm covered in Merchandise Information’’ and ‘‘18. other than being ground into finished this or any previous reviews or the Ministerial Errors,’’ of the Issues cement. Gray portland cement is original less-than-fair-value (LTFV) Appendix. The final weighted-average currently classifiable under the investigation, but the manufacturer is, dumping margin for CEMEX and CDC is Harmonized Tariff Schedule (HTS) item the cash deposit rate will be the rate 49.58 percent ad valorem. number 2523.29 and cement clinker is currently classifiable under HTS item established for the most recent period EFFECTIVE DATE: March 17, 1999. number 2523.10. Gray portland cement for the manufacturer of the FOR FURTHER INFORMATION CONTACT: has also been entered under HTS item merchandise; and (4) if neither the Diane Krawczun, Anne Copper, or number 2523.90 as ‘‘other hydraulic exporter nor the manufacturer is a firm George Callen; Import Administration, cements.’’ The HTS subheadings are covered in this review, the cash deposit International Trade Administration, provided for convenience and customs rate will continue to be 61.85 percent, U.S. Department of Commerce, 14th purposes only. The Department’s which was the ‘‘all others’’ rate in the Street and Constitution Avenue, NW., written description remains dispositive LTFV investigation. See Final Washington, DC. 20230; telephone (202) as to the scope of the product coverage. Determination of Sales at Less Than 482–0198, (202) 482–0090, and (202) Fair Value: Gray Portland Cement and 482–0180, respectively. Verification Clinker from Mexico, 55 FR 29244 SUPPLEMENTARY INFORMATION: Pursuant to section 782(i) of the Act, (1990). we verified information provided by The deposit requirements shall Applicable Statute and Regulations CEMEX using standard verification remain in effect until publication of the Unless otherwise indicated, all procedures, including on-site inspection final results of the next administrative citations to the statute are references to of the manufacturer’s facilities and the review. the provisions effective January 1, 1995, examination of relevant sales and This notice serves as a final reminder the effective date of the amendments financial records, and selection of to importers of their responsibility

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13149 under 19 CFR 351.402(f) to file a antidumping petition filed ‘‘on behalf petitioner also notes that both parties certificate regarding the reimbursement of’’ an industry must be supported by an challenged the initiation of the LTFV of antidumping duties prior to appropriate majority of the industry and investigation before a North American liquidation of the relevant entries that such support must be ascertained Free Trade Agreement (NAFTA) panel during this review period. Failure to prior to initiating an investigation. to review the final results of the third comply with this requirement could According to CEMEX, the panel’s administrative review. In a unanimous result in the Secretary’s presumption decision applies to the instant opinion issued on September 13, 1996, that reimbursement of antidumping administrative review for two reasons: according to the petitioner, the panel duties occurred and the subsequent (1) The Antidumping Agreement rejected the claims that CEMEX and assessment of double antidumping resulting from the Uruguay Round CDC advance here. duties. negotiations adopted the requirement of The petitioner also contends that This notice also serves as a reminder industry support articulated by the respondents’ claim is barred by the to parties subject to administrative GATT panel. CEMEX asserts U.S. law statute of limitations, requiring that protective order (APO) of their incorporated the new standing appeals to the decision to initiate an responsibility concerning the requirements contained in the investigation be filed within 30 days of disposition of proprietary information Antidumping Agreement, citing section the publication of the antidumping disclosed under APO in accordance 732(c)(4)(C) of the Act. order. The petitioner also contends that with 19 CFR 351.305. Timely (2) Even if the pre-URAA respondents did not raise the issue in notification of return/destruction of antidumping law applies, the the now-concluded U.S. Court of APO materials or conversion to judicial antidumping statute that was in effect in International Trade (CIT) appeal from protective order is hereby requested. 1989 did not define the term ‘‘on behalf the Department’s final determination in Failure to comply with the regulations of.’’ CEMEX argues that the Department the original investigation. Furthermore, and the terms of an APO is a is compelled by the decision in Murray the petitioner cites the Department’s sanctionable violation. v. Schooner Charming Betsy, 6 U.S. 64, sixth review final results (Gray Portland We are issuing and publishing this 2 Cranch 64 (1804), to reinterpret U.S. Cement and Clinker From Mexico, 63 determination in accordance with law in accordance with the international FR 12764 (March 16, 1998) (Sixth sections 751(a)(1) and 777(i)(1) of the obligations of the United States. Review Final Results)), in which the Based on the above, CEMEX asserts Act. Department noted that panel reports that the Department is therefore under the 1947 GATT were not self- Dated: March 9, 1999. required in this review to revisit the executing and had no legal effect under Robert S. LaRussa, issue of initiation in the original LTFV U.S. law and that neither the 1947 Assistant Secretary for Import investigation. GATT nor the 1979 GATT Antidumping Administration. According to CDC, the plain language Code obligated the United States to Issues Appendix Contents of section 771(4)(C) of the Act requires establish industry support in regional- petitions in regional-industry cases to be 1. Revocation of the Underlying Order industry cases. filed on behalf of the producers which The petitioner contends that the 2. Collapsing account for ‘‘all, or almost all, of the 3. Facts Available/CEMEX’s Hidalgo Sales Department lacks authority under the 4. As Invoiced vs. As Produced production in the region.’’ Since the statute to rescind its decision to initiate 5. Ordinary Course of Trade antidumping order covering cement or to re-examine the issue of industry 6. Difference-in-Merchandise Information from Mexico was based on a petition support in a review. Finally, citing 7. Level-of-Trade Determination for CEP that was unsupported by producers Suramerica de Aleaciones Laminada, Sales accounting for all or almost all of the C.A. v. United States, 966 F. 2d 660 8. CEP Offset Justification region’s production, CDC asserts, the (Fed. Cir. 1992) (Suramerica), and the 9. CEP Calculation Department issued the order in violation Sixth Review Final Results, the 10. Regional Assessment of U.S. law. petitioner asserts that courts have 11. Bulk vs. Bag Sales CDC argues that lack of standing to 12. Rebates affirmed the Department’s presumption 13. Freight file an antidumping duty petition is a of industry support. 14. Other Adjustments ‘‘jurisdictional’’ defect which parties Department’s Position: We agree with 15. Pre-sale Warehousing may raise at any time. Citing Zenith the petitioner that, as we stated in our 16. Advertising Expenses Electronics Corp. v. United States, 872 Sixth Review Final Results, the 17. Ministerial Errors F. Supp. 992 (CIT 1994) (Zenith Department has no obligation to Electronics), Gilmore Steel Corp. v. 1. Revocation of the Underlying Order determine whether a majority of the United States, 585 F. Supp. 670 (CIT industry or the region supported the CEMEX and CDC argue that the 1984) (Gilmore Steel), and Oregon Steel petition. Department must terminate this review Mills, Inc. v. United States, 862 F.2d Neither the 1947 GATT nor the 1979 and revoke the underlying antidumping 1541 (Fed. Cir. 1988) (Oregon Steel GATT Antidumping Code obligated the duty order. CEMEX contends that at the Mills), CDC contends that the United States to establish affirmatively time of the initiation of the original Department has the authority to revoke prior to the initiation of a regional- LTFV investigation (October 16, 1989), an order that never had the requisite industry case that all or almost all of the the Department assumed that the level of industry support. producers in the region supported the petition was filed ‘‘on behalf of’’ a The petitioner argues that the petition. Neither instrument suggested regional industry without measuring Department initiated the original that the standing requirements in whether a majority of the industry antidumping investigation properly. regional-industry cases were any more actually supported the request. The The petitioner notes that CEMEX and rigorous than the standing requirements Department should have done so, CDC raised the issue of whether the in national-industry cases. CEMEX argues, because a July 1992 Department initiated the investigation Furthermore, GATT panel reports, General Agreement on Tariffs and Trade improperly in the third, fourth, fifth, such as the report issued in 1992, had (GATT) panel decided that the 1979 and sixth reviews and were no legal effect or formal status unless antidumping code required that an unsuccessful without exception. The and until they were adopted by the

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GATT Council or, in the case of Department lacked the authority to In Suramerica the plaintiffs challenged antidumping measures, the GATT rescind the investigation based upon the Department’s interpretation of the Antidumping Code Committee. This insufficient industry support for the phrase ‘‘on behalf of’’ which applied to followed from the fact that the 1947 petition after the 20-day period both national- and regional-industry GATT operated, throughout its history, established in section 732(c) of the Act cases. In affirming the Department’s on the basis of consensus for purposes had elapsed. 585 F. Supp. at 673. In practice, the court observed that the of decision-making in general and the Zenith Electronics, the plaintiff alleged phrase ‘‘on behalf of’’ was not defined resolution of disputes in particular. It is that the petitioner was no longer a in the statute. Id. at 666–67. The statute undisputed in the present case that the domestic ‘‘interested party’’ with was, in fact, open ‘‘to several possible Antidumping Code Committee never standing to request an administrative interpretations.’’ In the opinion of the adopted the GATT panel report. Thus, review. 872 F. Supp. at 994. Nothing in court, the Department’s practice with the recommendations contained in the Zenith Electronics or Gilmore Steel regard to standing and industry support report were never binding, did not supports CDC’s argument that a party for a petition reflected a reasonable impose any international obligations may challenge industry support for a ‘‘middle position.’’ 966 F.2d at 667. upon the United States, and did not petition almost ten years after the fact in While there was a gap in the statute, the trigger the rule of statutory construction the context of an administrative review court stated, ‘‘Congress did make (one set forth in Murray v. Schooner under section 751(a) of the Act. thing) clear—Commerce has broad Charming Betsy. Oregon Steel Mills involved a discretion in deciding when to pursue The object of respondents’ comments challenge to the Department’s authority an investigation, and when to terminate is not the preliminary results of this to revoke an antidumping duty order one.’’ Id. Therefore, we reject review. Rather, respondents challenge based upon new facts, i.e., the industry’s respondents’ arguments that we lack the the initiation of the original LTFV affirmative expression of no further authority to assess antidumping duties investigation—an event which occurred support for the antidumping order, not pursuant to these final results of review almost ten years ago and over five years upon a reexamination of the facts as and that we must revoke the underlying before the effective date of the URAA. they existed during the original LTFV duty order. The time to voice such objections before investigation. The Federal Circuit held the Department was during the that it was lawful for the Department, in 2. Collapsing investigation. Instead, CEMEX and CDC, the context of a ‘‘changed CDC argues that the Department’s as well as the other Mexican cement circumstances’’ review pursuant to decision to collapse CDC and CEMEX is producer that participated in the section 751(b) of the Act, to revoke an contrary to law and the Department’s original investigation (Apasco, S.A. de order over the objection of one member established practice, and it is C.V.), did not raise this argument before of the industry. 862 F.2d at 1544–46. unsupported by the record of this the Department. See Final The court did not state that industry review. CDC cites Antifriction Bearings Determination of Sales at Less Than support for an order must be (Other Than Tapered Rolling Bearings) Fair Value; Gray Portland Cement and affirmatively established throughout the and Parts Thereof From the Federal Clinker From Mexico, 55 FR 29244 life of an order. Indeed, the court went Republic of Germany, Final (1990) (Original LTFV Investigation). to lengths to explain that it was not Determination of Sales at Less Than Moreover, neither CEMEX nor any other ruling on the claim that ‘‘loss of Fair Value, 54 FR 18992, 19089 (1989), party appealed the agency’s final industry support for an existing order in which the Department stated that ‘‘it affirmative LTFV determination creates a ‘jurisdictional defect.’ ’’ Id. at is the Department’s general practice not (including the decision to initiate) to the 1545 n. 4. As courts explained to collapse related parties except in appropriate court, and the deadline for subsequently, the holding in Oregon relatively unusual situations, where the doing so has long expired. See section Steel Mills is limited to the proposition type and degree of relationship is so 516A of the Act. Therefore, even if the that the Department may, but need not, significant that we find that there is Department, of its own volition, were to revoke an order when presented with strong possibility of price reinterpret U.S. law in light of the 1992 record evidence which demonstrates a manipulation.’’ GATT panel report, it lacks the legal lack of industry support for the authority in this review to revoke the continuation of the order. See, e.g., CDC asserts that the preamble to the order or otherwise rescind the initiation Suramerica at 666 and Citrosuco Department’s 1997 regulations supports of the underlying investigation. See also Paulista, S.A. v. United States, 704 F. this policy by rejecting a Gray Portland Cement and Clinker from Supp. 1075, 1085 (CIT 1988) recommendation that the Department Mexico; Final Results of Antidumping (Citrosuco). collapse upon finding ‘‘any potential for Duty Administrative Review, 62 FR Finally, we note, as we did in the price manipulation.’’ CDC notes further 17581 (1997) (Fourth Review Final final results of the third, fourth, fifth, that, in Nihon Cement Co. v. United Results); Gray Portland Cement and and sixth administrative reviews, that States, 17 CIT 400 (1993), the court Clinker from Mexico; Final Results of numerous courts upheld our practice criticized the Department for failing to Antidumping Duty Administrative under the pre-URAA statute of discuss key collapsing criteria, adding Review, 62 FR 17148 (1997) (Fifth assuming, in the absence of evidence to that the Department had to consider all Review Final Results); Sixth Review the contrary, that a petition filed on the criteria, although each of them need Final Results. behalf of a regional or national industry not be met. The cases cited by CEMEX and CDC is supported by that industry. See, e.g., CDC contends that the Department are inapposite. None of them supports NTN Bearing Corp. v. United States, 757 based its decision to collapse on an the argument that the Department has F. Supp. 1425, 1427–30 (CIT 1991), inadequate analysis of the collapsing the authority, in an administrative Citrosuco at 1085, and Comeau factors (i.e., affiliation, similar review under section 751(a) of the Act, Seafoods v. United States, 724 F. Supp. production facilities and the potential to reach back almost ten years and 1407, 1410–12 (CIT 1989). Indeed, this for price manipulation) and a lack of reexamine the issue of industry support issue raised by CEMEX and CDC was record evidence. CDC asserts that, for the original petition. In Gilmore before the Federal Circuit in the although it is affiliated with CEMEX, Steel, the plaintiff contended that the Suramerica case (966 F.2d at 665, 667). affiliation alone is insufficient for

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CDC claims process and U.S. importer, and the scheme to manipulate production or that the cement CEMEX and CDC export companies do not supply any material price. to the United States are not the same inputs to each other. Furthermore, the petitioner asserts type product and that CDC would have CDC distinguishes the facts in this that the following facts demonstrate that to take on substantial retooling at its case from those in Queen’s Flowers de CEMEX and CDC have intertwined plant in order to produce the cement Colombia v. United States, 981 F. Supp business operations: (1) CEMEX and type that CEMEX exports to the United 617 (CIT 1997) (Queen’s Flowers). CDC CDC formerly shipped to the United States. asserts that, unlike the Queen’s Flowers States through the same distribution CDC also contends that the decision, collapsing is not needed to channel; (2) CEMEX provides CDC with Department erroneously determined prevent circumvention of the consulting services and assistance in that there was a significant potential for antidumping law by means of marketing and exports; and (3) a 1996 price manipulation. According to CDC, significant manipulation of pricing or financial report stated that CDC’s the Department relied on evidence of production. CDC asserts that in the affiliation with CEMEX positively the level of common ownership and cement industry high inland freight influenced CDC’s stock. overlapping boards of directors, but not costs limit CDC’s natural market; Finally, the petitioner claims that the on intertwined business operations. therefore, regardless of the antidumping Department has expressly rejected the Regarding common ownership, CDC margin, CDC cannot increase its market argument that it may only collapse notes that CEMEX is only a minority beyond these geographic constraints. affiliated producers in ‘‘exceptional’’ shareholder in CAMSA (CDC’s parent Finally, CDC argues that CEMEX, as an circumstances. The petitioner cites the company) and the majority of shares are indirect minority shareholder, cannot Department’s determination in Stainless still retained by CDC. CDC asserts that authorize CDC to change its pricing and Steel Wire Rod from Sweden, 63 FR its sale of stock to CEMEX was purely production policies. 40449, 40453 (1998). The petitioner a business decision and CEMEX’s share The petitioner argues that the disagrees with CDC’s assertion that does not constitute a controlling interest Department should collapse CDC and circumvention as described by the under Mexican law. CEMEX as it has in previous reviews Department in Fresh Cut Flowers from Regarding overlapping boards of and in the LTFV investigation. The Columbia is not practicable because of directors, CDC acknowledges that petitioner asserts that CDC has provided the special characteristics of the cement members of CEMEX’s management sit no new evidence which would reverse industry and ‘‘the unique geographical on the boards of directors of CDC and the Department’s position. features of CDC’s market.’’ According to its affiliated companies. However, CDC The petitioner states that CDC the petitioner, the record evidence asserts, (1) CEMEX’s representatives are concedes that the first prong of the demonstrates that there is a natural in the minority on all of these boards; collapsing test (i.e., affiliation) is met. overlap in the U.S. market for imports (2) CDC’s pricing and production are not Regarding similar production facilities, from CDC and CEMEX. The petitioner discussed at the board meetings of CDC the petitioner asserts that the states that the two producers can or any of the group’s companies; (3) the Department found that substantial reallocate their geographic shares of the Terrazas/Marquez families are in the retooling of CEMEX or CDC’s facilities Mexican market in a manner that majority on all boards; and (4) CEMEX’s would not be necessary to produce manipulates the dumping margin and interest in CDC is only that of a passive cement Types II and V. The petitioner circumvents the order. investor. argues that CDC’s claim that CDC and Department’s Position: We agree with As mentioned above, CDC argues that CEMEX do not produce the same CDC that we must consider all relevant the Department did not address the product for export to the United States factors when collapsing two affiliated criteria of intertwined business was rejected by the Department as parties. Section 351.401(f) of the operations. CDC asserts that the factual untimely. However, even if the Department’s regulations describes basis upon which the Department relied Department considers CDC’s assertions, when the Department will treat two or in finding that this criterion was the petitioner argues, there is no more affiliated producers as a single satisfied in prior reviews does not exist evidence to support CDC’s claims. entity (i.e., ‘‘collapse’’) for purposes of in this review. CDC claims that: (1) The The petitioner agrees with the calculating a dumping margin: (1) The companies do not share information on Department’s determination that there is producers must be affiliated, (2) the possible sales opportunities in Mexico a potential for price manipulation. The producers must have production or the United States and there is no petitioner asserts that the level of facilities that are sufficiently similar so coordination of sales, pricing or common ownership between CEMEX that a shift in production would not marketing policies; (2) CEMEX has no and CDC and other relationships require substantial retooling, and (3) involvement in CDC’s pricing, sales and demonstrates that CEMEX has effective there must be a significant potential for production decisions; (3) CDC states control of CDC. The petitioner argues the manipulation of price or production. that CDC and CEMEX do not share that the Department has collapsed in First, it is uncontested that CEMEX facilities or employees and that each numerous cases where there is less than and CDC are affiliated within the company has its own facilities, a majority interest in another party, meaning of section 771(33)(E) of the employees, and accounting records; and focusing on joint manipulation of prices Act. (4) there were no commercial or production, not control. Second, a shifting of production transactions between the parties during Next, the petitioner claims that the between CEMEX and CDC would not the POR. level of shared board members indicates require substantial retooling given the CDC states that, in past cases, the a significant potential for the sharing of descriptions of respondents’ production Department has relied on other factors information about pricing and facilities and the fact that respondents in determining whether to collapse production. Despite CDC’s argument produce a fungible product, gray

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(See warrant the application of total adverse verifications but before the home market Memorandum to File Removing facts available in this review. The (HM) verifications were to begin, Untimely Information Submitted by petitioner also argues that the CEMEX discovered a discrepancy in its CDC, dated November 30, 1998.) Thus, Department should describe more fully, database regarding its Hidalgo sales based on the evidence on the record we for the final results of this review, the which amounted to less than one have concluded that a shift in circumstances surrounding the use of percent of CEMEX’s total HM sales. production would not require adverse facts available with regard to CEMEX argues that, to correct its substantial retooling. CEMEX’s Hidalgo sales in the submissions and reschedule Third, the Department may consider, preliminary results of this review. verification, it requested an extension of inter alia, the following factors in The petitioner asserts that, prior to time in accordance with the identifying the potential for May 15, 1998, CEMEX had represented Department’s statutory scheme. CEMEX manipulation of price or production: (1) to the Department that its Hidalgo plant notes that the Department verified Level of common ownership; (2) produced only Type I cement and not CEMEX’s U.S. and HM database and whether managerial employees or board Type V cement. The petitioner argues issued the preliminary results within its members of one of the affiliated that CEMEX, on May 15, 1998, canceled statutory deadlines. CEMEX concludes producers sit on the board of directors verification unilaterally, which was that the Department’s decision was in of the other affiliated person; and (3) scheduled to begin on May 18, 1998, accordance with the statutory whether operations are intertwined, because it became obvious that the requirement that determinations be such as through the sharing of sales Department would discover at based upon record information as information, involvement in production verification that CEMEX’s Hidalgo plant verified by the Department set forth in and pricing decisions, the sharing of produced and sold cement meeting section 782(i)(3) of the Act. facilities or employees, or significant Type V specifications. The petitioner CDC asserts that the petitioner’s transactions between the affiliated argues that CEMEX, a highly argument that the Department should producer. The level of common experienced respondent, could have apply total facts available to CEMEX ownership and cross-board members, discovered the Hidalgo sales reinforces CDC’s argument that it should provides a mechanism for the two information readily prior to verification, not be collapsed with CEMEX. Rather, parties to share pertinent pricing and should have provided the Department according to CDC, it should receive a production information, as well as with corrected sales information prior to separate rate as discussed in Issue 2, intertwined business operations, given May 15, 1998, and should have ‘‘Collapsing,’’ above. CDC maintains that CEMEX owns indirectly a large proceeded with the verification on the that a decision by the Department to percentage of CDC and that CEMEX’s scheduled date. The petitioner rely on facts available, to any extent, for managers and directors sit on the board maintains that CEMEX provided CDC’s indirect minority shareholder of directors of CDC and its affiliated inadequate and untimely explanations punishes CDC unfairly. companies. The Department finds that, for its cancellation of verification that Department’s Position: Section 776(a) if CDC and CEMEX are not collapsed, could only be seen as an effort to engage of the Act requires the Department to there is a significant potential for price in damage control, which illustrates use facts otherwise available when manipulation which could undermine CEMEX’s failure to provide full and necessary information is not on the the effectiveness of the order. The accurate information. The petitioner record or an interested party withholds decision to collapse is based upon the contends that CEMEX’s delay tainted requested information, fails to provide facts established on the record for this the integrity of the Department’s such information in a timely manner, period of review. These facts are similar verification conducted July 20 through significantly impedes a proceeding, or to the facts established on the record of 31, 1998. provides information that cannot be the fifth and sixth reviews. A complete The petitioner asserts that the verified. Section 776(b) of the Act analysis surrounding the Department’s Department has used adverse facts authorizes the Department to use an decision to collapse CDC and CEMEX, available or best information available adverse inference in determining the requiring reference to proprietary consistently in cases where a facts otherwise available whenever an information, is contained in the respondent refused to allow the interested party has not cooperated with Department’s memorandum from Department to conduct verification, as the Department by not acting to the best Roland L. MacDonald to Joseph A. in Tapered Roller Bearings And Parts of its ability to comply with requests for Spetrini, dated August 31, 1998, located Thereof, Finished And Unfinished, information. in the official file of this case. From The People’s Republic of China, First, with respect to its Hidalgo sales, 62 FR 36,764 (1997), Silicon Metal From CEMEX provided inaccurate 3. Facts Available/CEMEX’s Hidalgo Argentina, 60 FR 35551 (1995), and information and sought to submit Sales Sweaters Wholly Or In Chief Weight of corrected information after the deadline Comment 1: The petitioner argues that Man-Made Fiber From Taiwan, 58 FR for the submission of factual the Department should base CEMEX’s 63913 (1993). The petitioner also information had passed. Because dumping margin on total adverse facts contends that the Department erred in CEMEX provided information regarding available, i.e., the 109.43 percent using partial adverse facts available as it its Hidalgo sales in an untimely manner, calculated on judicial remand in the was not sufficiently adverse to CEMEX, we were unable to verify this second review, for this review given CEMEX’s failure to cooperate with information. Therefore, pursuant to completely. The petitioner contends the Department. section 776(d) of the Act, we have used that CEMEX’s reporting of incorrect CEMEX responds that the facts available to establish the normal information regarding its Hidalgo sales, Department’s use of CEMEX’s verified value (NV) of CEMEX’s Hidalgo sales in

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The to the best of its ability to provide the overall integrity of CEMEX’s home- petitioner asserts that CEMEX altered its accurate and timely information for use market data, noting that the Department production and shipping arrangements in our review and therefore our use of rejected and returned CEMEX’s revised for Type II cement to lower the dumping an adverse inference is appropriate Hidalgo sales data. margin artificially. under section 776(b) of the Act. Department’s Position: As noted in The petitioner contends that matching Therefore, as facts available, we the preliminary results, although all identical products by ASTM type ‘‘as substituted the highest calculated NV in data from the Hidalgo plant was invoiced’’ reflects commercial reality this review for all HM sales of cement reported as relating to sales or and allows for a fair comparison as produced at Hidalgo. production of only Type I cement, prior required by the statute. The petitioner We disagree with the petitioner that to the commencement of verification, asserts that the Department has noted we should have used total adverse facts CEMEX notified the Department that the that courts have recognized the available in determining a margin. In merchandise produced at its Hidalgo Department’s ‘‘broad discretion ‘to determining whether the use of total plant was either Type V or Type I. See choose the manner in which ‘‘such or adverse facts available was appropriate, CEMEX’s June 3, 1998, submission similar’ merchandise shall be we considered several factors. We explaining the discovery of misreported selected,’ ’’ citing Certain Cold-Rolled considered the degree of overall sales at Hidalgo. CEMEX filed a Carbon Steel Flat Products From cooperation we received from CEMEX at submission on June 16, 1998, revising Germany, 60 FR 65264, 65271 (1995) the time of our initially planned the home-market sales database for sales (Cold-Rolled From Germany). The verification and the small proportion of of Type V cement from Hidalgo. As this petitioner states further that cement HM sales affected by CEMEX’s error. We submission constituted unsolicited customers are only concerned that the determined that, despite the delay factual information received after the cement they purchase meets the ASTM caused by CEMEX’s cancellation, we deadline for submitting factual type they have specified and are were able to verify, with the exception information under § 351.302(d)(1)–(2) of indifferent to whether the type they of CEMEX’s Hidalgo sales data, our regulations, we rejected the purchase may satisfy the specifications CEMEX’s timely reported data and submission on June 25, 1998. (See of another cement type. Thus, the complete the administrative review Department’s Letter to CEMEX Rejecting petitioner maintains, prices of cement within the timelines prescribed by the Revised Database as Untimely Filed vary according to the invoiced type and statute and our regulations. Information, dated June 25, 1998.) not the actual physical specifications. In Accordingly, by using the highest While we recognize that addition, the petitioner argues, no calculated NV in this review for all sales § 351.301(c)(2) of our regulations cement meeting the same ASTM of cement produced by Hidalgo as authorizes us to request factual specifications is identical and cement adverse facts available, we have applied information at any time during the can possess a broad range of facts available in a manner that is proceeding, allowing a party to re- characteristics. The petitioner contends significantly adverse to CEMEX’s submit information already rejected as that to base matching criteria on interests. (See our response to Comment untimely would contravene the purpose physical characteristics, as CEMEX 2, below.) We consider this decision to of the established deadline for the propounds, results in a commercially be consistent with the Statement of submission of factual information. As a meaningless and an ‘‘apples-to-oranges’’ Administrative Action, Agreement on result, we did not request this comparison. Indeed, the petitioner Implementation of Article VI of the information pursuant to § 351.301(c)(2) asserts, CEMEX’s arguments in prior GATT (SAA) (at 870), and section 776 of our regulations. In addition, we reject segments of this proceeding establish of the Act. CEMEX’s assertion that we should that the differences in specifications of Comment 2: CEMEX contends that the accept its untimely filed Hidalgo cement CEMEX sells are commercially Department should use its corrected information because we verified the significant. sales database for the Hidalgo plant to overall integrity of its HM database. We The petitioner asserts that the calculate NV. The Department, CEMEX did not verify the accuracy of the Department should remain consistent claims, has the authority under Hidalgo information that CEMEX with its longstanding approach of § 351.301(c)(2) of the regulations to submitted improperly; rather we matching identical merchandise based accept and use this information which rejected it as described above. on whether the products meet the same the Department rejected as untimely Accordingly, CEMEX’s revised, rejected commercially significant characteristics, filed. CEMEX also contends that the HM database cannot be considered part citing, e.g., Certain Cut-To-Length Department’s two-week verification of the information we verified. Carbon Steel From Finland, 62 FR confirms the overall integrity of 18468, 18470 (1997) (Cut-To-Length CEMEX’s response, including data not 4. As Invoiced vs. As Produced From Finland). The petitioner argues verified. The petitioner contends that the that neither new facts nor legal The petitioner responds that the Department erred by matching justification exist for departing from the Department relied correctly upon merchandise in this review on the basis Department’s longstanding methodology adverse facts available for CEMEX’s of the ASTM cement type ‘‘as of matching cement ‘‘as invoiced’’ in the Hidalgo sales and that CEMEX provided produced’’ rather than matching, as it final results of this review. Citing Cut- no reason why the Department erred in had done in the original investigation To-Length From Finland, the petitioner using adverse facts available for its and in the first five administrative notes the Department’s finding that it Hidalgo sales. The petitioner notes that reviews, on an ‘‘as invoiced’’ basis. The would be inconsistent with its matching the Department’s regulations require the petitioner notes that the Department criteria to consider products sold to

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CEMEX noted, and the record at 18470. proceeding, we have seen that all reflects, that Yaqui and Campana are the CEMEX responds that the Department cement conforms generally to the only two CEMEX plants which, on a matched identical merchandise properly standards established by the ASTM. consistent basis, produce cement on the basis of the ASTM specification These standards tend to classify cement meeting the physical requirements of to which the cement was produced. according to all significant physical one type of cement and sell that cement CEMEX argues that matching characteristics, dimensional as another type of cement. merchandise according to how it was characteristics and/or performance As we stated in our preliminary sold does not meet the statutory properties. Also from the outset, results, under these circumstances, we requirement of section 771(16) of the interested parties and the Department believe it would be unreasonable to Act, which requires ‘‘foreign like have used ASTM standards to identify match merchandise on a ‘‘sold as’’ basis. product’’ to include only merchandise merchandise subject to this The appropriate product to which U.S. sold in the home market that is antidumping order and to establish sales should be matched is the HM physically identical with the how, and on what basis, the Department product that is physically identical to merchandise produced for sale to the should match sales of identical or the merchandise produced for U.S.- United States. CEMEX argues that, as similar merchandise. Specifically, the market sales. Therefore, we the Department recognized in the Sixth Department has sought, wherever appropriately calculated NV based on Review Final Results, the statute possible, to match sales of ASTM respondents’ sales of cement as compels the Department to base NV on standard Type II to Type II, ASTM produced. Further, such an approach its sales of cement that meet the standard Type V to Type V, and so would not address any sales that were customers’ specifications physically. forth. merely ‘‘gray portland cement’’ or CEMEX notes that the petitioner raises During the period covered by the ‘‘cement.’’ Finally, a ‘‘sold as’’ approach the same arguments and cites to the original investigation, the Department would lend itself to the type of product same cases already rejected by the discovered one or more instances where manipulation about which the Department in the sixth review and in Mexican producers sold cement meeting petitioner has so often expressed the preliminary results of this review. one ASTM standard on the basis of concern. Therefore, for purposes of the CEMEX contends that the prior cement meeting a lower (included) final results of this review, the determinations which the petitioner ASTM standard. However, in the final Department has continued to apply the cites do not support its argument determination, the Department matching methodology applied in the because they involved the identification described these sales as a mistake and sixth administrative review and the and order of matching characteristics, not ‘‘the ordinary practice in the preliminary results of this review. industry.’’ Original LTFV Investigation, The petitioner has expressed concern which are not at issue here. CEMEX 55 FR at 29248. Therefore, based on the that matching using physical notes that, in this case, no party fact that it was the normal industry characteristics will enable CEMEX to disputes that product characteristics of practice to produce and sell on the same manipulate HM sales to conform to cement are determined on the highest basis, the Department accepted that certain specifications, thereby limiting ASTM specifications that it meets. ‘‘matching by ASTM standard was the the Department’s ability to review sales Therefore, CEMEX concludes, the most reasonable basis for making of merchandise in the comparison Department’s identification of HM equitable identical merchandise markets properly. In order to address cement sales pursuant to the highest comparisons.’’ Id. at 29248. these concerns, the Department will ASTM specifications to which the Devising a methodology for matching continue to review and monitor closely cement is produced continues to be in sales is often a difficult task and the sales of both identical and similar accordance with law. courts have recognized that the merchandise in the home market to CDC, like CEMEX, argues that the Department has broad discretion ‘‘to ensure that, in subsequent reviews, an Department’s decision to match sales on choose the manner in which * ** accurate and reliable database of HM cement type ‘‘as produced’’ is justified merchandise shall be selected.’’ Koyo and U.S. sales are reported. For on the record of this review and that Seiko Co. v. United States, 66 F.3d 1204, example, we will continue to request this methodology should be applied 1209 (Fed. Cir. 1995). We have sought, that CEMEX report its HM sales on both consistently to CDC’s margin throughout the past reviews, and in the an ‘‘as sold’’ and ‘‘as produced’’ basis. calculations. present one, to (i) match based on This requirement will limit the Department’s Position: We agree, in physical characteristics, (ii) rely on possibility for manipulation and ensures part, with CEMEX. Section 771(16)(A) of ASTM standards to distinguish one type additional scrutiny of CEMEX’s the Act expresses a clear preference for of cement from another, and (iii) rely on production processes. matching sales in the United States with sales documentation as a convenient Finally, we agree with CDC that we sales in the home market of surrogate for more direct evidence (e.g., should apply our matching merchandise that is ‘‘identical in mill test certificates) of cement type. methodology consistently to its margin physical characteristics.’’ See CEMEX, In the instant review, the Department calculations and have adjusted our S.A. v. United States, 133 F.3d 897 (Fed. requested CEMEX to report HM and analysis accordingly. Cir. 1988) (CEMEX v. U.S.). When U.S. sales data on both an ‘‘as circumstances require the Department to produced’’ basis (i.e., reporting the 5. Ordinary Course of Trade compare non-identical merchandise, the physical properties of each product CEMEX argues that HM sales of statute, at section 773(a)(6)(C)(ii) of the sold) and on an ‘‘as sold’’ basis. CEMEX cement produced at Hermosillo were in Act, provides for a ‘‘difference-in- reported that it produced cement the ordinary course of trade and should merchandise’’ adjustment (DIFMER) meeting the physical characteristics of be used in the calculation of NV. which is normally equal to the Type V cement and sold this cement in CEMEX maintains that the Department difference in cost of production the home market as Types I, II, and V did not take into account all legally attributable to differences in physical cement. CEMEX produced Type V relevant factors, that sales invoiced as characteristics. See also 19 CFR cement at its Yaqui and Campana plants Type II and Type V were made pursuant 351.411. located in the Hermosillo region of to a bona fide home-market demand for

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13155 those types of cement, that the With regard to Type V cement, asserts that the Department must merchandise sold was not obsolete or of CEMEX also argues that the evaluate not just one factor taken in second quality, that it was sold for its Department’s preliminary results are isolation but rather all the intended purposes, and that there were factually incorrect because those results circumstances particular to the sales in no special sales arrangements for these failed to appreciate the prior history of question to determine whether the sales sales as a category. CEMEX also argues this case. Specifically, CEMEX states reflect the conditions and practices that the Department applied selected that, although the Department which, for a reasonable time prior to the factors in performing its ordinary- incorporated portions of the second exportation of the subject merchandise, course-of-trade analysis and that the review analysis memorandum into this have been normal. The petitioner notes Department’s analysis was not administrative review, the Department that the Department relied upon five key supported by substantial evidence. did not acknowledge that during the factors in determining that Types II and CEMEX contends that the Department’s second administrative review the V sales were outside the ordinary course analysis relies incorrectly on the volume Department verified that Tolteca, a of trade in the second review and that of the sales at issue relative to sales of CEMEX subsidiary whose production is the CIT and Federal Circuit affirmed Type I cement and that the volume of subject to this review, has made reliance on these five factors. The the sales at issue was significant in continuous HM sales of Type V cement petitioner argues that the Department absolute terms and pursuant to a bona since 1964. Thus, CEMEX contends that considered these same factors in the fide demand. CEMEX also argues that its sales of Types II and V in the home fifth and sixth administrative reviews judicial precedent and prior market meet the statutory definition of when it found Types II and V to be administrative practice establish that ordinary course of trade in section outside the ordinary course of trade. relatively low sales volume signifies 771(15) of the Act. CEMEX maintains The petitioner argues that there has sales outside the ordinary course of that, although the Department relied on been no material change in the evidence trade only when coupled with an facts available to infer that the sales at relating to these five factors which absence of bona fide HM demand, issue had a ‘‘promotional quality’’, there would justify a different decision. which does exist in this case. is evidence on the record showing that In addition to discussing the record the sales were no more promotional evidence regarding the above-described CEMEX also contends that the than Type I sales. CEMEX challenges factors, the petitioner argues that there Department should focus on the actual the overall relevance of ‘‘promotional are additional factors (e.g., changes in terms of delivery for the sales at issue, quality’’ as a factor in an ordinary- its shipping and production identical to those of Type I customers, course-of-trade inquiry and argues that arrangements for cement Types II and V, rather than the geographic distance, and there is no judicial or Departmental absorption of freight costs on sales of that the distance to the customers is a precedent which has referred to this cement Types II and V) supporting the geographic fact rather than a condition factor in any other ordinary-course-of- Department’s past determinations in or practice of sale. CEMEX argues that trade analysis. this matter. The petitioner also states the Department has not relied on Finally, CEMEX argues that that CEMEX’s HM sales produced as shipping distances in determining Hermosillo-produced cement sold as Type V but sold as Type I are outside whether sales were outside of ordinary Type I is within the ordinary course of the ordinary course of trade. Among a course of trade in prior cases. trade because four out of six factors number of arguments to support this Furthermore, CEMEX argues, if the (shipping distance, profit, promotional contention, the petitioner notes that the Department continues to consider nature, and historical pattern of sales) subject HM sales meet physical shipping distance in its analysis, it upon which the Department relied for specifications for Type V and that the should do so on an individual-sale its analysis of Type II and Type V sales customers do not need these traits, basis. CEMEX also contends that the were not present and that the suggesting production overruns as one Department’s reliance on the low Department’s two other factors (number possible explanation. Also, the profitability of the sales at issue ignores and type of customers and freight costs) petitioner notes, sales of this the fact that the profit levels on these are not supported by substantial merchandise as Type I cement represent sales, though not as high as sales evidence. Specifically, CEMEX notes a small percentage of HM sales of Type invoiced as Type I, are substantial and that the volume of its Hermosillo Type I cement as well as a small percentage significant in absolute terms. Moreover, I sales exceeded five percent of its U.S. of CEMEX’s production of Type V. The CEMEX notes that the profit differential sales and, thus, constituted a viable petitioner also notes that CEMEX’s is not the result of price disparities but basis to calculate NV under section freight costs for these sales were rather higher freight costs. CEMEX 351.404(b)(2) of the Department’s significantly different from the freight contends further that the Department’s regulations. In addition, CEMEX costs for other sales of Type I, that the reliance on the small number and type contends that the freight cost differences number and type of customers for these of customers for these sales is improper upon which the Department relied were sales are unusual, and that CEMEX’s because such evidence generally reflects insignificant. CEMEX also assserts that profits on sales of physically Type V sales outside the ordinary course of the number and type of customers cement sold as Type I are unusual. trade in cases of sales of export overrun buying Type I from the Hermosillo The petitioner contends that CEMEX’s and off-specification sales, rather than plants were consistent with the number HM sales of all cement produced as when sales are made to a bona fide and type of customers buying from other Type V, regardless of how they were home market, which exists in this case. plants. Last, CEMEX claims that the invoiced and sold, are outside of the Moreover, CEMEX argues that the Department inaccurately relied upon ordinary course of trade when twelve years of domestic sales of these differences in handling charges between considered in the aggregate. In support, products, before and after the Hermosillo and non-Hermosillo sales of the petitioner discusses volume sold, imposition of the order, constitutes a Type I cement. freight cost differences, type of ‘‘reasonable period of time’’ regardless The petitioner maintains that customers, and profit differences. The of the fact that such domestic sales did CEMEX’s HM sales of cement produced petitioner asserts that CEMEX’s not begin until after CEMEX began as Type V are outside the ordinary proposed ordinary-course-of-trade production for export. course of trade. First, the petitioner analysis is erroneous, that the

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Department expressly considered the of the Act) are in the ordinary course of In analyzing the ordinary-course-of- totality of the circumstances, and that trade must be based on an analysis trade issue in arriving at its preliminary the existence of a limited demand for comparing the sales in question with results in this administrative review, the sales of Type II and Type V does not sales of merchandise of the same class Department considered the establish that they are within the or kind generally made in the home circumstances surrounding CEMEX’s ordinary course of trade. Also, the market (i.e., the Department must HM sales of Types I, II, and V cement petitioner maintains, only those factors consider whether certain HM sales of from the Hermosillo plants, Yaqui and relevant to HM sales of cement are cement are ordinary in comparison with Campana. An expanded discussion of probative with respect to whether other HM sales of cement). the most recent analysis can be found in CEMEX’s sales are outside the ordinary The purpose of the ordinary-course- a memorandum dated August 31, 1998 course of trade and that the Department of-trade provision ‘‘is to prevent (Memorandum from Roland L. did not consider one factor in isolation. dumping margins from being based on MacDonald to Joseph A. Spetrini, Further, the petitioner contends, the sales which are not representative’’ of Seventh Antidumping Administrative Department’s analysis focuses on the home market. Thai Pineapple Public Review on Gray Portland Cement and whether the sales are normal relative to Co. v. United States, 946 F. Supp. 11, 15 Clinker from Mexico—Ordinary Course sales of other products of the same class (CIT 1996) (quoting Laclede Steel Co. v. of Trade). A public version of this or kind or the respondent’s usual United States, Slip Op. 95–144 at 6 (CIT memorandum is on file in room B–009 practice with respect to the merchandise Aug. 11, 1995)). Congress has not of the Department’s main building. As at issue. specified any criteria that the agency part of that analysis, the Department Finally, the petitioner asserts that should use in determining the considered certain data from the second, CEMEX’s argument that its sales of Type appropriate ‘‘conditions and practices.’’ fifth, and sixth reviews which were II and V cement represent sound Thus, the Department, ‘‘in its discretion, placed on the record of the instant business judgment is irrelevant. The chooses how best to analyze the many review. CEMEX provided no facts in petitioner maintains that CEMEX has factors involved in a determination of this review that would alter the waived its claim that consolidation of whether sales are made within the analysis. We find that the information production at Hermosillo was a ordinary course of trade.’’ Id. at 14–17. on the record continues to support the legitimate business decision because it In the instant review, the decision that all three types of cement did not mention this argument in its Department’s decision to exclude sales produced at the Hermosillo plants in the case brief. Also, the petitioner contends, of Type II and Type V cement from the home market are sold outside the whether CEMEX’s decisions regarding calculation of NV centered around the ordinary course of trade. production and distribution unusual nature and characteristics of arrangements were based on sound First, we found that during the POR, these sales compared to the vast bulk of business judgment is not a factor in as in previous reviews, CEMEX sold CEMEX’s other HM sales. The determining if those sales were outside very small amounts of Type II and Type Department’s ordinary-course-of-trade the ordinary course of trade. V in the home market compared to sales Department’s Position: Consistent inquiry is far-reaching. The agency must of cement produced as Type I. We found with our preliminary results, we have evaluate not just ‘‘one factor taken in that freight costs for Type II and Type determined that CEMEX’s HM sales of isolation but rather all the V cement were higher than freight costs Type II and Type V cement produced at circumstances particular to the sales in for Type I sales, with CEMEX absorbing the Hermosillo plants were outside the question.’’ Murata Mfg. Co. v. United some of these costs. While it is true, as ordinary course of trade during the POR. States, 820 F. Supp. 603, 607 (CIT 1993) CEMEX has pointed out, that shipping Section 773(a)(1)(B) of the Act states, in (quoting Certain Welded Carbon Steel terms for Type II and Type V cement are part, that NV is ‘‘the price at which the Standard Pipes and Tubes from India, in some respects similar to Type I, for foreign like product is first sold (or, in Final Results of Antidumping Duty the years preceding the antidumping absence of a sale, offered for sale) for Administrative Review, 56 FR 64753, order it was CEMEX’s normal business consumption in the exporting country, 64755 (1991)). This broad approach practice to pass along the cost of pre- in the usual commercial quantities and recognizes that each company has its sale freight to purchasers of its Type II in the ordinary course of trade.’’ The own conditions and practices particular cement. Thus, we find it an ‘‘unusual term ‘‘ordinary course of trade’’ is to its trade. In short, the Department circumstance’’ for CEMEX to absorb defined as ‘‘the conditions and practices examines the totality of the facts in each freight costs after the issuance of the which, for a reasonable time prior to the case to determine if sales are being order, particularly given the higher exportation of the subject merchandise, made for ‘‘unusual reasons’’ or under freight costs for Type II and Type V have been normal in the trade under ‘‘unusual circumstances.’’ Electrolytic cement than for Type I cement. Third, consideration with respect to Manganese Dioxide from Japan; Final we found that the normal practice for merchandise of the same class or kind.’’ Results of Antidumping Duty CEMEX is to ship cement, a heavy The SAA which accompanied the Administrative Review, 58 FR 28551, material, over relatively short distances. passage of the URAA clarifies this 28552 (1993). Over 95 percent of CEMEX’s sales of portion of the statute further when it We disagree with CEMEX that our cement in Mexico were shipped less states: ‘‘Commerce may consider other analysis used selective factors and was than 150 miles and, during the POR, types of sales or transactions to be not supported by substantial evidence. shipments of cement produced as Type outside the ordinary course of trade Pursuant to section 773(a)(1)(B) of the I conformed to this pattern. Shipments when such sales or transactions have Act, the Department has examined the of Type II and Type V, however, characteristics that are not ordinary as totality of the circumstances occurred over vastly greater distances. compared to sales or transactions surrounding CEMEX’s sales of cement Fourth, we found that CEMEX’s profits generally made in the same market.’’ in Mexico that are produced as Type V on Type II and Type V cement sales SAA, at 164. Thus, the statute and the cement and marketed as Types I, II, and during the POR are small compared to SAA are clear that a determination of V (which are identical in physical those earned on sales of Type I cement. whether sales (other than those characteristics to the cement that Fifth, we found that the number and specifically addressed in section 771(15) CEMEX sells in the United States). type of customers that purchase Type II

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13157 and Type V cement from CEMEX is distances of less than 150 miles. While market for Type II and Type V cement substantially different from those who CEMEX’s HM shipments of Type I and other characteristics noted above, purchase other cement types. cement conformed to this norm, its were also considered, and we find, The Department disagrees with shipments of Type II and Type V based on those factors, that this demand CEMEX’s contention that (i) low sales occurred over substantially greater does not compel us to consider sales of volume is only relevant to the ordinary- distances. CEMEX claims that the Type II and Type V within CEMEX’s course-of-trade issue if there is no bona ‘‘differences in shipping distances is ordinary course of trade. fide HM demand, and (ii) the presence simply a geographic fact’’ and the result Among the selected factors for which of HM demand is indicative of sales of a ‘‘legitimate business decision’’ and CEMEX argues the Department within the ordinary course of trade. that the Department has not relied on misapplied the record evidence were First, the Department verified in the shipping distances in determining historical sales trends and ‘‘promotional second review that there was a small, whether sales were outside of ordinary quality’’ of the products. We disagree. but apparently legitimate, HM demand course of trade in prior cases. These On September 25, 1997, the Department for Type II and Type V cements. claims are inapposite. We are not issued a questionnaire requesting However, that finding did not lead to a questioning the reasoning behind but CEMEX to support its position that HM determination that the subject sales the effect of the decision to ship long sales of Type V cement were in the were made within the ordinary course distances. As we noted in earlier ordinary course of trade by addressing, of trade. As we note above, the CAFC in reviews, a company may have sound among other things,‘‘historical sales CEMEX v. U.S. affirmed the business reasons for changing its trends’’ and various non-profit motives Department’s determination that methods of operation but, if sales for making these sales. CEMEX’s CEMEX’s HM sales of Types II and V resulting from this new business response (copies of its submission from were outside the ordinary course of practice are not normal for the company the fifth and sixth administrative trade. Second, the Department has often (for a reasonable time prior to reviews) did not address these two found sales to be outside the ordinary exportation), then they cannot be said to items. Thus, the Department found in course of trade where volume was be within that company’s ordinary the preliminary results that the facts considered with other, non-demand- course of trade. The CIT and CAFC regarding these items have not changed related, factors. For example, in Final affirmed this analysis in its examination since the second review, that CEMEX Determination of Sales at Less Than of the second administrative review. did not sell Type II and Type V cement Fair Value; Sulfur Dyes Including Sulfur CEMEX v. U.S. until it began production for export in Vat Dyes From the United Kingdom, 58 With respect to shipping terms, while the mid-eighties, despite the fact that a FR 3253, 3256 (1993), the Department it is true, as CEMEX points out, that small domestic demand for such existed concluded that sales were outside the shipping terms (e.g., CIF or FOB plant) prior to that time, and that sales of Type ordinary course of trade based upon for Type II and Type V are in some II and Type V cement continue to abnormally high volume, low price, and respects similar to Type I, we believe exhibit a promotional quality that is not the existence of a ‘‘special agreement’’ this contention proceeds from an evidenced in CEMEX’s ordinary sales of to promote the product at issue. In incorrect premise. In an ordinary- cement (for details on the conclusions Tapered Roller Bearings and Parts course-of-trade inquiry, the pertinent reached in the second review, see Thereof, Finished and Unfinished, From issue is whether the conditions and memorandum from Holly A. Kuga to Japan, 52 FR 30700, 30704 (1987), the practices are ‘‘normal’’ for the company Joseph A. Spetrini, dated August 31, Department determined that sales were in question. For the years preceding the 1993). outside the ordinary course of trade antidumping order, it was CEMEX’s For the reasons stated above, the because the sales in question were of normal business practice to pass along Department has determined that small volume and high prices, most of the cost of pre-sale freight to purchasers CEMEX’s HM sales of Type V cement the sales were canceled prior to invoice, of its Type II and Type V cement. For during the review period were outside and there were no comparable sales in CEMEX to absorb freight costs after the the ordinary course of trade. We note the United States. We have also issuance of the order is an ‘‘unusual that the facts established in the record excluded transactions from the circumstance,’’ particularly given the of this review are very similar to the calculation of NV based upon sales high freight costs for Type II and Type facts which led us to determine in the made to employees and negligible V cement. Thus, with respect to both second, fifth, and sixth reviews that HM volume. See, e.g., New Minivans from shipping distances and terms we find sales of Type V cement were outside the Japan, 57 FR 43, 46 (1992). In short, the sales of Type II and Type V to be ordinary course of trade. The decision Department’s consistent and outside the ordinary course of trade. in the second review, as noted above, longstanding practice has been to CEMEX argues that, in the was affirmed by the CIT and CAFC. In consider sales volume along with preliminary results, the Department did conclusion, the decision to exclude numerous other factors, depending not acknowledge a legitimate HM sales of Type V cement from the upon the specific product involved. demand for the cement from those calculation of NV centers around the We also disagree with CEMEX’s claim plants invoiced as Type II and Type V. unusual nature and characteristics of that, instead of considering shipping However, the Department did consider these sales compared to the vast distances and freight costs, we should this information in preparing the majority of CEMEX’s other HM sales. focus on shipping terms and practices. preliminary results. As CEMEX itself Based upon these differences, the In fact, in analyzing this issue, the states in its case brief, the Department Department has determined that they Department has examined both shipping acknowledged that a legitimate HM are not representative of CEMEX’s HM distances and shipping terms and demand existed for Type II and Type V sales and, therefore, these sales were not practices. With respect to shipping in the second review. The Department within CEMEX’s ordinary course of distances, we found that the normal acknowledged this in the Sixth Review trade. practice in Mexico is to ship cement Final Results and continues to recognize With respect to cement from the over relatively short distances. As we that a legitimate HM demand exists for Hermosillo plants meeting Type V noted earlier, over 95 percent of all Type II and Type V. But a range of other specifications but sold in the HM as cement shipments in Mexico cover factors, such as the size of the home Type I, as noted in the memorandum

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13158 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices referred to above (August 31, 1998 correctly. The petitioner maintains first variable costs associated with the Memorandum from Roland L. that the DIFMER issue is not moot physical differences in the merchandise. MacDonald to Joseph A. Spetrini with because the Department found correctly Where appropriate, we may also subject: Seventh Antidumping that all of CEMEX’s sales of cement consider differences in the market Administrative Review on Gray produced as Type V were outside the value. We determine that the record Portland Cement and Clinker from ordinary course of trade. The petitioner evidence demonstrates the existence of Mexico—Ordinary Course of Trade), the responds next that the inaccuracies differences in the physical record evidence indicates that only at contained in the Department’s DIFMER characteristics of cement Types I and V, the Hermosillo plants did CEMEX discussion in the preliminary results are and, therefore, a DIFMER adjustment is produce consistently a cement meeting irrelevant to the Department’s appropriate here. one ASTM standard and sell that conclusion that CEMEX did not provide Contrary to CEMEX’s assertions, the cement as a different ASTM type. That the requested DIFMER information. data and product information on the factor, and others discussed in that Moreover, the petitioner argues, record reflect the existence of memorandum, distinguishes sales of CEMEX’s description of the record is differences in the physical Type I cement produced at Hermosillo inaccurate. The petitioner asserts that characteristics of cement Types I and V. from CEMEX’s sales of Type I cement CEMEX did not respond to the These physical differences were produced as Type I from other Department’s requests for DIFMER originally made apparent in CEMEX’s production facilities. information and that, by its provision of reported variable manufacturing costs of variable cost of manufacturing (VCOM) producing Type I cement and Type V 6. Difference-in-Merchandise cement in the home market. In addition, Information data and suggestions for DIFMER calculation, it led the Department to the statements CEMEX made in its April Comment 1: CEMEX argues that the believe that it was requesting a DIFMER 20, 1998, and May 8, 1998, submissions Department should revise its treatment adjustment. After suggesting previously indicating that no DIFMER adjustment of difference-in-merchandise (DIFMER) that a DIFMER adjustment should be was necessary is contrary to the facts on information for the following reasons. made, the petitioner contends that the record of this and prior reviews First, CEMEX maintains that the issue of CEMEX requested a DIFMER adjustment (currently on the record of the instant a DIFMER adjustment is moot because expressly in its April 27, 1998, review), wherein CEMEX has CEMEX’s HM sales of Type V cement submission to the Department, where it demonstrated that there are differences were made in the ordinary course of supplied VCOM data for Types V LA in the physical characteristics of Types trade thus requiring no DIFMER and Type I cement. According to the I and V cement which contribute to a adjustment. Second, CEMEX claims that petitioner, CEMEX led the Department difference in their production costs. it neither requested a DIFMER Next, we note that CEMEX did not to believe that it was claiming a adjustment nor withdrew such a request provide information regarding process favorable DIFMER adjustment and then, and the Department described the or production differences that are in effect, withdrew its request on May record evidence incorrectly in the attributable to the differences in 8, 1998. Third, the petitioner claims that preliminary notice. CEMEX claims that physical characteristics of cement Types the record evidence demonstrates its views on various options for a I and V from which we could calculate affirmatively that physical differences DIFMER adjustment have been a DIFMER adjustment. While we between Types I and V cement consistent. Third, CEMEX contends that acknowledge that our DIFMER contribute to different production costs, cost differences between Types I and V discussion in the preliminary results of e.g., Types V and I differ in the amount cement are the result of plant review contained some sequential efficiencies. CEMEX maintains that the of an allowable raw material, tricalcium inaccuracies, none of these minor errors production process for all types of aluminate, and differing production affect our conclusion that CEMEX cement is identical. According to processes are also required. Fourth, the provided conflicting and incomplete CEMEX, cost differences among cement petitioner argues that the Department DIFMER information. We first requested types are solely a function of the should not apply CDC’s DIFMER CEMEX to provide DIFMER information extraction costs of clay and limestone, adjustment to CEMEX because to do so in our original questionnaire on October the two raw materials which compose would reward CEMEX improperly for its 3, 1997. CEMEX’s response on cement. CEMEX argues that the cost of lack of cooperation. The petitioner December 8, 1997, provided no these materials depends upon the concludes that the Department should information regarding process or condition of the quarry and the distance not base CEMEX’s DIFMER adjustment production differences that are between the plant and the quarry. Thus, on market values because CEMEX has attributable to the differences in CEMEX maintains, the cost differences not provided any information on which physical characteristics of Types I and among the cement types are not due to the Department could calculate such an V. CEMEX again did not provide physical differences in the merchandise; adjustment. Moreover, the petitioner information with which we could make rather they are a function of the quarry notes, the Department bases a DIFMER a DIFMER adjustment in its section D itself. In the alternative, CEMEX argues adjustment on differences in market response filed on March 3, 1998. On that the Department should either use value rarely and disfavors basing March 31, 1998, we requested parties to CDC’s DIFMER adjustment since the adjustments on market value rather than submit information to assist in our Department collapsed CDC and CEMEX actual costs. determination of the appropriate or calculate a DIFMER using market Department’s Position: We agree with DIFMER calculation. On April 17, 1998, values, as authorized by the the petitioner that section we made a second request for DIFMER Department’s regulations and in the 773(a)(6)(C)(ii) of the Act directs the information. In response to our March Department’s decision in Polyvinyl Department to make an adjustment to 31 and April 17 requests, on April 20, Alcohol From Taiwan, 63 FR 32810 NV to account for differences in the 1998, CEMEX stated its belief that no (June 16, 1998). physical characteristics of merchandise DIFMER adjustment was necessary in The petitioner responds that the where similar products are compared. this review but offered suggestions for Department based CEMEX’s DIFMER Section 351.411(b) of our regulations the calculation of its DIFMER adjustment on adverse facts available directs us to consider differences in adjustment based upon hypothetical

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00012 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13159 data. However, CEMEX again did not Course of Trade, above), the DIFMER specific, cement type-specific VCOM demonstrate the existence of variable issue remains active. In addition, using data, as the Department has here. cost differences between Types I and V CDC’s DIFMER adjustment for CEMEX Department’s Position: We do not resulting from physical differences in is contrary to our directive under agree that a more adverse rate should be the products. In a submission filed April section 776(b) of the Act to apply used. For the reasons stated in response 27, 1998, CEMEX suggested that the adverse facts available where an to comment 1, above, our DIFMER Department base the DIFMER interested party has failed to cooperate calculation is consistent with prior adjustment on CEMEX’s reported by not acting to the best of its ability to practice and based upon review- and difference in variable costs for the comply with a request for information. plant-specific reported data which we production of Types I and V although We conclude that using CDC’s DIFMER, verified. We consider our choice of facts CEMEX had not provided the requisite as suggested by CEMEX, would reward available to be sufficiently adverse in VCOM data. Finally, on May 8, 1998, CEMEX improperly for its failure to order to provide an incentive to CEMEX claimed in its second provide the information we requested. respondents to provide complete and supplemental response that no variable Further, we reject CEMEX’s proposal accurate responses to our requests for cost differences existed between Types that we base our DIFMER adjustment on information. I and V. Thus the record of this review differences in market value rather than 7. Level-of-Trade Determination for demonstrates that CEMEX did not actual costs. CEMEX provided no CEP Sales comply with the Department’s requests information upon which we could for data demonstrating the cost calculate such an adjustment and, The petitioner argues that the differences between cement Types I and although we retain the discretion to Department’s methodology for V resulting from their physical calculate DIFMER based upon market determining the level of trade (LOT) for differences and offered conflicting values, we do so rarely. See Preamble to CEP sales based on the level of the information several times. the Department’s Regulations, 62 FR at constructed export price (CEP) from the Because record evidence indicates the 27370. exporter to the related affiliated existence of physical differences Comment 2: The petitioner contends importer (after deductions required by between cement Types I and V and that the Department’s selection of facts section 772(d) of the Act) is contrary to because CEMEX did not submit viable available for DIFMER was not the Act and inconsistent with the bases for a DIFMER adjustment, we have sufficiently adverse. It concedes that methodology the Department used to calculated a DIFMER adjustment based CEMEX provided variable cost data for determine LOT for export price (EP) and upon facts otherwise available. Types I and V but, despite the NV sales. In Borden, Inc. v. United Moreover, because CEMEX failed Department’s requests, did not provide States, 4 F.Supp.2d 1221 (CIT 1998), the repeatedly to provide requested information on process/production petitioner notes that the CIT found this information, we conclude that CEMEX differences attributable to physical methodology to be contrary to the did not act to the best of its ability. differences. The petitioner argues that, requirements of the plain language of Thus, in accordance with section 776(b) instead, CEMEX offered a suggested the statute. of the Act, we have used an adverse DIFMER calculation based upon The petitioner notes that, for EP and inference in applying facts available. hypothetical data. The petitioner also NV, the Department bases LOT on the Therefore, as facts available, and in notes that CEMEX stated later that there unadjusted starting price in the relevant order to minimize the effect of varying were no variable cost differences market. The petitioner asserts that, in plant efficiencies, the Department has between Types I and V but that Type V order to make an ‘‘apples-to-apples’’ compared CEMEX’s VCOM to produce is in fact more expensive to produce LOT comparison, the statute requires cement at the Hermosillo plants (sold as (physically) than Type I. The petitioner the Department to analyze the LOT for Types I, II, and V but physically Type claims that CEMEX has also refused both HM and CEP sales equivalently, V) with the lowest variable costs repeatedly to provide DIFMER based on the selling functions reported by a CEMEX Type I facility. information in the second, fifth, and performed with respect to the sales to However, we have found that, in our sixth reviews. According to the the first unaffiliated customer in both preliminary results, we calculated petitioner, the Department should apply markets. The petitioner concludes that DIFMER using the VCOM from total facts available based on CEMEX’s the Department’s practice results in an CEMEX’s second-most efficient plant refusal to provide DIFMER or, at the unfair, skewed comparison between an rather than CEMEX’s most efficient very least, should use a 20-percent adjusted CEP and an unadjusted NV. plant. We have based this determination upward DIFMER adjustment to NV as CEMEX and CDC respond that the on findings at the cost verification and facts available, consistent with the final Department interpreted section 772(d) Exhibit C–8 of the cost verification remand results of the second review. of the Act properly and based the CEP report. See Cost Verification Report, CEMEX argues that if the Department LOT appropriately on the U.S. price dated August 21, 1998. Therefore, we bases CEMEX’s DIFMER on facts after adjustments. CEMEX and CDC have adjusted the DIFMER calculation available a 20-percent DIFMER argue that the petitioner’s sole reliance using the VCOM of CEMEX’s most adjustment is unreasonable as the upon the CIT decision in Borden is efficient Type I facility in accordance Department is authorized to rely on misplaced because, as the Department with the methodology we used in the information placed on the record. stated in prior determinations, the sixth review. This recalculation results CEMEX contends that its information decision is not final and the Department in an upward adjustment to NV in was timely, verified, and reliable. is appealing the decision. Respondents accordance with section 776(a) of the According to CEMEX, a 20-percent also assert that the Department’s Act. DIFMER adjustment as applied for the interpretation of the statute is supported CEMEX’s remaining arguments second review is unreasonable because in the SAA and the Department’s supporting the use of a different facts each review is a distinct proceeding and regulations as well as by Department available are without merit. First, as we the facts differ. CEMEX argues that, in practice. In light of this interpretation of have concluded that CEMEX’s HM sales the second review, the Department had the statute, argues CDC, any comparison of Type V cement are outside the only weighted-average VCOM data for of selling functions for the purpose of ordinary course of trade (see 5. Ordinary Types I and II and did not have plant- determining CDC’s eligibility for a CEP

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13160 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices offset must focus on CDC’s activities in (1996), and that minor or relatively CEMEX asserts that, based on the law selling to the two markets, not on the insignificant selling functions cannot and verified information on the record, activities of its U.S. affiliate. In addition, provide the basis for a determination the Department’s preliminary results CDC argues that the Department applied that there are different LOTs and that a properly included a CEP offset. First, the proper statutory interpretation in the CEP offset adjustment is warranted. CEMEX concurs with the Department’s sixth review. With regard to both CEMEX and CDC, determination that the sales to CEMEX’s Department’s Position: As we stated the petitioner argues that the record unaffiliated U.S. distributor, Sunbelt in prior determinations, our practice of does not support the Department’s Cement, were at a less-advanced LOT basing our LOT analysis on the CEP, finding that their HM sales were at a than the LOT of HM sales. CEMEX notes rather than at the starting price of CEP, more advanced stage of distribution that the CEP adjustments made under is in full compliance with the statute than their CEP sales. section 772(d) of the Act remove all the and the regulations. See Professional With regard to CEMEX, the petitioner marketing and distribution activities of Electric Cutting Tools from Japan, 63 FR argues that no basis exists for the Sunbelt Cement, thereby altering the 54441, 54444 (1998). In addition, we Department’s conclusion that CEMEX’s LOT of the starting price to a less- have stated that the CIT’s decision in sales to its affiliated U.S. distributor, remote link in the chain of distribution. Borden is not binding as we are Sunbelt Cement, were at a different CEMEX contends that the appropriate appealing this decision while we place in the distribution chain than comparison is based on the selling continue to apply our current CEMEX’s HM sales. To the contrary, the functions performed by CEMEX with methodology. See Porcelain-on-Steel petitioner adds, the record evidence respect to its sales in Mexico and its Cookware from Mexico, 63 FR at 38378. reflects that CEMEX’s selling activities sales to the United States. Accordingly, consistent with section with respect to its Sunbelt Cement sales CEMEX argues that the Department 351.412 of our regulations, we have were virtually identical to its selling determined appropriately that CEMEX continued to base our LOT analysis on activities with respect to its HM sales. performed significantly different selling the CEP reflecting the sale from exporter The petitioner also contends that the functions for CEP and HM sales and that to importer for these final results of Department’s LOT memorandum for the the HM level was more advanced. review. preliminary results contains several CEMEX rejects the petitioner’s inaccuracies. First, the petitioner implication that, because the 8. CEP Offset Justification maintains, for all but one expense, Department reached a different Comment 1: The petitioner argues that advertising, the activities listed in the determination in the fifth review, the the Department determined erroneously Department’s chart of expenses relating sixth review results must be wrong. that CEMEX’s and CDC’s HM sales were to CEMEX’s indirect selling expenses do CEMEX also rejects the petitioner’s at a different LOT than their sales to the not correspond to CEMEX’s itemized hypothesis that, because the U.S. market United States and, on that basis, granted indirect selling expenses as CEMEX is important to CEMEX’s business, CEMEX and CDC an inappropriate CEP reported in its response. The petitioner CEMEX’s centralized strategic planning offset adjustment to NV. According to next argues the Department relied in Mexico must support exports to the the petitioner, the Department found no incorrectly upon five selling functions United States. CEMEX states that differences in LOT in the fifth review in its determination that CEMEX’s HM activities with respect to procuring/ and the facts in this review are virtually sales were at a more advanced LOT than sourcing materials and other assets for identical to the facts in that review. its U.S. sales: strategic and economic U.S. operations are performed by Also, the petitioner claims that the planning, market research, personnel CEMEX’s U.S. affiliate. Finally, CEMEX Department’s methodology for analyzing training/personnel exchange, disagrees with the petitioner’s argument the LOT and CEP offset issues has not procurement and sourcing services and that market research, advertising, after- changed since the fifth review and, after-sales servicing/warranty service. sales service, and technical advice are therefore, no basis exists for a different The petitioner argues that the record all insignificant in selling cement. result with respect to the LOT and CEP demonstrates that the Department found CEMEX notes that the list of selling offset issues in this review. erroneously that CEMEX performs these activities that it included in its The petitioner argues that, in the functions only in the home market. The responses are representative of the preliminary results of this review, the petitioner also asserts that what the activities that the Department has Department found that CEMEX and CDC Department describes separately as included in LOT questionnaires issued perform more selling functions for sales ‘‘strategic and economic planning’’ and to companies in other cases. to end-users and ready-mixers in the ‘‘market research’’ are the same activity Department’s Position: In accordance home market than for sales to affiliated and should be merged for LOT-analysis with section 773(a)(1)(B) of the Act, to importers in the United States. The purposes. The petitioner maintains the extent practicable, we determine NV petitioner argues that, with regard to further that CEMEX performed sales based on sales in the comparison market CEMEX and CDC, the record either forecasting in neither the U.S. nor the at the same LOT as the EP or CEP. The contradicts or does not support the home market. The petitioner also argues NV LOT is that of the starting-price Department’s finding that their HM and that CEMEX provided insufficient and sales in the comparison market or, when adjusted CEP sales were at different inconsistent information regarding the NV is based on constructed value (CV), levels of trade. The petitioner argues after-sale services it provides and failed that of sales from which we derive that the Department must find more to establish that the selling functions selling, general and administrative than different levels of selling activities were applied consistently ‘‘to at least (SG&A) expenses and profit. For EP, the to determine that a respondent’s HM the vast majority of customers and sales U.S. LOT is also the level of the starting- and U.S.-affiliate sales are at different in each level of trade,’’ citing Certain price sale, which is usually from levels. Also, the petitioner asserts that Pasta From Italy. Finally, the petitioner exporter to importer. For CEP, it is the HM selling functions must be provided argues that selling functions such as level of the constructed sales from the to at least the majority of customers, market research, advertising, and exporter to the importer. citing Notice of Final Determination of technical advice are insignificant in a To determine whether NV sales are at Sales at Less Than Fair Value: Certain mature market such as gray portland a different LOT than EP or CEP, we Pasta From Italy, 61 FR 30326, 30338 cement. examine stages in the marketing process

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If the conclude that CEMEX performs eight of unchanged since the record comparison-market sales are at a its eleven selling functions with respect demonstrates that CEMEX performed different LOT, and the difference affects to only its HM sales and not with both selling functions for the home price comparability, as manifested in a respect to its CEP sales. market but neither for its U.S. sales pattern of consistent price differences In addition, CEMEX performs a higher Comment 2: The petitioner argues that between the sales on which NV is based degree of inventory maintenance for its the Department found erroneously that and comparison-market sales at the LOT HM sales than for its CEP sales. CDC’s U.S. and HM sales were at of the export transaction, we make a Contrary to the petitioner’s assertion, different levels of distribution. LOT adjustment under section differences in the level of intensity with Furthermore, according to the 773(a)(7)(A) of the Act. Finally, for CEP which a respondent performs a selling petitioner, the Department erred in sales, if the NV level is more remote function is relevant to our analysis. See finding that CDC’s HM sales were at a from the factory than the CEP level and Professional Electric Cutting Tools From more advanced stage of distribution based on the available information, we Japan; Preliminary Results of because CDC performed fewer and are unable to determine the amount of Antidumping Duty Review, 63 FR different selling functions for CEP sales a LOT adjustment, we adjust NV under 30706, 30708 (1998). than for its HM sales. The petitioner section 773(a)(7)(B) of the Act (the CEP Thus, as the record demonstrates, argues that CDC did not describe in offset provision). See Notice of Final CEMEX performs the majority of its sufficient detail its selling functions, Determination of Sales at Less Than selling functions with respect to its HM including ‘‘market research,’’ ‘‘technical Fair Value: Certain Cut-to-Length sales and not with respect to its CEP advice,’’ ‘‘customer approval,’’ Carbon Steel Plate from South Africa, sales. In addition, CEMEX performs no ‘‘solicitation of orders/customer visits,’’ 62 FR 61971 (November 19, 1997). services for its CEP sales that it does not ‘‘sales promotion discount programs,’’ Based upon our analysis of the record, perform for its HM sales. Accordingly, and ‘‘computer/legal/accounting/ we determine, as in the preliminary we determine that CEMEX’s HM sales business system development,’’ so that results of review, that CEMEX’s HM occur at a different and more advanced the Department could determine sales occurred at a different and more stage of distribution than its CEP sales. whether they involved distinct selling advanced stage of distribution than We also determine that the data functions. Moreover, the petitioner CEMEX’s sales to its U.S. affiliate. While provided do not permit us to calculate contends, CDC’s reported selling we note that the LOT memorandum a LOT adjustment; thus in accordance functions were not provided to at least outlining our analysis contains some with section 773(a)(7)(B) of the Act, a a vast majority of customers and sales in minor errors, none of these inaccuracies CEP offset is appropriate for these final the home market. Therefore, the alters our conclusion that CEMEX results. petitioner concludes, CDC’s claimed performs more selling functions at a Moreover, we disagree with the selling functions do not provide the more advanced stage of distribution in petitioner’s remaining arguments. The basis for a determination that CDC’s HM the home market than its CEP sales in petitioner challenges the Department’s and U.S. sales were at different levels of the United States. The record reflects decision to grant a CEP offset to CEMEX trade. The petitioner also notes that the that CEMEX performed eleven selling by asserting that CEMEX’s itemized list Department reported erroneously in its functions in the home market: (1) of indirect selling expenses and its LOT memorandum that it confirmed Strategic and economic planning; (2) selling functions do not correspond. CDC’s selling functions performed in market research; (3) advertising; (4) However, the list to which the petitioner the home market during verification technical advice; (5) personnel training/ refers (Exhibit B–14 of CEMEX’s when, in fact, the Department did not personnel exchange; (6) inventory December 8, 1997, Section B response) verify CDC’s response in this review. maintenance; (7) procurement and itemizes the names of CEMEX’s CDC argues that the Department sourcing services; (8) freight and accounts for its indirect selling expenses granted CDC a CEP offset properly. CDC delivery arrangements; (9) packaging; in the home market and does not argues that the record demonstrates that (10) credit; and (11) after-sales services/ provide the services performed as a its HM sales were made at a more warranties. We note that our LOT result of those expenditures. Because advanced LOT than its U.S. sales, thus memorandum relied incorrectly upon a the list of accounts upon which the satisfying the Department’s standard for function not performed by CEMEX, petitioner relies is not an itemization of a CEP offset. sales forecasting, and therefore we have CEMEX’s selling functions but rather Department’s Position: We disagree excluded this function from our lists the accounts to which CEMEX’s with the petitioner that CDC’s U.S. and analysis. selling functions are recorded, we HM sales were at the same levels of Table 6 of our LOT memorandum would, therefore, not expect CEMEX’s distribution. Based upon our analysis of regarding advertising for CEMEX’s CEP indirect selling expenses list and the record, we determine that CDC’s HM sales is in error because the record selling-functions chart to correspond. sales occur at a different and more reflects that CEMEX does not perform The petitioner also argues that ‘‘strategic advanced stage of distribution than advertising functions for its sales to and economic planning’’ and ‘‘market CDC’s sales to its U.S. affiliate. The Sunbelt Cement. However, the record research’’ should be merged for LOT- record reflects, and our LOT demonstrates that CEMEX performs analysis purposes. We disagree with the memorandum shows, that CDC performs strategic planning, market research, petitioner. The record characterizes ten selling functions in the home advertising, procurement and sourcing strategic planning as relating to long- market: (1) Inventory maintenance; (2) services, personnel training/personnel range production activity while market market research; (3) technical advice; (4) exchange, packaging, credit and after research relates to locating markets and advertising; (5) freight and delivery sales service/warranty service for its gauging their activity, and these arrangement; (6) customer approval; (7) sales in the home market but not for its distinctions are commonly recognized solicitation of orders/customer visits; (8) CEP sales to the U.S. affiliate after and understood. Regardless, assuming sales promotion/discount programs; (9) deducting the expenses pursuant to arguendo that we should merge the two packing; and (10) computer/legal/ section 772(d) of the Act. Thus, contrary functions, our conclusion that CEMEX’s accounting/business system

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Moreover, CDC maintenance and freight and delivery 772(d) referring to expenses ‘‘associated believes that Mitsubishi reinforces the arrangements, CDC performs its selling with economic activities occurring in Department’s position to limit functions for its sales in the home the United States’’ to be defined as only acceptable deductions from CEP. market but not for its CEP sales to the those expenses related to sales by the Department’s Position: We agree with U.S. affiliate after deducting the affiliated importer to unaffiliated respondents that we calculated CEP expenses pursuant to section 772(d) of purchasers. The petitioner contends that correctly. Upon analysis, the the Act. The record also demonstrates in the language is interpreted more Department determined that the indirect sufficient detail for the Department to properly to include all expenses related selling expenses at issue relate solely to determine that the selling functions that to U.S. sales. Fourth, the petitioner cites respondents’ sales to their affiliated CDC provides for its HM sales are the final results of the fifth review to importers and are not associated with greater in number and intensity than demonstrate that the Department acted economic activities in the United States. those selling functions that it provides inconsistently with section 772(d) by The Department does not deduct for its CEP sales. Accordingly, we limiting the deduction of ‘‘any’’ indirect expenses incurred in selling to determine that CDC’s HM sales occur at expenses incurred in selling subject the affiliated U.S. importer under a different and more advanced stage of merchandise in the United States. Fifth, section 772(d) of the Act. See Certain distribution than its CEP sales and that because the Department granted a CEP Pasta From Italy, 61 FR at 30352. Thus, a CEP offset is appropriate for these offset, the petitioner maintains that CEP we have used the same methodology for final results. We also determine that the and NV do not represent an ‘‘apples-to- calculating CEP in the final results, as data does not provide an appropriate apples’’ comparison. Sixth, the was done for the preliminary results. basis for a LOT adjustment; thus in petitioner claims that the Department Comment 2: The petitioner maintains accordance with section 773(a)(7)(B) of misinterprets Article 2.4 of the that the Department neglected to the Act, a CEP offset is appropriate for Antidumping Agreement to require only include indirect selling expenses in the the final results. We note that although the deduction of costs incurred between home market on sales to the United our LOT memorandum refers importation and resale from CEP when States in ‘‘total U.S. expenses’’ for erroneously to a verification at CDC this the Agreement ‘‘states that those purposes of calculating CEP profit under error does not alter our conclusion for expenses should be deducted in section 772(f) of the Act. The petitioner argues that by these final results. addition to any other expenses that including indirect selling expenses in affect price comparability.’’ Finally, the 9. CEP Calculation total U.S. expenses in calculating total petitioner contends that to allow a Comment 1: The petitioner disagrees actual profit but excluding them from deduction from CEP of only those with the Department’s decision not to total U.S. expenses in determining the indirect selling expenses incurred in the deduct indirect selling expenses expense ratio renders the calculation of United States permits respondents to incurred in the home market on sales to CEP profit inconsistent. The petitioner avoid deduction of any selling expenses its affiliate in the United States in argues that this contradictory treatment by shifting U.S.-related selling activities calculating CEP. The petitioner believes of the same expenses cannot be offshore. The petitioner also maintains that this decision, although consistent reconciled with the statute. The that the Department must interpret with the Department’s current practice petitioner also cites U.S. Steel Group v. and regulations as well as the final section 772(d) according to its plain United States, No. 97–05–00866, Slip results of the fifth and sixth reviews, is meaning, citing Mitsubishi Heavy Op. 98–96 (CIT 1998) (U.S. Steel), contrary to the Act, the URAA, the SAA Industries, Ltd. v. United States, 15 whereby the CIT rejected the and judicial precedent. The petitioner F.Supp.2d 807 (CIT 1998) (Mitsubishi). Department’s inconsistent treatment of argues that the indirect selling expenses, The CIT in Mitsubishi, the petitioner movement expenses in the calculation inventory carrying costs and general asserts, held that the plain language of of CEP. The petitioner concludes that if advertising expenses CEMEX and CDC section 772(d) of the Act requires the indirect selling expenses incurred in incurred in the home market with deduction, without limitation, of all Mexico are properly attributable to U.S. respect to U.S. sales to its affiliate all expenses generally incurred in selling sales for the purpose of calculating U.S. constitute selling expenses deductible the subject merchandise in the United selling expenses in the computation of under section 772(d)(1)(D) of the Act. States, regardless of where or when ‘‘total actual profit’’ they must be The petitioner challenges the paid. similarly attributable to U.S. sales for Department’s limitation of deductible CEMEX and CDC respond that the purposes of calculating ‘‘total U.S. indirect selling expenses incurred in the Department is correct in not deducting expenses’’ for the purpose of applying home market for its CEP calculation as indirect selling expenses incurred in the the ‘‘actual percentage.’’ artificial and unsupported by the statute home market from CEP calculations. CEMEX and CDC argue that the and by legislative history. First, the CEMEX and CDC state that the Department calculated ‘‘total U.S. petitioner argues that the Department petitioner raised the same argument expenses’’ correctly in its ‘‘total has discretion over which expenses can unsuccessfully in the fifth and sixth expenses’’ calculations for CEP profit. be deducted from CEP and should administrative reviews. CEMEX argues CEMEX contends that the petitioner has deduct all indirect expenses associated further that the petitioner attempts to not cited a determination supporting its with U.S. sales from CEP. Second, the rewrite the legislative history of the argument that the Department excluded petitioner argues that the Department’s URAA and that the Department rejected foreign indirect selling in ‘‘total U.S. use of the term ‘‘U.S. expenses’’ is arguments similar to those advanced by expenses’’ incorrectly. CEMEX argues limited incorrectly to expenses incurred the petitioner in the preamble to the that the petitioner’s citation to U.S. Steel in connection with a sale in the United Department’s regulations. CDC refutes Group is misplaced because the States and that it should be expanded to the petitioner’s claim that Mitsubishi decision is not final and it does not give include expenses incurred in relation to compels the Department to deduct from deference to the Department’s statutory sales by the affiliated importer to U.S. CEP expenses incurred in the home interpretation of the law that it is customers. Third, the petitioner market by a foreign producer and charged to administer.

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CDC asserts that it was appropriate for Accordingly, we have continued to imposed antidumping duties on all the Department to include in total U.S. include movement expenses in ‘‘total imports of subject merchandise, expenses for CEP profit only expenses expenses’’ for calculating CEP profit for including those consigned for related to U.S. operations. CDC cites these final results. This is consistent consumption outside the Southern Tier section 772(f) of the Act, stating that it with the Department’s practice in region as defined by the ITC in the directs the Department to exclude HM accordance with section 772(d)(3) of the original investigation. CDC argues that indirect selling expenses associated Act. the Department did not give exporters with U.S. sales and corresponding Comment 4: The petitioner argues that an opportunity to cease exporting at inventory carrying costs from its the Department should revise its dumped prices into the region prior to definition of total U.S. expenses. calculation of CDC’s U.S. indirect the assessment of duties and requests Department’s Position: Pursuant to expenses because the Department that the Department terminate this section 772(f) of the Act, CEP profit inadvertently allowed a deduction from review and revoke the antidumping includes the total revenue and total U.S. indirect selling expenses for the order or, alternatively, assess actual expenses incurred in making the imputed costs of financing antidumping antidumping duties only on CDC’s sale to the unaffiliated purchaser in the cash deposits. The petitioner notes that entries of merchandise consumed U.S. market. However, since the statute the Department denied such an within the Southern Tier region. directs that profit be allocated only to adjustment in the sixth review and that CEMEX requests only that the expenses deducted under sections this decision was consistent with past Department assess duties on its future 772(d) (1) and (2) of the Act, we must practice. entries consumed within the Southern exclude indirect selling expenses CDC responds that the Department’s Tier region. incurred in Mexico for U.S. sales from allowance of an offset for the cost of CDC contends that, because the ‘‘total U.S. expenses,’’ the numerator of financing cash deposits is in accordance United States did not implement Article the expense ratio. Thus, we did not with past practice and CIT precedent. 4.2 until it adopted the Uruguay Round include indirect selling expenses CDC argues that in the past the Agreement Act (URAA) in 1995, incurred in Mexico for U.S. sales in Department has not been consistent in implementation was untimely because ‘‘total U.S. expenses’’ in calculating CEP its treatment of imputed interest the regional assessment rules were profit. This interpretation is consistent payments on cash deposits. CDC absent from U.S. law during the original with the intent of the statute. With contends that the Department has investigation and during the first several respect to the petitioner’s reference to recognized that a company incurs a real reviews of the antidumping order. CDC U.S. Steel, see our response to Comment expense whether it actually obtained also asserts that, in adopting section 218 3, below. In preparing for these final loans or diverted funds from another of the URAA, the United States results, however, we discovered a investment activity to finance the implemented Article 4.2 inadequately. clerical error in the CEP calculation in antidumping cash deposits, citing For instance, CDC asserts, Section 218 our preliminary results. We Tapered Roller Bearings, Four Inches or does not address producers/exporters inadvertently did not include indirect Less in Outside Diameter, and who, like CDC, export merchandise both expenses for advertising in the Components Thereof, From Japan, 62 into and outside of the region. CDC calculation of profit to be allocated to FR 11825, 11831 (March 13, 1997). proffers other examples of the expenses deducted pursuant to section Department’s Position: We agree that inadequate U.S. implementation of 772(d) of the Act. We have corrected we have allowed CDC a deduction for Article 4.2, which are discussed below. this clerical error for the final results. the imputed costs of financing cash If the Department does not terminate Comment 3: The petitioner argues that deposits inadvertently. For the final this review and revoke the order, CDC the CIT’s recent decision in U.S. Steel results, we have denied an adjustment asserts, the Department should levy directs the Department to calculate CEP to CDC for imputed expenses which antidumping duties on a regional basis profit by excluding movement expenses CDC claims are related to financing cash under Article 4.2. from the denominator of the profit- deposits. This is consistent with the CEMEX and CDC argue that the allocation ratio. The petitioner notes Department’s treatment of such United States is obliged to comply with that, in that case, the CIT rejected the expenses in the sixth review and its Article 4.2 of the Antidumping Department’s argument that the statute practice as described in Antifriction Agreement, which states: required the inclusion of ‘‘all expenses,’’ Bearings (Other Than Tapered Roller including movement expenses, in the Bearings) and Parts Thereof from When the industry has been interpreted as ratio. referring to the producers in a certain area, France, et al., 62 FR 54043, 54079 i.e., a market as defined in paragraph 1(ii), CEMEX and CDC respond that the (October 17, 1997). As our position is anti-dumping duties shall be levied only on Department’s inclusion of movement unchanged from the prior review, we the product in question consigned for final expenses in its calculation of total adopt the discussion with respect to this consumption to that area. When the expenses used to calculate CEP profit is issue in our Sixth Review Final Results constitutional law of the importing country a reasonable interpretation of section (63 FR at 1278). does not permit the levying of anti-dumping 772(f) of the Act and is consistent with duties on such a basis, the importing Member the Department’s past practice. CEMEX 10. Regional Assessment may levy the anti-dumping duties without and CDC argue that the CIT’s decision CEMEX and CDC argue that the limitation only if (a) the exporters shall have been given an opportunity to cease exporting in U.S. Steel is not final and that the United States has not honored its at dumped prices to the area concerned or Department has not indicated its obligations under Article 4.2 of the otherwise give assurances pursuant to Article intention to abandon its prior policy WTO Antidumping Agreement and its 8 of this Agreement, and adequate assurances and adopt the decision. predecessor, Article 4.2 of the 1979 in this regard have not been promptly given, Department’s Position: We agree with Tokyo Round Antidumping Code. and (b) such duties cannot be levied only on the respondents that our inclusion of CEMEX and CDC claim that the products of specific producers which supply movement expenses in the calculation Department has not implemented the the area in question. of total expenses used to calculate CEP special antidumping duty assessment According to CEMEX and CDC, Article profit is proper. The CIT’s decision in requirements for regional-industry cases 4.2 compels the Department to refrain U.S. Steel is neither final nor binding. set forth in Article 4.2 because it has from assessing duties on its subject

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13164 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices merchandise destined for consumption for the seventh review period, this issue U.S. law must be administered in outside the Southern Tier. CDC is not ripe for the Department’s conformity with the GATT. contends that the exception to Article consideration. However, assuming it is The petitioner also argues that the 4.2 does not apply because none of the ripe for decision, the petitioner argues Department lacks the statutory authority conditions necessary to justify an that the Department need only consider to terminate the antidumping order or exception to Article 4.2 are satisfied in whether its assessment of antidumping assess duties regionally based on a this case. First, both CEMEX and CDC duties under the order is consistent with claim that the Department did not offer assert that there is no U.S. the U.S. statute. The petitioner asserts respondents an opportunity to enter into Constitutional prohibition against that, because the Department’s actions a suspension agreement. Citing the levying antidumping duties on a are consistent with the law, the Sixth Review Final Results, 63 FR at regional basis. CEMEX and CDC Department need not consider 12766, the petitioner notes that no contend that neither the port-preference respondents’ remaining arguments. The respondent appealed the Department’s clause of the Constitution, which petitioner contends that CEMEX, in final determination in 1990 based on an prohibits Congress from regulating referring only to Article 4.2, ignores the alleged lack of an opportunity for a commerce or revenue of ports in a U.S. law on this issue. suspension agreement and the discriminatory manner that would The petitioner asserts that the Department’s determination in the confer preferential treatment for the Department must act within its original investigation ‘‘is final and ports of one state over the ports of authority under sections 736(d)(1)–(2) binding on all persons, including the another state, nor the uniformity clause, and 734(m)(1)–(2) of the Act, which Department.’’ The petitioner also asserts which requires the uniform imposition were amended by the URAA to conform that neither the statute nor the of taxes throughout the United States, to the regional-industry provisions of Department’s regulations authorize the render the regional assessment of the Antidumping Agreement. The Department to rescind a determination antidumping duties unconstitutional, petitioner contends that these made in the original investigation and citing U.S. Const. Art. I, Sec. 9, cl. 6, provisions are inapplicable to revoke the order in the context of an and Art. I, Sec. 8, cl. 1. CDC argues respondents and thus confer no administrative review. The further that the United States has never authority upon the Department to Department’s authority in an explained its theory that implementing refrain from assessing antidumping administrative review is limited to the general assessment rule would result duties outside the Southern Tier. The calculating a margin and setting new in a constitutional violation. petitioner asserts that sections 736(d)(1) cash deposit rates, the petitioner asserts, Next, CDC contends that the and 734(m)(1)–(2) of the Act only apply citing the NAFTA binational panel condition by which the Department in investigations and not reviews. decision for the Third Review Final would be exempted from assessing Second, the petitioner asserts that both Results. antidumping duties regionally has not CEMEX and CDC do not qualify for the The petitioner also notes that CDC’s been satisfied. CDC argues that the regional assessment of duties under claim that the Department neglected to Department did not permit CDC to enter section 736(d)(2) of the Act because offer an opportunity for a suspension into a suspension agreement at the time both respondents exported subject agreement is barred by the statute of of the original investigation because, at merchandise into the Southern Tier limitations, by res judicata, and because the time of the investigation, the during the period of investigation (POI). CDC failed to exhaust administrative Department’s policy was one of refusal Third, the petitioners contend, the remedies in the original investigation. to enter into suspension agreements. Department has no obligation under Finally, the petitioner notes that, even if Moreover, CDC maintains, the sections 734(m)(1)–(2) of the Act to offer it were necessary to discuss the issue, Department’s decision to collapse respondents a suspension agreement Article 4.2 of the Antidumping CEMEX and CDC in the original because the Department may only Agreement does not require assessment investigation diminished CDC’s accept a suspension agreement during of duties only on imports of subject opportunity further to enter into a the pendency of an investigation or merchandise consigned for suspension agreement. CDC also argues within 60 days after the publication of consumption in the Southern Tier. The that the U.S. implementation included the antidumping order. For these petitioner argues that the Constitution no provisions by which the regional- reasons, the petitioner concludes, the bars regional assessment of duties, the assessment rules could apply to cases Department complied fully with U.S. respondents had the opportunity to predating the URAA. CDC argues the law. enter into a suspension agreement condition that duties cannot be levied In addition, the petitioner argues that during the original investigation, and only on products of specific producers the Department cannot ‘‘implement’’ its the Act complies with the requirement which supply the area in question has U.S. obligations under Article 4.2 that antidumping duties be applied not been met because the language of because the Tokyo Round Antidumping nationwide if they cannot be assessed Section 218 of the URAA and the Code is without legal force and only only on the products of exporters in the Department’s regulations demonstrate assumes binding character through region. that assessment on less than a national implementing legislation enacted by Department’s Position: Before basis is possible. CDC contends that the Congress. Citing the legislative history considering respondents’ substantive fact that Congress enacted Section 218 of the Trade Agreements Act of 1979 arguments on this issue, we disagree with language calling for the regional and the URAA, the petitioner asserts with the petitioner’s contention that this assessment of duties attests to the that Congress intended U.S. law to issue is not ripe for consideration since absence of a U.S. constitutional prevail in the event of a conflict we have not yet assessed duties prohibition against regional assessment. between U.S. law and these Agreements. pursuant to the results of this The petitioner responds that the Citing inter alia, Suramerica and administrative review. The purpose of Department has assessed antidumping Footwear Distrib. And Retailers of Am. an administrative review is to ‘‘review duties properly on all nationwide v. United States, 852 F.Supp. 1078 (CIT and determine * * * the amount of any entries of the subject merchandise. First, 1994), appeal dismissed, 43 F.3d 1486 antidumping duty’’ (section 751(a)(1)(B) the petitioner suggests that, since the (Fed. Cir. 1994), the petitioner notes that of the Act) and the results of an Department has not yet assessed duties courts have rejected the argument that administrative review ‘‘shall be the

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Therefore, the Department’s merchandise for sale in the region respondents an opportunity to enter into assessment procedures as they pertain during the period of investigation.’’ a suspension agreement in this review to the antidumping duties determined Because the original Mexican cement does not violate section 734(m) of the in this review are an appropriate issue antidumping investigation occurred in Act. for the Department to consider for these 1989–90 and the URAA applies only to Moreover, although CEMEX argues final results. investigations initiated on the basis of that the posting of cash deposits should Turning to arguments by CEMEX and petitions filed after January 1, 1995, this not be required of CEMEX’s entries CDC, we disagree that we should provision does not apply to CEMEX’s outside the Southern Tier, the Act exempt entries of subject merchandise and CDC’s exports. However, even if contains no provision and describes no exported into regions other than the section 736(d)(1) of the Act did apply to circumstances under which we may ‘‘Southern Tier’’ from antidumping this review, since CEMEX and CDC waive an importer’s requirement to post duties and cash deposits. Respondents’ exported subject merchandise into the cash deposits except when conducting argument focuses on the compatibility region during the POI, the Department new-shipper reviews under section of the U.S. antidumping law with the directed properly that antidumping 751(b) of the Act. Accordingly, for these United States’ obligations under the duties be assessed on all entries of final results, we will require the posting URAA. Specifically, respondents merchandise produced by CEMEX and of cash deposits and assess antidumping suggest that the U.S. antidumping law, CDC. For the same reasons, contrary to duties on entries of CEMEX’s and CDC’s as amended by the URAA, does not CDC’s argument, section 351.212(f) of subject merchandise that have entered implement the obligations contained in the Department’s regulations does not or will enter for consumption both Article 4.2 of the Antidumping apply to CEMEX’s and CDC’s entries. inside and outside the Southern Tier. Agreement, which governs the Moreover, section 736(d)(2) of the Act As demonstrated above, the assessment of antidumping duties in provides that, ‘‘after publication of the Department’s decision to assess duties regional industry cases, properly. antidumping order, if the administering on all subject merchandise exported The Department’s determinations in authority finds that a new exporter or into the United States by CEMEX and an antidumping proceeding are producer is exporting the subject CDC is consistent with the antidumping governed by the U.S. antidumping merchandise for sale in the region statute. Indeed, neither CEMEX nor CDC statute—specifically, Title VII of the concerned, the administering authority argue that the Department’s actions fail Tariff Act of 1930, as amended by the shall direct that duties be assessed on to conform to these statutory provisions. URAA in 1995. As numerous courts the subject merchandise of the new For purposes of this administrative have recognized, in the event of a exporter or producer consistent with the review, therefore, the Department need conflict between a GATT obligation and provisions of section 751(a)(2)(B).’’ not consider respondents’ arguments a statute, the statute must prevail. See Because neither CEMEX nor CDC is a further concerning the United States’ Federal Mogul Corp. v. United States, 63 new exporter or producer as described implementation of its obligations under F.3d 1572, 1581 (Fed. Cir. 1995), citing in this provision, section 751(a)(2)(B) of the Antidumping Agreement. Suramerica DeAleaciones Laminadas v. the Act is inapplicable to the assessment Nonetheless, we disagree with United States, 966 F.2d 660, 668 (Fed. of antidumping duties on subject respondents’ contention that the Cir. 1992). Congress codified this merchandise exported to the United antidumping statute does not fully principle in the URAA. Section 102 of States by CEMEX or CDC. implement the United States’ the URAA states that ‘‘[n]o provision of Finally, pursuant to section 734(m) of obligations under the Antidumping any of the Uruguay Round Agreements, the Act, in an investigation in which the Agreement. As the Federal Circuit in nor the application of any such ITC makes a regional-industry Federal Mogul explained: ‘‘GATT provision to any person or determination, the Department ‘‘shall agreements are international obligations, circumstance, that is inconsistent with offer exporters of the subject and absent express Congressional any law of the United States shall have merchandise who account for language to the contrary, statutes should effect.’’ See also SAA at 659 (‘‘The WTO substantially all exports of that not be interpreted to conflict with will have no power to change U.S. law. merchandise for sale in the region international obligations.’’ Federal If there is a conflict between U.S. law concerned the opportunity to enter into Mogul, 63 F.3d at 1581. Indeed, the U.S. and any of the Uruguay Round (a suspension) agreement.’’ Any such Supreme Court elaborated on this canon agreements * * * U.S. law will take agreement is ‘‘subject to all the of construction. ‘‘It has also been precedence.’’). Thus, even if requirements imposed under this observed that an act of Congress ought respondents were correct in asserting section for other (suspension) never to be construed to violate the law that the statutory provisions relating to agreements, except that if the of nations, if any other possible regional assessment of duties conflicted Commission makes a regional industry construction remains * * *.’’ Murray v. with the obligations contained in Article determination * * * in its final Schooner Charming Betsy, 6 U.S. (2 4.2 of the Antidumping Agreement, the determination * * * but not in the Cranch.) 64, 118 (1804). See also Department must act in conformity with preliminary affirmative determination Fundicao Tupy S.A. v. United States, the antidumping statute. ** * any agreement * * * may be 652 F. Supp. 1538, 1543 (CIT 1987)(‘‘An Sections 736(d)(1)–(2) and 734(m) of accepted within 60 days after the interpretation and application of the the Act govern the assessment of antidumping order is published under statute which would conflict with the antidumping duties in regional-industry section 736.’’ GATT Codes would clearly violate the cases. To this extent, section 736(d)(1) Under section 734(b) of the Act, we intent of Congress.’’); Footwear Dist. and of the Act provides that, in an may only accept a suspension Retailers of America v. United States, investigation in which the ITC makes a agreement during the pendency of an 852 F. Supp. 1078, 1092–93 (CIT 1994), regional-industry determination, the investigation. Because the Department quoting Restatement (Third) of the

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Foreign Relations Law of the United differences in the LOT and that ‘‘the merchandise. The petitioner maintains States, at 115, comment a, p. 64 (1987) amount of the adjustment shall be based that, in the fifth and sixth reviews, the (‘‘Congress does not intend to repudiate on the price differences between the two Department found that bulk and bagged an international obligation of the United levels of trade in the country in which sales ‘‘constitute identical States * * * Therefore, when an act of NV is determined.’’ Therefore, CEMEX merchandise,’’ citing Fifth Review Final Congress and an international argues, if the Department uses bagged Results at 17165, and Sixth Review Final agreement * * * relate to the same cement sales in its calculation of NV for Results at 12777. The petitioner argues subject, the courts, regulatory agencies, the final results, it must deduct the that CEMEX misinterpreted the and the Executive Branch will endeavor difference in average prices for bag and Department’s findings by stating that the to construe them so as to give effect to bulk cement from the net price of Department was attempting to both.’’). Because qualifying exporters are bagged cement. ‘‘equalize’’ the net prices of bagged and given an opportunity for exemption CDC argues that the Department bulk cement by excluding the cost of from the assessment of antidumping should compare bag sales in the United packing from NV. In fact, the duties, the statutory scheme described States to bag sales in the home market Department was making adjustments for above is consistent with Article 4.2 of and bulk sales in the United States to packaging differences which, the the Antidumping Agreement. Thus, the bulk sales in the home market in order petitioner asserts, accounted for the United States has fully implemented its to make a fair comparison without ‘‘only difference between these obligations with respect to the distortions. CDC states that, in past products.’’ assessment of antidumping duties in segments of this and other cement The petitioner contends that the regional industry cases. proceedings, the Department made Department rejected CEMEX’s argument We also disagree with CDC’s comparisons on a bag-to-bag and bulk- that sales of bagged cement were at a contention that we must terminate the to-bulk basis, citing Original LTFV different LOT than the HM sales of bulk review and revoke the underlying Investigation, 55 FR at 29245, and cement in the fifth and sixth reviews antidumping duty order because U.S. Concurrence Memorandum, Preliminary and that CEMEX has not demonstrated implementation of its international Determination: Gray Portland Cement that the facts in this review warrant a obligations is allegedly untimely and and Clinker from Venezuela (October different result. inadequate. First, as we stated in the 28, 1991). CDC acknowledges that, in Finally, the petitioner claims that third, fourth, fifth and sixth the fifth and sixth reviews of this order, CEMEX has not satisfied the administrative reviews and have when CDC made sales of bag and bulk Department’s two-step LOT analysis. reaffirmed in the ‘‘Revocation of cement in the home market and only First, the petitioner argues that CEMEX Underlying Order’’ section, above, we bulk cement in the United States, the has not demonstrated that bagged and have no authority to revoke the order. Department compared both bag and bulk cement are sold at different points Third Review Final Results. See also bulk sales made in the home market to in the chain of distribution. Second, the Fourth Review Final Results; Fifth bulk sales made in the United States. petitioner argues, CEMEX has not Review Final Results; and Sixth Review However, in this review, CDC argues, established differences in selling Final Results. Specifically, neither the Department should make functions with respect to different CEMEX nor CDC appealed the comparisons on a bag-to-bag and bulk- customer classifications. In conclusion, Department’s final determination based to-bulk basis as it did in the original the petitioner urges the Department to upon the Department’s alleged refusal to investigation under similar use bagged and bulk in its calculation of offer a suspension agreement. Thus, the circumstances. CDC asserts that NV. antidumping duty order, based upon the comparing bulk and bag separately in Department’s Position: We agree with Department’s LTFV determination, is both markets ensures that no addition to the petitioner and have included all final and binding. HM price is necessary for the bulk HM Type I sales, bulk and bagged, in the sales and the Department need only calculation of NV. The only difference 11. Bulk vs. Bag Sales subtract the HM packing from and add between these products is the CEMEX argues that the Department U.S. packing to NV for the HM bagged packaging; therefore, we have made an should calculate NV based only on bulk sale. adjustment downward to NV to account sales rather than combining both bulk The petitioner responds that the for packaging differences. In addition, as and bagged sales. CEMEX argues that Department compared both bulk and stated in the LOT section of this notice, the Department justified its use of bagged sales to the United States with we have determined that CEMEX sold at bagged cement sales in its calculation bulk and bagged sales in the home one LOT in the home market; therefore, incorrectly on the premise that, by market in the preliminary results distinguishing discrete channels of excluding the cost of packing from NV, correctly. The petitioner maintains that, distribution is not warranted as there is it made the price of cement in bags except for packaging, the cement sold in only one LOT. Therefore, we have not equal to the price of bulk cement. both bulk and bagged form is identical. calculated NV for each channel of CEMEX argues that consumers are The petitioner also argues that CDC has distribution as CEMEX requested and willing to pay a premium for the not established that the Department has have used our standard methodology for convenience of buying a bag of cement a rule of comparing bulk sales only to comparing NV to U.S. sales for purposes and that this fact is supported by record bulk sales and bagged sales only to of the final results. evidence. Additionally, CEMEX argues bagged sales which, the petitioner that, based on commercial realty, sales asserts, would be contrary to the statute. 12. Rebates of cement in bags are at a different LOT The petitioner states that sections The petitioner argues that the than sales in bulk. CEMEX maintains 773(a)(1)(A)–(B) and section 771(16) of Department should deny CEMEX’s that section 773(a)(7)(A) of the Act the Act require the Department to claimed adjustment to NV for rebates. requires the Department to adjust the compare U.S. sales with sales of the First, it claims that, prior to sale, sale price in the comparison market to ‘‘foreign like product,’’ which is defined CEMEX did not communicate the ‘‘make due allowances’’ for any as the identical merchandise sold in the conditions to be fulfilled to qualify for difference in the comparison market home market or, if there is no identical the rebate and the amount of the rebate, shown to be ‘‘wholly or partly’’ due to HM merchandise, the most similar which are requirements the Department

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13167 has established for granting rebate recognizes that it is not unusual for Sixth Review Final Results, we have claims (citing Certain Corrosion- price adjustments to be granted to allowed adjustments for rebates. Resistant Carbon Steel Flat Products customers on a specific basis. 13. Freight And Certain Cut-To-Length Carbon Steel Additionally, CEMEX claims that the Plate From Canada, 61 FR 13815, petitioner mischaracterizes the record Comment 1: The petitioner argues that 13822–23 (1996), and Certain Corrosion- evidence by stating that CEMEX did not the Department should deny CEMEX’s Resistant Carbon Steel Flat Products provide additional information reported HM freight adjustment. The And Certain Cut-To-Length Carbon Steel regarding the rebates reported in the petitioner argues that CEMEX did not Plate From Canada, 63 FR 12725, 12741 REBALH field. Contrary to the demonstrate adequately that it is (1998)). The petitioner also asserts that petitioner’s argument, CEMEX asserts entitled to the adjustment on HM sales. CEMEX must establish that it granted that, for the non-transaction-specific The petitioner contends that movement the rebate pursuant to its standard rebates, CEMEX identified where the expenses are allowable under the statute business practice or under a pre- allocated rebates were reported, the and under the Department’s practice established program and cites reasons why it allocated them, how it only if they are reported based on the Antifriction Bearings (Other Than allocated them, and why the allocation actual, transaction-specific expense or Tapered Roller Bearings) and Parts methodology it used was not distortive. on an allocation methodology that is not Thereof From The Federal Republic Of Therefore, CEMEX concludes, the distortive. The petitioner argues that Germany, 54 FR 18992, 19056 (1989), Department’s acceptance of the rebate CEMEX did not report its HM freight and Portable Electric Typewriters From claims was appropriate. expenses on a transaction-, customer-, Japan, 56 FR 14072, 14078 (1991). Department’s Position: We allow point-of-sale- or even a plant-specific Second, the petitioner argues that the adjustments to NV for rebates if we are basis and has not demonstrated that it allocation methodology CEMEX used for satisfied that such rebates reflect the was not feasible to report these expenses reporting certain rebates is distortive respondent’s normal business practice on a such a basis. The petitioner notes because the allocated rebates may and not an attempt by the respondent to specifically that CEMEX’s record- include rebates on sales of non-subject eliminate dumping margins once we keeping system compiles freight-cost merchandise. In this review, the initiate an antidumping investigation or data on a transaction-specific basis and petitioner contends, CEMEX used two review. See Certain Corrosion-Resistant thus CEMEX has failed to demonstrate Carbon Steel Flat Products From Japan, different methods for reporting rebates why it cannot provide the Department 63 FR 47465, 47468 (1998). In this on HM sales. The petitioner with freight expense information on the respect, based on CEMEX’s response acknowledges that, in most instances, same basis. The petitioner argues further and our verification of the response, we CEMEX reported rebates on a that CEMEX’s response demonstrates are satisfied that rebates are a long- transaction-specific basis. However, the CEMEX either did not report freight on established business practice of CEMEX petitioner argues that CEMEX reported a type- and presentation (bulk vs. bag)- and that CEMEX’s customers had a rebates in the REBALH field that it specific basis or failed to report a based on an allocation methodology, but reasonable expectation of receiving such significant volume of Type II cement it has not provided any information to rebates based on their long-standing sold in the home market. The petitioner demonstrate that this allocation is the business relationships with CEMEX. maintains that CEMEX provided an most specific calculation feasible. With respect to CEMEX’s reporting insufficient explanation for this Additionally, the petitioner claims that methodology, we have allowed discrepancy. The petitioner also argues CEMEX has provided no information CEMEX’s claimed rebate adjustments that CEMEX has not demonstrated that confirming that it paid allocated rebates because the data was submitted in its allocation methodology is not on sales of subject merchandise. accordance with our methodology and CEMEX argues that the Department’s was substantiated at verification. These distortive of the actual, transaction- preliminary results adjusted NV rebates were reported in the same specific freight cost. The petitioner correctly for CEMEX’s verified rebates. manner as the sixth review where we notes that, because cement costs vary CEMEX argues that the Department has granted the adjustment. While the widely depending upon transportation a long-standing practice of allowing a Department prefers that discounts, mode and shipment distances, CEMEX’s claimed rebate without documentary rebates, and other price adjustments be company-average reporting evidence if the rebates are consistent reported on a transaction-specific basis, methodology does not account for with a respondent’s normal business the Department has long recognized that potentially significant variances in practices and its past dealings with its some price adjustments are not granted freight costs among sales. The petitioner customers. CEMEX notes that it to customers on that basis and thus also asserts that CEMEX has not provided detailed descriptive data of its cannot be reported on that basis. demonstrated that freight provided by rebate program in its response and Generally, ‘‘we have accepted claims for affiliated freight companies was at arm’s adequate sample documentation. discounts, rebates, and other billing length. CEMEX rejects the petitioner’s claim adjustments as direct adjustments to CEMEX argues that the Department that CEMEX’s customers were not aware price if we determined that the deducted its reported HM freight of its rebate policies at the time they respondent, in reporting these expense from NV properly. CEMEX were purchasing cement from CEMEX. adjustments, acted to the best of its argues that it reported HM freight in the According to CEMEX, as all rebates ability and that its reporting most specific manner permitted by its were negotiated on a customer-specific methodology was not unreasonably record-keeping system and that its basis, customers were aware of the distortive.’’ See Antifriction Bearings methodology is not distortive. CEMEX discounts for which they were eligible. (Other than Tapered Roller Bearings) observes that the Department rejected Next, CEMEX rebuts the petitioner’s and Parts Thereof from France, et al., identical arguments made by the claim that the Department has a long- Final Results of Antidumping Duty petitioner concerning HM freight standing policy to reject claims for a Administrative Reviews, 62 FR 2081 expenses in the final results of the fifth rebate adjustment unless they are (1997). Based on CEMEX’s responses to and sixth administrative reviews. reported on a transaction-specific basis. our questionnaire and our verification of CEMEX also contends that it did present CEMEX argues that the Department those responses, and consistent with our evidence that the expenses for freight

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Thus, we have allowed specific a basis as is feasible given merchandise or for products sufficiently CDC’s claimed adjustment. CEMEX’s accounting system, and that similar to subject merchandise, we can 15. Pre-Sale Warehousing they provide a reasonable estimate of conclude the relative freight costs actual transaction-specific freight would be virtually identical so we find CEMEX argues that the Department expenses. Thus, it would be that CDC’s methodology is not should have deducted pre-sale inappropriate to apply adverse facts unreasonably distortive. Therefore, we warehousing expenses in Mexico from available to CEMEX’s freight expense by have deducted the reported HM expense NV. CEMEX cites section 773(a)(6)(B)(ii) rejecting the claimed adjustment. incurred by the affiliate from NV for the of the Act which requires the Furthermore, with regard to the final results. Department to reduce NV if included in petitioner’s assertion that CEMEX did the price, by the amount of not demonstrate that the expense for 14. Other Adjustments transportation and other expenses, freight provided by affiliated parties was The petitioner argues that CDC is not including warehousing expenses, at arm’s length, we find that, based on entitled to a specific deduction included incurred in bringing the foreign like data CEMEX submitted, the expense for under certain other price adjustments in product from the original place of freight provided by unaffiliated parties the OTHADJH field in its HM sales shipment to the place of delivery to the is generally higher than the expense for database. The petitioner claims that purchaser. As further support, CEMEX freight provided by affiliated parties. CDC did not provide documentation also cites the SAA at 827. CEMEX See Exhibit B–8–C of CEMEX’s demonstrating a standard policy or any argues further that § 351.401(e)(2) of the December 8, 1997, response. Based on agreements communicated to its Department’s regulations provides that this fact, we determine that the expense customers prior to sale and that the the warehousing expenses incurred after for freight provided by affiliated parties price adjustment benefits consumers of the subject merchandise leaves the was at arm’s length. Therefore, we have an out-of-scope product rather than original place of shipment are to be deducted CEMEX’s claimed HM freight subject merchandise. included in the adjustments for expense for Type I cement from NV for CDC disagrees and asserts that the movement expenses. In addition, the final results. Department deducted CDC’s OTHADJH CEMEX cites section 773a(6)(B)(ii) of Comment 2: The petitioner maintains from NV correctly. CDC states that in the Act, which recognizes that that CDC has failed to demonstrate other cases the Department has allowed warehousing expenses incurred at entitlement to a freight expense similar post-sale price adjustments facilities other than the production site adjustment for sales by its affiliate where it was satisfied that the are considered part of the movement Construcentro. Because CDC’s responses adjustments were not attributable to a expenses and should therefore be demonstrate that CDC’s freight-expense company’s attempt to lower or eliminate deducted from the sales price. methodology for Construcentro results antidumping margins. CDC states that, CEMEX disagrees with the in commingled expenses for subject and in its case, there is no evidence on the Department’s statement in its non-subject merchandise, the petitioner record to suggest that these adjustments Calculation Memorandum of August 31, argues, and because CDC has not were an attempt to manipulate prices to 1998, that it had reviewed the record of demonstrated, in accordance with the lower its margin. On the contrary, it the instant review and found that there preamble to the Department’s notes that the Department has accepted had been no change in the reporting regulations that its methodology is not these types of adjustments in the fifth methodology of this item from previous distortive, the Department should deny and sixth reviews. CDC also states that reviews. CEMEX claims that it provided CDC a freight-expense adjustment for it provided sample credit memoranda to the Department with new information sales by Construcentro. support its claim that customers were such as the per-ton cost of pre-sale CDC argues that the Department aware of the discount prior to sales. warehousing incurred in Mexico and deducted its reported HM inland freight CDC also notes that the Department that cost was calculated by company, by incurred by Construcentro from NV rejected in past administrative reviews month, and reflects only the costs properly. CDC argues that its allocation the petitioner’s argument that the associated with the remote terminals. is the most specific possible given its discount is not awarded to cement The petitioner agrees with the accounting system. CDC claims further customers. Department’s decision not to include that, because the majority of its total Department’s Position: Based on CEMEX’s HM pre-sale warehousing shipments were of subject cement, the information CDC submitted and our expenses as movement expenses. It freight expenses associated with its verification of similar information in asserts that, since the Department was shipments is not inherently distortive. prior reviews, we are satisfied that the not able to verify CEMEX’s reported pre- Finally, CDC observes that the price adjustments in question are sale warehousing expenses and no new Department made an adjustment for this consistent with CDC’s past business information has been provided, the expense in the fifth and sixth practices and that CDC’s customers Department has no reason to change its administrative reviews where CDC used would be knowledgeable of these treatment of these expenses. The the same methodology. practices based on long-term business petitioner contends that the expense Department’s Position: As in prior relationships with CDC. Also, no record figures CEMEX reported reflect reviews, we find that CDC reported its evidence for this review indicates that warehouses at locations remote from freight expenses to the best of its ability we should not conclude, as we have in CEMEX’s production plants. In given its accounting system. prior reivews, that the price adjustments conclusion, the petitioner cites the Furthermore, the record indicates that at covered by this item were paid to Department’s regulations, the statute, least 70 percent of this particular cement customers and not attributable and legislative history to define

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The petitioner agrees with Department’s Position: We agree with the petitioner’s argument that the CDC. the petitioner and have not deducted methodology CEMEX used to report Department’s Position: We agree with pre-sale warehousing expenses from these rebates was distortive, see our CDC and the petitioner and have NV. CEMEX did not, as in prior reviews, position for comment 11, above. corrected this ministerial error for the submit its data in accordance with the Comment 2: CEMEX claims that the final results. Department’s instructions. Because Department used the wrong month Comment 9: CEMEX claims that, in there were no changes in CEMEX’s variable in recalculating credit for the calculating the assessment rates, the reporting methodology from previous arm’s-length test. The petitioner agrees Department should have included the reviews, we again denied the with CEMEX. entered value of cement used in adjustment (see Calculation Department’s Position: We agree and CEMEX’s further-manufactured sales. Memorandum, dated August 31, 1998, have corrected this clerical error for the The petitioner agrees with CEMEX. located in Room B–009 of the final results. Department’s Position: We agree with Department’s main building). Comment 3: CEMEX claims that, CEMEX and the petitioner and have when the Department recalculated its 16. Advertising Expenses corrected this error for the final results. home-market imputed expenses using CDC argues that the Department its revised interest rates, the Department [FR Doc. 99–6402 Filed 3–16–99; 8:45 am] treated CDC’s HM advertising expenses inadvertently used the cumulative BILLING CODE 3510±DS±P incorrectly as indirect rather than direct average interest rate instead of the selling expenses. CDC maintains that it monthly interest rate although CEMEX DEPARTMENT OF COMMERCE demonstrated, through sample used the monthly interest rates in its documents, that it incurs these expenses original submission. The petitioner International Trade Administration directly in conjunction with sales of the argues that the Department apparently product under review and the used a monthly average interest rate. [A±580±825] advertising is directed towards the Department’s Position: We agree with customer’s customer. CEMEX and have corrected this clerical Oil Country Tubular Goods from The petitioner disagrees and asserts error for the final results. Korea: Final Results of Antidumping that the Department treated these Comment 4: CDC claims that the Duty Administrative Review expenses as indirect selling expenses Department mismatched interest rates in AGENCY: Import Administration, correctly. The petitioner maintains that recalculating its home-market credit International Trade Administration, the record evidence demonstrates that, expenses by using the rates that were off U.S. Department of Commerce. as in the previous review, CDC’s by one month. The petitioner agrees ACTION: Notice of Final Results of the advertising is corporate-image with CDC. advertising and is not related directly to Department’s Position: We agree and Antidumping Duty Administrative sales of gray portland cement. have corrected this clerical error for the Review of Oil Country Tubular Goods Department Position: As we have final results. From Korea. noted in prior reviews, we normally Comment 5: CDC argues that the SUMMARY: In response to a request from consider direct expenses as expenses Department should use 360 days in SeAH Steel Corporation (‘‘SeAH’’), the that result from, and bear a direct recalculating HM credit expenses Department of Commerce (‘‘the relationship to, sales of products under because that is the figure respondent Department’’) is conducting an review. With respect to advertising, the used in its original credit calculation. administrative review of the expense must be assumed on behalf of Department’s Position: We agree with antidumping duty order on oil country a customer and must be specifically CDC. Because CDC used the same tubular goods from Korea. This review associated with sales of subject number of days in its U.S. credit covers one manufacturer/exporter of the merchandise for the Department to treat expense calculation, we have changed subject merchandise to the United this expense as a direct selling expense. our calculation of CDC’s HM credit States, SeAH, and the period August 1, Although CDC argues that it submitted expenses to reflect a 360 day-credit 1996 through July 31, 1997, which is the evidence to support its claim that the calculation. second period of review (‘‘POR’’). expenses were direct, we disagree. The Comment 6: CDC argues that the We have made a final determination advertising at issue is associated with Department should convert packing that SeAH made sales below normal sales of subject and non-subject cement expenses from pesos to U.S. dollars value (‘‘NV’’). We will instruct the U.S. and promotes the overall corporate before making the packing adjustment to Customs Service to assess antidumping image of CDC rather than promoting NV. The petitioner agrees with CDC. duties based on the difference between Department’s Position: We agree with sales of gray portland cement. the constructed export price (‘‘CEP’’) CDC and the petitioner and have Therefore, consistent with our prior and the NV. practice, we have treated these expenses corrected this ministerial error for the as indirect selling expenses in the home final results. EFFECTIVE DATE: March 17, 1999. market. Comment 7: CDC argues that the FOR FURTHER INFORMATION CONTACT: Department should also add U.S. Doug Campau, Steve Bezirganian, or 17. Ministerial Errors packing to NV rather than deduct it Steven Presing, Import Administration, Comment 1: CEMEX claims that the from U.S. price. The petitioner agrees International Trade Administration, Department did not deduct certain with CDC. U.S. Department of Commerce, 14th rebates from NV inadvertently. The Department’s Position: We agree with Street and Constitution Avenue, NW, petitioner argues that, because the CDC and the petitioner and have Washington, DC 20230; telephone: (202)

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482–3964, –0162, or –0194, alloy), whether seamless or welded, Comment 1: Payment Date/Credit respectively. whether or not conforming to American Expenses SUPPLEMENTARY INFORMATION: Petroleum Institute (‘‘API’’) or non-API Respondent argues the Department specifications, whether finished or The Applicable Statute incorrectly concluded that SeAH unfinished (including green tubes and extended credit to one of its customers Unless otherwise indicated, all limited service OCTG products). This beyond the reported payment date of citations to the Tariff Act of 1930, as scope does not cover casing or tubing February 20, 1997 for several sales amended (the Act), are to the provisions pipe containing 10.5 percent or more of where SeAH had not received payment. effective January 1, 1995, the effective chromium, or drill pipe. The OCTG Respondent also believes the date of the amendments made to the Act subject to this order are currently Department incorrectly imputed a by the Uruguay Round Agreements Act classified in the Harmonized Tariff payment date other than the date on (URAA). In addition, unless otherwise Schedule of the United States which payment for the involved sales indicated, all citations to the (‘‘HTSUS’’) under item numbers: was actually made. Respondent claims Department’s regulations are to 19 CFR 7304.29.10.10, 7304.29.10.20, that payment was in fact made for the part 351 (1998). 7304.29.10.30, 7304.29.10.40, involved sales, but that such payment Background 7304.29.10.50, 7304.29.10.60, was misdirected to and misappropriated 7304.29.10.80, 7304.29.20.10, On August 11, 1995, the Department by an unrelated third party. published in the Federal Register (60 7304.29.20.20, 7304.29.20.30, For the involved sales, Panther FR 41057) the antidumping duty order 7304.29.20.40, 7304.29.20.50, Supply, Inc. (Panther), a sales division on oil country tubular goods from 7304.29.20.60, 7304.29.20.80, of State Pipe and Supply Co. (an affiliate Korea. On August 4, 1997, the 7304.29.30.10, 7304.29.30.20, of respondent), sold merchandise to an Department published in the Federal 7304.29.30.30, 7304.29.30.40, unaffiliated purchaser. According to Register (62 FR 41925) a notice 7304.29.30.50, 7304.29.30.60, respondent, the unaffiliated purchaser indicating an opportunity to request an 7304.29.30.80, 7304.29.40.10, accidentally directed payment for these administrative review of this order for 7304.29.40.20, 7304.29.40.30, sales to the wrong party. This other the period August 1, 1996, through July 7304.29.40.40, 7304.29.40.50, party then wrongfully misappropriated 31, 1997, and on August 29, 1997, SeAH 7304.29.40.60, 7304.29.40.80, the payment intended for Panther. requested an administrative review for 7304.29.50.15, 7304.29.50.30, Panther sued to secure payment, which its entries during that period. On 7304.29.50.45, 7304.29.50.60, in turn led to a June 24, 1998 summary September 25, 1997, in accordance with 7304.29.50.75, 7304.29.60.15, judgment order awarding full payment section 751 of the Act, we published in 7304.29.60.30, 7304.29.60.45, to Panther, plus interest beginning the Federal Register a notice of 7304.29.60.60, 7304.29.60.75, February 20, 1997. initiation of an administrative review of 7305.20.20.00, 7305.20.40.00, In its preliminary results, the this order for the period August 1, 1996 7305.20.60.00, 7305.20.80.00, Department did not take the court- through July 31, 1997 (62 FR 50292). 7306.20.10.30, 7306.20.10.90, ordered payments into account in Under section 751(a)(3)(A) of the Act, 7306.20.20.00, 7306.20.30.00, determining dates of payment. Instead, the Department may extend the 7306.20.40.00, 7306.20.60.10, the Department set the payment date for deadline for completion of an 7306.20.60.50, 7306.20.80.10, and these sales equal to the date of the last administrative review if it determines 7306.20.80.50. The HTSUS item submission made by SeAH prior to that it is not practicable to complete the numbers are provided for convenience determination of the preliminary results review within the statutory time limit of and Customs purposes. The written (August 19, 1998), and recalculated 365 days. On January 30, 1998, the description remains dispositive of the credit expense accordingly. Department published a notice of scope of this review. According to respondent, the extension of the time limit for the Department normally constructs Verification preliminary results in the review to imputed credit costs to represent credit that a seller extends to a customer for August 31, 1998. See Oil Country We verified cost and sales information the time between shipment and Tubular Goods from Korea; Extension of provided by SeAH, examining relevant payment. Respondent states that such Time Limit for Antidumping Duty accounting and financial records, costs are opportunity costs to the seller Administrative Review, 63 FR 4624. On production records, and original sales for not having possession of payment December 21, 1998, the Department documentation. Our verification results funds between the dates of shipment extended the deadline for determination are outlined in the verification report and actual payment. Respondent of the final results in this case to March from Abdelali Elouaradia and Juanita H. 8, 1999. See Extension of Time Limit for emphasizes that the basis for this theory Chen to The File, dated February 12, rests on the concept that the seller Final Results of Antidumping Duty 1999 (‘‘Verification Report’’). Administrative Review of Oil Country incurs an opportunity cost because it Tubular Goods from Korea, 63 FR Analysis of Comments Received voluntarily extends credit to the buyer 70389. until such time as payment is made. The Department is conducting this We gave interested parties an In this case, respondent argues, the review in accordance with section opportunity to comment on the Department was incorrect in assigning 751(a) of the Act. preliminary results. SeAH Steel August 19, 1998 as payment date and in Corporation, Ltd. (‘‘respondent’’) and concluding that the seller was extending Scope of Review Maverick Tube Corp., IPSCO Tubulars credit to one of its customers for two The merchandise covered by this Inc., and Lone Star Steel Co. reasons. First, respondent argues that order is oil country tubular goods (‘‘petitioners’’) submitted case briefs on assigning August 19, 1998 was incorrect (‘‘OCTG’’), hollow steel products of October 16, 1998. SeAH also submitted because a court had already recognized circular cross-section, including only oil a rebuttal brief on October 23, 1998. February 20, 1997 as the date of full well casing and tubing, of iron (other None of the parties requested a public payment. Second, respondent argues than cast iron) or steel (both carbon and hearing. that because the court also awarded

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SeAH interest revenue on the late at Less Than Fair Value: Static Random Petitioners argue the Department should payments from February 20, 1997 Access Memory Semiconductors From correct the margin program to properly forward, any opportunity costs that Taiwan, 63 FR 8909, 8915 (February 23, utilize the recalculated figures for would arise from an extension of credit 1998). Furthermore, neither SeAH nor CREDITU. To this end, petitioners cease to exist. its U.S. affiliates appear to have had a provide a replacement code for the Finally, respondent argues that if the practice of charging U.S. customers margin program used in the Preliminary Department uses any date other than interest on late payments; in response to Results, which designated August 19, February 20, 1997 as payment date for the aforementioned request that the 1998 as payment date for the involved the sales in question, the Department respondent report collected interest sales. must then conform the period used for revenue, the respondent indicated that Respondent contends that the calculation of the imputed credit ‘‘{n}either SeAH nor State charged Department should not correct the expense with a comparable period for customers interest for late payment clerical error identified by petitioners, calculating an interest income offset. To during the POR.’’ See SeAH’s November do so, respondent believes the 12, 1997 Section C response at 31. but should instead determine that the Department must add an additional Consequently, no adjustment for interest date of payment for the sales at issue is day—for each day beyond February 20, revenue is warranted. February 20, 1997, the date of the 1997 that the Department extends the It is the Department’s current practice aforementioned summary judgement. imputed credit periods—for which to calculate imputed credit for unpaid Respondent does not disagree with Panther is entitled to receive interest sales based on the last day of petitioners’ suggested changes to the income. verification. However, in this case use of margin program, and concurs with Petitioners did not submit comments the last day of verification, January 27, petitioners’ claim that the Department related to this issue. 1999, would be inappropriate for several made a clerical error in its preliminary margin calculation. However, Department’s Position reasons. First, in administrative reviews verifications are typically conducted respondent disagrees with the need to Contrary to SeAH’s claim, the prior to the issuance of the Department’s use August 19, 1998 as the payment Department normally calculates credit preliminary results. However, in this date for the sales at issue (those four expense based on the time between case verification was conducted several sales which were the subject of the shipment and actual payment to the months after the issuance of the aforementioned litigation) for the same seller, regardless of the credit terms preliminary results; consequently, using reasons articulated in Comment 1 above. given to a particular customer. For the last day of verification as the basis Department’s Position example, Appendix I at 4 of the for payment date extends the credit Department’s September 16, 1997 period several months beyond what is The Department acknowledges that it Questionnaire (‘‘Questionnaire’’) states typical for unpaid sales, covering a made a clerical error as described above. that credit expense ‘‘is the interest period in which the respondent was The Department has made a correction expense incurred (or interest revenue unable to provide new information. to the margin program and has properly foregone) between shipment of Second, references to ‘‘unpaid’’ sales merchandise to a customer and receipt utilized the recalculated figures for typically involve circumstances in CREDITU, based on a payment date of of payment from the customer which no payment has been made, (emphasis added). Similarly, the August 19, 1998, as described in rather than payment to the wrong party. Comment 1 above. Department asked SeAH to report While it is clear, as stated above, that interest revenue based on the per unit imputed credit is based on the receipt Comment 3: Adding Duty Drawback to interest charges collected on each sale of payment, the particular Third-Country Sales for Margin Analysis for late payment of the invoice circumstances of this case (i.e., payment and Cost Test (emphasis added) (see Questionnaire at made to the wrong party, court C–23). In this case, while a court judgment in favor of the U.S. affiliate, Respondent argues that the decision appears to indicate that State and a credit period of approximately Department should add duty drawback was entitled to receive payment and two years under the aforementioned to third-country comparison market interest revenue, it did not in fact Department practice) suggest that using sales price for purposes of running both receive it. In a previous case involving the last day of verification as the the margin analysis and cost test. For unpaid U.S. sales, the Department payment date would be unwarranted. the preliminary determination, the clearly stated that the issue of concern Consequently, we have decided to use Department used Myanmar as a for purposes of imputed credit was the as payment date the date of the last comparison market. However, receipt of payment: ‘‘Prior to submission made by SeAH prior to respondent points out that in doing so, verification OAB had not indicated in determination of the preliminary results the Department erroneously failed to its original questionnaire response or its (August 19, 1998), the same date we account for duty drawback, as it was not subsequent supplemental responses that utilized in our preliminary results. added into third-country prices for use it had not yet received payment for in the cost test and margin analysis. certain of its U.S. sales’’ (emphasis Comment 2: Clerical Error in Treatment Respondent notes that the Department added). See Brass Sheet and Strip From of CREDITU requested data on duty-inclusive costs, Sweden; Final Results of Antidumping Petitioners allege that the Department but not data on duty exclusive costs. As Administrative Review, 60 FR 3617, made a clerical error in the preliminary a result, in conducting the cost test and 3620 (January 18, 1995). This is also results by using outdated values for margin analysis, the Department true for interest revenue. For example, imputed U.S. credit expense compared duty-inclusive cost with in a recent case the Department ‘‘made (‘‘CREDITU’’) in the margin program. duty-exclusive third-country sale price. circumstance-of-sale adjustments for According to petitioners, the To remedy this alleged error, credit expenses (offset by interest Department recalculated CREDITU to respondent believes the Department revenue actually received by the replace several negative credit values, must include duty drawback in third- respondent)...’’ (emphasis added). See but failed to use the recalculated figures country sales price, and then rerun the Notice of Final Determination of Sales for CREDITU in the margin calculation. cost test and margin analysis.

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Department’s Position inequitable comparison is due to (September 17, 1992). Respondent We agree with the respondent. In a SeAH’s improper calculation of raw claims that according to this case, a recent case involving use of third material input costs. According to party must first demonstrate that import country sales as the basis for normal petitioners, SeAH calculated its raw duty and rebate are directly linked to, value, the Department made ‘‘an material input costs based on the total and dependent upon, one another. Id. adjustment to normal value for duty average cost of domestic and imported Second, a party must demonstrate that drawback’’ for a respondent, Mares steel for each product instead of on the the company claiming the adjustment Australes. See Notice of Final cost of steel for the subject merchandise can demonstrate that there were Determination of Sales at Less Than which only includes imported steel sufficient imports of imported raw Fair Value: Fresh Atlantic Salmon from weighted by the relative amount of the materials to account for the duty duty drawback claimed on each sale. drawback received on the exports of the Chile, 63 FR 31411 (June 9, 1998). The Petitioners note that according to 19 manufactured product. Id. Respondent Department had determined that the U.S.C. 1677b(e), ‘‘the constructed value argues that it has satisfied this two- home market was not viable for that of imported merchandise shall be an tiered test. According to respondent, respondent, and that sales to a third amount equal to the sum of . . . the petitioners’ argument that duty country, Japan, should be used as the cost of materials . . . employed in drawback and import duties included in basis of normal value. See Notice of producing the merchandise.’’ Thus, CV should be the same is not supported Preliminary Determination of Sales at petitioners assert, the statute requires by the law, regulations, or practice, and Less Than Fair Value and Postponement that the cost of materials used in CV be that previous arguments in favor of of Final Determination: Fresh Atlantic the cost of materials for the product imposing such a requirement have been Salmon From Chile, 63 FR 2664, 2668– imported into the U.S. Petitioners argue rejected in court (e.g., in the Laclede 69. Furthermore, we note that the that ignoring the resulting uneven case). Finally, respondent argues that calculation of third country price for use treatment of duties in CV and the Department has deliberately not in the cost test should also reflect an Constructed Export Price distorts the interpreted the relevant statutory addition for duty drawback. It is the dumping margin calculation. Thus, language to limit such cost to the Department’s current practice to request petitioners argue the Department must merchandise exported to the U.S. cost of production data inclusive of adjust for the difference. Respondent also argues that duty, as reflected at page D–12 of the In order to make this adjustment, petitioners’ suggested alternative Department’s September 16, 1997 petitioners argue that the Department adjustments to account for the Section D Questionnaire: ‘‘Direct should have respondent report material difference between normal value and materials costs should include costs for CV without including duties, CEP—either by limiting the drawback transportation charges, import duties and then add the amount of duty adjustment claimed by SeAH to the and other expenses normally associated drawback claimed on each sale to the amount of duties included in CV, or by with obtaining the materials that reported cost of manufacture when granting a circumstances of sale become an integral part of the finished calculating CV for each sale. If duty adjustment’would require that an entity product’’ (emphasis added). As noted by drawback is not claimed, petitioners prove that cost of manufacturing respondent, the Department only argue that the average duty calculated includes the same amount of duty as requested duty-inclusive cost data for by SeAH should be used. that claimed in the drawback. This, this review, and its reported costs Petitioners further argue that if the according to respondent, goes beyond include those duties. As a result, in Department does not include the full the requirements of the Department’s order to effectuate an ‘‘apples-to-apples’’ amount of duties claimed in the current two-tiered test. Respondent comparison, the Department must add drawback adjustment in CV, then it notes that prior attempts to add such duty drawback to the third-country must make some other adjustment for criteria to the two-tiered test have been prices used for the cost test. the difference between normal value rejected by the court. Respondent also Accordingly, the Department added and CEP caused by the different values argues that none of the cases cited in the duty drawback to both third-country net for duty by either limiting the drawback petitioners’ brief override the price for comparison to US price and to adjustment claimed by SeAH to the aforementioned court decision of third-country price for comparison to amount of duties included in CV, or by Laclede. cost of production in the cost test. granting a circumstances of sale adjustment per 19 U.S.C. Department’s Position Comment 4: Duty Drawback when 1677b(a)(6)(C)(iii). An upward adjustment to sale price Normal Value is Constructed Value According to respondent, petitioners’ for duty drawback is provided for in Petitioners argue that where SeAH’s arguments to add duty drawback to section 772(c)(1)(B) of the Act. The CEP sales are compared to constructed constructed value have been previously Department utilizes a two prong test to value (CV), the Department must rejected by the Court of International determine whether a party is entitled to account for differences between the Trade. Laclede Steele Co. v. United a duty drawback adjustment: (1) The amount of duty included in CV and the States, 18 CIT 965 (1994). Respondent import duty and rebate must be directly amount of duty drawback adjustment argues that there is nothing in the linked to, and dependent upon, one claimed for CEP sales. Petitioners note statute, the regulations or the another, and (2) the company claiming that SeAH included duties in the raw Department’s practice to sanction the adjustment must demonstrate that material costs reported for cost of petitioners’ approach. According to there were sufficient imports of manufacture for CV. However, respondent, the Department has a two- imported raw materials to account for petitioners state, the duties respondent tiered test for determining the the duty drawback received on exports included in CV are not equivalent to the appropriateness of a duty drawback of the manufactured products. See, e.g., duty drawback adjustments claimed for adjustment. Respondent cites Final Silicon Metal from Brazil: Notice of U.S. sales. As a result, petitioners Determination of Sales at Less Than Final Results of Antidumping Duty believe normal value and constructed Fair Value: Circular Welded Non-Alloy Administrative Review, 64 FR 6305, export price are not being compared on Steel Pipe from Korea in support of this 6318 (February 9, 1999). This test was the same basis. Petitioners state that this assertion. 57 FR 42942, 42946 in Far East Machinery Co. v. United

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States, 699 F. Supp. 309, 311 (CIT under a fixed rate system. However, and because duty drawback is paid on 1988). according to respondent, there were a theoretical weight basis, no The U.S. Court of International Trade only two observations in which adjustment to the reported duty has consistently held that there is no merchandise was received under a fixed drawback is necessary. requirement that a specific input be rate duty drawback system in the Final Results of Review traced from importation through present review. Respondent also notes exportation before allowing drawback that in the fourth review of the cited These administrative reviews and on duties paid. Laclede Steel Co. v. case, the entity selling under the fixed notices are published in accordance United States, 18 CIT 965, 972 (1994). rate system switched to an individual with 751(a)(1) of the Act (19 U.S.C. The only limit on the allowance for duty application system. See Circular Welded 1675(a)(1)) and 19 CFR 351.213 and 19 drawback is that the adjustment to U.S. Non-Alloy Steel Pipe from the Republic CFR 351.221(b)(5). sales price may not exceed the amount of Korea; Final Results of Antidumping of import duty actually paid. Id. Duty Administrative Review, 63 FR Oil Country Tubular Goods Respondent satisfied both prongs of 32833 (June 16, 1998). According to the aforementioned test, and was respondent, the Department determined Weighted-av- Producer/manufacturer/ex- erage margin therefore entitled to claim a duty that only the amounts received under porter (percent) drawback adjustment. Respondent’s the fixed rate system (received prior to duty drawback rebates are received the switch to the individual application SeAH ...... 2.93 under Korea’s individual application system) warranted an adjustment. Id. at system, which limits such rebates to 32837. Respondent notes that in the The Department shall determine, and actual duties paid. Duty drawback was present case, there is only one the U. S. Customs Service shall assess, reviewed at verification, and no observation where duty drawback was antidumping duties on all appropriate inconsistencies with respondent’s received under the fixed rate system. entries. We have calculated an importer- reported methodology were noted. See Respondent notes that the drawback specific duty assessment rate based on Verification Report at 13–14. Thus, duty arguably should be adjusted for the the ratio of the total amount of drawback rebates received by difference between the theoretical and antidumping duties calculated for the respondent are not excessive. actual weight under the precedent cited examined sales to the total entered It is the long standing-policy of the by petitioners. Respondent notes, value of the same sales. The rate will be Department to require that respondents however, that the adjustment factor assessed uniformly on all entries of that include import duties in constructed would be one, and thus have no effect, particular company made during the value. See Offshore Platform Jackets given that the product in question was POR. The Department shall issue and Piles from the Republic of Korea: produced and sold on a theoretical appraisement instructions directly to Final Determination of Sales at Less weight basis. In total, respondent argues the Customs Service. Than Fair Value, 51 FR 11795, 11796 that no additional adjustments to the Furthermore, the following deposit (April 7, 1986). Requesting duty- reported duty drawback are warranted. requirements shall be effective upon exclusive constructed value data would publication of this notice of final results add a new hurdle to the two prong Department’s Position of review for all shipments of oil drawback test that is not required under To the extent that duty drawback country tubular goods from Korea current Department regulations or rebates exceed actual duties paid, the entered, or withdrawn from warehouse, policy. Department agrees with petitioners that for consumption on or after the Accordingly, the respondent was not adjustments to U.S. price should be publication date, as provided for by required to report duty-exclusive limited to the amount of duties paid. section 751(a)(1) of the Act: (1) The cash constructed value data, nor otherwise However, with only one exception, the deposit rates for the reviewed company make additional adjustments to the duty U.S. sales in this review, unlike those in named above will be the rate for that drawback claimed. the review cited by petitioners, were firm as stated above; (2) for previously under the Korean individual application investigated companies not listed above, Comment 5: Duty Drawback Reported system, and the rebates received were the cash deposit rate will continue to be for CEP Sales limited to actual duties paid and were the company-specific rate published for Petitioners argue that because duties therefore not excessive. Again, duty the most recent period; (3) if the were paid on an actual weight basis in drawback was reviewed at verification, exporter is not a firm covered in these Korea, and because duty drawback was and no inconsistencies with reviews, or the original LTFV paid on a theoretical weight basis, the respondent’s reported methodology investigations, but the manufacturer is, Department should reduce duty were noted. As a result, the Department the cash deposit rate will be the rate drawback by multiplying the claimed has used the full amount of duty established for the most recent period drawback by the reported conversion. drawback as reported in the analysis for for the manufacturer of the Petitioners cite Final Results of the Final Results. merchandise; and (4) if neither the Antidumping Duty Administrative For the abovementioned single sale exporter nor the manufacturer is a firm Review and Partial Termination of made under the Korean fixed rate covered in these reviews, the cash Administrative Review; Circular Welded system, the Department agrees with the deposit rate will continue to be 12.17 Non-Alloy Steel Pipe from the Republic respondent that the conversion factor percent, which was the ‘‘all others’’ rate of Korea in support of this position. 62 would be one, and thus have no effect. in the LTFV investigations. 60 FR at FR 55574, 55577 (October 27, 1997). Both the total costs for the product in 41058. Respondent argues that the question and the total duty drawback The deposit requirements, when circumstances leading to the adjustment requested reflect a higher quantity of the imposed, shall remain in effect until in the case cited by petitioners are not imported material than would have publication of the final results of the applicable to the sales in this review. been the case if the product had been next administrative review. Respondent notes that the adjustment in produced and sold on an actual weight This notice serves as a final reminder the cited case was made because an basis. As this sale was of a product to importers of their responsibility entity was receiving duty drawback produced on a theoretical weight basis, under 19 CFR 351.402(f) to file a

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13174 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices certificate regarding the reimbursement CONSUMER PRODUCT SAFETY under the laws of the State Washington of antidumping duties prior to COMMISSION with principal corporate offices located liquidation of the relevant entries in Seattle, WA. Respondent is a fashion [CPSC Docket No. 99±C0005] during this review period. Failure to specialty retailer selling a wide comply with this requirement could Nordstrom, Inc., a Corporation; selection of apparel, shores, and result in the Secretary’s presumption Provisional Acceptance of a accessories of women, men, and that reimbursement of antidumping Settlement Agreement and Order children. duties occurred and the subsequent II Allegations of the Staff assessment of double antidumping AGENCY: Consumer Product Safety duties. Commission. A. Children’s Robes This notice also serves as a reminder ACTION: Notice. 4. In 1996, Respondent sold, or to parties subject to administrative SUMMARY: It is the policy of the offered for sale, in commerce, protective order (‘‘APO’’) of their Commission to publish settlements approximately 900 style no. G26 100% responsibility concerning the which it provisionally accepts under the cotton girls’ terry cloth robes. disposition of proprietary information Flammable Fabrics Act in the Federal 5s. On or about April 12, 1996, the disclosed under APO in accordance Register in accordance with the terms of Commission staff collected from a with § 351.306 of the Department’s 16 CFR 1605.13(d). Published below is Nordstrom store in King of Prussia, PA, regulations. Timely notification of a provisionally-accepted Settlement samples of 100% girls’ terry cloth robes, return/destruction of APO materials or Agreement with Nordstrom, Inc., a style no. G26. The staff found the robes conversion to judicial protective order is corporation, containing a civil penalty displayed for sale in the children’s hereby requested. Failure to comply of $150,000. sleepwear section of the store. with the regulations and the terms of an 6. Children’s sleepwear means any DATES: Any interested person may ask APO is a sanctionable violation. the Commission not to accept this product of wearing apparel sizes 7 Dated: March 8, 1999. agreement or otherwise comment on its through 14, such as robes intended to be contents by April 1, 1999. worn primary for sleeping or activities Robert LaRussa, relating to sleeping. Given the design ADDRESSES: Persons wishing to Assistant Secretary for Import and length of the robes identified above, comment on this Settlement Agreement Administration. they are suitable for use for activities should send written comments to the [FR Doc. 99–6401 Filed 3–16–99; 8:45 am] related to sleeping. Accordingly, the Comment 99–C0005, Office of the BILLING CODE 3510±DS±P robes identified above are items of Secretary, Consumer Product Safety children’s sleepwear and, therefore, Commission, Washington, D.C. 20207. subject to the Standard for the FOR FURTHER INFORMATION CONTACT: Flammability of Children’s sleepwear, CONSUMER PRODUCT SAFETY Dennis C. Kacoyanis, Trial Attorney, (hereinafter, ‘‘Sleepwear Standard’’), 16 COMMISSION Office of Compliance and Enforcement, CFR part 1616, issued under Section 4 Consumer Product Safety Commission, of the FFA, 15 U.S.C. 1193. Sunshine Act Meeting Washington, D.C. 20207; telephone 7. The staff tested samples of the (301) 504–0626, 1346. robes identified in paragraphs 4 and 5 AGENCY: U.S. Consumer Product Safety SUPPLEMENTARY INFORMATION: The text of above for compliance with the Commission. the Agreement and order appears below. requirements of the Sleepwear LOCATION: Room 410, East West Towers, Dated: March 11, 1999. Standard. See 16 CFR 1616.3 and .4. 4330 East West Highway, Bethesda, Sadye E. Dunn, The test results showed that the robes Maryland. Secretary. violated the requirements of the Sleepwear Standard. TIME AND DATE: Thursday, March 25, Settlement Agreement and Order 8. On or about June 11, 1996, the staff 1999, 10:00 a.m. 1. This Settlement Agreement and informed Respondent that the robes STATUS: Closed to the Public Order, entered into between Nordstrom, identified in paragraphs 4 and 5 above Inc., (hereinafter, ‘‘Nordstrom’’ or failed to comply with the Sleepwear MATTERS TO BE CONSIDERED: ‘‘Respondent’’), a corporation, and the Standard and requested that it cease sale Compliance Status Report staff of the Consumer Product Safety of the robes and correct future Commission (hereinafter, ‘‘staff ’’), production. The staff will brief the Commission on pursuant to the procedures set forth in 9. Respondent knowingly sold, or the status of various compliance 16 CFR 1118.20, is a compromise offered for sale, in commerce, the robes matters. resolution of the matter described identified in paragraphs 4 and 5 above, For a recorded message containing the herein, without a hearing or a as the term ‘‘knowingly’’ is defined in latest agenda information, call (301) determination of issues of law and fact. Section 5(e)(4) of the FFA, 15 U.S.C. 504–0709. 1194(e)(4), in violation of Section 3 of I. The Parties the FFA, 15 U.S.C. 1192, for which a CONTACT PERSON FOR ADDITIONAL 2. The ‘‘staff ’’ is the staff of the civil penalty may be imposed pursuant INFORMATION: Sadye E. Dunn, Office of Consumer Product Safety Commission to section 5(e)(1) of the FFA, 15 U.S.C. the Secretary, 4330 East West Highway, (hereinafter, ‘‘Commission’’), an 1194(e)(1). Bethesda, MD 20207 (301) 504–0800. independent regulatory commission of B. Chenille Sweaters Dated: March 15, 1999. the United States government established pursuant to Section 4 of the 10. In 1996, Respondent sold, or Sadye E. Dunn, Consumer Product Safety Act (CPSA), offered for sale, in commerce, Secretary. 15 U.S.C. 2053. approximately 8,900 style no. 3L89235P [FR Doc. 99–6659 Filed 3–15–99; 8:45 am] 3. Respondent Nordstrom is a women’s 90% rayon/10% nylon BILLING CODE 6355±01±M corporation organized and existing chenille sweaters.

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11. On or about October 21, 1996, the Flammable Fabrics Act and the Agreement and Order will be deemed to staff collected from a Nordstrom store, Consumer Product Safety Act. be finally accepted on the 20th day after in Bethesda, MD, samples of women’s 18. Respondent Nordstrom intended the date it is published in the Federal 90% rayon/10% chenille sweaters, style that the robes described in paragraphs 4 Register. no. 3L89235P. and 5 above be sold as beach cover-ups. 25. Upon final acceptance of this 12. The sweaters identified in The labels specifically noted that the Settlement Agreement by the paragraphs 10 and 11 above are subject cover-ups were not to be used as Commission and issuance of the Final to the Clothing Standard for the sleepwear. The robes did not constitute Order, Nordstrom knowingly, Flammability of Clothing Textiles sleepwear as the term ‘‘sleepwear’’ is voluntarily, and completely waives any (hereinafter, ‘‘Wearing Apparel defined in 16 CFR 1616.2(a) and, rights it may have in this matter (1) to Standard’’), 16 CFR Part 1610, issued therefore, were not subject to the an administrative or judicial hearing, (2) under section 4 of the FFA, 15 U.S.C. Sleepwear Standard at 16 CFR Part to judicial review or other challenge or 1193. 1616. Nevertheless, Nordstrom contest of the validity of the 13. The staff tested samples of the complied with the staff’s request that Commission’s actions, (3) to a sweaters identified in paragraphs 10 and the robes be further modified. determination by the Commission as to 11 above for compliance with the 19. Upon notification by the whether Nordstrom failed to comply requirements of the Wearing Apparel Commission that the chenille sweaters with the FFA and the Sleepwear and Standard. See 16 CFR 1610.3 and .4. described in paragraphs 10 and 11 Wearing Apparel Standards as aforesaid, The test results showed that the above did not meet the requirements of (4) to a statement of findings of facts and sweaters violated the requirements of the Wearing Apparel Standard, conclusions of law, and (5) to any the Wearing Apparel Standard and, Respondent Nordstrom immediately claims under the Equal Access to Justice therefore, were dangerously flammable ceased all sales of the garment, as well Act. and unsuitable for clothing because of as those garments not identified by the 26. In settlement of the staff’s their rapid and intense burning. Commission but which were composed allegations, Nordstrom agrees to pay a 14. On or about November 1, 1996, of the same fiber content. civil penalty of $150,000.00 as set forth the staff informed Respondent that the 20. When notified by the Commission, in the incorporated Order. sweaters identified in paragraphs 10 and Respondent Nordstrom promptly and 27. For purposes of section 6(b) of the 11 above failed to comply with the diligently assisted the Commission staff CPSA, 15 U.S.C 2055(b), this matter Wearing Apparel Standard and in its efforts to implement recall of the shall be treated as if a complaint had requested that it cease sale of the sweaters described in paragraphs 10 and issued, and the Commission may sweaters and conduct a consumer level 11 above. publicize the terms of the Settlement recall. 21. Respondent Nordstrom has Agreement and Order. 15. Respondent knowingly sold, or received no reports of consumer injury 28. Upon final acceptance by the offered for sale, in commerce, the resulting from the use of the robes Commission of this Settlement sweaters identified in paragraphs 10 and described in paragraphs 4 and 5 above Agreement and Order, the Commission 11 above, as the term ‘‘knowingly’’ is or from use of the sweaters described in shall issue the attached Order defined in section 5(e)(4) of the FFA, 15 paragraphs 10 and 11 above. incorporated herein by reference. U.S.C. 1194(e)(4), in violation of Section IV. Agreement of the Parties 29. A violation of the attached Order 3 of the FFA, 15 U.S.C. 1192, for which shall subject Respondent to appropriate 22. The Commission has jurisdiction a civil penalty may be imposed legal action. pursuant to Section 5(e)(1) of the FFA, over Respondent and the subject mater 30. Agreements, understandings, 15 U.S.C. 1194(e)(1). of this Settlement Agreement and Order under the Consumer Product Safety Act representations, or interpretations made III. Response of Nordstrom (CPSA), 15 U.S.C. 2051 et seq., the outside this Settlement Agreement and 16. Respondent denies the allegations Flammable Fabrics Act (FFA), 15 U.S.C. Order may not be used to vary or of the staff set forth in paragraphs 4 1191 et seq.; and the Federal Trade contradict its terms. through 15 above. Respondent Commission Act (FTCA), 15 U.S.C. 41 et 31. The provisions of this Settlement Nordstrom specifically denies that the seq. Agreement and Order shall apply to children’s robes were subject to the 23. This Agreement is entered into for Nordstrom and each of its successors Sleepwear Standard. Respondent settlement purposes only and does not and assigns. Nordstrom also specifically denies that constitute an admission by Respondent Dated: January 20, 1999. it knowingly sold or offered for sale the or a determination by the Commission Erik B. Nordstrom, chenille sweaters described in that Respondent knowingly violated the Co-President Nordstrom, Inc., 1617 Sixth paragraphs 10 and 11 above in violation FFA and the Sleepwear and Wearing Avenue, Seattle, Washington 98101. of the requirements of the Wearing Apparel Standards. Respondent Nordstrom, Inc. Apparel Standard. 24. Upon provisional acceptance of 17. Nordstrom purchased the robes this Settlement Agreement and Order by Dated: January 20, 1999. identified in paragraphs 4 and 5 and the the Commission, this Settlement D. Wayne Gittinger, Esq., chenille sweaters identified in Agreement and Order shall be placed on Lane Powell Spears Lubersky LLP, 1420 Fifth paragraphs 10 and 11 subject to a the public record and shall be published Avenue, Suite 4100, Seattle, Washington provision contained in Nordstrom’s in the Federal Register in accordance 98101–2338. Purchase Order by which the vendor with the procedures set forth in 16 CFR Commission Staff warranted and represented that such 1605.13(d). If the Commission does not Alan H. Schoem, robes and chenille sweaters comply receive any written request not to accept Assistant Executive Director, Office of with all applicable governmental the Settlement Agreement and Order Compliance, Consumer Products Safety regulations, including expressly, the within 15 days, the Settlement Commission, Washington, DC 20207–0001.

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Eric L. Stone, applications from all eligible entities, DEPARTMENT OF EDUCATION Director, Legal Division, Office of including Indian Economic Enterprises Compliance. and Indian Tribal Organizations. Notice of Proposed Information Dated: January 21, 1999. Contrary to previous notices, no Collection Requests Dennis C. Kacoyanis, separate solicitation will be issued for AGENCY: Department of Education. Trial Attorney. cooperative agreement proposals to SUMMARY: The Acting Leader, Ronald G. Yelenik, assist Indian Economic Enterprises and Information Management Group, Office Trial Attorney, Legal Division, Office of Indian Tribal Organizations. This of the Chief Information Officer, invites Compliance. solicitation will govern the submission comments on the proposed information of applications for calendar years 1999, Order collection requests as required by the 2000, 2001, and 2002. Paperwork Reduction Act of 1995. Upon consideration of the Settlement DATES: The closing date for the DATES: Interested persons are invited to Agreement entered into between submission of applications is April 30, submit comments on or before May 17, Respondent Nordstrom, Inc., 1999. (hereinafter, ‘‘Respondent’’), a 1999. The SCAA is available for review ADDRESSES: Written comments and corporation, and the staff of the on the Internet Website: requests for copies of the proposed Consumer Product Safety Commission http://www.dla.mil/ddas/scaa information collection requests should (‘‘Commission’’); and the Commission be addressed to Patrick J. Sherrill, having jurisdiction over the subject Printed copies are not available for Department of Education, 400 Maryland matter and Respondent; and it distribution. Avenue, SW, Room 5624, Regional appearing that the Settlement Eligible entities may only submit an Office Building 3, Washington, DC Agreement and Order is in the public application as outlined in Section IV of 20202–4651, or should be electronically interest, it is the SCAA. In order to comply with the mailed to the internet address Pat Ordered, that the Settlement electronic portion of the submission, [email protected], or should be faxed to Agreement and Order be and hereby is applicants must obtain a log in account 202–708–9346. accepted, as indicated below; and it is and password from DLA. To obtain Further ordered, that Respondent pay FOR FURTHER INFORMATION CONTACT: these, applicants must furnish the Patrick J. Sherrill (202) 708–8196. to the United States Treasury a civil Grants Officer written evidence that penalty of one hundred fifty thousand Individuals who use a they meet the criteria of an eligible telecommunications device for the deaf dollars ($150,000.00) within twenty (20) entity as set forth in paragraph 14 of days after service upon Respondent of (TDD) may call the Federal Information Section II of the SCAA. This the Final Order. Relay Service (FIRS) at 1–800–877–8339 information should be mailed or between 8 a.m. and 8 p.m., Eastern time, Provisionally accepted and Provisional otherwise delivered to: HQ, Defense Monday through Friday. Order issued on the 11th day of March, 1999. Logistics Agency, Small & SUPPLEMENTARY INFORMATION: Section By Order of the Commission. Disadvantaged Business Utilization 3506 of the Paperwork Reduction Act of Sadye E. Dunn, Office (DDAS Room 1127), 8725 John J. 1995 (44 U.S.C. Chapter 35) requires Secretary, Consumer Product Safety Kingman Road, Ft. Belvoir, VA 22060– that the Office of Management and Commission. 6221. Budget (OMB) provide interested [FR Doc. 99–6398 Filed 3–16–99; 8:45 am] Two pre-solicitation conferences will Federal agencies and the public an early BILLING 6355±01±M be held; the first is 1:00 P.M., on the opportunity to comment on information March 23, 1999 at the Camberley collection requests. OMB may amend or Gunther Hotel, San Antonio, Texas. The waive the requirement for public DEPARTMENT OF DEFENSE second conference will be held at 9:30 consultation to the extent that public A.M., Tuesday, March 30, 1999 at Ft. participation in the approval process Defense Logistics Agency would defeat the purpose of the Belvoir, VA. If you plan to attend the Ft. information collection, violate State or Cost Sharing Cooperative Agreement Belvoir conference please notify DLA Applications Federal law, or substantially interfere not later than March 24, 1999, of your with any agency’s ability to perform its intentions by mailing, faxing (703–767– AGENCY: Defense Logistics Agency statutory obligations. The Acting (DLA). 1670) or e-mailing Leader, Information Management ([email protected]) your ACTION: Notice of solicitation for cost Group, Office of the Chief Information name, organization, and the number of sharing cooperative agreement Officer, publishes that notice containing people planning to attend. applications. proposed information collection FOR FURTHER INFORMATION CONTACT: If requests prior to submission of these SUMMARY: The Defense Logistics Agency you have any questions or need requests to OMB. Each proposed (DLA) has issued a solicitation for additional information please contact information collection, grouped by cooperative agreement applications Mr. Kenneth G. Dougherty at (703) 767– office, contains the following: (1) Type (SCAA) to assist state and local 1657 or Ms. Diana Maykowskyj at (703) of review requested, e.g. new, revision, governments and other nonprofit extension, existing or reinstatement; (2) 767–1656. eligible entities in establishing or Title; (3) Summary of the collection; (4) maintaining procurement technical Anthony J. Kuders, Description of the need for, and assistance centers (PTACs). These Deputy Director, Small and Disadvantaged proposed use of, the information; (5) centers help business firms market their Business Utilization. Respondents and frequency of goods and services to the Department of [FR Doc. 99–6451 Filed 3–16–99; 8:45 am] collection; and (6) Reporting and/or Defense (DoD), other federal agencies, BILLING CODE 3620±01±M Recordkeeping burden. OMB invites and state and/or local government public comment at the address specified agencies. This solicitation applies to all above. Copies of the requests are

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13177 available from Patrick J. Sherrill at the Secondary Education integrated Individuals who use a address specified above. program review. The information States telecommunications device for the deaf The Department of Education is provide will complement their (TDD) may call the Federal Information especially interested in public comment responses to the Consolidated Relay Service (FIRS) at 1–800–877–8339 addressing the following issues: (1) is Performance Report, but also will between 8 a.m. and 8 p.m., Eastern time, this collection necessary to the proper provide specific information on program Monday through Friday. implementation that is needed for an functions of the Department; (2) will SUPPLEMENTARY INFORMATION: Section effective integrated review. The this information be processed and used 3506 of the Paperwork Reduction Act of Department intends that, once the ESEA in a timely manner; (3) is the estimate 1995 (44 U.S.C. Chapter 35) requires is reauthorized, it will work actively of burden accurate; (4) how might the that the Director of OMB provide with the public to revise their content Department enhance the quality, utility, interested Federal agencies and the so that they support an integrated and clarity of the information to be public an early opportunity to comment information collection system that collected; and (5) how might the on information collection requests. The responds to the new law and better Department minimize the burden of this Office of Management and Budget reflects how federal programs help to collection on the respondents, including (OMB) may amend or waive the promote State and local reform efforts. through the use of information requirement for public consultation to technology. [FR Doc. 99–6425 Filed 3–16–99; 8:45 am] the extent that public participation in Dated: March 11, 1999. BILLING CODE 4000±01±P the approval process would defeat the Patrick J. Sherrill, purpose of the information collection, Acting Leader, Information Management violate State or Federal law, or Group, Office of the Chief Information Officer. DEPARTMENT OF EDUCATION substantially interfere with any agency’s ability to perform its statutory Office of Elementary and Secondary Notice of Proposed Information obligations. The Acting Leader, Education Collection Requests Information Management Group, Office Type of Review: New. AGENCY: Department of Education. of the Chief Information Officer, Title: Consolidated State Performance ACTION: Notice of proposed information publishes this notice containing Report and State Self-Review. collection requests. proposed information collection Frequency: Annually. requests at the beginning of the Affected Public: State, local or Tribal SUMMARY: The Acting Leader, Departmental review of the information Gov’t, SEAs or LEAs. Information Management Group, Office collection. Reporting and Recordkeeping Hour of the Chief Information Officer, invites Each proposed information collection, Burden: comments on the proposed information grouped by office, contains the Responses: 53. collection requests as required by the following: (1) Type of review requested, Burden Hours: 207,514. Paperwork Reduction Act of 1995. e.g., new, revision, extension, existing Abstract: This information collection DATES: An emergency review has been or reinstatement; (2) Title; (3) Summary package contains two related parts: the requested in accordance with the Act of the collection; (4) Description of the Consolidated State Performance Report (44 U.S.C. Chapter 3507 (j)), since need for, and proposed use of, the and State Self-Review. The Elementary public harm is reasonably likely to information; (5) Respondents and and Secondary Education Act (ESEA), result if normal clearance procedures frequency of collection; and (6) in general, and its provision for are followed. Approval by the Office of Reporting and/or Recordkeeping submission of consolidated plans, in Management and Budget (OMB) has burden. ED invites public comment at particular (see section 14302 of the been requested by March 25, 1999. A the address specified above. Copies of ESEA), emphasize the importance of regular clearance process is also the requests are available from Patrick J. cross-program coordination and beginning. Interested persons are Sherrill at the address specified above. integration of federal programs into invited to submit comments on or before The Department of Education is educational activities carried out with May 17, 1999. especially interested in public comment State and local funds. States would use ADDRESSES: Written comments addressing the following issues: (1) is both instruments for reporting on regarding the emergency review should this collection necessary to the proper activities that occur during the 1999– be addressed to the Office of functions of the Department; (2) will 2000 school year and, if the ESEA when Information and Regulatory Affairs, this information be processed and used reauthorized does not become effective Attention: Danny Werfel, Desk Officer: in a timely manner, (3) is the estimate for the 2000–2001 school year, for that Department of Education, Office of of burden accurate; (4) how might the year as well. The documents allow State Management and Budget; 725 17th Department enhance the quality, utility, and local officials and educators to see Street, NW, Room 10235, New and clarity of the information to be at one time the full scope of their Executive Office Building, Washington, collected, and (5) how might the general reporting (and corresponding DC 20503. Comments regarding the Department minimize the burden of this data collection) responsibilities, and regular clearance and requests for copies collection on respondents, including promotes the Department’s interests in of the proposed information collection through the use of information (1) receiving essential information on request should be addressed to Patrick technology. how States have implemented their J. Sherrill, Department of Education, 400 approved consolidated State plans and Maryland Avenue, SW , Room 5624, Dated: March 11, 1999. (2) promoting the Department’s ability Regional Office Building 3, Washington, Patrick J. Sherrill, to provide assistance to States on how DC 20202–4651, or should be Acting Leader, Information Management they may be able to use federal funds electronically mailed to the internet Group, Office of the Chief Information Officer. most effectively. The State Self-Review address Pat—[email protected], or should be faxed to 202–708–9346. Office of Elementary and Secondary would be completed by those States Education (approximately 18 per year) that are the FOR FURTHER INFORMATION CONTACT: object of an Office of Elementary and Patrick J. Sherrill (202) 708–8196. Type of Review: New.

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Title: Guidance to State Educational Frequency: Guidance issued on as amending and vacating various natural Agencies (SEAs) Seeking to Use an needed basis. gas import and export authorizations. Alternative Method to Distribute Title I Affected Public: State, local or Tribal These Orders are summarized in the Funds to Local Educational Agencies Gov’t, SEAs or LEAs. attached appendix. (LEAs) with Fewer Than 20,000 Total Reporting and Recordkeeping Hour These Orders may be found on the FE Residents. Burden: Abstract: Guidance to SEAs seeking to Responses: 25. web site at http://www.fe.doe.gov., or use an alternative method to distribute Burden Hours: 25. on the electronic bulletin board at (202) 586–7853. Title I funds to LEAs with fewer than [FR Doc. 99–6426 Filed 3–16–99; 8:45 am] 20,000 total residents. BILLING CODE 4000±01±P They are also available for inspection Additional Information: The and copying in the Office of Natural Gas Department of Education has developed & Petroleum Import & Export Activities, guidance on the use of an alternative DEPARTMENT OF ENERGY Docket Room 3E–033, Forrestal method to distribute Title I funds to Building, 1000 Independence Avenue, local educational agencies (LEAs) with [FE Docket Nos. 99±08±NG, 89±69±NG et SW, Washington, DC 20585, (202) 586– al.] fewer than 20,000 total residents, and 9478. The Docket Room is open between supporting justification materials, the hours of 8:00 a.m. and 4:30 p.m., including a copy of the relevant parts of Office of Fossil Energy; Orders Monday through Friday, except Federal the Title I of the Elementary and Granting, Amending and Vacating holidays. Secondary Education Act (ESEA) as Authorizations To Import and/or Export amended by Pub. L. 103–382. Natural Gas Issued in Washington, DC, on March 9, 1999. We are requesting that this package be AGENCY: Office of Fossil Energy, DOE. John W. Glynn, reviewed and cleared on an emergency ACTION: Notice of Orders. basis. ED did not make a decision about Manager, Natural Gas Regulation, Office of allocating Title I Basic and SUMMARY: The Office of Fossil Energy Natural Gas & Petroleum Import & Export Concentration Grant funds to LEAs until (FE) of the Department of Energy gives Activities, Office of Fossil Energy. recently. notice that it has issued Orders granting,

APPENDIXÐORDERS GRANTING, AMENDING AND VACATING IMPORT/EXPORT AUTHORIZATION [DOE/FE Authority]

Two-year maximum Order No. Date issued Importer/exporter FE docket no. Import Export Comments volume volume

1458 ...... 02/02/99 Cogen Energy Technology L.P. 99±08±NG ...... 10 Bcf ...... Import from Canada, beginning on July 1, 1999, and ending on June 30, 2000. 429±B ...... 02/02/99 Cogen Energy Technology L.P. 89±69±NG ...... Vacating long-term import authority. 1459 ...... 02/02/99 Coast Energy Group A Division Of Corner- 100 Bcf .... 100 Bcf .... Import combined total from Canada and stone Propane L.P. 99±07±NG. Mexico, and to export combined total to Canada and Mexico, beginning January 1, 1999, and ending December 31, 2000. 1460 ...... 02/05/99 CanWest Gas Supply U.S.A., Inc. 99±10± 400 Bcf Import and export combined total from and NG. to Canada, beginning on March 1, 1999, and ending on February 28, 2001. 494±E ...... 02/08/99 Sumas Cogeneration Company, L.P. 90± ...... Amending long-term import authority to in- 92±NG. crease volumes. 1461 ...... 02/08/99 Boundary Gas, Inc. 99±09±NG ...... 67.5 Bcf Import and export combined total from and to Canada, beginning on date of first de- livery after February 24, 1999. 1462 ...... 02/11/99 Portland Natural Gas Transmission System 0.8 Bcf ...... Import from Canada, beginning on date of 99±11±NG. first delivery. 1463 ...... 02/23/99 Stampeder Energy (U.S.) Inc. 99±14±NG .. 100 Bcf 10 100 Bcf .... Import combined total from Canada and Bcf Mexico, and to export combined total to (LNG). Canada and Mexico, and to import LNG from any country beginning March 1, 1999, through February 28, 2001. 1464 ...... 02/24/99 British Columbia Power Exchange Corpora- 14 Bcf Import and export combined total from and tion 99±12±NG. to Canada, beginning on March 1, 1999, through February 28, 2001. 1465 ...... 02/24/99 Wisconsin Gas Company 99±13±NG ...... 200 Bcf ...... Import from Canada, beginning on the date of first delivery. 1466 ...... 02/26/99 Cabot Oil & Gas Marketing Corporation 10 Bcf ...... Import from Canada, beginning on the date 99±15±NG. of first delivery after March 31, 1999.

[FR Doc. 99–6476 Filed 3–16–99; 8:45 am]

BILLING CODE 6450±01±P

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DEPARTMENT OF ENERGY DEPARTMENT OF ENERGY implementation plan will be provided to the DNFSB by April 23, 1999. Office of Arms Control and DOE Response to Recommendation Yours sincerely, Nonproliferation Policy; Proposed 98±2 of the Defense Nuclear Facilities Bill Richardson, Subsequent Arrangement Safety Board, Safety Management at [FR Doc. 99–6478 Filed 3–16–99; 8:45 am] the Pantex Plant BILLING CODE 6450±01±P AGENCY: Department of Energy. ACTION: Subsequent Arrangement. AGENCY: Department of Energy. ACTION: Notice. DEPARTMENT OF ENERGY SUMMARY: This notice is being issued under the authority of Section 131 of the SUMMARY: The Defense Nuclear Site-Wide Environmental Impact Atomic Energy Act of 1954, as amended Facilities Safety Board published Statement (SWEIS); Oak Ridge Y±12 (42 U.S.C. 2160). The Department is Recommendation 98–2, concerning the Plant providing notice of a proposed safety management at the Pantex plant, AGENCY: ‘‘subsequent arrangement’’ under the on October 7, 1998 (63 FR 53884). U.S. Department of Energy Agreement for Cooperation in the Under section 315(e) of the Atomic (DOE). Peaceful Uses of Nuclear Energy Energy Act of 1954, as amended, 42 ACTION: Notice of Intent (NOI). Between the Government of the United U.S.C. 2286d(e), the Department of SUMMARY: Pursuant to the National States of America and the European Energy must transmit an Environmental Policy Act (NEPA), DOE Atomic Energy Community implementation plan on announces its intent to prepare a Site- (EURATOM). Recommendation 98–2 to the Defense Wide Environmental Impact Statement Nuclear Facilities Safety Board by This subsequent arrangement (SWEIS) for the Oak Ridge Y–12 Plant March 10, 1999, or submit a notification concerns the approval of RTD/RS(EU)– (Y–12), DOE’s primary site for enriched of extension for an additional 45 days. 2 which involves the retransfer of U.S.- uranium operations and storage related The Secretary’s notification of extension origin nuclear components including to the nation’s nuclear weapons for an additional 45 days follows. 632 pieces of stainless steel fuel guard, program. The SWEIS will analyze 649,690 meters of zircaloy fuel cladding ADDRESSES: Send comments, data, current levels of Y–12 operations and tubes, 7,296 pieces of zircaloy spacers, views, or arguments concerning the foreseeable new operations and facilities and 1,480 kilograms of zircaloy end- Secretary’s notification to: Defense for approximately the next ten years. plug from Germany to the Elektrostal Nuclear Facilities Safety Board, 625 The alternatives to be analyzed in the Nuclear Fuel Fabrication Facility in Indiana Avenue, NW, Suite 700, SWEIS include: an extensive upgrade/ Moscow, Russia for fabrication of fuel Washington, DC 20004. retrofit of existing processes and assemblies. Siemens AG will then sell FOR FURTHER INFORMATION CONTACT: Mr. facilities; construction of new facilities the fuel assemblies to nuclear power Gene Ives, Deputy Assistant Secretary to replace existing processes and plants in western Europe. for Military Application and Stockpile facilities; a combination of upgrades of This request is the commercial phase Management, Defense Programs, existing processes and facilities and of a three-part cooperation between Department of Energy, 1000 new construction; and the No Action Siemens AG and Elektrostal. DOE Independence Avenue, SW, Washington alternative. The No Action alternative is approved the qualification phase and DC, 20585. to continue current facility operations test phase in January 1995 and April Issued in Washington, DC, on March 11, throughout Y–12 in support of assigned 1998, respectively. The Russian missions. There is no preferred government has confirmed that the 1999. Mark B. Whitaker, Jr., alternative at this time. The purpose of assurances it gave in 1994 for the this notice is to invite public transfer of zircaloy fuel cladding tubes, Departmental Representative to the Defense Nuclear Facilities Safety Board. participation in the process and to confirming no nuclear explosive or encourage public dialogue on the March 10, 1999. other military use and no retransfer alternatives that should be considered. except to Western European countries The Honorable John T. Conway, DATES: The DOE invites other federal without prior U.S. consent, would apply Chairman agencies; state, local and tribal equally to the transfer of fuel guards, Defense Nuclear Facilities Safety Board 624 governments; and the general public to spacers, and end-plugs. Indiana Avenue, NW, Suite 700, Washington, DC 20004. comment on the scope of this SWEIS. In accordance with Section 131 of the Dear Mr. Chairman: This is to notify you, The public scoping period starts with Atomic Energy Act of 1954, as amended, pursuant to 42 U.S.C. 2286d(e), that the the publication of this Notice in the we have determined that this Department of Energy will require an Federal Register and will continue until subsequent arrangement will not be additional 45 days to transmit the May 17, 1999. DOE will consider all inimical to the common defense and implementation plan for addressing the comments received or postmarked by security. issues raised in the Defense Nuclear Facilities Safety Board (DNFSB) that date in defining the scope of this This subsequent arrangement will SWEIS. Comments received or take effect no sooner than fifteen days Recommendation 98–2, ‘‘Safety Management at the Pantex Plant.’’ The additional time will postmarked after that date will be after the date of publication of this be beneficial for both the Department and the considered to the extent practicable. notice. DNFSB to assure the implementation plan Public scoping meetings will be held in Dated: March 9, 1999. represents a comprehensive approach to this the Oak Ridge area and their dates, For the Department of Energy. complex issue. times, and locations will be published Terry Tyborowski, Mr. Gene Ives, Deputy Assistant Secretary in local newspapers and other for Military Application and Stockpile Acting Director, International Policy and Management, will further discuss the appropriate media. Analysis Division, Office of Arms Control and implementation plan with you on March 9, The DOE is requesting, by separate Nonproliferation. 1999. Together, we can then determine the correspondence and this Notice, that [FR Doc. 99–6477 Filed 3–16–99; 8:45 am] appropriate commitments for incorporation federal and state government agencies BILLING CODE 6450±01±P into the implementation plan. The desiring to be designated as cooperating

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13180 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices agencies on the Y–12 SWEIS inform and the transfer of highly specialized also store surplus enriched uranium DOE by April 30, 1999. technologies to support the capabilities pending disposition. ADDRESSES: Written comments or of the U.S. industrial base. The DOE NEPA strategy for both the suggestions to assist the DOE in In response to the end of the Cold War SSM and the S&D programs consists of identifying the appropriate scope of the and changes in the world’s political multiple phases. The first phase was to Y–12 SWEIS should be directed to: Gary regimes, the emphasis of the U.S. prepare PEISs (now completed) to S. Hartman, SWEIS Document Manager, weapons program has shifted support program-wide decisions. In the U.S. Department of Energy, Oak Ridge dramatically over the past few years second phase, DOE would prepare any Operations Office, Post Office Box 2001, from developing and producing new necessary site-wide and/or project- Oak Ridge, Tennessee 37831, or by weapons to dismantlement and specific NEPA documents required to facsimile at (423) 576–1237, or by E- maintenance of a smaller, enduring implement any programmatic decisions. Mail at [email protected]. stockpile. Even with these significant This Y–12 SWEIS is the next step for For general information on the DOE changes, however, DOE responsibilities DOE’s NEPA strategy for the Y–12 Plant. NEPA process, please contact: Carol M. for the nuclear weapons stockpile As such, the proposals in this NOI are Borgstrom, Director, Office of NEPA continue, and the President and consistent with previous decisions of Policy and Assistance, EH–42, U.S. Congress have directed DOE to continue the DOE in the PEIS RODs to downsize Department of Energy, 1000 to maintain the safety and reliability of the Y–12 Plant and store non-surplus Independence Avenue SW, Washington, the nuclear weapons stockpile. and surplus enriched uranium. As D.C. 20585. In order to meet the challenges of the described in the ‘‘alternatives’’ section Ms. Borgstrom can also be reached at post-Cold War era, DOE has prepared of this NOI, DOE is proposing several (202) 586–4600, or by leaving a message several Programmatic Environmental different approaches to carrying out at 1–800–472–2756. Impact Statements (PEISs) to determine these missions. Public scoping meetings held in the Additional information regarding how best to carry out its national Oak Ridge area will facilitate dialogue DOE NEPA activities and access to security requirements. The Stockpile between DOE and the public and many NEPA documents is available on Stewardship and Management PEIS provide an opportunity for individuals the Internet through the NEPA Home (SSM PEIS, DOE/EIS–0236), which was to provide written or oral statements. In Page at http://www.eh.doe.gov/nepa. completed in September 1996, addition to providing comments at the evaluated alternatives for maintaining SUPPLEMENTARY INFORMATION: public scoping meetings, all interested the safety and reliability of the nuclear parties are invited to record their Background weapons stockpile without underground comments, ask questions concerning the nuclear testing or production of new- The DOE is the federal agency Y–12 SWEIS, request time to speak, design weapons. The Storage and responsible for providing the nation request assistance for special needs at Disposition of Weapons-Usable Fissile with nuclear weapons and ensuring that the public meetings (e.g., an interpreter Material PEIS (S&D PEIS, DOE/EIS– those weapons remain safe and reliable. for the hearing impaired or special 0229), which was completed in As one of the DOE major production access), or request to be placed on the December 1996, evaluated alternatives facilities, Y–12 has been DOE’s primary Y–12 SWEIS mailing or document for the long-term storage of fissile site for enriched uranium processing distribution list. This may be done by material, and the disposition of surplus and storage, and one of the primary contacting the SWEIS Document fissile material. The Records of Decision manufacturing facilities for maintaining Manager at the address given above. the U.S. nuclear weapons stockpile. Y– (RODs) from these two PEISs form a 12 is located on the Oak Ridge starting point for the scope of actions Proposed Action Reservation (ORR), approximately 40 that are contemplated in this Y–12 DOE proposes to continue to provide km (25 mi) west of Knoxville, SWEIS. the capability and capacity to maintain Tennessee. For purposes of the SWEIS, In the SSM PEIS ROD, DOE decided the nation’s stockpile, in support of the the Y–12 Site is defined as to maintain the national security U.S. Nuclear Weapons Program. approximately 5,000 acres of the 34,516 missions at Y–12, but to downsize the Further, DOE proposes to continue the acre ORR, bounded by the DOE plant consistent with reduced processing and storage of enriched and Boundary and Pine Ridge to the north, requirements. These national security depleted uranium, lithium compounds, Scarboro Road to the east, Bethel Valley missions include: (1) maintaining the and other materials; and the Road to the south, west to Mount capability to fabricate uranium and manufacturing and assembly/ Vernon Road, and then extending west lithium components and parts for disassembly mission assigned to the Y– down Bear Creek Valley to the security nuclear weapons, (2) evaluating 12 Plant in the safest and most efficient fence-line near the Roane/Anderson components and subsystems returned manner practicable. The SWEIS will County boundary. Y–12 has a current from the stockpile, (3) storing enriched provide a baseline of impacts associated annual budget of approximately $460 uranium that is designated for national with current activities, analyze the million and houses approximately 5,000 security purposes (also referred to as potential impacts of constructing a new employees on site. non-surplus enriched uranium), (4) enriched uranium storage facility, and Nondefense-related activities at the storing depleted uranium and lithium address siting issues associated with Y–12 Plant include environmental materials and parts, (5) dismantling other possible modernization projects. monitoring, remediation, and nuclear weapon secondaries returned deactivation and decontamination from the stockpile, (6) processing Alternatives to be Analyzed activities of the Environmental uranium (which includes chemical As described below, DOE will analyze Management Program; management of recovery, purification, and conversion three broad alternatives involving waste materials from past and current of enriched uranium to a form suitable upgrades of existing facilities, operations; research activities operated for long-term storage and/or further construction of new facilities, and a by the Oak Ridge National Laboratory; use), and (7) providing support to combination of these two approaches. support of other federal agencies weapons laboratories. In the S&D PEIS Analysis will be performed at a level of through the Work-for-Others Program; ROD, DOE decided that Y–12 would detail sufficient to enable DOE to make

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13181 decisions regarding approach (i.e., manufacture and assembly/disassembly decision making; and (3) improve and upgrade or construct) and location (i.e., of weapons components, and the coordinate agency plans, functions, where on the site) for each function or continued processing and storage of programs, and resource utilization. A activity. Environmental considerations enriched uranium materials in existing SWEIS can be used to efficiently and will be addressed for footprint reduction facilities. As specified in the SSM PEIS effectively analyze multiple proposals activities as Y–12 surplus facilities are and the S&D PEIS, these operations and help establish an efficient, transitioned into the Environmental would continue in a reduced footprint environmentally sound, and cost- Management program consistent with of consolidated operations. This effective plan for operating the site and the SSM PEIS and the Department’s alternative also includes environmental its facilities. Additionally, a SWEIS Lifecycle Asset Management Order. For considerations of footprint reduction provides an overall NEPA baseline for a most major functions or activities, activities as Y–12 surplus facilities are site that is useful as a reference when additional NEPA evaluations would be transitioned into the Environmental project-specific NEPA documents are required as more detailed information Management program consistent with prepared. The NEPA process allows for becomes available in order to make the SSM PEIS and the Department’s federal, state, tribal, county, municipal, subsequent decisions regarding Lifecycle Asset Management Order. and public participation in the construction and operation. However, as Limited upgrades of existing facilities environmental review process. an exception to this general approach, are underway and their completion In accordance with 10 CFR DOE will analyze the potential impacts would be included in the No Action 1021.330(d), DOE will evaluate the of designing, constructing, and alternative. SWEIS at least every five years after its operating a new enriched uranium Other Alternatives Considered completion to determine whether it storage facility, for which conceptual remains adequate, should be design has begun and sufficient Members of the public have in the supplemented, or should be replaced information is available. past expressed interest in shutting down with a new SWEIS. Under the Upgrade Alternative, the all operations at Y–12 and deactivating SWEIS will assess impacts from some or all facilities. As discussed in The Y–12 Site-Wide Analysis extensive upgrade/retrofit of existing the Background section above, DOE has The SWEIS will address operations processes and facilities, such as: considered these suggestions in and activities that DOE foresees at Y–12 enriched uranium manufacturing, previous PEIS documents. DOE for the ten years following the depleted uranium manufacturing, recognizes that Y–12 has unique publication of the ROD. The SWEIS is lithium manufacturing, assembly/ capabilities and diverse roles supporting expected to facilitate and streamline disassembly, general manufacturing, a variety of national programs, and that subsequent NEPA reviews at Y–12 by office facilities, and other support there is an essential near-term need to allowing DOE to focus on project- facilities. manage and maintain the safety and specific issues and narrow and simplify Under the Construction Alternative, stability of the existing nuclear the scope of later reviews. This process the SWEIS will assess the impacts of materials inventory. In addition, the is called ‘‘tiering’’ (40 CFR 1508.28). replacing existing processes and National Security Strategy for a New DOE believes that the SWEIS analysis facilities with newly designed and Century, issued by The White House in will provide adequate NEPA analysis for constructed processes and facilities, October 1998, emphasizes the need to impacts related to existing and such as: enriched uranium ‘‘ensure the continued viability of the reasonably foreseeable activities and manufacturing, depleted uranium infrastructure that supports U.S. nuclear projects covered within the SWEIS. manufacturing, lithium manufacturing, forces and weapons.’’ Accordingly, the assembly/disassembly, general DOE view at this time is that a decision Preliminary Environmental Analysis manufacturing, office facilities, and to shut down or further reduce Y–12 The following issues have been other support facilities. missions within the time frame of the identified for analysis in the SWEIS. Under the Upgrade/Construction SWEIS would be highly unlikely. The list is tentative and intended to Alternative, the SWEIS will assess the Therefore, DOE does not plan to analyze facilitate public comment on the scope impacts of the combination of extensive an alternative involving an orderly of this SWEIS. It is not intended to be upgrades to certain existing processes shutdown or further reduction during all-inclusive, nor does it imply any and facilities and the design and this period. predetermination of potential impacts. construction of certain new processes The DOE specifically invites suggestions and facilities. This alternative will The Role of the SWEIS in the DOE NEPA Compliance Strategy for the addition or deletion of items on include a combination of both existing this list. upgraded/new processes and facilities, The SWEIS will be prepared pursuant 1. Potential effects on the public and such as: enriched uranium to the NEPA of 1969, 42 USC 4321 et workers from exposures to radiological manufacturing, depleted uranium seq., the Council on Environmental and hazardous materials during normal manufacturing, lithium manufacturing, Quality (CEQ) NEPA regulations (40 operations, construction, and credible assembly/disassembly, general CFR Parts 1500–1508) and the DOE accident scenarios. manufacturing, office facilities, and NEPA regulations (10 CFR Part 1021). 2. Impacts on surface and other support facilities. The DOE has a policy (10 CFR 1021.330) groundwater, floodplains and wetlands, The No Action Alternative would of preparing SWEISs for certain large, and on water use and quality. continue current facility operations multiple-facility sites such as Y–12. The 3. Impacts on air resources. throughout Y–12 in support of assigned purpose of a SWEIS is to: (1) provide 4. Impacts to plants and animals and missions. NEPA regulations require DOE and its stakeholders with an their habitat, including species which analysis of the No Action alternative to analysis of the individual and are federal- or state-listed as threatened provide a benchmark for comparison cumulative environmental impacts or endangered, of special concern, or with environmental effects of the other resulting from ongoing and reasonably economically/recreationally important. alternatives. This alternative reflects the foreseeable new operations and facilities 5. Impacts on physiography, current nuclear weapons program (and reasonable alternatives) at a DOE topography, geology, and soil missions at Y–12, and includes the site; (2) provide a basis for site-wide characteristics.

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6. Impacts to cultural resources such A ROD for the Treatment of Non- Lease of Land and Facilities Within as historic, archaeological, scientific, or Wastewater Hazardous Waste was the East Tennessee Technology Park culturally important sites. issued on July 30, 1998 (63 FR 41810, (ETTP) EA (DOE/EA–1175). A FONSI 7. Socioeconomic impacts to affected August 5, 1998). The DOE decided to was issued on December 1, 1997. The communities. continue to use off-site facilities for the EA evaluated impacts of alternatives on 8. Environmental Justice, particularly treatment of major portions of the non- future use and/or disposition of surplus whether or not activities at Y–12 have wastewater hazardous waste generated facilities at the former K–25 Site on the a disproportionately high and adverse at DOE sites. The ORR will treat some ORR, and allowed for the lease of some effect on minority and low-income of its own non-wastewater hazardous facilities and land to commercial populations. waste on site, where capacity is entities. 9. Potential impacts on land use available in existing facilities and where Long-Term Management and Use of plans, policies, and controls. this is economically favorable. A ROD Depleted Uranium Hexafluoride PEIS 10. Transportation of radiological and for Transuranic Waste was issued on (DOE/EIS–0269). The final PEIS and hazardous materials on and off the Y– January 20, 1998 (63 FR 3629, January ROD are scheduled to be issued in 1999. 12 Plant. 23, 1998). Transuranic waste at the ORR The ETTP is an alternative site for 11. Pollution prevention and waste will be packaged to meet waste management and storage of this management practices and activities. acceptance criteria for the Waste material. 12. Impacts on aesthetics and noise Isolation Pilot Plant (WIPP) in New Receipt and Storage of Uranium levels of the Y–12 facilities on the Mexico and then stored on site for Materials from the Fernald surrounding communities and ambient eventual disposal at the WIPP. Environmental Management Project Site environment. Decisions for managing low-level EA (DOE/EA–1291). The draft EA was 13. Unavoidable adverse impacts due radioactive waste, low-level radioactive issued for review in February 1999. Y– to natural phenomena (e.g., floods, and hazardous mixed waste, and high- 12 and ETTP are among the candidates earthquakes, etc.). level radioactive waste are still pending. for storage of materials being removed 14. Cumulative effects of past, in the cleanup effort at the Fernald site present, and future operations within Project-Specific NEPA Reviews in Ohio. the Y–12 region of influence. Disposition of Surplus Highly Transuranic Waste Treatment Facility 15. Reasonably foreseeable impacts Enriched Uranium EIS (DOE/EIS–0240). EIS (DOE/EIS–030J). An NOI was associated with the shutdown of excess A ROD was issued on August 5, 1996 published in January 1999. DOE facilities. (61 FR 40619, August 5, 1996). The proposes to treat wastes at ORNL at a 16. Status of compliance with all ORR, particularly Y–12, is one of four new facility to be constructed near the applicable federal, state, and local DOE sites selected for implementing Melton Valley Storage Tanks, where the statutes and regulations; required blending technologies for highly material is currently being stored. federal and state environmental enriched uranium. consultations and notifications; and Other Documents Interim Storage of Enriched Uranium DOE orders on environmental Environmental, Safety and Health Environmental Assessment (EA) (DOE/ protection and waste management. Vulnerabilities Associated with the EA–0929). A Finding of No Significant Storage of Highly Enriched Uranium Related NEPA Reviews Impact (FONSI) was issued on (HEU) (DOE/EH0525). This report was The following is a list of recent NEPA September 14, 1995. This allowed for issued in December 1996; the related and other documentation related to the the continued interim storage of Management Plan (DOE/DP–0139) was scope of this SWEIS. The summaries enriched uranium at Y–12, with an issued in April 1997. In this report, the below are intended to familiarize the increase in the amount of material DOE evaluated 22 sites that handle and reader with the purpose of these other stored above the historical maximum store HEU materials in a variety of NEPA reviews and how Y–12 is level. The S&D PEIS, discussed above, forms, including disassembled weapons considered in them. confirmed and extended this mission parts, reactor fuels, solids, solutions, beyond the ten years assessed in the EA. Programmatic NEPA Reviews and scrap and residues. Most of the Replacement and Operation of the HEU vulnerabilities identified at those Stockpile Stewardship and Anhydrous Hydrogen Fluoride (AHF) sites, including Y–12, are associated Management PEIS (DOE/EIS–0236). A Supply and Fluidized-Bed Chemical with poor facility conditions and ROD was issued on December 19, 1996 Processing Systems EA (DOE/EA–1049). institutional weaknesses. Further (61 FR 68014, December 26, 1996). The A FONSI was issued on September 20, analyses are being conducted on DOE decided to maintain, but downsize, 1995. This allowed for replacement of particular facilities and issues presented the weapons secondary and case the AHF supply and fluidized-bed in the Vulnerability Assessment Report. component fabrication capability at Y– reactor systems at Y–12 to meet Report on the Remedial Investigation 12. operational and safety requirements and (RI) of the Upper East Fork Poplar Creek Storage and Disposition of Weapons- extend the life of the process by Characterization Area at the Oak Ridge Usable Fissile Materials PEIS (DOE/EIS– approximately 20 years. Y–12 Plant (DOE/OR/01–1641/D2). The 0229). A ROD was issued on January 14, ORR Related NEPA Reviews RI was issued in August 1998. The 1997 (62 FR 3014, January 21, 1997). feasibility study that accompanies the RI Oak Ridge, in particular Y–12, will Spallation Neutron Source (SNS) EIS is still in draft form. A ROD on continue to store non-surplus highly (DOE/EIS–0247). The draft EIS was remediation of the Upper East Fork enriched uranium and surplus highly issued for review in December 1998. Poplar Creek watershed will be issued enriched uranium pending disposition This document evaluates four in the future. in upgraded and consolidated facilities. alternative DOE sites for construction Waste Management PEIS (DOE/EIS– and operation of a new SNS facility. The The SWEIS Preparation Process 0200). The Final PEIS was issued in preferred alternative is a site at the Oak After the scoping period, DOE will May 1997. Multiple RODs are being Ridge National Laboratory (ORNL) on prepare the draft Y–12 SWEIS. prepared for various categories of waste. the ORR. Additional public meetings or

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The DOE will Law 92–463, 86 Stat. 770) requires that Thompson at the Board’s office address hold public hearings to solicit public notice of these meetings be or telephone number listed above. comments on the draft SWEIS from the announced in the Federal Register. Issued at Washington, DC on March 11, public, organizations, and other DATES: Thursday, April 1, 1999: 6:00 1999. agencies, and will consider all p.m.–9:30 p.m. Rachel M. Samuel, comments in the preparation of the final ADDRESSES: College Hill Library, (Front Deputy Advisory Committee Management SWEIS. The DOE intends to complete Range Community College), 3705 West Officer. the final SWEIS in August 2000, and 112th Avenue, Westminster, CO. [FR Doc. 99–6479 Filed 3–16–99; 8:45 am] issue a ROD in October 2000, but at FOR FURTHER INFORMATION CONTACT: Ken BILLING CODE 6450±01±P least 30 days after the Environmental Korkia, Board/Staff Coordinator, EM Protection Agency’s Notice of SSAB-Rocky Flats, 9035 North Availability of the final SWEIS is Wadsworth Parkway, Suite 2250, DEPARTMENT OF ENERGY published in the Federal Register. Westminster, CO 80021, phone: (303) Classified Material 420–7855, fax: (303) 420–7579. International Energy Agency Meeting DOE will review classified material SUPPLEMENTARY INFORMATION: Purpose of AGENCY: Department of Energy. while preparing this SWEIS. Within the the Board: The purpose of the Board is ACTION: Notice of Meeting. limits of classification, DOE will to make recommendations to DOE and provide to the public as much its regulators in the areas of SUMMARY: The Industry Advisory Board information as possible to assist public environmental restoration, waste (IAB) to the International Energy understanding and comment. Any management, and related activities. Agency (IEA) will meet March 25, 1999 at the headquarters of the International classified material DOE needs to use to Tentative Agenda explain the purpose and need for the Energy Agency in Paris, France. 1. Follow-up discussion on low-level action, or the uses, materials, or impacts FOR FURTHER INFORMATION CONTACT: waste disposition issues; responses to analyzed in this SWEIS, will be Samuel M. Bradley, Acting Assistant questions, comments, and inquiry segregated into a classified appendix or General Counsel for International and requests from the Board. supplement, which will not be available Legal Policy, Department of Energy, 2. Review and approve the Request for for general public review. However, all 1000 Independence Avenue, S.W., Proposal (RFP) and contract for the unclassified results of calculations using Washington, D.C. 20585, 202–586–6738. Community Radiation Monitoring classified data will be reported in the SUPPLEMENTARY INFORMATION: (COMRAD) program. In unclassified section of the SWEIS, to the 3. Other Board business will be accordance with section 252(c)(1)(A)(i) extent possible in accordance with conducted as necessary. of the Energy Policy and Conservation federal classification requirements. Public Participation: The meeting is Act (42 U.S.C. 6272(c)(1)(A)(i)), the Availability of Scoping Documents open to the public. Written statements following meeting notice is provided: may be filed with the Committee either A meeting of the Industry Advisory Copies of all written comments and before or after the meeting. Individuals Board (IAB) to the International Energy transcripts of all oral comments related who wish to make oral statements Agency (IEA) will be held on March 25, to the Y–12 SWEIS will be available at pertaining to agenda items should 1999, at the headquarters of the IEA, 9 the following locations: contact Ken Korkia at the address or rue de la Federation, Paris, France, The DOE Public Reading Room, 230 telephone number listed above. beginning at approximately 9:00 a.m. Warehouse Road, Building 1916–T–2, Requests must be received 5 days prior The purpose of this meeting is to permit Suite 300, Oak Ridge, Tennessee to the meeting and reasonable provision attendance by representatives of U.S. 37831. will be made to include the presentation company members of the IAB at a Oak Ridge Public Library, 1401 Oak in the agenda. The Designated Federal meeting of the IEA’s Standing Group on Ridge Turnpike, Oak Ridge, Officer is empowered to conduct the Emergency Questions (SEQ) scheduled Tennessee 37831. meeting in a fashion that will facilitate to be held at the IEA’s offices on March Issued in Washington, D.C., this 11th day the orderly conduct of business. Each 25, including a preparatory encounter of March 1999, for the United States individual wishing to make public among company representatives from Department of Energy. comment will be provided a maximum approximately 9:00 a.m. to 9:30 a.m. Peter N. Brush, of 5 minutes to present their comments The Agenda for the preparatory Principal Deputy Assistant Secretary, at the beginning of the meeting. encounter among company Environment, Safety and Health. Minutes: The minutes of this meeting representatives is to elicit views [FR Doc. 99–6481 Filed 3–16–99; 8:45 am] will be available for public review and regarding items on the SEQ’s Agenda. BILLING CODE 6450±01±P copying at the Freedom of Information The Agenda for the SEQ meeting is Public Reading Room, 1E–190, Forrestal under the control of the SEQ. It is Building, 1000 Independence Avenue, expected that the SEQ will adopt the DEPARTMENT OF ENERGY SW, Washington, DC 20585 between following Agenda: 9:00 a.m. and 4 p.m., Monday–Friday, 1. Adoption of the Agenda Environmental Management Site- except Federal holidays. Minutes will 2. Approval of the Summary Records of Specific Advisory Board, Rocky Flats also be available at the Public Reading the 93rd and 94th Meetings AGENCY: Department of Energy. Room located at the Board’s office at 3. SEQ Work Program 9035 North Wadsworth Parkway, Suite • The 1999 SEQ Work Program ACTION: Notice of Open Meeting. 2250, Westminster, CO 80021; • First Elements of the Year 2000

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Work Program mark 25 years of SEQ work on measurement facilities, with 4. Appraisal of Emergency Response energy security appurtenances. Exercise 98 (ERE 98) • Emergency oil stocks and Asia FGT further requests that the • Draft Appraisal of ERE 98 by the Pacific Economic Cooperation Commission find that, upon Secretariat energy security (APERC Study) abandonment and sale of such facilities, • Appraisal of ERE 98 by • The year 2000 problem (the the South of MOPS facilities will be Administrations millennium bug) intrastate transportation facilities under • Appraisal of ERE 98 by Reporting As provided in section 252(c)(1)(A)(ii) Section 2(16) of the NGPA, and exempt Companies of the Energy Policy and Conservation from jurisdiction of the Commission • Appraisal of ERE 98 by Industry Act (42 U.S.C. 6272(c)(1)(A)(ii)), this under the NGA. FGT states that when Supply Advisory Group (ISAG) meeting is open only to representatives conveyed to Copano, the South of • Appraisal of ERE 98 by the IAB of members of the IAB and their MOPS facilities would be integrated 5. Policy and Legislative Developments counsel, representatives of members of with other Copano facilities and be in Member Countries the SEQ, representatives of the operated as a non-jurisdictional • Recent Strategic Petroleum Reserve Departments of Energy, Justice, and intrastate pipeline. Developments State, the Federal Trade Commission, Any person desiring to be heard or to • Developments in other IEA the General Accounting Office, make any protest with reference to said countries Committees of the Congress, the IEA, application should on or before April 1, 6. SEQ Issues for the IEA Ministerial and the European Commission, and 1999, file with the Federal Energy Meeting invitees of the IAB, the SEQ, or the IEA. Regulatory Commission, 888 First • Security Issues in the Transport Issued in Washington, D.C., March 11, Street, NE, Washington, D.C. 20426, a Sector 1999. motion to intervene or a protest in • Spare Oil Production Capacity in Mary Anne Sullivan, accordance with the requirements of the OPEC Countries Commission’s Rules of Practice and General Counsel. 7. Current IAB Activities Procedure (18 CFR 385.211 and [FR Doc. 99–6480 Filed 3–16–99; 8:45 am] 8. Emergency Reserve Situation of IEA 385.214) and the regulations under the Countries BILLING CODE 6450±01±P Natural Gas Act (18 CFR 157.10). All • Emergency Reserve and Net Import protests filed with the Commission will Situation of IEA Countries on 1 DEPARTMENT OF ENERGY be considered by it in determining the October 1998 appropriate action to be taken, but will 9. Emergency Reserve Issues Federal Energy Regulatory not serve to make the protestants parties • Seminar on IEA Oil Stock Strategy Commission to the proceeding. Any person wishing 10. Emergency Response Simulation to become a party in the proceeding • Proposal for Disruption Simulation [Docket No. CP99±233±000] herein must file a motion to intervene Exercise in accordance with the Commission’s 11. Emergency Response Issues of IEA Florida Gas Transmission Company; rules. Candidate Countries Notice of Application Take further notice that, pursuant to • Emergency Reserve Situation of IEA March 11, 1999. the authority contained in and subject to Candidate Countries the jurisdiction conferred upon the Take notice that on March 3, 1999, 12. Emergency Data System and Related Commission by Sections 7 and 15 of the Florida Gas Transmission Company Questions Natural Gas Act and the Commission’s (FGT) 1400 Smith Street, Houston, • Base Period Final Consumption Rules of Practice and Procedure, a Texas 77002, filed, in Docket No. CP99– hearing will be held without further Q497-Q398 233–000, an application pursuant to • Monthly Oil Statistics (MOS) notice before the Commission or its Section 7(b) of the Natural Gas Act and designee on this application if no October 1998 Part 157 of the Commission’s • motion to intervene is filed within the MOS November 1998 Regulations for an order permitting and • Quarterly Oil Forecast Q298-Q199 time required herein, if the Commission approving the abandonment by sale to on its own review of the matter finds 13. Emergency Response Reviews of IEA Copano Pipelines/South Texas, L.P., a Countries that permission and approval for the Texas Limited Partnership (Copano), of proposed abandonment are required by • Emergency Response Review of its South of MOPS facilities located in Finland the public convenience and necessity. If San Patricio, Refugio, and Nueces a motion for leave to intervene is timely • Emergency Response Review of Counties, Texas, as more fully set forth Greece filed, or if the Commission on its own in the application which is on file with motion believes that formal hearing is • Emergency Response Review of the Commission and open to public New Zealand required, further notice of such hearing inspection. This filing may be viewed will be duly given. • Updated Schedule of Emergency on the web at http://www.ferc.fed.us/ Response Reviews online/rims.htm (call 202–208–2222 for Under the procedure herein provided 14. Emergency Reference Guide— assistance). for, unless otherwise advised, it will be Update of Emergency Contact Specifically, FGT explains that the unnecessary for FGT to appear or to be Points List South of MOPS facilities consist of represented at the hearing. 15. Dispute Settlement Center—Panel of 70.25 miles of 20-inch diameter Linwood A. Watson, Jr., Arbitrators pipeline, FGT’s Compressor Station No. Acting Secretary. 16. Other Business 2, consisting of two units for a total of [FR Doc. 99–6416 Filed 3–16–99; 8:45 am] • Discussion of possible event to 4,000 horsepower, and various BILLING CODE 6717±01±M

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DEPARTMENT OF ENERGY protest is filed and not withdrawn k. Status of environmental analysis: within 30 days after the time allowed This application is not ready for Federal Energy Regulatory for filing a protest, the instant request environmental analysis at this time. Commission shall be treated as an application for l. Brief Description of the Project: The [Docket No. CP99±237±000] authorization pursuant to Section 7 of proposed project would consist of the the Natural Gas Act. existing Atlanta Power Station facilities, Williston Basin Interstate Pipeline Linwood A. Watson, Jr., located at the Forest Service’s Kirby Company; Notice of Request Under Acting Secretary. Dam, consisting of: (1) a penstock intake Blanket Authorization [FR Doc. 99–6417 Filed 3–16–99; 8:45 am] structure; (2) a powerhouse located at BILLING CODE 6717±01±M the dam, containing a single generating March 11, 1999. unit with a capacity of 187 kilowatts; (3) Take notice that on March 5, 1999, 4.8 miles of 3-phase, 2,400-volt Williston Basin Interstate Pipeline DEPARTMENT 0F ENERGY transmission line; and (4) related Company (Williston Basin), 200 North facilities. Third Street, Suite 300, Bismarck, North Federal Energy Regulatory m. Locations of the application: A Dakota 58501, filed in Docket No. CP99– Commission copy of the application is available for 237–000 a request pursuant to Sections inspection and reproduction at the 157.205 and 157.216 of the Notice of Application Tendered for Commission’s Public Reference Room, Commission’s Regulations under the Filing With the Commission and located at 888 First Street, NE., Room Natural Gas Act (18 CFR 157.205 and Soliciting Additional Study Requests 2A, Washington, DC 20426, or by calling 157.216) for authorization to abandon March 11, 1999. (202) 208–1371. This filing may be the South Byron supply lateral pipeline viewed on the web at http:// located in Big Horn County, Wyoming. Take notice that the following hydroelectric application has been filed www.ferc.fed.us/online/rims.htm (call Williston Basin makes such request 202–208–2222 for assistance). A copy is under its blanket certificate issued in with the Commission and is available for public inspection: also available for inspection and Docket Nos. CP82–487–000, et al., reproduction at the address in item h pursuant to Section 7 of the Natural Gas a. Type of Application: Minor above. Act, all as more fully set forth in the License. b. Project No.: P–11541–001. n. With this notice, we are initiating request on file with the Commission. c. Date filed: February 26, 1999. consultation with the IDAHO STATE The filing may be viewed on the web at d. Applicant: Atlanta Power HISTORIC PRESERVATION OFFICER http://www.ferc.fed.us/online/rims.htm Company, Inc. (SHPO), as required by § 106, National (call 202–208–2222 for assistance). e. Name of Project: Atlanta Power Specifically, Williston Basin proposes Historic Preservation Act, and the Station Hydroelectric Project. regulations of the Advisory Council on to abandon the 3.77 mile South Byron f. Location: On the Middle Fork Boise supply lateral pipeline that consists of Historic Preservation, 36 CFR 800.4. River in Elmore County, Idaho, near the Linwood A. Watson, Jr., 3.16 mile of 4-inch pipeline .07 mile of town of Atlanta within the Boise Acting Secretary. 7-inch pipeline and .54 mile of 8-inch National Forest (T5N, R11E, sections 5, pipelines. It is stated that the South 4, 3, 2, and 11, Boise Meridian). [FR Doc. 99–6418 Filed 3–16–99; 8:45 am] Byron supply lateral pipeline consists of g. Filed Pursuant to: Federal Power BILLING CODE 6717±01±M various vintage sections of pipeline, Act 16 U.S.C. 791(a)–825(r). which are deteriorated and prone to h. Applicant Contact: Lynn E. leaks. Stevenson, President, Atlanta Power ENVIRONMENTAL PROTECTION It is indicated that the South Byron Company, Inc., Box 100, Fairfield, ID, AGENCY supply lateral pipeline was previously (208) 352–4692; Michael C. Creamer, [FRL±6311±2] used to transport gas received from a Esq., Givens Pursley LLP, 277 N. 6th producer in the South Byron Field, but Street, Suite 200, P.O. Box 2720, Boise, Agency Information Collection that the producer no longer delivers gas ID 83701, (208) 388–1200. Activities: Submission for OMB into the South Byron supply lateral i. FERC Contact: Gaylord W. Review; Comments Request: Used Oil pipeline. Williston Basin avers that the Hoisington (202) 219–2756. Management Standards shipper who previously purchased the j. Deadline for filing additional study Recordkeeping and Reporting gas received through the South Byron requests: April 27, 1999. Requirements supply pipeline has informed Williston All documents (original and eight Basin that its gas purchase contract with copies) should be filed with: David P. AGENCY: Environmental Protection this producer was terminated, effective Boergers, Secretary, Federal Energy Agency (EPA). March 1, 1999. Regulatory Commission, 888 First ACTION: Notice. Any person or the Commission’s staff Street, NE., Washington, DC 20426. may, within 45 days after issuance of The Commission’s Rules of Practice SUMMARY: In compliance with the the instant notice by the Commission, and Procedure require all intervenors Paperwork Reduction Act (44 U.S.C. file pursuant to Rule 214 of the filing documents with the Commission 3501 et seq.), this notice announces that Commission’s Procedural Rules (18 CFR to serve a copy of that document on the following Information Collection 385.214) a motion to intervene or notice each person whose name appears on the Request (ICR) has been forwarded to the of intervention and pursuant to Section official service list for the project. Office of Management and Budget 157.205 of the Regulations under the Further, if an intervenor files comments (OMB) for review and approval: Used Natural Gas Act (18 CFR 157.205) a or documents with the Commission Oil Management Standards protest to the request. If no protest is relating to the merits of an issue that Recordkeeping and Reporting filed within the time allowed therefor, may affect the responsibilities of a Requirements, OMB Control Number the proposed activity shall be deemed to particular resource agency, they must 2050–0124, expires 3/31/99. The ICR be authorized effective the day after the also serve a copy of the document on describes the nature of the information time allowed for filing a protest. If a that resource agency. collection and its expected burden and

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Burden Statement: The annual public Agency Information Collection FOR FURTHER INFORMATION OR A COPY reporting and recordkeeping burden for Activities: Submission for OMB CALL: Contact Sandy Farmer at EPA by this collection of information is Review; Comment Request; Pesticide phone at (202) 260–2740, by email at estimated to range from six minutes to Registration Application, Notification [email protected], or 23 hours per response depending on the and Report for Pesticide-Producing download off the Internet at http:// type of response. Burden means the Establishments www.epa.gov/icr and refer to EPA ICR total time, effort, or financial resources AGENCY: No. 1286.05. expended by persons to generate, Environmental Protection Agency (EPA). SUPPLEMENTARY INFORMATION: Title: maintain, retain, or disclose or provide Used Oil Management Standards information to or for a Federal agency. ACTION: Notice. This includes the time needed to review Recordkeeping and Reporting SUMMARY: In compliance with the Requirements, ICR No. 1286.05, OMB instructions; develop, acquire, install, Paperwork Reduction Act (44 U.S.C. No. 2050–0124, expires 3/31/99. This is and utilize technology and systems for 3507 (a)(1)(D)), this document a request for extension of a currently the purposes of collecting, validating, announces that the Information approved collection. and verifying information, processing Collection Request (ICR) for the Abstract: The Used Oil Management and maintaining information, and Application for Registration of Standards, which include information disclosing and providing information; Pesticide-Producing Establishments, collection requests, were developed in adjust the existing ways to comply with and the Pesticides Report for Pesticide- accordance with section 3014 of the any previously applicable instructions Producing Establishments described Resource Conservation and Recovery and requirements; train personnel to be below has been forwarded to the Office Act (RCRA), as amended by the able to respond to a collection of of Management and Budget (OMB) for Hazardous and Solid Waste information; search data sources; review and comment. The ICR describes Amendments of 1984 (HSWA), which complete and review the collection of the nature of the information collection directs EPA to ‘‘promulgate regulations information; and transmit or otherwise and its expected burden and cost; and ** * as may be necessary to protect disclose the information. it includes the forms. Also included is public health and the environment from Respondent/Affected Entities: the Notification of Registration of the hazards associated with recycled business. Pesticide-Producing Establishments, oil’’ and, at the same time, to not which EPA uses to notify the company discourage used oil recycling. In 1985 Estimated Number of Respondents: of their newly registered pesticide- and 1992, EPA established mandatory 732. producing establishments, and the regulations that govern the management Frequency of Response: biennially. assignment of their Establishment of used oil (see 40 CFR part 279). To Estimated Total Annual Hour Burden: Number(s). document and ensure proper handling 363,664 hours. of used oil, these regulations establish DATES: Comments must be submitted on notification, testing, tracking and Estimated Total Annualized Cost or before April 16, 1999. recordkeeping requirements for used oil Burden: $0. FOR FURTHER INFORMATION CONTACT: transporters, processors, re-refiners, Send comments on the Agency’s need Contact Sandy Farmer at EPA by phone marketers, and off-specification burners. for this information, the accuracy of the at (202) 260–2740, by email at They also set standards for the provided burden estimates, and any [email protected], or prevention and cleanup of releases to suggested methods for minimizing download off the Internet at http:// the environment during storage and respondent burden, including through www.epa.gov/icr and refer to EPA ICR transit, and for the safe closure of the use of automated collection No. 0160.06. storage units and processing and re- techniques to the following addresses. SUPPLEMENTARY INFORMATION: Title: refining facilities to mitigate future Please refer to EPA ICR No. 1286.05 and Pesticide Registration Application, releases and damages. EPA believes OMB Control No. 2050–0124 in any Notification and Report for Pesticide- these requirements minimize potential correspondence. Producing Establishments; (OMB hazards to human health and the Ms. Sandy Farmer, U.S. Control No. 2070–0078; EPA ICR No. environment from the potential Environmental Protection Agency, 0160.06). mismanagement of used oil by used oil Office of Policy, Regulatory Information Abstract: The U.S. Environmental handlers, while providing for the safe Division (2137), 401 M Street, SW., Protection Agency (EPA) must collect recycling of used oil. Information from Washington, DC 20460. information on pesticide-producing these information collection establishments in order to meet the requirements is used to ensure and statutory requirements of Section 7 of compliance with the Used Oil Office of Information and Regulatory the Federal Insecticide, Fungicide, and Management Standards. Affairs; Office of Management and Rodenticide Act (FIFRA). FIFRA An agency may not conduct or Budget, Attention: Desk Officer for requires producers of pesticide sponsor, and a person is not required to EPA, 725 17th Street, NW., products, active ingredients, and respond to, a collection of information Washington, DC 20503. devices to register their establishments unless it displays a currently valid OMB Dated: March 11, 1999. with EPA and to submit an initial control number. The OMB control report, and thereafter, annually report numbers for EPA’s regulations are listed Joseph Retzer, on the types and amounts of products in 40 CFR Part 9 and 48 CFR Chapter Director, Regulatory Information Division. produced. The purpose of this notice is 15. The Federal Register Notice [FR Doc. 99–6501 Filed 3–16–99; 8:45 am] to request renewal of the collection required under 5 CFR 1320.8(d), BILLING CODE 6560±50±P process and reporting processes for the

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Application for Registration of Registration of Pesticide-Producing ENVIRONMENTAL PROTECTION Pesticide-Producing Establishments Establishments (EPA Form 3540–8A) AGENCY (EPA Form 3540–8), the Notification of because EPA completes this form. [FRL±6311±4] Registration of Pesticide-Producing Burden means the total time, effort, or Establishments (EPA Form 3540–8A), financial resources expended by persons Formation of a Task Force on and the Pesticides Report for Pesticide- to generate, maintain, retain, or disclose Innovative Approaches to Producing Establishments (EPA Form or provide information to or for a Environmental Protection and a Public 3540–16). Federal agency. This includes the time Meeting on draft recommendations for Application for Registration of needed to review instructions; develop, innovative actions by the Agency Pesticide-Producing Establishments acquire, install, and utilize technology information, collected on EPA Form AGENCY: U.S. Environmental Protection and systems for the purposes of 3540–8, is a one-time requirement for all Agency (EPA). collecting, validating, and verifying pesticide-producing establishments. The ACTION: Notice of formation of the Task information, processing and reporting of pesticide production Force on Innovative Approaches to maintaining information, and disclosing information collected on the Pesticides Environmental Protection and notice of and providing information; adjust the Report for Pesticide-Producing a public meeting on draft Establishments, EPA Form 3540–16, is existing ways to comply with any recommendations for innovative actions required within 30 days of receipt of the previously applicable instructions and by the Environmental Protection Notification of Registration of Pesticide- requirements; train personnel to be able Agency. Producing Establishments (EPA Form to respond to a collection of 3540–8A); and then annually thereafter, information; search data sources; SUMMARY: On January 28, 1999, on or before March 1. The information complete and review the collection of Administrator Browner formed a Task is entered and stored in EPA’s Office of information; and transmit or otherwise Force on Innovative Approaches to Enforcement and Compliance Assurance disclose the information. The burden Environmental Protection to assess the (OECA)/Office of Compliance (OC) associated with this ICR is described Agency’s progress on reinvention Section Seven Tracking System (SSTS), below: activities designed to achieve improved a computerized data processing and environmental protection at lower cost, Respondents/Affected Entities: with greater efficiency, and with less record-keeping system. Pesticide producing establishments. The Office of Compliance/OECA burden on the regulated community. collects the establishment and pesticide Estimated Number of Respondents: The Task Force will review the production information for compliance 13,262. effectiveness of innovative activities oversight and risk assessment. The Frequency of Response: One time and designed to achieve compliance with information is used by EPA Regional yearly. environmental requirements and to pesticide enforcement and compliance encourage broader environmental staffs, OECA, and the Office of Pesticide Estimated Total Annual Hour Burden: stewardship. The Task Force will Programs (OPP) within the Office of 18,173 hours. submit recommendations to the Prevention, Pesticides and Toxic Estimated Total Annualized Cost Administrator on May 15, 1999 that Substances (OPPTS), as well as the U.S. Burden: $0 include practical actions that can be implemented over the next 12 to 18 Department of Agriculture (USDA), the Send comments on the Agency’s need months to further our progress toward Food and Drug Administration (FDA), for this information, the accuracy of the other Federal agencies, States under compliance and stewardship. provided burden estimates, and any Involvement from EPA’s State partners, Cooperative Enforcement Agreements, suggested methods for minimizing and the public. the regulated community, the respondent burden, including through An agency may not conduct or environmental community and the sponsor, and a person is not required to the use of automated collection public, as well as EPA staff will be respond to, a collection of information techniques to the following addresses. essential to identifying the best unless it displays a currently valid OMB Please refer to EPA ICR No. 0160.06 and opportunities for successful action with control number. The OMB control OMB Control No. 2070–0078 in any the greatest environmental benefit. In numbers for EPA’s regulations are listed correspondence. order to obtain this input, EPA program in 40 CFR part 9 and 48 CFR Chapter Ms. Sandy Farmer, U.S. Environmental offices and regional offices are holding 15. The Federal Register document Protection Agency, Office of Policy, a series of focus group sessions to required under 5 CFR 1320.8(d), Office of Regulatory Management, develop a broad range of ideas. In soliciting comments on this collection Regulatory Information Division addition, input received in recent of information was published on 01/05/ (2137), 401 M Street, SW, stakeholder meetings conducted by the 99 (64 FR 499), and no comments were Washington, DC 20460; Office of Enforcement and Compliance received. Assistance will be integrated into the Burden Statement: The annual public and input that the Task Force considers in reporting and record keeping burden for Office of Information and Regulatory developing draft recommendations for this collection of information is Affairs, Office of Management and public comment, before preparing final estimated to be an average of 18 minutes Budget, Attention: Desk Officer for recommendations to submit to the for a one time response for the EPA, 725 17th Street, NW, Administrator. There are two Application for Registration of Washington, DC 20503. opportunities for comment in this Pesticide-Producing Establishments process. The Office of Reinvention has Dated: March 8, 1999. (EPA Form 3540–8), and 1 hour and 26 established a web site at http:// minutes for the annual yearly response Richard T. Westlund, www.epa.gov/reinvent/taskforce. Users for the Pesticides Report for Pesticide- Acting Director, Regulatory Information may provide comment directly at the Producing Establishments (EPA Form Division. web site with initial suggestions as well 3540–16). There is no public burden [FR Doc. 99–6509 Filed 3–16–99; 8:45 am] as comments on draft recommendations associated with the Notification of BILLING CODE 6560±50±P when they are available. The Office of

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Reinvention is also convening a one-day The Task Force is soliciting feedback II. Encouraging Environmental public meeting of stakeholders and State on these topics from EPA staff, state Stewardship: Partners to discuss draft partners and external stakeholders in The work of the the Task Force also recommendations, with a time allotted March and April 1999. The task force, includes identifying incentives to for public comments. chaired by Deputy Administrator Peter stimulate environmentally beneficial DATES: The public meeting will be on Robertson, will submit its final report to behavior beyond what is legally April 15, 1999 from 9 AM until 4:30 PM the Administrator by May 15. required. Included in this effort may be in room 6208 of the Ariel Rios Building, reductions in emissions below the levels Key Issues and Questions 1200 Pennsylvania Ave. NW, required by regulations and permits, Washington, DC 20004. The Ariel Rios I. Achieving the Compliance Baseline. helping to solve environmental Building is located at the Federal problems that are not regulated by EPA, Triangle Metro stop. If you plan to Full compliance with environmental such as energy or water use, or actions attend, please inform one of the contacts laws is the baseline standard of which support broadly desirable goals listed below, as seating is limited. environmental performance. A wide such as sustainability. There are an FOR FURTHER INFORMATION CONTACT: variety of EPA activities, in addition to increasing number of companies and Cynthia Nolt (telephone 202–260–9642) enforcement actions, address this issue. communities which are demonstrating or Patricia Cohn (202–260–9643) of the These activities include: leadership through pollution Office of Reinvention (MC1801), U. S. 1. New approaches in regulatory prevention, product stewardship, Environmental Protection Agency, 401 requirements. EPA is testing regulatory providing others with guidance about M St. SW, Washington, DC 20460. Also approaches that establish clear environmental responsibilities, and see http://www.epa.gov/reinvent/ standards, while providing flexibility in developing other creative ways to taskforce. how those standards are achieved. In achieve environmental results. 1. Encouraging top performance. SUPPLEMENTARY INFORMATION: one program, the Agency has Scope and Some companies consistently perform Objectives of the Innovations Task consolidated scattered rules that apply well above required levels Force: EPA’s leadership, at the direction to a single industry into a clearer and environmentally—not only meeting the of Vice President Gore and with the more understandable package. We are compliance baseline, but going well support of the National Partnership for also writing new regulations in ‘‘plain beyond it in addressing environmental Reinventing Government (NPR), has language’’ to reduce confusion about issues. Is EPA doing enough to reward formed the Task Force on Innovative what is expected of regulated parties. and encourage this kind of outstanding Approaches to Environmental These efforts should promote improved environmental performance? What Protection to take stock of EPA’s compliance. Are there additional steps specific opportunities are there to reinvention work and find new that EPA can take to make regulatory employ other incentive approaches to approaches to improve environmental requirements easier to understand and promote these objectives? What types of compliance and performance. The Task comply with? incentives are likely to be most Force is charged with developing a set 2. Results-oriented permitting and effective? of proposals that can be promptly 2. Encouraging voluntary implemented to improve or expand the reporting. Unnecessarily complicated permit conditions and reporting improvements. An increasing number of Agency’s reinvention activities with companies are interested in improving requirements can be sources of non- input from employees, EPA’s state their environmental performance compliance. EPA has carried out a partners and stakeholders. beyond minimum regulatory number of pilots to test simplified or Innovative efforts are underway in all requirements—e.g., by participating in parts of EPA—the media-based program consolidated environmental reporting targeted voluntary programs. Similarly, offices, the regional offices, and the and has experimented with many communities are working to solve local cross-cutting offices—and state approaches for getting better results environmental problems such as habitat environmental programs. Through from permits, such as watershed loss, traffic congestion, and loss of open various reinvention initiatives, the trading. Can EPA use this experience to space. There is widespread interest in Agency has streamlined regulatory make broader changes that will reduce actions individuals can take to reduce requirements, tested innovative the frequency of non-compliance their impact on the environment. Are regulatory approaches through programs associated with complex permit and there additional steps EPA should be such as Project XL and the Common reporting requirements? taking to encourage improvement by Sense Initiative, initiated voluntary 3. Compliance assistance. EPA and these parties? Are there unaddressed programs to encourage environmental other regulators are using a number of problems, or problems not fully improvement, and launched new addressed by regulatory approaches, programs and policies to assist innovative approaches to help regulated parties comply, ranging from that present promising opportunities for businesses in complying with using voluntary approaches? Is there a environmental laws. compliance assistance centers, to compliance manuals, to onsite technical particular industry or set of pollution It is now time to take stock of these sources that presents opportunities? assistance and hotlines. Should EPA efforts: to identify ‘‘what’s working’’ and Should EPA develop more expand the use of these strategies? What to integrate successful approaches more comprehensive strategies for broadly into day-to-day operations. The is EPA’s role versus the role of state encouraging continuous improvement task force will look for specific, concrete agencies in providing compliance by companies and communities? and readily implementable ideas, assistance? Based on the experience of 3. Integrating environmental and focusing on innovative ways to: the past five years, are there ways that business decisions. New business tools • achieve the baseline of regulatory compliance assistance strategies can be have been developed that incorporate compliance, and adjusted to get the maximum benefit? environmental considerations into • encourage environmental Are there new strategies that should be traditional business systems. For improvements beyond that baseline. adopted? example, some companies now use

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Are there SUPPLEMENTARY INFORMATION: This is the metals mixtures; (b) review of a Biotic additional opportunities to accelerate third in a series of meetings at locations Ligand Model (BLM) for establishing the adoption of these new practices in around the country to hear from aquatic life criteria for metals; and (c) related areas such as capital budgeting, regional and national experts on the review of a proposed approach for design, materials management, facts concerning oxygenate use in fuel. setting Ecological Soil Screening Levels underwriting, and finance? While in Sacramento, the panel will (Eco-SSLs) for use at Superfund sites. Dated: March 11, 1999. focus on understanding oxygenate and Background (a) Bioavailability and Jay Benforado, water issues in California. A number of Toxicity of Metals in Surface Waters presenters have been invited to offer a Acting Associate Administrator, Office of and Sediments: The Office of Water and Reinvention. variety of perspectives regarding the Office of Research and Development oxygenate issues. The panel will also be [FR Doc. 99–6513 Filed 3–16–99; 8:45 am] have been working over the past several accepting written public comment BILLING CODE 6560±50±P years to refine Agency approaches to submissions. Written submissions can developing criteria and guidance for be mailed to US EPA, 401 M Street, SW, metals levels that are protective of ENVIRONMENTAL PROTECTION Mail Code 6406J (Attn: Blue-Ribbon benthic organisms, aquatic life in the AGENCY Panel), Washington, DC 20460. Panel water column, and wildlife that members will be provided with copies consume aquatic organisms. A focus of [FRL±6311±6] of all written submissions. this recent work has been on improving Notice of Oxygenate Use in Gasoline Dated: March 12, 1999. the understanding of factors that Panel Meeting Margo T. Oge, influence metals bioavailability, and Director, Office of Mobile Sources. thus toxicity, in the environment. The AGENCY: Environmental Protection [FR Doc. 99–6619 Filed 3–16–99; 8:45 am] Office of Water is asking the SAB to Agency. BILLING CODE 6560±50±P review its integrated approach to ACTION: Notice. assessing bioavailability and toxicity of metals in surface waters and sediments SUMMARY: On November 30, 1998, U.S. ENVIRONMENTAL PROTECTION by evaluating proposed modifications to Environmental Protection Agency AGENCY the approaches used to develop Administrator Carol M. Browner sediment metals guidelines and aquatic announced the creation of a blue-ribbon [FRL±6311±1] life criteria for metals. The Charge to the panel of leading experts from the public Committee is as follows: health and scientific communities, Science Advisory Board; Notification automotive fuels industry, water of Public Advisory Committee Overall Charge utilities, and local and State government Meetings Does the integrated metals to review the important issues posed by Pursuant to the Federal Advisory methodology improve our ability to the use of MTBE and other oxygenates Committee Act, Public Law 92–463, make both protective and predictive in gasoline. EPA created the panel to notice is hereby given that two assessments of toxicity due to copper, gain a better understanding of the public Committees of the Science Advisory silver and other selected metals in the health concerns raised by the discovery Board (SAB) will meet on the dates and water column and sediment? of MTBE in some water supplies. The times described below. All times noted Biotic Ligand Model Questions: panel will be chaired by Mr. Daniel are Eastern Time. All meetings are open Greenbaum, President of the Health to the public, however, seating is (1) Does the BLM improve our ability Effects Institute (HEI) of Cambridge, limited and available on a first come to predict toxicity to water column Massachusetts, and Mr. Robert basis. Documents that are the subject of organisms due to metals (copper and Perciasepe, Assistant Administrator for SAB reviews are normally available silver) in comparison to the currently Air and Radiation, US EPA. from the originating U.S. Environmental applied dissolved metal concentration This notice announces the time and Protection Agency (EPA) office and are criterion? place for the third meeting of the panel. not available from the SAB Office. (2) Is the scientific and theoretical DATES: The blue-ribbon panel reviewing Public drafts of SAB reports are foundation of the model sound? (3) In comparison to the current Water the use of oxygenates in gasoline will available to the Agency and the public Effects Ration (WER) adjustment for conduct its third meeting on Thursday from the SAB office. Details on aquatic life criteria, will the application and Friday, March 25 and 26, 1999, in availability are noted below. of the BLM as a site-specific adjustment Sacramento, CA beginning at 8:30 a.m. 1. Ecological Processes and Effects reduce uncertainty associated with ADDRESSES: The meeting will be held Committee metals bioavailability and toxicity? from 8:30 a.m. to possibly 8:30 p.m. on (4) Are the data presented for the Thursday, March 25th and from 8:30 The Ecological Processes and Effects validation of the BLM sufficient to a.m.–12:00 p.m. on Friday, March 26th Committee (EPEC) of the Science support the incorporation of the BLM at the Sacramento Convention Center, Advisory Board (SAB) will hold a directly into copper and silver criteria 1030 15th Street, Room 202, public meeting on April 6–7, 1999 in documents? Sacramento, CA. Washington, DC. The meeting will be FOR FURTHER INFORMATION CONTACT: held in Room 1103 West Tower of the Equilibrium Sediment Guidelines for Karen Smith at U.S. Environmental EPA Waterside Mall Complex, 401 M Metals Mixtures Questions Protection Agency Office of Air and Street, SW, Washington, DC 20460, (1) By incorporating the fraction Radiation, 401 M Street, SW (6406J), beginning at 8:30 am and ending no organic carbon into the bioavailability

VerDate 03-MAR-99 16:11 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm01 PsN: 17MRN1 13190 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices equation, have we retained the background information for the Subcommittee: Data from Testing of protective features of the guidelines and sediment metals and Biotic Ligand Human Subjects; (b) Ecological improved its predictiveness of toxic Model reviews can be obtained by Processes and Effects Committee effects? contacting Jennifer Mitchell, Office of (EPEC): Review of the Agency’s Index of (2) If the BLM is used to derive or Water’s Health and Ecological Criteria Watershed Indicators (IWI); and (c) adjust a water quality criterion, is the Division, Mail Code 4304, U.S. Environmental Engineering Committee: revised criterion appropriate for use in Environmental Protection Agency, 401 Commentary on the Need to Address the interstitial water component of the M Street, SW, Washington, DC 20460; Source Reduction and Control Metals Mixtures ESG? by e-mail at: Technology in PM2.5 Research Plan. It (3) Are the data presented from lab ; or by is possible that other draft reports may and field experiments with chromium telephone at (202) 260–6101. Single be available for review at this meeting and silver sufficient to support their copies of the background material for as well. Please check with Ms. Tillery- addition to the Metals Mixtures ESG? the Eco-SSL advisory can be obtained by Gadson prior to the meeting to confirm contacting Steve Ells, Office of any changes in the planned review (b) Ecological Soil Screening Levels Emergency and Remedial Response, schedule. (Eco-SSLs): Mail Code 5204G, U.S. Environmental For Further Information: The Office of Emergency and Protection Agency, 401 M Street, SW, Remedial Response (i.e., the Superfund Washington, DC 20460; by e-mail at: Any member of the public wishing Program) has asked the SAB to provide ; or by telephone at further information concerning the an advisory on ongoing work to develop (703) 603–8822. meeting or wishing to submit comments Ecological Soil Screening Levels (Eco- Additional information about the should contact Dr. Donald G. Barnes, SSLs) that will be protective of the meeting, or the meeting agenda, can be Designated Federal Officer for the terrestrial environment. The Agency has obtained by contacting Ms. Mary Executive Committee, Science Advisory formed a multi-stakeholder workgroup Winston, Committee Operations Staff, Board (1400), U.S. Environmental to develop Eco-SSLs. Members include Science Advisory Board (1400), U.S. Protection Agency, Washington DC scientists and risk assessors from EPA, EPA, 401 M Street, SW, Washington, DC 20460; telephone (202) 260–4126; FAX Environment Canada, Department of 20460; by telephone at (202) 260–2554; (202) 260–9232; and via e-mail at: Energy, Army, Navy, Air Force, states, by fax at (202) 260–7118 or via e-mail . Copies of the industry, academia, and consulting at: . Anyone draft reports are available from the same firms. This collaborative project is wishing to make an oral presentation to source, or from the SAB Website (http:/ expected to result in a Superfund the Committee must contact Ms. /www.epa.gov/sab) at least one week guidance document that includes a Stephanie Sanzone, Designated Federal prior to the meeting. look-up table of generic Eco-SSLs for up Official for EPEC, in writing to the Providing Oral or Written Comments at to 24 chemicals or groups of chemicals address or fax above, or via e-mail at: SAB Meetings that are frequently of ecological concern no later at Superfund sites. The charge to the than 4:00 pm on March 31, 1999, in The Science Advisory Board expects Committee includes the following order to be included on the Agenda. The that public statements presented at its questions: request should identify the name of the meetings will not be repetitive of (1) Will the proposed procedures for individual who will make the previously submitted oral or written evaluating mammalian and avian presentation and an outline of the issues statements. In general, each individual toxicity data result in the selection and to be addressed. At least 35 copies of or group making an oral presentation use of the most appropriate data for any written comments to the Committee will be limited to a total time of ten generating wildlife Eco-SSL? are to be given to Ms. Sanzone no later minutes. For teleconference meetings, (2) Will the proposed procedures for than the time of the presentation for opportunities for oral comment will evaluating soil biota toxicity data result distribution to the Committee and the usually be limited to no more than three in the selection and use of the most interested public. minutes per speaker and no more than fifteen minutes total. Written comments appropriate available data for generating 2. Executive Committee plant, invertebrate, and microbial Eco- (at least 35 copies) received in the SAB SSLs? The Science Advisory Board’s (SAB) Staff Office sufficiently prior to a (3) Do the models and exposure Executive Committee, will conduct a meeting date (usually one week before factors used in the wildlife food chain public teleconference meeting on the meeting), may be mailed to the model reflect the state of the practice? Thursday, April 8, 1999, between the relevant SAB committee or (4) Do the proposed approaches for hours of 12:00 noon and 2:00 pm, subcommittee; comments received too selecting single Eco-SSL values for the Eastern Time. The meeting will be close to the meeting date will normally five receptor groups reflect a reasoned coordinated through a conference call be provided to the committee at its balance between conservativeness and connection in Room M3709 of the Mall meeting, or mailed soon after receipt by reasonableness? at the U.S. Environmental Protection the Agency. Written comments may be (5) Do the proposed efforts for Agency, 401 M Street SW, Washington, provided to the relevant committee or modifying the Eco-SSLs in Tier 2 DC 20460. The public is welcome to subcommittee up until the time of the consider the factors of greatest concern attend the meeting physically or meeting. (e.g., soil chemistry and bioavailability through a telephonic link. Additional Additional information concerning issues, unit area of exposure, instructions about how to participate in the Science Advisory Board, its probablilistic approaches)? the conference call can be obtained by structure, function, and composition, calling Ms. Priscilla Tillery-Gadson at may be found on the SAB Website For Further Information: (202) 260–4126. (http://www.epa.gov/sab) and in The The briefing and review materials During this meeting the Executive Annual Report of the Staff Director prepared by the Agency for this meeting Committee plans to review draft reports which is available from the SAB are NOT available from the Science from its Committees. Anticipated drafts Publications Staff at (202) 260–4126 or Advisory Board. Single copies of the include: (a) Executive Committee (EC) via fax at (202) 260–1889.

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Individuals requiring special WP 9 (3125–302). These cancellations general practice to accept registrant’s accommodation at SAB meetings, were announced in the Federal Register requests for cancellation of registrations including wheelchair access, should of August 27, 1997 (62 FR 45416) (FRL– or specific registered uses. contact the appropriate DFO at least five 5737–4), and became final March 9, Notice of the request for cancellation business days prior to the meeting so 1998. Initiation of the exiting stocks is published primarily for the purpose period began when the Agency received that appropriate arrangements can be of alerting affected parties so that they made. the request for cancellations and ran for may either attempt to convince the 18 months. On February 1, 1999, Bayer Dated: March 10, 1999. registrant to maintain the registration or requested cancellation of its remaining Donald G. Barnes, apply to register the product oxythioquinox registrations. After Staff Director, Science Advisory Board. cancellation orders for these products themselves. EPA proposes to approve [FR Doc. 99–6502 Filed 3–16–99; 8:45 am] are issued, there will be no remaining these cancellations expeditiously after BILLING CODE 6560±50±P registered products containing the close of the comment period unless oxythioquinox. the registrant withdraws its request or a compelling reason opposing termination ENVIRONMENTAL PROTECTION II. Terminations Pursuant to Voluntary is presented in public comments. If the AGENCY Requests requests are granted, any use of the [OPP±66265; FRL±6067±8] Under section 6(f)(1) of FIFRA, above mentioned chemicals would be registrants may request at any time that permitted only if the products are used Oxythioquinox; Voluntary Termination ‘‘a pesticide registration of the registrant in accordance with the terms and of Uses be canceled or amended to terminate conditions specified on the label. one or more pesticide uses.’’ (7 U.S.C. EPA also proposes to accept the AGENCY: Environmental Protection 136d(f)(1)). Consistent with 6(f)(1) of Agency (EPA). registrants’ requests for existing stocks FIFRA, EPA is issuing a notice of receipt provisions. Under FIFRA section 6(a)(1), ACTION: Notice of receipt of request to of the request. terminate uses. EPA may permit the continued sale and III. Termination Intent to Cancel use of a canceled pesticide if such sale SUMMARY: In accordance with section This notice announces receipt of or use ‘‘is not inconsistent with the 6(f)(1) of the Federal Insecticide, request for voluntary cancellation of purposes of this Act.’’ For each of the Fungicide, and Rodenticide Act EPA registrations listed in Table 1 chemicals listed in this notice: Morestan (FIFRA), as amended, EPA is issuing a below. Unless this request is 4 Ornamental Miticide, Morestan 4 notice of receipt of requests by Bayer withdrawn, oxythioquinox (Morestan) Nursery Miticide, and Morestan Corporation to voluntarily cancel will no longer appear in any registered Technical, the Agency has concluded products containing oxythioquinox products. that the limited short-term continued (Morestan), 6-methyl-1,3-dithiolo [4,5-b] use of these pesticides, when used in quinoxalin-2-one or chinomethionate, to Table 1.Ð6(F) Notice for Voluntary accordance with the label, will not terminate uses. Cancellation result in unreasonable risk or adverse DATES: Unless the request is withdrawn effects to human health or the by September 13, 1999, orders will be Product Name EPA Registration environment. issued canceling these registrations. Number If EPA grants any or all of the FOR FURTHER INFORMATION CONTACT: By requested cancellations, it is likely that mail: Jamil Mixon, Reregistration Morestan 4 Orna- 3125-381 mental Miticide the Agency will establish an existing Branch I, (7508C), Special Review and stocks provision consistent with the Reregistration Division, Office of Morestan 4 Nurs- 3125-437 following schedule. The distributors of Pesticide Programs, Environmental ery Miticide products containing the active Protection Agency, 401 M St., SW., ingredients, as listed in Table 1 in Unit Washington, DC 20046. Office location Morestan 4 Tech- 3125-205 III. of this notice, have requested an 18– for commercial courier, Reregistration nical month existing stocks provision from Branch I, 3rd floor, 2800 Crystal Drive, the effective date of cancellation as a Arlington, VA; telephone number: (703) IV. Procedures for Withdrawal of 308–8032. Request condition of its termination, so that existing supplies of oxythioquinox SUPPLEMENTARY INFORMATION: For Bayer to withdraw a request for (Morestan) can be exhausted. EPA use termination the company must I. Background Information agrees to registrant’s request and will submit such withdrawal in writing to permit sale and distribution of these Oxythioquinox (trade name Morestan) Jamil Mixon, at the address given above, is an insecticide/miticide/fungicide first postmarked before September 13, 1999. products for 18 months after the registered in 1968, to control mites, mite This written withdrawal of the request effective date of cancellation. The end- eggs on ornamental plants in green for use termination will apply only to users will then be allowed an additional houses, nurseries and landscapes. On the applicable 6(f)(1) request listed in year (for a total of 2 years beyond the October 17, 1996, Bayer requested this notice. The notice must include a registrant requested date) for the use of voluntary cancellation of all food uses commitment to pay any maintenance existing stocks for each of these but citrus. Bayer also requested fees and to fulfill any unsatisfied data chemicals. cancellation of all but two of the 24(c) requirements. Dated: March 3, 1999. registrations (California and Louisiana). Jack E. Housenger, Subsequently, on June 4, 1997, the V. Existing Stocks Provision EPA proposes to accept the Acting Director, Special Review and Agency received a request from Bayer to Reregistration, Office of Pesticide Programs. cancel registration of the remaining registrants’ request for amendment to food-use products: Morestan 25WP terminate all products listed in Table 1 [FR Doc. 99–6182 Filed 3–16–99; 8:45 am] (3125–117) and Morestan Solupak 25 in Unit III. of this notice. It is EPA’s BILLING CODE 6560±50±F

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ENVIRONMENTAL PROTECTION proposing the establishment and/or EPA is publishing the petition AGENCY amendment of regulations for residues summaries verbatim without editing of certain pesticide chemical in or on them in any way. The petition summary [PF±864; FRL±6066±7] various food commodities under section announces the availability of a ICI Surfactants; Pesticide Tolerance 408 of the Federal Food, Drug, and description of the analytical methods Petition Filing Comestic Act (FFDCA), 21 U.S.C. 346a. available to EPA for the detection and EPA has determined that this petition measurement of the pesticide chemical AGENCY: Environmental Protection contains data or information regarding residues or an explanation of why no Agency (EPA). the elements set forth in section such method is needed. ACTION: Notice. 408(d)(2); however, EPA has not fully evaluated the sufficiency of the 1. ICI Surfactants SUMMARY: This notice announces the submitted data at this time or whether PP 6E4987 initial filing of pesticide petitions the data supports granting of the EPA has received a pesticide petition proposing the establishment of petition. Additional data may be needed (PP 6E4987) from ICI Surfactants, 3411 regulations for residues of certain before EPA rules on the petition. pesticide chemicals in or on various The official record for this notice of Silverside Road, Wilmington, DE 19803- food commodities. filing, as well as the public version, has 8340, proposing pursuant to section been established for this notice of filing 408(d) of the Federal Food, Drug, and DATES: Comments, identified by the Cosmetic Act, 21 U.S.C. 346a(d), to docket control number PF–864, must be under docket control number [PF–864] (including comments and data amend 40 CFR 180.1001(c), and (e) to received on or before April 16, 1999. establish an exemption from the ADDRESSES: By mail submit written submitted electronically as described below). A public version of this record, requirement of a tolerance for methyl comments to: Information and Records methacrylate-methacrylic acid- Integrity Branch, Public Information and including printed, paper versions of electronic comments, which does not monomethoxypolyethylene glycol Services Divison (7502C), Office of methacrylate copolymer when used as Pesticides Programs, Environmental include any information claimed as CBI, is available for inspection from 8:30 an inert ingredient in pesticide Protection Agency, 401 M St., SW., formulations applied to growing crops Washington, DC 20460. In person bring a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The official or to raw agricultural commodities after comments to: Rm. 119, CM #2, 1921 harvest or to animals. EPA has Jefferson Davis Highway, Arlington, VA. record is located at the address in ‘‘ADDRESSES’’ at the beginning of this determined that the petition contains Comments and data may also be data or information regarding the submitted electronically by following document. Electronic comments can be sent elements set forth in section 408(d)(2) of the instructions under the FFDCA; however, EPA has not fully ‘‘SUPPLEMENTARY INFORMATION.’’ directly to EPA at: [email protected] evaluated the sufficiency of the No confidential business information submitted data at this time or whether should be submitted through e-mail. the data supports granting of the Information submitted as a comment Electronic comments must be submitted as an ASCII file avoiding the petition. Additional data may be needed concerning this document may be before EPA rules on the petition. claimed confidential by marking any use of special characters and any form part or all of that information as of encryption. Comment and data will A. Residue Chemistry also be accepted on disks in ‘‘Confidential Business Information’’ Magnitude of residues. No residue (CBI). CBI should not be submitted Wordperfect 5.1/6.1 file format or ASCII file format. All comments and data in chemistry data or environmental fate through e-mail. Information marked as data are presented in the petition as the CBI will not be disclosed except in electronic form must be identified by the docket control number [PF–864] and Agency does not generally require some accordance with procedures set forth in or all of the listed studies to rule on the 40 CFR part 2. A copy of the comment appropriate petition number. Electronic comments on this notice may be filed exemption from the requirement of a that does not contain CBI must be tolerance for an inert ingredient. submitted for inclusion in the public online at many Federal Depository record. Information not marked Libraries. B. Toxicological Profile confidential may be disclosed publicly List of Subjects 1. Acute toxicity. The Agency has by EPA without prior notice. All written established a set of criteria which comments will be available for public Environmental protection, identifies categories of polymers that inspection in Rm. 119 at the address Agricultural commodities, Food present low risk. These criteria given above, from 8:30 a.m. to 4 p.m., additives, Feed additives, Pesticides and (described in 40 CFR 723.250 ) identify Monday through Friday, excluding legal pests, Reporting and recordkeeping polymers that are relatively unreactive holidays. requirements. and stable compared to other chemical FOR FURTHER INFORMATION CONTACT: Dated: March 3, 1999. substances as well as polymers that Bipin Gandhi, Registration Support typically are not readily absorbed. ICI Branch, Registration Division (7505C), Peter Caulkins, Acting believes that methyl methacrylate- Office of Pesticide Programs, Director, Registration Division, Office of methacrylic acid- Environmental Protection Agency, 401 Pesticide Programs. monomethoxypolyethylene glycol M St., SW, Washington, DC 20460. methacrylate copolymer conforms to the Office location, telephone number, and Summary of Petition definition of a polymer given in 40 CFR e-mail address: Rm. 707A, Crystal Mall The petitioner summary of the 723.250 and meet the criteria used to #2, 1921 Jefferson Davis Highway, pesticide petition is printed below as identify a low risk polymer. We also Arlington, VA 22202, (703) 308–8380; e- required by section 408(d)(3) of the believe that based on this substance mail: [email protected]. FFDCA. The summary of the petition conformance to the above mentioned SUPPLEMENTARY INFORMATION: EPA has was prepared by the petitioner and criteria, no mammalian toxicity is received a pesticide petition as follows represents the views of the petitioner. anticipated from dietary, inhalation or

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13193 dermal exposure to methyl the Agency to implement a screening A. Residue Chemistry methacrylate-methacrylic acid- program with respect to endocrine Magnitude of residues. No residue monomethoxypolyethylene glycol effects. chemistry data or environmental fate methacrylate copolymer and that methyl C. Cumulative Effects data are presented in the petition as the methacrylate-methacrylic acid- Agency does not generally require some ICI believes sufficient information monomethoxypolyethylene glycol or all of the listed studies to rule on the was submitted in the petition to assess methacrylate copolymer will present exemption from the requirement of a minimal or no risk. the hazards of methacrylate-methacrylic tolerance for an inert ingredient. i. This polymer is not a cationic acid-monomethoxypolyethylene glycol substance. methacrylate copolymer. Based on this B. Toxicological Profile ii. It contains as an integral part of it’s polymer confirming to the definition of 1. Acute toxicity. The Agency has composition the atomic elements a polymer and meeting the criteria of a established a set of criteria which carbon, hydrogen, and oxygen. polymer under 40 CFR 723.250 ICI iii. It does not contain as an integral identifies categories of polymers that believes there are no concerns for risks present low risk. These criteria part of it’s composition, except as associated with cumulative effects. impurities, any elements other than (described in 40 CFR 723.250) identify those listed in 40 CFR 723.250(d)(2)(ii). D. Safety Determination polymers that are relatively unreactive and stable compared to other chemical iv. This polymer is not designed or 1. U.S. population. ICI believes substances as well as polymers that reasonably anticipated to substantially sufficient information was submitted in typically are not readily absorbed. ICI degrade, decompose, or depolymerize. the petition to assess the hazards of believes that 12-hydroxystearic acid- v. It is not manufactured or imported methacrylate-methacrylic - acid- polyethylene glycol copolymer (CAS from monomers and/or other reactants monomethoxypolyethylene glycol Reg. No. 70142-34-6) conforms to the that are not already on the TSCA methacrylate copolymer. Based on this definition of a polymer given in 40 CFR Chemical Substance Inventory or polymer conforming to the definition of 723.250 and meet the criteria used to manufactured under an applicable a polymer and meeting the criteria of a identify a low risk polymer. We also TSCA Section 5 exemption. polymer under 40 CFR 723.250, ICI believe that based on this substances vi. It is not a water absorbing polymer. believes there are no concerns for risks conformance to the above mentioned vii. The minimum average molecular associated with any potential exposure criteria, no mammalian toxicity is weight of the above mentioned polymer to adults. anticipated from dietary, inhalation or is greater than 1,000. Substances with 2. Infants and children. ICI believes dermal exposure to 12-hydroxystearic molecular weights greater than 400 are sufficient information was submitted in acid-polyethylene glycol copolymer and generally not readily absorbed through the petition to assess the hazards of that 12-hydroxystearic acid- the intact skin, and substances with methacrylate-methacrylic - acid- polyethylene glycol copolymer will molecular weights greater than 1,000 are monomethoxypolyethylene glycol present minimal or no risk. generally not absorbed through the methacrylate copolymer. Based on this i. This polymer is not a cationic intact gastrointestinal (GI) tract. polymer conforming to the definition of substance. Chemicals not absorbed through the GI a polymer and meeting the criteria of a ii. It contains as an integral part of it’s tract are generally incapable of eliciting polymer under 40 CFR 723.250, ICI composition the atomic elements a toxic response. believes there are no concerns for risks viii. This polymer has an oligomer carbon, hydrogen, and oxygen. associated with any potential exposure content less than 10% below MW 500, iii. It does not contain as an integral to infants and children. and less than 25% MW 1,000. ICI part of it’s composition, except as believes sufficient information was 2. ICI Surfactants impurities, any elements other than submitted in the petition to assess the those listed in 40 CFR 723.250 (d)(2)(ii). PP 8E4988 hazards of methyl methacrylate- iv. This polymer is not designed or methacrylic acid- EPA has received a pesticide petition reasonably anticipated to substantially monomethoxypolyethylene glycol (PP 8E4988) from ICI Surfactants, 3411 degrade, decompose, or depolymerize. methacrylate copolymer. No toxicology Silverside Road, Wilmington, DE 19803- v. It is not manufactured or imported data were presented in the petition as 8340, proposing pursuant to section from monomers and/or other reactants the Agency does not generally require 408(d) of the Federal Food, Drug, and that are not already on the TSCA some or all of the listed studies to rule Cosmetic Act, 21 U.S.C. 346a(d), to Chemical Substance Inventory or on the exemption from the requirement amend 40 CFR 180.1001(c) and (e) to manufactured under an applicable of a tolerance for an inert ingredient. establish an exemption from the TSCA Section 5 exemption. Based on this polymer conforming to requirement of a tolerance for 12- vi. It is not a water absorbing polymer. the definition of a polymer and meeting hydroxystearic acid-polyethylene glycol vii. The minimum average molecular the criteria of a polymer under 40 CFR copolymer (CAS Reg. No. 70142-34-6) weight of the above mentioned polymer 723.250 ICI believes there are no when used as an inert ingredient in is greater than 1,000. Substances with concerns for risks associated with pesticide formulations applied to molecular weights greater than 400 are toxicity. growing crops or to raw agricultural generally not readily absorbed through 2. Endocrine disruption. ICI has no commodities after harvest or to animals. the intact skin, and substances with information to suggest that EPA has determined that the petition molecular weights greater than 1,000 are methacrylate-methacrylic acid- contains data or information regarding generally not absorbed through the monomethoxypolyethylene glycol the elements set forth in section intact gastrointestinal (GI) tract. methacrylate copolymer will have an 408(d)(2) of the FFDCA; however, EPA Chemicals not absorbed through the GI effect on the immune and endocrine has not fully evaluated the sufficiency tract are generally incapable of eliciting systems. EPA is not requiring of the submitted data at this time or a toxic response. information on the endocrine effects of whether the data supports granting of viii. This polymer has an oligomer this substance at this time; Congress has the petition. Additional data may be content less than 10% below MW 500, allowed 3 years after August 3, 1996, for needed before EPA rules on the petition. and less than 25% MW 1,000. ICI

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It is not manufactured or imported on the exemption from the requirement Cosmetic Act, 21 U.S.C. 346a(d), to from monomers and/or other reactants of a tolerance for an inert ingredient. amend 40 CFR 180.1001(c), and (e) to that are not already on the TSCA Based on this polymer conforming to establish an exemption from the Chemical Substance Inventory or the definition of a polymer and meeting requirement of a tolerance for manufactured under an applicable polyethylene glycol-polyisobutenyl the criteria of a polymer under 40 CFR TSCA Section 5 exemption. anhydride-tall oil fatty acid copolymer 723.250 ICI believes there are no vi. It is not a water absorbing polymer. when used as an inert ingredient in vii. The minimum average molecular concerns for risks associated with pesticide formulations applied to toxicity. weight of the above mentioned polymer growing crops or to raw agricultural is greater than 1,000. Substances with 2. Endocrine disruption. ICI has no commodities after harvest or to animals. molecular weights greater than 400 are information to suggest that 12- EPA has determined that the petition generally not readily absorbed through hydroxystearic acid-polyethylene glycol contains data or information regarding the intact skin, and substances with copolymer (CAS Reg. No. 70142-34-6) the elements set forth in section molecular weights greater than 1,000 are will have an effect on the immune and 408(d)(2) of the FFDCA; however, EPA generally not absorbed through the endocrine systems. EPA is not requiring has not fully evaluated the sufficiency intact gastrointestinal (GI) tract. information on the endocrine effects of of the submitted data at this time or Chemicals not absorbed through the GI this substance at this time; Congress has whether the data supports granting of tract are generally incapable of eliciting allowed 3 years after August 3, 1996, for the petition. Additional data may be a toxic response. the Agency to implement a screening needed before EPA rules on the petition. viii. This polymer has an oligomer program with respect to endocrine A. Residue Chemistry content less than 10% below MW 500, effects. and less than 25% MW 1,000. ICI Magnitude of residues. No residue believes sufficient information was C. Cumulative Effects chemistry data or environmental fate submitted in the petition to assess the data are presented in the petition as the ICI believes sufficient information hazards of polyethylene glycol- Agency does not generally require some polyisobutenyl anhydride-tall oil fatty was submitted in the petition to assess or all of the listed studies to rule on the acid copolymer. No toxicology data the hazards of 12-hydroxystearic acid- exemption from the requirement of a were presented in the petition as the polyethylene glycol copolymer (CAS tolerance for an inert ingredient. Agency does not generally require some Reg. No. 70142-34-6). Based on this B. Toxicological Profile or all of the listed studies to rule on the polymer conforming to the definition of exemption from the requirement of a a polymer and meeting the criteria of a 1. Acute toxicity. The Agency has tolerance for an inert ingredient. Based polymer under 40 CFR 723.250 ICI established a set of criteria which on this polymer conforming to the believes there are no concerns for risks identifies categories of polymers that definition of a polymer and meeting the associated with cumulative effects. present low risk. These criteria criteria of a polymer under 40 CFR (described in 40 CFR 723.250) identify D. Safety Determination 723.250 ICI believes there are no polymers that are relatively unreactive concerns for risks associated with 1. U.S. population. ICI believes and stable compared to other chemical toxicity. sufficient information was submitted in substances as well as polymers that 2. Endocrine disruption. ICI has no the petition to assess the hazards of 12- typically are not readily absorbed. ICI information to suggest that polyethylene hydroxystearic acid-polyethylene glycol believes that polyethylene glycol- glycol-polyisobutenyl anhydride-tall oil copolymer (CAS Reg. No. 70142-34-6). polyisobutenyl anhydride-tall oil fatty fatty acid copolymer will have an effect Based on this polymer conforming to acid copolymer conforms to the on the immune and endocrine systems. the definition of a polymer and meeting definition of a polymer given in 40 CFR EPA is not requiring information on the 723.250 and meet the criteria used to the criteria of a polymer under 40 CFR endocrine effects of this substance at identify a low risk polymer. We also 723.250 ICI believes there are no this time; Congress has allowed 3 years believe that based on this substances concerns for risks associated with any after August 3, 1996, for the Agency to conformance to the above mentioned potential exposure to adults. implement a screening program with criteria, no mammalian toxicity is respect to endocrine effects. 2. Infants and children. ICI believes anticipated from dietary, inhalation or sufficient information was submitted in dermal exposure to polyethylene glycol- C. Cumulative Effects the petition to assess the hazards of 12- polyisobutenyl anhydride-tall oil fatty ICI believes sufficient information hydroxystearic acid-polyethylene glycol acid copolymer and that polyethylene was submitted in the petition to assess copolymer (CAS Reg. No. 70142-34-6). glycol-polyisobutenyl anhydride-tall oil the hazards of polyethylene glycol- Based on this polymer conforming to fatty acid copolymer will present polyisobutenyl anhydride-tall oil fatty the definition of a polymer and meeting minimal or no risk. acid copolymer. Based on this polymer the criteria of a polymer under 40 CFR i. This polymer is not a cationic conforming to the definition of a 723.250 ICI believes there are no substance. polymer and meeting the criteria of a concerns for risks associated with any ii. It contains as an integral part of it’s polymer under 40 CFR 723.250 ICI potential exposure to infants and composition the atomic elements believes there are no concerns for risks children. carbon, hydrogen, and oxygen. associated with cumulative effects.

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D. Safety Determination through e-mail. Information marked as file format. All comments and data in 1. U.S. population. ICI believes CBI will not be disclosed except in electronic form must be identified by sufficient information was submitted in accordance with procedures set forth in the docket control number [PF–863] and the petition to assess the hazards of 40 CFR part 2. A copy of the comment appropriate petition number. Electronic polyethylene glycol-polyisobutenyl that does not contain CBI must be comments on this notice may be filed anhydride-tall oil fatty acid copolymer. submitted for inclusion in the public online at many Federal Depository Based on this polymer conforming to record. Information not marked Libraries. the definition of a polymer and meeting confidential may be disclosed publicly the criteria of a polymer under 40 CFR by EPA without prior notice. All written List of Subjects comments will be available for public 723.250 ICI believes there are no Environmental protection, concerns for risks associated with any inspection in Rm. 119 at the address given above, from 8:30 a.m. to 4 p.m., Agricultural commodities, Food potential exposure to adults. additives, Feed additives, Pesticides and 2. Infants and children. ICI believes Monday through Friday, excluding legal holidays. pests, Reporting and recordkeeping sufficient information was submitted in requirements. the petition to assess the hazards of FOR FURTHER INFORMATION CONTACT: polyethylene glycol-polyisobutenyl Bipin Gandhi, Registration Support Dated: March 3, 1999. anhydride-tall oil fatty acid copolymer. Branch, Registration Division (7505C), Based on this polymer conforming to Office of Pesticide Programs, Peter Caulkins, the definition of a polymer and meeting Environmental Protection Agency, 401 Acting Director, Registration Division, Office the criteria of a polymer under 40 CFR M St., SW, Washington, DC 20460. of Pesticide Programs. 723.250 ICI believes there are no Office location, telephone number, and Summary of Petition concerns for risks associated with any e-mail address: Rm. 707A, Crystal Mall potential exposure to infants and #2, 1921 Jefferson Davis Highway, The petitioner summary of the children. Arlington, VA 22202, (703) 308–8380; e- pesticide petition is printed below as [FR Doc. 99–6184 Filed 3–16–99; 8:45 am] mail: [email protected]. required by section 408(d)(3) of the SUPPLEMENTARY INFORMATION: BILLING CODE 6560±50±F EPA has FFDCA. The summary of the petition received a pesticide petition as follows was prepared by the petitioner and proposing the establishment and/or represents the views of the petitioner. ENVIRONMENTAL PROTECTION amendment of regulations for residues EPA is publishing the petition AGENCY of certain pesticide chemical in or on summaries verbatim without editing various food commodities under section [PF±863; FRL±6065±5] them in any way. The petition summary 408 of the Federal Food, Drug, and announces the availability of a Notice of Filing; Pesticide Petitions Comestic Act (FFDCA), 21 U.S.C. 346a. description of the analytical methods EPA has determined that this petition available to EPA for the detection and AGENCY: Environmental Protection contains data or information regarding measurement of the pesticide chemical Agency (EPA). the elements set forth in section residues or an explanation of why no ACTION: Notice. 408(d)(2); however, EPA has not fully such method is needed. evaluated the sufficiency of the SUMMARY: This notice announces the submitted data at this time or whether 1. Rhodia Inc. initial filing of pesticide petitions the data supports granting of the PP 8E4956 proposing the establishment of petition. Additional data may be needed regulations for residues of certain before EPA rules on the petition. EPA has received a pesticide petition pesticide chemicals in or on various The official record for this notice of (PP 8E4956) from Rhodia Inc., CN 7500 food commodities. filing, as well as the public version, has Cranbury, NJ 08512-7500, proposing DATES: Comments, identified by the been established for this notice of filing pursuant to section 408(d) of the Federal docket control number PF–863, must be under docket control number [PF–863] Food, Drug, and Cosmetic Act, 21 U.S.C. received on or before April 16, 1999. (including comments and data 346a(d), to amend 40 CFR part 180 to ADDRESSES: By mail submit written submitted electronically as described request exemption from the comments to: Information and Records below). A public version of this record, requirements of a tolerance for a-alkyl Integrity Branch, Public Information and including printed, paper versions of (C8-C16)-w-hydroxy poly(oxyethylene) Services Divison (7502C), Office of electronic comments, which does not mixture of dihydrogen phosphate and Pesticides Programs, Environmental include any information claimed as CBI, monohydrogen phosphate esters and the Protection Agency, 401 M St., SW., is available for inspection from 8:30 corresponding ammonium, calcium, Washington, DC 20460. In person bring a.m. to 4 p.m., Monday through Friday, isopropylamine, magnesium, comments to: Rm. 119, CM #2, 1921 excluding legal holidays. The official monoethanolamine, potassium, sodium Jefferson Davis Highway, Arlington, VA. record is located at the address in and zinc salts of the phosphate esters; Comments and data may also be ‘‘ADDRESSES’’ at the beginning of this the poly(oxyethylene) content averages submitted electronically by following document. 3 - 20 moles, in or on raw agricultural the instructions under Electronic comments can be sent commodities. EPA has determined that ‘‘SUPPLEMENTARY INFORMATION.’’ directly to EPA at: the petition contains data or information No confidential business information [email protected] regarding the elements set forth in should be submitted through e-mail. section 408(d)(2) of the FFDCA; Information submitted as a comment Electronic comments must be however, EPA has not fully evaluated concerning this document may be submitted as an ASCII file avoiding the the sufficiency of the submitted data at claimed confidential by marking any use of special characters and any form this time or whether the data supports part or all of that information as of encryption. Comment and data will granting of the petition. Additional data ‘‘Confidential Business Information’’ also be accepted on disks in may be needed before EPA rules on the (CBI). CBI should not be submitted Wordperfect 5.1/6.1 file format or ASCII petition.

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A. Residue Chemistry April 22, 1987 (52 FR 13305) (FRL-3190- previously been alleged to cause The Federal Register of July 7, 1995 1), the Agency set forth a list of studies endocrine effects. which would generally be used to (60 FR 35396) announced the C. Aggregate Exposure evaluate the risks posed by the presence reclassification of a number of inert 1. Food. As noted above, a-alkyl (C10 ingredients from List 3 to List 4B of an inert ingredient in a pesticide formulation. However, where it can be - C16)-w-hydroxypoly(oxyethylene) (minimal risk). The EPA included mixture of dihydrogen phosphate and octyloxypoly(ethyleneoxy)ethyl determined without the data that the inert ingredient will present minimal or monohydrogen phosphate esters and the phosphate (C8 ethoxylated phosphate no risk, the Agency generally does not corresponding ammonium, calcium, ester) among the inerts of minimal risk require some or all of the listed studies magnesium, monoethanolamine, indicating: to rule on the proposed tolerance or potassium, sodium,and zinc salts of the 1. ‘‘On behalf of the Office of exemption from the requirement of a phosphate esters; the poly(oxyethylene) Pesticide Programs, these substances tolerance for an inert ingredient. Rhodia content averages 3-20 moles have were reviewed by the Structure Activity Inc. believes that the data and already been exempted from the Team of EPA’s Office of Pollution information described below is adequate requirements of a tolerance under 40 Prevention and Toxics with each judged to ascertain the toxicology and CFR 180.1001(d). The expansion of the to be of low concern for potential characterize the risk associated with the alkyl range to include the C8 alkyl human health and/or environmental use of a-alkyl (C8-C16)-w-hydroxy moiety is not expected to significantly effects.’’ poly(oxyethylene) mixture of affect the dietary exposure to these 2. ‘‘These inert ingredients were dihydrogen phosphate and compounds. The inclusion of the evaluated by the Office of Pesticide monohydrogen phosphate esters and the isopropylamine salts of these phosphate Program’s Inert Review Group and corresponding ammonium, calcium, esters merely acknowledges the fact that determined to be of minimal risk.’’ isopropylamine, magnesium, isopropylamine is a common counterion 3. ‘‘A list of these inert ingredients monoethanolamine, potassium, sodium in water-soluble herbicides, and thus proposed for reclassification was and zinc salts of the phosphate esters; approval of this petition would not be provided to EPA’s Office of Water and the poly(oxyethylene) content averages expected to substantially increase the to the FDA’s Center for Food Safety and 3 - 20 moles. dietary intake of these compounds. Applied Nutrition for comment; no While not highly acutely toxic, alkyl 2. Drinking water. This class of adverse comments were received.’’ ethoxylate phosphate esters are known products have been shown to readily Additionally, EPA has already to be severely irritating to skin and eyes. biodegrade and are therefore, not likely exempted from the requirements of a However, their corresponding salts have to be present in potable water supplies. tolerance under 40 CFR 180.1001(d): a- a reduced irritation potential. For the 3. Non-dietary exposure. Phosphate alkyl (C10-C16)-w-hydroxy specific alkylethoxylate phosphate ester esters of alkyl ethoxylates, and their poly(oxyethylene) mixture of salt blend that Rhodia Inc. petitions for salts are extensively used industrially as dihydrogen phosphate and exemption from the requirements of a water-soluble lubricants, as detergents monohydrogen phosphate esters and the tolerance, the acute oral LD50 (rat) is and household cleaners, and in personal corresponding ammonium, calcium, greater than 2,000 milligram kilogram care products in addition to their use as magnesium, monoethanolamine, (mg/kg), and the acute dermal LD50 (rat) emulsifiers, dispersants and suspending potassium, sodium and zinc salts of the is greater than 2,000 mg/kg. The product agents in pesticide formulations. The phosphate esters; the poly(oxyethylene) is considered to be an eye irritant. The slight contribution to total exposure content averages 3 - 20 moles. product is non-irritating to rabbit skin resulting from granting the petition is The extension of the alkyl range to and is negative for skin sensitization. not expected to significantly alter the include the C8 analog will not alter the 2. Genotoxicity. An Ames test risk profile. residue profile of the phosphate esters conducted on the product (blended D. Cumulative Effects and their salts. In fact, a number of alkyl ethoxylate phosphates, exemptions including the C8 alkyl isopropylamine salts) was negative. As stated above, there are a wide moiety are found in 40 CFR 180.1001, 3. Reproductive and developmental range of structurally similar compounds including n-octyl alcohol, alkyl amine toxicity. The broad range of structurally that are used in many products to which acetates, alkyl ethoxylates and alkyl similar products which are presently the U.S. population is exposed. Rhodia sulfate isopropylamine salts. Further, it approved for use in pesticide Inc. is unaware of any cumulative is widely acknowledged that alcohol formulations has not been reported to effects occurring from such uses. ethoxylates of the C10 - C16 range cause reproductive or developmental Further, the use of the product that is contain minor amounts of the C8 and toxicity. the subject of the tolerance exemption lower alkyl analogs, as well as C18 and 4. Subchronic toxicity. Similar petition is not likely to significantly higher analogs. This petition merely compounds are not known to exert increase daily exposure to this class of requests expansion of the existing significant subchronic toxic effects. similar compounds. exemption from tolerance for the C10 - 5. Chronic toxicity. Similar C16 range to include C8 alkyl ethoxylate compounds are not known to exert E. Safety Determination phosphates and their salts. significant chronic toxic effects. 1. U.S. population. In its notice The addition of the isopropylamine 6. Metabolite toxicology. Alcohol Federal Register, July 7, 1995, (60 FR salts of these phosphate esters ethoxylates are already exempted from 35396) which reclassified acknowledges the fact that the requirements of a tolerance under 40 octyloxypoly(ethyleneoxy)ethyl isopropylamine is a common counterion CFR 180.1001 (c). phosphate from List 3 to List 4B (inerts in water-soluble herbicides. 7. Endocrine disruption. There is no of minimal risk), the Agency has stated evidence that this product has : B. Toxicological Profile endocrine disruptor effects, individually i. ‘‘On behalf of the Office of Pesticide 1. Acute toxicity. As part of the EPA or in combination with any other Programs, these substances were policy statement on inert ingredients chemical. Further, this product is not reviewed by the Structure Activity published in the Federal Register of part of a class of compounds that has Team of EPA’s Office of Pollution

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Prevention and Toxics with each judged Australia, New Zealand, Brazil and to the FDA’s Center for Food Safety and to be of low concern for potential Argentina. Applied Nutrition for comment; no human health and/or environmental Rhodia Inc. therefore respectfully adverse comments were received.’’ effects.’’ requests that an exemption from the Additionally, EPA has already ii. ‘‘These inert ingredients were requirements of a tolerance be exempted from the requirements of a evaluated by the Office of Pesticide established for a-alkyl (C8-C16)-w- tolerance under 40 CFR 180.1001(d) the Program’s Inert Review Group and hydroxy poly(oxyethylene) mixture of residues of butoxytriethyleneglycol determined to be of minimal risk.’’ dihydrogen phosphate and phosphate when used as a surfactant for iii. ‘‘A list of these inert ingredients monohydrogen phosphate esters and the arsenical herbicides. proposed for reclassification was corresponding ammonium, calcium, The addition of the isopropylamine provided to EPA’s Office of Water and isopropylamine, magnesium, salts of this phosphate ester to the list to the FDA’s Center for Food Safety and monoethanolamine, potassium, sodium of substances considered exempt from Applied Nutrition for comment; no and zinc salts of the phosphate esters; the requirements of a tolerance merely adverse comments were received.’’ the poly(oxyethylene) content averages acknowledges the fact that Expansion of the uses of the product 3 - 20 moles, in or on raw agricultural isopropylamine is a common counterion to food uses is not likely to significantly commodities. increase the U.S. population’s exposure in water-soluble herbicides. 2. Rhodia Inc. to the product and related compounds. B. Toxicological Profile Therefore, there is a reasonable certainty PP 8E4990 that no harm to the U.S. population will 1. Acute toxicity. As part of the EPA result from the use described. EPA has received a pesticide petition policy statement on inert ingredients 2. Infants and children. FFDCA (PP 8E4990) from Rhodia Inc., CN 7500, published in the Federal Register of section 408 provides that EPA shall Cranbury, NJ 08512-7500, proposing April 22, 1987 (52 FR 13305) (FRL 3190- apply an additional tenfold margin of pursuant to section 408(d) of the Federal 1), the Agency set forth a list of studies safety for infants and children in the Food, Drug, and Cosmetic Act, 21 U.S.C. which would generally be used to case of threshold effects to account for 346a(d), to amend 40 CFR part 180 to evaluate the risks posed by the presence pre- and postnatal toxicity and the request exemption from the requirement of an inert ingredient in a pesticide completeness of the data base unless of a tolerance for formulation. However, where it can be EPA concludes that a different margin of butoxytriethyleneglycol phosphate and determined without the data that the safety will be safe for infants and the corresponding ammonium, calcium, inert ingredient will present minimal or children. Margins of safety are isopropylamine, magnesium, no risk, the Agency generally does not incorporated into EPA risk assessments monoethanolamine, potassium, sodium require some or all of the listed studies either directly through the use of margin and zinc salts of the phosphate esters, to rule on the proposed tolerance or of exposure (MOE) analysis or through and to include use with water-soluble exemption from the requirement of a using uncertainty (safety) factors in herbicide formulations in or on raw tolerance for an inert ingredient. Rhodia calculating a dose level that poses no agricultural commodities. EPA has Inc. believes that the data and appreciable risk to humans. There is no determined that the petition contains information described below is adequate available data to indicate any additional data or information regarding the to ascertain the toxicology and sensitivity of infants and children to elements set forth in section 408(d)(2) of characterize the risk associated with the this product or to other similar products the FFDCA; however, EPA has not fully use of butoxytriethyleneglycol which have been in use for many years evaluated the sufficiency of the phosphate and the corresponding and for numerous uses. There is no data submitted data at this time or whether ammonium, calcium, isopropylamine, which suggests that there is a basis to the data supports granting of the magnesium, monoethanolamine, require an additional margin of safety to petition. Additional data may be needed potassium, sodium and zinc salts of the be applied. before EPA rules on the petition. phosphate esters. F. International Tolerances A. Residue Chemistry Alkyl ethoxylate phosphate esters are known to be severely irritating to skin Rhodia Inc. has demonstrated to the The Federal Register of July 7, 1995 and eyes. However, their corresponding satisfaction of the Australian (60 FR 35396) announced the salts have a reduced irritation potential. Environmental Protection Authority and reclassification of a number of inert For the specific alkyl ethoxylate the Australian National Registration ingredients from List 3 to List 4B phosphate ester blend that Rhodia Inc. Authority that certain formulations of (minimal risk). The EPA included petitions for exemption from the blended alkyl ethoxylate phosphate butylpolyethoxyethanol esters of requirements of a tolerance, acute oral esters and salts are safe for use in and phosphoric acid among those LD50 (rat) is greater than 2,000 milligram near aquatic environments. Further, substances on List 4B, indicating: kilogram (mg/kg), and the acute dermal because of its enhanced properties, use 1. ‘‘On behalf of the Office of LD50 (rat) is greater than 2,000 mg/kg. of this blend allows reduction of the Pesticide Programs, these substances The product is non-irritating to rabbit total chemical burden of the pesticide were reviewed by the Structure Activity skin and is negative for skin inert ingredients on the environment. Team of EPA’s Office of Pollution The alkyl ethoxylate phosphate Prevention and Toxics with each judged sensitization. The product is considered monohydrogen and dihydrogen esters to be of low concern for potentialhuman to be an eye irritant. and their salts, including the health and/or environmental effects.’’ 2. Genotoxicity. An Ames test isopropylamine salts are being used as 2. ‘‘These inert ingredients were conducted on the blended alkyl inert ingredients in registered pesticide evaluated by the Office of Pesticide ethoxylate phosphate salts was negative. formulations applied to food crops in 14 Program’s Inert Review Group and 3. Reproductive and developmental nations including European, African, determined to be of minimal risk.’’ toxicity. The broad range of structurally South American and Pacific Rim 3. ‘‘A list of these inert ingredients similar compounds has not been nations. These include: United proposed for reclassification was reported to produce reproductive or Kingdom, France, Italy, Spain, Japan, provided to EPA’s Office of Water and developmental toxicity.

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4. Subchronic toxicity. Similar D. Cumulative Effects F. International Tolerances compounds are not know to exert As stated above, there are a wide Rhodia Inc. has demonstrated to the significant subchronic toxic effects. range of structurally similar compounds satisfaction of the Australian 5. Chronic toxicity. Similar that are used in many products to which Environmental Protection Authority and compounds are not know to exert the U.S. population is exposed. Rhodia the Australian National Registration significant chronic toxic effects. 6. Metabolite toxicology. Alcohol Inc. is unaware of any cumulative Authority that certain formulations of ethoxylates are already exempted from effects occurring from such uses. blended alkyl ethoxylate phosphate the requirements of a tolerance under 40 Further, the use of the product that is esters and salts are safe for use in and CFR 180.1001(c). Diethyleneglycol the subject of the tolerance exemption near aquatic environments. Further, monobutyl ether, ethyleneglycol petition is not likely to significantly because of its enhanced properties, use monobutyl ether and n-butanol are increase daily exposure to this class of of this blend allows reduction of the specifically exempted from the similar compounds. total chemical burden on the environment. requirements of a tolerance under 40 E. Safety Determination CFR 180.1001(d). Triethylene glycol The alkyl ethoxylate phosphate 1. U.S. population. In its notice of July monobutyl ether, a likely metabolite, monohydrogen and dihydrogen esters has been reported Patty’s Industrial 7, 1995 (60 FR 35396); which moved and their salts, including the Hygiene and Toxicology, Fourth butylpolyethoxyethanol esters of isopropylamine salts are being used as Edition, Volume II, Part D, ed. George D. phosphoric acid from List 3 to List 4B inert ingredients in registered pesticide Clayton, and Florence E. Clayton (New (inerts of minimal risk), EPA stated : formulations applied to food crops in 14 York: John Wiley & Sons, 1994), 2,860 i. ‘‘On behalf of the Office of Pesticide nations including European, African, to exhibit low acute toxicity by oral and Programs, these substances were South American and Pacific Rim dermal routes, to be non-toxic by the reviewed by the Structure Activity nations. These include: United inhalation route, and to cause eye Team of EPA’s Office of Pollution Kingdom, France, Italy, Spain, Japan, irritation and slight skin irritation. Prevention and Toxics with each judged Australia, New Zealand, Brazil and 7. Endocrine disruption. There is no to be of low concern for potential Argentina. evidence that this product has human health and/or environmental Rhodia Inc. therefore, respectfully endocrine disruptor effects, individually effects.’’ requests that an exemption from the or in combination with any other ii. ‘‘These inert ingredients were requirements of a tolerance be chemical. Further, this product is not evaluated by the Office of Pesticide established for butoxytriethyleneglycol part of a class of compounds that has Program’s Inert Review Group and phosphate and the corresponding previously been alleged to cause determined to be of minimal risk.’’ ammonium, calcium, isopropylamine, endocrine effects. iii. ‘‘ List of these inert ingredients magnesium, monoethanolamine, proposed for reclassification was potassium, sodium and zinc salts of the C. Aggregate Exposure provided to EPA’s Office of Water and phosphate esters, and to include use 1. Food. As noted above, to the FDA’s Center for Food Safety and with water-soluble herbicide butoxytriethyleneglycol phosphate has Applied Nutrition for comment; no formulations in or on raw agricultural already been exempted from the adverse comments were received.’’ commodities under 40 CFR 180.1001(d). requirements of a tolerance under 40 Expansion of the uses of the product [FR Doc. 99–6183 Filed 3–16–99; 8:45 am] CFR 180.1001(d). The addition of the to food uses is not likely to significantly BILLING CODE 6560±50±F expanded use to include use with water- increase the U.S. population’s exposure soluble herbicides is not expected to to the product and related compounds. significantly affect the dietary exposure Therefore, there is a reasonable certainty ENVIRONMENTAL PROTECTION to these compounds. The inclusion of that no harm to the U.S. population will AGENCY the isopropylamine salts of these result from the use described. [NCEA±CD±99±1015; FRL±6310±4] phosphate esters merely acknowledges 2. Infants and children. FFDCA the fact that isopropylamine is already section 408 provides that EPA shall Air Quality Criteria for Carbon a common counterion in water-soluble apply an additional tenfold margin of Monoxide (External Review Draft); herbicides. Thus approval of this safety for infants and children in the Estimation of Carbon Monoxide petition would not be expected to case of threshold effects to account for Exposures and Associated substantially increase the dietary intake pre- and postnatal toxicity and the Carboxyhemoglobin Levels in Denver of these compounds. completeness of the data base unless Residents Using pNEM/CO (Version 2. Drinking water. The product has EPA concludes that a different margin of 2.0) (Draft) been shown to readily biodegrade and safety will be safe for infants and therefore is not likely to be present in children. Margins of safety are AGENCY: Environmental Protection potable water supplies. incorporated into EPA risk assessments Agency. 3. Non-dietary exposure. Phosphate either directly through the use of margin ACTION: Notice of two drafts for public esters of alkyl ethoxylates are widely of exposure (MOE) analysis or through review and comment. used industrially as water-soluble using uncertainty (safety) factors in lubricants, as detergents and household calculating a dose level that poses no SUMMARY: The U.S. Environmental cleaners, and in personal care products appreciable risk to humans. There is no Protection Agency (EPA), National in addition to their use as emulsifiers, available data to indicate any additional Center for Environmental Assessment, is dispersants and suspending agents in sensitivity of infants and children to announcing the availability of an pesticide formulations. Given the this product or to other similar products external review draft of the document, widespread use of this group of which have been in use for many years Air Quality Criteria for Carbon compounds, the additional exposure and for numerous uses. There is no data Monoxide. Required under sections 108 resulting from granting the petition is which suggests that there is a basis to and 109 of the Clean Air Act, the not expected to significantly alter the require an additional margin of safety to purpose of this document is to provide risk profile. be applied. an assessment of the latest, relevant

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13199 scientific information that may have an [email protected]. Mr. Raub will Act (CERCLA), 42 U.S.C. 9622(h)(1), impact on the next periodic review of provide information on the draft with respect to costs incurred or to be the National Ambient Air Quality document, Air Quality Criteria for incurred relative to the Interstate Lead Standards (NAAQS) for carbon Carbon Monoxide. Company (ILCO) Superfund Site in monoxide (CO). For further information related to the Leeds, Alabama on an ability-to-pay The EPA’s Office of Air Quality draft exposure analysis methodology basis. EPA will consider public Planning and Standards (OAQPS) is report for Denver, contact Mr. Harvey comments on the proposed settlement announcing the availability of a draft Richmond, Office of Air Quality for thirty (30) days. EPA may withdraw carbon monoxide exposure analysis Planning and Standards (MD–15), U.S. from or modify the proposed settlement methodology report, Estimation of Environmental Protection Agency, should such comments disclose facts or Carbon Monoxide Exposures and Research Triangle Park, NC 27711; considerations which indicate the Associated Carboxyhemoglobin Levels telephone: 919–541–5271; facsimile: proposed settlement is inappropriate, in Denver Residents Using pNEM/CO 919–541–0840; E-mail: improper or inadequate. Copies of the (Version 2.0). This document is part of [email protected]. proposed settlement are available from: the technical support work that will be SUPPLEMENTARY INFORMATION: The U.S. Ms. Paula V. Batchelor, U.S. EPA, summarized in the OAQPS staff paper Environmental Protection Agency (EPA) Region 4 (WMD–PSB), 61 Forsyth Street on carbon monoxide. is updating and revising, where SW, Atlanta, Georgia 30303, (404) 562– DATES: Anyone who wishes to comment appropriate, the EPA’s Air Quality 8887. on the draft document, Air Quality Criteria for Carbon Monoxide (CO). Written comments may be submitted Criteria Document for Carbon Sections 108 and 109 of the Clean Air to Ms. Batchelor within 30 calendar Monoxide, may do so in writing by May Act require that the EPA carry out a days of the date of this publication. 15, 1999. Send the written comments to periodic review and revision, where Dated: March 3, 1999. the Project Manager for Carbon appropriate, of the criteria and the Franklin E. Hill, Monoxide, National Center for National Ambient Air Quality Standards Chief, Program Services Branch, Waste Environmental Assessment-RTP Office (NAAQS) for the ‘‘criteria’’ air Management Division. (MD–52), U.S. Environmental Protection pollutants such as carbon monoxide. [FR Doc. 99–6510 Filed 3–16–99; 8:45 am] Agency, Research Triangle Park, NC After the completion of the comment 27711. period, the EPA will present the BILLING CODE 6560±50±M The OAQPS draft report will be external review draft of the Air Quality available by March 15, 1999. A letter Criteria for Carbon Monoxide and, as that will be included with copies of the supporting documentation for the EQUAL EMPLOYMENT OPPORTUNITY draft will discuss the length of time that OAQPS staff paper on carbon monoxide, COMMISSION OAQPS is allowing the public for the Estimation of Carbon Monoxide Agency Information Collection comment and will provide mailing Exposures and Associated Activities: Submission for OMB information for the comments. Carboxyhemoglobin Levels in Denver Review; Final Comment Request ADDRESSES: To obtain a copy of the Air Residents Using pNEM/CO (Version 2.0) Quality Criteria for Carbon Monoxide for review before the Clean Air AGENCY: Equal Employment (External Review Draft) 1999, EPA/600/ Scientific Advisory Committee (CASAC) Opportunity Commission. P–99/001, contact the National Service later in 1999. The EPA will issue a ACTION: Final notice of submission for Center for Environmental Publications. subsequent Federal Register document OMB review. Request a copy by telephoning 1–800– to inform the public of the exact date 490–9198 and provide the title and the and time of this meeting. SUMMARY: In accordance with the Paperwork Reduction Act, the Equal EPA number for the document. Internet Dated: March 9, 1999. users may obtain a copy from the EPA’s Employment Opportunity Commission William H. Farland, (EEOC) has submitted a request for National Center for Environmental Director, National Center for Environmental Assessment (NCEA’s) home page. The clearance of the information collection Assessment. described below to the Office of URL is http://www.epa.gov/ncea/. [FR Doc. 99–6508 Filed 3–16–99; 8:45 am] To obtain a copy of the Estimation of Management and Budget (OMB). A BILLING CODE 6560±50±P Carbon Monoxide Exposures and notice that EEOC would be submitting Associated Carboxyhemoglobin Levels this request was published in the in Denver Residents Using pNEM/CO Federal Register on December 24, 1998, ENVIRONMENTAL PROTECTION allowing for a 60-day public comment (Version 2.0), Internet users can go to AGENCY the EPA’s OAR Policy and Guidance period. No comments were received. page on the OAQPS TTNWeb. The URL [FRL±6310±5] DATES: Written comments on this final is http://www.epa.gov/ttn/caa/ notice must be submitted on or before ILCO Superfund Site; Notice of t1sp.html. A limited number of paper April 16, 1999. Proposed Settlement copies of this document will be ADDRESSES: Comments on this final available and can be obtained from: U.S. AGENCY: Environmental Protection notice should be submitted to the Office Environmental Protection Agency Agency. of Information and Regulatory Affairs, Library, MD–35, Research Triangle Park, ACTION: Notice of proposed settlement. Attention: Danny Werfel, Desk Officer NC 27711, telephone (919) 541–2777. for the U.S. Equal Employment FOR FURTHER INFORMATION CONTACT: Mr. SUMMARY: The United States Opportunity Commission, Office of James Raub, National Center for Environmental Protection Agency is Management and Budget, 725 17th Environmental Assessment-RTP Office proposing to enter into a settlement Street, N.W., Room 10235, New (MD–52), U.S. Environmental Protection with Vinton Scrap & Metal, Inc., Executive Office Building, Washington, Agency, Research Triangle Park, NC pursuant to section 122(h)(1) of the D.C. 20503 or electronically mailed to 27711; telephone: 919–541–4157; Comprehensive Environmental [email protected]. Requests facsimile: 919–541–1818; E-mail: Response, Compensation, and Liability for copies of the proposed information

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13200 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices collection request should be addressed is between one (1) and five (5) hours. April 16, 1999 to both the OMB to Mr. Neckere at the address below. Based upon the large number of school reviewer and the FDIC contact listed FOR FURTHER INFORMATION CONTACT: districts responding via diskette, the above. Joachim Neckere, Director, Program total number of response hours is ADDRESSES: Information about this Research and Surveys Division, 1801 L estimated to equal 12,000 each time the submission, including copies of the street, NW, Room 9222, Washington, DC survey is conducted (i.e. biennially). proposed collection of information, may 20507, (202) 663–4958 (voice) or (202) Respondents are encouraged to report be obtained by calling or writing the 663–7063 (TDD). data on electronic media such as FDIC contact listed above. SUPPLEMENTARY INFORMATION: magnetic tapes and diskettes. SUPPLEMENTARY INFORMATION: The Collection Title: Elementary- Dated: March 9, 1999. collection involves the submission of Secondary Staff Information Report For the Commission. information on Form 1600/07 by EEO–5. Ida L. Castro, contractors who wish to do business, OMB Number: 0346–0003. Chairwoman. have done business, or are currently under contract with the FDIC. The Frequency of Report: Biennial. [FR Doc. 99–6397 Filed 3–16–99; 8:45 am] Type of Respondent: Public information is used to enter contractors elementary and secondary school BILLING CODE 6570±01±M on the FDIC’s nationwide contractor districts with 100 or more employees. database (the National Contractor Description of Affected Public: State System); ensure compliance with and Local government. FEDERAL DEPOSIT INSURANCE established contractors ethics Number of Responses: 5,000. CORPORATION regulations (12 CFR 366); obtain Reporting Hours: 12,000. Agency Information Collection information on a contractor’s past Federal Cost: $80,000. Activities: Submission for OMB performance for proposal evaluation Number of Forms: 1. Review; Comment Request purposes; and review a potential lessor’s Abstract: Section 709(c) of Title VII of fitness and integrity prior to entering the Civil Rights Act of 1964 requires AGENCY: Federal Deposit Insurance into a lease transaction. employers to make and keep records Corporation (FDIC). Dated: March 10, 1999. relevant to a determination of whether ACTION: Notice of information collection Federal Deposit Insurance Corporation. unlawful employment practices have to be submitted to OMB for review and Robert E. Feldman, been or are being committed and to approval under the Paperwork Executive Secretary. make reports therefrom as required by Reduction Act of 1995. the EEOC. Pursuant to that section, the [FR Doc. 99–6410 Filed 3–16–99; 8:45 am] EEOC has issued regulations which set SUMMARY: In accordance with BILLING CODE 6714±01±P forth the reporting requirement for requirements of the Paperwork various kinds of employers. Public Reduction Act of 1995 (44 U.S.C. 3501 elementary and secondary schools et seq.), the FDIC hereby gives notice FEDERAL RESERVE SYSTEM systems and districts have been required that it plans to submit to the Office of to submit EEO–5 reports to EEOC since Management and Budget (OMB) a Agency Information Collection 1974 (biennially in even numbered request for OMB review and approval of Activities: Announcement of Board years since 1982). Since 1996 each the information collection system Approval Under Delegated Authority school district or system has submitted described below. and Submission to OMB all of the district data on a single form, Type of Review: Revision of a AGENCY: Board of Governors of the EEOC Form 168A. The individual currently approved collection. Federal Reserve System school form, EEOC Form 168B, was Title: Acquisition Services BACKGROUND: Notice is hereby given of discontinued in 1996, greatly reducing Information Requirements. the final approval of proposed the respondent burden and cost. Form Number: 1600/07. information collection by the Board of EEO–5 data are used by the EEOC to OMB Number: 3064–0072. Governors of the Federal Reserve investigate charges of employment Annual Burden: System (Board) under OMB delegated discrimination against public Estimated annual number of authority, as per 5 CFR 1320.16 (OMB elementary and secondary school respondents: 31,528 Regulations on Controlling Paperwork districts. The data are used to support Estimated time per response: varies Burdens on the Public). Board-approved EEOC decisions and conciliations, and from 0.25 hours to one hour collections of information are for research. The data are shared with Average annual burden hours: 13,233 incorporated into the official OMB the Department of Education (Office for hours inventory of currently approved Civil Rights and the National Center for Expiration Date of OMB Clearance: collections of information. Copies of the Education Statistics) and the August 31, 2001. OMB 83-Is and supporting statements Department of Justice. Pursuant to OMB Reviewer: Alexander T. Hunt, and approved collection of information Section 709(d) of Title VII of the Civil (202) 395–7860, Office of Management instruments are placed into OMB’s Rights Act of 1964, EEO–5 data are also and Budget, Office of Information and public docket files. The Federal Reserve shared with State and local Fair Regulatory Affairs, Washington, D.C. may not conduct or sponsor, and the Employment Practices Agencies. 20503. respondent is not required to respond Burden Statement: The estimated FDIC Contact: Tamara R. Manly, (202) to, an information collection that has number of respondents included in the 898–7453, Office of the Executive been extended, revised, or implemented EEO–5 collection is 5,000 public Secretary, Room F–4058, Federal on or after October 1, 1995, unless it elementary and secondary school Deposit Insurance Corporation, 550 17th displays a currently valid OMB control districts. The number of responses per Street NW, Washington, DC 20429. number. respondent is one (1) report. The annual Comments: Comments on this FOR FURTHER INFORMATION CONTACT: number of responses is approximately collection of information are welcome Chief, Financial Reports Section—Mary 5,000 and the total hours per response and should be submitted on or before M. West—Division of Research and

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Statistics, Board of Governors of the effective with the March 31, 1999, calculations. As a result of the revised Federal Reserve System, Washington, reporting date. regulatory capital treatment of NMSAs, DC 20551 (202-452-3829). CHANGES RELATED TO CURRENT REVISIONS these assets need to be distinguished OMB Desk Officer—Alexander T. TO THE CALL REPORT from All other identifiable intangible Hunt—Office of Information and Schedule HC — Consolidated Balance assets. This change is needed to enable Regulatory Affairs, Office of Sheet the Federal Reserve to verify the Management and Budget, New (1) Add an item on the balance sheet regulatory capital amounts that bank Executive Office Building, Room for net gains (losses) on cash flow holding companies report in the FR Y- 3208, Washington, DC 20503 (202- hedges due to Financial Accounting 9C and to calculate regulatory capital 395-7860). Standards Board (FASB) Statement No. ratios. SUPPLEMENTARY INFORMATION: 133, Accounting for Derivative Schedule HC-A — Securities General Information: On December Instruments and Hedging Activities Eliminate memorandum item 5, High- 28, 1998, the Board issued for public (FAS 133). This statement takes effect risk mortgage securities. The definition comment proposed revisions to certain for fiscal years beginning after June 15, of high-risk mortgage securities was bank holding company reports (63 FR 1999, with earlier application taken from the Supervisory Policy 71470). The comment period expired on encouraged. Statement on Securities Activities, February 26, 1999. The Board did not Under FAS 133, all derivatives must which the FFIEC approved and the receive any letters of comment. be reported as either assets or liabilities Federal Reserve adopted in December Final approval under OMB delegated on the balance sheet and must be 1991, effective February 10, 1992 (57 FR authority of the extension for three carried at fair value. If certain 4029, February 3, 1992). In April 1998, years, with revision, of the following conditions are met, a derivative may be the FFIEC and the Federal Reserve reports: specifically designated as a cash flow rescinded this policy statement and 1. Report title: Consolidated Financial hedge. In a cash flow hedge, to the approved in its place a Supervisory Statements for Bank Holding Companies extent the hedge is effective, the gain or Policy Statement on Investment Agency form number: FR Y-9C loss on the derivative is initially Securities and End-User Derivatives OMB control number: 7100-0128 reported outside of earnings in a Activities, effective May 26, 1998 (63 FR Frequency: Quarterly component of equity capital. The gain or 20191, April 23, 1998). In adopting the Reporters: Bank holding companies loss will subsequently go through new policy statement, the Federal Annual reporting hours: 211,995 earnings in the period or periods when Reserve removed the previous policy Estimated average hours per response: the transaction being hedged affects statements specific constraints 33.93 earnings. The ineffective portion of the concerning investments in high-risk Number of respondents: 1,562 hedge is reported in earnings mortgage securities, including its high Small businesses are affected. immediately. risk tests, and substituted broader General description of report: This As part of the disclosure requirements guidance covering all investment information collection is mandatory (12 of FAS 133, an entity must disclose the securities. U.S.C. 1844(b) and (c) and 12 CFR accumulated net gains (losses) on cash Schedule HC-I — Risk-Based Capital 225.5(b)). Confidential treatment is not flow hedges that are included in equity Revise memorandum item 7.b, Fair routinely given to the data in these capital as of the balance sheet date. The market value of purchased credit card reports. However, confidential treatment Board approved adding the item relationships to include the fair market for the reporting information, in whole Accumulated net gains (losses) on cash value of nonmortgage servicing assets. or in part, can be requested in flow hedges, as of the report date, as This item would be renumbered accordance with the instructions to the new item 27.f in the equity capital memorandum item 7 since the current form. Data reported on the FR Y-9C, section of the balance sheet. Current memorandum item 7.a will be Schedule HC-H, Column A, requiring items 27.f through 27.h will be eliminated (see Other Revisions Not information of assets past due 30 renumbered as items 27.g through 27.i. Related to Call Report Changes section through 89 days and still accruing and (2) Revise balance sheet item 10.b(1), below). The caption for this item will be memorandum item 2 are confidential Purchased credit card relationships, to Fair value of purchased credit card pursuant to Section (b)(8) of the include nonmortgage servicing assets relationships and nonmortgage servicing Freedom of Information Act 5 U.S.C. (NMSAs). The caption for this item will assets. The Federal Reserve has 552(b)(8). be Purchased credit card relationships determined that this information is Abstract: The FR Y-9C consists of and nonmortgage servicing assets. On needed to accurately measure the risk- standardized consolidated financial August 10, 1998, the Federal Reserve based capital treatment of servicing statements similar to commercial bank published a final rule amending the assets under the Federal Reserves Report of Condition and Income (Call regulatory capital treatment of servicing amended capital adequacy guidelines. Report) (FFIEC 031-034; OMB No. 7100- assets (63 FR 42668). Under this Schedule HI-A — Changes in Equity 0036). The FR Y-9C is filed quarterly by amendment, NMSAs will now be Capital top-tier bank holding companies that recognized (rather than deducted) for Add an item for the change in have total assets of $150 million or more regulatory capital purposes. However, accumulated net gains (losses) on cash and by lower-tier bank holding these servicing assets are subject to a flow hedges. As part of the disclosure companies that have total consolidated sublimit of 25 percent of Tier 1 capital requirements of FAS 133, bank holding assets of $1 billion or more. In addition, that previously applied only to companies will also disclose the year-to- multibank holding companies with total purchased credit card relationships date change in accumulated net gains consolidated assets of less than $150 (PCCRs). To date, bank holding (losses) on cash flow hedges that are million with debt outstanding to the companies have reported their NMSAs included in equity capital. Bank holding general public or engaged in certain as part of All other identifiable companies will report the year-to-date nonbank activities must file the FR Y- intangible assets, item 10.b.(2). This is change in these accumulated gains 9C. because these intangibles generally have (losses), net of any reclassification Current actions: The Board approved been deducted in full from Tier 1 capital adjustment, in the changes in equity the following changes to the FR Y-9C and from assets in regulatory capital capital schedule as new item 13.b.

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Existing item 13 on Schedule HI-A will 225.5(b)). Confidential treatment is not statement information for the parent be renumbered as item 13.a. routinely given to the data in this report. company, information on intangible Other Revisions Not Related to Call However, confidential treatment for the assets, and information on Report Changes reporting information, in whole or in intercompany transactions. Schedule HC-A — Securities part, can be requested in accordance Current actions: The Board approved Add an item for net unrealized with the instructions to the form. the following revisions to the FR Y-9SP holding gains on available-for-sale Abstract: The FR Y-9LP includes effective with the June 30, 1999, equity securities included in standardized financial statements filed reporting date. supplemental (Tier 2) capital. On quarterly on a parent company only Balance Sheet August 26, 1998, the Federal Reserve basis from each bank holding company Add an item on the balance sheet for along with the other banking agencies that files the FR Y-9C. In addition, for accumulated net gains (losses) on cash announced a final rule amending the tiered bank holding companies, a flow hedges. As part of the disclosure capital treatment of unrealized holding separate FR Y-9LP must be filed for each requirements for FAS 133, the Federal gains on certain equity securities. The lower tier bank holding company. Reserve will add the item Accumulated final rule permits bank holding Current actions: The Board approved net gains (losses) on cash flow hedges, companies to include in supplementary the following revisions to the FR Y-9LP as of the report date, as new item 16.e (Tier 2) capital up to 45 percent of the effective with the March 31, 1999, in the equity capital section of the pretax net unrealized holding gains (that reporting date. balance sheet. Current item 16.e will be is, of the fair value over historical cost) Schedule PC — Parent Company Only renumbered as item 16.f. on available-for-sale equity securities Balance Sheet Instructions with readily determinable fair values. Add an item on the balance sheet for Instructional revisions and This is an optional designation for bank accumulated net gains (losses) on cash clarifications will be made as necessary, holding companies. However, if an flow hedges. As part of the disclosure to conform with changes made to the FR institution opts to include an amount of requirements for FAS 133, the Federal Y-9C. unrealized holding gains in its Tier 2 Reserve will add the item Accumulated Final approval under OMB delegated capital, it must also include that same net gains (losses) on cash flow hedges, authority of the extension for three amount in its risk-weighted assets for all as of the report date, as new item 20.f years, without revision, of the following of its risk-based capital ratios (including in the equity capital section of the report: the Tier 1 risk-based capital ratio). Bank balance sheet. Current items 20.f and 1. Report title: Supplement to the holding companies that take this option 20.g would be renumbered as items 20.g Consolidated Financial Statements for will report net unrealized holding gains and 20.h. Bank Holding Companies on available-for-sale equity securities Instructions Agency form number: FR Y-9CS included in Tier 2 and total capital Instructional revisions and OMB control number: 7100-0128 ratios on Schedule HC-A, in new clarifications will be made as necessary, Frequency: up to 4 times per year memorandum item 4.c. to conform with changes made to the FR Reporters: Bank holding companies Schedule HC-I — Risk-Based Capital Y-9C. Annual reporting hours: 1,200 Eliminate the reporting requirements 3. Report title: Parent Company Only Estimated average hours per response: of memorandum item 7.a, Purchased Financial Statements for Small Bank 0.50 credit card relationships: Discounted Holding Companies Number of respondents: 600 value. The Federal Reserve has Agency form number: FR Y-9SP Small businesses are affected. determined that this item is of limited OMB control number: 7100-0128 General description of report: This use. Frequency: Semiannual information collection is mandatory (12 Notes to the Balance Sheet/Income Reporters: Bank holding companies U.S.C. 1844(b) and (c)) and 12 CFR Statement Annual reporting hours: 31,324 225.5(b). Confidential treatment is not Expand the Notes to the Balance Estimated average hours per response: routinely given to the data in this report. Sheet and Notes to the Income 3.87 However, confidential treatment for the Statement sections to allow space for up Number of respondents: 4,047 reporting information, in whole or in to twenty optional comments. Small businesses are affected. part, can be requested in accordance Instructions General description of report: This with the instructions to the form. Instructional revisions and information collection is mandatory (12 Abstract: The FR Y-9CS is a free form clarifications will be done in accordance U.S.C. 1844(b) and (c) and 12 CFR supplement to the Consolidated with changes made to the Call Report 225.5(b)). Confidential treatment is not Financial Statements for Bank Holding instructions and revisions to the Capital routinely given to the data in this report. Companies (FR Y-9C; OMB No. 7100- Guidelines. However, confidential treatment for the 0128) used to collect any additional 2. Report title: Parent Company Only reporting information, in whole or in information deemed critical and needed Financial Statements for Large Bank part, can be requested in accordance in an expedited manner. The FR Y-9C Holding Companies with the instructions to the form. consists of standardized consolidated Agency form number: FR Y-9LP Abstract: The FR Y-9SP is a parent financial statements filed quarterly by OMB control number: 7100-0128 company only financial statement filed bank holding companies. Frequency: Quarterly on a semiannual basis by one-bank Final approval under OMB delegated Reporters: Bank holding companies holding companies with total authority of the revision, without Annual reporting hours: 34,925 consolidated assets of less than $150 extension, of the following reports: Estimated average hours per response: million, and multibank holding 1. Report title: Quarterly Financial 4.61 companies with total consolidated Statements of Nonbank Subsidiaries of Number of respondents: 1,894 assets of less than $150 million that Bank Holding Companies Small businesses are affected. meet certain other criteria. This report, Agency form number: FR Y-11Q General description of report: This an abbreviated version of the more OMB control number: 7100-0244 information collection is mandatory (12 extensive FR Y-9LP, is designed to Frequency: Quarterly U.S.C. 1844(b) and (c) and 12 CFR obtain basic balance sheet and income Reporters: Bank holding companies

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Annual reporting hours: 10,683 to conform with changes made to the FR rule, the Board has chosen to follow the Estimated average hours per response: Y-9C. more detailed notice and comment 6.24 2. Report title: Annual Financial procedures of substantive rulemaking Number of respondents: 428 Statements of Nonbank Subsidiaries of that are contained in the Administrative Small businesses are affected. Bank Holding Companies Procedure Act and the Paperwork General description of report: This Agency form number: FR Y-11I Reduction Act. The Administrative information collection is mandatory (12 OMB control number: 7100-0244 Procedures Act (5 U.S.C. 553(d)) U.S.C. 1844(b) and (c) and 12 CFR Frequency: Annual provides that the required publication 225.5(b)). Confidential treatment is not Reporters: Bank holding companies or service of a substantive rule shall be routinely given to most of the data in Annual reporting hours: 6,762 made not less that 30 days before its this report. However, confidential Estimated average hours per response: effective date, except as otherwise treatment for the reporting information, 3.24 provided by the agency for good cause in whole or in part, can be requested in Number of respondents: 2,087 found and published with the rule. The accordance with the instructions to the Small businesses are affected. substantive changes to these reports are General description of report: This form. FR Y-11Q, memorandum item 7.a, proposed to keep the reporting information collection is mandatory (12 loans and leases past due 30 through 89 requirements consistent with those U.S.C. 1844(b) and (c) and 12 CFR days and FR Y-11Q, memorandum item changes being incorporated in the Call 225.5(b)). Confidential treatment is not 7.d, loans and leases restructured and Report to be filed by commercial banks routinely given to the data in this report. included in past due and nonaccrual as of March 31, 1999. In the past, bank However, confidential treatment for the loans are confidential pursuant to holding companies have commented reporting information, in whole or in Section (b)(8) of the Freedom of that the reporting burden is minimized part, can be requested in accordance Information Act 5 U.S.C. 552(b)(8). by keeping the Call Report and the bank with the instructions to the form. FR Y- Abstract: The FR Y-11Q is filed holding company reports consistent and 11I, Schedule A, item 7.a, loans and quarterly by the top tier bank holding by implementing the changes on the leases past due 30 through 89 days and companies for each nonbank subsidiary same date. Furthermore, the effective FR Y-11I, Schedule A, item 7.d, loans of a bank holding company with total date of the revisions was published in and leases restructured and included in consolidated assets of $150 million or the initial notice and no comments were past due and nonaccrual loans are more in which the nonbank subsidiary received addressing the effective date. confidential pursuant to Section (b)(8) has total assets of 5 percent or more of For these reasons, in accordance with 5 of the Freedom of Information Act 5 the top-tier bank holding companys U.S.C. 553(d)(3), the Board finds there is U.S.C. 552(b)(8). consolidated Tier 1 capital, or where the good cause not to follow the 30-day Abstract: The FR Y-11I is filed nonbank subsidiaries total operating notice requirements of 5 U.S.C. 553(d) annually by the top tier bank holding revenue equals 5 percent or more of the and to make the implementation date companies for each of their nonbank top-tier bank holding companys for the revised FR Y-9C, FR Y-9LP, and subsidiaries that are not required to file consolidated total operating revenue. FR Y-11Q reports effective for March 31, a quarterly FR Y-11Q. The FR Y-11I The report consists of a balance sheet, 1999. report consists of similar balance sheet, income statement, off-balance-sheet Regulatory Flexibility Act Analysis income statement, off-balance-sheet, items, information on changes in equity The Board certifies that the above and change in equity capital capital, and a memoranda section. bank holding company reporting information that is included on the FR Current actions: The Board approved requirements are not expected to have a Y-11Q. However, some of the items on minor revisions to the FR Y-11Q significant economic impact on small the FR Y-11I are collected in a less effective with the March 31, 1999, entities within the meaning of the detailed manner. In addition, the FR Y- reporting date. Regulatory Flexibility Act (5 U.S.C. 601 Balance Sheet 11I also includes a loan schedule to be et seq.). The reporting requirements for Add an item on the balance sheet for submitted only by respondents engaged the small companies require accumulated net gains (losses) on cash in extending credit. flow hedges. As part of the disclosure Current actions: The Board approved significantly fewer items of data to be requirements for FAS 133, the Board a minor revision to the FR Y-11I submitted than the amount of approved adding the item Accumulated effective with the December 31, 1999, information required of large bank net gains (losses) on cash flow hedges, reporting date. holding companies. as of the report date, as new item 20.f Notes to the Financial Statements The information that is collected on in the equity capital section of the Add a section for Notes to the the reports is essential for the detection balance sheet. Current items 20.f Financial Statements. The Board of emerging financial problems, the through 20.h will be renumbered as approved adding this section to allow assessment of a holding company’s items 20.g through 20.i. respondents the opportunity to provide, financial condition and capital Notes to the Financial Statements at their option, any material information adequacy, the performance of pre- Add a section for Notes to the included in specific line items on the inspection reviews, and the evaluation Financial Statements. The Board financial statements that the bank of expansion activities through mergers approved adding this section to allow holding company wishes to explain. and acquisitions. The imposition of the respondents the opportunity to provide, The section will have space for up to ten reporting requirements is essential for at their option, any material information comments. the Board’s supervision of bank holding included in specific line items on the Instructions companies under the Bank Holding financial statements that the bank Instructional revisions and Company Act. holding company wishes to explain. clarifications will be made as necessary, Board of Governors of the Federal Reserve System, March 11, 1999. The section will have space for up to ten to conform with changes made to the FR comments. Y-9C. Robert deV. Frierson, Instructions Administrative Procedure Act Associate Secretary of the Board. Instructional revisions and Because the data collections referred [FR Doc. 99–6457 Filed 3–16–99; 8:45AM] clarifications will be made as necessary, to herein are contained in a substantive Billing Code 6210±01±F

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FEDERAL RESERVE SYSTEM U.S.C. 248(i), 248-l, and 464) and is Stock (Other than Banks, Brokers, or given confidential treatment (5 U.S.C. Dealers); Agency Information Collection 552 (b)(4)). Deregistration Statement for Persons Activities: Announcement of Board Abstract: The Federal Reserve’s Registered Pursuant to Regulation U; Approval Under Delegated Authority payment system risk reduction policy Statement of Purpose for an Extension and Submission to OMB relies in part on the efforts of individual of Credit Secured by Margin Stock by a institutions to identify, control, and Person Subject to Registration Under AGENCY: Board of Governors of the reduce their exposure. Institutions that Regulation U; Federal Reserve System incur daylight overdrafts in their Annual Report; SUMMARY Federal Reserve accounts and wish to Statement of Purpose for an Extension Background. Notice is hereby given of establish a capacity for overdrafts of Credit by a Creditor; the final approval of proposed greater than that afforded by an exempt Statement of Purpose for an Extension information collections by the Board of cap, or that use interaffiliate transfer of Credit Secured by Margin Stock Governors of the Federal Reserve arrangements, submit the FR 2226 Agency form numbers: FR G-1, FR G- System (Board) under OMB delegated resolutions. 2, FR G-3, FR G-4, FR T-4, FR U-1 authority, as per 5 CFR 1320.16 (OMB Final approval under OMB delegated OMB control numbers: Regulations on Controlling Paperwork authority of the extension for three 7100-0011: FR G-1, FR G-2, FR G-4 Burdens on the Public). Board-approved years, with minor revision, of the 7100-0018: FR G-3 collections of information incorporated following reports: 7100-0019: FR T-4 into the official OMB inventory of 1. Report title: Annual Daylight 7100-0115: FR U-1 currently approved collections of Overdraft Capital Report for U.S. Frequency: information. Copies of the OMB 83-Is Branches and Agencies of Foreign Banks FR G-1, FR G-2, FR G-3, FR T-4, FR and supporting statements and Agency form number: FR 2225 U-1: on occasion approved collection of information OMB control number: 7100-0216 FR G-4: annual instruments are placed into OMB’s Frequency: annual Reporters: individuals and businesses public docket files. The Federal Reserve Reporters: foreign banks with U.S. Annual reporting hours: 1,688 may not conduct or sponsor, and the branches or agencies reporting; 254,032 recordkeeping respondent is not required to respond Annual reporting hours: 50 Estimated average hours per response: to, an information collection that has Estimated average hours per response: FR G-1: 2.5 been extended, revised, or implemented 1.0 FR G-2: 15 minutes on or after October 1, 1995, unless it Number of respondents: 50 FR G-3: 10 minutes displays a currently valid OMB control Small businesses are not affected. FR G-4: 2.0 number. General description of report: This FR T-4: 10 minutes FOR FURTHER INFORMATION CONTACT: information collection is voluntary (12 FR U-1: 10 minutes Chief, Financial Reports Section—Mary U.S.C. 248(i), 248-l, and 464) and is not Number of respondents: M. West—Division of Research and given confidential treatment. FR G-1: 96 Statistics, Board of Governors of the Abstract: This report was FR G-2: 71 Federal Reserve System, Washington, implemented in March 1986 as part of FR G-3: 810 DC 20551. (202-452- the procedures used to administer the FR G-4: 715 3829)Telecommunications Device for Federal Reserve’s Payments System Risk FR T-4: 125 the Deaf (TDD) users may contact Policy. Foreign banks with U.S. FR U-1: 6,971 Diane Jenkins (202-452-3544), Board branches or agencies have the option of Small businesses are affected. of Governors of the Federal Reserve filing the FR 2225 to provide the Federal General description of reports: This System, Washington, DC 20551. Reserve with their parent bank’s information collection is mandatory (FR OMB Desk Officer—Alexander T. worldwide capital figure. A percentage G-1, FR G-3, FR G-4, FR T-4, FR U-1) or Hunt—Office of Information and of this figure is used in place of publicly required to obtain a benefit (FR G-2) (15 Regulatory Affairs, Office of available data to calculate the bank’s U.S.C. 78g and 78w). The information in Management and Budget, New daylight overdraft limit. Because the FR the FR G-1 and FR G-4 is given Executive Office Building, Room 2225 data are based on the capital of the confidential treatment (5 U.S.C. 552 3208, Washington, DC 20503 (202- worldwide bank, not just its United (b)(4)). The FR G-2 does not contain 395-7860) States offices, foreign banks seeking to confidential information. The FR G-3, Final approval under OMB delegated maximize their daylight overdraft limit FR T-4, and FR U-1 are not submitted authority of the extension for three may find it advantageous to file the FR to the Federal Reserve and, as such, no years, without revision, of the following 2225. issue of confidentiality arises. report: Currently the FR 2225 data are treated Abstract: The Securities Exchange Act 1. Report title: Report of Net Debit Cap as confidential. Because much of the of 1934 authorizes the Federal Reserve Agency form number: FR 2226 data reported by respondents is publicly to regulate securities credit issued by OMB control number: 7100-0217 available, however, the Federal Reserve banks, brokers and dealers, and other Frequency: annual has determined upon review that it does lenders. The purpose statements, FR U- Reporters: depository institutions, not have the authority to treat all reports 1, FR T-4, and FR G-3, are Edge and agreement corporations, U.S. filed as confidential. The Federal recordkeeping requirements for banks, branches and agencies of foreign banks Reserve changed the confidentiality brokers and dealers, and other lenders, Annual reporting hours: 2,160 statement on the form to a question to respectively, to document the purpose Estimated average hours per response: provide respondents an opportunity to of their loans secured by margin stock. 1.0 request confidentiality treatment for any Other lenders also must register and Number of respondents: 2,160 portion of the report. deregister with the Federal Reserve Small businesses are not affected. 2. Report titles: using the FR G-1 and FR G-2, General description of report: This Registration Statement for Persons respectively, and must file an annual information collection is mandatory (12 Who Extend Credit Secured by Margin report (FR G-4). The Federal Reserve

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13205 uses the data to identify lenders subject describes the terms of the consent Reynolds advertises as having no to Regulation U (which now agreement, and the allegations in the additives.) The disclosure must be incorporates Regulation G), to verify complaint. An electronic copy of the included in all advertising for Winston compliance with Regulations T, U, and full text of the consent agreement no-additive cigarettes, regardless of X, and to monitor margin credit. package can be obtained from the FTC whether that advertising contains a ‘‘no The revisions update the reports for Home Page (for March 3,1999), on the additives’’ claim, for a period of one recent modifications in the applicable World Wide Web, at ‘‘http:// year beginning no later than July 15, regulations. The Federal Reserve www.ftc.gov/os/actions97.htm.’’ A 1999. The disclosure must be included amended Regulations G, T, U, and X paper copy can be obtained from the in all Winston advertising that effective April 1, 1998, to reflect FTC Public Reference Room, Room H– represents (through such phrases as ‘‘no changes in the Federal Reserve’s 130, Sixth Street and Pennsylvania additives’’ or ‘‘100% tobacco’’) that the statutory authority made by the National Avenue, NW, Washington, DC 20580, product has no additives, for the Securities Markets Improvement Act of either in person or by calling (202) 326– duration of the order. This Part also 1996. None of the modifications result 3627. Public comment is invited. Such contains certain exemptions from the in substantive changes in the comments or views will be considered disclosure requirement: information collections. by the Commission and will be available • Board of Governors of the Federal Reserve for inspection and copying at its Advertisements not required to bear System, March 11, 1999. principal office in accordance with the Surgeon General’s health warning; Robert deV. Frierson, Section 4.9(b)(6)(ii) of the Commission’s •Certain ads for bona fide events or Associate Secretary of the Board. Rules of Practice (16 CFR 4.9(b)(6)(ii)). teams sponsored by Winston which [FR Doc. 99–6427 Filed 3–16–99; 8:45AM] Analysis of Proposed Consent Order to contain neither a ‘‘No additives’’ claim Billing Code 6210±01±F Aid Public Comment nor any other selling message or product description; and The Federal Trade Commission has • accepted an agreement to a proposed If Reynolds possesses scientific FEDERAL TRADE COMMISSION consent order from R.J. Reynolds evidence demonstrating that its ‘‘no [File No. 992±3025] Tobacco Company (‘‘Reynolds’’). additives’’ cigarette poses materially The proposed consent order has been lower health risks than other cigarettes R.J. Reynolds Tobacco Company; placed on the public record for sixty (60 of the same type. Analysis to Aid Public Comment days for receipt of comments by Part I also specifies the manner in interested persons. Comments received AGENCY: Federal Trade Commission. which the disclosure must be made, during this period will become part of ACTION: Proposed Consent Agreement. which is exemplified by two model the public record. After sixty (60) days, advertisements attached to the order. In SUMMARY: the consent agreement in this the Commission will again review the general, the disclosure must be within a matter settles alleged violations of agreement and the comments received, rectangular box that is no less than 40% federal law prohibiting unfair or and will decide whether it should of the size of the box containing the deceptive acts or practices or unfair withdraw from the agreement or make Surgeon General’s warning. methods of competition. The attached final the agreements’ proposed order. Part II of the order requires Reynolds Analysis to Aid Public Comment This matter involves an alleged to instruct each of its sales describes both the allegations in the deceptive representation for Winston representatives to remove or sticker, draft compliant that accompanies the cigarettes, that Reynolds has advertised with the applicable disclosure, any consent agreement and the terms of the do not contain additives. According to consent order—embodied in the consent the FTC complaint, through these advertisement displayed in a retail agreement—that would settle these advertisements, Reynolds represented establishment representing that Winston allegations. that smoking Winston cigarettes, cigarettes have no additives. All such because they contain no additives, is actions must be completed by July 15, DATES: Comments must be received on less hazardous to a smoker’s health than 1999. or before May 17, 1999. smoking otherwise comparable Part III–VII of the order require ADDRESSES: Comments should be cigarettes that contain additives. The directed to: FTC/Office of the Secretary, Reynolds to keep copies of relevant complaint alleges that Reynolds did not advertisements and materials Room 159, 6th St. and Pa. Ave., NW., have a reasonable basis for the Washington, DC 20580. substantiating claims made in the representation at the time it was made. advertisements; to provide copies of the FOR FURTHER INFORMATION CONTACT: Joel Among other reasons, according to the Winston or Beth Grossman, FTC/S– order to certain of its personnel; to complaint, the smoke from Winston notify the Commission of changes in the 4002, Washington, DC 20580. (202) 326– cigarettes, like the smoke from all 3153 or 326–3019. composition or formula of Winston cigarettes, contains numerous cigarettes that may affect the order; to SUPPLEMENTARY INFORMATION: Pursuant carcinogens and toxins. notify the Commission of changes in to Section 6(f) of the Federal Trade The proposed consent order contains corporate structure; and to file Commission Act, 38 Stat. 721, 15 U.S.C. provisions designed to prevent compliance reports with the 46 and Section 2.34 of the Commission’s Reynolds from engaging in similar acts Commission. Part VIII provides that the Rules of Practice (16 CFR 2.34), notice and practices in the future. is hereby given that the above-captioned Part I of the order requires Reynolds order will terminate after twenty (20 consent agreement containing a consent to include the following clear and years under certain circumstances. order to cease and desist, having been prominent disclosure in certain The purpose of this analysis is to filed with and accepted, subject to final advertising for its Winston cigarettes: facilitate public comment on the approval, by the Commission, has been No additives in our tobacco does NOT proposed order, and it is not intended placed on the public record for a period mean a safer cigarette. (The order to constitute an official interpretation of of sixty (60) days. The following requires a similar disclosure in the agreement and proposed order to Analysis to Aid Public Comment advertising for other tobacco products modify in any way their terms.

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By direction of the Commission. to comment. The committee will then Dated: March 8, 1999. Donald S. Clark, discuss what, if any, recommendations Margaret A. Hamburg, Secretary. to make to the Department on this Assistant Secretary for Planning and matter. It will then consider old and Evaluation. Concurring Statement of Commissioner new business as time permits. [FR Doc. 99–6415 Filed 3–16–99; 8:45 am] Orson Swindle Prospective speakers should notify BILLING CODE 4150±05±M R.J. Reynolds Tobacco Co., File No. 992– the Executive Secretary of their desire to 3025 address the Committee and should plan DEPARTMENT OF HEALTH AND I have voted to accept this consent for no more than 5 minutes of comment. HUMAN SERVICES agreement for public comment because FOR FURTHER INFORMATION CONTACT: the remedies, including corrective Stephen D. Nightingale, M.D., Executive Centers for Disease Control And statement in Winston Advertisements Prevention for one year, are warranted by the facts Secretary, Advisory Committee on of this case. The nationwide advertising Blood Safety and Availability, Office of [INFO±99±12] campaign for ‘‘no additives’’ Winston Public Health and Science, Department Proposed Data Collections Submitted cigarettes, launched in August 1997, is of Health and Human Services, Room for Public Comment and unusually extensive. Based on my 736E, 200 Independence Avenue SW., Recommendations reading of the record, I am convinced Washington, DC 20201. Phone (202) that many consumers interpret ads 690–5560, FAX (202) 690–6584 e-mail In compliance with the requirement containing express ‘‘no additives’’ [email protected]. of Section 3506(c)(2)(A) of the claims to mean that Winstons are not as Dated: March 8, 1999. Paperwork Reduction Act of 1995 the harmful as other cigarettes, and such Stephen D. Nightingale, Center for Disease Control and health claim is presumably important to Prevention is providing opportunity for Executive Secretary, Advisory Committee on consumers in their purchasing Blood Safety and Availability. public comment on proposed data decisions. Based on the extent and collection projects. To request more [FR Doc. 99–6414 Filed 3–16–99; 8:45 am] magnitude of the ongoing ad campaign information on the proposed projects or and the demonstrated strength of the BILLING CODE 4160±17±M to obtain a copy of the data collection implied health claim, I am willing to plans and instruments, call the CDC infer that the claim will linger in the Reports Clearance Officer on (404) 639– DEPARTMENT OF HEALTH AND minds of consumers for one year absent 7090. a corrective statement. I am particularly HUMAN SERVICES Comments are invited on: (a) Whether the proposed collection of information concerned about a lingering effect of the Office of the Assistant Secretary for ads because of the well-recognized is necessary for the proper performance Planning and Education health risks of smoking. Under these of the functions of the agency, including circumstances, I support the corrective Privacy Act of 1974; Deletion of a whether the information shall have advertising remedy contained in the System of Records practical utility; (b) the accuracy of the proposed consent order. agency’s estimate of the burden of the proposed collection of information; (c) [FR Doc. 99–6486 Filed 3–16–99; 8:45 am] AGENCY: Office of the Assistant ways to enhance the quality, utility, and BILLING CODE 6750±01±M Secretary for Planning and Evaluation (ASPE), Office of the Secretary (OS). clarity of the information to be collected; and (d) ways to minimize the ACTION: Notification of Deletion of burden of the collection of information DEPARTMENT OF HEALTH AND Department of Health and Human on respondents, including through the HUMAN SERVICES Services Privacy Act System of Records. use of automated collection techniques Notice of Meeting of the Advisory for other forms of information Committee on Blood Safety and SUMMARY: In accordance with the technology. Send comments to Seleda Availability requirements of the Privacy Act of 1974, Perryman, CDC Assistant Reports as amended, 5 U.S.C. 552a, the Office of Clearance Officer, 1600 Clifton Road, AGENCY: Office of the Secretary. the Assistant Secretary for Planning and MS–D24, Atlanta, GA 30333. Written ACTION: Notice of meeting. Evaluation, Department of Health and comments should be received within 60 Human Services, is deleting form the days of this notice. The Advisory Committee on Blood agency’s inventory the system of records Proposed Project Safety and Availability will meet on entitled ‘‘National Long-Term Care 1. Management of Occupational Blood Thursday, April 29, 1999 from 8:00 a.m. Channeling Demonstration, HHS/OS/ Exposures and Antibiotic Prescription to 5:00 p.m. and Friday, April 30, 1999, ASPE, 09–90–0088.’’ This system or from 8:00 a.m. to 5:00 p.m. The meeting Practices Among United States records is obsolete and the information will take place in the Holiday Inn Dentists—NEW—National Center for is no longer collected or maintained. Bethesda, 8120 Wisconsin Avenue, Chronic Disease Prevention and Health Bethesda, Maryland 20814. The meeting EFFECTIVE DATE: March 17, 1999. Promotion (NCCDPHP). In U.S. health will be entirely open to the public. care facilities, both occupational FOR FURTHER INFORMATION CONTACT: At its meeting the Committee will transmission of bloodborne pathogens examine the extend of the nation’s Joan Turek, ASPE Privacy Act officer, and antimicrobial resistance are reserves of blood and blood products. Department of Health and Human important problems with significant The committee will review information Services, Office of the Assistant morbidity and costs. Several public presented to it by representatives of Secretary for Planning and Evaluation, health initiatives have been undertaken consumers, industry and government H.H.H. Building—Room 447D, 200 or are being developed to increase agencies. At the conclusion of these Independence Ave, SW, Washington, compliance with recently published presentations, the public will be invited DC 20201, Telephone: (202) 690–5965. recommendations to reduce

VerDate 03-MAR-99 16:11 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm01 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13207 occupational transmission of practices among United States dentists. A random sample of currently bloodborne pathogens and to assess Information provided by these data are practicing U.S. dentists will be mailed current antibiotic use by physicians, critical to the Division of Oral Health’s questionnaires with two follow-up hospital and other medical health-care ongoing efforts to protect dental workers mailings to non-respondents. The workers. However, to date, there are from infection with bloodborne diseases information collected will include limited data on dentists’ and to target educational efforts aimed demographic information, office implementation and knowledge of at increasing awareness of and policies for management of occupational postexposure recommendations or on compliance with current CDC blood exposures and training of dental their antibiotic use. Therefore, the recommendations. Information on staff, the weekly number of antibiotic Centers for Disease Control and antibiotic prescribing practices will help prescriptions, the most commonly Prevention, National Center for Chronic identify the most effective strategies for prescribed antibiotics, and the most Disease Prevention and Health promoting appropriate use of antibiotics common oral conditions for which Promotion, Division of Oral Health, among dentists, provide an intends to conduct a survey of the epidemiologic baseline on which to antibiotics are prescribed. The total cost management of occupational blood measure future behaviors, and assess the to respondents is $24,000.00. exposures and antibiotic prescription need for comprehensive guidelines.

Average Number of Number of burden/ Total Respondents respondents responses/ response burden respondent (in hours) (in hours)

Practicing U.S. Dentists ...... 3,600 1 0.25 900

2. An Evaluation of Targeted Health if all women capable of becoming materials on folic acid information will Communication Messages: Folic Acid pregnant consume 400 micrograms of be collected and measured to determine and Neural Tube Defects—NEW– folic acid daily both prior to and during whether these exposures influenced the National Center for Environmental early pregnancy. women’s knowledge and usage of folic Health (NCEH). The Division of Birth CDC and the March of Dimes Birth acid. Data will be collected via Defects and Pediatric Genetics, National Defects Foundation developed health telephone interviews. The number and Center for Environmental Health, CDC, communication media messages and frequency of women’s exposures to the launched a national education campaign educational materials targeted to health media messages such as television and care providers, as well as to English and in January 1999 to increase women’s radio PSAs will be collected from media Spanish-speaking women. These media knowledge about neural tube birth channels and compared to information messages and educational materials defects (NTDs) and the beneficial role consist of television and radio public collected from survey data, National folic acid, a B vitamin, plays in the service announcements (PSA), Council on Folic Acid organizations and prevention of NTDs. Studies show that brochures and resource manuals. the National Clearinghouse on Folic a 50 to 70 percent reduction in the risk Information about women’s exposure Acid activities. The total cost to of neural tube birth defects is possible to media messages and educational respondents is $0.

Average Number of Number of burden/ Total Respondents respondents responses/ response burden respondent (in hours) (in hours)

Targeted Market for the Folic Acid Messages ...... 2,000 1 .33 666

3. Health Assessment of Persian Gulf collection consisted of a telephone health questionnaires will be War Veterans From Iowa: Follow-up on survey of 3,695 military personnel who administered. Review of medical Asthma (0920–0425)—EXTENSION— served during the time of the Persian records, standard physical examination, National Center for Environmental Gulf War and listed Iowa as their home and laboratory evaluation will be Health (NCEH). The purpose of this of residence. Data will be collected from conducted to validate multi systemic proposed study is to collect additional subjects who participated in the conditions, including chronic fatigue data to validate health outcomes telephone survey to validate the self- syndrome and fibromyalgia. The total reported by participants in the Health report of asthma. Lung function cost to respondents is $0.00. Assessment of Persian Gulf War assessment, tests of airways Veterans From Iowa. The original data hyperactivity, and standard respiratory

Average Number of Number of burden/ Total Respondents respondents responses/ response burden respondent (in hrs) (in hours)

PGW Exposed and Non-PGW Veterans self-reporting asthma. Question- naire (ATS and Adult Respiratory Health); Pulmonary Function Tests (spirometry, DLCO, lung volumes); Histamine Challenge ...... 100 1 2.25 225

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Average Number of Number of burden/ Total Respondents respondents responses/ response burden respondent (in hrs) (in hours)

Normal Controls. (PGW/Non-PGW Vets denying symptoms of asthma). Questionnaire (ATS and Adult Respiratory Health); Pulmonary Function Tests (spirometry, DLCO, lung volumes); Histamine Challenge ...... 50 1 2.25 112.5 TOTAL ...... 337.5

Dated: March 11, 1999. of the functions of the agency, including part of the standard application for State Nancy Cheal, whether the information shall have and local governments and for private Acting Associate Director for Policy, Planning practical utility; (b) the accuracy of the non-profit and for-profit organizations and Evaluation, Centers for Disease Control agency’s estimate of the burden of the when applying for financial assistance and Prevention (CDC). proposed collection of information; (c) from PHS grant programs. The Checklist [FR Doc. 99–6435 Filed 3–16–99; 8:45 am] ways to enhance the quality, utility, and assists applicants to ensure that they BILLING CODE 4163±18±P clarity of the information to be have included all required information collected; and (d) ways to minimize the necessary to process the application. burden of the collection of information The Checklist data helps to reduce the DEPARTMENT OF HEALTH AND on respondents, including through the time required to process and review HUMAN SERVICES use of automated collection techniques grant applications, expediting the for other forms of information issuance of grant awards. The PHSIS Centers for Disease Control And technology. Send comments to Seleda Third Party Notification Form is used to Prevention Perryman, CDC Assistant Reports inform State and local health agencies of [INFO±99±13] Clearance Officer, 1600 Clifton Road, community-based proposals submitted MS-D24, Atlanta, GA 30333. Written by non-governmental applicants for Proposed Data Collections Submitted comments should be received with 10 Federal funding. In addition, we are for Public Comment and days of this notice. adding two new supplements to the Recommendations information collection request. One Proposed Project In compliance with the requirement form will be used by CDC and the other of Section 3506(c)(2)(A) of the 1. PHS Supplements to the by SAMHSA. Paperwork Reduction Act of 1995 the Application for Federal Assistance SF The current OMB approval for the Centers for Disease Control and 424 (0920–0428)—Reinstatement—The supplements was previously submitted Prevention is providing opportunity for Centers for Disease Control and by the Department of Health and Human public comment on proposed data Prevention (CDC) is requesting an Services (DHHS), Office of the Assistant collection projects. To request more emergency clearance for the three-year Secretary of Health (OASH) under OMB information on the proposed projects or extension and revision of OMB approval number 0937–0189. This submission is to obtain a copy of the data collection for continued use of the Supplements to time-sensitive and requests emergency plans and instruments, call the CDC the Request for Federal Assistance approval because these supplements Reports Clearance Officer on (404) 639– Application (SF–424). We also plan on will be utilized by several agencies 7090. modifying the SF 424 form. The within DHHS immediately after Comments are invited on: (a) Whether Checklist, Program Narrative, and the clearance is granted. The total annual the proposed collection of information Public Health System Impact Statement cost to the respondents is estimated to is necessary for the proper performance (third party notification) (PHSIS) are a be $1,184,452.

Average Number of Number of burden/ Total Respondents respondents responses/ response burden respondent (in hrs.) (in hrs.)

State and local health departments; non-profit and for-profit organizations 7,643 1 4.215 32,215

Total ...... 32,215

Dated: March 11, 1999. DEPARTMENT OF HEALTH AND Budget (OMB) in compliance with the Nancy Cheal, HUMAN SERVICES Paperwork Reduction Act (44 U.S.C. Acting Associate Director for Policy, Planning Chapter 35). To request a copy of these and Evaluation, Centers for Disease Control Centers for Disease Control and requests, call the CDC Reports Clearance and Prevention (CDC). Prevention Officer at (404) 639–7090. Send written [FR Doc. 99–6434 Filed 3–16–99; 8:45 am] [30DAY±09±99] comments to CDC, Desk Officer; Human BILLING CODE 4163±18±P Resources and Housing Branch, New Agency Forms Undergoing Paperwork Executive Office Building, Room 10235; Reduction Act Review Washington, DC 20503. Written The Centers for Disease Control and comments should be received within 30 Prevention (CDC) publishes a list of days of this notice. information collection requests under review by the Office of Management and

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Proposed Project guidelines exist. Evidence suggests that Prevention and Control, intends to colorectal cancer screening can save conduct a pilot survey of HMOs to 1. Validity of Recall of Prostate and lives and efforts are under way to obtain information on the validity of Colorectal Cancer Screening Tests— increase participation in screening. An recall on prostate and colorectal cancer New—The National Center for Chronic increasing number of people are served screening tests. Members of three Disease Prevention and Health by managed care organizations where prepaid health plans (HMO’s) will be Promotion (NCCDPHP), Division of they may receive cancer screening tests. interviewed by telephone, and medical Cancer Prevention and Control. Prostate However, for both types of cancer little records will be abstracted. Information and colorectal cancer are among the screening information is available on from this pilot study will allow the leading causes of cancer deaths in the screening guidelines for practitioners of Program to explore whether screening U.S. Prostate cancer screening has managed care organizations (HMOs). rates can be determined from self- increased rapidly during the past few Therefore, the Centers for Disease reports and whether future studies are years although it is unknown whether Control and Prevention, National Center screening decreases prostate cancer for Chronic Disease Prevention and warranted. The total annual burden mortality and conflicting screening Health Promotion, Division of Cancer hours are 573.

Average Number of Number of burden/ Respondents respondents responses/ respondent respondent (in hrs.)

HMOs ...... 2,293 1 0.25

2. Evaluation of the Use of Data the National Center for Infectious other sources, to address these issues. Transmitted Through the National Diseases (NCID), Centers for Disease The results of the project will assist the Electronic Telecommunications System Control and Prevention (CDC) with the EPO, and NCID in carrying out CDC’s for Surveillance (NETSS)—New— capacity to assess the degree to which mission of protecting the health of the Epidemiology Program Office (EPO). A data processed locally and at CDC after United States public, through improved questionnaire has been designed to transmission through NETSS is used by use of surveillance data by public health collect information for the project State and Local Health Departments. officials at local, state, and national entitled: ‘‘Evaluation of the Use of Data This evaluation will encompass: (1) levels. In order to focus efforts and Transmitted Through the National Dissemination of processed data, (2) resource allocation, a clear Electronic Telecommunications System Access to disseminated data, and (3) understanding of the barriers to access for Surveillance (NETSS)’’. The purpose Use of accessed data for analysis by and use of NETSS data is needed. The of the project is to develop and State and Local health authorities. The total annual burden hours are 129. implement a comprehensive evaluation information gathered will be analyzed, strategy which will provide EPO, and in conjunction with data collected from

Average Number of Number of burden/ Respondents respondents responses/ respondent respondent (in hrs.)

State and Territorial Epidemiologists ...... 56 1 0.25 CDC Program Staff who work with NETSS ...... 40 ...... 0.25 State Infectious Disease Control Staff who work with NETSS ...... 42 1 1.5 State and Local Health Departments who work with VPD* from NETSS ...... 28 1 1.5 * vaccine-preventable diseases

Dated: March 11, 1999. DEPARTMENT OF HEALTH AND March 8, 1999, [Vol. 64 FR No. 44]. The Nancy Cheal, HUMAN SERVICES notice is amended as follows: Acting Associate Director for Policy, Planning On page 11025, second column, under Centers for Disease Control and and Evaluation, Centers for Disease Control ‘‘C. Availability of Funds’’, the first Prevention and Prevention (CDC). paragraph should read: [FR Doc. 99–6436 Filed 3–16–99; 8:45 am] [Program Announcement 99018] Approximately $1,800,000 is available BILLING CODE 4163±18±P in FY 1999 to fund approximately two Water Intervention Studies To awards. It is expected that the average Determine the Fraction of award will be $900,000 ranging from Gastrointestinal Illness Attributable to $900,000 to $1,800,000. It is expected Drinking Water; Notice of Availability that the awards will begin on or about of Funds; Amendment August 15, 1999, and will be made for A notice announcing the availability a 12-month budget period within a of Fiscal Year 1999 funds for the Water project period of up to two years. The Intervention Studies to Determine the funding estimate may change. Fraction of Gastrointestinal Illness Attributable to Drinking Water was published in the Federal Register on

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Dated: March 10, 1999. the authority to sign Federal Register Scientific Review, National Institutes of John L. Williams, notices pertaining to announcements of Health, 6701 Rockledge Drive, Room 5112, Director, Procurement and Grants Office, meetings and other committee MSC 7852, Bethesda, MD 20892, (301) 435– Centers for Disease Control and Prevention management activities, for both the 1169. (CDC). This notice is being published less than 15 Centers for Disease Control and days prior to the meeting due to the timing [FR Doc. 99–6433 Filed 3–16–99; 8:45 am] Prevention and the Agency for Toxic limitations imposed by the review and BILLING CODE 4163±18±P Substances and Disease Registry. funding cycle. Carolyn J. Russell, Name of Committee: Center for Scientific Director, Management Analysis and Services Review Special Emphasis Panel. DEPARTMENT OF HEALTH AND Office, Centers for Disease Control and Date: March 18, 1999. HUMAN SERVICES Prevention (CDC). Time: 10:00 AM to 4:00 PM. [FR Doc. 99–6432 Filed 3–16–99; 8:45 am] Agenda: To review and evaluate grant Centers for Disease Control and applications. BILLING CODE 4163±18±P Prevention (CDC) Place: Washington, National Airport Hilton, 2399 Jefferson Davis Highway, Office of the Director, National Center Arlington, VA 22202. for HIV, STD and TB Prevention of the DEPARTMENT OF HEALTH AND Contact Person: Everett E. Sinnett, PHD, Center for Disease Control and HUMAN SERVICES Scientific Review Administrator, Center for Scientific Review, National Institutes of Prevention (CDC), Announces the National Institutes of Health Following Meeting Health, 6701 Rockledge Drive, Room 4120, MSC 7818, Bethesda, MD 20892, (301) 435– Name: Consultation Meeting to Center for Scientific Review; Notice of 1016, [email protected]. discuss the revision of the U.S. Public Closed Meetings This notice is being published less than 15 days prior to the meeting due to the timing Health Service recommendations for Pursuant to section 10(d) of the human immunodeficiency virus limitations imposed by the review and Federal Advisory Committee Act, as funding cycle. counseling and voluntary testing for amended (5 U.S.C. Appendix 2), notice pregnant women [MMWR 1995; 44 (No. Name of Committee: Center for Scientific is hereby given of the following Review Special Emphasis Panel. RR–7)]. meetings. Times and Dates: 10 a.m.–5 p.m., Date: March 18, 1999. The meetings will be closed to the Time: 2:00 PM to 5:00 PM. April 26,1999; 8 a.m.–3 p.m., April 27, public in accordance with the Agenda: To review and evaluate grant 1999. provisions set forth in sections applications. Place: Atlanta Marriot Marquis Hotel, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: Hotel Sofitel, 1914 Connecticut Ave, 265 Peachtree Center Ave., Atlanta, GA as amended. The grant applications and NW, Washington, DC 20009. 30303, telephone 404/521–0000. the discussions could disclose Contact Person: Zakir Bengali, PHD, Status: Attendees will include invited confidential trade secrets or commercial Scientific Review Administrator, Center for experts in the area of perinatal Scientific Review, National Institutes of property such as patentable material, transmission of HIV; legal issues; Health, 6701 Rockledge Drive, Room 5150, and personal information concerning behavioral science; and ethicists from MSC 7842, Bethesda, MD 20892, (301) 435– individuals associated with the grant both public and private organizations; 1742. applications, the disclosure of which representing public health; medical This notice is being published less than 15 professionals; advocacy groups; patient would constitute a clearly unwarranted days prior to the meeting due to the timing invasion of personal privacy. limitations imposed by the review and populations; persons with HIV/AIDS; funding cycle. and maternal and child health groups. Name of Committee: Center for Scientific Name of Committee: Center for Scientific The meeting is open to the public, Review Special Emphasis Panel, ZRG1–SSS– 2 (5). Review Special Emphasis Panel. limited only by space available. The Date: March 19, 1999. meeting room will accommodate Date: March 16–17, 1999. Time: 8:00 AM to 4:00 PM. Time: 8:00 AM to 5:00 PM. approximately 70 people. Agenda: To review and evaluate grant Agenda: To review and evaluate grant Purpose: Attendees will discuss the applications. applications. potential revisions to the U.S. Public Place: St. James Hotel, 950 24th Street, Place: Holiday Inn, 5520 Wisconsin Health Service recommendations for N.W., Washington, DC 20037. Avenue, Chevy Chase, MD 20815. human immunodeficiency virus Contact Person: Jean D. Sipe, PHD, Contact Person: Mohindar Poonian PHD, counseling and voluntary testing for Scientific Review Administrator, Center for Scientific Review Administrator, Center for pregnant women. [MMWR 1995; 44 (No. Scientific Review, National Institutes of Scientific Review, National Institutes of RR–7)]. Health, 6701 Rockledge Drive, Room 5152, Health, 6701 Rockledge Drive, Room 5110, Matters to be Discussed: Agenda items MSC 7842, Bethesda, MD 20892, (301) 435– MSC 7852, Bethesda, MD 20892, 301–435– 1168, [email protected]. include discussion of the recent report 1743. This notice is being published less than 15 This notice is being published less than 15 issued by the National Research days prior to the meeting due to the timing day prior to the meeting due to the timing Council, Institute of Medicine, limitations imposed by the review and limitations imposed by the review and ‘‘Reducing the Odds, Preventing funding cycle. funding cycle. Perinatal Transmission of HIV in the Name of Committee: Center for Scientific Name of Committee: Center for Scientific United States’’. Review Special Emphasis Panel, ZRG1–(06)– Review Special Emphasis Panel, ZRG–1 CONTACT PERSON FOR MORE INFORMATION: (01). VACC (02). Mary Helen Witten, Office of the Date: March 18–19, 1999. Date: March 19, 1999. Director, National Center for HIV, STD Time: 8:00 AM to 5:30 PM. Time: 8:30 AM to 5:00 PM. Agenda: To review and evaluate grant and TB Prevention, Division of HIV and Agenda: To review and evaluate grant applications. applications. AIDS Prevention 1600 Clifton Rd., NE, Place: Bethesda Holiday Inn, Versailles III, Place: Holiday Inn Chevy Chase, 5520 M/S D–21, Atlanta, GA, 30333, 404/ 8120 Wisconsin Avenue, Bethesda, MD Wisconsin Avenue, Chevy Chase, MD 20815. 639–4592. E-mail: [email protected]. 20814. Contact Person: Mary Clare Walker, PHD, The Director, Management Analysis Contact Person: Sami A. Mayyasi, PHD, Scientific Review Administrator, Center for and Services office has been delegated Scientific Review Administrator, Center for Scientific Review, National Institutes of

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Health, 6701 Rockledge Drive, Room 5104, Contact Person: Priscilla B. Chen, PHD, Contact Person: Sami A. Mayyasi, PHD, MSC 7852, Bethesda, MD 20892, (301) 435– Scientific Review Administrator, Center for Scientific Review Administrator, Center for 1165. Scientific Review, National Institutes of Scientific Review, National Institutes of This notice is being published less than 15 Health, 6701 Rockledge Drive, Room 4104, Health, 6701 Rockledge Drive, Room 5112, days prior to the meeting due to the timing MSC 7814, Bethesda, MD 20892, (301) 435– MSC 7852, Bethesda, MD 20892, (301) 435– limitations imposed by the review and 1787. 1169. funding cycle. This notice is being published less than 15 This notice is being published less than 15 Name of Committee: Center for Scientific days prior to the meeting due to the timing days prior to the meeting due to the timing Review Special Emphasis Panel BBCB ZRG1 limitations imposed by the review and limitations imposed by the review and (3). funding cycle. funding cycle. Date: March 19, 1999. Name of Committee: Center for Scientific (Catalogue of Federal Domestic Assistance Time: 2:00 PM to 3:00 PM. Review Special Emphasis Panel. Program Nos. 93.306, Comparative Medicine, Agenda: To review and evaluate grant Date: March 23, 1999. 93.306; 93.333, Clinical Research, 93.333, applications. Time: 1:00 PM to 3:00 PM. 93.337, 93.393–93.396, 93.837–93.844, 93– Place: NIH Rockledge 2, Bethesda, MD Agenda: To review and evaluate grant 846–93.878, 93.892, 93.893, National 20892, (Telephone Conference Call). applications. Institutes of Health, HHS) Contact Person: Donald Schneider PHD, Place: NIH, Rockledge 2, Bethesda, MD Dated: March 9, 1999. Scientific Review Administrator, Center for 20892, (Telephone Conference Call). LaVerne Y. Stringfield, Scientific Review, National Institutes of Contact Person: Eugene Zimmerman, PHD, Health, 6701 Rockledge Drive, Room 4172, Scientific Review Administrator, Center for Committee Management Officer, NIH. MSC 7806, Bethesda, MD 20892, (301) 435– Scientific Review, National Institutes of [FR Doc. 99–6409 Filed 3–16–99; 8:45 am] 1727. Health, 6701 Rockledge Drive, Room 4202, BILLING CODE 4140±01±M This notice is being published less than 15 MSC 7812, Bethesda, MD 20892, (301) 435– days prior to the meeting due to the timing 1220. limitations imposed by the review and This notice is being published less than 15 DEPARTMENT OF HEALTH AND funding cycle. days prior to the meeting due to the timing HUMAN SERVICES Name of Committee: Center for Scientific limitations imposed by the review and Review Special Emphasis Panel, ZRG1–SSS– funding cycle. Administration for Children and 8 (53). Name of Committee: Center for Scientific Families Date: March 21–23, 1999. Review Special Emphasis Panel. Time: 7:00 PM to 2:00 PM. Date: March 23, 1999. Agency Recordkeeping/Reporting Agenda: To review and evaluate grant Time: 1:00 PM to 4:00 PM. Requirements Under Emergency applications. Agenda: To review and evaluate grant Review by the Office of Management Place: St. Louis Marriott Pavilion, One applications. Broadway, St. Louis, MO 63102. Place: NIH, Rockledge 2, Bethesda, MD and Budget (OMB) Contact Person: Nadarajen Vydelingum, 20892, (Telephone Conference Call). Title: ACF–696 Child Care PHD, Scientific Review Administrator, Contact Person: Jo Pelham, BA, Scientific Special Study Section—8, Center for Review Administrator, Center for Scientific Development Fund Financial Reporting Scientific Review, National Institutes of Review, National Institutes of Health, 6701 Form. Health, 6701 Rockledge Drive, MSC 7854, Rm Rockledge Drive, Room 4104, MSC 7814, OMB No.: 0970–0163. 5122, Bethesda, MD 20892, (301) 435–1176, Bethesda, MD 20892, (301) 435–1786. Description: The form provides [email protected]. This notice is being published less than 15 specific data regarding claims and This notice is being published less than 15 days prior to the meeting due to the timing provides a mechanism for States to days prior to the meeting due to the timing limitations imposed by the review and request grant awards and certify the limitations imposed by the review and funding cycle. availability of State matching funds. funding cycle. Name of Committee: Center for Scientific Failure to collect this data would Name of Committee: Center for Scientific Review Special Emphasis Panel, ZRG1– seriously compromise ACF’s ability to Review Special Emphasis Panel. AARR 6–03. monitor expenditures. This information Date: March 23, 1999. Date: March 23, 1999. Time: 1:00 PM to 2:00 PM. Time: 3:00 PM to 4:00 PM. is also used to estimate outlays and may Agenda: To review and evaluate grant Agenda: To review and evaluate grant be used to prepare ACF budget applications. applications. submissions to Congress. Place: NIH, Rockledge 2, Bethesda, MD Place: NIH, Rockledge 2, Bethesda, MD Respondents: State, Local or Tribal 20892, (Telephone Conference Call). 20892, (Telephone Conference Call). Govt.

ANNUAL BURDEN ESTIMATES

Number of Average bur- Instrument Number of responses per den hours per Total burden respondents respondent response hours

ACF±696 ...... 54 4 8 1,728

Estimated Total Annual Burden may be obtained by calling the Attn: OMB Desk Officer for ACF, Office Hours: 1,728. Administration for Children and of Management and Budget, Paper Additional Information: ACF is Families, Reports Clearance Officer, Bob Reduction Project, 725 17th Street, NW., requesting that OMB grant a 180 day Sargis at (202) 690–7275. Washington, DC 20503 (202) 395–7316. approval for this information collection Comments and questions about the under procedures for emergency information collection described above processing by May 31, 1999. A copy of should be directed to the following this information collection, with address by May 31, 1999: Office of applicable supporting documentation, Information and Regulatory Affairs,

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Dated: March 10, 1999. legibly dated, machine produced www.acf.dhhs.gov/programs/add; or Bob Sargis, postmark of a commercial mail service [email protected]. Reports Clearance Officer. is affixed to the envelope/package FOR FURTHER INFORMATION CONTACT: [FR Doc. 99–6396 Filed 3–16–99; 8:45 am] containing the application(s). To be Administration for Children and BILLING CODE 4184±01±M acceptable as proof of timely mailing, a Families (ACF), Pat Laird, 370 L’Enfant postmark from a commercial mail Promenade, S.W., Washington, D.C., service must include the logo/emblem 20447, 202/690–7447; or DEPARTMENT OF HEALTH AND of the commercial mail service company [email protected]. HUMAN SERVICES and must reflect the date the package NOTICE OF INTENT TO SUBMIT APPLICATION: was received by the commercial mail If you intend to submit an application, Administration for Children and service company from the applicant. please send a post card with the number Families Private Metered postmarks shall not be and title of this announcement, your [Program Announcement No. 93631±99±01] acceptable as proof of timely mailing. organization’s name and address, and Applications handcarried by your contact person’s name, phone and Developmental Disabilities: Final applicants, applicant couriers, other fax numbers, and e-mail address to: Notice of Availability of Financial representatives of the applicant, or by Administration on Developmental Assistance and Request for overnight/express mail couriers shall be Disabilities, 370 L’Enfant Promenade Applications To Support Family considered as meeting an announced SW, Washington, DC, 20447, Attn: Support Model Demonstration Projects deadline if they are received on or Family Support. Under the Projects of National before the deadline date, between the This information will be used to Significance Program hours of 8:00 a.m. and 4:30 p.m., EST, determine the number of expert AGENCY: Administration on at the U.S. Department of Health and reviewers needed and to update the Developmental Disabilities (ADD), ACF, Human Services, ACF/Administration mailing list to whom program DHHS. on Developmental Disabilities, 370 announcements are sent. L’Enfant Promenade SW, ACF Mail ACTION: Invitation to apply for financial SUPPLEMENTARY INFORMATION: Center, 2nd Floor (near loading dock), assistance. Aerospace Center, 901 D Street, SW, Part I. General Information SUMMARY: The Administration on Washington, DC 20024, between A. Goals of the Administration on Developmental Disabilities, Monday and Friday (excluding Federal Developmental Disabilities Administration for Children and holidays). This address must appear on The Administration on Families (ACF), announces that the envelope/package containing the Developmental Disabilities (ADD) is applications are being accepted for application with the note ‘‘Attention: located within the Administration for funding of Fiscal Year 1999 under Lois Hodge. Applicants using express/ Children and Families (ACF), family support. overnight services should allow two Department of Health and Human This program announcement consists working days prior to the deadline date Services (DHHS). Although different of five parts. Part I, the Introduction, for receipt of applications. (Applicants from the other ACF program discusses the goals and objectives of are cautioned that express/overnight administrations in the specific ACF and ADD. Part II provides the mail services do not always deliver as populations it serves, ADD shares a necessary background information on agreed.) Any applications received after common set of goals that promote the ADD for applicants. Part III describes 4:30 p.m. on the deadline date will not economic and social well being of the review process. Part IV describes the be considered for competition. families, children, individuals and priority under which ADD requests ADD cannot accommodate communities. Through national applications for Fiscal Year 1999 transmission of applications by fax or leadership, ACF and ADD envision: funding of projects. Part V describes in through other electronic media. • Families and individuals detail how to prepare and submit an Therefore, applications transmitted to empowered to increase their own application. ADD electronically will not be accepted economic independence and Grants will be awarded under this regardless of date or time of submission productivity; program announcement subject to the and time of receipt. • Strong, healthy, supportive availability of funds for support of these LATE APPLICATIONS: Applications that do communities having a positive impact activities. not meet the criteria above are on the quality of life and the DATES: The closing date for submittal of considered late applications. ADD shall development of children; applications under this announcement notify each late applicant that its • Partnerships with individuals, May 17, 1999. Mailed or handcarried application will not be considered in front-line service providers, applications received after 4:30 p.m. on the current competition. communities, States and Congress that the closing date will be classified as enable solutions which transcend late. EXTENSION OF DEADLINES: ADD may extend the deadline for all applicants traditional agency boundaries; DEADLINE: Mailed applications shall be • Services planned and integrated to because of acts of God such as floods considered as meeting an announced improve client access; deadline if they are received on or and hurricanes, or when there is • A strong commitment to working before the deadline time and date at the widespread disruption of the mails. with Native Americans, persons with U.S. Department of Health and Human However, if ADD does not extend the developmental disabilities, refugees and Services, ACF/Administration on deadline for all applicants, it may not migrants to address their needs, Developmental Disabilities, 370 waive or extend the deadline for any strengths and abilities; and L’Enfant Promenade SW, Mail Stop 6C– applicants. • A community-based approach that 462, Washington, DC 20447, Attention: ADDRESSES: Application materials are recognizes and expands on the Lois Hodge.’’? available from Pat Laird, 370 L’Enfant resources and benefits of diversity. Applicants must ensure that a legibly Promenade, S.W., Washington, D.C. Emphasis on these goals and progress dated U.S. Postal Service postmark or a 20447, 202/690–7447; http:// toward them will help more

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The The Administration on and their families receive; and play authority for this program was to expire Developmental Disabilities (ADD) is the decision making roles in policies and at the end of fiscal year 1998 or lead agency within ACF and DHHS programs that affect the lives of such September 30, 1998. responsible for planning and individuals and their families; and In the fiscal year 1999 appropriations administering programs that promote • It is in the nation’s interest for bill funds were provided for this the self-sufficiency and protect the people with developmental disabilities program for one year. It allows for the rights of persons with developmental to be employed, and to live award of competitive, statewide systems disabilities. conventional and independent lives as a The Developmental Disabilities change grants to conduct training and part of families and communities. technical assistance and other national Assistance and Bill of Rights Act (42 Toward these ends, ADD seeks: to U.S.C. 6000, et seq.) (the Act) supports activities designed to address the enhance the capabilities of families in problems which impede the self- and provides assistance to States and assisting people with developmental public and private nonprofit agencies sufficiency of families of children with disabilities to achieve their maximum disabilities. and organizations to assure that potential; to support the increasing individuals with developmental ability of people with developmental Part III. The Review Process disabilities and their families participate disabilities to exercise greater choice A. Eligible Applicants in the design of and have access to and self-determination; to engage in culturally competent services, supports, leadership activities in their Before applications under this and other assistance and opportunities communities; as well as to ensure the Announcement are reviewed, each will that promote independence, protection of their legal and human be screened to determine that the productivity, integration and inclusion rights. applicant is eligible for funding as into the community. The four programs funded under the specified under the selected priority In the Act, Congress expressly found Act are: area. Applications from organizations that: • • Federal assistance to State that do not meet the eligibility Disability is a natural part of the developmental disabilities councils; requirements for the priority area will human experience that does not • State system for the protection and not be considered or reviewed in the diminish the right of individuals with advocacy of individuals rights; competition, and the applicant will be developmental disabilities to enjoy the • Grants to University Affiliated so informed. opportunity for independence, Programs for interdisciplinary training, Only public or non-profit private productivity, integration and inclusion exemplary services, technical into the community; entities, not individuals, are eligible to • assistance, and information apply under any of the priority areas. Individuals whose disabilities occur dissemination; and during their developmental period • All applications developed jointly by Grants for Projects of National more than one agency or organization frequently have severe disabilities that Significance. are likely to continue indefinitely; must identify only one organization as • Individuals with developmental C. Statutory Authorities Covered Under the lead organization and official disabilities often require lifelong This Announcement applicant. The other participating agencies and organizations can be specialized services and assistance, The Developmental Disabilities included as co-participants, subgrantees provided in a coordinated and Assistance and Bill of Rights Act of or subcontractors. culturally competent manner by many 1996, 42 U.S.C. 6000, et.seq. The agencies, professionals, advocates, Projects of National Significance is Part Nonprofit organizations must submit community representatives, and others E of the Developmental Disabilities proof of nonprofit status in their to eliminate barriers and to meet the Assistance and Bill of Rights Act of applications at the time of submission. needs of such individuals and their 1996, 42 U.S.C. 6081, et.seq. The One means of accomplishing this is by families; Omnibus Appropriations Bill, FY ‘99, providing a copy of the applicant’s The Act further established as the P.L. 105–277, 31 U.S.C. 1553(b). listing in the Internal Revenue Service’s policy of the United States: • most recent list of tax-exempt Individuals with developmental Part II. Background Information For organizations described in section 501 disabilities, including those with the Applicants (c) (3) of the IRS code or by providing most severe developmental disabilities, A. Description of Family Support a copy of the currently valid IRS tax are capable of achieving independence, Program exemption certificate, or by providing a productivity, integration and inclusion copy of the articles of incorporation into the community, and often require The Individuals with Disabilities bearing the seal of the State in which the provision of services, supports and Education Act (20 U.S.C. 1400 et. seq.) the corporation or association is other assistance to achieve such; was amended in 1994 by adding at the domiciled. • Individuals with developmental end the ‘‘Families of Children With disabilities have competencies, Disabilities Support Act of 1994’’. The ADD cannot fund a nonprofit capabilities and personal goals that purpose of this new family support applicant without acceptable proof of its should be recognized, supported, and program was for states to create or nonprofit status. encouraged, and any assistance to such expand statewide systems change. Under this priority area proof of individuals should be provided in an Although authorization levels were designation as lead agency by the individualized manner, consistent with provided, funds were never governor/CEO must be provided.

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B. Review Process and Funding (primarily experts from outside the • Project Duration: This section Decisions Federal government) will review the specifies the maximum allowable length Timely applications under this applications. To facilitate this review, of the project period; it refers to the Announcement from eligible applicants applicants should ensure that they amount of time for which Federal received by the deadline date will be address each minimum requirement in funding is available. • reviewed and scored competitively. the priority area description under the Federal Share of Project Costs: This Experts in the field, generally persons appropriate section of the Program section specifies the maximum amount from outside of the Federal government, Narrative Statement. of Federal support for the project. will use the appropriate evaluation Reviewers will determine the • Matching Requirement: This section criteria listed later in this Part to review strengths and weaknesses of each specifies the minimum non-Federal and score the applications. The results application in terms of the evaluation contribution, either cash or in-kind of this review are a primary factor in criteria listed below, provide comments, match, required. making funding decisions. and assign numerical scores. The point • Anticipated Number of Projects To ADD reserves the option of discussing value following each criterion heading Be Funded: This section specifies the applications with, or referring them to, indicates the maximum numerical number of projects ADD anticipates other Federal or non-Federal funding weight that each section may be given funding under the priority area. sources when this is determined to be in the review process. • CFDA: This section identifies the in the best interest of the Federal D. Structure of Priority Area Catalog of Federal Domestic Assistance government or the applicant. It may also Descriptions (CFDA) number and title of the program solicit comments from ADD Regional under which applications in this Office staff, other Federal agencies, The priority area description is priority area will be funded. This interested foundations, national composed of the following sections: information is needed to complete item organizations, specialists, experts, States • Eligible Applicants: This section 10 on the SF 424. and the general public. ADD will specifies the type of organization that is Please note that applications under consider these comments, along with eligible to apply under the particular this Announcement that do not comply those of the expert reviewers, in making priority area. Specific restrictions are with the specific priority area funding decisions. also noted, where applicable. requirements in the section on ‘‘Eligible In making decisions on awards, ADD • Purpose: This section presents the Applicants’’ will not be reviewed. will consider whether applications basic focus and/or broad goal(s) of the Applicants under this Announcement focus on or feature: services to priority area. must clearly identify the specific culturally diverse or ethnic populations • Background Information: This priority area under which they wish to among others; a substantially innovative section briefly discusses the legislative have their applications considered, and strategy with the potential to improve background as well as the current state- tailor their applications accordingly. theory or practice in the field of human of-the-art and/or current state-of- Experience has shown that an services; a model practice or set of practice that supports the need for the application which is broader and more procedures that holds the potential for particular priority area activity. general in concept than outlined in the replication by organizations Relevant information on projects priority area description is less likely to administering or delivering of human previously funded by ACF and/or other score as well as an application more services; substantial involvement of State models are noted, where clearly focused on, and directly volunteers; substantial involvement applicable. responsive to, the concerns of that (either financial or programmatic) of the • Evaluation Criteria: This section specific priority area. private sector; a favorable balance presents the basic set of issues that must E. Available Funds between Federal and non-Federal funds be addressed in the application. available for the proposed project; the Typically, they relate to need for ADD intends to award new grants potential for high benefit for low assistance, results expected, project resulting from this announcement Federal investment; a programmatic design, and organizational and staff during the fourth quarter of fiscal year focus on those most in need; and/or capabilities. Inclusion and discussion of 1999, subject to the availability of substantial involvement in the proposed these items is important since the funding. The size of the awards will project by national or community information provided will be used by vary. Each priority area description foundations. the reviewers in evaluating the includes information on the maximum This year, 5 points will be awarded in application against the evaluation Federal share of the project costs and scoring for any project that includes the anticipated number of projects to be partnership and collaboration with the criteria. • funded. 112 Empowerment Zones/Enterprise Minimum Requirements for Project Communities. Design: This section presents the basic The term ‘‘budget period’’ refers to the To the greatest extent possible, efforts set of issues that must be addressed in interval of time (usually 12 months) into will be made to ensure that funding the application. Typically, they relate to which a multi-year period of assistance decisions reflect an equitable project design, evaluation, and (project period) is divided for budgetary distribution of assistance among the community involvement. This section and funding purposes. The term States and geographical regions of the also asks for specific information on the ‘‘project period’’ refers to the total time country, rural and urban areas, and proposed project. Inclusion and a project is approved for support, ethnic populations. In making these discussion of these items is important including any extensions. decisions, ADD may also take into since they will be used by the reviewers Where appropriate, applicants may account the need to avoid unnecessary to evaluate the applications against the propose shorter project periods than the duplication of effort. evaluation criteria. Project products, maximums specified in the various continuation of the project after Federal priority areas. Non-Federal share C. Evaluation Process support ceases, and dissemination/ contributions may exceed the Using the evaluation criteria below, a utilization activities, if appropriate, are minimums specified in the various panel of at least three reviewers also addressed. priority areas.

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For multi-year projects, continued prepare the project description ‘‘collection of information’’ that is Federal funding beyond the first budget statement in accordance with the ‘‘conducted or sponsored’’ by ACF. List period, but within the approved project following instructions. organizations, cooperating entities, period, is subject to the availability of 2. Project summary/abstract: Provide a consultants, or other key individuals funds, satisfactory progress of the summary of the project description (a who will work on the project along with grantee and a determination that page or less) with reference to the a short description of the nature of their continued funding would be in the best funding request. effort or contribution. interest of the Government. 3. Objectives and need for assistance: 6. Organization Profile: Provide Clearly identify the physical, economic, information on the applicant F. Grantee Share of Project Costs social, financial, institutional, and/or organization(s) and cooperating partners Grantees must match $1 for every $3 other problem(s) requiring a solution. such as organizational charts, financial requested in Federal funding to reach The need for assistance must be statements, audit reports or statements 25% of the total approved cost of the demonstrated and the principal and from CPAs/Licensed Public project. The total approved cost of the subordinate objectives of the project Accountants, Employer Identification project is the sum of the ACF share and must be clearly stated; supporting Numbers, names of bond carriers, the non-Federal share. Cash or in-kind documentation, such as letters of contact persons and telephone numbers, contributions may meet the non-Federal support and testimonials from child care licenses and other share, although applicants are concerned interests other than the documentation of professional encouraged to meet their match applicant, may be included. Any accreditation, information on requirements through cash relevant data based on planning studies compliance with Federal/State/local contributions. Therefore, a project should be included or referred to in the government standards, documentation requesting $100,000 in Federal funds endnotes/footnotes. Incorporate of experience in the program area, and (based on an award of $100,000 per demographic data and participant/ other pertinent information. budget period) must include a match of beneficiary information, as needed. In Any non-profit organization at least $33,333 (total project cost is developing the project description, the submitting an application must submit $133,333, of which $33,333 is 25%). applicant may volunteer or be requested proof of its non-profit status in its An exception to the grantee cost- to provide information on the total application at the time of submission. sharing requirement relates to range of projects currently being The non-profit agency can accomplish applications originating from American conducted and supported (or to be this by providing a copy of the Samoa, Guam, the Virgin Islands, and initiated), some of which may be applicant’s listing in the Internal the Commonwealth of the Northern outside the scope of the program Revenue Service’s (IRS) most recent list Mariana Islands. Applications from announcement. of tax-exempt organizations described in these areas are covered under Section 4. Results or benefits expected: Section 501(c)(3) of the IRS code, or by 501(d) of P. L. 95–134, which requires Identify the results and benefits to be providing a copy of the currently valid that the Department waive ‘‘any derived. For example, when applying IRS tax exemption certificate, or by requirement for local matching funds for for a grant to establish a neighborhood providing a copy of the articles of grants under $200,000.’’ child care center, describe who will incorporation bearing the seal of the The applicant contribution must occupy the facility, who will use the State in which the corporation or generally be secured from non-Federal facility, how the facility will be used, association is domiciled. sources. Except as provided by Federal and how the facility will benefit the statute, a cost sharing or matching community which it will serve. H. Cooperation in Evaluation Efforts requirement may not be met by costs 5. Approach: Outline a plan of action Grantees funded by ADD may be borne by another Federal grant. which describes the scope and detail of requested to cooperate in evaluation However, funds from some Federal how the proposed work will be efforts funded by ADD. The purpose of programs benefiting Tribes and Native accomplished. Account for all functions these evaluation activities is to learn American organizations have been used or activities identified in the from the combined experience of to provide valid sources of matching application. Cite factors which might multiple projects funded under a funds. If this is the case for a Tribe or accelerate or decelerate the work and particular priority area. Native American organization state your reason for taking the submitting an application to ADD, that proposed approach rather than others. I. Closed Captioning for Audiovisual organization should identify the Describe any unusual features of the Efforts programs which will be providing the project such as design or technological Applicants should include ‘‘closed funds for the match in its application. innovations, reductions in cost or time, captioning’’ in the development of any If the application successfully competes or extraordinary social and community audiovisual products. for PNS grant funds, ADD will involvement. Part IV. Fiscal Year 1999 Families of determine whether there is statutory Provide quantitative monthly or Children With Disabilities Support authority for this use of the funds. The quarterly projections of the Projects—Description and Administration for Native Americans accomplishments to be achieved for Requirements and the DHHS Office of General Counsel each function or activity. When will assist ADD in making this accomplishments cannot be quantified The following section presents the determination. by activity or function, list them in final announcement for the area of chronological order to show the family support for Fiscal Year 1999 and G. General Instructions for the Uniform schedule of accomplishments and their solicits the appropriate applications. Project Description target dates. • Eligible Applicants: A State entity The following ACF Uniform Project Identify the kinds of data to be or office designated by the chief Description (UPD) has been approved collected, maintained, and/or executive officer of the state as the lead under OMB Control Number 0970–0139. disseminated. Note that clearance from agency for this project. 1. Introduction: Applicants required the U.S. Office of Management and • Purpose: Project funds are to be to submit a full project description shall Budget might be needed prior to a utilized to support systems change

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13216 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices activities designed to assist each State to within ‘‘family support’’—cash subsidy and who are youth with disabilities develop and implement, or expand and payments, respite care, family (ages 18–21); enhance, a family-centered and family- counseling, architectural adaptation of • Training and technical assistance directed, culturally competent, the home, in-home counseling, sibling for family members, service providers, community-centered, comprehensive, support programs, education and community members, professionals, statewide system of family support for behavior management services and the members of the Policy Council, state families of children with disabilities purchase of specialized equipment. agency staff, students and others; designed to— Family support is a growing • Interagency coordination of Federal (1) Ensure the full participation, expenditure in state budgets; in 1996 it and State policies, resources, and choice and control of families of constituted 2.3% of total MR/DD services; interagency workgroups to children with disabilities in decisions resources, compared to 1.6% in 1992. enhance public funding options and related to the provision of such family The number of families supported is coordination; and other interagency support for their family; also growing, from 174,441 in 1992 to activities that promote coordination; (2) Ensure the active involvement of 280,535 in 1996. • Outreach to locate families who are families of children with disabilities in The Federal government’s eligible for family support and to the planning, development, involvement in family support began in identify groups who are underserved or implementation, and evaluation of such 1982 with what is known as the ‘‘Katie unserved; a statewide system; Beckett Waiver’’, an option under • Policy studies that relate to the (3) Increase the availability of, Medicaid which allows a state to waive development and implementation, or funding for, access to, and provision of the deeming of parental income and expansion and enhancement, of a family support for families of children resources for any child eighteen years of statewide system of family support for with disabilities; age and under who is eligible for families of children with disabilities; (4) Promote training activities that are placement in a Medicaid certified long • Hearings and forums to solicit input family-centered and family-directed and term care institution or hospital, ICF/ from families of children with that enhance the ability of family MR or nursing home. This waiver disabilities regarding family support members of children with disabilities to allows parents access to an array of programs, policies, and plans for such increase participation, choice, and family, home and community supports. families; control in the provision of family A majority of states have not exercised • Public awareness and education to support for families of children with this option. families of children with disabilities, disabilities; Federal disability policy in the 1980s parent groups and organizations, public (5) Increase and promote interagency increasingly began to reflect the and private agencies, students, coordination among State agencies, and principles of family-centered, policymakers, and the general public; between State agencies and private community-based, coordinated care as • Needs assessment; entities that are involved in these Federal programs were established or • Data collection and analysis related projects; and reauthorized. The Temporary Respite to the statewide system of family (6) Increase the awareness of laws, Care and Crisis Nurseries Act of 1986 support for families of children with regulations, policies, practices, funded a variety of in-home and out-of- disabilities; procedures, and organizational home respite programs; a new Part H for • Implementation plans to utilize structures, which facilitate or impede infants, toddlers, and their families was generic community service the availability or provision of family added in 1986 to the then Education of organizations in innovative partnerships support for families of children with the Handicapped Act; the to include families of children with disabilities. reauthorization of the Maternal and disabilities; • Background Information: The Child Health Care Block grant in 1989 • Pilot demonstration projects to concept of family support for families emphasized these principles in it’s demonstrate new approaches to the with a child with a disability is a Children with Special Health Care provision of family support for families relatively new phenomenon in Needs program; and in the of children with disabilities; disability policy. Historically, the only Developmental Disabilities Assistance • Evaluation system using measurable means of receiving publicly funded and Bill of Rights Act a definition of outcomes based on family satisfaction services for a child with a severe family support services was added in indicators such as the extent to which disability was by placing the child in a 1990. a service or support meets a need, solves state institution. With a shift in thinking • Minimum Requirements for Project a problem, or adds value for a family, in the early 1980s to a more family- Design: ADD is interested in awarding as determined by the individual family. centered approach to service provision grant funds that will maximize ADD is particularly interested in many states initiated family support opportunities for systems change applications that incorporate into these legislation. This legislation was often through the collaboration with and activities one or more of the following the result of initiatives developed by the strengthening of generic community populations relevant to their state: (1) state developmental disabilities action service organizations in order to Unserved and underserved populations councils. Currently, all the states plus ensure the provision of family support which includes populations such as the District of Columbia offer some type to families of children with disabilities. individuals from racial and ethnic of family support program; this has Activities should contain the following minority backgrounds, economically consisted of any community-based key components: disadvantaged individuals, individuals service administered or financed by the • Establish a state policy council of with limited-English proficiency, and state MR/DD agency providing for families of children with disabilities or individuals from underserved vouchers, direct cash payments to utilize an existing council which will geographic areas (rural or urban); (2) families, reimbursement, or direct advise and assist the lead entity in the aging families of adult children with payments to service providers which the performance of activities of this disabilities who are over age 21 with a state agency itself identified as family application and be composed of a focus on assisting those families and support. A review of these programs majority of members who are family their adult child to be included as self- reveals the range of services that fall members of children with disabilities determining members of their

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13217 communities; (3) foster/adoptive included under each of these headings possibility of additional project periods. families of children with disabilities; (4) is described in Section G of Part III, Awards, on a competitive basis, can be families participating in the state’s General Instructions for the Uniform up to a seventeen-month budget period Temporary Assistance to Needy Project Description. Additional although project periods may be for a Families Program (TANF) , welfare-to- information that should be included is longer period. Applications for work, and/or SSI program; (5) veterans described below. continuation grants funded under this with families having a child with a Criterion 1: Objectives and Need for announcement beyond the budget disability; (6) parents with disabilities, Assistance (20 points) period, but within a project period, will especially with cognitive disabilities, The application must identify the be entertained in subsequent years on a having children with or without precise location of the project and area non-competitive basis, subject to the disabilities; and (7) families of children to be served by the proposed project. availability of funds, satisfactory with behavioral/emotional issues Maps and other graphic aids should be progress of the grantee, and a As a general guide, ADD will expect attached determination that continued funding to fund only those proposals for projects Criterion 2: Results or Benefits would be in the best interest of the that incorporate the following elements: Expected (20 points) The extent to Government. • Consumer/self-advocate orientation which they are consistent with the • Federal Share of Project Costs: The and participation. objectives of the application, and the maximum Federal share is not to exceed • Key project personnel with direct extent to which the application $200,000 for a state and not to exceed life experience with living with a indicates the anticipated contributions $100,000 for a territory for the first disability. to policy, practice, theory and/or budget period or a minimum of • Strong advisory components that research. The extent to which the $600,000 for a state and $300,000 for a consist of a majority of individuals with proposed project costs is reasonable in territory for the entire project period. disabilities and a structure where view of the expected results. There is a possibility of increased individuals with disabilities make real Criterion 3: Approach (35 points) funding in year two and three decisions that determine the outcome of Discuss the criteria to be used to contingent on additional funds. the grant. evaluate the results, and explain the • Matching Requirement: Grantees • Research reflects the principles of methodology that will be used to must match $1 for every $3 requested in participatory action. determine if the needs identified and Federal funding to reach 25% of the • Cultural competency. discussed are being met and if the total approved cost of the project. The • A description of how individuals results and benefits identified are being total approved cost of the project is the with disabilities and their families will achieved. sum of the ACF share and the non- be involved in all aspects of the design, Criterion 4: Organization Profile (25 Federal share. Cash or in-kind implementation, and evaluation of the points) contributions may meet the non-Federal project. The application identifies the share, although applicants are • Attention to unserved and background of the project director/ encouraged to meet their match inadequately served individuals, having principal investigator and key project requirements through cash a range of disabilities from mild to staff (including name, address, training, contributions. Therefore, a project severe, from multicultural backgrounds, educational background and other requesting $200,000 in Federal funds rural and inner-city areas, migrant, qualifying experience) and the (based on an award of $200,000 per homeless, and refugee families, with experience of the organization to budget period) must include a match of severe disabilities. demonstrate the applicant’s ability to at least $66,666 (the total project cost is • Compliance with the Americans effectively and efficiently administer $266,666, of which $66,666 is 25%). with Disabilities Act and Section 504 of this project. The application describes • Anticipated Number of Projects to the Rehabilitation Act of 1973 as the relationship between this project be Funded: It is anticipated that up to amended by the Rehabilitation Act and other work planned, anticipated or seventeen (17) projects will be funded. amendments of 1998 (P.L. 105–220). under way by the applicant which is Subject to availability of additional • Collaboration through partnerships being supported by Federal assistance. resources in FY 2000 and the number of and coalitions. This section should consist of a brief acceptable applications received as a • Development of the capacity to (two to three pages) background result of this program announcement, communicate and disseminate description of how the applicant the ADD Commissioner may elect to information and technical assistance organization (or the unit within the select recipients for the FY 2000 cohort through e-mail and other effective, organization that will have of programs out of the pool of affordable, and accessible forms of responsibility for the project) is applications submitted for FY 1999 electronic communication. organized, the types and quantity of funds. Applications should also include services it provides, and/or the research • CFDA: ADD’s CFDA (Code of provisions for the travel of a key staff and management capabilities it Federal Domestic Assistance) number is person during the first and last years of possesses. It may include descriptions 93.631—Developmental Disabilities— the project to Washington, DC for a one- of any current or previous relevant Projects of National Significance. This day meeting with ADD staff. experience, or describe the competence information is needed to complete item • Evaluation Criteria: The four of the project team and its demonstrated 10 on the SF 424. criteria that follow will be used to ability to produce a final product that is review and evaluate each application readily comprehensible and usable. An Part V. Instructions for the under this announcement. Each of these organization chart showing the Development and Submission of criterion should be addressed in the relationship of the project to the current Applications project description section of the organization should be included. This Part contains information and application. The point values indicate • Project Duration: This instructions for submitting applications the maximum numerical weight each announcement is soliciting applications in response to this announcement. criterion will be accorded in the review for a project period up to seventeen (17) Application forms and package along process. The specific information to be months under this area with the with a checklist and other materials can

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13218 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices be obtained by any of the following to comment on proposed new or are considered late applications. ACF/ methods: Pat Laird, ADD, 370 L’Enfant competing continuation awards. ADD shall notify each late applicant Promenade SW, Washington, DC, 20447, However, there is insufficient time to that its application will not be 202/690–7447; http:// www. acf. dhhs. allow for a complete SPOC comment considered in the current competition. gov/programs/add; [email protected]. period. Therefore, we have reduced the Extension of deadlines: ACF may Please copy and use these forms in comment period to 30 days from the extend the deadline for all applicants submitting an application. closing date for applications. These due to acts of God, such as floods, Potential applicants should read this comments are reviewed as part of the hurricanes, or earthquakes; or when section carefully in conjunction with award process. Failure to notify the there is a widespread disruption of the the information contained within the SPOC can result in delays in awarding mails. However, if the granting agency specific priority area under which the grants. does not extend the deadline for all application is to be submitted. The SPOCs are encouraged to eliminate applicants, it may not waive or extend priority area description is in Part IV. the submission of routine endorsements the deadline for any applicants. as official recommendations. A. Required Notification of the State D. Instructions for Preparing the Single Point of Contact (SPOC) Additionally, SPOCs are requested to clearly differentiate between mere Application and Completing All applications under the ADD advisory comments and those Official Application Forms priority areas are required to follow the State process recommendations that The SF 424, SF 424A, SF 424A-Page Executive Order (E.O.) 12372 process, may trigger the ‘‘accommodate or 2 and Certifications/ Assurances are ‘‘Intergovernmental Review of Federal explain’’ rule. contained in the application package Programs,’’ and 45 CFR Part 100, When comments are submitted that can be accessed as mentioned ‘‘Intergovernmental Review of directly to ACF, they should be earlier in this announcement. Please Department of Health and Human addressed to: Department of Health and prepare your application in accordance Services Program and Activities.’’ Under Human Services, Administration for with the following instructions: the Order, States may design their own Children and Families, Division of processes for reviewing and Discretionary Grants and Audit 1. SF 424 Page 1, Application Cover commenting on proposed Federal Resolution, 370 L’Enfant Promenade, Sheet assistance under covered programs. SW, Mail Stop 6C–462, Washington, DC Please read the following instructions Note: State/territory participation in the 20447, Attn: 93.631 ADD—Projects of before completing the application cover intergovernmental review process does not National Significance. sheet. An explanation of each item is signify applicant eligibility for financial Contact information for each State’s included. Complete only the items assistance under a program. A potential SPOC is found in the application specified. applicant must meet the eligibility package. requirements of the program for which it is Top of Page. Enter the single priority applying prior to submitting an application B. Notification of State Developmental area number under which the to its SPOC, if applicable, or to ACF. Disabilities Planning Councils application is being submitted. An As of November 20, 1998, all States application should be submitted under A copy of the application must also be only one priority area. and territories, except Alabama, Alaska, submitted for review and comment to American Samoa, Colorado, Item 1. ‘‘Type of Submission’’— the State Developmental Disabilities Preprinted on the form. Connecticut, Hawaii, Idaho, Kansas, Council in each State in which the Item 2. ‘‘Date Submitted’’ and Louisiana, Massachusetts, Minnesota, applicant’s project will be conducted. A ‘‘Applicant Identifier’’—Date Montana, Nebraska, New Jersey, Ohio, list of the State Developmental application is submitted to ACF and Oklahoma, Oregon, Palau, Disabilities Councils is included in the applicant’s own internal control Pennsylvania, South Dakota, Tennessee, application package. Vermont, Virginia, and Washington, number, if applicable. have elected to participate in the C. Deadline for Submittal of Item 3. ‘‘Date Received By State’’— Executive Order process and have Applications State use only (if applicable). established a State Single Point of One signed original and two copies of Item 4. ‘‘Date Received by Federal Contact (SPOC). Applicants from these the application must be submitted on or Agency’’—Leave blank. jurisdictions or for projects before May 17, 1999 to: U.S. Department Item 5. ‘‘Applicant Information’’. administered by Federally recognized of Health and Human Services, ‘‘Legal Name’’—Enter the legal name Indian Tribes need take no action Administration for Children and of applicant organization. For regarding E.O. 12372. Otherwise, Families, Administration on applications developed jointly, enter the applicants should contact their SPOCs Developmental Disabilities, 370 name of the lead organization only. as soon as possible to alert them of the L’Enfant Promenade, SW, Mail Stop 6C– There must be a single applicant for prospective applications and receive 462, Washington, DC 20447, Attn: Lois each application. any necessary instructions. Hodge. ‘‘Organizational Unit’’—Enter the Applicants must submit all required Applications may be mailed or hand- name of the primary unit within the materials to the SPOC as soon as delivered. Hand-delivered applications applicant organization which will possible so that the program office can are accepted during the normal working actually carry out the project activity. obtain and review SPOC comments as hours of 8:00 a.m. to 4:30 p.m., Monday Do not use the name of an individual as part of the award process. It is through Friday. Applications shall be the applicant. If this is the same as the imperative that the applicant submit all considered as meeting an announced applicant organization, leave the required materials and indicate the date deadline if received by the deadline organizational unit blank. of this submittal (or date SPOC was date at the ACF Grants Office (Close of ‘‘Address’’—Enter the complete contacted, if no submittal is required) Business: 4:30 p.m., local prevailing address that the organization actually on the SF 424, item 16a. time). uses to receive mail, since this is the Under 45 CFR 100.8(a)(2), a SPOC has Late applications: Applications that address to which all correspondence 60 days from the application due date do not meet the criterion stated above will be sent. Do not include both street

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13219 address and P.O. box number unless Item 15a. Enter the amount of Federal Item 18a-c. ‘‘Typed Name of both must be used in mailing. funds requested in accordance with the Authorized Representative, Title, ‘‘Name and telephone number of the preceding paragraph. This amount Telephone Number’’—Enter the name, person to be contacted on matters should be no greater than the maximum title and telephone number of the involving this application (give area amount specified in the priority area authorized representative of the code)’’—Enter the full name (including description. applicant organization. academic degree, if applicable) and Items 15b-e. Enter the amount(s) of Item 18d. ‘‘Signature of Authorized telephone number of a person who can funds from non-Federal sources that Representative’’ —Signature of the respond to questions about the will be contributed to the proposed authorized representative named in Item application. This person should be project. Items b-e are considered cost 18a. At least one copy of the application accessible at the address given here and sharing or ‘‘matching funds.’’ The value must have an original signature. Use will receive all correspondence of third party in-kind contributions colored ink (not black) so that the regarding the application. should be included on appropriate lines original signature is easily identified. Item 6. ‘‘Employer Identification as applicable. For more information Item 18e. ‘‘Date Signed’’—Enter the Number (EIN)’’—Enter the employer regarding funding as well as exceptions date the application was signed by the identification number of the applicant to these rules, see Part III, Sections E authorized representative. organization, as assigned by the Internal and F, and the specific priority area 2. SF 424A—Budget Information—Non- Revenue Service, including, if known, description. Construction Programs the Central Registry System suffix. Item 15f. Enter the estimated amount Item 7. ‘‘Type of Applicant’’—Self- of program income, if any, expected to This is a form used by many Federal explanatory. be generated from the proposed project. agencies. For this application, Sections A, B, C, E and F are to be completed. Item 8. ‘‘Type of Application’’— Do not add or subtract this amount from Section D does not need to be Preprinted on the form. the total project amount entered under item 15g. Describe the nature, source completed. Item 9. ‘‘Name of Federal Agency’’— Sections A and B should include the and anticipated use of this program Preprinted on the form. Federal as well as the non-Federal income in the Project Narrative Item 10. ‘‘Catalog of Federal Domestic funding for the proposed project Statement. Assistance Number and Title’’—Enter covering (1) the total project period of Item 15g. Enter the sum of items 15a– the Catalog of Federal Domestic 17 months or less or (2) the first year 15e. Assistance (CFDA) number assigned to budget period, if the proposed project Item 16a. ‘‘Is Application Subject to the program under which assistance is period exceeds 15 months. requested and its title. For all of ADD’s Review By State Executive Order 12372 Section A—Budget Summary. This priority areas, the following should be Process? Yes.’’—Enter the date the section includes a summary of the entered, ‘‘93.631—Developmental applicant contacted the SPOC regarding budget. On line 5, enter total Federal Disabilities: Projects of National this application. Select the appropriate costs in column (e) and total non- Significance.’’ SPOC from the listing provided at the Federal costs, including third party in- Item 11. ‘‘Descriptive Title of end of Part IV. The review of the kind contributions, but not program Applicant’s Project’’—Enter the project application is at the discretion of the income, in column (f). Enter the total of title. The title is generally short and is SPOC. The SPOC will verify the date (e) and (f) in column (g). descriptive of the project, not the noted on the application. Section B—Budget Categories. This priority area title. Item 16b. ‘‘Is Application Subject to budget, which includes the Federal as Item 12. ‘‘Areas Affected by Review By State Executive Order 12372 well as non-Federal funding for the Project’’—Enter the governmental unit Process? No.’’—Check the appropriate proposed project, covers (1) the total where significant and meaningful box if the application is not covered by project period of 17 months or less or impact could be observed. List only the E.O. 12372 or if the program has not (2) the first-year budget period if the largest unit or units affected, such as been selected by the State for review. proposed project period exceeds 17 State, county, or city. If an entire unit Item 17. ‘‘Is the Applicant Delinquent months. It should relate to item 15g, is affected, list it rather than subunits. on any Federal Debt?’’—Check the total funding, on the SF 424. Under Item 13. ‘‘Proposed Project’’—Enter appropriate box. This question applies column (5), enter the total requirements the desired start date for the project and to the applicant organization, not the for funds (Federal and non-Federal) by projected completion date. person who signs as the authorized object class category. Item 14. ‘‘Congressional District of representative. Categories of debt A separate budget justification should Applicant/Project’’—Enter the number include audit disallowances, loans and be included to explain fully and justify of the Congressional district where the taxes. major items, as indicated below. The applicant’s principal office is located Item 18. ‘‘To the best of my types of information to be included in and the number of the Congressional knowledge and belief, all data in this the justification are indicated under district(s) where the project will be application/preapplication are true and each category. For multiple year located. If Statewide, a multi-State correct. The document has been duly projects, it is desirable to provide this effort, or nationwide, enter ‘‘00.’’ authorized by the governing body of the information for each year of the project. applicant and the applicant will comply Items 15. Estimated Funding Levels The budget justification should with the attached assurances if the immediately follow the second page of In completing 15a through 15f, the assistance is awarded.’’—To be signed the SF 424A. dollar amounts entered should reflect, by the authorized representative of the Personnel—Line 6a. Enter the total for a 17-month or less project period, applicant. A copy of the governing costs of salaries and wages of applicant/ the total amount requested. If the body’s authorization for signature of this grantee staff. Do not include the costs of proposed project period exceeds 17 application by this individual as the consultants, which should be included months, enter only those dollar amounts official representative must be on file in on line 6h, ‘‘Other.’’ needed for the first 12 months of the the applicant’s office, and may be Justification: Identify the principal proposed project. requested from the applicant. investigator or project director, if

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13220 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices known. Specify by title or name the contracts, and the estimated dollar For training grant applications, the percentage of time allocated to the amounts of the awards as part of the entry under line 6j should be the total project, the individual annual salaries, budget justification. Whenever the indirect costs being charged to the and the cost to the project (both Federal applicant/grantee intends to delegate project. The Federal share of indirect and non-Federal) of the organization’s part or the entire program to another costs is calculated as shown above. The staff who will be working on the project. agency, the applicant/grantee must applicant’s share is calculated as Fringe Benefits—Line 6b. Enter the complete this section (Section B, Budget follows: total costs of fringe benefits, unless Categories) for each delegate agency by (a) Calculate total project indirect treated as part of an approved indirect agency title, along with the supporting costs (a*) by applying the applicant’s cost rate. information. The total cost of all such approved indirect cost rate to the total Justification: Provide a break-down of agencies will be part of the amount project (Federal and non-Federal) direct amounts and percentages that comprise shown on Line 6f. Provide backup costs. fringe benefit costs, such as health documentation identifying the name of (b) Calculate the Federal share of insurance, FICA, retirement insurance, contractor, purpose of contract, and indirect costs (b*) at 8 percent of the etc. major cost elements. amount allowed for total project Travel—6c. Enter total costs of out-of- Construction—Line 6g. Not (Federal and non-Federal) direct costs town travel (travel requiring per diem) applicable. New construction is not exclusive of any equipment charges, for staff of the project. Do not enter costs allowable. rental of space, tuition and fees, post- for consultant’s travel or local Other—Line 6h. Enter the total of all doctoral training allowances, transportation, which should be other costs. Where applicable, such contractual items, and alterations and included on Line 6h, ‘‘Other.’’ costs may include, but are not limited renovations. Justification: Include the name(s) of to: insurance; medical and dental costs; (c) Subtract (b*) from (a*). The traveler(s), total number of trips, noncontractual fees and travel paid remainder is what the applicant can destinations, length of stay, directly to individual consultants; local claim as part of its matching cost transportation costs and subsistence transportation (all travel which does not contribution. allowances. require per diem is considered local Justification: Enclose a copy of the Equipment—Line 6d. Enter the total travel); space and equipment rentals; indirect cost rate agreement. Applicants costs of all equipment to be acquired by printing and publication; computer use; subject to the limitation on the Federal the project. For State and local training costs, including tuition and reimbursement of indirect costs for governments, including Federally stipends; training service costs, training grants should specify this. recognized Indian Tribes, ‘‘equipment’’ including wage payments to individuals Total—Line 6k. Enter the total is tangible, non-expendable personal and supportive service payments; and amounts of lines 6i and 6j. property having a useful life of more staff development costs. Note that costs Program Income—Line 7. Enter the than one year and acquisition cost of identified as ‘‘miscellaneous’’ and estimated amount of income, if any, $5,000 or more per unit. ‘‘honoraria’’ are not allowable. expected to be generated from this Justification: Equipment to be Justification: Specify the costs project. Do not add or subtract this purchased with Federal funds must be included. amount from the total project amount. justified. The equipment must be Total Direct Charges—Line 6i. Enter Justification: Describe the nature, required to conduct the project, and the the total of Lines 6a through 6h. source, and anticipated use of program applicant organization or its subgrantees Indirect Charges—6j. Enter the total income in the Program Narrative must not have the equipment or a amount of indirect charges (costs). If no Statement. reasonable facsimile available to the indirect costs are requested, enter Section C—Non-Federal Resources. project. The justification also must ‘‘none.’’ Generally, this line should be This section summarizes the amounts of contain plans for future use or disposal used when the applicant (except local non-Federal resources that will be of the equipment after the project ends. governments) has a current indirect cost applied to the grant. Enter this Supplies—Line 6e. Enter the total rate agreement approved by the information on line 12 entitled ‘‘Totals.’’ costs of all tangible expendable personal Department of Health and Human In-kind contributions are defined in title property (supplies) other than those Services or another Federal agency. 45 of the Code of Federal Regulations, included on Line 6d. Local and State governments should Parts 74.51 and 92.24, as ‘‘property or Justification: Specify general enter the amount of indirect costs services which benefit a grant-supported categories of supplies and their costs. determined in accordance with HHS project or program and which are Contractual—Line 6f. Enter the total requirements. When an indirect cost contributed by non-Federal third parties costs of all contracts, including (1) rate is requested, these costs are without charge to the grantee, the procurement contracts (except those included in the indirect cost pool and subgrantee, or a cost-type contractor which belong on other lines such as should not be charged again as direct under the grant or subgrant.’’ equipment, supplies, etc.) and (2) costs to the grant. Justification: Describe third party in- contracts with secondary recipient In the case of training grants to other kind contributions, if included. organizations, including delegate than State or local governments (as Section D—Forecasted Cash Needs. agencies. Also include any contracts defined in title 45, Code of Federal Not applicable. with organizations for the provision of Regulations, part 74), the Federal Section E—Budget Estimate of Federal technical assistance. Do not include reimbursement of indirect costs will be Funds Needed For Balance of the payments to individuals on this line. If limited to the lesser of the negotiated (or Project. This section should only be the name of the contractor, scope of actual) indirect cost rate or 8 percent of completed if the total project period work, and estimated total costs are not the amount allowed for direct costs, exceeds 17 months. available or have not been negotiated, exclusive of any equipment charges, Totals—Line 20. For projects that will include on Line 6h, ‘‘Other.’’ rental of space, tuition and fees, post- have more than one budget period, enter Justification: Attach a list of doctoral training allowances, the estimated required Federal funds for contractors, indicating the names of the contractual items, and alterations and the second budget period (months 13 organizations, the purposes of the renovations. through 24) under column ‘‘(b) First.’’ If

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13221 a third budget period will be necessary, (b) Results and Benefits Expected; those individuals without familial enter the Federal funds needed for (c) Approach; and protection) who will receive services months 25 through 36 under ‘‘(c) (d) Organization Profile. under projects assisted under Part E will Second.’’ Columns (d) and (e) are not The specific information to be be protected consistent with section 110 applicable in most instances, since ACF included under each of these headings (relating to the rights of individuals funding is almost always limited to a is described in Section G of Part III, with developmental disabilities). Each three-year maximum project period. General Instructions for the Uniform application must include a statement They should remain blank. Project Description. providing this assurance. Section F—Other Budget Information. The narrative should be typed double- For research projects in which human ′′ Direct Charges—Line 21. Not spaced on a single-side of an 8 1/2 x subjects may be at risk, a Protection of ′′ ′′ applicable. 11 plain white paper, with 1 margins Human Subjects Assurance may be Indirect Charges—Line 22. Enter the on all sides, using black print no smaller required. If there is a question regarding type of indirect rate (provisional, than 12 pitch or 12 point size. All pages the applicability of this assurance, predetermined, final or fixed) that will of the narrative (including charts, contact the Office for Research Risks of be in effect during the funding period, references/footnotes, tables, maps, the National Institutes of Health at (301) the estimated amount of the base to exhibits, etc.) must be sequentially 496–7041. which the rate is applied, and the total numbered, beginning with ‘‘Objectives indirect expense. and Need for Assistance’’ as page E. Checklist for a Complete Application Remarks—Line 23. If the total project number one. Applicants should not The checklist below is for your use to period exceeds 17 months, you must submit reproductions of larger size ensure that your application package enter your proposed non-Federal share paper, reduced to meet the size has been properly prepared. of the project budget for each of the requirement. —One original, signed and dated remaining years of the project. The length of the application, application, plus two copies. including the application forms and all 3. Project Summary/Abstract Applications for different priority attachments, should not exceed 60 areas are packaged separately; Clearly mark this separate page with pages. This will be strictly enforced. A ′′ —Application is from an organization the applicant name as shown in item 5 page is a single side of an 8 1/2 x 11 that is eligible under the eligibility of the SF 424, the priority area number sheet of paper. Applicants are requested requirements defined in the priority as shown at the top of the SF 424, and not to send pamphlets, brochures or area description (screening the title of the project as shown in item other printed material along with their requirement); 11 of the SF 424. The summary application as these pose copying —Application length does not exceed 60 description should not exceed 300 difficulties. These materials, if pages, unless otherwise specified in words. These 300 words become part of submitted, will not be included in the the priority area description. review process if they exceed the 60- the computer database on each project. A complete application consists of the Care should be taken to produce a page limit. Each page of the application following items in this order: summary description that accurately will be counted to determine the total —Application for Federal Assistance and concisely reflects the proposal. It length. (SF 424, REV 4–88); should describe the objectives of the 5. Part V—Assurances/Certifications —A completed SPOC certification with project, the approaches to be used and Applicants are required to file a SF the date of SPOC contact entered in the outcomes expected. The description line 16, page 1 of the SF 424 if should also include a list of major 424B, Assurances—Non-Construction Programs and the Certification applicable. products that will result from the —Budget Information—Non- Regarding Lobbying. Both must be proposed project, such as software Construction Programs (SF 424A, REV signed and returned with the packages, materials, management 4–88); application. Applicants must also procedures, data collection instruments, —Budget justification for Section B— provide certifications regarding: (1) training packages, or videos (please note Budget Categories; that audiovisuals should be closed Drug-Free Workplace Requirements; and —Table of Contents; captioned). The project summary (2) Debarment and Other —Letter from the Internal Revenue description, together with the Responsibilities. These two Service, etc. to prove non-profit information on the SF 424, will certifications are self-explanatory. status, if necessary; constitute the project ‘‘abstract.’’ It is the Copies of these assurances/certifications —Copy of the applicant’s approved major source of information about the are reprinted at the end of this indirect cost rate agreement, if proposed project and is usually the first announcement and should be appropriate; part of the application that the reproduced, as necessary. A duly —Project Description (See Part III, reviewers read in evaluating the authorized representative of the Section C); application. applicant organization must certify that —Any appendices/attachments; the applicant is in compliance with —Assurances—Non-Construction 4. Project Description these assurances/certifications. A Programs (Standard Form 424B, REV The Project Description is a very signature on the SF 424 indicates 4–88); important part of an application. It compliance with the Drug Free —Certification Regarding Lobbying; and should be clear, concise, and address Workplace Requirements, and Certification of Protection of Human the specific requirements mentioned Debarment and Other Responsibilities Subjects, if necessary. under the priority area description in certifications, and need not be mailed —Certification of the Pro-Children Act Part IV. The narrative should also back with the application. of 1994; signature on the application provide information concerning how the In addition, applicants are required represents certification. application meets the evaluation under Section 162(c)(3) of the Act to criteria, using the following headings: provide assurances that the human F. The Application Package (a) Objectives and Need for rights of all individuals with Each application package must Assistance; developmental disabilities (especially include an original and two copies of

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13222 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices the complete application. Each copy recommendations to the agency on for Quality-Food, Drug, and Cosmetic should be stapled securely (front and FDA’s regulatory issues. Division (ASQ–FDC) is announcing the back if necessary) in the upper left-hand Date and Time: The meeting will be following seminar: Human Tissue corner. All pages of the narrative held on April 23, 1999, 8:30 a.m. to 5 Seminar. The topic to be discussed is (including charts, tables, maps, exhibits, p.m. public health regulations and guidance etc.) must be sequentially numbered, Location: Holiday Inn, Kennedy for recovery, screening, testing, beginning with page one. In order to Grand Ballroom, 8777 Georgia Ave., processing, storage, or distribution of facilitate handling, please do not use Silver Spring, MD. human tissue intended for covers, binders or tabs. Do not include Contact Person: Rhonda W. Stover, transplantation. This seminar is being extraneous materials as attachments, Center for Drug Evaluation and Research held for tissue firms in Southern such as agency promotion brochures, (HFD–21), Food and Drug California and Arizona. slides, tapes, film clips, minutes of Administration, 5600 Fishers Lane, Date and Time: The seminar will be meetings, survey instruments or articles Rockville, MD 20857, 301–827–6767, or held on Thursday, April 8, 1999, 8 a.m. of incorporation. FDA Advisory Committee Information to 5 p.m. Return the registration form by Line, 1–800–741–8138 (301–443–0572 Thursday, April 1, 1999. G. Paper Reduction Act of 1995 (P.L. in the Washington, DC area), code Location: The seminar will be held at 104–13) 12530. Please call the Information Line the Food and Drug Administration, Los The Uniform Project Description for up-to-date information on this Angeles District Office, 19900 information collection within this meeting. MacArthur Blvd., suite 300, Irvine, CA announcement is approved under the Agenda: The subcommittee will 92612. Uniform Project Description (0970– discuss issues in the development and Contact: Jonetta I. Collins, 0139), Expiration Date 10/31/2000. study of all therapies in children Supervisory Consumer Safety Officer, Public reporting burden for this relative to the implementation of the Food and Drug Administration, 19900 collection of information is estimated to agency’s new legislative and regulatory MacArthur Blvd., suite 300, Irvine, CA average 10 hours per response, efforts to ensure adequate labeling and 92612, 949–798–7780, FAX 949–798– including the time for reviewing proper pediatric use. 7771, e-mail ‘‘[email protected]’’, or instructions, gathering and maintaining Procedure: Interested persons may Ofelia U. Barretto, West Coast Program the data needed, and reviewing the present data, information, or views, Chair, ASQ–FDC, 714–870–4471, FAX collection of information. orally or in writing, on issues pending 714–879–2737. Registration: Space is limited; An agency may not conduct or before the subcommittee. Written therefore, preregistration and sponsor, and a person is not required to submissions may be made to the contact confirmation is required. Obtain respond to, a collection of information person by April 16, 1999. Oral registration forms from Ofelia U. unless it displays a currently valid OMB presentations from the public will be Barretto, ASQ–FDC (see above). There is control number. scheduled between approximately 11 a.m. and 12 m. Time allotted for each a $95 registration fee payable to ASQ– (Federal Catalog of Domestic Assistance presentation may be limited. Those FDC (address above) for the seminar. Number 93.631 Developmental Disabilities— desiring to make formal oral The fee will cover actual expenses Projects of National Significance) presentations should notify the contact including refreshments, a boxed lunch, Dated: March 11, 1999. person before April 16, 1999, and materials, and some speaker expenses. Sue Swenson, submit a brief statement of the general In addition, building parking is $8 per Commissioner, Administration on nature of the evidence or arguments car to attend the seminar. Return your Developmental Disabilities. they wish to present, the names and completed registration form to Ofelia U. [FR Doc. 99–6456 Filed 3–16–99; 8:45 am] addresses of proposed participants, and Barretto by Thursday, April 1, 1999. BILLING CODE 4184±01±P an indication of the approximate time If you need special accommodations requested to make their presentation. due to a disability, please contact Notice of this meeting is given under Jonetta I. Collins at least 7 days in DEPARTMENT OF HEALTH AND the Federal Advisory Committee Act (5 advance. HUMAN SERVICES U.S.C. app. 2). Dated: March 9, 1999. Food and Drug Administration Dated: March 10, 1999. William K. Hubbard, Michael A. Friedman, Acting Deputy Commissioner for Policy. Subcommittee of the Anti-Infective Deputy Commissioner for Operations. [FR Doc. 99–6395 Filed 3–16–99; 8:45 am] Drugs Advisory Committee; Notice of [FR Doc. 99–6459 Filed 3–16–99; 8:45 am] BILLING CODE 4160±01±F` Meeting BILLING CODE 4160±01±F

AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Notice. HUMAN SERVICES National Institutes of Health This notice announces a forthcoming Food and Drug Administration meeting of a public advisory committee National Cancer Institute; Notice of of the Food and Drug Administration Human Tissue Seminar Closed Meeting (FDA). The meeting will be open to the AGENCY: Food and Drug Administration, Pursuant to section 10(d) of the public. HHS. Federal Advisory Committee Act, as Name of Committee: Subcommittee of ACTION: Notice of meeting. amended (5 U.S.C. Appendix 2), notice the Anti-Infective Drugs Advisory is hereby given of the following Committee. The Food and Drug Administration meeting. General Function of the Committee: (FDA), Los Angeles District Office, in The meeting will be closed to the To provide advice and cooperation with the American Society public in accordance with the

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13223 provisions set forth in sections Dated: March 10, 1999. DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Anna Snouffer, HUMAN SERVICES as amended. The contract proposals and Acting NIH Committee Management Officer. National Institutes of Health the discussions could disclose [FR Doc. 99–6404 Filed 3–16–99; 8:45 am] confidential trade secrets or commercial property such as patentable material, BILLING CODE 4140±01±M National Institute on Deafness and and personal information concerning Other Communication Disorders; Notice of Closed Meeting individuals associated with the contract DEPARTMENT OF HEALTH AND proposals, the disclosure of which HUMAN SERVICES Pursuant to section 10(d) of the would constitute a clearly unwarranted Federal Advisory Committee Act, as invasion of personal privacy. National Institutes of Health amended (5 U.S.C. Appendix 2), notice Name of Committee: National Cancer is hereby given of the following Institute Special Emphasis Panel, National Institutes of Nursing meeting. ‘‘Innovative Approaches to Clinical Trials Research; Notice of Closed Meeting The meeting will be closed to the Information’’. public in accordance with the Date: March 24, 1999. Pursuant to section 10(d) of the provisions set forth in sections Time: 1:00 pm to 3:00 pm. Agenda: To review and evaluate contract Federal Advisory Committee Act, as 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., proposals. amended (5 U.S.C. Appendix 2), notice as amended. The grant applications and Place: 6130 Executive Blvd., 6th Floor, is hereby given of the following the discussions could disclose Rockville, MD 20852. meeting. confidential trade secrets or commercial Contact Person: Wilna A. Woods, PhD, property such as patentable material, Deputy Chief, Special Review, Referral and The meeting will be closed to the and personal information concerning Research Branch, Division of Extramural public in accordance with the individuals associated with the grant Activities, National Cancer Institute, National provisions set forth in sections applications, the disclosure of which Institutes of Health, Rockville, MD 20852, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., would constitute a clearly unwarranted (301) 496–7903. as amended. The grant applications and This notice is being published less than 15 invasion of personal privacy. the discussions could disclose days prior to the meeting due to the timing Name of Committee: National Institute on limitations imposed by the review and confidential trade secrets or commercial Deafness and Other Communications funding cycle. property such as patentable material, Disorders Special Emphasis Panel. (Catalogue of Federal Domestic Assistance and personal information concerning Date: April 8, 1999. Program Nos. 93.392, Cancer Construction; individuals associated with the grant Time: 8:00 am to 5:00 pm. 93.393, Cancer Cause and Prevention applications, the disclosure of which Agenda: To review and evaluate grant Research; 93.394, Cancer Detection and would constitute a clearly unwarranted applications. Diagnosis Research; 93.395, Cancer invasion of personal privacy. Place: Best Western Inn, 1251 W. Treatment Research; 93.396, Cancer Biology Montgomery Avenue, Rockville, MD 20850. Research; 93.397, Cancer Centers Support; Name of Committee: National Institute of Contact Person: Richard S. Fisher, PhD, 93.398, Cancer Research Manpower; 93.399, Nursing Research Special emphasis Panel, Scientific Review Administrator, Scientific Cancer Control, National Institutes of Health, Review Nursing Research Center Core Grant Review Branch, Division of Extramural HHS) Applications (P30s). Activities, NIDCD/NIH, 6120 Executive Dated: March 9, 1999. Date: April 1–2, 1999. Blvd., Room 400C, MSC–7180, Bethesda, MD 20892, 301–496–8683. LaVerne Y. Stringfield, Time: April 1, 1999, 8:30 a.m. to 5:00 p.m. Committee Management Officer, NIH. Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance [FR Doc. 99–6408 Filed 3–16–99; 8:45 am] applications. Program Nos. 93.173, Biological Research Related to Deafness and Communicative BILLING CODE 4140±01±M Place: Bethesda Ramada Inn, 8400 Disorders, National Institutes of Health, HHS) Wisconsin Ave., Bethesda, MD 20814. Dated: March 9, 1999. Time: April 2, 1999, 8:30 a.m. to 5:00 p.m. LaVerne Y. Stringfield, DEPARTMENT OF HEALTH AND Agenda: To review and evaluate grant HUMAN SERVICES applications. Committee Management Officer, NIH. [FR Doc. 99–6406 Filed 3–16–99; 8:45 am] National Institutes of Health Place: Bethesda Ramada Inn, 8400 Wisconsin Ave., Bethesda, MD 20814. BILLING CODE 4140±01±M National Institute of Neurological Contact Person: Mary J. Stephens-Frazier, PhD, Scientific Review Administrator, Disorders and Stroke; Amended Notice DEPARTMENT OF HEALTH AND of Meeting National Institute of Nursing Research, National Institutes of Health, Natcher HUMAN SERVICES Notice is hereby given of a change in Building, Room 3AN32, Bethesda, MD 20892, National Institutes of Health the meeting of the National Advisory (301) 594–5971. Neurological Disorders and Stroke (Catalogue of Federal Domestic Assistance National Institute on Deafness and Special Emphasis Panel, February 26, Program Nos. 93.361, Nursing Research, Other Communication Disorders; 1999, 10:00 a.m., Hotel Washington, National Institutes of Health, HHS) Notice of Closed Meeting 15th St. & Pennsylvania Ave, NW, Dated: March 9, 1999. Washington, DC, 20005, which was Pursuant to section 10(d) of the published in the Federal Register on LaVerne Y. Stringfield, Federal Advisory Committee Act, as January 28, 1999, (64 FR 4456). Committee Management Officer, NIH. amended (5 U.S.C. Appendix 2), notice The meeting will now be held as a [FR Doc. 99–6405 Filed 3–16–99; 8:45 am] is hereby given of the following teleconference on March 11 from 11:00 BILLING CODE 4140±01±M meeting. a.m. to 12:00 p.m. at NIH/NINDS, The meeting will be closed to the Federal Building, Room 9C10, 7550 public in accordance with the Wisconsin Ave., Bethesda, MD 20892. provisions set forth in sections The meeting is closed to the public. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13224 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices as amended. The grant applications and Scientist Administrator, Office of Extramural Matters To Be Discussed: The meeting will the discussions could disclose Programs, National Library of Medicine, 6705 convene in closed session from 1:30 p.m. to confidential trade secrets or commercial Rockledge Drive, Suite 301, Bethesda, MD 2:30 p.m. on March 30, 1999. The purpose of property such as patentable material, 20892. this closed session is for the Science and This notice is being published less than 15 Program Review Work Group (SPRWG) to and personal information concerning days prior to the meeting due to the timing consider Injury Control Research Center grant individuals associated with the grant limitations imposed by the review and applications recommended for further applications, the disclosure of which funding cycle. consideration by the CDC Injury Research would constitute a clearly unwarranted (Catalogue of Federal Domestic Assistance Grant Review Committee. On March 31, invasion of personal privacy. Program Nos. 93.879, Medical Library 1999, from 8:30 a.m. to 9 a.m., the ACIPC Name of Committee: National Institute on Assistance, National Institutes of Health, voting members will convene in closed Deafness and Other Communications HHS) session to vote on a funding recommendation. These portions of the Disorders Special Emphasis Panel. Dated: March 11, 1999. meeting will be closed to the public in Date: April 5, 1999. LaVerne Y. Stringfield, Time: 1:00 pm to 3:30 pm. accordance with provisions set forth in Committee Management Officer, NIH. Agenda: To review and evaluate grant section 552b(c)(4) and (6) title 5 U.S.C., and applications. [FR Doc. 99–6403 Filed 3–16–99; 8:45 am] the Determination of the Associate Director Place: Executive Plaza South, Room 400C, BILLING CODE 4140±01±M for Management and Operations, CDC, 6120 Executive Blvd., Rockville, MD 20852 pursuant to Pub. L. 92–463. (Telephone Conference Call). Following the SPRWG closed session, there Contact Person: Craig A. Jordan, PhD, DEPARTMENT OF HEALTH AND will be a program oversight session which will include discussion of upcoming program Acting Director, NIH/NIDCD/DEA, Executive HUMAN SERVICES Plaza South, Room 400C, Bethesda, MD announcements, upcoming requests for 20892–7180, 301–496–8693. proposals, the grant review process, and Centers for Disease Control and progress on standing Work Group issues. The (Catalogue of Federal Domestic Assistance Prevention Committee will discuss (1) an update from Program Nos. 93.173, Biological Research the Director, National Center for Injury Related to Deafness and Communicative Advisory Committee for Injury Prevention and Control (NCIPC); (2) a Disorders, National Institutes of Health, HHS) Prevention and Control Meeting presentation on unintentional injury Dated: March 9, 1999. prevention; and reports from (3) SPRWG and LaVerne Y. Stringfield, In accordance with section 10(a)(2) of (4) ACIPC’s Subcommittee on Family and Committee Management Officer, NIH. the Federal Advisory Committee Act Intimate Violence Prevention. [FR Doc. 99–6407 Filed 3–16–99; 8:45 am] (Pub. L. 92–463), the Centers for Disease Agenda items are subject to change as priorities dictate. BILLING CODE 4140±01±M Control and Prevention (CDC) announces the following committee For Further Information Contact: Mr. meeting. Thomas E. Blakeney, Executive Secretary, ACIPC, NCIPC, CDC, 4770 Buford Highway, DEPARTMENT OF HEALTH AND Name: Advisory Committee for Injury NE, M/S K61, Atlanta, GA 30341–3724. HUMAN SERVICES Prevention and Control (ACIPC). Telephone 770/488–1481. Times and Dates: 1:30 p.m.–4:30 p.m., The Director, Management Analysis and National Institutes of Health March 30, 1999. 8:30 a.m.–3:30 p.m., March Services Office, has been delegated the 31, 1999. authority to sign Federal Register notices National Library of Medicine; Notice of Place: Embassy Suites Atlanta Airport, pertaining to announcements of meetings and Closed Meeting 4700 Southport Rd, College Park, GA 30337– other committee management activities, for 5613. both the Centers for Disease Control and Pursuant to section 10(d) of the Status: Closed: 1:30 p.m.–2:30 p.m., March Prevention and the Agency for Toxic Federal Advisory Committee Act, as 30, 1999, and 8:30 a.m.–9 a.m., March 31, Substances and Disease Registry. amended (5 U.S.C. Appendix 2), notice 1999; Open: 2:30 p.m.–4:30 p.m., March 30, John Burckhardt, is hereby given of the following 1999, and 9 a.m.–3:30 p.m., March 31, 1999. Acting Director, Management Analysis and meeting. Purpose: The Committee advises and makes recommendations to the Secretary, the Services Office, Centers for Disease Control The meeting will be closed to the and Prevention (CDC). public in accordance with the Assistant Secretary for Health, and the [FR Doc. 99–6309 Filed 3–16–99; 8:45 am] provisions set forth in sections Director, CDC, regarding feasible goals for the prevention and control of injury. The BILLING CODE 4163±18±P 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee makes recommendations as amended. The grant applications and regarding policies, strategies, objectives, and the discussions could disclose priorities, and reviews progress toward injury DEPARTMENT OF HOUSING AND confidential trade secrets or commercial prevention and control. The Committee property such as patentable material, provides advice on the appropriate balance URBAN DEVELOPMENT and personal information concerning and mix of intramural and extramural [Docket No. FR±4443±N±04] individuals associated with the grant research, including laboratory research, and applications, the disclosure of which provides guidance on intramural and Announcement of OMB Approval would constitute a clearly unwarranted extramural scientific program matters, both Number for Part 990ÐPublic Housing present and future, particularly from a long- Performance Funding System invasion of personal privacy. range viewpoint. The Committee provides Name of Committee: National Library of second-level scientific and programmatic Incentives Medicine Special Emphasis Panel. review for applications for research grants, AGENCY: Office of the Assistant Date: March 31, 1999. cooperative agreements, and training grants Secretary for Public and Indian Time: 11:00 am to 1:00 pm. related to injury control and violence Housing, HUD. Agenda: To review and evaluate grant prevention, and recommends approval of applications. projects that merit further consideration for ACTION: Announcement of OMB Place: National Library of Medicine, 6705 funding support. The Committee approval number. Rockledge Drive, Suite 301, Bethesda, MD recommends areas of research to be 20892 (Telephone Conference Call). supported by contracts and provides concept SUMMARY: The purpose of this notice is Contact Person: Sharee Pepper, PhD, review of program proposals and to announce the effectiveness of the Scientific Review Administrator, Health announcements. approval of information collections

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13225 contained in provisions of HUD’s public to, a collection of information, unless it SUPPLEMENTARY INFORMATION: The housing Performance Funding System displays a currently valid OMB control Department has submitted the proposal (PFS) regulations by the Office of number. for the collection of information, as Management and Budget (OMB). The described below, to OMB for review, as Catalog approval covers §§ 990.109, 990.114, required by the Paperwork Reduction and 990.116, which pertain to projecting The Catalog of Federal Domestic Act (44 U.S.C. Chapter 35). operating income level, phase-down of Assistance number for the program The Notice lists the following subsidy for units approved for affected by this rule is 14.850. information: (1) The title of the demolition, and three-year incentive Dated: March 11, 1999. information collection proposal; (2) the adjustments approving information Camille E. Acevedo, office of the agency to collect the collections contained throughout those Assistant General Counsel for Regulations. information; (3) the OMB approval regulations. This notice is necessary to number, if applicable; (4) the [FR Doc. 99–6470 Filed 3–16–99; 8:45 am] inform the public of the effectiveness of description of the need for the these provisions and to assure that the BILLING CODE 4210±33±P information and its proposed use; (5) codified regulations for 24 CFR part 990 the agency form number, if applicable; do not contain inaccurate notations DEPARTMENT OF HOUSING AND (6) what members of the public will be about the effectiveness of the URBAN DEVELOPMENT affected by the proposal; (7) how information collections. frequently information submissions will FOR FURTHER INFORMATION CONTACT: [Docket No. FR±4441±N±19] be required; (8) an estimate of the total Mildred Hamman, Reports Liaison number of hours needed to prepare the Submission for OMB Review: information submission including Officer, Office of Public and Indian Comment Request Housing, Department of Housing and number of respondents, frequency of Urban Development, Room 4244, 451 AGENCY: Office of the Assistant response, and hours of response; (9) Seventh Street, SW, Washington, DC Secretary for Administration, HUD. whether the proposal is new, an 20410, telephone (202) 708–3642, ext. ACTION: Notice. extension, reinstatement, or revision of 4128. (This is not a toll-free number.) an information collection requirement; For persons with hearing or speech SUMMARY: The proposed information and (10) the names and telephone impairments, this number may be collection requirement described below numbers of an agency official familiar accessed by TTY through the Federal has been submitted to the Office of with the proposal and of the OMB Desk Information Relay Service, (800) 877– Management and Budget (OMB) for Officer for the Department. 8339. review, as required by the Paperwork Authority: Section 3507 of the Paperwork SUPPLEMENTARY INFORMATION: On Reduction Act. The Department is Reduction Act of 1995, 44 U.S.C. 35, as September 30, 1996, HUD published a soliciting public comments on the amended. final rule revising the regulations for the subject proposal. Dated: March 10, 1999. PFS to add §§ 990.114 and 990.116 and DATES: Comments due date: April 16, David S. Cristy, to revise § 990.109, to provide a 1999. Director, IRM Policy and Management mechanism to encourage Public ADDRESSES: Interested persons are Division. Housing Agencies (PHAs) to demolish invited to submit comments regarding Title of Proposal: Schedule of and replace obsolete units and to this proposal. Comments must be Subscribers and Ginnie Mae Guaranty/ encourage its residents to increase received within thirty (30) days from the Contractual Agreement. earned income. In accordance with the date of this Notice. Comments should Office: Government National Paperwork Reduction Act of 1995 (44 refer to the proposal by name and/or Mortgage Association. U.S.C. Chapter 35, as amended), this OMB approval number and should be OMB Approval Number: 2503–0009. notice advises that the approval sent to: Joseph F. Lackey, Jr., OMB Desk Description of the Need for the numbers for the new sections are as Officer, Office of Management and Information and its Proposed Use: This follows: Budget, Room 10235, New Executive form is used to provide Ginnie Mae with Office Building, Washington, DC 20503. a listing of subscribers/purchasers of the OMB ap- Section No. proval No. Expiration date FOR FURTHER INFORMATION CONTACT: mortgage-backed securities, as well as Wayne Eddins, Reports Management other information needed to prepare the 990.114 ...... 2577±0075 07/31/2001 Officer, Department of Housing and securities. It also provides the 990.116 ...... 2577±02 12/31/1999 Urban Development, 451, 7th Street, contractual agreement between issuer Southwest, Washington, DC 20410, and Ginnie Mae. The OMB approval number for telephone (202) 708–1305. This is not a Form Number: HUD–11705. § 990.109, 2577–0066, has expired and toll-free number. Copies of the proposed Respondents: Business or Other For- HUD is in the process of reinstating it. forms and other available documents Profit and the Federal Government. An agency may not conduct or sponsor, submitted to OMB may be obtained Frequency of Submission: and a person is not required to respond from Mr. Eddins. Reporting of Burden:

Number of × Frequency of × Hours per respondents response response = Burden hours

HUD±11705 ...... 900 59 .17 4,002

Total Estimated Burden Hours: 4,002. Contact: Sonya Suarez, HUD, (202) Dated: March 10, 1999. Status: Reinstatement with changes. 708–2772; Joseph F. Lackey, Jr., OMB, [FR Doc. 99–6471 Filed 3–16–99; 8:45 am] (202) 395–7316. BILLING CODE 4120±01±M

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DEPARTMENT OF THE INTERIOR distance calls; records indicating Federal agency that has requested assignment of telephone numbers of information necessary or relevant to the Office of the Secretary employees; and records relating to the hiring, firing, or retention of an location of telephones. employee, or the issuance of a security Privacy Act of 1974; as Amended; Note: Records of telephone calls made to clearance, contract, license, grant or Revisions to the Existing System of other benefit, but only to the extent that Records the Department’s Office of Inspector General Hotline number are excluded from the the information disclosed is relevant AGENCY: Office of the Secretary, records maintained in this system pursuant and necessary to the requesting agency’s Department of the Interior. to the provisions of 5 U.S.C., Appendix 3 decision on the matter; and (6) To a Section 7(b) (Inspector General Act of 1978). ACTION: Proposed revisions to an congressional office from the record of an individual in response to an inquiry existing system of records. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: the individual has made to the SUMMARY: In accordance with the 31 U.S.C. 1348(b), which prohibits congressional office. Privacy Act of 1974, as amended (5 agencies from using appropriated funds U.S.C. 552a), the Office of the Secretary to pay for personal calls; 44 U.S.C. 3101, POLICIES AND PRACTICES FOR STORING, is issuing public notice of its intent to which authorizes agencies to create and RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: modify an existing Privacy Act system preserve records documenting agency of records notice, DOI–36, ‘‘Telephone organizations, functions, procedures, STORAGE: Call Detail Records.’’ The revisions will and transactions; and 43 CFR 201– Official records are stored in update the addresses for the System 38.007, which limits the use of electronic form. Locations and the System Managers. Government telephone systems to the conduct of official business. RETRIEVABILITY: EFFECTIVE DATE: These actions will be effective on March 17, 1999. ROUTINE USES OF RECORDS MAINTAINED IN THE Records are retrieved by employee FOR FURTHER INFORMATION CONTACT: SYSTEM, INCLUDING CATEGORIES OF USERS AND name, telephone number, identification Chief, Telecommunications Systems THE PURPOSE OF SUCH USES: number, or by account code. Division, Office of Information Disclosures within the Department of SAFEGUARDS: Resources Management, MS–5312, 1849 the Interior may be made to employees Access to the records is limited to C Street NW, Washington, DC 20240. of the Department to determine Departmental employees who have an SUPPLEMENTARY INFORMATION: In this responsibility for long distance official need to use the records in the notice, the Department of the Interior is telephone calls, and to resolve disputes performance of their duties. Records are amending the DOI–36, ‘‘Telephone Call and facilitate the verification of stored in a controlled area and Detail Records,’’ to update and more discrepancies relating to the billing, maintained with safeguards meeting the accurately identify the addresses of the payment, or reconciliation of telephone requirements of 43 CFR 2.51 for System Locations and the System operational or accountability record. computer and paper records. Automated Managers. Accordingly, the Department Disclosures outside the Department of records are protected from unauthorized of the Interior proposes to amend the the Interior may be made: (1) To access through password identification ‘‘Telephone Call Detail Records,’’ DOI– representatives of a telecommunications procedures and other system-based 36 in its entirety to read as follows: company providing telecommunications protection methods. Sue Ellen Sloca, support to permit the servicing of the Office of the Secretary Privacy Act Officer, account; (2) To representatives of the RETENTION AND DISPOSAL: National Business Center. General Services Administration or the In accordance with National Archives National Archives and Records and Records Administration’s General INTERIOR/DOI±36 Administration to conduct records Records Schedule 12, Item 4, official SYSTEM NAME: management inspections under (electronic) records are retained for Telephone Call Detail Records— authority of 44 U.S.C. 2904 and 2906; three (3) years and then destroyed. Interior, DOI–36. (3) To the U.S. Department of Justice or Paper reference copies are destroyed in a proceeding before a court or when no longer needed or, if not before, SYSTEM LOCATION: adjudicative body when (a) the United when three (3) years old. (1) U.S. Department of the Interior, States, the Department of the Interior, a Office of Information Resources component of the Department, or, when SYSTEM MANAGER(S) AND ADDRESS: Management, Telecommunications represented by the government, an (1) Chief, Telecommunications Systems Division, MS–5312, 1849 C employee of the Department is a party Systems Division, Office of Information Street NW, Washington, DC 20240. to litigation or anticipated litigation or Resources Management, MS–5312, MIB, (2) Office of Bureau System Managers. has an interest in such litigation, and (b) 1849 C Street NW, Washington, DC (3) Bureau offices nationwide. The Department of the Interior 20240. CATEGORIES OF INDIVIDUALS COVERED BY THE determines that the disclosure is (2) Telecommunications Manager, SYSTEM: relevant or necessary to the litigation Office of Facilities Management, Bureau Individuals (generally Department, and is compatible with the purpose of of Indian Affairs, PO Box 1246, bureau/office, and contractor which the records were compiled; (4) Of Albuquerque, NM 87103. employees) who make long distance information indicating a violation or (3) Chief, Branch of telephone calls and individual who potential violation of a statue, Telecommunications, Bureau of Land receive long distance telephone calls regulation, rule, order or license, to Management, Denver Federal Center, placed from or charged to DOI appropriate Federal, State, local or MS–DW101, BLD. 50, PO Box 25047, telephones. foreign agencies responsible for Lakewood, CO 80225. investigating or prosecuting the (4) Telecommunications Manager, CATEGORIES OF RECORDS IN THE SYSTEM: violation or for enforcing or Bureau of Reclamation, Denver Federal Records relating to the use of DOI implementing the stature, rule, Center, MS–D–7190, PO Box 25007, telephone systems to place long regulation, order or license; (5) To a Denver, CO 80225.

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(5) Telecommunications Manager, DEPARTMENT OF THE INTERIOR ADDRESSES) and should be received on U.S. Fish and Wildlife Service, IRM/ or before April 17, 1999. TFO, PO Box 25207, Denver, CO 80225. Fish and Wildlife Service ADDRESSES: Persons wishing to review (6) Chief, Branch of the Plan may obtain a copy by writing Receipt of an Application for an Telecommunications Services, U.S. the Service’s Southeast Regional Office, Incidental Take Permit for construction Geological Survey, MS–809, National Atlanta, Georgia. Documents will also of Oak Grove High School, in Lamar Center, Reston, VA 22092. be available for public inspection by County, Mississippi. (7) Chief, Safety and Facilities appointment during normal business Management Branch, Minerals AGENCY: Fish and Wildlife Service, hours at the Regional Office, 1875 Management Service, MS–2000, 381 Interior. Century Boulevard, Suite 200, Atlanta, Georgia 30345 (Attn: Endangered Elden Street, Herndon, VA 22070. ACTION: Notice. (8) Telecommunications Manager, Species Permits), or Field Supervisor, U.S. Fish and Wildlife Service, 6578 Information and Telecommunications SUMMARY: The Lamar County School Division, National Park Service, MS– Board District (Applicant), is seeking an Dogwood View Parkway, Suite A, 2505, 1849 C Street NW, Washington, incidental take permit (ITP) from the Jackson, Mississippi 39213. Written data DC 20240. Fish and Wildlife Service (Service), or comments should be submitted to the pursuant to section 10(a)(1)(B) of the Regional Office. (9) Telecommunications Requests for the documentation must Endangered Species Act of 1973 (Act), Administrator, Office of Inspector be in writing to be processed. Comments as amended. The ITP would authorize General, MS–124, SIB, 1849 C Street must be submitted in writing to be the take of the threatened Gopher NW, Washington DC 20240. processed. Please reference permit tortoise, Gopherus polyphemus, for a (10) Chief, Telecommunications number TE–007399–0 in such fifty (50) year period. The proposed Service Office, National Business comments, or in requests of the taking is incidental to land clearing and Center, Office of the Secretary, MS– documents discussed herein. other activities associated with the 1445, MIB, 1849 C Street NW, FOR FURTHER INFORMATION CONTACT: Mr. Washington, DC 20240. construction and use of Oak Grove High School, a public education facility for Rick G. Gooch, Regional Permit (11) Telecommunications Manager, grades nine through twelve, occupying Coordinator, (see ADDRESSES above), Office of Surface Mining Reclamation a 39-acre site in Lamar County, telephone: 404/679–7110, facsimile: and Enforcement, MS–10, SIB, 1849 C Mississippi (Project). Surveys on the 404/679–7081. Street NW, Washington, DC 20240. Project site indicate that at least one SUPPLEMENTARY INFORMATION: The Gopher tortoise (Gopherus NOTIFICATION PROCEDURE: adult Gopher tortoise inhabits the Project. A description of the mitigation polyphemus), is listed as a threatened A request for notification of the and minimization measures outlined the species in the western part of its range, existence of records shall be addressed Applicant’s Habitat Conservation Plan from the Tombigbee and Mobile Rivers to the appropriate System Manager. The (HCP or Plan) to address the effects of in Alabama west to southeastern request shall be in writing, signed by the the Project to the protected species is as Louisiana. As a native burrowing requester, and comply with the content described further in the SUPPLEMENTARY species of the fire-maintained longleaf requirements of 43 CFR 2.60. INFORMATION section below. pine ecosystem, typical gopher tortoise habitat consists of frequently burned RECORD ACCESS PROCEDURES: Further, the Service has determined that the Applicant’s Plan qualifies as a longleaf pine or longleaf pine/scrub oak A request for access to records shall ‘‘low-effect’’ Plan as defined by the uplands on moderately well drained to be addressed to the appropriate System Service’s Habitat Conservation Planning xeric soils. About 80 percent of the Manager. The request shall be in Handbook (November 1996). The original habitat for gopher tortoises has writing, signed by the requester, and Service has further determined that been lost due to urbanization and comply with the content requirements approval of the Plan qualifies as a agriculture. Certain forest management of 43 CFR 2.63. categorical exclusion under the National practices in remaining upland pine habitats have also adversely affected the CONTESTING RECORD PROCEDURES: Environmental Policy Act (NEPA), as provided by the Department of Interior gopher tortoise. Silvicultural systems A request for amendment of records Manual (516 DM 2, Appendix 1 and 516 using intensive site preparation, dense shall be addressed to the appropriate DM 6, Appendix 1). plantations and stands of loblolly pine or slash pine, and infrequent fire have System Manager. The request shall be in Copies of the Applicant’s Plan may be reduced or eliminated the open forest writing, signed by the requester, and obtained by making a request to the and sunny forest floor of grasses and comply with the content requirements Regional Office (see ADDRESSES). forbs where gopher tortoises burrow, of 43 CFR 2.71. Requests must be in writing to be nest, and feed. Though gopher tortoises processed. This notice is provided RECORD SOURCE CATEGORIES: are widely distributed in south pursuant to Section 10 of the Act and Mississippi, most populations are Telephone assignment records, call NEPA regulations (40 CFR 1506.6). detail listings, and results of fragmented, small in size, and The Service specifically requests functionally non-viable. administrative inquiries relating to information, views, opinions from the assignment of responsibility for Section 9 of the Act, and public via this Notice, including implementing regulations, prohibits placement of specific long distance information regarding the adequacy of calls. taking the gopher tortoise. Taking, in the Plan as measured against the part, is defined as an activity that kills, Service’s ITP issuance criteria found in EXEMPTIONS CLAIMED FOR THE SYSTEM: injures, harms, or harasses a listed 50 CFR Parts 13 and 17. endangered or threatened species. None. DATES: Written comments on the Section 10(a)(1)(B) of the Act provides [FR Doc. 99–6441 Filed 3–16–99; 8:45 am] application and Plan should be sent to an exemption, under certain BILLING CODE 4310±94±M the Service’s Regional Office (see circumstances, to the Section 9

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13228 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices prohibition if the taking is incidental to, as provided by the Department of the community, road improvements, and not the purpose of otherwise lawful Interior Manual (516 DM 2, Appendix 1 ongoing management on open space and activities. and 516 DM 6, Appendix 1). No further facilities, and implementation of Gopher tortoise surveys conducted by NEPA documentation will therefore be conservation measures in the planning the Applicant have identified at least prepared. In the Service’s continuing area located in the City of Lake Elsinore, one adult gopher tortoise within the efforts to ensure compliance with Riverside County, California. The Project. Land clearing, construction and section 106 of the National Historic proposed permit would allow take in heavy equipment operations can Preservation Act, the Service’s Regional the form of harm or harassment of 3 directly kill or injure tortoises as a result Archaeologist will determine, after currently listed species [coastal of their becoming crushed or entombed further investigations which are California gnatcatcher (Polioptila in burrows. currently underway, the effect of the californica californica), least Bell’s vireo The Plan describes measures the proposed construction on cultural (Vireo bellii pusillus), and Stephens’ Applicant will take to avoid and resources that may be present within the kangaroo rat (Dipodomys stephensi)] mitigate such taking, including: (1) project area. Results of these and 30 sensitive species that may be Translocation of all resident tortoises investigations will be considered and listed as threatened or endangered from the Project to a suitable 25-acre incorporated into the Service’s final during the period permit. The proposed recipient site which already contains a determinations on this Plan. permit also would allow take in the colony of the species; (2) management of The Service will evaluate the Plan form of harassment of 16 bird and the recipient site for the long term and comments submitted thereon to mammal species, primarily raptors and benefit of the relocated tortoise(s) and determine whether the application bats that forage in the area. In addition, the resident population; and, (3) meets the requirements of section 10(a) the Partners anticipate that 12 monitoring and reporting on the of the Act. If it is determined that those additional species would need to be effectiveness of the chosen mitigation requirements are met, an ITP will be added to the permit (if found to be and minimization strategy. issued for the incidental take of the present and a taking would occur) and As earlier stated, the Service has Gopher Tortoise. The Service will also have proposed a streamlined determined that the Plan qualifies as a evaluate whether the issuance of a amendment process to determine ‘‘low-effect’’ Habitat Conservation Plan Section 10(a)(1)(B) ITP complies with measures to avoid, minimize, mitigate, (HCP) as defined by the Service’s Section 7 of the Act by conducting an and authorize take of those species. As Habitat Conservation Planning intra-Service Section 7 consultation. required under the Act, the Partners Handbook (November 1996). Low-effect The results of the consultation, in have prepared a habitat conservation HCPs are those involving: (1) Minor or combination with the above findings, plan (Plan) for the species that would be negligible effects on federally listed and will be used in the final analysis to covered by the incidental take permit candidate species and their habitats, determine whether or not to issue the and have submitted the Plan to the and (2) minor or negligible effects on ITP; the final decision will be made no Service, together with an other environmental values or sooner than 30 days from the date of Implementation Agreement. The Plan resources. The Applicant’s Plan this notice. and Implementation Agreement are part qualifies for the following reasons: of the permit application. 1. Approval of the Plan would result Dated: March 11, 1999. H. Dale Hall, The Service announces the in minor or negligible effects on the availability of the permit application Deputy Regional Director. Gopher tortoise and its habitat. The and the Environmental Assessment for Service does not anticipate significant [FR Doc. 99–6437 Filed 3–16–99; 8:45 am] public review and comment. All direct or cumulative effects to the BILLING CODE 4310±55±P comments received, including names Gopher tortoise resulting from and addresses, will become part of the construction of the Project. DEPARTMENT OF THE INTERIOR administrative record and may be made 2. Approval of the Plan would not available to the public. have adverse effects on known unique DATES: Written comments on the permit geographic, historic or cultural sites, or Fish and Wildlife Service application and the Environmental involve unique or unknown Availability of an Environmental Assessment should be received on or environmental risks. Assessment and Receipt of an before April 16, 1999. 3. Approval of the Plan would not Application for a Permit to Allow result in any significant adverse effects ADDRESSES: Comments should be Incidental Take of Threatened and addressed to Jim Bartel, Assistant Field on public health or safety. Endangered Species in Connection 4. The project does not require Supervisor, Fish and Wildlife Service, With the North Peak Development compliance with Executive Order 11988 2730 Loker Avenue West, Carlsbad, Project in the City of Lake Elsinore, (Floodplain Management), Executive California 92008. Comments may be Riverside County, California Order 11990 (Protection of Wetlands), or sent by facsimile to 760–431–9624. the Fish and Wildlife Coordination Act, AGENCY: Fish and Wildlife Service, FOR FURTHER INFORMATION CONTACT: nor does it threaten to violate a Federal, Interior. Michelle Shaughnessy, Branch Chief, or State, local or tribal law or requirement ACTION: Notice of Availability. Dan Brown, Fish and Wildlife Biologist, imposed for the protection of the at the above address (telephone: 760– environment. SUMMARY: North Peak Partners, L.P., 431–9440). 5. Approval of the Plan would not (Partners) have applied to the Fish and SUPPLEMENTARY INFORMATION: establish a precedent for future action or Wildlife Service for an incidental take represent a decision in principle about permit pursuant to the Endangered Availability of Documents future actions with potentially Species Act of 1973, as amended (Act). If you would like a copy of the significant environmental effects. The Partners request a 30-year permit documents, contact the Service’s The Service has therefore determined authorizing incidental take of certain Carlsbad Fish and Wildlife Office at the that approval of the Plan qualifies as a species in connection with the above referenced address or telephone. categorical exclusion under the NEPA, development of a master planned Documents also are available for public

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13229 inspection, by appointment, during impacts and increased onsite appropriation is $18,780,383. This normal business hours at the above conservation in the master planned Notice of Fund Availability describes address. community through elimination of one the process by which this appropriation of two proposed golf courses. The third will be distributed to Bureau Area Background Information alternative considers preservation of the Offices and subsequently for individual Under section 9 of the Act and its area proposed for the master planned eligible grantees through Indian tribal implementing regulations, ‘‘taking’’ of community under a mitigation banking governments for FY 1999. threatened or endangered wildlife agreement. Two variations of the third FOR FURTHER INFORMATION CONTACT: June species is prohibited. That is, no one alternative are presented: one that Henkel, Office of Tribal Services, may harass, harm, pursue, hunt, shoot, covers the plan area identified in the Bureau of Indian Affairs, Department of wound, kill, trap, capture or collect Partner’s Plan, and one that would the Interior, 1849 C Street, NW, MS– listed animal species, or attempt to conserve an additional 773 acres in the 4603–MIB, Washington, D.C. 20240. engage in such conduct (16 USC 1538). Specific Plan area as part of the Telephone 202–208–3667, Fax 202– The Service, however, may issue mitigation bank. The 773 acres that 208–2648. permits to take such species if the taking would be added under the second SUPPLEMENTARY INFORMATION: The is incidental to, and not the purpose of, variation have already been proposed by otherwise lawful activities. Regulations purpose of this notice is to identify the the Partners as a mitigation bank. The methodology that will be used to governing such permits are in 50 CFR fourth alternative considers additional 17.32 for threatened species and 50 CFR distribute the Housing Improvement residential development instead of two Program FY 1999 Appropriation. 17.22 for endangered species. golf courses in the master planned The permit requested by the Partners community. The fifth alternative Background would allow incidental take of up to 61 considers development and onsite species in connection with direct and The HIP provides housing services to conservation as proposed in the 1991 indirect effects of development and individuals, in the form of a grant, and Specific Plan for the property. The sixth management activities identified in the is available to the neediest of the needy alternative (No Action) considers a Plan. The area covered by the proposed Indian applicants residing on Indian continuation of existing conditions in permit includes approximately 997 reservations or within ‘‘approved the plan area. acres within a Specific Plan area and 23 service areas.’’ An Indian reservation This notice is provided pursuant to means any federally recognized Indian acres along the road providing access to section 10 (a) of the Act and Service the site. It is estimated that 1 pair of tribe’s reservation, Pueblo, or Colony, regulations for implementing the California gnatcatchers, 1 acre of including former reservations in National Environmental Policy Act of potential least Bell’s vireo habitat, and Oklahoma, Alaska Native regions 1969 (40 CFR 1506.6). The Service will 220 acres of Stephens’ kangaroo rat established pursuant to the Alaska evaluate the application, associated habitat would be harmed. Take of other Native Claims Settlement Act, Pub. L. documents, and comments submitted species covered by the Plan is estimated 92–203, and Indian allotments. Eligible thereon to determine whether the in terms of habitat removal and would individual Indian applicants are those application meets the requirements of range from 1 to 621 acres depending on with limited resources who do not law. If the Service determines that the the habitat of the species. To avoid, qualify for or otherwise cannot receive requirements are met, a permit will be minimize, and mitigate the effects of assistance from other housing programs. take, the Partners propose to limit direct issued for the incidental take of the The HIP provides a non-duplicative harm to species, conserve 511 acres of listed species. A final decision on service and differs from the Department natural habitats (including 340 acres of permit issuance will be made no sooner of Housing and Urban Development coastal sage scrub and 19 acres of than 30 days from the date of this (HUD) Indian housing programs riparian/wetland habitats), provide for notice. specifically because the recipients of the ongoing management of onsite Dated: March 10, 1999. HIP grants are unable to meet HUD’s conserved habitat, and maintain wildlife Elizabeth H. Stevens, minimum income requirements. corridors and habitat connections across Deputy Manager, California/Nevada Revised HIP regulations, published in the property and to other protected Operation Office, Region 1, Sacramento, the Federal Register on March 2, 1998, lands. Approximately 411 acres would California. and effective on April 1, 1998 (63 FR be conserved onsite (including 36.6 [FR Doc. 99–6438 Filed 3–16–99; 8:45 am] 10134), establish the Bureau’s housing acres revegetated with coastal sage scrub BILLING CODE 4310±55±P policy that every American Indian and 11 acres of created/enhanced family should have the opportunity for riparian and wetland habitats). Onsite a decent home and suitable living conserved habitat would include 1 DEPARTMENT OF THE INTERIOR environment. To the extent possible, the coastal California gnatcatcher use area, program will serve the neediest of the 6 acres of least Bell’s vireo habitat, and Bureau of Indian Affairs needy Indian applicants. Accordingly, 290 acres providing regionally the Bureau defines the HIP as a Notice of Fund Availability and significant habitat connections for secondary safety net program which Distribution Process of the FY 1999 Stephens’ kangaroo rat. Two parcels provides assistance to Indian applicants Housing Improvement Program totaling 100 acres would be dedicated to who have no other recourse for housing Appropriation existing wildlife reserves in the region. assistance. The Environmental Assessment AGENCY: Bureau of Indian Affairs, The limited availability of funds for considers six alternatives, including No Interior. this program require the continued use Action. The first alternative considers ACTION: Notice. of a needs based distribution the effects of the development project methodology. Funds are made available on the species of concern assuming SUMMARY: The Fiscal Year (FY) 1999 to tribal governments based upon the implementation of the Plan as proposed Department of the Interior, Bureau of submission of: (1) viable, annual work by the Applicant. The second Indian Affairs (Bureau), Housing plans, containing (a) the identification alternative considers reduced habitat Improvement Program (HIP) of eligible applicants; (b) identification

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Prospective members are Area Offices will distribute FY 1999 Housing Improvement Program advised that membership on a Council HIP funds to the tribes within their Appropriation does not include FY 1998 calls for a substantial commitment of respective areas who: (1) Have eligible TPA funds that were prioritized by time and energy. applicants as defined under the revised tribes to be used for HIP. Individuals may nominate themselves rule in 25 CFR 256, effective April 1, or others. Council members may be 1998; (2) have submitted their FY 1997 Dated: February 18, 1999. Kevin Gover, renominated upon the expiration of inventory of housing needs; (3) have their terms. The Southeast Oregon RAC Assistant Secretary—Indian Affairs. viable work plans; (4) are in compliance is composed of 15 members who serve with the intent of the program; (5) have [FR Doc. 99–6399 Filed 3–16–99; 8:45 am] 3-year terms with one-third of the terms an approved service area; and, (6) BILLING CODE 4310±02±P expiring each year. This provides an provide a report of prior year experienced panel of members at any accomplishments. given time. Nominees must be residents A viable work plan means that DEPARTMENT OF THE INTERIOR of the State of Oregon. planned work projects fall within the Nominees are being sought to fill the scope and framework of the HIP and Bureau of Land Management vacant Transportation/Right-of-Way that the tribe has eligible HIP [OR±010±1430±00; GP9±0119] representative and the Energy/Minerals applicants. Funds will be distributed representative positions, for terms only to tribes with eligible HIP Call for Nominations for the Southeast which expire in August 2000 and applicants. Oregon Resource Advisory Council The HIP funds identified for the September 1999, respectively. Nominees Office of Self-Governance (OSG) tribes AGENCY: Lakeview District, Bureau of will be evaluated based on their with an annual funding agreement are Land Management, Interior. experience working with the interest area they choose to represent, and their provided under the same general ACTION: Notice. guidance as for other tribes. HIP funding knowledge of the geographic area should only be made available to tribes SUMMARY: The Bureau of Land covered by the Council. Nominees must with eligible HIP applicants and in Management Oregon State Office is also have demonstrated a commitment accordance with the payment provision, calling for nominations to fill two to collaborative resource decision Pub. L. 103–413, Sec. 403(g)(3), which unexpired terms in the Group I category making. All nominations must be requires the Secretary to ‘‘* * * provide on the Southeast Oregon Resource accompanied by letters of reference funds to the tribe under an agreement Advisory Council. The Southeast from represented interests or under this title for programs, services, Oregon Council currently provides organizations, a completed background functions, and activities, or portions advice and recommendations to the information nomination form, as well as thereof, in an amount equal to the Bureau of Land Management (BLM) and any other information that speaks to the amount that the tribe would have been the Forest Service (FS). The nomination nominee’s qualification. To obtain a eligible to receive under contracts and period will close on Monday, April 26, nomination form or additional grants under the Act.’’ 1999. information, please contact Public Area Offices are to ensure that The purpose of Resource Advisory Affairs, Bureau of Land Management, distributed amounts are sufficient to Councils is to enable State residents and Oregon State Office, P.O. Box 2965, fund at least one complete project. local citizens to have a meaningful say Portland, OR 97208 (503) 952–6027, or Therefore, Area Offices must devise or in how federal lands are managed. The your local BLM District Office. follow a previously established plan to Councils, which were established in Completed nomination forms and rotate funds between tribes with August, 1995, provide advice on the letters of reference should be sent to projects requiring two or more years broad array of resource issues that face Elaine Zielinski, State Director, Bureau funding. (The intention is to fund as federal land managers. of Land Management, Oregon State many HIP projects as possible, while The Southeast Oregon RAC advises Office, P.O. Box 2965, Portland, OR curtailing the amount of unexpended federal officials on the management of 97208. The BLM State Director, the funds, to enable the Bureau to attain federal lands in Southeast Oregon. The Forest Service Regional Forester, and performance goals as outlined in the FY area covers most of Malheur, Harney, the Governor’s Office will forward these 1998 strategic plan). Accordingly, Area and Lake Counties and small portions of nominations to the Secretary of Interior, Offices are authorized to redistribute Klamath, Deschutes, Crook, Grant, and who will make the appointments to the funds from those tribes unable to Baker Counties. Council. expend some or all of their FY 1998 The Southeast Oregon RAC operates Dated: February 26, 1999. funding, to other tribes capable of on principles of collaboration and expending the funds. Area Offices must consensus. Council members are sought FOR FURTHER INFORMATION, CONTACT: notify Central Office of such actions. In who are committed to working with Sonya Hickman, Bureau of Land addition, the areas and the OSG will be other interests for the long term benefit Management, Lakeview District Office, required to submit a report to Central of public lands and national forests. HC 10 Box 337, Lakeview, OR 97630 Office in May 1999, identifying the The Southeast Oregon RAC worked (Telephone: 541/947–2177). funds obligated/expended and the funds with the BLM on the development of Joe Tague, available to be withdrawn for draft standards for rangeland health and Acting Designated Federal Official. reallocation to other locations because guidelines for grazing management and [FR Doc. 99–6221 Filed 3–16–99; 8:45 am] of the lack of HIP eligible applicants. has been providing the BLM with BILLING CODE 4310±33±P

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DEPARTMENT OF THE INTERIOR disposal site in a reasonable location path of the vessel or in waves created by without incurring the major expenses to the vessel. Bureau of Land Management close the existing site and develop a These seasonal restrictions in the [NM±030±1430±00; NMNM 96531 & NMNM new one. ‘‘Wild and Scenic’’ segments of the 98501] For a period of 45 days from the date Upper Missouri National Wild and of publication of this notice in the Scenic River Corridor are necessary to Notice of Realty Action; Recreation Federal Register interested parties may reduce user conflicts, limit noise and Public Purposes (R&PP) Act submit comments to the District impacts, protect all boaters from Classification; New Mexico Manager, P.O. Box 550, Prineville, capsizing or collisions, and to protect Oregon 97754. In the absence of timely boats and canoes tied at the rivers edge. AGENCY: Bureau of Land Management objections, this proposal shall become SUPPLEMENTARY INFORMATION: Any (BLM), Interior. the final determination of the person convicted of violating these ACTION: Correction notice. Department of the Interior. restrictions shall be punished by a fine not to exceed $500.00 or by SUMMARY: FOR FURTHER INFORMATION CONTACT: Ron In Federal Register Volume imprisonment for a period not to exceed 64, Page 6114, Number 25 of Monday, Lane, P.O. Box 550, Prineville, Oregon 97754, or call (541) 416–6700. 6 months, or both, and shall be February 8, 1999, Notices, under the adjudged to pay all costs of the SUMMARY heading, change the legal Dated: March 5, 1999. proceedings (43 CFR 8351.2–1). description of ‘‘Parcel 1’’ to read: James L. Hancock, FOR FURTHER INFORMATION CONTACT: District Manager. Parcel 1 Lewistown Field Manager, Lewistown [FR Doc. 99–6413 Filed 3–16–99; 8:45 am] Field Office, P.O. Box 1160, Lewistown, T. 29 S., R. 4 E., NMPM BILLING CODE 4310±33±M Montana 406/538–7461. Sec. 17, Lots 6, 8, and 9, W1⁄2E1⁄2NE1⁄4. Containing 138.88 acres, more or less. Dated: March 8, 1999. Dated: March 11, 1999. DEPARTMENT OF THE INTERIOR David L. Mari, Tim L. Sanders, Field Manager. Acting Assistant Field Manager, Las Cruces Bureau of Land Management [FR Doc. 99–6412 Filed 3–16–99; 8:45 am] Field Office. BILLING CODE 4310±DN±P [FR Doc. 99–6439 Filed 3–16–99; 8:45 am] [MT±060±08±1220±00] BILLING CODE 4310±VC±M Notice of Upstream Travel Restrictions DEPARTMENT OF THE INTERIOR in ``Wild and Scenic'' Segments of the Minerals Management Service DEPARTMENT OF THE INTERIOR Upper Missouri National Wild and Scenic River Agency Information Collection Bureau of Land Management SUMMARY: Notice is hereby given that Activities: Submitted for Office of [OR±050±1150±00; GP9±0133] effectively immediately and in Management and Budget Review; accordance with the Upper Missouri Comment Request Notice of Noncompetitive Sale of National Wild and Scenic River Public Lands in Grant County, Oregon Title: Designation of Royalty Payment Management Plan Update, February Responsibility, OMB Control Number AGENCY: Bureau of Land Management, 1993, seasonal boating restrictions are in 1010–0107. Prineville District Office. effect on the ‘‘Wild and Scenic’’ Comments: This collection of ACTION: Notice of noncompetitive sale of segments of the Upper Missouri information has been submitted to the public lands in Grant County, Oregon. National Wild and Scenic River from Office of Management and Budget for the Saturday before the observed approval. In compliance with the SUMMARY: The following land has been Memorial Day through the Sunday after Paperwork Reduction Act of 1995, found suitable for direct sale under Labor Day. Section 3506 (c)(2)(A), we are notifying Section 203 of the Federal Land Policy Open Segments: from Fort Benton you, members of the public and affected and Management Act of 1976 (90 Stat. (river mile 0) to Pilot Rock (river mile agencies, of this collection of 2750, 43 U.S.C. 1713). The land will not 52) and Deadman’s Rapids (river mile information, and are inviting your be offered for sale until at least 60 days 84.5) to Holmes Council Island (river comments. Is this information collection after the date of notice. mile 92.5). In these segments, motorized necessary for us to properly do our job? travel upstream and downstream Willamette Meridian Have we accurately estimated the allowed. public’s burden for responding to this T. 12 S., Range 33 E., Seasonal Restricted Segments: from collection? Can we enhance the quality, Section 24: NW1⁄4SW1⁄4 Pilot Rock (river mile 52) to Deadman’s utility, and clarity of the information we Containing approximately 40 acres. Rapids (river mile 84.5) and from collect? Can we lessen the burden of The land described is hereby Holmes Council Island (river mile 92.5) this information collection on the segregated from appropriation under the to Fred Robinson Bridge (river mile respondents by using automated public land laws, including mining 149). In these seasonally restricted collection techniques or other forms of laws, pending disposition of this. segments, extended upstream travel by information technology? A decision to convey the land to the motorized watercraft is limited to Comments should be made directly to city of Prairie City, Oregon was signed official administrative, emergency, or the Attention: Desk Officer for the on February 23, 1999. The action would law enforcement watercraft only. Interior Department, Office of result in the disposal of the tract that Downstream travel by motorized craft is Information and Regulatory Affairs, contains the cities solid waste disposal allowed in these segments, but cannot Office of Management and Budget, landfill. The action has been determined exceed a white water wake speed. A Washington, DC 20503; telephone (202) to be a logical means to resolve Prairie white water wake speed is defined as a 395–7340. Copies of these comments City’s continuing need for a solid waste speed where white water occurs in the should also be sent to us. The U.S.

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Postal Service address is Minerals DEPARTMENT OF THE INTERIOR Title: National Register of Historic Management Service, Royalty Places Registration Form, National Management Program, Rules and National Park Service Register of Historic Places Continuation Publications Staff, P.O. Box 25165, MS Sheet, and National Register of Historic 60 Day Notice of Intention To Request 3021, Denver, Colorado, 80225–0165; Places Multiple Property Clearance of Collection of Information: Documentation Form. the courier address is Building 85, Opportunity for Public Comment Room A–613, Denver Federal Center, Form: NPS 100, –a,–b. Denver, Colorado 80225; and the e:Mail AGENCY: National Park Service, The OMB Number: NPS 1024–0018. address is [email protected]. Department of the Interior. Type of Request: Renewal. OMB has up to 60 days to approve or ACTION: Notice and request for Description of need: The National disapprove the information collection comments. Historic Act requires the Secretary of the Interior to maintain and expand the but may respond after 30 days; SUMMARY: Under the provisions of the National Register of Historic Places, and therefore, public comments should be Paperwork Reduction Act of 1995 (Pub. to establish criteria and guidelines for submitted to OMB within 30 days in L. 104–13, 44 U.S.C., Chapter 3507) and including properties in the National order to assure their maximum 5 CFR Part 1320, Reporting and Register. The National Register of consideration. Recordkeeping Requirements, the Historic Places Registration Form Copies of the proposed information National Park Service invites public documents properties nominated for collection and related explanatory comments on a proposed information listing in the National Register and material may be obtained by contacting collection request (ICR). Comments are demonstrates that they meet the criteria Dennis C. Jones, Rules and Publications invited on: (1) The need for information established for inclusion. The Staff, telephone (303) 231–3046, FAX including weather the information has documentation is used to assist in (303) 231–3385, e-Mail practical utility; (2) the accuracy of the preserving and protecting the properties [email protected]. reporting burden estimate; (3) ways to and for heritage education and enhance the quality, utility, and clarity interpretation National Register DATES: Written comments should be of the information to be collected: and properties must be considered in the received on or before April 16, 1999. (4) ways to minimize the burden of planning for Federal or federally SUMMARY: The Federal Oil and Gas information collection on respondents, assisted projects. National Register Royalty Simplification and Fairness Act including the use of automated listing is required for eligibility for the of 1996 (RSFA), Pub. L. 104–185, as collection techniques or other forms of federal rehabilitation tax incentives. information technology. corrected by Pub. L. 104–200, Description of respondents: The The primary purpose if the ICR is to affected public are State, tribal, and establishes the owners of operating nominate properties for listing in the local governments, Federal agencies, rights and/or lease record title (who are National Register of Historic Places, the business, non-profit organizations, and jointly defined as ‘‘lessees’’ under office list of the Nation’s cultural individuals. Nominations to the RSFA) as responsible for making royalty resources worthy of preservation, which National Register of Historic Places are and related payments on a Federal lease. public law requires that the Secretary of voluntary. Currently, it is common for a payor the Interior maintain and expand. Estimated annual reporting burden: rather than a lessee to make royalty and Properties are listed in the National 56,700 hours. related payments on a Federal lease. Register upon nomination by State Estimated average burden hours per When a payor pays royalties on a Historic Preservation Officers and response: 18 hours. Federal lease on behalf of a lessee, Federal Preservation Officers. Law also Estimated average number of RSFA requires that the lessee certify to requires Federal agencies to request respondents: 1,575. MMS in writing that a particular payor determinations of eligibility for property Estimated frequency of response: has been designated by the lessee to under their jurisdiction of affected by 1,575 annually. make such royalty and related payments their program and projects. The forms Leonard Stowe, to MMS on behalf of the lessee. RSFA provide the historic documentation on Information Collection Clearance Officer, made this payor designation which decisions for listing and National Park Service, WAPC. requirement effective for lease eligibility are based. [FR Doc. 99–6422 Filed 3–16–99; 8:45 am] production beginning September 1, DATES: Public comments will be BILLING CODE 4310±70±M 1996. accepted on or before May 17, 1999. Description of Respondents: Federal ADDRESSES: Send comments to Carol DEPARTMENT OF THE INTERIOR lessees. Shull, Keeper of the National Register, National Park Service, 1849 ‘‘C’’ Street Frequency of Response: As necessary. NW, Rm. NC 400, Washington, DC National Park Service Estimated Reporting and 20240. Notice of Boundary Revision, Cabrillo Recordkeeping Burden: 45 minutes. All responses to this notice will be summarized and included in the request National Monument Annual Responses: 11,500. for OMB approval. All comments will AGENCY: National Park Service, DOI. Annual Burden Hours: 8,625 hours. become a matter of public record. ACTION: Notice of boundary revision, Copies of the proposed ICR requirement Bureau Clearance Officer: Jo Ann Cabrillo National Monument. Lauterbach, (202) 208–7744. can be obtained from Carol Shull, Dated: February 17, 1999. Keeper of the National Register, SUMMARY: This notice announces a Lucy Querques Denett, National Park Service, 1849 ‘‘C’’ Street, revision of the boundary of Cabrillo Rm. NC 400, Washington, D.C. 20240. Associate Director for Royalty Management. National Monument to include three FOR FURTHER INFORMATION CONTACT: parcels of land needed for (1) the proper [FR Doc. 99–6450 Filed 3–16–99; 8:45 am] Carol Shull, (202) 343–9504. care and management of the Monument BILLING CODE 4310±MR±P SUPPLEMENTARY INFORMATION: and the historical landmarks and

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The surveys were conducted to gather information and express their views, Department of the Navy has declared information and the opinions of and to meet with interested members of these parcels as excess to its needs and stakeholders in order to begin the public in assessing the potential has recommended they be transferred to preparation of the ORVMP/SEIS. effects of the alternative options of the the National Park Service for inclusion DATES: Public comments will be ORVMP/SEIS. in the boundary of the Monument in accepted on or before April 16, 1999. The National Park Service will accordance with a Memorandum of Anyone wishing to provide comments analyze alternatives so as to evaluate Agreement dated January 12, 1970. or suggestions on the proposed action differing options for resource protection, FOR FURTHER INFORMATION CONTACT: should provide comments to the visitor use, access, safety and Sondra S. Humphries, Chief, Pacific Superintendent at the address stated operations. As a conceptual framework Land Resources Program Center at (415) below. for formulating these alternatives, the 427–1416. Following publication of a draft purposes of the Preserve and associated ORVMP/SEIS, representatives of significant natural and cultural SUPPLEMENTARY INFORMATION: Notice is Federal, Tribal, State and local agencies, resources, major visitor experiences and hereby provided that the boundary of private organizations and individuals management objectives will be Cabrillo National Monument, from the general public will be afforded specified. established pursuant to Presidential an opportunity to comment at a public The subsequent availability of the Proclamation No. 1255 on October 14, meeting. The date, time, and location of ORVMP/SEIS will be announced by 1913, as amended, is revised, effective the public meeting will be announced in formal notice and via local and regional as of the date of publication of this local and regional news media. news media. The draft ORVMP/SEIS is notice, to include three parcels of land ADDRESSES: Anyone wishing to provide anticipated to be completed and situated in San Diego County, State of available for public review in 1999. The California. The above parcels aggregate comments or suggestions on the ORVMP/SEIS may send such final ORVMP/SEIS is expected to be 25.60 acres, more or less, and are completed approximately four months identified as Tract Nos. 01–103, 01–104 information to: Superintendent, Big Cypress National Preserve, HCR 61, Box later, with a Record of Decision and 01–106 on Boundary Proposal Map, published in the Federal Register not Drawing No. 342/80,034, dated July, 110, Ochopee, FL 34141. SUPPLEMENTARY INFORMATION: An ORV sooner than 30 days after distribution of 1997. The map is on file at the National the final ORVMP/SEIS documents. Park Service, Pacific Land Resources management plan was initially called Program Center, 600 Harrison Street, for in the final General Management Dated: March 10, 1999. Suite 600, San Francisco, California Plan/Environmental Impact Statement Danielle Brown, 94107–1372 (1992) for the Preserve. An October 1995 Regional Director, Southeast Region. Settlement Agreement filed in the U.S. [FR Doc. 99–6421 Filed 3–16–99; 8:45 am] Dated: February 26, 1999. District Court for the Middle District of BILLING CODE 4310±70±M John Reynolds, Florida also required issuance of the Regional Director, Pacific West Region. ORVMP/SEIS. [FR Doc. 99–6423 Filed 3–16–99; 8:45 am] Since 1995, working through a DEPARTMENT OF THE INTERIOR BILLING CODE 4310±70±P cooperative agreement with the Virginia Polytechnic Institute and State National Park Service University, the National Park Service DEPARTMENT OF THE INTERIOR Notice of Availability of a Plan of has been collecting data and public Operations and Environmental opinion for the development of an ORV National Park Service, DOI Assessment for Existing Natural Gas plan for the Preserve. Efforts to collect Pipelines at Padre Island National Notice of Intent To Prepare an Off- data and information included meetings Seashore, Kenedy and Kleberg Road Vehicle Management Plan/ and interviews with groups, Counties, Texas Supplement to the Final Environmental organizations and individuals from a Impact Statement (ORVMP/SEIS), Big variety of sectors including ORV and The National Park Service has Cypress National Preserve, National hunting groups, hiking clubs, received, for approval, from Houston Park Service environmental groups, employees or Pipe Line Company, a Plan of associates of the Miccosukee or Operations for Existing Natural Gas SUMMARY: A notice of intent for this Seminole Tribes, state agencies, and Pipelines at Padre Island National action that omitted a reference to the other federal agencies. Other methods Seashore. An approved Plan of SEIS component of the plan was used to gather and solicit information Operations would serve as a permit for published on January 22, 1996. One from the public included a mail-back the pipeline operations. purpose of this notice is to correct this ORV visitors-use survey, a Website and Pursuant to § 9.52(b) of Title 36 of the omission. Further, in accordance with E-mail, and two newsletters, distributed Code of Federal Regulations, Part 9, Section 102(2)(C) of the Environmental in 1996 and 1997 to an estimated 1600 Subpart B (36 CFR 9B); the Plan of Policy Act of 1969 (Pub. L. 91–190), the people. Operations and Environmental National Park Service has initiated a The National Park Service has now Assessment are available for public supplemental environmental impact entered that phase of the project in review and comment for a period of 30 analysis process to identify and assess which alternatives for the management days from the publication date of this potential impacts of alternative options of ORVs in the Preserve will be notice in the Office of the for the management of off-road vehicles developed and considered. In Superintendent, Padre Island National within the Big Cypress National accordance with the aforementioned Seashore, 20301 Park Road 22, Corpus Preserve. Key management concerns National Environmental Policy Act Christi, Texas. Copies of the documents

VerDate 03-MAR-99 16:11 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm01 PsN: 17MRN1 13234 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices are available from the Superintendent, publication revises the system location Appropriation Act, 1977, Pub. L. 94– Padre Island National Seashore, P.O. and the system manager’s title and 438, 90 Stat. 1415; and annual Energy Box 181300 Corpus Christi, Texas address. Federal Government and Water Development Appropriation 78480–1300, Telephone (361) 949–8173, organization titles have been updated Acts. extension 224. and other minor editorial changes made. Jock Whitworth, • Acreage Limitation, WBR–31, PURPOSE(S): previously published in the Federal Superintendent. For settlement of damages relating to [FR Doc. 99–6420 Filed 3–16–99; 8:45 am] Register on March 9, 1994 (59 FR 11085). This publication revises the tort and non-tortious claims and for loss BILLING CODE 4310±70±P retention and disposal statement to or damage to employee’s personal reflect the revisions to the Acreage property resulting from activities of Reclamation. Routine uses of records DEPARTMENT OF THE INTERIOR Limitation Rules and Regulations, 43 CFR part 426, which became effective maintained in the system, including Bureau of Reclamation January 1, 1998. Specifically, the categories of users and the purposes of retention period of the certification and such uses: Privacy Act of 1974, as Amended; reporting forms (including verification The primary uses of the records are to System of Records forms) is changed from 3 to 6 years and establish the facts and circumstances of the Code of Federal Regulations cited is AGENCY: Bureau of Reclamation, each claim, compile statistical data, and changed from 43 CFR 426.10(h) to 43 Interior. evaluate claims. Disclosures outside the CFR 426.19(e). The term ‘‘Federal ACTION: Notice of minor changes to two Department of the Interior may be made: Employer’s Identification Numbers’’ is (1) To the Department of Justice when systems of records. changed to ‘‘Taxpayer’s Identification related to litigation or anticipated Numbers’’ in the categories of records in SUMMARY: Pursuant to the provisions of litigation; (2) of information indicating a the system and the retrievability the Privacy Act of 1974, as amended (5 violation or potential violation of a statements. In addition, the term U.S.C. 552a), notice is hereby given that statute, regulation, rule, order, or license the Department of the Interior proposes ‘‘Individual Taxpayer’s Identification Numbers’’ is added to both statements. to appropriate Federal, State, local, or minor changes to two systems of records foreign agencies responsible for managed by the Bureau of Reclamation Organization titles have been updated and other minor editorial changes made. investigating or prosecuting the (Reclamation). These changes are to the violation or for enforcing or systems of records: All other changes proposed are editorial in nature. implementing the statute, rule, ‘‘Claims, WBR–5’’ regulation, order, or license; (3) from the ‘‘Acreage Limitation, WBR–31’’ Rayleen Cruz, Manager, Property and Facilities Group. record of an individual in response to The above notices are published in an inquiry from a congressional office their entirety below. INTERIOR/WBR±5 made at the request of that individual; DATES: These actions are effective March SYSTEM NAME: (4) where relevant or necessary to the 17, 1999. hiring or retention of an employee, or Claims. FOR FURTHER INFORMATION CONTACT: For the issuance of a security clearance, information regarding ‘‘Claims, BOR–5’’ SYSTEM LOCATION: license, contract, grant, or other benefit, contact Ms. Debra Lange, Property and Commissioner’s Office, Reclamation information may be disclosed: (a) To a Office Services, Policy and Systems Service Center, and Regional Offices: Federal agency that has requested the Team at (303) 445–2030, or for Pacific Northwest, Mid-Pacific, Lower information, or (b) to a Federal, State, or information regarding ‘‘Acreage Colorado, Upper Colorado, and Great local agency to enable the Department of Limitation, BOR–31’’ contact Mr. Plains. See appendix for addresses. the Interior to obtain information from Richard Rizzi, Reclamation Law, such agency; (5) to the Soil Contracts, and Repayment Office at CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Conservation Service, and Farm Service (303) 445–2900. For general information Agency of the Department of regarding Reclamation’s Privacy Act Individuals who have filed tort, employee, or appropriation act claims, Agriculture (USDA); Federal Emergency program, call Mr. Casey Snyder at (303) Management Agency, Army Corps of 445–2048. and claims under the Teton Dam Disaster Assistance Act. Engineers, and Department of Housing SUPPLEMENTARY INFORMATION: Recent and Urban Development to assure that Privacy Act Compilations list the CATEGORIES OF RECORDS IN THE SYSTEM: benefits to claimants have not been following systems of records with a Records include claims and duplicated by the several agencies prefix of ‘‘Reclamation’’ (e.g., supporting documents submitted, involved in disaster programs; (6) to the Reclamation-5). When originally information developed during Department of Treasury, Internal published in the Federal Register these investigations of claims, and final Revenue Service, and State revenue and systems of records were identified with disposition. taxation departments relative to an organization prefix of ‘‘WBR’’ (e.g., WBR–5). The content of the systems of AUTHORITY FOR MAINTENANCE OF THE SYSTEM: compensation for loss of salary or records is the same; the prefixes on Federal Tort Claims Act, 28 U.S.C. income; (7) to the Small Business these systems were changed to reflect 2671–2680; Military Personnel and Administration, Farm Service Agency, organizational changes. Civilian Employees’ Claims Act, 31 and Department of Housing and Urban The system of records notices being U.S.C. 3701, 3721; Public Works for Development regarding loans secured revised and the reason for revision are Water and Power Development and through those agencies; and (8) to listed below: Energy Research Appropriation Act, General Services Administration (GSA) • Claims, WBR–5, previously 1977, Pub. L. 94–355, 90 Stat. 889; to document problems with GSA published in the Federal Register on Teton Dam Disaster Assistance Act, Pub. contract movers which result in claims September 27, 1984 (49 FR 38195). This L. 94–400, 90 Stat. 1211; Supplemental against Reclamation.

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POLICIES AND PRACTICES FOR STORING, acreage limitation provisions of Federal that the disclosure is relevant or RETRIEVING, ACCESSING, RETAINING, AND reclamation law, and individuals that necessary to the litigation and is DISPOSING OF RECORDS IN THE SYSTEM: operate such land. compatible with the purpose for which STORAGE: Note: Records pertaining to corporate or the records were compiled; (2) Of Maintained in manual form in file other commercial entities are also maintained information indicating a violation or folders. in the system. Only records pertaining to potential violation of a statute, individuals are protected by the Privacy Act. regulation, rule, order, lease, license, RETRIEVABILITY: contract, grant, or other agreement to By claimant’s name. CATEGORIES OF RECORDS IN THE SYSTEM: appropriate Federal, State, tribal, For owners, lessees, and operators: territorial, local, or foreign agencies SAFEGUARDS: Names, addresses, and telephone responsible for investigating or Records are maintained with numbers. prosecuting the violation of, or for safeguards in accordance with the For owners and lessees: Taxpayer’s enforcing, implementing, or requirements of 43 CFR 2.51 for manual Identification Numbers; Individual administering a statute, regulation, rule, records. Taxpayer’s Identification Numbers; order, lease, license, contract, grant, or Social Security Numbers; citizenship RETENTION AND DISPOSAL: other agreement; (3) To a congressional status; status pursuant to Federal office from the record of an individual In accordance with approved reclamation law; legal descriptions or in response to an inquiry the individual retention and disposal schedules. assessor parcel numbers; deeds; has made to the congressional office; (4) SYSTEM MANAGER(S) AND ADDRESS: contracts or agreements relative to the To non-Federal auditors under contract transfer of land ownerships, including Claims Officers in the Reclamation with the Department of the Interior to excess land sales and pertinent details Service Center, Commissioner’s Office, perform audits relating to the acreage of such sales; signature authorization and Regional Offices: Pacific Northwest, limitation program; (5) To the Internal documents; power-of-attorney Mid-Pacific, Lower Colorado, Upper Revenue Service for the purpose of documents; irrevocable elections; terms Colorado, and Great Plains. See reporting the existence of ‘‘illegal and effective dates of leases; leases; appendix for addresses. Federal irrigation subsidies’’ as defined lease/purchase options; trust by Section 90 of the Internal Revenue NOTIFICATION PROCEDURE: agreements; partnership agreements; Code; and (6) To financial institutions Inquiries regarding the existence of a and corporate resolutions. for the purpose of acquiring information record(s) should be addressed to the For farm operators: Farm operating needed by the lender to complete the System Manager at the appropriate agreements, type of services provided, certification and reporting requirements address listed in the appendix. See 43 acreage operated by farm operators, and of the Reclamation Reform Act of 1982 CFR 2.60. other pertinent details. (43 U.S.C. 390aa) for involuntarily Authority for maintenance of the acquired irrigable or irrigation land. RECORD ACCESS PROCEDURES: system: Reclamation Act of 1902, as Same as Notification above. See 43 amended and supplemented (43 U.S.C. DISCLOSURE TO CONSUMER REPORTING CFR 2.63. 371), especially sections 206, 224(c), AGENCIES: 224(g), and 228 of the Reclamation Disclosure pursuant to 5 U.S.C. CONTESTING RECORD PROCEDURES: Reform Act of 1982 (43 U.S.C. 390aa). 552a(b)(12). Disclosures may be made Written petitions for amendment from this system to consumer reporting should be sent to the System Manager PURPOSE(S): agencies as defined in the Fair Credit at the appropriate address listed in the The primary purpose of the system is Reporting Act (15 U.S.C. 1681a(f)) or the appendix. See 43 CFR 2.71. to obtain from landowners and lessees Federal Claims Collection Act of 1966 written information on their (31 U.S.C. 3701(a)(3)). RECORD SOURCE CATEGORIES: landholdings that is pertinent to their POLICIES AND PRACTICES FOR STORING, Claimants. Investigations conducted compliance with the ownership and by Reclamation officials and RETRIEVING, ACCESSING, RETAINING, AND full-cost pricing provisions of Federal DISPOSING OF RECORDS IN THE SYSTEM: contractors, officials of the Department reclamation law. of the Interior, and State and local STORAGE: governments. ROUTINE USES OF RECORDS MAINTAINED IN THE Records are maintained in manual SYSTEM, INCLUDING CATEGORIES OF USERS AND form in file folders and, where INTERIOR/WBR±31 THE PURPOSES OF SUCH USES: automated, on magnetic media. SYSTEM NAME: The data collected are used by district and Bureau of Reclamation personnel to RETRIEVABILITY: Acreage Limitation. determine compliance with Federal Manual records are retrieved by SYSTEM LOCATION: reclamation law. district and/or landholder name, by (1) District offices in which subject Disclosures outside the Department of assessor parcel number, by excess land individuals submitted certification and the Interior may be made pursuant to 43 sale number, and/or by acreage reporting forms (addresses may be CFR 2.56 and: (1) To the U.S. limitation topic (e.g., trusts, farm obtained from the applicable regional Department of Justice or in a proceeding operators, etc.). Automated records are office); (2) Regional offices listed in the before a court or adjudicative body retrieved by district identification appendix; and (3) Bureau of when (a) the United States, the number; sale number; landholder name; Reclamation, PO Box 25007, Denver, Department of the Interior, a component operator name; Social Security Number Colorado 80225–0007. of the Department, or when represented (if available); Taxpayer’s Identification by the Government, an employee of the Number; Individual Taxpayer’s CATEGORIES OF INDIVIDUALS COVERED BY THE Department is a party to litigation or Identification Number; telephone SYSTEM: anticipated litigation or has an interest number; address; and/or identifying Individuals that directly or indirectly in such litigation, and (b) the property characteristics, such as an own or lease land that is subject to the Department of the Interior determines assessor’s parcel number.

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SAFEGUARDS: in which they have filed forms. For public and affected agencies have an Records are maintained with request for amendment of other records opportunity to comment on information safeguards in accordance with in this system, individuals may send a collection and recordkeeping activities requirements of 43 CFR 2.51 for manual written request to the appropriate office [see 5 CFR 1320.8(d)]. OSM has and computer records, and 43 CFR 2.52 listed under ‘‘System Location.’’ If you submitted two requests to OMB to for conduct of employees handling are unable to determine which office renew its approval of the collections of records subject to the Act. has the records, you may address your information contained in: 30 CFR Part inquiry to the nearest Reclamation office 750, Requirements for surface coal RETENTION AND DISPOSAL: listed in the appendix, or to the System mining and reclamation operations on Certiification and reporting forms Manager. Requests for amendment of Indian Lands; and 30 CFR Part 877, (including verification forms) are records shall be in writing, signed by Rights of entry. OSM is requesting a 3- retained for 6 years, at a minimum. The the requester, and in compliance with year term of approval for each most current fully completed the content requirements of 43 CFR information collection activity. certification and reporting forms are 2.71. An agency may not conduct or maintained on file with the most current sponsor, and a person is not required to RECORD SOURCE CATEGORIES: verification form, in accordance with 43 respond to, a collection of information CFR 426.19(e). All other records are Individuals on whom records are unless it displays a currently valid OMB retained in compliance with Bureau of maintained, certain Federal agencies, control number. The OMB control Reclamation retention schedules that State and local governmental units, and numbers for these collections of have been approved by the National land appraisers. information are 1029–0091 for Part 750, Archives and Records Administration. [FR Doc. 99–6470 Filed 3–12–99; 8:45 am] and 1029–0055 for Part 877. SYSTEM MANAGER(S) AND ADDRESS: BILLING CODE 4310±10±P As required under 5 CFR 1320.8(d), a Manager, Reclamation Law, Contracts, Federal Register notice soliciting and Repayment Office, Bureau of comments for these collections of Reclamation, Denver Federal Center, PO DEPARTMENT OF THE INTERIOR information was published on January 4, 1999 (64 FR 179). No comments were Box 25007, Denver, Colorado 80225– Office of Surface Mining Reclamation 0007. received. This notice provides the and Enforcement public with an additional 30 days in NOTIFICATION PROCEDURE: which to comment on the following Notice of Proposed Information For inquiries regarding the existence information collection activities: Collection of their own certification and reporting Title: Requirements for surface coal forms, individuals should contact the AGENCY: Office of Surface Mining mining and reclamation operations on districts in which they have filed forms. Reclamation and Enforcement. Indian Lands—30 CFR Part 750. For requests for access to other records ACTION: Notice and request for OMB Control Number: 1029–0091. in the system, individuals may send a comments. Summary: Operators who conduct or written request to the appropriate office propose to conduct surface coal mining listed under ‘‘System Location.’’ If you SUMMARY: In compliance with the and reclamation operations on Indian are unable to determine which office Paperwork Reduction Act of 1995, the lands must comply with the has the records, you may address your Office of Surface Mining Reclamation requirements of 30 CFR 750 pursuant to inquiry to the nearest Reclamation office and Enforcement (OSM) is announcing Section 710 of SMCRA. listed in the appendix, or to the System that the information collection requests Bureau Form Number: None. Manager. Requests for notification of the for the titles described below have been Frequency of Collection: On occasion. existence of records shall be in writing, forwarded to the Office of Management Description of Respondents: signed by the requester, and in and Budget (OMB) for review and Applicants for coal mining permits. compliance with the content comment. The information collection Total Annual Responses: 75. requirements of 43 CFR 2.60. requests describe the nature of the Total Annual Burden Hours: 1,400. information collections and the Title: Rights of Entry—30 CFR Part RECORDS ACCESS PROCEDURES: expected burden and cost for 30 CFR For requests for access to their own 877. Parts 750 and 877. OMB Control Number: 1029–0055. certification and reporting forms, DATES: OMB has up to 60 days to individuals may contact the district(s) Summary: This regulation establishes approve or disapprove the information procedures for non-consensual entry in which they have filed forms. For collections but may respond after 30 requests for access to other records in upon private lands for the purpose of days. Therefore, public comments abandoned mine land reclamation the system, individuals may send a should be submitted to OMB by April written request to the appropriate office activities or exploratory studies when 16, 1999 in order to be assured of the landowner refuses consent or is not listed under ‘‘System Location.’’ If you consideration. are unable to determine which office available. FOR FURTHER INFORMATION CONTACT: To has the records, you may address your Bureau Form Number: None. request a copy of either information inquiry to the nearest Reclamation office Frequency of Collection: On occasion. collection request, explanatory listed in the appendix, or to the System Description of Respondents: State information and related forms, contact Manager. Requests for access to records abandoned mine land reclamation John A. Trelease at (202) 208–2783, or shall be in writing, signed by the agencies. electronically to [email protected]. requester, and in compliance with the Total Annual Responses: 30. content requirements of 43 CFR 2.63. SUPPLEMENTARY INFORMATION: The Office Total Annual Burden Hours: 30. of Management and Budget (OMB) Send comments on the need for the CONTESTING RECORD PROCEDURES: regulations at 5 CFR 1320, which collections of information for the For requests for amendment of their implement provisions of the Paperwork performance of the functions of the own certification and reporting forms, Reduction Act of 1995 (Pub. L. 104–13), agency; the accuracy of the agency’s individuals shall contact the district(s) require that interested members of the burden estimates; ways to enhance the

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13237 quality, utility and clarity of the Information Management and Security instrument with instructions, or information collections; and ways to Staff, Attention: Department Clearance additional information, please contact minimize the information collection Officer, Suite 850, 1001 G Street, NW., Mr. Richard A. Sloan, 202–514–3291, burdens on respondents, such as use of Washington, DC 20530. Comments may Director, Policy Directives and automated means of collections of the also be submitted to DOJ via facsimile Instructions Branch, Immigration and information, to the following addresses. to 202–514–1534. Naturalization Service, U.S. Department Please refer to the appropriate OMB Written comments and suggestions of Justice, Room 5307, 425 I Street, NW., control numbers in all correspondence. from the public and affected agencies Washington, DC 20536. ADDRESSES: Office of Information and should address one or more of the If additional information is required Regulatory Affairs, Office of following four points: contact: Mr. Robert B. Briggs, Clearance Management and Budget, Attention: (1) Evaluate whether the proposed Officer, United States Department of Department of Interior Desk Officer, 725 collection of information is necessary Justice, Information Management and 17th Street, NW, Washington, DC 20503. for the proper performance of the Security Staff, Justice Management Also, please send a copy of your functions of the agency, including Division, Suite 850, Washington Center, comments to John A. Trelease, Office of whether the information will have 1001 G Street, NW, Washington, DC Surface Mining Reclamation and practical utility; 20530. (2) Evaluate the accuracy of the Enforcement, 1951 Constitution Ave, Dated: March 9, 1999. agency’s estimate of the burden of the NW, Room 210—SIB, Washington, DC Richard A. Sloan, 20240, or electronically to proposed collection of information, [email protected]. including the validity of the Department Clearance Officer, United States methodology and assumptions used; Department of Justice, Immigration and Dated: March 12, 1999. Naturalization Service. (3) Enhance the quality, utility, and Richard G. Bryson, clarity of the information to be [FR Doc. 99–6462 Filed 3–16–99; 8:45 am] Chief, Division of Regulatory Support. collected; and BILLING CODE 4410±10±M [FR Doc. 99–6443 Filed 3–16–99; 8:45 am] (4) Minimize the burden of the BILLING CODE 4310±05±M collection of information on those who are to respond, including through the DEPARTMENT OF JUSTICE use of appropriate automated, Immigration and Naturalization Service DEPARTMENT OF JUSTICE electronic, mechanical, or other technological collection techniques or Agency Information Collection Immigration and Naturalization Service other forms of information technology, Activities: e.g., permitting electronic submission of Agency Information Collection responses. ACTION: Notice of Information Collection Activities Under Review; ABC Change of Address Overview of this Information Collection ACTION: Notice of Information Collection form and Special Filing Instructions for Under Review; Guam Visa Waiver (1) Type of Information Collection: ABC Class Members. Agreement. Reinstatement without change of previously approved information The Office of Management and Budget The Office of Management and Budget collection. (OMB) approval is being sought for the (OMB) approval is being sought for the (2) Title of the Form/Collection: Guam information collection listed below. information collection listed below. Visa Waiver Agreement. This proposed information collection This proposed information collection (3) Agency form number, if any, and was previously published in the Federal was previously published in the Federal the applicable component of the Register on June 22, 1998 at 63 FR Register on August 13, 1998 at 63 FR Department of Justice sponsoring the 33951, allowing for a 60-day public 43420, allowing for a 60-day public collection: Form I–760. Inspections comment period. No comments were comment period. No comments were Division, Immigration and received by the Immigration and received by the Immigration and Naturalization Service. Naturalization Service. The purpose of Naturalization Service. The purpose of (4) Affected public who will be asked this notice is to allow an additional 30 this notice is to allow an additional 30 or required to respond, as well as a brief days for public comments. Comments days for public comments. Comments abstract: Primary: Business or other for- are encouraged and will be accepted are encouraged and will be accepted profit. Public Law 99–396 provides for until; April 16, 1999. This process is until April 16, 1999. This process is certain aliens to be exempt from the conducted in accordance with 5 CFR conducted in accordance with 5 CFR nonimmigrant visa requirements if Part 1320.10. Part 1320.10. seeking entry into and stay on Guam as Written comments and/or suggestions Written comments and/or suggestions a visitor under certain conditions. This regarding the item(s) contained in this regarding the item(s) contained in this form is the agreement between the notice, especially regarding the notice, especially regarding the carrier of the alien and the United estimated public burden and associated estimated public burden and associated States. response time, should be directed to the response time, should be directed to the (5) An estimate of the total number of Office of Management and Budget, Office of Management and Budget, respondents and the amount of time Office of Information and Regulatory Office of Information and Regulatory estimated for an average respondent to Affairs, Attention: Stuart Shapiro, 202– Affairs, Attention: Stuart Shapiro, 202– respond: 5 responses at 15 minutes (.25 395–7316, Department of Justice Desk 395–7316, Department of Justice Desk hours) per response. Officer, Washington, DC 20503. Officer, Washington, DC 20503. (6) An estimate of the total public Additionally, comments may be Additionally, comments may be burden (in hours) associated with the submitted to OMB via facsimile to 202– submitted to OMB via facsimile to 202– collection: 1 annual burden hour. 395–7285. Comments may also be 395–7285. Comments may also be If you have additional comments, submitted to the Department of Justice submitted to the Department of Justice suggestions, or need a copy of the (DOJ), Justice Management Division, (DOJ), Justice Management Division, proposed information collection Information Management and Security

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Staff, Attention: Department Clearance If you have additional comments, 7. Abstract: The mandatory Officer, Suite 850, 1001 G Street, NW., suggestions, or need a copy of the requirements of the NRCAR implement Washington, DC 20530. Comment may proposed information collection and supplement the government-wide also be submitted to DOJ via facsimile instrument with instructions, or Federal Acquisition Regulation, and to 202–514–1534. additional information, please contact ensure that the regulations governing Written comments and suggestions Mr. Richard A. Sloan, 202–514–3291, the procurement of goods and services from the public and affected agencies Director, Policy Directives and within the NRC satisfy the needs of the should address one or more of the Instructions Branch, Immigration and agency. following four points: Naturalization Service, U.S. Department Submit by (May 17, 1999), comments (1) Evaluate whether the proposed of Justice, Room 5307, 425 I Street, NW., that address the following questions: collection of information is necessary Washington, DC 20536. 1. Is the proposed collection of for the proper performance of the If additional information is required information necessary for the NRC to functions of the agency, including contact: Mr. Robert B. Briggs, Clearance properly perform its functions? Does the whether the information will have Officer, United States Department of information have practical utility? practical utility; Justice, Information Management and 2. Is the burden estimate accurate? (2) Evaluate the accuracy of the Security Staff, Justice Management 3. Is there a way to enhance the agency’s estimate of the burden of the Division, Suite 850, Washington Center, quality, utility, and clarity of the proposed collection of information, 1001 G Street, NW., Washington, DC information to be collected? including the validity of the 20530. 4. How can the burden of the methodology and assumptions used; information collection be minimized, (3) Enhance the quality, utility, and Dated: March 9, 1999. including the use of automated clarity of the information to be Richard A. Sloan, collection techniques or other forms of collected; and Department Clearance Officer, United States information technology? (4) Minimize the burden of the Department of Justice, Immigration and A copy of the supporting statement collection of information on those who Naturalization Service. may be viewed free of charge at the NRC are to respond, including through the [FR Doc. 99–6463 Filed 3–16–99; 8:45 am] Public Document Room, 2120 L Street, use of appropriate automated, BILLING CODE 4410±10±M NW (lower level), Washington, DC. electronic, mechanical, or other OMB clearance requests are available at technological collection techniques or the NRC worldwide website (http:// other forms of information technology, NUCLEAR REGULATORY www.nrc.gov/NRC/PUBLIC/OMB/ e.g., permitting electronic submission of COMMISSION index.html). The document will be responses. available on the NRC home page site for Agency Information Collection 60 days after the signature date of this Overview of this Information Collection Activities: Proposed Collection; notice. (1) Type of Information Collection: Comment Request Comments and questions should be Reinstatement without change of directed to the NRC Clearance Officer, previously approved information AGENCY: U.S. Nuclear Regulatory Brenda Jo Shelton, U.S. Nuclear collection. Commission (NRC). Regulatory Commission, T–6 F33, (2) Title of the Form/Collection: ABC ACTION: Notice of pending NRC action to Washington, DC. 20555–0001, or by Change of Address Form and Special submit an information collection telephone at (301) 415–7233, or by Filing Instructions for ABC Class request to OMB and solicitation of Internet electronic mail at Members. public comment. [email protected]. (3) Agency form number, if any, and SUMMARY: The NRC is preparing a Dated at Rockville, Maryland, this 11th day the applicable component of the of March, 1999. Department of Justice sponsoring the submittal to OMB for review of For the Nuclear Regulatory Commission. collection: Forms I–855 and M–426. continued approval of information Office of International Affairs, Asylum collections under the provisions of the Brenda Jo Shelton, Division, Immigration and Paperwork Reduction Act of 1995 (44 NRC Clearance Officer, Office of the Chief Naturalization Service. U.S.C. Chapter 35). Information Officer. (4) Affected public who will be asked Information pertaining to the [FR Doc. 99–6453 Filed 3–16–99; 8:45 am] or required to respond, as well as a brief requirement to be submitted: BILLING CODE 7590±01±P abstract: Primary: Individuals or 1. The title of the information Households. This form is mandated by collection: U.S. Nuclear Regulatory the American Baptist Churches v. Commission Acquisition Regulation NUCLEAR REGULATORY Thornburgh, 760 F. Supp. 796 (N.D. Cal. (NRCAR). COMMISSION 1991) and will be used by class 2. Current OMB approval number: Agency Information Collection members to inform the INS of address 3150–0169. Activities: Submission for OMB changes. 3. How often the collection is Review; Comment Request (5) An estimate of the total number of required: On occasion; one time. respondents and the amount of time 4. Who is required to report: Offerors AGENCY: U. S. Nuclear Regulatory estimated for an average respondent to responding to NRC solicitations and Commission (NRC). respond: 250,000 I–855 responses at 30 contractors receiving contract awards ACTION: Notice of the OMB review of minutes (.50 hours) per response; and from NRC. information collection and solicitation 250,000 M–426 responses at 2 hours per 5. The number of annual respondents: of public comment. response. 750. (6) An estimate of the total public 6. The number of hours needed SUMMARY: The NRC has recently burden (in hours) associated with the annually to complete the requirement or submitted to OMB for review the collection: 625,000 annual burden request: 120,449 (10.6 hours per following proposal for the collection of hours. response). information under the provisions of the

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Paperwork Reduction Act of 1995 (44 because of the addition of requirements form of uranium waste tailings U.S.C. Chapter 35). The NRC hereby for decommissioning funding generated by the licensee’s milling informs potential respondents that an requirements, financial assurance operations at the site. In accordance agency may not conduct or sponsor, and provisions, documentation additions for with the requirements of 10 CFR Part that a person is not required to respond decommissioning and license 51, an Environmental Assessment (EA) to, a collection of information unless it termination, and notification of was performed by the NRC staff in displays a currently valid OMB control incidents. support of its review of PMC’s number. A copy of the final supporting Environmental Report (ER) on the status 1. Type of submission, new, revision, statement may be viewed free of charge of Reid Draw. The conclusion of the or extension: Revision. at the NRC Public Document Room, Environmental Assessment is a Finding 2. The title of the information 2120 L Street, NW (lower level), of No Significant Impact (FONSI) of ‘‘no collection: 10 CFR Part 72, Licensing Washington, DC. OMB clearance action’’ proposal on cleanup of Reid Requirements for the Independent requests are available at the NRC Draw. Storage of Spent Nuclear Fuel and High- worldwide web site (http:// SUPPLEMENTARY INFORMATION: Level Radioactive Waste. www.nrc.gov/NRC/PUBLIC/OMB/ Background 3. How often the collection is index.html). The document will be required: Required reports are collected available on the NRC home page site for By its letter dated August 28, 1998, and evaluated on a continuing basis as 60 days after the signature date of this PMC submitted an ER on the status of events occur. Applications for new notice. radiological contamination of Reid licenses and amendments may be Comments and questions should be Draw. The draw is downgradient of the submitted at any time. Applications for directed to the OMB reviewer listed Lucky Mc tailings system at Gas Hills, renewal of licenses would be required below by April 16, 1999. Comments Wyoming. PMC presented three action every 20 years for an Independent Spent received after this date will be alternatives in the ER, and requested the Fuel Storage Installation (ISFSI) and considered if it is practical to do so, but NRC concurrence on its proposed ‘‘no every 40 years for a Monitored assurance of consideration cannot be action’’ alternative. Retrievable Storage (MRS) facility. given to comments received after this Reid Draw developed as a result of 4. Who will be required or asked to date. surface water erosion in the general area report: Vendors of casks for the storage Erik Godwin, Office of Information of the current Lucky Mc uranium mill of spent fuel, licensees and applicants and Regulatory Affairs (3150–0135), site and portions of the uranium mine for a license to possess power reactor NEOB–10202, Office of Management site that lie further to the south. Upon spent fuel and other radioactive and Budget, Washington, DC 20503. developing the mill, the mill tailings materials associated with spent fuel Comments can also be submitted by management structures were built at the storage in an ISFSI, and the Department telephone at (202) 395–3084. head of Reid Draw. In the early days of of Energy for licenses to receive, The NRC Clearance Officer is Brenda mill operation, there was only one transfer, package and possess power Jo. Shelton, 301–415–7233. embankment, the No. 1 solid tailings reactor spent fuel, high-level waste, and dam. It served as the sole tailings other radioactive materials associated Dated at Rockville, Maryland, this 11th day storage facility from the inception of with spent fuel and high-level waste of March 1999. milling in 1958 until 1960 when the No. storage in an MRS. For the Nuclear Regulatory Commission. 2 dam was constructed. A review of 5. The number of annual respondents: Brenda Jo. Shelton, early company records indicates that 8. NRC Clearance Officer, Office of the Chief excess tailings solution was routinely 6. The number of hours needed Information Officer. discharged down Reid Draw from the annually to complete the requirement or [FR Doc. 99–6452 Filed 3–16–99; 8:45 am] No. 1 dam until June 1, 1960, when the request: 21,529 (an average of BILLING CODE 7590±01±P No. 2 dam was commissioned. approximately 167 hours per response Apparently, this discharge was for applications and reports, plus considered acceptable and normal approximately 765 hours annually per NUCLEAR REGULATORY practice in those days since the site was recordkeeper). COMMISSION subject to Atomic Energy Commission 7. An indication of whether Section [Docket No. 40±2259] inspections during the timeframe of 3507(d), Pub. L. 104–13 applies: Not interest. The furthest down-gradient applicable. Pathfinder Mines Corporation embankment in the tailings system, the 8. Abstract: 10 CFR Part 72 establishes No. 4 dam was constructed in 1961. requirements, procedures, and criteria AGENCY: U.S. Nuclear Regulatory Reid Draw is subject to only for the issuance of licenses to receive, Commission. intermittent flows. However, a period of transfer, and possess power reactor ACTION: Final finding of no significant unusually rainy weather in June 1963 spent fuel and other radioactive impact notice of opportunity for culminated with a protracted storm on materials associated with spent fuel hearing. June 15. The No. 4 solution pond storage in an ISFSI, and requirements capacity had been taxed due to the for the issuance of licenses to the SUMMARY: Notice is hereby given that earlier precipitation, and the three Department of Energy to receive, the U.S. Nuclear Regulatory inches of rain on June 15 proved too transfer, package, and possess power Commission (NRC) proposes to amend much for the system. Out of concern for reactor spent fuel and high-level NRC Source Material License SUA–672, the integrity of the No. 4 dam in the radioactive waste, and other associated approving Pathfinder Mines imminent event of an uncontrolled radioactive materials, in an MRS. The Corporation’s (PMC’s ‘‘no action’’ overtopping, the decision was made to information in the applications, reports proposal on cleanup of Reid Draw cut a relief overflow, allowing some of and records is used by NRC to make located downgradient of the Lucky Mc the impounded water to escape. The licensing and other regulatory tailings system at Gas Hills, Wyoming. licensee documentation at the time determinations. The revised estimate of This license currently authorizes PMC indicates that an estimated 23 million burden reflects an increase primarily to possess byproduct material in the gallons of water were released. It should

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13240 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices be noted that this released water was revised pages to the ER; (2) results of Based on its review, the NRC staff has significantly diluted due to the NRC staff site visits and inspections of concluded that the environmental precipitation runoff. the facility; and (3) consultation with impacts associated with the ‘‘no action’’ The early releases and the single No. the Wyoming Department of proposal on cleanup of Reid Draw do 4 dam breach event account at least in Environmental Quality, Bureau of Land not warrant either the limiting of PMC’s part for the levels of radionuclides Management, and Philp Sheep future operations or the denial of the found in Reid Draw at the present time. Company. The technical aspects of the licensee’s request. Additionally, in the It is also likely that there is a natural proposal will be discussed separately in TER for this action, the staff will contribution to the radionuclide levels a Technical Evaluation Report (TER) document its evaluation of the in Reid Draw due to the fact that Reid that will accompany the final agency licensee’s proposal with respect to the Draw heads at the outcrop of a naturally licensing action. criteria for cleanup of off-pile areas of mineralized area. It is reasonable to The results of the staff’s appraisal are uranium mill sites as specified in 10 hypothesize that the erosion forces that documented in an EA placed in the CFR Part 40, Appendix A. Therefore, the created Reid Draw over time carried docket file. Based on its review, the staff considers that Alternative 1 is the some of this mineralization down the NRC staff has concluded that there are appropriate alternative for selection. draw. Since the controlled release no significant environmental impacts Finding of No Significant Impact during June 1963, there have been no associated with the ‘‘no action’’ other releases of tailings solutions to proposal. The NRC staff has prepared an EA for Reid Draw. the ‘‘no action’’ proposal on cleanup of The No. 4 dam underwent a major Conclusions Reid Draw. On the basis of this reconstruction during 1980–1981 that assessment, the NRC staff has concluded The NRC staff has examined actual entailed excavation down to competent that the environmental impacts that may and potential impacts associated with Cody Shale in order to key the dam into result from the ‘‘no action’’ proposal PMC’s ‘‘no action’’ proposal on cleanup impermeable material, and the overall would not be significant and, therefore, of Reid Draw, and has determined that size of the dam was expanded greatly. preparation of an Environmental Impact authorizing implementation of the ‘‘no There is no evidence of ground-water Statement is not warranted. action’’ proposal will not have long- impacts from seepage through the The EA and other related documents term detrimental impacts on the reconstructed dam, based upon the are available for public inspection and environment. The following statements monitoring data from the piezometers, copying at the NRC Public Document summarize the conclusions resulting and the monitoring of water quality in Room, in the Gelman Building, 2120 L from the staff’s environmental the immediately down-gradient point of Street NW, Washington, DC 20555. compliance well R–2 located in Reid assessment, and support the FONSI: Draw. (1) Present and potential risks were Notice of Opportunity for Hearing The Reid Draw gamma surveys assessed. The NRC staff determined that the The NRC hereby provides notice that conducted down-gradient from tailings risk factors for health and environmental this is a proceeding on an application dam No. 4 and beyond Reid Reservoir, hazards are insignificant in the licensee for a licensing action falling within the located on the draw owned by Philp proposed ‘‘no action’’ alternative; and scope of Subpart L, ‘‘Informal Hearing Sheep Company, indicate that the (2) Remediation would cause irreversible Procedures for Adjudications in damage to the current, very stable, measurable contamination terminates environment of Reid Draw. Materials and Operators Licensing just above Reid Reservoir. Reid Proceedings,’’ of the Commission’s Reservoir is some 3,000 meters (1.9 Because the staff has determined that Rules of Practice for Domestic Licensing miles) down the draw from the toe of there will be no significant impacts Proceedings and Issuance of Orders in No. 4 dam. The reservoir existed prior associated with approval of the ‘‘no 10 CFR Part 2 (54 FR 8269). Pursuant to to any up-gradient milling activity. action’’ proposal, there can be no § 2.1205(a), any person whose interest Additionally, radionuclide analysis of disproportionally high and adverse may be affected by this proceeding may surface water and a sample of water effects or impacts on minority and low- file a request for a hearing. In taken from Reid Reservoir indicate that income populations. Consequently, accordance with § 2.1205(c), a request the concentrations are well within the further evaluation of Environmental for a hearing must be filed within thirty NRC effluent water concentration limits Justice concerns, as outlined in (30) days from the date of publication of for radionuclides, as specified in 10 CFR Executive Order 12898 and NRC’s Office this Federal Register notice. The request Part 20, Appendix B, Table 2. Cleanup of Nuclear Material Safety and for a hearing must be filed with the criteria for off-pile areas of uranium mill Safeguards Policy and Procedures Letter Office of the Secretary either: sites are specified in 10 CFR Part 40, 1–50, Revision 1, is not warranted. (1) By delivery to the Rulemakings Appendix A, Technical Criteria. and Adjudications Staff of the Office of Alternatives to the Proposed Action Summary of the Environmental the Secretary at One White Flint North, Assessment The proposed action is to amend NRC 11555 Rockville Pike, Rockville, MD Source Material License SUA–672 20852; or In accordance with 10 CFR Part 51, authorizing PMC to implement ‘‘no (2) By mail or telegram addressed to Licensing and Regulatory Policy action’’ proposal on cleanup of Reid the Secretary, U.S. Nuclear Regulatory Procedures for Environmental Draw, as requested by PMC. Therefore, Commission, Washington, DC 20555, Protection, the NRC staff performed an the principal alternatives available to Attention: Rulemakings and appraisal of the environmental impacts NRC are to: Adjudications Staff. associated with the ‘‘no action’’ Each request for a hearing must also proposal on cleanup of Reid Draw. In (1) Approve the licensee’s ‘‘no action’’ alternative, as proposed; or (2) Amend the be served by delivering it personally or conducting its appraisal, the NRC staff license with such additional conditions as by mail to: considered the following information: are considered necessary or appropriate to (1) The applicant, Pathfinder Mines (1) PMC’s ER on remediation of Reid protect public health and safety and the Corporation, 935 Pendell Boulevard, Draw, and its subsequent submittal environment; or (3) Deny the licensee’s P.O. Box 730, Mills, Wyoming 82644, providing additional information and request. Attention: Tom Hardgrove; and

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(2) The NRC staff, by delivery to the (Contact: Mike Bell, 301–415–7252) al. (Seabrook Station Unit 1) Docket No. Executive Director of Operations, One Wednesday, March 17 50–443, Draft Commission White Flint North, 11555 Rockville Memorandum and Order Addressing Pike, Rockville, MD 20852, or by mail 9:00 a.m. Meeting with Advisory Committee on Intervention Petitions and Hearing addressed to the Executive Director for Nuclear Waste and Nuclear Waste Requests of New England Power Operations, U.S. Nuclear Regulatory Technical Review Board (Public Company (NEPCO) and United Commission, Washington, DC 20555. Meeting) Illuminating Co.’’ (Public Meeting) be In addition to meeting other Contact: John Larkins, 301–415–7360) held on March 5, and on less than one applicable requirements of 10 CFR Part 11:30 a.m. week’s notice to the public. 2 of the Commission’s regulations, a Affirmation Session (Public Meeting) * * * * * request for a hearing filed by a person *(Please Note: This item will be affirmed other than an applicant must describe in immediately following the conclusion of the The NRC Commission Meeting detail: preceding meeting.) Schedule can be found on the Internet (1) the interest of the requestor in the a: Radiological Criteria for License at: http://www.nrc.gov/SECY/smj/ Termination of Uranium Recovery Facilities. proceeding; schedule.htm. (2) how that interest may be affected 1:30 p.m. * * * * * by the results of the proceeding, Briefing on Part 50 Decommissioning Issues (Public Meeting) This notice is distributed by mail to including the reasons why the requestor (Contact: Seymour Weiss, 301–415–2170) several hundred subscribers; if you no should be permitted a hearing, with longer wish to receive it, or would like particular reference to the factors set out Thursday, March 18 to be added to it, please contact the in § 2.1205(g); 9:30 a.m. Office of the Secretary, Attn: Operations (3) the requestor’s areas of concern Briefing on Design Basis Threat (Closed— Branch, Washington, D.C. 20555 (301– about the licensing activity that is the ex. 1) 415–1661). In addition, distribution of 2:00 p.m. subject matter of the proceeding; and this meeting notice over the Internet (4) the circumstances establishing that Briefing by Executive Branch (Closed—ex. 1) system is available. If you are interested the request for a hearing is timely in in receiving this Commission meeting accordance with § 2.1205(c). Friday, March 19 schedule electronically, please send an The request must also set forth the 9:00 a.m. electronic message to [email protected] or specific aspect or aspects of the subject Briefing on Status of External Regulation of [email protected]. matter of the proceeding as to which DOE Facilities (Public Meeting) petitioner wishes a hearing. (Contact: Charlie Haughney, 301–415– Dated: March 12, 1999. FOR FURTHER INFORMATION CONTACT: 7198) William M. Hill, Jr., Mohammad Haque, Uranium Recovery Week of March 22—Tentative SECY Tracking Officer, Office of the Branch, Division of Waste Management, Secretary. Office of Nuclear Material Safety and Thursday, March 25 [FR Doc. 99–6571 Filed 3–15–99; 11:36 am] Safeguards, U.S. Nuclear Regulatory 1:00 p.m. BILLING CODE 7590±01±M Commission, Mail Stop T7-J8, Briefing on Part 35 Rulemaking (Public Washington, D.C. 20555. Telephone Meeting) (Contact: Patricia Holahan, 301–415–8125) 301/415–6640. Dated at Rockville, Maryland, this 11th day Friday, March 26 RAILROAD RETIREMENT BOARD of March 1999. 9:00 a.m. Proposed Collection: Comment For the Nuclear Regulatory Commission. Briefing on Proposed Reactor Oversight Request N. King Stablein, Process Improvements & Enforcement (Public Meeting) Acting Chief, Uranium Recovery Branch, (Contact: William Dean, 301–415–2240) SUMMARY: In accordance with the Division of Waste Management, Office of 12:00 p.m. requirement of Section 3506(c)(2)(A) of Nuclear Material Safety and Safeguards. Affirmation Session (Public Meeting) (If the Paperwork Reduction Act of 1995 [FR Doc. 99–6454 Filed 3–16–99; 8:45 am] needed) which provides opportunity for public BILLING CODE 7590±01±P Week of March 29—Tentative comment on new or revised data collections; the Railroad Retirement There are no meetings scheduled for the Board (RRB) will publish periodic NUCLEAR REGULATORY Week of March 29. summaries of proposed data collections. COMMISSION Week of April 5—Tentative Comments are Invited On Sunshine Act Meeting There are no meetings scheduled for the Week of April 5. (a) Whether the proposed information DATE: Weeks of March 15, 22, 29, and *The Schedule for Commission meeting is collection is necessary for the proper April 5, 1999. subject to change on short notice. To verify performance of the functions of the PLACE: Commissioners’ Conference the status of meetings call (recording)—(301) agency, including whether the Room, 11555 Rockville Pike, Rockville, 415–1292. information has practical utility; (b) the Maryland. CONTACT PERSON FOR MORE INFORMATION: accuracy of the RRB’s estimate of the STATUS: Public and Closed. Bill Hill (301) 415–1661. burden of the collection of the MATTERS TO BE CONSIDERED: * * * * * information; (c) ways to enhance the quality, utility, and clarity of the Week of March 15 Additional Information information to be collected; and (d) Tuesday, March 16 By a vote of 5–0 on March 5, the ways to minimize the burden related to 1:00 p.m. Commission determined pursuant to the collection of information on Briefing on Status of DOE High Level U.S.C. 552b(e) and § 9.107(a) of the respondents, including the use of Waste Viability Assessment (Public Commission’s rules that ‘‘Affirmation of automated collection techniques or Meeting) North Atlantic Energy Service Corp., et other forms of information technology.

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Title and Purpose of Information SECURITIES AND EXCHANGE GSCC with the authority to require such Collection COMMISSION testing. Nonetheless, GSCC proposes to supplement its rules on operational Application for Reimbursement for [Release No. 34–41153; File No. SR– capability standards to clarify that these Hospital Insurance Services in Canada; GSCC–99–02] standards include the fulfillment of OMB 3220–0086. testing and related reporting Self-Regulatory Organizations; Under section 7(d) of the Railroad requirements that may be imposed on Government Securities Clearing members by GSCC from time to time to Retirement Act (RRA), the RRB Corporation; Notice of Filing and Order administers the Medicare program for ensure the continuing operational Granting Accelerated Approval of a capability of each member. The scope of persons covered by the railroad Proposed Rule Change Regarding Year retirement system. Payments are such Year 2000 testing and reporting 2000 Testing requirements have been determined by provided under section 7(d)(4) of the GSCC in its sole discretion and have RRA for medical services furnished in March 10, 1999. Pursuant to Section 19(b)(1) of the been conveyed to members through Canada to the same extent as for those Important Notices. GSCC believes that furnished in the United States. Security Exchange Act of 1934 (‘‘Act’’),1 notice is hereby given that on February the rule change is broad enough to cover However, payments for the services Year 2000 testing without specifically furnished in Canada are made from the 5, 1999, the Government Securities Clearing corporation (‘‘GSCC’’) filed referring to Year 2000 in order to Railroad Retirement Account rather with the Securities and Exchange alleviate the need to rescind the rule than from the Federal Hospital Commission (‘‘Commission’’) the when Year 2000 testing is no longer Insurance Trust Fund, with the payment proposed rule change as described in relevant and also to enable GSCC to limited to the amount by which Items I and II below, which items have apply it to other contexts in which insurance benefits under Medicare been prepared primarily by GSCC. The testing might be required. exceed the amounts payable under Commission is publishing this notice GSCC expressly reserves the right to Canadian Provincial plans. and order to solicit comments from take remedial action against members Form AA–104, Application for interested persons and to grant that do not fulfill the testing and related reporting requirements referred to above Canadian Hospital Benefits Under accelerated approval of the proposal. within the time frames established by Medicare—Part A, is provided by the I. Self-Regulatory Organization’s GSCC. The proposed rule change RRB for use in claiming benefits for Statement of the Terms of Substance of provides generally that GSCC may take covered hospital services received in the Proposed Rule Change the remedial actions already available to Canada. The form obtains information The propose of the proposed rule it in its rules (i.e., increased clearing needed to determine eligibility for, and change is to clarify that GSCC’s rules on fund deposit and termination of the amount of any reimbursement due operational capability include certain membership) in the event a member the applicant. One response is requested reporting and testing requirements such does not fulfill the operational testing of each respondent. Completion is as the requirement that all GSCC and related reporting requirements required to obtain a benefit. No changes members conduct Year 2000 testing within the time frames specified by are proposed to Form AA–104. with GSCC. GSCC. GSCC has specified these time Number of respondents: 35. frames in an Important Notice to II. Self-Regulatory Organization’s members. Estimated Completion Time: 10 Statement of the Purpose of, and GSCC believes that the proposed rule minutes. Statutory Basis for, the Proposed Rule change is consistent with the Estimated annual burden hours: 6. Change requirements of the Act and the rules and regulations thereunder. In ADDITIONAL INFORMATION OR COMMENTS: In its filing with the Commission, particular, the proposed rule change is To request more information or to GSCC included statements concerning the purpose of and basis for the consistent with Section 17A(b)(3)(F) of obtain a copy of the information proposed rule change and discussed any the Act 3 which requires that the rules collection justification, forms, and/or comments it received on the proposed of a clearing agency be designed to supporting material, please call the RRB rule changes. The text of these promote the prompt and accurate Clearance Officer at (312) 751–3363. statements may be examined at the clearance and settlement of securities Comments regarding the information places specified in Item IV below. GSCC transactions and, in general, to protect collection should be addressed to has prepared summaries, set forth in investors and the public interest. Ronald J. Hodapp, Railroad Retirement sections (A), (B), and (C) below, of the Board, 844 N. Rush Street, Chicago, (B) Self-Regulatory Organization’s most significant aspects of such Statement on Burden on Competition Illinois 60611–2092. Written comments statements.2 should be received within 60 days of GSCC does not believe that the this notice. (A) Self-Regulatory Organization’s proposed rule change will have an Statement of the Purpose of, and Chuck Mierzwa, impact, or impose a burden, on Statutory Basis for, the Proposed Rule competition. Clearance Officer. Change [FR Doc. 99–6493 Filed 3–16–99; 8:45 am] (C) Self-Regulatory Organization’s The proposed rule change requires all BILLING CODE 7905±01±M Statement on Comments on the GSCC members to participate in Year Proposed Rule Change Received from 2000 testing with GSCC. GSCC believes Members, Participants, or Others that its rules on operational requirements for members provide Written comments relating to the proposed rule change have not yet been 1 15 U.S.C. 78s(b)(1). solicited or received. GSCC will notify 2 The Commission has modified the text of the summaries prepared by GSCC. 3 15 U.S.C. 78q-1(b)(3)(F).

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13243 the Commission of any written It is therefore ordered, pursuant to Dated: March 10, 1999. comments received by GSCC. Section 19(b)(2) of the Act, 5 that the Don A. Christensen, proposed rule change (File No. SR– III. Date of Effectiveness of the Associate Administrator for Investment. GSCC–99–2) be and hereby is approved. [FR Doc. 99–6469 Filed 3–16–99; 8:45 am] Proposed Rule Change and Timing for For the Commission by the Division of BILLING CODE 8025±01±P Commission Action Market Regulation, pursuant to delegated Section 17A(b)(3)(F) of the Act 4 authority. 6 requires that the rules of a clearing Margaret H. McFarland, agency be designed to promote the Deputy Secretary. SOCIAL SECURITY ADMINISTRATION prompt and accurate clearance and [FR Doc. 99–6455 Filed 3–16–99; 8:45 am] Finding Regarding the Social settlement of securities transactions. BILLING CODE 8010±01±M Insurance System of Hungary The Commission believes that the proposed rule change is consistent with AGENCY: Social Security Administration. this obligation because the required SMALL BUSINESS ADMINISTRATION ACTION: Notice of finding regarding the Year 2000 testing should allow GSCC to Social Insurance System of Hungary. address potential problems associated [(License No. 02/72±0573)] with its members’ Year 2000 readiness. Finding: Section 202(t)(1) of the EOS Partners SBIC II, L.P.; Notice As a result, GSCC should be able to Social Security Act (42 U.S.C. 402(t)(1)) Seeking Exemption Under Section 312 continue to provide prompt and prohibits payment of monthly benefits of the Small Business Investment Act, accurate clearance and settlement of to any individual who is not a United Conflicts of Interest securities transactions before, on, and States citizen or national for any month after Year 2000 without interruption. Notice is hereby given that Eos after he or she has been outside the GSCC requested that the Commission Partners SBIC II, L.P. (‘‘EOS II’’), 320 United States for 6 consecutive months, find good cause for approving the Park Avenue, 22nd Floor, New York, and prior to the first month thereafter proposed rule change prior to the New York 10022, a Federal Licensee for all of which the individual has been thirtieth day after the publication of under the Small Business Investment in the United States. This prohibition notice of the filing. The Commission Act of 1958, as amended (‘‘the Act’’), in does not apply to such an individual finds good cause for approving the connection with the proposed financing where one of the exceptions described proposed rule change prior to the of a small concern is seeking an in sections 202(t)(2) through 202(t)(5) of thirtieth day after the publication of exemption under section 312 of the Act the Social Security Act (42 U.S.C. notice of the filing because such and section 107.730, Financings which 402(t)(2) through 402(t)(5)) affects his or approval will allow GSCC to implement Constitute Conflicts of Interest of the her case. its mandatory Year 2000 testing program Small Business Administration (‘‘SBA’’) Section 202(t)(2) of the Social in a timely manner. Rules and Regulations (13 CFR 107.730 Security Act provides that, subject to certain residency requirements of IV. Solicitation of Comments (1998)). An exemption may not be granted by SBA until Notices of this section 202(t)(11), the prohibition Interested persons are invited to transaction have been published. EOS II against payment shall not apply to any submit written data, views, and proposes to provide equity financing to individual who is a citizen of a country arguments concerning the foregoing, Providence Service Corporation, 620 N. which the Commissioner of Social including whether the proposed rule Craycroft, Tucson, Arizona 85710. The Security finds has in effect a social change is consistent with the Act. financing is contemplated for funding insurance system which is of general Persons making written submissions growth and acquisitions. application in such country and which: should file six copies thereof with the The financing is brought within the (a) Pays periodic benefits, or the Secretary, Securities and Exchange purview of section 107.730 (a) (1) of the actuarial equivalent thereof, on account Commission, 450 Fifth Street, N.W., Regulations because Eos Partners SBIC, of old age, retirement, or death; and Washington, D.C. 20549. Copies of the L.P., an Associate of EOS II, owns (b) Permits individuals who are submission, all subsequent greater than 10 percent of Providence United States citizens but not citizens of amendments, all written statements Service Corporation and therefore that country and who qualify for such with respect to the proposed rule Providence Service Corporation is benefits to receive those benefits, or the change that are filed with the considered an Associate of EOS II as actuarial equivalent thereof, while Commission, and all written defined in section 107.50 of the outside the foreign country regardless of communications relating to the Regulations. the duration of the absence. proposed rule change between the Notice is hereby given that any The Commissioner of Social Security Commission and any person, other than interested person may, not later than has delegated the authority to make those that may be withheld from the fifteen (15) days from the date of such a finding to the Associate public in accordance with the publication of this Notice, submit Commissioner for International provisions of 5 U.S.C. § 552, will be written comments on the proposed Programs. Under that authority, the available for inspection and copying in transaction to the Associate Associate Commissioner for the Commission’s Public Reference Administrator for Investment, U.S. International Programs has approved a Room, 450 Fifth Street, N.W., Small Business Administration, 409 finding that Hungary, as of January 1, Washington, D.C. 20549. Copies of such Third Street, SW Washington, DC 1996, has a social insurance system of filing will also be available for 20416. general application which: inspection and copying at the principal A copy of this Notice shall be (a) Pays periodic benefits, or the office of GSCC. All submissions should published, in accordance with section actuarial equivalent thereof, on account refer to the File No. SR–GSCC–99–02 107.730 (g), in the Federal Register by of old age, retirement, or death; and and should be submitted by April 7, SBA. (b) Permits United States citizens who 1999. are not citizens of Hungary and who 5 15 U.S.C. 78s(b)(2). qualify for the relevant benefits to 4 15 U.S.C. 78q–1 (b)(3)(F). 6 17 CFR 200.30–3(a) (12). receive those benefits, or their actuarial

VerDate 03-MAR-99 16:11 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm01 PsN: 17MRN1 13244 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices equivalent, while outside of Hungary, Related to Airspace Design: a. Dr. Robert Rovinsky, the SatNav regardless of the duration of the absence Obstruction Evaluation; b. National Investment Analysis Team Lead, ASD– of these individuals from Hungary. Parks; c. Commercial Space; d. Special 410, at (202) 358–5212 and via e:mail at Accordingly, it is hereby determined Use Airspace Management System [email protected]. and found Hungary has in effect, as of (SAMS)/Military Airspace Management SUPPLEMENTARY INFORMATION: The January 1, 1996, a social insurance System (MAMS); (6) Update on Federal Aviation Administration is system which meets the requirements of Architecture and Free Flight Phase 1; (7) reviewing its plan to transition to a section 202(t)(2) of the Social Security Briefings on Working Group Activities; totally satellite-based navigation (Sat/ Act (42 U.S.C. 402(t)(2)). (8) Tour of National Airspace Redesign Nav) infrastructure. A Sat/Nav public On July 1, 1968, it was determined Lab; (9) Work Group Breakout Sessions; meeting is planned to obtain input from that the Hungarian system did not meet (10) Set Agenda for Next Meeting; (11) the aviation community as the FAA part B of section 202(t)(2) because its Date and Location of Next Meeting. considers alternatives and develops a social insurance law did not permit Attendance is open to the interested business case for a particular approach payment of benefits to those who public but limited to space availability. to navigation within the Nation’s resided outside Hungary. Although a With the approval of the chairman, airspace. new law was passed in 1990 that members of the public may present oral At this meeting, the FAA will provide allowed benefits to be paid abroad, the statements at the meeting. Persons organizations an opportunity to review Hungarian Forint was not convertible at wishing to present statements or obtain the preliminary results of the that time, thereby constituting a information should contact the RTCA alternatives analysis led by the MITRE currency restriction for section 202(t)(2) Secretariat, 1140 Connecticut Avenue, Corporation’s Center for Advanced purposes. Effective January 1, 1996, the NW., Washington, DC, 20036; (202) Aviation System Development Forint became fully convertible, and 833–9339 (phone), (202) 833–9434 (fax), (CAASD). This is the second in a series payments could be made to qualified or http://www.rtca.org (web site). of three public meetings. The first one United States citizens residing outside Members of the public may present a was held on February 25 to solicit Hungary as required by section written statement to the committee at comments on the alternatives analysis. 202(t)(2)(B) of the Social Security Act. any time. The next public meeting is tentatively FOR FURTHER INFORMATION CONTACT: Issued in Washington, DC, on March 9, scheduled for May 19 to review the Donna Powers, Room 1104, West High 1999. economic analysis and preliminary Rise Building, PO Box 17741, 6401 Janice L. Peters, findings. The FAA investment analysis Security Boulevard, Baltimore, MD Designated Official. team will incorporate user information 21235, (410) 965–3568. [FR Doc. 99–6519 Filed 3–16–99; 8:45 am] from these meetings into the investment (Catalog of Federal Domestic Assistance: BILLING CODE 4910±13±M analysis process leading to an FAA Joint Program Nos. 96.001 Social Security— Resources Council investment decision Disability Insurance; 96.002 Social by the end of June 1999. Security—Retirement Insurance; 96.004 DEPARTMENT OF TRANSPORTATION The public is invited to attend the Social Security—Survivors Insurance) meeting as observers and/or to provide Dated: March 9, 1999. Federal Aviation Administration comment during the breakout sessions. Barry L. Powell, Requests to attend this meeting and to Acting Associate Commissioner for Notice of Public Meeting; Satellite- obtain information should be directed to International Programs. based Navigation User Forum the contact persons listed above. Additional information will be posted [FR Doc. 99–6400 Filed 3–16–99; 8:45 am] AGENCY: Federal Aviation BILLING CODE 4190±29±P Administration, Office of System on the Internet at www.faa.gov/asd. Architecture and Investment Analysis. Issued in Washington, DC., on March 11, 1999. SUMMARY: The Federal Aviation DEPARTMENT OF TRANSPORTATION Administration (FAA) Office of System Janice L. Peters, Architecture and Investment Analysis Designated Official. Federal Aviation Administration (ASD) will hold a forum to obtain [FR Doc. 99–6520 Filed 3–16–99; 8:45 am] [RTCA Special Committee 192] information from the aviation user BILLING CODE 4910±13±M community as part of the investment National Airspace Review Planning analysis process to determine navigation and Analysis alternatives as we transition to a DEPARTMENT OF TRANSPORTATION Pursuant to section 10(a)(2) of the satellite-based navigation (Sat/Nav) infrastructure. National Highway Traffic Safety Federal Advisory Committee Act (P.L. Administration 92–463, 5 U.S.C., Appendix 2), notice is DATES: The Sat/Nav user forum public hereby given for a Special Committee meeting will be held on April 6, 1999, [Docket No. NHTSA±99±5207] 192 meeting to be held March 30–31, at the Federal Aviation Administration, 1999, starting at 9:00 a.m. The meeting 800 Independence Avenue, SW., Notice of Receipt of Petition for will be held at RTCA, Inc., 1140 Washington, DC, in the third-floor Decision That Nonconforming 1986± Connecticut Avenue, NW., Suite 1020, auditorium from 8:30 am to 12 noon. 1995 BMW R80 and R100 Motorcycles Washington, DC, 20036. Time will be made available for specific Are Eligible for Importation follow-on meetings, as necessary, in the The agenda will be as follows: (1) AGENCY: National Highway Traffic afternoon. Chairman’s Introductory Remarks; (2) Safety Administration, DOT. Review/Approval of Meeting Agenda; FOR FURTHER INFORMATION CONTACT: Ms. ACTION: Notice of receipt of petition for (3) Review/Approval of Summary of the Millie Butler-Harris, Investment decision that nonconforming 1986–1995 Previous Meeting; (4) Update on ATA’s Analysis and Operations Research, BMW R80 and R100 motorcycles are National Airspace Redesign Activities; ASD–400, at (202) 358–5399 and via eligible for importation. (5) Update on the FAA’s Activities e:mail at [email protected] or

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SUMMARY: This document announces petitioned NHTSA to decide whether 20590. It is requested but not required receipt by the National Highway Traffic non-U.S. certified 1986–1995 BMW R80 that 10 copies be submitted. Safety Administration (NHTSA) of a and R100 motorcycles are eligible for All comments received before the petition for a decision that 1986–1995 importation into the United States. The close of business on the closing date BMW R80 and R100 motorcycles that vehicles which Champagne believes are indicated above will be considered, and were not originally manufactured to substantially similar are 1986–1995 will be available for examination in the comply with all applicable Federal BMW R80 and R100 motorcycles that docket at the above address both before motor vehicle safety standards are were manufactured for importation into, and after that date. To the extent eligible for importation into the United and sale in, the United States and possible, comments filed after the States because (1) they are substantially certified by their manufacturer, closing date will also be considered. similar to vehicles that were originally Bayerische Motoren Werke, A.G., as Notice of final action on the petition manufactured for importation into and conforming to all applicable Federal will be published in the Federal sale in the United States and that were motor vehicle safety standards. Register pursuant to the authority certified by their manufacturer as The petitioner claims that it carefully indicated below. complying with the safety standards, compared non-U.S. certified 1986–1995 Authority: 49 U.S.C. 30141(a)(1)(A) and and (2) they are capable of being readily BMW R80 and R100 motorcycles to (b)(1); 49 CFR 593.8; delegations of authority altered to conform to the standards. their U.S. certified counterparts, and at 49 CFR 1.50 and 501.8. DATES: The closing date for comments found the vehicles to be substantially Issued on: March 11, 1999. on the petition is April 16, 1999. similar with respect to compliance with Marilynne Jacobs, ADDRESSES: Comments should refer to most Federal motor vehicle safety Director, Office of Vehicle Safety Compliance. standards. the docket number and notice number, [FR Doc. 99–6472 Filed 3–16–99; 8:45 am] Champagne submitted information and be submitted to: Docket BILLING CODE 4910±59±P Management, Room PL–401, 400 with its petition intended to Seventh St., SW, Washington, DC demonstrate that non-U.S. certified 20590. [Docket hours are from 10 am to 1986–1995 BMW R80 and R100 DEPARTMENT OF TRANSPORTATION 5 pm]. motorcycles, as originally FOR FURTHER INFORMATION CONTACT: manufactured, conform to many Federal National Highway Traffic Safety George Entwistle, Office of Vehicle motor vehicle safety standards in the Administration same manner as their U.S. certified Safety Compliance, NHTSA (202–366– [Docket No. NHTSA±99±5209] 5306). counterparts, or are capable of being readily altered to conform to those SUPPLEMENTARY INFORMATION: Notice of Receipt of Petition for standards. Decision That Nonconforming 1992± Background Specifically, the petitioner claims that 1993 Bentley Turbo R Passenger Cars Under 49 U.S.C. 30141(a)(1)(A), a non-U.S. certified 1986–1995 BMW R80 Are Eligible for Importation motor vehicle that was not originally and R100 motorcycles are identical to manufactured to conform to all their U.S. certified counterparts with AGENCY: National Highway Traffic applicable Federal motor vehicle safety respect to compliance with Standard Safety Administration, DOT. standards shall be refused admission Nos. 106 Brake Hoses, 111 Rearview ACTION: Notice of receipt of petition for into the United States unless NHTSA Mirrors, 116 Brake Fluid, 119 New decision that nonconforming 1992–1993 has decided that the motor vehicle is Pneumatic Tires for Vehicles other than Bentley Turbo R passenger cars are substantially similar to a motor vehicle Passenger Cars, and 122 Motorcycle eligible for importation. originally manufactured for importation Brake Systems. SUMMARY: This notice announces receipt into and sale in the United States, Petitioner additionally contends that by the National Highway Traffic Safety certified under 49 U.S.C. 30115, and of the vehicles are capable of being readily Administration (NHTSA) of a petition the same model year as the model of the altered to meet the following standard, for a decision that 1992–1993 Bentley motor vehicle to be compared, and is in the manner indicated: Turbo R passenger cars that were not capable of being readily altered to Standard No. 108 Lamps, Reflective originally manufactured to comply with conform to all applicable Federal motor Devices and Associated Equipment: (a) all applicable Federal motor vehicle vehicle safety standards. installation of U.S.-model head lamp Petitions for eligibility decisions may assemblies; (b) installation of U.S.- safety standards are eligible for be submitted by either manufacturers or model reflectors on vehicles that are not importation into the United States importers who have registered with already so equipped. because (1) they are substantially NHTSA pursuant to 49 CFR Part 592. As Standard No. 120 Tire Selection and similar to vehicles that were originally specified in 49 CFR 593.7, NHTSA Rims for Vehicles other than Passenger manufactured for importation into and publishes notice in the Federal Register Cars: installation of a tire information sale in the United States and that were of each petition that it receives, and label. certified by their manufacturer as affords interested persons an Standard No. 123 Motorcycle Controls complying with the safety standards, opportunity to comment on the petition. and Displays: installation of a U.S.- and (2) they are capable of being readily At the close of the comment period, model speedometer calibrated in miles altered to conform to the standards. NHTSA decides, on the basis of the per hour. DATES: The closing date for comments petition and any comments that it has The petitioner also states that a on the petition is April 16, 1999. received, whether the vehicle is eligible vehicle identification number plate will ADDRESSES: Comments should refer to for importation. The agency then be affixed to the vehicle to meet the the docket number and notice number, publishes this decision in the Federal requirements of 49 CFR Part 565. and be submitted to: Docket Register. Comments should refer to the docket Management, Room PL–401, 400 Champagne Imports of Lansdale, number and be submitted to: Docket Seventh St., SW, Washington, DC Pennsylvania (‘‘Champagne’’) Management, Room PL–401, 400 20590. [Docket hours are from 9 am to (Registered Importer 90–009) has Seventh Street, S.W., Washington, DC 5 pm].

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FOR FURTHER INFORMATION CONTACT: capable of being readily altered to or a belt webbing-actuated microswitch George Entwistle, Office of Vehicle conform to those standards. inside the driver’s seat belt retractor; (b) Safety Compliance, NHTSA (202–366– Specifically, the petitioner claims that installation of an ignition switch- 5306). non-U.S. certified 1992–1993 Bentley actuated seat belt warning lamp and SUPPLEMENTARY INFORMATION: Turbo R passenger cars are identical to buzzer; (c) replacement of the driver’s their U.S. certified counterparts with side air bag and knee bolster with U.S.- Background respect to compliance with Standards model components. The petitioner Under 49 U.S.C. § 30141(a)(1)(A), a Nos. 102 Transmission Shift Lever states that the vehicles are equipped motor vehicle that was not originally Sequence . . . ., 103 Defrosting and with combination lap and shoulder manufactured to conform to all Defogging Systems, 104 Windshield restraints that adjust by means of an applicable Federal motor vehicle safety Wiping and Washing Systems, 105 automatic retractor and release by standards shall be refused admission Hydraulic Brake Systems, 106 Brake means of a single push button at both into the United States unless NHTSA Hoses, 109 New Pneumatic Tires, 113 front designated seating positions, with has decided that the motor vehicle is Hood Latch Systems, 116 Brake Fluid, combination lap and shoulder restraints substantially similar to a motor vehicle 124 Accelerator Control Systems, 201 that release by means of a single push originally manufactured for importation Occupant Protection in Interior Impact, button at both rear outboard designated into and sale in the United States, 202 Head Restraints, 204 Steering seating positions, and with a lap belt in certified under 49 U.S.C. § 30115, and of Control Rearward Displacement, 205 the rear center designated seating the same model year as the model of the Glazing Materials, 206 Door Locks and position. motor vehicle to be compared, and is Door Retention Components, 207 Standard No. 214 Side Impact capable of being readily altered to Seating Systems, 209 Seat Belt Protection: installation of reinforcing conform to all applicable Federal motor Assemblies, 210 Seat Belt Assembly beams. vehicle safety standards. Anchorages, 212 Windshield Retention, Standard No. 301 Fuel System Petitions for eligibility decisions may 216 Roof Crush Resistance, 219 Integrity: installation of a rollover valve be submitted by either manufacturers or Windshield Zone Intrusion, and 302 in the fuel tank vent line between the importers who have registered with Flammability of Interior Materials. fuel tank and the evaporative emissions NHTSA pursuant to 49 CFR Part 592. As Petitioner also contends that the collection canister. specified in 49 CFR 593.7, NHTSA vehicles are capable of being readily Additionally, the petitioner states that publishes notice in the Federal Register altered to meet the following standards, the bumpers on the non-U.S. certified of each petition that it receives, and in the manner indicated: 1992–1993 Bentley Turbo R passenger affords interested persons an Standard No. 101 Controls and cars must be reinforced or U.S.-model opportunity to comment on the petition. Displays: (a) substitution of a lens bumper components must be installed At the close of the comment period, marked ‘‘Brake’’ for a lens with a to comply with the Bumper Standard NHTSA decides, on the basis of the noncomplying symbol on the brake found in 49 CFR Part 581. petition and any comments that it has failure indicator lamp; (b) installation of The petitioner also states that a received, whether the vehicle is eligible a seat belt warning lamp that displays vehicle identification number plate for importation. The agency then the appropriate symbol; (c) recalibration must be affixed to the vehicle to meet publishes this decision in the Federal of the speedometer/odometer from the requirements of 49 CFR Part 565. Register. kilometers to miles per hour. Interested persons are invited to Champagne Imports of Lansdale, Standard No. 108 Lamps, Reflective submit comments on the petition Pennsylvania (‘‘Champagne’’) Devices and Associated Equipment: (a) described above. Comments should refer (Registered Importer 90–009) has installation of U.S.-model headlamp to the docket number and be submitted petitioned NHTSA to decide whether assemblies that incorporate headlamps to: Docket Section, National Highway 1992–1993 Bentley Turbo R passenger with DOT markings; (b) installation of Traffic Safety Administration, Room cars are eligible for importation into the U.S.-model front and rear sidemarker/ 5109, 400 Seventh Street, S.W., United States. The vehicles which reflector assemblies; (c) installation of Washington, DC 20590. It is requested Champagne believes are substantially U.S.-model taillamp assemblies; (d) but not required that 10 copies be similar are 1992–1993 Bentley Turbo R installation of a center high mounted submitted. passenger cars that were manufactured stop lamp on vehicles that are not All comments received before the for importation into, and sale in, the already so equipped. close of business on the closing date United States and certified by their Standard No. 110 Tire Selection and indicated above will be considered, and manufacturer as conforming to all Rims: installation of a tire information will be available for examination in the applicable Federal motor vehicle safety placard. docket at the above address both before standards. Standard No. 111 Rearview Mirror: and after that date. To the extent The petitioner claims that it carefully replacement of the passenger side possible, comments filed after the compared non-U.S. certified 1992–1993 rearview mirror with a U.S.-model closing date will also be considered. Bentley Turbo R passenger cars to their component. Notice of final action on the petition U.S. certified counterparts, and found Standard No. 114 Theft Protection: will be published in the Federal the vehicles to be substantially similar installation of a warning buzzer Register pursuant to the authority with respect to compliance with most microswitch in the steering lock indicated below. Federal motor vehicle safety standards. assembly and a warning buzzer. Champagne submitted information Standard No. 118 Power Window Authority: 49 U.S.C. 30141 (a)(1)(A) and with its petition intended to (b)(1); 49 CFR 593.8; delegations of authority Systems: rewiring of the power window at 49 CFR 1.50 and 501.8. demonstrate that non-U.S. certified system so that the window transport is Issued on: March 11, 1999. 1992–1993 Bentley Turbo R passenger inoperative when the ignition is cars, as originally manufactured, switched off. Marilynne Jacobs, conform to many Federal motor vehicle Standard No. 208 Occupant Crash Director, Office of Vehicle Safety Compliance. safety standards in the same manner as Protection: (a) installation of a U.S.- [FR Doc. 99–6473 Filed 3–17–99; 8:45 am] their U.S. certified counterparts, or are model seat belt in the driver’s position, BILLING CODE 4910±59±P

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DEPARTMENT OF TRANSPORTATION importers who have registered with 214 Side Impact Protection, 216 Roof NHTSA pursuant to 49 CFR Part 592. As Crush Resistance, 219 Windshield Zone National Highway Traffic Safety specified in 49 CFR 593.7, NHTSA Intrusion, and 302 Flammability of Administration publishes notice in the Federal Register Interior Materials. [Docket No. NHTSA±99±5197] of each petition that it receives, and Additionally, the petitioner states that affords interested persons an non-U.S. certified 1993–1996 Lexus Notice of Receipt of Petition for opportunity to comment on the petition. GS300 passenger cars comply with the Decision That Nonconforming 1993± At the close of the comment period, Bumper Standard found in 49 CFR Part 1996 Lexus GS300 Passenger Cars Are NHTSA decides, on the basis of the 581. Eligible for Importation petition and any comments that it has Petitioner also contends that the received, whether the vehicle is eligible vehicles are capable of being readily AGENCY: National Highway Traffic for importation. The agency then altered to meet the following standards, Safety Administration, DOT. publishes this decision in the Federal in the manner indicated: ACTION: Notice of receipt of petition for Register. Standard No. 101 Controls and decision that nonconforming 1993–1996 Wallace Environmental Testing Displays: substitution of a lens marked Lexus GS300 passenger cars are eligible Laboratories, Inc. of Houston, Texas ‘‘Brake’’ for a lens with an ECE symbol for importation. (‘‘Wallace’’)(Registered Importer 90– on the brake failure indicator lamp. 005) has petitioned NHTSA to decide Petitioner claims that the odometer is SUMMARY: This notice announces receipt whether 1993–1996 Lexus GS300 labeled as reading in kilometers. by the National Highway Traffic Safety passenger cars are eligible for Standard No. 108 Lamps, Reflective Administration (NHTSA) of a petition importation into the United States. The Devices and Associated Equipment: for a decision that 1993–1996 Lexus vehicles which Wallace believes are replacement of nonconforming GS300 passenger cars that were not substantially similar are 1993–1996 headlight and sidemarker assemblies. originally manufactured to comply with Lexus GS300 passenger cars that were Standard No. 110 Tire Selection and all applicable Federal motor vehicle manufactured for importation into, and Rims: installation of a tire information safety standards are eligible for sale in, the United States and certified placard. importation into the United States by their manufacturer, Toyota Motor Standard No. 111 Rearview Mirror: because (1) they are substantially Corporation, as conforming to all inscription of the required warning similar to vehicles that were originally applicable Federal motor vehicle safety statement on the passenger side manufactured for importation into and standards. rearview mirror. sale in the United States and that were The petitioner claims that it carefully Standard No. 114 Theft Protection: certified by their manufacturer as compared non-U.S. certified 1993–1996 installation of a warning buzzer complying with the safety standards, Lexus GS300 passenger cars to their microswitch and a warning buzzer in and (2) they are capable of being readily U.S. certified counterparts, and found the steering lock assembly. altered to conform to the standards. the vehicles to be substantially similar Standard No. 208 Occupant Crash DATES: The closing date for comments with respect to compliance with most Protection: (a) installation of a safety on the petition is April 16, 1999. Federal motor vehicle safety standards. belt warning system through ADDRESSES: Comments should refer to Wallace submitted information with replacement of the driver’s seat belt the docket number and notice number, its petition intended to demonstrate that latch and the addition of a seat belt and be submitted to: Docket non-U.S. certified 1993–1996 Lexus warning buzzer; (b) replacement of the Management, Room PL–401, 400 GS300 passenger cars, as originally driver’s side (on 1993 models) and the Seventh St., SW, Washington, DC manufactured, conform to many Federal driver’s and passenger’s side (on 1994 20590. [Docket hours are from 9 am to motor vehicle safety standards in the through 1996 models) air bags and knee 5 pm]. same manner as their U.S. certified bolsters with U.S.-model components FOR FURTHER INFORMATION CONTACT: counterparts, or are capable of being on vehicles that are not already so George Entwistle, Office of Vehicle readily altered to conform to those equipped. The petitioner states that the Safety Compliance, NHTSA (202–366– standards. vehicles are equipped with Type II seat 5306). Specifically, the petitioner claims that belts at both front and rear outboard SUPPLEMENTARY INFORMATION: non-U.S. certified 1993–1996 Lexus designated seating positions, and with a GS300 passenger care are identical to lap belt in the rear center designated Background their U.S. certified counterparts with seating position. Under 49 U.S.C. § 30141(a)(1)(A), a respect to compliance with Standards Standard No. 301 Fuel System motor vehicle that was not originally Nos. 102 Transmission Shift Lever Integrity: installation of a rollover valve manufactured to conform to all Sequence . . . ., 103 Defrosting and in the fuel tank vent line between the applicable Federal motor vehicle safety Defogging Systems, 104 Windshield fuel tank and the evaporative emissions standards shall be refused admission Wiping and Washing Systems, 105 collection canister. into the United States unless NHTSA Hydraulic Brake Systems, 106 Brake Additionally, the petitioner states that has decided that the motor vehicle is Hoses, 109 New Pneumatic Tires, 113 all vehicles will be inspected prior to substantially similar to a motor vehicle Hood Latch Systems, 116 Brake Fluid, importation to assure compliance with originally manufactured for importation 118 Power Window Systems, 124 the Theft Prevention Standard found in into and sale in the United States, Accelerator Control Systems, 201 49 CFR Part 541. certified under 49 U.S.C. § 30115, and of Occupant Protection in Interior Impact, The petitioner also states that a the same model year as the model of the 202 Head Restraints, 204 Steering vehicle identification number plate motor vehicle to be compared, and is Control Rearward Displacement, 205 must be affixed to the vehicles to meet capable of being readily altered to Glazing Materials, 206 Door Locks and the requirements of 49 CFR Part 565. conform to all applicable Federal motor Door Retention Components, 207 Interested persons are invited to vehicle safety standards. Seating Systems, 209 Seat Belt submit comments on the petition Petitions for eligibility decisions may Assemblies, 210 Seat Belt Assembly described above. Comments should refer be submitted by either manufacturers or Anchorages, 212 Windshield Retention, to the docket number and be submitted

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13248 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices to: Docket Management, Room PL–401, Seventh St., SW, Washington, DC 1997–1999 Ferrari Maranello 550 400 Seventh St., SW, Washington, DC 20590. [Docket hours are from 9 am to passenger cars, as originally 20590. [Docket hours are from 9 am to 5 pm]. manufactured, conform to many Federal 5 pm]. It is requested but not required FOR FURTHER INFORMATION CONTACT: motor vehicle safety standards in the that 10 copies be submitted. George Entwistle, Office of Vehicle same manner as their U.S. certified All comments received before the Safety Compliance, NHTSA (202–366– counterparts, or are capable of being close of business on the closing date 5306). readily altered to conform to those standards. indicated above will be considered, and SUPPLEMENTARY INFORMATION: will be available for examination in the Specifically, the petitioner claims that docket at the above address both before Background non-U.S. certified 1997–1999 Ferrari and after that date. To the extent Under 49 U.S.C. § 30141(a)(1)(A), a Maranello 550 passenger cars are possible, comments filed after the motor vehicle that was not originally identical to their U.S. certified closing date will also be considered. manufactured to conform to all counterparts with respect to compliance Notice of final action on the petition applicable Federal motor vehicle safety with Standards Nos. 102 Transmission Shift Lever Sequence . . . ., 103 will be published in the Federal standards shall be refused admission Defrosting and Defogging Systems, 104 Register pursuant to the authority into the United States unless NHTSA Windshield Wiping and Washing indicated below. has decided that the motor vehicle is Systems, 105 Hydraulic Brake Systems, Authority: 49 U.S.C. 30141(a)(1)(A) and substantially similar to a motor vehicle 106 Brake Hoses, 109 New Pneumatic (b)(1); 49 CFR 593.8; delegations of authority originally manufactured for importation Tires, 113 Hood Latch Systems, 116 at 49 CFR 1.50 and 501.8. into and sale in the United States, Brake Fluid, 124 Accelerator Control Issued on: March 11, 1999. certified under 49 U.S.C. § 30115, and of Systems, 201 Occupant Protection in Marilynne Jacobs, the same model year as the model of the Interior Impact, 202 Head Restraints, motor vehicle to be compared, and is Director, Office of Vehicle Safety Compliance. 204 Steering Control Rearward capable of being readily altered to [FR Doc. 99–6474 Filed 3–16–99; 8:45 am] Displacement, 205 Glazing Materials, conform to all applicable Federal motor BILLING CODE 4910±59±P 206 Door Locks and Door Retention vehicle safety standards. Components, 207 Seating Systems, 209 Petitions for eligibility decisions may Seat Belt Assemblies, 210 Seat Belt be submitted by either manufacturers or DEPARTMENT OF TRANSPORTATION Assembly Anchorages, 212 Windshield importers who have registered with Retention, 216 Roof Crush Resistance, National Highway Traffic Safety NHTSA pursuant to 49 CFR Part 592. As 219 Windshield Zone Intrusion, and 302 Administration specified in 49 CFR 593.7, NHTSA Flammability of Interior Materials. [Docket No. NHTSA±99±5208] publishes notice in the Federal Register Petitioner also contends that the of each petition that it receives, and vehicles are capable of being readily Notice of Receipt of Petition for affords interested persons an altered to meet the following standards, Decision That Nonconforming 1997± opportunity to comment on the petition. in the manner indicated: 1999 Ferrari Maranello 550 Passenger At the close of the comment period, Standard No. 101 Controls and Cars Are Eligible for Importation NHTSA decides, on the basis of the Displays: (a) substitution of a lens petition and any comments that it has marked ‘‘Brake’’ for a lens with a AGENCY: National Highway Traffic received, whether the vehicle is eligible Safety Administration, DOT. noncomplying symbol on the brake for importation. The agency then failure indicator lamp; (b) installation of ACTION: Notice of receipt of petition for publishes this decision in the Federal a seat belt warning lamp that displays decision that nonconforming 1997–1999 Register. the appropriate symbol; (c) recalibration Ferrari Maranello 550 passenger cars are Champagne Imports of Lansdale, of the speedometer/odometer from eligible for importation. Pennsylvania (‘‘Champagne’’) kilometers to miles per hour. (Registered Importer 90–009) has Standard No. 108 Lamps, Reflective SUMMARY: This notice announces receipt petitioned NHTSA to decide whether by the National Highway Traffic Safety Devices and Associated Equipment: (a) 1997–1999 Ferrari Maranello 550 installation of U.S.-model headlamp Administration (NHTSA) of a petition passenger cars are eligible for for a decision that 1997–1999 Ferrari assemblies that incorporate headlamps importation into the United States. The with DOT markings; (b) installation of Maranello 550 passenger cars that were vehicles which Champagne believes are not originally manufactured to comply U.S.-model front and rear sidemarker/ substantially similar are 1997–1999 reflector assemblies; (c) installation of with all applicable Federal motor Ferrari Maranello 550 passenger cars vehicle safety standards are eligible for U.S.-model taillamp assemblies; (d) that were manufactured for importation installation of a center high mounted importation into the United States into, and sale in, the United States and because (1) they are substantially stop lamp on vehicles that are not certified by their manufacturer as already so equipped. similar to a vehicles that were originally conforming to all applicable Federal manufactured for importation into and Standard No. 110 Tire Selection and motor vehicle safety standards. Rims: installation of a tire information sale in the United States and that were The petitioner claims that it carefully certified by their manufacturer as placard. compared non-U.S. certified 1997–1999 Standard No. 111 Rearview Mirror: complying with the safety standards, Ferrari Maranello 550 passenger cars to replacement of the passenger side and (2) they are capable of being readily their U.S. certified counterparts, and rearview mirror with a U.S.-model altered to conform to the standards. found the vehicles to be substantially component. DATES: The closing date for comments similar with respect to compliance with Standard No. 114 Theft Protection: on the petition is April 16, 1999. most Federal motor vehicle safety installation of a warning buzzer ADDRESSES: Comments should refer to standards. microswitch in the steering lock the docket number and notice number, Champagne submitted information assembly and a warning buzzer. and be submitted to: Docket with its petition intended to Standard No. 118 Power Window Management, Room PL–401, 400 demonstrate that non-U.S. certified Systems: rewiring of the power window

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13249 system so that the window transport is Issued on: March 11, 1999. Affected Public: Business or other for- inoperative when the ignition is Marilynne Jacobs, profit organizations and individuals. switched off. Director, Office of Vehicle Safety Compliance. Estimated Number of Respondents: Standard No. 208 Occupant Crash [FR Doc. 99–6475 Filed 3–16–99; 8:45 am] 5,000. Estimated Time Per Respondent: 13 Protection: (a) Installation of a U.S.- BILLING CODE 4910±59±P hours, 40 minutes. model seat belt in the driver’s position, Estimated Total Annual Burden or a belt webbing-actuated microswitch Hours: 68,360. inside the driver’s seat belt retractor; (b) DEPARTMENT OF THE TREASURY The following paragraph applies to all installation of an ignition switch- Internal Revenue Service of the collections of information covered actuated seat belt warning lamp and by this notice: buzzer; (c) replacement of the driver’s Proposed Collection; Comment An agency may not conduct or and passenger’s side air bags and knee Request for Form 8697 sponsor, and a person is not required to bolsters with U.S.-model components respond to, a collection of information on vehicles that are not already so AGENCY: Internal Revenue Service (IRS), unless the collection of information equipped. The petitioner states that the Treasury. displays a valid OMB control number. vehicles are equipped with combination ACTION: Notice and request for Books or records relating to a collection lap and shoulder restraints that adjust comments. of information must be retained as long by means of an automatic retractor and as their contents may become material release by means of a single push button SUMMARY: The Department of the in the administration of any internal at both front designated seating Treasury, as part of its continuing effort revenue law. Generally, tax returns and positions. to reduce paperwork and respondent tax return information are confidential, Standard No. 214 Side Impact burden, invites the general public and as required by 26 U.S.C. 6103. Protection: installation of reinforcing other Federal agencies to take this Request for Comments: Comments beams. opportunity to comment on proposed submitted in response to this notice will and/or continuing information be summarized and/or included in the Standard No. 301 Fuel System collections, as required by the request for OMB approval. All Integrity: installation of a rollover valve Paperwork Reduction Act of 1995, comments will become a matter of in the fuel tank vent line between the Public Law 104–13 (44 U.S.C. public record. Comments are invited on: fuel tank and the evaporative emissions 3506(c)(2)(A)). Currently, the IRS is (a) whether the collection of information collection canister. soliciting comments concerning Form is necessary for the proper performance Additionally, the petitioner states that 8697, Interest Computation Under the of the functions of the agency, including the bumpers on the non-U.S. certified Look-Back Method for Completed Long- whether the information shall have 1997–1999 Ferrari Maranello 550 Term Contracts. practical utility; (b) the accuracy of the passenger cars must be reinforced or DATES: Written comments should be agency’s estimate of the burden of the U.S.-model bumper components must received on or before May 17, 1999 to collection of information; (c) ways to be installed to comply with the Bumper be assured of consideration. enhance the quality, utility, and clarity Standard found in 49 CFR Part 581. ADDRESSES: Direct all written comments of the information to be collected; (d) The petitioner also states that a to Garrick R. Shear, Internal Revenue ways to minimize the burden of the vehicle identification number plate Service, room 5571, 1111 Constitution collection of information on must be affixed to the vehicle to meet Avenue NW., Washington, DC 20224. respondents, including through the use the requirements of 49 CFR Part 565. FOR FURTHER INFORMATION CONTACT: of automated collection techniques or other forms of information technology; Interested persons are invited to Requests for additional information or copies of the form and instructions and (e) estimates of capital or start-up submit comments on the petition costs and costs of operation, described above. Comments should refer should be directed to Carol Savage, (202) 622–3945, Internal Revenue maintenance, and purchase of services to the docket number and be submitted to provide information. to: Docket Section, National Highway Service, room 5569, 1111 Constitution Traffic Safety Administration, Room Avenue NW., Washington, DC 20224. Approved: March 11, 1999. 5109, 400 Seventh Street, S.W., SUPPLEMENTARY INFORMATION: Garrick R. Shear, Washington, DC 20590. It is requested Title: Interest Computation Under the IRS Reports Clearance Officer. but not required that 10 copies be Look-Back Method for Completed Long- [FR Doc. 99–6514 Filed 3–16–99; 8:45 am] submitted. Term Contracts. BILLING CODE 4830±01±U OMB Number: 1545–1031. All comments received before the Form Number: Form 8697. close of business on the closing date Abstract: Taxpayers who are required DEPARTMENT OF THE TREASURY indicated above will be considered, and to account for all or part of any long- will be available for examination in the term contract entered into after February Internal Revenue Service docket at the above address both before 28, 1986, under the percentage of and after that date. To the extent completion method must use Form 8697 Proposed Collection; Comment possible, comments filed after the to compute and report interest due or to Request for Form 8825 closing date will also be considered. be refunded under Internal Revenue AGENCY: Internal Revenue Service (IRS), Notice of final action on the petition Code section 460(b)(3). The IRS uses Treasury. will be published in the Federal Form 8697 to determine if the interest Register pursuant to the authority ACTION: Notice and request for has been figured correctly. comments. indicated below. Current Actions: There are no changes Authority: 49 U.S.C. 30141(a)(1)(A) and being made to Form 8697 at this time. SUMMARY: The Department of the (b)(1); 49 CFR 593.8; delegations of authority Type of Review: Extension of a Treasury, as part of its continuing effort at 49 CFR 1.50 and 501.8. currently approved collection. to reduce paperwork and respondent

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 13250 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices burden, invites the general public and in the administration of any internal FOR FURTHER INFORMATION CONTACT: other Federal agencies to take this revenue law. Generally, tax returns and Requests for additional information or opportunity to comment on proposed tax return information are confidential, copies of the form(s) and instructions and/or continuing information as required by 26 U.S.C. 6103. should be directed to Carol Savage, collections, as required by the Request for Comments: Comments (202) 622–3945, Internal Revenue Paperwork Reduction Act of 1995, submitted in response to this notice will Service, room 5569, 1111 Constitution Public Law 104–13 (44 U.S.C. be summarized and/or included in the Avenue NW., Washington, DC 20224. 3506(c)(2)(A)). Currently, the IRS is request for OMB approval. All SUPPLEMENTARY INFORMATION: soliciting comments concerning Form comments will become a matter of Title: Low-Income Housing Credit 8825, Rental Real Estate Income and public record. Comments are invited on: Allocation Certification and Schedule A Expenses of a Partnership or an S (a) Whether the collection of (Form 8609), Annual Statement. Corporation. information is necessary for the proper OMB Number: 1545–0988. DATES: Written comments should be performance of the functions of the Form Number: Form 8609 and received on or before May 17, 1999 to agency, including whether the Schedule A (Form 8609). be assured of consideration. information shall have practical utility; Abstract: Owners of residential low- (b) the accuracy of the agency’s estimate ADDRESSES: Direct all written comments income rental buildings may claim a of the burden of the collection of low-income housing credit for each to Garrick R. Shear, Internal Revenue information; (c) ways to enhance the Service, room 5571, 1111 Constitution qualified building over a 10-year credit quality, utility, and clarity of the period. Form 8609 is used to obtain a Avenue NW., Washington, DC 20224. information to be collected; (d) ways to FOR FURTHER INFORMATION CONTACT: housing credit allocation from the minimize the burden of the collection of housing credit agency. The form, along Requests for additional information or information on respondents, including copies of the form and instructions with Schedule A, is used by the owner through the use of automated collection to certify necessary information should be directed to Faye Bruce, (202) techniques or other forms of information 622–6665, Internal Revenue Service, required by the law. technology; and (e) estimates of capital Current Actions: There are no changes room 5571, 1111 Constitution Avenue or start-up costs and costs of operation, NW., Washington, DC 20224. being made to Form 8609 or Schedule maintenance, and purchase of services A at this time. SUPPLEMENTARY INFORMATION: to provide information. Type of Review: Extension of a current Title: Rental Real Estate Income and Approved: March 3, 1999. OMB approval. Expenses of a Partnership or an S Garrick R. Shear, Affected Public: Business or other for- Corporation. profit organizations, individuals, and OMB Number: 1545–1186. IRS Reports Clearance Officer. state, local or tribal governments. Form Number: 8825. [FR Doc. 99–6515 Filed 3–16–99; 8:45 am] Abstract: Partnerships and S BILLING CODE 4830±01±U Estimated Number of Respondents: corporations file Form 8825 with either 120,000. Form 1065 or Form 1120S to report Estimated Time Per Respondent: 20 income and deductible expenses from DEPARTMENT OF THE TREASURY hours, 24 minutes. Estimated Total Annual Burden rental real estate activities, including Internal Revenue Service Hours: 2,447,400. net income or loss from rental real estate The following paragraph applies to all activities that flow through from Proposed Collection; Comment of the collections of information covered partnerships, estates, or trusts. The IRS Request For Form 8609 by this notice: uses the information on the form to An agency may not conduct or verify that partnerships and S AGENCY: Internal Revenue Service (IRS), sponsor, and a person is not required to corporations have correctly reported Treasury. respond to, a collection of information their income and expenses from rental ACTION: Notice and request for unless the collection of information real estate property. comments. Current Actions: There are no changes displays a valid OMB control number. SUMMARY: The Department of the being made to the form at this time. Books or records relating to a collection Type of Review: Extension of a Treasury, as part of its continuing effort of information must be retained as long currently approved collection. to reduce paperwork and respondent as their contents may become material Affected Public: Business or other for- burden, invites the general public and in the administration of any internal profit organizations. other Federal agencies to take this revenue law. Generally, tax returns and Estimated Number of Respondents: opportunity to comment on proposed tax return information are confidential, 705,000. and/or continuing information as required by 26 U.S.C. 6103. Estimated Time Per Respondent: 8 collections, as required by the REQUEST FOR COMMENTS: Comments hrs., 43 min. Paperwork Reduction Act of 1995, submitted in response to this notice will Estimated Total Annual Burden Public Law 104–13 (44 U.S.C. be summarized and/or included in the Hours: 6,147,600. 3506(c)(2)(A)). Currently, the IRS is request for OMB approval. All The following paragraph applies to all soliciting comments concerning Form comments will become a matter of of the collections of information covered 8609, Low-Income Housing Credit public record. Comments are invited on: by this notice: Allocation Certification and Schedule A (a) whether the collection of information An agency may not conduct or (Form 8609), Annual Statement. is necessary for the proper performance sponsor, and a person is not required to DATES: Written comments should be of the functions of the agency, including respond to, a collection of information received on or before May 17, 1999, to whether the information shall have unless the collection of information be assured of consideration. practical utility; (b) the accuracy of the displays a valid OMB control number. ADDRESSES: Direct all written comments agency’s estimate of the burden of the Books or records relating to a collection to Garrick R. Shear, Internal Revenue collection of information; (c) ways to of information must be retained as long Service, room 5571, 1111 Constitution enhance the quality, utility, and clarity as their contents may become material Avenue NW., Washington, DC 20224. of the information to be collected; (d)

VerDate 03-MAR-99 10:40 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.XXX pfrm07 PsN: 17MRN1 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices 13251 ways to minimize the burden of the under Internal Revenue Code section DEPARTMENT OF THE TREASURY collection of information on 6655(e)(2)(C)(i) or (ii) for purposes of respondents, including through the use figuring the corporation’s estimated tax Internal Revenue Service of automated collection techniques or payments under the annualized income Proposed Collection; Comment other forms of information technology; installment method. and (e) estimates of capital or start-up Request for Form 8838 Current Actions: There are no changes costs and costs of operation, being made to Form 8842 at this time. AGENCY: Internal Revenue Service (IRS), maintenance, and purchase of services Treasury. Type of Review: Extension of a current to provide information. ACTION: Notice and request for OMB approval. Approved: March 10, 1999. comments. Garrick R. Shear, Affected Public: Business, or other SUMMARY: The Department of the IRS Reports Clearance Officer. for-profit organizations. Treasury, as part of its continuing effort Estimated Number of Respondents: [FR Doc. 99–6516 Filed 3–16–99; 8:45 am] to reduce paperwork and respondent BILLING CODE 4830±01±U 1700. burden, invites the general public and Estimated Time Per Respondent: 2 other Federal agencies to take this hrs., 8 min. DEPARTMENT OF THE TREASURY opportunity to comment on proposed Estimated Total Annual Burden and/or continuing information Internal Revenue Service Hours: 3,638. collections, as required by the Paperwork Reduction Act of 1995, Proposed Collection; Comment The following paragraph applies to all Public Law 104–13 (44 U.S.C. Request for Form 8842 of the collections of information covered 3506(c)(2)(A)). Currently, the IRS is by this notice: soliciting comments concerning Form AGENCY: Internal Revenue Service (IRS), An agency may not conduct or 8838, Consent To Extend the Time To Treasury. sponsor, and a person is not required to Assess Tax Under Section 367-Gain ACTION: Notice and request for respond to, a collection of information Recognition Agreement. comments. unless the collection of information DATES: Written comments should be SUMMARY: The Department of the displays a valid OMB control number. received on or before May 17, 1999, to Treasury, as part of its continuing effort Books or records relating to a collection be assured of consideration. to reduce paperwork and respondent of information must be retained as long ADDRESSES: Direct all written comments burden, invites the general public and as their contents may become material to Garrick R. Shear, Internal Revenue other Federal agencies to take this in the administration of any internal Service, room 5571, 1111 Constitution opportunity to comment on proposed revenue law. Generally, tax returns and Avenue NW., Washington, DC 20224. and/or continuing information tax return information are confidential, FOR FURTHER INFORMATION CONTACT: collections, as required by the as required by 26 U.S.C. 6103. Requests for additional information or Paperwork Reduction Act of 1995, copies of the form and instructions REQUEST FOR COMMENTS: Comments Public Law 104–13 (44 U.S.C. should be directed to Faye Bruce, (202) submitted in response to this notice will 3506(c)(2)(A)). Currently, the IRS is 622–6665, Internal Revenue Service, be summarized and/or included in the soliciting comments concerning Form Room 5577, 1111 Constitution Avenue 8842, Election To Use Different request for OMB approval. All NW., Washington, DC 20224. comments will become a matter of Annualization Periods for Corporate SUPPLEMENTARY INFORMATION: Estimated Tax. public record. Comments are invited on: Title: Consent To Extend the Time To (a) Whether the collection of DATES: Written comments should be Assess Tax Under Section 367-Gain information is necessary for the proper received on or before May 17, 1999, to Recognition Agreement. be assured of consideration. performance of the functions of the OMB Number: 1545–1395. agency, including whether the Form Number: 8838. ADDRESSES: Direct all written comments information shall have practical utility; Abstract: Form 8838 is used to extend to Garrick R. Shear, Internal Revenue (b) the accuracy of the agency’s estimate the statute of limitations for U.S. Service, room 5571, 1111 Constitution persons who transfer stock or securities Avenue NW., Washington, DC 20224. of the burden of the collection of information; (c) ways to enhance the to a foreign corporation. The form is FOR FURTHER INFORMATION CONTACT: quality, utility, and clarity of the filed when the transferor makes a gain Requests for additional information or information to be collected; (d) ways to recognition agreement. This agreement copies of the form and instructions minimize the burden of the collection of allows the transferor to defer the should be directed to Faye Bruce, (202) payment of tax on the transfer. The IRS 622–6665, Internal Revenue Service, information on respondents, including through the use of automated collection uses Form 8838 so that it may assess tax Room 5577, 1111 Constitution Avenue against the transferor after the NW., Washington, DC 20224. techniques or other forms of information technology; and (e) estimates of capital expiration of the original statute of SUPPLEMENTARY INFORMATION: or start-up costs and costs of operation, limitations. Title: Election To Use Different Current Actions: There are no changes maintenance, and purchase of services Annualization Periods for Corporate being made to Form 8838 at this time. Estimated Tax. to provide information. Type of Review: Extension of a current OMB Number: 1545–1409. Approved: March 8, 1999. OMB approval. Form Number: 8842. Garrick R. Shear, Affected Public: Business or other for- Abstract: Form 8842 is used by IRS Reports Clearance Officer. profit organizations and individuals. corporations, tax-exempt organizations Estimated Number of Respondents: [FR Doc. 99–6517 Filed 3–16–99; 8:45 am] subject to the unrelated business income 1000. tax, and private foundations to annually BILLING CODE 4830±01±U Estimated Time Per Respondent: 8 elect the use of an annualization period hrs., 14 min.

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Estimated Total Annual Burden quality, utility, and clarity of the 27, 1978 (43 FR 13359, March 29, 1978), Hours: 8,440. information to be collected; (d) ways to and Delegation Order No. 85–5 of June The following paragraph applies to all minimize the burden of the collection of 27, 1985 (50 FR 27393, July 2, 1985). I of the collections of information covered information on respondents, including hereby determine that the objects to be by this notice: through the use of automated collection included in the exhibit ‘‘Nainsukh: An agency may not conduct or techniques or other forms of information Painter from the Punjab Hills,’’ sponsor, and a person is not required to technology; and (e) estimates of capital imported from abroad for temporary respond to, a collection of information or start-up costs and costs of operation, exhibition without profit within the unless the collection of information maintenance, and purchase of services United States, is of cultural significance. displays a valid OMB control number. to provide information. These objects are imported pursuant to Books or records relating to a collection Approved: March 8, 1999. a loan agreement with the foreign of information must be retained as long Garrick R. Shear, lender. I also determine that the as their contents may become material IRS Reports Clearance Officer. exhibition or display of the listed in the administration of any Internal [FR Doc. 99–6518 Filed 3–16–99; 8:45 am] exhibit objects at the Arthur M. Sackler Revenue law. Generally, tax returns and BILLING CODE 4830±01±U Gallery of Art, Smithsonian Institution, tax return information are confidential, Washington, DC, from on or about April as required by 26 U.S.C. 6103. 25, 1999, to on or about July 18, 1999, REQUEST FOR COMMENTS: Comments UNITED STATES INFORMATION is in the national interest. Public Notice submitted in response to this notice will AGENCY of these determinations is ordered to be be summarized and/or included in the published in the Federal Register. Culturally Significant Objects Imported request for OMB approval. All FOR FURTHER INFORMATION CONTACT: for Exhibition Determinations comments will become a matter of Neila Sheahan, Assistant General public record. Comments are invited on: AGENCY: United States Information Counsel, 202–619–5030, and the (a) Whether the collection of Agency. address is Room 700, U.S. Information information is necessary for the proper ACTION: Notice. Agency, 301 4th Street, SW., performance of the functions of the Washington, DC 20547–0001. agency, including whether the SUMMARY: Notice is hereby given of the R. Wallace Stuart, information shall have practical utility; following determinations: Pursuant to (b) the accuracy of the agency’s estimate the authority vested in me by the Act of Deputy General Counsel. of the burden of the collection of October 19, 1965 (79 Stat. 985, 22 U.S.C. [FR Doc. 99–6495 Filed 3–16–99; 8:45 am] information; (c) ways to enhance the 2459), Executive Order 12047 of March BILLING CODE 8230±01±M

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DEPARTMENT OF HEALTH AND proposed to amend several specific comment on two labeling studies it HUMAN SERVICES warnings, including the required conducted. In the Federal Register of pregnancy-nursing warning, the ‘‘keep December 30, 1997 (62 FR 67770), the Food and Drug Administration out of reach of children’’ warning, and agency sought comment (until February the accidental overdose/ingestion 13, 1998) on a study entitled 21 CFR Parts 201, 330, 331, 341, 346, warnings, to make these warnings as ‘‘Evaluation of Revised Formats for 355, 358, 369, and 701 direct and understandable as possible. Over-the-Counter (OTC) Drugs’’ (Study [Docket Nos. 98N±0337, 96N±0420, 95N± Finally, the agency proposed to preempt B). Study B consisted of a survey of 0259, and 90P±0201] State and local rules that establish more than 900 respondents to evaluate different requirements than those in the consumer preference for design RIN 0910±AA79 proposed rule, to promote a national, variations in drug labeling formats. In Over-The-Counter Human Drugs; standardized format for all OTC drug the Federal Register of February 13, Labeling Requirements product labeling. 1998 (63 FR 7331), the agency solicited The agency discussed at length its comment (until March 30, 1998) on a AGENCY: Food and Drug Administration, basis for proposing to improve labeling second study entitled ‘‘Evaluation of HHS. design (62 FR 9024 at 9027 through Proposed Over-the-Counter (OTC) Label 9031). The agency stated that a ACTION: Final rule. Format Comprehension Study’’ (Study standardized labeling format would A). Study A consisted of a survey of SUMMARY: The Food and Drug significantly improve readability by more than 1,200 consumers on the Administration (FDA) is issuing a final familiarizing consumers with the types influence of variations in labeling rule establishing a standardized format of information in OTC drug product formats on the communication of and standardized content requirements labeling and the location of that directions for use and required for the labeling of over-the-counter information. In addition, a standardized warnings. (OTC) drug products. This final rule is appearance and standardized content, In response to the proposed rule and intended to assist consumers in reading including various ‘‘user-friendly’’ visual the publication of Studies A and B, the and understanding OTC drug product cues, would help consumers locate and agency received more than 1,800 labeling so that consumers may use read important health and safety comments from health professionals and these products safely and effectively. information and allow quick and students, professional organizations, This final rule will require all OTC drug effective product comparisons, thereby trade associations, manufacturers, products to carry the new, easy-to-read helping consumers to select the most consumers, and consumer format and the revised content appropriate product. organizations. An overwhelming The agency reviewed literature requirements within prescribed majority of the comments supported the studies that confirmed that OTC drug implementation periods. agency’s initiative to standardize the product labeling often lacks the DATES: format of OTC drug product labeling graphical features and visual cues Effective Date: April 16, 1999. needed to ensure readability and and to make the labeling easier to read Compliance Dates: For compliance comprehension. These and other studies and understand by requiring a dates see section V of the recommended ways to make labeling minimum type size, user-friendly SUPPLEMENTARY INFORMATION section of easier to read and understand, described headings, and other well-accepted this document. the importance of adherence to visual cues. FOR FURTHER INFORMATION CONTACT: directions for use, and reported on a However, a number of specific points Debra L. Bowen, Food and Drug number of preventable adverse drug in the proposal generated extensive, and Administration, Center for Drug reactions from OTC drug products (see sometimes divergent, comment: (1) Evaluation and Research (HFD–560), 62 FR 9024 at 9027 and 9028). Whether pharmacists, nurses, or other 5600 Fishers Lane, Rockville, MD The agency also has benefitted health professionals should be 20852, 301–827–2222, or email significantly in this proceeding from the specifically referenced in certain of the ‘‘[email protected]’’. experience it gained in redesigning food proposed headings; (2) an appropriate SUPPLEMENTARY INFORMATION: labeling under the Nutrition Labeling minimum type size for the required and Education Act of 1990 (NLEA) (Pub. labeling information; (3) application of I. Background L. 101–535, November 8, 1990). The the proposed labeling format to In the Federal Register of February agency’s required nutrition labeling products traditionally marketed in small 27, 1997 (62 FR 9024), FDA proposed to panel (§ 101.9 (21 CFR 101.9)) provides containers and products marketed as establish a standardized format for the a standardized graphic presentation for both drugs and cosmetics; and (4) labeling of OTC drug products that food nutrients, allowing consumers to continued reference to Poison Control included: (1) Specific headings and judge the significance of the level of a Centers in the required accidental subheadings presented in a particular nutrient in a product in the ingestion warning. These and other standardized order, (2) standardized context of a total daily diet. Since its comments are addressed at length in graphical features such as Helvetica implementation in 1993, the agency has section IV of this document. type style and the use of ‘‘bullet points’’ received praise from consumers and The agency has considered the to introduce key information, and (3) nutritionists, noting the impact and information presented in the proposed minimum standards for type size and utility of the standardized food label. rule, the comments received, the results spacing. The proposal included an The agency provided over 7 months from Studies A and B, and all other extensive list of ‘‘connecting terms’’ that for interested persons to comment on relevant information, and concludes manufacturers may omit from product the OTC labeling proposal, which that the standardized format and labeling, and an expanded list of included an extension of the comment content requirements for OTC drug ‘‘interchangeable terms’’ to facilitate the period from June 27, 1997, to October 6, product labeling, as set forth in this use of more concise and easy to 1997, published in the Federal Register final rule, will enable consumers to understand language in OTC drug on June 19, 1997 (62 FR 33379). In better read and understand the product labeling. The agency also addition, the agency solicited public information presented and apply this

VerDate 03-MAR-99 13:31 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00002 Fmt 4701 Sfmt 4701 E:\FR\FM\17MRR2.XXX pfrm01 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13255 information to the safe and effective use ‘‘cognitive load,’’ such as the task of the labeling will increase significantly of OTC drug products. reading densely worded consumer and, thereby, result in an improved As discussed in the proposed rule, information (Ref. 5). overall understanding of the research on reading behavior and The new OTC drug product labeling information presented. Finally, the new document simplification shows that the is expected to decrease ‘‘cognitive load’’ labeling is expected to provide clear use of less complex terminology, by, among other things, decreasing the signals regarding important information, presented in shorter sentences with an memory demands necessary for leading to increased processing and organized or ‘‘chunked’’ structure, is processing the information. This, in communication of this information. likely to improve consumer processing turn, will allow consumers to process II. Prototype Labeling Based on This of the information (Refs. 1, 2, and 3). the information faster. In addition, the Final Rule Research also shows that consumers are new format offers a more structured, more likely to engage in behavior that organized, and compact presentation, An outline of the various labeling they believe they can successfully which places fewer and less imposing provisions for OTC drug products is complete than in behavior that appears processing demands on the reader. The shown below: overwhelming (Ref. 4) or that presents a consumer’s self-perceived ability to read BILLING CODE 4160±01±F

BILLING CODE 4160±01±C

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An example of labeling for a single ingredient antihistamine OTC drug product, annotated for illustrative purposes, is shown below. FDA recommends use of the type style and font sizes shown below:

An example of labeling for an antacid OTC drug product, applying the modified, small package labeling provisions in this final rule and annotated for illustrative purposes, is shown below. FDA recommends use of the type style and font sizes shown below:

BILLING CODE 4160±01±C

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Examples of prototype OTC drug the sample product label. Attention of dividing lines between sections (thick product labeling are attached in (focused or divided) was varied through versus thin lines). Appendix A of this document. The instructions given to the respondents. This study included 904 respondents information in these examples is Study participants were asked to read a in 8 geographically distributed shopping presented using ordinary package sizes food label, then a drug label to test for malls in the United States, with for these types of products. These divided and focused attention. Half of approximately equal numbers of examples are for illustrative purposes the participants were told they would be respondents from each location. The only and are not intended to depict asked questions about both labels respondents were asked to evaluate 16 specific products. Some are based on (divided attention); the other half were labeling variations of either a sample proposed monograph requirements told they would be tested only on the cough-cold or sunscreen drug product. only. Example 1 depicts sample labeling drug label (focused attention) and that The respondents were also asked to rank for a single ingredient antihistamine the food label was to serve only as the randomly ordered labels from most product, using the format and content reading practice. to least preferred, to specify the reasons provisions set forth in this final rule. The study included 1,202 respondents for their first and second choices, and to Example 2 depicts labeling for a in 8 geographically distributed shopping rate a current OTC drug product that did combination cough/cold product using malls in the United States, with not follow the new format. the format and content provisions set approximately equal numbers of The study showed that the presence forth in this final rule. Example 3 respondents from each location. demonstrates how the same information of a title was the most important factor Respondents were asked to evaluate the in determining preference, as shown in Example 2 can be presented presentation of label information on one directly on the package label for an 8- participants were more likely to choose OTC drug sample and were asked labeling with a title than without. When ounce bottle of syrup, using the small questions about the labeling to package modifications specified in the asked why they preferred the label determine their knowledge, opinions, ranked as number one, the respondents final rule. Example 4 depicts a and willingness to read the labeling. toothpaste that is marketed as a standing indicated that it: (1) Was easy to read, Dependent measures were analyzed and (2) begins with ‘‘Medication Facts.’’ tube without an outer carton, using the using a general linear model analysis of format and content provisions set forth variance. The study demonstrated that The agency performed a primary in this final rule. Example 5 the proposed new format took less time conjoint analysis on the preference demonstrates labeling for a drug product and was easier to read and understand rankings. A conjoint analysis that is also marketed for cosmetic uses than a product that did not follow the simultaneously weighs multiple using the format and content provisions new format. Study respondents variables and allows for a determination set forth in this final rule. Example 5 indicated a general preference for the of the relative importance of each also demonstrates an acceptable proposed format and, when their particular attribute of a variable, in ‘‘similar enclosure’’ to a box. Example 6 attention was divided, respondents felt addition to the level at which each depicts labeling for a topical acne more confident in their ability to use the attribute is preferred (SPSS Categories, product that is marketed in a tube and proposed format labeling. When more 1994). Results indicated that, of the four packaged in a carton with a riser, in graphical design features were used, factors examined, title had the greatest order to provide additional labeling respondents who were instructed to impact on rankings, with a utility range space. Example 7 depicts labeling for an focus on the labeling made more correct from -1.83 for no title and +1.83 for the antacid product, applying the small ‘‘Medication Facts’’ title. In this primary package modifications. product use decisions, compared to respondents whose attention was analysis, the effect of the other three III. Summary of Studies A and B divided. There were no conditions variables was not significant. Studies A and B tested whether the under which a product with an existing The agency also performed a proposed format improves the labeling format outperformed the secondary analysis of the data, to look readability and understandability of proposed new format. at differences between variables, OTC drug product labeling and The results from Study A suggest that independent of context. For labeling investigated consumer preference for consumers who are presented with the with a title, the mean ranks were 6.67 certain format variations. The studies new labeling format will be: (1) More and 10.33 (Z=-20, SD=1.95, p<0.001), confirm that the new labeling format confident in their ability to use the clearly confirming that the presence of will increase communication of OTC information in the labeling, and (2) a title was the most important factor in drug product information. better able to make correct product use determining preference rankings. The decisions. secondary analysis of the other three A. Study A format variables showed mean ranks in B. Study B Study A examined the influence of the middle range (between 8.18 and labeling formats and the use of selective This study investigated consumer 8.82, SDs=0.94 to 1.97). However, as highlighting on the communication of preferences for format and graphical stated previously, the primary analysis directions for use and warnings. The design variations. The study examined of these three variables showed that study examined two levels of four two levels of each of four independent none had a statistically significant independent variables in a factorial variables in a factorial design: (1) The influence on preference when the design: (1) Labeling format (prototypical order of the ‘‘Warning(s)’’ and variable was considered in context. existing format versus proposed new ‘‘Direction(s)’’ section (i.e., warnings Again, the presence of an introductory format), (2) drug type (cough-cold before directions or warnings after title proved to be the preferred variable. versus pain reliever), (3) the use of directions), (2) the placement of the IV. Summary and Response to highlighting (more versus less emphasis ‘‘Active ingredients’’ section at the top Comments on graphic design features), and (4) of the labeling versus bottom, (3) the use consumer attention (divided versus of a title as an introduction to the This section summarizes each section focused). Highlighting, label format, and required information (‘‘Medication of the final rule and provides the drug type were varied in the design of Facts’’ versus no title), and (4) the use agency’s response to comments.

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A. Scope (§ 201.66(a)) United States. One comment ingredients are not used for the same Section 201.66(a) states that the recommended that the labeling indication. content and format requirements in requirements should apply to Several comments focused on the placement of the inactive ingredient § 201.66 apply to the labeling of all OTC homeopathic drug products to promote section, with some suggesting that drug products. This would include their safe use. inactive ingredients should be listed products marketed under a final OTC Homeopathic drug products generally separately from active ingredients drug monograph, an approved new drug are subject to the drug provisions of the because the inactive ingredients are of application (NDA) or abbreviated new act, including the misbranding only minor concern to most consumers. drug application (ANDA) under section provisions in section 502 of the act, and Others were opposed to the separation 505 of the Federal Food, Drug, and therefore, the agency has concluded that an express exemption would not be of active and inactive ingredients. Cosmetic Act (the act) (21 U.S.C. 355), Many comments addressed the and OTC products for which there is no appropriate. However, as emphasized in the proposed rule, the agency’s stated relative placement of the ‘‘Directions’’ final OTC drug monograph or approved and ‘‘Warnings’’ sections. Consumer drug application. Thus, for example, policy is that such products ordinarily will not be recommended for regulatory and professional groups and industry OTC drug products that are the subject representatives generally preferred that of tentative final monographs will, in action if the product is a homeopathic drug as described in Compliance Policy the warnings be presented first, to time, be required to comply with the ensure proper self-selection of the new labeling requirements. Guide 7132.15 entitled ‘‘Conditions Under Which Homeopathic Drugs May appropriate drug at the point of The proposed rule stated that the new purchase. A smaller number of labeling would apply to products that Be Marketed’’ (62 FR 9024 at 9031), and the product follows the labeling and all comments favored placing the are the subject of a final monograph or directions first, based on the idea that other recommendations outlined in that an approved drug application. Under this section would contain the most guidance document. By its terms, the both the proposed and the final rule, all important information on the proper use policy of generally not recommending OTC drug products in time would be of the product. required to adopt the new labeling. The homeopathic products for regulatory As discussed previously in section revised wording of the scope provision action will extend to this rule. III.B of this document, the primary is consistent with and furthers two B. Definitions (§ 201.66(b)) statistical analysis performed in Study B central themes of this proceeding. First, did not find a significant respondent the agency has concluded that Section 201.66(b) contains applicable preference for the placement of consistent, standardized labeling of OTC definitions, including explanations of ‘‘Warnings,’’ ‘‘Directions,’’ and ‘‘Active drug products will improve the certain printing, typesetting, and ingredients.’’ Therefore, the order for selection and the safe and effective use graphics terms applicable to this rule. the placement of information in the of all OTC drug products. Second, all The agency has also added definitions final rule is modeled after the drug products, irrespective of their for the terms ‘‘bullet,’’ ‘‘title,’’ and decisionmaking process consumers regulatory status, must bear labeling that ‘‘inactive ingredient.’’ The definition for would be expected to follow, and is ‘‘likely to be read and understood by inactive ingredient is identical to the should follow, when selecting and using the ordinary individual under definition in the agency’s good OTC drug products. customary conditions of purchase and manufacturing practice regulations in 21 First, consumers need to know what use.’’ (Section 502 of the act (21 U.S.C. CFR 210.3(b)(8). the product is and what it is intended 352(c)).) With all products following the C. Content Requirements (§ 201.66(c)) to do. This information often is not new format, consumers will be able to apparent from the principal display readily distinguish OTC drug products Section 201.66(c) contains the content panel (PDP), especially for combination from other categories of products (such requirements for the standardized OTC drug products. This information as dietary supplements and foods), labeling format and states that all also is critical to consumers’ ability to make product-to-product comparisons information must be organized under select the most appropriate product. across all therapeutic classes, and will the title, headings, and subheadings set Therefore, the agency is requiring the begin to recognize where to find forth in paragraphs (c)(1) through (c)(8), listing of the active ingredients and their information that is critical to the best and it may contain the information purposes as the first information use of any OTC drug product. The final under the heading in paragraph (c)(9), in presented under the title ‘‘Drug Facts.’’ rule ensures that by a date certain all the order prescribed. This information Foremost, the agency believes that OTC drug products will display the new must appear on the outside container or consumers need to be able to identify labeling. wrapper of the retail package, or the the active drug ingredients, to readily The agency has chosen an outside immediate container label if there is no access that information, and to associate implementation date of 6 years for outside container or wrapper. As the ingredients with their respective marketed OTC drug products that are discussed below, the agency has purposes. not and do not become the subject of amended some of the headings and Next, the consumer needs to select an final OTC monographs (see section V of subheadings and included additional appropriate product for its intended this document). Because most, if not all, headings and subheadings, including uses. Therefore, this section, entitled drug products undergo at least one the title ‘‘Drug Facts.’’ ‘‘Use(s),’’ follows the active ingredient major labeling revision every 6 years 2. Several comments supported the and purpose information. (see section VIII of this document), the order for listing information, as The ‘‘Warnings’’ section, which revised scope is not expected to impose prescribed in § 201.66(c). One comment follows the ‘‘Use(s),’’ contains any significant additional burdens. stated that listing active ingredients and information that is relevant to both the 1. Several comments asked that their purposes first allows consumers to product selection decision and to proper § 201.66 include an express exemption compare ingredients, avoid certain use. This section contains information for homeopathic drug products, ingredients for reasons of safety or regarding when the product should including those products listed in the personal preference, and helps to ensure absolutely not be used, drug-drug and Homeopathic Pharmacopeia of the that products with different active drug-food interactions, when to consult

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Moreover, the proposed appropriate product, correct carton is often discarded, leaving the rule itself added more flexibility in administration and dosing is essential. immediate container as the sole source selecting language, making it less likely The ‘‘Directions’’ section contains for important warnings and dosage that manufacturers would avail dosage and administration information information. themselves of the labeling features necessary for the safe and effective use For products that are sold with an specified in § 330.1. The agency of the product. Therefore, this section outer package, the agency encourages therefore solicited comment on whether follows the ‘‘Warnings’’ section. manufacturers to try to meet all of the to retain the idea of allowing special ‘‘Other information’’ is listed in the labeling requirements in this rule on the titles and boxes for manufacturers who next section, for products that need to immediate container as well. If the follow precise monograph language (62 provide additional information that is immediate container is too small to FR 9024 at 9039). important for complete understanding meet the format requirements of The agency did not receive of the product’s use, including § 201.66(d)(1) through (d)(9), the agency substantive comments on this issue. The information for consumers who may be encourages manufacturers to include the agency did, however, receive one allergic to certain ingredients, such as required information as provided in the comment stating that the title ‘‘FDA aspartame, or who restrict the intake of small package format in § 201.66(d)(10). Approved Uses’’ violated section 301(1) dietary ingredients such as sodium. In addition, manufacturers must include of the act and could create confusion The ‘‘Inactive ingredients’’ section is on the immediate container any between products marketed under new listed near the conclusion of the FDA- information that is specifically required drug applications and similar products required information, because some by regulation (including an OTC drug marketed under OTC drug monographs. products contain a large number of The first issue was rendered moot by the inactive ingredients. The location of this monograph) to appear on the immediate container, in the manner described in repeal of section 301(1) of the act under section will help maintain the section 421 of the Food and Drug systematic presentation of the that regulation or monograph (see, e.g., § 201.314(h)(2) (21 CFR 201.314(h)(2))), Administration Modernization Act of information listed under the other 1997 (FDAMA) (Pub. L. 105–115), while requiring Reye’s syndrome warning on headings. the second issue was addressed by the the immediate container). Finally, the agency has included a agency in the rulemaking for § 330.1(c) location for a telephone number. The 1. Title (§ 201.66(c)(1)) (see 51 FR 16258 at 16260 and 16261, telephone number, if provided, would May 1, 1986). appear after the header ‘‘Questions?’’ (or Section 201.66(c)(1) requires the title The agency agrees, however, that the ‘‘Questions or comments?’’), does not ‘‘Drug Facts’’ as the first heading in the availability of a title should not be need to be a toll-free number, and may standardized format. A title provides an limited to products marketed under include the days of the week and time important visual cue for introducing OTC drug monographs. The agency also when someone is available to respond to required information. The agency finds, based in part on the strong questions. evaluated the use of a title as a graphical support for a title under Study B, that As described in section III.B in this design feature in Study B and solicited consumers would benefit by having a document, the agency examined the comment on both the design of Study B title on all OTC drug products (rather order of certain headings in Study B, and the results of the study. As than only on those few products that including the relative placement of the summarized in section III of this chose to use certain language specified ‘‘Warnings’’ and ‘‘Directions’’ sections document, respondents in Study B under an OTC drug monograph). The and the placement of the ‘‘Active strongly preferred labeling that agency has therefore included a title as ingredients’’ section. When all of the contained a title, such as ‘‘Medication part of this final rule to introduce the design variables in the study were Facts,’’ and considered such labeling to required information on all OTC drug analyzed simultaneously, the variable be more credible and reliable than products. In addition, the agency is placement of these three headings had labeling without a title. When the revoking the titles and boxed labeling little relative impact on preference or agency analyzed simultaneously the provisions from § 330.1(c). readability ratings of the entire labeling. impact of all design variables tested in 5. Several comments contended that a The agency selected the order Study B, the introductory title had the title such as ‘‘Medication Facts’’ was not prescribed in § 201.66(c) because it most greatest relative impact on preference specifically discussed in the proposed closely tracks a logical decisionmaking rankings. rule and, therefore, should not be process that would allow for the best 4. The existing regulations governing included in this final rule. The selection and best use of OTC drug OTC monograph products allow comments also contended that this title products. manufacturers to use titles such as has not been shown to actually improve 3. The agency sought comment on ‘‘FDA Approved Uses’’ and ‘‘FDA consumer use of OTC drug products and whether the new labeling should apply Approved Information’’ to introduce would take up too much space. to the immediate container label even if required monograph information. These As discussed, the agency included the the product is marketed with an outer titles, and the ability to enclose labeling title ‘‘Medication Facts’’ as a key package or wrapper (62 FR 9024 at 9037 information in a highlighted ‘‘box,’’ are variable in Study B and provided ample and 9038). Several comments stated that available under FDA’s ‘‘exclusivity opportunity for interested persons to the labeling requirements should not policy.’’ Under the policy, comment on the design and on the apply to the immediate container, or manufacturers may include a specified results of the study. should be voluntary for the immediate title and box if they follow certain A title on the information panel container, when there is an outer precise or ‘‘exclusive’’ language provides a strong cue to the consumer package, because space is often provided by FDA in a final OTC that important labeling information especially limited on the container. monograph (see § 330.1 (21 CFR 330.1)). follows. This is similar to the highly

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13260 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations successful ‘‘Nutrition Facts’’ title applicable monograph or approved drug product. Regardless of placement on the required on the information panel for application. PDP, such uniform and prominent food products (§ 101.9). Indeed, This provision incorporates a recent placement will help to ensure proper respondents in Study B stated that they amendment to section 502(e) of the act product selection, especially for product preferred a label with a title and that under FDAMA. FDAMA amended line extensions. they considered the information to be section 502(e) of the act to require that 3. Purpose(s) (§ 201.66(c)(3)) more credible and reliable when the quantity (or the proportion, if introduced by a prominent title. determined to be appropriate by the Section 201.66(c)(3) requires the The agency does not believe that it Secretary of Health and Human Services heading ‘‘Purpose’’ or ‘‘Purposes,’’ must prove that the title alone improves (the Secretary)) of each active ingredient followed by the general pharmacological consumer use of OTC drug products. A appear in the labeling of all OTC drug category(ies) or the principal intended number of factors combined determine products intended for human use. In the actions of the drug or of each active consumer use, including format proposed rule, the agency provided for ingredient, when more than one variables, legibility, readability, the placement and formatting of the ingredient is listed. When an OTC drug comprehension, and consumer quantity of each active ingredient, but monograph contains a statement of motivation. It is difficult to separate out requested comment on whether to identity, the pharmacological action the influence of each variable. require all products to include this described in the statement of identity Nevertheless, it is important to note that information. At that time, the agency’s shall also be stated as the purpose of the when all of the design variables in regulations encouraged (but did not active ingredient. Section 201.66(c)(3) of Study B were considered require) manufacturers to include the the final rule does not differ from the simultaneously, the title had the most quantity per dosage unit in the labeling proposal. significant impact in determining which (§ 330.1(j)). The vast majority of OTC 4. Use(s) (§ 201.66(c)(4)) label consumers preferred. Overall, a drug products already include such title creates an important, concise visual information in their labeling. As a result Section 201.66(c)(4) requires that all cue for consumers and serves to of the statutory change, this final rule OTC drug product labeling include the reinforce the importance of the makes clear that the established name heading ‘‘Use’’ or ‘‘Uses’’ followed by information that follows. and quantity of each active ingredient the indications for use of the drug The agency has decided to use the must be included in the required product. Section 201.66(c)(4) of the final title ‘‘Drug Facts,’’ in place of the test information set forth in § 201.66(c), in rule does not differ from the proposal. title ‘‘Medication Facts,’’ because the the location and format established by 5. Warning(s) (§ 201.66(c)(5)) phrase ‘‘Drug Facts’’ is short, concise, the agency. In an agency guidance easy to print in large type, and best document titled ‘‘National Uniformity Section 201.66(c)(5) requires the signals an OTC drug product. for Nonprescription Drugs—Ingredient heading ‘‘Warning’’ or ‘‘Warnings’’ Consumers may use the term Listing for OTC Drugs (April 1998)’’ followed by the specific information ‘‘Medication’’ to refer to remedies which (Ref. 6), the agency stated that it does and subheadings listed in may not be marketed as drug products. not intend to object if manufacturers, §§ 201.66(c)(5)(i) through (c)(5)(x), as It is also a four syllable word which packers, and distributors defer applicable. requires a higher level of reader relabeling their products to comply with 7. Several comments requested that comprehension. Consumers, for the statutory requirement until the the warning ‘‘For external use only’’ example, commonly use the term ‘‘drug earliest applicable implementation date appear immediately following the store’’ to refer to a pharmacy. The specified in this final rulemaking ‘‘Warnings’’ heading, on the same line agency therefore concludes that the document. of text as the heading. The agency agrees word ‘‘drug’’ in this title is more 6. Several comments favored placing that for topical drug products not precise, readable, comprehensible and, the active ingredient section on the PDP, intended for ingestion, this warning in response to the comments, will rather than on another panel. The should appear first. The agency, require less labeling space. comments argued that product line however, believes that the ‘‘Warnings’’ The title will take up one line of text extensions (i.e., OTC drug products with heading should signal the entire on each panel that it appears. The the same brand name that contain warning facts information and, previously allowed titles (‘‘FDA different active ingredients) invite the therefore, disagrees with the request to APPROVED USES’’ and ‘‘FDA need for more prominent placement of display this statement on the same line APPROVED INFORMATION’’) also took the active ingredients. According to as the heading. The agency is also up one line of text. Based in part on the these comments, most consumers are specifying that the placement of the results of study data and on the agency’s able to recognize brand names but are warnings ‘‘For rectal use only’’ or ‘‘For experience with other forms of labeling, unable to identify the relevant active vaginal use only,’’ where applicable, the agency concludes that the benefits of ingredients. Placement of the active immediately follow the ‘‘Warning’’ having a title outweigh the minimum ingredients on the PDP would allow heading. space required. consumers to distinguish products sold 8. The proposed rule would have under the same brand name. required certain ingredient-specific 2. Active Ingredient(s) (§ 201.66(c)(2)) This final rule requires the listing of warnings, such as the Reye’s syndrome Section 201.66(c)(2) requires the active ingredients as the very first warning in § 201.314(h)(1), to be listed heading ‘‘Active ingredient(s),’’ information within a clearly defined first under the heading. Several followed by the established name and panel, immediately below a prominent comments recommended that the the quantity of each active ingredient title. This location will enable agency integrate such warnings into the per dosage unit. For products marketed consumers to quickly and systematically various subheadings set forth in without a discrete dosage unit, such as compare ingredients within products for § 201.66(c)(5). Although the topical OTC drug products, the similar uses. In addition, because the subheadings provide important visual proportion of each active ingredient respective purposes will be listed next and organizational cues, the agency must be stated instead of the quantity, to each active ingredient, consumers believes that the warnings listed in unless otherwise specified in an will know why the ingredient is in the § 201.66(c)(5)(ii) of the final rule need to

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An doctor before use.’’ The agency This issue was also presented to the effective way to ensure that these specifically sought comment on whether FDA’s Nonprescription Drugs Advisory special warnings are prominently the phrase ‘‘or pharmacist,’’ as in ‘‘Ask Committee at its July 14, 1997, meeting. displayed is to require that they be your doctor or pharmacist,’’ should be The committee did not reach consensus listed immediately under the included in OTC drug product labeling whether ‘‘pharmacist’’ should be ‘‘Warnings’’ heading, with a subheading and, if so, in what section of the included in the labeling. However, that describes the key aspect of the labeling, and for which products (62 FR several presenters suggested a specific warning. The agency has incorporated 9024 at 9039). A majority of the consultative role for the pharmacist special subheadings for the warnings comments supported the inclusion of when considering drug-drug and drug- that will appear in this section. Some of the pharmacist in OTC drug product food interactions. the subheadings appear in current labeling. Other comments suggested The agency has determined that regulations or approved drug phrases such as ‘‘other health warnings for persons with certain applications, and others are being added professional,’’ ‘‘other healthcare preexisting conditions (e.g., glaucoma) to provide consumers with signal words professional,’’ or ‘‘other healthcare and symptoms (e.g., cough with fever, that describe the key aspect of the practitioner.’’ rash, or persistent headache) be listed warning statement. Those comments favoring the phrase under the subheading, ‘‘Ask a doctor 9. One comment suggested that the ‘‘or pharmacist’’ stated that pharmacists before use if you have,’’ and that subheading ‘‘Do not use’’ include the often are immediately accessible at the warnings concerning drug-drug or drug- word ‘‘if,’’ to read ‘‘Do not use if.’’ time of OTC drug purchase, are well food interactions be listed under the Another suggested listing allergic equipped to provide information subheading, ‘‘Ask a doctor or reaction warnings under this regarding benefits and risks associated pharmacist before use if you are.’’ subheading. with OTC drug products, have extensive However, the pregnancy/breast-feeding warning in § 201.63 (21 CFR 201.63) The agency disagrees with adding ‘‘if’’ training, and in many instances have will continue to use the term ‘‘health to this subheading because conditional immediate access to patient profiles and professional.’’ words other than ‘‘if’’ may be part of prescribing histories. The comments As stated in the proposed rule, the certain warnings (e.g., ‘‘on broken added that when pharmacists do not agency recognizes that pharmacists are skin’’). With respect to allergic have enough information about a knowledgeable about OTC drug reactions, the agency considers serious person’s medical condition, or products. Also, pharmacists are readily allergic reactions (e.g., immediate otherwise recognize the need to contact accessible to a majority of consumers hypersensitivity reactions) to be of such a doctor, they are trained to advise the who purchase OTC drug products and importance that it is requiring these consumer to speak with a doctor before are a valuable resource for general warnings to appear immediately under taking an OTC drug product. Several questions. Survey studies submitted to the ‘‘Warnings’’ heading, preceded by comments noted that about 60 percent the docket for this proceeding suggest the subheading ‘‘Allergy alert.’’ of OTC drug products are purchased in that direct consumer counseling by In the labeling examples included in retail pharmacies. pharmacists may change initial OTC the proposed rule, the agency showed Those supporting phrases such as drug purchasing decisions and may the prescription monoamine oxidase ‘‘other health professional’’ or ‘‘other prevent potential adverse events (Refs. 7 inhibitor (MAOI) warning under the healthcare professional’’ or ‘‘other and 8). In addition, pharmacists are ‘‘Do Not Use’’ subheading. No healthcare practitioner’’ stated that for trained to provide advice about drug- comments to the contrary were received, many consumers the primary healthcare drug and drug-food interactions and and the agency concludes that the provider is a nurse practitioner, clinical often have access to computer data warning should appear after this nurse specialist, nurse midwife, bases which contain (and frequently subheading. physician assistant, or other healthcare update) this information. Therefore, the The MAOI warning appears in several professional, and not a physician. The agency concludes that warnings places in the cough-cold monograph comments argued that limiting the concerning interactions be listed under (§§ 341.74(c)(4)(v) and (c)(4)(vi), reference to ‘‘doctor’’ sends the message the subheading, ‘‘Ask a doctor or 341.76(c)(4), and 341.80(c)(1)(i)(D) and that only a ‘‘doctor’’ is qualified to know pharmacist before use if you are.’’ The (c)(1)(ii)(D) (21 CFR 341.74(c)(4)(v) and about a drug product’s benefits, risks, drug interaction precautions in 21 CFR (c)(4)(vi), 341.76(c)(4), and side effects, and precautions. 331.30(d) and 346.50(c)(7)(ii) have been 341.80(c)(1)(i)(D) and (c)(1)(ii)(D)). The A few comments stated that a revised to fit this new subheading. agency has determined that the words subheading such as ‘‘Ask a doctor or If a consumer has a preexisting ‘‘Drug Interaction Precaution’’ and ‘‘this pharmacist before use’’ would equate disease or clinical symptoms, the product,’’ which are currently included the role of a pharmacist with that of a agency concludes that the subheading, in these sections, need not appear when doctor. These comments contended that ‘‘Ask a doctor before use if you have,’’ the information appears after the new pharmacists do not have the same level should be retained. The agency has ‘‘Do not use’’ heading. Therefore, the of knowledge or training regarding decided not to include the phrase ‘‘or agency is including the words ‘‘Drug patient specific conditions, symptoms, pharmacist’’ in this subheading because Interaction Precaution’’ and ‘‘this side effects, and concomitant therapies. questions concerning preexisting product’’ in new § 330.1(j) in this final Further, only a physician is trained in diagnoses or clinical symptoms are best rule, which lists connecting terms that medical history-taking, physical answered by a healthcare provider who can be deleted from the labeling of OTC examination, and diagnosis. The is trained and licensed specifically to drug products. The MAOI warning comments stated that although a make differential diagnoses and to treat would now appear in labeling as follows pharmacist may be qualified to help disease entities. ‘‘Do not use if you are now taking a consumers select OTC drug products, a The agency has also decided to use prescription monoamine oxidase phrase such as ‘‘or pharmacist’’ is likely only the term ‘‘doctor’’ in this inhibitor (MAOI) * * * .’’ to confuse consumers about the role of subheading, rather than a longer list of

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13262 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations healthcare providers. The agency about preexisting conditions when The agency has also added to the final acknowledges that in addition to consumers should not use the product rule a ‘‘catch-all’’ provision in physicians, surgeons, and dentists, other before a doctor is consulted. The § 201.66(c)(5)(viii) that directs the licensed professionals play important subheading ‘‘Ask a doctor or pharmacist placement of any other required roles in delivering clinical services before use if you are’’ (§ 201.66(c)(5)(v) warning that does not fit within the directly to consumers and that nurse in this final rule) cautions consumers categories listed in § 201.66(c)(5)(i) practitioners and physician’s assistants about potential drug-drug or drug-food through (c)(5)(vii), (c)(5)(ix), and may sometimes serve as primary interactions when consumers should (c)(5)(x), to appear following the medical care providers. However, the not use the product before a doctor or warnings described in (c)(5)(vii). agency has decided not to endeavor to pharmacist is consulted. Organizing or 14. Many comments disagreed with list each specific practitioner who is ‘‘chunking’’ the information under the proposal to eliminate the reference licensed and qualified in the clinical separate subheadings makes it more to Poison Control Centers in the practice of medicine and in disease likely that the information will be read accidental overdose/ingestion warning management. For OTC drug products, and understood by consumers who have in § 330.1(g), which is incorporated by the term ‘‘doctor’’ in this subheading is certain conditions or are taking other reference in § 201.66(c)(5)(x) of the final sufficiently broad and inclusive (Ref. 9). drugs. rule. The comments cited several The agency is retaining the phrase, 12. Section 201.66(c)(5)(vi) requires factors, including: (1) Medical ‘‘health professional’’ in the revised the subheading ‘‘When using this professionals may lack complete pregnancy/breast-feeding warning in product,’’ followed by any side effects knowledge about treating an accidental § 201.63(a), which requires, when that the consumer may experience and overdose of an OTC drug product; (2) appropriate, the warning, ‘‘If pregnant the substances (e.g., alcohol) or advising consumers to ‘‘get medical or breast-feeding, ask a health activities (e.g., operating machinery, help right away’’ is likely to encourage professional before use.’’ In establishing driving a car) to avoid while using the consumers to proceed immediately to a this warning (47 FR 54750, December 3, product. One comment suggested that hospital emergency room when Poison 1982), the agency noted that certain because this subheading is not parallel Control Centers can often help treat health professionals (e.g., physicians, in grammar with the other subheadings, such exposures at home; and (3) Poison nurses, certified nurse midwives, nurse it should read, ‘‘Be aware when using Control Centers in appropriate practitioners, and physician’s assistants) this product.’’ Another comment circumstances can direct consumers to may be familiar with problems related requested that warnings for drugs in an emergency provider, inform hospital to medication use during pregnancy and dispensers pressurized by gaseous personnel of a patient’s imminent nursing because they receive specific propellants be included under this arrival, and provide hospital staff with training in this area and they directly subheading. critical information. One comment deliver healthcare to women who are Although the subheading ‘‘When indicated that Poison Control Centers pregnant or nursing. As a consequence, using this product’’ is not grammatically now serve the entire U.S. population, 24 for these specific physiologic parallel with the other subheadings, the hours a day, 7 days a week, providing conditions, these health professionals phrase ‘‘Be aware’’ is implied in the immediate free advice to consumers and may be appropriately relied upon as subheading because it appears under the health professionals. sources of information advising caution general heading, ‘‘Warnings.’’ The agency agrees that Poison Control concerning drug use while pregnant or Consumers are already cautioned that Centers are a valuable resource in the nursing. The agency has amended they need to read and take note of the event of an accidental overdose or § 201.63(a) in this final rule by requiring warning information that follows. In ingestion of an OTC drug product. that the first four words of the warning addition, the words ‘‘Be aware’’ would Accordingly, the agency is retaining, appear in bold type, to ensure that this unnecessarily lengthen the subheading. and adding where needed, the reference warning is as prominent and The agency agrees with the comment to Poison Control Centers in revised conspicuous as the required that the warnings for drugs in § 330.1(g), 21 CFR 369.9, 21 CFR 369.20, subheadings. dispensers pressurized by gaseous §§ 369.21, and 201.314(a) and (g)(1). Finally, the agency is including in propellants (§ 369.21 (21 CFR 369.21), this final rule a conforming amendment 21 CFR 310.201(a)(11) and (a)(18)) 6. Directions (§ 201.66(c)(6)) to the MAOI warning (§§ 341.74(c)(4)(v) would appear under this subheading. Section 201.66(c)(6) requires the and (c)(4)(vi), 341.76(c)(4), and 13. Section 201.66(c)(5)(vii) requires heading ‘‘Directions’’ followed by the 341.80(c)(1)(i)(D) and (c)(1)(ii)(D)), the subheading ‘‘Stop use and ask a applicable directions for use. substituting the words ‘‘doctor or doctor if,’’ followed by any signs of 15. One comment suggested that this pharmacist’’ for the words ‘‘health toxicity or other serious reactions that heading read ‘‘Follow these directions,’’ professional.’’ This change is consistent would necessitate immediately to give consumers a stronger cue. The with the respective roles of pharmacists, discontinuing use of the product. This agency believes that the heading doctors, and health professionals in subheading, as proposed, read ‘‘Stop ‘‘Directions’’ is an implicit instruction assisting consumers of OTC drug using this product if,’’ followed by the to not only read the directions for use, products. required warnings, followed by ‘‘Ask a but also to follow the directions. 11. Several comments recommended doctor. These may be signs of a serious Accordingly, the agency prefers the consolidating the subheading ‘‘Ask a condition.’’ Several comments raised more concise heading. doctor before use if you have’’ the concern that the ‘‘Ask a doctor’’ (proposed § 201.66(c)(iii)(A)) with the portion of this warning may be de- 7. Other Information (§ 201.66(c)(7)) subheading ‘‘Ask a doctor before use if emphasized within the proposed Section 201.66(c)(7) requires the you are’’ (proposed § 201.66(c)(iii)(B)), labeling format. The agency agrees and heading ‘‘Other information,’’ when to allow greater flexibility in labeling has amended the subheading to ensure appropriate, followed by information design. that consumers are adequately advised that does not fall within any of the other The subheading ‘‘Ask a doctor before to contact a doctor if they experience categories in § 201.66(c), but which is use if you have’’ (§ 201.66(c)(5)(iv) in certain signs of toxicity or other required by or is made optional under this final rule) cautions consumers reactions. an applicable OTC drug monograph,

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13263 other OTC drug regulation, or an information about specific ingredients products that are also cosmetics. approved drug application. be included in the labeling of OTC drug Manufacturers may follow § 701.3(a), 16. One comment asked whether products. Examples include sodium which generally requires the listing of information regarding proper storage of content (21 CFR 201.64), proposed ingredients in descending order of an OTC drug product must appear calcium content (§ 201.72 (21 CFR predominance, or § 701.3(f), which under this heading. The agency 201.72)), proposed magnesium content allows ingredients to be grouped in recognizes that there are space (§ 201.71), proposed potassium content certain categories. The provisions in constraints for placement of information (§ 201.72), and phenylalanine/aspartame § 701.3 in paragraphs (e), (g), (h), (l), on OTC drug product labeling. For content (21 CFR 201.21(b)). The agency (m), (n), and (o) and 21 CFR 720.8, may products that include United States did not include a separate heading for also apply, as appropriate. The names of Pharmacopeia (USP) or manufacturer’s such dietary information in the cosmetic ingredients are to be storage information in their labeling, proposed rule. However, the agency determined in the manner described in this information may be placed under requested comment on the appropriate § 701.3(c). the ‘‘Other information’’ heading or placement of this information. Several outside the ‘‘Drug Facts’’ labeling. comments suggested that a separate This final rule incorporates the recent However, if an OTC drug monograph heading would help ensure appropriate amendment to section 502(e) of the act contains storage requirements (e.g., wart product selection and reduce health under section 412 of FDAMA. Section remover drug products in 21 CFR risks associated with certain nutrients. 502(e)(iii) of the act, as amended, 358.150(c)(3) and corn and callus Other comments disagreed with the authorizes the Secretary to require the remover drug products in 21 CFR need for such a heading, arguing that listing of the established name of each 358.550(c)(3)), then that information this information can be placed in the inactive ingredient in alphabetical order must be included in the ‘‘Drug Facts’’ ‘‘Other information’’ section. on the outside container of the retail labeling under this heading. The agency has determined that this package and, if determined to be 17. Several comments suggested that information can appropriately appear appropriate by the Secretary, on the other required information for OTC drug after the heading ‘‘Other information.’’ immediate container as well, as products (such as the identification of This information is significant for prescribed in regulations issued by the certain inactive ingredients and the individuals who monitor their intake of Secretary. Further, the amendment to required tamper-resistant packaging certain nutrients, including persons section 502(e) of the act provides that if statement) appear below the ‘‘Other with hypertension and renal the drug product is also a cosmetic, then information’’ heading. The agency is insufficiency, and for persons who want the inactive ingredients need not be requiring inactive ingredients to be to increase their intake of certain listed in alphabetical order. listed in a separate section. However, nutrients (e.g., calcium). The agency is required information about certain requiring this important information to In a guidance document entitled ingredients (e.g., the sodium content) be the first statement under ‘‘Other ‘‘National Uniformity for will appear as the first required information’’ to draw attention to it. The Nonprescription Drugs—Ingredient statement in the ‘‘Other information’’ information will appear as follows: Listing for OTC Drugs’’ (April 1998), the section. The required tamper-resistant ‘‘each (insert appropriate dosage unit) agency stated that it would consider labeling statement (now referred to as contains:’’ [in bold type] (insert name(s) whether to provide an additional ‘‘tamper-evident’’ labeling (see 63 FR of ingredient(s) and the quantity of each opportunity for comment before 59463, November 4, 1998) must be ingredient), (e.g., sodium 50 mg). The finalizing provisions implementing new prominently placed to alert consumers phenylalanine/aspartame content, if section 502(e)(1)(iii) of the act. Because about the product’s tamper-evident applicable, should appear as the next the final rule essentially codifies the features (see (21 CFR 211.132(c)). The item of information. Additional provisions of the statute, and because agency will continue to allow flexibility information that is authorized to appear the final rule requires the listing of as to where this statement appears in under this heading shall appear as the inactive ingredients in the same location labeling and is not requiring that it be next item(s) of information. There is no as that described in the proposal, an included within the ‘‘Drug Facts’’ area. required order for this subsequent additional opportunity to comment is However, if the statement is included in information. not needed at this time. However, the the ‘‘Drug Facts’’ area, it should be 8. Inactive Ingredients (§ 201.66(c)(8)) agency recognizes the possibility that placed under ‘‘Other information.’’ more detailed regulations or guidance 18. The agency also received Section 201.66(c)(8) requires the on the listing of inactive ingredients comments asking whether a ‘‘sell copy’’ heading ‘‘Inactive ingredients,’’ may prove necessary. The agency also statement or other promotional followed by a listing of the inactive intends to consider whether to information, such as a statement of ingredients. If the product is an OTC consolidate, to the extent permitted approval of the American Dental drug product that is not also a cosmetic, under the act, the requirements for Association, may appear under ‘‘Other then the established name of each listing inactive ingredients in OTC drug inactive ingredient (any ingredient that information.’’ Although promotional products with the requirements for OTC is not an active ingredient as defined in copy may be important to the sale of a drug products that are also marketed as § 201.66(b)(2)) shall be listed in drug product, it is generally not cosmetics. Either or both of those necessary for the safe and effective use alphabetical order. If the product is both initiatives, if they resulted in of the product. Therefore, this a drug and a cosmetic, then the inactive rulemaking, would provide further information may not appear under the ingredients would be listed in opportunities for public comment. ‘‘Other information’’ heading or within accordance with § 701.3 (21 CFR 701.3). the ‘‘Drug Facts’’ area, but may appear However, because § 701.3 includes Finally, the agency is not requiring at elsewhere in the labeling (e.g., PDP or format requirements that may not be this time the listing of inactive side or end panel) if otherwise consistent with this final rule, the ingredients on immediate containers permitted by law. agency has enumerated the paragraphs when the product is marketed with an 19. FDA regulations require or will within § 701.3 that would apply to the outside retail package that includes the require in the future that certain listing of ingredients in OTC drug required list of inactive ingredients.

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9. Questions or Comments? standardized presentation of greater than the largest type size used (§ 201.66(c)(9)) information will benefit consumers and within the ‘‘Drug Facts’’ area. The type Section 201.66(c)(9) identifies where health professionals, several comments size for the title ‘‘Drug Facts manufacturers may include a telephone raised concerns regarding specific (continued)’’ must appear in no smaller number for consumers. The telephone features of the format. These concerns than 8-point type. The headings in number would appear after the header included the need to: (1) Further paragraphs (c)(2) through (c)(9) must ‘‘Questions?’’ (or ‘‘Questions or improve readability; (2) maintain appear in 8-point or greater type, or in internal consistency with respect to comments’’), is in a minimum 6-point a type size that is at least 2-point sizes periods, spacing, and other type setting bold type (but preferably larger), and greater than the text, whichever type features; (3) increase usable labeling does not need to be a toll-free number. size is larger. Thus, if the required space without decreasing readability; (4) It is recommended that the days of the information is presented in 7-point type, provide flexibility to accommodate week and the times when someone is the headings must appear in at least 9- required information on small packages; available to respond to questions also be point type. This will ensure that the and (5) minimize the potential for included. A graphic of a telephone or headings, which serve as important consumer confusion. telephone receiver may appear before visual cues, stand out from the balance the heading. 1. Alignment and Punctuation of of the text, while preserving flexibility 20. Several comments urged the Headings (§ 201.66(d)(1)) for manufacturers to use larger type sizes to enhance readability. The agency to allot space for the Section 201.66(d)(1) requires that the manufacturer’s toll-free telephone subheadings and all of the information first letter of each word of the title in described in § 201.66(c)(2) through (c)(9) number in bold Helvetica type. At least § 201.66(c)(1) appear in uppercase. one comment also requested the agency must appear in at least 6-point type. Section 201.66(d)(1) also requires that 23. Many comments, particularly from to require a telephone number in clear only the first letter of the first word of consumers, urged the agency to adopt braille over-print, to assist those with each heading and subheading set forth the 6-point minimum type size for all impaired eyesight in obtaining usable in paragraphs (c)(2) through (c)(9) required OTC labeling, except for the labeling. appear in upper case, and that the title, manufacturer’s name and address. Some Many OTC drug products already headings, and subheadings set forth in comments argued that anything less include a section entitled ‘‘Questions or paragraphs (c)(1), (c)(2), and (c)(4) than 6-point type is not readable, Comments?’’ and provide a telephone through (c)(9) must be left justified. number. The agency considers this 21. Several comments recommended especially for elderly consumers. Other information very beneficial because it the use of upper case letters only for the comments contended that a 6-point provides a place to report concerns after first letter of the first word in each minimum should be required because, if product use and a source to contact heading and subheading to be consistent industry is allowed to use anything less when the product is not purchased in a with conventional rules of graphics and than 6-point, smaller type size will pharmacy. A telephone number also labeling design. The agency agrees that become the standard. A study (Ref. 7) provides a contact for the elderly or limiting the use of upper case letters to was submitted demonstrating that many visually impaired who may not be able the first word in the phrases in OTC drug products did not conform to read the product’s labeling, and for § 201.66(c)(2) through (c)(9) will with the Nonprescription Drug individuals who do not use English as enhance readability. The agency has Manufacturers Association (NDMA) a primary language. incorporated this recommendation into Readability Guidelines (Ref. 10) The agency has allotted space for a the final rule. The length of the title, recommended for use by the industry telephone number within the ‘‘Drug however, is sufficiently short to allow for OTC drug products. Facts’’ area. While this labeling is not the first letter of both words to appear Manufacturers and several trade required, the agency strongly in uppercase without compromising associations argued that the 6-point encourages all manufacturers, readability. However, when the title minimum should be optional, to allow distributors, and packers to include a appears on additional panels, the term flexibility in fitting all of the required telephone number. The agency also ‘‘(continued)’’ will appear in lowercase information into the proposed format. encourages the use of a point size letters. Manufacturers urged that a 6- point type greater than 6 to display the 22. Several comments recommended be used where feasible, but that smaller information, to help those unable to that all headings be left justified, rather types (down to 4.5 point) be permitted read 6-point type. Further, the than centered, to enhance readability. when necessary. At least one comment telephone number, if shown, must The comments contended that claimed that if 6-point type is required, appear in bold type. As requested by the information that is centered may be the OTC labeling information would not comments, a Helvetica type style may be missed or overlooked, particularly when fit on nearly 33 percent of the branded used. The agency recommends that the most of the information presented is left products and 95 percent of generic days of the week and the time of the day justified. In general, the agency agrees. products. Data were not submitted to when a person is available to respond to However, to preserve the association of support these figures. The comments questions (e.g., Monday to Friday, 9 a.m. each active ingredient with its purpose, also noted that the agency has allowed to 5 p.m.) also be included. Braille the agency has retained in the final rule 4.5-point type for dietary supplements labeling is discussed in comment 43 of the requirement that the heading in certain situations. this document. ‘‘Active ingredients’’ appear Upon careful review of the comments and supportive studies and the rationale D. Format Requirements (§ 201.66(d)) immediately adjacent and to the left of the heading ‘‘Purpose(s)’’ set forth in the proposed rule (see 62 FR Section 201.66(d) prescribes the (§ 201.66(d)(6)). 9024 at 9027), the agency has required format for presenting the title, determined that the type size for headings, subheadings, and information 2. Type Size (§ 201.66(d)(2)) required OTC drug product labeling set forth in § 201.66(c)(1) through (c)(9). Section 201.66(d)(2) requires that the information must be no smaller than 6- Although the comments on balance letter height or type size for the title point, under the conditions set forth in strongly support the conclusion that a ‘‘Drug Facts’’ must appear in a type size this final rule, including format

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13265 exceptions for small packages as defined packaging. It also tends to vary have limited type style to Helvetica, the in this final rule. considerably from product to product, final rule will allow any single, clear, The proposed rule summarized and is no less important on small easy-to-read, type style. The agency literature studies that demonstrated how packages than it is on larger packages. notes that san serif type styles have been important type size is in evaluating As a result, OTC drug product labeling adopted by at least one trade association readability, as well as the difficulty places particularly significant demands as the industry standard. The agency consumers have in reading OTC drug on the reader. The agency therefore believes that san serif types styles are product labeling because of small type believes that while 4.5 point type may the most likely to be considered clear (see 62 FR 9024 at 9027 to 9029). For be appropriate in exceptional cases for and easy-to-read. The agency also is example, a survey of consumers’ ability nutritional information on a dietary requiring the title ‘‘Drug Facts’’ and the to read OTC drug product labeling supplement product, it is not an ‘‘Drug Facts’’ part of the ‘‘Drug Facts printed with the minimum type sizes appropriate minimum type size for OTC (continued)’’ title to appear in bold recommended by NDMA’s Readability drug products. italic print to draw even more attention Guidelines demonstrated that a The agency recognizes the delicate to the required information panel and, significant portion of the adult balance between: (1) The need for the thereby, contribute to the goal of population over 20 years of age is not required information to fit within ensuring that consumers are able to read OTC drug product labeling customary labeling and packaging appropriately signaled to read and use with 4.5-point minimum type size. constraints, and (2) the need to ensure the information which follows. The Further, only 48 percent of the public that the required information is agency is requiring the type to be all who currently purchase OTC drug prominent and readable under black or one dark color, printed on a products are able to read labels with the customary conditions of purchase and white or other light, neutral color, 4.5-point minimum type size. People use. The agency believes it has selected contrasting background. over 51 years of age have the most type sizes and styles that are consistent 25. Several comments requested that trouble reading labels with 4.5-point with the need for readable OTC drug the agency allow the use of any sans type size, with only 32 percent able to product labeling by a majority of OTC serif type style in OTC drug product read them, and only 63 percent of drug consumers, while at the same time labeling. people under age 51 were able to read taking into account the manner in The agency is allowing any single, the existing (or tested) labels (62 FR which OTC products are marketed and clear, easy-to-read, type style. Because 9024 at 9029). the economic impact posed by setting font styles vary in their stroke weight Another study evaluated the ability of these minimum requirements (see characteristics (i.e., the thickness of the persons over 60 years of age to read OTC section VIII of this document). character of each letter is variable). drug product labeling (Ref. 11). The 24. Some comments suggested a Helvetica and Univers font styles in study found a significant portion of this sliding scale for type size based on particular have consistent and uniform population cannot adequately read the package size, similar to the stroke weight characteristics and are print on certain existing OTC drug requirements for dietary supplements both commonly available. The agency products due to small type size (vertical and food labeling (§§ 101.9(j)(13) and therefore recommends the use of either height) and horizontal letter 101.36(i)(2)). The agency generally one of these font styles. compression (type style). The study supports the approach of requiring 26. Several comments requested that concluded that to maximally enhance larger type sizes and more generous only the format layout should be readability for this target population, formatting for products marketed in required and not the graphical features OTC drug information should be progressively larger packages. There is, (i.e., type size, leading, kerning, and presented in a minimum vertical type however, less of need to develop such highlighting). If graphical features are size of 6.7-point and a letter an approach for OTC drug products than required, the comments requested compression of no more than 39 for food products because the range of reduced type size and leading. characters per inch. Recognizing the package sizes for OTC drug products is Based on the discussion in the space constraints in existing labeling, much smaller than the range for food proposed rule (62 FR 9024 at 9036), the the agency chose to require a minimum packages. Therefore, the agency has agency has determined that both format type size of 6-point and type styles focused in this rulemaking on layout and graphical features are which ensure letter compression of no developing minimum requirements necessary to ensure that labeling more than 39 characters per inch. suitable for typical OTC drug products. information is conveyed in a manner Finally, the agency acknowledges that Nevertheless, the agency encourages that enables the consumer to readily it has allowed 4.5-minimum type size drug manufacturers to enlarge point size notice and comprehend such under certain conditions in dietary wherever the package may information. The agency has revised the supplement labeling for small packages accommodate larger labeling text. To leading requirement from the proposed (see § 101.36(i)(2) (21 CFR 101.36(i)(2)). that end, the agency has specified in 1-point leading to 0.5-point leading in In these instances, however, much of § 201.66(d)(2) the relative increase in this final rule. the required labeling consists of point size for the title and headings 4. Bullets (§ 201.66(d)(4)) numerical information regarding the when a larger type size is used for the content of the product. With limited required text. Section 201.66(d)(4) specifies the exception, this information may be style and format for using bullet points presented in a well-defined tabular 3. Font, Leading, Kerning, Contrast, and to introduce and highlight statements of format with ample white space to Highlighting (§ 201.66(d)(3)) information. The bullet style is limited enhance readability. OTC drug product Section 201.66(d)(3) contains font, to solid squares or solid circles of 5- labeling, on the other hand, consists leading, kerning, contrast, and point type size and must be presented largely of running text, including highlighting requirements. The agency in the same shape and color throughout descriptive information essential to the has determined that at least 0.5-point the labeling. The use of a solid circle or safe and effective use of the product. leading (i.e., the space between two square will avoid selection of an icon This information often occupies one or lines of text) is needed to ensure that may have an independent meaning, more full panels of the product’s readability. While the proposal would such as an octagon (stop) or inverted

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13266 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations triangle (caution). This format provides a graphic such as an arrow, directing the Under § 201.66(d)(8), a barline must a valuable visual cue for introducing consumer to the continuation of the be used to form a box or similar each required ‘‘chunk’’ of information, information on the next panel. The enclosure around the information without unnecessarily distracting or continuation of the required content and described in § 201.66(c). Example 7 of confusing the reader. The bullets and format onto multiple panels must retain the sample labeling in the proposed rule bulleted statements under each heading the required order and flow of headings, (62 FR 9024 at 9060) depicted the or subheading must be vertically subheadings, and information. The UPC required information surrounded by a aligned, to ensure visual separation and symbol may appear on the same panel hairline forming a box. Also under adequate white space between discrete as some of the information, but must be § 201.66(d)(8), a horizontal hairline information chunks. This section also outside the box or enclosed. Section extending within two spaces on either establishes standards for presenting 201.66(d)(7) provides that graphical side of the ‘‘Drug Facts’’ box or similar more than one bulleted statement in the images, such as the UPC symbol, and enclosure must immediately follow the same horizontal line of text and for the information not set forth in paragraphs title set forth in § 201.66(c)(1). A vertical alignment of such additional (c)(1) through (c)(9) and (d)(1) through distinctive horizontal barline extending bulleted statements. (d)(10), may not appear in or otherwise to each end of the ‘‘Drug Facts’’ box or 27. To increase usable labeling space, interrupt the content and format similar enclosure must provide several comments requested that the required by these parts of the final separation between each of the headings agency allow more than one bulleted regulation. listed in § 201.66(c)(2) through (c)(9). labeling statement per line and not And, a horizontal hairline extending require that bulleted phrases be 6. Active Ingredient, Purpose, and within two spaces on either side of the separated by at least two square ‘‘ems’’ Warning Headings (§ 201.66(d)(6)) ‘‘Drug Facts’’ box or similar enclosure (two squares of the size of the letter Section 201.66(d)(6) establishes the must immediately precede the ‘‘M’’). The agency agrees that allowing required format for listing the subheadings set forth in § 201.66(c)(5), more than one bulleted statement per established name, the quantity or except the subheadings in line is an effective way to optimize proportion, and the ‘‘purpose’’ of each § 201.66(c)(5)(ii)(A) through (c)(5)(ii)(G). labeling space. The agency has active ingredient. This section also The placement and style of barlines incorporated this into the final rule. provides that no other text is permitted and hairlines set forth in § 201.66(d)(8) However, if more than one bulleted to appear on the same line as the will highlight the information, making it statement appears on the same ‘‘Warning’’ or ‘‘Warnings’’ heading. more prominent and easier to read and horizontal line, each statement must be 29. Several comments recommended process. Section 330.1(c)(2) previously separated by at least two square ems. that the agency allow products provided for the use of a boxed area, in containing more than one active conjunction with titles such as ‘‘FDA 5. Multiple Panels (§ 201.66(d)(5)) ingredient with the same purpose to list Approved Uses’’ and ‘‘FDA Approved The proposed rule would have the purpose only once, adjacent to the Information,’’ to set off this information required that all of the information listing of the last active ingredient. The from other OTC labeling information. presented under the ‘‘Warnings’’ agency agrees. However, the The agency has used the box technique heading appear in one continuous presentation must allow the reader to to highlight information in several other space, on one panel. As described in the readily associate each active ingredient notable instances (see, e.g., following paragraphs, § 201.66(d)(5) of with its purpose. The agency has § 101.9(d)(1)(i)). the final rule provides increased incorporated this recommendation into 9. Directions (§ 201.66(d)(9)) flexibility with respect to the the final rule. presentation of the required labeling Section 201.66(d)(9) adds the information on more than one panel of 7. Graphical Images and Interruptions requirement that dosage directions, the retail package. (§ 201.66(d)(7)) when provided for three or more age 28. Several comments requested that Section 201.66(d)(7) requires that groups or populations, must be the agency allow the warnings section to graphical images, such as the UPC presented in a table format. The agency appear on more than one panel if: (1) symbol, and any information that is not displayed this labeling technique in Text or a visual graphic such as an set forth under § 201.66(c), must not example 2, 7, and 9 of the proposed rule arrow leads the consumer to the interrupt the required information panel (62 FR 9024 at 9055, 9060, and 9062 and continuation onto the next adjacent or panels. The UPC symbol may appear in the sample cough-cold product used panel, (2) the adjacent panel has an on the same panel as required in Study B. appropriate heading, and (3) there is no information but must be outside the box 30. Several comments requested that intervening copy or symbols. One or enclosure. the agency allow flexibility in the comment noted that the Universal arrangement of information under Product Code (UPC) symbol should not 8. Required Lines (§ 201.66(d)(8)) ‘‘Direction(s)’’ and not mandate a table be allowed to interrupt the flow of Section 201.66(d)(8) sets forth the format. One comment added that other information in the required OTC drug placement and style of lines that define formats, e.g., running text, can product labeling. the title, headings, subheadings, and adequately convey the information The agency agrees with these information described in § 201.66(c)(1) while maximizing text in a minimal comments. Section 201.66(d)(5) of this through (c)(9). The proposed rule amount of space. final rule provides that the headings, requires a horizontal line to separate the Study A confirmed that consumers subheadings, and information required information under each major heading are less likely to make a dosing error under § 201.66(c), including the (62 FR 9024 at 9036 and 9051). In this when dosing information for multiple warnings section, may appear on more final rule, the agency is including more populations is separated within an easy- than one panel. However, appropriate specific requirements for the use of to-read table as compared to such visual cues must be provided, so that these hairlines and is requiring a barline information appearing in a paragraph the flow of information is retained. The to set off the ‘‘Drug Facts’’ labeling from format. Tables are now widely used in title ‘‘Drug Facts (continued)’’ must other information that appears in the the labeling of many OTC drug appear on each subsequent panel with labeling. products, including those marketed

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13267 under NDA’s and ANDA’s. The agency package, packet, or single use unit. § 201.66(d)(1) through (d)(9) and any therefore has incorporated into this final Some comments proposed that any drug other FDA required information for drug rule a requirement that a table be used or drug-cosmetic product that meets this products and, as appropriate, cosmetic when dosing information is complex, as definition be exempt from the new products, other than information when separate dosing instructions are format and content requirements, but required to appear on a principle presented for three or more age groups. should still bear all required labeling. display panel. This formula is A text format may be used when there Some comments stated that a consistent with the idea that 40 percent are less than three dosage directions. performance standard, as described in of available labeling space is generally the proposed rule (62 FR 9024 at 9036), reserved for the UPC symbol and PDP 10. Small Packages (§ 201.66(d)(10)) has not been established or validated (see, e.g., 21 CFR 101.1 and § 201.60 (21 Section 201.66(d)(10) establishes a and would be impractical to use for CFR 201.60)). modified labeling format for packages small packages at this time. In determining whether more than 60 that cannot meet the format The agency agrees that some percent of the available surface area is requirements of paragraphs (d)(1) manufacturers may have difficulty needed, the indications listed under the through (d)(9). providing important drug information, ‘‘Use(s)’’ heading must be limited to the 31. Several comments urged the which is prominent and easy to read, on minimum required uses allowed under agency to adopt a broad, blanket small packages that are irregular (i.e., bottle the applicable monograph. Also, for package exemption from the proposed labels) or small (i.e., unit does). purposes of this rule, the ‘‘total surface content and format requirements. The However, the agency also considers the area available to bear labeling’’ does not comments described small packages as required OTC drug labeling information include the flanges at the tops and those products that are marketed in unit essential for the safe and effective use of bottoms of cans and the shoulders and doses, convenience sizes, samples, OTC drug products, irrespective of the necks of bottles and jars. All other minimal net content packages, analgesic size or the shape of the package. surface areas are considered to be products with less than 6 square inches Because readability is especially ‘‘available to bear labeling.’’ of usable labeling space, uniquely dependent on vertical letter height and 32. Several comments stated that the shaped containers (e.g., envelope letter compression, the agency disagrees format under the proposed rule would packaging, which has a front and back that less than 6-point type or letter require manufacturers to increase the panel only), tubes, roll packs commonly compression allowing more than 39 package or container size of a significant used for antacids, some ophthalmic characters per inch should be permitted number of OTC drug products. NDMA, products, a number of drug-cosmetic (Ref. 11), even on ‘‘small packages.’’ As for example, reported that a survey of its products, and bottles without an outer discussed in response to comment 23 in members showed 33 percent of branded carton. section IV.D of this document, the products and 95 percent of private label Many comments suggested graphical agency considers 6.0 type the minimum products could not comply with the flexibility to accommodate products allowable for OTC drug product proposed format without making some marketed in small packages, such as: (1) labeling. change in package or container size. Use of more than one panel, (2) use of The agency, however, is including in Some comments also opposed the sans serif fonts or more than one font, § 201.66(d)(10) of this final rule several mandatory use of alternative packaging (3) reduced type size (to 4.5-point), (4) modifications that may be used with designs, such as extending a single side reduced or no leading, (5) interlined packages that are too small to meet the panel of a package to increase labeling spacing such that one line’s ascenders format requirements of paragraphs (d)(1) space, as had been suggested by the do not touch the preceding line’s through (d)(9). Under § 201.66(d)(10), agency in the proposed rule (62 FR 9024 descenders, (6) eliminate hairlines and headings may be presented in a at 9036). According to these comments, required bullet spacing, and (7) minimum 7-point or greater type size. the cost of adding such packaging consolidate warning information. One The leading may be adjusted so that the features, and the additional comment suggested that graduated type ascenders and descenders of the letters environmental waste associated with size requirements could be adopted do not touch, rather than the 0.5-point increasing package size or configuration, depending on the available label space leading required under § 201.66(d)(3). outweighs the need to set a minimum and cited the dietary supplement Also, bulleted statements may continue 6.0 type size and other minimum format labeling provisions in § 101.36(c)(6) to the next line of text and need not be requirements. Several comments made (amended and recodified at § 101.36(i), vertically aligned. Finally, the box or general reference to state ‘‘slack fill’’ effective March 23, 1999 (62 FR 49826, similar enclosure required in laws, which prohibit the use of September 23, 1997)). Another comment § 201.66(d)(8) may be omitted if the oversized containers to mislead pointed out that the dietary supplement headings, subheadings, and information consumers. labeling provisions allow a minimum in § 201.66(c)(1) through (c)(9) are set off Other comments, however, 4.5-point type size. from the rest of the label by color encouraged the use of alternative Some comments contended that contrast. packaging to ensure that important relying on a subjective standard to As suggested by the comments, a information is presented in a readable support an exemption would be product will be considered ‘‘small,’’ and type size with user-friendly visual cues. inefficient. These comments will be permitted to apply these They emphasized that consumers need recommended that a small package be modifications, if more than 60 percent the information, and need to be able to defined as any outer package: (1) Where of the total surface area available to bear read and understand the information, the total surface area available to bear labeling on the entire outside container for proper self-selection and self- labeling is less than 12 square inches or wrapper, or the immediate container medication, and that these concerns (including the PDP); or (2) where more label if there is no outside container or support the required use of alternative than 60 percent of the total surface area wrapper, would be needed to present packaging to increase available labeling available for labeling on the back and FDA required labeling. This consists of space. side panels must be used to satisfy the the labeling required by § 201.66(c)(1) As discussed in section VIII of this ‘‘content requirements’’ in proposed through (c)(9), in accordance with the document, the comments that oppose § 201.66(c); or (3) that is a trial size minimum specifications in the required use of alternative packaging

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13268 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations design greatly overestimated the number container or wrapper of the retail The comments contended that the of products that would not be able to package (or the immediate container petition process is too slow and accommodate the proposed format label if there is no outside container or burdensome for both industry and the within the confines of current wrapper) of all marketed OTC drug agency, and would cause marketing packaging. In addition, the modified products. As explained in the following delays. Some comments suggested a format authorized under § 201.66(d)(10) paragraphs, the agency has eliminated simple notification process when a of the final rule is expected to enable this requirement to give manufacturers company is unable to comply with the many small package products to comply more flexibility. In addition, the agency final rule. The company would notify without increasing container or package has codified proposed § 201.66(f), the agency, a certain time would be size. Exemptions and deferrals, as § 201.66(e) allowed for the agency to respond with For those remaining products that are and has made several changes to make any objections, and, if no objections unable to accommodate the modified, the exemption process less burdensome were provided, marketing could then small package format, a number of on manufacturers and on the agency. proceed. design techniques are available to 33. Several comments recommended Section 201.66(e) in this final rule increase labeling space. As suggested in that the agency allow the inclusion of a provides that FDA, on its own initiative, the proposed rule, labeling space can be brand name and product attributes or in response to a written request from increased by, for example, extending a anywhere on the information panel as any manufacturer, packer, or distributor, single side panel or widening the label long as they do not interrupt the flow may exempt or defer, based on the affixed to a bottled drug product (62 FR of the required information and as long particular circumstances presented, one 9024 at 9036). In a survey described in as the labeling is in compliance with the or more specific requirements set forth section VIII of this document, the type size requirements. Several in § 201.66(a) through (d), on the basis agency found that many products are comments requested that the product that the requirement is inapplicable, now marketed with extended panels, brand name be the first text allowed on impracticable, or would be contrary to peel back or fold out labels, or are the information panel and that the public health or safety. otherwise mounted on cardboard cards equivalent of three lines of type be The agency agrees that the exemption or placards. These alternative packaging allocated at the top of the panel for a process need not require a citizen techniques often increase labeling space brand name and product attributes such petition. However, the process should for promoting the sale of the product as: (1) Information about dosage form, be a matter of public record and and could also be used to accommodate flavor, the absence of certain requests for exemptions must be granted FDA required information. The agency ingredients, directions for opening the by the agency prior to marketing. likewise expects that any packaging package, and reference to the Requests for exemptions must be changes needed to conform to this rule importance and benefits of proper use; submitted in three copies in the form of will be sufficiently minimal, and can be (2) references to alternative products an ‘‘Application for Exemption’’ to the done in a manner, as to not render the that are available; and (3) information agency. The requests shall be clearly product misleading under a ‘‘slack fill’’ from organizations endorsing the identified on the envelope as a ‘‘Request law or similar provision (see, e.g., product. Other comments raised for Exemption from 21 CFR 201.66 (OTC section 502(i)(1) of the act). concerns about whether adequate space Labeling Format)’’ and with Docket No. Thus, products that are unable to would be allowed for guarantee 98N–0337. A separate request must be meet the labeling format described in statements, signage, and sell copy. submitted for each OTC drug product. § 201.66(d)(1) through (d)(9), or the Another comment suggested that the In addition to the three copies of the modified format authorized under space for a brand name and product exemption request submitted to the § 201.66(d)(10), will be expected to be attributes should be equivalent to the agency, manufacturers of a product reconfigured to meet the format greater of either: (1) Three lines of the marketed under an approved drug requirements of this rule. The agency minimum size copy across the width of application must also submit a single will not routinely grant exemptions or the information panel; or (2) 10 percent copy of the exemption request to their deferrals under § 201.66(e) for products of the main information panel, at the application. Decisions on exemptions that claim to be too small to meet the option of the manufacturer. The and deferrals will be maintained in a requirements of this rule. comments maintained that this permanent file in this docket for public Finally, the agency is not requiring information is important to consumers review. manufacturers to increase the size of for comparative purposes and for The request for exemption or deferral immediate containers (for those identification of products with desired must: (1) Document why a particular products that are marketed with outside features. requirement is inapplicable, retail packages) in order for the required The agency has determined that the impracticable, or would be contrary to format to be applied to the immediate required OTC drug product labeling public health or safety, and (2) include container (see 62 FR 9024 at 9037). As information need not appear as the first a representation of the proposed label stated in response to comment 3 in information on the back or side panel, and labeling, including outserts, panel section IV.C of this document, for provided there is adequate space on the extensions, or other graphical or products that are sold with an outer outside container or wrapper for the packaging intended to be used with the package, the agency is encouraging, but labeling to conform with § 201.66(c)(1) product. not requiring, the use of the modified, through (c)(9) and § 201.66(d)(1) 35. In the proposed rule, the agency small package format in § 201.66(d)(10) through (d)(10). Accordingly, the agency asked for comment on whether there are on the immediate container. is not including proposed § 201.66(e) in particular types of products or packages this final monograph. Thus, a brand that should be granted a regulatory E. Exemptions and Deferrals name and product attributes may appear exemption (62 FR 9024 at 9038). At least (§ 201.66(e)) anywhere on the labeling outside of the one comment, from a trade association, Proposed § 201.66(e) provided that boxed area. requested that ‘‘drug-cosmetic the required labeling information must 34. A number of comments suggested products,’’ and particularly those that be the first information that appears on that FDA establish an exemption do not have a dosage limitation (e.g., the back or side panel of the outside process other than a citizen petition. antidandruff shampoos, anticaries

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13269 toothpastes, antiperspirants, and The agency disagrees and finds no The agency also disagrees with the sunscreens), be exempted from the new basis for including a broad exemption suggestion that the required labeling in labeling requirements. The comment because a product is marketed both as such products consists of nothing more argued that these products do not raise a drug and a cosmetic, because a than ‘‘general common-sense serious adverse event concerns, are not product does not require a precise limitations’’ such as ‘‘if condition used to treat serious health problems, do dosage limitation, or because the persists, consult a health professional’’ not raise serious misuse concerns, do labeling of the product includes or ‘‘if a rash develops, stop use.’’ For not have the potential for significant ‘‘common-sense’’ statements. When example, a number of acne medications new therapeutic uses in the future, and therapeutic claims are made for a (which are marketed for both drug and are limited in the space available for product, the drug provisions of the act cosmetic uses) contain important other information concerning product apply to ensure the safety and warnings for persons who are sensitive attribute labeling. Several comments effectiveness of the drug ingredients, to or have a known allergy to salicylic contended that some drug-cosmetic whether or not these products may also acid. Dandruff products that contain products are used primarily for their be used for other purposes (see sections coal tar likewise must bear important cosmetic effects, and one comment 201(g)(1) and (p) (21 U.S.C. 321(g)(1) drug-drug and sunburn warnings (see 21 argued that most of the required and (p)), 502, and 505 of the act). The CFR 358.750). In any case, the agency information on these products consists agency also does not agree that it lacks does not accept the argument that of ‘‘common-sense’’ statements and, a sufficient factual basis for requiring ‘‘common-sense’’ precautions need not therefore, do not need to be subject to the new format and content be prominent and readable. However, this rule. requirements on all OTC drug products. the agency will continue to consider One comment also argued that drug- The agency does not believe that whether required labeling for these cosmetic products must include more consumers should be denied the products can be simplified and mandatory labeling information than benefits of the new labeling condensed even more. other OTC drug products, leaving even requirements simply because a product The agency has an ample factual less space on drug-cosmetic products for may have both drug and cosmetic record, discussed elsewhere in this the required format. In particular, the attributes. Moreover, under the document and in the proposed rule, to comment stated that drug-cosmetic approach suggested by the comment, a support the conclusion that current products, unlike other products, must manufacturer who markets a standard labeling conventions are inadequate. The act requires readable and include a full list of all ingredients (see sunscreen product for sunscreen (i.e., understandable labeling, irrespective of § 701.3). According to the comment, the ‘‘drug’’) uses and for moisturizing (i.e., a specific showing of harm. The agency proposed format would force this ‘‘cosmetic’’) uses, would not be required endeavors to require the least amount of information to be listed on more than to follow the new labeling requirements, information possible to assure proper one panel, making it difficult for while a manufacturer whose product is self-selection and use. Nevertheless, the consumers (particularly those who may marketed solely as a sunscreen would information the agency does require be allergic to certain ingredients) to find be required to follow those under the act must be prominently and important ingredient information. This requirements. Both products, conspicuously displayed (section 502(c) comment, however, has largely been nevertheless, are regarded as drug of the act) and must be readable and superseded by the recent amendment to products and share the intended use of understandable to ensure that all section 502(e) of the act, which sunburn prevention. The agency is material facts are provided to consumers authorizes the agency to require that all concerned that consumers may be (sections 201(n) and 502(a) of the act). OTC drug products bear a full list of unneccessarily confused if the rule Moreover, improved labeling is needed ingredients. The final format includes a would allow these products to bear not only to address potential safety prominent location for the listing of this markedly different labeling. issues, but also to ensure selection of information on all OTC drug products, The agency also disagrees with the the most appropriate product and use of including those that may also be comment that products without dosage that product in an effective manner. intended for cosmetic uses. limitations do not raise safety issues With respect to whether sunscreen The agency also received comments and, therefore, the agency lacks a ingredient names have little meaning to questioning whether the factual record rational basis for applying the new consumers, the same argument can supports the need to standardize the labeling requirements to such products. currently be made for many OTC drug labeling format for drug-cosmetic While the agency takes steps to ensure active ingredients. The new format products, especially those without a that all OTC drug products are safe for requires prominent listing of the active specified dosage limitation. One their intended uses, adverse reactions ingredients for all products, together comment noted that the agency failed to do occur in the categories of products with the purpose of each active include drug-cosmetic products in its for which a blanket exemption has been ingredient. The agency believes that this consumer research studies, and that the requested. For example, certain element of the new format will improve agency lacks a factual basis for applying sunscreen ingredients have the potential consumer understanding of the names this rule to these products. to cause photo allergenicity; certain and purposes of active drug ingredients, Finally, several comments provided antidandruff ingredients may promote including those typically used in additional reasons why sunscreens, in sunburn or cause even more serious sunscreens. This will assist the particular, should be exempted: (1) The events if used for prolonged consumer and pharmacist in identifying names of sunscreen active ingredients applications; and fluoride-containing changes in formulation (and purpose) of have little meaning to consumers; and preparations may contribute to fluorosis many combination OTC drug products (2) the prominent display of words such or may cause acute symptoms in so that medication errors can be avoided as ‘‘Active ingredients,’’ ‘‘Uses,’’ and overdose ingestions. Thus, even and consumers can appropriately self- ‘‘Warnings’’ may discourage the use of products that do not require discrete select an OTC drug product for their traditional cosmetic products containing dosage limitations contain ingredients condition(s). a sunscreen or cause manufacturers to that raise safety risks which the labeling The agency also emphasizes that with leave out the sunscreen ingredient. must convey to the consumer. drug-cosmetic products, self-selection is

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13270 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations very important because consumers often or in response to a written request from interchangeable terms. In addition, two must choose between a cosmetic or a any manufacturer, packer, or distributer, of the proposed terms were combined drug-cosmetic product. A consumer may exempt or defer one or more and seven others were modified slightly who has dandruff should select an specific requirements set forth in in this final rule. (See § 330.1(i)(12), antidandruff-conditioner shampoo § 201.66 (a) through (d). (i)(16), (i)(48), (i)(49), (i)(52), (i)(54), rather than a conditioner shampoo; a 36. One comment noted that OTC (i)(68), (i)(69), and (i)(72).) consumer who wishes to prevent drug product labeling varies among Although the agency specifically sunburn should select a sunscreen- different countries, particularly for sought recommendations on additional moisturizer rather than a moisturizer; a products that are considered drug- connecting terms that should be added consumer who perspires heavily should cosmetics in the United States but are to the list (62 FR 9024 at 9039), no terms select an antiperspirant-deodorant regulated as cosmetics in other were submitted. Proposed § 330.1(k) has rather than a deodorant; a consumer countries. The comment contended that been redesignated as § 330.1(j) in this who needs to prevent caries should these variations make it difficult to label final rule and modified to include seven select a fluoride toothpaste rather than products intended to be sold in more additional connecting terms based on a nonfluoride toothpaste. This final rule than one country. The comment pointed further analysis of OTC drug monograph provides a format for presenting out that FDA is increasingly focused on labeling. The agency recognizes that information that will allow consumers international harmonization as a matter there may be other connecting terms to readily distinguish among seemingly of policy. However, requiring products that can be deleted and that will help similar products and to readily access to meet the new OTC labeling content required statements and clauses fit into important drug information. and format requirements represents a the new format. The agency encourages The agency agrees that there may be barrier to trade and harmonization. manufacturers, packers, and distributors limited instances in which a labeling Another comment requested that FDA to submit these terms to the agency as requirement may discourage exempt OTC drug products intended for soon as possible so this list can be manufacturers from marketing certain export from the new labeling further amended before the products for a drug use (e.g., lipsticks requirements. implementation dates for this final rule. containing sunscreens or lip balms The agency disagrees with these 37. One comment requested that an containing skin protectant ingredients). comments. As discussed, sound public interchangeable term be added to These products, when they contain an policy and the dictates of the act require accommodate products intended for use ingredient intended to provide a that drug-cosmetic products present only in children under 12 years of age, therapeutic effect, do provide significant readable, understandable, prominent, because the information should be public health benefits to consumers. and conspicuous drug labeling. With directed to the child’s guardian or care When developing drug labeling, the respect to export issues, section 802 of giver. agency considers the risks and benefits the act (21 U.S.C. 382) sets forth those The agency agrees that for products of the drug, the intended use, and the instances in which exported drug intended for use only in children under need to communicate limitations or products are not required to be labeled 12 years of age the information should restrictions about the use of the product in accordance with the requirements for be directed to a care giver, rather than to the target population. The quantity domestic marketing. The agency notes to the child. Accordingly, for such and complexity of information which that an OTC drug product exported in products, the term ‘‘the child’’ may be must be communicated to ensure accordance with section 802 of the act interchanged with ‘‘you’’ or the term appropriate product selection, convey would not be required to meet labeling ‘‘the child’s’’ may be interchanged with the effectiveness of the drug, requirements for domestic marketing ‘‘your.’’ communicate risks, and provide (such as the requirements imposed by complete directions for use, varies with this rule), except to the extent that the G. Liable to Regulatory Action the drug ingredient, the target import country itself has adopted U.S. (§ 201.66(g)) population, the disease or symptoms the requirements (see section 802(b)(1) and Section 201.66(g) states that an OTC product is intended to treat or prevent, (f) of the act). drug product that is not in compliance and related information about the with the format and content conditions which must be provided for F. Interchangeable and Connecting requirements is subject to regulatory the safe and effective use of the drug. Terms (§§ 201.66(f) and 330.1(i) and (j)) action. The wording in § 201.66(g) of the In some cases (e.g., lipsticks or lip Section 201.66(f) permits specific final rule is changed slightly from the balms containing sunscreen), minimal terms codified in § 330.1(i) proposal, but the meaning remains the information is needed for the safe and (‘‘interchangeable terms’’) to be used same. effective use of the product. Such interchangeably in the labeling of OTC products may typically be packaged in drug products, provided such use does H. Flexibility for Uses (§ 330.1(c)(2)) small amounts, have a high therapeutic not alter the meaning of labeling Section 330.1(c)(2) retains flexibility index, carry extremely low risk in actual established in an applicable OTC drug of labeling for the OTC drug product’s consumer use situations, provide a monograph or regulation. Section ‘‘Uses’’ section by allowing alternative favorable public health benefit, require 201.66(f) also permits the terms listed in truthful and nonmisleading statements no specified dosage limitation, and § 330.1(j) (‘‘connecting terms’’) to be describing those indications for use that require few specific warnings and no deleted from the labeling of OTC drug have been established in an applicable general warnings (e.g., pregnancy or products, provided again that such OTC drug monograph. The agency, overdose warnings). The agency will deletion does not alter the meaning of however, is shortening and simplifying identify products with these established labeling. However, the title, the previous labeling requirements in characteristics and will consider headings, and subheadings listed in § 330.1(c)(2). This reflects the decision appropriate exemptions in their § 201.66(c)(1) through (c)(9) cannot be to require the title ‘‘Drug Facts’’ and the respective monographs and drug changed through the use of boxed or similar enclosure format for all marketing applications to the extent interchangeable or connecting terms. OTC drug products, in place of the possible. In addition, under new Proposed § 330.1(i) has been modified ‘‘Approved Uses’’ or ‘‘Approved § 201.66(e), FDA, on its own initiative, in the final rule to include 43 additional Indications’’ title and format. The

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13271 agency is consolidating into a new appear under the appropriate headings categorically exempt multilingual or § 330.1(c)(2) the ‘‘exact language’’ to further protect consumers from braille labeling from the new format. requirement currently in possible misuse of the product. 44. Several comments recommended § 330.1(c)(2)(vi) for language (other than Otherwise, placement of such that the agency continue to permit indications) established and identified information outside of the headings voluntary use of symbols or pictograms by quotation marks in an applicable could create the impression that these in addition to required warning OTC drug monograph or by regulation warnings are less or more important language. Some stated that symbols and (e.g., § 201.63), except as provided in than the required warnings. pictograms may confuse consumers § 330.1(i) and (j). A number of The agency encourages manufacturers because they may have different comments expressed their support for to discuss with the agency the addition meanings for different people. One the existing flexibility policy, which is of voluntary warnings to OTC drug comment recommended that if being retained in this final rule. products. As a general matter, FDA pictograms are used, USP pictograms agrees that consumers may be confused should be adopted. I. Miscellaneous Comments if an appropriate warning were placed The use of symbols and pictograms 38. Several comments requested that outside of the Drug Facts area. Thus, the will remain voluntary, provided their OTC drug product labeling include agency expects such warnings to appear use is not a substitute for required OTC information on: (1) When to take the under the ‘‘Warnings’’ heading, drug product labeling. In addition, a drug, e.g., morning or night, before or preceded by an appropriate subheading. symbol or pictogram that directs after meals; (2) whether the drug can be 41. In the proposed rule, the agency attention away from required taken with liquids; (3) whether invited comment on whether current information, or one that is ambiguous or analgesics or antibiotics interfere with regulations should be revised to require can be misunderstood by consumers, effectiveness; and (4) a warning to the expiration dating to appear in a specific may render the product misbranded. elderly that a smaller dosage may be location with specific legibility The agency is allowing voluntary use of needed. The comments argued that requirements on both the outer and a telephone or telephone receiver in these facts should be in the labeling immediate container packaging, § 201.66(c)(9). because many consumers may not ask, especially for products marketed in 45. One comment recommended field and some health professionals do not tubes (62 FR 9024 at 9035 to 9036) as testing new OTC drug labels to: (1) provide, this information. requested by a citizen petition (Ref. 12). Assist in the development of criteria The agency notes that this The agency evaluated the petition and that define good OTC drug labeling; and information is currently included in concluded in a letter dated April 22, (2) confirm, with representative OTC drug product labeling when the 1997 (Ref. 13) that the expiration date consumer groups, that the new labels information is known and when it is should be readily seen under usual and are readable, understandable, and cause considered to be necessary for the safe customary circumstances but did not the desired drug use behavior. and effective use of the product. For require that it be placed in a specific The agency agrees. Over the past example, labeling for an OTC drug location in the labeling. Comments to several years, the agency has approved product containing naproxen sodium the proposed rule provided no new OTC drug product labeling, similar to includes information on how to reduce information for the agency to revise this the format required in this final rule, for the dosage for the elderly. The labeling conclusion. new drugs that have moved from for acid reducer products indicates how 42. Several comments were uncertain prescription to OTC marketing status. the drug should be taken in relation to about whether the proposed rule would This labeling often is field tested by foods or beverages. In addition, the affect the PDP. This final rule does not manufacturers under OTC usage warnings section for OTC analgesic affect the PDP requirements set forth in conditions, and is presented to the products must indicate when particular § 201.60, and 21 CFR 201.61 and 201.62. agency in supplemental ‘‘switch’’ drinks (e.g., alcohol) or substances (e.g., 43. Several comments requested that applications. The agency has caffeine) should be avoided while taking products with multilingual or braille incorporated in this rule content and these products. labeling be exempted from the format elements that have emerged 39. Several comments recommended requirements of the final rule because through that process. Studies A and B that OTC drug product labeling should space is not available on these labels to (see section III.A and B of this state how long a drug remains in the follow the requirements. document) also involved field testing body. Current regulations (21 CFR 201.15) which led to refinements of earlier The agency believes that information set forth the requirements for using labeling prototypes. about how long a drug remains in the foreign languages in labels and labeling. body is important. However, it is (Although analogous to multilingual J. Reporting Requirements difficult to state the actual time that a labeling, braille is not specifically Products that are marketed under an drug remains in the body in terms addressed in current regulations.) The OTC drug monograph are not required meaningful to consumers because of the regulations provide that ‘‘No exemption to submit labeling to the agency for variability of metabolism in individuals depending on insufficiency of label preapproval. However, if manufacturers and because the time may vary space, as prescribed in regulations have questions about how to implement depending on whether the drug is taken promulgated under section 502(b) or (e) the new requirements, they are with or without food. Instead, when of the act, shall apply if such encouraged to seek FDA guidance from known and when relevant, the agency insufficiency is caused by: * * * The the Division of OTC Drug Products. requires labeling that tells consumers use of label space for any representation Labeling changes to an OTC drug when to redose, the maximum number in a foreign language.’’ When product marketed under a NDA or of doses to take per day, and which multilingual or braille labeling is used, ANDA must be made in accordance drugs or foods to avoid to obtain the agency considers it important that with § 314.70 (21 CFR 314.70). maximum effectiveness and safety in all labeling on the package be readable Manufacturers of these products are also the use of their OTC drug products. and understandable because it is not encouraged to seek agency guidance. 40. Several manufacturers requested known which language the purchaser 46. The agency specifically requested that FDA allow voluntary warnings to will use. Therefore, the agency will not comment on whether labeling changes

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13272 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations required by the rule, for products generally retains a 2-year establish or continue in effect any marketed under approved applications, implementation period for currently ‘‘requirement’’ that relates to a should be made under § 314.70(b), (c), marketed products that are the subject nonprescription drug that is ‘‘different or (d), and whether these changes of final monographs or approved drug from or in addition to, or that is should require agency preapproval (62 applications. An additional year is otherwise not identical with’’ a FR 9024 at 9042). allowed for low volume products. The requirement under the act. A Several comments stated that the economic basis for retaining this ‘‘requirement’’ that relates to a changes should be considered implementation plan is discussed in nonprescription drug is defined in ‘‘editorial’’ or ‘‘minor.’’ The comments section VIII of this document. In section 751(c)(2) of the act as ‘‘any contended that the rulemaking itself addition, an outside date of 6 years from requirement relating to public takes the place of approving product- the effective date of this rule, or the next information or any other form of public specific supplements, and that the filing major labeling revision (whether communication relating to a warning of of a supplement would impose an required or voluntary) after the rule has any kind for a drug.’’ Similar to the unnecessary burden. One comment been in effect for 2 years, whichever preemption provision in the proposed favored preapproval supplements as the comes first, is set for all marketed OTC rule, section 751(b) of the act establishes appropriate mechanism, because close drug products (except those marketed a process by which a State or political collaboration between the agency and under final monographs or approved subdivision may seek an exemption drug sponsors will be needed to ensure drug applications) to comply with the from the preemptive effect of section that final OTC drug product labeling new format and content requirements. 751(a) of the act. meets the requirements of the new rule. The plan is intended to minimize the Section 751 of the act also addresses Another comment argued that the economic burden on the industry while the two issues on which FDA had appropriate process under § 314.70 providing consumers with the benefit of specifically requested comment, i.e., the would vary from product to product more readable and understandable OTC preemptive effect of the proposed OTC depending upon the nature and extent drug product labeling at the earliest drug product labeling requirements on of the changes needed. feasible date. As discussed in section product liability lawsuits and the The agency agrees that it should not VIII of this document, this preemptive effect of the proposed single out one process because the implementation plan provides labeling requirements on State nature and extent of the changes needed manufacturers with sufficient time to initiatives such as California to conform to the new format and design and print new labeling and to Proposition 65. On the issue of product content labeling requirements will vary deplete existing stock. Products that do liability suits, section 751(e) of the act depending on the product class and not comply with the format and content states that ‘‘[n]othing in [section 751] uses. The agency expects, however, that requirements in this final rule on or shall be construed to modify or the majority of the changes required by after the applicable implementation date otherwise affect any action or the this final rule can be submitted under may be considered for regulatory action. liability of any person under the § 314.70(d)(3). Section 314.70(d)(3) The agency will review and, as needed, product liability law of any State.’’ On would cover any labeling changes that initiate steps to revise existing the issue of whether the proposed precisely follow § 201.66(c) and (d) and statements of enforcement policy to be labeling requirements preempt State that require editorial changes specified consistent with this final rule initiatives, section 751(d)(2) of the act in § 330.1(i) or (j). All other labeling document. specifically provides that the national changes would be submitted under uniformity requirements in section 751 L. Preemption § 314.70(b)(3) or (c)(2), as appropriate. ‘‘shall not apply to a State requirement However, most changes to required In the proposed rule, the agency adopted by a State public initiative or content beyond those specified in tentatively concluded that State and referendum enacted prior to September § 330.1(i) or (j) are expected to require local laws that would establish different 1, 1997.’’ preapproval under § 314.70(b). or additional format or content This amendment to the act supersedes requirements than those in the proposed the agency’s proposed regulation K. Implementation Plan rule should be preempted (62 FR 9024 preempting State and local labeling 47. Several comments urged that the at 9041 to 9042). The agency is not requirements. The agency, therefore, has time allowed for implementation of a finalizing the proposed preemptions removed the preemption provision from final regulation on OTC drug labeling be sections (proposed § 201.66(h) and (i) as this final rule and will, at this time, rely extended to 3 years, with one comment a result of a recent amendment to the act on the terms of the statute in addressing urging an extension to 4 years. The under FDAMA. preemption issues. comments argued that the number of 48. The agency received a significant product lines and stock keeping units number of comments supporting the M. Comments on Studies A and B (SKU’s) involved creates a tremendous proposed preemptive effect of the 49. Two comments stated that it is workload, especially in the case of labeling requirements. Several generally accepted by industry and by private label manufacturers who may comments suggested that the agency experts in label readability that a format have to change hundreds of labels and extend the scope of the preemption and that includes a standard order of must obtain approval of changes from preempt State requirements on safety information, standard headings, bullet their clients. One comment presented and efficacy, dosage form, and points, and interchangeable terms is data intended to show that incremental packaging. superior to the ‘‘old’’ format. However, costs to comply with a final rule in 2 Subsequent to the issuance of the the comments maintained that the years would be $140 million but would proposed rule, Congress enacted section results of Studies A and B should be drop by half to only $70 million for a 412(a) of FDAMA, which added to the given little or no weight in FDA’s 3-year implementation date. No cost act section 751 (21 U.S.C. 379r), titled deliberations because these studies data were presented for a 4-year ‘‘National Uniformity for covered only a small segment of all label implementation date. Nonprescription Drugs.’’ Section 751(a) readability issues. The final implementation plan, set of the act provides that no State or The agency agrees that a number of forth in section V of this document, political subdivision of a State may format variables can affect readability,

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations 13273 and that Studies A and B did not products, including those marketed as consumer in the appropriate selection evaluate all format variables that affect drug-cosmetics. and use of OTC drug products. readability. The agency has been Study A evaluated the influence of However, Study B clearly indicated mindful of the limitations of these label format, comparing the existing that the presence of a title for OTC studies in its deliberations. Indeed, all style formats to the proposed new labeling information was the most of the significant conclusions in this format. This comparison demonstrated important factor in determining proceeding have been informed by data that the new format takes less time to preference rankings. Consumers are the gathered from a variety of sources. In read and helps people make better ultimate users of the OTC drug product addition to the two studies, the agency product use decisions. This comparison labeling. They stated that they preferred has considered and relied upon also found that consumers preferred the the title because it drew their attention information provided by comments, new format to the existing format. The to the required information and made information gathered from the leading agency believes that these findings the required information appear more literature on label design, graphics, and would not differ if the product were credible. The agency considers such readability, and information drawn from marketed as a drug-cosmetic because the unequivocal consumer input very the agency’s own expertise in drug drug information would appear in the important and useful in the design of labeling. ‘‘Drug Facts’’ labeling format (see also OTC drug product labeling format. 50. The comments requested that the comment 35 section IV.E of this 53. One comment stated that because agency provide an extension to the document). inactive ingredients were not included comment period for Studies A and B. Study A also evaluated how the in Study B and because the terms for the The comments also requested that the amount of information affected the time active ingredients were not authentic, agency provide its analyses of the it takes to find information needed to there was no way to determine whether studies for public comment. answer specific questions. This was these omissions or fabrications would The agency provided two 45-day done by examining two drug types, a have any impact on consumer label comment periods for these studies (see three-ingredient cough-cold product and preference. section I of this document). In order to a single-ingredient analgesic. The study The agency used fabricated names for facilitate public comment, the agency demonstrated that the greater the the active ingredients to reduce the also made available in electronic format amount of information, the longer it influence of preconceived knowledge all of the data collected for these takes to find relevant information in the about specific OTC drug products. studies, including full tabulations of the labeling. Again, although a drug- Because new drug ingredients are novel data organized along key variables. The cosmetic was not evaluated in Study A, to consumers when these products first agency’s summary analyses for these there is no reason to expect the results enter the marketplace, use of novel studies are contained in this document to be different if the product were a names for active ingredients would and an expanded review will be placed multi-ingredient drug-cosmetic versus a simulate this condition. The agency has on file in the Dockets Management single ingredient drug-cosmetic. no reason to believe that not including Branch (Ref. 14). Finally, Study A evaluated the inactive ingredients or using fabricated In light of the opportunities for influence of highlighting, or graphic names for the active ingredients comment already provided on the design emphasis, on communication of influenced consumer preference in design and outcome of the studies, and important OTC drug product labeling Study B. the extent to which the agency in the information. The results showed that V. Final Implementation Plan end relied on the studies, the agency more, compared to less, highlighting The applicable implementation dates disagrees that there is a need for one helped participants make correct vary according to the regulatory status more opportunity for comment. product use decisions when there is a of the product. Any product that does 51. One comment stated that the data large amount of information in the not comply with this final rule as of the from Study A are irrelevant to whether labeling. Labeling with more applicable implementation date may be the proposed new OTC labeling is highlighting was also considered more considered for regulatory action. The necessary for ‘‘drug-cosmetic products,’’ useful. The agency considers the use of agency will review and, as needed, because no such product was evaluated highlighting equally applicable to drug- initiate steps to revise existing in the study. The comment contended cosmetic products that contain a large statements of enforcement policy to that consumer research concerning OTC amount of information in the labeling. ensure consistency with this analgesic and cough-cold drug products 52. One comment maintained that implementation plan. is not relevant to drug-cosmetic Study B is flawed in design and products. The comment urged the rationale because of its complexity and A. Products in the OTC Drug Review agency to undertake consumer research its intention to use consumer Products marketed under final OTC relevant to drug-cosmetic labeling, preferences as indicators of important drug monographs must comply with taking into account the differences labeling elements. The comment stated this rule as of April 16, 2001. Products between OTC drug products and OTC that the order of information should not for which a final monograph becomes drug-cosmetic products. be determined by consumer preference. effective on or after April 16, 1999, must For several recent prescription-to- The agency carefully designed the comply with this rule as of: (1) The OTC switches of drug-cosmetic protocol for Study B and solicited applicable implementation date for that products, the agency has observed public comment on the design prior to final monograph, (2) the next major labeling comprehension results similar initiating the study. The agency agrees, revision to any part of the label or to that seen in Study A. The results of however, that consumer preference labeling after April 16, 2001, or (3) April several of these studies have been should not be the sole determinant of 18, 2005, whichever occurs first. presented and discussed at open public labeling design or information (Ref. 15). Combination drug products in which advisory committee meetings (e.g., Thus, the final order and placement of all of the active ingredients are the Rogaine). Given this experience, the label information in this rule is subject of a final monograph or agency believes that the findings from intended to follow a logical monographs must comply with this rule Study A can be applied to all OTC drug decisionmaking process that assists the as of April 16, 2001. Combination

VerDate 03-MAR-99 10:50 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\A17MR0.001 pfrm07 PsN: 17MRR2 13274 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Rules and Regulations products in which one or more active ANDA) before April 16, 1999, must to come into compliance with this final ingredients are the subject of a final comply with this rule as of April 16, rule. monograph, and one or more 2001. Products that become the subject Finally, irrespective of the regulatory ingredients are still under review as of of an approved marketing application status of the product, the agency the effective date of this rule, must (NDA or ANDA) on or after April 16, strongly encourages all manufacturers, comply with this rule as of the 1999, must immediately comply with distributors, and packers of OTC drug implementation date for the last this rule. applicable final monograph for the products to voluntarily implement the combination, or as of April 16, 2001, C. Additional Provisions new content and format requirements as soon as possible, particularly when whichever is earlier. Combination Any OTC drug product not described products in which none of the active existing labeling is exhausted and in section V.A. and B of this document relabeling would occur in the normal ingredients is the subject of a final must comply with this rule as of: (1) monograph or monographs as of the course of business. The agency also The next major revision to any part of effective date of this rule, must comply encourages sponsors of products the label or labeling after April 16, 2001, with this rule as of: (1) The marketed under NDA’s and ANDA’s to or (2) April 18, 2005, whichever occurs implementation date of the last submit any required labeling first. applicable final monograph for the supplements as soon as possible, to combination, (2) the next major revision Products (including combinations) ensure timely review. to any part of the label or labeling after marketed under a final OTC drug monograph or monographs, or under an Provided below is a chart that April 16, 2001, or (3) April 18, 2005, summarizes the time periods within whichever comes first. approved drug application (NDA or ANDA), with annual sales of less than which the various categories of B. Products Marketed under NDA’s and $25,000, must comply with this rule as marketed OTC drug products must be in ANDA’s of April 16, 2002. This is intended to compliance with this final rule. Unless Products that are the subject of an provide marketed products with a low otherwise stated, all time periods begin approved drug application (NDA or level of distribution an additional year on the effective date of this final rule.

TABLE 1.ÐIMPLEMENTATION CHARTS

Products Time Periods

Single entity and combination products subject to drug marketing appli- Within 2 years (or within 3 years if annual sales of the product are less cations approved before April 16, 1999. than $25,000).

Single entity and combination products subject to drug marketing appli- Immediately upon approval of the application. cations approved on or after April 16, 1999.

Single entity products subject to an OTC drug monograph finalized be- Within 2 years (or within 3 years if annual sales of the product are less fore April 16, 1999. than $25,000).

Single entity products subject to an OTC drug monograph finalized on Within the period specified in the final monograph. However, if a or after April 16, 1999. monograph has not been finalized as of April 16, 2001, then the product must comply as of the first major labeling revision after April 16, 2001 or within 6 years, whichever occurs first.

Combination products subject to an OTC drug monograph or mono- Within 2 years (or within 3 years if annual sales of the product are less graphs in which all applicable monographs were finalized before April than $25,000). 16, 1999.

Combination products subject to an OTC drug monograph or mono- Within the period specified in the last applicable monograph to be final- graphs in which at least one applicable monograph was finalized be- ized, or within 2 years (or 3 years if annual sales of the product are fore April 16, 1999 and at least one applicable monograph was final- less than $25,000), whichever occurs first. ized on or after April 16, 1999.

Combination products subject to an OTC drug monograph or mono- Within the period specified in the last applicable monograph to be final- graphs in which all applicable monographs are finalized on or after ized. However, if the last monograph is not finalized as of April 16, April 16, 1999. 2001, then the product must comply as of the first major labeling re- vision after April 16, 2001 or within 6 years, whichever occurs first.

All other single entity and combination OTC drug products (e.g., prod- If a monograph has not been finalized as of April 16, 2001, then the ucts in the OTC Drug Review that are not yet the subject of pro- product must comply as of the first major labeling revision after April posed OTC drug monographs). 16, 2001 or within 6 years, whichever occurs first.

VI. The Paperwork Reduction Act of title, description, and respondent completing and reviewing the collection 1995 description of the information collection of information. provisions are shown below with an With respect to this collection of This final rule contains information estimate of the annual reporting burden. information, FDA invited comments on: collections that are subject to review by Included in the estimate is the time for (1) Whether the proposed collection of the Office of Management and Budget reviewing instructions, gathering and information is necessary for proper (OMB) under the Paperwork Reduction maintaining the data needed, and performance of FDA’s functions, Act of 1995 (44 U.S.C. 3501–3520). The including whether the information will

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FDA has FDA’s estimate of the burden of the container label if there is no outside estimated that of the 400 respondents proposed collection of information, container or wrapper) of all OTC drug who produce OTC products, including including the validity of the products include uniform headings and the 12,573 products described above, methodology and assumptions used; (3) subheadings, presented in a each may be required to respond ways to enhance the quality, utility, and standardized order, with minimum approximately 31.4 times to this rule clarity of the information to be standards for type size and other outside of their usual and customary collected; and (4) ways to minimize the graphical features. FDA is issuing these practice. Each response is estimated to burden of the collection of information requirements because it has determined take, on the average, 4 hours, for a total on respondents, including through the that the design and format of labeling of 50,292 hours per year. This burden is use of automated collection techniques, information varies considerably among expected to be a one-time burden. when appropriate, and other forms of OTC drug products and consumers may Although the usual and customary information technology. FDA received have difficulty reading and practice of label redesign will minimize no comments concerning the proposed understanding the information the burden for the remainig 68 percent burden estimates of this rulemaking presented on OTC drug product of SKU’s currently marketed, or 26,737 under the Paperwork Reduction Act of labeling. The rule is intended to enable products, additional time may be 1995 (62 FR 9024 at 9044). consumers to better read and necessary for each company to make the Regarding OMB’s concerns about understand OTC drug product labeling format changes under this rule. FDA has various label formats informing and to apply this information to the safe estimated that of the 400 respondents consumers about purchasing and using and effective use of OTC drug products. who produce OTC products, each may OTC drug products in a manner that FDA’s legal authority to modify and be required to respond approximately will improve their health, FDA simplify the manner in which certain 66.8 times to bring the 26,737 products discussed this subject in the February information is presented in OTC drug into compliance with this rule. FDA 27, 1997 (62 FR 9024 at 9031) proposal. product labeling derives from sections estimates that for this group, each The agency points out that the required 201, 502, 503, 505, and 701 of the act. response will take an average of 2.5 label format (i.e., the order for the Regulating the order, appearance, and hours for a total of 66,842 hours. This placement of information) is modeled format of OTC drug product labeling is is expected to be a one time burden. The after the decisionmaking process consistent with FDA’s authority to chart reflects this group on the second consumers would be expected to follow, ensure that drug labeling conveys all line. and should follow, when selecting and material information to the consumer Section 201.66(c) and (d) will also using OTC drug products. This new (sections 201(n) and 502(a) of the act), trigger the requirement that OTC required labeling format should help and that labeling communicates this manufacturers with approved or consumers to more efficiently and better information in a manner that is ‘‘likely pending new drug applications (NDA’s) use OTC drug products. to be read and understood by the and abbreviated new drug applications OMB, in its notice of action did state ordinary individual under customary (ANDA’s) must submit to FDA that it wished to allow the industry and conditions of purchase and use’’ supplements and amendments regarding the public to consider the notice of (section 502(c) of the act). labeling changes under 21 CFR proposed rulemaking, specifically its FDA concludes that the labeling 314.60(a), § 314.70, 21 CFR 314.96(a), concerns about the utility of various statements required under this rule are and 21 CFR 314.97. In the proposed label formats to inform consumers about not subject to review by the OMB rule, the agency attributed this purchasing and using OTC drug because they are ‘‘originally supplied by paperwork burden to these specific products in a manner that will improve the Federal government to the recipient NDA and ANDA regulations. For the their health. FDA has met with the for the purpose of disclosure to the final rule, the agency has redesignated industry on numerous occasions over public’’ (5 CFR 1320.3(c)(2)) and the burden under § 201.66(c) and (d). the past 4 years to discuss various therefore do not constitute a ‘‘collection Based on its records and experience, aspects of the new labeling formats and of information’’ under the Paperwork FDA estimates that approximately 61 believes that the industry and public Reduction Act of 1995 (44 U.S.C. 3501 respondents hold applications (41 NDA sector has had ample opportunity to et seq.). holders and 20 ANDA holders) for express their views and be aware of the Section 201.66 requires all OTC which supplements and amendments reporting burdens established by this manufacturers to format labeling as set will be required. FDA expects that final rule. Throughout the preamble, the forth in subsections (c) and (d). FDA has approximately 522 submissions (350 to agency has addressed numerous learned from the industry that OTC NDA’s and 172 to ANDA’s) will be comments received concerning manufacturers routinely redesign the required regarding labeling changes information collection. The agency adds labeling of OTC products as part of their under § 201.66(c) and (d), which that many manufacturers of OTC drug usual and customary business practice. averages to 8.5 submissions per products have begun on their own This rule provides varied timeframes for respondent. Based on information and initiative implementing the labeling implementing the OTC labeling experience, FDA further estimates that format provided in this rule as part of requirements. Therefore, the majority of each submission will take an average of their routine labeling redesign practice. respondents will be able to format OTC 2 hours to prepare, for a total of 1,040 Title: Over-the-Counter Human Drugs; labeling in accordance with § 201.66 as hours annually. This burden is also Final Rule for Labeling Requirements. part of their routine redesign practice, expected to be a one-time burden. Description: FDA is amending its creating no additional paperwork or Under § 201.66(e), respondents regulations governing labeling economic burden. However, of the subject to this rule will be required to requirements for human drug products 39,310 SKU’s currently marketed under submit requests in writing for to establish a standardized format and a final monograph, FDA has determined exemptions and deferrals from the standardized content requirements for that approximately 32 percent, or 12,573 specific requirements of § 201.66. Based the labeling of all marketed OTC drug products, may necessitate labeling on its experience with exemption and products. The rule requires that the format changes sooner than provided deferral requests under similar outside container or wrapper of the under their usual and customary provisions, FDA estimates that

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TABLE 2.ÐESTIMATED ANNUAL REPORTING BURDEN1

Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response

201.662 400 31.43 12,573 4 50,292 201.66 400 66.8 26,737 2.5 66,842 201.66(c) and (d)2 61 8.5 522 2 1,044 201.66(e) 25 4 100 24 2,400 Total 120,578 1 There are no capital costs or operation and maintenance costs associated with this collection of information. 2 One-time burden.

VII. Environmental Impact policy issues it raises. It is also an drug products. FDA estimates that the The agency has determined under 21 economically significant regulatory required labeling redesign will cost CFR 25.30(h) that this action is of a type action because of its substantial about $19.4 million. In addition, the that does not individually or benefits. With respect to the Regulatory minimum print size and other format cumulatively have a significant effect on Flexibility Act, the following analysis changes will require a small percentage the human environment. Therefore, constitutes the agency’s Final of products (estimated at 6.4 percent) to neither an environmental assessment Regulatory Flexibility Analysis. Because increase the size of their label and/or nor an environmental impact statement the rule does not impose any mandates package. These size-related adjustments is required. on State, local, or tribal governments, or will add about $38 million in one-time the private sector, that will result in an costs and $11.5 million in annually VIII. Analysis of Impacts expenditure in any 1 year of $100 recurring costs. Overall, therefore, the million or more, FDA is not required to A. Background and Summary agency estimates that the one-time costs perform a cost-benefit analysis of this rule will amount to about $58 FDA has examined the impacts of the according to the Unfunded Mandates million and the annual recurring costs final rule under Executive Order 12866, Reform Act. about $11.5 million. the Regulatory Flexibility Act (5 U.S.C. The standardized format and easier- 601–612), and the Unfunded Mandates to-read labels established by this rule B. Benefits of Regulation Reform Act (2 U.S.C. 1501 et seq.). will have a positive effect on the Executive Order 12866 directs agencies nation’s public health by enhancing the The purpose of this final rule is to to assess all costs and benefits of ability of consumers to find, read, and establish a standardized format for the available regulatory alternatives and, understand important safety and use labeling of all OTC drug products so when regulation is necessary, to select information. The expected benefits of that the labeling will be easier to read regulatory approaches that maximize the rule will include: (1) Improved drug and understand, and will provide net benefits (including potential effectiveness for labeled indications, (2) consistent information in like situations. economic, environmental, public health reduced adverse drug reactions, and (3) Thus, the final rule will enhance the and safety, and other advantages; more efficient consumer search safe and effective use of OTC drug distributive impacts; and equity). Under activities. The health benefits that will products by improving the ability of the Regulatory Flexibility Act, if a rule result from improved drug effectiveness consumers to find, read, and understand has a significant impact on a substantial could not be quantified, but FDA important safety and use information. number of small entities, an agency believes that they are substantial. With As discussed in section III.A of this must analyze regulatory options that respect to the anticipated reduction in document, the agency conducted a would minimize any significant impact adverse drug events, the agency finds study (Study A) to examine the of the rule on small entities. Title II of that if the rule prevents just 5 percent influence on comprehension of the new the Unfunded Mandates Reform Act of the hospitalizations associated with versus the previously used OTC labeling requires that agencies prepare a written the unintended consequences of self- format. That study supports the assessment and economic analysis medication, the economic savings could conclusion that the new format will take before proposing any rule that may be $39 million annually in direct less time to read and will help result in an expenditure in any 1 year benefits and $52 million annually from consumers make a greater number of by State, local, and tribal governments, indirect benefits. In addition, by correct product use decisions when in the aggregate, or by the private sector, reducing consumer search time, the such decisions require a simple search of $100 million (adjusted annually for uniform format could lead to consumer for information in the product labeling. inflation). time savings valued at from $19 million The study found that individuals like a The agency believes that this final to $38 million per year. The total format with strong visual cues and rule is consistent with the principles set benefits of this rule range from $110.5 consider information easier to use when out in the Executive Order and in these million to $129.6 million per year. presented in easy to read ‘‘chunks.’’ two statutes. The final rule is a The costs of the product redesign and Especially when attention is divided, significant regulatory action as defined relabeling imposed by this rule will be individuals felt more confident in their by the Executive Order due to the novel incurred by the manufacturers of OTC ability to use such a format.

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Both the variability and the such incorrect product use decisions. consequences of self-medicating. If the presentation of existing OTC drug Although FDA cannot quantify the improved labeling format and larger product labeling make it difficult for value of the health improvements that print size contributed to the avoidance consumers to select the most would result, the agency is confident of only 5 percent of these appropriate OTC drug product and to that the more informed OTC drug hospitalizations, the economic savings use the product safely and effectively. selection and use produced by this rule would amount to $39 million annually. For consumers to gain the greatest will increase consumer satisfaction and, The indirect benefits from reduced benefit from these products, relevant at times, reduce health care costs for drug-related illnesses include avoided information must be easy to find, additional or supplemental medications, costs due to lost work time or reduced readable, readily understood, noted, and doctor visits, and hospitalizations. productivity. Roughly 58 percent of acted upon. Despite the critical adverse drug reaction admissions were 2. Savings From Reduced Adverse Drug importance of safety and use for patients aged 20 to 59. The Reactions information, OTC drug product labeling remaining 42 percent of admissions is often printed in small type with a Although adverse events associated were for patients under 20 years (<10 crowded layout and minimal white with some OTC drug products are not percent) and over 59 years old (Refs. 17, space. Although the OTC drug industry systematically tracked and recorded, 18, and 22). To calculate productivity has developed voluntary labeling substantial documentation does exist for losses, the agency assumed 56 hours per standards encouraging a minimum 6- the more serious events. Numerous admission for the patients aged 20 to 59 point type size, many OTC drug product studies in the literature have years (40 hours of lost work per labels fail to meet this standard. documented drug-related hospitalization plus 16 additional hours Moreover, the placement of the hospitalizations (60 FR 44182 at 44232, for recovery and followup doctor visits) information varies, making it harder for August 24, 1995). One comprehensive and 14 hours for the remaining group (to consumers to find and compare similar review of 36 articles focused specifically account for lost volunteer time or for information on competing products. on adverse drug reactions (ADR’s) as the time away from work for the care givers The revised labeling will produce at primary cause of hospitalization. This of dependent patients). Using the least three important benefits: (1) The study counted the number of events average hourly production workers new label will enhance the therapeutic attributed to the unintended earnings plus 30 percent for fringe value of OTC drug products by helping consequences of drug therapy, benefits of $15.96, the estimated value consumers select appropriate products excluding admissions due to overdose, of lost productivity is $44.2 million and adhere to proper dosage regimens; intentional poisoning, attempted patients for aged 20 to 60 and $8 million (2) consumers will find it easier to avoid suicides, drug abuse or intoxication, and for the remaining patients or their care ingredients or products that in some found that the percentage of givers (Ref. 23). These estimates may circumstances cause adverse events hospitalizations due to ADR’s ranged somewhat overstate the value of lost such as allergic reactions, adverse drug from 0.2 to 22 percent, with a mean of productivity for the 20 to 59 age group interactions, or other unintended 5.5 percent (Ref. 16). Of those studies because all patients are assumed to be outcomes, ranging from minor that distinguished between prescription employed. On the other hand, indirect discomfort to hospitalization; and (3) and OTC drugs, the reported OTC share benefits for the remaining age groups are consumers will increase the economic ranged from between 4 (Ref. 17) and 18 understated because many of these efficiency of their OTC drug purchases percent (Refs. 18 and 19). Thus, FDA patients are in the workforce and for by more quickly locating and estimates that unintended OTC drug- those who are not, data are inadequate identifying key elements of product related hospitalizations may account for to measure their contribution to society. information, such as appropriate about 0.55 percent (5.5 percent x 10 Although less severe adverse ingredients, uses, and warnings. percent), or 170,500 of the nation’s 31 incidents have not been systematically million annual hospital admissions. tracked and recorded, they likely occur 1. Improved Product Selection and Use Investigators have determined that frequently, as over 5 billion OTC drug The number of consumers relying on between 48 and 55 percent of all products are purchased annually. The self-diagnosis and self-treatment has hospital admissions related to adverse crowded format and small print size increased rapidly over the past decade, reactions are preventable (60 FR 44182 found on many of these products due in part to the rising cost of health at 44232). (A recent study of in-hospital obscures important directions and care and the increasing number of drug adverse drug reactions also found that warnings that might otherwise be products switched from prescription to almost 50 percent were preventable.) heeded by consumers. For example, OTC status. Consumers, however, are (Ref. 20). Consequently, on the certain OTC drug products contain faced with a growing number of choices assumption that 50 percent of the warnings about not driving or operating for purchase decisions and often find it hospitalizations attributable to OTC heavy equipment when using those difficult to determine the product that is drug adverse reactions are preventable products. Some consumers best for their particular condition. The and that the cost of an average hospital inadvertently overdose because they are absence of uniform and easily readable stay is $9,191 (Ref. 21), FDA finds that unaware that a particular ingredient was product information complicates $784 million (170,500 x 50 percent x also contained in a multi-symptom product comparisons and can result in $9,191) is spent annually on product. In the case of combination less than optimal health outcomes. hospitalizations due to potentially products with multiple active Moreover, even informed product avoidable OTC drug ADR’s. ingredients, especially in the cough/ selections can produce disappointing The realized benefits of the rule will cold category, consumers often treat results if directions for use are misread. depend on the degree to which symptoms that are not present, raising Inappropriate product selections or consumers are better able to read and the likelihood of an adverse drug event. illegible dosage directions can postpone understand OTC drug product labeling The new label format will establish a relief from aches or pains, or permit and to act on that information to make consistent order of presentation and other discomforts to persist longer than choices that would reduce drug side group similar information (such as necessary. Study A suggests that the effects, drug interactions, allergic ingredients, warnings, and directions) standardized labeling format will reduce reactions, and other unintended together under relevant headings so that

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Savings From More Efficient Product In summary, FDA expects revised Search and sizes affected; the number of years OTC drug product labeling to generate of labeling life lost; and the value of By facilitating product comparisons, substantial benefits, many of which the each year of labeling life lost (see 62 FR easier-to-read labeling will reduce those agency could not quantify. While the 9024 at 9045 through 9049). As suboptimal purchases that result from majority of the costs attributed to this explained below, upon review of the inappropriate price-quality rule are one-time costs associated with comments, FDA has concluded that its relationships and competitive labeling redesign and packaging methodology for estimating the cost of inefficiencies. For example, the uniform reconfiguration, the benefits from a labeling change was sound. The format will reduce consumer search and improved labeling will accrue annually. agency has, however, refined its earlier transaction costs, because all products Better informed product selection and cost estimates, based on the comments will display information in the same use will raise the likelihood that OTC and other supplemental information, order. In turn, consumers will find it drugs will produce desired health and has added costs for increasing the easier to purchase more economical outcomes. The standardized format and size of certain packages and labeling. items by comparing products with easier-to-read labeling is expected to similar ingredients and uses. Although reduce the number of ADR’s associated 1. Number of Products Affected FDA could not assign an economic with OTC drug products. A 5 percent value to this expected efficiency gain, decrease, for example, would reduce Once the rule is fully effective, a new Study A found that the time required to annual hospital costs by about $39 OTC drug product labeling design will read the complete safety and use million and reduce annual productivity be required for each SKU. For its initial information in the proposed format was losses by $59 million. Finally, FDA analysis, FDA based its estimate of the reduced by a statistically significant 10 expects that easier-to-read information size of the affected OTC drug market on seconds compared to traditional will lead to more efficient marketing data from Nielsen. According to formats. The total time saved searching transactions, because product and price Nielsen, OTC drug products in 1995 for specific information components, comparisons will be simpler and faster, accounted for $18.7 billion in sales in such as ingredients and their permitting consumers to obtain grocery stores, drug stores, and mass therapeutic benefits, or for conducting comparable results in less time. The merchandise outlets. FDA allocated the product comparisons, should be even value of the reduced search time could products in Nielsen’s inventory into greater at the point of purchase. range from $19 to $38 million annually. review categories based on their According to A.C. Nielsen (Nielsen), a The total benefits of this rule range from monograph review status. This recognized provider of market research $110 million to $129 million annually. categorization indicated that almost business information and analysis, 30,000 brand name SKU’s were consumers purchased 5.6 billion units C. Costs of Regulation regulated under the OTC drug of OTC drug products in 1995. (This For its analysis of the proposed rule, monograph review process. The figure excludes dandruff shampoos and FDA determined that the cost of revising breakdown of these branded SKU’s by facial makeup and lipstick with labeling for thousands of OTC drug monograph review status showed: sunscreen.) If 10 percent of these products would be substantial, 10,910 under a final monograph purchases represent first time or annual involving numerous levels of review (including products switched from evaluations of purchase decisions, 0.6 and verification, in addition to prescription to OTC status), 8,241 billion product decisions are made extensive graphic redesign. The agency scheduled to become final before this annually. If consumers save only the found, however, that regulatory costs final rule, and the remaining 8,488 reported 10 seconds per purchase would be moderated by the standard scheduled to become final after this decision, they would save 1.6 million business practice of periodic redesign. final rule is published. (The latter figure hours annually. Using 1997 average Because a majority of the labeling would was subject to greater uncertainty hourly production worker earnings of undergo design changes even in the because of incomplete coverage of $12.28, the approximate economic value absence of a new rule, FDA estimated products with sunscreens in the Nielsen of this time savings is $19.1 million per the costs of redesign by counting only data base.) (See Table 3 of this year (Ref. 23). If consumers compare the value of the label-years that would document.)

TABLE 3.ÐNUMBER OF ESTIMATED SKU'S BY REGULATORY STATUS

Brand name Private Total

Marketed under final monograph 10,910 28,400 39,310 Under review, scheduled for final monograph 8,241 21,300 29,541 Remaining 8,488 21,300 29,788 Total 27,639 71,000 98,639

Because the Nielsen data base did not Nielsen data on the average number of the same regulatory status distribution break out SKU’s for private label store SKU’s carried by firms that relabel as for branded SKU’s. brands, FDA estimated the number of generic OTC drug products. The agency While this rule will ultimately affect private label SKU’s using data on the estimated 71,000 private label SKU’s (62 all OTC drug products, the number of retail chains likely to market FR 9024 at 9046 to 9047) and assumed implementation dates for the labeling private label brands (Ref. 24) and changes will vary according to the

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The 29,541 SKU’s was thought to be labeling that would normally be following section addresses each of potentially affected, depending on the redesigned within the implementation these issues while focusing primarily on timing of the publication of their final period was assumed to incur no the comments and alternative economic OTC drug monographs. The agency additional costs. To represent the analysis submitted by NDMA. Appendix assumed that monographs for the distribution of typical labeling G of NDMA’s comment provides a full remaining 29,788 SKU’s would become replacement intervals, the agency had description of its explanatory data and final only after publication of the final estimated that the labeling for 20 methodology (Ref. 25). rule. Because products marketed under percent of the affected SKU’s would be NDMA stated that the cost to comply this latter group of OTC drug redesigned at least every 2 years, 40 with the proposed rule, assuming a 2- monographs would require labeling percent every 3 years, and 40 percent year implementation period, would be a changes regardless of the final rule, no every 6 years. Both the number of OTC minimum of $140 million, even without design-related costs were assigned to drug products requiring redesign and changes to package and label sizes. this group of products. Although FDA the market value of the labeling were NDMA subsequently recommended the received no comments questioning this assumed to be evenly distributed over use of a net present value approach, SKU allocation, the agency has now their labeling lifetimes. That is, for which reduced its cost estimate to $114 determined that the 29,541 SKU’s in the labeling with a 6-year lifetime, one-sixth million. Further, FDA had proposed an review category will not be finalized would be redesigned in year 1, one-sixth additional implementation year for before this rule is published. As a result, in year 2, and so on. FDA then SKU’s with annual sales below $25,000. only those 39,310 SKU’s currently measured the economic cost of the This adjustment reduces NDMA’s cost covered by final OTC drug monographs proposed labeling redesign requirement estimate (assuming no package or label are expected to incur incremental as the lost value of the remaining life- size changes) to $86 million, labeling design costs. years of the existing labeling designs. substantially less than the originally stated $140 million figure, but still far 2. Original Agency Estimate For example, given a 2-year phase-in period, product labeling with a above FDA’s estimate of $14.2 million. a. Cost of labeling redesign. FDA’s remaining 3-year lifetime would lose the a. Cost of redesigning drug label. previous analysis (62 FR 9024 at 9045 value of 1 year of labeling-life.1 NDMA agreed that FDA ‘‘approached to 9049) found that redesign cost FDA found that, with a 2-year the very complex task of assessing the estimates varied from $2,700 to $10,000 implementation period, the cost of the economic costs resulting from the per SKU for branded products and from proposed requirements would be $19.7 proposed rule in a rational, data-based $500 to $1,500 per SKU for private label million. To reduce the economic impact manner’’ and that ‘‘many of the products. These costs included the on small entities, the agency proposed parameters that FDA used as a basis to drafting of language, art work, review, an additional 1 year extension for OTC determine label design costs were and implementation and generally drug products with sales of less than supported by reliable market research included redesign of the PDP. FDA $25,000 per year. Based on the Nielsen data.’’ For example, NDMA accepted assumed that the PDP accounted for 50 data, this extension applied to about 40 FDA estimates for both the number and percent of the cost to redesign branded percent of OTC drug products, but only life cycle of the affected drug labels. product labeling and reduced the about 1 percent of OTC drug retail sales. Nevertheless, NDMA asserted that the estimated redesign costs by one-half, on With this added deferral, FDA estimated agency had understated the cost of the presumption that the rule would not the cost of the proposed rule at $14.2 redesigning a label for the following affect the PDP. To derive an average million. reasons: (1) FDA’s unit cost estimate cost, the agency weighted the affected was based on a small, nonrandom share of private label and branded 3. Response to Comments sample; (2) FDA was incorrect in SKU’s at 80 and 20 percent, A number of comments from the OTC eliminating PDP redesign from the cost respectively, based on FDA’s estimate of drug industry asserted that the agency of relabeling branded OTC drug 71,000 private label SKU’s and an understated the cost of the proposed products; and (3) FDA did not consider analysis of Nielsen sales data covering rule. These comments stated that: (1) either the cost of scrapping label the remaining 27,639 branded SKU’s. inventory or the administrative burden Because the analysis found that a 1 Mathematically, the following formula was used that would be incurred by firms in substantial proportion of the branded to calculate the costs: developing compliance strategies. products were regional and/or low sales Costyx = ΣjNxAx(1/x), where j = 1 to (x-y) i. Unit cost estimate (without scrap). volume items, FDA assumed that the Total Costy = Costy6 + Costy3 + Costy2 NDMA reports that it developed a cost redesign costs for regional and low sales where: estimate by surveying 74 member firms volume branded products would be x = life of labeling in years (2, 3, or 6), regarding the average cost of redesigning similar to that for private label products. y = implementation period in years, an OTC drug product label. The survey Nx = number of SKU’s with labeling life of x Using the midpoints of the cost ranges, years, and (Ref. 25) requested information on and reducing the cost for branded minor and major label changes. Thirty- Ax = amortized annual value of labeling with a products by 50 percent to account for life of x years. four firms responded, of which 31 were the PDP adjustment, the analysis (Ax is equivalent to the annuity value to pay off brand label manufacturers and 3 were { calculated an average redesign cost of an initial investment, i.e., Ax = C x I / [1 - (1/ private label manufacturers. The (1 + I)x)]}; where C = the average weighted cost to $1,500 per SKU. However, as described redesign a labeling ($1,500); I = the discount rate reported cost per SKU to redesign a in section VIII.E.3 of this document, (7%); and x = the life of a labeling in years (2, 3, label ranged from $500 to $420,000. based on additional information, the or 6).) Excluding three extreme outliers,

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NDMA projected an average cost differentials between branded and other elaborately packaged cosmetic (omitting scrap) of $15,154 per SKU to private label manufacturers, with survey products. redesign a branded label and $1,261 for costs for branded SKU’s from 3 to 40 To finalize its estimate of the average a private label. Assuming a 20/80 times greater than those for private label cost of redesigning an OTC drug label, market split for branded and private SKU’s. For graphics development FDA considered several approaches. label products, NDMA calculated a (directions for studio, draft/mock-ups, First, the agency maintained its initial weighted average cost per SKU of review, and concurrence), the average estimating methodology, but adjusted $4,039, roughly double the earlier FDA SKU cost reported was $6,215 for the estimated unit cost per SKU. Based estimate (without a PDP adjustment) of branded and $291 for private label on all available information, FDA $2,070. products. Assuming an hourly wage rate concludes that the cost of redesigning To validate its estimate, NDMA cited of $40 for branded and private product nationally branded products a cost model that had been developed personnel, manufacturers of branded manufactured by large companies by the Research Triangle Institute (RTI) products spend 155 hours per SKU on ranges from $5,000 to $15,000 per SKU. to estimate the regulatory impact of the this function compared to 7 hours by The cost to redesign regional or low NLEA. The RTI model assumed that the private labelers. For separations (color sales volume brands of smaller cost of changing a food product label mock-ups created and reviewed), the manufacturers is considerably less, was a function of administrative, survey reported the per SKU cost for ranging from about $1,000 to $8,000 per analytical, marketing, printing, and branded and private label companies at SKU. The cost to redesign labels for label inventory costs. Printing costs $3,210 and $82, respectively, almost a private label brands is smaller still, but depended on the type of printing 40-fold difference. The agency approximates FDA’s original estimate of process, the frequency of redesign, the acknowledges that large manufactures of $1,000 and NDMA’s survey estimate of number of SKU’s affected, the nationally branded products involve $1,261 per SKU. Accordingly, to complexity of the label changes, and the more personnel in decision making and calculate a final estimate, the agency length of the compliance period (Ref. may use higher quality packaging divided OTC drug products into three 26). NDMA estimated, based on materials. Nevertheless, in view of the classes: (1) Branded products responses from 21 member firms, that substantial degree of market manufactured by large NDMA member about 50 percent of the industry’s SKU’s competition in this industry, private companies, with a midpoint cost are printed using lithography, 47 labelers typically package goods to estimate of $10,000 per SKU; (2) percent by flexography, 1 percent by resemble the competing national brand. branded products manufactured by gravure, and the remaining by other Moreover, while questioning the size of smaller companies, with a mid-point methods. Applying these proportions to the reported range, FDA could not cost estimate of $4,500 per SKU; and (3) the RTI model for complex printing review the basis for NDMA’s estimates, private label products, assumed to cost tasks with four or more color changes, because the supporting data, such as the $1,261 per SKU, as reported by NDMA. The agency used its original estimate NDMA derived a label printing cost of number of labor hours or labor costs of the SKU distribution, which $3,458 per SKU for an average OTC drug used in its calculations, were not indicated that about 30 percent of all product and concluded that this result submitted. verified its estimate of $4,039 per SKU OTC drug SKU’s are branded, and the Furthermore, while the proposed rule (without scrap). NDMA member survey to determine The agency agrees that the cost data required manufacturers to reformat the costing weights to apply to each used in FDA’s economic analysis of the information panels, the NDMA survey industry sector. Respondents to proposed rule were not drawn from a instructed respondents to include the NDMA’s survey reported that they random sample, although they were cost of changing all labeling, including account for about 4,000 branded SKU’s, supplied by sources familiar with the certain promotional materials. Thus, which amount to 15 percent of all OTC drug industry, including smaller some manufacturers may have reported branded SKU’s. As these survey and private label manufacturers. FDA costs for developing new product respondents comprise almost half of notes, however, that the survey identities, advertising campaigns, etc. NDMA’s membership, FDA assumed underlying the NDMA cost estimates Also, survey respondents were asked to that branded products of all NDMA was likewise not based on a random estimate the cost to redesign only one members may account for about 30 sample of manufacturers. While NDMA SKU, which ignores both learning curve percent of all branded SKU’s, or member firms include a range of large, and economy of scale effects. For the approximately 10 percent of all affected small, brand-label, and private-label most part, the same industry personnel SKU’s (30 percent branded x 30 percent manufacturers, many smaller firms do are responsible for copy and layout NDMA members). The remaining not belong to NDMA. Indeed, NDMA decisions for numerous product lines branded products, therefore, account for indicates that its 74 members (which and SKU’s. Moreover, FDA does not 20 percent of all affected SKU’s, and the may represent less than 20 percent of all agree that the RTI model necessarily private label products account for the OTC drug manufacturers), account for validates NDMA’s redesign cost remaining 70 percent. This calculation 90 to 95 percent of all OTC drug sales. estimate. The portion of the RTI model results in a weighted average cost of A survey limited to this membership used by NDMA was developed to $2,783 (without scrap) to redesign a necessarily over-represents large estimate the cost of printing food labels, label (i.e., ($10,000 x 10 manufacturers of nationally branded which are often considerably larger than percent)+($4,500 x 20 percent)+($1,261 products and under-represents smaller OTC drug labels. x 70 percent)), a figure higher than the manufacturers of regionally branded NDMA’s recent estimate also differs prior FDA estimates but below the products. from the average cost of $7,900 per SKU NDMA survey estimate of $4,039. Following review of the survey data submitted by the Cosmetic, Toiletry, A second approach was developed by provided by NDMA, FDA concludes and Fragrance Association to change a the Eastern Research Group, Inc. (ERG), that NDMA’s figures overstate the drug-cosmetic label (Ref. 27). OTC drug- a private economics consulting firm industry average cost of redesigning cosmetics are generally considered to under contract to FDA. ERG developed OTC drug labels. For example, the have more expensive labeling than OTC its model based on data collected during survey reports unreasonably large drugs alone, because they compete with site visits to several large and small drug

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OTC drugs are regulatory affairs, art/graphics, those plates would need to be highly regulated products and manufacturing changes, and inventory redesigned, the others could be reused manufacturers are expected to have losses by firm size (by employment), or simply copied at significantly regulatory personnel on staff or firm type (branded or private label), and reduced cost. Nevertheless, the agency consultants available to address type of label changed (carton, container, acknowledges that many manufacturers compliance matters. The complexity of etc.). Under ERG’s model, the estimated would, at the time of redesigning the the rule is not unusual compared to weighted average cost of label redesign information panel, also make other OTC drug regulations and the (without scrap) is $1,210 per SKU (Ref. incremental changes to the PDP. requirements will be clear to graphics 28). Therefore, the agency has adopted the design and regulatory personnel. Because the OTC industry is so NDMA position and eliminated any Moreover, the rule is expected to receive diverse and the relevant cost data are so downward PDP adjustment from its widespread publicity when issued and limited, no single model or single calculation of the cost of the final rule. most OTC drug firms belong to trade estimate can be viewed as definitive. iii. Scrap. NDMA also argued that the associations or have access to trade Nevertheless, the agency continues to cost of scrapping unused inventory publications that provide additional believe that its overall approach should be included as a regulatory cost. sources of information. Because the rule represents a rational basis for estimating Based on its survey, it estimated that permits a 2- to 3-year implementation the redesign costs associated with this scrap labeling inventory adds about period, FDA continues to believe that rule. The agency in its proposed $1,000 to the weighted redesign cost per managing the label changes will not analysis arrived at an estimate of $2,070 SKU ($2,968 per SKU for higher cost impose burdens beyond the costs per SKU (without a PDP adjustment). firms and $576 per SKU for lower cost included in the agency’s estimate. b. Methodology for calculating That figure, when revised to take into firms), raising its average unit cost economic impact. NDMA disagreed account certain data from the NDMA estimate to about $5,000. NDMA with the methodology the agency used survey, is increased to $2,783 per SKU. declared this a conservative estimate to calculate the economic impact of the ERG employed a more complex model that would underestimate the cost of proposed rule for two reasons: (1) FDA and arrived at a figure of $1,210 (or half scrap label inventory if the treated the cost to redesign as a financed that of FDA), while NDMA arrived at a implementation date were less than 2 weighted average of $4,039 (or twice rather than an expensed cost and years. that of FDA). Given this spread, and calculated the impact using an FDA agrees that some scrap label given the agency’s concerns about amortized cost rather than a net present NDMA’s methodology and input data, inventory loss is inevitable when label value, and (2) FDA treated label the agency is adopting the revised figure changes are made, but notes that the redesign as an accelerated change rather of $2,783 as its base average cost longer the implementation period the than an additional change. estimate. The agency acknowledges that easier it is for manufacturers to i. Economic versus accounting costs. it has adopted a conservative figure, minimize the cost. The final rule allows NDMA asserted that FDA used an relative to that derived by ERG. either a 2- or 3-year implementation incorrect valuation method to assess the However, nothing in the ERG model, or phase (depending on sales volume), economic impact of the rule, because in the NDMA model, suggests that FDA which is sufficient time to minimize the agency’s valuation of amortized lost should discard its methodology or its inventory losses. Because the NDMA label life incorrectly implies that the assumptions for estimating unit costs. survey question failed to state the length costs of label redesign are financed ii. Principal display panel. In its of the phase-in period, the survey costs, rather than sunk costs expensed original analysis, FDA assumed that the response cannot be considered reliable. in the year they incur. According to PDP need not be altered and therefore Nonetheless, because a better estimate NDMA, the proper approach is not to adjusted its unit cost estimate for of the average scrap cost is not available, amortize, but to calculate the net branded products downward by 50 FDA accepts NDMA’s figures, but present value of the incremental costs of percent. NDMA argued that this adjusts the weighting to 10 percent for label redesign. correction was inappropriate as it failed the higher cost firms and 90 percent for FDA does not agree that the to account for many commonly used the lower cost firms, for a weighted amortization of lost label life is labeling and packaging configurations. average of $800. This weighting is based inappropriate. Executive Order 12866 NDMA pointed out that, with the on the assumption that both small brand charges Federal agencies to determine exception of labels with separate front name manufacturers and private label the economic cost of its rules, but such and back panels, all PDP’s must be manufacturers have less expensive costs are not necessarily identical to reprinted when the information panel is labels and smaller inventories than large financial costs, as interpreted by changed. Based on a poll of 7-member brand-name companies. The accounting convention. According to companies, NDMA estimated that about consideration of scrap, therefore, raises the U.S. Office of Management and 90 percent of all OTC drug SKU’s FDA’s weighted average design cost Budget (Ref. 29), the preferred measure require the PDP to be reprinted when estimate to approximately $3,600 per for economic analyses is ‘‘the changes are made to the information SKU. opportunity cost’ of the resources used panel. iv. Administrative costs. NDMA or the benefits forgone as a result of the The fact that the PDP needs to be suggested that the agency also include regulatory action.’’ Whether firms reprinted when the information panel is administrative costs in its calculation of expense label design costs in the year changed does not mean that it has to be the cost to redesign the label. NDMA they occur is largely irrelevant to the redesigned. For the majority of labels, provided no estimate of these costs, but proper calculation of economic costs, the PDP and information labeling are noted that there would be a burden to i.e., the opportunity cost of the rule.

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Moreover, FDA’s calculation yields affected SKU, compared to FDA’s private label SKU’s could not results that are identical to those estimate of about $1,000. accommodate the proposed label format. obtained through a net present value The agency does not dispute the NDMA estimated that exemption approach. To derive its results, FDA theoretical possibility of NDMA’s petitions would be filed for 33,500 estimated a net present value and then, argument. If ‘‘market driven’’ reasons for SKU’s, that 32,600 SKU’s would alter for ease of exposition, converted this label adjustments always compelled an package configuration at a cost of over figure into an equivalent stream of immediate response, companies could $1 billion, and that about 15,500 SKU’s annual costs. not coordinate voluntary label updates would be removed from the market. ii. Additive versus accelerated costs. with mandatory label redesign; the While not including administrative The primary reason that NDMA’s regulatory cost for each affected label, costs for feasibility studies to determine methodology produces substantially therefore, would be the full cost of the cost-effective packaging and labeling higher costs than FDA’s estimate is that design change. However, FDA does not configurations, NDMA stated that they NDMA’s approach assumes a ‘‘market agree that such abrupt shifts in would be large. One manufacturer driven’’ label cycle that is independent marketing strategies are the industry suggested that a new packaging line to of the design changes required by the norm. Many of the examples of ‘‘market accommodate a label change for just one rule. For example, if the average lifetime driven’’ label changes NDMA cited are product line would result in a one-time of a particular label type is 3 years and for exactly the kind of incremental equipment expenditure of about $2.5 a design change costs $3,000 per SKU, adjustments that would be deferred and million (including equipment, both FDA and NDMA agree that a 2-year consolidated in a major redesign effort. installation, validation, depreciation of phase-in would allow two-thirds of the For example, the demand for most old equipment, facility renovation, and labels to be replaced under normal changes to product attribute copy or inventory loss) and recurring costs of business conditions without additional graphics mounts gradually in response almost $500,000 for the more expensive costs (assuming no package size to shifting advertising and marketing labeling. changes). FDA’s methodology, however, styles. Once changed, such The previously mentioned projections also assumed that the remaining one- modifications postpone the need for greatly overestimate the percentage of third of the labels lose only 1-year of future change. Revisions for litigation- SKU’s that will not be able to their expected lifetime, so that the driven warnings are less common events accommodate the new format and the economic cost (ignoring any discounting that would be expected to have a small cost of increasing the size of the adjustment) would be $1,000 per SKU effect on industry averages. According labeling, where necessary. In particular, (1/3 x $3,000) for one-third of these to the RTI study (Ref. 26), line copy the assertion that 95 percent of private SKU’s. This approach, however, changes or changes affecting just one label SKU’s could not accommodate the implicitly assumes that the label design color are minor changes that, in most proposal requirements is difficult to cycle would resume at a 3-year interval, cases, are made without the assistance understand, as the vast majority of so that the next voluntary label of a label artist and cost one-sixth the private label OTC drug products are redesign, on average, would not occur cost of a four-or-more color change. packaged almost identically to the until 3 years after the mandated change. Such minor adjustments would not be leading branded products for In contrast, NDMA argues that expected to alter the underlying design competitive reasons. Moreover, the voluntary label redesign occurs in cycle. agency carefully reviewed labels response to external ‘‘market driven’’ The agency finds it more likely that submitted as examples of those that factors that would be independent of the demand for most major label would not fit the proposed format and this mandated change. According to changes is a steadily increasing function found that many could, in fact, NDMA, such redesigns are to change of the time that has elapsed since the accommodate the final rule without a product attribute copy; change graphics; last labeling revision and that change in label or package size. add litigation-driven warnings; delete manufacturers continually refine FDA also questions the methodology ‘‘new’’ flags after 6 months; add marketing techniques and strategies. As for calculating the costs of package size multilingual labeling; change labeling most companies will find it cost- changes. Although details of these information, such as manufacturer, effective to complete these incremental calculations were not submitted, it distributor, or inactive ingredient; or labeling changes concurrently with the appears that NDMA estimated the cost add or change SKU’s in a product line. mandatory redesign required by this of purchasing or modifying equipment NDMA contends that, because the rule, FDA’s revised analysis maintains by multiplying the unit costs by the mandated changes required by this rule the assumption that the current labeling number of affected SKU’s, with no would not affect the underlying ‘‘market change cycle will continue unaltered. allowance for multiple SKU’s packaged driven’’ design cycle, the full cost of the Moreover, it is important to note that on a given production line, or for the redesign, rather than just the value of the agency’s decision not to exclude widespread usage of contract packagers. the remaining life of the former label, PDP design costs is based on its finding Although agreeing that such factors measures the economic cost of the that incremental style modifications should be considered when determining regulation. accompany mandated changes. If firms costs, NDMA nonetheless assumed With respect to the previous would not bundle incremental style substantial equipment requirements for numerical example, NDMA’s changes with the mandated changes, the each SKU. Moreover, NDMA does not methodology implies that those labels PDP design costs should be subtracted differentiate between the costs of that were redesigned in year 2 for from the regulatory cost estimate. branded and private label regulatory reasons would, on average, be c. Cost of increasing size of packages manufacturers. Most private label redesigned again in year 3 for ‘‘market and/or labels. Several comments products are manufactured by firms that driven’’ reasons. (FDA would assume objected to FDA’s assumption that the produce hundreds of SKU’s on the same that the labels that had to be redesigned proposed rule would require few equipment, as most packaging machines in year 2 would not, on average, be changes to the size or configuration of can accommodate a spectrum of changes redesigned again until year 5.) NDMA’s OTC drug packages or labels. NDMA with only minor modification or methodology, therefore, would calculate reported that its survey indicated that retooling. As firms will choose the most the economic cost at about $3,000 per 33 percent of branded and 95 percent of cost-effective means of implementing

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TABLE 4.ÐFINDINGS FOR 6.0-POINT FONT, CONDENSED TYPE ALLOWED1

Percent of Labeling outcome SKU's

Revised label can fit using existing area allotted for regulatory information 75.9 Revised label fits if area allotted for regulatory information is increased 16.0 Revised label fits if expanded on existing container 1.7 Revised label will not fit 4.5 Indeterminate 1.9 Total 100 1 Horizontal width of the characters reduced by approximately 20 percent while the vertical height of the characters is unchanged.

To evaluate the estimate of 4. Total Incremental Costs regardless of the monograph status of reconfiguration costs (i.e., changes to The costs of labeling redesign apply the product, all 98,639 SKU’s are the size of the labeling or packaging) only to products covered by final OTC potentially subject to label presented in the comments, ERG drug monographs or applications. reconfiguration costs; 39,310 within 2 considered several options for Currently there are about 39,310 SKU’s years of the effective date of this final packaging changes, including adding a in this category (see Table 3 of this rule, the remaining 59,330 within 6 carton (if not already present), adding a document). No redesign costs are years of the effective date of this final fifth panel, increasing the size of the assigned to the remaining 59,330 SKU’s rule. The estimated reconfiguration packaging, or switching to a because the 6-year implementation costs amount to $38.1 million in one- nonstandard form of labeling such as period for these products will allow time costs and $11.5 million in annual peel-back or accordion labels (Ref. 28). manufacturers to incorporate the design recurring costs. The latter reflects the Where applicable, the costs for changing changes in their usual redesign cycle. incremental increases in labeling or packaging materials to accommodate the a container size included container Using a weighted average cost to format requirements. inventory loss, adjustment of the redesign a label of $3,600 per SKU and Table 5 of this document presents packaging line, and stability testing. The assuming labels are redesigned FDA’s estimate of the one-time and estimated packaging change costs varied voluntarily every 2, 3, or 6 years, the total incremental costs for redesigning annual recurring costs and the total with the option chosen (for example, labeling using the methodology annualized cost by compliance activity. adjustment or retooling of existing discussed earlier is $19.4 million. The total one-time costs of $57.5 million machinery versus the purchase of new Reconfiguration costs apply to those include $19.4 million for label redesign equipment), although the lower cost products that cannot accommodate the and $38.1 million for packaging options had a higher probability of small package format allowed in changes. The annual costs are $11.5 selection. ERG also considered the § 201.66(d)(10). These costs include the million. The total annualized cost to recurring annual costs that would be one-time cost to increase labeling size industry (using a 7 percent discount associated with the need for larger (the label or package, where applicable) rate) is estimated at $18.4 million. The labels or packages. A detailed to accommodate a minimum 6.0 cost to individual firms will vary with description of ERG’s assumptions, condensed font, plus the recurring cost the number of SKU’s, the type of calculations, and unit costs is presented of producing larger labeling. Because changes needed, and the timing of the in the full report. these costs are applied to this rule changes.

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TABLE 5.ÐTOTAL INDUSTRY COMPLIANCE COSTS

One-Time Annual Total Activity ($Million) ($Million) Annualized

Label redesign 19.4 NA 1.4 Packaging 38.1 11.5 17.0 Total 57.5 11.5 18.4

These estimates may overstate the drugs. Over 92 percent of the roughly ANDA’s will need to submit revised costs attributable to this rule. First, 700 establishments and over 87 percent labeling to the agency in accordance reconfiguration costs will be reduced to of the 650 firms in this sector have with § 314.70. This is a standard the extent that companies opt to fewer than 500 employees. The Small procedure that companies routinely eliminate some smaller packaging sizes Business Administration (SBA) follow for labeling changes. The final within a product line. In these considers firms with fewer than 750 rule will not require new reporting and instances, however, consumers will bear employees in this industry to be small, recordkeeping activities. Therefore, no some of the added costs. Second, the but the U.S. Census size categories do additional professional skills are recent amendment to section 502(e) of not correspond to the SBA designation. necessary. the act under FDAMA requires that OTC An alternative data source, IMS, The economic impact of this rule on drug manufacturers list the inactive identified roughly 400 firms as small firms is particularly difficult to ingredients in their labeling. The ERG manufacturers of OTC drug products. measure, because published financial retail outlet survey (Ref. 28) found that Using the SBA size designation of 750 data do not distinguish between firms about 7 percent of the SKU’s currently employees, about 70 percent of the 400 manufacturing mostly OTC drugs and do not include inactive ingredients on affected manufacturing firms would be firms manufacturing mostly prescription their labels. Some of these products may considered small. drugs. ERG adopted Census data on firm need larger label or package sizes This regulation will affect the size and revenue for SIC 2834, irrespective of this rule. information content and format Pharmaceutical Preparations, and associated with OTC drug product assumed 400 manufacturers of OTC D. Small Business Impact labeling. Firms that manufacture or drug products to derive the figures in Manufacturers and those entities that relabel OTC drug products will need to Table 6 of this document. These data engage in the relabeling of OTC drug change the information panel for each indicate that if 90 percent of the OTC products will be required to redesign affected product and may need to drug product firms meet the SBA size the labeling of their products to comply increase the size of the packaging or criteria for small businesses, the with this rule. Census data provide labeling for a few SKU’s. These costs annualized industry cost attributed to aggregate industry statistics on the will be mitigated, however, by the small businesses would amount to $12.3 number of manufacturers for several year implementation period, million out of the total $18.4 million. If Standardized Industrial Classification which will permit many of these revenues of small OTC drug product Code 2834, Pharmaceutical changes to be coordinated with those manufacturers are similar to those of all Preparations, by establishment size, but labeling changes conducted in the small manufacturers in SIC 2834, these do not distinguish between normal course of business. OTC drug costs represent only 0.17 percent of manufacturers of prescription and OTC products subject to new drug and small business OTC drug revenues.

TABLE 6.ÐSMALL BUSINESS IMPACT

OTC Manufacturing Total OTC Small Business Total

Firms 400 357 Establishments 478 374 Employees 86,849 18,942 Average employees per firm 217 53 Percentage of total small business employment NA 100% Receipts ($000) $42,363,000 $7,411,000 Receipts per firm ($000) $106,000 $21,000 Total SKU's affected 98,639 65,792 As percentage of all SKU's 100% 66.7% Total annualized compliance costs ($ millions) $18.4 $12.3 Total annualized compliance costs as percentage of annual revenues 0.0004 0.0017

These calculations, however, assume $6,000 to $12,000 within the permitted entities, including: (1) A 2- to 6- year that small businesses can finance the implementation period. In view of the implementation period to allow the sale one-time outlays over time. In fact, some figures developed for Table 6 of this of existing product inventories and to small firms may have difficulty raising document, which imply that the annual permit coordination of required labeling the funds. FDA finds that, on average, revenue per SKU averages about changes with routine industry-initiated the incremental one-time cost per SKU $100,000 for small businesses, such one- labeling changes, (2) a modified format is about $600 ($57.5 million ÷ 98,639 time outlays should be manageable for for small packages, (3) an additional SKU’s). If a small firm manufactures 10 most small firms. phase-in year for OTC drug products The agency has taken a number of or 20 SKU’s, it might need to raise from covered by a final monograph or an steps to minimize the impact on small

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TABLE 7.ÐEFFECT OF IMPLEMENTATION PERIOD ON REDESIGN COSTS

Redesign Cost With 1 Ad- Implementation Period for Final Monographs Cost ($ Millions) ditional Year for Low Vol- ume Products ($ Millions)

1 year 59.1 46.9 2 years 27.0 19.4 3 years 11.9 8.9

FDA also considered alternative recurring label, carton, and container requirement would be $25 million. The requirements for minimum font sizes costs, under varied font size and print final rule allows condensed print, and print types. Table 8 of this requirements. The annualized cost for a which reduces this cost to $17 million. document presents, for several minimum 6.0 font but not condensed The agency considered but rejected alternatives, ERG’s estimates of the type (i.e., the horizontal width of the labeling with smaller than 6-point type percent of SKU’s with current labels too characters reduced approximately 10 to size because of the readability issues small to fit, the one-time costs for 20 percent while the vertical height of associated with such labeling. labeling reconfiguration, and the the characters is unchanged)

TABLE 8.ÐEFFECT OF PRINT REQUIREMENTS ON LABELING RECONFIGURATION COSTS

Percent of SKU's That Recurring Incremental Minimum Font Size, Print Cannot Fit or Are One-Time Packaging Label, Carton and Con- Total Annualized Packag- Type Required Indeterminate Reconfiguration ($ Millions) tainer Materials ($ Millions) ing Cost ($ Millions)

6.0, not condensed 9.5 45.9 18.3 25.0 6.0, condensed allowed 6.4 38.1 11.5 17.0 4.5, not condensed 3.4 21.0 5.1 8.2 4.5, condensed allowed 2.3 14.0 3.4 5.4

This final rule has been determined to Mechanisms and Complex Decision Making,’’ 12. Comment No. CP1, Docket No. 96P– be a major rule for purposes of 5 U.S.C. Journal of Personality and Social Psychology, 0318, Dockets Management Branch. 801 et. seq., subtitle E of the Small 56(3): 407–415, 1989. 13. Letter from R. G. Chesemore, FDA, to Business Regulatory Enforcement 5. Chandler, P., and J. Sweller, ‘‘Cognitive B. Nakutin, dated April 22, 1997, coded Fairness Act of 1996 (Pub. L. 104–121). Load Theory and the Format of Instruction,’’ PDN1, Docket No. 96P–0318, Dockets FDA is submitting the information and Cognition and Instruction, 8(4):293–332, Management Branch. reports as required by the statute. 1991. 14. Food and Drug Administration 6. Food and Drug Administration, ‘‘Consumer Comprehension and Preference IX. References ‘‘National Uniformity for Nonprescription for Variation in the Proposed Over-the- The following references are on Drugs—Ingredient Listing for OTC Drugs,’’ Counter Drug Labeling Format,’’ in OTC vol. April 1998, Docket No. 98D–0149, Dockets 28FR, Docket No. 96N–0420, Dockets display in the Dockets Management Management Branch. Management Branch. Branch (address above) and may be seen 7. Comment No. 718, Docket No. 96P– 15. Levy, A. S., S. B. Fein, and R. E. by interested persons between 9 a.m. 0318, Dockets Management Branch. Schucker, ‘‘More Effective Nutrition Label and 4 p.m., Monday through Friday. 8. Comment No. 684, Docket No. 96P– Formats Are Not Necessarily More 1. Miller, G. A., ‘‘The Magical Number 0318, Dockets Management Branch. Preferred,’’ Journal of the American Dietetic Seven, Plus or Minus Two: Some limits on 9. Webster’s Ninth New Collegiate Association, 92(10):1230–1234, 1992. Our Capacity for Processing Information,’’ Dictionary, p. 371, 1990. 16. Einarson, T. R., ‘‘Drug-Related Hospital Psychological Review, 101(2):343–352, 1994. 2. Shiffrin, R. M., and R. M. Nosofsky, 10. Nonprescription Drug Manufacturers Admissions,’’ The Annals of ‘‘Seven Plus or Minus Two: A Commentary Association, ‘‘Label Readability Guidelines,’’ Pharmacotherapy, 27:832–840, 1993. On Capacity Limitations,’’ Psychological May 1996, in OTC vol. 28FR, Docket No. 17. Ives, T. J., E. J. Bentz, and R. E. Review, 101(2):357–361, 1994. 96N–0420, Dockets Management Branch. Gwyther, ‘‘Drug-Related Admissions to a 3. Allen, P. A., and L. C. Crozier, ‘‘Age and 11. Watanabe, R. K., ‘‘The Ability of the Family Medicine Inpatient Service,’’ Ideal Chunk Size,’’ Journal of Gerontology: Geriatric Population to Read Labels on Over- Archives of Internal Medicine, 147:1117– Psychological Sciences, 47(1):47–51, 1992. the-Counter Medication Containers,’’ Journal 1120, 1987. 4. Wood, R., and A. Bandura, ‘‘Impact of of the American Optometric Association, 18. Caranasos, G. J., R. Stewart, and L. E. Conceptions of Ability on Self-Regulatory 65:32–37, 1994. Cluff, ‘‘Drug-induced Illness Leading to

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Hospitalization,’’ Journal of the American PART 201ÐLABELING provided in the applicable monograph Medical Association, 228:713–7171, 1974. or regulation. 19. Mitchell, A. A. et al., ‘‘Adverse Drug 1. The authority citation for 21 CFR (b) Definitions. The following Reactions in Children Leading to Hospital part 201 continues to read as follows: definitions apply to this section: Admission,’’ Pediatrics, 82:24–29, 1988. Authority: 21 U.S.C. 321, 331, 351, 352, 20. Classen, D. C. et al., ‘‘Adverse Drug (1) Act means the Federal Food, Drug, 353, 355, 358, 360, 360b, 360gg–360ss, 371, Events in Hospitalized Patients,’’ Journal of and Cosmetic Act (secs. 201 et seq. (21 374, 379e; 42 U.S.C. 216, 241, 262, 264. the American Medical Association, U.S.C. 321 et seq.)). 277(4):301–306, 1997. 2. Section 201.63 is amended by (2) Active ingredient means any 21. Agency for Health Care Policy and revising the section heading, the first component that is intended to furnish Research, ‘‘National Medical Expenditure sentence in paragraph (a), and pharmacological activity or other direct Survey: Annual Expenses and Sources of paragraph (e) to read as follows: effect in the diagnosis, cure, mitigation, Payment for Health Care Services Research treatment, or prevention of disease, or to Findings 14,’’ p. 7, 1995. § 201.63 Pregnancy/breast-feeding affect the structure or any function of 22. McKenney, J. M., and W. L. Harrison, warning. ‘‘Drug-related Hospital Admissions,’’ the body of humans. The term includes American Journal of Hospital Pharmacists, (a) The labeling for all over-the- those components that may undergo 33:792–795, 1976. counter (OTC) drug products that are chemical change in the manufacture of 23. U.S. Department of Commerce, intended for systemic absorption, unless the drug product and be present in the ‘‘Statistical Abstract of the United States specifically exempted, shall contain a drug product in a modified form 1998,’’ The National Data Book, Table 683, general warning under the heading intended to furnish the specified 118:426, 1998. ‘‘Warning’’ (or ‘‘Warnings’’ if it appears activity or effect. 24. U.S. Department of Commerce, ‘‘1992 with additional warning statements) as (3) Approved drug application means Census of Retail Trade; Establishment and Firm Size,’’ Table 3, pp. 56, 57, and 68, 1992. follows: ‘‘If pregnant or breast-feeding, a new drug (NDA) or abbreviated new 25. Comment No. 716, Supplement No. 2 ask a health professional before use.’’ drug (ANDA) application approved (attachment 1, appendix G), Docket No. 96N– [first four words of this statement in under section 505 of the act (21 U.S.C. 0420, Dockets Management Branch. bold type] * * * 355). 26. Research Triangle Institute, * * * * * (4) Bullet means a geometric symbol ‘‘Compliance Cost of Food Labeling (e) The labeling of orally or rectally that precedes each statement in a list of Regulations: Final Report (January, 1991),’’ administered OTC aspirin and aspirin- statements. For purposes of this section, FDA contract number 223–87–2097, Docket containing drug products must bear a the bullet style is limited to solid Nos. 90N–0134 and 90N–0135, Dockets squares or solid circles, in the format set Management Branch. warning that immediately follows the 27. Comment No. C717, Docket No. 96N– general warning identified in paragraph forth in paragraph (d)(4) of this section. 0420, Dockets Management Branch. (a) of this section. The warning shall be (5) Established name of a drug or 28. Eastern Research Group, Inc., ‘‘Cost as follows: ingredient thereof means the applicable Impacts of the Over-the-Counter ‘‘It is especially important not to use’’ official name designated under section Pharmaceutical Labeling Rule,’’ in OTC vol. (select ‘‘aspirin’’ or ‘‘carbaspirin 508 of the act (21 U.S.C. 358), or, if there 28FR, Docket No. 96N–0420, Dockets calcium,’’ as appropriate) ‘‘during the is no designated official name and the Management Branch. last 3 months of pregnancy unless drug or ingredient is recognized in an 29. Office of Management and Budget, definitely directed to do so by a doctor official compendium, the official title of ‘‘Economic Analysis of Federal Regulations the drug or ingredient in such Under Executive Order 12866,’’ 1996. because it may cause problems in the unborn child or complications during compendium, or, if there is no List of Subjects delivery.’’ designated official name and the drug or 3. Section 201.64 is amended by ingredient is not recognized in an 21 CFR Part 201 revising the last sentence in paragraph official compendium, the common or Drugs, Labeling, Reporting and (b) to read as follows: usual name of the drug or ingredient. recordkeeping requirements. (6) FDA means the Food and Drug § 201.64 Sodium labeling. Administration. 21 CFR Part 330 * * * * * (7) Heading means the required Over-the-counter drugs. (b) * * * The sodium content per statements in quotation marks listed in dosage unit shall follow the heading paragraphs (c)(2) through (c)(9) of this 21 CFR Parts 331, 341, 346, 355, and ‘‘Other information’’ as stated in section, excluding subheadings (as 358 § 201.66(c)(7). defined in paragraph (a)(9) of this section). Labeling, Over-the-counter drugs. * * * * * 4. Section 201.66 is added to subpart (8) Inactive ingredient means any 21 CFR Part 369 C to read as follows: component other than an active ingredient. Labeling, Medical devices, Over-the- § 201.66 Format and content requirements (9) Subheading means the required counter drugs. for over-the-counter (OTC) drug product statements in quotation marks listed in 21 CFR Part 701 labeling. paragraphs (c)(5)(ii) through (c)(5)(vii) of (a) Scope. This section sets forth the this section. Cosmetics, Labeling, Reporting and content and format requirements for the (10) Drug facts labeling means the recordkeeping requirements. labeling of all OTC drug products. title, headings, subheadings, and Therefore, under the Federal Food, Where an OTC drug product is the information required under or otherwise Drug, and Cosmetic Act, the Public subject of an applicable monograph or described in paragraph (c) of this Health Service Act, and under authority regulation that contains content and section. delegated to the Commissioner of Food format requirements that conflict with (11) Title means the heading listed at and Drugs, 21 CFR parts 201, 330, 331, this section, the content and format the top of the required OTC drug 341, 346, 355, 358, 369, and 701 are requirements in this section must be product labeling, as set forth in amended as follows: followed unless otherwise specifically paragraph (c)(1) of this section.

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(12) Total surface area available to (c)(5)(ii)(G) of this section with the drug-drug and drug-food interaction bear labeling means all surfaces of the appropriate subheadings highlighted in warnings. outside container of the retail package bold type: (vi) ‘‘When using this product’’ [in or, if there is no such outside container, (A) Allergic reaction warnings set bold type], followed by the side effects all surfaces of the immediate container forth in any applicable OTC drug that the consumer may experience, and or container wrapper except for the monograph or approved drug the substances (e.g., alcohol) or flanges at the tops and bottoms of cans application for any product that requires activities (e.g., operating machinery, and the shoulders and necks of bottles a separate allergy warning. This warning driving a car, warnings set forth in and jars. shall follow the subheading ‘‘Allergy § 369.21 of this chapter for drugs in (c) Content requirements. The outside alert:’’ dispensers pressurized by gaseous container or wrapper of the retail (B) Reye’s syndrome warning for drug propellants) to avoid while using the package, or the immediate container products containing salicylates set forth product. label if there is no outside container or in § 201.314(h)(1). This warning shall (vii) ‘‘Stop use and ask a doctor if’’ [in wrapper, shall contain the title, follow the subheading ‘‘Reye’s bold type], followed by any signs of headings, subheadings, and information syndrome:’’ toxicity or other reactions that would set forth in paragraphs (c)(1) through (C) Flammability warning, with necessitate immediately discontinuing (c)(8) of this section, and may contain appropriate flammability signal word use of the product. the information under the heading in (e.g., §§ 358.150(c) and 358.550(c) of (viii) Any required warnings in an paragraph (c)(9) of this section, in the this chapter). This warning shall follow applicable OTC drug monograph, other order listed. a subheading containing the appropriate OTC drug regulations, or approved drug (1) (Title) ‘‘Drug Facts’’. If the drug flammability signal word described in application that do not fit within one of facts labeling appears on more than one an applicable OTC drug monograph or the categories listed in paragraphs panel, the title ‘‘Drug Facts (continued)’’ approved drug application. (c)(5)(i) through (c)(5)(vii), (c)(5)(ix), and shall appear at the top of each (D) Water soluble gums warning set (c)(5)(x) of this section. subsequent panel containing such forth in § 201.319. This warning shall (ix) The pregnancy/breast-feeding information. follow the subheading ‘‘Choking:’’ warning set forth in § 201.63(a); the (2) ‘‘Active ingredient’’ or ‘‘Active (E) Alcohol warning set forth in third trimester warning set forth in ingredients’’ ‘‘(in each [insert the dosage § 201.322. This warning shall follow the § 201.63(e) for products containing unit stated in the directions for use (e.g., subheading ‘‘Alcohol warning:’’ aspirin or carbaspirin calcium; the third tablet, 5 mL teaspoonful) or in each (F) Sore throat warning set forth in trimester warning set forth in approved gram as stated in §§ 333.110 and § 201.315. This warning shall follow the drug applications for products 333.120 of this chapter])’’, followed by subheading ‘‘Sore throat warning:’’ containing ketoprofen, naproxen the established name of each active (G) Warning for drug products sodium, and ibuprofen (not intended ingredient and the quantity of each containing sodium phosphates set forth exclusively for use in children). active ingredient per dosage unit. in § 201.307(b)(2)(i) or (b)(2)(ii). This (x) The ‘‘Keep out of reach of Unless otherwise provided in an warning shall follow the subheading children’’ warning and the accidental applicable OTC drug monograph or ‘‘Dosage warning:’’ overdose/ingestion warning set forth in approved drug application, products (iii) ‘‘Do not use’’ [in bold type], § 330.1(g) of this chapter. marketed without discrete dosage units followed by all contraindications for use (6) ‘‘Directions’’, followed by the (e.g., topicals) shall state the proportion with the product. These directions for use described in an (rather than the quantity) of each active contraindications are absolute and are applicable OTC drug monograph or ingredient. intended for situations in which approved drug application. (3) ‘‘Purpose’’ or ‘‘Purposes’’, consumers should not use the product (7) ‘‘Other information’’, followed by followed by the general pharmacological unless a prior diagnosis has been additional information that is not category(ies) or the principal intended established by a doctor or for situations included under paragraphs (c)(2) action(s) of the drug or, where the drug in which certain consumers should not through (c)(6), (c)(8), and (c)(9) of this consists of more than one ingredient, use the product under any section, but which is required by or is the general pharmacological categories circumstances regardless of whether a made optional under an applicable OTC or the principal intended actions of each doctor or health professional is drug monograph, other OTC drug active ingredient. When an OTC drug consulted. regulation, or is included in the labeling monograph contains a statement of (iv) ‘‘Ask a doctor before use if you of an approved drug application. identity, the pharmacological action have’’ [in bold type] or, for products (i) Required information about certain described in the statement of identity labeled only for use in children under ingredients in OTC drug products (e.g., shall also be stated as the purpose of the 12 years of age, ‘‘Ask a doctor before use sodium in § 201.64(c)) shall appear as active ingredient. if the child has’’ [in bold type], followed follows: ‘‘each (insert appropriate (4) ‘‘Use’’ or ‘‘Uses’’, followed by the by all warnings for persons with certain dosage unit) contains:’’ [in bold type] indication(s) for the specific drug preexisting conditions (excluding (insert name(s) of ingredient(s) and the product. pregnancy) and all warnings for persons quantity of each ingredient). This (5) ‘‘Warning’’ or ‘‘Warnings’’, experiencing certain symptoms. The information shall be the first statement followed by one or more of the warnings under this heading are those under this heading. following, if applicable: intended only for situations in which (ii) The phenylalanine/aspartame (i) ‘‘For external use only’’ [in bold consumers should not use the product content required by § 201.21(b), if type] for topical drug products not until a doctor is consulted. applicable, shall appear as the next item intended for ingestion, or ‘‘For’’ (select (v) ‘‘Ask a doctor or pharmacist before of information. one of the following, as appropriate: use if you are’’ [in bold type] or, for (iii) Additional information that is ‘‘rectal’’ or ‘‘vaginal’’) ‘‘use only’’ [in products labeled only for use in authorized to appear under this heading bold type]. children under 12 years of age, ‘‘Ask a shall appear as the next item(s) of (ii) All applicable warnings listed in doctor or pharmacist before use if the information. There is no required order paragraphs (c)(5)(ii)(A) through child is’’ [in bold type], followed by all for this subsequent information.

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(8) ‘‘Inactive ingredients’’, followed subheadings and all other information or the immediate container label if there by a listing of the established name of described in paragraphs (c)(2) through is no outside container or wrapper. The each inactive ingredient. If the product (c)(9) of this section shall be no smaller continuation of the required content and is an OTC drug product that is not also than 6-point type. format onto multiple panels must retain a cosmetic product, then the inactive (3) The title, headings, subheadings, the required order and flow of headings, ingredients shall be listed in and information in paragraphs (c)(1) subheadings, and information. A visual alphabetical order. If the product is an through (c)(9) of this section shall be graphic (e.g., an arrow) shall be used to OTC drug product that is also a legible and clearly presented, shall not signal the continuation of the Drug Facts cosmetic product, then the inactive appear in reverse type, shall have at labeling to the next adjacent panel. ingredients shall be listed as set forth in least 0.5-point leading (i.e., space (6) The heading and information § 701.3(a) or (f) of this chapter, the between two lines of text), and shall not required under paragraph (c)(2) of this names of cosmetic ingredients shall be have letters that touch. The type style section shall appear immediately determined in accordance with for the title, headings, subheadings, and adjacent and to the left of the heading § 701.3(c) of this chapter, and the all other required information described and information required under provisions in § 701.3(e), (g), (h), (l), (m), in paragraphs (c)(2) through (c)(9) of this paragraph (c)(3) of this section. The (n), and (o) of this chapter and § 720.8 section shall be any single, clear, easy- active ingredients and purposes shall be of this chapter may also apply, as to-read type style, with no more than 39 aligned under the appropriate headings appropriate. If there is a difference in characters per inch. The title and such that the heading and information the labeling provisions in this § 201.66 headings shall be in bold italic, and the required under paragraph (c)(2) of this and §§ 701.3 and 720.8 of this chapter, subheadings shall be in bold type, section shall be left justified and the the labeling provisions in this § 201.66 except that the word ‘‘(continued)’’ in heading and information required under shall be used. the title ‘‘Drug Facts (continued)’’ shall paragraph (c)(3) of this section shall be (9) ‘‘Questions?’’ or ‘‘Questions or be regular type. The type shall be all right justified. If the OTC drug product comments?’’, followed by the telephone black or one dark color, printed on a contains more than one active number of a source to answer questions white or other light, neutral color, ingredient, the active ingredients shall about the product. It is recommended contrasting background, except that the be listed in alphabetical order. If more that the days of the week and times of title and the headings may be presented than one active ingredient has the same the day when a person is available to in a single, alternative, contrasting dark purpose, the purpose need not be respond to questions also be included. color unless otherwise provided in an repeated for each active ingredient, A graphic of a telephone or telephone approved drug application, OTC drug provided the information is presented in receiver may appear before the heading. monograph (e.g., current requirements a manner that readily associates each The telephone number must appear in for bold print in §§ 341.76 and 341.80 of active ingredient with its purpose (i.e., a minimum 6-point bold type. this chapter), or other OTC drug through the use of brackets, dot leaders, (d) Format requirements. The title, regulation (e.g., the requirement for a or other graphical features). The headings, subheadings, and information box and red letters in § 201.308(c)(1)). information described in paragraphs set forth in paragraphs (c)(1) through (4) When there is more than one (c)(4) and (c)(6) through (c)(9) of this (c)(9) of this section shall be presented statement, each individual statement section may start on the same line as the on OTC drug products in accordance listed under the headings and required headings. None of the with the following specifications. In the subheadings in paragraphs (c)(4) information described in paragraph interest of uniformity of presentation, through (c)(7) of this section shall be (c)(5) of this section shall appear on the FDA strongly reccommends that the preceded by a solid square or solid same line as the ‘‘Warning’’ or Drug Facts labeling be presented using circle bullet of 5-point type size. Bullets ‘‘Warnings’’ heading. the graphic specifications set forth in shall be presented in the same shape (7) Graphical images (e.g., the UPC appendix A to part 201. and color throughout the labeling. The symbol) and information not described (1) The title ‘‘Drug Facts’’ or ‘‘Drug first bulleted statement on each in paragraphs (c)(1) through (c)(9) of this Facts (continued)’’ shall use uppercase horizontal line of text shall be either left section shall not appear in or in any letters for the first letter of the words justified or separated from an way interrupt the required title, ‘‘Drug’’ and ‘‘Facts.’’ All headings and appropriate heading or subheading by at headings, subheadings, and information subheadings in paragraphs (c)(2) least two square ‘‘ems’’ (i.e., two squares in paragraphs (c)(1) through (c)(9) of this through (c)(9) of this section shall use of the size of the letter ‘‘M’’). If more section. Hyphens shall not be used an uppercase letter for the first letter in than one bulleted statement is placed on except to punctuate compound words. the first word and lowercase letters for the same horizontal line, the end of one (8) The information described in all other words. The title, headings, and bulleted statement shall be separated paragraphs (c)(1) through (c)(9) of this subheadings in paragraphs (c)(1), (c)(2), from the beginning of the next bulleted section shall be set off in a box or and (c)(4) through (c)(9) of this section statement by at least two square ‘‘ems’’ similar enclosure by the use of a barline. shall be left justified. and the complete additional bulleted A distinctive horizontal barline (2) The letter height or type size for statement(s) shall not continue to the extending to each end of the ‘‘Drug the title ‘‘Drug Facts’’ shall appear in a next line of text. Additional bulleted Facts’’ box or similar enclosure shall type size larger than the largest type size statements appearing on each provide separation between each of the used in the Drug Facts labeling. The subsequent horizontal line of text under headings listed in paragraphs (c)(2) letter height or type size for the title a heading or subheading shall be through (c)(9) of this section. When a ‘‘Drug Facts (continued)’’ shall be no vertically aligned with the bulleted heading listed in paragraphs (c)(2) smaller than 8-point type. The letter statements appearing on the previous through (c)(9) of this section appears on height or type size for the headings in line. a subsequent panel immediately after paragraphs (c)(2) through (c)(9) of this (5) The title, headings, subheadings, the ‘‘Drug Facts (continued)’’ title, a section shall be the larger of either 8- and information set forth in paragraphs horizontal hairline shall follow the title point or greater type, or 2-point sizes (c)(1) through (c)(9) of this section may and immediately precede the heading. A greater than the point size of the text. appear on more than one panel on the horizontal hairline extending within The letter height or type size for the outside container of the retail package, two spaces on either side of the ‘‘Drug

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Facts’’ box or similar enclosure shall display panel, requires more than 60 point or greater type, or 1-point size immediately follow the title and shall percent of the total surface area greater than the point size of the text. immediately precede each of the available to bear labeling, then the Drug (iii) Paragraph (d)(3) of this section subheadings set forth in paragraph (c)(5) Facts labeling shall be printed in shall apply except that less than 0.5- of this section, except the subheadings accordance with the specifications set point leading may be used, provided the in paragraphs (c)(5)(ii)(A) through forth in paragraphs (d)(10)(i) through ascenders and descenders do not touch. (c)(5)(ii)(G) of this section. (d)(10)(v) of this section. In determining (iv) Paragraph (d)(4) of this section (9) The information set forth in whether more than 60 percent of the shall apply except that if more than one paragraph (c)(6) of this section under total surface area available to bear bulleted statement is placed on the same the heading ‘‘Directions’’ shall appear in labeling is required, the indications for horizontal line, the additional bulleted a table format when dosage directions use listed under the ‘‘Use(s)’’ heading, statements may continue to the next line are provided for three or more age as set forth in paragraph (c)(4) of this of text, and except that the bullets under groups or populations. The last line of section, shall be limited to the each heading or subheading need not be the table may be the horizontal barline minimum required uses reflected in the vertically aligned. immediately preceding the heading of applicable monograph, as provided in (v) Paragraph (d)(8) of this section the next section of the labeling. § 330.1(c)(2) of this chapter. (10) If the title, headings, shall apply except that the box or subheadings, and information in (i) Paragraphs (d)(1), (d)(5), (d)(6), and similar enclosure required in paragraph paragraphs (c)(1) through (c)(9) of this (d)(7) of this section shall apply. (d)(8) of this section may be omitted if section, printed in accordance with the (ii) Paragraph (d)(2) of this section the Drug Facts labeling is set off from specifications in paragraphs (d)(1) shall apply except that the letter height the rest of the labeling by use of color through (d)(9) of this section, and any or type size for the title ‘‘Drug Facts contrast. other FDA required information for drug (continued)’’ shall be no smaller than 7- (11)(i) The following labeling outlines products, and, as appropriate, cosmetic point type and the headings in the various provisions in paragraphs (c) products, other than information paragraphs (c)(2) through (c)(9) of this and (d) of this section: required to appear on a principle section shall be the larger of either 7- BILLING CODE 4160±01±F

BILLING CODE 4160±01±C

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(ii) The following sample label illustrates the provisions in paragraphs (c) and (d) of this section:

(iii) The following sample label illustrates the provisions in paragraphs (c) and (d) of this section, including paragraph (d)(10) of this section, which permits modifications for small packages:

BILLING CODE 4160±01±C

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(iv) The following sample label illustrates the provisions in paragraphs (c) and (d) of this section for a drug product marketed with cosmetic claims:

BILLING CODE 4160±01±C (1) Document why a particular (g) Regulatory action. An OTC drug (e) Exemptions and deferrals. FDA on requirement is inapplicable, product that is not in compliance with its own initiative or in response to a impracticable, or is contrary to public the format and content requirements in written request from any manufacturer, health or safety; and this section is subject to regulatory packer, or distributor, may exempt or (2) Include a representation of the action. 5. Section 201.314 is amended by defer, based on the circumstances proposed labeling, including any revising the first two sentences in presented, one or more specific outserts, panel extensions, or other paragraph (a) and by revising requirements set forth in this section on graphical or packaging techniques paragraphs (g)(1) and (h)(1) to read as the basis that the requirement is intended to be used with the product. follows: inapplicable, impracticable, or contrary (f) Interchangeable terms and to public health or safety. Requests for connecting terms. The terms listed in § 201.314 Labeling of drug preparations exemptions shall be submitted in three § 330.1(i) of this chapter may be used containing salicylates. copies in the form of an ‘‘Application interchangeably in the labeling of OTC (a) The label of any oral drug for Exemption’’ to the Food and Drug drug products, provided such use does preparation intended for sale without Administration, 5630 Fishers Lane, rm. not alter the meaning of the labeling that prescription and which contains any 1061, Rockville, MD 20852. The request has been established and identified in salicylate ingredient (including aspirin, shall be clearly identified on the an applicable OTC drug monograph or salicylamide, other salicylates, and envelope as a ‘‘Request for Exemption by regulation. The terms listed in combinations) must conspicuously bear, from 21 CFR 201.66 (OTC Labeling § 330.1(j) of this chapter may be deleted on a clearly contrasting background, the Format)’’ and shall be directed to Docket from the labeling of OTC drug products warning statement: ‘‘Keep out of reach No. 98N–0337. A separate request shall when the labeling is revised to comply of children [highlighted in bold type]. In be submitted for each OTC drug with this section, provided such case of overdose, get medical help or product. Sponsors of a product deletion does not alter the meaning of contact a Poison Control Center right marketed under an approved drug the labeling that has been established away,’’ or ‘‘Keep out of reach of children application shall also submit a single and identified in an applicable OTC [highlighted in bold type],’’ except that copy of the exemption request to their drug monograph or by regulation. The if the article is an aspirin preparation, application. Decisions on exemptions terms listed in § 330.1(i) and (j) of this it shall bear the first of these warning and deferrals will be maintained in a chapter shall not be used to change in statements. * ** permanent file in this docket for public any way the specific title, headings, and * * * * * review. Exemption and deferral requests subheadings required under paragraphs (g)(1) The label of any drug containing shall: (c)(1) through (c)(9) of this section. more than 5 percent methyl salicylate

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(wintergreen oil) should bear a or esophagus and may cause choking. Do not enclosure), providing separation between conspicuous warning such as: ‘‘Do not take this product if you have difficulty in each of the headings. use otherwise than as directed.’’ These swallowing. If you experience chest pain, 2. A 0.5-point horizontal hairline extends drug products must also include the vomiting, or difficulty in swallowing or within 2 spaces on either side of the ‘‘Drug ‘‘Keep out of reach of children’’ warning breathing after taking this product, seek Facts’’ box (or similar enclosure), immediate medical attention;’’ and immediately following the title and and the accidental ingestion warning as ‘‘‘Directions’ [highlighted in bold type]:’’ immediately preceding the subheadings. required in § 330.1(g) of this chapter. (Select one of the following, as appropriate: 3. A 0.5-point horizontal hairline follows * * * * * ‘‘Take’’ or ‘‘Mix’’) ‘‘this product (child or the title, immediately preceding the heading, (h)(1) The labeling of orally or rectally adult dose) with at least 8 ounces (a full when a heading appears on a subsequent administered over-the-counter aspirin glass) of water or other fluid. Taking this panel immediately after the ‘‘Drug Facts and aspirin-containing drug products product without enough liquid may cause (continued)’’ title. choking. See choking warning.’’ subject to this paragraph is required to D. Box or Enclosure * * * * * prominently bear a warning. The 1. All information is enclosed by a 2.5- warning shall be as follows: ‘‘Children 7. Appendix A is added to part 201 point barline. and teenagers should not use this to read as follows: medicine for chicken pox or flu II. Section 201.66 Modified Labeling Format symptoms before a doctor is consulted Appendix A to Part 201—Examples of A. Overall about Reye syndrome, a rare but serious Graphic Enhancements Used by FDA 1. The ‘‘Drug Facts’’ labeling is presented illness reported to be associated with I. Section 201.66 Standard Labeling Format in all black type printed on a white color aspirin.’’ contrasting background. A. Overall * * * * * B. Typeface and size 6. Section 201.319 is amended by 1. The ‘‘Drug Facts’’ labeling is set off in revising paragraph (b) to read as follows: a box or similar enclosure by the use of a 1. ‘‘Drug Facts’’ is set in 9 point Helvetica barline with all black type printed on a Bold Italic, left justified. white, color contrasting background. 2. The headings (e.g., ‘‘Directions’’) are set § 201.319 Water-soluble gums, hydrophilic in 8 point Helvetica Bold Italic, left justified. gums, and hydrophilic mucilloids B. Typeface and size 3. The subheadings (e.g., ‘‘Ask a doctor or (including, but not limited to agar, alginic pharmacist before use if you are’’) are set in acid, calcium polycarbophil, 1. ‘‘Drug Facts’’ is set in 14 point Helvetica Bold Italic, left justified. 6 point Helvetica Bold, left justified. carboxymethylcellulose sodium, 4. The information is set in 6 point carrageenan, chondrus, glucomannan ((B- 2. ‘‘Drug Facts (continued)’’ is set in 8 point Helvetica Bold Italic for the words Helvetica Regular with 6.5 point leading, left 1,4, linked) polymannose acetate), guar justified. gum, karaya gum, kelp, methylcellulose, ‘‘Drug Facts’’ and 8 point Helvetica Regular for the word ‘‘(continued)’’ and is left 5. The heading ‘‘Purpose’’ is right justified. plantago seed (psyllium), polycarbophil, 6. The bullet is a 5 point solid square. tragacanth, and xanthan gum) as active justified. 3. The headings (e.g., ‘‘Directions’’) are set 7. Bulleted information may start on same ingredients; required warnings and line as headings (except for the ‘‘Warnings’’ directions. in 8 point Helvetica Bold Italic, left justified. 4. The subheadings (e.g., ‘‘Ask a doctor or heading) and subheadings, with 2 em spacing * * * * * pharmacist before use if you are’’) are set in separating bullets, and need not be vertically (b) Any drug products for human use 6 point Helvetica Bold, left justified. aligned. containing a water-soluble gum, 5. The information is set in 6 point C. Barlines and hairlines hydrophilic gum, or hydrophilic Helvetica Regular with 6.5 point leading, left mucilloid as an active ingredient in an justified. 1. A 2.5-point horizontal barline extends to oral dosage form when marketed in a 6. The heading ‘‘Purpose’’ is right justified. each end of the ‘‘Drug Facts’’ box (or similar 7. The bullet is a 5 point solid square. enclosure), providing separation between dry or incompletely hydrated form as each of the headings. described in paragraph (a) of this 8. Two em spacing separates bullets when more than one bullet is on the same line. 2. A 0.5-point horizontal hairline extends section are misbranded within the within 2 spaces on either side of the ‘‘Drug meaning of section 502 of the Federal 9. A table format is used for 3 or more dosage directions. Facts’’ box (or similar enclosure), Food, Drug, and Cosmetic Act unless 10. A graphic appears at the bottom of the immediately following the title and their labeling bears the following first panel leading the reader to the next immediately preceding the subheadings. warnings (under the subheading panel. D. Box or Enclosure ‘‘Choking’’) and directions: 1. All information is set off by color ‘‘‘Choking’ [highlighted in bold type]: C. Barlines and hairlines contrast. No barline is used. Taking this product without adequate fluid 1. A 2.5-point horizontal barline extends to may cause it to swell and block your throat each end of the ‘‘Drug Facts’’ box (or similar BILLING CODE 4160±01±F

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III. Examples of § 201.66 Standard Labeling and Modified Labeling Formats A. Section 201.66 Standard Labeling Format

B. Section 201.66 Modified Labeling Format

BILLING CODE 4160±01±C

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PART 330ÐOVER±THE±COUNTER administration, ‘‘In case of overdose, get (28) ‘‘Exceed’’ or ‘‘use more than’’ or (OTC) HUMAN DRUGS WHICH ARE medical help or contact a Poison ‘‘go beyond’’. GENERALLY RECOGNIZED AS SAFE Control Center right away’’; for drugs (29) ‘‘Exceed recommended dosage’’ AND EFFECTIVE AND NOT used topically, rectally, or vaginally and or ‘‘use more than directed’’. MISBRANDED not intended for oral ingestion, ‘‘If (30) ‘‘Excessive’’ or ‘‘too much’’. swallowed, get medical help or contact (31) ‘‘Excitability may occur’’ or ‘‘you 8. The authority citation for 21 CFR a Poison Control Center right away’’; may get excited’’. part 330 continues to read as follows: and for drugs used topically and (32) ‘‘Experience’’ or ‘‘feel’’. Authority: 21 U.S.C. 321, 351, 352, 353, intended for oral use, ‘‘If more than (33) ‘‘For relief of’’ or ‘‘relieves’’. 355, 360, 371. used for’’ (insert intended use, e.g., (34) ‘‘For temporary reduction of’’ or ‘‘temporarily reduces’’. 9. Section 330.1 is amended by pain) ‘‘is accidentally swallowed, get (35) ‘‘For the temporary relief of’’ or revising paragraphs (c)(1), (c)(2), (i), and medical help or contact a Poison ‘‘temporarily relieves’’. (j), and by removing the first three Control Center right away.’’ * ** (36) ‘‘For the treatment of’’ or ‘‘treats’’. sentences in paragraph (g) and adding * * * * * (37) ‘‘Frequently’’ or ‘‘often’’. two sentences in their place to read as (i) The following terms may be used (38) ‘‘Give to’’ or ‘‘use in’’. follows: interchangeably in the labeling of OTC (39) ‘‘Immediately’’ or ‘‘right away’’ or drug products, provided such use does ‘‘directly’’. § 330.1 General conditions for general not alter the meaning of the labeling that (40) ‘‘Immediately’’ or ‘‘as soon as’’. recognition as safe, effective, and not has been established and identified in (41) ‘‘Immediately following’’ or misbranded. an applicable monograph or by ‘‘right after’’. * * * * * regulation. The following terms shall (42) ‘‘Improve(s)’’ or ‘‘get(s) better’’ or (c)(1) The product is labeled in not be used to change in any way the ‘‘make(s) better’’. compliance with chapter V of the title, headings, and subheadings (43) ‘‘Increased’’ or ‘‘more’’. Federal Food, Drug, and Cosmetic Act required under § 201.66(c)(1) through (44) ‘‘Increase your risk of’’ or (the act) and subchapter C et seq. of this (c)(9) of this chapter: ‘‘cause’’. chapter, including the format and (1) ‘‘Abdominal’’ or ‘‘stomach’’ (in (45) ‘‘Indication(s)’’ or ‘‘Use(s)’’. content requirements in § 201.66 of this context only). (46) ‘‘Inhalation’’ or ‘‘puff’’. chapter. An OTC drug product that is (2) ‘‘Administer’’ or ‘‘give’’. (47) ‘‘In persons who’’ or ‘‘if you’’ or not in compliance with chapter V and (3) ‘‘Aggravate(s)’’ or ‘‘make(s) ‘‘if the child’’. subchapter C, including § 201.66 of this worse’’. (48) ‘‘Instill’’ or ‘‘put’’. chapter, is subject to regulatory action. (4) ‘‘Application of this product’’ or (49) ‘‘Is (are) accompanied by’’ or For purposes of § 201.61(b) of this ‘‘applying’’. ‘‘you also have’’ (in context only) or chapter, the statement of identity of the (5) ‘‘Are uncertain’’ or ‘‘do not know’’. ‘‘(optional: that) occur(s) with’’. product shall be the term or phrase used (6) ‘‘Ask’’ or ‘‘consult’’ or ‘‘contact’’. (50) ‘‘Longer’’ or ‘‘more’’. in the applicable OTC drug monograph (7) ‘‘Asking’’ or ‘‘consulting’’. (51) ‘‘Lung’’ or ‘‘pulmonary’’. established in this part. (8) ‘‘Assistance’’ or ‘‘help’’ or ‘‘aid’’. (52) ‘‘Medication(s)’’ or ‘‘medicine(s)’’ (2) The ‘‘Uses’’ section of the label (9) ‘‘Associated with’’ or ‘‘due to’’ or or ‘‘drug(s)’’. and labeling of the product shall contain ‘‘caused by’’. (53) ‘‘Nervousness, dizziness, or the labeling describing the (10) ‘‘Avoid contact with eyes’’ or ‘‘do sleeplessness occurs’’ or ‘‘you get ‘‘Indications’’ that have been established not get into eyes’’. nervous, dizzy, or sleepless’’. in an applicable OTC drug monograph (11) ‘‘Avoid inhaling’’ or ‘‘do not (54) ‘‘Not to exceed’’ or ‘‘do not or alternative truthful and inhale’’. exceed’’ or ‘‘not more than’’. nonmisleading statements describing (12) ‘‘Before a doctor is consulted’’ or (55) ‘‘Obtain(s)’’ or ‘‘get(s)’’. only those indications for use that have ‘‘without first consulting your doctor’’ (56) ‘‘Passages’’ or ‘‘passageways’’ or been established in an applicable or ‘‘consult your doctor before’’. ‘‘tubes’’. monograph, subject to the provisions of (13) ‘‘Beverages’’ or ‘‘drinks’’. (57) ‘‘Perforation of’’ or ‘‘hole in’’. (14) ‘‘Clean’’ or ‘‘cleanse’’. section 502 of the act relating to (58) ‘‘Persistent’’ or ‘‘that does not go (15) ‘‘Consulting’’ or ‘‘advising’’. misbranding and the prohibition in away’’ or ‘‘that continues’’ or ‘‘that (16) ‘‘Continue(s)’’ or ‘‘persist(s)’’ or section 301(d) of the act against the lasts’’. ‘‘is persistent’’ or ‘‘do(es) not go away’’ introduction or delivery for introduction (59) ‘‘Per day’’ or ‘‘daily’’. or ‘‘last(s)’’. (60) ‘‘Presently’’ or ‘‘now’’. into interstate commerce of unapproved (17) ‘‘Daily’’ or ‘‘every day’’. new drugs in violation of section 505(a) (61) ‘‘Produce(s)’’ or ‘‘cause(s)’’. (18) ‘‘Develop(s)’’ or ‘‘begin(s)’’ or (62) ‘‘Prompt(ly)’’ or ‘‘quick(ly)’’ or of the act. Any other labeling under this ‘‘occur(s)’’. ‘‘right away’’. subchapter and subchapter C et seq. of (19) ‘‘Difficulty’’ or ‘‘trouble’’. (63) ‘‘Reduce’’ or ‘‘minimize’’. this chapter shall be stated in the exact (20) ‘‘Difficulty in urination’’ or (64) ‘‘Referred to as’’ or ‘‘of’’. language where exact language has been ‘‘trouble urinating’’. (65) ‘‘Sensation’’ or ‘‘feeling’’. established and identified by quotation (21) ‘‘Discard’’ or ‘‘throw away’’. (66) ‘‘Solution’’ or ‘‘liquid’’. marks in an applicable OTC drug (22) ‘‘Discontinue’’ or ‘‘stop’’ or (67) ‘‘Specifically’’ or ‘‘definitely’’. monograph or by regulation (e.g., ‘‘quit’’. (68) ‘‘Take’’ or ‘‘use’’ or ‘‘give’’. § 201.63 of this chapter), except as (23) ‘‘Doctor’’ or ‘‘physician’’. (69) ‘‘Tend(s) to recur’’ or ‘‘reoccur(s)’’ provided in paragraphs (i) and (j) of this (24) ‘‘Drowsiness’’ or ‘‘the drowsiness or ‘‘return(s)’’ or ‘‘come(s) back’’. section. effect’’. (70) ‘‘To avoid contamination’’ or * * * * * (25) ‘‘Drowsiness may occur’’ or ‘‘you ‘‘avoid contamination’’ or ‘‘do not (g) The labeling for all drugs contains may get drowsy’’. contaminate’’. the general warning: ‘‘Keep out of reach (26) ‘‘Enlargement of the’’ or ‘‘an (71) ‘‘To help’’ or ‘‘helps’’. of children.’’ [highlighted in bold type]. enlarged’’. (72) ‘‘Unless directed by a doctor’’ or The labeling of drugs shall also state as (27) ‘‘Especially in children’’ or ‘‘except under the advice of a doctor’’ or follows: For drugs used by oral especially children’’. ‘‘unless told to do so by a doctor’’.

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(73) ‘‘Use caution’’ or ‘‘be careful’’. [bullet]1 presently taking a prescription prescription monoamine oxidase (74) ‘‘Usually’’ or ‘‘generally’’ (in drug. Antacids may interact with certain inhibitor (MAOI) (certain drugs for context only). prescription drugs.’’ depression, psychiatric, or emotional (75) ‘‘You’’ (‘‘Your’’) or ‘‘the child’’ * * * * * conditions, or Parkinson’s disease), or (‘‘the child’s’’). for 2 weeks after stopping the MAOI (76) ‘‘You also have’’ or ‘‘occurs PART 341ÐCOLD, COUGH, ALLERGY, drug. If you do not know if your with’’. BRONCHODILATOR, AND prescription drug contains an MAOI, (77) ‘‘When practical’’ or ‘‘if ANTIASTHMATIC DRUG PRODUCTS ask a doctor or pharmacist before taking possible’’. FOR OVER±THE±COUNTER HUMAN this product.’’ (78) ‘‘Whether’’ or ‘‘if’’. USE * * * * * (79) ‘‘Worsen(s)’’ or ‘‘get(s) worse’’ or 12. The authority citation for 21 CFR 15. Section 341.80 is amended by ‘‘make(s) worse’’. part 341 continues to read as follows: revising paragraphs (c)(1)(i)(D) and (j) The following connecting terms (c)(1)(ii)(D) to read as follows: may be deleted from the labeling of OTC Authority: 21 U.S.C. 321, 351, 352, 353, drug products, provided such deletion 355, 360, 371. § 341.80 Labeling of nasal decongestant does not alter the meaning of the 13. Section 341.74 is amended by drug products. labeling that has been established and revising paragraphs (c)(4)(v) and * * * * * identified in an applicable monograph (c)(4)(vi) to read as follows: (c) * * * or by regulation. The following terms (1) * * * shall not be used to change in any way § 341.74 Labeling of antitussive drug (i) * * * the specific title, headings, and products. (D) Drug interaction precaution. ‘‘Do subheadings required under * * * * * not use if you are now taking a § 201.66(c)(1) through (c)(9) of this (c) * * * prescription monoamine oxidase chapter: (4) * * * inhibitor (MAOI) (certain drugs for (l) ‘‘And’’. (v) For products containing depression, psychiatric, or emotional (2) ‘‘As may occur with’’. dextromethorphan or conditions, or Parkinson’s disease), or (3) ‘‘Associated’’ or ‘‘to be dextromethorphan hydrobromide as for 2 weeks after stopping the MAOI associated’’. identified in § 341.14(a)(3) and (a)(4) drug. If you do not know if your (4) ‘‘Consult a doctor’’. when labeled for adults or for adults prescription drug contains an MAOI, (5) ‘‘Discontinue use’’. and children under 12 years of age. ask a doctor or pharmacist before taking (6) ‘‘Drug Interaction Precaution’’. Drug interaction precaution. ‘‘Do not this product.’’ (7) ‘‘Due to’’. use if you are now taking a prescription (ii) * * * (8) ‘‘Except under the advice and monoamine oxidase inhibitor (MAOI) (D) Drug interaction precaution. ‘‘Do supervision of a physician’’. (certain drugs for depression, not give to a child who is taking a (9) ‘‘If this occurs’’. psychiatric, or emotional conditions, or prescription monoamine oxidase (10) ‘‘In case of’’. Parkinson’s disease), or for 2 weeks after inhibitor (MAOI) (certain drugs for (11) ‘‘Notice’’. stopping the MAOI drug. If you do not depression, psychiatric, or emotional (12) ‘‘Or’’. know if your prescription drug contains conditions, or Parkinson’s disease), or (13) ‘‘Occurring with’’. an MAOI, ask a doctor or pharmacist for 2 weeks after stopping the MAOI (14) ‘‘Or as directed by a doctor’’. before taking this product.’’ drug. If you do not know if your child’s (15) ‘‘Such as’’. (vi) For products containing prescription drug contains an MAOI, (16) ‘‘Such as occurs with’’. dextromethorphan or ask a doctor or pharmacist before giving (17) ‘‘Tends to’’. dextromethorphan hydrobromide as this product.’’ (18) ‘‘This product’’. identified in § 341.14(a)(3) and (a)(4) * * * * * (19) ‘‘Unless directed by a doctor’’. when labeled only for children under 12 PART 346ÐANORECTAL DRUG (20) ‘‘While taking this product’’ or years of age. Drug interaction PRODUCTS FOR OVER±THE± ‘‘before taking this product’’. precaution. ‘‘Do not give to a child who COUNTER HUMAN USE (21) ‘‘Within’’. is taking a prescription monoamine oxidase inhibitor MAOI) (certain drugs 16. The authority citation for 21 CFR * * * * * for depression, psychiatric, or emotional part 346 continues to read as follows: PART 331ÐANTACID PRODUCTS FOR conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI Authority: 21 U.S.C. 321, 351, 352, 353, OVER±THE±COUNTER (OTC) HUMAN 355, 360, 371. USE drug. If you do not know if your child’s prescription drug contains an MAOI, 17. Section 346.50 is amended by 10. The authority citation for 21 CFR ask a doctor or pharmacist before giving revising paragraph (c)(7)(ii) to read as part 331 continues to read as follows: this product.’’ follows: Authority: 21 U.S.C. 321, 351, 352, 353, * * * * * 355, 360, 371. 14. Section 341.76 is amended by § 346.50 Labeling of anorectal drug revising paragraph (c)(4) to read as products. 11. Section 331.30 is amended by follows: * * * * * revising paragraph (d) to read as (c) * * * follows: § 341.76 Labeling of bronchodilator drug (7) * * * products. (ii) ‘‘Ask a doctor or pharmacist before 1 § 331.30 Labeling of antacid products. * * * * * use if you are [bullet] presently taking * * * * * (c) * * * a prescription drug for high blood (d) Drug interaction precaution. The (4) Drug interaction precaution. ‘‘Do pressure or depression.’’ labeling of the product contains the not use if you are now taking a * * * * * following statement ‘‘Ask a doctor or pharmacist before use if you are 1 See § 201.66(b)(4) of this chapter. 1 See § 201.66(b)(4) of this chapter.

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PART 355ÐANTICARIES DRUG 23. Section 369.9 is revised to read as in conditions affecting children under PRODUCTS FOR OVER±THE± follows: 12 years of age, consult a physician COUNTER HUMAN USE immediately. § 369.9 General warnings re accidental c. The entry ‘‘SALICYLATES: 18. The authority citation for 21 CFR ingestion by children. METHYL SALICYLATE part 355 continues to read as follows: Section 369.20 includes under certain (WINTERGREEN OIL).’’ is revised to Authority: 21 U.S.C. 321, 351, 352, 353, items, but not all medicines, the read as follows: 355, 360, 371. statement: ‘‘Keep this and all medicines SALICYLATES: METHYL SALICYLATE 19. Section 355.50 is amended by out of children’s reach. In case of (WINTERGREEN OIL). (See also revising paragraphs (c)(1) and (c)(2) to overdose, get medical help or contact a §§ 201.303 and 201.314 of this chapter.) read as follows: Poison Control Center right away,’’ or ‘‘Do not use otherwise than as ‘‘Keep out of reach of children.’’ directed. Keep out of reach of children § 355.50 Labeling of anticaries drug However, in view of the possibility of to avoid accidental poisoning. If products. accidental ingestion of drugs, it is not swallowed, get medical help or contact a Poison Control Center right away.’’ * * * * * only suggested but is recommended that If the preparation is a counter-irritant (c) * * * one of these statements be used on the (1) For all fluoride dentifrice (gel, or rubefacient the statement: label of all drug products. Caution—Discontinue use if excessive paste, and powder) products. ‘‘Keep out irritation of the skin develops. Avoid of reach of children under 6 years of § 369.20 Drugs; recommended warning getting into the eyes or on mucous age. [highlighted in bold type] If more and caution statements. [Amended] membranes. than used for brushing is accidentally 24. Section 369.20 is amended as If offered for use in arthritis or swallowed, get medical help or contact follows: rheumatism, in juxtaposition therewith, a Poison Control Center right away.’’ a. The entry ‘‘NUX VOMICA AND the statement: These warnings shall be used in place STRYCHNINE PREPARATIONS.’’ is Caution—If pain persists for more of the general warning statements revised to read as follows: than 10 days, or redness is present, or required by § 330.1(g) of this chapter. NUX VOMICA AND STRYCHNINE in conditions affecting children under (2) For all fluoride rinse and PREPARATIONS. 12 years of age consult a physician preventive treatment gel products. ‘‘Do not use more than the immediately. ‘‘Keep out of reach of children. recommended dosage. Keep out of reach d. The entry ‘‘ZINC STEARATE [highlighted in bold type] If more than of children. In case of overdose, get DUSTING POWDERS.’’ is revised to used for’’ (select appropriate word: medical help or contact a Poison read as follows: ‘‘brushing’’ or ‘‘rinsing’’) ‘‘is Control Center right away.’’ ZINC STEARATE DUSTING POWDERS. accidentally swallowed, get medical b. The entry beginning ‘‘Keep out of reach of children; avoid help or contact a Poison Control Center ‘‘SALICYLATES, INCLUDING inhaling. If swallowed, get medical help right away.’’ These warnings shall be ASPIRIN’’ is revised to read as follows: or contact a Poison Control Center right used in place of the general warning SALICYLATES, INCLUDING ASPIRIN away.’’ statements required by § 330.1(g) of this AND SALICYLAMIDE (EXCEPT chapter. § 369.21 Drugs; warning and caution METHYL SALICYLATE, * * * * * statements required by regulations. EFFERVESCENT SALICYLATE [Amended] PART 358ÐMISCELLANEOUS PREPARATIONS, AND 25. Section 369.21 is amended as EXTERNAL DRUG PRODUCTS FOR PREPARATIONS OF follows: OVER±THE±COUNTER HUMAN USE AMINOSALICYLIC ACID AND ITS SALTS). (See also § 201.314 of this a. The entry ‘‘‘COUGH–DUE–TO– 20. The authority citation for 21 CFR chapter.) COLD’ PREPARATIONS part 358 continues to read as follows: ‘‘Keep out of reach of children. In case (CARBETAPENTANE CITRATE).’’ is of overdose, get medical help or contact revised to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, ‘‘COUGH–DUE–TO–COLD’’ 355, 360, 371. a Poison Control Center right away;’’ or ‘‘Keep out of reach of children.’’ PREPARATIONS (CARBETAPENTANE 21. Section 358.650 is amended in If the article is an aspirin preparation, CITRATE). (See § 310.201(a)(20) of this paragraph (d)(1) by revising the it should bear the first of the above two chapter.) information in the brackets to read as ‘‘Keep out of reach of children. In case warning statements. In either case, the follows: of overdose, get medical help or contact above information should appear on the a Poison Control Center right away.’’ § 358.650 Labeling of pediculicide drug label. b. The entry ‘‘SODIUM GENTISATE.’’ products. Caution—For children under 3 years is revised to read as follows: of age, consult your physician; or * * * * * SODIUM GENTISATE. (See §§ 201.314 (d) * * * Caution—For younger children, and 310.301(a)(2) of this chapter.) (1) * * * [statement in boldface type]. consult your physician. Warning—Do not give to children One of the two immediately preceding * * * * * under 6 years of age or use for caution statements is required on the prolonged period unless directed by PART 369ÐINTERPRETATIVE label of all aspirin tablets, but such a physician. STATEMENTS RE WARNINGS ON statement is not required on the labels ‘‘Keep out of reach of children. In case DRUGS AND DEVICES FOR OVER± of other salicylates clearly offered for of overdose, get medical help or contact THE±COUNTER SALE administration to adults only. a Poison Control Center right away.’’ If offered for use in arthritis or If offered for use in arthritis or 22. The authority citation for 21 CFR rheumatism, in juxtaposition therewith, rheumatism, in juxtaposition therewith, part 369 continues to read as follows: the statement: the statement: Authority: 21 U.S.C. 321, 331, 351, 352, Caution—If pain persists for more Caution—If pain persists for more 353, 355, 371. than 10 days, or redness is present, or than 10 days, or redness is present, or

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Appendix A to Preamble—Examples of Prototype OTC Drug Product Labeling

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[FR Doc. 99–6296 Filed 3–11–99; 11:59 am] BILLING CODE 4160±01±C

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DEPARTMENT OF AGRICULTURE comments, please include the name of designee for use in meeting the the program and the fiscal year requirements of section 103(c)(2) of the Cooperative State Research, solicitation of applications to which you Agricultural Research, Extension, and Education, and Extension Service are responding. Education Reform Act of 1998 (Pub. L. FOR FURTHER INFORMATION CONTACT: 105–185). This section requires the Food and Agricultural Sciences Howard E. Sandberg, Ph.D., Higher Secretary to solicit and consider input National Needs Graduate Fellowship Education Programs; Cooperative State on a current request for proposals from Grants Program for Fiscal Year 1999: Research, Education, and Extension persons who conduct or use agricultural Request for Proposals and Request for Service; U.S. Department of Agriculture; research, education, or extension for use Input STOP 2251; 1400 Independence in formulating the next year’s request AGENCY: Cooperative State Research, Avenue, S.W.; Washington, D.C. 20250– for proposals. Education, and Extension Service. 2251; telephone: (202) 720–2193; e-mail: In your comments, please include the name of the program and the fiscal year ACTION: Notice of request for proposals [email protected]. request for proposals to which you are and Request for Input. SUPPLEMENTARY INFORMATION: responding. Comments are requested SUMMARY: The Cooperative State Table of Contents within six months from the issuance of Research, Education, and Extension Stakeholder Input the request for proposals. Comments received after that date will be Service (CSREES) announces the Part I. Food and Agricultural Sciences availability of grant funds and requests National Needs Graduate Fellowship Grants considered to the extent practicable. proposals for the Food and Agricultural Section A—General Information Part I. Food and Agricultural Sciences Sciences National Needs Graduate 1. Administrative Provisions National Needs Graduate Fellowship Fellowship Grants Program for Fiscal 2. Legislative Authority Grants Years (FY’s) 1999 and 2000, and for FY 3. Catalog of Federal Domestic Assistance 1999 Supplemental Grants for Special 4. Eligibility Section A—General Information International Study or Thesis/ Section B—Program Description 1. Administrative Provisions Dissertation Research Travel 1. Purpose of the Program This Program is subject to the Allowances. Proposals are hereby 2. Targeted National Need Areas 3. Degree Level Supported provisions found at 7 CFR Part 3402 for requested from eligible institutions as 4. Proposal Submission Limitations the Food and Agricultural Sciences identified herein for competitive 5. Limitations on Number of Fellowships National Needs Graduate Fellowship consideration of National Needs 6. Availability Funding Grants Program. These provisions set Graduate Fellowship Grant awards. 7. Stipend Level forth procedures to be followed when Additionally, CSREES seeks proposals Section C—How to Obtain Application submitting grant proposals, rules from recipients of currently active Food Materials governing the evaluation of proposals and Agricultural Sciences National Section D—Submission of a Proposal and the awarding of grants, and Needs Fellowship Grants for 1. What to Submit 2. Where and When to Submit regulations relating to the post-award supplemental grants to support special 3. Acknowledgment of Proposals administration of grant projects. international study or thesis/ 4. Intent to Submit a Proposal dissertation research experiences for Section E—Selection Process and Evaluation 2. Legislative Authority current Fellows. By this notice CSREES Criteria The authority for this program is additionally solicits stakeholder input Part II. 1999 Special International Study or contained in Section 1417(b)(6) of the from any interested party regarding the Thesis/Dissertation Research Travel National Agricultural Research, FY 1999 request for proposals for this Allowances Extension, and Teaching Policy Act of program. Section A—General Information 1977, as amended (NARETPA) (7 U.S.C. DATES: Proposals for Food and 1. Administrative Provisions 3152(b)(6)). This program is subject to Agricultural Sciences National Needs 2. Legislative Authority the provisions found at 7 CFR Part 3402. Graduate Fellowship Grants must be 3. Catalog of Federal Domestic Assistance In accordance with the statutory received on or before June 7, 1999. 4. Announcement of Availability of authority, subject to the availability of Proposals received after the closing date Supplemental Grants 5. Eligibility funds, the Secretary of Agriculture, who will not be considered for funding. Section B—Program Description has delegated the authority to the Proposals for supplemental grants to 1. Purpose of the Program Administrator of CSREES, may make support special international study or 2. Available Funding competitive grants, for periods not to thesis/dissertation research experiences 3. Travel Allowances exceed five years, to land-grant colleges for current Fellows must be received by Section C—How to Obtain Application and universities, to colleges and February 16, 2000. Comments regarding Materials universities having significant minority this request for proposals are requested Section D—Submission of a Proposal enrollments and a demonstrable within six months from the issuance of 1. What to Submit capacity to carry out the teaching of this notice. Comments received after 2. Where and When to Submit 3. Acknowledgment of Proposals food and agricultural sciences, and to that date will be considered to the Section E—Selection Process and Evaluation other colleges and universities having a extent practicable. Criteria demonstrable capacity to carry out the ADDRESSES: Written stakeholder teaching of food and agricultural comments should be submitted by first- Stakeholder Input sciences, to administer and conduct class mail to: Office of Extramural CSREES is soliciting comments graduate fellowship programs to help Programs; Competitive Research Grants regarding this request for proposals from meet the Nation’s needs for and Awards Management; USDA- any interested party. These comments development of scientific and CSREES; STOP 2299; 1400 will be considered in the development professional expertise in the food and Independence Avenue, S.W.; of the next request for proposals for this agricultural sciences. For this program, Washington, D.C. 20250–2299, or via e- program. Such comments will be the term ‘‘food and agricultural mail to: [email protected]. In your forwarded to the Secretary or his sciences’’ means basic, applied, and

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Proposal Submission Limitations doctoral fellow for three years at related to subject areas defined in A doctoral degree-granting institution $22,000 per year; and (2) provide for an section 1404(8) of NARETPA, 7 U.S.C. may only submit a maximum of six institution annual cost-of-education 3103(8). proposals, and no more than one allowance of $1,000, not to exceed a total of $3,000 over the duration of the 3. Catalog of Federal Domestic proposal may be submitted in any one grant. Total funds awarded to an Assistance national need area. institution under the program in FY This program is listed in the Catalog 5. Limitations on Number of 1999/2000 shall not exceed $648,000. of Federal Domestic Assistance under Fellowships No. 10.210, Food and Agricultural For the FY 1999/2000 program, a Section C—How to Obtain Application Sciences National Needs Graduate proposal may request funding in only Materials Fellowship Grants. one national need area. A proposal may An Application Kit containing request a minimum of two fellowships program application materials will be 4. Eligibility and a maximum of four fellowships in made available to eligible institutions Proposals may be submitted by the national need area for which upon request. These materials include institutions that confer a graduate funding is requested. While proposals the Administrative Provisions, degree in at least one area of the food must document institution willingness Solicitation, forms, instructions, and and agricultural sciences targeted for to recruit and train at least two, but not other relevant information needed to national needs fellowships. For more than four, fellows in a national prepare and submit grant proposals. proposals involving more than one need area, CSREES may fund fewer Copies of the application kit may be institution, all institutions must meet fellows than requested in a proposal. requested from the Proposal Services the eligibility requirement. Proposals 6. Available Funding Unit; Office of Extramural Programs; may also be submitted by a research Cooperative State Research, Education, foundation maintained by an eligible CSREES anticipates that and Extension Service; U.S. Department college or university. approximately $5,600,000 will be of Agriculture; STOP 2245; 1400 available for fellowship grants for the Independence Avenue, S.W.; Section B—Program Description FY 1999/2000 combined competition, Washington, D.C. 20250–2245. The 1. Purpose of the Program including $2.8 million from FY 1999 telephone number is 202–401–5048. appropriations and $2.8 million in This program seeks to award grants to When contacting the Proposal Services anticipated FY 2000 appropriations. Unit, please indicate that you are colleges and universities which have Contingent on the availability of these notable teaching and research requesting forms for the FY 1999 funds, approximately $933,000 will be National Needs Graduate Fellowship competencies in the food and allocated to each of the six national agricultural sciences. The grants are Grants Program. needs areas. This program is highly Application materials may also be specifically intended to support competitive, and it is anticipated that fellowship programs that encourage requested via Internet by sending a available funding will support message with your name, mailing outstanding students to pursue and approximately 81 doctoral fellows complete a Ph.D. degree at such address (not e-mail) and phone number through approximately seven grants in to [email protected] which states that institutions in an area of the food and each of the six targeted areas. No-year agricultural sciences for which there is you want to receive a copy of the funds drawn from expired fellowship application materials for the Fiscal Year a national need for the development of grants with unspent funds remaining scientific and professional expertise. 1999/2000 Food and Agricultural may be used to fund additional fellows. Sciences National Needs Graduate 2. Targeted National Need Areas Please note that Congress has not yet Fellowship Grants Program. The enacted a Fiscal Year 2000 Food and agricultural sciences areas materials will then be mailed to you appropriations bill for the Department. (not e-mailed) as quickly as possible. appropriate for fellowship grant Therefore, the $5.6 million cited for FY applications are those in which 1999/2000 grants is only tentative and Section D—Submission of a Proposal shortages of expertise have been USDA is not bound by this estimate. If 1. What to Submit determined and targeted by CSREES for Congress appropriates other than the national needs graduate fellowship anticipated amount, the combined An original and seven (7) copies of a support. Beginning with FY 1997, appropriated FYs 1999 and 2000 funds proposal must be submitted. Proposals CSREES supports six national need will be allocated equally among all six should contain all requested areas on a biennial basis and combines national need areas. information when submitted. Each appropriations from two fiscal years proposal should be typed on 81⁄2’’ x 11’’ into one competition to be held during 7. Stipend Level white paper, double-spaced, and on one odd-numbered years. The targeted Each institution funded will receive side of the page only. Please note that national need areas to be supported for $69,000 for each doctoral fellowship the text of the proposal should be the combined FY 1999/2000 awarded. However, it is anticipated that prepared using a font no smaller than 12 competition are: (1) Biotechnology— total program funds available will not be point and one-inch margins. All copies Animal; (2) Biotechnology—Plant; (3) evenly divisible by $69,000. Therefore, of the proposal must be submitted in Engineering—Food, Forest Products, or one fellowship may be supported on a one package. Each copy of the proposal Agricultural; (4) Human Nutrition and/ partial basis with a lesser amount of must be stapled securely in the upper or Food Science; (5) Marketing or funds, or one fellowship may be left-hand corner (DO NOT BIND). Management—Food, Forest Products, or supported fully by a combination of FY The proposal should be paginated and Agribusiness; and (6) Water Science. 1999/2000 funds and unspent funds a Table of Contents should be included

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Where and When to Submit provisions found at 7 CFR Part 3402. modified to include new criteria for These provisions set forth procedures to Hand-delivered proposals (brought in proposals demonstrating enhanced be followed when submitting grant person by the applicant or through a coordination among eligible institutions proposals, rules governing the courier service) must be received on or and focusing on innovative, evaluation of proposals, the awarding of before June 7, 1999, at the following multidisciplinary education programs, grants, and regulations relating to the address: National Needs Graduate material, or curricula. The following post-award administration of such Fellowship Grants Program; c/o criteria and weights will be used to grants. Proposal Services Unit; Office of evaluate proposals submitted for The Administrative Provisions (7 CFR Extramural Programs; Cooperative State funding to the FY 1999/2000 part 3402) for this program specify that, Research, Education, and Extension competition: based on the amount of funds Service; U.S. Department of Agriculture; (A) 30 points—The degree to which appropriated in any fiscal year, CSREES Room 303, Aerospace Center; 901 D the proposal establishes clearly that the will determine whether a new Street, S.W.; Washington, D.C. 20024. proposed program of graduate study competition for special international The telephone number is (202) 401– will result in the development of study or thesis/dissertation research 5048. Proposals transmitted via outstanding scientific/professional travel allowances will be held during facsimile (fax) machine will not be expertise related to the national need that fiscal year, and publish that accepted. determination as part of the annual Proposals submitted through the U.S. area and will do so in a reasonable program announcement. mail must be received on or before June period of time. 7, 1999. Proposals submitted through (B) 10 points—The degree to which 2. Legislative Authority the proposal contains any special the U.S. mail should be sent to the The authority for this program is features such as a focus on innovative, following address: National Needs contained in Section 1417(b)(6) of the multidisciplinary education programs, Graduate Fellowship Grants Program; c/ National Agricultural Research, material, or curricula; enhanced o Proposal Services Unit; Office of Extension, and Teaching Policy Act of coordination among institutions eligible Extramural Programs; Cooperative State 1977, as amended (NARETPA) (7 U.S.C. Research, Education, and Extension for grants under the Food and Service; U.S. Department of Agriculture; Agricultural National Needs Fellowship § 3152(b)(6)). STOP 2245; 1400 Independence Grant Program; an inter-disciplinary, 3. Catalog of Federal Domestic Avenue, S.W.; Washington, D.C. 20250– multi-disciplinary, or cross-disciplinary Assistance 2245. approach, an unusual collateral This program is listed in the Catalog specialization in a related discipline, of Federal Domestic Assistance under 3. Acknowledgment of Proposals experiential learning opportunities, No. 10.210. The receipt of all proposals will be unique mentoring programs, seminars, 4. Announcement of Availability of acknowledged in writing and via the or a multi-university collaborative Supplemental Grants Internet (e-mail). Therefore it is approach. important to include your e-mail (C) 20 points—The degree to which CSREES has determined that a new address on Form CSREES–712 when the proposal substantiates clearly that competition for special international applicable. This acknowledgment will the institution’s faculty, facilities and study or thesis/dissertation research contain a proposal identification equipment, instructional support travel allowances will be held during number. Once your proposal has been resources, and other academic attributes FY 1999, and hereby solicits proposals assigned a proposal number, please cite are excellent for providing outstanding for competitive supplemental grants. In that number in future correspondence. graduate study and research at the accordance with the Administrative Provisions for the Food and Agricultural 4. Intent to Submit a Proposal forefront of science and technology related to the chosen area of national Sciences National Needs Graduate Submission of an Intent to Submit a need. Fellowship Grants Program (7 CFR Proposal form (Form CSREES–706) is 3402.5(e)), CSREES will award (D) 20 points—The degree to which neither required nor requested for the supplemental grants, on a competitive the institution’s plans and procedures FY 1999/2000 competition. basis, for special international study or for recruiting and selecting thesis/dissertation research travel Section E—Selection Process and academically outstanding Fellows and allowances. Evaluation Criteria for advising and guiding Fellows Section 223(2) of the Agricultural through a program of study reflect 5. Eligibility Research, Extension, and Education excellence as documented in the Institutions eligible to receive Reform Act of 1998, Public Law 105– proposal. supplemental grants are those that have 185, amended section 1417 of (E) 10 points—The degree to which active National Needs Graduate NARETPA to require that certain supplementary summary data Fellowship Grants (awarded in FY 1998 priorities be given in awarding grants substantiate program quality in the or earlier). Eligibility for this for teaching enhancement projects targeted need area. opportunity is limited to any current under section 1417(b) of NARETPA. (F) 10 points—The quality of the Fellow with sufficient time to complete This program is authorized under proposal as reflected by its substantive the international experience before the section 1417(b). CSREES considers all content, organization, clarity, and termination date of the fellowship grant applications received in response to this accuracy. under which he/she is supported.

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Before the international study or thesis/ made available to eligible institutions dissertation research travel allowance, dissertation research travel may upon request. These materials include each application for a supplemental commence, a Fellow must have the Administrative Provisions, grant must contain a narrative which completed one academic year of full- Solicitation, forms, instructions, and provides the following: (1) the specific time study, as defined by the institution, other relevant information needed to destination(s) and duration of the travel; under the fellowship appointment and prepare and submit a proposal. Copies (2) the specific study or thesis/ arrangements must have been of the Application Kit may be requested dissertation research activities in which formalized for the Fellow to study and/ from the Proposal Services Unit; Office the Fellow will be engaged; (3) how the or conduct research in the foreign of Extramural Programs; Cooperative international experience will contribute location(s). All national need areas State Research, Education, and to the Fellow’s program of study; (4) a previously supported under the Food Extension Service; U.S. Department of budget narrative specifying and and Agricultural Sciences National Agriculture; STOP 2245; 1400 justifying the dollar amount requested Needs Graduate Fellowships Grants Independence Avenue, S.W.; for the travel; (5) summary credentials Program are eligible for the Washington, D.C. 20250–2245. The of both the U.S. and international supplementary grants for special telephone number is 202–401–5048. faculty or other professionals with international study or thesis/ When contacting the Proposal Services whom the Fellow will be working dissertation research travel allowances. Unit, please indicate that you are during the international experience Section B—Program Description requesting an Application Kit for the FY (summary credentials must not exceed 1999 Special International Study or three pages per person; ‘‘Summary 1. Purpose of the Program Thesis/Dissertation Research Vita—Teaching Proposal,’’ Form These supplementary grants provide Supplemental Grant. CSREES–708, may be used for this support for a fellow to conduct special Application Kits may also be purpose); (6) a letter from the dean of international study thesis/dissertation requested via Internet by sending a the Fellow’s college or equivalent research or to undertake studies at a site message with your name, mailing administrative unit supporting the outside of the United States primarily address (not e-mail) and telephone Fellow’s travel request and certifying for the pursuit of activities that are not number to [email protected] which that the travel experience will not generally available within the United states that you wish to receive a copy of jeopardize the Fellow’s satisfactory States. the Application Kit for the FY 1999 progress toward degree completion; and Special International Study or Thesis/ (7) a letter from the fellowship grant 2. Available Funding Dissertation Research Supplemental project director certifying the Fellow’s Estimated funds for supplemental Grant. The materials will then be mailed eligibility, the accuracy of the Fellow’s grants in FY 1999 are approximately to you (not e-mailed) as quickly as travel request, and the relevance of the $60,000. These funds are obtained from possible. travel to the Fellow’s advanced degree no-year funds drawn from expired objectives. Section D—Submission of a Proposal fellowship grants with unspent funds The narrative portion of the remaining. CSREES has determined that 1. What to Submit application must not exceed 10 pages, no FY 1999 appropriations will be An original plus six copies of each excluding the summary vita/vitae. targeted to supplemental grants application must be submitted. supporting special international study 2. Where and When to Submit Proposals should contain all requested or thesis/dissertation research travel Applications for the special information when submitted. Each allowances. international study or thesis/ proposal should be typed on 81⁄2′′ x 11′′ dissertation research travel allowance 3. Travel Allowance white paper, double-spaced, and on one supplemental grants may be submitted side of the page only. Please note that For each travel allowance, the at any time prior to February 16, 2000. the text of the proposal should be institution may request up to $5,000. However, to allow time for CSREES to prepared using a font no smaller than 12 Travel allowance monies may be used process the applications, proposals point and one-inch margins. Each copy only to pay travel and living expenses should be submitted at least three of the application should be stapled for the Fellow while the Fellow is on months prior to the proposed beginning securely in the upper left-hand corner the specific international assignment as date of the international research (DO NOT BIND). All copies of the proposed in the application for the project. Applicants are urged to submit application must be submitted in one special international study or thesis/ their proposals early. dissertation research travel allowance. package. Applications transmitted via a No limitation is placed on the number facsimile (FAX) machine will not be (Note: Proposals for these special of applications an institution may accepted. supplemental awards should not be A separate application must be submitted as part of the application for a FY submit. Awards will be made to the 1999/2000 Graduate Fellowship grant.) extent possible based on availability of submitted by a fellowship grant project funds. To the extent possible, all director at an eligible institution on Hand-delivered proposals (brought in applications associated with one behalf of each Fellow for which a person by the applicant or through a CSREES grant number should be special international study or thesis/ courier service) must be received on or submitted at the same time in order to dissertation research travel allowance is before February 16, 2000, at the facilitate the award of these requested. following address: Special International supplemental grants and minimize Each application must include an Study or Thesis/Dissertation Research accounting activity at the grantee ‘‘Application for Funding,’’ Form Supplemental Grant; c/o Proposal institution. CSREES–661, and a ‘‘Budget,’’ Form Services Unit; Office of Extramural CSREES–55. To provide the office of Programs; Cooperative State Research, Section C—How to Obtain Application Higher Education Programs (HEP) with Education, and Extension Service; U.S. Materials sufficient information upon which to Department of Agriculture; Room 303, An Application Kit containing evaluate the merits of the requests for a Aerospace Center; 901 D Street, S.W.; program application materials will be special international study or thesis/ Washington, D.C. 20024. The phone

VerDate 03-MAR-99 15:17 Mar 16, 1999 Jkt 183247 PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 E:\FR\FM\17MRN2.XXX pfrm01 PsN: 17MRN2 13310 Federal Register / Vol. 64, No. 51 / Wednesday, March 17, 1999 / Notices number is 202–401–5048. Proposals grants are exhausted. Upon receipt of an c. Advance preparations—the degree transmitted via a facsimile (fax) application, CSREES staff will first to which the proposed study or research machine will not be accepted. determine the eligibility of the Fellow activities are well-planned, including Proposals submitted through the U.S. for whom the application was submitted the likelihood that these activities will mail must be received on or before for an international travel experience. come to fruition and that the February 16, 2000. Proposals submitted Eligible and complete requests then will participation of identified personnel through the U.S. mail should be sent to be reviewed, using the criteria and will materialize—20 points. the following address: Special weights indicated below, by International Study or Thesis/ professional staff from USDA or other d. Budget—the degree to which the Dissertation Research Supplemental Federal agencies, as appropriate. budget for the international experience Grant; c/o Proposal Services Unit; Office Proposals judged to be worthy of is justified—10 points. of Extramural Programs; Cooperative funding will be eligible for e. Personnel—the degree to which the State Research, Education, and supplemental awards. Since awards for personnel, both U.S. and international, Extension Service; U.S. Department of supplemental grants will be made as involved with the travel experience Agriculture; STOP 2245; 1400 reviews are completed, there is no have the appropriate credentials and Independence Avenue, S.W.; assurance funds will be available late in experience to direct the Fellow’s Washington, D.C. 20250–2245. the application period for every international experience, and the acceptable proposal. 3. Acknowledgment of Proposals likelihood that their participation as The evaluation criteria for special mentors, trainers, advisors, or teachers The receipt of all proposals will be international study or thesis/ will contribute to the educational value acknowledged in writing and via the dissertation research travel allowance of the travel experiences—20 points. Internet (e-mail). Therefore it is applications are indicated below. The important to include your e-mail points are provided as a guide to the f. Supporting documentation—the address on Form CSREES–712 when relative importance of each criterion, degree to which letters from the dean of applicable. This acknowledgment will but all criteria must be addressed the college (or equivalent administrative contain a proposal identification satisfactorily. unit) and the fellowship grant project number. Once your proposal has been a. Destination and duration—the director support the application—10 assigned a proposal number, please cite degree to which the destination and points. that number in future correspondence. duration of the travel experience is Done at Washington, D.C., this 11th day of appropriate for enhancing the Fellow’s March 1999. Section E—Selection Process and academic program—10 points. Evaluation Criteria b. Travel experience activities—the Colien Hefferan, Applications for the special degree to which the specific Acting Administrator, Cooperative State international travel allowances will be international experiences contribute to Research, Education, and Extension Service. evaluated as they are received until the Fellow’s program of study—30 [FR Doc. 99–6487 Filed 3–16–99; 8:45 am] available funds for the supplemental points. BILLING CODE 3410±22±P

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Reader Aids Federal Register Vol. 64, No. 51 Wednesday, March 17, 1999

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING MARCH

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202±523±5227 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since the revision date of each title. Laws 523±5227 3 CFR 10 CFR 708...... 12862 Presidential Documents 100...... 12881 Proclamations: Proposed Rules: Executive orders and proclamations 523±5227 21...... 12117 The United States Government Manual 523±5227 7168...... 10101 7169...... 10379 50...... 12117 7170...... 10383 54...... 12117 Other Services 7171...... 10385 63...... 10405 Electronic and on-line services (voice) 523±4534 7172...... 11373 707...... 11819 Privacy Act Compilation 523±3187 7173...... 12879 11 CFR Public Laws Update Service (numbers, dates, etc.) 523±6641 Executive Orders: TTY for the deaf-and-hard-of-hearing 523±5229 12170 (See Notice of Proposed Rules: March 10, 1999)...... 12239 2...... 10405 12852 (Amended by 4...... 10405 ELECTRONIC RESEARCH EO 13114)...... 10099 5...... 10405 World Wide Web 12957 (See Notice of 12 CFR March 10, 1999)...... 12239 Full text of the daily Federal Register, CFR and other 12959 (See Notice of 3...... 10194 publications: March 10, 1999)...... 12239 208...... 10194 http://www.access.gpo.gov/nara 13059 (See Notice of 225...... 10201 325...... 10194 Federal Register information and research tools, including Public March 10, 1999)...... 12239 567...... 10194 Inspection List, indexes, and links to GPO Access: 13114...... 10099 Administrative Orders: 960...... 12079 http://www.nara.gov/fedreg Notice of March 10, Proposed Rules: E-mail 1999 ...... 12239 602...... 10954 PENS (Public Law Electronic Notification Service) is an E-mail Presidential Determinations: 14 CFR service that delivers information about recently enacted Public No. 99±15 of February 26, 1999 ...... 11319 25...... 10740 Laws. To subscribe, send E-mail to 39...... 9906, [email protected] 5 CFR 9908, 9910, 9911, 9912, 10205, 10208, 10209, 10211, with the text message: 532...... 9905, 9905 10213, 10216, 10555, 10557, subscribe publaws-l 2635...... 13063 10560, 10935, 11375, 11533, Use [email protected] only to subscribe or unsubscribe to 11757, 11759, 11761, 11764, PENS. We cannot respond to specific inquiries at that address. 7 CFR 12241, 12242, 12244, 12247, 3...... 11755 12249, 12252, 12743 Reference questions. Send questions and comments about the 360...... 12881 71 ...... 10387, 10562, 10563, Federal Register system to: 361...... 12881 10740, 10937, 10938, 10939, [email protected] 782...... 12884 10940, 12084, 12254, 12255 The Federal Register staff cannot interpret specific documents or 989...... 10919 73...... 12743 regulations. 1381...... 11755 97...... 9912, 9914 1434...... 10923 204...... 12084 1469...... 10929 257...... 12838 FEDERAL REGISTER PAGES AND DATES, MARCH Proposed Rules: 258...... 12854 399...... 12838 9905±10100...... 1 301...... 11392 10101±10204...... 2 915...... 13123 Proposed Rules: 39 ...... 9939, 10237, 10578, 10205±10386...... 3 916...... 11346 917...... 11346 10959, 11401, 12770, 12772 10387±10554...... 4 1065...... 13125 71 ...... 9940, 10238, 10239, 10555±10918...... 5 1301...... 12769 10241, 10242, 10243, 10410, 10919±11372...... 8 1823...... 10235 10411, 10962, 11533, 11819, 11373±11754...... 9 1956...... 10235 11820, 12126, 12404 11755±12078...... 10 12079±12238...... 11 8 CFR 15 CFR 12239±12742...... 12 274a...... 11533 774...... 10852, 12744 806...... 10387 12743±12880...... 15 9 CFR 12881±13062...... 16 16 CFR 13063±13310...... 17 52...... 13064 Proposed Rules: Proposed Rules: 1...... 10400 1213...... 10245 3...... 10400 1500...... 10245 113...... 10400 1513...... 10245 391...... 10402 1615...... 10963, 13126

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1616...... 10963, 13126 984...... 13056 63...... 11536, 12762 320...... 10181 1630...... 13132 3500...... 10080 80...... 10366 324...... 10181 1631...... 13132 Proposed Rules: 81 ...... 11775, 12002, 12005, 325...... 10181 1632...... 13137 990...... 12920 12257, 13146 328...... 10181 82...... 10374 333...... 10181 17 CFR 26 CFR 136...... 10391, 13053 336...... 10181 180 ...... 10227, 10233, 10567, 202...... 13065 1...... 10218, 11378 45 CFR 228...... 11103 602...... 10218 11782, 11789, 11792, 11799, 60...... 9921 229...... 11103 Proposed Rules: 13078, 13086, 13088, 13094, 230 ...... 11090, 11095, 11103 13097, 13103, 13106 302...... 11802 1...... 10262 303...... 11802, 11810 239...... 11103, 11118 20...... 10964 271...... 10111 240...... 10564, 13065 300...... 11801 304...... 11802 242...... 13065 27 CFR 302...... 13113 Proposed Rules: 249...... 13065 355...... 13113 92...... 10412 13...... 10949 95...... 10412 Proposed Rules: 439...... 10391, 13053 1224...... 10872 210...... 10579 28 CFR Proposed Rules: Ch. 1 ...... 10066 2508...... 10872 228...... 10579 Proposed Rules: 230...... 12908 25...... 10262 52...... 9951, 46 CFR 9952, 10118, 10265, 10342, 232...... 12908 302...... 11821 11822, 12025, 12141, 12798, 502...... 9922 239...... 11118, 12908 549...... 10095 510...... 11156 240 ...... 9948, 10579, 11124, 12799, 13143, 13146 60...... 10119, 11555, 514...... 11186 12127, 12908 29 CFR 515...... 11156 270...... 12908 63...... 11555, 11560 4044...... 12745 81...... 11822, 12025 520...... 11218 274...... 12908 530...... 11186 94...... 10596 30 CFR 535...... 11236 19 CFR 97...... 10118 545...... 9922 914...... 12890 136...... 10596 133...... 11376 565...... 10395 934...... 12896 271...... 10121 Proposed Rules: Proposed Rules: 571...... 9922 24...... 13141 372...... 9957, 10597 572...... 11236 206...... 12267 435...... 10266 146...... 13142 938...... 12269 583...... 11156 42 CFR 47 CFR 20 CFR 32 CFR Proposed Rules: 73 ...... 9923, 12767, 12902, 10...... 12684 199...... 11765 409...... 12277 404...... 10103 12903 410...... 12277 90...... 10395 33 CFR 411...... 12277 21 CFR Proposed Rules: 62...... 10104 412...... 12277 26...... 11376 1...... 9960 117...... 10104 413...... 12277 50...... 10942 2...... 10266 165...... 11771, 12746 416...... 12278 101...... 12886, 12887 73 ...... 12922, 12923, 12924 320...... 11708 419...... 12277 177...... 10943 95...... 10266 326...... 11708 447...... 10412 201...... 13066, 13254 331...... 11708 457...... 10412 48 CFR 216...... 10944 488...... 12278 330...... 13254 Proposed Rules: Ch. 1...... 10530, 10552 117...... 12795, 12797 489...... 12277 1...... 10531, 10548 331...... 13254 498...... 12277 341...... 13254 167...... 12139 4...... 10531 1003...... 12277 5...... 10535 346...... 13254 34 CFR 355...... 13254 43 CFR 8...... 10535 300...... 12406 11...... 10538 358...... 13254 Proposed Rules: 369...... 13254 303...... 12406 12...... 10531, 10535 694...... 10184 428...... 12141 13...... 10538 520 ...... 10103, 10389, 13068 3400...... 12142 Proposed Rules: 14...... 10531 556...... 10103, 13068 3420...... 12142 303...... 12674 15...... 10544 558...... 13068, 13069 3800...... 9960 701...... 13254 16...... 10538 36 CFR 812...... 10942 44 CFR 19...... 10535 874...... 10947 61...... 11736 22...... 10545 61...... 13115 25...... 10548 Proposed Rules: 64...... 9919 37 CFR 26...... 10531 864...... 12774 65 ...... 11378, 11380, 11382, 1...... 12900 27...... 10531 866...... 12774 11384 31...... 10547 201...... 12902 868...... 12774 67...... 11386, 11388 32...... 10531, 10548 202...... 12902 870...... 12774 Proposed Rules: 41...... 10531 872...... 12774 67...... 11403, 11409 39 CFR 52 ...... 10531, 10535, 10538, 874...... 12774 77...... 10181 10545, 10548 876...... 12774 20...... 9915, 10219 80...... 10181 53 ...... 10548, 00913, 12862 878...... 12774 111...... 10950, 12072 81...... 10181 913...... 12862 884...... 12774 Proposed Rules: 82...... 10181 922...... 12862 886...... 12774 111...... 11402 83...... 10181 915...... 12220 888...... 12774 152...... 10181 970...... 12220, 12862 40 CFR 207...... 10181 1806...... 10571 22 CFR 52 ...... 9916, 11773, 11775, 220...... 10181 1815...... 10573 171...... 10949 12002, 12005, 12015, 12019, 221...... 10181 1819...... 10571 12085, 12087, 12256, 12257, 222...... 10181 1842...... 10573 24 CFR 12749, 12751, 12759, 13070 301...... 10181 1852...... 10571, 10573 5...... 13056 58...... 10389 303...... 10181 887...... 13056 60...... 10105, 11536 306...... 10181 49 CFR 982...... 13056 62...... 13075 308...... 10181 171...... 9923, 10742

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172...... 10742 596...... 10786 285...... 10576 17...... 12924 173...... 10742 1000±1199...... 10234 600...... 9932 285...... 10438 174...... 10742 Proposed Rules: 622...... 13120 600...... 10438, 12925 175...... 10742 192...... 12147 630...... 12903 622...... 10612, 10613 176...... 10742 350...... 11414 660...... 9932, 12092 630...... 10438 177...... 10742 571...... 9961, 10604 679 ...... 9937, 10397, 10398, 635...... 10438 178...... 10742 572...... 10965 10952, 11390, 12093, 12094, 644...... 10438 180...... 10742 12103, 12265, 12767, 12768, 648...... 11431 531...... 12090 50 CFR 13121, 13122 571...... 10786, 11724 17...... 13116 Proposed Rules: 660...... 10439, 12279 575...... 11724 216...... 9925 216...... 9965 678...... 10438

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REMINDERS Nebraska-Western Iowa; Clean Air Act: FEDERAL MARITIME The items in this list were comments due by 3-24- Interstate ozone transport COMMISSION editorially compiled as an aid 99; published 3-17-99 reductionÐ Tariffs and service contracts: to Federal Register users. AGRICULTURE Nitrogen oxides budget Carrier automated tariff Inclusion or exclusion from DEPARTMENT trading program; systems; comments due this list has no legal Food Safety and Inspection Section 126 petitions; by 3-23-99; published 3-8- significance. Service findings of significant 99 Meat and poultry inspection: contribution and GENERAL SERVICES rulemaking; comments ADMINISTRATION RULES GOING INTO Beef products contaminated due by 3-26-99; Federal Acquisition Regulation with Escherichia coli EFFECT MARCH 17, 1999 published 3-2-99 (FAR): 0157:H7; agency policy; State operating permits Cost accounting standards ENVIRONMENTAL comments due by 3-22- programsÐ post-award notification; PROTECTION AGENCY 99; published 1-19-99 comments due by 3-26- Pesticides; tolerances in food, Wyoming; comments due COMMERCE DEPARTMENT 99; published 1-25-99 animal feeds, and raw by 3-24-99; published National Oceanic and Option clause consistency; agricultural commodities: 2-22-99 Atmospheric Administration comments due by 3-23- Azoxystrobin; published 3- Wyoming; comments due 99; published 1-22-99 17-99 Fishery conservation and by 3-24-99; published management: Dicloran; published 3-17-99 2-22-99 HEALTH AND HUMAN Maneb (manganous Northeastern United States Hazardous waste program SERVICES DEPARTMENT ethylene fisheriesÐ authorizations: Food and Drug bisdithiocarbamate ) ; Atlantic salmon; Massachusetts; comments Administration published 3-17-99 comments due by 3-22- due by 3-26-99; published Human drugs: Pendimethalin; published 3- 99; published 2-5-99 2-24-99 Antibiotic drug certification; 17-99 Northeast multispecies Pesticides; tolerances in food, regulations repealed; Potato leaf roll virus and monkfish; animal feeds, and raw comments due by 3-22- resistance gene (orf1/orf2 comments due by 3-23- agricultural commodities: 99; published 1-5-99 gene); published 3-17-99 99; published 1-22-99 Fenpropathrin; comments Pharmacy compounding; Propiconazole; published 3- Northeast multispecies due by 3-22-99; published bulk drug substances that 17-99 and monkfish; 1-20-99 may be used as Tebufenozide; published 3- comments due by 3-26- Imidacloprid; comments due ingredients; list; comments 17-99 99; published 2-16-99 by 3-22-99; published 1- due by 3-23-99; published 1-7-99 Superfund program: CONSUMER PRODUCT 20-99 HEALTH AND HUMAN Radionuclide releases; SAFETY COMMISSION Propiconazole; comments administrative reporting SERVICES DEPARTMENT Flammable Fabrics Act: due by 3-22-99; published exemptions; published 3- 1-20-99 Health Care Financing Children's sleepwear (sizes 17-99 Tebufenozide; comments Administration 0-6X and 7-14); HEALTH AND HUMAN due by 3-23-99; published Medicare and Medicaid: flammability standardsÐ SERVICES DEPARTMENT 1-22-99 Home health agenciesÐ Amendments revocation; Food and Drug Superfund program: Outcome and comments due by 3-22- √2√assessment Administration National oil and hazardous 99; published 1-19-99 information set (OASIS) Animal drugs, feeds, and substances contingency data; reporting as part related products: DEFENSE DEPARTMENT planÐ Bacitracin methylene of participation Federal Acquisition Regulation National priorities list disalicylate powder; (FAR): conditions; comments update; comments due due by 3-26-99; published 3-17-99 Cost accounting standards by 3-22-99; published published 1-25-99 Lasalocid; published 3-17-99 post-award notification; 1-19-99 Monensin and Virginiamycin; Medicare program: comments due by 3-26- FARM CREDIT published 3-17-99 99; published 1-25-99 Ambulance services; ADMINISTRATION coverage and payment TRANSPORTATION Option clause consistency; DEPARTMENT Farm credit system: policies; comments due comments due by 3-23- Funding and fiscal affairs by 3-26-99; published 1- Federal Aviation 99; published 1-22-99 Administration loan policies and 25-99 Airworthiness directives: ENVIRONMENTAL operations, and funding HOUSING AND URBAN PROTECTION AGENCY Construcciones operationsÐ DEVELOPMENT Aeronauticas, S.A.; Acquisition regulations: Financial assistance to DEPARTMENT published 2-10-99 Service contracting; avoiding associations; comments Public and Indian housing: McDonnell Douglas; improper personal due by 3-22-99; Public and Indian Housing published 2-10-99 services relationships; published 2-18-99 Drug Elimination Program; TREASURY DEPARTMENT comments due by 3-22- FEDERAL formula allocation; Customs Service 99; published 1-20-99 COMMUNICATIONS comments due by 3-22- Foreign trade zones; weekly Air quality implementation COMMISSION 99; published 2-18-99 entry procedure; withdrawal; plans; approval and Radio stations; table of INTERIOR DEPARTMENT published 3-17-99 promulgation; various assignments: Fish and Wildlife Service States: Florida; comments due by Endangered and threatened COMMENTS DUE NEXT Delaware; comments due by 3-22-99; published 2-5-99 species: WEEK 3-25-99; published 2-23- Montana; comments due by Pecos pupfish; comments 99 3-22-99; published 2-5-99 due by 3-26-99; published AGRICULTURE Illinois; comments due by 3- Texas; comments due by 3- 2-24-99 DEPARTMENT 24-99; published 2-22-99 22-99; published 2-5-99 INTERIOR DEPARTMENT Agricultural Marketing Maryland; comments due by Wisconsin; comments due Minerals Management Service 3-22-99; published 2-18- by 3-22-99; published 2-8- Service Milk marketing orders: 99 99 Royalty management:

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Federal marginal properties; Ports and waterways safety: Class E airspace; comments The text of laws is not accounting and auditing Atlantic Ocean adjacent to due by 3-22-99; published published in the Federal relief; comments due by Cape Henlopen State 2-19-99 Register but may be ordered 3-22-99; published 1-21- Park, DE; safety zone; IFR altitudes; comments due in ``slip law'' (individual 99 comments due by 3-25- by 3-25-99; published 2-19- pamphlet) form from the INTERIOR DEPARTMENT 99; published 2-8-99 99 Superintendent of Documents, U.S. Government Printing Surface Mining Reclamation TRANSPORTATION TRANSPORTATION Office, Washington, DC 20402 and Enforcement Office DEPARTMENT DEPARTMENT (phone, 202±512±1808). The Surface coal mining and Administrative practice and Federal Highway text will also be made reclamation operations: procedure: Administration available on the Internet from Mining operations ownership Special services; fees and Right-of-way and environment: GPO Access at http:// and control; definitions, charges; comments due Right-of-way program www.access.gpo.gov/nara/ application and permit by 3-22-99; published 1- administration; comments index.html. Some laws may information requirements, 21-99 due by 3-24-99; published not yet be available. permit eligibility, etc.; TRANSPORTATION 12-24-98 comments due by 3-25- DEPARTMENT TREASURY DEPARTMENT .R. 882/P.L. 106±2 99; published 2-23-99 Federal Aviation NATIONAL AERONAUTICS Administration Internal Revenue Service To nullify any reservation of AND SPACE Air carrier certification and Estate and gift taxes: funds during fiscal year 1999 ADMINISTRATION operations: Prior gifts valuation; for guaranteed loans under Federal Acquisition Regulation Foreign air carrier adequate disclosure; the Consolidated Farm and (FAR): operations; security comments due by 3-22- Rural Development Act for Cost accounting standards programs; comments due 99; published 12-22-98 qualified beginning farmers or post-award notification; by 3-23-99; published 11- Income taxes: ranchers, and for other purposes (Mar. 15, 1999; 113 comments due by 3-26- 23-98 Determining earned income Stat. 5) 99; published 1-25-99 Airworthiness directives: credit eligibility; paid Option clause consistency; Airbus; comments due by 3- preparer due diligence Last List March 11, 1998 comments due by 3-23- 22-99; published 2-19-99 requirements; comments 99; published 1-22-99 Avions Pierre Robin; due by 3-22-99; published NUCLEAR REGULATORY comments due by 3-26- 12-21-98 COMMISSION 99; published 3-2-99 Intercompany obiligations; Public Laws Electronic Production and utilization Bell Helicopter Textron transfer or extinguishment Notification Service facilities; domestic licensing: Canada; comments due of rights; comments due (PENS) Electric utility industry; by 3-22-99; published 1- by 3-22-99; published 12- restructuring and 19-99 21-98 economic deregulation; British Aerospace; Retirement plans; increase potential joint ownership comments due by 3-22- in cash-out limit; PENS is a free electronic mail liability; rulemaking 99; published 2-18-99 comments due by 3-22- notification service of newly petition; comments due by Dornier; comments due by 99; published 12-21-98 enacted public laws. To 3-22-99; published 1-5-99 3-23-99; published 2-26- subscribe, send E-mail to Quality assurance programs; 99 [email protected] with LIST OF PUBLIC LAWS the text message: routine and administrative General Electric Co.; changes; comments due comments due by 3-25- This is a continuing list of subscribe PUBLAWS-L Your by 3-25-99; published 2- 99; published 2-23-99 23-99 public bills from the current Name. McDonnell Douglas; session of Congress which TRANSPORTATION comments due by 3-22- have become Federal laws. It Note: This service is strictly DEPARTMENT 99; published 1-19-99 may be used in conjunction for E-mail notification of new Coast Guard Saab; comments due by 3- with ``P L U S'' (Public Laws public laws. The text of laws Drawbridge operations: 22-99; published 2-18-99 Update Service) on 202±523± is not available through this New Jersey; comments due Schweizer Aircraft Corp.; 6641. This list is also service. PENS cannot respond by 3-22-99; published 2- comments due by 3-22- available online at http:// to specific inquiries sent to 18-99 99; published 1-19-99 www.nara.gov/fedreg. this address.

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