[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)] [Proposed Rules] [Pages 24815-24817] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-11386] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 185 and 186 [FAP 9H5587/P614; FRL-4950-6] RIN 2070-AC18 Tralomethrin; Food and Feed Additive Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA proposes to establish time-limited food and feed additive regulations for residues of the synthetic pyrethroid tralomethrin in or on the processed commodity tomato puree and the animal feed tomato pomace, wet and dry. AgrEvo USA Co. (formerly Hoechst Roussel Agri-Vet Co.) requested these regulations pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA) that would establish the maximum permissible levels for residues of the pesticide in or on the processed food commodity and animal feed. DATES: Comments, identified by the document control number [PP 9H5587/ P614], must be received on or before June 9, 1995. ADDRESSES: By mail, submit written comments to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring comments to: Rm. 1132, Crystal Mall Building #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted as a comment concerning this notice may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. All written comments will be available for public inspection in Rm. 1132 at the address given above, from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: [email protected]. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number [FAP 9H5587/P614]. No CBI should be submitted through e-mail. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found below in this document. FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product Manager (PM) 13, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. Office location and telephone number: Rm. 200, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100; e-mail: [email protected]. SUPPLEMENTARY INFORMATION: On June 13, 1989, Hoechst-Roussel Agri-Vet Co. submitted pursuant to section 409 of the FFDCA, 21 U.S.C. 348, food/feed additive petition (FAP) 9H5587 proposing to amend 40 CFR 185.5450 and 40 CFR part 186 by establishing time-limited food/feed additive regulations to permit residues of the insecticide tralomethrin, (S)-alpha-cyano-3-phenoxybenzyl (1R,3S)-2,2-dimethyl-3- [(RS)1,2,2,2-tetrabromoethyl]-cyclopropanecarboxylate, and its metabolites in or on the processed commodity tomato puree at 1.00 part per million (ppm) and the animal feed tomato pomace, wet and dry, at 1.50 ppm and 4.00 ppm, respectively. Based on information furnished by AgrEvo USA Co., an experimental use [[Page 24816]] permit (EUP) under section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 983), will be issued concurrently with the establishment of this food/feed additive regulation. The permit authorizes the use of 33 gallons of tralomethrin for 1 year in California, Florida, Georgia, New Jersey, Maryland, Ohio, Pennsylvania, and Texas for the evaluation of insect control on tomatoes. Also, a pesticide petition, 9G3774, has been submitted pursuant to section 408(d) of the FFDCA to amend 40 CFR 180.422 to establish temporary tolerances which allow a maximum permissible level for residues of tralomethrin in or on certain raw agricultural commodities (RAC's): tomato at 0.20 ppm; fat, meat, and meat byproducts of cattle, goats, hogs, horses, sheep at 0.10 ppm, 0.01 ppm, and 0.01 ppm, respectively; and milk at 0.02 ppm. The raw agricultural commodities (RAC's) regulation will be established concurrently with the food/feed additive regulation. The data submitted in support of these tolerances and other relevant material have been evaluated. The toxicological and metabolism data and analytical methods for enforcement purposes considered in support of these tolerances are discussed in detail in related documents published in the Federal Register of September 18, 1985 (50 FR 37581). In addition, mutagenicity studies were submitted and considered in support of these tolerances. Based on the studies submitted (an unscheduled DNA synthesis study in rat primary hepatocytes and a chromosome aberration study in Chinese hamster ovary cells), tralomethrin is not considered mutagenic. A dietary exposure/risk assessment was performed for tralomethrin using a Reference Dose (RfD) of 0.0075 mg/kg bwt/day, based on a no- observed-effect level (NOEL) of 0.75 mg/kg bwt/day and an uncertainty factor of 100. The NOEL was determined in a 2-year rat feeding study. The end-point effect of concern was decreased body weight. The Theoretical Maximum Residue Contribution (TMRC) from established tolerances utilizes less than 1% of the RfD for the U.S. population or 18% of the RfD if the new tolerances are granted. Established tolerances utilize 1% of the RfD for nonnursing infants less than 1- year old or 26% of the RfD if the new tolerances are granted. Established tolerances utilize less than 1% of the RfD for children (age 1 to 6 years), the subgroup with the highest estimated exposure to tralomethrin residues or 39% of the RfD if the new tolerances are granted. Generally speaking, EPA has no cause for concern if total residue contribution for published and proposed tolerances is less than the RfD. The nature of the residue in tomatoes and ruminants is adequately understood for the establishment of a time-limited tolerance. An adequate analytical method, gas-liquid chromatography, is available for enforcement purposes. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual, Vol. II (PAM II). Because of the long lead time for publication of the method in PAM II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Response and Program Resources Branch, Field Operations Divisions (7506C), Office of Pesticide Programs, Environmental Protection Agency 401 M St., Washington, DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232. There are currently no actions pending against the continued registration of this chemical. Based on the information and data considered, the Agency has determined that the time-limited tolerances established by amending 40 CFR parts 185 and 186 would protect the public health. Therefore, it is proposed that the tolerances be established as set forth below. Any person who has registered or submitted an application for registration of a pesticide, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, which contains any of the ingredients listed herein, may request within 30 days after publication of this notice in the Federal Register that this rulemaking proposal be referred to an Advisory Committee in accordance with section 409 of the FFDCA. Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the document control number, PP 9H5587/P614. All written comments filed in response to this petition will be available in the Public Response and Program Resources Branch, at the address given above from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays. A record has been established for this rulemaking under docket number [FAP 9H5587/P614] (including comments and data submitted electronically). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The public record is located in Rm. 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: opp-D[email protected]. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in the ADDRESSES section above in this document. Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of this Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that [[Page 24817]] regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Parts 185 and 186 Environmental protection, Administrative practice and procedure, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 28, 1995. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR parts 185 and 186 be amended as follows: PART 185--[AMENDED] 1. In part 185: a. The authority citation for part 185 continues to read as follows: Authority: 21 U.S.C. 346a and 348. b. By revising Sec. 185.5450, to read as follows: Sec. 185.5450 Tralomethrin. (a) A time-limited food additive regulation is established for the combined residues of the insecticide tralomethrin ((S)-alpha-cyano-3- phenoxybenzyl-(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]- cyclopropanecarboxylate; CAS Reg. No. 66841-25-6) and its metabolites (S)-alpha-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2- dimethylcyclopropanecarboxylate and (S)-alpha-cyano-3- phenoxybenzyl(1S,3R)-3-(2,2-dibromovinly)-2,2- dimethylcyclopropanecarboxylate calculated as the parent in or on the following food commodities when present as a result of application of the insecticide to the growing crops: ------------------------------------------------------------------------ Parts per Expiration Commodity million date ------------------------------------------------------------------------ Cottonseed oil................................ 0.20 Nov. 15, 1997. ------------------------------------------------------------------------ (b) A time-limited food additive regulation is established permitting residues of the pesticide tralomethrin ((S)-alpha-cyano-3- phenoxybenzyl-(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]- cyclopropanecarboxylate; CAS Reg. No. 66841-25-6) and its metabolites (S)-alpha-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2- dimethylcyclopropanecarboxylate and (S)-alpha-cyano-3- phenoxybenzyl(1S,3R)-3-(2,2-dibromovinly)-2,2- dimethylcyclopropanecarboxylate calculated as the parent in or on the following food commodity resulting from application of the insecticide to tomatoes in accordance with an experimental program (34147-EUP-2). The conditions set forth in this section shall be met. ------------------------------------------------------------------------ Parts Commodity per Expiration date million ------------------------------------------------------------------------ Tomato puree................................ 1.00 June 1, 1997. ------------------------------------------------------------------------ (1) Residues in the food not in excess of the established tolerance resulting from the use described in paragraph (b) of this section remaining after expiration of the experimental program will not be considered to be actionable if the insecticide is applied during the term of and in accordance with the provisions of the experimental use program and feed additive regulation. (2) The company concerned shall immediately notify the Environmental Protection Agency of any findings from the experimental use that have a bearing on safety. The firm shall also keep records of production, distribution, and performance, and on request make the records available to any authorized officer or employee of the Environmental Protection Agency or the Food and Drug Administration. PART 186--[AMENDED] 1. The authority citation for part 186 continues to read as follows: Authority: 21 U.S.C. 348. 2. By adding new Sec. 186.5450, to read as follows: Sec. 186.5450 Tralomethrin. (a) A time-limited feed additive regulation is established permitting residues of tralomethrin ((S)-alpha-cyano-3-phenoxybenzyl- (1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]- cyclopropanecarboxylate; CAS Reg. No. 66841-25-6) and its metabolites (S)-alpha-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2- dimethylcyclopropanecarboxylate and (S)-alpha-cyano-3- phenoxybenzyl(1S,3R)-3-(2,2-dibromovinly)-2,2- dimethylcyclopropanecarboxylate calculated as the parent in or on the following feed resulting from application of the insecticide to tomatoes in accordance with an experimental program (34147-EUP-2). The conditions set forth in this section shall be met. ------------------------------------------------------------------------ Parts Feed per Expiration date million ------------------------------------------------------------------------ Tomato pomace, wet.......................... 1.50 June 1, 1997. Tomato pomace, dry.......................... 4.00 June 1, 1997. ------------------------------------------------------------------------ (b) Residues in the feed not in excess of the established tolerance resulting from the use described in paragraph (a) of this section remaining after expiration of the experimental program will not be considered to be actionable if the insecticide is applied during the term of and in accordance with the provisions of the experimental use program and feed additive regulation. (c) The company concerned shall immediately notify the Environmental Protection Agency of any findings from the experimental use that have a bearing on safety. The firm shall also keep records of production, distribution, and performance, and on request make the records available to any authorized officer or employee of the Environmental Protection Agency or the Food and Drug Administration. [FR Doc. 95-11386 Filed 5-9-95; 8:45 am] BILLING CODE 6560-50-F